Articulated automatic suturing instrument and automatic suturing method

Abstract

The automatic suturing instrument includes a shaft having a longitudinal axis. The shaft has a joint that is rotatable about a joint axis at an angle >0° relative to the longitudinal axis. The instrument includes a clamp at a distal end of the shaft. The clamp is configured to be positioned across a length of tissue to be sutured. A driver is configured to engage threads on the shaft such that rotation of the driver translates along the length of the shaft. A helical needle is connected to the driver such that rotation of the driver rotates the helical needle, thereby advancing or retracting the needle across the length of the clamp and past the joint in the shaft.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to pending U.S. Provisional Application No. 63 / 035,820, filed June 7, 2020, the disclosure of which is incorporated herein by reference. [Technical Field]

[0002] The present disclosure relates to suturing, and in particular to suturing performed in minimally invasive surgery. Summary of the Invention

[0003] In a first aspect, the present disclosure may be embodied as an instrument for automatic suturing. The instrument includes a shaft, the shaft having a longitudinal axis. The shaft has a joint that is rotatable about a joint axis at an angle >0° relative to the longitudinal axis. The instrument includes a clamp at a distal end of the shaft. The clamp is configured to be positioned across the length of tissue to be sutured. A driver is configured to engage threads on the shaft such that rotation of the driver translates along the length of the shaft. A helical needle is connected to the driver such that rotation of the driver rotates the helical needle, thereby advancing or retracting the needle across the joint of the shaft and across the length of the clamp. In some embodiments, the helical needle further includes one or more windows. In some embodiments, a tip of the helical needle is at a radially outer portion of the helical needle for movement across the joint of the shaft. The helical needle may be configured to be advanced along the outside of the clamp.

[0004] In some embodiments, the device further comprises a suture having a tip near the tip of the helical needle. The helical needle may be hollow, and the suture is disposed through the helical needle. The device may further comprise at least one cutter for cutting the suture. The suture has a diameter, the helical needle has an inner diameter, and the ratio of the diameter of the suture to the inner diameter of the helical needle is in the range of 1:6 to 1:10. In some embodiments, the ratio of the diameter of the suture to the inner diameter of the helical needle is greater than 1:8.

[0005] The instrument may further include a lock for reversibly locking the clamp in the closed position. The instrument may further include a shaft attached to the clamp, and the helical needle may be configured to be disposed on the shaft when in the retracted position. In some embodiments, the motor is operatively connected to the driver.

[0006] In another aspect, the present disclosure may be implemented as a method for automatic suturing. The method includes engaging a clamp of an instrument of any one of the disclosed embodiments onto a first portion of tissue to be sutured. The clamp may be locked in a predetermined position (e.g., a closed position). The helical needle of the instrument is advanced along the length of the clamp so that the helical needle penetrates the tissue to be sutured. A tip of a suture is attached near the tip of the helical needle, thereby threading the suture through the tissue along with the helical needle. The method may include capturing the tip of the suture and retracting the helical needle through the tissue to leave the suture in place. The clamp may then be released from the tissue.

[0007] The leading and / or trailing ends of the suture may be secured to form one or more sutures, for example, by a knot.

[0008] The needle may be advanced, for example, using a motor (e.g., an electric motor). The helical needle may be advanced continuously or selectively (e.g., in rotational increments).

[0009] A method for automatic suturing is provided. The method includes engaging a clamp over a length of tissue to be sutured. In some embodiments, the clamp may be locked in place over the tissue (e.g., over the length of the tissue). A helical needle is advanced along the length of the clamp such that the helical needle penetrates the tissue to be sutured. A tip of a suture may be attached to the tip of the helical needle. The tip of the suture is captured, for example, when the tip of the helical needle advances to an end point. In some embodiments, a detachable tip of the needle is captured along with the tip of the suture. In such embodiments, the helical needle is retracted without the tip. The helical needle is retracted through the tissue to leave the thread in place. The method includes releasing the clamp from the tissue.

