Limited Access Suturing Devices, System, and Methods

• US 20080228204A1
• Filed: 03/17/2008
• Published: 09/18/2008
• Est. Priority Date: 03/15/2007
• Status: Active Grant

• Current Assignee: Boss Instruments, Ltd., Inc.
• Original Assignee: Rhaphis Medical, Inc.
• Inventors: Hamilton, Henry H., Belman, Yuri, Zatyuryukin, Alexander Borisovich, Moore, Patricia A.
• Granted Patent: US 8,257,371 B2
• Time in Patent Office: Days
• US Class Current: 606/148
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0491 Sewing machines for surgery
• CPC Class Codes: A61B 17/062 Needle manipulators
• 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 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61B 90/94 coded with symbols, e.g. text

Abstract

Medical suturing devices, systems, and methods will be useful for endoscopic (with or without access ports) or other surgeries in which access is limited, including ear, nose, and throat procedures. Articulation motions may be transferred from a handle to needle grasping jaws using an axial movement of a shaft that has axial stiffness (such as being stiff in compression) and lateral flexibility or an axial movement of a cable. An extension body (within which the shaft or cable moves) between the handle and jaws can be pre-bent or custom bent by the user. Portions of the devices may be disposable, replaceable, and/or reusable. A spring adjacent the clamp may open the clamp or impose a gripping force.

Claims

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

a body having a proximal end and a distal end, the body having an elongate extension extending along an axis toward the distal end, the extension configured to define a bend in the axis;

a first clamp near the distal end of the body;

a linkage effecting a movement of the first clamp between a grasping configuration and a released configuration, the first clamp configured for grasping the needle in the grasping configuration and the needle being released in the released configuration, the linkage comprising a shaft movable along the axis within the extension so as to effect the movement of the first clamp, the shaft having axial stiffness and being laterally flexible so as to transmit the movement and accommodate the bend.

2. The suturing device of claim 1, wherein the extension comprises a plastically deformable tubular body sufficiently stiff to allow support the needle relative to the proximal end, and sufficiently deformable to allow manual imposition of the bend.

3. The suturing device of claim 2, wherein the shaft comprises a series of shaft elements with joints therebetween so as to transmit compressive movement and accommodate propagation of the bend relative to the shaft as the shaft moves axially within the extension.

4. The suturing device of claim 1, wherein the clamp comprises first and second jaws elements having needle grasping surfaces, wherein each jaw has a slide surface for slidably engaging a wedge surface of the linkage, axial movement of a shaft within the tubular body effecting sliding movement of the wedge along the slide surfaces of the jaws so as to articulate the clamp, wherein axial movement of the wedge in a first axial direction forces the clamp toward a closed configuration, and axial movement of the wedge in a second axial direction allows a spring to urge the clamp open with a spring-imposed clamp opening force.

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

a body having a proximal end and a distal end;

an extension extendable along an axis distally of the body, the extension configured to define a bend in the axis;

a first clamp supportable near the distal end of the extension; and

a linkage effecting a movement of the first clamp between a grasping configuration and a released configuration, the first clamp configured for grasping the needle in the grasping configuration and the first clamp configured to release the needle in the released configuration, the linkage comprising an elongate member movable along the axis of the extension so as to effect the movement of the first clamp, the member being laterally flexible and axially inelastic so as to accommodate the bend while transmitting the movement.

6. The suturing device of claim 5, wherein the extension comprises a plastically deformable tubular body sufficiently stiff to support the needle relative to the proximal end during suturing, and sufficiently deformable to allow manual imposition of the bend.

7. The suturing device of claim 6, wherein the member comprises a series of elements with joints therebetween so as to transmit compressive movement and accommodate propagation of the bend relative to the member as the member moves axially within the extension, the shaft elements comprising spherical bodies, the joints comprising indentations in the spherical bodies to slidingly receive an adjacent spherical body, the bend defining an angle of greater than 10 degrees.

8. The suturing device of claim 5, wherein the clamp comprises first and second jaws elements having needle grasping surfaces, wherein each jaw has a slide surface for slidably engaging a wedge surface of the linkage, axial movement of a member within the tubular body effecting sliding movement of the wedge along the slide surfaces of the jaws so as to articulate the clamp.

