Introducer for an expandable vascular occlusion device

• US 5,895,410 A
• Filed: 09/12/1997
• Issued: 04/20/1999
• Est. Priority Date: 09/12/1997
• Status: Expired due to Term

• Current Assignee: Scion Medical Ltd. (Siemens AG)
• Original Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Inventors: Venbrux, Anthony C., Forber, Simon J.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRINH, HOA B
• Application Number:
  US08/927,535
• Time in Patent Office: 585 Days
• Field of Search: 606/200, 606/191, 606/194, 606/198, 606/151, 606/108, 606/159, 604/159, 604/164
• US Class Current: 606/200
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 2017/1205 Introduction devices

Abstract

An introducer for introducing an expandable implantable device into a catheter includes an outer tube and an inner core which slides in the outer tube. The distal end of the core has a tubular configuration with a slit which allows it to expand radially to grip an end of the device. The distal end of the core holding the device is pulled into the distal end of the outer tube which further tightens the grip on the device. A handle is then preferably attached to the proximal end of the core which extends beyond the proximal end of the outer tube to prevent the core from moving distally and releasing the device. The device remains in its relaxed condition attached to the introducer and mostly outside of it until use. At that time the core is moved proximally which pulls the device inside the outer tube and into its stretched condition as it does so. As the distal end of the inner core exits the proximal end of the outer tube, the end of the device is released and remains mostly inside of the outer tube in its stretched condition. The distal end of the introducer is then inserted into a catheter and a pushrod used to push the device distally from the introducer into the catheter.

Claims

1. An introducer for introducing an implantable device into a catheter, comprising:

(a) an outer tube having a distal end, a proximal end and an axial bore; and

(b) an inner core slidably disposed inside said axial bore of said outer tube, said inner core having a distal end, a distal end portion of tubular configuration with at least one slot which allows said distal end portion to expand radially and which is adapted to grip an end of said implantable device, and a proximal end extending beyond said proximal end of said outer tube when said distal end of said inner core is aligned with said distal end of said outer tube, said inner core being slidable proximally through said axial bore of said outer tube to pull the implantable device into said axial bore of said outer tube, said distal end portion of said inner core being adapted to release the implantable device when said distal end of said inner core exits said proximal end of said outer tube such that a portion of the implantable device remains disposed inside said outer tube; and

(c) a rod disposed inside said inner core, said rod having a proximal end attached to said proximal end of said inner core.

2. The introducer of claim 1, wherein said outer tube has a distal end portion having an external taper.

3. The introducer of claim 2, wherein said axial bore of said outer tube has a proximal portion of a first diameter and a distal portion of a second diameter which is smaller than said first diameter, said distal portion of said axial bore being adjacent said external taper.

4. The introducer of claim 1, further comprising a handle connected to said proximal end of said inner core.

5. The introducer of claim 4, wherein said rod has a distal end disposed proximally of said at least one slot.

6. The introducer of claim 4, wherein said inner core is tubular having an inner diameter, and said rod has an outer diameter that is less than said inner diameter of said tubular inner core.

7. The introducer of claim 1 further comprising a hub connected to said outer tube, said hub having an axial bore which receives said outer tube, a distal end, a distal portion of a first outer diameter, a proximal portion of a second outer diameter which is smaller than said first outer diameter, and a proximal end;

said outer tube being received in said axial bore of said hub and said outer tube extending distally beyond said distal end of said hub.

8. The introducer of claim 7, wherein said proximal end of said outer tube aligns with said proximal end of said hub.

9. The introducer of claim 8, further comprising a handle connected to said proximal end of said inner core, said handle being disposed adjacent said hub when said distal end of said inner core is aligned with said distal end of said outer tube.

10. The introducer of claim 7, wherein said proximal end of said hub extends proximally beyond said proximal end of said outer tube.

11. The introducer of claim 9, further comprising a sleeve received by said axial bore of said hub at said proximal end of said hub, said sleeve having a distal end, a proximal end and an axial bore, said axial bore of said sleeve receiving said inner core, said distal end of said sleeve being disposed within said axial bore of said hub and spaced a distance from said proximal end of said outer tube, said distance being sufficiently long to allow said distal portion of said inner core to release said implantable device as said distal end of said inner core exits said proximal end of said outer tube.

12. The introducer of claim 11, wherein said axial bore of said sleeve and said axial bore of said outer tube are the same diameter.

13. The introducer of claim 11, wherein said proximal end of said sleeve extends proximally beyond said proximal end of said hub.

14. The introducer of claim 13, further comprising a handle connected to said proximal end of said inner core, said handle having a recess which receives said proximal end of said sleeve, said handle being disposed adjacent said hub when said distal end of said inner core is aligned with said distal end of said outer tube.

15. A method of assembling an introducer for introducing an implantable device into a catheter comprising the steps of:

(a) positioning said inner core relative to said outer tube so that said distal end portion of said inner core extends beyond said distal end of said outer tube;

(b) inserting an end of an expandable implantable device into said distal end of said inner core so that said distal end portion expands radially and grips said end of said expandable implantable device;

(c) sliding said inner core proximally to move said distal end portion with said end of said implantable device into said axial bore of said outer tube at said distal end of said outer tube thereby tightening said grip of said distal end portion on said end of said implantable device; and

(d) stopping said sliding of said inner core when said distal end of said inner core is aligned with said distal end of said outer tube thereby leaving said implantable device in a relaxed condition outside of said outer tube.