[0010] The leading end of the suture may be secured to form one or more sutures. Similarly, the trailing end of the suture may be secured to form one or more sutures. In some embodiments, both the leading end and the trailing end are secured to form one or more sutures. For example, a suture may be formed at each of the leading end and the trailing end. The leading end and / or the trailing end of the suture may be secured using a knot (e.g., by tying the ends).

[0011] In some embodiments, the method may include cutting the tip of the suture to separate the tip of the helical needle from the portion of thread (e.g., the portion of thread forming the suture) and leave it in place following retraction of the helical needle.

[0012] The helical needle may be advanced and / or retracted by an electric motor. The helical needle may be advanced in one rotation increments. The helical needle may be advanced in less than one rotation. The helical needle may be advanced in more than one rotation. The helical needle may be advanced to an end point.

[0013] In another aspect, the present disclosure may be embodied as an instrument for automatic suturing. The instrument includes a clamp. The clamp is configured to be placed across a length of tissue to be sutured. A lock may be provided to reversibly lock the clamp in a closed position. A helical needle is configured to be advanced and retracted along the length of the clamp. For example, the helical needle may be advanced along an inner portion of the clamp. In another example, the helical needle may be advanced across an outer portion of the clamp. The needle has a tip, and a suture thread having a tip is attached to the tip of the helical needle. The needle may be hollow, and the thread may be disposed through the needle.

[0014] The device may include a trap configured to capture the tip of the suture when the helical needle is advanced along at least a portion of the length of the clamp. The needle tip may be removable. The trap may be configured to capture the tip of the needle with the tip of the suture attached.

[0015] The clamp may include a helical guide configured to guide the helical needle during advancement and retraction. The guide may be configured on an inner portion of the clamp. The instrument may further include at least one cutter for severing the suture. [Brief explanation of the drawings]

[0016] For a fuller understanding of the nature and objects of the present disclosure, reference should be made to the following detailed description taken in conjunction with the accompanying drawings. [Figure 1] FIG. 1 is a perspective view of an apparatus according to an embodiment of the present disclosure. [Figure 2A] FIG. 2 is a perspective view of the device of FIG. 1, showing the clamp in an open position. [Figure 2B] FIG. 2B is a perspective view of the device of FIGS. 1-2A, showing the clamp in a closed position. [Figure 3A] FIG. 2C is a perspective view of the clamp of the device of FIGS. 1-2B, showing details of the clamp in an open position. [Figure 3B]FIG. 3B is a perspective view of the clamp of the device of FIGS. 1-3A, showing details of the clamp in a closed position. [Figure 4] FIG. 3C is a perspective view of the device of FIGS. 1-3B showing the needle advanced over the clamp. [Figure 5] FIG. 5 is a perspective view showing details of the clamp and needle of FIG. 4. [Figure 6] 10A-10C illustrate needles according to other embodiments of the present disclosure. [Figure 7] FIG. 7 shows a detail of the tip of the needle of FIG. 6. [Figure 8] 10 is a chart illustrating a method according to another embodiment of the present disclosure. [Figure 9] FIG. 10 is a perspective view of an apparatus according to another embodiment of the present disclosure. [Figure 10A] FIG. 10 is a detailed view of the driver and needle of the device of FIG. 9. [Figure 10B] FIG. 10B is a partially exploded view of the driver and needle of FIG. 10A. [Figure 11] FIG. 10 is a perspective view of a driver head and needle according to another embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0017] Referring to FIG. 1 , the present disclosure may be embodied in one aspect as an automatic suturing instrument 10. The instrument 10 includes a shaft 30 having a longitudinal axis. A clamp 12 is disposed at a distal end 31 of the shaft. In the exemplary embodiment, the clamp 12 includes a first side 13 and a second side 14, each hingedly connected to the other. The first and second sides 13, 14 may be spring-biased toward each other (i.e., toward the "closed" position of the clamp 12). Such a clamp 12 is configured to be opened and positioned across a length of tissue. The clamp 12 may be engaged by returning the clamp to a closed position (e.g., a partially closed position, i.e., since one or more tissues may move the opening of the clamp 12 somewhat apart). In other embodiments, the clamp is not spring-biased, and the clamp is moved from an open state to a closed state and to various degrees therebetween in response to manipulation by a user.

