WO2013180731A1 - Système d'implantation ayant un manche et un cathéter et son procédé d'utilisation - Google Patents

Système d'implantation ayant un manche et un cathéter et son procédé d'utilisation Download PDF

Info

Publication number
WO2013180731A1
WO2013180731A1 PCT/US2012/040453 US2012040453W WO2013180731A1 WO 2013180731 A1 WO2013180731 A1 WO 2013180731A1 US 2012040453 W US2012040453 W US 2012040453W WO 2013180731 A1 WO2013180731 A1 WO 2013180731A1
Authority
WO
WIPO (PCT)
Prior art keywords
zone
catheter
tubular member
handle
implantable medical
Prior art date
Application number
PCT/US2012/040453
Other languages
English (en)
Other versions
WO2013180731A9 (fr
Inventor
Eric K. Mangiardi
Martina Schmitt
Original Assignee
Quali-Med Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Quali-Med Gmbh filed Critical Quali-Med Gmbh
Priority to PCT/US2012/040453 priority Critical patent/WO2013180731A1/fr
Priority to CN201280073602.9A priority patent/CN104334122B/zh
Priority to CN201710427780.1A priority patent/CN107157633B/zh
Priority to CN201710428370.9A priority patent/CN107242923A/zh
Publication of WO2013180731A1 publication Critical patent/WO2013180731A1/fr
Publication of WO2013180731A9 publication Critical patent/WO2013180731A9/fr

Links

Classifications

    • 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
    • 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
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof

