IMPLANT DELIVERY ASSEMBLY WITH DISTAL PROTECTION

Abstract

A delivery system for deploying a medical implant includes a delivery wire assembly disposed within a delivery catheter lumen, the assembly having an implant loading region configured for seating the implant when the assembly is constrained within the delivery catheter lumen and the implant is in a compressed configuration, the assembly further including an implant distal protection having a central portion coupled to the assembly, distal of the implant loading region, and a peripheral portion extending proximally from the central portion to at least partially cover a distal end portion of the implant when the assembly, implant and distal protection are constrained within the catheter lumen, wherein the peripheral portion remains extending in the proximal direction when the implant assumes an expanded configuration after being released from the catheter lumen, and the peripheral portion of the distal protection comprises a plurality of stems, each comprising a respective petal-like member.

Claims

1. A delivery system for deploying an implant at a target site within a mammalian vasculature, the implant having a compressed delivery configuration and an expanded deployed configuration, the delivery system comprising: a delivery catheter having a lumen; an elongate delivery wire assembly at least partially disposed within the delivery catheter lumen, the delivery wire assembly being translatable relative to the delivery catheter and having an implant loading region configured for seating the implant when a distal portion of the delivery wire assembly including the implant is constrained within the delivery catheter lumen and the implant is in the compressed delivery configuration; and an implant distal protection feature comprising a central portion coupled to the delivery wire assembly distally of the implant loading region, and a peripheral portion comprising a plurality of circumferentially spaced elongated stems with petal-like members that extend proximally from the central portion and at least partially cover a distal end portion of the implant when the implant and implant distal protection feature are constrained within the delivery catheter lumen, wherein the peripheral portion is configured to remain extending proximally from the central portion when the implant is released from the delivery catheter lumen and assumes the expanded deployed configuration.

2. The delivery system of claim 1, wherein the respective petal-like members are configured to collective cover the elongated stems when the implant and implant distal protection feature are constrained within the delivery catheter.

3. The delivery system of claim 2, wherein the petal-like members include a first petal-like member disposed on or covering between about eighty percent to about ninety percent of a total length of the respective elongated stem, a second petal-like member disposed on or covering between about sixty percent to about fifty percent of the total length of the respective elongated stem, and a third petal-like member disposed on or covering between about forty percent to about thirty percent of the total length of the respective elongated stem.

4. The delivery system of claim 3, wherein the respective stems and pedal-like members of the implant distal protection feature are configured to expand from a compressed delivery configuration to an expanded deployed configuration in a sequential order in which the first petal-like member expands first, the second petal-like member expands after the first petal-like member, and the third petal-like member expands after the second petal-like member.

5. The delivery system of claim 1, wherein the stems and petal-like members are substantially evenly circumferentially spaced around the delivery wire assembly.

6. The delivery system of claim 1, wherein the petal-like members comprise an arcuate, annular strip, or concave configuration.

7. The delivery system of claim 1, wherein the central portion of the implant distal protection feature is fixedly attached to the delivery wire assembly.

8. The delivery system of claim 1, wherein the central portion of the implant distal protection feature is rotatably coupled to the delivery wire assembly.

9. The delivery system of claim 1, wherein the implant distal protection feature covers about twenty percent of a total length of the implant when the implant and implant distal protection feature are constrained within the delivery catheter lumen.

10. The delivery system of claim 1, wherein the implant distal protection covers between about ten percent and about twenty percent of a total length of the implant when the implant and implant distal protection feature are constrained within the delivery catheter lumen.

11. The delivery system of claim 1, wherein the implant distal protection covers between about five percent and about ten percent of a total length of the implant when the implant and implant distal protection feature are constrained within the delivery catheter lumen.

12. The delivery system of claim 1, wherein the implant distal protection covers about five percent or less of a total length of the implant when the implant and implant distal protection feature are constrained within the delivery catheter lumen.

13. The delivery system of claim 1 wherein the respective stems and petal-like portions of the implant distal protection feature are configured to exert negligible force on the distal portion of the implant as the implant expands from the compressed delivery configuration to the expanded deployed configuration.

