WO2019009738A1

WO2019009738A1 - Suturing device

Info

Publication number: WO2019009738A1
Application number: PCT/NZ2018/050094
Authority: WO
Inventors: Adrian Chun Hoow NG; Gregory Brian O'grady; Khai Vern SIM; Scott Faulkner; Ben Catt; Edward Scholten; David White; John Windsor
Original assignee: Ng Adrian Chun Hoow; Ogrady Gregory Brian; Sim Khai Vern; Scott Faulkner; Ben Catt; Edward Scholten; David White; John Windsor
Priority date: 2017-07-07
Filing date: 2018-07-09
Publication date: 2019-01-10

Abstract

The present disclosure relates to a medical device, more particularly a suturing device, which manipulates a suturing needle during tissue closure in a surgery to improve the speed and precision of the surgery. The suturing device as disclosed comprises a needle driver capable of receiving an arc shaped needle with a length of suture attached thereto, the needle driver also capable of rotating the needle in a circular path, a triggering device attached to the needle driver, the triggering device actioned by a user's thumb and forefingers, that comprises: at least one elongate member for holding by the user and being connected to the needle driver, and a user activated member that captures the force from the user's thumb or forefingers and converts that force into a rotational movement, so as to rotate the needle.

Description

Suturing Device

Technical Field

The present disclosure relates to a medical device, more particularly a suturing device, which manipulates a suturing needle during tissue closure in a surgery. The suturing device improves speed and precision in surgery.

Background

The art of surgery can be tracked back thousands of years. This branch of medicine does not only require a physician to have extensive knowledge about the pathophysiology of disease, but also require high level hand-on skills and techniques. Precision, speed, and technique are major factors for surgical outcome.

One of the cornerstones of surgery is the formation of anastomosis (joining) between two tissues. Examples of anastomosis are: closure skin incisions, anastomosis of the great vessel in a heart transplant surgery, anastomosis of the cornea and the sclera in a corneal transplant surgery. The anastomosis of tissues is commonly done by using a suture that is attached to a curved needle. Common suturing techniques involve a surgeon picking up a needle at 2/3 of the distance from the sharp end of the needle using a grasping forceps with their dominant hand. The surgeon then uses their non-dominant hand to "pick-up" the tissue using another forceps, applying sufficient tension on the tissue to be joined for the penetration of the needle. Then, the needle is advanced in a circular motion to penetrate the tissue, commonly refer as taking a "bite". After sufficient length of the needle has passed through the tissue, the surgeon will release the needle from the grasping forceps and pick up the needle again from the opposite site of the tissue. The remaining length of the suture is then pulled through the tissue. Then the surgeon will need to re-orientate the needle on the grasping forceps in the way that is suitable for the next "bite". These steps are repeated until the desired length of sutures is achieved.

The precision of suture is very important in certain surgeries, such as transplant surgery, which involves the anastomosis of a blood vessel. Factors such as the distance between suture, the tension and the location to take the "bite" are very important for the surgical outcome. For instance, in a heart transplant surgery, slight flaws on the suture will result in a leaking aorta, which can be fatal. In addition, the speed of the surgery also plays an important factor in surgical outcome. Taking a heart transplant surgery again as an example, the viability of the donor heart is inversely proportional to the surgical time. In other words, the faster the heart get back its' blood supply, the less cellular injury due to hypoxia and hence better surgical outcome. In other settings, it has also been shown that shorter surgical time reduces the risk of infection and other injury due to prolonged anaesthesia.

Various suturing devices are known in the prior art. For example, EP 1300 116, US2014/0257345 and US 5454823 disclose double jaw suturing mechanisms. In EP 1300 116, a doubled edge curved needle with a suture attached to its belly is used. The needle is initially attached to one of the jaws of the suturing mechanism. Squeezing action of the hand will trigger the device to close the jaws and advance the needle to take a "bite" off the tissue. Then the second jaw will pick up the needle from the other side of the tissue. After that, the remaining length of suture is pulled through. The process is repeated for subsequent suture.