[0018] In some embodiments, the instrument 10 includes a joint 34 on the shaft 30 near the clamp 12, which allows at least the distal portion of the shaft, including the clamp, to be rotated to a position off of the longitudinal axis of the shaft (i.e., at an angle >0° relative to the longitudinal axis). For example, the joint may have a rotation axis that is perpendicular to the longitudinal axis of the shaft. An articulation control member is disposed through the shaft such that the joint can be operated from the proximal end 32 of the shaft.

[0019] The instrument 10 further includes a helical needle 20 movably disposed over a portion of the shaft 30 and / or clamp 12. A driver 24 is connected to the proximal end 22 of the needle 20 such that rotation of the driver 24 about the longitudinal axis of the shaft rotates the needle 20 about the shaft. Similarly, translation of the driver 24 along the length of the shaft similarly translates the needle 20. The shaft 30 includes a thread 36 onto which the driver 24 is threaded. In this manner, rotating the driver advances it along the thread (and retracts it when rotated in the opposite direction), thereby also translating the driver (and needle) along the length of the shaft. The thread may have a trapezoidal thread profile (e.g., an ACME thread profile) or other thread profile. The driver may have a length that allows it to be manually manipulated from outside the body during use. In some embodiments, the driver may be advanced using a motor, such as an electric motor. In such embodiments, the driver may have a short length such that the driver is completely contained within the body in use, or may have a long length such that at least a portion of the driver is located outside the body in use.

[0020] The helical needle 20 is configured so that, upon advancement, the needle penetrates material (e.g., one or more tissues) contained within the clamp. The needle penetrates the material one or more times as it rotates along the length of the clamp. In some embodiments, the helical needle 20 may be disposed on the shaft 30 when in a retracted position (FIGS. 3A and 3B). In this manner, the clamp 12 may be opened (FIG. 3A) or closed (FIG. 3B) on one or more tissues. The helical needle 20 may be advanced along the length of the clamp 12, i.e., along the length of the longitudinal axis of the clamp 12, when the clamp 12 is closed (clamped) on one or more tissues to be sutured (see, e.g., FIGS. 4 and 5). For example, the helical needle may be advanced over the outer surface of the clamp. The shaft and / or clamp may include one or more guides (not shown) for guiding the helical needle during advancement and retraction. The device may further comprise a sheath configured to surround at least a portion of the helical needle when in the retracted position.

[0021] The needle 20 is configured to advance over the clamp 12 when the joint 34 is straight (i.e., when the clamp is coaxial with the longitudinal axis of the shaft 30) or when the joint 34 is curved (i.e., angled at an angle >0° from the longitudinal axis of the shaft 30). For example, the needle may be made of metal (e.g., surgical steel) or a hard plastic or composite material (e.g., carbon fiber). The diameter of the needle may also be configured to advance over a curved joint. Non-limiting experimental testing has shown that a surgical steel needle having a diameter of 0.065 inches can be advanced over a curved shaft joint. In some embodiments, the needle tip 22 may be cut (i.e., sharpened) at an angle such that the distal portion of the needle is radially outward of the helix (see FIG. 4 ). Experimental testing has shown that a radially outward needle tip is advantageous when used with a curved shaft joint.

[0022] The needle 20 may have a gauge of, for example, 20G to 10G (Birmingham gauge; approximately 0.91 to 3.4 mm, outer diameter), but may be smaller or larger as desired depending on the application. The overall diameter of the helical shape may be, for example, between 0.25 and 2.0 inches (approximately 6.35 to 50.8 mm), but may be smaller or larger as desired for a particular application. In certain embodiments, the instrument is designed for use with a 15 mm port size. Thus, the helical shape has a diameter of less than 15 mm. Generally, the overall diameter of the instrument (diameter of the shaft, clamp, needle, driver, etc.) is smaller than the port size used in a particular procedure.