Definitions

  • the present application relates generally to medical devices and, in particular, to a delivery system and method for introducing implantable medical devices into a body cavity.
  • Implants may be placed in the human body for a variety of reasons.
  • stents are placed in a number of different body lumens such as blood vessels and biliary ducts; vena cava filters are implanted in the vena cava to catch thrombus sloughed off from other sites within the body; and vaso-occlusive devices are used for the treatment of intra ascular aneurysms .
  • the catheter comprises an elongated, body having a distal end and a proximate end.
  • the elongated body further comprises a stabilization zone at the distal end, a protection zone located between the stabilization zone and the proximate end, a
  • Another aspect of the present application relates to a method for deploying an implantable medical device comprising: advancing the catheter for deploying an implantable medical device, the catheter having a tip at its distal end and. a connector at its proximate end and comprising a stabilization zone proximate to the tip.
  • a protection zone proximate to the stabilization zone a flexibility zone proximate to the protection zone, a pushability zone proximate to the trackability zone and a strain relief area between the flexibility zone and the connector into a body lumen
  • an implantable medical device affixed to the protection zone of said catheter, attaching the proximal end of the catheter to an advancing device, the advancing device comprising: a base member comprising a base handle; and a deployment extension having a distal end. and a proximate end.
  • the proximate end is connected to the base handle; a first tubular member that fits over the deployment extension and is longitudinally slidable over the deployment extension, the first tubular member comprising: a first tubular body with a distal end and a proximal end; and a first handle for controlling movement of the first tubular member; and. a second, tubular member that fits over the first tubular member and is longitudinally slidable over the first tubular member, the second tubular member comprising: a second, tubular body with a distal end and a proximal end; and a second handle for controlling movement of the second tubular member, wherein the first handle is located between the base handle and.
  • kits comprising: a catheter for deploying an implantable medical device, the catheter having a tip at its distal end and a connector at its proximate end. and. comprising a stabilization zone proximate to the tip, a protection zone proximate to the stabilization zone, a flexibility zone proximate to the
  • FIG. lA shows a perspective view of an exemplary a catheter device 40 of the present application.
  • FIG IB shows the catheter device 40 attached to a delivery device 100 in a pre-deployment configuration.
  • FIGS. 2A-C show a vie of the catheter de vice 40 comprising radio opaque markers in the protection zone 43.
  • FIG. 3 shows a perspective view of an exemplary delivery device 100 in a pre- deployment configuration.
  • FIGS. 4A-4C are perspective views of an embodiment of the base member of the delivery system 100.
  • FIGS. 5A-5C are perspective views of the first tubular member of the delivery system 100.
  • FIGS. 6A-6C are perspective view of the first tubular member in a retracted position.
  • FIGS. 7A-7C are perspective views of the second tubular member of the deliver system 100.
  • FIGS, 8A-8C are perspective views of the exemplary delivery system 100 in a deployment configuration.
  • FIG. 9 shows a perspective view of another exemplary deliver ⁇ ' ' system 100 in a pre- deployment configuration.
  • FIG. 10 is a diagram comparing trackability force of the catheter of the present application (EX) to that of other comparable devices (C1-C8).
  • FIG. 11 is a diagram comparing ease of flexibility of the catheter of the present application (EX) to that of other comparable devices (C1-C6).
  • FIG. 12 is a diagram comparing deployment accuracy of the catheter of the present application (EX) to that of comparable devices (C1 -C6).
  • the catheter has an elongated body with a distal end and a proximate end.
  • the elongated body comprises a stabilization zone at the distal end, a protection zone adapted to carry a medical device and located between the stabilization zone and the proximate end and is proximate to the stabilization, a flexibility zone located between the protection zone and the proximate end and is proximate to the protection zone, a trackability zone located, between the flexibility zone and.
  • proximate end and is proximate to the flexibilit zone
  • a pushability zone located between the trackability zone and the proximate end and is proximate to the trackability zone
  • a connector at the proximate end to connect the catheter to a delivery device.
  • the stabilization and protection zones have the highest flexibility to facilitate placement of the medical device, such as a stent, carrying on the protection zone.
  • the flexibility zone has a flexibility that equals to, or is less than, that of the stabilization and protection zones.
  • the trackability zone has a flexibility that is less than that of the pushability zone.
  • the pushability zone is the least [0025]
  • the different zones have different material compositions in order to achieve desired flexibility.
  • zones of different flexibility are connected through transition areas. Each transition area is an area of intermediate flexibility between the adjacent zones it resides between. In some embodiments, the transition area consist of a gradual mixture of the polymer mixture of one zone into the adjacent zone, or a gradual change in the weave pattern of the polymer from one zone into the adjacent zone.
  • the distal end of the stability zone contains a tip that allows the catheter to move through a body lumen without damaging the tissue lining of the body lumen due to the conical elongated tip made of a polyemite blend that allows for a soft flexible contour when traversing various tortuous lumens.
  • the elongated body further contains a strain relief area between the pushability zone and the connector that reduces the pressure of the pushability zone closest to the handle to allow for the area to flex while applying significant pushing- pressure thus eliminating the potential for kinking.
  • the strain relief is made of alternating undulating open and closed levels that allow for compression and bending much like that of a standard, computer cord or iron. It is more flexible than the pushability zone.
  • the catheter further comprises an implantable medical device affixed to the protection zone.
  • the implantable medical device is a stent.
  • the protection zone comprises an inflatable balloon for deploying the implantable medical device.
  • the stabilization zone is coated with or comprises an embedded radio-opaque substance.
