Embolization device delivery system

Abstract

The present disclosure relates to an embolic device delivery system. In some examples, a distal portion of an elongated body is configured to mate with a distal portion of an interface member mechanically coupled to an embolic device. The embolic device is additionally attached to the elongated body. The elongated body distal portion and the interface member proximal portion can collectively define a protrusion and a recess configured to receive the protrusion to provide the mating. The elongated body, the interface member, and the embolic device can be configured for delivery to a target site in a vasculature, and manipulation of the deployed embolic device can be facilitated by the mating between the elongated body and the interface member.

Description

Technical Field

[0001] This disclosure relates to an embolization device. Background Technology

[0002] Implantable embolic devices can be used for embolization, such as blocking a vascular site. Possible clinical applications include controlling bleeding in cases of major hemorrhage, reducing blood flow to tumors, and treating a variety of conditions, including lesions of the brain, heart, and peripheral vascular system. In other examples, implantable embolic devices can be used to treat aneurysms, vascular malformations, arteriovenous fistulas, pelvic congestion syndrome, and varicocele. Implantable embolic devices can be configured to fill vascular sites within a patient's body, thereby reducing blood flow, promoting clotting, and ultimately blocking the vessel. Summary of the Invention

[0003] Generally, this disclosure describes a system including an embolization device and a delivery device configured to deliver the embolization device to a target site within a patient's vascular system. The delivery device includes an elongated body configured to engage with an interface member mechanically connected to a proximal portion of the embolization device. During delivery of the embolization device to the target site, the embolization device is attached to the elongated body. The elongated body is configured to transmit actuating force to the embolization device, for example, to deploy the embolization device from a delivery catheter. The interface member is configured to engage with the elongated body when the embolization device is attached and to transmit actuating force from the elongated body to the embolization device. For example, the interface member or the elongated body may define a protrusion, and another of the interface member or the elongated body may define a recess configured to receive the protrusion. The engaging configuration of the interface member and the elongated body allows for better maneuverability of the embolization device compared to, for example, if the interface member and the elongated body only engage with each other along flat surfaces orthogonal to the longitudinal axis of the elongated body.

[0004] In some examples, the maximum cross-sectional dimension of the embolization device (when the embolization device is in its delivery configuration) is larger than, for example, the maximum cross-sectional dimension of the elongated body at its distal portion. The maximum cross-sectional dimension can be, for example, the diameter. The interface member can be configured to provide a transition of the maximum cross-sectional dimension between the elongated body and the embolization device to help minimize any adverse effects that the difference in the maximum cross-sectional dimension between the elongated body and the embolization device might have on the effective transmission of motive force from the elongated body to the embolization device.

[0005] This disclosure also describes example methods for using the system.

[0006] Clause 1: In some examples, the system includes: an elongated body comprising a proximal portion and a distal portion, the proximal portion having a first maximum cross-sectional dimension; an interface member comprising a proximal portion and a distal portion; and an embolization device configured to extend from a delivery configuration to a deployment configuration. In the delivery configuration, the embolization device includes a proximal portion having a second maximum cross-sectional dimension greater than the first maximum cross-sectional dimension. The proximal portion is mechanically connected to the interface member. When the embolization device is attached to the elongated body, the proximal portion of the interface member is configured to mate with the distal portion of the elongated body, the third maximum cross-sectional dimension of the interface member being greater than the first maximum cross-sectional dimension.

[0007] Clause 2: In some examples of the systems in Clause 1, the elongated body includes a metal thiopanel tube.

[0008] Clause 3: In some examples of systems in Clause 1 or 2, the minimum cross-sectional dimension of the interface member is less than the second maximum cross-sectional dimension of the proximal portion of the embolization device.

[0009] Clause 4: In some examples of systems in any of Clauses 1-3, the proximal portion of the device is mechanically connected to the distal portion of the interface member.

[0010] Clause 5: In some examples of systems in any of Clauses 1-4, the interface component tapers in the proximal direction.

[0011] Clause 6: In some examples of the systems of any of Clauses 1-5, the interface member tapers from a distal portion to a proximal portion, the maximum cross-sectional dimension of the distal portion being substantially equal to the second maximum cross-sectional dimension of the embolization device, and the cross-sectional dimension of the proximal portion being less than the second maximum cross-sectional dimension of the embolization device.

[0012] Clause 7: In some examples of the systems of any of Clauses 1-6, a proximal portion of the interface member or a distal portion of the elongated body defines a protrusion, and another proximal portion of the interface member or a distal portion of the elongated body defines a recess configured to receive the protrusion.

[0013] Clause 8: In some examples of the system in Clause 7, when the proximal portion of the interface member mates with the distal portion of the elongated body, the protrusion and the recess engage frictionally, and the recess may translate over the protrusion.

[0014] Clause 9: In some examples of the systems in Clause 7 or 8, the protrusion has at least one shape selected from the group consisting of: truncated cone, hemispherical and conical.

[0015] Clause 10: In some examples of systems in any of Clauses 1–9, the interface component includes a tapered coil.

[0016] Clause 11: In some examples of the systems in any of Clauses 1-10, the tapered coil defines a constant taper.

[0017] Clause 12: In some examples of the systems in any of Clauses 1-11, the tapered coil defines a stepped taper.

[0018] Clause 13: In some examples of the system of Clause 12, the tapered coil comprises an inner layer formed by a first segment of a wound elongated structure and an outer layer formed by a second segment of a wound elongated structure partially wound around the inner layer.

[0019] Clause 14: In some examples of the systems of any of Clauses 1-13, the interface component includes multiple coils with different diameters.

[0020] Clause 15: In some examples of the system of Clause 14, a plurality of coils include a first coil having a first diameter and a second coil having a second diameter greater than the first diameter, the first coil being partially arranged inside the second coil to define a stepped taper of the interface member.

[0021] Clause 16: In some examples of the systems of any of Clauses 1-15, an elongated body defines a first inner lumen and an interface member defines a second inner lumen, the second inner lumen being configured to align with the first inner lumen when a proximal portion of the interface member mates with a distal portion of the elongated body.