[0023] Referring to FIG. 7, the instrument 10 further includes a suture 28 for suturing tissue contained within the clamp 12. The suture 28 has a tip 29 that can be attached to the needle 20 (see, e.g., FIG. 4). In some embodiments, the tip 29 is attached to (i.e., near) the tip 22 of the needle 20. In one example, the suture 28 may be attached by a spring-loaded multi-pronged gripper, as known in the art. In other embodiments, the suture 28 is attached by being knotted into the bore of the needle 20. In other embodiments, the suture is attached to the tip of the needle by virtue of being disposed through the lumen of the needle. Other techniques for attachment, including, for example, adhesives, will become apparent in light of the present disclosure. In some embodiments, the needle 20 is hollow, and the suture 28 is disposed through the hollow portion (lumen) of the needle 20 and emerges at the tip 22. In other embodiments, the suture may be generally outside the needle and attached at its tip. The needle 20 and suture 28 are configured so that as the needle 20 is advanced along the length of the clamp (e.g., through the guide 18 of the clamp 12) and through one or more portions of tissue held by the clamp 12, the suture 28 is likewise transported through the tissue.

[0024] The number of sutures that can be placed through the held tissue roughly corresponds to the number of spirals. For example, if the spiral needle 20 includes 24 spirals, then roughly a maximum of 24 sutures will be created (assuming the tissue is properly positioned within the clamp 12, etc.). However, rather than 24 individual sutures, the resulting sutures are running sutures or "continuous stitches," i.e., continuous sutures with only the end stitches tied. The needle 20 may include, for example, between 12 and 24 spirals, although it may have more or fewer spirals. The needle 20 may have a length of, for example, 3 to 6 inches (approximately 76.2 to 152.4 mm), although it may be longer or shorter.

[0025] The instrument 10 may include a trap 40 configured to engage the tip 22 of the needle 20 once the needle 20 has completed its advancement through the clamp 12. By engaging the needle 20, it is intended that the trap 40 is configured to capture the suture 28, e.g., at least a portion of the thread, e.g., at or near the tip 29 of the suture 28. In some embodiments, the trap 40 is configured so that the tip 22 of the needle 20 enters the trap 40. In some embodiments, the tip 22 is removable, and the trap 40 may be configured to remove and retain the tip 29 (along with at least a portion of the thread tip 29) within the trap 40. By capturing the suture 28, the helical needle 20 may be retracted through the clamp 12, leaving the suture 28 in place. In other embodiments, the suture may be held using another tool (e.g., a laparoscopic tool, etc.) while the needle is being retracted.

[0026] In some embodiments, once the suture 28 is retracted, leaving the suture 28 in place, the thread 28 may be reattached to the needle, e.g., the tip 22 of the needle 20 (i.e., at a portion spaced from the portion of the thread in place). The needle may include a part to which the thread may be attached, such as a hook, a slit, a clamp, etc. For example, the thread may be reattached by tying the thread to the needle (e.g., to a part of the needle). Once the thread is reattached to the needle, the needle can be advanced again through the tissue. For example, another portion of one or more tissues can be clamped, and the suturing can continue from the previous position. In some embodiments, the suture passes through the shaft and is positioned within the end of the needle that engages with the driver. In some embodiments, the suture enters the needle at a position on the needle near the driver.

[0027] In some embodiments, the instrument 10 may further include one or more cutters at the leading and / or trailing ends for severing the suture, so that the instrument 10 may be removed from the body while leaving the suture threaded through one or more tissues.

[0028] In another aspect, the present disclosure may be implemented as a method 100 of automated suturing. For example, method 100 may be used to construct a running suture across one or more lengths of tissue. A clamp is engaged (103) across the length of one or more tissues to be sutured. For example, if a bowel of intestine may need to be sutured closed across its length, the clamp is positioned across the length of the intestine such that the two tissue portions to be sutured fit within the clamp. The clamp may be engaged (103) to hold the tissue therein. The clamp may be engaged (103) with a lock configured to prevent the clamp from opening.

