Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
  • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
  • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
  • A61B17/1214—Coils or wires
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
  • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
  • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
  • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
  • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
  • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
  • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
  • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
  • A61B17/1214—Coils or wires
  • A61B17/12154—Coils or wires having stretch limiting means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00526—Methods of manufacturing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
  • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
  • A61B2017/1205—Introduction devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
  • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
  • A61B2017/1205—Introduction devices
  • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/03—Automatic limiting or abutting means, e.g. for safety
  • A61B2090/037—Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
  • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
  • A61F2002/9511—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
  • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
  • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

• the present invention relates generally to systems and method for delivery of one or more implants into a patient, and in particular implant delivery systems and devices that provide a rapid release of the implant at a desired implantation location.
• Vaso-occlusive devices, stents and other implants are used for a variety of medical treatments, including the treatment of intra-vascular aneurysms and vascular restrictions.
• Vaso-occlusive devices often include a soft, helically wound coil that is positioned in a blood vessel or aneurysm, such as a blood vessel or aneurysm of the brain.
• Stents can comprise resiliently biased structures that self-expand or plastically deformable structures that are expanded through the use of an inflatable balloon.
• Vaso-occlusive devices, stents and other implants are often accompanied by a catheter-based delivery device which is introduced percutaneously into a patient, and advanced proximate a site for implantation. Precision of placement of one or more implants at a desired location is often difficult to the manner in which the implant is released from the delivery catheter.
• An aspect of the present teachings provides an implant delivery system for delivering and deploying an implant into a patient.
• the delivery system comprises an implant pusher shaft, an implant engagement feature, an implant release mechanism and an implant engagement wire.
• the implant pusher shaft comprises a proximal end, a distal end, and a longitudinal lumen.
• the implant pusher shaft also has a distal flexible portion, a middle transition portion, and a proximal portion, wherein the implant pusher shaft.
• the implant engagement feature has a cylindrical body joining to the distal end of the implant pusher shaft, two fingers extending distally from the cylindrical body, and a cross pin joining the two fingers.
• the implant release mechanism releasably attaches to the proximal end of the implant pusher shaft.
• the implant engagement wire slidably disposes within the longitudinal lumen of the implant pusher shaft.
• the implant engagement wire having a distal end and a proximal end.
• the proximal end of the implant engagement wire joins the implant release mechanism.
• the implant delivery system comprises an implant delivery configuration and an implant release configuration.
• the implant release mechanism attaches to the implant pusher shaft and the distal end of the implant engagement wire extends distally beyond the cross pin of the implant engagement feature.
• the implant release mechanism detaches from the implant pusher shaft and the distal end of the implant engagement wire retracts proximally back inside the longitudinal lumen of the implant pusher shaft.
• the implant release mechanism is of one unity with the implant pusher shaft with a circumferentially weakened location in between.
• the implant release mechanism is configured to break away from the implant pusher shaft at the circumferentially weakened location.
• One embodiment of the present teachings provides that the flexible portion of the implant pusher shaft has a first stiffness; and the proximal portion of the implant pusher shaft has a second stiffness. The second stiffness is greater than the first stiffness.
• Another embodiment of the present teachings provides that the transition portion of the implant pusher shaft is configured with a gradual increasing stiffness from the first stiffness at a distal end to the second stiffness at a proximal end.
• One embodiment of the present teachings provides that the flexible portion of the implant pusher shaft comprises a multi-filar tube.
• the transition portion of the implant pusher shaft comprises an inner liner having a longitudinal lumen and a hypotube extending over the inner liner and an outer jacket.
• the hypotube of the transition portion has a laser cutting pattern with more material remove at its distal portion than its proximal portion.
• an inner liner forming the longitudinal lumen of the implant pusher shaft extends from the proximal portion to the flexible portion of the of the implant pusher shaft.
• a hypo tube extends from the proximal portion to the transition portion of the of the implant pusher shaft.
• the hypo tube extends over the inner liner that forms the longitudinal lumen of the implant pusher shaft.
• at least a portion of the hypo tube at the transition portion of the implant pusher has less stiffness than at least a portion of the hypo tube at the proximal portion of the implant pusher shaft.
• a medical system for delivering and deploying an implant into a patient.
• the medical system comprises a medical implant and an implant delivery system.
• the medical implant has an engagement loop configured to releasably engaging to an implant delivery system.
• the implant delivery system comprises an implant engagement feature and an implant engagement wire.
• the implant engagement feature has two fingers extending distally at a distal end of the implant delivery system. A cross pin joins the two fingers.
• the implant engagement wire slidably disposes within a longitudinal lumen of the implant delivery system.
• One embodiment of the present teachings provide that as the implant delivery system engages the medical implant, the engagement loop extends proximally over the cross pin from a first side; the implant engagement wire extends distally first through the engagement loop of the medical implant first, then further distally over the cross pin from a second side, and thereby trapping the engagement loop.
• the medical system has a first configuration where the medical implant engages to the implant delivery system, and a second configuration where the medical implant disengages from the implant delivery system.
• the proximal end of the engagement wire extends proximally away from the cross pin and releases the engagement loop of the medical implant.
