초록 ▼

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 including a housing having a distal end and an opposite proximal end;a suturing needle for advancing a suture through the tissue, the suturing needle having a first pointed end and an opposite second end;a first needle gripper coupled to the housi

1. A device for suturing tissue comprising: a handle including a housing having a distal end and an opposite proximal end;a suturing needle for advancing a suture through the tissue, the suturing needle having a first pointed end and an opposite second end;a first needle gripper coupled to the housing, wherein the first needle gripper includes a biased pin and is movable between a first position in which the suturing needle can freely move relative thereto and a second position in which the suturing needle is held by the first needle gripper, wherein the movement of the biased pin results in grasping and releasing of the suturing needle;a second needle gripper coupled to the housing, the second needle gripper being movable between a first position in which the suturing needle can freely move relative thereto and a second position in which in the suturing needle is held by the second needle;an actuator disposed within the housing and operatively coupled to the second needle gripper for moving the second needle gripper between the first and second positions; anda safety mechanism coupled to the housing and configured for shielding the pointed end of the needle;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 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;wherein the first needle gripper is fixedly attached to the housing, while the second needle gripper is rotatable about a first axis, 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 needle from the tissue, the handle also being rotatable about the same first axis. 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 gripper at least partially surrounded by the safety mechanism in that the second gripper pivotally travels within a hollow interior space defined by a frame of the safety mechanism. 3. The device of claim 1, wherein the first needle gripper holds the suturing needle proximate the second end and the second needle gripper holds the suturing needle proximate the first pointed end. 4. The device of claim 1, wherein the second needle gripper is configured to move to a position in which the suture needle is captured and retained by the second needle gripper, the first pointed end of the suturing needle is contained within the housing. 5. The device of claim 1, further including a cam shaft disposed along and rotatable about the first axis, wherein contact between the cam shaft and the biased pin causes the reciprocating movement of the biased pin between the first and second positions, thereby allowing the suturing needle to be transferred between the first and second needle grippers. 6. The device of claim 1, wherein the actuator and the first and second needle grippers are configured such that subsequent activation of the 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. 7. The device of claim 6, wherein during transfer of the suturing needle from the second needle gripper to the first needle gripper, the second needle gripper assumes the first position and the first needle gripper assumes the second position causing the suturing needle to be held by the first needle gripper. 8. The device of claim 1, wherein activation of the actuator causes each of the first and second needle grippers to move in a reciprocating manner between the first and second positions and causes the second needle gripper to rotate about a first axis to a needle transfer position, the handle also being rotatable about the same first axis. 9. The device of claim 8, 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 first and second positions, the drive assembly including a cam shaft that is disposed along and rotatable about the first axis and a linkage for operatively coupling the actuator to the cam shaft, whereby activation of the actuator is translated into rotation of the cam shaft. 10. The device of claim 9, wherein the linkage comprises a plurality of gears and a link arm that connects the actuator to the drive assembly, wherein movement of the actuator drives the link arm and causes rotation of the gears and rotation of the cam shaft which in turn causes the first and second needle grippers to move in a reciprocating manner and thereby causes each needle gripper to assume one of the first and second positions. 11. The device of claim 10, further including a mechanism that engages at least one of the gears to ensure that the gears rotate only in one direction. 12. The device of claim 8, 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 which is perpendicular to a longitudinal axis of the handle. 13. The device of claim 12, wherein the safety mechanism comprises a spring biased shield that 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 substantially hollow shield member and a second substantially hollow shield member spaced from the first shield member. 14. The device of claim 13, wherein the first and second shields can be positioned generally 180 degrees apart from one another. 15. The device of claim 12, 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 needle passes through the respective shield, the alignment feature including alignment indicia that defines the location. 16. 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 actuator element to the lockout element, wherein the lockout element is configured to prevent the safety mechanism from exposing the first pointed end until the lockout mechanism is deactivated. 17. 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. 18. A device for suturing tissue comprising: a handle having a distal end and an opposite proximal end and being rotatable about a first axis;a suturing needle having a first pointed end and an opposite second end;a needle gripping mechanism disposed within the handle and including first and second needle grippers, wherein the first needle gripper includes a first biased pin and is movable between a first position in which the suturing needle can freely move relative thereto and a second position in the first biased pin of the first needle gripper intimately contacts and applies a biasing force to the suturing needle resulting in the suturing needle being is securely held by the first needle gripper;a second needle gripper coupled to the handle, wherein the second needle gripper includes a second biased pin and is movable between a first position in which the suturing needle can freely move relative to the second needle gripper and a second position in which the second biased pin of the second needle gripper intimately contacts and applies a biasing force to the suturing needle resulting in the suturing needle being securely held by the second needle gripper; andan actuator disposed within the handle and operatively coupled to the needle gripping mechanism for shuttling the suturing needle between the first and second grippers, wherein the actuator is configured such that a single actuator cycle resulting from operating of the actuator causes both the first and second needle grippers to move between the first and second positions;wherein in a first operating position 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 movement of the handle about the first axis from the first position to a second operating position in which the handle is positioned at a second acute angle relative the tissue surface causes the suturing needle to be driven into and through the tissue and permits capture of the first pointed end by the second gripping element upon activation of the actuator. 