US2014/0257345 discloses a "forceps" like device with the tips of the forceps modified to drive a straight needle. The suture is attached to the belly of the straight needle. With pressure applied to the device, the needle is advanced to take a "bite". Then the second jaw of the modified forceps will pick up the suture from the opposite side of the tissue. The remaining length of suture is then pulled through. The tip of the "forceps" like devices is fixed at a lower angle in relative to the horizontal axis of the device.

In US 5454823, a curved needle is attached to a jaw. The needle is fixed and exposed on the surgical field. The closure motion of the second jaw pushes the tissue towards the needle, hence penetrating the tissue. Then the needle is picked up by the second jaw when both jaws is released. Then, the suture is pulled through the tissue by retracting the device.

EP 1300 116 and US 5454823 were designed primarily for laparoscopic or endoscopic surgery. The triggering mechanism of these devices are by applying crude forces applied by the hand, ie, the squeezing motion of the hand. This mechanism does not allow the surgeon to have fine control over the needle when the device is triggered. In addition, the slight movement by the wrist or arm will result in large deviation from desired penetration site to take the "bite". Therefore, these designs are not suitable for surgeries which require high precision. Although US2014/0257345 can speed up suturing and possibly improve accuracy, its design has some drawbacks. Firstly, the "suturing point" is fixed and cannot be manipulated. There will be difficulty in accessing the suturing site that is 180 degrees away from the surgeon's sight. In other words, the suturing of the posterior surface of the anastomosis or full circumference of the anastomosis is difficult. In addition, the design uses a straight needle where the suture is attached at the belly of the needle. This design is non-ideal, as each "bite" will cause additional tissue injury, as the size of the puncture must accommodate the diameter of the needle and the suture material. In addition, in the event that the suturing needs to be done manually, the small straight needle is difficult to manipulate by conventional suturing methods. EP 1300116 uses a curve needle with the suture material attached to its belly. Hence, it has the same drawback of causing unnecessary tissue injury.

US 6923819, US 5437681, US 5709693, US 5954733 and US 5308 353 disclose suturing devices that drive a curved needle in a circular motion. US 6923819 and US 5437681 disclose a needle driver that uses a curved needle with an arc of approximately 200 degrees. Multiple notches are created on the needle. A pawl that moves in an alternating semi-circular motion is used to drive the needle at its notches. The triggering mechanism features a "scissor like" and "pistol like" structure respectively. Pressure applied by the hand will trigger the needle driver.

US 5954733 discloses a device that has a needle driver and needle catcher mechanism. The needle driver advances a curved needle in a circular motion to penetrate tissue. Then the needle is released from the driver and picked up by the needle catcher. Subsequently, the needle catcher then acts as a needle driver for the subsequent stich. The triggering mechanism features a "pistol" like design and is triggered by the rotation of multiple screws attached to it.

US 5308 353 discloses a device that drives a curved needle in a circular motion using a belt system. The external surface of the needle is barbed and is in contact with a belt that drives the needle in a circular motion. The triggering mechanism is powered by a motor. With the turning of the belt, the needle is pushed in a circular motion.

The triggering mechanism of US 6923819, US 5437681, US 5709693 and US 5954733 is by application of crude force by the hand. These designs do not allow the surgeon to have a fine control over the needle during tissue penetration. The design in US 5308353, which is powered by a motor, also shares the same drawback.

The long shaft structure of the devices featured in US 6923819, US 5437681, US 5709693, US 5954733 and US 5308 353 have the drawback of reduced precision. Slight movement by the hand or the arm of the surgeon will result in a large deviation from the desired "biting" location. In fact, the long shaft design is primarily for laparoscopic or endoscopic surgery and is not suitable for surgeries which require high precision.

In US 5954733, after the second stich and every subsequent stitch, the needle catcher will be grasping near the sharp end of the needle. This configuration made the next stich impossible and re-orientation of the needle is required. The repetitive manipulation of the needle risk needle stick injury and prolong time of surgery.

In US 5308353 a barbed needle is used to enhance the grip of belt onto the needle. The barbed needle will cause unnecessary tissue injury, which is not ideal in any kind of surgery.

The designs of US 6923819, US 5437681, US 5709693, US 5954733 and US 5308353 are made up of multiple small parts. This makes the production of these designs costly and not economical. In addition, this also make these design less reliable.