[0029] The helical needle is advanced (106) along at least a portion of the length of the clamp. For example, the needle may be advanced over the clamp with or without one or more guides. The clamp and helical needle may be of any configuration as described herein. The helical needle is advanced (106) in a corkscrew-like manner, i.e., by rotating the needle about the central axis of the helical shape. By advancing along at least a portion of the length of the clamp, the needle penetrates one or more tissues to be sutured. Depending on the configuration of the clamp and needle and / or the manner in which one or more tissues are clamped within the clamp, the needle may penetrate the tissue once per needle rotation or twice per needle rotation. The needle may be advanced by an actuator controlled by the surgeon. For example, each time the actuator is activated (e.g., by pulling a trigger, pressing a button, flipping a switch, pressing a foot pedal, etc.), the helical needle may advance one rotation and puncture one or two tissues.

[0030] In some embodiments, the needle is hollow and includes a thread (suture) disposed at least partially through the hollow interior of the needle. The suture is then passed through the clamp and tissue by the helical needle. In some embodiments, the suture is on the outside of the needle and attached to the tip of the needle. The suture is then threaded by the needle through the tissue as the needle is advanced through the clamp (106). In some embodiments, the needle is advanced one full rotation at a time (i.e., with each actuation of the instrument) (106). In some embodiments, actuation of the instrument may advance the needle less than one full rotation. For example, the actuator may advance the needle a half, a third, a quarter, or any amount less than a full rotation. In this manner, the tissue may be pierced once, twice, or not at all by each actuation of the instrument. In other embodiments, the needle is advanced more than one full rotation at a time (106). For example, the needle may be advanced by the surgeon, and such advancement may continue until the needle has traveled its entire path through the clamp. In some embodiments, the needle may be advanced only while actuated by the operator (106). For example, the surgeon may pull a trigger to advance the needle, and the needle may continue to advance until the surgeon releases the trigger. The needle may be advanced at a selectively variable rate. For example, the advancement rate may be proportional to the position of an actuator (e.g., a variable trigger, foot pedal position, etc.). In another example, the advancement rate is determined according to a control separate from the actuator, such as, for example, a multi-setting switch, a dial, a rotatable knob, etc. Other advancement mechanisms will become apparent in light of this disclosure.

[0031] The tip of the suture may be captured or otherwise secured at the tissue location (109) as the needle is advanced through the clamp (106). For example, the suture may be captured when the tip of a helical needle is advanced to an end point. The end point may be at the distal end of the clamp. In some embodiments, the end point may be spaced from the distal end of the clamp. In some embodiments, the end point may be selected by the user depending on the application. For example, as described further below, in some embodiments, a trap is placed on the clamp to capture at least a portion of the suture (109). In some embodiments, the needle tip is removable, and the tip is captured along with at least a portion of the suture (109). In other embodiments, the suture is manually captured by an operator (e.g., a surgeon) using a separate instrument.

[0032] Once the suture is captured (109), the needle is retracted (112) along the length of the clamp. For example, the needle is retracted (112) using a corkscrew motion opposite the forward motion, i.e., by rotating the needle in the opposite direction about the central longitudinal axis of the helix. Since at least a portion of the suture has been captured (109), the suture is left in place (112) during needle retraction. By left in place, it is intended that the suture remains positioned through one or more tissues at the location where the needle penetrated the one or more tissues. In embodiments in which the suture is positioned through a hollow portion of the needle, the needle is retracted (112) by passing over the suture (the suture slides through the hollow portion, thereby remaining in place as the needle is retracted).

[0033] The clamp is removed from the tissue (115). In some embodiments, the thread may be reattached to the needle, e.g., the tip of the needle (118). This allows the device to be immediately reused to place another suture in the same or a different tissue. By immediately, it is intended that subsequent sutures may be placed without necessarily removing the device from the individual's body. In some embodiments, the suture may be cut at the leading and / or trailing end (121) so that the clamp and needle may be moved or removed while leaving the suture in place.

