Apparatus and method for surgical suturing with thread management

• US 20020193809A1
• Filed: 04/22/2002
• Published: 12/19/2002
• Est. Priority Date: 06/14/2001
• Status: Active Grant

• Current Assignee: Intuitive Surgical Operations, Inc. (Intuitive Surgical Holdings, LLC)
• Original Assignee: Suturtek Incorporated
• Inventors: Meade, John C., Brecher, Gerald I., Deloughery, Niall G., Bleck, James H.
• Granted Patent: US 6,923,819 B2
• Time in Patent Office: Days
• US Class Current: 606/144
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/0491 Sewing machines for surgery
• CPC Class Codes: A61B 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• CPC Class Codes: A61B 17/06004 Means for attaching suture to needle tipping A61B17/06195; connecting wire to other metallic objects B21F15/00
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/06114 Packages or dispensers for needles or sutures packages for sharps A61B50/3001; for dental floss A61C15/043; packages for needles in general B65D85/24
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 2017/00367 Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00407 Ratchet means
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable
• CPC Class Codes: A61B 2017/00473 Distal part, e.g. tip or head A61B2017/00464 takes precedence
• CPC Class Codes: A61B 2017/00544 pneumatically
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/0498 for advancing a suture filament along a helical path through tissue
• CPC Class Codes: A61B 2017/06014 spring-loaded
• CPC Class Codes: A61B 2017/06019 : by means of a suture-receiving lateral eyelet machined in the needle
• CPC Class Codes: A61B 2017/06028 : by means of a cylindrical longitudinal blind bore machined at the suture-receiving end of the needle, e.g. opposite to needle tip
• CPC Class Codes: A61B 2017/06042 : located close to needle tip
• CPC Class Codes: A61B 2017/06071 : with an abrupt angle formed between two adjacent sections
• CPC Class Codes: A61B 2017/0608 : J-shaped
• CPC Class Codes: A61B 2017/06085 : having a blunt tip
• CPC Class Codes: A61B 2017/06171 : helically or spirally coiled
• CPC Class Codes: A61B 2017/2927 : the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2090/035 : preventing further rotation

Abstract

An apparatus and a method for surgical suturing with thread management. An apparatus for tissue suturing comprising a cartridge having a suturing needle having a pointed end and a blunt end, the suturing needle capable of rotating about an axis; a pusher assembly comprising a cartridge holder having a needle rotation drive capable of releasably engaging the cartridge and rotating the suturing needle about the axis; and an actuator capable of releasably engaging the needle rotation drive to rotate the needle rotation drive. A method for suturing tissue comprising placing a suturing device having a cartridge containing a suturing needle to span separated tissue segments; activating an actuator to cause rotational movement of the suturing needle through the separated tissue segments; and deactivating the actuator to stop an advancing movement of the suturing needle to cause a suturing material to be pulled through the separated tissue segments forming a stitch.

Claims

1. A suturing device comprising:

a cartridge having a suturing needle having a pointed end and a blunt end, the suturing needle capable of rotating about an axis;

a pusher assembly comprising a cartridge holder having a needle rotation drive capable of releasably engaging the cartridge and rotating the suturing needle about the axis; and

an actuator capable of releasably engaging the needle rotation drive to rotate the needle rotation drive.

2. The cartridge of claim 1 further comprising:

a curved lip covering an arc greater than about 180° and

less than about 330°

;

a track in a wall whereby the suturing needle follows a curved path along the track during needle rotation; and

an aperture in the curved lip which intercepts the track whereby the pointed end of the suturing needle traverses the aperture during each revolution of the suturing needle along the path.

3. The cartridge of claim 2 further comprising at least one mounting clip whereby the cartridge is releasably engaged with a cartridge holder having the needle rotation drive.

4. The cartridge of claim 2 further comprising a suturing material dispenser containing a suturing material.

5. The cartridge of claim 2 further comprising a thread management system.

6. The suturing device of claim 1 wherein the suturing needle covers an arc greater than about 180°

and less than about 330°

having an aperture located adjacent to the blunt end for engaging a suturing material.