14. The delivery system of claim 1, wherein the implant distal protection feature remains in a substantially compressed delivery configuration implant is released from the delivery catheter lumen and assumes the expanded deployed configuration.

15. The delivery system of claim 1, wherein the respective stems and petal-like portions of the implant distal protection feature are configured to not evert to a distally facing direction as the implant expands from the compressed delivery configuration to the expanded deployed configuration.

16. The delivery system of claim 1, wherein the peripheral portion of the distal protection feature comprises more than three stems with petal-like members.

17. The delivery system of claim 16, wherein each petal-like member covers a different percentage of a length of the corresponding elongated stem when the implant and implant distal protection feature are constrained within the delivery catheter.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] FIG. 1 is a side view of an implant delivery system (Prior Art).

[0033] FIGS. 2A-E are partially cut-away side, perspective and exploded views of a delivery wire assembly (Prior Art) of the implant delivery system of FIG. 1, showing portions of the system in greater detail.

[0034] FIGS. 3A-B are partially cut-away side and detailed view of a delivery wire assembly of the implant delivery system, showing the implant distal protection, according to one embodiment of the disclosed inventions.

[0035] FIGS. 4A-B are elevated end views and FIG. 4C is a perspective side view of the implant distal protection; FIG. 4D is cross-sectional view of a petal like member and FIG. 4E is a perspective side view of the implant distal protection, according to embodiments of the disclosed inventions.

[0036] FIGS. 5A-B are elevated end and partial views of an implant distal protection; and FIG. 5C is a perspective side view of the implant distal protection 800, according to alternative embodiments of the disclosed inventions.

[0037] FIG. 6 is an alternative implant distal protection, similar to that of FIGS. 5A-5C.

[0038] FIGS. 7A-7B are another alternative implant distal protection, according to other embodiments of the disclosed inventions.

[0039] FIG. 8 is yet another alternative implant distal protection, according to further embodiments of the disclosed inventions.

[0040] FIGS. 9A-D are cut-away, side and perspective views of the implant distal protection of FIGS. 4A-4E depicted as the delivery wire assembly is loaded into the delivery catheter 120, according to embodiments of the disclosed inventions.

[0041] FIGS. 10A-H are side and perspective views of the implant distal protection of FIGS. 4A-4E depicted during delivery and deployment of an implant at a targeted site in a vasculature using the implant delivery system of FIGS. 1-3.

DETAILED DESCRIPTION

[0042] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

[0043] All numeric values are herein assumed to be modified by the terms substantially or about, whether or not explicitly indicated. The terms substantially and about refer to a range of numbers that one of skill in the art would consider equivalent to the recited parameter, structure or value (i.e., having the same function or result). In many instances, the terms about and substantially include numbers that are rounded to the nearest significant figure. The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0044] As used in this specification and the appended claims, the singular forms a, an, and the include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term or is generally employed in its sense including and/or unless the content clearly dictates otherwise.

[0045] As used in this specification and the appended claims, the terms proximal and proximally (and the like) when used to describe a relative position, the location or direction of a structure or action of the implant delivery system that is towards the outside of the patient's body; and the terms distal and distally (and the like) when used to describe a relative position, the location or direction of a structure or action of the implant delivery system that is extended deepest into the patient's body.

[0046] Various embodiments of the disclosed inventions are described hereinafter with reference to the figures. The figures are not necessarily drawn to scale, the relative scale of select elements may have been exaggerated for clarity, and elements of similar structures or functions are represented by like reference numerals throughout the figures. It should also be understood that the figures are only intended to facilitate the description of the embodiments, and are not intended as an exhaustive description of the disclosed inventions, or as a limitation on the scope thereof, which is defined only by the appended claims and their equivalents.

[0047] In addition, the respective illustrated embodiments of the disclosed inventions need not have all of the depicted features, and a feature, aspect or advantage described in conjunction with a particular embodiment is not necessarily limited to that embodiment, but can be practiced in other embodiments, even if not so illustrated.

