Device and method for locating and sealing a blood vessel

• US 5,876,411 A
• Filed: 03/11/1997
• Issued: 03/02/1999
• Est. Priority Date: 03/11/1997
• Status: Expired due to Term

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: X-Site LLC
• Inventors: Kontos, Stavros
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): PHAM, THUY D
• Application Number:
  US08/814,221
• Time in Patent Office: 721 Days
• Field of Search: 606/139, 606/144, 606/145, 606/147, 606/148, 606/205, 606/207
• US Class Current: 606/144
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00663 the implement being a suture

Abstract

A device and a method for sealing an opening in an anatomical structure is provided. The device includes a flexible tube including a proximal portion and a distal portion extending along a common axis. The proximal portion is coupled to the distal portion by a central portion, which extends from a distal end of the proximal portion to a proximal end of the distal portion. The central portion bends away from the axis along a curve so that the distal end of the proximal portion faces the proximal end of the distal portion across a gap formed by the central portion. In use, the device is inserted through an opening in a wall of the anatomical structure so that a portion of the wall is received within the gap. A needle, that is attached to a first length of suture, is then inserted through a first needle lumen to an opening formed in the distal end of the proximal portion and crosses the gap penetrating the wall to enter a needle receiving chamber that is formed in the distal portion. The needle bends around the needle receiving chamber to exit the needle receiving chamber at a point opposite the second needle lumen. The needle is withdrawn from the structure via the second needle lumen and the device is rotated to a second position where a second length of suture is drawn through a second portion of the wall and secured to the first length of suture to seal the opening.

Claims

1. A device for sealing an opening in a wall of an anatomical structure comprising:

a tube including a proximal portion and a distal portion extending along a common central axis, wherein the proximal portion is coupled to the distal portion by a central portion, the central portion extending from a central portion proximal end that is coupled to a distal end of the proximal portion to a central portion distal end that is coupled to a proximal end of the distal portion, wherein a central axis of the central portion bends away from the common central axis along a curve so that the distal end of the proximal portion faces the proximal end of the distal portion across a gap formed by the central portion with the common central axis extending between the proximal and distal portions through the gap, wherein, when the device extends through the opening in an operative position, the wall of the anatomical structure is received within the gap;

a first needle lumen extending through the proximal portion substantially parallel to the common central axis from a proximal end of the proximal portion to a first opening formed in the distal end of the proximal portion;

a second needle lumen extending through the proximal portion substantially parallel to the common central axis from a proximal end of the proximal portion to a second opening formed in the distal end of the proximal portion; and

a needle receiving chamber formed in the distal portion, the needle receiving chamber extending from a third opening formed in the proximal end of the distal portion to a distal wall extending from a first point opposite the first needle lumen around a curve to a second point opposite the second needle lumen so that, when a flexible needle enters the needle receiving chamber from the first needle lumen, the flexible needle curves along the distal wall to exit the needle receiving chamber at a point opposite the second needle lumen.

2. The device according to claim 1, further comprising:

a flash-back lumen extending from the proximal end of the proximal portion through the proximal portion and into the central portion to a flash-back opening formed in the central portion.

3. The device according to claim 1, wherein the needle receiving chamber is substantially U-shaped in cross-section and wherein lines tangent to the curved distal wall at the first and second points extend substantially parallel to the axis.

4. The device according to claim 1, wherein the needle receiving chamber includes two substantially straight sides extending proximally from the first and second points respectively, and wherein each of the two straight sides of the needle receiving chamber is substantially aligned with one of the first and second openings.

5. The device according to claim 1, wherein the flexible tube is composed of a thermoplastic material.

6. The device according to claim 1, wherein device is formed of two pieces bonded together.

7. The device according to claim 1, wherein at least a portion of the flexible tube is one of a circular and an elliptical in cross-section.

8. The device according to claim 1, wherein, when the device extends through the anatomical structure opening in the operative position, a flexible needle inserted into the proximal end of the proximal portion through the first needle lumen will penetrate the anatomical structure at a first penetrating location and enter the needle receiving chamber.

9. The device according to claim 4, wherein the sides and the curved distal wall of the needle receiving chamber are oriented so that a flexible needle entering the needle receiving chamber from the first needle lumen slides along a first of the sides of the needle receiving chamber, around the curved distal wall to a second of the sides to exit the needle receiving chamber to penetrate the anatomical structure at a second penetrating location and extend into the second needle lumen.

10. The device according to claim 1, further comprising:

first and second guide tubes, each of the first and second guide tubes being slidably received within a respective one of the first and second needle lumens.