[0022] Clause 17: In some examples of the systems in Clause 16, the embolization device is attached to the elongated body by a connecting member extending through a first inner lumen and a second inner lumen, wherein the connecting member is removably attached to the elongated body.

[0023] Clause 18: In some examples of the systems of any of Clauses 1-17, the interface component comprises at least one of platinum, nickel-titanium, or stainless steel.

[0024] Clause 19: In some examples of the systems in any of Clauses 1-18, the plug device is welded to the interface member.

[0025] Clause 20: In some examples of the systems of any of Clauses 1-19, the embolization device defines a proximal opening, and the distal portion of the interface member is configured to be received in the proximal opening to mechanically connect the proximal portion of the device and the distal portion of the interface member.

[0026] Clause 21: In some examples of the systems of any of Clauses 1-20, the system further includes a delivery conduit defining a lumen, wherein an elongated body, an interface member, and an embolization device are configured to be received within the lumen.

[0027] Clause 22: In some examples of the systems in Clause 21, the embolization device is configured to extend radially outward when deployed from the lumen.

[0028] Clause 23: In some examples of systems in Clause 22 or 23, an elongated body is configured to transmit actuating force to an embolization device for deployment of the embolization device from the lumen.

[0029] Clause 24: In some examples, the system includes: an elongated body comprising a proximal portion and a distal portion; an interface member comprising a proximal portion and a distal portion; and an embolization device comprising a proximal portion mechanically connected to the distal portion of the interface member. One of the proximal portion of the interface member or the distal portion of the elongated body defines a protrusion, while the other defines a recess configured to receive the protrusion. When the embolization device is attached to the elongated body, the proximal portion of the interface member is configured to mate with the distal portion of the elongated body, wherein, when the proximal portion of the interface member mates with the distal portion of the elongated body, the recess receives the protrusion, a nominal contact area is defined between the protrusion and the recess, and the recess is translatable in three dimensions on the protrusion. The elongated body is configured to transmit force to the embolization device through a portion of the nominal contact area and through the interface member.

[0030] Clause 25: In some examples of the system of Clause 24, an elongated body defines a first inner lumen and an interface member defines a second inner lumen, the second inner lumen being configured to align with the first inner lumen when a proximal portion of the interface member mates with a distal portion of the elongated body, and wherein the embolizing device is attached to the elongated body by a connecting member extending through the first and second inner lumens.

[0031] Clause 26: In some examples of systems in Clause 24 or 25, the proximal portion of the device is mechanically connected to the distal portion of the interface component.

[0032] Clause 27: In some examples of the systems of any one of Clauses 24-26, the protrusion has at least one shape selected from the group consisting of truncated conical, hemispherical and conical shapes.

[0033] Clause 28: In some examples of the systems of any of Clauses 24-27, the recess includes a concave surface surrounding the insertion volume, and at least some portions of the protrusion are inserted into the insertion volume when the proximal portion of the interface member mates with the distal portion of the elongated body.

[0034] Clause 29: In some examples of the systems of any of Clauses 24-28, the embolization device defines a proximal opening, and the distal portion of the interface member is configured to be received in the proximal opening to mechanically connect the proximal portion of the device and the distal portion of the interface member.

[0035] Clause 30: In some examples of systems in any of Clauses 24-29, the system includes a delivery conduit defining a lumen, wherein an elongated body, an interface member, and an embolization device are configured to be received within the lumen, wherein the elongated body is configured to transmit actuating force to the embolization device to deploy the embolization device from the lumen.

[0036] Clause 31: In some examples, a method includes introducing an embolization device system into a patient's vascular system, wherein the embolization device system includes: an elongated body including a proximal portion and a distal portion, the proximal portion having a first maximum cross-sectional dimension; an interface member including a proximal portion and a distal portion; and an embolization device configured to extend from a delivery configuration to a deployment configuration. In the delivery configuration, the embolization device includes a proximal portion having a second maximum cross-sectional dimension greater than the first maximum cross-sectional dimension, wherein the proximal portion is mechanically connected to the interface member, and wherein the proximal portion of the interface member is configured to mate with the distal portion of the elongated body when the embolization device is attached to the elongated body. A third maximum cross-sectional dimension of the interface member is greater than the first maximum cross-sectional dimension. The method further includes deploying the embolization device at a target site within the vascular system.

[0037] Clause 32: In some examples of the methods in Clause 31, introducing an embolization device system into a vascular system includes introducing the embolization device system into a vascular system via a delivery catheter.

[0038] Clause 33: In some examples of the methods in Clause 31 or 32, deployment of an embolization device at a target site within a vascular system includes deploying the embolization device from a delivery catheter by applying a pushing force at least to the proximal portion of the elongated body.

[0039] Clause 34: In some examples of the methods in any of Clauses 31-33, the method further includes separating the elongated body from the embolization device and withdrawing the elongated body from the vascular system.

[0040] Details of one or more examples are set forth in the accompanying drawings and the following description. Other features, objects, and advantages will be apparent from the specification, the drawings, and the claims. Attached Figure Description

[0041] Figure 1 This is a conceptual plan view illustrating an exemplary system including an exemplary embolization device and an exemplary delivery device.

[0042] Figure 2 It shows including Figure 1 A conceptual plan view of an exemplary delivery assembly, including an embolization device, a delivery device, and a delivery conduit.

[0043] Figure 3 It shows the inside of the human body Figure 2 A conceptual plan view of an exemplary delivery component.

[0044] Figure 4 It is the patient's vascular system and the target site located within the vascular system. Figure 2 A cross-sectional schematic diagram of an exemplary delivery component.

[0045] Figure 5 It is a conceptual cross-sectional view of the patient's vascular system and shows the embolization device deployed at the target site.

[0046] Figure 6 This is a plan view including a cross-sectional view of an exemplary system including an exemplary embolization device and an exemplary delivery device.

[0047] Figure 7 This is a perspective view showing exemplary recesses and protrusions.

[0048] Figure 8 It is a plan view including a cross-sectional view illustrating the construction of an exemplary system including an exemplary embolization device and an exemplary delivery device.

[0049] Figure 9A It is a plan view including cross-sectional views, which shows an exemplary embolization device and an exemplary delivery device.

