Steerable endoluminal punch

• US 8,961,550 B2
• Filed: 01/25/2013
• Issued: 02/24/2015
• Est. Priority Date: 04/17/2012
• Status: Active Grant

• Current Assignee: Indian Wells Medical, Inc.
• Original Assignee: Indian Wells Medical, Inc.
• Inventors: Lenker, Jay A., Pool, Scott Louis
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US13/750,689
• Publication Number:
  US 20130274784A1
• Time in Patent Office: 760 Days
• Field of Search: 606/184, 606/185, 606/198, 606/213, 604/22, 604/164.01, 604/164.03, 604/164.12, 604/166.01, 604/272, 600/585
• US Class Current: 606/185
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• 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 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/00318 Steering mechanisms
• CPC Class Codes: A61M 2025/09116 Design of handles or shafts or gripping surfaces thereof for manipulating guide wires
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

Abstract

A steerable transseptal punch.

Claims

1. A transseptal punch comprising:

an outer tube characterized by a proximal end, a distal end, and a flexible region at the distal end, said flexible region characterized by a proximal and a distal end; and

an inner tube characterized by a proximal and a distal end, said inner tube having a flexible region near the distal end thereof and a distal tip adapted to pierce body tissue;

said inner tube being disposed within the outer tube, extending from the proximal end of the outer tube to the distal end of the outer tube, and terminating distally beyond the distal end of the outer tube, said inner tube fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube, wherein the flexible region of the outer tube comprises a segment of the outer tube which is snake-cut with a plurality of radially oriented slots in the wall of the outer tube, said radially oriented slots being substantially radially aligned along one side of the outer tube; and

the flexible region of the inner tube comprises a segment of the inner tube with a longitudinally oriented slot and an angled slot extending from an end of the longitudinally oriented slot.

2. The transseptal punch of claim 1 further comprising:

a proximal hub connected to the outer tube and the inner tube, and means on the proximal hub for tensioning the inner tube proximally relative to the outer tube.

3. The transseptal punch of claim 1, wherein the inner tube is fixed to the outer tube at a point radially aligned with the radially oriented slots.

4. The transseptal punch of claim 1, wherein the longitudinally oriented slot and the angled slot of the inner tube form an opening through the side wall of the inner tube.

5. The transseptal punch of claim 1 wherein:

a connection point between the inner tube and the outer tube such that the side of the inner tube that is not separated from the proximal inner tube is affixed to the outer tube on the side of the outer tube comprising the radially oriented slots;

wherein the hub comprises an internal lumen capable of receiving a jack-screw body element and preventing said jack-screw body element from rotating about the longitudinal axis of the hub, wherein the inner tube is constrained to not move relative to the hub;

a jack-screw body element affixed to the proximal end of the axially elongate outer tube, wherein the jack-screw body element comprises a traveler thread on at least a portion of its outer surface, and further wherein the outer tube can move axially relative to the inner tube in response to movement of the jack-screw body element;

a knob affixed to the hub, capable of being rotated by a user, wherein the knob comprises a knob thread on an inner lumen such that the knob thread and the traveler thread engage; and

a fixation element configured to prevent longitudinal motion of the knob relative to the hub, when the knob is rotated.

6. The apparatus of claim 5 wherein longitudinal movement of the outer tube relative to the inner tube causes deflection of the outer tube at a region of the radially oriented slots and results in selective bending of the outer tube and inner tube at the region of the radially oriented slots.

7. The apparatus of claim 5 wherein the angled slot in the inner tube is formed at an angle of 2 to 20°

from a longitudinal axis of the inner tube.

8. The apparatus of claim 5 wherein the distal end can controllably curve between about 0 and at least 90 degrees from the longitudinal axis in response to rotation of the knob.

9. The apparatus of claim 5 wherein axial advancement of the inner tube relative to the outer tube curves the distal end of the apparatus.

10. The transseptal punch of claim 4 further comprising:

a lumen extending from the proximal end to the distal end of the inner tube, said inner tube disposed within the lumen of the outer tube; and

a stylet characterized by a proximal end, a distal end, and a self-expandable basket disposed on the distal end of the stylet, said self-expandable basket having a small diameter configuration which fits within lumen of the inner tube and a large diameter configuration which it takes on when not constrained, said stylet slidably disposed within the lumen of the inner tube, and operable from the proximal end of the stylet to withdraw the self-expandable basket into the lumen of the inner tube and eject the self-expandable basket from the lumen of the inner tube.

11. The transseptal punch system of claim 10 wherein the stylet further comprises a tube, and the self-expanding basket comprises a split tube comprising a plurality of longitudinally extending struts biased outwardly to create a radially bulging basket structure when unrestrained.

12. The transseptal punch system of claim 10, wherein the diameter of the basket in the large diameter configuration equals or exceeds the inner diameter of the inner tube.

13. The transseptal punch system of claim 10, wherein the diameter of the basket in the large diameter configuration equals or exceeds the outer diameter of the inner tube.