Stent delivery systems and medical device delivery systems
By using the design of rotary coupling assembly in the stent delivery system, the problem of difficult stents to efficiently position and expand in the prior art is solved, and a more efficient aneurysm treatment effect is achieved.
Patent Information
- Application Number
- CN201980025178.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2018-04-12
- Filing Date
- 2019-04-10
- Publication Date
- 2025-02-11
- Estimated Expiration
- 2039-04-10
Smart Images

Figure CN112004504B_ABST
Abstract
Description
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application claims the benefit of priority to U.S. Patent Application No. 15 / 951,779, filed on April 12, 2018, U.S. Patent Application No. 15 / 951,890, filed on April 12, 2018, U.S. Patent Application No. 15 / 951,967, filed on April 12, 2018, and U.S. Patent Application No. 15 / 952,001, filed on April 12, 2018, each of which is incorporated herein by reference in its entirety. Background Art
[0003] The walls of the vascular system, particularly the walls of the arteries, may develop pathological dilated areas known as aneurysms, which typically have weak walls that are prone to rupture. Aneurysms are typically caused by weakening of the blood vessel wall due to disease, injury, or congenital abnormalities. Aneurysms occur in different parts of the body, and the most common are abdominal aortic aneurysms and brain (e.g., cerebral) aneurysms in the neurovascular vessels. When the weakened walls of the aneurysm rupture, especially if it is a cerebral aneurysm, death can result.
[0004] Aneurysms are typically treated by excluding or at least partially isolating a weakened portion of a blood vessel from the arterial circulation. For example, conventional aneurysm treatments include: (i) surgical clipping, in which a metal clip is secured around the base of the aneurysm; (ii) packing the aneurysm with small, flexible wire coils (microcoils); (iii) "filling" the aneurysm with embolic materials; (iv) occluding the parent vessel supplying the aneurysm using a detachable balloon or coil; and (v) endovascular stenting.
[0005] As is well known, intravascular stents are used in the medical field to treat vascular stenosis or aneurysms. A stent is a prosthesis that expands radially or otherwise within a blood vessel or lumen to support the vessel from collapsing. Methods for delivering these intravascular stents are also well known.
[0006] The conventional method of introducing the compressed stent into the blood vessel and positioning it in the stenosis or aneurysm region comprises percutaneously advancing the distal portion of the guide catheter through the patient's vascular system until the distal portion approaches the stenosis or aneurysm. The guide wire in the second inner catheter and the inner catheter is advanced through the distal region of the guide catheter. The guide wire is then pushed into the blood vessel from the distal region of the guide catheter until the distal portion of the guide wire carrying the compressed stent is positioned at the lesion point in the blood vessel. Then, the compressed stent is released and expanded so that it supports the blood vessel at the lesion point. Summary of the invention
[0007] For example, the present invention is presented according to the various aspects described below. For convenience, various examples of various aspects of the present invention are described as numbered clauses (1, 2, 3, etc.). These clauses are provided as examples and do not limit the present invention. It should be noted that any dependent clauses can be combined in any combination and placed in corresponding independent clauses (e.g., clause 1 or clause 23). Other clauses can be presented in a similar manner.
[0008] Clause 1. A stent delivery system comprising:
[0009] a core member configured for advancement within a body lumen;
[0010] a stent extending along the core member, the stent being characterized by a pore length; and
[0011] A coupling assembly positioned around the core member, the coupling assembly comprising:
[0012] a first plate rotatably coupled to the core member, the first plate including an outer surface having three or more projections that engage the bracket; and
[0013] a second plate rotatably coupled to the core member, the second plate comprising an outer surface having three or more projections that engage the bracket;
[0014] The protrusion of the first plate is longitudinally spaced apart from the protrusion of the second plate by a first longitudinal distance, and the first longitudinal distance is slightly smaller than an integral multiple of the hole length.
[0015] Clause 2. A system according to any clause 1, wherein, in a delivery configuration, the protrusion of the first plate engages with the hole of the bracket at a first longitudinal position, and wherein the protrusion of the second plate engages with the hole of the bracket at a second longitudinal position, and wherein the first longitudinal position and the second longitudinal position are separated by the first longitudinal distance.
[0016] Clause 3. The system of any one of clauses 1 to 2, wherein the first longitudinal distance is less than two hole lengths.
[0017] Clause 4. The system of any one of clauses 1 to 3, wherein the protrusion of the first plate engages a first hole of the bracket, the protrusion of the second plate engages a second hole of the bracket, and wherein the first hole and the second hole are longitudinally adjacent.
[0018] Clause 5. The system of any one of Clauses 1 to 4, wherein the projection of the first plate engages the stent at a location less than five hole lengths from a proximal end of the stent.
[0019] Clause 6. The system of any one of Clauses 1 to 5, wherein the projection of the first plate engages the stent at a location less than three hole lengths from the proximal end of the stent.
[0020] Clause 7. The system of any one of Clauses 1 to 7, wherein the first plate is configured to be inclined relative to a longitudinal axis of the core member.
[0021] Clause 8. The system of Clause 7, wherein the first plate is configured to be inclined up to 30 degrees relative to the longitudinal axis of the core member.
[0022] Clause 9. The system of any of Clauses 7 to 8, wherein the first plate is configured to be inclined up to 20 degrees relative to the longitudinal axis of the core member.
[0023] Clause 10. The system of any of Clauses 7 to 9, wherein the first plate is configured to be inclined up to 10 degrees relative to the longitudinal axis of the core member.
[0024] Clause 11. The system of any one of Clauses 1 to 11, wherein the second plate is configured to be inclined relative to a longitudinal axis of the core member.
[0025] Clause 12. The system of any clause 11, wherein the second plate is configured to be inclined up to 30 degrees relative to the longitudinal axis of the core member.
[0026] Clause 13. The system of any of Clauses 11 to 12, wherein the second plate is configured to be inclined up to 20 degrees relative to the longitudinal axis of the core member.
[0027] Clause 14. The system of any of Clauses 11 to 13, wherein the second plate is configured to be inclined up to 10 degrees relative to the longitudinal axis of the core member.
[0028] Clause 15. The system of any one of clauses 1 to 14, wherein the first longitudinal distance is less than an integer multiple of the bore length by a decrement equal to 1% to 50% of the bore length.
[0029] Clause 16. The system of any one of clauses 1 to 15, wherein the first longitudinal distance is less than an integer multiple of the bore length by a decrement equal to 1% to 40% of the bore length.
[0030] Clause 17. The system of any one of clauses 1 to 16, wherein the first longitudinal distance is less than an integer multiple of the bore length by a decrement equal to 1% to 30% of the bore length.
[0031] Clause 18. The system of any one of clauses 1 to 17, wherein the first longitudinal distance is less than an integer multiple of the bore length by a decrement equal to 1% to 20% of the bore length.
[0032] Clause 19. The system of any one of clauses 1 to 18, wherein the first longitudinal distance is less than an integer multiple of the bore length by a decrement equal to 1% to 10% of the bore length.
[0033] Clause 20. The system of any one of clauses 1 to 19, wherein the first longitudinal distance is less than an integer multiple of the bore length by a decrement equal to 1% to 5% of the bore length.
[0034] Clause 21. A system according to any one of clauses 1 to 20, wherein the connecting assembly further includes a spacer between the first plate and the second plate, and when the core member is in a straight orientation and the first plate and the second plate abut against the spacer, the spacer maintains the protrusions of the first plate and the second plate at the first longitudinal distance.
[0035] Clause 22. The system of any one of clauses 1 to 21, wherein the projections of the first plate and the second plate engage the bracket by projecting into holes of the bracket.
[0036] Clause 23. A system according to any one of clauses 1 to 22, wherein the hole length of the stent is obtained when the outer diameter of the stent is equal to the inner diameter of the catheter containing the stent and the connecting assembly and the first plate and the second plate are maintained in engagement with the stent.
[0037] Clause 24. A system according to any one of clauses 1 to 23, wherein:
[0038] The stent is a braided stent comprising braided filaments;
[0039] The protrusion of the first plate protrudes into the first hole of the bracket;
[0040] The protrusion of the second plate protrudes into the second hole of the bracket;
[0041] The first hole and the second hole are longitudinally adjacent and are separated by a filament longitudinally located between the first hole and the second hole;
[0042] The projection of the first plate is longitudinally offset from the center of the first hole in a direction toward the intersection of the filaments; and
[0043] The projection of the second plate is longitudinally offset from a center of the second aperture in a direction toward the filament intersection and the projection of the first plate.
[0044] Clause 25. The system of any one of Clauses 1 to 24, further comprising: a proximal restraint device carried by the core member, wherein the coupling assembly is positioned distal to the proximal restraint device.
[0045] Clause 26. A stent delivery system comprising:
[0046] Core components;
[0047] a stent extending along the core member, the stent comprising a plurality of pores and characterized by pore lengths; and
[0048] A connecting assembly, the connecting assembly being carried by the core component; the connecting assembly comprising:
[0049] a first stent engaging member rotatably coupled to the core member, the first stent engaging member comprising projections that engage a first plurality of apertures of the stent;
[0050] a second stent engaging member rotatably coupled to the core member, the second stent engaging member comprising projections that engage a second plurality of apertures of the stent;
[0051] The protrusion of the first bracket engaging member is longitudinally spaced apart from the protrusion of the second bracket engaging member by a first longitudinal distance, and the first longitudinal distance is slightly smaller than an integral multiple of the hole length.
[0052] Clause 27. The system of Clause 26, wherein the first plurality of holes and the second plurality of holes are longitudinally adjacent along a length of the stent.
[0053] Clause 28. The system of any of Clauses 26 to 27, wherein the first plurality of holes is less than five hole lengths from the proximal end of the stent.
[0054] Clause 29. The system of any one of Clauses 26 to 28, wherein the first plurality of holes is less than three hole lengths from the proximal end of the stent.
[0055] Clause 30. The system of any one of Clauses 26 to 29, wherein the first engagement member is configured to be inclined relative to a longitudinal axis of the core member.
[0056] Clause 31. The system of clause 30, wherein the first engagement member is configured to be inclined up to 30 degrees relative to the longitudinal axis of the core member.
[0057] Clause 32. The system of any of Clauses 30 to 31, wherein the first engagement member is configured to be inclined up to 20 degrees relative to the longitudinal axis of the core member.
[0058] Clause 33. The system of any one of clauses 30 to 32, wherein the first engagement member is configured to be inclined up to 10 degrees relative to the longitudinal axis of the core member.
[0059] Clause 34. The system of any one of Clauses 26 to 33, wherein the second engagement member is configured to be inclined relative to a longitudinal axis of the core member.
[0060] Clause 35. The system of clause 34, wherein the second engagement member is configured up to 30 degrees relative to the longitudinal axis of the core member.
[0061] Clause 36. The system of any of Clauses 34 to 35, wherein the second engagement member is configured to be inclined up to 20 degrees relative to the longitudinal axis of the core member.
[0062] Clause 37. The system of any of Clauses 34 to 36, wherein the second engagement member is configured to be inclined up to 10 degrees relative to the longitudinal axis of the core member.
[0063] Clause 38. The system of any of Clauses 26 to 37, wherein the first stent-engaging member and the second stent-engaging member are spaced apart by less than two hole lengths.
[0064] Clause 39. The system of any one of clauses 26 to 38, wherein the first longitudinal distance is less than an integer multiple of the bore length by a decrement equal to 1% to 50% of the bore length.
[0065] Clause 40. The system of any one of clauses 26 to 39, wherein the first longitudinal distance is less than an integer multiple of the bore length by a decrement equal to 1% to 40% of the bore length.
[0066] Clause 41. The system of any one of clauses 26 to 40, wherein the first longitudinal distance is less than an integer multiple of the bore length by a decrement equal to 1% to 30% of the bore length.
[0067] Clause 42. The system of any one of clauses 26 to 41, wherein the first longitudinal distance is less than an integer multiple of the bore length by a decrement equal to 1% to 20% of the bore length.
[0068] Clause 43. The system of any one of clauses 26 to 42, wherein the first longitudinal distance is less than an integer multiple of the bore length by a decrement equal to 1% to 10% of the bore length.
[0069] Clause 44. The system of any one of clauses 26 to 43, wherein the first longitudinal distance is less than an integer multiple of the bore length by a decrement equal to 1% to 5% of the bore length.
[0070] Clause 45. A system according to any one of clauses 26 to 44, wherein the connecting assembly further includes a spacer between the first joining member and the second joining member, and when the core member is in a straight-ahead orientation and the first joining member and the second joining member abut against the spacer, the spacer maintains the protrusions of the first joining member and the second joining member at the first longitudinal distance.
[0071] Clause 46. The system of any one of Clauses 26 to 45, wherein the protrusions of the first and second engagement members engage the stent by protruding into holes of the stent.
[0072] Clause 47. A system according to any one of clauses 26 to 46, wherein the hole length of the stent is obtained when the outer diameter of the stent is equal to the inner diameter of the catheter containing the stent and the connecting assembly and the first engaging member and the second engaging member are maintained in engagement with the stent.
[0073] Clause 48. A system according to any one of clauses 26 to 47, wherein:
[0074] The stent is a braided stent comprising braided filaments;
[0075] The protrusion of the first engagement member protrudes into the first hole of the bracket;
[0076] The protrusion of the second engagement member protrudes into the second hole of the bracket;
[0077] The first hole and the second hole are longitudinally adjacent and are separated by a filament longitudinally located between the first hole and the second hole;
[0078] The projection of the first engagement member is longitudinally offset from a center of the first aperture in a direction toward the intersection of the filaments; and
[0079] The projection of the second engagement member is longitudinally offset from a center of the second aperture in a direction toward the filament intersection and the projection of the first engagement member.
[0080] Clause 49. The system of any one of Clauses 26 to 48, further comprising: a proximal restraint device carried by the core member, wherein the coupling assembly is positioned distal to the proximal restraint device.
[0081] Clause 50. A method of advancing a stent within a catheter, the method comprising:
[0082] Distalizing a core member within the lumen of the catheter, the core member carrying a coupling assembly engaged with at least a portion of the stent, the coupling assembly comprising:
[0083] a first stent engaging member rotatably carried by the core member and comprising a projection that engages the stent; and
[0084] a second stent-engaging member rotatably carried by the core member and comprising a projection that engages the stent;
[0085] wherein the scaffold is characterized by pore length; and
[0086] wherein the projection of the first bracket engaging member is longitudinally spaced apart from the projection of the second bracket engaging member;
[0087] Distally moving the stent within the lumen of the catheter by distally moving the core member, wherein the first engagement member moves no more than a first hysteresis distance relative to the stent before initiating distal movement of the stent;
[0088] Wherein the first hysteresis distance does not exceed 40% of the hole length.
[0089] Clause 51. The method of Clause 50, wherein after the core member is advanced distally such that a portion of the stent is allowed to extend out of the catheter and expand, a proximal portion of the stent remains engaged with the first stent engagement member.
[0090] Clause 52. The method of Clause 51, further comprising retracting the core member proximally prior to releasing the stent such that the stent is recaptured within the catheter lumen.
[0091] Clause 53. The method of Clause 52, wherein the first stent-engaging member pulls the stent proximally within the catheter lumen by proximally retracting the core member.
[0092] Clause 54. The method of any one of Clauses 52 to 53, wherein the expanded portion of the stent prior to re-harvesting is at least 50% of the length of the stent.
[0093] Clause 55. The method of any one of Clauses 52 to 54, wherein the expanded portion of the stent prior to re-harvesting is at least 75% of the length of the stent.