• the medical implant has a coil body with an axial lumen and a stretch resistance member joining the coil body at a distal end of the coil body.
• a distal end of the engagement loop joins a proximal end of the stretch resistance member.
• the engagement loop is configured to be extended proximally and longitudinally outside of a proximal end of the coil body in a tensioned state.
• the engagement loop is made of superelastic material.
• An aspect of the present teachings provides a medical implant comprising a coil body (102), a stepper band, a stretch resistance member, and an engagement loop joining a proximal end of the stretch resistance member by an anchor band.
• the coil body includes an axial lumen.
• the stepper band has an axial lumen, and joins a proximal end of the coil body.
• the stretch resistance member joins a distal end of the coil body, and extends inside the axial lumen of the coil body.
• the engagement loop extends through the axial lumen of the stepper band and the axial lumen of the coil body.
• the anchor band has a greater exterior profile than axial lumen of the stepper band such that when the anchor band engages the stepper band, an interference between the anchor band and the stepper band is then formed.
• the engagement loop releasably engages to an implant delivery system.
• FIG. 1 is a perspective view of a medical system where an implant engages to an implant delivery system in accordance with the present teachings
• FIG. 2 is a perspective view of an exemplary implant delivery system in accordance with the present teachings
• FIG. 3 A is a perspective view of a distal flexible portion of an exemplary implant pusher shaft in accordance with the present teachings
• FIG. 3B is a perspective view of a middle transition portion of an exemplary implant pusher shaft in accordance with the present teachings
• FIG. 3C is a perspective view of a proximal portion of an exemplary implant pusher shaft in accordance with the present teachings
• FIG. 4 is a perspective view of an exemplary implant release mechanism attaching to an implant engagement wire in accordance with the present teachings
• FIG. 5 is a perspective view of an exemplary implant engagement feature in accordance with the present teachings.
• FIG. 6 is a perspective view of an implant in accordance with the present teachings.
• FIG. 7A is a perspective view of a distal portion of the exemplary implant engagement feature in accordance with the present teachings
• FIG. 7B is a perspective view of a proximal portion of the exemplary implant engagement feature in accordance with the present teachings
• FIG. 8A is a perspective view of the implant release mechanism breaking away from the implant pusher shaft in accordance with the present teachings
• Fig. 8B is a perspective view of the implant engagement wire releasing the engagement loop of the implant in accordance with the present teachings; DETAILED DESCRIPTION
• the term “lumen” means a canal, a duct, or a generally tubular space or cavity in the body of a subject, including a vein, an artery, a blood vessel, a capillary, an intestine, and the like.
• the term “lumen” can also refer to a tubular space in a catheter, a sheath, a hollow needle, a tube, or the like.
• proximal shall mean close to the operator (less into the body) and “distal” shall mean away from the operator (further into the body).
• distal refers to the direction relatively away from a catheter insertion location and “proximal” refers to the direction relatively close to the insertion location.
• wire can be a strand, a cord, a fiber, a yam, a filament, a cable, a thread, or the like, and these terms may be used interchangeably.
• sheath may also be described as a “catheter” and, thus, these terms can be used interchangeably.
• first element when a first element is referred to as being “in”, “on” and/or “within” a second element, the first element can be positioned: within an internal space of the second element, within a portion of the second element (e.g. within a wall of the second element); positioned on an external and/or internal surface of the second element; and combinations of one or more of these.
• spatially relative terms such as “beneath,” “below,” “lower,” “above,” “upper” and the like may be used to describe an element and/or feature's relationship to another element(s) and/or feature(s) as, for example, illustrated in the figures. It will be further understood that the spatially relative terms are intended to encompass different orientations of the device in use and/or operation in addition to the orientation depicted in the figures. For example, if the device in a figure is turned over, elements described as “below” and/or “beneath” other elements or features would then be oriented “above” the other elements or features. The device can be otherwise oriented (e.g.
• the term“diameter” where used herein to describe a non-circular geometry is to be taken as the diameter of a hypothetical circle approximating the geometry being described.
• the term“diameter” shall be taken to represent the diameter of a hypothetical circle with the same cross sectional area as the cross section of the component being described.
• the present teaching relate to an implant-delivery system assembly for engaging, delivering, deploying and releasing one or more implants into a patient.
• the delivery system includes an implant pusher shaft for pushing the implant forward during delivery and deployment; an implant engagement mechanism configured to releasably engage a medical implant during delivery and deployment.
• the delivery system further includes an implant release mechanism for disengaging the medical implant and release it at the treatment location.
• the control mechanism is constructed and arranged to release the engagement between the implant and the delivery system.
• Fig. 1 illustrates an embodiment of an implant (100) engaging to a delivery system (10).
• the delivery system (10 includes an implant release mechanism (20), an implant pusher shaft (50), and an implant engagement wire (40).
• the implant release mechanism (20) is at a proximal end of the implant pusher shaft (50), and is configured to be broken away from the implant pusher shaft (50).
• a proximal end of the implant engagement wire (40) fixedly attaches to the implant release mechanism (20).
• the implant release mechanism (20) attaches to the proximal end of the implant pusher shaft (50).
• the delivery system (10) engages the implant by the pusher shaft (50) and the implant engagement wire (40).