  • the protection zone is coated with or comprises an embedded radio-opaque substance.
  • the flexibility zone is coated with or comprises an embedded radio-opaque substance.
  • the trackability zone is coated with or comprises an [0034]
  • the pushability zone is coated with or comprises an embedded radio-opaque substance.
  • Another aspect of the present application relates to a method, for deploying an implantable medical device comprising: advancing the a catheter for deploying an
  • the catheter having a tip at its distal end and a connector at its proximate end and comprising a stabilization zone proximate to the tip, a protection zone proximate to the stabilization zone, a flexibility zone proximate to the protection zone, a pushability zone proximate to the flexibility zone and a strain relief area between the pushability zone and the connector into a body lumen, wherein an implantable medical device affixed to the protection zone of said catheter, attaching the proximal end of the catheter to an advancing device, the advancing device comprising: a base member comprising a base handle; and a deployment extension having a distal end and a proximate end, the proximate end is connected to the base handle; a first tubular member that fits over the deployment extension and is longitudinally slidable over the deployment extension, the first tubular member comprising: a first tubular body with a distal end and a proximal end; and a first handle for controlling movement of the
  • distal ends of the deployment extension, the first tubular body, and the second tubular body are adapted to deploy an implantable medical device, and retracting the first tubular member and the second tubular member towards the base member to deploy the implantable medical device in the body lumen.
  • the implantable medical device is a stent.
  • the method further comprises attaching a viewing device to the base member.
  • the viewing device is an endoscope.
  • the viewing device is a fiber optic based viewing device.
  • the body lumen is a blood vessel or a bile duct.
  • kits comprising: a catheter for deploying an implantable medical device, the catheter having a tip at its distal end and a connector at its proximate end and. comprising a stabilization zone proximate to the tip. a protection zone proximate to the stabilization zone, a flexibility zone proximate to the
  • the kit farther comprises an implantable medical device.
  • the implantable medical device is a stent.
  • the kit further comprises a guidewire.
  • the kit further comprises an introducer sheath.
  • the kit further comprises a viewing device attachable to the base member.
  • the viewing device is an endoscope.
  • FIG. 1A shows an embodiment of the catheter device 40 of the present application.
  • the catheter device 40 comprises a tip 41 at the end of the catheter device 40 most distal to the delivery system 100.
  • Immediately proximate to the tip 41 are functional zones of the catheter device 40 for stabilization 42, protection 43, flexibility 44, trackabiiity 45, and pushability 46.
  • Immediately proximate to the pushability zone 46 is a region of the catheter device 40 serving as a strain relief area 47 and a connector 48 for attaching the catheter device 40 to a delivery device 100 described herein or to some other type of medical device.
  • FIG. IB is a diagram showing the catheter device 40 attached to the delivery device 100.
  • the diameters of the zones of the catheter may be the same as one another or different.
  • the durometer, or hardness, of the different zones may be the same as one another or different.
  • the different zones may be made of the same material, or from different materials.
  • a zone of the catheter may comprise a material selected [0046]
  • the distal end of the catheter device 40 comprises a tip 41 that allows the catheter to move into or through a body lumen without catching on or damaging the tissues lining said body lumen.
  • the tip 41 comprises a radio-opaque substance that is visible under fluoroscopy.
  • the radio-opaque substance is embedded into or sealed within the tip 41.
  • the tip 41 is coated or painted with the radio-opaque substance.
  • the catheter device 40 comprises a
  • the stabilization zone 42 immediately proximate to the distal tip 41.
  • the stabilization zone 42 provides an area of the catheter distal to the region upon which the implantable medical device is carried that enhances the stability of the catheter during deployment of the implantable medical device in the body lumen.
  • the length of said stabilization zone 42 is between about 1 mm and about 7 mm. In a further embodiment, the length of said stabilization zone 42 is between about 1 mm and about 5 mm. In a still further embodiment, the length of said stabilization zone 42 is between about 2 mm and about 4 mm. In a yet still further embodiment, the length of said stabilization zone 42 is about 3 mm. In a particular embodiment, the stabilization zone 42 has a flexibility index of about 2000-4000 mN in a 3 point bending deflection test. In another embodiment, the stabilization zone 42 has a flexibility index of about less than 3000 mN in a 3-point bending deflection test. In a further embodiment, the stabilization zone 42 has a flexibility index of about 2700-3000 mN in a 3 point bending deflection test. All 3-point bending deflection tests described, hereinafter are performed using the ASTM Standards 790
  • the stabilization zone 42 comprises a magnetic or ferrous material that allows the direction of the catheter to be manipulated during insertion with an externally controlled, magnetic field.
  • the magnitude of the externally controlled magnetic field is between about 0.01 Tesla and about 0.5 Tesla, In a further embodiment, the magnitude of the externally controlled magnetic field, is between about 0.05 Tesla and. about 0.2 Tesla. In a still farther embodiment, the magnitude of the externally controlled, magnetic field is between about 0.08 Tesla and about 0.1 Tesla.
  • the catheter device 40 comprises a "protection" zone 43 immediately proximate to the stabilization zone 42.
  • the protection zone 43 comprises an area upon which an implantable medical device is emplaced for insertion and implantation in a body lumen.
  • the implantable medical device is a stent.
  • the area upon which the implantable medical device is emplaced comprises an inflatable balloon. Inflation of the balloon upon which the implantable medical device is emplaced causes the implantable medical device to expand against the walls of the body lumen. Subsequent deflation of said area leaves the implantable medical device expanded against the walls of the body lumen and dissociates the implantable medical device from the catheter in general and from the protection zone 43 in particular.
  • the protection zone further comprises at least one radio-opaque marker coated onto the catheter.