[0048] FIG. 3A illustrates the implant delivery wire assembly 300 of the implant delivery system 100, including an implant distal protection 700, according to one embodiment of the disclosed inventions. The core wire 350 that is pushed through the delivery catheter lumen 125 (FIG. 1) for delivering the implant 200 carried on a distal end portion of the core wire 350 into a targeted site in a patient's vasculature. The implant 200 may be a stent, a flow diverter, or other type of vasculature implant, and may comprise a variety of biocompatible materials, as previously disclosed. The implant 200 is depicted in FIG. 3A in a compressed, elongated delivery configuration disposed (i.e., radially constrained) within the lumen 125 of the delivery catheter 120. The implant 200 is preferably biased to self-expand radially outwards into an expanded deployed configuration when deployed out the distal end opening of (i.e., no longer radially constrained within) the delivery catheter 120. The core wire 350 of the delivery wire assembly 300 is coaxially disposed within the delivery catheter lumen 125, and the implant 200 is coaxially disposed around the core wire 350, also constrained within the delivery catheter lumen 125. Radiopaque markers 360 (e.g., laser etched, radiopaque bands or any other suitable markers) are preferably located along the distal portion of the core wire 350 to assist in positioning the core wire 350 and implant 200 relative to the delivery catheter 120. The coil 357 is disposed around the core wire 350 for providing structural support just proximal of the implant 200. The tapered radiopaque marker 455, and atraumatic tip 457, respectively, are disposed proximate a distal end opening 452 of the delivery catheter 120. In FIG. 3A, a distal locking member 750 is shown, as a proximal locking member 750 is obscured by the implant distal protection 700. In the illustrated embodiment, the implant distal protection 700 is fixedly attached to the core wire 350 by the locking members 750, so that the implant distal protection does not rotate relative to the core wire 350.

[0049] In an alternative embodiment, the implant distal protection 700 may be attached to a collar (not shown) that is still fixed in a relative longitudinal position on the core wire 350 by the locking members 750 in a manner that allows the collar, and thus the implant distal protection 700, to rotate relative to the core wire 350 and locking members 750. The rotatable implant distal protection 700 is configured to allow torque transmission to the distal end of the core wire 350 (e.g., atraumatic distal tip portion 380), which further allows vessel selection and facilitates navigation of the delivery wire assembly 300 to the targeted implantation site. When the implant distal protection 700 rotates with respect to the core wire 350, any externally induced (e.g., by patient's anatomy, user, clinician) relative torsion between the delivery catheter 120 and the core wire 350 is avoided or substantially minimized, preventing accumulation of torsional energy, detrimental to the deployment of the implant 200. As such, the rotatable implant distal protection 700 is configured to prevent accumulation of torsional energy in the delivery wire assembly 300 and the implant 200, when assembly 300 and implant 200 are in the delivery configuration (e.g., radially constrained) disposed within the lumen 125 of the delivery catheter 120.

[0050] Additionally, the atraumatic distal tip 380 (e.g., a soft coil member) is attached to the core wire proximate to the distal locking member 550 (FIGS. 3A-B). FIG. 3B illustrate a close-up view of the implant distal protection 700 in a compressed, elongated delivery configuration (i.e., radially constrained). The implant distal protection 700 will be described in further detail below.

[0051] FIGS. 4A-4E illustrate the implant distal protection 700 of the delivery wire assembly 300, according to one embodiment of the disclosed inventions. FIGS. 4A-B are elevated end views and FIG. 4C is a perspective side view of the implant distal protection 700 in an unconstrained deployment configuration; FIG. 4D is cross-sectional view of a petal like member and FIG. 4E is a perspective side view of the implant distal protection 700 in a radially constrained delivery configuration. The implant distal protection 700 is composed of biocompatible material, such as TFN, ePTFE, polymers, Nitinol or the like. In one embodiment, the implant distal protection 700 comprises a reinforcement member 710 having three elongated arms, ribs or stems 715a-715c extending from a central portion 712. The central portion 712 includes an opening 714 configured to receive or be disposed around the core wire 350 of the implant delivery wire assembly 300. The central portion 712 and the opening 714 may have respective circular configurations, as shown in FIGS. 4A-4E, or any other suitable configuration (not shown). Stems 715a-715c extend from and are disposed around the central portion 712 of the implant distal protection 700. Each stem 715a-715c has a respective proximal section 715, a middle section 715 and a distal section 715. The respective proximal sections 715 of the stems 715a-715c are coupled to the central portion 712 of the implant distal protection 700. The central portion 712 and the stems 715a-715c are composed of Nitinol or any other suitable superelastic material.

