Connection of intravascular intervention elements to elongated steering members

Abstract

A device for intravascular intervention can include an intervention element, an elongate manipulation member having a retention portion, and a coupling element. The elongate element can include a distally located attachment portion. The intervention element includes a proximal portion having a bore therethrough, the attachment portion of the elongate member extending through the bore at a bend such that a first segment and a second segment of the elongate member each extend proximally from the bore. The retention portion includes an arm extending proximally of the bore and a shoulder projecting radially outward from a proximal portion of the arm. The coupling element circumferentially surrounds at least a portion of the retention portion and at least a portion of the first segment and the second segment of the elongate member such that a proximal end of the coupling element is positioned distally from the shoulder of the retention portion.

Description

Technical Field

[0001] The present invention generally relates to apparatus and methods for connecting intravascular interventional elements to elongated manipulation components. Background Technology

[0002] Various procedures can be performed by manipulating an endovascular interventional element connected to a manipulator (e.g., a lead or hypotube). In some cases, the interventional element can be manipulated by a physician from an external location using the manipulator. Therefore, the manipulator can be extended from an external location to a treatment site within the body. The manipulator can be extended from an external location to the treatment site via a catheter. Endovascular interventional elements can be connected to the manipulator in various ways. Summary of the Invention

[0003] For example, the present invention is illustrated by various aspects described below. For convenience, various examples of the aspects of the present invention are described as numbered clauses (1, 2, 3, etc.). These clauses are provided as examples but do not limit the present invention. It should be noted that any dependent clauses may be combined in any combination and placed in the corresponding independent clauses. Other clauses may be presented in a similar manner.

[0004] Clause 1. A device for endovascular intervention, the device comprising:

[0005] An elongated actuating component includes a distal attachment portion comprising a first segment, a second segment, and a bend between the first segment and the second segment;

[0006] Interventional element, comprising:

[0007] The proximal portion includes a hole therethrough, the attachment portion of the elongated member extending through the hole at the bend, such that the first segment and the second segment each extend proximally from the hole; and

[0008] A retaining portion comprising an arm extending proximally toward the aperture and a shoulder projecting radially outward from the proximally portion of the arm; and

[0009] A connecting element is configured to circumferentially surround at least a portion of the retaining portion and at least a portion of the first and second segments of the elongated member, such that the proximal end of the connecting element is positioned away from the shoulder of the retaining portion.

[0010] Clause 2. The device according to any one of the clauses herein, wherein the arm is a first arm and the shoulder is a first shoulder, and the retaining portion further comprises:

[0011] A second arm extending proximal to the hole; and

[0012] A second shoulder protrudes radially outward from the proximal portion of the second arm.

[0013] The connecting element is configured to circumferentially surround at least a portion of the retaining portion, such that the proximal end of the connecting element is positioned away from the second shoulder of the retaining portion.

[0014] Clause 3. The device according to any one of the clauses herein further includes a longitudinal axis intersecting the aperture, wherein the first arm extends away from the longitudinal axis in a first direction, and wherein the second arm extends away from the longitudinal axis in a second direction opposite to the first direction.

[0015] Clause 4. The device according to any one of the clauses herein further includes a third shoulder that projects radially outward from the first arm at a location remote from the first shoulder; and a fourth shoulder that projects radially outward from the second arm at a location remote from the second shoulder.

[0016] Clause 5. The device according to any one of the clauses herein, wherein the third shoulder and the fourth shoulder are configured to engage the distal end of the coupling element.

[0017] Clause 6. The device according to any one of the clauses herein, wherein the shoulder comprises a substantially planar distal surface and an angled proximal surface, the distal surface being configured to engage the proximal end of the coupling element.

[0018] Clause 7. The device according to any one of the clauses herein, wherein the connecting element comprises a cylindrical belt.

[0019] Clause 8. The device according to any one of the clauses herein, wherein each of the first and second segments of the elongated member extends toward the proximal side of the band.

[0020] Clause 9. The apparatus according to any one of the clauses herein, wherein the arm is radially outwardly biased, and wherein the coupling element is configured to hold the arm in a displaced state.

[0021] Clause 10. The device according to any one of the clauses herein, wherein the shoulder protrudes laterally to an amount greater than or equal to the wall thickness of the connecting element as measured from the arm.

[0022] Clause 11. The apparatus according to any one of the clauses herein, wherein:

[0023] The proximal portion of the interventional element has a top side and a bottom side;

[0024] The hole extends through the proximal portion between the top side and the bottom side;

[0025] At least one of the first or second segments of the elongated member has an extension that extends into (i) the area between the top and bottom sides of the proximal portion and (ii) the area between the shoulder and the hole of the retaining portion.

[0026] Clause 12. A device for endovascular intervention, the device comprising:

[0027] A band with an internal cavity;

[0028] An elongated actuating member having an attachment portion located distally, the actuating member extending through the cavity; and

[0029] Interventional element, comprising:

[0030] The proximal portion includes a hole therethrough, through which the attachment portion of the elongated member extends; and

[0031] Multiple protrusions extend proximally to the hole and through the cavity, at least one of the protrusions including a flange that extends laterally away from the longitudinal axis of the device and is configured to engage the band.

[0032] Clause 13. The device according to any one of the clauses herein, wherein the flange is configured to abut a proximal portion of the strip.

[0033] Clause 14. The device according to any one of the clauses herein, wherein the at least one protrusion includes a proximal-facing surface opposite the flange, the proximal-facing surface being inclined in the proximal direction toward the central longitudinal axis of the device.

[0034] Clause 15. The device according to any one of the clauses herein, wherein the plurality of protrusions are offset laterally outward from the central longitudinal axis of the device.

[0035] Clause 16. The device according to any one of the clauses herein, wherein the flange restricts the movement of the intervention element relative to the distal side of the band.

[0036] Clause 17. A device for endovascular intervention, the device comprising:

[0037] A slender operating component, which includes an attachment portion located on the distal side;

[0038] Interventional element, comprising:

[0039] The proximal portion includes a hole therethrough, through which the attachment portion of the elongated member extends; and

[0040] A plurality of arms extending proximal to the aperture and laterally outward from the longitudinal axis of the device, each arm having a protrusion having a proximal-facing surface and a distal-facing surface; and

[0041] A connecting element that circumferentially surrounds the arm, such that each of the distally facing surfaces of the protrusions adjoins the proximally facing engagement surface of the connecting element.