7. The suturing device of claim 1 wherein the suturing needle comprises an aperture between the pointed end and blunt end.

8. The suturing device of claim 1 further comprising an interlocking mechanism capable of releasably locking the suturing needle with the needle rotation drive whereby rotational movement of the needle rotation drive causes the suturing needle to rotate.

9. The tissue suturing device of claim 8 wherein the interlocking mechanism further comprises a plurality of engagement notches that interfit with the needle rotation drive whereby the suturing needle is rotated by said needle rotation drive in a direction which advances the pointed end of the suturing needle.

10. The suturing device of claim 9 wherein the interlocking mechanism engages at least one notch on a surface of a suturing needle.

11. The pusher assembly of claim 1 comprising:

a cartridge holder having a distal end and a proximal end, the distal end capable of engaging the cartridge and the proximal end releasably attached to a support arm assembly having at least one arm; and

a drive shaft having at least one segment attached to the proximal end of the cartridge holder.

12. The pusher assembly of claim 11 wherein the support arm assembly has two arms that are spatially configured to provide visual access between the support arms.

13. The cartridge holder of claim 11 further comprising:

a curved ring having a lip covering an arc greater than about 180° and

less than about 330°

;

a track in the lip whereby the suturing needle follows a curved path along the track during needle rotation;

an aperture in a wall which intercepts the track whereby the pointed end of the suturing needle traverses the aperture during each revolution of the suturing needle along the curved path wherein the needle rotation drive capable of rotation about an axis that releasably engages the suturing needle whereby rotation of the needle rotation drive in a curved path causes a corresponding rotation of the needle;

a pawl capable of controlling the direction of rotation of the suturing needle; and

at least one segment of a drive shaft that is releasably attached to the needle rotation drive.

14. The cartridge holder of claim 13 further comprising a releasably locking gate assembly.

15. The cartridge holder of claim 14 further comprising at least one mounting clip whereby the cartridge holder releasably engages the cartridge having a suturing needle.

16. The needle rotation drive of claim 1 comprising:

a rotatable needle driver mounted in a terminally located housing capable of coupling to a cartridge capable of releasably engaging a suturing needle contained therein whereby rotation of the rotatable needle driver causes rotation of the suturing needle; and

a drive shaft attaching to an end of the housing capable of rotating the rotatable needle driver.

17. The needle rotation drive of claim 16 wherein the needle rotation drive causes rotation of the suturing needle comprising a blunt end and a sharp pointed end by providing a pushing force adjacent to said blunt end and a pulling force adjacent to said sharp pointed end.

18. The needle rotation drive of claim 16 wherein the drive shaft couples the needle driver to an actuator to rotate the needle driver about an axis.

19. The drive shaft of claim 16 comprising a plurality of separable shaft segments that are coupled by a universal joint assembly that allows said plurality of segments to rotate together.

20. The universal joint assembly of claim 19 comprises at least one universal coupler that enables said drive shaft coupled by said universal coupler to rotate when the plurality of shaft segments are configured non-linearly with respect to each other and with respect to a longitudinal axis of the drive shaft.

21. The drive shaft of claim 19 wherein the plurality of separable shaft segments are configured linearly or non-linearly with respect to one another and are coupled by at least one universal joint assembly.

22. The universal joint assembly of claim 19 further comprising a sleeve capable of releasably enclosing the joint assembly in an angular rigid configuration with respect to the longitudinal axis of the drive shaft.

23. The drive shaft of claim 16 comprising a ratchet assembly capable of restrictably controlling the extent and direction of rotation of the drive shaft and the needle driver attached to the drive shaft upon actuation of the drive shaft by the actuator.

24. The ratchet assembly of claim 23 comprising:

a ratchet ring comprising a central bore capable of allowing the passage of a drive shaft segment therethrough and a plurality of grooves covering at least part of an external surface mounted in a housing;

a locking mechanism capable of releasably locking the ratchet ring to the drive shaft whereby rotational movement of the drive shaft causes a similar rotation of the ratchet ring;

a plurality of wedges symmetrically located on a surface of the ratchet ring;

a pawl that engages the grooves of the ratchet ring;

a shuttle attached to the housing capable of contacting the wedges and controlling the rotation of the ratchet ring; and

a pinion gear comprising a substantially cylindrical grooved segment attached to a terminal end of the drive shaft segment.