[0050] Figure 9B It is possible to be with Figure 9A An isometric view of an exemplary interface component used in conjunction with a plugging device and a delivery device.

[0051] Figure 10A It is a plan view including a sectional view, which shows an exemplary embolization device and an exemplary delivery device.

[0052] Figure 10B Is with Figure 10A An isometric view of an exemplary interface component used in conjunction with a plugging device and a delivery device.

[0053] Figure 11A It is a plan view including a sectional view, which shows an exemplary embolization device and an exemplary delivery device.

[0054] Figure 11B Is with Figure 11A An isometric view of an exemplary interface component used in conjunction with a plugging device and a delivery device.

[0055] Figure 12A It is a plan view including a sectional view, which shows an exemplary embolization device and an exemplary delivery device.

[0056] Figure 12B Is with Figure 12A An isometric view of an exemplary interface component used in conjunction with a plugging device and a delivery device.

[0057] Figure 13 This is a flowchart illustrating example methods using the example system. Detailed Implementation

[0058] The example medical system (“System”) described herein includes an embolization device mechanically connected to an interface member and further attached to an elongated body. The elongated body may be, for example, a delivery device or part of a delivery device. The interface member is generally located between a distal portion of the elongated body and a proximal portion of the embolization device. In some aspects, the proximal portion of the interface member is configured to engage with the distal portion of the elongated body using, for example, a protrusion-recess structure, wherein the recess is translatable over the protrusion. Additionally, the embolization device is attached to the elongated body during delivery of the embolization device to a target site within the patient’s vascular system.

[0059] The translatably mating arrangement between the elongated body and the interface component, and the individual attachment between the elongated body and the embolic device, allow the system to be configured such that the narrower elongated body can provide force to the wider embolic device in all directions, the embolic device being held attached to the elongated body by the individual attachment. In this way, the system delivers the embolic device via, for example, a delivery catheter, and improves the maneuverability of the embolic device using the elongated body once it has been deployed from the catheter to the target site within the patient. In some examples, the elongated body includes a positioning element (e.g., a pushing member) configured to advance and withdraw the embolic device distally through and from the lumen of the delivery catheter, and in some cases, the positioning element is configured to retract the embolic device proximally into the lumen of the delivery catheter.

[0060] In some examples, the elongated body has a maximum cross-sectional dimension (e.g., diameter), while the embolization device has a maximum cross-sectional dimension (e.g., diameter) larger than the maximum cross-sectional dimension of the elongated body. The interface member can be configured to provide a transition of the maximum cross-sectional dimension between the elongated body and the embolization device to help minimize the negative impact that the difference in maximum cross-sectional dimensions between the elongated body and the embolization device might have on the effective transmission of driving force from the elongated body to the embolization device. For example, the embolization device can be designed to radially extend from the delivery configuration to the deployment configuration once released from the boundary of the delivery catheter. When the embolization device is in the deployment configuration, the mating between the distal portion of the elongated body and the proximal portion of the interface member provides the ability to more effectively position the embolization device at the target site within the patient's vascular system using the smaller-sized elongated body before full deployment of the embolization device by terminating the dissociation attachment between the embolization device and the elongated body.

[0061] To achieve mating between the interface member and the elongated body, a proximal portion of the interface member (“interface member proximal portion”) or a distal portion of the elongated body (“elongated body distal portion”) may define a protrusion, while another portion of the interface member proximal portion or the elongated body distal portion defines a recess configured to receive the protrusion. The protrusion may have various shapes, including but not limited to: a truncated cone shape, a hemispherical shape, a conical shape, or any shape suitable for reception by the recess. In some aspects, the protrusion and recess engage frictionally during mating, and the recess may translate over the protrusion. This allows manipulation of the elongated body to adjust the configuration of the mating connection and to transmit forces to the embolization device in various directions. Additionally, the mating of the elongated body and the interface member may define a nominal contact area between the protrusion and the recess, through which the elongated body provides force to the interface member and the embolization device.

[0062] Any suitable technique can be used to attach the embolization device and the elongated body. In some examples, flexible or rigid connecting members provide simultaneous attachment of the embolization device to the elongated body. Before attachment to the embolization device, the connecting member may extend through a first inner lumen of the elongated body and through a second inner lumen of the interface member. Alternatively, the connecting member may be attached to an internal component of the embolization device located within the lumen of the embolization device to minimize potential interference to the embolization device as the elongated body steers the embolization device and causes longitudinal and radial displacement of the connecting member. The manner in which the connecting member is attached allows clinicians to easily terminate the attachment between the elongated body and the embolization device once the embolization device is positioned within the patient's target site.

[0063] The system described herein can be advanced, along with a delivery catheter, to a target location (also referred to herein as the target site) within a patient's vascular system. For example, the system can be configured to slidably translate within the lumen of a positioned delivery catheter in response to a pushing force provided by a clinician via the elongated body. As described in further detail below, the mating connection between the elongated body and the interface member, operating simultaneously with the attachment between the elongated body and the embolization device, allows for effective control of the embolization device, whose maximum cross-sectional dimension is larger than that of the elongated body, and can improve the operability of the embolization device after deployment from the delivery catheter to the target site.

[0064] Figure 1 An example system 10 is shown, comprising an elongated body 12 including a proximal portion 14 and a distal portion 16. System 10 also includes an interface member 18 engaging the distal portion 16 and a plugging device 22 engaging the interface member 18. System 10 can be applied in a component 60, which may include an actuator 56, such as... Figure 2 As shown. Clinicians can use actuator 56 to manipulate embolization device 22 relative to delivery catheter (e.g., Figure 3 The longitudinal position of the catheter 44 shown.

[0065] Any suitable technique can be used to introduce and navigate the system 10 through the patient's vascular system to the target site within the vascular system. In some examples, the clinician can use a guiding tube 50 (e.g., a catheter) to position the catheter 44 within the patient's vascular system, such as... Figure 3 As shown. For example, a clinician can introduce the guiding catheter 50 into the patient's vascular system, for example by means of a guidewire, through an entry point such as the groin, and guide the distal end 52 of the guiding catheter 50 through the vascular system until it reaches the proximal side of the target site 54. The clinician can then introduce a catheter 44 into the guiding catheter 50 and advance the catheter 44 through the guiding catheter 50 until the distal end 48 of the catheter 44 exits the distal end 52 of the guiding catheter 50 and is positioned near the target site 54.