  • the at least one radio-opaque marker is a coating of tungsten in urethane.
  • the marker is sealed by overcoating with an additional layer of urethane.
  • the at least one radio-opaque marker is an integrated tantal marker (ITM). Coating of at least one radio-opaque marker onto the protection zone 43 of the catheter 40 allows for the elimination of marker bands on the device, giving the device a lower profile and allowing more flexibility and pushabiiity of the catheter device 40 because there are no defects in the device for the seating of markers. Additionally, the at least one radio-opaque marker in the protection zone 43 of the catheter 40 allows for the visualization of the exact placement of the stent or other implantable medical device.
  • FIG. 2A is an exemplary depiction of a single tungsten-containing radio- opaque marker 51 spanning the length of the protection zone 43.
  • the single tungsten-containing radio-opaque marker 51 does not span the entire length of the protection zone 43, but is the same length as the implantable medical device.
  • FIG. 2B is an exemplary depiction of a pair of tungsten-containing radio- opaque markers 52 at the ends of the protection zone 43.
  • the pair of tungsten-containing radio-opaque markers 52 are directly under the proximal and distal ends of the implantable medical device. In other embodiments, the pair of tungsten-containing radio-opaque markers 52 are immediately proximal and distal to the ends of the implantable medical device.
  • FIG. 2C is an exemplary depiction of a pair of integrated tantal markers 53 at the ends of the protection zone 43.
  • the pair of integrated tantal [0057]
  • the length of the protection zone 43 is between about 50 mm and about 250 mm. In a further embodiment, the length of the protection zone
  • the protection zone 43 is between about 100 mm and about 200 mm. In a still further embodiment, the length of the protection zone 43 is about 152 mm. In a particular embodiment, the protection zone 43 has a flexibility index of about 2000-4000 mN in a 3 point bending deflection test. In another embodiment, the protection zone 43 has a flexibility index of about less than 3000 mN in a 3- point bending deflection test. In a further embodiment, the protection zone 43 has a flexibility index of about 2700-3000 m in a 3 point bending deflection test.
  • the catheter device 40 further comprises a protective sheath that extends from the delivery device 100 to and covering the implantable medical device emplaced on the protection zone 43.
  • a protective sheath that extends from the delivery device 100 to and covering the implantable medical device emplaced on the protection zone 43.
  • the implantable medical device is a self-expanding stent or other implantable device, wherein drawing back of the sheath allows the device to immediately expand against the walls of the body lumen,
  • the catheter device 40 comprises a
  • the flexibility zone 44 is between about 50 mm and about 150 mm. In a further embodiment, the length of the flexibility zone 44 is between about 70 mm and about 120 mm. In a still further embodiment, the length of the flexibility zone 44 is about 90 mm. In a particular embodiment, the flexibility zone 44 has a flexibility index of about 2000-4000 mN in a 3 point bending deflection test. In another embodiment, the flexibility zone 44 has a flexibility index of about less than 3500 mN in a 3-point bending deflection test. In a further embodiment, the flexibility zone 44 has a flexibility index of [0062] In another particular embodiment, the catheter device 40 comprises a
  • the trackability zone 45 immediately proximate to the flexibility zone 44.
  • the trackability zone 45 is of an intermediate flexibility between that of the more flexible flexibility zone 44 and the more rigid pushability zone 46.
  • the trackability zone 45 has a flexibility index of about 3000-5000 mN in a 3 point bending deflection test.
  • the trackability zone 45 has a flexibility index of about less than 4500 mN in a 3 -point bending deflection test.
  • the trackability zone 45 has a flexibility index of about 3900-4100 mN, more particularly of about 4000 mN, in a 3 point bending deflection test,.
  • the flexibility index of the trackability zone 45 is higher than that of the of the flexibility index of the flexibility zone 44. In some embodiments, the flexibility index of the trackability zone 45 is within the range of about 1 10% - 150% of the flexibility index of the flexibility zone 44.
  • the intermediate rigidity of the trackability zone allows the cathether device 40 to easily track through complex bends in a lumen or vessel without kinking or folding.
  • a radio-opaque substance is embedded into the trackability zone 45. In another still further embodiment, the trackability zone 45 is coated or painted with a radio-opaque substance,
  • the trackability zone 45 is between about 100 mm and about 300 mm. In a further embodiment, the length of the trackability zone 45 is between about 150 mm and about 250 mm. In a still further embodiment, the length of the trackability zone 45 is about 195 mm.
  • the catheter device 40 comprises a "pushability'" zone 46, In one embodiment, the pushability zone 46 is immediately proximate to the trackability zone 45.
  • the pushability zone 46 is a relatively rigid zone of the catheter that allows the practitioner to apply force in order to advance the catheter device 40 into/through the body lumen or vessel.
  • the pushability zone 46 may be made of any biocompatible material with suitable hardness and rigidity for the delivery of the implantable medical device, but is flexible enough to allow the catheter to bend and twist through body lumensor vessels.
  • the biocompatible material is made of nylon, a poly amide, or polyetheretherketone (PEEK).
  • PEEK polyetheretherketone
  • the pushability zone is more rigid than
  • the pushability zone 46 is between about 100 mm and about 620 mm. In a farther embodiment, the length of the pushability zone 46 is between about 230 mm and about 490 mm. In a still further embodiment, the length of the pushability zone 46 is about 360 mm.
  • the pushability zone 46 is between about 500 mm and about 1020 mm. In a further embodiment, the length of the pushability zone 46 is between about 630 mm and about 890 mm. In a still further embodiment, the length of the pushability zone 46 is about 760 mm. In another still farther embodiment, the length of the pushability zone 46 is about 767 mm.
  • the total combined length of the stabilization zone 42, protection zone 43, flexibility zone 44, trackabiiity zone 45 and pushability zone 46 is about 800 mm. In another particular embodiment, the total combined length of the stabilization zone 42, protection zone 43, flexibility zone 44, trackabiiity zone 45 and pushability zone 46 is about 1200 mm. In still another particular embodiment, the total combined length of the stabilization zone 42, protection zone 43, flexibility zone 44, trackabiiity zone 45 and pushability zone 46 is about 1207 mm.