[0094] Clause 56. The method of any one of Clauses 52 to 55, wherein the expanded portion of the stent prior to re-harvesting is at least 90% of the length of the stent.
[0095] Clause 57. The method of any one of Clauses 52 to 56, wherein the moving comprises rotating the stent relative to the core member.
[0096] Clause 58. A method according to any one of clauses 52 to 57, further comprising moving the stent proximally within the catheter lumen by proximally retracting the core member, wherein before the proximal movement of the stent begins, the first engaging member moves no more than a second lag distance relative to the stent, wherein the second lag distance does not exceed 40% of the length of the hole.
[0097] Clause 59. The method of any one of clauses 50 to 58, wherein the projection of the first stent-engaging member is longitudinally spaced from the projection of the second stent-engaging member by a first longitudinal distance, the first longitudinal distance being slightly less than an integer multiple of the hole length.
[0098] Clause 60. The method of any one of clauses 50 to 59, wherein the first lag distance does not exceed 33% of the hole length.
[0099] Clause 61. The method of any one of clauses 50 to 60, wherein the first lag distance is no more than 25% of the hole length.
[0100] Clause 62. The method of any one of clauses 50 to 61, wherein the first lag distance is no more than 20% of the hole length.
[0101] Clause 63. The method of any one of clauses 50 to 62, wherein the first lag distance is no more than 15% of the hole length.
[0102] Clause 64. The method of any one of clauses 50 to 63, wherein the first lag distance is no more than 10% of the hole length.
[0103] Clause 65. The method of any one of clauses 50 to 64, wherein the first lag distance does not exceed 5% of the hole length.
[0104] Clause 66. A stent delivery system comprising:
[0105] a core member configured for advancement within a body lumen;
[0106] a stent engagement member coupled to the core member, the engagement member comprising:
[0107] proximal surface;
[0108] distal surface;
[0109] a side surface extending between the proximal face and the distal face, the side surface comprising three or more protrusions separated by recesses, wherein the protrusions are unevenly spaced from one another along the side surface; and
[0110] an aperture extending through the proximal and second end faces, the core member extending through the aperture so that the engagement member can rotate about the core member; and
[0111] A stent extends along the core member and over the engagement member.
[0112] Clause 67. The stent delivery system of Clause 66, wherein the projections are spaced apart such that each projection is substantially aligned with an aperture of the stent when the stent is engaged with the engagement member.
[0113] Clause 68. The stent delivery system of any one of Clauses 66 to 17, wherein the stent comprises a braided stent having 48, 54, or 64 wires.
[0114] Clause 69. A stent delivery system according to any one of clauses 66 to 68, wherein the stent includes a plurality of holes surrounding the circumference of the stent at a given longitudinal position along the stent, and wherein the number of holes is not divisible by the number of protrusions of the engaging member.
[0115] Clause 70. The stent delivery system of Clause 69, wherein the stent comprises 32 holes at a first longitudinal position along the stent, and wherein the stent engagement member has 3, 5, 6, or 7 projections.
[0116] Clause 71. The stent delivery system of any one of Clauses 69 to 70, wherein the stent comprises 24 holes at a first longitudinal position along the stent, and wherein the stent engagement member has 5, 7 or 9 protrusions.
[0117] Clause 72. A stent delivery system according to any one of clauses 69 to 71, wherein the stent comprises 27 holes at a first longitudinal position along the stent, and wherein the stent engagement member has 4, 5, 6, 7 or 8 protrusions.
[0118] Clause 73. The stent delivery system of any one of Clauses 66 to 72, wherein the recesses each comprise a concave portion having a radius of curvature, and wherein the radius of curvature of the concave portion varies between a plurality of recesses.
[0119] Clause 74. The stent delivery system of any one of Clauses 66 to 73, wherein the recesses each comprise a recessed portion having a surface area, and wherein the surface area of the recessed portion varies between recesses.
[0120] Clause 75. The stent delivery system of any one of Clauses 66 to 74, wherein the recesses each have an angular size, and the angular sizes of the recesses vary.
[0121] Clause 76. A stent delivery system according to any one of clauses 66 to 75, wherein the joining member includes a first edge and a second edge, the first edge is formed at the intersection of the proximal face and the side surface, the second edge is formed at the intersection of the distal face and the side surface, and wherein the first edge and the second edge are circular.
[0122] Clause 77. The stent delivery system of any one of Clauses 66 to 76, wherein the projections each include a radially outermost contact region configured to engage the stent.
[0123] Clause 78. The stent delivery system of Clause 77, wherein each contact region comprises:
[0124] Central part;
[0125] a first shoulder portion extending from the central portion toward a first adjacent recess; and
[0126] A second shoulder portion extends from the central portion toward a second adjacent recess.
[0127] Clause 79. The stent delivery system of Clause 78, wherein the central portion comprises a substantially flat outer surface.
[0128] Clause 80. The stent delivery system of any one of Clauses 66 to 79, wherein the projections each include a radially outermost contact region configured to interlock with the stent.
[0129] Clause 81. The stent delivery system of any one of Clauses 66 to 80, wherein the projections each include a radially outermost contact region configured to project into one or more apertures of the stent.
[0130] Clause 82. A stent delivery system according to any one of clauses 66 to 81, further comprising a catheter having an inner surface and an inner lumen, the core member extending through the inner lumen, wherein at least a portion of the stent is radially positioned between a side surface of the engagement member and an inner surface of the catheter.
[0131] Clause 83. The stent delivery system of any one of Clauses 66 to 82, wherein the engagement member has a thickness of between about 50-100 microns.
[0132] Clause 84. The stent delivery system of any one of Clauses 66 to 83, wherein the number of projections is between three and six.
[0133] Clause 85. The stent delivery system of any one of Clauses 66 to 84, wherein the stent engagement member comprises a rigid plate.
[0134] Clause 86. The stent delivery system of any one of Clauses 66 to 85, wherein the stent engagement member comprises a sprocket.
[0135] Clause 87. The stent delivery system of any one of Clauses 66 to 86, wherein the maximum radial dimension of the stent engaging member is at least five times greater than the thickness of the stent engaging member.
[0136] Clause 88. The stent delivery system of any one of Clauses 66 to 87, wherein the aperture is configured such that the engagement member can be tilted relative to a longitudinal axis of the core member.
[0137] Clause 89. The stent delivery system of any of Clause 88, wherein the engagement members can be tilted up to 30 degrees relative to the longitudinal axis of the core member.
[0138] Clause 90. The stent delivery system of any one of Clauses 88 to 89, wherein the engagement member can be tilted up to 20 degrees relative to the longitudinal axis of the core member.
[0139] Clause 91. The stent delivery system of any one of Clauses 88 to 90, wherein the engagement member can be tilted up to 10 degrees relative to the longitudinal axis of the core member.
[0140] Clause 92. A stent engagement member for use in a stent delivery system, the engagement member comprising:
[0141] a first end surface;
[0142] a second end surface, the second end surface being opposite to the first end surface;
[0143] a side surface extending between the proximal face and the distal face, the side surface comprising three or more protrusions separated by recesses, wherein the protrusions are unevenly spaced from one another along the side surface; and
[0144] A central opening extends through the proximal end surface and the second end surface, the opening being configured to receive a core member therethrough.
[0145] Clause 93. The stent-engaging member of Clause 92, wherein the recesses each comprise a concave portion having a radius of curvature, and wherein the radius of curvature of the concave portion varies between the plurality of recesses.
[0146] Clause 94. The stent delivery system of any one of Clauses 92 to 93, wherein the recesses each have an angular size, and the angular sizes of the recesses vary.
[0147] Clause 95. The stent-engaging member of any of Clauses 92 to 94, wherein the recesses each comprise a recessed portion having a surface area, and wherein the surface area of the recessed portion varies between recesses.
[0148] Clause 96. A joining member system according to any one of clauses 92 to 95, wherein the joining member includes a first edge and a second edge, the first edge is located between the proximal face and the side surface, the second edge is located between the distal face and the side surface, and wherein the first edge and the second edge are circular.
[0149] Clause 97. The stent-engaging member of any one of Clauses 92 to 96, wherein the projections each include a radially outermost contact region, wherein each contact region comprises:
[0150] Central part;
[0151] a first shoulder portion extending from the central portion toward a first adjacent recess; and
[0152] A second shoulder portion extends from the central portion toward a second adjacent recess.
[0153] Clause 98. The stent-engaging member of Clause 97, wherein the central portion comprises a generally flat outer surface.
[0154] Clause 99. The stent engagement member of any one of Clauses 92 to 98, wherein the engagement member has a thickness between about 50-100 microns.
[0155] Clause 100. The stent-engaging member of any of Clauses 92 to 99, wherein the number of protrusions is between three and six.
[0156] Clause 101. The stent engaging member of any one of Clauses 92 to 100, wherein the stent engaging member comprises a rigid plate.
[0157] Clause 102. The bracket engagement member of any one of Clauses 92 to 101, wherein the bracket engagement member comprises a sprocket.
[0158] Clause 103. The stent-engaging member of any of Clauses 92 to 102, wherein a maximum radial dimension of the stent-engaging member is at least five times greater than a thickness of the stent-engaging member.
[0159] Clause 104. The stent engagement member of any one of Clauses 92 to 103, wherein the aperture is configured such that the engagement member can be tilted relative to a longitudinal axis of the core member.
[0160] Clause 105. A method of advancing a stent delivery assembly through a catheter, the method comprising:
[0161] A core member is distally moved within the lumen of the catheter, the core member carrying an engagement member that engages at least a portion of the stent, the engagement member comprising:
[0162] a proximal face, a distal face, and a side surface extending between the proximal face and the distal face, the side surface comprising three or more protrusions separated by recesses, wherein the protrusions are unevenly spaced from one another along the side surface, and the protrusions contact an inner surface of the stent; and
[0163] an orifice extending through the proximal end face and the second end face, the core member extending through the orifice;
[0164] Pulling the stent distally within the catheter lumen by moving the core member; and
[0165] The core member is advanced distally so that a portion of the stent carried by the core member is allowed to extend out of the catheter and expand.
[0166] Clause 106. The method of any of Clauses 105, wherein after the core member is advanced distally such that a portion of the stent is allowed to extend out of the catheter and expand, a proximal portion of the stent remains engaged with the stent engagement member.
[0167] Clause 107. The method of any one of Clauses 105 to 106, further comprising proximally retracting the core member prior to releasing the stent such that the stent is recaptured within the catheter lumen.
[0168] Clause 108. The method of Clause 107, wherein the stent engaging member pulls the stent proximally within the catheter lumen by proximally retracting the core member.
[0169] Clause 109. The method of Clause 108, wherein the expanded portion of the stent prior to re-harvesting is at least 50% of the length of the stent.
[0170] Clause 110. The method of any one of Clauses 108 to 19, wherein the expanded portion of the stent prior to re-harvesting is at least 75% of the length of the stent.
[0171] Clause 111. The method of any one of Clauses 108 to 110, wherein the expanded portion of the stent prior to re-harvesting is at least 90% of the length of the stent.
[0172] Clause 112. The method of any one of Clauses 108 to 111, wherein the moving comprises rotating the stent relative to the core member.
[0173] Clause 113. A stent delivery system comprising:
[0174] a core member configured for advancement within a body lumen;
[0175] A coupling assembly positioned around the core member, the coupling assembly comprising:
[0176] a first plate rotatably positioned about the core member, the first plate comprising an outer surface having three or more protrusions separated by recesses;
[0177] a push element positioned on the core member proximate the first plate, the push element having a distally facing engagement surface; and
[0178] a stent extending along the core member such that the stent is engaged by one or more projections of the first plate, the stent having a proximal edge;
[0179] Wherein the distally facing engagement surface of the pushing element abuts the proximal edge of the stent.
[0180] Clause 114. The system of any of Clauses 113, wherein the pushing element is configured to transmit a distally directed force to the stent, rather than a proximally directed force.
[0181] Clause 115. The system of any of clauses 113 to 114, wherein the coupling assembly is configured such that the first plate transmits proximally directed forces to the stent, but transmits little or no distal directed forces.
[0182] Clause 116. The system of any one of clauses 113 to 115, wherein the coupling assembly further comprises a rigid first spacer located between the first plate and the urging element.
[0183] Clause 117. The system of Clause 116, wherein the first spacer comprises a solid tube of metal or a rigid polymer.
[0184] Clause 118. The system of clause 117, wherein the first spacer lacks a flexibility enhancing cutout.
[0185] Clause 119. A system according to any one of clauses 113 to 118, wherein the first spacer includes a proximal face, a distal face, and an outer surface, wherein the outer surface extends along the longitudinal axis between the proximal face and the distal face, and wherein the proximal face and the distal face are each substantially orthogonal to the longitudinal axis of the first spacer.
[0186] Clause 120. The system of any one of clauses 113 to 119, wherein the first spacer comprises a flattened proximal surface configured to abut the pushing element.
[0187] Clause 121. The system of any of clauses 113 to 120, wherein the bracket forms a plurality of openings, and the protrusion of the first plate engages the bracket by extending into the openings.
[0188] Clause 122. A system according to any one of clauses 113 to 121, wherein the connecting assembly further includes a second plate that is rotatably positioned around the core member, the second plate comprising an outer surface having three or more protrusions separated by recesses, and wherein one or more of the protrusions of the second plate engage the bracket through an opening formed in the bracket.
[0189] Clause 123. The system of any one of Clauses 113 to 122, further comprising: a sheath or catheter, wherein the core member, coupling assembly, and stent are positioned within the sheath or catheter.
[0190] Clause 124. The system of any of clauses 113 to 123, wherein the urging element comprises a proximal restraining member.
[0191] Clause 125. A medical device delivery system comprising:
[0192] Core components;
[0193] A coupling assembly, the coupling assembly being carried by the core component, the coupling assembly comprising:
[0194] a first device engagement member rotatably coupled to the core member, the first device engagement member comprising an outer surface having projections separated by recesses; and
[0195] A push element is positioned on the core member proximate the first device engagement member, the push element having a distally facing engagement surface.
[0196] Clause 126. The system of clause 125, further comprising:
[0197] a medical device extending along the core member such that the medical device is engaged by one or more projections of the first plate;
[0198] wherein the medical device has a proximal edge;
[0199] Wherein the distally facing engagement surface of the pushing element abuts the proximal edge of the medical device.
[0200] Clause 127. The system of Clause 126, wherein the push element is configured to transmit a distally directed force to the medical device rather than a proximally directed force.
[0201] Clause 128. The system of any one of clauses 126 to 127, wherein the coupling assembly is configured such that the first device engagement member transmits a proximal guiding force to the medical device, but transmits little or no distal guiding force.
[0202] Clause 129. The system of any one of clauses 125 to 128, wherein the coupling assembly further comprises a rigid first spacer located between the first device engagement member and the urging element.
[0203] Clause 130. The system of Clause 129, wherein the first spacer comprises a solid tube of metal or a rigid polymer.
[0204] Clause 131. The system of clause 130, wherein the first spacer lacks a flexibility enhancing cutout.
[0205] Clause 132. The system of any one of clauses 126 to 131, wherein the medical device forms a plurality of openings, and the projection of the first device engagement member engages the medical device by extending into the openings.
[0206] Clause 133. A system according to clause 132, wherein the connection assembly further includes a second device engaging member that is rotatably positioned around the core member, the second device engaging member comprising an outer surface having three or more protrusions separated by recesses, and wherein one or more of the protrusions of the second device engaging member engages the medical device through an opening formed in the medical device.
[0207] Clause 134. The system of any one of clauses 126 to 133, further comprising: a sheath or catheter, wherein the core member, coupling assembly, and medical device are positioned within the sheath or catheter.