• the implant pusher shaft (50) has a proximal end, a distal end, and a longitudinal lumen extending from the proximal end to its distal end.
• the implant pusher shaft (50) is configured to have a gradual decreased stiffness from its proximal end to its distal end.
• the stiffness of the implant pusher shaft (50) is designed to gradually increase from its distal end to its proximal end. The relative less stiff distal portion is configured to minimize the impact to the surround vessel tissue as the implant pusher shaft (50) being extended toward the treatment location.
• the relative stiff proximal portion (58) is configured to provide adequate force to advance the implant (100).
• the implant pusher shaft (50) includes a distal flexible portion (54) with a distal end attaching to an implant engagement feature (52), a middle transition portion (56), and a proximal portion (58).
• the distal flexible portion (54) of the implant pusher shaft (50) is configured to offer mechanical properties such as column strength for pushing the medical implant (100), stretch resistance when the product is retracted, and flexibility when the distal end of the implant pusher shaft (50) enters the aneurysm or when the medical implant (100) is deployed.
• the flexible portion (54) of the implant pusher shaft (50) is constructed to have a gradual increase in its stiffness from its proximal end to its distal end. This design purpose is achieved by construct different layers at various sections of the flexible portion (54).
• the transition portion (56) of the implant pusher shaft (50) is constructed of a hypotube (70) extending over an inner liner (82). The hypotube (70) at distal portion of transition portion (56) has a reduced outer profile/diameter and a spiral cutting pattern.
• the hypotube (70) at proximal portion (74) of transition portion (56) has a tapered outer profile with a gradual increase in its outer diameter toward the proximal end of the transition portion (56).
• An outer jacket (80) extends over the distal portion (72) of the transition portion (56).
• the proximal portion (58) of the implant pusher shaft (50) is constructed of a hypotube (70) without any cutting pattern alone over an inner liner (82).
• the hypotube (70) in the proximal portion (58) of the implant pusher shaft (50) has a constant profile, similar to the outer diameter at the proximal end of the transition portion (56).
• the inner liner (82) has an elongated lumen extending from a middle section (64) of the flexible portion (54) to a place near the proximal end of the proximal portion (58) of the implant pusher shaft (50).
• the inner liner (82) has a 0.004” inner diameter and a 0.006” outer diameter.
• the outer jacket (80) extends from a middle section (64) of the flexible portion (54) to the proximal end of the distal portion (72) of the transition portion (56) of the implant pusher shaft (50).
• the distal portion (54) of the implant pusher shaft (50) is more flexible than the middle portion (56) of the implant pusher shaft (50); and the middle portion (56) of the implant pusher shaft (50) is more flexible than the proximal portion (58) of the implant pusher shaft (50).
• the distal portion (54) of the implant pusher shaft (50) is less stiff than the middle portion (56) of the implant pusher shaft (50); and the middle portion (56) of the implant pusher shaft (50) is less stiff than the proximal portion (58) of the implant pusher shaft (50).
• the distal flexible portion (54) of the implant pusher shaft (50) is constructed of a multi-filar tube (60) made with multi wires wounded in a helical configuration forming a longitudinal lumen.
• the multi -filar wire tube (60) comprises 6, 8, 12, or 18 wires.
• the multi-filar tube (60) could be wound in a left hand or a right hand direction.
• the multi-filar tube (60) could have a closed pitch of 4-8 mm.
• the filament used in the multi-filar tube (60) construction ranges from 0.001” to 0.003” in size.
• the distal flexible portion (54) of the implant pusher shaft (50) is constructed of an 18-wire multi- filar wire tube wounded in a hand direction, with a pitch of 6.3 mm.
• the multi-filar tube (60) extends throughout the entire flexible portion (54).
• a distal section (62) of the flexible portion (54) has multi-filar tube (60) alone.
• a middle section (64) and a proximal section (66) of the multi-filar tube (60) are lined with an inner liner (82).
• the middle section (64) of the multi-filar tube (60) further has a shrink tube layer extending in between the inner layer and the multi-filar tube (60).
• the proximal section (66) of the multi-filar tube (60) further incorporate an additional layer of the shrink tube extending over the exterior luminal surface of the multi-filar tube (60).
• An outer jacket (80) extends over the middle and proximal sections (64, 66) of the flexible portion (54) to provide additional stiffness and surface smoothness.
• a distal section (62) of the flexible portion (54) of the implant pusher shaft (50) has a one-layer construction, i.e. the multi-filar tube (60).
• a middle section (64) of the flexible portion (54) of the implant pusher shaft (50) has a 4-layer construction, an outer jacket (80) over the multi -filar tube (60) over a shrink tube and finally over an inner liner (82).
• a proximal section (66) of the flexible portion (54) of the implant pusher shaft (50) has a 5-layer construction, i.e. an outer jacket (80) over a first shrink tube over the multi-filar tube (60) over a shrink tube and finally over an inner liner (82).
• the proximal section (66) of the flexible portion (54) is stiffer than the middle section (64) of the flexible portion (54) of the implant pusher shaft (50).