  • the catheter device 40 further comprises transition areas between the stabilization zone 42 and the protection zone 43, between the protection zone 43 and the flexibility zone 44, between the flexibility zone 44 and the trackabiiity zone 45, and/or between the trackabiiity zone 45 and the pushability zone 46,
  • Each transition area is an area of intermediate flexibility between the adjacent zones it resides between, consisting of a gradual mixture of the polymer mixture of one zone into the adjacent zone, or a gradual change in the weave pattern of the polymer from one zone into the adjacent zone.
  • a radio-opaque substance is coated on or embedded into the stabilization zone 42.
  • a radio-opaque substance is coated on or [0071]
  • a radio-opaque substance is coated on or embedded into the flexibility zone 44.
  • a radio-opaque substance is coated on or embedded into the pushability zone 46.
  • a radio-opaque substance is coated on or embedded into the entire catheter 40.
  • the catheter device 40 further comprises a ""strain relief" area 47 that is proximate to the pushability zone 46 and distal to an instrument for deploying an implantable medical device in a body lumen, such as the delivery device 100 as described herein. Said strain relief area 47 is interposed between the catheter device 40 and a connector unit 48 attached to the instrument for deploying an implantable medical device in a body lumen.
  • the connector unit 48 comprises a Y-connector that allows the attachment of a fluid reservoir or syringe.
  • Said fluid reservoir or syringe may comprise an opacity enhancing substance that allows visualization of the balloon when it is inflated.
  • said fluid reservoir is emplaced between the connector unit 48 and the delivery device 100.
  • the connector unit 48 is attached to the delivery device 100 at distal end 32 of the second tubular member 30.
  • FIGS 3-9 show more details of the deliver ⁇ ' device 100.
  • the delivery device 100 allows the user to install the implantable device with one hand.
  • an embodiment of the delivery device 100 contains a base member 10, a first tubular member 20 that fits over the deployment extension 12 and is longitudinally slidable along the deployment extension 12, and a second tubular member 30 that fits over the first tubular member 20 and is longitudinally slidable along the first tubular member 20.
  • the base member 10 contains a base handle 11 and a deployment extension 12.
  • the deployment extension 12 is a rod-like structure having a proximate end 13, a distal end 14, and a pair of compression stopper 16 (one on each side of the extension 12, see e.g.
  • the base handle 11 further contains a guiding extension 15 that matches with, a stabilizing ring on the first tubular member 20 to prevent rotation of the first tubular member 20.
  • the base member 10 further contains a scope coupling
  • the first tubular member 20 contains a first tubular body 21 with a distal end 22 and a proximal end 23, and a first handle 24 for controlling movement of the first tubular member 20.
  • the first tubular body 21 has a center lumen with a cross -sectional shape adopted to fit the outside contour of the deployment extension 12 and to slide longitudinally along the deployment extension 12.
  • the first handle 24 further contains a stabilizing ring 25 that fits over the guiding extension 15 of the base handle 12. As shown in Figure 3, the stabilizing ring 25 slides along the guiding extension 15 of the base handle 11 and prevents rotation of the first tubular member 20 along the central axis of the deployment extension 12.
  • the first tubular member 20 is dissociable from the base member 10 by sliding off from the distal end 14 of the deployment extension 12, Figures 6A-6C show the first tabular member 20 in a retracted position with the base member 10.
  • the second tubular member 30 contains a second tubular body 31 having a distal end 32 and a proximal end 33, and a second handle 34 for controlling movement of the second tubular member 30.
  • the second tubular body 31 has a center lumen with a cross-sectional shape adopted to fit the outside contour of the first tubular body 21 and to slide longitudinally along the first tubular body 21.
  • the second tubular member 30 is dissociable from the first tubular member 20.
  • the first tubular member 20 is connected to the base member 10 through an under-to-over connection.
  • the first tubular member 20 is connected to the base member 10 by sliding the first tubular body 21 over the deployment extension 12 and the stabilizing ring 25 over the guiding extension 15.
  • the second tubular member 30 is also connected to the first tubular member 20 through an under-to-over connection, i.e. , by sliding the second tubular body 31 over the first tubular body 21.
  • the connection can be done in a number of sequences depending on the length of the implantable medical device to be delivered.
  • the device 100 also includes an interlocking feature that allows the first tubular member 20 to be locked relative to the second tubular member 30.
  • the interlocking feature inc3ud.es a locking tab 26 on the first tubular member 20 and a matching locking hole 33 on the second tubular member 30. As shown in Figure 3, the locking tab 26 engages with the locking hole 36 to prevent the second tubular member 30 from falling off from the distal end of the first tubu3ar member 20.
  • the tab 26, however, has a beveled front side that allows the second tubular member 30 to slide over the locking tab 26 towards the proximate end 23 of the first tubular body.
  • the first tubular member 20 is the first tubular member 20
  • the device 100 further contains a locking guide 27 (see Figures 5A-5C).
  • the device 100 further includes a second, interlocking feature that allow the first tubular member 20 to be locked relative to the base member 10.
  • the distal ends of the deployment extension 12, the first tubular body 21 and the second tubular body 31 are configured to hold, contain or attach to an implantable device.
  • implantable device is broadly interpreted, to include stents and other medical devices that can be placed into a body lumen or body cavity.
  • the implantabie devices include implantable devices of the Stent Technology System (STS) family developed by ALVEOLUS®, as well as implantable devices developed in accordance with U.S. Patent Application Ser. Nos. 10/190,770, 10/288,615, and 60/493,402 and International Patent Application Ser, No. PCT DE02/01244, which are incorporated in their entirety by this reference,
  • the distal portion of the device can be configured to accommodate variable shafts to allow for ease of manufacturing and interchangeability of varying catheter diameters.