[0208] Clause 135. The system of any one of clauses 125 to 134, wherein the first device engagement member is in the form of a plate or a sprocket.
[0209] Clause 136. A method of delivering a tubular medical device via a catheter, the method comprising:
[0210] Manipulating a delivery system comprising a core component and a coupling assembly, the coupling assembly comprising:
[0211] a first device engaging member comprising an outer surface having protrusions separated by recesses, the protrusions engaging the medical device through an opening in the medical device; and
[0212] a push element positioned on the core member proximal to the first device engagement member; and
[0213] The medical device is moved distally by transmitting a distally directing force to the medical device via the urging element and not transmitting a distally directing force to the medical device via the first device engagement member.
[0214] Clause 137. The method of clause 136, further comprising moving the medical device proximally by transmitting a proximally directing force to the stent via the first device engagement member and not transmitting a proximally directing force to the stent via the urging element.
[0215] Clause 138. The method of clause 137, wherein moving the medical device proximally comprises re-sheathing the medical device.
[0216] Clause 139. A method according to any one of clauses 137 to 138, wherein moving the medical device distally comprises partially extending the medical device from an end of a catheter or sheath, and moving the medical device proximally comprises re-sheathing the medical device into the catheter or sheath.
[0217] Clause 140. The method of any one of clauses 136-39, wherein the coupling assembly further comprises a first spacer positioned on the core member between the first device engagement member and the pushing element.
[0218] Clause 141. The method of Clause 140, further comprising maintaining engagement between the medical device and the push element via the first spacer.
[0219] Clause 142. The method of any one of Clauses 136 to 141, wherein the medical device comprises a stent.
[0220] Clause 143. The method of any one of clauses 136 to 142, wherein the first device engagement member is in the form of a plate or a sprocket.
[0221] Clause 144. A stent delivery system comprising:
[0222] a core member configured for advancement within a body lumen;
[0223] A coupling assembly positioned around the core member, the coupling assembly comprising:
[0224] a first plate rotatably positioned about the core member, the first plate comprising an outer surface having three or more protrusions separated by recesses;
[0225] a coil spacer positioned about the core member proximate to and adjacent the first plate; and
[0226] A stent extends along the core member such that the stent is engaged by the one or more projections of the first plate and can thereby be advanced distally through the core member.
[0227] Clause 145. The system of clause 144, wherein the coil spacer comprises a zero-pitch coil.
[0228] Clause 146. The system of any of clauses 144 to 145, wherein the coil spacer is substantially incompressible in the axial direction.
[0229] Clause 147. The system of any one of clauses 144 to 146, wherein the coil spacer is rotatably positioned about the core member.
[0230] Clause 148. A system according to any one of clauses 144 to 147, wherein the coil spacer includes a proximal face, a distal face, and an outer surface, wherein the outer surface extends along a longitudinal axis between the proximal face and the distal face, and wherein the proximal face and the distal face are each substantially orthogonal to the longitudinal axis of the coil spacer.
[0231] Clause 149. A system according to any one of clauses 144 to 148, further comprising: a proximal restraint device connected to the core member, and wherein the coil spacer includes a flattened proximal surface, which is configured to abut against the proximal restraint device.
[0232] Clause 150. The system of any of clauses 144 to 149, wherein the coil spacer comprises a flattened distal face configured to abut the first plate.
[0233] Clause 151. The system of any one of clauses 144 to 150, wherein the coil spacer has a length between about 1-2 mm.
[0234] Clause 152. The system of any one of clauses 144 to 151, wherein the coil spacer is coated with a lubricating material.
[0235] Clause 153. The system of clause 152, wherein the lubricating material comprises PTFE.
[0236] Clause 154. The system of any of clauses 144 to 153, wherein an outer diameter of the coil spacer is less than or equal to a recess diameter of the first plate.
[0237] Clause 155. The system of any one of clauses 144 to 154, wherein the maximum radial dimension a of the first plate is configured to fit within a .017", .021", or .027" inner diameter conduit.
[0238] Clause 156. The system of any of clauses 144 to 155, wherein the coil spacer comprises a wire having a square or rectangular cross-section wound into a coil configuration.
[0239] Clause 157. A system according to any one of clauses 144 to 156, wherein the coil spacer comprises a wire wound into a coil configuration, and the wound wire forms a plurality of windings, each winding having a flat distal side and a proximal side, wherein the faces of adjacent windings contact each other so that the coil spacer can withstand longitudinal compressive loads without shortening.
[0240] Clause 158. The system of any one of clauses 144 to 157, further comprising: a proximal restriction device coupled to the core member proximate to and adjacent to the coil spacer to prevent longitudinal movement of the coil spacer proximate to the proximal restriction device.
[0241] Clause 159. A system according to any one of clauses 144 to 158, wherein the connecting assembly further includes a second plate that is rotatably positioned around the core member, the second plate comprising an outer surface having three or more protrusions separated by recesses, and wherein one or more of the protrusions of the second plate engage the stent so that the stent can be advanced distally through the core member.
[0242] Clause 160. The system of Clause 159, further comprising a distal restraint disposed distally of the second plate, the distal restraint being longitudinally fixed relative to the core member.
[0243] Clause 161. A system according to any of clauses 159 to 160, wherein the maximum radial dimension of the first plate is at least 5 times larger than the maximum width dimension of the first plate, and wherein the maximum radial dimension of the second plate is at least 5 times larger than the maximum width dimension of the second plate.
[0244] Clause 162. The system of any one of clauses 159 to 161, wherein the coupling assembly further comprises a second spacer positioned about the core member and disposed between the first plate and the second plate.
[0245] Clause 163. The system of clause 162, wherein the second spacer comprises a second coil spacer.
[0246] Clause 164. The system of any one of clauses 162 to 163, wherein the second spacer comprises a solid tubular member.
[0247] Clause 165. The system of any one of clauses 144 to 164, wherein the coupling assembly is rotatably positioned about the core member.
[0248] Clause 166. A medical device delivery system comprising:
[0249] Core components;
[0250] A coupling assembly, the coupling assembly being carried by the core component, the coupling assembly comprising:
[0251] a first device engagement member rotatably coupled to the core member, the first device engagement member comprising an outer surface having projections separated by recesses; and
[0252] A coil spacer is coupled to the core member and is positioned proximate and adjacent to the first device engagement member.
[0253] Clause 167. The system of clause 166, wherein the coil spacer comprises a zero pitch coil.
[0254] Clause 168. The system of any of clauses 166 to 167, wherein the coil spacer is substantially incompressible in the axial direction.
[0255] Clause 169. The system of any one of clauses 166 to 168, wherein the coil spacer is rotatably coupled to the core member.
[0256] Clause 170. A system according to any one of clauses 166 to 169, wherein the coil spacer includes a proximal face, a distal face, and an outer surface, wherein the outer surface extends along a longitudinal axis between the proximal face and the distal face, and wherein the proximal face and the distal face are each substantially flat and orthogonal to the longitudinal axis of the coil spacer.
[0257] Clause 171. The system of any of clauses 166 to 170, wherein the coil spacer comprises a flattened proximal face configured to abut a proximal restraint coupled to the core member.
[0258] Clause 172. The system of any one of clauses 166 to 171, wherein the coil spacer comprises a flattened distal face configured to abut against the first device engagement member.
[0259] Clause 173. The system of any one of clauses 166 to 172, wherein the coil spacer has a length between about 1-2 mm.
[0260] Clause 174. The system of any one of clauses 166 to 173, wherein the coil spacer is coated with a lubricating material.
[0261] Clause 175. The system of clause 174, wherein the lubricating material comprises PTFE.
[0262] Clause 176. The system of any one of clauses 166 to 175, wherein an outer diameter of the coil spacer is less than or equal to a recess diameter of the first device engagement member.
[0263] Clause 177. The system of any one of clauses 166 to 176, wherein the first device engagement member comprises a rigid plate or a sprocket.
[0264] Clause 178. The system of clause 177, wherein the coupling assembly further comprises a second device engagement member comprising a rigid plate or a sprocket.
[0265] Clause 179. The system of any of clauses 166 to 178, wherein the coil spacer comprises a wire having a square or rectangular cross-section wound into a coil configuration.
[0266] Clause 180. A system according to any one of clauses 166 to 179, wherein the coil spacer comprises a wire wound into a coil configuration, and the wound wire forms a plurality of windings, each winding having a flat distal side and a proximal side, wherein the faces of adjacent windings contact each other so that the coil spacer can withstand longitudinal compressive loads without shortening.
[0267] Clause 181. The system of any one of clauses 166 to 180, further comprising a proximal restraint coupled to the core member proximate to and adjacent to the coil spacer to prevent longitudinal movement of the coil spacer proximate to the proximal restraint.
[0268] Clause 182. A system according to any one of clauses 166 to 181, wherein the connection assembly further includes a second device engagement member, the second device engagement member being rotatably positioned around the core member, the second device engagement member comprising an outer surface having three or more protrusions separated by recesses.
[0269] Clause 183. The system of clause 182, further comprising a distal restraint disposed distally of the second device engagement member, the distal restraint being longitudinally fixed relative to the core member.
[0270] Clause 184. A system according to any one of clauses 182 to 183, wherein the maximum radial dimension of the first device joining member is at least 5 times larger than the maximum width dimension of the first device joining member, and wherein the maximum radial dimension of the second device joining member is at least 5 times larger than the maximum width dimension of the second device joining member.
[0271] Clause 185. A system according to any one of clauses 182 to 184, further comprising an expandable medical device that extends along the core member so that the medical device is engaged by one or more protrusions of the first device engagement member and the second device engagement member and can thereby be advanced distally through the core member.
[0272] Clause 186. The system of clause 185, wherein the medical device comprises a stent.
[0273] Clause 187. The system of any one of clauses 182 to 186, wherein the coupling assembly further comprises a second spacer positioned about the core member and disposed between the first device engagement member and the second device engagement member.
[0274] Clause 188. The system of clause 187, wherein the second spacer comprises a second coil spacer.
[0275] Clause 189. The system of clause 187, wherein the second spacer comprises a solid tubular member.
[0276] Clause 190. The system of any one of clauses 166 to 189, wherein the coupling assembly is rotatably positioned about the core member.
[0277] Clause 191. The system of any one of clauses 166 to 190, wherein the core member is configured for advancement within a body lumen.
[0278] Clause 192. A method of advancing a medical device within a catheter, the method comprising:
[0279] Distalizing a core member within the lumen of the catheter, the core member carrying a coupling assembly within the catheter engaged with at least a portion of the medical device, the coupling assembly comprising:
[0280] a first device engagement member rotatably carried by the core member and comprising a projection that engages the medical device; and
[0281] a coil spacer carried by the core member and positioned proximal to the first device engagement member;
[0282] Distal movement of the medical device within the catheter by distal movement of the core member; and
[0283] While moving the core member distally, a distal directing force is transmitted from the core member to the first device engagement member and the medical device via the coil spacer without longitudinally shortening the coil spacer.
[0284] Clause 193. The method of clause 192, wherein the medical device comprises a stent.
[0285] Clause 194. The method of any one of Clauses 192 to 193, wherein moving the medical device distally further comprises extending the medical device out of the catheter and expanding.
[0286] Clause 195. The method of Clause 194, further comprising retracting the core member proximally prior to releasing the medical device such that the device is recaptured within the catheter lumen.
[0287] Clause 196. The method of any one of clauses 193 to 195, wherein the first device engagement member pulls the stent proximally within the catheter lumen as a result of proximally retracting the core member.
[0288] Clause 197. The method of any one of Clauses 195 to 196, wherein the expanded portion of the medical device prior to reacquisition is at least 50% of the length of the device.
[0289] Clause 198. The method of any one of Clauses 195 to 197, wherein the expanded portion of the medical device prior to reacquisition is at least 75% of the length of the device.
[0290] Clause 199. The method of any one of Clauses 195 to 198, wherein the expanded portion of the medical device prior to reacquisition is at least 90% of the length of the device.
[0291] Clause 200. The method of any one of clauses 192 to 199, wherein the moving comprises rotating the medical device relative to the core member.
[0292] Clause 201. The method of any one of Clauses 192 to 200, further comprising advancing the core member and coil spacer through a bend in the catheter and thereby bending the coil spacer.
[0293] Clause 202. The method of clause 201, wherein bending the coil spacer comprises bending the coil spacer while transmitting a distal guiding force from the core member to the first device engagement member and the medical device via the coil spacer.
[0294] Clause 203. The method of any one of clauses 192 to 202, wherein the coupling assembly further comprises a second device engagement member rotatably carried by the core member and comprising a protrusion that engages with the medical device.
[0295] Clause 204. The method of clause 203, further comprising transmitting a distal guiding force from the core member to the second device engagement member and the medical device via the coil spacer while moving the core member distally.
[0296] Clause 205. The method of any one of clauses 203 to 204, wherein the coupling assembly further comprises a second spacer carried by the core member and positioned between the first device engagement member and the second device engagement member.
[0297] Clause 206. The method of any one of Clauses 192 to 205, wherein the medical device comprises a flow-diverting stent, and further comprising deploying the stent from the catheter across an aneurysm to treat the aneurysm with flow-diverting therapy.
[0298] Additional features and advantages of the present technology will be set forth in the following description, and in part will become apparent from the description, or may be learned through practice of the subject technology. The advantages of the present technology are realized and obtained through the structures specifically pointed out in the written description and its claims together with the drawings.
[0299] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the technology as claimed. BRIEF DESCRIPTION OF THE DRAWINGS
[0300] Many aspects of the present disclosure may be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on clearly demonstrating the principles of the present technology. For ease of reference, throughout this disclosure, the same reference numerals may be used to identify the same or at least generally similar or similar components or features.
[0301] Figure 1 is a schematic diagram of a medical device delivery system configured in accordance with some embodiments.
[0302] Figure 2 is a cross-sectional side view of a medical device delivery system according to some embodiments.
[0303] Figure 3A is an enlarged perspective view of a coupling assembly having a bracket engagement member according to some embodiments.
[0304] Figure 3B yes Figure 3A An enlarged perspective view of a coupling assembly with an overlying bracket.
[0305] Figure 4A and 4B They are Figure 2-3B A side view and a cross-sectional side view of a spacer of a coupling assembly are shown.
[0306] Figures 5A-5C They are Figure 2-3B Side, top and perspective views of individual engagement members of the coupling assembly are shown.
[0307] Fig. 6A yes Figure 3B Schematic cross-sectional view of a joining member and a bracket.
[0308] Figure 6B yes Figure 3B An enlarged detail view of a portion of the stent is shown.
[0309] Fig. 7A is a perspective view of another embodiment of a joining member.
[0310] Figure 7B yes Fig. 7A Schematic cross-sectional view of an engagement member engaged with an overlying support.
[0311] Fig. 8A is a perspective view of another embodiment of a joining member.
[0312] Figure 8B yes Fig. 8A Schematic cross-sectional view of an engagement member engaged with an overlying support.
[0313] Fig. 9A and 9B 1 and 2 are side and bottom views, respectively, of another embodiment of a stent engagement member.
[0314] Fig. 10A and 10B 1 and 2 are side and bottom views, respectively, of another embodiment of a stent engagement member.