[0052] In some embodiments, as shown in FIG. 4A-B, the stems 715a-715c are symmetrically disposed with respect to a y-axis, around the central portion 712, such as, stem 715a is at angle ?, approximately 120? apart from stem 715b, stem 715b is also at angle ?, approximately 120? apart from stem 715c, and stem 715c is at angle ?, approximately 120? apart from stem 715c. It should be appreciated that stems 715a-715c may be disposed in a non-symmetrical configuration around the central portion 712, at any suitable angle ? separation (not shown).

[0053] In the embodiments of FIGS. 4A-4E, the implant distal protection 700 further comprises three petal-like members (or petals) 720a-720c disposed over each of the respective stems 715a-715c. The petal-like members 720a-720c are composed of substantially uniform layers of ePTFE, each having a thickness of approximately between 0.0152 millimeters (0.0006 inches) to 0.030 millimeters (0.0012 inches). The petals 720a-720c are composed of biocompatible material, such as TFN, ePTFE, polymers, combination thereof or the like. For example, commercially-available Polyimide (PI) film with FEP coating could be used external or internal to the ePTFE material for the petal-like members 720a-720c. Additionally or alternatively, FEP-coated PI film may be incorporated between layers of ePTFE during the sintering process of manufacturing of the petal-like members 720a-720c.

[0054] As shown in FIGS. 4A-B, each of the petals 720a-720c may be disposed on or cover approximately between 40% to 90% of each of their respective stems 715a-715c. As better appreciated in the embodiment of FIG. 4A depicting the contour of the stems 715a-715c within the petals 720a-720c, the petal 720a is disposed on or cover between approximately 80% to 90% of the stem 715a, the petal 720b is disposed on or cover between approximately 50% to 60% of the stem 715b, and the petal 720c is disposed on or cover between approximately 40% to 30% of the stem 715c. Such as, the proximal sections 715 of stems 715a-715c are not covered by the petals 720a-720c, a small part of the middle section 715 of 715b is not covered by petal 720b and a larger part of the of the middle section 715 of 715c is not covered by petal 720c.

[0055] Although in the implant distal protection 700 of FIGS. 4A-4E the petals 720a-720c have the same length, petal 720c extends further distally than petals 720a-720b, and petal 720b extends further distally than petal 720a. The petals 720a-720b extend distally with respect to the central portion 712 of the implant distal protection 700, however, as it will be described in further detail below, the petals 720a-720b will be proximally directed, when the implant distal protection 700 is not constrained within the delivery catheter 120.

[0056] It should be appreciated that the petals 720a-720c may include different lengths and be disposed around the same sections over their respective stems 715a-715c to create a similar implant distal protection having different distally extending petals-like members. The different distally extending petals 720a-720c of FIGS. 4A-4E are configured to provide implant coverage with minimal material for better flushing during delivery of the implant 200. Additionally, the different distally extending petals 720a-720c of the implant distal protection 700 are configured to allow sequential deployment each of the petals 720a-720c as they exit the delivery catheter 120 (e.g., via the delivery catheter 120 being withdrawn proximally relative to the core wire 350, or the core wire 350 being pushed distally relative to the delivery catheter 120, or some of each, thereby exposing the implant distal protection 700 out the distal end opening 452 of the delivery catheter 120) avoiding or minimizing the risk of entanglement of the petals 720a-720c and/or avoiding or minimizing potential failure of the implant distal protection 700 (e.g., failure to radially expand). The sequential radial expansion of the petals 720a-720c (e.g., no longer radially constrained by the delivery catheter 120) would be in the following order of: i) first, petal 720a, then ii) the petal 720b and finally, iii) petal 720c, as it will be described in further detailed below.

[0057] As better appreciated in FIGS. 4C-4D depicting a perspective side view and a cross-section of the implant distal protection 700, the petals 720a-720c of FIGS. 4A-E have an arcuate configuration along the length L of the petals. For example, FIG. 4D depicts a cross-sectional view of the petal 720b having an arcuate, annular strip, concave configuration, as also appreciated in FIG. 4E. FIG. 4E depicts a perspective side view of the implant distal protection 700 in a radially constrained delivery configuration, additionally showing the different distally extending petals 720a-720c with respect to the central portion 712, having petal 720c extending further distally that any of the other petals 720a-720b, and petal 720b extends further distally that the petal 720a.