  • the distal end. 14 of the deployment extension 12, the distal end 22 of the first tubular body 21, or the distal end 32 of the second tubular body 31 is configured such that a catheter may be removably attached to the distal end. 14, 22 or 32.
  • the catheter may be screwed onto the distal end 14, 22 or 32, or coupled to the device by other conventional means such as a luer, hub, or other standard attachment mechanism.
  • the device 100 is a proportional release system.
  • only the base member 10 and the first tubular member 20 are assembled together for deployment of implantable medical devices within a certain length range (e.g., less than about 50 mm).
  • the base member 10, the first tubular member 20, and the second tubular member 30 are
  • the handles 11 , 24 and 34 can be pulled together with a single hand.
  • the handles can be interlocked into each other in a ma3e-and female connection.
  • the second handle 34 may have a hollow interior to accommodate the first handle 24.
  • the first handle 24 may have a hollow interior to accommodate the base handle 1 1.
  • both the second handle 34 and the first handle 24 may wrap around base handle 1 1 when fully compressed.
  • the second handle 34 is spaced at specific distances from the first handle 24 and. the base handle 11 to optimize the closer comfort for the device and improve placement accuracy.
  • the handles may have a beveled, or rounded shape to improve ergonomics.
  • the device 100 may be made of any biocompatible material with suitable hardness and rigidity for the delivery of the implantable medical de vice.
  • the device should have sufficient flexibility to adapt to anatomical curvatures without loss of ability to push or pull.
  • the device is made from a plastic material that can be molded to reduce production cost.
  • the individual parts of the device 100 such as the base member 10, the first tubular member 20 and the second tubular member 30 are inierchaiigeable among different devices 100.
  • the interchangeable parts allow the device 100 to be manufactured in different configurations, such as in a single handle (base member only), double handle (base member + first tubular member), triple handle (base member + first tubular member + second tubular member) or more complex configurations.
  • the diameter and the length of the deployment extension 12, the first tubular body 21 and/or the second tubular body 31 may be designed in compliant with the implantable devices to be delivered and the insertion procedure to be employed.
  • the dimensions of the device must offer enough space for crimped implantable devices.
  • Each individual part of the device should have smooth outer and. inner surfaces to provide low friction between the moving parts.
  • the deployment extension 12. as well as the first tubular body 21 has external measurement markers 18 and 28 for the [0088] Also disclosed is a method for delivering an implantable medical device using the delivery device of the present application.
  • the method includes the steps of: attaching the first tubular member 20 to the base member 10 by sliding the first tubular body 21 over the implantable medical device and the deployment extension 12; attaching the second tubular member 30 to the base member 10 by sliding the second tubular body 31 over the first tubular body 21 ; attaching a proximate end of a catheter to the distal end 32 of the second tubular body 31 , wherein an implantable medical device is attached to a distal end. of the catheter; advancing the distal end of the catheter into a body lumen; retracting the first tubular member 20 and the second, tubular member 30 towards the base member 10 to deploy the medical device.
  • the order of retraction can vary. In one embodiment, the first tubular member 20 is retracted first, followed with the retraction of the second tubular member 30. In another embodiment, the second tubular member 30 is retraced first, followed with the retraction of the first tubular member 20.
  • the retraction of the first or second tubular member can be easily performed with a single hand using handles 24 or 34.
  • a user of the device 100 can hold the base handle 1 1, pull the first handle 24 towards the base handle 1 1 and hence retract the first tubular member 20.
  • the user may first hold the first handle 24, pull the second handle 34 towards the first handle 24 and hence retract the second tubular member 30.
  • the implantable device is exposed and deployed.
  • An introducer sheath is inserted in an appropriate site in order to gain access to a vessel or lumen.
  • a guide wire is inserted through the introducer sheath and advanced through the vessel or lumen to span the area where the implantable medical device is to be deployed.
  • the tip 41 of the catheter device 40 is advanced onto the guide wire and the catheter device 40 is advanced through the introducer sheath into the vessel or lumen.
  • the catheter device 40 is advanced through the vessel or lumen such that the stabilization zone 42 is advanced beyond the deployment site and the implantable medical device on the protection [0094]
  • the protective sheath is withdrawn by pulling handle 24 toward base handle 1 1 , thereby exposing the implantable medical device at the deployment site.
  • the implantable medical device is deployed at the site by pulling handle 34 towards handle 24 and base handle 11. thereby inflating the protection zone 43 and expanding the implantable medical device against the Avails of the lumen.
  • the catheter device 40 is withdrawn from the vessel or lumen.
  • the guide wire and. introducer sheath are removed and the incision at the entry point is sutured.
  • the catheter of the present application were tested against a number of comparable catheter products. As shown in Figures 10-12, the catheter of the present application exhibits the best trackability, flexibility and deployment accuracy among the catheters tested.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un système qui permet de poser un dispositif médical implantable dans une lumière corporelle. Le système comporte un cathéter ayant des zones fonctionnelles pour la stabilité, la protection, la flexibilité, la surveillance et la poussée. Le système comporte en outre un dispositif pour poser un dispositif médical implantable avec le cathéter. L'invention concerne également un procédé pour poser un dispositif médical implantable dans une lumière corporelle à l'aide du système.
PCT/US2012/040453 2012-06-01 2012-06-01 Système d'implantation ayant un manche et un cathéter et son procédé d'utilisation WO2013180731A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
PCT/US2012/040453 WO2013180731A1 (fr) 2012-06-01 2012-06-01 Système d'implantation ayant un manche et un cathéter et son procédé d'utilisation
CN201280073602.9A CN104334122B (zh) 2012-06-01 2012-06-01 带把手和导管的植入系统及其使用方法
CN201710427780.1A CN107157633B (zh) 2012-06-01 2012-06-01 带把手和导管的植入系统及其使用方法
CN201710428370.9A CN107242923A (zh) 2012-06-01 2012-06-01 带把手和导管的植入系统及其使用方法