[0034] The leading and / or trailing ends of the suture may be secured to complete the suturing. In some embodiments, one or both ends are secured by tying the thread (securing the thread to itself) (121). In some embodiments, the suture is knotted so that one or both ends cannot be pulled through the tissue. In some embodiments, the suture is configured to expand to a thicker diameter (here, "thicker" means a diameter larger than the initial diameter of the suture), thereby holding the suture within the tissue. Such threads are known in the art. Prior to securing one or both ends, the suture may be adjusted so that the suture is tightened as desired. One or both ends of the suture may be secured before or after removing the clamp (115).

[0035] In some embodiments, the helical needle is advanced (106) and / or retracted (112) using an electric motor, hi some embodiments, the helical needle is advanced (106) and / or retracted (112) by manual means (e.g., a handle, a hand crank, etc.).

[0036] In some cases, it has been found that a thread diameter sufficiently smaller than the needle's inner diameter allows for easier movement through the needle. For example, when using 16RW hypodermic tubing (with an inner diameter of 0.047 inches (1.19 mm) and an outer diameter of 0.065 inches (1.65 mm)) as a needle, thread dimensions of 4-0 (0.15 mm diameter) or smaller provide good performance. In certain embodiments, 4-0 poly suture has been successfully used with helical needles formed from 16RW stainless steel hypodermic tubing. Other ratios of suture diameter to needle inner diameter may be acceptable and may depend on one or more factors, such as the suture material, needle material, needle helix parameters (helix diameter, helix angle), etc. Acceptable ratios of suture diameter to needle inner diameter may range from 1:6 to 1:10 and all values ​​therebetween. In some embodiments, the ratio may be even higher or lower than these exemplary values / ranges. In some embodiments, the ratio of the diameter of the suture to the inner diameter of the helical needle is greater than 1:8 (e.g., 1.81, 1.82, . . ., 1:9, 1.91, . . ., 1:10, etc.).

[0037] FIG. 9 illustrates another embodiment of an instrument 200 for automatic suturing. The instrument 200 includes a threaded shaft 230 for advancing the driver 224 when the driver 224 is rotated. The driver 224 is configured to move the needle 220 as described above. The clamp 212 is operable to secure tissue for suturing when the needle 220 is advanced over the clamp 212. The instrument 200 also includes a handle 250 configured to manipulate the clamp 212 using a rod 252. FIGS. 10A and 10B show detailed views of the driver 224 and the needle 220. This embodiment of the instrument 200 utilizes a two-piece driver 224 having a driver body 226 and a driver head 228. The driver body 226 is configured to rotate the driver head 228, but by design, advances the driver body at a different speed than the driver head. This allows for differences between helical and threaded (shaft) configurations.

[0038] FIG. 11 illustrates one embodiment of a driver head 328 and needle 320. The needle in this embodiment includes multiple windows 322 (openings) through the needle wall, allowing external access to the needle lumen. This allows the needle to be loaded with suture by inserting the thread from one window 322 to the next sequentially until the suture is loaded into the needle. In the embodiment shown in FIG. 11, the needle includes windows 322 every 90° of the helix (i.e., four windows per helix revolution). Other embodiments utilize fewer or more windows.

[0039] Yet another example Example 1. An instrument for automatic suturing, the instrument comprising: a shaft having a longitudinal axis and a joint rotatable about the joint axis at an angle >0° relative to the longitudinal axis; a clamp at a distal end of the shaft and configured to be positioned across a length of tissue to be sutured; a driver configured to engage threads on the shaft so as to translate along the length of the shaft when rotated; and a helical needle connected to the driver so as to be rotated while being advanced and retracted across the length of the clamp and past the joint on the shaft.

[0040] Example 2. The device of Example 1, wherein the tip of the helical needle is at a radially outer portion of the helical needle for movement across the joint of the shaft.

[0041] Example 3. The device of Example 1 or Example 2, further comprising a suture having a tip near the distal end of the helical needle.

[0042] Example 4. The device of Example 3, wherein the helical needle is hollow and the suture is placed through the helical needle.

[0043] Example 5. The device of example 3 or example 4, further comprising at least one cutter for severing the suture.