[0042] Clause 18. The apparatus according to any one of the clauses herein, wherein the distally facing engagement surface of the coupling element comprises the proximal end face of the coupling element.

[0043] Clause 19. The device according to any one of the clauses herein, wherein the distal surface of the protrusion is laterally inwardly inclined in the proximal direction.

[0044] Clause 20. The device according to any one of the clauses herein, wherein a portion of the elongated manipulating member extends laterally between the arms.

[0045] Clause 21. A device for endovascular intervention, the device comprising:

[0046] An elongated actuating component includes a distal attachment portion comprising a first segment, a second segment, and a bend between the first segment and the second segment;

[0047] Interventional element, comprising:

[0048] The proximal portion includes a hole therethrough, the attachment portion of the elongated member extending through the hole at the bend, such that the first segment and the second segment each extend proximally from the hole; and

[0049] Multiple protrusions extending proximally from the proximal portion, each of the protrusions having a first end and a second end at the proximal portion, wherein—

[0050] At least one of the protrusions includes a flange extending radially outward from the longitudinal axis of the device; and,

[0051] Each of the protrusions has (a) a first configuration in which the second end is separated from the longitudinal axis of the device by a first radial distance, and (b) a second configuration in which the second end is separated from the longitudinal axis of the device by a second radial distance less than the first radial distance, wherein the first radial distance and the second radial distance are measured as dimensions generally orthogonal to the longitudinal axis of the device.

[0052] A connecting element having an inner cavity therethrough, wherein the first segment and the second segment are located within the inner cavity, and the protrusion is located within the inner cavity such that the protrusion presents the second configuration.

[0053] Clause 22. The device according to any one of the clauses herein, wherein the flange abuts the surface of the connecting element.

[0054] Clause 23. The device according to any one of the clauses herein, wherein the flange prevents the coupling element from translating proximally and / or distally relative to the flange.

[0055] Clause 24. The apparatus according to any one of the clauses herein, wherein the connecting element prevents the first segment and the second segment from translating proximally and / or distally relative to the aperture.

[0056] Clause 25. The device according to any one of the clauses herein, wherein the proximal portion has a top side and a bottom side, wherein the first segment is on the top side and the second segment is on the bottom side, and in the second configuration, the protrusion is located between the first segment and the second segment, and the plurality of protrusions provide rigidity for the attachment portion of the elongated actuating member.

[0057] Clause 26. A device for endovascular intervention, the device comprising:

[0058] An elongated actuating component includes a distal attachment portion comprising a first segment, a second segment, and a bend between the first segment and the second segment;

[0059] Interventional element, comprising:

[0060] The proximal portion includes a hole therethrough, the attachment portion of the elongated member extending through the hole at the bend, such that the first segment and the second segment each extend proximally from the hole; and

[0061] Multiple protrusions extending proximally from the proximal portion and radially outward from the longitudinal axis of the device; and

[0062] A connecting element having an inner cavity therethrough, wherein the connecting element is positioned circumferentially around the protrusion such that the protrusion applies a force to the connecting element to prevent the connecting element from translating relative to the elongated actuating member.

[0063] Further features and advantages of the present invention are described below, and will be apparent in part from the description, or may be learned by practicing the present invention. The advantages of the present invention will be realized and obtained through the structures specifically pointed out in the written description and its claims and drawings. Attached Figure Description

[0064] Many aspects of the invention can be better understood by referring to the following accompanying drawings. The components in the drawings are not necessarily to scale; rather, the focus is on clearly illustrating the principles of this disclosure.

[0065] Figure 1A This is a schematic diagram of an example device for intravascular intervention according to some embodiments.

[0066] Figure 1B yes Figure 1A An enlarged perspective view of the connection between the manipulator and the intervention element.

[0067] Figure 2 This is a schematic side view of the attachment portion of the operating component according to some embodiments.

[0068] Figure 3A This is a plan view of the intervention element in an unfolded configuration according to some embodiments.

[0069] Figure 3B yes Figure 3A An enlarged view of the proximal portion of the interventional element shown.

[0070] Figure 4A This is a schematic top view of the connection between the operating component and the intervention element according to some embodiments.

[0071] Figure 4B yes Figure 4A A schematic side view of the connector shown.

[0072] Figure 4C yes Figure 4A and 4B The schematic side view of the connector shown has the connecting elements omitted for clarity.

[0073] Figure 5 An enlarged view of the proximal portion of the interventional element according to some embodiments is shown.

[0074] Figure 6A This is a schematic top view of the connection between the operating component and the intervention element according to some embodiments.

[0075] Figure 6B yes Figure 6A A schematic side view of the connector shown.

[0076] Figures 7 to 11 Is using Figure 1A A schematic diagram of the steps of an exemplary intravascular procedure performed by a device for intravascular intervention to restore blood flow in an obstructed blood vessel. Detailed Implementation

[0077] I. Example of an intravascular interventional device

[0078] In the following detailed description, specific details are set forth to provide an understanding of the subject matter. However, it will be apparent to those skilled in the art that the subject matter can be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the subject matter.

[0079] This invention provides apparatus, systems, and methods for removing clot material from the lumen of blood vessels. Although numerous embodiments are described below with respect to apparatus, systems, and methods for treating cerebral embolism or intracranial embolism, other applications and embodiments besides those described herein are also within the scope of this invention. For example, the treatment systems and methods of this invention can be used to remove emboli from cavities other than blood vessels (e.g., the digestive tract, etc.) and / or can be used to remove emboli from blood vessels outside the brain (e.g., blood vessels in the lungs, abdomen, cervix, or chest, or peripheral blood vessels including those in the legs or arms, etc.). Additionally, the treatment systems and methods of this invention can be used to remove cavities obstructing the lumen other than clot material (e.g., plaque, excised tissue, foreign bodies, etc.).

[0080] Figure 1A This is a schematic diagram of an example medical device 100 for intravascular intervention according to some embodiments. Figure 1A The illustrated device 100 includes an interventional element 102 and an actuating component 104 connected at a connector 106. The device 100 is shown extending from the distal end of a catheter 108.

