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

• US 9,161,777 B2
• Filed: 08/25/2011
• Issued: 10/20/2015
• 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): Eastwood, David
• Assistant Examiner(s): COLELLO, ERIN L
• Application Number:
  US13/218,349
• Publication Number:
  US 20110313426A1
• Time in Patent Office: 1,517 Days
• Field of Search: 606/167, 606/185, 606/198, 606/119, 606/181, 606/184, 606/191, 606/99, 606/108, 600184-185, 600/190, 600/194, 600/201, 600/204, 600/206, 600/208, 600/210, 600/211, 600/214, 600/219, 600/235
• US Class Current: 1/1
• 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 method for accessing the left atrium of a patient comprising:

inserting a dilating tip of a device into the right atrium of the patient, the device comprising;

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

the dilating tip slidably mounted on the distal end of the tubular body and comprising;

a segmented surface that is generally transverse to the axis of the tubular body, the segmented surface comprising a plurality of segments having proximal and distal ends, wherein the plurality of segments is configured to move between a closed configuration in which the segments combine to form the segmented surface and an open configuration in which the segments separate from one another,

a plurality of generally rigid tube segments extending distally from the segmented surface, each tube segment having a proximal end affixed to the distal end of a corresponding one of the plurality of segments of the segmented surface and extending distally therefrom, wherein when the plurality of segments of the segmented surface is in the closed configuration, the plurality of generally rigid tube segments combine to form a generally rigid tube having a sharp distal end configured to puncture tissue, and when the plurality of segments of the segmented surface are in the open configuration, the plurality of generally rigid tube segments have free distal ends that are separate from each other, and

a ring slidably mounted on the tubular body, wherein the proximal ends of the segments of the segmented surface are hingedly attached to the ring;

wherein proximal movement of the ring relative to the elongated tubular body exerts a force on the segmented surface to thereby open the segmented surface;

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

advancing the ring proximally relative to the elongated tubular body to open the segmented surface and introduce a distal portion of the elongated tubular body into the left atrium through the trans-septal hole.

2. A method according to claim 1, further comprising advancing at least a portion of the dilating tip through the trans-septal hole prior to advancing the ring proximally relative to the elongated tubular body.

3. The method of claim 1, further comprising monitoring the pressure in the elongated tubular body.

4. The method according to claim 1, wherein the elongated tubular body is generally cylindrical.

5. The method according to claim 1, wherein the segmented surface comprises three or more segments.

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

7. The method according to claim 1, wherein the generally rigid tube has a length ranging from about 2 mm to about 6 mm.

8. The method according to claim 1, wherein the generally rigid tube has a length ranging from about 3 mm to about 5 mm.

9. The method according to claim 1, wherein the generally rigid tube has an outer diameter ranging from about 0.6 mm to about 1 mm.

10. The method according to claim 1, wherein the generally rigid tube has an outer diameter ranging from about 0.7 mm to about 0.8 mm.

11. The method according to claim 1, wherein the dilating tip comprises nitinol.

12. The method according to claim 1, wherein the device further comprises a wire extending proximally from the ring to near the proximal end of the elongated tubular body to affect proximal movement of the ring relative to the elongated tubular body.

13. The method according to claim 12, wherein the device further comprises a slidable member on the proximal end of the elongated tubular body, the slidable member being connected to the wire so that proximal movement of the slidable member pulls the wire and causes proximal movement of the ring relative to the elongated tubular body.

14. The method according to claim 13, wherein the device further comprises a latch for maintaining the position of the slidable member relative to the elongated tubular body when the dilating tip is in an open configuration.

15. The method according to claim 1, wherein the device further comprises a pressure valve at or near the proximal end of the elongated tubular body.

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

inserting a dilating tip of a device into the right atrium of the patient, the device comprising;

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

the dilating tip slidably mounted on the distal end of the tubular body and comprising;

a ring 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, the segmented surface comprising three or more, segments, each segment being hingedly attached to the ring, wherein the three or more segments are configured to move between a closed configuration in which the segments combine to form the segmented surface and an open configuration in which the segments separate from one another;

three or more generally rigid tube segments, each tube segment having a proximal end affixed to a distal end of a corresponding one of the three or more segments of the segmented surface and extending distally therefrom, wherein when the three or more segments of the segmented surface are in the closed configuration, the three or more generally rigid tube segments combine to form a generally rigid tube having a sharp distal end configured to puncture tissue, and when the three or more segments of the segmented surface are in the open configuration, the three or more generally rigid tube segments have free distal ends that are separate from each other; and

a slidable member connected to the ring of the dilating tip, wherein proximal movement of the slidable member relative to the elongated tubular body exerts a force on the segmented surface to thereby open the segmented surface;

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

advancing the slidable member proximally relative to the elongated tubular body to open the segmented surface and introduce a distal portion of the elongated tubular body into the left atrium through the trans-septal hole.

17. The method according to claim 16, wherein the device further comprises:

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

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