[0066] Clinicians can deliver the embolization device 22 to the target site 54 by inserting the embolization device 22, the interface member 18 and the elongated body 12 into the catheter 44 and using the pushing force applied to the proximal portion 14 of the elongated body to advance the elongated body 12, the interface member 18 and the embolization device 22 toward the distal end 48 of the catheter 44. Figure 4 and 5 This exemplary mode of implant delivery is illustrated. The embolization device 22 can be sized differently depending on its surroundings. This can include: a first size as the embolization device 22 is delivered through the catheter 44 when the embolization device 22 is in a delivery configuration within the lumen of the catheter 44; and a second size once the embolization device 22 is deployed at the target site 54 and in a deployment configuration (e.g., ...). Figure 5 (As shown). In some examples, the embolization device 22 is configured to extend from the delivery configuration to the deployment configuration in response to release from the catheter 44. (As shown) Figure 5 As shown, in its deployment configuration, the embolization device 22 can be configured to fill a target site of a blood vessel, thereby reducing blood flow, promoting clotting, and ultimately blocking the vessel. The embolization device 22 may include, for example, coils, such as, but not limited to, frame or anchoring coils and / or filler coils.

[0067] Embolization devices have been used in this manner to treat massive hemorrhage, aneurysms, and a wide variety of vascular lesions, including malignancies, vascular malformations, arteriovenous fistulas, pelvic congestion syndrome, and varicocele. In some cases, a relatively large amount of embolic material is required to achieve the desired therapeutic effect. For example, a total of 4–5 meters of coil may be used to embolize an aneurysm measuring 2–3 cm. The delivery system described herein, including the elongated body 12 and the interface member 18, can facilitate the efficient delivery of relatively large-sized embolization devices, which can provide more efficient medical procedures because the larger size of the embolization device reduces the total number of embolization devices required to achieve the same packing density in a given procedure.

[0068] Delivering a relatively large embolic device to the target site 54 can present several challenges. For example, delivery of some embolic devices may be achieved using a delivery device with a relatively small diameter at the distal end (e.g., compared to the delivery catheter 44 and / or the relatively large embolic device) to maintain the desired softness and flexibility for guiding the delivery device through the patient's vasculature. For larger embolic devices, this creates a gap in size, for example, the gap between the diameter of the delivery device and the diameter of the embolic device. This boundary disruption between the delivery device and the embolic device can adversely affect the smoothness of the embolic device's advance and retraction during the procedure, as well as the extent to which force can be applied to the embolic device along a substantially non-longitudinal direction using the delivery device once the embolic device has been deployed from the delivery catheter. The system described herein, including the interface member 18, helps mitigate these challenges by providing a mating connection between the smaller delivery device 12 and the larger embolic device 22. The mating connection provides smooth boundaries between different sizes to facilitate a more uniform transmission of pushing and retracting forces and also provides an arrangement through which non-longitudinal forces can be effectively applied to the embolization device when manipulation is required to position it within a target area or for other reasons.

[0069] Figure 6 This is a side view showing an exemplary system 10 including an elongated body 12, an interface member 18, and an embolization device 22, and further illustrates in detail the relationship between the elongated body 12, the interface member 18, and the embolization device 22. The interface member 18 includes a proximal portion 19 and a distal portion 20, and the embolization device 22 includes a proximal portion 24 and a distal portion 26. The proximal portion 24 of the embolization device 22 is mechanically connected to the interface member 18, for example, mechanically connected to the distal portion 20, and the embolization device 22 is further attached to the elongated body 12. Figure 6 In the example shown, the embolization device 22 is attached to the elongated body 12 via a connecting member represented by the detachment component 70.

[0070] The proximal portion 19 of the interface member is configured to mate with the distal portion 16 of the elongated body. In some examples, the proximal portion 19 of the interface member defines a protrusion, while the distal portion 16 of the elongated body defines a recess, such as... Figure 6 As shown. In other examples, the proximal portion 19 of the interface member defines a recess, while the distal portion 16 of the elongated body defines a protrusion. The recess may be configured to receive the protrusion, and when the recess receives the protrusion, the proximal portion 19 of the interface member and the distal portion 16 of the elongated body may mate and form a mating connection. In some aspects, the recess is a concave surface surrounding an insertion volume, and when the distal portion 16 of the elongated body mates with the proximal portion 19 of the interface member to form a mating connection, at least some portions of the protrusion are inserted into the insertion volume.

[0071] Figure 7 Exemplary recesses and protrusions are shown. Figure 7 An isometric view of a first component 80 and a second component 84 is shown. The first component 80 has a protrusion 82, and the second component 84 defines a recess 86, wherein the recess 86 is configured to receive the protrusion 82 and provide a mating between the first component 80 and the second component 84. In some examples, the first component 80 may be an interface member 18, and the second component 84 may be an elongated body 12; in other examples, the first component 80 may be an elongated body 12, and the second component 84 may be an interface member 18.

[0072] In some examples, the proximal portion 19 of the interface member is configured to engage with the distal portion 16 of the elongated body, at least when the embolization device 22 is attached to the elongated body 12. As discussed below, any suitable technique can be used to attach the embolization device 22 and the elongated body 12. Attachment allows clinicians greater control over the positioning of the embolization device 22 within the patient's vascular system by enabling proximal retraction of the embolization device 22 during implantation (e.g., retraction into or towards the delivery catheter 44) and by applying actuating forces to the embolization device 22 in multiple directions after release from the delivery catheter 44.

