Replaceable Tip Suturing Devices, System, and Methods for Use with Differing Needles

• US 20080243147A1
• Filed: 03/17/2008
• Published: 10/02/2008
• 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 8,617,187 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 17/0491 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 or open surgeries, 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. Portions of the devices may be disposable, replaceable, and/or reusable, with different needle-grasping jaws and/or different elongate extension bodies having different configurations optionally being selectably coupleably to an articulatable handle and housing so as to allow the user to configure the device for a particular procedure.

Claims

1. A suturing system for use with a first suturing needle or a second suturing needle, the system comprising:

a body having a proximal end and a distal end;

at least one clamp mountable near the distal end of the body;

a linkage effecting a movement of the at least one clamp between a grasping configuration and a released configuration when the linkage cycles, the linkage having a first configuration and a second configuration, the linkage in the first configuration applying a first clamping suitable for suturing with the first suturing needle when the linkage effects movement from the released configuration to the grasping configuration, the linkage in the second configuration applying a second clamping suitable for suturing with the second needle when the linkage effects movement from the released configuration to the grasping configuration.

2. The suturing system of claim 1, the first needle defining a first arc, the second needle defining a second arc different than the first arc, the suturing system further comprising:

a first clamp unit and a second clamp unit, each clamp unit removably mountable to the body and including an associated plurality of clamps, the clamps sequentially grasping an associated needle when the clamp unit is mounted to the body and the linkage is cycled;

wherein the clamps of first clamp unit define a first clamping offset angle corresponding to the first arc, and wherein the clamps of second clamp unit define a second clamping offset angle corresponding to the second arc, such that replacement of the first clamp unit with the second clamp unit reconfigures the linkage from the first configuration to the second configuration.

3. A suturing system for use with a first suturing needle having a first needle geometry and a second suturing needle having a second needle geometry different than the first needle geometry, the system comprising:

a drive unit having a body with a proximal end and a distal end;

a first clamp unit mountable near the distal end of the body and including a plurality of clamps;

a second clamp unit mountable near the distal end of the body and including a plurality of clamps;

a linkage operationally coupling the drive unit to an associated clamp unit mounted thereon, the linkage effecting sequentially alternating grasping and releasing by the clamps of the first clamp unit when the first clamp unit is mounted to the drive unit and the linkage is cycled, the grasping of the first clamp unit corresponding to the geometry of the first needle;

the linkage effecting sequentially alternating grasping and releasing by the clamps of the second drive unit when the second clamp unit is mounted to the drive unit and the linkage is cycled, the grasping of the second clamp unit corresponding to the geometry of the second needle.

4. The suturing system of claim 3, wherein the clamps of the first drive unit are laterally separated so as to grasp the first needle near opposed ends of the needle, wherein cycling the linkage effects needle movement relative to the body which is insufficient to advance the first needle through tissue so that suturing can be effected by moving the body relative to the tissue.

5. The suturing system of claim 3, wherein each clamp articulates with cycling of the linkage so as to grasp the needle laterally relative to a local axis of the needle, wherein the clamps of the first clamp unit are angularly offset by a first angle so as to accommodate a first arc angle of the first needle geometry between the clamps, and wherein the clamps of the second clamp unit are angularly offset by a second angle so as to accommodate a second arc angle of the second needle geometry between the clamps, the offset angle of the first clamp being different than the second offset angle of the second clamp.

6. The suturing system of claim 3, wherein each clamp articulates with cycling of the linkage so as to grasp the needle laterally relative to a local axis of the needle, wherein the clamps of the first clamp unit separated by a first separation distance so as to accommodate a first arc length of the first needle geometry between the clamps, and wherein the clamps of the second clamp unit are separated by a second separation distance so as to accommodate a second arc length of the second needle geometry between the clamps, the first separation of the first clamp being different than the second separation of the second clamp.

7. The suturing system of claim 6, wherein first and second extension portions of the first clamp unit each support an associated clamp, the first and second extension portions angling per an extension angle along a first length between the body of the drive unit and the first needle when in use.

8. The suturing system of claim 7, wherein first and second extension portions of the second clamp unit each support an associated clamp, the first and second extension portions angling per the extension angle along a second length between the body of the drive unit and the first needle when in use, the second length being different that the first length.

9. The suturing system of claim 3, wherein the clamp unit comprises polymer, and wherein needle engaging surfaces of the clamp unit comprise metal, the clamp unit comprising a disposable clamp unit.

10. The suturing system of claim 3, wherein the drive unit comprises metal and is configured to withstand repeated sterilization.

11. The suturing system of claim 3, wherein the each clamp unit has indicia of an associated needle size visible thereon so as to facilitate selection of an appropriate clamp unit for use.