[0081] Interventional element 102 may include elements for performing endovascular interventions, such as stent-like devices or other types of interventional elements. Interventional element 102 may include devices configured for various purposes, such as aneurysm bridging or treatment of ischemic stroke. In various embodiments, interventional element 102 may take any number of forms, such as removal devices, thrombectomy devices, or other suitable medical devices. For example, in some embodiments, interventional element 102 may be a stent and / or a stent thrombectomy device, such as Medtronic's Solitaire. TM Blood flow reconstruction devices, Stryker neurovascular intervention ProVue TMA thrombectomy device, or other suitable means. In some embodiments, the interventional element 102 may be a coiled thread, textile, and / or braid formed of a plurality of braided filaments. Examples of suitable interventional elements 102 include any one of those disclosed in U.S. Patent No. 7,300,458, filed November 5, 2007; U.S. Patent No. 8,940,003, filed November 22, 2010; U.S. Patent No. 9,039,749, filed October 1, 2010; and U.S. Patent No. 8,066,757, filed December 28, 2010, each of which is incorporated herein by reference in its entirety.

[0082] The manipulator 104 can be any suitable elongated component configured to advance the interventional element 102 into a treatment site within a blood vessel. For example, the manipulator 104 can be or include a lead, tube (e.g., a hypotube), coil, or any combination thereof. The manipulator 104 may have a length sufficient to extend from a location outside the patient's body through the vascular system to the treatment site within the patient's body. In some embodiments, the manipulator 104 may be integral or formed of multiple interconnected segments. In some embodiments, the manipulator 104 may include a laser-cut hypotube having a helical cut pattern (or other pattern of cut gaps) formed in its sidewalls along at least a portion of its length. The manipulator 104 may comprise or be composed of a nickel-titanium alloy, stainless steel, or other metals or alloys, or any polymer suitable for in vivo use. In embodiments comprising multiple interconnected segments, the segments may be the same or different materials. For example, some or all of the manipulator 104 may be formed of stainless steel or other suitable materials known to those skilled in the art. Nickel-titanium alloys are preferred for resistance to kinking and reduction of imaging artifacts.

[0083] The catheter 108 can be configured to enter relatively distal locations in the patient, including, for example, the middle cerebral artery (MCA), internal carotid artery (ICA), circle of blood at the base of the brain, and tissue sites further distal than the MCA, ICA, and circle of blood at the base of the brain. The MCA and other vascular systems or other relatively distal tissue sites in the brain (e.g., relative to the point of vascular entry) may be relatively difficult to reach with a catheter, at least in part due to the tortuous path (e.g., involving relatively sharp twists or turns) through the vascular system to reach these tissue sites. Thus, the catheter can be structurally configured to be relatively flexible, maneuverable, and relatively kink-resistant and bend-resistant, such that the catheter resists bending when a thrust is applied to a relatively proximal portion of the catheter to advance it distally through the vascular system, and resists kinking when traversing the vascular system by sharp turns. In some instances, the catheter 108 is configured to substantially conform to the curvature of the vascular system. In addition, in some instances, catheter 108 has column strength and flexibility that allows at least the distal portion of the catheter to navigate from the femoral artery, through the patient's aorta, and into the patient's intracranial vascular system, for example, to reach a relatively distant treatment site.

[0084] Although primarily described as being for accessing relatively distal vascular system sites, catheter 108 can also be configured for other target tissue sites. For example, catheter 108 can be used to access tissue sites throughout the coronary arteries and surrounding vascular system, the gastrointestinal tract, urethra, ureter, fallopian tubes, veins, and other body cavities.

[0085] According to some embodiments, the catheter 108 may be formed as a generally tubular component extending along and around a central axis. According to some embodiments, the microcatheter 108 may typically be configured to follow and enter cerebral blood vessels associated with the brain on a conventional guidewire in the neck anatomy, and may also be selected according to several standard designs commonly available. Thus, the catheter 108 may have a length of at least 125 cm, and more specifically, a length between about 125 cm and about 175 cm. In some embodiments, the catheter may have an inner lumen diameter of less than about 0.03", such as about 0.017", 0.021", or 0.027". Other designs and sizes are contemplated.

[0086] During advancement, interventional element 102 can be removably placed within catheter 108 in a low-profile or restricted configuration. Once catheter 108 is positioned such that its distal end is adjacent to the treatment site (e.g., the site of a blood clot within a blood vessel), interventional element 102 can be released from catheter 108 (e.g., retracted proximally via catheter 108) and interventional element 102 can be released to its swollen state.

[0087] According to some embodiments, the body of the catheter 108 may be made of various thermoplastics, such as polytetrafluoroethylene (PTFE) or... Materials such as fluorinated ethylene propylene (FEP), high-density polyethylene (HDPE), and polyether ether ketone (PEEK) can be used, and the inner or adjacent surfaces of the conduit can optionally be lined with a hydrophilic material, such as polyvinylpyrrolidone (PVP) or some other plastic coating. Furthermore, any surface can be coated with various combinations of different materials, depending on the desired result.

[0088] The interventional element 102 and the actuating member 104 may be substantially permanently attached together at the connector 106. That is, the interventional element 102 and the actuating member 104 may be attached together in a manner that prevents the interventional element and the actuating member from unintentionally separating from each other under the intended conditions of use of the device 100. In some embodiments, the device 100 may include a portion located proximal or distal to the connector 106 configured to selectively separate the interventional element 102 from the actuating member 104. For example, this portion may include an electrolytically separable segment of the actuating member. In some embodiments, the device 100 may not have any features that allow selective separation of the interventional element 102 from the actuating member 104. As described in more detail elsewhere herein, in some embodiments, the connector 106 may provide a mechanical interlock between the interventional element 102 and the actuating member 104.

[0089] Figure 1B An enlarged perspective view of the connector 106 between the manipulation member 104 and the intervention element 102 according to some embodiments is shown. Figure 2 A schematic top view of the attachment portion 110 of the control component 104 is shown. Figure 3A A plan view of the interventional element 102, including the proximal portion 112, is shown, and Figure 3B An enlarged detail view of the proximal portion 112 of the interventional element 102 is shown. Figure 4A and 4B A schematic top view and a side view are shown of the connector 106 between the operating component 104 and the intervention element 102 (including the connecting element 114). Figure 4C A schematic side view of connector 106 is shown, with connecting element 114 omitted for clarity.

[0090] Let's refer to each other. Figures 1A to 4CThe connector 106 may include an attachment portion 110 of the actuating member 104. The attachment portion 110 may extend through a hole 136 disposed in the proximal portion 112 of the interventional element 102. A coupling element 114 (e.g., a band, cannula, collar, clip, coil, or other suitable structure) may at least partially circumferentially surround at least a portion of the proximal portion 112 of the interventional element 102. A plurality of engaging members 142 disposed on the retaining portion 138 of the interventional element 102 may be positioned proximal to the coupling element 114 and configured to engage the coupling element 114 to retain the interventional element 102 relative to the actuating member 104, as described in more detail herein.