[0073] In some examples, when the proximal portion 19 of the interface member mates with the distal portion 16 of the elongated body in a protrusion-recess structure, the protrusion and recess engage frictionally, and the recess is translatable over the protrusion. This translational capability allows for increased maneuverability of the embolization device 22 once delivered to the target site within the patient. In some cases, effective positioning of the embolization device 22 within the target site 54 may require the clinician to manipulate the elongated body 12 to maneuver the embolization device 22 to the desired orientation once it is outside the delivery catheter 44 and within the target site 54. The engagement between the distal portion 16 of the elongated body and the proximal portion 19 of the interface member, as disclosed herein, can help transfer maneuvering force from the clinician to the embolization device by allowing for a greater swing angle of the deployed embolization device. This engagement can provide an advantage over the arrangement of a flat interface connected to the embolization device by a push element. While a flat interface may be useful, limited surface contact on the flat interface can restrict the maneuverability of the embolization device when a swing angle is generated during the manipulation of the deployed embolization device.

[0074] For example, Figure 8 An elongated body 12 and an embolization device 22, constructed outside a delivery conduit 44, are depicted, wherein the embolization device 22 forms an oscillation angle relative to the elongated body 12, as indicated by the orientation of a first longitudinal axis L1 relative to a second longitudinal axis L2. The oscillation angle shown is approximately θ. As shown, a distal portion 16 of the elongated body defines a recess, and a proximal portion 19 of the interface member forms a protrusion. The recess receives the protrusion, thereby providing a mating connection between the distal portion 16 of the elongated body and the proximal portion 19 of the interface member. Under the orientation described by the oscillation angle θ, the distal portion 16 of the elongated body and the proximal portion 19 of the interface member establish a nominal contact area, which includes areas generally indicated by C1 and C2.

[0075] In which the distal portion 16 of the elongated body and the proximal portion 19 of the interface member have, for example, a first component 80 and a second component 84. Figure 7 In examples of shapes like ) Figure 8The nominal contact area generated under the orientation extends at least partially and possibly entirely around the distal portion 16 of the elongated body and the proximal portion 19 of the interface member. This particular nominal contact area, operating at least partially around the first longitudinal axis L1 and the second longitudinal axis L2, enables the transmission of forces (e.g., torque T) acting on the elongated body 12 to the embolization device 22 more effectively. This efficient transmission is beneficial when the embolization device 22 is deployed outside the delivery catheter, as clinicians apply different forces to the elongated body 12 during the effort to manipulate the embolization device 22. In some examples, the recess of the mating connection can translate in three dimensions on the protrusion, which allows clinicians to change the direction of the force applied from the elongated body 12 to the embolization device 22 while maintaining the effective nominal contact area between the distal portion 16 of the elongated body and the proximal portion 19 of the interface member.

[0076] In some aspects, when the distal portion 16 of the elongated body and the proximal portion 19 of the interface member form a mating connection and the second longitudinal axis L2 intersects the distal portion 20 of the interface member and the proximal portion 19 of the interface member, the geometric plane intersecting the second longitudinal axis L2 defines a cross-sectional region of the interface member 18, and the nominal contact region between the distal portion 16 of the elongated body and the proximal portion 19 of the interface member extends at least partially around the periphery of the cross-sectional region. In some examples, the second longitudinal axis L2 extends between a first portion and a second portion of the nominal contact region. In some examples, the nominal contact region surrounds the second longitudinal axis L2.

[0077] The proximal portion 14 of the elongated body has a first maximum cross-sectional dimension, which, in an example where the cross-section of the elongated body 12 is circular, can be, for example, the maximum diameter. For example, in... Figure 6 In the example shown, the proximal portion 14 of the elongated body has a first maximum cross-sectional dimension indicated by the diameter D1. However, in other examples, the first maximum cross-sectional area can be at any axial location of the proximal portion 14 of the elongated body. Additionally, the embolization device 22 has a second maximum cross-sectional dimension in its delivery configuration, such as... Figure 6 It is represented by the diameter D2. In some examples, the second maximum cross-sectional dimension is greater than the first maximum cross-sectional dimension of the proximal portion 14 of the slender body.

[0078] In some examples, when the embolization device 22 is in its deployment configuration, the maximum cross-sectional dimension of the embolization device 22 may be different from the second maximum cross-sectional dimension and larger than the first maximum cross-sectional dimension of the elongated body 12. For example, the embolization device 22 may have one maximum cross-sectional dimension when constrained by a surrounding structure such as the catheter 44, and another different maximum cross-sectional dimension when unconstrained. In some examples, the embolization device 22 extends radially outward when deployed from the lumen of a delivery conduit such as the catheter 44, for example, as... Figure 5 As shown.

[0079] In some examples, the elongated body 12 defines a first inner lumen 36, and the interface member 18 defines a second inner lumen 38, the second inner lumen 38 being configured to align with the first inner lumen 36 when the proximal portion 19 of the interface member mates with the distal portion 16 of the elongated body. In some examples and as... Figure 6 As shown, the first longitudinal axis L1 intersects with and extends through the proximal portion 14 and the distal portion 16 of the elongated body, and the second longitudinal axis L2 intersects with and extends through the proximal portion 24 and the distal portion 26 of the device. The second inner lumen 38 is configured to align with the first inner lumen 36 when the first longitudinal axis L1 is parallel to or coincides with the second longitudinal axis L2.

[0080] During delivery of the embolization device 22 to the target site 54, the proximal portion 24 of the embolization device 22 is mechanically connected to the interface member 18. In some examples, the proximal portion 24 is mechanically connected to the distal portion 20 of the interface member 18. In certain cases, such as... Figure 6 As shown, the proximal portion 24 of the device forms a proximal opening 42, and the distal portion 20 of the interface member is configured to be received within the proximal opening 42. The plugging device 22 can be mechanically attached to the interface member 18 by any suitable attachment mechanism. In some examples, the proximal portion 24 of the device is welded to the interface member 18.

[0081] Alternatively, the embolization device 22 can be attached to the elongated body 12 by any suitable attachment mechanism. In some examples, the embolization device 22 is attached to the elongated body 12 by a flexible or rigid member attached to the embolization device 22 at a first end and to the elongated body 12 at a second end. The flexible or rigid member may extend through a first inner lumen 36 of the elongated body 12 and a second inner lumen 38 of the interface member 18. In some examples, a proximal opening 42 of the embolization device 22 defines a lumen, and the embolization device 22 also includes an internal device member 25 located within the lumen, to which the flexible or rigid member is attached. In some aspects, the embolization device 22 is attached to the elongated body 12 by a release assembly 70 comprising a ball 72, a rod 74, and an eyelet 76, wherein the ball 72 is attached to the elongated body 12 and the eyelet 76 is attached to the embolization device 22. The embolization device 22 can be attached to the elongated body 12 using a variety of attachment mechanisms, including those described in U.S. Patent No. 8,328,860 entitled “IMPLANT INCLUDING ACOIL AND A STRETCH-RESISTANT MEMBER,” the entire contents of which are incorporated herein by reference.

