Suturing Device, System, and Method

• US 20070060931A1
• Filed: 09/14/2006
• Published: 03/15/2007
• Est. Priority Date: 09/14/2005
• Status: Active Grant

• Current Assignee: Boss Instruments, Ltd., Inc.
• Original Assignee: Rhaphis Medical, Inc.
• Inventors: Belman, Yuri, Hamilton, Henry, Moore, Patricia, Zatyuryukin, Alexander
• Granted Patent: US 7,998,149 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 17/062 Needle manipulators
• CPC Class Codes: A61B 17/2841 Handles
• 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

Abstract

Improved medical suturing devices, systems, and methods may hold a suture needle at a fixed location relative to a handle of the device, allowing the surgeon to grasp and manipulate the handle of the suturing device to insert the needle through tissues in a manner analogous to use of a standard needle gripper. Cycling the handle from a closed position to an open position and back to the closed position may alternate the device between gripping the needle with a first clamp (for example, along a proximal portion of the needle) to gripping the needle with a second clamp (for example, along a distal portion of the needle) and optionally back to gripping with the first clamp, with the needle often staying at a substantially fixed location relative to the suturing device body. Related single-clamp needle grasping devices can be bent plastically by a surgeon, and/or have bodies that are grasped by a hand while a portion of the hand actuates a handle.

Claims

1. A suturing method comprising:

inserting a distal portion of a suturing needle distally through a tissue by moving a body of a suturing device while a first clamp of the suturing device holds the needle at a fixed location relative to the body;

grasping the distal portion of the needle with a second clamp of the suturing device;

releasing the proximal portion of the needle from the first clamp; and

pulling the proximal portion of the needle through the tissue by moving the body while the second clamp holds the needle.

2. The suturing method of claim 1, wherein the second clamp fixedly holds the needle relative to the body while pulling the proximal portion of the needle through the tissue.

3. The suturing method of claim 2, further comprising:

grasping the proximal portion of the needle with the first clamp and then releasing the distal portion of the needle from the second clamp; and

repeating the inserting of the distal portion and pulling of the proximal portion so as to define a plurality of suture stitches.

4. The suturing method of claim 3, wherein the grasping and releasing steps are effected by actuating a handle of the suturing device with a hand of a surgeon.

5. The suturing method of claim 4, wherein the handle moves relative to the body between an open-handed configuration and a closed grasp configuration, and wherein the handle is in the closed grasp configuration during the inserting of the distal portion, and is in the open-handed configuration during the pulling of the proximal portion.

6. The suturing method of claim 1, wherein the suturing device grasps the needle with both the first and second clamps before releasing of the first clamp and before releasing of the second clamp.

7. The suturing method of claim 6, wherein grasping and releasing of the clamps are effected by moving a handle between a first configuration relative to the body and a second configuration relative to the body, movement of the handle from the first configuration to the second configuration and back to the first configuration defining a handle actuation cycle, and wherein the needle alternates at least once between being supported by the first clamp and being supported by the second clamp with each handle actuation cycle.

8. The suturing method of claim 7, further comprising alternating a configuration of an alternatable drive element of a linkage between a first configuration and a second configuration with each handle actuation cycle, the alternatable drive element driving a first linkage portion coupled to the first clamp in the first configuration and driving a second linkage portion coupled to the second clamp in the second configuration.

9. The suturing method of claim 8, wherein the handle actuation cycle rotates a drive wheel, wherein the first and second linkage portions each comprise a driven wheel, wherein the alternatable drive element in the first configuration drivingly couples the drive wheel with the driven wheel of the first linkage portion, and wherein the alternatable drive element in the second configuration drivingly couples the drive wheel with the driven wheel of the second linkage portion.

10. The suturing method of claim 1, wherein the first clamp is displaced laterally from around the needle when the second clamp is inserting the needle, and wherein the second clamp is displaced laterally from around the needle when the first clamp is pulling the needle.

11. The suturing method of claim 10, wherein each clamp is mounted to an associated reciprocatable shaft, and wherein grasping of the needle with each clamp comprises distally extending the associated shaft from a proximal housing of the body, and thereafter closing the clamp around the needle.

12. The suturing method of claim 11, wherein grasping of the needle with each clamp further comprising rotating the clamp about an axis of the shaft between a retracted position and an extended grasping position.

13. The suturing method of claim 11, wherein at least one associated spring inhibits closing of each clamp before the clamp is adjacent the needle.

14. The suturing method of claim 1, further comprising actuating a release input of the suturing device so as to release the needle from the first and second clamps.

15. The suturing method of claim 1, wherein the needle comprises an off-the-shelf needle sold primarily for standard open or laparoscopic surgery.