[0058] FIGS. 5A-5C illustrate an alternative implant distal protection 800 of the delivery wire assembly 300, according to further embodiments of the disclosed inventions. FIGS. 5A-B are elevated end and partial views of the implant distal protection 800 in an unconstrained deployment configuration; and FIG. 5C is a perspective side view of the implant distal protection 800 in a radially constrained delivery configuration. Similar to the implant distal protection 700 of FIGS. 4A-B, the implant distal protection 800 comprises a reinforcement member 810 having three elongated arms, ribs or stems 815a-815c extending from a central portion 812. The central portion 812 includes an opening 814 configured to receive or be disposed around the core wire 350 of the implant delivery wire assembly 300.

[0059] Further, the implant distal protection 800 of FIGS. 5A-5C is similar to the implant distal protection 700 of FIGS. 4A-B, except that the implant distal protection 800 FIGS. 5A-5C have petals 820a-820c that are composed of an unitary thin, substantially uniform layer of ePTFE, or other suitable material. As better shown in FIG. 5B, the petals 820a-820c meet at a central portion 812 that is configured to be coupled to the core wire 350. As shown in FIGS. 5B-5C, the petals 820a-820c extend generally radially outward from the central portion 812, and proximally directed, when the implant distal protection 800 is not constrained within the delivery catheter 120. Although the petals 820a-820c are composed of a substantially uniform layer of ePTFE, or other suitable material, the implant distal protection 800 of FIGS. 5A-5C also have different distally extending petals 820a-820c with respect to the central portion 812, having petal 820c extending further distally than any of the other petals, in particular petal 820b, as better appreciated in FIG. 5C.

[0060] FIG. 6 illustrates another alternative implant distal protection 900 of the delivery wire assembly 300, according to other embodiments of the disclosed inventions. The implant distal protection 900 includes three elongated arms, ribs or stems 915a-915c extending from a central portion 912. The implant distal protection 900 of FIG. 6 is similar to that of FIGS. 5A-5C, except that more material of the unitary thin, substantially uniform layer of ePTFE forming petals 920a-920c is disposed around the central portion 912.

[0061] FIGS. 7A-7B illustrate yet another alternative implant distal protection 1000 of the delivery wire assembly 300, according to other embodiments of the disclosed inventions. The implant distal protection 1000 of FIGS. 7A-7B has three petals 1020a-1020c disposed around the central portion 1012. The implant distal protection 1000 of FIGS. 7A-7B are similar to that of FIG. 6, except that the three elongated arms, ribs or stems 1015a-1015c extending from a central portion 1012 are shorter than the stems 915a-915c of FIG. 6. Additionally, FIG. 7B illustrate the distal locking member 750 (also shown in FIGS. 3A-3B) and the proximal locking member 750 coupled to the implant distal protection 1000. Further in the implant distal protection 1000 (as better appreciated in FIG. 7B), the stems 1015a-1015c are disposed over or side-by-side to petals 1020a-1020c.

[0062] FIG. 8 illustrates an alternative implant distal protection 1100 of the delivery wire assembly 300, according to other embodiments of the disclosed inventions. Similar to the implant distal protection 700 of FIGS. 4A-E, FIG. 9 comprises different distally extending petals 1120a-1120c with respect to a central portion 1112, having petal 1120c extending further distally than any of the other petals 1120a-1120b, and petal 1120b extends further distally than the petal 1120a. The implant distal protection 1100 further comprises a reinforcement member 1110 having three elongated bifurcated arms, ribs or stems 1115a-1015c extending from the central portion 1112. The central portion 1112 includes an opening 1114 configured to receive or be disposed around the core wire 350 of the implant delivery wire assembly 300. The bifurcated stems 1115a-1115c extend from and are disposed around the central portion 1112 of the implant distal protection 1100. Each stem 1115a-1115c bifurcates into two branches having respective petals 1120a-1120c disposed between each of their respective branches, as shown in FIG. 8. For example, stem 1115a bifurcates into a first branch 1115a (i) and a second branch 1115a (ii) forming a U like configuration and having petal 1120a disposed between branches 1115a (i) and 1115a (ii). The bifurcated stems 1115a-1115c of FIG. 8 are configured to provide additional structural support to the petals 1120a-1120c allowing the petals to be proximally directed, when the implant distal protection 1100 is not constrained within the delivery catheter 120.