[0315] Figures 11A-11C Enlarged detail views of portions of stent engagement members are shown according to various embodiments. DETAILED DESCRIPTION
[0316] Conventional stent engagement members include soft "pads" that rely on a friction fit to secure a stent (such as a braided, knitted or woven stent, or a laser cut stent, or other tubular implant or medical device) to the inner wall of a catheter. Such friction fit pads may require several different pad diameters to accommodate different stent sidewall thicknesses, which may vary based on the size of the wire (or combination of wire sizes) or the sidewall thickness of the tube blank used to form a given stent. That is, within a given catheter size, the inner diameter of the compressed (braided, knitted or woven, or laser cut) stent contained in the catheter will vary based on the size (diameter) of the wire, or the wall thickness of the tube blank, and possible other parameters of the stent corresponding to different deployment sizes or target vessel sizes. This may require the use of different pad diameters to accommodate different stent sizes within a desired range (e.g., pad diameters of approximately 3.5 to 5 mm), which requires pads of various diameters to be manufactured to very small dimensional tolerances. Embodiments of the present technology may allow a single sized stent engagement member to be used with a relatively wide range of stent inner diameters within a given catheter size (e.g., a .027", .021" or .017" inner diameter catheter). For example, a stent engagement member comprising a rigid plate, sprocket, or member having a plurality of protrusions separated by recesses may be used to secure a range of different stent sizes within a given catheter.
[0317] References Figure 1-11CThe specific details of several embodiments of the technology of the present invention are described. Although many embodiments are described with respect to devices, systems and methods for delivering stents, tubular implants (such as filters, shunts or stent grafts) and other medical devices, other applications and other embodiments other than those described herein are also within the scope of the technology of the present invention, and can be used in any embodiment of the embodiment of the system disclosed herein, instead of the generally disclosed stent. It should be noted that, in addition to the embodiments disclosed herein, other embodiments are also within the scope of the technology of the present invention. Further, embodiments of the technology of the present invention may have configurations, components and / or processes different from those shown or described herein. In addition, embodiments of the technology of the present invention may have configurations, components and / or processes other than those shown or described herein, and without departing from the technology of the present invention, these and other embodiments may not have several configurations, components and / or processes shown or described herein.
[0318] As used herein, the term "distal" and "proximal" define a position or direction relative to a clinician or clinician's control device (e.g., a handle of a delivery catheter). For example, the term "distal and distally" refers to a position along the length of the device away from a clinician or clinician's control device or in a direction away from a clinician or clinician's control device. In a related example, the term "proximal and proximally" refers to a position along the length of the device close to a clinician or clinician's control device or located in a direction toward a clinician or clinician's control device. The title provided herein is for convenience only and should not be construed as limiting the disclosed subject matter.
[0319] Selected Examples of Coupling Assemblies for Medical Device Delivery Systems
[0320] Figure 1-11C Embodiments of medical device delivery systems that can be used to deliver and / or deploy medical devices such as, but not limited to, stents into hollow anatomical structures such as blood vessels are depicted. The stents may include braided stents or other forms of stents, such as woven stents, knitted stents, laser cut stents, rolled stents, and the like. The stents may optionally be configured to act as a "flow shunt" device for treating aneurysms, such as those present in blood vessels containing arteries in the brain or within the skull, or other locations in the body, such as peripheral arteries. The stent may optionally be similar to any version or size of the PIPELINE sold by Medtronic Neurovascular of Irvine, California, USA. TMEmbolic devices. The stent may alternatively include any suitable tubular medical device and / or other features as described herein. In some embodiments, the stent may be any of the stents described in U.S. Application No. 15 / 892,268, filed on February 8, 2018, entitled “VASCULAR EXPANDABLE DEVICES,” the entire contents of which are hereby incorporated by reference herein and become a part of this specification.
[0321] Figure 1 1 is a schematic diagram of a medical device delivery system 100 configured according to an embodiment of the present technology. The system 100 may include an elongated tube or catheter 101 that slidably receives a core member or core assembly 103 configured to carry a stent 105 through the catheter 101. The depicted catheter 101 has a proximal region 107 and a relatively distal region 109 that can be positioned at a treatment site within a patient, a lumen 111 extending from the proximal region 107 to the distal region 109, and an inner surface 113 defining the lumen 111. The catheter 101 has a distal opening 115 at the distal region 109 through which the core member 103 can be advanced beyond the distal region 109 to expand or deploy the stent 105 within a blood vessel 116. The proximal region 107 may include a catheter hub (not shown). The catheter 101 may define an overall longitudinal dimension extending between the proximal region 107 and the distal region 109. The longitudinal dimension need not be straight along some or any of its length when the delivery system 100 is in use.
[0322] The core member 103 is configured to extend generally longitudinally through the lumen 111 of the catheter 101. The core member 103 may generally include any one or more members having sufficient flexibility and breaking strength to enable the stent 105 or other medical device to be moved through the catheter 101. Thus, the core member 103 may include a wire, a tube (e.g., a hypotube), a braid, a coil, or other suitable one or more members, or a combination of one or more wires, one or more tubes, one or more braids, one or more coils, etc.
[0323] The system 100 may also include a coupling assembly 120 or a re-sheathing assembly 120 configured to releasably retain a medical device or stent 105 relative to the core member 103. The coupling assembly 120 may be configured to engage the stent 105 by mechanical interlocking with the holes and filaments of the stent 105, abutting the proximal side or edge of the stent 105, frictional engagement with the inner wall of the stent 105, or any combination of these modes of action. Thus, the coupling assembly 120 may cooperate with the overlying inner surface 113 of the catheter 101 to grasp and / or abut the stent 105, so that the coupling assembly 120 may move the stent 105 along and within the catheter 101, e.g., distal and / or proximal movement of the core member 103 relative to the catheter 101 results in corresponding distal and / or proximal movement of the stent 105 within the catheter lumen 111.
[0324] In some embodiments, the coupling assembly 120 (or one or more portions thereof) can be configured to rotate around the core member 103. In some such embodiments, the coupling assembly 120 can include a proximal restraint 119 and a distal restraint 121. The proximal restraint 119 and the distal restraint 121 can be fixed to the core member 103 to prevent or limit the proximal or distal movement of the coupling assembly 120 along the longitudinal direction of the core member 103. For example, the proximal restraint 119 and the distal restraint 121 can be welded or fixed to the core wire 103 with an adhesive. The outer diameter or other radial outermost dimension of one or both of the proximal restraint 119 and the distal restraint 121 can be smaller than the outer diameter or other radial outermost dimension of the overall coupling assembly 120, so that during operation of the system 100, one or both of the restraints 119, 121 do not contact the inner surface of the stent 105. (In some embodiments, as described in further detail below, the distal side of proximal restraint 119 can be sized to abut the proximal side of stent 105 and deploy during delivery to urge the stent toward.) Distal restraint 121 can taper downwardly in the distal direction toward core member 103. Such taper can reduce the risk of distal restraint 121 contacting the inner surface of stent 105, particularly during navigation of tortuous vasculature in which system 100 can assume a highly tortuous configuration.
[0325] The coupling assembly 120 may also include a first stent engagement member (or device engagement member or re-sheathing member) 123a and a second stent engagement member 123b (collectively referred to as "engagement members 123") disposed around the core member 103 between the proximal restraint 119 and the distal restraint 121, and a first spacer 125a and a second spacer 125b (collectively referred to as "spacer 125"). In the illustrated embodiment, from proximal to distal, the elements of the coupling assembly 120 include the proximal restraint 119, followed by the first spacer 125a, the first stent engagement member 123a, the second spacer 125b, the second stent engagement member 123b, and finally the distal restraint 121. In this configuration, the first spacer 125a defines the relative positioning of the first engagement member 123a and the proximal restraint 119. The second spacer 125b defines the relative longitudinal spacing between the first engagement member 123a and the second engagement member 123b.
[0326] As described in more detail below, one or both of the spacers 125 can take the form of a wire loop, solid tube, or other structural element that can be mounted on the core member 103 to longitudinally separate adjacent components of the coupling assembly 120. In some embodiments, as described below with respect to Figure 4A and 4B Described in more detail, one or two of the spacers 125 can be zero pitch coils with flattened ends. In some embodiments, one or two of the spacers 125 can be a solid tube (e.g., a laser cut tube) that is rotatably mounted or non-rotatably fixed (e.g., welded) to the core member 103. The radially outermost dimension of the spacer 125 can be smaller than the radially outermost dimension of the engagement member 123 so that the spacer 125 does not contact the stent 105 during normal operation of the system 100. As described in more detail below, the size, construction, and configuration of the spacer 125 can be selected to improve the grip between the coupling assembly 120 and the overlying stent 105.
[0327] As follows about Figure 3A , 3B 5A-11C, one or both of the stent engagement members 123 can be a rigid plate, sprocket, or member configured to have a central aperture configured to receive the core member 103 therein. The stent engagement member 123 is configured to mechanically interlock or engage the stent 105 such that the stent engagement member 123 limits longitudinal movement of the stent 105 relative to the core member 103.
[0328] although Figure 1The illustrated embodiment includes two stent engagement members 123 and two spacers 125, but the number of stent engagement members and spacers can vary. In at least one embodiment, the coupling assembly 120 includes only a single stent engagement member without any spacers. In other embodiments, the number of stent engagement members can vary, for example, two, three, four, five, six or more stent engagement members separated by spacers.
[0329] exist Figure 1 In the depicted embodiment of the coupling assembly 120, the proximal restraint 119 is configured to abut the proximal side or proximal edge of the stent 105. In this arrangement, the proximal restraint 119 can be used to move (e.g., push) the stent 105 distally through the distal side of the catheter 101 in response to a thrust applied to the core member 103. The diameter of such a proximal restraint 119 can be slightly smaller than the inner diameter of the catheter 101, thereby leaving a small circumferential or radial gap between the outer edge of the proximal restraint 119 and the inner wall of the catheter 101. In addition, the length of the proximal spacer 125a can be determined so that the proximal edge of the stent 105 abuts the distal side of the proximal spacer 119.
[0330] When the proximal restraint 119 is configured to push the stent 105 distally, the proximal restraint thus transmits some, most, or all of the distal longitudinal (thrust) forces to the stent 105 in a manner that replaces all or part of one or more stent engagement members 123. In such a configuration, the stent engagement member 123 can transmit little or no thrust to the stent 105 while the stent 105 is delivered distally along the length of the catheter. Advantageously, when the engagement member is used to transmit force to the stent 105 within the catheter 101 and move the guide stent, this reduces or eliminates the tendency of one or more stent engagement members 123 to deform the hole of the stent 105 that is engaged with the engagement member. Using the proximal restraint 119 to move the stent 105 in this manner can also reduce or eliminate the longitudinal movement of the stent 105 relative to the core member 103, which is sometimes accompanied by the above-mentioned hole deformation. In most cases, the vast majority of the travel of the stent 105 within the catheter 101 during delivery to the treatment site is in the distal or "push" direction, compared to the relatively short travel involved in re-sheathing the stent 105 in the proximal or "push" direction. Therefore, configuring the proximal restraint 119 to transmit most or all of the push force to the stent 105 can significantly reduce or substantially eliminate such deformation and / or relative longitudinal movement of the stent.
[0331] Figure 1The coupling assembly 120 of the embodiment can therefore use the proximal restraint 119 as a pushing element to transmit at least some, most, or all of the distal guiding thrust to the stent 105 during delivery. In such a coupling assembly 120, one or more stent engagement members 123 do not transmit any distal guiding thrust to the stent 105 during delivery (or only transmit a small portion of such force, or only do so intermittently). The one or more stent engagement members 123 can transmit proximal guiding pulling forces to the stent 105 during retraction or re-sheathing, and the proximal restraint 119 may not transmit proximal guiding pulling forces to the stent (or the proximal restraint may occasionally or intermittently do so, for example, when a portion of the stent 105 is trapped between the outer edge of the proximal restraint 119 and the inner wall of the catheter 101).
[0332] exist Figure 1 In some embodiments of the coupling assembly 120, the first spacer 125a can be a rigid tube. Such a rigid tube can include a solid (e.g., lacking a flexibility-enhancing cut such as a spiral cut or a periodic arcuate cut) tube of a rigid material (e.g., metal or a rigid polymer). When the delivery system is advanced through a curved path, the use of a rigid tube as the first spacer 125a tends to reduce or eliminate lateral bending of the delivery system 100 around the junction of the proximal restriction device 119 and the first spacer 125a. When the proximal restriction device 119 is used as a pushing element to transmit a distal guiding thrust to the stent 105 during delivery, the lack of bending in this area may be advantageous. When bending occurs, the distal side of the proximal restriction device 119 may become poorly engaged with the proximal end of the stent 105, for example, only engaged along a portion of the circumference of the stent. This may cause the thrust to be concentrated on only a small portion of the stent, and / or cause the stent to slide into the radial gap between the outer edge of the proximal restriction device and the inner wall of the catheter 101. Any of these failure modes could adversely affect the function of the delivery system, or damage the stent, or both.
[0333] In some embodiments, one or more stent engagement members 123 are used for both distal and proximal movement of stent 105 relative to catheter 101. One or more engagement members 123 transmit distal guiding forces to stent 105 to move the stent distally within catheter 101 during delivery, and transmit proximal guiding forces to stent 105 to move the stent proximally into catheter 101 during re-sheathing. In such embodiments, proximal restraint 119 may be made with a relatively small outer diameter, and / or positioned sufficiently proximal to stent 105 to prevent proximal restraint 119 from transmitting distal guiding thrusts to stent 105 during delivery.
[0334] In operation, the stent 105 can be moved distally or proximally in the catheter 101 via the core member 103 and the coupling assembly 120. In order to remove the stent 105 from the catheter 101, the core member 103 is moved distally while the catheter 101 is kept stationary, or the core member 103 is kept stationary while the catheter 101 is withdrawn proximally. When the core member 103 is moved distally, the distal side of the proximal limiting device 119 abuts against the proximal end or edge of the stent 105 and propels the stent distally, and finally moves out of the distal region 109 of the catheter 101. (In embodiments in which one or more stent engagement members 123 are used to transmit a thrust to stent 105, mechanical engagement or interlocking between stent engagement member 123 and stent 105 causes stent 105 to move distally through and out of catheter 101 in response to application of a distally directing force to core member 103.) Conversely, to resheath or otherwise move stent 105 into catheter 101, relative movement between core member 103 and catheter 101 is reversed as compared to moving stent 105 out of the catheter, such that a proximal region of distal restraint 121 abuts a distal region of second spacer 125b, and spacer 125 and stent engagement member 123 are thereby retracted relative to catheter 101. Mechanical engagement between stent engagement member 123 and stent 105 thus retains stent 105 relative to core member 103 such that proximal movement of stent 105 relative to catheter 101 enables resheathing of stent 105 back into distal region 109 of catheter 101. This is useful when the stent 105 has been partially deployed and a portion of the stent 105 remains disposed between at least one of the stent engagement members 123 (e.g., the first stent engagement member 123a) and the inner surface 113 of the catheter 101, because the stent 105 can be retracted into the distal opening 115 of the catheter 101 by moving the core member 103 proximally relative to the catheter 101 (and / or moving the catheter 101 distally relative to the core member 103). Resheathing in this manner remains possible until the stent engagement members 123 and / or the catheter 101 have been moved to a point where the first stent engagement member 123a is outside of the distal opening 115 of the catheter 101, and the stent 105 is released from between the first stent engagement member 123a and the catheter 101.