[0091] The connector 106 may be sized to fit through a catheter (e.g., catheter 108) to a treatment location within a patient. In some embodiments, the connector 106 may be sized to fit through a microcatheter adapted for delivery into a neurovascular system. For example, the microcatheter may have an inner diameter of about 0.027 inches or less, about 0.021 inches or less, or about 0.017 inches or less.

[0092] In some embodiments, the actuating member 104 may taper gradually from proximal to distal, for example, having a larger diameter at the proximal end than at the distal end. The actuating member 104 may taper continuously or at intervals or discrete locations along its entire length, or at all intervals. Any taper portion of the actuating member 104 may taper at a constant rate or at a variable rate per unit length. The attachment portion 110 may taper from approximately 0.0065 inches in diameter just near the connector 106 to approximately 0.0045 inches at the end and actuating member 104. In some embodiments, the actuating member 104 may have a diameter of approximately 0.007 inches along the attachment portion 110.

[0093] like Figure 2 As best shown, the attachment portion 110 may include a first segment 130, a second segment 132, and a bend 134 between the first and second segments. In some embodiments, the attachment portion 110 may be formed as a hook or U-shaped element. One or both of the first segment 130 and the second segment 132 may be substantially straight or curved. In some embodiments, the first segment 130 and the second segment 132 may be generally parallel to each other away from the bend 134. As shown, the distal end of the actuating member 104 may be located proximal to the bend 134 in the device actuating member 104. In some embodiments, the attachment portion 110 may include a bend of approximately 180°.

[0094] In some embodiments, the actuating member 104 may have a nominal diameter of 0.0055 inches at the bend 134 of the attachment portion 110. In some embodiments, the actuating member 104 has a circular cross-section before bending and an oval cross-section after bending. In some embodiments, the bend 134 may have a radius less than twice the maximum cross-sectional dimension (e.g., diameter) of the actuating member 104 in the bend. In some embodiments, the bend 134 may have a radius less than the maximum cross-sectional dimension (e.g., diameter) of the actuating member 104 in the bend. In some embodiments, the radius of the bend may vary throughout the bend.

[0095] The attachment portion 110 may have a maximum lateral dimension, measured in a direction perpendicular to the longitudinal axis of the device 100, extending in a proximal-distal direction. In some embodiments, the maximum lateral dimension is less than 0.027 inches, less than 0.021 inches, or less than 0.015 inches. In some embodiments, the maximum lateral dimension is less than 0.07 mm, less than 0.05 mm, or less than 0.04 mm. In some embodiments, the maximum lateral dimension is less than four times the maximum cross-sectional dimension (e.g., diameter) of the actuating member 104 along the attachment portion 110. In some embodiments, the maximum lateral dimension is less than 0.07 mm, less than 0.05 mm, or less than 0.04 mm. In some embodiments, the maximum lateral dimension is less than three times the maximum cross-sectional dimension (e.g., diameter) of the actuating member 104 along the attachment portion 110.

[0096] Figure 3A This is a plan view of the intervening element 102, depicting both unfolded and flat configurations for ease of understanding. Figure 3B This is an enlarged detail view of the proximal portion 112 of the interventional element 102. The proximal portion 112 may be formed of any of the following materials: nickel-titanium alloy, stainless steel, or other materials suitable for introduction into the body for endovascular intervention. The proximal portion 112 may be configured such that the attachment portion 110 of the manipulating member 104 may extend around a portion of the proximal portion 112. For example, the proximal portion 112 may include an opening 136 therethrough, such as a hole, slot, window, or orifice.

[0097] Figure 3B The size and shape of the opening 136 shown allow the bend 134 of the attachment portion 110 to extend through it. For example, the opening 136 may be slightly larger than the cross-section of the attachment portion 110 extending through the hole. The opening 136 may be, for example, oval. The hole or groove may be located near the proximal end of the intervention element 102.

[0098] The proximal portion 112 of the intervention element 102 may include a retaining portion 138 positioned proximal to the opening 136. The retaining portion 138 may include one or more protrusions or arms 140 extending proximal to the opening 136. In some embodiments, each arm 140 may include an engaging member 142, such as a protrusion, flange, ridge, ridge, shoulder, barb, or other suitable structural feature. In some embodiments, the engaging member 142 extends radially or laterally outward away from the arm 140 and / or away from the central longitudinal axis of the device 100. The engaging member 142 may be positioned at the proximal portion of its arm 140 (e.g., at or near the proximal end). In some embodiments, the engaging member 142 may be positioned at other locations relative to the arm 140. In some embodiments, the proximal portion 112 of the intervention element 102 (including the retaining portion 138) may have a substantially constant thickness, such as the thickness produced by cutting the intervention element 102 from, for example, a tube or sheet of material. In other embodiments, the thickness of the proximal portion 112 may vary in its length, width, or both.

[0099] Arms 140 may optionally be configured such that the lateral or radial distance between their outer edges is slightly greater than the inner diameter or internal width of the connecting element 114. In such embodiments, when the connecting element 114 is in place on the arm, the arm 140 retains residual spring tension or outward preload or bias. This is because the connecting element 114 prevents the arms from moving laterally outward to their rest or unbiased positions. The resulting residual tension increases the stability of the connection and holds the connecting element in place on the arm 140.

[0100] In the illustrated embodiment, the retaining portion 138 includes two arms 140 arranged symmetrically with respect to a central longitudinal axis 144 and laterally spaced apart from each other to define a region 146. In various embodiments, the number of arms 140 can vary. For example, the retaining portion 138 may include a single arm 140, or three, four, five, six, or more arms 140. Similarly, only some arms 140 may include engaging members 142, or all arms 140 may include engaging members 142.

[0101] The engaging member 142 of the retaining portion 138 may each include a distally facing surface 148 and a proximally facing surface 150. In some embodiments, the distally facing surface 148 forms a shoulder, a flat surface, a flange, or other suitable engaging surface, configured to abut or otherwise engage with the corresponding engaging surface of the connecting element 114. For example, such as Figure 4AAs shown, the distal surface 148 may be positioned adjacent to the proximal end face 152 of the connecting element 114. In some embodiments, the distal surface 148 may extend radially outward away from the arm 140, for example, laterally to a degree greater than the wall thickness of the connecting element 114 as measured from the arm 140. In some embodiments, the distal surface 148 forms an oblique angle with the longitudinal axis of the device 100, for example, substantially orthogonal to the longitudinal axis of the device 100.