[0063] It should be appreciated that the petals of FIGS. 5A-8 have an arcuate, annular strip, concave cross-sectional configuration, as shown in FIG. 4D. Other suitable cross-sectional configuration of the petals of FIGS. 5A-8 could be considered. In other embodiments (not shown), the implant distal protection 700 may include more or less than three stems and/or petals configured to deployed sequentially, as described in further detail below.

[0064] FIGS. 9A-D illustrate the front loading of the delivery wire assembly 300 into the delivery catheter 120, according to one embodiment of the disclosed inventions. The implant distal protection 700 of FIGS. 4A-E is shown in FIGS. 9A-D as an exemplary distal protection used to load the delivery wire assembly 300, including implant 200 into the delivery catheter 120. It should be appreciated that any of the implant distal protections disclosed in the alternative embodiments of FIGS. 5A-8 may be used to load the delivery wire assembly 300, including implant 200 and into the delivery catheter 120.

[0065] FIG. 9A depicts the distal end portion of the delivery wire assembly 300, including the implant distal protection 700 and implant 200, just prior to being loaded into the delivery catheter 120, wherein the petals 720a-720c of the implant distal protection 700 are shown extending generally proximally in a radially unconstrained configuration. As described above, the implant distal protection 700 comprises different extending petals 720a-720c (e.g., distally with respect to the central portion 712, FIGS. 4A-4E), where the difference in the extension of the petals 720a-720c of the implant distal protection 700 are shown as proximally directed with respect to the implant 200. As such, petal 720c extending further proximately towards the implant 200 that any of the other petals 720b-720a, and petal 720b extends further proximately than the petal 720a.

[0066] The implant 200 is coaxially disposed around the core wire 350 (not shown), and held in the radially constrained delivery configuration by a tubular loading member 390, with the distal end portion 240 of the implant 200 is partially exposed out a distal end opening of the loading member 390.

[0067] The distal end portion of the delivery wire assembly 300, including the implant distal protection 700 and the compressed implant 200, is either advanced into the delivery catheter 120, or the delivery catheter 120 is advanced over the distal portion of the delivery wire assembly 300, or some of each, thereby radially compressing the petals 720a-720c of the implant distal protection 700 over and onto the distal portion 240 of the implant 200, as shown in FIGS. 9B-C. Additionally or alternatively, the radial compression of the 720a-720c of the implant distal protection 700 over and onto the distal portion 240 of the implant 200, may be assisted by orderly compressing the petals, such as, first, compressing petal 720c, then, compressing petal 720b, and lastly compressing petal 720a. The radially compressed petals 720a-720c are disposed on and/or partially covering the distal portion 240 of the implant 200. In some embodiments, the stems 715a-715c are not disposed on and do not cover the distal portion 240 of the implant 200, as shown in FIGS. 9A-9B and FIGS. 10A-10D.

[0068] Once the delivery catheter 120 is disposed over the respective implant distal protection 700 and loading member 390, the loading member 390 is withdrawn, while the implant 200 remains in the compressed delivery configuration within the lumen 125 of the delivery catheter 120, and the petals 720a-720c of the implant distal protection 700 remain compressed onto, and at least partially covering the distal portion 240 of the implant 200 (FIG. 9D).

[0069] Although the disclosed inventions are not so limited, the illustrated three-petal configuration (e.g., stems and petals) of the implant distal protections 700-1100 are configured to minimize the amount of material covering the distal end of the distal portion 240 of the implant 200, thereby reducing and minimizing resistive or frictional forces imparted by the implant on the inner wall of the delivery catheter 120 as the implant 200 is pushed through the lumen 125. In particular, the inventor(s) of the disclosed inventions have found that, by employing the depicted configuration of the implant distal protections 700-1100, the coefficient of friction between the implant 200 and the inner wall of the delivery catheter 120 ranges from approximately 0.01 to approximately 0.04 when there is relative motion between the core wire 350 and the delivery catheter 120.