• the middle section (64) of the flexible portion (54) of the implant pusher shaft (50) is stiffer than the distal section (62) of the flexible portion (54) of the implant pusher shaft (50).
• this embodiment of the present teaching provides only one exemplary way to vary the stiffness within the same portion of the implant pusher shaft (50), i.e. by adding additional material layer, such as a shrink tube layer.
• additional material layer such as a shrink tube layer.
• the radiopaque marker band (84) is incorporated at a distal end of the middle section (64), i.e. the 4-layer section, of the flexible portion (54) of the implant pusher shaft (50).
• the marker band (84) has a 0.0131” outer diameter and a 0.0115” inner diameter and a 2-3 mm length.
• the flexible portion (54) of the implant pusher shaft (50) is about 30 cm long, with its distal 1 -layer construct section (62) about 2-3 cm long, its middle 4-layer construct section (64) about 10-15 cm long, and its proximal 5-layer construct section (66) about 13-17 cm.
• the multi-filar tube (60) has a 0.011”-0.0145” outer diameter and a 0.007”-0.0085” inner diameter.
• the middle transition portion (56) of the implant pusher shaft (50) is constructed of a hypotube (70) extending over an inner liner (82).
• a distal section (62) of the hypotube (70) has a reduced outer diameter with a laser cutting pattern.
• the outer jacket (80) extends over the laser cutting pattern in order to provide a smoother exterior.
• a proximal section (66) of the hypotube (70) has a gradual tapered outer profile with a reduced diameter distal end (75) and a larger diameter at its proximal end (76).
• the distal section (62) of the transition portion (56) of the implant pusher shaft (50) is configured to have a gradual increase in flexibility from its distal portion to its proximal portion (58).
• the distal section (62) of the transition portion (56) of the implant pusher shaft (50) is configured to have a gradual decrease in stiffness from its distal section (72) to its proximal section (74).
• the hypotube (70) in the distal section (72) of the transition portion (56) of the implant pusher shaft (50) has some material removed, i.e. by a laser cutting pattern. The more material removed, the more flexible, and the less stiff, the hypotube (70) is.
• the amount of material removed gradually decreases from its distal end (71) to its proximal end (73).
• the laser cutting pattern is in a helical shape with the pitch of the helix decreased from a distal end (71) to a proximal end (73) of the distal section (72) of the transition portion (56).
• the thickness of the hypotube (70) could gradually increase from its distal section (72) to its proximal section (74).
• the material removing could be the result of another pattern, and/or in combination with the change in thickness of the hypotube (70).
• the proximal section (74) of the transition portion (56) of the implant pusher shaft (50) is configured to have a gradual increase in flexibility from its distal end (75) to its proximal end (76).
• the proximal section (74) of the transition portion (56) of the implant pusher shaft (50) is configured to have a gradual decrease in stiffness from its distal end (75) to its proximal end (76).
• the hypotube (70) in the proximal section (74) of the transition portion (56) of the implant pusher shaft (50) has a gradual change in its wall thickness.
• the outer diameter of the hypotube (70) in the distal section (74) of the transition portion (56) of the implant pusher shaft (50) is grinded down to a smaller diameter, thereby reduce the wall thickness of the hypotube (70) in this section.
• the outer profile of the proximal section (74) of the transition portion (56) of the implant pusher shaft (50) is then grinded to a tapered shape with a smaller diameter matching the distal section 72) and a larger dimeter matching the proximal portion (58) of the implant pusher shaft (50).
• the wall thickness of the hypotube (70) in this section gradually increased toward the proximal portion (58).
• the transition portion (56) further comprises an inner liner (82) extends throughout this portion.
• the distal end of the hypotube (70) in the transition is welded to the proximal end of the multi-filar tube (60) of the flexible portion (54) of the implant pusher shaft (50).
• the transition portion (56) further comprises an outer jacket (80) extending over the distal section (62) of the transition portion (56).
• the outer jacket (80) is configured to provide a smooth external surface of the hypotube (70), as well as increase the stiffness of the transition portion (56).
• the hypotube (70) in the transition portion (56) of the implant pusher shaft (50) is a continuous piece with the hypotube (70) in the proximal portion (58) of the implant pusher shaft (50).
• the outer jacket (80) in the transition portion (56) of the implant pusher shaft (50) is a continuous piece with the outer jacket (80) in the flexible portion (54) of the implant pusher shaft (50).
• the distal end (71) of the transition portion (56) has a similar flexibility and/or stiffness to the proximal section (66) of the flexible portion (54) of the implant pusher shaft (50).
• the proximal end (76) of the transition portion (56) has a similar flexibility and/or stiffness to the proximal portion (58) of the implant pusher shaft (50).
• the transition portion (56) of the implant pusher shaft (50) is about 28-37 cm long with the distal section (72) of the transition portion (56) about 10-15 cm long, and proximal section (74) of the transition portion (56) about 18-22 cm long.
• the distal section (62) of the transition portion (56) has an outer diameter about 0.011”.
• the proximal section (66) of the transition portion (56)’ s outer diameter gradually increases from 0.01” to 0.014”.