19. The device of claim 18, further including a safety mechanism coupled to the handle and configured for shielding the first pointed end of the needle. 20. The device of claim 18, further including a drive assembly for moving the second gripper about the first axis and causing the first and second grippers to move between the first and second positions, the drive assembly including a cam shaft that is disposed along and rotatable about the first axis and a linkage for operatively coupling the actuator to the cam shaft, whereby activation of the actuator is translated into rotation of the cam shaft. 21. The device of claim 20, wherein the linkage comprises at least one gear and a link arm that connects the actuator to the drive assembly, wherein movement of the actuator drives the link arm and causes rotation of the gears and rotation of the cam shaft which in turn causes the first and second grippers to move in a reciprocating manner and thereby causes each needle gripper to assume one of the first and second positions depending upon a position of the cam shaft. 22. The device of claim 20, wherein the safety mechanism is rotatable about the first axis, the rotation of the safety mechanism being independent from rotation of the second gripper about the same first axis. 23. A device for suturing tissue comprising: a handle having a distal end and an opposite proximal end and being rotatable about a first axis;a suturing needle having a first pointed end and an opposite second end;a needle shuttle mechanism coupled to the handle and including a first part and a second part, each of the first and second parts being movable between a needle release position in which the suturing needle can freely move relative thereto and a needle retaining position in which the suturing needle is captured and held thereby, the second part being rotatable about the first axis;an actuator disposed within the handle and operatively coupled to the needle shuttle mechanism for causing the suturing needle to be shuttled between the first and second parts to permit the suturing needle to be driven into and passed through the tissue; anda spring biased safety mechanism coupled to the housing by a spring and configured for shielding the pointed end of the needle, the safety mechanism being rotatable about the first axis independent from the rotation of the needle shuttle mechanism about the same first axis, wherein the first axis is perpendicular to a longitudinal axis of the handle. 24. The device of claim 23, 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 part upon activation of the actuator. 25. The device of claim 24, wherein successive activations of the actuator cause rotation of the second part about the first axis and depending upon an operating state of the second part either causes capture of the suturing needle by the second part or release of the suturing needle by the second part to allow capture of the suturing needle by the first part and permit return of the suturing needle to the first part, thereby allowing the suturing needle to be again driven into the tissue. 26. The device of claim 24, wherein the first and second acute angles are at least 90 degrees apart from one another. 27. A device for suturing tissue comprising: a handle having a distal end and an opposite proximal end and being rotatable about an axle that extends along a first axis, in response to rotational movement of a user's hand;a suturing needle having a first pointed end and an opposite second end;a needle transfer mechanism coupled to the handle and including a first part and a second part, the second part being rotatable about the first axis to move between a retracted rest position and an extended needle transfer position, the needle transfer mechanism being constructed such that the suturing needle is initially held by the first part prior to contact between the suturing needle and the tissue, wherein the first part includes a biased pin that is configured to grasp the suturing needle by applying a biasing force to the suturing needle; andan actuator disposed within the handle and operatively coupled to the needle transfer mechanism for moving the second part between the retracted rest position and the extended needle transfer position and effectuating transfer of the suturing needle between the first and second parts, wherein the actuator is operatively connected to both the first and second parts;wherein the needle transfer mechanism is configured such that when the suturing needle is held by second part, it is completely free of the first part and the needle transfer mechanism is configured to transfer the suturing needle from the second part back to the first part. 28. The device of claim 27, wherein 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 part upon activation of the actuator. 29. The device of claim 27, wherein each of the first and second parts include a needle receiving channel formed therein, wherein a shape of the needle receiving channel is complementary to a shape of the suturing needle so as to prevent rotation of the suturing needle within the needle receiving channel. 30. A device for suturing tissue comprising: a handle having a distal end and an opposite proximal end and being rotatable about a first axis;a suturing needle having a first pointed end and an opposite second end;a needle transfer mechanism coupled to the handle and including a first part and a second part, the second part being rotatable about the first axis to move between a rest position and a needle transfer position, the needle transfer mechanism being constructed such that the suturing needle is initially held by the first part prior to contact between the suturing needle and the tissue;an actuator disposed within the handle and operatively coupled to the needle transfer mechanism for moving the second part between the rest position and the needle transfer position and effectuating transfer of the suturing needle between the first and second parts, wherein the needle transfer mechanism is configured to return the suturing needle from the second part to the first part after removal from the tissue and upon motion of the actuator which causes the second part to assume the needle transfer position; anda safety mechanism coupled to the housing and configured for shielding the pointed end of the needle, wherein the safety mechanism comprises a spring biased structure that rotates about the first axis and includes first and second shields that are spaced apart and positioned at an angle relative to one another. 31. The device of claim 1, further including a suture that is carried by the suturing needle. 32. The device of claim 1, wherein the first axis is perpendicular to a longitudinal axis of the handle. 33. A device for suturing tissue comprising: a handle including a housing having a distal end and an opposite proximal end;a suturing needle having a first pointed end and an opposite second end; anda safety mechanism coupled to the housing and configured for shielding the pointed end of the needle, wherein the safety mechanism comprises a spring biased shield that is coupled to the housing by a spring and shrouds the suturing needle during needle penetration and when the suturing needle exits the tissue, the shield being rotatable about a first axis, wherein the shield comprises a first shield member and a second shield member spaced from the first shield member, wherein the first axis is perpendicular to a longitudinal axis of the handle.