[0082] In a particular example, the embolization device 22 is removably attached to the elongated body 12, allowing for deliberate modifications to the attachment by a clinician to facilitate ideal separation of the elongated body 12 and the embolization device 22. Modifications to the attachment can be achieved through a variety of mechanisms and methods, including but not limited to mechanical separation, electrolytic separation, hydraulic separation, thermal separation, and other mechanisms and methods known in the art. In a particular example, when the disengagement assembly 70 is attached to the embolization device 22 and the elongated body 12, a cord 62 can be placed to partially block the first inner lumen 36 to prevent the ball 72 from passing through. Retraction of the cord 62 sufficiently widens the opening of the first inner lumen 36 to allow the ball 72 to pass through the first inner lumen 36.

[0083] The elongated body 12, interface member 18, and embolization device 22 can be formed of any suitable material. In some examples, the elongated body 12 includes a flexible longitudinal member, such as a hypotube, under the control of a clinician. The elongated body 12 can be constructed of stainless steel, polymer, or any other suitable material. The interface member 18 can be constructed of any suitable material with good biocompatibility. In some examples, the interface member 18 is constructed of one or more of platinum, platinum alloys, nitinol, stainless steel, and other metals. The embolization device 22 may include an embolization coil, such as, but not limited to, a frame or anchoring coil and / or a filler coil, and can be formed of any suitable biocompatible material. In some examples, the embolization device 22 can be a metal or metal alloy, including platinum, platinum alloys, nitinol, stainless steel, and / or any other metallic material characterized by suitable biocompatibility.

[0084] In some examples, system 10 may further include a delivery conduit, such as conduit 44. Conduit 44 defines a lumen 46, an elongated body 12, and an interface member 18, and the embolization device 22 may be configured to be received within the lumen 46. When within the lumen 46 of conduit 44, the embolization device 22 may be in a delivery configuration. The embolization device 22 may be configured to extend radially outward to its deployment configuration upon deployment from the lumen 46, for example, as... Figure 5 As shown. In addition, in this arrangement, the elongated body 12 may be configured to transmit the driving force to the embolization device 22, thereby deploying the embolization device 22 from the lumen 46.

[0085] In some examples, the first maximum cross-sectional dimension of the proximal portion 14 of the elongated body is the dimension of the cross-section of the proximal portion 14 of the elongated body located in a plane perpendicular to the first longitudinal axis L1. In some examples, the second maximum cross-sectional dimension of the embolization device 22 is the dimension of the cross-section of the embolization device 22 located in a plane perpendicular to the second longitudinal axis L2. In some examples, the second longitudinal axis L2 intersects and extends through the proximal portion 19 and the distal portion 20 of the interface member, and the maximum cross-sectional dimension of the interface member 18 (referred to herein as the "third" maximum cross-sectional dimension, in some examples, to distinguish it from other maximum cross-sectional dimensions referenced herein) is the dimension of the cross-section of the interface member 18 located in a plane perpendicular to the second longitudinal axis L2. In other examples, the minimum cross-sectional dimension of the interface member 18 is the dimension of the cross-section of the interface member 18 located in a plane perpendicular to the second longitudinal axis L2. Cross-sectional dimensions as used herein may refer to diameter, width, or average diameter D. A D A = 4A / P, where A is the area of ​​the cross-section and P is the perimeter of the cross-section.

[0086] In some examples, the interface member 18 tapers along the proximal direction from a cross-sectional size substantially equal to the cross-sectional size of the embolization device 22 to a smaller cross-sectional size. The taper can be constant or stepped. The interface device may include a deformable or non-deformable body and may include a wound coil having one or more diameters defining an inner lumen.

[0087] In some examples where the interface member 18 tapers proximally, the profile of the interface member 18 can assist in the efficient transfer of pushing force from the relatively thin, elongated body 12 to the embolization device 22 when the system 10 is configured for placement within the lumen 46 of the catheter 44. The minimum cross-sectional dimension of the interface member 18 may be smaller than the second maximum cross-sectional dimension of the proximal portion 24 of the device. The interface member 18 may taper from a distal portion 20 of the interface member having a maximum cross-sectional dimension substantially equal to the second maximum cross-sectional dimension of the embolization device 22 to a proximal portion 19 of the interface member having a cross-sectional dimension smaller than the second maximum cross-sectional dimension of the embolization device 22. In some aspects, the interface member 18 may taper from a proximal portion 20 of the interface member having a maximum cross-sectional dimension smaller than the second maximum cross-sectional dimension of the embolization device 22 to a proximal portion 19 of the interface member having a cross-sectional dimension smaller than the maximum cross-sectional dimension of the distal portion 20 of the interface member.

[0088] As discussed, the protrusion of the mating connection can have any suitable shape, and the recess of the mating connection can have any shape suitable for receiving the protrusion. For example, as Figure 9A As shown, the protrusions and recesses can create a basic rectangular cross-sectional portion. Figure 9A The distal portion 110 of the elongated body, the proximal portion 111 of the interface member, and the plugging device 112 are shown, wherein the concave profile of the distal portion 110 of the elongated body is configured to receive the convex profile of the proximal portion 111 of the interface member in the recess 126, and vice versa. Figure 9B An exemplary interface member 113 employing truncated conical and cylindrical shapes is shown, which can be used to create this profile of the protrusion. As shown, an example is provided for the proximal portion 114 of the interface member, where the cylindrical shape is approximately at the top of the truncated conical shape, which lies between the cylindrical shape and the distal portion 115 of the interface member. In, for example... Figure 9B In examples comprising two or more combined shapes, the first and second shapes may have any axial length relative to each other or relative to any portion of interface member 113, the proximal portion 114 of interface member, or the distal portion 115 of interface member. In some examples, the axial length represents the dimension in a direction parallel to the axis intersecting the proximal portion 114 and the distal portion 115 of interface member.