• the proximal portion (58) of the implant pusher shaft (50) is constructed of a hypotube (70) extending over an inner liner (82). Unlike the transition portion (56), the proximal portion (58) of the hypotube (70) of the proximal portion (58) of the implant pusher shaft (50) is a solid tube has no material removed, and thus with a consistent stiffness throughout its length. According to one embodiment of the present teaching, the proximal end of the inner liner (82) locates proximal to the proximal end of the hypotube (70).
• the proximal portion (58) of the implant pusher shaft (50) is about l20cm long, with an inner diameter of 0.007” and an outer diameter of 0.014”.
• the proximal end of the inner liner (82) is 12-20 mm away from the proximal end of the hypotube (70).
• the flexible portion (54) can be constructed of a unifilar tube, multi-filar tube (60), or a braid.
• the tube construct can be of a helical or spiral pattern.
• the transition portion (56) could also be constructed in a coil configuration with a gradual increase in the stiffness.
• multi-filar tube (60) in the flexible portion (54) and the hypotube (70) in both the transition (56) and proximal portion (58) are the same material. In another embodiment, the multi-filar tube (60) in the flexible portion (54) and the hypotube (70) in both the transition and proximal portion (58) are different material. In one embodiment, the multi- filar tube (60) in the flexible portion (54) and the hypotube (70) in both transition (56) and proximal portion (58) are one continuous piece with difference construction ln another embodiment, as described with reference to Figs. 3A-3B, the multi-filar in the flexible portion (54) and the hypotube (70) in both transition (56) and proximal portion (58) are two separate pieced which are joined together by the inner liner (82).
• the overall size of implant pusher shaft (50) could varies from portion to portion.
• the implant pusher shaft (50) could have a tapered transition portion (56) with a smaller size at its distal end, a greater size at its proximal end, and a smooth transition in between.
• the overall size of the flexible portion (54) is similar to the size of the distal end (71) of the transition portion (56), and the overall size of the proximal portion (58) is similar to the size of the proximal end (76) of the transition portion (56).
• the proximal portion (58) of the implant pusher shaft (50) could have a 0.014” general diameter
• the flexible portion (54) of the implant pusher shaft (50) could have a 0.011” general diameter.
• the implant pusher shaft (50) is made of one or more plastic and/or metal materials, each independently chosen from stainless steels; shaped memory metals; nickel titanium alloys; polymers; shaped memory polymers; or combinations of one or more of these.
• the filament used in making the coil/braid construction can be of a metal and/or a plastic.
• the outer jacket (80) is made of a polymer, for example PTFE or PET which is a heat shrinkable material, or a combination of both.
• a polymer for example PTFE or PET which is a heat shrinkable material, or a combination of both.
• the outer jacket (80) has a thickness between 0.0010” and 0.0025”. In yet another embodiment, the outer jacket (80) could have various thickness covering each portion of the implant pusher shaft (50). Although an outer jacket (80) is disclosed and described here, one skilled in the art should understand that as the design, material, and/or construct of the implant pusher shaft (50) varies, the outer jacket (80) might not be necessary. Thus, what has been disclosed herein should not be viewed as limiting to the overall scope of the present teachings.
• the proximal end of the implant pusher shaft (50) joins to an implant release mechanism (20).
• the implant release mechanism (20) is configured to attach to the implant pusher shaft (50) during implant delivery and break away from the implant pusher shaft (50) in order to release the implant (100).
• the implant release mechanism (20) is of one piece construction with the proximal portion (58) of the implant pusher shaft (50).
• the implant release mechanism (20) is has a tubular body made of the same hypotube (70) extending beyond the proximal end of the implant pusher shaft (50).
• the implant release mechanism (20) has a circumferentially weakened spot (22).
• the circumferentially weakened location is achieved by various means known to those skilled in the art such as reducing the thickness of the outer jacket (80), removing material, or perforating material along the circumference of the hypotube (70).
• a clinician bends the implant release mechanism (20) to an angle, resulting a break-away of hypotube (70) of the implant release mechanism (20) from the proximal portion (58) of the implant pusher shaft (50).
• the implant release mechanism (20) has a longitudinal lumen extending from its distal end to its proximal end.
• a cap (24) is used to joins the proximal end of the implant engagement wire (40) to the proximal end of the implant release mechanism (20).
• the cap (24) is also configured to close the proximal end of the hypotube (70) of the implant release mechanism (20).
• the implant release mechanism (20) has an overall length of 45-55 mm, an overall size similar to the proximal portion (58) of the implant pusher shaft (50).
• shrink bands (26) are incorporated, one on the implant release mechanism (20), proximal to the circumferentially weakened spot (22) between the implant release mechanism (20) and the implant pusher shaft (50), the other one on the proximal portion (58) of the implant pusher shaft (50) distal to the circumferentially weakened spot (22).
• the shrink bands (26) is to indicate clinician a holding location for a clean break-away of the implant release mechanism (20) from the implant pusher shaft (50).
• the shrink bands (26) is configured to have a different color than the outer jacket (80) of the implant pusher shaft (50).
• the shrink bands (26) is configured to have a different surface feature than the outer jacket (80) of the implant pusher shaft (50). In one embodiment, both shrink bands (26) are 19 mm away from the circumferentially weakened spot (22). In another embodiment, both shrink bands (26) are 25 mm in length.
