A suturing device of the present invention is in the form a compact, light-weight handheld device that includes a needle and suture assembly, a mechanism for gripping and releasing the needle/suture (a “needle transfer mechanism” or “needle shuttle mechanism”), safely capturing the needle/suture upo
A suturing device of the present invention is in the form a compact, light-weight handheld device that includes a needle and suture assembly, a mechanism for gripping and releasing the needle/suture (a “needle transfer mechanism” or “needle shuttle mechanism”), safely capturing the needle/suture upon exit from the patient's tissue, and returning the needle to a position such that the process of delivering additional sutures to the patient can be repeated. A safety shield mechanism ensures the user is protected from the needle at all times. The device of the present invention accommodates the right or left-handed user, rests comfortably in the user's hand, allows sufficient visualization of the procedure site, and permits the user to either control penetration depth of the needle or default to a device-determined depth. The present device permits the user to utilize a wrist-rotation (pivoting) suture delivery technique.
대표청구항▼
1. A device for suturing tissue comprising: a handle;a suturing needle having a first pointed end and an opposite second end;a first needle gripper coupled to the handle, the first needle gripper having an open position in which the suturing needle can freely move relative thereto and a closed posit
1. A device for suturing tissue comprising: a handle;a suturing needle having a first pointed end and an opposite second end;a first needle gripper coupled to the handle, the first needle gripper having an open position in which the suturing needle can freely move relative thereto and a closed position in which the suturing needle is held by the first needle gripper, the first needle gripper having a base part and a movable part that moves relative to the base part;a second needle gripper coupled to the handle, the second needle gripper being movable relative to the handle and having an open position in which the suturing needle can freely move relative thereto and a closed position in which in the suturing needle is held by the second needle gripper, the second needle gripper being rotatable about a first axis, the second needle gripper having a base part and a moveable part that moves relative to the base part; anda single actuator that is operatively coupled to the second needle gripper, wherein actuation of the single actuator: (1) rotates the second needle gripper relative to the handle, and (2) acts on the first needle gripper to cause the movable part of the first needle gripper to move relative to the base part and assume one of the open and closed positions and acts on the second needle gripper to cause the movable part of the second needle gripper to move relative to the base part and assume the other of the open and closed positions;wherein prior to insertion of the suturing needle into the tissue, the suturing needle is held by the first needle gripper and subsequent to passage of the suturing needle through the tissue and upon activation of the single actuator, the suturing needle is released from the first needle gripper and is captured and held by the second needle gripper to allow retraction of the suturing needle from the tissue. 2. The device of claim 1, wherein the suturing needle is held by at least one of the first and second grippers at all times and the second needle gripper is at least partially surrounded by a safety mechanism in that the second needle gripper pivotally travels within an interior space defined by a frame of the safety mechanism, the safety mechanism being coupled to the handle for shielding the first pointed end of the suturing needle. 3. The device of claim 1, wherein the first needle gripper is fixedly attached to the handle, wherein rotation of the second needle gripper in a first direction towards the tissue allows capture of the suturing needle after the suturing needle exits the tissue and subsequent rotation of the second needle gripper about the first axis in an opposite second direction away from the tissue causes retraction of the suturing needle from the tissue, the handle being rotatable about the first axis. 4. The device of claim 3, wherein each of the first and second needle grippers includes a biased pin member that moves in a reciprocating manner between the open and closed positions and intimately engages the suturing needle in the closed position resulting in the suturing needle being held by the respective needle gripper. 5. The device of claim 3, wherein the single actuator and the first and second needle grippers are configured such that subsequent activation of the single actuator, after the suturing needle has been captured by the second needle gripper, causes rotation of the second needle gripper back in the first direction to effectuate transfer of the suturing needle from the second needle gripper back to the first needle gripper, thereby allowing the suturing needle to be again driven into and through the tissue. 6. The device of claim 5, wherein during transfer of the suturing needle from the second needle gripper to the first needle gripper, the second needle gripper assumes the open position and the first needle gripper assumes the closed position causing the suturing needle to be held by the first needle gripper. 7. The device of claim 1, further including a safety mechanism coupled to the handle and configured for shielding the first pointed end of the suturing needle, wherein activation of the single actuator causes each of the first and second needle grippers to move in a reciprocating manner between the open and closed positions and causes the second needle gripper to rotate about the first axis to a needle transfer position. 8. The device of claim 7, wherein the safety mechanism is rotatable about the first axis, the rotation of the safety mechanism being independent from rotation of the second needle gripper about the same first axis. 9. The device of claim 8, wherein the safety mechanism comprises a spring biased shield that is spaced from the second needle gripper and shrouds the suturing needle during needle penetration and when the suturing needle exits the tissue, the shield being rotatable about the first axis, wherein the shield comprises a first shield member and a second shield member spaced from the first shield member. 