12. A suturing system for use with a plurality of differing suturing needles, the system comprising:

a drive unit having a body with a proximal end and a distal end;

a plurality of alternative clamp units releasably mountable to the distal end of the drive body, each clamp unit having a plurality of clamps for engaging an associated plurality of locations of an associated needle, the clamps of the clamp units defining different geometries so as to accommodate the differing needles and their use for suturing differing tissues.

13. The suturing system of claim 12, each suturing needle being an off-the-shelf suturing needle having a standard size identifier associated therewith, wherein each clamp unit has a visible indicia of the size identifier of an associated needle.

14. An apparatus for use with a suture needle selected from among a plurality of differing suturing needles, each needle having an axis, and for use with a drive unit having a body with a proximal end and a distal end, an interface near the distal end, and a drive unit linkage portion, the apparatus comprising:

a clamp unit releasably mountable to the interface of the drive body, the clamp unit having a plurality of clamps and a clamp unit linkage portion actuated by the drive unit linkage portion, when the clamp unit is mounted to the drive unit and in use, so as to alternatingly actuate the clamps;

the clamps defining therebetween a geometry corresponding to the selected needle so as to grasp axially separated locations of the needle.

15. The suturing apparatus of claim 14, further comprising a plurality of alternatively selectable clamp units, each clamp unit releasably mountable to the interface of the drive body and having a plurality of clamps defining therebetween a geometry corresponding to an associated needle so as to facilitate suturing with the differing needles by picking an associated clamp unit.

16. The suturing apparatus of claim 15, each suturing needle being an off-the-shelf suturing needle having a size identifier associated therewith, wherein each camp unit has a visible indicia of the size identifier of the associated needle.

17. A suturing apparatus for use with a plurality of differing suturing needles and an associated plurality of alternative clamp units, the clamp units each having a plurality of clamps for engaging an associated plurality of locations of the associated needle, the clamp units defining different geometry therebetween so as to accommodate the differing needles, the apparatus comprising:

a drive unit having a body with a proximal end and a distal end;

an interface disposed near the distal end of the body, the interface selectably receiving any of the plurality of alternative clamp units; and

a drive linkage portion configured to drivingly couple to the clamps of the selected clamp unit mounted to the interface so as to alternately articulate the clamps suitably for grasping the associated needle.

18. The suturing apparatus of claim 17, each clamp unit having a first clamp and a second clamp, each clamp having a first jaw with a gripping surface, a second jaw with a gripping surface, an openably jaw aperture between the gripping surfaces, and at least one jaw back surface extending between the jaw surfaces opposite the jaw aperture, the linkage portion of the drive unit operationally coupling the clamps of the mounted clamp unit so that:

a first cycling of the linkage portion of the drive unit drives the first clamp distally beyond a needle gripping location so as to promote engagement between the at least one jaw back surface of the first clamp and the associated needle, and closes the first clamp so as to engage the gripping surfaces of the first clamp against the associated needle in use, and releases the second clamp and proximally withdraws the second clamp; and

a second cycling of the linkage portion of the drive unit drives the second clamp distally beyond a needle gripping location so as to promote engagement between the at least one jaw back surface of the second clamp and the associated needle, and closes the second clamp so as to engage the gripping surfaces of the second clamp against the associated needle in use, and releases the first clamp and proximally withdraws the first clamp.

19. A suturing method comprising:

selecting a first clamp unit from among a plurality of alternative clamp units based on a suture needle size or type;

mounting the first clamp unit to a body of a drive unit; and

suturing a tissue of a patient by alternatingly grasping a first portion of the needle with a first clamp of the first clamp unit and a second portion of the needle with a second clamp of the first clamp unit, and by moving the body of the drive unit between alternating of the clamps.

20. The suturing method of claim 19, further comprising replacing the first clamp unit on the drive unit with a second clamp unit in response to a different suture needle size or type, the second clamp unit having first and second clamps with a geometry corresponding the different needle;

and

suturing a tissue by alternatingly grasping a first portion of the different needle with the first clamp of the second clamp unit and a second portion of the different needle with the second clamp of the second clamp unit, and by moving the body of the drive unit between alternating of the clamps.

21. The suturing method of claim 19, alternating of the clamps is effected by moving a handle of the drive unit from a first configuration to a second configuration and back to the first configuration, and wherein the movement of the handle effect corresponding movements of the needle so as to advance the needle into the tissue with the first clamp and pull the needle from the tissue with the second clamp, and so that advancing of the needle and pulling of the needle are effected with a single hand.

22. The suturing method of claim 19, wherein the needle has a needle identifier, and wherein selecting the first clamp unit comprises selecting a clamp unit having indicia thereon corresponding to the needle identifier.

23. The suturing method of claim 19, further comprising using a plurality of differing clamp units for a plurality of differing needle sizes during treatment of the patient, sterilizing the drive unit for use with a second patient, and disposing of the used clamp units after treatment of the patient so as to preclude use with the second patient.