• an implant engagement wire (40) slidably disposes within the axial lumen of the implant pusher shaft (50) and the implant release mechanism (20).
• the implant engagement wire (40) is configured to extend distally or retract proximally independent of the implant pusher shaft (50).
• a proximal end of the implant engagement wire (40) fixes to the proximal end of the implant release mechanism (20).
• the proximal end of the implant engagement wire (40) extends through the axial lumen of the implant release mechanism (20) and fixedly joins to the proximal end of the implant release mechanism (20)
• the proximal end of the implant engagement wire (40) joins to the implant release mechanism (20) through a chemical mean (for example, an adhesive), a thermal mean (for example, welding), or a mechanical means (for example, crimping).
• a chemical mean for example, an adhesive
• a thermal mean for example, welding
• a mechanical means for example, crimping
• an epoxy cap is used to fuse the proximal end of the implant engagement wire (40) to the proximal end of the implant pusher shaft (50).
• the above described epoxy cap is only one exemplary embodiment for such attachment, other techniques known in the field could all be incorporated to achieve the same purpose
• the implant engagement wire (40) retracts proximally relative to the implant pusher shaft (50). As explained herein, this configuration prevents the implant engagement wire (40) from accidentally extending distally during implant delivery. Thus, as the implant pusher shaft (50) remains steady, the implant engagement wire (40) can only be retracted proximally independent of the implant pusher shaft (50) when breaking the engagement between the implant pusher shaft (50) and the implant release mechanism (20). Without limiting the scope of the present teachings with any particular theory, such a design would prevent an accidental advancement of the implant and avoid any damage to nearby anatomy.
• the implant engagement wire (40) can be made of a metal and/or a plastic material, each chosen from stainless steels, superelastic metals, nickel titanium alloys, shaped memory alloys, shaped memory polymers, polymers, or combinations of one or more of the foregoing.
• the implant engagement wire (40) has a general diameter between 0.001” and 0.005”.
• a proximal portion (58) and/or a distal portion of the implant engagement wire (40) has a different physical property or is made of a different material.
• the distal end of the implant pusher shaft (50) joins to an implant engagement feature (52).
• the implant engagement feature (52) fixedly joins to the distal end of the implant pusher shaft (50) and is configured to engage the implant with the implant engagement wire (40).
• the implant engagement feature (52) has a cylindrical body portion (30) with an axial lumen connected to the distal end of the multi-filar tube (60), two fingers (32) extending distally from the cylindrical body portion (30), an a cross pin (34) joining two opposing fingers (32).
• Fig. 5 illustrates that the two fingers (32) as directly opposing each other across the axial center of the implant pusher shaft (50), one skilled in the art should understand that modifications could be made according to the treatment purpose and location, such as the two fingers (32) could be configured to be not directly across each other from the axial center. Additionally, Fig.
• FIG. 5 illustrates that the cross pin (34) joins two fingers (32) at their distal tips, and one skilled in the art should understand that the location where the cross pin (34) joins the fingers can vary according to the need during the manufacturing process. Thus, the specific embodiments disclosed herein should not be viewed as limiting to the scope of the present teachings.
• the overall length of the implant engagement feature (52) is about 0.5mm with the two fingers (32) ranging from 0.008” to 0.04”.
• the overall size of the axial lumen of the implant engagement feature (52) is configured to be similar to the overall size of the axial lumen of the multi-filar tube (60).
• the cross pin (34) has a diameter around 0.001” to 0.002”.
• the different part of the implant engagement feature (52) is made of different material.
• the cross pin (34) is made of stainless steel, the fingers (32) are made of platinum or iridium
• the implant (100) has a coil body (102) extending from a proximal end (103) to a distal end (101), with an elongated lumen extended from one end to the other end of the coil body (102).
• the implant (100) further includes a stretch resistance member (110), and an engagement loop (120), where the proximal end (113) of the stretch resistance member (110) and the distal lend (122) of the engagement loop (120) are joined together by an anchor band (114). Both the stretch resistance member (110) and the engagement loop (120) extend inside the axial lumen of the coil boy (102).
• FIG. 7A illustrates a distal end portion of the implant (100).
• the stretch resistance member (110) is made of polypropylene and/or another plastic material
• the distal end (111) of the stretch resistance member (110) joins the distal end (101) of the coil body (102).
• the distal end (111) of the stretch resistance member (110) has an enlarged distal end with a smaller ball and a distal cap, all in one piece.
• the distal cap is configured to be positioned outside and against the distal end the coil body (102) with the smaller ball positioned inside the coil lumen.
• the enlarged distal end of the stretch resistance member (110) could be of the same material as the rest portion of the member, for example, polypropylene and/or another plastic material.
• the enlarged distal end of the stretch resistance member (110) could be made of a radiopaque material or is incorporated with a radiopaque material.
• epoxy is used to fuse the enlarged distal end of the stretch resistance member (110) to the distal end (101) of the coil body (102).
• such enlarged distal end of the stretch resistance member (110) is configured to increase the tensile value. When pulling on the resistance member (110), the tensile force is transferred to the distal cap and subsequently onto the coil body (102).