32. The suturing method of claim 1, wherein the body extends along an axis from a proximal end to a distal end adjacent the first and second clamps, and further comprising:

moving an alternatable drive element laterally between a first configuration and a second configuration, the alternatable drive element driving the first clamp in the first configuration, the alternatable drive element driving the second clamp in the second configuration; and

moving the alternatable drive element axially so as to actuate and displace the driven clamp from about the needle; and

alternately latching the first and the second clamps so as to inhibit axial movement when not the driven clamp.

33. The suturing method of claim 1, the tissue being included on a first patient, further comprising replacing the first and second clamps with third and fourth clamps, disposing of the first and second clamps so as to avoid sterilizing the first and second clamps, and suturing tissue of a second patient with the third and fourth clamps.

34. The suturing method of claim 1, wherein an extension is disposed between a housing of the body and the clamps, and further comprising plastically bending the extension for use in suturing a particular patient, wherein the grasping and releasing of the needle with the clamps is effected via the bent extension.

35. The suturing method of claim 1, further comprising securing the suture to the tissue by tying a knot in the suture without releasing the body from a hand of a surgeon.

36. The suturing method of claim 1, wherein an actuation axis extends between each clamp and the body, each clamp comprising a pair of opposed driven surfaces which angle laterally outwardly along the axis, wherein the driven surfaces of each clamp are moved axially by pushing engagement of corresponding driving surfaces so that the clamp moves along the axis, and are driven laterally by sliding engagement between the driving surfaces and the driven surfaces so that the clamp articulates.

37. The suturing method of claim 1, wherein the first and second clamps are alternatingly latched by an alternatable latch, and further comprising moving the alternatable latch laterally between a first configuration and a second configuration in response to movement of the drive element, wherein the altematable latch in the first configuration inhibits movement of the first clamp, and wherein the alternatable latch in the second configuration inhibits movement of the second clamp.

38. The suturing method of claim 1, wherein the body is moved by manually grasping and manipulating the body with a hand of a surgeon, and wherein the grasping and releasing of the needle are effected by articulating a handle with fingers of the hand while the hand grasps the body.

39. The suturing method of claim 1, wherein the body extends along an axis from a proximal end to a distal end adjacent the clamps, and further comprising bending the body so that the axis has a desired bend for a particular patient, wherein the body is bent while the clamps are supported thereby, wherein the grasping and releasing are performed while the body has the bend and the bend helps position the clamps.

40. The suturing method of claim 1, wherein the tissue is from a first patient, further comprising detaching the first and second clamps from the body after suturing of the first patient and disposing of the first and second clamps, attaching third and fourth clamps to the body, suturing tissue of the second tissue, detaching the third an fourth clamps from the body and disposing of the third and fourth clamps so that each clamps is used to suture tissue of only a single patient.

41. The suturing method of claim 1, further comprising forming a plurality of stitches by repeatedly and alternatingly grasping the suturing needle with the first and second clamps, wherein the first clamp has a first clamp position when the first clamp holds the needle at the fixed location, wherein the second clamp holds the needle at a second clamp position for pulling of the proximal portion of the needle, and wherein gradual displacement of the needle relative to the body during the alternatingly graspingof the clamps is inhibited by:

each grasping of the needle with the first clamp comprising extending the first clamp slightly beyond the fixed location, closing the extended first clamp on the needle, and withdrawing the needle with the first clamp to the fixed location; and

each grasping of the needle with the second clamp comprising extending the second clamp slightly beyond the second clamp position, closing the extended second clamp on the needle, and withdrawing the second clamp to the second clamp position.

42. The suturing method of claim 1, further comprising manually establishing an oblique angle between the needle and the first clamp for proximal or distal suturing, and wherein cycling of the suturing device between grasping of the needle with the first and second clamps substantially maintains the oblique angle.

16. A suturing device for use with a suturing needle, the device comprising:

a body having a proximal end and a distal end;

a first clamp near the distal end of the body;

a second clamp near the distal end of the body;

a linkage effecting movement of the first and second clamps between a grasping configuration and a displaced configuration, each clamp grasping the needle at an associated grasping location in the grasping configuration and laterally displaced from the needle in the displaced configuration, the grasping locations substantially fixed relative to the body.

17. The suturing device of claim 16, further comprising a handle disposed at the proximal end of the body and coupled to the first and second clamps by the linkage so that actuation of the handle alternates between:

the first clamp in the grasping configuration and the second clamp in the displaced configuration, and

the second clamp in the grasping configuration and the first clamp in the displaced configuration.