9. The suturing device of claim 5, wherein axial movement of the wedge in a first axial direction forces the clamp toward one of the configurations, and axial movement of the wedge in a second axial direction allows a spring to urge the clamp toward the other of the configurations with a spring-imposed clamp articulation force.

10. The suturing device of claim 9, wherein axial movement of the wedge in a first axial direction forces the clamp toward the released configuration, and axial movement of the wedge in a second axial direction allows a spring disposed adjacent the clamp to urge the clamp toward the grasping configuration with a spring-imposed grasping force.

11. The suturing device of claim 9, wherein axial movement of the wedge is effected by proximally displacing the member from the body by articulating a handle relative to the body, the member comprising a flexible tension member so that the proximal displacement articulates the clamp.

12. The suturing device of claim 5, wherein the bend of the body defines an angle of less than 30 degrees, and wherein the member comprises a flexible tension member so that proximal displacement articulates the clamp.

13. The suturing device of claim 5, wherein the extension has an outer surface suitable for insertion into a minimally invasive surgical site, and wherein the member moves within the outer surface of the extension when the member effects the movement so that the outer surface of the extension does not increase in profile during suturing.

14. The suturing device of claim 13, wherein the outer surface is suitable for use through a trocar.

15. The suturing device of claim 13, wherein the outer surface is not suitable for use through a standard trocar.

16. The suturing device of claim 5, wherein the clamp comprises a first jaw element with a first gripping surface and a second jaw element with a second gripping surface, the first gripping surface moving axially so as to grasp the needle axially while a needle axis extends between the gripping surfaces.

17. The suturing device of claim 5, wherein the clamp comprises a first jaw element with a first gripping surface and a second jaw element with a second gripping surface, the first gripping surface moving laterally so as to grasp the needle laterally while a needle axis extends between the gripping surfaces.

18. The suturing device of claim 5, wherein the extension engages the body at a first interface, wherein the extension engages the clamp at a second interface, and wherein at least one of the first interface and the second interface accommodate manual rotation about the axis of the extension so as to alter an orientation of:

the bend relative to the body, and/or

the clamp relative to the extension.

19. The suturing device of claim 5, wherein at least a portion of the extension, at least a portion of a member of the linkage movable axially within the extension to articulate the clamp, and the clamps are releasably coupled to a proximal drive unit of the device as a quickly replaceable clamp unit.

20. The suturing device of claim 17, further comprising a plurality of alternative releasably attachable clamp units, the clamp units, when mounted to the drive unit, defining different bend angles, extension lengths, clamping forces, needle sizes, and/or clamp types.

21. The suturing device of claim 17, wherein the clamp unit comprises a polymer, and wherein needle engaging surfaces of the clamp unit comprise metal, the clamp unit comprising a disposable clamp unit.

22. The suturing device of claim 17, wherein the drive unit comprises metal and is configured to withstand repeated sterilization.

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

a body having a proximal end and a distal end;

an extension extendable along an axis distally of the body, the extension configured to define a bend in the axis;

a first clamp supportable near the distal end of the extension; and

a linkage effecting a movement of the first clamp between a grasping configuration and a released configuration, the first clamp configured for grasping the needle in the grasping configuration and the first clamp configured to release the needle in the released configuration, the linkage comprising an elongate member movable along the axis of the extension so as to effect the movement of the first clamp, the member being laterally flexible so as to accommodate the bend while transmitting the movement.

24. A suturing method comprising:

grasping a needle with a clamp;

supporting the clamp with an extension, the extension having an axis with a bend in the axis;

inserting the needle into a tissue region by moving a body supporting the extension so that the needle moves in correlation with the body;

articulating the clamp by moving a laterally flexible member axially relative to the extension, the member being axially inelastic.

25. The suturing method of claim 24, wherein a distal end of the needle is inserted through the tissue by moving the needle in rigid correlation with the body, and wherein the needle is pulled free from the tissue by moving the needle in rigid correlation with the body.

26. 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, wherein the handle is configured for engagement by the thumb of the hand; 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.