[0089] In such Figure 10A In some of the examples shown, the protrusions and recesses can create a roughly semi-circular cross-sectional profile. Figure 10AThe distal portion 116 of the elongated body, the proximal portion 117 of the interface member, and the plugging device 118 are shown, wherein the concave profile of the distal portion 116 of the elongated body is configured to receive the generally semi-circular convex profile of the proximal portion 117 of the interface member in the recess 127, or vice versa. Figure 10B An exemplary interface member 119 is shown, having a proximal portion 120 of the interface member in a hemispherical shape, which can be used to create this profile of the protrusion. In, for example... Figure 10B In the examples, the hemispherical or circular shape may have any axial length relative to any portion of interface member 119, the proximal portion 120 of interface member 121, or the distal portion 121 of interface member 129. The hemispherical or circular shape may have a constant radius or may have a radius that varies along its axial length, and may have any radius relative to any portion of interface member 119, the proximal portion 120 of interface member 129, or the distal portion 121 of interface member 129. In some examples, the axial length represents the dimension in a direction parallel to the axis intersecting the proximal portion 120 and the distal portion 121 of interface member 129, and the radius or multiple radii represent the dimension in a direction substantially perpendicular to the axis.

[0090] In some examples, such as Figure 11A As shown, the proximal portion of the interface component includes a coil, such as a tapered coil. In some examples, the tapered coil may define a constant taper. Figure 11A The diagram shows a distal portion 122 of an elongated body, a proximal portion 123 of an interface member including a coil 125, and a plugging device 124, wherein the concave profile of the distal portion 122 of the elongated body is configured to receive the convex profile of the proximal portion 123 of the interface member in a recess 128, or vice versa. Figure 11B An exemplary interface member 126 including a wound coil 130 is shown, wherein a proximal portion 127 of the interface member defines a shape that can be used to create a protrusion. In some examples, the wound coil 130 includes a distal portion 128 of the interface member having a first segment of the wound coil 130 mechanically connected to an embolic device 124. In some examples, the embolic device 129 is partially wound on the first segment of the wound coil 130. In such... Figure 11BIn some examples, the wound coil 130 may define a shape having any axial length relative to the interface member 126, the proximal portion 127 of the interface member, or the distal portion 128 of the interface member. In some examples, the wound coil 130 may have a constant radius or may have multiple radii varying along its axial length and may have any radius relative to any portion of the interface member 126, the proximal portion 127 of the interface member, or the distal portion 128 of the interface member. In some examples, the axial length represents the dimension in a direction parallel to the axis intersecting the proximal portion 127 and the distal portion 128 of the interface member, and the radius or multiple radii represent the dimension in a direction generally perpendicular to the axis.

[0091] In some examples, the tapered coil can also define a stepped coil, such as Figure 12A As shown. Figure 12A The diagram shows a distal portion 131 of an elongated body, a proximal portion 132 of an interface member, and a plugging device 133, wherein the concave profile of the distal portion 131 of the elongated body is configured to accommodate the convex profile of the proximal portion 132 of the interface member within a recess 134, and vice versa. Figure 12A As shown, the proximal portion 132 of the interface component may include one or more coils, such as a first coil 135 and a second coil 136. Figure 12B An exemplary interface member 137 is shown, comprising a first winding coil 140 and a second winding coil 141, wherein a proximal portion 138 of the interface member defines a shape that can be used to create a protrusion. In some examples, the first winding coil 140 includes an inner layer, and the second winding coil 141 includes an outer layer partially wound around the inner layer. In some examples, the second winding coil 141 includes a distal portion 139 of the interface member mechanically connected to an embolization device 142. In some examples, the embolization device 142 is partially wound around the second winding coil 141. Figure 12B In the examples shown, the first and / or second winding coils may have any axial length relative to each other or relative to any portion of interface member 137, the proximal portion 138 of interface member, or the distal portion 139 of interface member. In some examples, the first and / or second winding coils may have a constant radius or may have multiple radii varying along the axial length, and may have any radius relative to any portion of interface member 137, the proximal portion 138 of interface member, or the distal portion 139 of interface member. In some examples, the axial length represents the dimension in a direction parallel to the axis intersecting the proximal portion 138 and the distal portion 139 of interface member, and the radius or multiple radii represent the dimension in a direction substantially perpendicular to the axis.

[0092] Other arrangements are conceivable, in which the protrusion of the mating connection has a specific shape, and the recess of the mating connection is configured to accommodate at least some of the specific shape, thereby creating a mating connection.

[0093] Figure 13 Is using system 10 ( Figure 6 The flowchart illustrates an example method. In some examples, the embolization device 22, interface member 18, and elongated body 12 are preloaded into the lumen 46 of the catheter 44 via a dispenser of the embolization device 22. In other examples, a clinician may introduce the embolization device 22, interface member 18, and elongated body 12 into the lumen 46 of the catheter 44. The clinician may position the distal portion of the catheter 44 near the target site 54 and advance the embolization device 22 through the lumen 46 to at least partially deploy the embolization device 22 at the target site (102) within the patient's body. For example, the clinician may apply a pushing force to the elongated body 12 (e.g., to the proximal portion 14 of the elongated body), which is transmitted to the interface member 18 and the embolization device 22 via a mating connection. The clinician may continue to advance the system 10 toward the distal end of the catheter 44 until the device 22 is at least partially deployed from the lumen 46 at the target site 54.

[0094] In some examples, clinicians can adjust the position (104) of the embolization device 22 relative to the target site 54. For example, a clinician can manipulate the position of the embolization device 22 by maintaining or establishing a fit between the distal portion 16 of the elongated body and the proximal portion 19 of the interface member, then applying an axial or non-axial force to the proximal portion 14 of the elongated body and transmitting the force from the proximal portion 14 of the elongated body through the fit connection to the interface member 18 and the embolization device 22 until the force causes movement of the embolization device 22 in the target site 54, thereby positioning the embolization device 22 at the target site 54 as needed.