Statements of Invention

In first embodiment the present invention consists in a suturing device comprising:

a needle driver capable of receiving an arc shaped needle with a length of suture attached thereto, the needle driver also capable of rotating the needle in a circular path,

a triggering device attached to the needle driver, the triggering device actioned by a user's thumb and forefingers, that comprises:

a) at least one elongate member for holding by the user and being connected to the needle driver, and

b) a user activated member that captures the force from the user's thumb or forefingers and converts that force into a rotational movement, so as to rotate the needle.

Preferably the connection between the at least one elongate member and the needle driver is a pivoting connection.

Preferably the pivoting connection enables the needle driver to at least be aligned to the elongate member at any one of or all of 0 degrees, 45 degrees and 90 degrees. Preferably the at least one elongate member two forceps like arms.

Preferably in use, the forceps like arms are pinched together by a user's thumb and forefingers, so as to activate the user activated member,

Preferably the user activated member is a rack and pinion, operatively connected to the arms and the needle driver.

Alternatively the at least one elongate member is a handle connected to the needle driver.

Preferably the user activated member is operatively connected to the handle.

Preferably the user activated member is a rotatable dial operatively connected to a gearing mechanism, which is operatively connected to the needle driver and causes the needle to move in a forward and backward movement through the needle driver.

Preferably the gearing mechanism is a belt and plurality of rods, where when the user activated member is actioned a cog causes the belt to move through a plurality of rods, the belt connected to the needle, thereby moving it within the needle recess.

Preferably the rack and pinion is connected to a set of arms within the needle driver, such that upon application of the force to the rack and pinion a gearing system causes the arms to move the needle within the needle recess.

Preferably the arms engage and disengage the needle in a guided manner.

Preferably the needle advancement is a moment to moment control and movement by the fingers and thumb of the user, so as to provide high precision movement of the needle in use.

In another embodiment the present invention consists in a suturing device comprising:

a needle driver including a circular recess for receiving an arc sharped needle with a length of suture attached thereto and an aperture, the needle driver capable of rotating the needle in the circular recess and past an aperture, the needle in use puncturing tissue place near or at the aperture, a triggering device operatively connected to the needle driver, which is actioned by a user's thumb and forefingers, which comprises:

a) at least one elongate member for holding by the user that is operatively connected to the needle driver,

b) a user activated member that captures the force from the user's thumb or forefingers and converts that force into a rotational movement, so as to cause the needle driver rotate the needle.

Preferably the user activated member is operatively connected to the handle.

Preferably the arms engage and disengage the needle in a guided manner.

A method of suturing a tissue with a series of interrupted or continuous stitching comprising the steps of:

a. placing the suturing device of claim 1 or 2 near the tissue to be sutured, b. activating the suturing device to thereby advance the needle to pierce the tissue, c. pull the suturing device away from the tissue allowing the suture to pull be pulled through the tissue making a stitch,

d. repeating steps a to c until the tissue suture is completed.

The disclosed subject matter also provides a method or system that may broadly be said to consist in the parts, elements and features referred to or indicated in this specification, individually or collectively, in any or all-combinations of two or more of those parts, elements or features. Where specific integers are mentioned in this specification that have known equivalents in the art to which the invention relates, such known equivalents are deemed to be incorporated in the specification. Further aspects of the invention, which should be considered in all its novel aspects, will become apparent from the following description.

Brief Description of Drawings

A number of embodiments of the invention will now be described by way of example with reference to the drawings as follows.

Figure la shows the front view of the needle driver unit of a first embodiment of the suturing device of the present invention.

Figures lb to le show the motion of a needle being driven over 360 degrees through the needle driver unit by a belt.

Figure 2 shows the diagonal cross-sectional area of the needle driver unit of Figure la.

Figure 3 shows the vertical cross-sectional view of the needle driver unit of Figure la.

Figure 4 shows the rear view of the needle driver unit of Figure la.

Figure 5 shows a perspective view of the first embodiment of the suturing device of the present invention.

Figure 6 shows the pictorial view of a second embodiment of the suturing device of the present invention, where a needle driving unit includes is a set of arms connected to a forceps like structure. Figure 7 shows the posterior view of the suturing device of Figure 6.

Figure 8 shows the needle driving unit of the suturing device of Figure 6.