• This configuration prevents accidental detachment between the distal end (111) of the stretch resistance member (110) from the distal end (101) of the coil body (102).
• the distal end (111) of the stretch resistance member (110) could join to the distal end (101) of the coil body (102) by any chemical means (for example, an adhesive), any thermal means (for example, welding), or any mechanical means (for example, friction) known to those skilled in the field.
• the coil body (102) of the implant (100) is made of platinum tungsten alloy, platinum, or platinum iridium alloy. It overall length in the delivery profile is lcm to 60cm.
• the coil body (102) is configured to have none or minimum stretchability. One skilled in the art should understand that if the coil body (102) is stretched, a physician will have to employ a greater amount of force in order to retrieve implant (100) back into the delivery system (10).
• the coil body (102) is a continuous coil, or a plurality of coils that connect with one another.
• each coil body (102) is made of platinum, platinum tungsten alloy, and platinum iridium alloy.
• the coil body (102) could have an outer diameter of 0.009”-0.0l8”. In a preferred embodiment, the coil body (102) has an outer diameter of 0.011”-0.015”.
• the stretch resistance member (110) is made of polypropylene or other suitable plastic material.
• the stretch resistance member (110) has a general size of 0.0008” to 0.0035” in diameter.
• the stretch resistance member (110) has a general size of 0.001” to 0.002” in diameter.
• the stretch resistance member (110) is configured to resist stretch in order to minimize the tension on the coil body (102).
• the stretch resistance member (110) has an overall length general similar to the length of the coil body (102). Thus, during implant deliver, the proximal end of the stretch resistance member (110) rests within the axial lumen of the coil body (102).
• Fig. 7B illustrates a proximal end portion of the implant (100) as the implant engaging to the delivery system (10).
• the proximal end (113) of the stretch resistance member (110) joins to a distal end (121) of an engagement loop (120) by an anchor band (114).
• the anchor band (114) crimps both free ends (121) of the engagement loop (120) to a proximal end (113) of the stretch resistance member (110).
• the proximal end (113) of the stretch resistance member (110) is in a form of a knot, preventing it accidentally slipping through the anchor band (114).
• the anchor band (114) has an overall length of 0.012”.
• One skilled art should understand that other technique could be used to join the stretch resistance member (110) to the engagement loop (120).
• the proximal end (103) of the coil body (102) engages to a stepper band (130).
• the stepper band (130) has a cylindrical body with an axial lumen configured to extend partially inside the axial lumen of the coil body (102).
• a distal portion of the stepper band (130) extends from the proximal end into the axial lumen of the coil body (102).
• a proximal portion (58) of the stepper band (130) remains outside and proximal to the coil body (102).
• the stepper band (130) joins to the coil body (102) by frictional fit.
• epoxy is used to fuse the stepper band (130) to the coil body (102).
• epoxy (132) binds the proximal end of the coil boy with the stepper bank, and forms a proximal ramp toward the end of the epoxy binding. According to one embodiment, this ramp is configured to help the re-entry of coil body (102) back into a delivery sheath.
• epoxy is used to join the stepper band (130) to the coil body (102), weld, or other methods known in the field could also be used
• the stepper band (130) has an outer diameter of 0.0065”and an overall length of 0.0l25”-0.016” with 2/3 length housed inside the axial lumen of the coil body (102), and 1/3 length remains outside.
• the stepper band (130) further includes a through lumen of 0.0075” in diameter.
• the through lumen of the stepper band (130) is configured to allow the engagement loop (120) to extend through.
• the stepper band (130) is made of platinum iridium alloy material.
• stepper band (130) works to transfer pushing force applied by the cross pin (34) to the entire coil body (102).
• the anchor band (114) is configured to have a slightly greater outer profile than the inner diameter of the stepper band (130).
• the anchor band (114) is then being pulling against the stepper band (130).
• the interference between the anchor band (114) and the stepper band (130) allows the force to be distributed among the entire coil body (102) and the stretch resistance member (110), instead of the stretch resistance member (110) alone.
• the stepper band (130) has an outer diameter of 0.0065”- 0.0075”, an inner diameter of 0.0045”, and an overall length of 0.0125”-0.016”.
• the anchor band (114) has an outer diameter of 0.005”, an inner diameter of 0.003” and an overall length of 0.012”.
• the engagement loop (120) is made of filament is a single filar, for example, a polypropylene fiber with a diameter of approximately 0.001” folded into a loop with both open ends crimped to the stretch resistance member (110).
• the engagement loop (120) is made of multiple filaments, such as two or more filaments in a side-by-side configuration.
• the engagement loop (120) is made of a plastic or metal material, for example a nickel titanium alloy.
• the engagement loop (120) is made of material with superelasticity, which facilitates de-attachment between the implant (100) and the implant engagement feature (52).
• the engagement loop (120) has a general natural length of 1 mm in its collapsed and elongated profile.
• the engagement loop could be made of stretchy material allows the loop to be stretched longer from its natural length. As shown FIG. 7B, as the implant (100) engages to the delivery system (10), the engagement loop (120) is stretched so that the loop’s proximal end extends beyond the proximal end of the stepper band (130).
