SUTURE-BASED CLOSURE WITH HEMOSTATIC TRACT PLUG

• US 20150105805A1
• Filed: 10/11/2013
• Published: 04/16/2015
• Est. Priority Date: 10/11/2013
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Fortson, Aaron M.
• Granted Patent: US 9,301,746 B2
• Time in Patent Office: Days
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/061 hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/22038 with a guide wire

Abstract

Devices for closing a passage through tissue communicating with a body lumen. The device may include an elongate body, a sheath disposed at the distal end of the device for disposition within a body lumen, a hollow needle disposed within a needle lumen of the body, the needle being selectively advancable through the needle lumen, a suture-anchor ejection mandrel disposed within the hollow needle that is also selectively advancable through the hollow needle, a suture-anchor and suture disposed within the hollow needle, a distal end of the suture attached to the suture anchor for ejection out the hollow needle by the mandrel. A needle guide disposed between the sheath and proximal end of the body may include a needle port through which the needle can exit. A hemostatic plug is disposed over the needle port so as to be penetrated by the needle upon exiting the port.

Claims

1. A device for closing a passage through tissue communicating with a body lumen, the device comprising:

an elongate device body extending from a proximal end to a distal end;

a sheath disposed at the distal end of the device for disposition within a body lumen during use;

at least one hollow needle disposed within a corresponding needle lumen of the elongate body, the at least one hollow needle being selectively advancable through the needle lumen;

at least one suture-anchor ejection mandrel disposed within the at least one hollow needle, the at least one suture-anchor ejection mandrel being selectively advancable through the hollow needle;

a suture-anchor and suture disposed within the hollow needle for ejection out a distal end of the hollow needle by the suture-anchor ejection mandrel, a distal end of the suture being attached to the suture-anchor;

a needle guide disposed between the sheath and the proximal end of the elongate body, the needle guide comprising at least one needle port through which the corresponding hollow needle can exit during use;

at least one hemostatic plug disposed over the needle port, within a receiving recess disposed about the needle port on an exterior surface of the needle guide so as to be penetrated by a corresponding hollow needle during use;

a needle advancement assembly disposed on or within the elongate body configured to selectively deploy the at least one hollow needle through the needle port and into tissue adjacent the passage during use; and

a suture-anchor ejection assembly disposed on or within the elongate body configured to selectively advance the at least one suture-anchor ejection mandrel so as to eject the suture-anchor from the hollow needle to a location adjacent a wall of the body lumen during use.

2. The device of claim 1, further comprising a marker port disposed on an exterior surface of the needle guide or sheath that is in fluid communication with a marker lumen extending through the needle guide and the elongate device body so that fluid entering the marker port exits an opposite end of the marker lumen, indicating appropriate placement of the sheath within a body lumen.

3. The device of claim 1, wherein the needle advancement and suture-anchor ejection assemblies, the suture-anchor ejection mandrel, and the hollow needle are together detachable from a distal portion of the device to allow a user to easily access an end of the suture opposite the suture-anchor.

4. The device of claim 1, wherein the needle lumen further comprises a guide ramp, the guide ramp guiding deflection of the hollow needle as it exits the needle port, penetrates the hemostatic plug, and advances into tissue during use.

5. The device of claim 1, wherein the needle guide comprises a mechanical retention mechanism for inhibiting premature dislodgement of the hemostatic plug from the receiving recess.

6. The device of claim 5, wherein the mechanical retention mechanism comprises one or more protrusions and corresponding mating recesses within the retaining recess and hemostatic plug received therein for inhibiting premature dislodgement of the hemostatic plug.

7. The device of claim 1, wherein at least a portion of the suture is barbed so as to resist movement of the hemostatic plug once the barbed portion of the suture engages the hemostatic plug.

8. A device for closing a passage through tissue communicating with a body lumen, the device comprising:

an elongate device body extending from a proximal end to a distal end;

a sheath disposed at the distal end of the device for disposition within a body lumen during use;

a pair of hollow needles disposed within corresponding needle lumens of the elongate body, the hollow needles being selectively advancable through the needle lumens;

a pair of suture-anchor ejection mandrels disposed within the hollow needles, each suture-anchor ejection mandrel being selectively advancable through a corresponding one of the hollow needles;

a suture-anchor and suture disposed within each hollow needle, a distal end of each suture being attached to the suture-anchor for ejection out a distal end of the corresponding hollow needle by the corresponding suture-anchor ejection mandrel;

a needle guide disposed between the sheath and the proximal end of the elongate body, the needle guide comprising a pair of needle ports, each of which through a respective one of the corresponding hollow needles can exit during use;

a hemostatic plug disposed over each needle port, within a receiving recess disposed about each needle port on an exterior surface of the needle guide so as to be penetrated by a corresponding hollow needle during use;

a needle advancement assembly disposed on or within the elongate body configured to selectively deploy the hollow needles through the needle ports and into tissue adjacent the passage during use; and

a suture-anchor ejection assembly disposed on or within the elongate body configured to selectively advance the suture-anchor ejection mandrels so as to eject the suture-anchors from the corresponding hollow needles to a location adjacent a wall of the body lumen during use.

