Source: https://patents.google.com/patent/US20130041388A1/en
Timestamp: 2019-07-23 01:44:53
Document Index: 500612641

Matched Legal Cases: ['art 110', 'art 120', 'arts 110', 'arts 110', 'art 120', 'art 500', 'art 500', 'art 500', 'art 500']

US20130041388A1 - Apparatus and method for suturing tissue - Google Patents
Apparatus and method for suturing tissue Download PDF
US20130041388A1
US20130041388A1 US13/584,536 US201213584536A US2013041388A1 US 20130041388 A1 US20130041388 A1 US 20130041388A1 US 201213584536 A US201213584536 A US 201213584536A US 2013041388 A1 US2013041388 A1 US 2013041388A1
US13/584,536
US9125644B2 (en
2012-08-13 Priority to US13/584,536 priority patent/US9125644B2/en
2012-10-22 Assigned to SafePath Medical, Inc. reassignment SafePath Medical, Inc. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SUTHERLAND, MICHAEL W., LANE, JOSEPH P., DEPIANO, JOHN, EGAN, THOMAS D.
2013-02-14 Publication of US20130041388A1 publication Critical patent/US20130041388A1/en
2015-09-08 Publication of US9125644B2 publication Critical patent/US9125644B2/en
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.
The present application claims the benefit of U.S. patent application Ser. No. 61/523,356, filed Aug. 14, 2011; U.S. patent application Ser. No. 61/595,310, filed Feb. 6, 2012, and U.S. patent application Ser. No. 61/602,052, filed Feb. 22, 2012, each of which is hereby incorporated by reference in its entirety.
The present invention relates to devices and methods for suturing tissue and more specifically, relates to a handheld device that includes a suturing needle, a needle transfer (shuttle) mechanism for selectively gripping and releasing the suturing needle and shuttling the suturing needle between needle grippers to allow capture of the suturing needle upon exit from the patient's tissue and to allow return of the needle to its initial position, thereby allowing the suturing process to start over, and a safety shield mechanism for shielding the suturing needle during the suturing operation including the needle transfer operation.
Needles and suture are used throughout the healthcare industry for indications such as wound and incision closure, securing catheters, and affixing implantable meshes, and other medical apparatus. Because needles represent injury and illness risks to the user, there is a need to make needle usage safer without sacrificing ease of use, performance, and cost. A medical device that can be used to safely suture the tissue of a patient is valuable and appealing to physicians, surgeons, nurses, physician assistants, military personnel, and other clinical and non-clinical users of suture. As described herein, the present invention overcomes the disadvantages of conventional suturing devices and provides a device that has a number of mechanisms that not only shield the needle during operation but also provide a needle shuttling action to ensure effective and complete suturing.
In one embodiment, a device for suturing tissue includes a handle including a housing having a distal end and an opposite proximal end and a suturing needle having a first pointed end and an opposite second end. The device further includes a first needle gripper coupled to the housing. The first needle gripping element 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 first needle gripping element.
According to one exemplary embodiment, a device for suturing tissue includes a handle having a distal end and an opposite proximal end and being rotatable (pivotable) about a first axis. The device also includes a suturing needle having a first pointed end and an opposite second end. A needle shuttle mechanism is coupled to the handle and includes a first part and a second part. Each of the first and second parts is 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 is rotatable (pivotable) about the first axis.
According to one exemplary embodiment, a device for suturing tissue includes a handle having a distal end and an opposite proximal end and being rotatable (pivotable) about an axle that extends along a first axis, in response to rotational movement of a user's hand. The device also includes a suturing needle having a first pointed end and an opposite second end. A needle shuttle mechanism is coupled to the handle and including a first part and a second part. Each of the first and second parts is 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 is rotatable (pivotable) about the first axis.
The present invention is also directed to a method for suturing tissue using one device described herein. The suturing action is performed in part by rotating (pivoting) the handle about and axis of the device from one position to another position and in particular, the first and second positions can be positions at which the handle is at an acute angle relative to the tissue.