• Fig. 7B further illustrates an embodiment of the present teaching where the implant (100) engages the delivery system (10).
• the engagement loop (120) is tensioned and therefore extends proximally beyond the proximal end of the stepper band (130) and beyond the cross pin (34) of the delivery system (10).
• the distal end of the implant engagement wire (40) extends first through the engagement loop (120) of the implant (100), then beyond the cross pin (34) of the implant engagement feature (52), and further distally into the axial lumen of the stepper band (130).
• the engagement loop (120) is tensioned and therefore extends proximally beyond the proximal end of the stepper band (130) and beyond the cross pin (34) of the delivery system (10).
• the distal end of the implant engagement wire (40) extends first through the engagement loop (120) of the implant (100), then beyond the cross pin (34) of the implant engagement feature (52), and further distally into the axial lumen of the stepper band (130).
• engagement loop (120) extends over one side of the cross pin (34), and the engagement wire extends over the opposing side of the cross pin (34), such that the cross pin (34) is secured in between the engagement loop (120) and engagement wire.
• the implant engagement wire (40) remains steady, the distal movement of the engagement loop (120) is stopped by the cross pin (34). This allows the implant (100) to be securely engaged to the delivery system (10).
• the implant (100) is pushed distally, for example, by cross pin (34) pushing onto the proximal end of the stepper band (130).
• the engagement between the delivery system (10) and the implant (100) also allows a rotational movement of the delivery system (10) to be transferred to the implant (100).
• Fig. 7B shows a gap between the cross pin (34) of the delivery system (10) and the proximal end of the stepper band (130) of the implant (100), those skilled in the art should understand that during the implant’s distal advancement, there could be no gap. What’s shown in Fig. 7B is a merely an illustration solely for the purpose of explaining various embodiments of the present teachings.
• the engagement loop (120) extends proximally over one side of the cross pin (34), and the implant engagement wire (40) extends distally through the center of the engagement loop (120) and over another side of the cross pin (34).
• the engagement loop (120) bends away from the longitudinal axis of the implant pusher shaft (50).
• the distal portion of the engagement wire could be bent to a degree while the engagement loop (120) remain its general linear profile.
• the distal end portion of the implant engagement wire (40) retracts proximally over the cross pin (34), out of the engagement loop (120), and then back inside the elongated lumen of the implant pusher shaft (50).
• the engagement loop (120) of the implant (100) is free from constrain as shown in Fig. 8B. Once freed, the engagement loop (120) relaxes and resume its original non-tensioned profile, and subsequently retracts into the axial lumen of the stepper band (130) or coil body (102).
• the implant (100) relaxes from its general linear delivery profile as it contains inside the delivery sheath, and resumes a pre-configured or randomly-arranged curl profile which fills space at the implantation (such as aneurysm) site.
• the stretch resistance member (110) and the engagement loop (120) are configured to be flexible and conforming without imposing any stiffness to the surrounding coil body (102).
• vascular introducer sheath such as an introducer sheath comprising high-density polyethylene (HDPE), PTFE, and/or polypropylene can be used for creating a conduit for advancing the delivery system and coil implant assembly to a treatment location.
• Access devices can also include one or more standard guide catheters, interventional guidewires, and/or microcatheters.
• a clinician may also employ other tools during a treatment procedure.
• imaging devices such as fluoroscope; X-ray; CT scanner; MRI; ultrasound imager; and combinations of these could be used during delivery and positioning.
• one or more radioopaque markers are used to aid visualization. Such marker could be incorporated either on the medical implant or the delivery system. Without attempting to limit to any particular function, these radioopaque markers can be visualized by using radiographic imaging equipment such as X-ray, magnetic resonance, ultrasound or other imaging techniques. Marker as disclosed herein can be applied to any part of a device or a delivery system of the present teachings.
• a radioopaque marker can be sewed, adhered, swaged riveted, otherwise placed, and secured in or on the device.
• the radioopaque marker may be made of tantalum, tungsten, platinum, irridium, gold, or alloys of these materials or other materials that are known to those skilled in the art.
• the radioopaque marker can also be made of numerous paramagnetic materials, including one or more elements with atomic numbers 21-29, 42, 44, and 58-70, such as chromium (III), manganese (II), iron (III), iron (II), cobalt (II), copper (II), nickel (II), praesodymium (III), neodymium (III), samarium (III), ytterbium (III), gadolinium (III), terbium (III), dysprosium (III), holmium (III) and erbium (III), or other MR visible materials that are known to those skilled in the arts.
• chromium (III) manganese (II), iron (III), iron (II), cobalt (II), copper (II), nickel (II), praesodymium (III), neodymium (III), samarium (III), ytterbium (III), gadolinium
• exemplary embodiments described above refers to an embolic coil implant
• exemplary embodiments for implant- delivery system attachment embodiments and for the implant release mechanism could be used with other implants such as other vaso-occlusive devices, stents, and etc.
• exemplary embodiment for delivery system is constructed and arranged to precisely deliver an implant into an aneurysm, such as a brain aneurysm.
• the exemplary embodiment for delivery system is arranged to precisely delivery an implant into a blood vessel such as a blood vessel of the brain, a patent blood vessel, or other locations.

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