[0335] The stent engagement member 123 and the spacer 125 (or any of the engagement members or spacers disclosed herein) can be fixed to the core member 103 in a longitudinal / sliding manner and / or in a radial / rotational manner so as to be immovable relative to the core member 103. Alternatively, the spacer 125 and / or the stent engagement member 123 can be coupled to (e.g., mounted on) the core member 103 so that the spacer 125 and / or the stent engagement member 123 can rotate about the longitudinal axis of the core member 103 and / or move or slide longitudinally along the core member 103. In such embodiments, the spacer 125 and / or the stent engagement member 123 can each have a lumen or orifice in which the core member 103 is received so that the spacer 125 and / or the stent engagement member 123 can slide and / or rotate relative to the core member 103. Additionally, in such embodiments, the proximal restraint 119 and the distal restraint 121 can be spaced apart along the core member 103 by a longitudinal distance slightly greater than the combined length of the spacer 125 and the stent engagement member 123 to maintain one or more longitudinal gaps between the first spacer 125a and the second spacer 125b and between the proximal restraint 119 and the distal restraint 121, respectively. When one or more longitudinal gaps are present, the gaps allow the spacer 125 and the stent engagement member 123 to slide longitudinally between the restraint 119 and the restraint 121 along the core member 103. The range of longitudinal motion of the spacer 125 and the stent engagement member 123 between the restraint 119 and the restraint 121 is approximately equal to the total combined length of the one or more longitudinal gaps, if any.
[0336] In lieu of or in addition to one or more longitudinal gaps, the coupling assembly 120 can also include radial gaps between the outer surface of the core member 103 and the inner surfaces of the spacer 125 and the stent engagement member 123. Such radial gaps can be formed when the spacer 125 and / or the stent engagement member 123 are configured with a hole that is slightly larger than the outer diameter of the corresponding portion of the core member 103. When radial gaps are present, the gaps allow the spacer 125 and / or the stent engagement member 123 to rotate about the longitudinal axis of the core member 103 between the restriction device 119 and the restriction device 121. The presence of a longitudinal gap of at least a minimum size on either side of the spacer 125 and the stent engagement member 123 can also facilitate rotation of the spacer 125 and the stent engagement member 123.
[0337] In some embodiments, the stent engagement member 123 can be mounted to the core member 103 to allow not only rotational movement but also a certain degree of tilting of the engagement member 123 relative to the longitudinal axis of the core member 103. For example, the hole in the stent engagement member 123 can be larger than the outer diameter of the corresponding portion of the core member 103, thereby allowing both rotational movement and tilting relative to the core member 103. As used herein, "tilted" means that the long axis of the stent engagement member 123 (i.e., the axis extending along the longest dimension of the stent engagement member 123, substantially parallel to the proximal end face and the distal end face of the stent engagement member 123) is not orthogonal to the longitudinal axis of the core member 103. For example, in an inclined configuration, the long axis of the first stent engagement member 123a can intersect the core member 103 at approximately 85 degrees, which indicates a tilt of 5 degrees. Depending on the size of the stent engagement member 123 and the core member 103, the degree of tilt allowed can vary. In some embodiments, one or both of stent engagement members 123 can be tilted 30 degrees or less, 20 degrees or less, 10 degrees or less, or 5 degrees or less relative to core member 103. In some embodiments, one or both of stent engagement members 123 can be tilted at least 5 degrees, at least 10 degrees, at least 20 degrees, or more relative to the core member.
[0338] By allowing one or two of the stent engagement members 123 to tilt relative to the core member 103, the coupling assembly 120 can better navigate the curved anatomical structure of the delivery system 100 in a highly curved state. In addition, the tilting of the stent engagement member 123 can promote the re-sheathing of the overlying stent 105 from a partially deployed state. For example, when a portion of the stent 105 has been moved distally beyond the distal 113 of the catheter 101, the stent 105 can be in a partially deployed state, so that the stent 105 has been released from the second stent engagement member 123b, but the stent 105 still remains engaged with the first stent engagement member 123a. From this partially deployed state, the stent 105 can be re-sheathed or re-retracted by advancing the catheter 101 distally relative to the coupling assembly 120 (or alternatively, by retracting the core member 103 and the coupling assembly 120 proximally relative to the catheter 101). During this movement, as the stent 105 moves proximally relative to the catheter 101, the stent 105 begins to collapse along its length until the stent assumes an outer diameter corresponding to the inner diameter of the catheter 101 and engages the second stent engagement member 123b. With continued distal movement of the catheter relative to the coupling assembly 120, the second stent engagement member 123b is ultimately received within the lumen 111 of the catheter 101, wherein the stent 105 is interlocked with the stent engagement member 123b and maintained in that relationship by the catheter. When the second stent engagement member 123b initially contacts the distal side 113 of the catheter 101, there is some risk that the proximally facing end surface of the second stent engagement member 123b will abut the distal side 113 of the catheter 101, thereby inhibiting the second stent engagement member 123b from retracting into the lumen 111 of the catheter 101. By allowing the second stent engagement member 123b to tilt relative to the core member 103, the second stent engagement member 123b can be tilted to allow at least a portion of the second stent engagement member 223b to easily enter the lumen 111 of the catheter 101 when the proximally facing end surface of the second stent engagement member 123b abuts the distal side of the catheter 101. Once at least a portion of the second stent engagement member 123b is positioned within the lumen 111, the coupling assembly 120 can continue to be retracted until the second stent engagement member 123b is fully received within the lumen 111, and the stent 105 can be fully resheathed or retracted.
[0339] Figure 2 A side cross-sectional view of another embodiment of a medical device delivery system 200 configured in accordance with an embodiment of the present technology is shown. Figure 1 In the described operation, the delivery system 200 can be configured to carry a stent (or other vascular implant or device) 205 thereon to advance the stent to a target site in a patient through a surrounding catheter. (For clarity, Figure 2The surrounding catheter is omitted). The delivery system 200 can be advanced distally relative to the distal side of the catheter to expand or deploy the stent 205 at the target site.
[0340] The delivery system 200 can be used with any number of catheters. For example, the catheter can optionally include a MARKSMAN® catheter of various lengths available from Medtronic Neurovascular, Inc., Irvine, California, USA. TM The catheter may optionally include a microcatheter having an inner diameter of about 0.030 inches or less and / or an outer diameter of 3 French or less near the distal region. In lieu of or in addition to these specifications, the catheter may include a microcatheter configured to percutaneously access the internal carotid artery or another location within the neurovascular distal to the internal carotid artery.
[0341] The delivery system 200 may include a core member or core assembly 202 configured to extend generally longitudinally through the lumen of a catheter. The core member 202 may have a proximal region 204 and a distal region 206 that may optionally include a tip coil 208. The core member 202 may also include an intermediate portion 210 positioned between the proximal region 204 and the distal region 206. The intermediate portion 210 is a portion of the core member 202 that is positioned when the core member 202 is in a position such as Figure 2 The pre-deployment configuration is shown with the support 205 extending over or above the portion.
[0342] The core member 202 may generally include any one or more members having sufficient flexibility and breaking strength to allow a stent or other medical device to move through the surrounding conduit. Thus, the core member 202 may include a wire, a tube (e.g., a hypotube), a braid, a coil, or other suitable one or more members, or a combination of one or more wires, one or more tubes, one or more braids, one or more coils, etc. Figure 2 The depicted embodiment of the core component 202 is a multi-component construction that includes a wire 212 having a tube 214 surrounding the wire along at least a portion of its length. A layer of lubricating material, such as PTFE (polytetrafluoroethylene or TEFLON) may be included. TM ) or other lubricating polymer can cover some or all of the tube 214 and / or the wire 212. The wire 212 can taper or vary in diameter along part or all of its length. The wire 212 can include one or more fluorine-safe markers (not shown), and such one or more markers can be positioned on a portion of the wire 212 not covered by the outer layer 218 (e.g., the proximal side of the outer layer 218). This portion of the wire 212 marked by one or more markers and / or the proximal side of any outer layer 218 can include an exposed metal outer surface.
[0343] The core member 202 may further include a proximal coupling assembly 220 and / or a distal interface assembly 222 that can interconnect the stent 205 with the core member 202. The proximal coupling assembly 220 may include one or more stent engagement members 223a-b (collectively referred to as "engagement members 223") configured to mechanically engage or interlock with the stent 205. In this way, for example, when a user pushes the core member 202 distally and / or pulls the core member proximally relative to the catheter, causing the stent 205 to move distally and / or proximally within the catheter lumen, the proximal coupling assembly 220 cooperates with the overlying inner surface of the surrounding catheter (not shown) to grasp the stent 205, so that the proximal coupling assembly 220 can move the stent 205 along and within the catheter.
[0344] In some embodiments, the proximal coupling assembly 220 can be similar to the Figure 1 Any of the versions or embodiments of the coupling assembly 120 described. For example, the proximal coupling assembly 220 can include a proximal restraint 219 and a distal restraint 221 that are fixed to the core member 202 (e.g., fixed to the guide wire 212 in the depicted embodiment) in a longitudinal / sliding manner or a radial / rotational manner so as to be immovable relative to the core member 202. The proximal coupling assembly 220 can also include a plurality of stent engagement members 223 separated by spacers 225a-b (collectively referred to as "spacers 225"). The stent engagement members 223 and the spacers 225 can be coupled to (e.g., mounted on) the core member 202 so that the proximal coupling assembly 220 can rotate around the longitudinal axis of the core member 202 (e.g., the intermediate portion 210), and / or move or slide longitudinally along the core member 202. In some embodiments, the proximal restraint 219 includes a substantially cylindrical body having an outer diameter greater than or equal to the outer diameter of the first spacer 225a. The distal restraint 221 can taper downwardly in the distal direction toward the core member 202. Such taper can reduce the risk of the distal restraint 221 contacting the inner surface of the overlying stent 205, particularly during navigation in a tortuous vasculature in which the system 200 can assume a highly tortuous configuration. In some embodiments, the outer diameter or other radially outermost dimension of the distal restraint 221 can be smaller than the outer diameter or other radially outermost dimension of the overall proximal coupling assembly 220, such that the distal restraint 221 will tend not to contact the inner surface of the inner overlying stent 205.
[0345] exist Figure 2In the proximal coupling assembly 220 shown, the stent 205 can be moved distally or proximally within an overlying catheter (not shown) through the proximal coupling assembly 220. In some embodiments, after the stent 205 is partially deployed from the distal opening of the catheter, the stent 205 can be moved in a manner similar to that described above with respect to Figure 1 The proximal coupling assembly 220 is re-sheathed in the manner described for the coupling assembly 120 in FIG.
[0346] The proximal coupling assembly 220 may be similar to Figure 1 The embodiment of the coupling assembly 120 depicted is configured and operated in a manner. Specifically, the proximal restraint 219 can be made to function as a pushing element by appropriately adjusting the outer diameter of the proximal restraint 219 and the length of the first spacer 225a so that the distal side of the proximal restraint 219 abuts the proximal side or edge of the stent 105. When the proximal coupling element 220 is so arranged, the proximal restraint 219 can transmit at least some, most, or all of the distal guiding thrust to the stent 205 during delivery, and the one or more stent engagement members 223 do not transmit any distal guiding thrust to the stent 205 during delivery (or only transmit a small portion of such force, or only do so intermittently). The one or more stent engagement members 223 can transmit a proximal guiding pulling force to the stent 205 during retraction or re-sheathing, and the proximal restraint 219 can not transmit a proximal guiding pulling force to the stent (or the proximal restraint can occasionally or intermittently transmit such a force, for example, when a portion of the stent 205 is trapped between the outer edge of the proximal restraint 219 and the inner wall of the catheter). Again similar to Figure 1 In the illustrated coupling assembly 120 , when the proximal coupling assembly 220 includes a proximal restraining device 219 configured as a pushing element, the first spacer 225a may optionally take the form of a solid tube.
[0347] Although the proximal coupling assembly 220 may be configured in such a manner that the proximal restraint 219 abuts the stent 205 so that the proximal restraint 219 can serve as a pushing element, the coupling assembly 220 is Figure 2 and 3A -3B. As described elsewhere herein, the depicted configuration requires the use of stent-engaging member 223 for both distal (delivery) and proximal (re-sheathing) movement of stent 205.
[0348] Optionally, when in the delivery configuration, the proximal edge of the proximal coupling assembly 220 can be positioned just distal to the proximal edge of the stent 205. In some such embodiments, this enables re-sheathing of the stent 205 when as little as a few millimeters of the stent remains in the catheter. Thus, for stents of typical lengths, a re-sheathability of 75% or more can be provided (i.e., the stent can be re-sheathed when the stent has been deployed 75% or more).
[0349] Continue to refer Figure 2 , the distal interface assembly 222 can include a distal engagement member 224 that can take the form of, for example, a distal device cover or a distal stent cover (generally, a "distal cover"). The distal cover 224 can be configured to reduce friction between the stent 205 (e.g., its distal portion) and the inner surface of the surrounding catheter. For example, the distal cover 224 can be configured as a lubricated flexible structure having a free first end or segment 224a that can extend over at least a portion of the stent 205 and / or the intermediate portion 266 of the core member 202, and a fixed second end or segment 224b that can be coupled (directly or indirectly) to the core member 202.
[0350] The distal covering 224 can have a first or delivery position, configuration, or orientation, wherein the distal covering can extend proximally relative to the distal tip 264 or from the second segment 224b or its (direct or indirect) attachment to the core member 202 and at least partially surround or cover the distal portion of the stent 205. The distal covering 224 can be moved from the first or delivery orientation to a second or re-sheathing position, configuration, or orientation (not shown), wherein the distal covering can be everted such that the first end 224a of the distal covering is positioned distally relative to the second end 224b of the distal covering 224 to enable the core member 202 to be re-sheathed with or without the stent 205 it carries. Figure 2 As shown, the first section 224a of the distal cover 224 can originate from the proximal side of the second section 224b. In another embodiment, the first section 224a can originate from the distal side of the second section 224b.
[0351] Lubricating and / or hydrophilic materials (such as PTFE or ) to make the distal cover 224, but the distal cover can be made of other suitable lubricating materials or lubricating polymers. The distal cover can also include a radiopaque material that can be mixed into the main material (e.g., PTFE) to impart radiopacity. The thickness of the distal cover 224 can be between about 0.0005" and about 0.003". In some embodiments, the distal cover can be one or more PTFE strips having a thickness of about 0.001".
[0352] The distal cover 224 (e.g., the second end 224b thereof) can be fixed to the core member 202 (e.g., to the wire 212 or its distal tip) in a longitudinal / sliding manner or a radial / rotational manner so as to be immovable relative to the core member 202. Alternatively, as Figure 2 As depicted, the distal cover 224 (e.g., its second end 224b) can be coupled to (e.g., mounted on) the core member 202 so that the distal cover 224 can rotate around the longitudinal axis of the core member 202 (e.g., the wire 212) and / or move or slide longitudinally along the core member. In such embodiments, the second end 224b can have an inner cavity in which the core member 202 is received so that the distal cover 224 can slide and / or rotate relative to the core member 202. In addition, in such embodiments, the distal interface assembly 222 can further include a proximal restriction device 226 and / or a distal restriction device 228, the proximal restriction device is fixed to the core member 202 and positioned proximal to the distal cover 224 (the second end 224b of the distal cover), and the distal restriction device is fixed to the core member 202 and positioned distal to the distal cover 224 (the second end 224b of the distal cover). The distal interface assembly 222 can include a radial gap between the outer surface of the core member 202 (e.g., the guide wire 212) and the inner surface of the second end 224b. Such a radial gap can be formed when the second end 224b is configured to have an inner diameter of the lumen that is slightly larger than the outer diameter of the corresponding portion of the core member 202. When the radial gap exists, the radial gap allows the distal cover 224 and / or the second end 224b to rotate around the longitudinal axis of the core member 202 between the restriction device 226 and the restriction device 228.