The present invention is directed to devices and methods for safely suturing tissue, skin, muscle, ligament, tendon and similar structures. Healthcare workers need a safe device and method for closing wounds and incisions and for securing catheters to a patient. The current procedure typically consists of a user grasping an unprotected needle and suture with hemostats, a needle driver, or forceps and then piercing the patient's tissue by utilizing hand and wrist movements. In this scenario, the needle point is exposed to the user throughout the procedure and provides risk for accidental needle stick injuries (NSI) to the user and procedural staff. These NSIs can transmit blood borne pathogens such as hepatitis and HIV to the user and others from the patient and potentially cause illness or death. Users that are injured in this manner are required to report the injury, undergo diagnostic tests and begin receiving prophylactic treatment. They may also be required to take a leave of absence from work or continue indefinitely with a prescribed drug regimen.
As described in great detail below, a device according to the present invention is a compact, light-weight handheld device that includes a needle and suture assembly, a mechanism for gripping and releasing the needle and suture assembly (a “needle transfer mechanism” or “needle shuttle mechanism”), safely capturing the needle assembly 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. 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 suture delivery technique that is currently employed for securing a catheter, closing a wound, or in related procedures.
The suture is the thread-like structure that is used to close wounds and incisions or to secure catheters or other components to patients. The suture can come in a variety of diameters, textures, forms, i.e., single strand or braided, and materials depending upon the desired properties and intended application. Sutures can be absorbable, i.e., collagen, polyglactin, polydioxanone, polyglycolide-lactide copolymers, or non-absorbable, i.e., silk, nylon, polyester, polypropylene. Sutures can be treated with antimicrobial, bioabsorbable, hydrophilic or other functional additives. In addition, sutures can be textured with raised “unidirectional” features, which permit the suture to pass easily through tissue when drawn in one direction, however, impedes the suture from being pulled out of the tissue when it is drawn in the reverse direction.
The suturing device 100 includes a housing that contains a number of the working components and allows a user to easily hold and use the device 100. For example and as shown in the illustrated embodiment, the housing can be in the form of an elongated handle that is formed of a first part 110 and a second part 120. The first and second parts 110, 120 are complementary to one another and include a means for attaching the two parts together to form an assembled handle that can be easily grasped and manipulated by the user. For example, the first and second parts 110, 120 can be attached to one another by a mechanical attachment, such as by using fasteners, by establishing a snap-fit between the two parts, etc. The handle not only houses many of the working components but also provides a means for the user to grasp the device 100 but also manipulate it in such a way to cause the needle 101 to be advanced into and through the tissue 10 and then exists the tissue 10.
As shown in the figures and described in detail herein, the suturing device 100 is configured to move a curved suturing needle 101 in a controlled manner such that the suturing needle is advanced into and through target tissue 10 and is then extracted from the tissue 10 to complete one suturing action and allow the user to tie off the suture element itself. As mentioned herein, any number of different types of suturing needles 101 can be used with the device 100. In general, the suturing needle 101 includes a sharp distal end 103 for penetrating the tissue 10 and an opposite proximal end 105 (see, FIG. 4) which is typically a blunt end.
In the illustrated embodiment, the actuator body 200 is connected to a needle transfer mechanism 400, which as mentioned herein, is designed to controllably move the needle 101 from one operating position to another operating position and more specifically, to transfer the suturing needle 101 from one needle transfer structure (member) to another needle transfer structure (member) to allow the suturing needle 101 to be extracted from the tissue 10 once it passes therethrough. The connection can be achieved by using a linkage, such as by using a link arm 270 that is coupled to the actuator body 200 at one end thereof. In particular, the handle part 120 can include a feature, such as a protrusion (boss) 210, that is received within an opening 272 formed in one end of the link arm 270, thereby defining a pivot between the link arm 270 and the body 200. Movement of the actuator body 200 is translated into movement of the link arm 270 to thereby drive the needle transfer mechanism 600 and in the illustrated embodiment, the link arm 270 is depressed and causes the link arm 270 to move downward. The link arm 270 includes an opening 274 at a distal end that is configured for coupling the link arm 270 to the needle transfer mechanism 600.
The biasing force can be generated by a spring that is disposed within a spring housing 250 that contains the spring and also includes a rotatable gear 235 that meshes within the teeth of the racks 220, 240 for controlled linear movement of the actuator body 200 as the body 200 is depressed by the user and when a return force is automatically generated to return the actuator body 200. A return spring guide 230 is disposed between the housing 250 and an undercut wall 204 of the actuator body 200. The return spring guide 230 seats flush against the wall 204 and therefore a force applied to the wall 204 results in a driving of the actuator body 200 in an upward direction to return it to its normal rest position. When the user applies a downward force to activate the actuator assembly, this applied force overcomes the biasing force generated by the spring and thus, the actuator body 200 can be driven downward by the user, thereby causing the desired movement of the link arm 270 (in this case, driving the link arm 270 in a downward direction). The illustrated drive mechanism 225 also includes a drive finger 260 is disposed within the housing 250 at a lower end thereof and is configured to move as the actuator body 200 moves in the manner described herein and is configured to allow for rotation of the needle transfer mechanism 400 and permit both capture and return of the suture needle 101 to the original positions.