9. The device of claim 8, further comprising a marker port disposed on an exterior surface of the needle guide or sheath that is in fluid communication with a marker lumen extending through the needle guide and the elongate device body so that fluid entering the marker port exits an opposite end of the marker lumen, indicating appropriate placement of the sheath within a body lumen.

10. The device of claim 8, wherein the needle advancement assembly, the suture-anchor ejection assembly, the suture-anchor ejection mandrels, and the hollow needles are together detachable from a distal end of the device to allow a user to easily access an end of the sutures opposite the suture-anchors once the suture-anchors have been deployed to a location adjacent the wall of the body lumen during use.

11. The device of claim 8, wherein the needle lumen further comprises a guide ramp, the guide ramp guiding deflection of the hollow needle as it exits the needle port, penetrates the hemostatic plug, and advances into tissue during use.

12. The device of claim 8, wherein the needle guide comprises a mechanical retention mechanism for inhibiting premature dislodgement of the hemostatic plug from the receiving recess.

13. The device of claim 12, wherein the mechanical retention mechanism comprises one or more protrusions and corresponding mating recesses within the retaining recess and hemostatic plug received therein for inhibiting premature dislodgement of the hemostatic plug.

14. The device of claim 8, wherein at least a portion of the sutures are barbed so as to resist movement of the hemostatic plugs once the barbed portions of the sutures engage the hemostatic plugs.

15. A device for closing a passage through tissue communicating with a body lumen, the device comprising:

an elongate device body extending from a proximal end to a distal end;

a sheath disposed at the distal end of the device for disposition within a body lumen during use;

a pair of hollow needles disposed within corresponding needle lumens of the elongate body, the hollow needles comprising an anterior needle and a posterior needle and being selectively advancable through the needle lumens;

a pair of suture-anchor ejection mandrels disposed within the hollow needles, each suture-anchor ejection mandrel being selectively advancable through a corresponding one of the hollow needles;

a suture-anchor and suture disposed within each hollow needle, a distal end of each suture being attached to the suture-anchor for ejection out a distal end of the corresponding hollow needle by the corresponding suture-anchor ejection mandrel;

a needle guide disposed between the sheath and the proximal end of the elongate body, the needle guide comprising anterior and posterior needle ports through which the corresponding anterior and posterior hollow needles can exit during use, the anterior needle port being disposed anterior relative to the posterior needle port along the needle guide;

a hemostatic plug disposed over each needle port, within a receiving recess disposed about each needle port on an exterior surface of the needle guide so as to be penetrated by a corresponding hollow needle during use;

a needle advancement assembly disposed on or within the elongate body configured to selectively deploy the hollow needles through the needle ports and into tissue adjacent the passage during use;

a suture-anchor ejection assembly disposed on or within the elongate body configured to selectively advance the suture-anchor ejection mandrels so as to eject the suture-anchors from the corresponding hollow needles to a location adjacent a wall of the body lumen during use;

wherein the needle advancement assembly, the suture-anchor ejection assembly, the suture-anchor ejection mandrels, and the hollow needles are together detachable from the distal end of the device to allow a user to easily access an end of the suture opposite the suture-anchor once the suture-anchor has been deployed to a location adjacent the wall of the body lumen during use.

16. The device of claim 15, further comprising a marker port disposed on an exterior surface of the needle guide or sheath that is in fluid communication with a marker lumen extending through the needle guide and the elongate device body so that fluid entering the marker port exits an opposite end of the marker lumen, indicating appropriate placement of the sheath within a body lumen.

17. The device of claim 15, wherein the needle lumen further comprises a guide ramp, the guide ramp guiding deflection of the hollow needle as it exits the needle port, penetrates the hemostatic plug, and advances into tissue during use.

18. The device of claim 15, wherein the needle guide comprises a mechanical retention mechanism for inhibiting premature dislodgement of the hemostatic plug from the receiving recess.

19. The device of claim 18, wherein the mechanical retention mechanism comprises one or more protrusions and corresponding mating recesses within the retaining recess and hemostatic plug received therein for inhibiting premature dislodgement of the hemostatic plug.

20. The device of claim 15, wherein at least a portion of the sutures are barbed so as to resist movement of the hemostatic plugs once the barbed portions of the sutures engage the hemostatic plugs.