11. The device according to claim 10, wherein the first guide tube is extendable by a user from a first position in which a distal end of the first guide tube is received in the first needle lumen to a second position in which the distal end of the first guide tube is received in the needle receiving chamber.

12. A method for sealing an opening of an anatomical structure within a living body, comprising the steps of:

guiding into the opening a device including;

a flexible tube having a proximal portion and a distal portion extending along a common central axis, the proximal portion being coupled to the distal portion by a central portion, wherein a central axis of the central portion curves away from the common central axis to form a gap between a distal end of the proximal portion and a proximal end of the distal portion, and wherein the common central axis extends between the proximal and distal portions through the gap,

first and second needle lumens, each extending through the proximal portion substantially parallel to the common central axis to a respective lumen opening formed in the distal end of the proximal portion, and

a needle receiving chamber formed in the distal portion extending from a proximal end of the distal portion to a curved distal wall;

positioning the device in a first desired orientation so that a first portion of a wall of the anatomical structure is received within the gap formed by the curved central portion, so that each of the lumen openings is positioned on a side of the anatomical structure opposite to the needle receiving chamber;

projecting, through the first needle lumen, a first flexible needle coupled to a first length of suture, so that a first sharp forward end of the first flexible needle passes through the anatomical structure wall at a first location and enters the needle receiving chamber;

thereafter, further projecting the first flexible needle around the curved distal wall of the needle receiving chamber to exit the needle receiving chamber, pierce the anatomical structure wall at a second location spaced from the first location, and enter the second needle lumen;

extracting the first flexible needle from the second needle lumen to draw the first length of suture through the anatomical structure wall to extend from the device;

rotating the device within the opening to a second desired orientation so that a second portion of the wall of the anatomical structure is received within the gap;

projecting a second flexible needle coupled to a second length of suture through the first needle lumen, so that a sharp forward end of the second flexible needle passes through the anatomical structure at a third location and enters the needle receiving chamber;

thereafter, further projecting the second flexible needle around the curved distal wall of the needle receiving chamber to exit the needle receiving chamber, pierce the wall of the anatomical structure at a fourth location spaced apart from the third location, and enter the second needle lumen;

coupling the first and second lengths of suture to seal the anatomical structure opening.

13. The method according to claim 12, wherein the device further includes at least two guide tubes corresponding to the needle lumens, each guide tube being slidably received within a respective one of the first and second needle lumens.

14. The method according to claim 13, wherein, prior to the step of projecting a first flexible needle, the user performs the steps of:

extending a first one of the two guide tubes through the respective needle lumen to pierce the anatomical structure wall at the first location and enter the needle receiving chamber; and

extending a second one of the two guide tubes through the respective needle lumen to pierce the anatomical structure wall at the third location and enter the needle receiving chamber.

15. The method according to claim 14, wherein prior to the step of rotating the device to the second desired orientation, the user performs the step of:

retracting each of the two guide tubes into the respective one of the first and second needle lumens.

16. A device for sealing an opening in a wall of an anatomical structure comprising:

a flexible tube including a proximal portion and a distal portion extending along a common central axis, wherein the proximal portion is coupled to the distal portion by a central portion, the central portion extending from a central portion proximal end that is coupled to a distal end of the proximal portion to a central portion distal end that is coupled to a proximal end of the distal portion, wherein a central axis of the central portion bends away from the common central axis along a curve so that the distal end of the proximal portion faces the proximal end of the distal portion across a gap formed by the central portion with the common central axis extending between the proximal and distal portions through the gap, wherein, when the device extends through the opening in an operative position, the wall of the anatomical structure is received within the gap;

a first needle lumen extending through the proximal portion substantially parallel to the common central axis from a proximal end of the proximal portion to a first opening formed in the distal end of the proximal portion; and

a second needle lumen extending through the proximal portion substantially parallel to the common central axis from a proximal end of the proximal portion, around the curve of the central portion to a second opening formed in the proximal end of the distal portion, the second opening facing the first opening, so that when a flexible needle is passed through the first needle lumen to exit from the first opening, the flexible needle crosses the gap and enters the second opening.