[0070] In various embodiments, the implant distal protections 700-1100 are sized and configured to cover differing amounts of the distal end portion 240 of the implant 200 when a distal portion of the delivery wire assembly 300 including the implant 200 and implant distal protections 700-1100 are constrained within the delivery catheter lumen 125. By way of non-limiting examples, in one embodiment, the implant distal protections 700-1100 are sized and configured to cover as much as about twenty percent of a total length of the implant 200 when a distal portion of the delivery wire assembly 300 including the implant 200 and implant distal protections 700-1100 are constrained within the delivery catheter lumen 125. In another embodiment, the implant distal protections 700-1100 are sized and configured to cover between about ten percent and about twenty percent of a total length of the implant 200 when a distal portion of the delivery wire assembly 300 including the implant 200 and the implant distal protections 700-1100 are constrained within the delivery catheter lumen 125. In still another embodiment, the implant distal protections 700-1100 are sized and configured to cover between about five percent and about ten percent of a total length of the implant 200 when a distal portion of the delivery wire assembly 300 including the implant 200 and implant distal protections 700-1100 are constrained within the delivery catheter lumen 125. In yet another embodiment, the implant distal protections 700-1100 are sized and configured to cover about five percent or less of a total length of the implant 200 when a distal portion of the delivery wire assembly 300 including the implant 200 and implant distal protections 700-1100 are constrained within the delivery catheter lumen 125.

[0071] FIGS. 10A-H illustrate the implant distal protection 700 for delivery and deployment of the implant 200 to/at a targeted site in a vasculature (not shown). The implant distal protection 700 of FIGS. 4A-E is shown in FIGS. 10A-E as an exemplary distal protection used for the delivery and deployment of the implant 200. It should be appreciated that any of the implant distal protections disclosed in the alternative embodiments of FIGS. 5A-8 may be used for the delivery and deployment of the implant 200 to/at a targeted site.

[0072] FIG. 10A depicts a distal end portion of the delivery wire assembly 300 as the core wire 350 (not seen in FIG. 10A) is pushed through the delivery catheter lumen 125. The implant 200 and distal implant protection 700 are shown in the compressed delivery configuration, constrained within the delivery catheter lumen 125, with the petals 720a-720c of implant distal protection 700 covering and protecting the distal portion 240 of the implant 200.

[0073] Once the distal end portion of the delivery assembly 300 is located proximate to the targeted implantation site, the delivery catheter 120 is withdrawn proximally relative to the core wire 350 (shown by arrows I), or the core wire 350 is pushed distally relative to the delivery catheter 120 (shown by arrows II), or some of each, thereby exposing the implant distal protection 700 and the implant 200 out the distal end opening 452 of the delivery catheter 120, allowing the no-longer radially constrained implant 200 to self-expand radially, starting at the distal end portion 240, to the expanded configuration, as shown in FIGS. 10B-10E.

[0074] As the petals 720a-720c of the implant distal protection 700 have different extending lengths (e.g., petal 720a is shorter than either petals 720b-720c, petal 720b is shorter than petal 720c but longer than petal 720c, and petal 720c is longer than either petals 720a-720b), the implant distal protection 700 is configured to allow sequential deployment each of the petals 720a-720c as they exit out of the distal end opening 452 of the delivery catheter 120 avoiding or minimizing the risk of entanglement of the petals 720a-720c and/or avoiding or minimizing potential failure of the implant distal protection 700 (e.g., failure to radial expand). The sequential exit out of the delivery catheter 120 and radial expansion of the petals 720a-720c would be in the following order of: i) first, petal 720a, as the shortest of the petals (FIG. 10B), then ii) the petal 720b as the middle size (FIG. 10C), and finally, iii) petal 720c as the longest of the petals (FIG. 10D), to exit out of the distal end opening 452 of the delivery catheter 120. Notably, the petals 720a-720c remain generally extending in the proximal direction (i.e., in the delivery configuration) as the distal end portion 240 of the implant 200 assumes the expanded configuration and is no longer covered by the implant distal protection 700, as shown in FIGS. 10D-10H.