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2012/040453 WO2013180731A1 (fr) 2012-06-01 2012-06-01 Système d'implantation ayant un manche et un cathéter et son procédé d'utilisation

Publications (2)

Publication Number Publication Date
WO2013180731A1 true WO2013180731A1 (fr) 2013-12-05
WO2013180731A9 WO2013180731A9 (fr) 2015-02-26

Family

ID=49673776

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2012/040453 WO2013180731A1 (fr) 2012-06-01 2012-06-01 Système d'implantation ayant un manche et un cathéter et son procédé d'utilisation

Country Status (2)

Country Link
CN (3) CN104334122B (fr)
WO (1) WO2013180731A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9393139B2 (en) 2009-08-24 2016-07-19 Qualimed Innovative Medizinprodukte Gmbh Implantation system with handle and catheter and method of use thereof

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109773820B (zh) * 2017-11-14 2022-09-20 元心科技(深圳)有限公司 一种夹具

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5891112A (en) * 1995-04-28 1999-04-06 Target Therapeutics, Inc. High performance superelastic alloy braid reinforced catheter
US6077258A (en) * 1997-10-03 2000-06-20 Scimed Life Systems, Inc. Braided angiography catheter having full length radiopacity and controlled flexibility
US20050038495A1 (en) * 2003-08-16 2005-02-17 Trevor Greenan Double sheath deployment system
US20090118740A1 (en) * 2004-01-08 2009-05-07 Alveolus Inc. Implantable device delivery system handle and method of use
US20110046710A1 (en) * 2009-08-24 2011-02-24 Qualimed Gmbh Implantation device with handle and method of use thereof

