Suturing devices and methods for suturing an anatomic structure

• US 9,706,988 B2
• Filed: 05/09/2013
• Issued: 07/18/2017
• Est. Priority Date: 05/11/2012
• Status: Active Grant

• Current Assignee: Heartstitch, Inc
• Original Assignee: Heartstitch, Inc
• Inventors: Cohn, William Ettlinger, Haines, Daniel W., Nobles, Anthony A., Brosch, Benjamin G.
• Primary Examiner(s): Hammond, Ellen C
• Assistant Examiner(s): Negrellirodrigue, Christina
• Application Number:
  US14/400,309
• Publication Number:
  US 20150126815A1
• Time in Patent Office: 1,531 Days
• Field of Search: 606138, 606139, 606144, 606145, 606147, 606148
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 17/0491 Sewing machines for surgery
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• 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 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/0061 Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/0237 for heart surgery endoscopic heart surgery A61B2017/00243; endoscopic access devices, i.e. trocars, A61B17/34
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/047 : having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0472 : Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/048 : for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/3405 : using mechanical guide means
• CPC Class Codes: A61B 2217/005 : with suction drainage system
• CPC Class Codes: A61M 25/09 : Guide wires

Abstract

Suturing devices and systems used to close openings into a biological structure. The suturing device can comprise an elongate member having a proximal end, a distal end, one or more arms, and one or more needles. One or more sheaths may be used with the device to maintain or substantially maintain haemostasis while the device is used and while a procedure is performed in the biological structure.

Claims

1. A suturing system, comprising:

a suturing device comprising an elongate body having a proximal end and a distal end;

a plurality of arms near the distal end, wherein each arm is configured to move between a first position wherein the arm is retracted within the elongate body, and a second position wherein the arm has a free end extending away from the elongate body, each arm comprising at least one suture mount at the free end;

a plurality of needles, each needle configured to move between a retracted position in which the needle is within the elongate body to a deployed position in which the distal point of the needle extends out of the elongate body and into a corresponding suture mount; and

a first sheath adapted to surround at least a portion of the elongate body;

a second sheath adapted to surround at least a portion of the first sheath;

a plurality of suture portions, wherein each suture portion has a suture end releasably retained within a suture mount of a corresponding arm, each suture portion extending from a corresponding suture end, between the first sheath and the second sheath, to a position proximal to at least the second sheath.

2. The suturing system of claim 1, wherein the suturing device comprises four arms, each arm having a suture mount configured to releasably retain a separate suture portion, and four needles, each needle associated with a corresponding arm.

3. The suturing system of claim 1, wherein the needles are configured to simultaneously move to the deployed position.

4. The suturing system of claim 1, wherein each needle is configured to fit at least partially within a respective channel inside the elongate body.

5. The suturing system of claim 1, wherein a first arm and a second arm are spaced 180 degrees apart about the elongate body and a third arm and a fourth arm are spaced 180 degrees apart about the elongate body.

6. The suturing system of claim 5, wherein the first arm and second arm releasably retain in their respective suture mounts separate sutures of a first color suture, and the third arm and the fourth arm releasably retain in their respective suture mounts separate sutures of a second color different from the first color.

7. The suturing system of claim 1, wherein the second sheath is a peel away sheath.

8. The suturing device of claim 1, wherein the plurality of arms is positioned distal to the first sheath and the first sheath is positioned distal to the second sheath.

9. A suturing device for suturing an opening in a heart wall, comprising:

an elongate body comprising a proximal end and a distal end, a first section at the distal end, a second section proximal to the first section, and a distally facing body surface between the first and second sections;

a plurality of arms near the distal end in the second section, wherein each arm is configured to move between a first position wherein the arm is retracted within the elongate body, and a second position wherein the arm has a free end extending away from the elongate body, each arm comprising at least one suture mount at the free end and configured to releasably retain a suture portion; and

a plurality of needles, each needle configured to move between a retracted position in which the needle is within the elongate body to a deployed position in which a distal point of the needle extends out of the elongate body and into a suture mount;

wherein the second section has a larger outer dimension than the first section and the distally facing body surface is configured to press against an external surface of a heart when the first section is advanced into the opening in the heart.

10. The suturing device of claim 9, further comprising at least one lumen within the elongate body and an opening at an external surface of the second section that connects to the at least one lumen.

11. The suturing device of claim 10, wherein a proximal end of the at least one lumen is adapted to connect to a source of negative pressure.

12. The suturing device of claim 9, wherein each arm comprises a proximal side that faces proximally when the arm is in the second position and a hook on the proximal side.

13. The suturing device of claim 9, wherein the free end of each arm extends away from the elongate body at about a 90 degree angle.