[0095] After positioning the embolization device 22 at the target site 54 as needed, the clinician can disengage the embolization device 22 from the elongated body 12 (106). For example, the clinician can do so by retracting the cord 62 and allowing the ball 72 to pass through the first inner lumen 36. Figure 6 Alternatively, detachment can be facilitated by using another appropriate method.

[0096] After the embolization device 22 is disengaged (and separated) from the elongated body 12, the clinician can, for example, withdraw the elongated body 12 proximally from the patient’s vascular system through the lumen 46 of the catheter 44, while the embolization device 22 and the interface component 18 remain at the target site 54 (108).

[0097] Various examples have been described. These and other examples are within the scope of the appended claims.

Claims

1. A system for delivering an embolic device, the system comprising: An elongated body, the elongated body comprising a proximal portion and a distal portion, the proximal portion having a first maximum cross-sectional dimension; An interface component, the interface component comprising a proximal portion of the interface component and a distal portion of the interface component; and An embolization device configured to extend from a delivery configuration to a deployment configuration, wherein in the delivery configuration, the embolization device includes a proximal portion having a second maximum cross-sectional dimension larger than a first maximum cross-sectional dimension, wherein the proximal portion is mechanically connected to the interface member, and When the embolization device is attached to the elongated body, the proximal portion of the interface member is configured to mate with the distal portion of the elongated body, and the third maximum cross-sectional dimension of the interface member is larger than the first maximum cross-sectional dimension. The interface member proximal portion or the elongated body distal portion defines a protrusion, and the other portion defines a recess, the recess being configured to receive the protrusion. The protrusion includes a tapered shape, and when the embolization device is attached to the elongated body, and when the proximal portion of the interface member mates with the distal portion of the elongated body, the protrusion and the recess engage frictionally, and the recess is translatable in three dimensions on the protrusion, and the tapered shape of the protrusion and the engagement of the recess allow the embolization device to form a swing angle of less than 180 degrees relative to the elongated body.

2. The system according to claim 1, wherein the elongated body comprises a metal thiopanel tube.

3. The system of claim 1, wherein the minimum cross-sectional dimension of the interface member is smaller than the second maximum cross-sectional dimension of the proximal portion of the embolization device.

4. The system of claim 1, wherein the proximal portion of the device is mechanically connected to the distal portion of the interface member.

5. The system of claim 1, wherein the interface member tapers in the proximal direction.

6. The system of claim 5, wherein the interface member tapers from a distal portion to a proximal portion, the maximum cross-sectional dimension of the distal portion being substantially equal to the second maximum cross-sectional dimension of the embolization device, and the cross-sectional dimension of the proximal portion being smaller than the second maximum cross-sectional dimension of the embolization device.

7. The system of claim 1, wherein the protrusion has at least one shape selected from the group consisting of: truncated cone, hemispherical and conical.

8. The system of claim 1, wherein the interface component comprises a tapered coil.

9. The system of claim 8, wherein the tapered coil defines a constant taper.

10. The system of claim 9, wherein the tapered coil defines a stepped taper.

11. The system of claim 10, wherein the tapered coil comprises an inner layer formed by a first segment of a wound elongated structure and an outer layer formed by a second segment of the wound elongated structure partially wound around the inner layer.

12. The system of claim 1, wherein the interface component comprises a plurality of coils having different diameters.

13. The system of claim 12, wherein the plurality of coils includes a first coil having a first diameter and a second coil having a second diameter greater than the first diameter, the first coil being partially disposed inside the second coil to define a stepped taper of the interface member.

14. The system of claim 1, wherein the elongated body defines a first inner lumen and the interface member defines a second inner lumen, the second inner lumen being configured to align with the first inner lumen when a proximal portion of the interface member engages with a distal portion of the elongated body.

15. The system of claim 14, wherein the embolization device is attached to the elongated body by a connecting member extending through the first inner lumen and the second inner lumen, wherein the connecting member is removably attached to the elongated body.

16. The system of claim 1, wherein the interface component comprises at least one of platinum, nickel-titanium, or stainless steel.

17. The system of claim 1, wherein the plugging device is welded to the interface member.

18. The system of claim 1, wherein the embolization device defines a proximal opening, and the distal portion of the interface member is configured to be received in the proximal opening to mechanically connect the proximal portion of the device and the distal portion of the interface member.

19. The system of claim 1, wherein the system further comprises a delivery conduit defining a lumen, wherein the elongated body, the interface member, and the embolization device are configured to be received within the lumen.

20. The system of claim 19, wherein the embolization device is configured to extend radially outward when deployed from the lumen.

21. The system of claim 20, wherein the elongated body is configured to transmit a driving force to the embolization device to deploy the embolization device from the lumen.

22. A system for delivering an embolic device, the system comprising: An elongated body, the elongated body comprising a proximal portion of the elongated body and a distal portion of the elongated body; An interface component, the interface component comprising a proximal portion of the interface component and a distal portion of the interface component; and An embolization device, the embolization device including a proximal portion of the device, the proximal portion of the device being mechanically connected to a distal portion of the interface member, and One of the proximal portion of the interface member or the distal portion of the elongated body defines a protrusion, while the other defines a recess configured to receive the protrusion. The protrusion includes a tapered shape, and when the embolization device is attached to the elongated body, the proximal portion of the interface member is configured to mate with the distal portion of the elongated body. When the proximal portion of the interface member mates with the distal portion of the elongated body, the recess receives the protrusion and defines a nominal contact area between the protrusion and the recess. The recess is translatable in three dimensions on the protrusion, and the tapered shape of the protrusion and the mate with the recess allow the embolization device to form a swing angle of less than 180 degrees relative to the elongated body. The elongated body is configured to transmit force through a portion of the nominal contact area and through the interface member to the embolization device.

23. The system of claim 22, wherein the elongated body defines a first inner lumen and the interface member defines a second inner lumen, the second inner lumen being configured to align with the first inner lumen when a proximal portion of the interface member engages with a distal portion of the elongated body, and wherein the embolizing device is attached to the elongated body via a connecting member extending through the first inner lumen and the second inner lumen.

24. The system of claim 22, wherein the protrusion has at least one shape selected from the group consisting of: truncated cone, hemispherical and conical.

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