[0102] In some embodiments, the proximal surface 150 of the engaging member 142 may be inclined, for example, radially inward in the proximal direction. In this orientation, the engaging member 142 can be easily slidably engaged with the connecting element 114 to achieve mechanical interlocking. For example, with the actuating member 104 positioned such that the attachment portion 110 extends through the hole 136 in the intervention element 102, the connecting element 114 may initially be positioned proximal to the intervention element 102, wherein the actuating member 104 extends through the cavity of the connecting element 114. When the connecting element is slidably advanced in the distal direction, the distal end face 154 of the connecting element may contact the proximal surface 150 of the engaging member 142. Due to the inclined surface of the proximal surface 150, the engaging member 142 and the arm 140 can be radially inwardly pushed into a flexed or bow-shaped configuration. In this state, the combined lateral dimension of the engaging member 142 may be smaller than the cavity diameter of the connecting element 114, such that the connecting element 114 can be slidably advanced on the engaging member 142 in the distal direction. Once the proximal surface 152 of the connecting element 114 has moved distally beyond the distally facing surface 148 of the engaging member 142, the engaging member 142 can be at least partially released from the radially constrained state (e.g., the arm 140 can move radially outward) to achieve Figure 4A The interlocking configuration shown is such that, once in this interlocking configuration, the distal movement of the intervening element 102 is restricted by the engagement between the distally facing surface 148 and the connecting element 114.

[0103] In some embodiments, the arms 140 may be configured such that they are not located below the attachment portion 110 of the actuating member 104 in the device 100. For example, the arms 140 do not extend into the region 146. In some embodiments, when the attachment portion 110 of the actuating member 104 engages with the proximal portion 112 of the intervention element 102, one or both of the first segment 130 and the second segment 132 of the attachment portion 110 may extend into the space 146 located between the arms 140 of the retaining portion 138.

[0104] In some embodiments, the retaining portion 138 may have a length sufficient to allow or facilitate the deformation of a portion of the manipulating member 104 into the region 146. In some embodiments, when the interventional element 102 is positioned within the cerebrovascular system and the retaining portion 138 extends through the access catheter, the retaining portion 138 may extend proximally a distance sufficient to allow manipulation of the retaining portion 138. In some embodiments, the retaining portion 138 may extend proximally indefinitely.

[0105] Figure 5 Another embodiment of the retaining portion 138 of the intervention element 102 is illustrated. Figure 6A and 6B The use of each is illustrated separately. Figure 5 Top and side views of the connector 106 of the retaining portion 138 are shown. In the illustrated embodiment, in addition to... Figures 4A to 4C In addition to the proximal engagement member 142 in the illustrated embodiment, the retaining portion 138 also includes a distal engagement member 156. For example... Figure 5 As shown, each arm 140 may include a distal engagement member 156, which may take the form of a shoulder, barb, ridge, bulge, protrusion, or other suitable structural feature configured to engage the connecting element 114. In the illustrated embodiment, each distal engagement member 156 includes a proximal surface 158 and a distal surface 160. The proximal surface 158 may take the form of a flange, shoulder, or other engagement surface configured to abut the distal end face 154 of the connecting element 114. The distal surface 160 may be inclined, for example, radially inwardly inclined in the distal direction. In other embodiments, the distal surface 160 may have other shapes or configurations. In operation, the proximal surface 158 may abut the connecting element 114 to limit distal movement of the intervention element 102 relative to the connecting element 114.

[0106] As described above, in some embodiments, the connector 106 may include a connecting element 114 in the form of a tape, loop, coil, etc. For example, an annular tape may hold the attachment portion 110 against the retaining portion 138 and / or otherwise hold portions 110, 138 in an interlocking relationship. Additionally or alternatively, the tape may be used as a radiopaque marker. In some embodiments, the tape may prevent separation of the attachment portion 110 from the retaining portion 138. In some embodiments, the tape may slide or curl onto one or both of the attachment portion 110 and the retaining portion 138. In some embodiments, the tape may slide or curl onto each of the attachment portion 110 and the retaining portion 138. In embodiments where the tape is used as a radiopaque marker, in cases where accidental separation of the actuating member 104 from the intervening element 102 is unlikely, sliding or curling the tape directly onto the retaining portion 138 may retain the marker tape on the retaining portion 138.

[0107] The connecting element 114 may surround all or part of the length of the attachment portion 110, the retaining portion 138, or both in the device 100. In some embodiments, the connecting element 114 does not extend over at least a portion of the proximal portion 112 of the intervening element 102. For example, in some embodiments, the connecting element 114 does not surround a portion of the surrounding opening 136 of the proximal portion 112.

[0108] The connecting element 114 may be a circumferentially continuous sleeve. Alternatively, the connecting element 114 may be circumferentially discontinuous and may have lateral edges that overlap when the belt is attached at the connector 106. In some embodiments, in addition to or instead of the connecting element 114, a clip may be used that only partially surrounds all or a portion of the length of the attachment portion 110, the retaining portion 138, or both in the device 100. In some embodiments, the connecting element completely or substantially surrounds at least a portion of the attachment portion 110 and a section of the retaining portion 138.

[0109] In embodiments where the connecting element serves as a marker, the connecting element may be formed of a radiopaque material, such as platinum or platinum alloys, including platinum-iridium. In some embodiments, the connecting element may be formed of a non-radiopaque material.

[0110] In some embodiments, the coupling element 114 may have a maximum cross-sectional (lateral) dimension of 0.027 inches or less, 0.021 inches or less, or 0.015 inches or less. The coupling element 114 may have a cross-sectional dimension that inhibits or prevents distal movement of the coupling element on the proximal portion 112 of the intervening element 102. For example, the cross-sectional dimension may be a diameter (inner or outer diameter) smaller than the width of the proximal portion 112.