25. The locking mechanism of claim 24 wherein the locking mechanism is selected from the group consisting of a screw, a pin and a bolt.

26. The suturing device of claim 1 wherein the actuator is a manually operable trigger, button or switch.

27. The suturing device of claim 1 wherein the actuator is mechanically operable by an electrical device or a fuel driven device.

28. The suturing device of claim 1 wherein the actuator is activated by automation using a power source selected from the group consisting of electrical, electromagnetic, compressed air, compressed gas, hydraulic, vacuum and hydrocarbon fuels.

30. The suturing needle of claim 29 wherein the opening comprises a hollow bore that retains the end of a suturing material.

31. The suturing needle of claim 29 made from a sterilizable medical grade metallic material.

29. A suturing needle comprising:

a curved body with a sharp pointed end, a blunt end, and an aperture between the sharp pointed end and the blunt end, wherein the curved body covers an arc greater than about 180° and

less than about 330°

;

an opening adjacent to the blunt end capable of engaging a terminal end of a suturing material;

at least one notch for engaging a pin of a needle rotation drive; and

at least one notch located along an outer surface of the curved body capable of engaging a pawl for controlling the direction of needle rotation by the needle rotation drive.

32. A surgical device for suturing mammalian tissue comprising:

an actuator handle having an attachment end;

an elongated drive shaft having a distal end, a proximal end attached to the attachment end of the actuator handle, and a longitudinal axis extending between the distal end and the proximal end;

a support arm assembly having a proximal end and a distal end releasably attached to a cartridge holder having a needle rotation drive capable of engaging and rotating a suturing needle about a rotational axis, the proximal end of the support arm assembly releasably attached to the distal end of the drive shaft to fix the support arm assembly relative to the drive shaft;

a cartridge having the suturing needle releasably attached to the cartridge holder whereby the suturing needle is capable engaging the needle rotation drive in the cartridge holder, wherein the cartridge extends from a distal end of the cartridge holder; and

an actuator attached to the actuator handle for causing rotation of the drive shaft and the needle rotation drive, thereby rotating the suturing needle about the rotational axis of said needle rotation drive.

33. The surgical device of claim 32 wherein the suturing needle is arcuate having a radius commensurate with a rotational radius of the needle rotation drive of the cartridge holder, the needle rotation drive releasably engaging the suturing needle so the suturing needle is oriented around the longitudinal axis of the drive shaft.

34. The surgical device of claim 32 wherein the actuator is selected from the group consisting of a trigger, a push button, a lever, a pedal and a mechanically driven switch.

35. The surgical device of claim 32 wherein the actuator is operated by applying a manual or an automated mechanical force.

36. The surgical device of claim 35 wherein the automated mechanical force is a power source selected from the group consisting of electrical, electromagnetic, compressed air, compressed gas, hydraulic, vacuum and hydrocarbon fuels.

38. The method of claim 37 wherein the surgical device comprises:

an actuator handle having an attachment end;

an elongated drive shaft having a distal end, a proximal end attached to the attachment end of the actuator handle, and a longitudinal axis extending between the distal end and the proximal end;

a support arm assembly having a proximal end and a distal end releasably attached to a cartridge holder having a needle rotation drive capable of engaging and rotating a suturing needle, the proximal end of the support arm assembly releasably attached to the distal end of the drive shaft to fix the support arm assembly relative to the drive shaft;

a cartridge having the suturing needle releasably attached to the cartridge holder whereby the suturing needle is capable engaging the needle rotation drive in the cartridge holder, wherein the cartridge extends from a distal end of the cartridge holder; and

an actuator attached to the actuator handle for causing rotation of the drive shaft and the needle rotation drive, thereby rotating the suturing needle about the longitudinal axis of the drive shaft.