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4351341A (en) * 1980-08-15 1982-09-28 Uresil Company Balloon catheter
US4996974A (en) * 1989-04-17 1991-03-05 Welch Allyn, Inc. Adjustable steering control for flexible probe
US5226898A (en) * 1989-08-30 1993-07-13 The Kendall Company Catheter adapter with strain relief
US5139032A (en) * 1990-04-18 1992-08-18 Cordis Corporation Fixed balloon on a guidewire extension wire system and kit
US5324269A (en) * 1991-09-19 1994-06-28 Baxter International Inc. Fully exchangeable dual lumen over-the-wire dilatation catheter with rip seam
US5380301A (en) * 1992-07-10 1995-01-10 Sherwood Medical Company Catheter/hub strain relief and method of manufacture thereof
US5358493A (en) * 1993-02-18 1994-10-25 Scimed Life Systems, Inc. Vascular access catheter and methods for manufacture thereof
CA2106353A1 (fr) * 1993-03-10 1994-09-11 George W. Bourne, Iv Assemblage catheter-tubulure et methode pour sa fabrication
WO1995015780A2 (fr) * 1993-12-10 1995-06-15 Schneider (Usa) Inc. Catheter de guidage
US6702802B1 (en) * 1999-11-10 2004-03-09 Endovascular Technologies, Inc. Catheters with improved transition
WO2004014296A2 (fr) * 2002-08-13 2004-02-19 U.S. Department Of Veterans Affairs Methode de detection et de prevention de la maladie d'alzheimer, en particulier a des stades prodromiques et precoces de la maladie
US7621904B2 (en) * 2004-10-21 2009-11-24 Boston Scientific Scimed, Inc. Catheter with a pre-shaped distal tip
US8027714B2 (en) * 2005-05-27 2011-09-27 Magnetecs, Inc. Apparatus and method for shaped magnetic field control for catheter, guidance, control, and imaging
CN1961847A (zh) * 2005-11-09 2007-05-16 温宁 人工心脏支架瓣膜及其输放装置
KR101450932B1 (ko) * 2007-03-07 2014-10-14 메드-엘 엘렉트로메디지니쉐 게라에테 게엠베하 제거가능한 자석을 갖는 이식형 장치
JP5460610B2 (ja) * 2007-11-30 2014-04-02 セント・ジュード・メディカル・エイトリアル・フィブリレーション・ディヴィジョン・インコーポレーテッド 磁場制御および誘導のための磁気先端部を有する灌流アブレーションカテーテル
CN102309809B (zh) * 2010-07-09 2013-11-20 同济大学 造口术系统

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5891112A (en) * 1995-04-28 1999-04-06 Target Therapeutics, Inc. High performance superelastic alloy braid reinforced catheter
US6077258A (en) * 1997-10-03 2000-06-20 Scimed Life Systems, Inc. Braided angiography catheter having full length radiopacity and controlled flexibility
US20050038495A1 (en) * 2003-08-16 2005-02-17 Trevor Greenan Double sheath deployment system
US20090118740A1 (en) * 2004-01-08 2009-05-07 Alveolus Inc. Implantable device delivery system handle and method of use
US20110046710A1 (en) * 2009-08-24 2011-02-24 Qualimed Gmbh Implantation device with handle and method of use thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9393139B2 (en) 2009-08-24 2016-07-19 Qualimed Innovative Medizinprodukte Gmbh Implantation system with handle and catheter and method of use thereof

Also Published As

Publication number Publication date
WO2013180731A9 (fr) 2015-02-26
CN104334122B (zh) 2017-07-04
CN107157633A (zh) 2017-09-15
CN107242923A (zh) 2017-10-13
CN104334122A (zh) 2015-02-04
CN107157633B (zh) 2020-02-14

Similar Documents

Publication Publication Date Title
US10058444B2 (en) Implantation system with handle and catheter and method of use thereof
US10137022B2 (en) Implantation device with handle and method of use thereof
US7608099B2 (en) Medical appliance delivery apparatus and method of use
JP5728023B2 (ja) 傾斜部を備えた内視鏡キャップ
EP2512385B1 (fr) Système de distribution pourvu d'une extrémité proximale rétractable
US7981152B1 (en) Vascular delivery system for accessing and delivering devices into coronary sinus and other vascular sites
US20080255651A1 (en) Telescoping Stability Sheath and Method of Use
WO2013180731A1 (fr) Système d'implantation ayant un manche et un cathéter et son procédé d'utilisation
US10779977B2 (en) Variable scale stent deployment device
WO2017048308A1 (fr) Dispositif de déploiement de stent à échelle variable

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 12878154

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE