Transseptal needle apparatus

• US 9,358,039 B2
• Filed: 05/07/2013
• Issued: 06/07/2016
• Est. Priority Date: 05/08/2012
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Kimmel, Scott, Katra, Rodolphe, Pietsch, Kevin, Loushine, Brian, Zweber, Jeffrey, Goff, Ed, Larson, Blane, Honeck, Jordon, Scheibe, Grant
• Primary Examiner(s): Bosques, Edelmira
• Assistant Examiner(s): Meghri, Nicholas
• Application Number:
  US13/888,845
• Publication Number:
  US 20130304036A1
• Time in Patent Office: 1,127 Days
• Field of Search: 604/264, 604/523, 604/528, 604/164.01, 60416406-16409, 604/164.1, 604/164.11, 604/164.12, 604/167.01, 604/167.02
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• CPC Class Codes: A61B 2218/007 Aspiration
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence

Abstract

In various examples, an apparatus includes a needle assembly including an outer cannula including a tubular sidewall disposed around a lumen. At least a portion of the sidewall includes an exterior including a polymeric material configured to inhibit skiving of an interior of a dilator with movement of the outer cannula within the dilator. An inner cannula is disposed within the lumen and is selectively slidable with respect to the outer cannula. A handle is disposed at a proximal portion of the needle assembly. The handle includes a first handle portion coupled to and movable with the outer cannula. A second handle portion is coupled to and movable with the inner cannula, wherein the first handle portion is selectively movable with respect to the second handle portion to extend a distal end of the inner cannula from within the lumen of the outer cannula.

Claims

1. An apparatus comprising:

a needle assembly including;

an outer cannula including a tubular sidewall disposed around a lumen, at least a portion of the sidewall including an exterior including a polymeric material configured to inhibit skiving of an interior of a dilator with movement of the outer cannula within the dilator;

an inner cannula disposed within the lumen and selectively slidable with respect to the outer cannula, the inner cannula including a distal end including a sharpened tip, wherein the sharpened tip of the inner cannula remains disposed within the outer cannula during insertion of the needle assembly within the dilator to protect the interior of the dilator from the sharpened tip and inhibit skiving of the interior of the dilator by the sharpened tip; and

an outer cannula cover extending distally from the outer cannula to cover over and completely close off a distal opening of the outer cannula and to shield the sharpened tip of the inner cannula to further guard against skiving of the interior of the dilator by the sharpened tip, wherein the outer cannula cover includes a frangible distal end, such that a non-resealable opening is formed in the outer cannula cover with extension of the sharpened tip of the inner cannula through the outer cannula cover; and

a handle disposed at a proximal portion of the needle assembly, the handle including;

a first handle portion coupled to and movable with the outer cannula; and

a second handle portion coupled to and movable with the inner cannula, wherein the first handle portion is selectively movable with respect to the second handle portion to extend the sharpened tip of the inner cannula outwardly from within the lumen of the outer cannula.

2. The apparatus of claim 1, wherein the outer cannula is formed from the polymeric material.

3. The apparatus of claim 1, wherein the outer cannula is formed from polyethylene.

4. The apparatus of claim 3, wherein the outer cannula is formed from Petrothane.

5. The apparatus of claim 1, comprising a handle lock including a first position in which the handle lock inhibits movement of the second handle portion with respect to the first handle portion and a second position in which the handle lock allows movement of the second handle portion with respect to the first handle portion.

6. The apparatus of claim 5, wherein the handle lock includes a spacer removably disposed with respect to the handle, wherein the spacer in the first position includes the spacer engaged with the handle to inhibit movement of the second handle portion with respect to the first handle portion, and the spacer in the second position includes the spacer removed from engagement with the handle to allow movement of the second handle portion with respect to the first handle portion to allow movement of the inner cannula with respect to the outer cannula.

7. The apparatus of claim 5, wherein the handle lock includes a movable lock associated with the handle, wherein the movable lock in the first position includes the movable lock disposed with respect to the handle to inhibit movement of the second handle portion with respect to the first handle portion, and the movable lock in the second position includes the movable lock disposed with respect to the handle to allow movement of the second handle portion with respect to the first handle portion to allow movement of the inner cannula with respect to the outer cannula.

8. The apparatus of claim 7, wherein the movable lock includes a rotational lock, wherein the rotational lock in the first position includes the rotational lock in a first rotational orientation with respect to the handle, and the rotational lock in the second position includes the rotational lock in a second rotational orientation with respect to the handle.

9. The apparatus of claim 8, wherein one of the rotational lock and the handle includes a protrusion and the other of the rotational lock and the handle includes a slot, wherein in the first rotational orientation, the slot and the protrusion are misaligned to inhibit movement of the second handle portion with respect to the first handle portion, and, in the second rotational orientation, the slot and the protrusion are aligned to allow the protrusion to move within the slot and allow movement of the second handle portion with respect to the first handle portion.

10. The apparatus of claim 1, comprising a puncture assembly including:

a potential energy storage member disposed between the first handle portion and the second handle portion; and

an actuator operatively coupled to the potential energy storage member, wherein triggering of the actuator releases the potential energy storage member to move the second handle portion with respect to the first handle portion.

11. The apparatus of claim 10, wherein the potential energy storage member includes a spring.

12. The apparatus of claim 10, comprising a guard movable between a locked position and an unlocked position, wherein the guard in the locked position inhibits releasing of the potential energy storage member, and the guard in the unlocked position allows releasing of the potential energy storage member.

13. The apparatus of claim 12, wherein the guard in the locked position covers the actuator, and the guard in the unlocked position allows access to the actuator.

14. The apparatus of claim 1, comprising an adjustable stop associated with the handle, wherein movement of the adjustable stop adjusts a distance the first handle portion is movable with respect to the second handle portion to adjust a puncture length of the inner cannula, the puncture length including a distance the distal end of the inner cannula extends from within the lumen of the outer cannula with movement of the first handle portion with respect to the second handle portion.

15. The apparatus of claim 1, wherein the outer cannula cover is puncturable by the inner cannula with extension of the distal end of the inner cannula from within the lumen and out of the distal opening of the outer cannula.

16. The apparatus of claim 1, wherein the distal end of the inner cannula is biased to a position within the lumen of the outer cannula, such that the distal end of the inner cannula withdraws back into the outer cannula after a puncture is performed.

17. The apparatus of claim 1, wherein the sharpened tip of the inner cannula is configured to remain housed within the outer cannula except when the sharpened tip is extended from within the lumen of the outer cannula to puncture the outer cannula cover and perform a puncture of a septum.

18. An apparatus comprising:

a needle assembly including;

an outer cannula including a tubular sidewall disposed around a lumen, at least a portion of the sidewall including an exterior including a polymeric material configured to inhibit skiving of an interior of a dilator with movement of the outer cannula within the dilator;

an inner cannula disposed within the lumen and selectively slidable with respect to the outer cannula, the inner cannula including a distal end including a sharpened tip, wherein the sharpened tip of the inner cannula remains disposed within the outer cannula during insertion of the needle assembly within the dilator to protect the interior of the dilator from the sharpened tip and inhibit skiving of the interior of the dilator by the sharpened tip; and

an outer cannula cover extending distally from the outer cannula to cover over and completely close off a distal opening of the outer cannula and to shield the sharpened tip of the inner cannula to further guard against skiving of the interior of the dilator by the sharpened tip, wherein the outer cannula cover includes a frangible distal end, such that a non-resealable opening is formed in the outer cannula cover with extension of the sharpened tip of the inner cannula through the outer cannula cover;

a handle disposed at a proximal portion of the needle assembly, the handle including;

a first handle portion coupled to and movable with the outer cannula; and

a second handle portion coupled to and movable with the inner cannula, wherein the first handle portion is selectively movable with respect to the second handle portion to extend the sharpened tip of the inner cannula outwardly from within the lumen of the outer cannula, wherein the outer cannula cover is puncturable by the sharpened tip of the inner cannula with extension of the distal end of the inner cannula from within the lumen and out of the distal opening of the outer cannula; and

a handle lock including a first position in which the handle lock inhibits movement of the second handle portion with respect to the first handle portion and a second position in which the handle lock allows movement of the second handle portion with respect to the first handle portion.

19. The apparatus of claim 18, wherein the outer cannula is formed entirely from the polymeric material.

20. The apparatus of claim 18, wherein the handle lock includes a spacer removably disposed with respect to the handle, wherein the spacer in the first position includes the spacer engaged with the handle to inhibit movement of the second handle portion with respect to the first handle portion, and the spacer in the second position includes the spacer removed from engagement with the handle to allow movement of the second handle portion with respect to the first handle portion to allow movement of the inner cannula with respect to the outer cannula.

21. The apparatus of claim 18, comprising a puncture assembly including:

a potential energy storage member disposed between the first handle portion and the second handle portion; and

an actuator operatively coupled to the potential energy storage member, wherein triggering of the actuator releases the potential energy storage member to move the second handle portion with respect to the first handle portion.

22. The apparatus of claim 18, wherein the sharpened tip of the inner cannula is configured to remain housed within the outer cannula except when the sharpened tip is extended from within the lumen of the outer cannula to puncture the outer cannula cover and perform a puncture of a septum.