Trans-septal sheath with splitting dilating needle and method for its use

• US 9,693,764 B2
• Filed: 10/19/2015
• Issued: 07/04/2017
• Est. Priority Date: 07/11/2003
• Status: Active Grant

• Current Assignee: Biosense Webster Incorporated (Johnson & Johnson)
• Original Assignee: Biosense Webster Incorporated (Johnson & Johnson)
• Inventors: Keidar, Yaron
• Primary Examiner(s): Tyson, Melanie
• Assistant Examiner(s): COLELLO, ERIN L
• Application Number:
  US14/887,213
• Publication Number:
  US 20160038134A1
• Time in Patent Office: 624 Days
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• 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 17/3417 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 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A device useful for accessing the left atrium is provided. The device comprises an elongated tubular body and a dilating tip. The tubular body has an axis, a proximal end, a distal end and a lumen longitudinally extending therethrough. The dilating tip is slidably mounted on the distal end of the tubular body. The dilating tip comprises a segmented surface that is generally transverse to the axis of the tubular body, and a generally rigid tube extending distally from the segmented surface and having a sharp distal end. Distal movement of the tubular body relative to the dilating tip exerts a force on the segmented surface to thereby open the segmented surface.

Claims

1. A device comprising:

an elongated tubular body having an axis, a proximal end, a distal end and a lumen longitudinally extending therethrough;

a dilating tip slidably mounted on the distal end of the tubular body and movable between a closed configuration and an open configuration, the dilating tip comprising a segmented surface that is generally transverse to the axis of the tubular body in the closed configuration, and a segmented generally rigid tube extending distally from the segmented surface generally coaxial with the axis of the tubular body in the closed configuration, the segmented surface and the segmented generally rigid tube together being configured to move between the closed configuration in which the segmented generally rigid tube extends from the segmented surface and forms a sharp distal end and the open configuration in which the segmented surface and the segmented generally rigid tube together separate into segments having free distal ends that are separate from each other;

a distal ring slidably mounted on the tubular body and connected to the segmented surface, wherein proximal movement of the distal ring relative to the elongated tubular body exerts a force on the segmented surface by the elongated tubular body to thereby open the segmented surface and the segmented generally rigid tube to the open configuration;

a proximal slidable member on the elongated tubular body proximal of the distal ring, the proximal slidable member being connected to the distal ring so that proximal movement of the proximal slidable member causes proximal movement of the distal ring relative to the elongated tubular body; and

one or more latches configured to engage one or more notches on the proximal slidable member for maintaining the proximal slidable member in position relative to the elongated tubular body when the dilating tip is in the open configuration.

2. A device according to claim 1, wherein the elongated tube is generally cylindrical.

3. A device according to claim 1, where the segmented surface comprises two or more segments.

4. A device according to claim 1, where the segmented surface comprises three or more segments.

5. A device according to claim 1, wherein the segmented surface comprises a plurality of segments, each of which is hingedly attached to the distal ring.

6. A device according to claim 1, wherein the dilating tip is generally funnel-shaped.

7. A device according to claim 1, wherein the segmented generally rigid tube of the dilating tip has a length ranging from about 2 mm to about 6 mm.

8. A device according to claim 1, wherein the segmented generally rigid tube of the dilating tip has a length ranging from about 3 mm to about 5 mm.

9. A device according to claim 1, wherein the segmented generally rigid tube of the dilating tip has an outer diameter ranging from about 0.6 mm to about 1 mm.

10. A device according to claim 1, further comprising a wire having a distal end connected to the distal ring and a proximal end connected to the proximal slidable member to effect proximal movement of the dilating tip relative to the tubular body.

11. A device according to claim 10, wherein the proximal slidable member is connected to the wire such that proximal movement of the proximal slidable member pulls the wire and causes proximal movement of the distal ring relative to the tubular body.

12. A device according to claim 1, further comprising a pressure valve at or near the proximal end of the tubular body.

13. A method for accessing the left atrium of a patient comprising:

inserting the dilating tip of the device of claim 1 into the right atrium of the patient;

puncturing the atrial septum with the sharp distal end of the segmented generally rigid tube of the dilating tip to create a trans-septal hole;

advancing the elongated tubular body distally relative to the dilating tip to introduce a distal portion of the tubular body into the left atrium through the trans-septal hole.

14. A method according to claim 13, further comprising advancing at least a portion of the dilating tip through the trans-septal hole prior to advancing the tubular body distally relative to the dilating tip.

15. The method of claim 13, further comprising monitoring the pressure in the tubular body.

16. The method of claim 13, wherein the advancing the elongated tubular body distally relative to the dilating tip comprises moving the proximal slidable member proximally to open the segmented surface and the segmented generally rigid tube to the open configuration prior to introducing the distal portion of the elongated tubular body tip into the left atrium.

17. The method of claim 16, further comprising engaging the one or more latches with the one or more notches on the proximal slidable member to thereby lock the proximal slidable member in position after introducing the distal portion of the elongated tubular body into the left atrium.

18. A device comprising:

an elongated tubular body having an axis, a proximal end, a distal end and a lumen longitudinally extending therethrough;

a dilating tip slidably mounted on the distal end of the tubular body and movable between a closed configuration and an open configuration, the dilating tip comprising;

a distal ring slidably mounted in surrounding relation to the distal end of the tubular body;

a segmented surface that is generally transverse to the axis of the tubular body in the closed configuration, the segmented surface comprising three or more segments, each segment being hingedly attached to the distal ring;

a segmented generally rigid tube extending distally from the segmented surface generally coaxial with the longitudinal axis of the tubular body in the closed configuration, the segmented generally rigid tube being segmented into three or more segments which form a sharp distal end adapted to puncture tissue when in the closed configuration, wherein proximal movement of the distal ring relative to the elongated tubular body exerts a force on the segmented surface and the segmented generally rigid tube to thereby open the segmented surface and the segmented generally rigid tube to the open configuration in which the three or more segments of the segmented generally rigid tube have free distal ends that are separate from each other;

a proximal slidable member slidably mounted on the elongated tubular body proximal of the distal ring, the proximal slidable member being connected to the distal ring so that proximal movement of the proximal slidable member causes proximal movement of the distal ring relative to the elongated tubular body; and

one or more latches configured to engage one or more notches on the proximal slidable member for maintaining the proximal slidable member in position relative to the elongated tubular body when the dilating tip is in the open configuration.

19. A device according to claim 18, further comprising:

a wire having a distal end attached to the distal ring of the dilating tip and a proximal end attached to the proximal slidable member;

wherein proximal movement of the proximal slidable member pulls the wire and causes proximal movement of the distal ring relative to the tubular body.