The cam shaft 340 includes a cam (cam body) 350 located therealong. The cam 350 is designed in part to cause selective movement of parts of the needle transfer mechanism 600 depending upon the location of the cam 350. The cam action of the shaft 340 is described in detail below and its cooperation with the parts of the needle transfer mechanism 400 serves to allow both secure grasping (holding) of the suturing needle 101 and a clean transfer or shuttle action of the suturing needle 101 from a position prior to advancement into and through the tissue to a position in which the suturing needle 101 is extracted from the tissue 10.
In the illustrated embodiment, the needle transfer mechanism 400 includes a first needle gripper 410 and a second needle gripper 420. The first needle gripper 410 can be in the form of a needle gripping assembly or a needle gripping structure (member) 410 and the second needle gripper 420 can be in the form of a needle gripping assembly or a needle gripping structure (member) 420. It will therefore be understood that a “needle gripper” can be formed of a single part or be in the form of an assembly of several parts that provide a needle gripping structure that selectively grasps and holds the suturing needle 101 and therefore, while one or more of the illustrated needle grippers are formed as an assembly of several parts, it is within the scope of the present invention that the needle gripper can be constructed of a single part that performs the function described herein.
As shown in FIG. 6, in one embodiment, the first reciprocating part 500 is in the form of a clamp pin that is biased relative to the cam shaft 340 and in particular, relative to the cam member 350 thereof and is received within the first gripper 410. The first reciprocating part 500 is in the form of an elongated pin that includes a first end 502 and an opposite second end 504. The first end 502 can be in the form of an enlarged head and the part 500 includes a shaft portion that is of lesser dimension that the head. For ease of illustration, the part 500 is described and referenced herein as being pin 500; however, other non-pin like structure can be equally used and therefore, the reference as being a pin is not limiting. The shaft includes an opening, notch or slot 510 that is formed therein and is sized and configured to receive the suturing needle 101. When the first reciprocating pin 500 is in the needle receiving position, the notch 510 is in the open (needle receiving) position in which the suturing needle can freely travel within the notch 510. Conversely, in the closed position, the suturing needle 101 disposed within the notch 510 is not free to move relative to the pin 500 but instead, the suturing needle 101 is firmly grasped by the pin 500 by being intimately disposed between the pin 500 and an underlying structure of the first needle gripper 410 (the needle is held within the channel 412).
As with the first needle gripper body 410, the second needle gripper body 440 has an open bottom to allow the second pin 500 contained therein to be in intimate contact with the cam member 350 and the body 440 has an opening formed in the notch 442 that allows passage of the pin 500 therethrough. The second needle gripper body 440 is also configured to be operatively coupled to the link arm 270 to thereby provide a means for transferring the movement of the actuator body 200 into movement of the second needle gripper 420. Thus, unlike the first gripper 410, the second gripper 420 is a movable gripper that can move to different positions and in different directions as described herein. Any number of different means can be used to couple the link arm 470 to the second needle gripper 420 and in the illustrated embodiment, the second needle gripper body 440 includes a protrusion (boss) that is received within the opening 274 that is located at the distal end of the link arm 270. This arrangement allows the second gripper 420 to rotate relative to the cam shaft 340 upon activation of the actuator and in particular in response to movement of the actuator body 200. As a result of the above arrangement and mechanical coupling of parts, the downward and upward movement of the actuator body 200 causes a pivoting of the second needle gripper 420 about the cam shaft 340. As described herein and appreciated by viewing the figures, downward movement of the actuator body 200 is translated into pivoting of the second needle gripper 420 in a direction away from the handle and toward the distal end of the device 100. Conversely, when actuator body 200 is moved in an upward direction, the second needle gripper 420 pivots about cam shaft 340 in the opposite direction (i.e., in a direction back towards the handle).