Figures 8a to 8d show the progressive motion of the needle being driven over 360 degrees through the needle driving unit of Figure 6.

Figure 9 and 10 show a close up of the needle driving unit of Figure 6 with arms that cause the needle to move through the driving unit.

Figure 11 shows the detailed interaction between the needle and the arms of the needle driving unit of Figure 6.

Figures 12 and 13 show views of the needle driver unit of Figure 6 interacting with the forceps arms, where a linear motion (from the forceps like structure) is converted into a circular motion.

Figures 14a to 14c show how the angle between the forceps arms and needle driver unit can be altered, at 90, 45 and 0 degrees respectively.

Figure 15 shows the pictorial view of a third embodiment of the suturing device of the present invention, the suturing device comprising a needle driver unit, a handle and the interacting mechanism or gears between the needle driver unit and handle.

Figure 16 shows the posterior view of the suturing device of Figure 15. Figure 17 shows the needle driver in relation to a user activated mechanism, where that mechanism is a roller or dial.

Figure 18a and 18b show a detailed view of the suturing device of Figure 15 and in particular the mechanism that converts a rolling motion (or a stroke) by a finger of a user into rotational motion, that causes the driving of a needle.

Figure 19a to 19c show how the angle between the forceps arms and needle driver unit can be altered, at 90, 45 and 0 degrees respectively.

Detailed Description

The present invention is a suturing device with a needle driver attached to a forceps "like" structure. This device emulates a manual suturing action carried out by a surgeon, but with improved speed and preserved precision. The suturing device can be used by surgeon to produce an interrupted or continuous stitching in all kind of tissues, including but not limited to subcuticular, skin, muscle, vascular and subcutaneous.

During manual suturing, the surgeon has to re-orientate the sharp end of the needle repetitively by using a grasping forceps and a normal forceps. During this period, the surgeon needs to focus their visual field away from the surgical site and onto the needle to re-orientate it. This action can sometimes be made more complicated by use of surgical binoculars, as the focus point of the binoculars is fixed. In addition, these actions are time consuming especially in a surgery that requires large numbers of anastomosis.

The suturing device of the present invention will now be described with reference to the figures. A first embodiment of the suturing device of the present invention is shown in Figures 1 to 5. A forceps like structure 18 is attached to a needle driver l. The needle driver 1 has a circular shaped housing 26 and has a circumference approximate to the circumference of the arc of a curved needle 6. The needle 6 sits in use within a casing which is a curved recess 27 on located proximal to the outer circumference of housing 26, the driver 1 is able to push and pull the curved needle 6 in a 360-degree rotation through the curved recess 27.

The needle driver 1 has an aperture 25 that allows the driver 1 to be positioning at the tissue to be sutured. The aperture 25 is a wedge shaped portion removed from the circular driver. In use, when the needle driver 1 is triggered, the needle 6 is driven around the circular recess 27 out an outlet hole 23 on the housing, across the aperture 25, through the tissue to be sutured (not shown), and back into an inlet hole 24 on the housing. The suture material 9 that attaches to the tail of the needle 6 will remain outside of the needle driver 1 during this process.

The driving mechanism itself is a cog and belt system that is attached to the forceps arms 18 (see Figures 4 and 5). One of the arms is fixed (by appropriate fixing mechanisms, for example, glue or welding or the like) to the needle driver housing 26 at point 19 in Figure 4. The other arm is attached to a rod such that when a user (using their fingers 20, 21) pinches the arms 18 together this movement is transformed into a rotational movement of a central cog (or belt driver) 5, driving the belt 2, which is turn drives the needle 6 through the housing 26.

