SUTURING DEVICES AND METHODS FOR SUTURING AN ANATOMIC STRUCTURE

• US 20150126815A1
• Filed: 05/09/2013
• Published: 05/07/2015
• Est. Priority Date: 05/11/2012
• Status: Active Grant

• Current Assignee: Heartstitch, Inc
• Original Assignee: Heartstitch, Inc
• Inventors: Nobles, Anthony A., Brosch, Benjamin G., Cohn, William Ettlinger, Haines, Daniel W.
• Granted Patent: US 9,706,988 B2
• Time in Patent Office: Days
• US Class Current: 600/204
• 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 method of delivering suture portions to an opening in a heart wall of a patient, the method comprising:

delivering a suturing system through the heart wall, wherein the suturing system comprises;

a suturing device comprising an elongate body having a proximal end and a distal end, the suturing device having a distal section that extends through the heart wall and into the heart once the suturing system is delivered, the suturing device comprising a plurality of arms positioned outside of the heart and a plurality of needles positioned inside the heart once the suturing system is delivered;

a first sheath positioned over the suturing device, a distal end of the first sheath being proximal to the plurality of arms once the suturing system is delivered; and

a second sheath positioned over the first sheath;

extending the plurality of arms from the elongate body of the suturing device, each of the arms carrying a suture portion having a suture end releasably retained in a respective arm, wherein each suture portion extends from its respective arm proximally between the first sheath and the second sheath to a location outside of the patient;

positioning the plurality of arms against the outside surface of the heart;

advancing the plurality of needles from the elongate body through the heart wall, each needle aligned with a respective arm and engaging a respective suture end carried by the respective arm;

retracting the plurality of needles through the heart wall to draw the respective suture ends through the heart wall;

retracting the arms into the elongate body of the suturing device while maintaining a distal section of the elongate body within the heart;

advancing the first sheath positioned around the elongate body into the opening in the heart wall; and

withdrawing the elongate body from the heart wall while leaving the first sheath within the heart wall, the withdrawing of the elongate body drawing the suture ends engaged by the needles through a lumen of the first sheath to a location outside of the patient.

10. The method of claim 9, further comprising removing the second sheath from around the first sheath after withdrawing the elongate body.

11. The method of claim 9, further comprising joining a pair of suture portions extending through the first sheath, thereby forming a single suture.

12. The method of claim 11, further comprising pulling on one or both of the remaining free ends of the single suture to remove the single suture from the first sheath and provide a continuous length of suture extending into the heart and across the opening in the heart wall.

13. The method of claim 12, further comprising attaching a pledget to one or both of the suture portions before joining the pair of suture portions, wherein pulling on one or both of the remaining free ends comprises pulling on one of the free ends until the pledget enters the heart.

14. The method of claim 12, further comprising performing one or more procedures on the heart with the suture extending into the heart and across the opening of the heart wall.

15. The method of claim 14, further comprising using said suture to close the opening in the heart wall after the one or more procedures on the heart are performed.

16. The method of claim 12, further comprising tightening the single suture while withdrawing the first sheath, thereby closing the opening in the heart as the first sheath is withdrawn to substantially maintain haemostasis within the heart.

17. The method of any one of claims 9-16, wherein the plurality of arms comprises a first arm and a second arm positioned approximately 180 degrees apart from the first arm around a circumference of the elongate body.

18. The method of any one of claims 9-16, further comprising attaching a pledget to one of the suture ends and pulling a suture portion such that the pledget is within the heart.

19. The method of claim 9, wherein the suturing device comprises four arms, and further comprising joining a first and second pair of suture portions extending through the first sheath, thereby forming a pair of separate sutures.

20. The method of claim 19, further comprising attaching a first pledget to one of the sutures of the first pair of suture portions prior to joining the sutures of the first pair, and attaching a second pledget to one of the sutures of the second pair of suture portions prior to joining the sutures of the second pair.

21. The method of claim 20, further comprising attaching the first pledget to one of the sutures of the second pair of suture portions prior to joining the sutures of the first and second pairs, and attaching the second pledget to a separate one of the sutures of the first pair of suture portions prior to joining the sutures of the first and second pairs.

22. The method of any one of claims 9-16, comprising, prior to delivering the suturing system through the heart wall:

delivering a trocar through a patient'"'"'s chest to provide access to the thoracic cavity;

delivering a hollow needle through the trocar and into the heart through a heart wall;

delivering a guidewire through the trocar and through the hollow needle into the heart;

removing the hollow needle;

wherein the suturing system is delivered through the trocar into the thoracic cavity and over the guidewire into the heart.

23. 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.

24. The suturing device of claim 23, 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.

25. The suturing device of claim 24, wherein a proximal end of the at least one lumen is adapted to connect to a source of negative pressure.