18. The suturing device of claim 17, wherein the handle is configured for grasping by a hand of a surgeon and is actuatable between a closed hand configuration and an open hand configuration, movement of the handle from the closed-hand configuration to the open-hand configuration and back to the closed-hand configuration defining a handle actuation cycle, and wherein support for the needle alternates at least once between the first clamp and the second clamp during each handle actuation cycle, and wherein the surgeon can insert the needle into tissue by closing his hand on the handle and manipulating the handle while the needle is grasped by one of the clamps.

19. The suturing device of claim 18, wherein each clamp opens after the other clamp has closed during the handle actuation cycle so that the clamps maintain the needle at a substantially fixed location relative to the body.

20. The suturing device of claim 17, wherein the linkage comprises an alternatable drive element, the alternatable drive element moving between a first configuration and a second configuration with each handle actuation cycle, the alternatable drive element driving a first linkage coupled to the first clamp in the first configuration and driving a second linkage coupled to the second clamp in the second configuration.

21. The suturing device of claim 20, wherein the handle actuation cycle rotates a drive wheel, wherein the first and second linkages each comprise a driven wheel, wherein the alternatable drive element in the first configuration drivingly couples the drive wheel with the driven wheel of the first linkage, and wherein the alternatable drive element in the second configuration drivingly couples the drive wheel with the driven wheel of the second linkage.

22. The suturing device of claim 16, wherein during actuation the linkage displaces the first clamp laterally from around the needle after the second clamp grasps the needle, and wherein during actuation the linkage displaces the second clamp laterally from around the needle after the first clamp grasps the needle.

23. The suturing device of claim 22, wherein each clamp has a reciprocatable shaft extending proximally from the clamp to the body, wherein the linkage reciprocates the shafts relative to the body during the actuation cycle so as to move each clamp distally, and wherein the linkage thereafter closes the distally extended clamp around the needle.

24. The suturing device of claim 23, wherein the linkage rotates each clamp about an axis of the shaft between a retracted position and an extended grasping position.

25. The suturing device of claim 23, wherein at least one associated spring inhibits closing of each clamp before the clamp is adjacent the needle.

26. The suturing device of claim 16, further comprising a release input coupled to the linkage so as to release the needle from the first and second clamps.

27. The suturing device of claim 16, further comprising the needle, wherein the needle comprises an off-the-shelf needle sold primarily for standard open or laparoscopic surgery.

28. The suturing device of claim 16, wherein the clamping locations of the first and second clamps are axially offset along a length of the needle and angularly offset so as to accommodate axial curvature of the needle.

29. The suturing device of claim 16, further comprising a proximal handle coupled to the body so as to actuate along a handle actuation plane, wherein the first and second clamps are oriented to support the needle so that an axis of the needle traverses the handle actuation plane

30. The suturing device of claim 16, wherein the suturing device is composed of chemically sterilizable materials.

43. The suturing device of claim 16, wherein the body extends along an axis from a proximal end to a distal end adjacent the first and second clamps, and further comprising an alternatable drive element movable laterally between a first configuration and a second configuration, the alternatable drive element drivingly coupled to the first clamp in the first configuration, the alternatable drive element drivingly coupled to the second clamp in the second configuration;

the alternatable drive element movable axially so as to actuate and displace the driven clamp from about the needle.

44. The suturing device of claim 43, further comprising an alternatable latch movable laterally between a first configuration and a second configuration in response to movement of the drive element, wherein the alternatable latch in the first configuration inhibits movement of the first clamp, and wherein the alternatable latch in the second configuration inhibits movement of the second clamp.

45. The suturing device of claim 16, wherein the body extends from a proximal handle of the body distally toward the first and second clamps, and further comprising a handle articulatably coupled to the body so that a hand can grasp and move the body while fingers of the hand articulate the handle, and wherein the articulation of the handle effects grasping and releasing of the needle by the clamps.

46. The suturing device of claim 16, wherein an extention of the body is disposed between the clamps and a proximal housing of the body, the extension extending along an axis, wherein the body is plastically bendable to have an axial bend desired for a particular patient while the clamps are supported thereby, and wherein a drive member is articulatable from within the housing and through the bent extension so that the clamps can grasp and release the needle while the body has the bend.

47. The suturing device of claim 16, wherein an actuation axis extends between each clamp and the body, each clamp comprising a pair of opposed driven surfaces which angle laterally outwardly along the axis, wherein the driven surfaces of each clamp are moved axially by pushing engagement of corresponding driving surfaces of a drive mechanism so that the clamp moves along the axis, and are driven laterally by sliding engagement between the driving surfaces and the driven surfaces so that the clamp opens and closes.

48. The suturing device of claim 16, wherein the first and second clamps are alternatingly latched by an alternatable latch, and further comprising moving the alternatable latch laterally between a first configuration and a second configuration in response to movement of the drive element, wherein the alternatable latch in the first configuration inhibits movement of the first clamp, and wherein the alternatable latch in the second configuration inhibits movement of the second clamp.