[0353] In some embodiments, the outer diameter or other radially outermost dimension of one or both of the proximal restraint 226 and the distal restraint 228 may be smaller than the (e.g., pre-deployment) outer diameter or other radially outermost dimension of the distal cover 224, such that one or both of the restraints 226, 228 tend not to abut or contact the inner surface of the catheter during manipulation of the core member 202. Alternatively, it may be preferred to have the outer diameter of the restraints 226 and 228 larger than the maximum radial dimension of the distal cover 224 before deployment, and / or to have the outer diameter of the proximal restraint 226 larger than the outer diameter of the distal restraint 228. This configuration allows the distal cover 224 and the restraints 226, 228 to be easily and smoothly retracted into the catheter after stent deployment.
[0354] In operation, when the stent 205 is moved distally through the surrounding catheter, the distal covering 224, and in particular the first section 224a, can generally cover and protect the distal region of the stent 205. The distal covering 224 can act as a bearing or buffer layer that, for example, inhibits the filament ends of the distal region of the stent 205 (wherein the stent includes a braided stent) from contacting the inner surface of the catheter, which may damage the stent 205 and / or the catheter, or otherwise compromise the structural integrity of the stent 205. Since the distal covering 224 can be made of a lubricating material, the distal covering 224 can exhibit a low friction coefficient that allows the distal region of the stent to slide axially in the catheter relatively easily. The friction coefficient between the distal covering and the inner surface of the catheter can be between about 0.02 and about 0.4. For example, in an embodiment in which the distal covering and the catheter are formed of PTFE, the friction coefficient can be about 0.04. Such embodiments can advantageously improve the ability of the core member 202 to pass through the catheter, particularly in a curved vascular system.
[0355] The structure other than the embodiment of the distal cover 224 described herein can be used to cover the distal region of the stent 205 or otherwise be connected with the distal region of the stent in the core member 202 and / or the distal interface assembly 222. For example, a protective coil or other sleeve with a longitudinally oriented, proximally open inner cavity can be adopted. In other embodiments, the distal interface assembly 222 can omit the distal cover 224, or the distal cover can be replaced with an assembly similar to the proximal coupling assembly 220. In the case of adopting the distal cover 224, the distal cover can be connected to the distal tip coil 208 (for example, by surrounding and encircling some or all of the windings in the coil 208 windings) or attached to or connected to the outer surface of the coil by an adhesive or a shrink tube around it. The distal cover 224 can be (directly or indirectly) connected to other parts of the core member 202, such as the wire 212.
[0356] In the embodiment of the core member 202 that adopts both the rotatable proximal coupling assembly 220 and the rotatable distal cover 224, the stent 205 can be rotated relative to the core member around the longitudinal axis of the core member 202 by means of the rotatable connection of the proximal coupling assembly 220 and the distal cover 224. In such embodiments, the stent 205, the proximal coupling assembly 220 and the distal cover 224 can rotate together around the core member 202 in this way. When the stent 205 can rotate around the core member 202, the core member 202 can be more easily advanced through the curved blood vessel because the tendency of the blood vessel to distort the stent 205 and / or the core member 202 is eliminated by the rotation of the stent 205, the proximal coupling assembly 220 and the distal cover 224 around the core member 202. In addition, since the input thrust of the user is not transferred to the torsion of the stent 205 and / or the core member 202, the required thrust or delivery force is reduced. Also reduce or eliminate the tendency of twisted support 205 and / or core member 202 to suddenly untie or " whip " when exiting the curvature of support 205 or unfolding, and the tendency of twisted support to resist expansion when unfolding. Further, in some such embodiments of core member 202, the user can make core member 202 " turn " by tip coil 208, particularly if coil 208 is bent into a certain angle in its unstressed configuration. Such coil tip can rotate around the longitudinal axis of system 200 relative to support, coupling assembly 220 and / or distal covering 224 by rotating the distal region 206 of core member 202. Therefore, the user can point coil tip 208 to the desired direction of travel of core member 202, and when advancing core member, tip will guide core member along selected direction.
[0357] Figure 3A is an enlarged perspective view of the coupling assembly 220 of the medical device delivery system 200, and Figure 3B A coupling assembly 220 having an overlying stent 205 is shown. The coupling assembly 220 includes a first engagement member 223a and a second engagement member 223b mounted on a core member 202 adjacent to a first spacer 225a and a second spacer 225b. A proximal restraint 219 is disposed proximal to the proximal-most spacer 225a, and a distal restraint 221 is disposed distal to the distal-most engagement member 223b. Figure 3B As shown, first stent engagement member 223a and second stent engagement member 223b can interlock with the stent, for example, by protruding into a hole in stent 205. Engagement members 223 can thereby cooperate with an overlying catheter (not shown) to secure stent 205.
[0358] Figure 4A and 4B225a or any spacer configuration of any embodiment of the coupling assembly or delivery system disclosed herein. In at least some embodiments, the first spacer 225a includes a wire coil 230 that defines a central lumen 232 through which the core member 202 extends. The coil 230 may have a proximal face 234 and a distal face 236 relative to the core member. The end faces 234, 236 may be substantially planar and substantially orthogonal to the longitudinal axis of the coil 230. For example, in some embodiments, the end faces 234, 236 may be ground, polished or otherwise flattened to provide a plane substantially orthogonal to the long axis of the spacer 225a. Since the plane increases the contact area between the proximal limiting device 219 and the proximal face 234, and also increases the contact area between the distal face 236 of the spacer 225a and the first stent engagement member 223a, this may improve the pushability or breaking strength of the entire system 200.
[0359] In some embodiments, the coil wire 230 is a zero pitch coil, which is configured so that each winding of the coil 230 is in direct contact with the adjacent winding of the coil 230 under unconstrained conditions. In such embodiments, the coil 230 can be substantially incompressible in the axial direction under the forces typically encountered during the use of the delivery system 200. This incompressibility can provide the pushability of the solid tube spacer while also allowing the bending flexibility of the coil. During the bending of the coil 230, one or more windings of the coil 230 can become partially separated from each other to accommodate the bending movement. In the absence of external forces, the coil 230 can return to its unconstrained state (i.e., with zero pitch).
[0360] Continue to refer Figure 4A and 4B , the lumen 232 of the coil 230 can define an inner diameter ID that is slightly larger than the corresponding outer diameter of the core member 202. For example, in some embodiments, the diameter of the lumen 232 can be approximately between about 0.008"-0.02", or between about 0.0160"-0.018", or between about 0.0165"-0.017". In at least some embodiments, the coil 230 can be freely rotatable relative to the core member 202. In other embodiments, the coil wire 230 can be rotationally fixed relative to the core member 202, for example, by attaching all or a portion of the coil 230 to the core member 202 using solder, adhesive or other attachment techniques. In some embodiments, the radial outermost diameter (OD) of the coil 230 can be smaller than the stent engagement member 223 ( Figure 3A and 3B) such that the coil 230 does not contact the overlying stent 205 during normal operation of the delivery system 200. In some embodiments, the radial outermost diameter OD of the coil 230 can be between about 0.008"-0.02", or between about 0.016"-0.018", or between about 0.0165"-0.017".
[0361] In some embodiments, the individual thickness or strand diameter SD of the wire forming coil 230 ( Figure 4B ) can be between about 0.0015-0.006" or approximately 0.005". The wire forming the coil 230 can have a square or rectangular cross-section along its length. In the case of such a square or rectangular cross-section, the wire can form a winding having planes facing in the distal direction and the proximal direction. The longitudinally adjacent planes are in contact with each other, and the flat nature of the surfaces provides a stable, non-bending structure under longitudinal compression loads. At the same time, the overall coil configuration of the spacer is flexible and bendable under bending loads. The longitudinal length L of the spacer 225 can vary depending on the desired positioning between the proximal restraint 219 and the first stent engagement member 223a ( Figure 3A and 3B ). For example, in some embodiments, the longitudinal length L can be between about 0.03"-0.05", or between about 0.036"-0.042", or about 0.039". In other embodiments, as described above, the first spacer 225a can be a rigid tube and / or a solid tube.
[0362] In some embodiments, the second spacer 225b can be similar to the first spacer 225a configuration, that is, the second spacer 225b can also be a coil such as a zero pitch coil rotatably mounted on the core member 202. In other embodiments, the second spacer 225b can be a solid tubular member. The second spacer 225b can have a substantially cylindrical outer surface, a substantially planar proximal face and a distal face and be configured to slidably receive the lumen of the core member 202 therein. As described in more detail below, the second spacer 225b can also be configured to have a longitudinal length that separates the first engagement member 223a and the second engagement member 223b from the desired amount. For example, in at least some embodiments, the length of the second spacer 225b can make the first engagement member 223a and the second engagement member 223b be separated by approximately 1-3 times the hole pitch of the overlying support 205, for example, in some embodiments, approximately equal to the hole length of the overlying support 205.
[0363] In some embodiments, the first spacer 225a and / or the second spacer 225b can be coated with a lubricating material, such as PTFE, polyparaxylene or other coatings. The coating can be provided along the outer surface of the spacer 225, in the lumen (e.g., the lumen 232 of the coil 230), or in both. In some embodiments, the lubricating coating improves the rotatability of the spacer 225 relative to the core member 202, and can also reduce the friction between the spacer 225 and the overlying stent 205 or the catheter when the spacer 225 contacts these components during use of the delivery system 200.
[0364] Figures 5A-5C They are Figure 3A and 3B Side, end, and perspective views of bracket engagement member 223 of coupling assembly 220 are shown. Fig. 6A is a schematic cross-sectional view of stent engagement member 223 engaging stent 205 within overlying catheter 267, and Figure 6B is an enlarged detail view of a portion of a stent 205. The depicted stent 205 is braided (although other types of stents as disclosed elsewhere herein may be used) and includes a mesh 263 forming a plurality of apertures 265 defined by filaments, wires, or struts and separated by points where the filaments, wires, or struts cross (e.g., in the case of a braided or interwoven device) or intersect (e.g., in the case of a laser cut device).
[0365] Also refer to Figure 3A , 3B 5A-6B, each of the stent engagement members 223 can have a plate-like or sprocket-like configuration having a first end face 251 and a second end face 253 and a side surface 255 extending between the first end face 251 and the second end face 253. In the assembled delivery system 200, the first end face 251 and the second end face 253 can be oriented and maintained to be substantially orthogonal to the long axis of the core member 202 (or as discussed elsewhere herein, the engagement member can be configured to be tilted to a desired degree). This can be achieved by configuring the spacer 225 with a distal end face and a proximal end face orthogonal to the longitudinal axis of each spacer 225 (and / or the core member 202), and / or minimizing the amount of longitudinal movement space (or "play") between the stent engagement members and the spacers of the coupling assembly 220. Each stent engagement member forms a plurality of radially extending protrusions 257 separated by recesses 259. In the illustrated embodiment, there are four protrusions 257 separated by four recesses 259. However, in other embodiments, the number of protrusions may vary, such as two, three, four, five, six, seven or more protrusions separated by a corresponding number of recesses.
[0366] In some embodiments, the projections 257 include rounded edges or raised portions, and the recesses 259 include rounded depressions or raised portions. During use of the delivery system 200, the rounded edges can reduce scraping of the projections 257 against the inner wall of the overlying catheter 267, which reduces particle generation and damage to the catheter 267. When the delivery system 200 is used with a braided stent such as the depicted stent 205, the recesses 259 can be sized to accommodate the thickness of the braided wire crossings, so that each projection 257 can extend at least partially into the holes 265 of the stent 205 between adjacent wire crossings, and the wire crossings around the holes 265 can be at least partially received within the recesses 259 of the stent engagement member. In other embodiments, the projections and / or recesses can take on other forms, such as having sharper or flatter peaks formed by the projections 257.
[0367] Each stent engagement member 223 can include an opening or central aperture 261 configured to receive therein a core member 202. The opening of the aperture 261 can be larger than the diameter of the core member 202 so that the stent engagement member 223 can be rotated about the long axis of the core member 202. As described above, in some embodiments, the aperture 261 can be sufficiently larger than the diameter of the core member 202 to allow a certain degree of tilting of the engagement member 223 relative to the longitudinal axis of the core member 202.
[0368] The stent engagement member 223 can be made to have a relatively thin and / or plate-like or sprocket-like configuration. Such a configuration can facilitate the formation of a projection 257 that is small enough to fit within the hole 265 of the stent 205. Therefore, the stent engagement member 223 can be characterized by a maximum radial dimension or diameter D along the first end surface 251 and the second end surface 253 and a thickness T measured along the side surface 255. In some embodiments, the diameter D is at least five times greater than the thickness T. In at least one embodiment, the thickness T is between about 25-200 microns, or between 50 and 100 microns, for example, about 80 microns.
[0369] In order to effectively push or pull the stent 205 along the surrounding catheter, the stent engagement member 223 can be made rigid (e.g., cannot be compressed by the forces encountered in typical use of the delivery system). The rigidity of the stent engagement member 223 can be attributed to its material composition, its shape / configuration, or both. In some embodiments, the stent engagement member 223 is made of metal (e.g., stainless steel, nitinol, etc.) or a rigid polymer (e.g., polyimide, PEEK), or both. In some embodiments, even if the stent engagement member is made of a rigid material, based on structural features, the stent engagement member itself can be non-rigid and at least partially compressible.
[0370] As described above, the spacer 225 can be a substantially cylindrical body, whose outer diameter is less than the maximum outer diameter of the stent engagement member 223. In some embodiments, the spacer 225 includes a size determined to be and configured to allow the spacer 225 to be rotatably mounted on the core member 202. As previously described, the spacer 225 can have an end wall orthogonal to the major axis of the core member 202. These orthogonal end walls can help keep the stent engagement member 223 relative to the orthogonal orientation of the core member 202 to prevent the loss of engagement with the stent 205. (Alternatively, as discussed elsewhere herein, the engagement member can be configured to tilt the desired degree.) As described above, in some embodiments, one or two of the first spacer 225a and the second spacer and 225b can be a wire coil that limits the cylinder mounted on the core member 225a, such as a zero pitch coil. In other embodiments, one or two of the first spacer 225a and the second spacer 225b can take other forms, such as a solid cylindrical tube or other elements connected to the core member 202.
[0371] In some embodiments, coupling assembly 220 can be configured to engage only a proximal portion of stent 205 (e.g., the most proximal 5%, the most proximal 10%, the most proximal 20%, only the proximal half, etc.). In other embodiments, coupling assembly 220 can engage stent 205 substantially along its entire length.
[0372] The stent engagement members 223 can be mechanically interlocked or engaged with the stent 205 such that each protrusion 257 is at least partially received within one of the apertures 265. In some embodiments, the first engagement member 223a can engage the proximal portion of the stent 205, for example, at a location less than 5 apertures or aperture lengths from the proximal side of the stent, or less than 3 apertures or aperture lengths from the proximal side of the stent 205. The spacer 225 can be configured to have a length such that the protrusions 257 of adjacent stent engagement members 223 (e.g., a first stent engagement member 223a and an adjacent second stent engagement member 223b) are longitudinally separated by a distance substantially equal to the "aperture length" (or "aperture pitch") of the stent 205 (defined herein as the longitudinal distance between the centers of longitudinally adjacent and non-overlapping apertures 265 when the stent is in a compressed configuration, wherein the outer diameter of the stent is equal to the inner diameter of the catheter), or in some embodiments, a distance that is an integer multiple of the aperture length of the stent 205. For example, in some embodiments, when the stent is positioned at the inner diameter of the catheter 267, the first stent engagement member 223a and the second stent engagement member 223b are spaced apart by a length between about 1-3 times the length of the hole of the stent 205. Thus, each projection can extend into and engage one of the holes 265 of the stent 205.