26. The suturing device of claim 23, 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.

27. The suturing device of claim 23, wherein the free end of each arm extends away from the elongate body at about a 90 degree angle.

28. A method of performing a procedure on the heart of a patient, the method comprising:

delivering an elongate device through a heart wall such that the a distal section of the device is positioned within the heart; and

removing fluid exiting the heart along the distal section of the elongate device and through the heart wall, said removing of fluid comprising causing said fluid to flow through at least one opening positioned on the elongate device on an outside of the heart to remove fluid that may accumulate between the outside of the heart and the pericardial sac.

29. The method of claim 28, wherein fluid flows through the at least one opening by applying negative pressure to the at least one opening from outside of the patient.

30. The method of claim 28, wherein the elongate device comprises a distally facing surface in its distal section, and delivering the elongate device comprises pushing the distal facing surface against an outer surface of the heart.

31. The method of claim 30, wherein the elongate device comprises a plurality of openings proximal to the distally facing surface.

32. The method of claim 28, wherein the elongate device is a suturing device comprising a plurality of arms and a plurality of needles, and further comprising:

moving the plurality of arms from a first position wherein the arms are retracted within the elongate body to a second position wherein the arms each has a free end extending away from the elongate device and are positioned adjacent an outer surface of the heart, each arm comprising at least one suture mount at the free end releasably retaining a suture portion; and

moving a plurality of needles from a retracted position in which needles are within the elongate device to a deployed position in which distal points of the needles extend out of the elongate device, through the heart wall and into a suture mount of a corresponding arm.

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

an elongate body comprising a proximal end and a distal end, the distal end of the elongate body configured to be delivered through the heart wall into a heart;

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 and configured to releasably retain a suture portion, wherein each arm has a proximal side configured to engage the pericardial sac as the arm moves from the first position to the second position, and each arm in its second position is configured to be positioned along an outer surface of the heart; and

a plurality of needles, each needle configured to move between a retracted position in which 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 needles are configured to pass through the heart wall when the arms are positioned along an outer surface of the heart.

34. The device of claim 33, wherein the proximal side comprises a sharp edge configured to engage the pericardial sac.

35. A method of suturing an opening in the heart of a patient, the method comprising:

delivering a suturing device comprising an elongate body through a heart wall such that a distal section of the device is positioned within the heart, the suturing device comprising a plurality of arms and a plurality of needles; and

moving the plurality of arms from a first position wherein the arms are retracted within the elongate body to a second position wherein the arms each has a free end extending away from the elongate body, wherein the arms engage the pericardial sac as they move to their second positions to move the pericardial sac away from an outer surface of the heart, each arm comprising at least one suture mount at the free end releasably retaining a suture portion; and

moving a plurality of needles from a retracted position in which needles are within the elongate body to a deployed position in which distal points of the needles extend out of the elongate body, through the heart wall and into a suture mount of a corresponding arm.

36. A method of closing an opening in the heart with sutures, the method comprising:

inserting four sutures through tissue of a heart wall such that each suture has an end that runs through an opening in the heart and an end that runs outside of the heart, wherein the four sutures comprise a first pair and a second pair of sutures, the sutures of the first pair positioned opposite each other with respect to the opening in the heart and the sutures of the second pair positioned opposite each other with respect to the opening in the heart;

attaching a first end of a first pledget to a first end of a first suture and attaching a first end of a second pledget to a first end of a second suture, wherein the first pair comprises the first suture and a third suture with a first end, and the second pair comprises the second suture and a fourth suture with a first end;

securing together the ends of the first pair that run through the opening in the heart;

securing together the ends of the second pair that run through the opening in the heart; and

pulling on at least one of the ends of each pair that run outside of the heart.

37. The method of claim 36, further comprising attaching a second end of the first pledget to the first end of the third suture and attaching a second end of the second pledget to the first end of the fourth suture, prior to securing together the ends of the first suture pair that run through the opening in the heart and the ends of the second suture pair that run through the opening in the heart.

38. The method of claim 36, further comprising attaching a second end of the first pledget to the first end of the fourth suture and attaching a second end of the second pledget to the first end of the third suture, prior to securing together the ends of the first suture pair that run through the opening in the heart and the ends of the second suture pair that run through the opening in the heart.

39. The method of claim 36, wherein the first end of each suture is the end that runs through the opening in the heart, and the end of each suture than runs outside of the heart is a second end.

40. The method of claim 39, further comprising attaching a third pledget to the second ends of the first and fourth sutures and a fourth pledget to the second ends of the second and third sutures.

41. The method of claim 40, further comprising pushing the third and fourth pledgets to a position adjacent an external wall of the heart.

42. The method of claim 39, further comprising attaching a third pledget to the second ends of the first and third sutures and a fourth pledget to the second ends of the second and fourth sutures.

43. The method of claim 42, further comprising pushing the third and fourth pledgets to a position adjacent an external wall of the heart.