Safety introducer apparatus and method therefor

• US 20040092879A1
• Filed: 10/24/2003
• Published: 05/13/2004
• Est. Priority Date: 11/06/2000
• Status: Abandoned Application

• Current Assignee: Enpath Medical, Inc. (Integer Holdings Corporation Inc)
• Original Assignee: Enpath Medical, Inc. (Integer Holdings Corporation Inc)
• Inventors: Glazier, Valerie, Kraus, Mark C., Latterell, Todd
• Application Number:
  US10/692,614
• Publication Number:
  US 20040092879A1
• Time in Patent Office: Days
• US Class Current: 604/158
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24
• CPC Class Codes: A61B 2017/347 Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61M 2025/09125 Device for locking a guide wire in a fixed position with respect to the catheter or the human body
• CPC Class Codes: A61M 25/0612 Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
• CPC Class Codes: A61M 25/065 Guide needles
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 5/3243 being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel devices for protecting guide needles in combination with catheters A61M25/0612

Abstract

An introducing apparatus is provided which includes an elongate tubular sheath extending from a sheath proximal end to a sheath distal end. The sheath has a bore sized to receive a dilator therethrough. The sheath further includes at least one tab extending away from a longitudinal axis of the sheath. The dilator extends from a dilator proximal end to a dilator distal end. The introducing apparatus further includes a needle disposed within the dilator, and retractably coupled with the dilator. One or more portions of the needle is flexible.

Claims

1. An introducing apparatus comprising:

a tubular sheath extending from a sheath proximal end to a sheath distal end, the sheath sized to receive a dilator therethrough;

the dilator extending from a dilator proximal end to a dilator distal end;

a needle disposed within the dilator, the needle extending from a needle proximal end to a needle distal end and including an intermediate portion therebetween, at least a portion of the needle is at least as flexible as the dilator;

the needle distal end extending out of the dilator distal end in a first position, the needle distal end retracted within the dilator distal end in a second position; and

means for retracting the needle distal end within the dilator.

2. The introducing apparatus as recited in claim 1, wherein the sheath is separable without damage to an instrument inserted therethrough.

3. The introducing apparatus as recited in claim 1, wherein the needle distal end is more flexible than the dilator.

4. The introducing apparatus as recited in claim 1, wherein the needle distal end has the same or more flexibility as the dilator.

5. The introducing apparatus as recited in claim 1, wherein the intermediate portion of the needle comprises a flexible coil.

6. The introducing apparatus as recited in claim 1, wherein the intermediate portion and the needle distal end are flexible, and the intermediate portion and the needle distal end are formed of a unitary structure of nitinol.

7. The introducing apparatus as recited in claim 1, wherein the needle proximal end includes a member sized and shaped to prevent re-extension of the needle.

8. The introducing apparatus as recited in claim 1, further comprising a locking mechanism configured to temporarily lock the sheath with the dilator.

9. The introducing apparatus as recited in claim 1, wherein the dilator further includes a blood flashback chamber.

10. The introducing apparatus as recited in claim 1, further including a valve coupled with the sheath.

11. The introducing apparatus as recited in claim 10, wherein the valve comprises a sliding valve assembly slidingly engaged with the at least one tab, the sliding valve adapted to slide from a first position to a second position, in the first position the sliding valve disposed through the longitudinal axis of the sheath, in the second position the sliding valve disposed away from the longitudinal axis of the sheath.

12. An introducing apparatus comprising:

an elongate tubular sheath extending from a sheath proximal end to a sheath distal end, the sheath sized to receive a dilator therethrough;

the dilator extending from a dilator proximal end to a dilator distal end;

a needle disposed within the dilator, the needle extending from a needle proximal end to a needle distal end and including an intermediate portion therebetween, at least a portion of the needle is flexible;

the needle distal end extending out of the dilator distal end in a first position, the needle distal end retracted within the dilator distal end in a second position; and

a needle retraction mechanism associated with the needle and the dilator, and the needle is retractably coupled with the dilator.

13. The introducing apparatus as recited in claim 12, wherein the needle includes a catch sized and shaped to prevent extension of the distal end of the needle from the dilator distal end.

14. The introducing apparatus as recited in claim 12, wherein the needle distal end is more flexible than the dilator.

15. The introducing apparatus as recited in claim 12, wherein the dilator further includes a blood flashback chamber and a gas permeable filter.

16. The introducing apparatus as recited in claim 12, further including a valve coupled with the sheath.

17. The introducing apparatus as recited in claim 16, wherein the valve comprises a sliding valve assembly slidingly engaged with the at least one tab, the sliding valve adapted to slide from a first position to a second position, in the first position the sliding valve disposed through the longitudinal axis of the sheath, in the second position the sliding valve disposed away from the longitudinal axis of the sheath.

18. A method comprising:

disposing a needle within a dilator;

retractably coupling a needle with a dilator, the dilator extending to a dilator distal end, where the needle extends to a needle distal end and at least a portion of the needle is more flexible than the dilator, and the needle distal end extends beyond the dilator distal end in a first position; and

disposing the needle and dilator within a sheath to form an introducing apparatus.

19. The method as recited in claim 18, further comprising retracting the needle distal end within the dilator.

20. The method as recited in claim 18, further comprising retaining the dilator with the sheath and retracting the needle distal end within the dilator.

21. The method as recited in claim 19, further comprising preventing re-extension of the needle from the dilator.

22. The method as recited in claim 18, further comprising removing the dilator and needle from the sheath, inserting an instrument through the sheath, and separating the sheath from the instrument without damage to the instrument.

23. The method as recited in claim 18, further comprising coupling a valve with the sheath.

24. The method as recited in claim 18, further comprising coupling a coil between a position adjacent to the needle distal end and a needle proximal end to form a flexible portion therebetween.