Now turning to FIG. 8C, the actuator body 200 has been depressed to activate the actuator and the second gripper 420 engages the sharp end 103 of the needle 101. More specifically, as the actuator body 200 is depressed, the actuator body causes the link arm 270 which is coupled thereto to move downward and at the same time the drive (return) mechanism 225 stores energy due to the biasing member (e.g., a spring) (not shown) associated with the mechanism 225 being compressed. Since the link arm 270 is coupled at its distal end directly to the second gripper 420 (i.e., the body 440) and the second gripper 420 is directly coupled to the cam shaft 340, the movement of the actuator body 200 is directly translated into rotation of the second gripper 420 and in this case, the movement of the second gripper 420 is a rotation about the cam shaft 340. The gear 300 is driven by the movement of the actuator body 200 and this causes rotation of the other gears and this results in rotation of the cam member 350 since the third gear 320 is directly coupled to the cam shaft 340. This movement (rotation) of the cam member 350 causes the reciprocating motion of the pins 500 that is described above. This reciprocating movement causes the pins 500 to selectively open and close depending upon the position of the cam member 350 and this action in combination with the controlled movement of the second gripper 420 provide a means for effectively transferring the suturing needle 101 from one gripper to another gripper depending upon the particular operating stage of the present device 100. As mentioned above, the pawl 280 and ratchet 290 allow the gears 300, 310, 320 to rotate only in one direction.
FIGS. 9A and 9B illustrate front and back views of a two piece safety shield that can be used with the device 100 for shielding the suturing needle 101 over its range of motion in the manner described herein. The first safety shield 610 is rotatably coupled to the device handle by shaft (axle) 340 and a torsion spring 800 or other suitable means. The first safety shield is also rotatably coupled to the second safety shield 620 by a torsion spring or other suitable means. Thus, two springs 800 are used in this design. The spring-loaded engagement between the first safety shield 610 and the handle permits the user to rotate this shield 610 relative to the handle and to safely penetrate the patient's tissue with the needle. The spring-loaded engagement between the first safety shield 610 and the second safety shield 620 forces the latter shield to follow the rotational path of the former while simultaneously providing flexibility between the two shields 610, 620. This flexibility enables the shields 610, 620 to adapt to variable topographies (e.g., tissue, catheter hubs) and still protect the user from the point of the needle throughout the operation. More specifically, the shields 610, 620 contact the tissue which applies a force that counters the biasing force of the shields 610, 620, yet the biasing force of the shields 610, 620 drives the shields 610, 620 into engagement with the tissue and as shown, when in contact with the tissue 10, the shields 610, 620 rest thereagainst at two different (opposite) locations along the tissue 10.
At the proximal end of the receiver shuttle body 1210 of FIGS. 14 and 15, a rectangular pin 1240 is shown, as well as a series of gear teeth 1250. As described above, the gear teeth 1250 of the receiver shuttle body 1210 are mated with the receiving side rack 1192 in the typical rack and pinion type configuration. The proximal most end of the sliding rack 1220 features a rack pin 1221. The rectangular pin 1240, which is a round pin featuring a pair of parallel, flat edges, and the rack pin 1221 both ride between a number of ribs, which together create a well defined path that allows for a controlled motion of the two parts. The exact motion of the receiver shuttle assembly 1200 and the constituent parts are best described in a later drawing. For now it is sufficient to know that the motion of the sliding rack and rectangular pin are well defined and controlled. Furthermore it is important to understand that the receiver shuttle assembly is driven by the travel of the actuator. This travel translates into the actuation of the receiver shuttle assembly 1200 by way of the main drive wheel 1140, linkage 1180, and reciprocating rack assembly 1190.
a suturing needle having a first pointed end and an opposite second end;
a first needle gripper coupled to the housing, the first 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 first needle gripper;
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 gripper;
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; and
a 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.
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 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.
5. The device of claim 4, wherein in a normal rest position prior to activation of the actuator and upon release of the actuator, the second needle gripper is contained at least substantially within the housing.
6. The device of claim 4, wherein each of the first and second needle grippers includes a biased pin member that moves in a reciprocating manner between the first and second positions and intimately engages the suturing needle in the second position resulting in the suturing needle being held by the respective needle gripper.
7. The device of claim 6, further including a cam shaft disposed along and rotatable about the first axis, wherein contact between the cam shaft and the biased pin member causes the reciprocating movement of the biased pin member between the first and second positions, thereby allowing the suturing needle to be transferred between the first and second needle grippers.