49. The suturing device of claim 16, wherein the suturing device is configured for manually grasping and manipulation of the body with a hand of a surgeon, wherein the body comprises a rigid grasping base, and wherein the clamps are operatively coupled to an articulatable handle so that grasping and releasing of the needle can be effected by articulating the handle with fingers of the hand while the hand grasps the grasping base of the body.

50. The suturing device of claim 16, further comprising a detachable coupler releasably coupling the first and second clamps to the body, the first and second clamps being disposable, and third and fourth disposable clamps for releasably coupling to the body in place of the first and second clamps so that each clamp can be used to suture tissue of only a single patient.

51. The suturing device of claim 16, wherein cycling of the linkage effects grasping of the needle with each clamp by:

extending the clamp slightly beyond the grasping location of the grasping configuration;

closing the extended clamp on the needle; and

withdrawing the needle with the clamp to the grasping location;

so that gradual displacement of the needle relative to the body during repeated cycling of the linkage is inhibited.

52. The suturing device of claim 16, wherein the clamps accommodate a range of oblique angles between the needle and a shaft of the clamp for proximal or distal suturing, and wherein cycling of the linkage substantially maintains the oblique angle.

31. A suturing device for use with a suturing needle, the device comprising:

a body having a proximal end and a distal end;

a handle disposed near the proximal end of the body, the handle actuatable from a first configuration to a second configuration and back to the first configuration so as to define an actuation cycle;

a first clamp and a second clamp disposed near the distal end of the body, the first and second clamps coupled to the handle so that;

a first portion of the actuation cycle, initiated while the first clamp is grasping the needle, effects grasping of the needle with the second clamp and release of the needle from the first clamp; and

a second portion of the actuation cycle, initiated while the second clamp is grasping the needle, effects grasping of the needle with the first clamp and release of the needle from the second clamp.

53. A method for securing suture using a needle driver, the method comprising:

placing a suture through a tissue by grasping a proximal end of a needle with the needle driver, inserting the needle into the tissue at a first insertion point with the needle driver so that a distal end of the needle protrudes from the tissue at a first exit point, grasping the distal end of the needle with the needle driver and pulling the needle distally from the tissue, the suture being coupled with the needle;

forming a first suture loop in the tissue by, after placing the suture through the tissue, supporting the proximal end of the needle with the needle driver, inserting the needle into the tissue at a second insertion point with the needle driver so that a distal end of the needle protrudes from the tissue at a second exit point, supporting the distal end of the needle with the needle driver and pulling the needle distally from the second exit point;

forming a second loop through the tissue adjacent the first loop by supporting the proximal end of the needle with the needle driver, inserting the needle into the tissue at a third insertion point with the needle driver so that the distal end of the needle protrudes from the tissue at a third exit point, supporting the distal end of the needle with the needle driver and pulling the needle distally from the third exit point; and

forming a third loop through the tissue by supporting a proximal end of the needle with the needle driver, inserting the needle into the tissue at a fourth insertion point with the needle driver so that a distal end of the needle protrudes from the tissue at a fourth exit point, supporting the distal end of the needle with the needle driver and pulling the needle, the third loop extending across at least one of the first and second loops between the third exit point and the fourth insertion point so as to define crossed loops, the needle being pulled sufficiently that the crossed loops secure the suture to the tissue.

54. The suture securing method of claim 53, wherein the third loop crosses the first and second loops.

55. The suture securing method of claim 54, wherein the first, second and third loops are formed by manipulating a body of the needle grasper with a hand of a surgeon and the suture is secured without releasing the needle grasper from the hand of the surgeon.

56. A suturing device for use with a suturing needle, the suturing device comprising:

a body having a proximal end and a distal end;

a clamp extendable distally of the body;

biasing means coupled to the clamp to urge the clamps closed sufficiently to grasp the needle therein;

an articulatable handle near the proximal end of the body; and

a linkage coupling the handle to the clamp so that manual articulation of the handle opens the clamp to release the needle.

57. The suturing device of claim 56, wherein the clamp is opened by engagement between an axially moving wedge and angled surfaces associated with jaw elements of the clamp.

58. A suturing device for use with a suturing needle, the suturing device comprising:

a rigid body having a proximal end and a distal end;

a clamp extendable distally of the body;

an articulatable handle near the proximal end of the body, the handle configured for manipulation by fingers of a hand while the hand engages the body near the proximal end; and

a linkage coupling the handle to the clamp so that manual articulation of the handle by the fingers effects opening and closing of the clamp to grasp and release the needle.