10. The device of claim 9, wherein at least one of the first and second shield members includes an alignment feature for indicating to a user a location at which the first pointed end of the suturing needle passes through the respective shield, the alignment feature including alignment indicia that defines the location. 11. The device of claim 1, further including a lockout mechanism including a lockout deactivating element for deactivating the lockout mechanism, a lockout element and means to connect the single actuator element to the lockout element, wherein the lockout element is configured to prevent a safety mechanism, which is coupled to the handle, from exposing the first pointed end until the lockout mechanism is deactivated. 12. The device of claim 1, further including a suture cutter disposed within one of the handle and the actuator, the cutter including a slideable blade, an actuator, and a notch to align the suture for cutting. 13. The device of claim 1, wherein the handle is configured to rotate about an axle that defines the first axis such that prior to insertion of the suturing needle into the tissue, the handle is positioned at a first acute angle relative to a tissue surface and the device is configured such that rotation of the handle about the first axis to a different position, in which the handle is positioned at a second acute angle relative the tissue surface, causes the suturing needle to be manually driven into and through the tissue and permits capture of the first pointed end by the second needle gripper upon activation of the single actuator. 14. The device of claim 13, wherein successive activations of the actuator cause rotation of the second needle gripper about the first axis and depending upon an operating state of the second needle gripper either causes capture of the suturing needle by the second needle gripper or release of the suturing needle by the second needle gripper to allow capture of the suturing needle by the first needle gripper and permit return of the suturing needle to the first needle gripper, thereby allowing the suturing needle to be again driven into the tissue. 15. The device of claim 1, further including a drive assembly for moving the second needle gripper about the first axis and causing the first and second needle grippers to move between the open and closed positions, the drive assembly including a cam shaft, the rotation of which causes the first and second needle grippers to assume one of the open and closed positions, the drive assembly being operatively coupled to the single actuator, whereby activation of the single actuator is translated into rotation of the cam shaft. 16. The device of claim 1, wherein the single actuator is operatively coupled to a drive assembly that has a rotatable component that is configured such that rotation of the rotatable component is translated into the first needle gripper assuming one of the open and closed positions and the second needle gripper assuming the other of the open and closed positions. 17. The device of claim 16, wherein the rotatable component comprises a cam shaft that contacts the first and second needle grippers in an alternating manner. 18. The device of claim 1, wherein the second needle gripper rotates about the first axis between a fully retracted position and a fully extended position, wherein in the fully retracted position, a distal end of the second needle gripper is at least partially contained within the handle. 19. The device of claim 1, wherein the single actuator is configured such that during an instroke of the actuator, the second needle gripper rotates about the first axis between a fully retracted position and a fully extended position and each of the first and second needle grippers assumes one of the open and closed positions. 20. The device of claim 1, wherein the single actuator is operatively connected to: (1) a first linkage for controlling rotation of the second needle gripper about the first axis between a fully retracted position and a fully extended position and (2) a second linkage for altering a state of each of the first and second needle grippers between the open and closed positions. 21. A device for suturing tissue comprising: a handle;a suturing needle having a first pointed end and an opposite second end;a first needle gripper coupled to the handle, the first needle gripper having an open position in which the suturing needle can freely move relative thereto and a closed position in which the suturing needle is held by the first needle gripper;a second needle gripper coupled to the handle, the second needle gripper being movable relative to the handle and having an open position in which the suturing needle can freely move relative thereto and a closed position in which in the suturing needle is held by the second needle gripper, the second needle gripper being rotatable about a first axis; anda single actuator that is operatively coupled to the second needle gripper by a first linkage, wherein actuation of the single actuator rotates the second needle gripper relative to the handle, and wherein the single actuator is operatively coupled to the first needle gripper and the second needle gripper by a second linkage and the single actuator is also configured such that the actuation of the single actuator causes the first needle gripper to assume one of the open and closed positions as a result of a movable part of the first needle gripper moving relative to a base portion of the first needle gripper and to cause the second needle gripper to assume the other of the open and closed positions as a result of a movable part of the second needle gripper moving relative to a base portion of the second needle gripper, the second linkage being different than the first linkage;wherein prior to insertion of the suturing needle into the tissue, the suturing needle is held by the first needle gripper and subsequent to passage of the suturing needle through the tissue and upon activation of the single actuator, the suturing needle is released from the first needle gripper and is captured and held by the second needle gripper to allow retraction of the suturing needle from the tissue.
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