8. The device of claim 4, 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.
9. The device of claim 8, 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.
10. 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.
11. The device of claim 10, 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.
12. The device of claim 11, 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.
13. The device of claim 12, further including a mechanism that engages at least one of the gears to ensure that the gears rotate only in one direction.
14. The device of claim 10, 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.
15. The device of claim 14, 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.
16. The device of claim 15, wherein the first and second shields can be positioned generally 180 degrees apart from one another.
17. The device of claim 14, 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.
18. 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.
19. 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.
a handle having a distal end and an opposite proximal end and being rotatable about a first axis;
a needle gripping mechanism disposed within the handle and including first and second needle grippers, the first 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 securely held thereby;
a second needle gripper coupled to the handle, the second needle gripper being 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 in the suturing needle is held by the second needle gripper; and
an 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 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.
21. The device of claim 20, further including a safety mechanism coupled to the handle and configured for shielding the first pointed end of the needle.
22. The device of claim 20, 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.
23. The device of claim 22, 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.
24. The device of claim 22, 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.
25. A device for suturing tissue comprising:
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; and
a safety mechanism coupled to the housing 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.
26. The device of claim 25, 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.
27. The device of claim 26, 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.
28. The device of claim 26, wherein the first and second acute angles are at least 90 degrees apart from one another.
29. 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 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; and
an 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.
30. The device of claim 29, 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.
31. The device of claim 29, 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.
32. A device for suturing tissue comprising:
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; and
a safety mechanism coupled to the housing and configured for shielding the pointed end of the needle.
positioning a handle of a suturing device at a first position relative to the tissue, the suturing device including a suturing needle having a first pointed end and an opposite second end; and
moving, as a result of rotational movement of a user's hand, the handle about a first axis to a second position to cause the suturing needle to be driven into and pass through and exit the tissue;
wherein each of the first and second positions is a position in which the handle is at an acute angle relative to the tissue.
34. The method of claim 33, wherein the suturing device includes:
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 when the suturing device is in the first position prior to contact between the suturing needle and the tissue; and
an 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 release position; and wherein the method further includes the step of:
activating the actuator after the suturing needle has exited the tissue to cause the second part to rotate to the needle transfer position and capture and hold the suturing needle and release of the actuator causes the second part to return to the retracted rest position, thereby extracting the suturing needle from the tissue.
35. The method of claim 34, further including the step of activating the actuator a second time to cause the second part to move to the extended transfer position and cause the first part to capture and hold the suturing needle and release of the actuator causes the second part to return to the retracted rest position, with the suturing needle being held only by the first part to allow additional suturing.
US13/584,536 2011-08-14 2012-08-13 Apparatus and method for suturing tissue Active 2033-06-18 US9125644B2 (en)
US13/584,536 US9125644B2 (en) 2011-08-14 2012-08-13 Apparatus and method for suturing tissue
US14/802,422 US10258323B2 (en) 2011-08-14 2015-07-17 Apparatus and method for suturing tissue
US14/802,422 Continuation US10258323B2 (en) 2011-08-14 2015-07-17 Apparatus and method for suturing tissue
US20130041388A1 true US20130041388A1 (en) 2013-02-14
US9125644B2 US9125644B2 (en) 2015-09-08
US13/584,536 Active 2033-06-18 US9125644B2 (en) 2011-08-14 2012-08-13 Apparatus and method for suturing tissue
US14/802,422 Active 2034-04-14 US10258323B2 (en) 2011-08-14 2015-07-17 Apparatus and method for suturing tissue
WO2015179247A3 (en) * 2014-05-17 2016-01-28 SafePath Medical, Inc. Systems and methods for suturing tissue
EP3145421A4 (en) * 2014-05-17 2018-01-10 Safepath Medical Inc. Systems and methods for suturing tissue
JP2017518855A (en) * 2014-05-17 2017-07-13 セイフパス メディカル，インコーポレーテッド System and method for suturing tissue
EP2741681B1 (en) 2018-10-03
EP1990015A2 (en) 2008-11-12 Surgical stapling and cutting instrument with manually retractable firing member
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:LANE, JOSEPH P.;SUTHERLAND, MICHAEL W.;EGAN, THOMAS D.;AND OTHERS;SIGNING DATES FROM 20120812 TO 20121018;REEL/FRAME:029167/0451