[0111] In some embodiments, in addition to or instead of the straps in some embodiments, the connector 106 may comprise an adhesive. The adhesive may reinforce the connector 106 between the intervention element 102 and the actuating member 104, and / or prevent separation of the attachment portion 110 from the retaining portion 138. The adhesive may bond to each of the attachment portion 110 and the retaining portion 138. The adhesive may include adhesives, solders, fluxes, brazing fluxes, etc. In some embodiments, the adhesive may bond to the attachment portion 110 in the retaining portion 138 without applying heat. For example, the adhesive may comprise a UV-curing adhesive. In embodiments comprising a polymer coating of a wire or polymer tube, an adhesive that avoids applying heat that could damage the polymer may be preferred.

[0112] In some embodiments, the adhesive may cover the bend 134 of the attachment portion 110, the proximal end of the connector 106, or both. In embodiments comprising a tape and adhesive, the adhesive may fill all or part of the internal volume of the tape, in addition to or alternatively covering one or both ends of the connector 106. By covering one or both ends of the connector 106, the adhesive may form a rounded, non-invasive end face that covers any relatively sharp ends of the assembly forming the connector 106. In some embodiments, the actuating member 104 tapers at its intersection with the adhesive. In the event of a breakage of the actuating member 104, the tapering of the wire at its intersection with the adhesive may concentrate stress at the intersection to promote breakage at the intersection, thereby retaining the connecting element 114 on the intervention element 102. In embodiments where the tape is used as a marker, retention of the tape on the intervention element may be desirable.

[0113] In some embodiments, the actuating member 104 may be attached to the interventional element 102 at the connector 106 via the process described below and variations thereof. The attachment portion 110 of the actuating member 104 may be positioned around a portion of the proximal portion 112 of the interventional element 102. For example, the distal portion of the actuating member 104 may extend through the opening 136. The attachment portion 110 of the actuating member 104 may extend through the opening 136 at the bend 134, such that the first segment 130 and the second segment 132 are on different sides of the proximal portion 112 of the interventional element 102. In some embodiments, the distal end of the actuating member 104 may be located proximal to the bend 134. In some embodiments, the actuating member 104 may be bent to interlock with the proximal portion 112 of the interventional element 102.

[0114] In some embodiments where the actuating component 104 comprises multiple components, the components of the actuating component may be assembled together before the actuating component is attached to the interventional element 102. For example, in some embodiments, the wire, coil, and one or more tubes may be assembled together before a portion of the wire passes through the opening 136 in the proximal portion 112 of the interventional element 102, before the wire is bent, or both.

[0115] The actuating member 104 can be bent in one or more stages between an initial straight configuration and a final configuration in the complete device 100. For example, the actuating member 104 can be bent an initial amount before any portion of the actuating member 104 passes through the opening 136, and then bend further thereafter. Before any portion of it passes through the opening 136, the actuating member 104 can initially be bent from a straight configuration by 10° to 170°, 45° to 160°, 90° to 145°, or 125° to 135°. After a segment of the actuating member 104 has passed through the opening 136, the actuating member 104 can be bent further to accommodate the connecting element 114 (if present). In some embodiments, the actuating member 104 can be finally bent to between 150° and 210°, between 160° and 200°, or between 170° and 190°. Preferably, the final bend 134 is substantially free of surface cracks.

[0116] If the connecting element 114 cannot be positioned above the attachment portion 110 without further deflection of the actuating member 104, the actuating member 104 may be bent or further bent to accommodate the connecting element 114. In some embodiments, the connecting element 114 may be positioned above the actuating member 104 or the intervention element 102 before coupling the actuating member and the intervention element. The connecting element 114 may be positioned around all or a portion of the attachment portion 110 and all or a portion of the retaining portion 138 by means of the moving band and the proximal or distal direction. In some embodiments, the connecting element 114 moves on the actuating member 104 in the distal direction, and as the connecting element 114 advances onto the attachment portion 110, the distal end of the wire may be deflected to enter the interior of the connecting element 114. Then, as the connecting element 114 is further advanced distally, and optionally, the actuating member 104 may be further bent while the distal end of the actuating member 104 remains stationary.

[0117] In embodiments incorporating adhesive, after a section of the actuating member has been positioned around the proximal portion 112, adhesive (not shown) can be applied to the attachment portion 110 of the actuating member 104 and the retaining portion 138 of the intervention element 102. If the connector 106 comprises a tape and adhesive, the adhesive can be applied to the connector 106 before or after attaching the tape. If the distal end of the actuating member 104 extends proximally beyond the proximal end of the tape, the actuating member 104 can be trimmed such that the distal end of the wire is substantially flush with the proximal end of the tape before the adhesive is applied.

[0118] While some embodiments include both tape and adhesive, some embodiments include tape without adhesive, and some embodiments include adhesive without tape. In some embodiments, both tape and adhesive may be omitted. For example, in some embodiments, the actuating member 104 and the interventional element 102 may be integrally formed. In another example, the actuating member 104, formed separately from the interventional element 102, may be attached to the interventional element without using tape or adhesive.

[0119] Various methods can be used to bend the actuating member 104 before attachment to the interventional element 102. For example, the actuating member 104 may be bent around a fixed mandrel. However, bending the lead around a fixed mandrel may produce inconsistent results and may damage the lead by introducing surface cracks that reduce the tensile strength of the actuating member 104. Similarly, manual bending of the lead may also produce inconsistent results and may damage the actuating member 104 by introducing significant surface cracks. As another example, the bent portion in the actuating member 104 may be heat-set. However, heat-setting may take longer than other bending methods and may adversely affect other portions of the actuating member 104. For example, if the actuating member comprises a tube containing a polymer or other heat-sensitive material, heat-setting may damage those portions of the actuating member 104. These and other methods can be used to bend the actuating member 104 comprising stainless steel, nickel-titanium alloy, or other metals.

[0120] During endovascular intervention using device 100, connector 106 can substantially permanently couple interventional element 102 and manipulator 104. For example, connector 106 can couple interventional element manipulator during insertion of the interventional element into a blood vessel (e.g., a cerebral vessel) using the manipulator, manipulation of the interventional element to perform treatment within the blood vessel, and removal of the interventional element from the blood vessel using the manipulator. In some embodiments, device 100 can be inserted via a microcatheter. In some embodiments, the interventional element can be removed from the blood vessel by pulling the manipulator 104 proximally, for example, retracting the interventional element into the microcatheter. In some embodiments, the interventional element can be deployed by maintaining its position while retracting the microcatheter from above the interventional element.