39. The method of claim 37 wherein the needle rotation drive causes rotation of the suturing needle comprising a blunt end and a sharp pointed end by providing a pushing force adjacent to said blunt end and a pulling force adjacent to said sharp pointed end.

40. The method of claim 38 wherein the suturing needle is arcuate having a radius commensurate with a rotational radius of the needle rotation drive of the cartridge holder, the needle rotation drive releasably engaging the suturing needle so the suturing needle is oriented around a rotational axis of said needle rotation drive.

41. The method of claim 38 wherein the actuator is selected from the group consisting of a trigger, a push button, a lever, a pedal and a mechanically driven switch.

42. The method of claim 38 wherein the actuator is operated by applying a manual or automated mechanical force.

43. The method of claim 42 wherein the automated mechanical force is a power source selected from the group consisting of electrical, electromagnetic, compressed air, compressed gas, hydraulic, vacuum and hydrocarbon fuels.

44. The method of claim 37 wherein the tissue is mammalian tissue.

46. The method of claim 45 for obtaining a series of continuous sutures to close the wound or incision site.

47. The method of claim 45 wherein the surgical device comprises:

an actuator handle having an attachment end;

an elongated drive shaft having a distal end, a proximal end attached to the attachment end of the actuator handle, and a longitudinal axis extending between the distal end and the proximal end;

a support arm assembly having a proximal end and a distal end releasably attached to a cartridge holder having a needle rotation drive capable of engaging and rotating a suturing needle, the proximal end of the support arm assembly releasably attached to the distal end of the drive shaft to fix the support arm assembly relative to the drive shaft;

a cartridge having the suturing needle releasably attached to the cartridge holder whereby the suturing needle is capable engaging the needle rotation drive in the cartridge holder, wherein the cartridge extends from a distal end of the cartridge holder; and

an actuator attached to the actuator handle for causing rotation of the drive shaft and the needle rotation drive, thereby rotating the suturing needle about the longitudinal axis of the drive shaft.

48. The method of claim 47 wherein the needle rotation drive causes rotation of the suturing needle comprising a blunt end and a sharp pointed end by providing a pushing force adjacent to said blunt end and a pulling force adjacent to said sharp pointed end.

49. The method of claim 47 wherein the suturing needle is arcuate having a radius commensurate with a rotational radius of the needle rotation drive of the cartridge holder, the needle rotation drive releasably engaging the suturing needle so the suturing needle is oriented around the longitudinal axis of the drive shaft.

50. The method of claim 47 wherein the actuator is selected from the group consisting of a trigger, a push button, a lever, a pedal and a mechanically driven switch.

51. The method of claim 47 wherein the actuator is operated by applying a manual or automated mechanical force.

52. The method of claim 51 wherein the automated mechanical force is a power source selected from the group consisting of electrical, electromagnetic, compressed air, compressed gas, hydraulic, vacuum and hydrocarbon fuels.

53. The method of claim 45 wherein the tissue is mammalian tissue.

37. A method for suturing tissue comprising the steps of:

(a) placing a suturing device having a cartridge containing a suturing needle to cause an aperture in the cartridge to span a plurality of separated tissue segments;

(b) activating an actuator to cause rotational movement of the suturing needle across the aperture and advance the suturing needle through the plurality of separated tissue segments; and

(c) deactivating the actuator to stop an advancing movement of the suturing needle to cause a suturing material attached to the suturing needle to be pulled through the plurality of separated tissue segments forming a stitch.

45. A method for suturing tissue at a wound or incision site comprising the steps of:

(a) placing a suturing device having a cartridge containing a suturing needle at the wound site or incision site to cause an aperture in the cartridge to span a tissue of the wound or incision site;

(b) activating an actuator to cause rotational movement of the suturing needle across the aperture and advance the suture needle through the tissue of the wound or incision site; and

(c) deactivating the actuator at the completion of advancing movement of the suturing needle to cause a suturing material attached to the suturing needle to be pulled through the tissue of the wound or incision site; and

repeating steps A through C to cause a plurality of stitches to be placed through the tissue of the wound or incision site.