17. A method for sealing an opening of an anatomical structure within a living body, comprising the steps of:

guiding into the opening a device including;

a flexible tube having a proximal portion and a distal portion extending along a common central axis, the proximal portion being coupled to the distal portion by a central portion, wherein a central axis of the central portion curves away from the common central axis to form a gap between a distal end of the proximal portion and a proximal end of the distal portion, with the common central axis extending between the proximal and distal portions through the gap,

a first needle lumen extending through the proximal portion substantially parallel to the common central axis to a first opening formed in the distal end of the proximal portion, and

a second needle lumen extending through the proximal portion substantially parallel to the common central axis from a proximal end of the proximal portion, around the curve of the central portion to a second opening formed in the proximal end of the distal portion, the second opening facing the first opening;

positioning the device in a first desired orientation so that a first portion of a wall of the anatomical structure adjacent to the opening of the anatomical structure is received within the gap, so that the first opening is positioned on a proximal side of the wall of the anatomical structure and the second opening is positioned on a distal side of the wall of the anatomical structure;

projecting a flexible needle coupled to a first length of suture through the first needle lumen, so that a forward end of the flexible needle passes through the wall of the anatomical structure at a first location;

thereafter, further projecting the flexible needle to enter the second needle lumen through the second opening;

extracting the flexible needle from the second needle lumen to draw the first length of suture through the anatomical structure and out of the device;

rotating the device within the opening of the anatomical structure to a second desired orientation so that a second portion of the wall of the anatomical structure is received within the gap;

projecting the flexible needle coupled to a second length of suture through the first needle lumen, so that a forward end of the flexible needle passes through the anatomical structure at a second location;

thereafter, further projecting the flexible needle to enter the second needle lumen through the second opening;

extracting the flexible needle from the second needle lumen to draw the second length of suture through the anatomical structure; and

coupling the first and second lengths of suture together to seal the opening of the anatomical structure.

18. A method for sealing an opening of an anatomical structure within a living body, comprising the steps of:

guiding into the opening a device including;

a flexible tube having a proximal portion and a distal portion extending along a common central axis, the proximal portion being coupled to the distal portion by a central portion, wherein a central axis of the central portion curves away from the common central axis to form a gap between a distal end of the proximal portion and a proximal end of the distal portion,

a first needle lumen extending through the proximal portion substantially parallel to the common central axis to a first opening formed in the distal end of the proximal portion, and

a second needle lumen extending through the proximal portion substantially parallel to the common central axis from a proximal end of the proximal portion, around the curve of the central portion to a second opening formed in the proximal end of the distal portion, the second opening facing the first opening;

positioning the device in a first desired orientation so that a first portion of a wall of the anatomical structure adjacent to the opening of the anatomical structure is received within the gap, so that the first opening is positioned on a proximal side of the wall of the anatomical structure and the second opening is positioned on a distal side of the wall of the anatomical structure;

projecting a flexible needle coupled to a length of suture through the first needle lumen, so that a forward end of the flexible needle passes through the wall of the anatomical structure at a first location;

thereafter, further projecting the flexible needle to enter the second needle lumen through the second opening;

extracting the flexible needle from the second needle lumen to draw the length of suture through the anatomical structure and out of the device;

rotating the device within the opening of the anatomical structure to a second desired orientation so that a second portion of the wall of the anatomical structure is received within the gap;

projecting the flexible needle coupled to the length of suture through the second needle lumen, so that a forward end of the flexible needle passes through the anatomical structure at a second location;

thereafter, further projecting the flexible needle to enter the first needle lumen through the first opening;

extracting the flexible needle from the first needle lumen to draw the length of suture through the anatomical structure; and

coupling a first end of the length of suture to a second end of the length of suture to seal the opening of the anatomical structure.

19. A device for sealing an opening in a wall of an anatomical structure comprising:

a tube including a proximal portion and a distal portion extending along a common central axis, wherein the proximal portion is coupled to the distal portion by a central portion, the central portion extending from a central portion proximal end that is coupled to a distal end of the proximal portion to a central portion distal end that is coupled to a proximal end of the distal portion, wherein a central axis of the central portion bends away from the common central axis along a curve so that the distal end of the proximal portion faces the proximal end of the distal portion across a gap with the common central axis extending between the proximal and distal portions through the gap, wherein, when the device extends through the opening in an operative position, the wall of the anatomical structure is received within the gap;

a first needle lumen extending through the proximal portion substantially parallel to the common central axis from a proximal end of the proximal portion to a first opening formed in the distal end of the proximal portion;

a second needle lumen extending through the proximal portion substantially parallel to the common central axis from a proximal end of the proximal portion to a second opening formed in the distal end of the proximal portion; and

a needle receiving chamber formed in the distal portion, the needle receiving chamber extending from a third opening formed in the proximal end of the distal portion to a distal wall shaped so that, when a flexible needle enters the needle receiving chamber from the first needle lumen, the flexible needle curves along the distal wall to exit the needle receiving chamber at a point opposite the second needle lumen, wherein sides of the curved distal wall are oriented so that a flexible needle entering the needle receiving chamber from the first needle lumen slides along a first of the sides of the needle receiving chamber, around the curved distal wall to a second of the sides to exit the needle receiving chamber to penetrate the anatomical structure at a second penetrating location and extend into the second needle lumen.