[0121] II. Example usage method

[0122] refer to Figures 7 to 11The device 100, including the manipulator 104 and the interventional element 102, can be used as a flow restoration device. For example, the interventional element may include a self-expanding component for restoring blood flow to a medical patient experiencing ischemic stroke due to large intracranial vascular occlusion. In a preferred arrangement, the device 100 can be used in conjunction with a microcatheter 108. The device 100 can remove thrombi from highly tortuous, small, and thin-walled vessels. The device 100 can be used to treat vessels with diameters ranging from, for example, 2.0 mm to 5.5 mm, such as the internal carotid artery, the M1 and M2 segments of the middle cerebral artery, the anterior cerebral artery, the basilar artery, and the vertebral artery, but can also treat other ranges, sizes, and specific types of vessels.

[0123] During flow restoration, a balloon-guided catheter (not shown) can be moved toward the treatment area via the vascular system. A balloon located distal to the balloon-guided catheter can inflate against the wall of vessel 176. A microcatheter 108 can be delivered first through the balloon-guided catheter. An interventional element 102 can then be delivered through the microcatheter 108. Alternatively, the interventional element 102 can be delivered together with the microcatheter 108. The interventional element 102 can be in a reduced-volume form within the microcatheter 108. The microcatheter 108 can be advanced through vessel 176 and placed near the thrombus 178. The interventional element 102 can be positioned such that a connector 106 is upstream of the thrombus 178, the distal end of the interventional element is downstream of the thrombus, and a portion of the interventional element 102 is located radially adjacent to the thrombus 178. Figure 8 In the preferred arrangement shown, the microcatheter 108 may be placed side-by-side with the thrombus 178 such that the distal tip 180 of the microcatheter 108 extends beyond the thrombus 178, wherein the distal tip 180 extends beyond the thrombus 178 by more than about 0 mm to about 10 mm or more, or about 3 mm to about 5 mm, but other ranges and values ​​are also possible. In the preferred arrangement, the interventional element 102 may be positioned such that portions of the interventional element 102 extend proximally and distally to the thrombus 178.

[0124] like Figure 9 As shown, the interventional element 102 can be held in a fixed position by keeping the manipulating member 104 stationary while the microcatheter 108 is withdrawn (i.e., pulled proximally). When the microcatheter is withdrawn, the interventional element 102 can be released from its reduced-volume form and can expand. At least a portion of the interventional element 102 can be presented in its unconstrained form, thereby expanding to allow at least a portion of the interventional element 102 to penetrate and contact the thrombus 178. If adjustment of the position of the interventional element 102 is required, the manipulating member 104 and / or the microcatheter 108 can be moved together or separately, and if necessary, the interventional element 102 can be returned to the microcatheter and then expanded or re-deployed.

[0125] Once deployed, as described above, the interventional element 102 can apply an outward radial force to the thrombus 178, thereby reducing the cross-sectional area of ​​the thrombus 178, forming a channel for immediately re-establishing at least a portion of the blood flow through the thrombus 178 through the vessel 176, and / or loosening the thrombus from the vessel wall. In some embodiments, for example, after the interventional element 102 is deployed, about 10% to about 60% of the circumference of the original thrombus 178 can be separated from the vessel wall, and the ability of the thrombus 178 to adhere to the vessel wall via adhesion and friction can be correspondingly reduced. In some embodiments, the cross-sectional area of ​​the thrombus 178 can be significantly reduced by the deployed interventional element 102, resulting in the thrombus 178 having about 30% to about 95% of its original cross-sectional area, but more typically about 50% to about 80% of its original cross-sectional area. In some embodiments, an effective amount of a blood clot-dissolving drug, such as tissue plasminogen activator (tPA), can be further applied to the site of the thrombus 178 during the blood flow restoration process to enhance the dissolution of the thrombus 178. In some embodiments, the open channel created by the interventional element 102 can increase the exposed surface area of ​​the thrombus 178, thereby facilitating faster dissolution of the thrombus 178 with such blood clot-dissolving drugs.

[0126] refer to Figure 10 and 11 Once the interventional element 102 has engaged and captured the thrombus 178, the thrombus 178 can be removed. The microcatheter 108 can be manipulated before the retraction manipulator 104 is pulled back. For example, the microcatheter 108 can be moved forward relative to the interventional element 102 to a predetermined point. Marking along the microcatheter 108 and / or the interventional element 102 can be used to determine the relative positions of the microcatheter 108 and the interventional element 102. For example, the microcatheter 108 can be moved distally until it covers the connecting element 114. The microcatheter 108 and the interventional element 102 can then be removed together.

[0127] refer to Figure 11During retrieval of device 100 and thrombus 178, the initial channel created for the restoration of flow through or across thrombus 178 can remain open. The balloon can be kept inflated to provide maximum proximal flow control. For example, in some embodiments, the balloon can ensure no flow from the balloon through the vessel proximal to interventional element 102. As part of the retrieval process, continuous aspiration can be performed through the balloon guiding catheter with forceful suction as interventional element 102 approaches the distal tip of the balloon guiding catheter. Aspiration assistance enables backflow through interventional element 102 and thrombus 178. Backflow aspiration can help allow continued perfusion of the distal vascular system through the vessel during the retrieval process and can suppress the possibility of distal embolism. If a thrombolytic drug is provided, allowing blood to flow through the self-expanding device 102 and thrombus 178 has the advantage of the possibility of spontaneous blood dissolution and increased surface area for the thrombolytic drug. Backflow aspiration can also facilitate the thrombus recovery process by helping to remove thrombus 178. Due to aspiration, flow can be directed into the lumen of the balloon guiding catheter. The interventional element 102 and the thrombus 178 can thus be aided by the flow entering the lumen of the balloon guiding catheter. In some embodiments, if it is difficult to withdraw into the balloon guiding catheter during aspiration for any reason, the balloon can be deflated, and the balloon guiding catheter, microcatheter 108, and device 100 can be withdrawn simultaneously as a unit while maintaining aspiration.

[0128] In some embodiments, device 100 can be used as a device for use as an implantable component (e.g., a stent). For example, the manipulator 104 and interventional element 102 coupled at connector 106 can be delivered via microcatheter 108 to a treatment site such as a stenosis or aneurysm. Similar to the method described above, the microcatheter can be withdrawn, and interventional element 102 can expand against the vessel wall. Similar to its use as a flow restoration device, interventional element 102 can be repositioned if necessary if it is not correctly positioned on the first attempt. Once interventional element 102 is in the desired position at the treatment site, interventional element 102 can be detached from manipulator 104 and used as an implantable component.