[0044] Example 6. The device of Example 3 or Example 4, wherein the suture has a diameter and the helical needle has an inner diameter, and the ratio of the diameter of the suture to the inner diameter of the helical needle is in the range of 1:6 to 1:10.

[0045] Example 7. The device of Example 6, wherein the ratio of the diameter of the suture to the inner diameter of the helical needle is greater than 1:8.

[0046] Example 8. The device of any one of Examples 1-7, further comprising a lock for reversibly locking the clamp in a closed position.

[0047] Example 9. The device of any one of Examples 1-8, wherein the helical needle is configured to be advanced over the outside of the clamp.

[0048] Example 10. The device of any one of Examples 1-9, further comprising a shaft attached to the clamp, wherein the helical needle is configured to be disposed on the shaft when in the retracted position.

[0049] Example 11. The apparatus of any one of Examples 1-10, further comprising a motor operatively connected to the driver.

[0050] Example 12. The device of any one of Examples 1-11, wherein the helical needle further comprises one or more windows.

[0051] Example 13. A method of automatic suturing, the method including: engaging a clamp of an instrument described in any one of Examples 1 to 12 over a first portion of tissue to be sutured; advancing a helical needle of the instrument along the length of the clamp, the helical needle having a distal end of a suture attached near the distal end of the helical needle, such that the helical needle penetrates the tissue to be sutured; capturing the distal end of the suture; retracting the helical needle back through the tissue to leave the suture in place; and releasing the clamp from the tissue.

[0052] Example 14. The method of Example 13, further comprising securing a leading end of the suture and / or a trailing end of the suture to form one or more sutures.

[0053] Example 15 The method of Example 14, wherein the leading end of the suture and / or the trailing end of the suture is secured by a knot.

[0054] Example 16. The method of any one of Examples 13-15, wherein the clamp is locked in place on the tissue.

[0055] Example 17. The method of any one of Examples 13-16, wherein the helical needle is advanced by a motor.

[0056] Example 18. The method of any one of Examples 13-17, wherein the helical needle is advanced in one rotational increment.

[0057] Although the present disclosure has been described in terms of one or more particular embodiments, it will be understood that other embodiments of the present disclosure may be made without departing from the spirit and scope of the present disclosure.

Claims

1. An automatic suturing device, a shaft having a longitudinal axis, the shaft having a joint that can rotate about a joint axis at an angle of >0° relative to the longitudinal axis, and a thread disposed along the longitudinal axis; a clamp at a distal end of the shaft configured to be placed across a length of tissue to be sutured; a driver configured to engage the threads on the shaft so as to translate along the length of the shaft when rotated; a helical needle connected to the driver so as to be rotated back and forth along the length of the clamp and past the joint of the shaft; The instrument, wherein the clamp is configured to be positionable at an angle >0° relative to the longitudinal axis.

2. The device of claim 1 , wherein the tip of the helical needle is at a radially outer portion of the helical needle for movement past the joint of the shaft.

3. The device of claim 1 further comprising a suture having a tip near the distal end of the helical needle.

4. The device of claim 3 , wherein the helical needle is hollow and the suture is disposed through the helical needle.

5. The device of claim 3 further comprising at least one cutter for severing the suture.

6. 4. The device of claim 3, wherein the suture has a diameter and the helical needle has an inner diameter, and the ratio of the suture diameter to the helical needle inner diameter is in the range of 1:6 to 1:

10.

7. 7. The device of claim 6, wherein the ratio of the diameter of the suture to the inner diameter of the helical needle is greater than 1:

8.

8. The instrument of claim 1 , further comprising a lock for reversibly locking the clamp in a closed position.

9. The device of claim 1 , wherein the helical needle is configured to be advanced over the outside of the clamp.

10. The device of claim 1 , further comprising a shaft attached to the clamp, the helical needle configured to be disposed on the shaft when in a retracted position.

11. The instrument of claim 1 , further comprising a motor operatively connected to the driver.

12. The device of claim 1 , wherein the helical needle further comprises one or more windows.

Images