[0373] Figure 6Bis a schematic diagram of a portion of a stent 205 including a plurality of holes 265a-265d. As described above, the protrusion 257 of the stent engagement member 223 can engage a separate hole 265 of the stent 205. In some embodiments, adjacent stent engagement members 223 engage longitudinally adjacent holes 265 of the stent 205. As used herein, "longitudinally adjacent" means that there are no intermediate holes in the longitudinal direction between the two holes. However, longitudinally adjacent holes may be non-adjacent in the radial direction, for example, a first hole positioned at a "twelve o'clock" position on the periphery of the stent may be longitudinally adjacent to a second hole positioned at a "six o'clock" position on the periphery of the stent (or at any point on the periphery therebetween) if there are no intermediate holes between the two in the longitudinal direction. For example, referring to Figure 6B , the first hole 265a is adjacent to each of the second hole 265b, the third hole 265c and the fourth hole 265d in the longitudinal direction. However, the first hole 265a is not adjacent to the fifth hole 265e in the longitudinal direction because there is an intermediate hole between the two. In other embodiments, adjacent bracket engagement members 223 engage holes that are not adjacent in the longitudinal direction but are spaced apart in the longitudinal direction by one or more intermediate holes (e.g., the first hole 265a and the fifth hole 265e). Therefore, the first bracket engagement member 223a and the second bracket engagement member 223b can be spaced apart from each other by a longitudinal distance corresponding to the hole pitch of the bracket 205 or a longitudinal distance corresponding to an integer multiple of the hole pitch.
[0374] In some embodiments, the longitudinal spacing between the first stent engagement member 223a and the second stent engagement member 223b can be slightly less than the hole length (e.g., 50%, 40%, 30%, 20%, 10%, or 5%, etc. less than the hole length), or slightly less than an integer multiple of the hole length (e.g., less than a certain decrement, the decrement is equal to 50%, 40%, 30%, 20%, 10%, or 5%, etc. of the length of a single hole). This smaller spacing between the first stent engagement member 223a and the second stent engagement member 223b can improve the grip of the stent 205 by minimizing the longitudinal "play" between the protrusions 257 of the first and second engagement members 223a and 223b and one or more wire crossings or one or more intersections located between the engagement members. Thus, longitudinal movement of the core member allows the stent to perform corresponding longitudinal movement with minimal delay and high precision. For example, the proximal movement of core member (and / or one or more engagement members carried thereby) causes the proximal movement of support, wherein before the proximal movement of support is started, the one or more engagement members move no more than the first hysteresis distance relative to support. The first hysteresis distance can be greater than 40% of the hole length of support, or no more than 33% of the hole length, or no more than 25% of the hole length, or no more than 20% of the hole length, or no more than 15% of the hole length, or no more than 10% of the hole length or no more than 5% of the hole length. Instead of or in addition to such first hole length, the distal movement of core member (and / or one or more engagement members carried thereby) causes the distal movement of support, wherein before the distal movement of support is started, the one or more engagement members move no more than the second hysteresis distance relative to support. The second lag distance may be greater than 40% of the hole length of the support, or not greater than 33% of the hole length, or not greater than 25% of the hole length, or not greater than 20% of the hole length, or not greater than 15% of the hole length, or not greater than 10% of the hole length, or not greater than 5% of the hole length.
[0375] The interaction between the protrusion 257 and the hole 265 can create a mechanical interlock between the stent engagement member 223 and the hole 265. This is in contrast to conventional compressible pads that elastically push against the stent in its entirety (including the wire crossing). In at least some embodiments, the mechanical interlock provided by the stent engagement member 223 secures the stent 205 without the wire crossing being pressed against the stent 205. In some embodiments, the stent engagement member 223 is configured to secure a range of different stent sizes within a given catheter size (e.g., within a .017", .021" or .027" catheter (inner diameter) range).
[0376] The support member 223 can be made of a substantially rigid material, such as a metal, a biocompatible polymer (e.g., PEEK) or other suitable material. In some embodiments, the support member 223 can be made of stainless steel and manufactured using laser cutting followed by electropolishing. For example, multiple engagement members can be laser cut from a stainless steel plate having a desired thickness (e.g., approximately 100 microns thick). Electropolishing can further reduce the thickness of the resulting support member, for example, from 100 microns to approximately 80 microns. In other embodiments, other techniques such as injection molding, chemical etching or machining can be used to manufacture the support member.
[0377] It is worth noting that Figure 2 The various components of the delivery system 200 of -6 are incorporated into Figure 1 100 of the delivery system 100, and vice versa. For example, any disclosed embodiment of the disclosed embodiments of the coupling assembly 220 can be used as the coupling assembly 120 of the delivery system 100. Similarly, any embodiment of the embodiment of the stent engagement member 223 can be used as one or more stent engagement members 123 of the delivery system 100, and / or any embodiment of the embodiment of the spacer 225 can be used as one or more spacers 125 of the delivery system 100. Although many of the embodiments discussed herein include two engagement members 223, in other embodiments, the delivery system 200 may include three, four or more engagement members separated from each other by additional spacers. The spacing of such additional engagement members may be regular or irregular. For example, in one embodiment, a third engagement member may be provided at a position configured to engage the distal region of the overlying stent, while the first engagement member and the second engagement member only engage the proximal region of the overlying stent.
[0378] Additional Examples of Bracket Engagement Members of Coupling Assemblies
[0379] In various embodiments, the bracket engagement member of the coupling assembly can take other forms. For example, the number of protrusions, the profiles of the protrusions and recesses, the selected materials, and the dimensions can all be varied to achieve the desired operation of the coupling assembly. Figure 7A-11C Various alternative embodiments of stent engagement members are shown. These stent engagement members can be incorporated into the above-referenced Figure 1-6 described in and in combination with the coupling assemblies 120 and 220. In addition, aspects of these stent coupling members can be combined and intermixed, so that the features of any of these stent coupling members (e.g., the number of protrusions or recesses, etc.) can be combined with the features of any of the other stent coupling members disclosed herein (e.g., the width of the contact area, the spacing of the protrusions, etc.). In some embodiments, the shape, size, and configuration of the individual stent coupling members of a given coupling assembly can be substantially the same. However, in other embodiments, the characteristics of the individual stent coupling members can vary within a single coupling assembly, such as having different sizes, shapes, or material configurations. For example, a single coupling assembly can have a first stent coupling member having a given number of protrusions and a second stent coupling member having a different number of protrusions.
[0380] Fig. 7A A perspective view of another embodiment of a stent engagement member 723 is shown, and Figure 7B Shown Fig. 7A 767 is a cross-sectional view of a stent engagement member 723 engaged with an overlying stent 705 disposed within a conduit 767. An embodiment of the engagement member 723 may be similar to the embodiment described above with respect to the engagement member 223, except that the engagement member 723 includes three protrusions 757 separated by three recesses 759. The engagement member 723 engages the overlying stent 705 and mechanically interlocks with it, and the surrounding conduit 767 helps maintain such engagement until the interlocked portion of the stent exits the conduit. The stent 705 includes a grid 763 defining a plurality of holes 765, the plurality of holes being separated by points where the wires, filaments, struts, etc. of the grid 763 cross (e.g., in the case of a braided stent) or intersect (e.g., in the case of a laser cut stent). The radially extending protrusions 757 may each extend at least partially into the holes 765 between adjacent intersections or intersections of the stent 705, and the intersections or intersections surrounding the holes 765 may be at least partially received within the recesses 759 of the stent engagement member 723. In other embodiments, the projections and / or recesses can present other forms, for example having sharper or flatter peaks formed by projections 759. The support engagement member 723 comprises an opening or central aperture 761 configured to receive a core member or core assembly therethrough. The opening of aperture 761 can be larger than the diameter of the core member so that the support engagement member 763 can rotate around the long axis of the core member. As described above, in some embodiments, the hole 761 can be larger than the diameter of the core member to allow the engagement member 723 to tilt to a certain degree relative to the longitudinal axis of the core member.
[0381] Fig. 8A A perspective view of another embodiment of a stent engagement member 823 is shown, and Figure 8B Shown Fig. 8A 867 is a cross-sectional view of a stent engagement member 823 engaged with an overlying stent 805 disposed within a conduit 867. Embodiments of the engagement member 823 can be similar to the embodiments described above with respect to the engagement members 223 and 723, except that the engagement member 823 includes six protrusions 857 separated by six recesses 859. The stent 805 includes a grid 863 defining a plurality of holes 865, the plurality of holes being separated by points where the wires, filaments, struts, etc. of the grid cross or intersect. The radially extending protrusions 857 can each at least partially extend into the holes 865 between adjacent intersections or intersections of the stent 805, and the intersections or intersections surrounding the holes 865 can be at least partially received within the recesses 859 of the stent engagement member 823. In other embodiments, the protrusions and / or recesses can take on other forms, such as having sharper or flatter peaks formed by the protrusions 859. Central aperture 861 may be configured to receive a core member or core assembly therethrough and may be sized to allow stent engagement member 823 to rotate and / or tilt relative to the core member.
[0382] Depending on the particular configuration of the overlying stent 705, 805, in some embodiments, the projections 757, 857 of the stent engagement members 723, 823 may be evenly spaced radially around the engagement members. Figure 7B , the center point of each protrusion 759 can be separated from the next protrusion 759 by 120 degrees. Figure 8B As shown, the six protrusions 857 of the stent engagement member 823 can be evenly spaced radially around the engagement member 823, such that each protrusion 857 is separated by 60 degrees from an adjacent protrusion 857. In a braided stent, the number of strands defines a number of available holes that are radially aligned at any particular longitudinal position along the stent. For example, Figure 7B and 8B A cross-sectional view of a 48-wire braided stent 705, 805 engaged with stent engagement members 723 and 823, respectively, is shown. The 48-wire stents 705, 805 each define 24 holes 765, 865 around the periphery of the stent 705, 805. In some embodiments, aligning each protrusion 757, 857 with a hole 765, 865 can improve the strength of the interlocking of the stent engagement members 723, 823 with the overlying stent 705, 805, as well as the overall mechanical fit and compatibility. Therefore, it can be advantageous to align the protrusions 757, 857 with the holes 765, 865 of the overlying stents 705, 805. Due to Figure 7B The stent 705 includes 24 holes 765, and because the 24 holes can be evenly divided into thirds, the three protrusions 757 of the stent engagement member 723 can be evenly spaced radially, with each protrusion aligned with one of the holes 765. Similarly, because Figure 8BThe stent 805 of the embodiment includes 24 holes 865, and because the 24 holes can be evenly divided into six parts, the six protrusions 857 of the stent engagement member 823 can be evenly spaced radially, with each protrusion aligned with one of the holes 865. In other embodiments, the number of protrusions can be two, four, or eight, and the protrusions can be evenly spaced around the stent engagement member.
[0383] In other embodiments, the number of projections of the stent engagement member and the number and / or position of the holes defined by the overlying stent can make the uniform radial spacing of the projections disadvantageous. For example, a braided stent with 48 wires (and 24 holes) can be used with a stent engagement member with 5 projections, in which case the projections cannot be evenly spaced around the engagement member and still align with the holes of the stent. As another example, a braided stent with 54 wires will define 27 holes at a specific longitudinal position of the stent. Since the 27 holes cannot be evenly divided between four, five or six projections, the projections may be unevenly spaced radially instead. In yet another example, a 64-wire stent will have 32 holes, which cannot be evenly divided between three, five or six projections. In each of these cases, it may be advantageous to provide a stent engagement member with projections unevenly spaced from each other around the periphery of the engagement member. Similarly, in the case of laser cut stents, the holes may not be evenly radially spaced around the circumference of the device, and unevenly radially spaced stent engagement members may be used with such stents.
[0384] Figures 9A-10B Two embodiments of such stent engagement members having unevenly spaced protrusions are shown. Embodiments of stent engagement members 923, 1023 described herein may be similar to stent engagement members 123, 223, 723, and 823 described above, except that at least some embodiments may include unevenly spaced protrusions. Fig. 9A and 9B A side view and a bottom view are shown, respectively, of a stent engagement member 923 comprising six protrusions 957a-f separated by six recesses 959a-f. Fig. 9AAs shown, the shapes and sizes of recesses 959a-f can be different from each other, so that protrusions 959a-f are unevenly spaced around the periphery of the engagement member 923. For example, the space or angle separation between the first protrusion 957a and the second protrusion 957b is less than the space or angle separation between the second protrusion 957b and the third protrusion 957c. In an example, the angle between the first protrusion 957a and the second protrusion 957b can be 55.8 degrees, and the angle between the second protrusion 957b and the third protrusion 957c can be 68.5 degrees. The spacing of this change can be achieved, for example, by changing the structure of a separate recess 959a-f. For example, each recess 959a-f can be included in a concave surface that bends inwardly between adjacent protrusions 959a-f. Some recess surface areas and / or radius of curvature can be larger than the surface area and / or radius of curvature of other protrusions, thereby extending radial spacing between adjacent protrusions. For example, the surface area and the radius of curvature of the second recess 959b are both larger than those of the first recess 959a. This structure results in the spacing between the first protrusion 957a and the second protrusion 957b being smaller than the spacing between the second protrusion 957b and the third protrusion 957c. In the illustrated embodiment, the first recess 959a, the third recess 959c, the fourth recess 959d, and the sixth recess 959d are similarly configured to provide corresponding radial spacings between adjacent protrusions at approximately 55.8 degrees, while the second recess 959b and the fifth recess 959e are similarly configured to provide corresponding radial spacings between adjacent protrusions at approximately 68.5 degrees. This provides radial symmetry about certain axes while also providing uneven spacings for improving engagement with overlying stents. Other variations are possible, wherein the particular angle between adjacent projections may vary within a range such that each projection 957a-f is configured to project into or mechanically interlock with a hole in an overlying bracket.
[0385] like Fig. 9BAs best seen in FIG. 1 , the engagement member 923 includes opposing first and second end faces 951 and 953, with a side surface 955 extending between the two end faces. Both the projections 957a-f and the recesses 959a-f may be disposed along the side surface 955. In some embodiments, the edges formed at the intersection of the first end face 951 and the side surface 955 and the edges formed at the intersection of the second end face 953 and the side surface 955 may be rounded. Specifically, the edges at the projections 957a-f may be rounded because, in at least some embodiments, only these outermost portions of the engagement member 923 contact (or otherwise engage) an overlying stent or catheter. Compared to embodiments in which there are sharp edges between these surfaces (e.g., approximately right angles between two flat and orthogonal surfaces), the rounded edges may reduce scraping of the inner wall of the catheter as the overlying catheter moves relative to the engagement member 923, thereby reducing damage and generation of particulate matter.
[0386] Fig. 10A and 10B A side view and a bottom view of another embodiment of a stent engagement member 1023 having five protrusions 1057a-e spaced unevenly from each other by five recesses 1059a-e are shown, respectively. The shapes and sizes of the recesses 1059a-e can be different from each other, so that the protrusions 1059a-e are spaced unevenly around the periphery of the engagement member 1023. In contrast, the angle between the first protrusion 1057a and the second protrusion 1057b and the angle between the first protrusion and the fifth protrusion 1057e can each be approximately 78.8 degrees. In contrast, the angle between the second protrusion 1057b and the fourth protrusion 1059b and the angle between the fourth protrusion 1057d and the fifth protrusion 1057e can each be approximately 67.7 degrees. Finally, the angle between the third protrusion 1057c and the fourth protrusion 1057d can be approximately 66.9 degrees. Such varying spacing can be achieved by varying the configuration of the individual recesses 1059a-e. For example, the surface area and radius of curvature of the first recess 1059a are both larger than the surface area and radius of curvature of the second recess 1059b, resulting in a spacing between the first protrusion 1057a and the second protrusion 1057b being larger than the spacing between the second protrusion 1057b and the third protrusion 1057c. Other variations are possible, wherein the specific angles between adjacent protrusions can vary within a range such that each protrusion 1057a-e is configured to protrude into a hole of an overlying support or mechanically interlock with it.