[0129] III. in conclusion

[0130] This disclosure is not intended to be exhaustive or to limit the invention to the precise forms disclosed herein. While specific embodiments have been disclosed herein for illustrative purposes, various equivalent modifications are possible without departing from the invention, as will be recognized by those skilled in the art. In some instances, well-known structures and functions have not been shown and / or described in detail to avoid unnecessarily obscuring the description of embodiments of the invention. Although steps of a method may be presented in a particular order herein, in alternative embodiments, the steps may have another suitable order. Similarly, in other embodiments, certain aspects of the invention disclosed in the context of a particular embodiment may be combined or omitted. Furthermore, while advantages associated with certain embodiments have been disclosed in the context of those embodiments, other embodiments may also exhibit these advantages, and not all embodiments are required to exhibit such advantages or other advantages disclosed herein to fall within the scope of the invention. Therefore, this disclosure and associated techniques may cover other embodiments not explicitly shown and / or described herein.

[0131] Throughout this disclosure, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” include plural referents. Similarly, unless the word “or” is explicitly limited to meaning only a single item other than those in a list having two or more items, its use in such a list should be interpreted as including any single item in list (a), all items in list (b), or any combination of items in list (c). Furthermore, the terms “comprising,” etc., throughout this disclosure are used to mean including at least one or more of the listed features, such that no further number of one or more of the same features and / or one or more features of another type are excluded. Directional terms such as “up,” “down,” “front,” “back,” “vertical,” and “horizontal” may be used herein to express and clarify relationships between various elements. It should be understood that such terms do not indicate absolute orientation. References herein to “an embodiment,” “embodiment,” or similar expressions mean that a particular feature, structure, operation, or characteristic described in connection with an embodiment may be included in at least one embodiment of the inventive technique. Therefore, the appearance of such phrases or expressions herein does not necessarily refer to the same embodiment. Furthermore, specific features, structures, operations, or characteristics can be combined in one or more embodiments in any suitable manner.

Claims

1. A device for endovascular intervention, the device comprising: An elongated actuating component includes a distal attachment portion comprising a first segment, a second segment, and a bend between the first segment and the second segment; Interventional element, comprising: The proximal portion includes a hole therethrough, and the attachment portion of the actuating member extends through the hole at the bend, such that the first segment and the second segment each extend proximally from the hole; as well as The retaining portion includes a first arm extending proximally to the hole and a first shoulder projecting radially outward from a proximally portion of the first arm, and a second arm extending proximally to the hole and a second shoulder projecting radially outward from a proximally portion of the second arm. as well as A connecting element is configured to circumferentially surround at least a portion of the retaining portion and at least a portion of the first and second segments of the elongated actuating member, such that the proximal end of the connecting element is located distal to the first and second shoulders of the retaining portion. The first arm and the second arm are laterally offset outward from the central longitudinal axis of the device, and when the connecting element is in place on the arm, the first arm and the second arm maintain residual spring tension or outward preload or offset.

2. The apparatus of claim 1, further comprising: a third shoulder projecting radially outward from the first arm at a position distal to the first shoulder; and a fourth shoulder projecting radially outward from the second arm at a position distal to the second shoulder.

3. The apparatus of claim 2, wherein the third shoulder and the fourth shoulder are configured to engage the distal end of the coupling element.

4. The device of claim 1, wherein the first shoulder and the second shoulder comprise a substantially planar distal surface and an angled proximal surface, the distal surface being configured to engage the proximal end of the coupling element.

5. The apparatus of claim 1, wherein the connecting element comprises a cylindrical strip.

6. The device of claim 5, wherein each of the first and second segments of the elongated actuating member extends proximally toward the belt.

7. The apparatus of claim 1, wherein the first arm and the second arm are radially outwardly biased, and wherein the connecting element is configured to hold the first arm and the second arm in a displaced state.

8. The apparatus of claim 1, wherein the first shoulder and the second shoulder protrude laterally to an amount greater than or equal to the wall thickness of the connecting element as measured from the first arm and the second arm, respectively.

9. The apparatus according to claim 1, wherein: The proximal portion of the interventional element has a top side and a bottom side; The hole extends through the proximal portion between the top side and the bottom side; At least one of the first or second segments of the elongated manipulator has an extension that extends to (i) between the top and bottom sides of the proximal portion and (ii) in the region between the first and second shoulders of the retaining portion and the hole.

10. A device for endovascular intervention, the device comprising: A band with an internal cavity; An elongated actuating member having an attachment portion located on the distal side, the elongated actuating member extending through the cavity; as well as Interventional element, comprising: The proximal portion includes a hole therethrough, through which the attachment portion of the elongated actuating member extends; as well as A plurality of protrusions extend proximally toward the orifice and through the cavity, at least one of the plurality of protrusions including a flange extending laterally away from the longitudinal axis of the device and configured to engage the band, wherein the flange restricts movement of the intervention element relative to the distal side of the band, and wherein the plurality of protrusions are laterally outwardly biased from the central longitudinal axis of the device, and wherein the plurality of protrusions maintain residual spring tension or outward preload or bias when the band is in place on the protrusions.

11. The apparatus of claim 10, wherein the flange is configured to abut against a proximal portion of the band.

12. The device of claim 10, wherein the at least one protrusion includes a proximal-facing surface opposite the flange, the proximal-facing surface being inclined in the proximal direction toward the central longitudinal axis of the device.

13. A device for endovascular intervention, the device comprising: A slender operating component, which includes an attachment portion located on the distal side; Interventional element, comprising: The proximal portion includes a hole therethrough, through which the attachment portion of the elongated actuating member extends; as well as Multiple arms extend proximal to the aperture and laterally outward from the central longitudinal axis of the device, each of the multiple arms having a protrusion having a proximal surface and a distal surface; as well as A connecting element circumferentially surrounds the arm such that each of the distally facing surfaces of the protrusion abuts against the proximally facing engagement surface of the connecting element. When the connecting element is in place on the arm, the plurality of arms maintain residual spring tension or outward preload or bias.

14. The apparatus of claim 13, wherein the proximal engagement surface of the coupling element comprises the proximal end face of the coupling element.

15. The device of claim 13, wherein the distal surface of the protrusion is laterally inwardly inclined in the proximal direction.

16. The device of claim 13, wherein a portion of the elongated manipulator extends laterally between the arms.

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