[0075] Further, the implant distal protection 700 respective stems 715a-715c are composed of Nitinol or any suitable superelastic material, such that the stems 715a-715c are configured assist and further allow radial expansion of their respective petals 720a-720c with elastic energy during deployment of the implant 200 and release of the distal end portion 240 of the implant, yet the petals 720a-720c remain extending in the proximal direction (e.g., facing toward the implant 200) in the delivery configuration (FIGS. 10A-10H). This feature further facilitates and allows recapture of the implant distal protection 700 during pullback into the delivery catheter 120 after the implant 200 is deployed to/at a targeted site (not shown).

[0076] The implant distal protection 700 is configured to exert negligible or otherwise insignificant forces over the distal portion 240 of the implant 200 as the implant 200 expands. In some embodiments, the implant distal protection 700 may outwardly radially expand when no longer radially constrained by the delivery catheter 120. In the described embodiments, when the implant distal protection 700 retains the delivery configuration or outwardly expands when no longer constrained by the delivery catheter 120, the petals 720a-720c are configured to extend and/or face in a proximal direction, (i.e., oriented towards the delivery system or implant, the individual petals 720a-720c preferably do not evert as the implant 200 expands).

[0077] After deployment of the implant 200 at the targeted site, the delivery wire assembly 300 is withdrawn back into the delivery catheter (not shown), and the delivery system 100 is withdrawn from the body, leaving the expanded implant 200 implanted at the targeted site. Notably, the core wire 350 and distal implant protection 700 are pulled through the lumen 260 of the implant 200 and back into the delivery catheter lumen 125 without interfering with the deployed expanded implant 200, due to the implant distal protection 700 proximal facing configuration and its relatively small size with respect to the expanded implant 200, as shown in FIG. 10G-10H. FIG. 10H is an enlarged view of the section shown in FIG. 10G, to better illustrate that the implant distal protection 700 substantially retains its delivery configuration even when the delivery catheter 120 is no longer constraining the implant distal protection 700.

[0078] The implant distal protection 700 may be fixedly attached to the core wire 350 by the locking members 750, so that the implant distal protection does not rotate relative to the core wire 350. Alternatively, the implant distal protection 700 may by rotatable relative to the core wire 350 and locking members 750. The rotatable implant distal protection 700 is configured to allow torque transmission to the distal end of the core wire 350 (e.g., atraumatic distal tip portion 380), which further allows vessel selection and facilitates navigation of the delivery wire assembly 300 to the targeted implantation site. When the implant distal protection 700 rotates with respect to the core wire 350, any externally induced (e.g., by patient's anatomy, user, clinician) relative torsion between the delivery catheter 120 and the core wire 350 is avoided or substantially minimized, preventing accumulation of torsional energy, detrimental to the deployment of the implant 200. As such, the rotatable implant distal protection 700 is configured to prevent accumulation of torsional energy in the delivery wire assembly 300 and the implant 200, when assembly 300 and implant 200 are radially constrained within the lumen 125 of the delivery catheter 120. Further, the rotatable implant distal protection 700 is configured to allow the petals 720a-720c to be coupled (e.g., maintain contact) to the implant 200 in the delivery configuration, when the core wire 350 is subjected to torsion.

[0079] It should be appreciated that any of the features disclosed for the implant distal protection 700, particularly in FIGS. 9A-10H, are also disclosed for the alternative embodiments of FIGS. 5A-8 except where they expressly differed, as described above.

[0080] Although particular embodiments have been shown and described herein, it will be understood by those skilled in the art that they are not intended to limit the disclosed inventions, and it will be obvious to those skilled in the art that various changes, permutations, and modifications may be made (e.g., the dimensions of various parts, combinations of parts) without departing from the scope of the disclosed inventions, which is to be defined only by the following claims and their equivalents. The specification and drawings are, accordingly, to be regarded in an illustrative rather than restrictive sense, and the embodiments depicted and described herein are intended to cover alternatives, modifications, and equivalents of thereof, which may be included within the scope of the appended claims.