16. An introducer for introducing an implantable device into a catheter, comprising:

(a) an outer tube having a distal end, a distal end portion having an external taper, a proximal end and an axial bore, said axial bore having a proximal portion of a first diameter and a distal portion of a second diameter which is smaller than said first diameter, said distal portion being adjacent said external taper;

(b) a hub connected to said outer tube, said hub having an axial bore which receives said outer tube, a distal end, a distal portion of a first outer diameter, a proximal portion of a second outer diameter which is smaller than said first outer diameter, and a proximal end, said outer tube being received in said axial bore of said hub and said outer tube extending distally beyond said distal end of said hub, said proximal end of said hub extending proximally beyond said proximal end of said outer tube;

(c) a sleeve received by said axial bore of said hub at said proximal end of said hub, said sleeve having a distal end, a proximal end and an axial bore, said axial bore of said sleeve receiving an inner core, said distal end of said sleeve being disposed within said axial bore of said hub and spaced a distance from said proximal end of said outer tube, said proximal end of said sleeve extending proximally beyond said proximal end of said hub;

(d) an inner core slidably disposed inside said axial bore of said outer tube and said axial bore of said sleeve, said inner core having a distal end, a distal end portion of tubular configuration with at least one slot which allows said distal end portion to expand radially to receive and grip an end of an implantable device, said inner core having a proximal end extending beyond said proximal end of said outer tube when said distal end of said inner core is aligned with said distal end of said outer tube, said inner core sliding proximally through said axial bore of said outer tube to pull an implantable device into said axial bore of said outer tube, said distal end portion of said inner core releasing said implantable device when said distal end of said inner core exits said proximal end of said outer tube such that most of said implantable device remains disposed inside said outer tube; and

(e) a handle connected to said proximal end of said inner core, said handle having a recess which receives said proximal end of said sleeve, said handle being disposed adjacent said hub when said distal end of said inner core is aligned with said distal end of said outer tube.

17. An expandable implantable device and introducer system, comprising:

(a) an expandable implantable device having an end, a relaxed condition of a first diameter and a first length, and a stretched condition of a second diameter which is smaller than said first diameter and a second length which is shorter than said first length;

(b) an introducer for introducing said expandable implantable device into a catheter, said introducer having;

(i) an outer tube having a distal end, a proximal end and an axial bore; and

(ii) an inner core slidably disposed inside said axial bore of said outer tube, said inner core having a distal end, a distal end portion constructed to receive and grip said end of said implantable device, said end of said expandable device disposed in and gripped by said distal end portion of said inner core, said distal end portion with said end of said implantable device disposed in said axial bore of said outer tube at said distal end of said outer tube so that said implantable device remains in said relaxed condition and most of said implantable device is outside of said outer tube, said inner core being slidable proximally to thereby pull said expandable device into and along said axial bore of said inner core in said stretched condition and to release said implantable device from said distal end portion when said distal end of said inner core exits said proximal end of said outer tube such that most of said implantable device remains in said stretched condition and disposed inside said outer tube.

18. The system of claim 17, wherein said inner core has a proximal end extending beyond said proximal end of said outer tube, and further comprising a handle attached to said proximal end of said inner core, said handle constructed and arranged to interact with said outer tube so as to prevent said inner core from sliding distally and releasing said end of said implantable device.

19. The system of claim 17, wherein said implantable device is a self expanding vascular occlusion device.

20. The system of claim 17, wherein said implantable device is a wire coil for occluding vasculature.

21. A method of using the system for introducing an implantable device into a catheter, comprising the steps of:

(a) sliding said inner core proximally to pull said expandable device into said axial bore of said outer tube, said expandable device thereby being moved to said stretched condition;

(b) continuing to slide said inner core proximally thereby moving said implantable device along said axial bore of said inner core in said stretched condition, said distal end portion releasing said implantable device when said distal end of said inner core exits said proximal end of said outer tube such that most of said implantable device remains in said stretched condition and disposed inside said outer tube;

(b) inserting said distal end of said outer tube into an opening in a catheter;

(c) positioning a pushrod so that an end of said pushrod is near said proximal end of said outer tube and said pushrod aligns with said axial bore of said outer tube; and

(d) advancing said pushrod distally to push said implantable device along said axial bore, out said distal end of said outer tube and into said catheter, said implantable device remaining in said stretched condition.

22. An introducer for introducing an implantable device into a catheter, comprising:

(a) an outer tube having a first end, a second end and an axial bore;

(b) an inner core slidably disposed inside said axial bore of said outer tube, said inner core having a first end, a first end portion of tubular configuration with at least one slot which allows said first end portion to expand radially and which is adapted to grip an end of said implantable device, and a second end extending beyond said second end of said outer tube when said first end of said inner core is aligned with said first end of said outer tube, said inner core being slidable through said axial bore toward said second end of said outer tube to pull the implantable device into said axial bore of said outer tube, said first end portion of said inner core being adapted to release the implantable device when said first end of said inner core exits said second end of said outer tube such that a portion of the implantable device remains disposed inside said outer tube; and

(c) a rod disposed inside said inner core, said rod having a proximal end attached to said proximal end of said inner core.

23. The introducer of claim 22, wherein said first end of said outer tube is a distal end and said second end of said outer tube is a proximal end, and wherein said first end of said inner core is a distal end and said second end of said inner core is a proximal end.