The needle is "sandwiched" between the needle driver housing 26 and belt 2. The turning of gear 5 will pull on belt 2. In turn, belt 2 will drive the needle 6 in a circular motion, by the frictional force between the needle 6 and the belt 2. The friction between the belt 2 and needle 6 can be increased by but not limited to using a toothed belt, adding a notch on the needle, and using a material that has high friction. The position of the belt 2 is guided by cylinders 3, 4 to ensure a tight contact between the belt 2 and the needle 6. In preferred forms of the present invention, the belt 2 has a tooth like structure on its outer surface to provide additional grip to the central cog 5 and onto needle 6. For additional grip on the needle 6, the tooth like structure of the belt 2 similarly preferably protrudes into notches 7, 8 optionally located at the either ends of the inner surface of the needle 6. Hence, when the belt 2 moves, the any one of the teeth on the belt drive catch with the notches 7,8 of the needle to cause the needle to move through the housing 26 and particularly through the recess 27. The sharp end of the needle 6 will exit the needle casing at 23 and penetrate the tissue exposed in the aperture 25. After penetrating the tissue, the sharp end of the needle will re-enter the needle casing at 24. Shortly after that, the sharp end of the needle will re-gain contact with the belt 2. This will pull the remainder of the needle 6 and suture 9 through the tissue. The tooth of the belt will again protrude into notch 7 and increase the grip of the belt 2 on the needle. The belt 2 is held into position by the cylindrical belt stabilisers 3, 4. Additional support is provided by rods 5, located in between cylinders 3, 4. Figure 2 shows the diagonal cross section of the needle driver 1. The circular space 22 is the housing casing for the needle. This view shows that the tooth of the belt 2 is in contact with needle 6 in the upper part needle casing 22. Figure 3 shows the vertical cross-section of the needle driver unit 1. The rotational force of the belt driver 5 is driven by gear 11 and crank shaft 13.

Figure 4 shows the rear view of the needle driver 1. This view provides a clearer picture of the crank mechanism that converts the motion of forceps arms 18 to rotational motion of belt driver 5. The arc motion is generated by the index finger 21. This motion is converted in to an oscillating motion on crank shaft 13. The connection between the forceps 18 and crank shaft 13 is made at the rod 15. Rod 15 is attached permanently onto the tip of forceps 18. However, rod 15 can move freely in the groove of crank shaft 13 and groove 17. Groove 17 is created to stabilise the unit during motion. When the index finger 21 pinches the forceps, the rod 15 will push the crank shaft 13 in one direction. Similarly, the release of the forceps 18 will move the crank shaft 13 in the opposite direction. These^* repetitive motions will generate an oscillating motion on the crank shaft 13.

The crank shaft 13 is anchored at point 14 and is in contact with gear 11 by way of rod 12. Rod 12 is attached permanently onto the gear 11. However, the rod 12 is free to move in the second groove of crank 13. During the oscillation of the crank shaft 13, the rod 12 will be pushed into a circular motion. Hence this will generate a circular motion in gear 11, which in turn rotates the belt driver 5.

When a user's finger 21 exerts its first pinch to the forceps arms, rotation is generated at belt driver 5 which in turn drive the needle driver belt 2 and then the needle 6. With the release of the first pinch, the rotation is further generate at belt driver 5 to pull the needle 6, further along its arc. With subsequent pinching and release the needle 6 can travelled 360 degrees along its arc within the recess 27 and hence return to its original position and ready for another bite.

The following describes the process of using this suturing device in a surgery. However, this use is merely one example of a use and other uses outside of surgery are envisaged. Similarly, a surgeon is merely one of the many possible users of the suturing device of the present invention.

Firstly, a surgeon will identify the point to take a "bite" of the tissue to be sutured. After that, they will move the device and align the needle point at the "needle outlet" 23 of the device. The surgeon will then cause the forceps arms 18 to be moved together in a pinch like movement -termed the "first pinch" of the device. The needle is moved in a circular motion through the needle driver housing, approximately 180 degrees along the full arc through the housing. This will cause the needle to penetrate the tissue exposed in the aperture 25, making a first stitch or suture. After penetrating the tissue, the sharp end of the needle will enter the needle inlet 24. The surgeon will pull the remaining length of the suture through the tissue by moving the device away from the tissue. Then the surgeon will pinch and release the device to drive the needle for another 180 degrees to reload the needle. At this point, the device is ready for the second stitch. A second embodiment of the suturing device of the present invention will now be described with reference to Figures 6 to 14.

The suturing device 100 of the second embodiment of the present invention has a needle driver unit similar to that of the first embodiment, however, the driving (or triggering) mechanism within the unit is different. The needle driving unit 102 is attached to a forceps like structure 118, preferably having two arms 123, 124. One of the arms 123 is moveable in relation to the other arm, and the other arm 124 is fixed to the needle driving unit 102. Note, the different type of driving (or triggering) mechanisms described herein, for any of the three embodiment described, offer certain features which are advantageous for particular types of stitching.