[0387] like Fig. 10BAs best seen in FIG. 1 , the joint member 1023 includes opposing first and second end faces 1051 and 1053, with a side surface 1055 extending between the two end faces. Both the protrusions 1057a-e and the recesses 1059a-e may be disposed along the side surface 1055. Fig. 9B As discussed, in some embodiments, the edge formed at the intersection of the first end surface 1051 and the side surface 1055 and the edge formed at the intersection of the second end surface 1053 and the side surface 1055 may be rounded to reduce friction and damage to an overlying catheter or stent.
[0388] Figures 11A-11C Shown are enlarged detail views of projections 1157a-c of stent engagement members according to different embodiments. As described above with respect to engagement members 123, 223, 723, 823, 923 and 1023, the engagement member may include a plurality of projections separated by recesses. The projections may form the radially outermost components of the stent engagement member, which may contact the overlying stent or cooperate with the inner wall of the overlying conduit and otherwise interlock with the overlying stent in use. Projections 1157a-c each include an outermost contact region 1169 characterized by a length D and configured to contact the overlying stent (or otherwise engage therewith). The contact region 1169 may include a central portion 1171, which is flanked by relative shoulder portions 1173a and 1173b. Shoulder portions 1173a and 1173b may extend between the central portion 1171 and relative extensions 1175a and 1175b. Extensions 1175a and 1175b extend away from contact area 1169 and toward corresponding recesses (not shown) of the stent engagement member. Center portion 1171 may have a substantially planar outermost surface that may be coplanar with adjacent shoulder portions 1173a and 1173b. However, shoulder portions 1173a and 1173b may have a curved outer surface connecting center portion 1171 and adjacent extensions 1175a and 1175b.
[0389] The center portion 1171 and the shoulder portions 1173a, 1173b together define a length D of the contact area 1169. In certain embodiments, it may be advantageous to increase the total surface area of the contact area 1169 by increasing the length D, as compared to embodiments in which there is little or no center portion 1171. Fig.11A In the embodiment shown in -C, the length D of the contact area 1169 is varied so that the length D is Fig.11A The protrusion 1157a is the largest, and then Fig. 11B The protrusion 1157b is smaller and Fig. 11CThe smallest of the protrusions 1157c. Thus, protrusion 1157a has the largest surface area configured to contact an overlying stent or catheter, followed by protrusion 1157b having a smaller surface area configured to contact an overlying stent or catheter, and finally protrusion 1157c having a still smaller surface area configured to contact an overlying stent or catheter. In various embodiments, the length D of contact region 1169 can be between about 0.001"-0.004", or between about 0.002"-0-.003". For example, in some embodiments, contact region 1169 can have a length D of about 0.002", about 0.0025", or about 0.003". As should be appreciated, various embodiments of contact region 1169 can generally include a flat or planar center region, and a first shoulder and a second shoulder located on either side of the center region. The shoulders can be oriented in up to two directions (e.g., Figures 11A-11C radial direction as seen in Fig. 9B and 10B It is circular in the axial direction (as seen in FIG. 2 ).
[0390] in conclusion
[0391] The present disclosure is not intended to be exhaustive or to limit the present invention to the precise form disclosed herein. Although specific embodiments are disclosed herein for the purpose of illustration, various equivalent modifications are possible without departing from the present invention as will be appreciated by those skilled in the relevant art. In some cases, known structures and functions have not yet been shown and / or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present invention. Although the steps of the method may be presented in a particular order herein, in alternative embodiments, the steps may have another suitable order. Similarly, certain aspects of the present invention disclosed in the context of a particular embodiment may be combined or removed in other embodiments. In addition, although the advantages associated with those embodiments have been disclosed in the context of certain embodiments, other embodiments may also exhibit these advantages, and not all embodiments necessarily exhibit such advantages or other advantages disclosed herein to fall within the scope of the present invention. Therefore, the present disclosure and associated technologies may encompass other embodiments not explicitly shown and / or described herein.
[0392] Throughout this disclosure, unless the context clearly indicates otherwise, the singular forms "a / an" and "the" include plural references. Similarly, unless the word "or" is explicitly limited to mean only a single item other than other items in a list with two or more items, the use of "or" in such a list should be interpreted as including any single item in (a) the list, all items in (b) the list, or any combination of items in (c) the list. In addition, the term "including" and the like are used throughout this disclosure to mean including at least one or more of the listed features, so that any greater number of one or more identical features and / or one or more other types of features are not excluded. Directional terms such as "upper", "lower", "front", "back", "vertical" and "horizontal" can be used in this article to express and clarify the relationship between each element. It should be understood that such terms do not represent absolute orientation. References to "one embodiment", "embodiment" or similar expressions herein mean that specific features, structures, operations or characteristics described in conjunction with the embodiment may be included in at least one embodiment of the present invention. Therefore, the appearance of such phrases or expressions in this article does not necessarily all refer to the same embodiment. Furthermore, the particular features, structures, operations, or characteristics may be combined in any suitable manner in one or more embodiments.
Claims
1. A stent delivery system, comprising: a core member configured for advancement within a body lumen; A coupling assembly positioned around the core member, the coupling assembly comprising: a distal restraint device non-slidably coupled to the core member; a first plate rotatably positioned about the core member proximal to the distal restriction device, the first plate comprising an outer surface having three or more projections separated by recesses; a coil spacer rotatably and non-slidably positioned about the core member adjacent to and proximal to the first plate; and a stent extending along the core member such that the stent is engaged by one or more projections of the first plate extending into the aperture of the stent and thereby can be advanced distally through the core member, wherein the first plate is configured to slide longitudinally relative to the core member over a limited range of motion between the coil spacer and the distal restraint, and Wherein the first plate is configured to be inclined relative to the longitudinal axis of the core member. 2 . The system of claim 1 , wherein the coil spacer comprises a zero-pitch coil.
3. The system of claim 1, wherein the coil spacer is substantially incompressible in the axial direction.
4. The system of claim 1 , further comprising a proximal restraint coupled to the core member, and wherein the coil spacer comprises a flattened proximal end face configured to abut against the proximal restraint. 5 . The system of claim 1 , wherein the coil spacer comprises a flattened distal surface configured to abut the first plate.
6. The system of claim 1, wherein an outer diameter of the coil spacer is less than or equal to a recess diameter of the first plate.
7. The system of claim 1, wherein the coil spacer comprises a wire having a square or rectangular cross-section wound into a coil configuration.
8. The system of claim 1 , wherein the coil spacer comprises a wire wound into a coil configuration, and the wound wire forms a plurality of windings, each winding having a flat distal side and a proximal side, wherein faces of adjacent windings contact each other so that the coil spacer can withstand longitudinal compressive loads without shortening.
9. A system according to claim 1, wherein the connecting assembly further includes a second plate, which is rotatably positioned around the core member, the second plate includes an outer surface having three or more protrusions separated by recesses, and wherein one or more of the protrusions of the second plate engage the stent so that the stent can be advanced distally through the core member.
10. The system of claim 9, wherein the second plate is configured to slide longitudinally relative to the core member over a limited range of motion and is configured to tilt relative to a longitudinal axis of the core member.
11. The system of claim 9, wherein the coupling assembly further comprises a second spacer positioned around the core member and disposed between the first plate and the second plate.
12. The system of claim 11, wherein the second spacer comprises a second coil spacer.
13. The system of claim 11, wherein the second spacer comprises a solid tubular member.
14. A medical device delivery system comprising: Core components; A coupling assembly, the coupling assembly being carried by the core component, the coupling assembly comprising: a distal restraint device non-slidably coupled to the core member; a first device engagement member rotatably coupled to the core member and disposed proximally of the distal restriction device, the first device engagement member comprising an outer surface having projections separated by recesses; and a coil spacer rotatably coupled to the core member and disposed proximally of the first device engagement member adjacent to the first device engagement member, wherein the first device engagement member is configured to slide longitudinally relative to the core member over a limited range of motion between the coil spacer and the distal restriction device, and wherein the first device engagement member is configured to be tilted relative to a longitudinal axis of the core member; An expandable medical device extends along the core member such that the medical device is engaged by one or more projections of the first device engagement member extending into the aperture of the medical device and thereby can be advanced distally through the core member.
15. The system of claim 14, wherein the coil spacer comprises a zero pitch coil.
16. The system of claim 14, wherein the coil spacer comprises a flattened proximal end face configured to abut a proximal restraint coupled to the core member.
17. The system of claim 14, wherein the coil spacer comprises a flattened distal surface configured to abut the first device engagement member.
18. The system of claim 14, wherein the outer diameter of the coil spacer is less than or equal to a recess diameter of the first device engagement member.
19. The system of claim 14, wherein the first device engagement member comprises a rigid plate or a sprocket.
20. The system of claim 14, wherein the coil spacer comprises a wire having a square or rectangular cross-section wound into a coil configuration.
21. The system of claim 14, wherein the coil spacer comprises a wire wound into a coil configuration, and the wound wire forms a plurality of windings, each winding having a flat distal side and a proximal side, wherein faces of adjacent windings contact each other so that the coil spacer can withstand longitudinal compressive loads without shortening.
22. The system of claim 14, wherein the coupling assembly further comprises a second device engagement member rotatably positioned about the core member, the second device engagement member comprising an outer surface having three or more protrusions separated by recesses.
23. The system of claim 22, wherein the medical device is engaged by one or more projections of the second device engagement member extending into the aperture of the medical device and thereby can be advanced distally through the core member.
24. The system of claim 22, wherein the coupling assembly further comprises a second spacer positioned about the core member and disposed between the first device engagement member and the second device engagement member.
25. A stent delivery system comprising: a core member configured for advancement within a body lumen; a stent extending along the core member, the stent being characterized by a pore length, the pore length being the longitudinal distance between centers of pores adjacent to each other and aligned along a longitudinal axis when the stent is in a compressed configuration; as well as A coupling assembly positioned around the core member, the coupling assembly comprising: a first plate rotatably coupled to the core member, the first plate comprising an outer surface having three or more projections that engage the bracket such that at least one of the projections extends into a first aperture of the bracket; and a second plate rotatably coupled to the core member, the second plate comprising an outer surface having three or more projections that engage the bracket such that at least one of the projections extends into a second aperture of the bracket; The protrusion of the first plate is longitudinally spaced apart from the protrusion of the second plate by a first longitudinal distance, the first longitudinal distance being smaller than an integer multiple of the hole length by a certain decrement, the decrement being equal to 1% to 50% of the hole length.
26. A system according to claim 25, wherein in a delivery configuration, the protrusion of the first plate engages with the hole of the bracket at a first longitudinal position, and wherein the protrusion of the second plate engages with the hole of the bracket at a second longitudinal position, and wherein the first longitudinal position and the second longitudinal position are separated by the first longitudinal distance.
27. The system of claim 25, wherein the first aperture and the second aperture are longitudinally adjacent.
28. The system of claim 25, wherein the first hole is less than five hole lengths from the proximal end of the stent.
29. The system of claim 25, wherein the first plate is configured to be inclined relative to a longitudinal axis of the core member.
30. The system of claim 25, wherein the second plate is configured to be inclined relative to a longitudinal axis of the core member.
31. The system of claim 25, wherein the first longitudinal distance is less than an integer multiple of the bore length by a decrement equal to 1% to 50% of the bore length.
32. A system according to claim 25, wherein the connecting assembly further includes a spacer between the first plate and the second plate, and when the core member is in a straight orientation and the first plate and the second plate are against the spacer, the spacer maintains the protrusions of the first plate and the second plate at the first longitudinal distance.
33. The system of claim 25, wherein the hole length of the stent is obtained when the outer diameter of the stent is equal to the inner diameter of a catheter containing the stent and the coupling assembly and the first plate and the second plate are maintained in engagement with the stent.
34. The system of claim 25, wherein: The stent is a braided stent comprising braided filaments; The first hole and the second hole are longitudinally adjacent and are separated by a filament longitudinally located between the first hole and the second hole; the projection of the first plate is longitudinally offset from the center of the first aperture in a direction toward the intersection of the filaments; as well as The projection of the second plate is longitudinally offset from a center of the second aperture in a direction toward the filament intersection and the projection of the first plate.
35. The system of claim 25, further comprising a proximal restraint carried by the core member, wherein the coupling assembly is positioned distal to the proximal restraint.
36. A stent delivery system comprising: Core components; a stent extending along the core member, the stent comprising a plurality of pores and characterized by a pore length, the pore length being a longitudinal distance between centers of the pores adjacent to each other and aligned along a longitudinal axis when the stent is in a compressed configuration; as well as A coupling assembly, the coupling assembly being carried by the core component, the coupling assembly comprising: a first stent engaging member rotatably coupled to the core member, the first stent engaging member comprising projections that engage a first plurality of apertures of the stent; a second stent engaging member rotatably coupled to the core member, the second stent engaging member comprising projections that engage a second plurality of apertures of the stent; The protrusion of the first bracket engaging member is longitudinally spaced apart from the protrusion of the second bracket engaging member by a first longitudinal distance, the first longitudinal distance being less than an integer multiple of the hole length by a certain decrement, the decrement being equal to 1% to 50% of the hole length.
37. The system of claim 36, wherein the first plurality of holes and the second plurality of holes are longitudinally adjacent along the length of the stent.
38. The system of claim 36, wherein the first plurality of holes are less than five hole lengths from the proximal end of the stent.
39. The system of claim 36, wherein the first stent-engaging member is configured to be inclined relative to a longitudinal axis of the core member.
40. The system of claim 36, wherein the second stent-engaging member is configured to be inclined relative to a longitudinal axis of the core member.
41. The system of claim 36, wherein the first stent-engaging member and the second stent-engaging member are spaced apart by less than two aperture lengths.
42. The system of claim 36, wherein the first longitudinal distance is less than an integer multiple of the bore length by a decrement equal to 1% to 30% of the bore length.
43. A system according to claim 36, wherein the connecting assembly further includes a spacer between the first bracket engaging member and the second bracket engaging member, and when the core member is in a straight orientation and the first bracket engaging member and the second bracket engaging member abut against the spacer, the spacer maintains the protrusions of the first bracket engaging member and the second bracket engaging member at the first longitudinal distance.
44. The system of claim 36, wherein the hole length of the stent is obtained when the outer diameter of the stent is equal to the inner diameter of a catheter containing the stent and the coupling assembly and the first stent engagement member and the second stent engagement member are maintained in engagement with the stent.
45. The system of claim 36, wherein: The stent is a braided stent comprising braided filaments; The protrusion of the first bracket engagement member protrudes into the first hole of the bracket; The protrusion of the second bracket engagement member protrudes into the second hole of the bracket; The first hole and the second hole are longitudinally adjacent and are separated by a filament longitudinally located between the first hole and the second hole; the projection of the first stent-engaging member being longitudinally offset from the center of the first aperture in a direction toward the intersection of the filaments; as well as The projection of the second stent-engaging member is longitudinally offset from a center of the second aperture in a direction toward the filament intersection and the projection of the first stent-engaging member.
46. The system of claim 36, further comprising a proximal restraint carried by the core member, wherein the coupling assembly is positioned distal to the proximal restraint.
Citation Information
Patent Citations
Vascular expandable devices
US20190240049A1
Vascular intervention system
CN107405160A
Apparatus for luminal stenting
EP2630936A1