As with the first embodiment of the suturing device, a user or surgeon will hold the suturing device using their fingers, similar to how a normal forceps (or tweezer) is held. In use, the user's index finger will be positioned at the movable arm 123 while the middle finger and the thumb will be positioned at the fixed arm 124. The device is triggered when the user pinches the movable arm 123 against the fixed arm 124. During each pinch, the needle driver unit 102 will drive a needle 104 around its arc by 180 degrees. Hence, two pinches are required to drive the needle 104 over the whole 360 degrees through the needle driver unit as shown in Figures 8a to 8d.

In use, a surgeon will visually identify a location for the needle penetration. Then they will advance the suturing device 100 by aligning the needle outlet 131 or the sharp tip of needle 104 to the penetration site. One pinch on the forceps 118 will move the needle over 180 degrees. This will cause the curved needle 104 to penetrate the tissue and re-enter into the needle driver unit 102 via needle inlet 132. Then the user will pull the rest of the suture 113 through the tissue. The second pinch and release will drive the needle to complete another 180 degrees and return to its original position. Figure 8 and Figures 8a to 8d show the needle 104 being driven by two arms 109. The needle is "sandwiched" between the needle driver housing 110 and arms 109. The turning of an arms holder 117 will turn the arms 109 in a circular motion. In turn, the arms 109 will drive the needle 104 in a circular motion.

Figure 11 shows the detailed interaction between the arms 109 and needle 104. Here, a suture 113 is shown attached to the tail of the needle 104. Each arm has at its distal end a membrane 116 and a pin 115 attached to the distal end 114. Each end 114 also has a moveable plunger 120. The plunger is biased to push the distal end out from the central region. The membrane 116 has the purpose of increasing the friction between the arm 109 and the needle 104. The pin 115 on each arm is fitted precisely into a groove that is preferably formed between the tail of the needle 104 and the beginning of the suture 113. This interaction provides a positive engagement between the arm 109 and needle 104. Both the positive engagement generated by the pin 115 and friction generated by the membrane 116 drive the needle in a forward direction. The membrane 116 will drive the needle 104 in a backward direction when or if the device is triggered in the opposite direction.

Figures 8, 9 and 10 show the guide mechanisms that move the arms 109 in and out to engage and disengage the needle 104. A groove 111 carved on the needle driver housing 110 and a pin 112 extends from beneath of arms 109. The pins 112 fit in use into the groove 111. The groove 111 is carved in a curved shape that it guides the arms 109 to move in and out as shown by Fig 8a to 8d.

The needing driving unit and mechanism of the first and second embodiments allows a "moment to moment" control of the needle in both forward and back ward direction by a user's (usually a surgeon) fingers. All of the prior art as described herein only allow a single directional needle drive and once triggered, there is no return mechanism. The "moment to moment" control of the suturing device of the present invention allows for fine and precise positioning of the needle and hence increases the precision of stitching which is paramount in all types of stitching. Figures 10 and 11 show the mechanism within the needle driving unit that converts a linear motion into a rotational motion. As already described, arm 124 is attached and fixed onto needle driver unit 102, preferably by any appropriate fastener or fastening means. The arm 123 moves linearly when the arms are pinched or compressed by the fingers. A toothed rack 119 is attached to arm 123 and is stabilised by and can move along rods 122. Rack 119 converts the linear force generated when the arms move in relation to one another, into a rotational force on the gear 130. The gear 130 is part of a sprag clutch 121. The sprag clutch 121 will engage and turn the arms 109 in a forward direction when the forceps arms are being compressed. When the forceps are released, (ie. the gear 130 is being turned in an opposite direction), the sprag clutch 121 allows "free-wheeling" and results in no motion on arms 109. In other words, the sprag clutch 121 acts as a one-way gear in the system.

A third embodiment of the suturing device of the present invention will now be described with reference to Figures 15 to 19. Figures 15 and 16 shows a needle driver unit 131 of the third embodiment attached to an elongate handle 125. A user or surgeon can hold this embodiment of the suturing device using their finger just like holding a pencil. The index finger will preferably be positioned in use at a roller (or dial) mechanism 126. The needle driver device 202 is triggered when the user/surgeon strokes the roller 126 backward. During each stroke, the needle driver unit 202 will drive the needle approximately around 90 degrees about its arc. Hence, four strokes are required to drive the needle 204360 degrees around the needle driver.

An additional feature of this configuration is that the needle 204 can preferably turn in the opposite direction when a surgeon strokes the roller 126 in the opposite direction. This feature allows the user/surgeon to retract the needle from the tissue when they find that the location of tissue penetration is not perfect.

In this third embodiment the user/surgeon will visually identify a location for the needle to penetrate. Then they will move the suturing device by aligning the needle outlet 231 or the sharp tip of needle 204 to the penetration site. One stroke on the roller 126 will turn the needle 90 degrees. This will cause the curved needle 204 to penetrate the tissue and re-enter the needle driver via needle inlet 232 (after two strokes). Then the user/surgeon. will pull the rest of the suture (attached to the needle as described previously) through the tissue. The third and fourth strokes will drive the needle to complete another 180 degrees and return to its original position.

Figures 17, 18a and 18b illustrate the mechanism that converts the force generated by a finger stroke (as described above) into a force that drives the needle. The gears 127, 129 and belt 128 transfer the force generated by the user's finger on roller 126 to gear 230. In turn, gear 230 is responsible for rotation of arms 209 which drive the needle. A stroke in the opposite direction (pushing direction) of the roller 126 will result in the needle moving in the opposite direction. This feature will allow more intricate control over the needle 204 in both forward and backward motion.

The gears 127, 129 and belt 128 are necessary to enable a pivoting of the angle between needle driver unit 202 and handle 125 as shown in Fig. 19a to 19c (this is similarto that pivoting of the needle driver unit and arms as described above in relation to the first and second embodiments of the suturing device of the present invention).

The needle driving/triggering mechanism in this third embodiment minimises crude motion during suturing and will thus improve precision of the suture. This configuration is suitable but not limited to vascular suturing.

The first and second embodiments of the suturing device are suitable, but not limited to, skin stitching where a higher force on the needle is required. The third embodiment of the suturing device as shown in Figure 15 is suitable, but not limited to, vascular stitching where the access to the stitching site is small and requires less movement of the stitching device.

All configurations allow a flexible angle between the motion of the needle and the axis of the handle or arms, as the needle driver unit can be pivoted in relation to the arms or handle. The flexibility of the angle is shown in Figures 14a to 14c and Figures 19a to 19c. Additionally, this pivoting feature increases the accessibility of the device and can improve the visual field of the surgeon toward the stitching site.

The suturing device of the present invention has several advantages over the prior art. This invention will eliminate the need to re-orientate the needle after each stitch hence improving the speed of suturing. In addition to speed, this invention will also allow the visual field of the surgeon to maintain at the suturing site. With this, the surgeon can access the quality of the stich that it has just been made, and also to make visual plan on where to take the second, third and even fourth "bite". The fingers are parts of our body that can carry out the most intricate movement. Our finger pulp also contains large amounts of touch and pressure receptors which enable us to have fine control over the pressure exert by our finger. The present invention is mainly controlled by fingers and as such allows for higher precision during suturing than both the prior art described and manual suturing. In particular, the driving or triggering mechanism of the first two embodiments is mainly controlled by the index finger of the user. The thumb and middle finger will act as the anchor to stabilise the suturing device. When a surgeon depresses the forceps arms this will manoeuvre the needle to take a "bite". During this process, the surgeon will have fine control over the speed of the needle advancement and the feel of the needle meeting resistant over the tissue. The fine coordination of the thumb, index and middle finger allows the surgeon to have intricate control over the needle and the device. In comparison to manual suturing, the circular motion of the needle is driven mainly by the wrist, where the motion is more crude and rough compared to the near perfect circular motion provided by this invention. This will result in less tissue injury. The control of the needle using the present invention is also superior compared to the prior art which feature, electrical motor, "pistol" like structures or "scissor" like structure triggering mechanisms.

Another feature of this invention that can improve precision and safety is the option of exposing or hiding the needle before triggering. The benefits of exposing the needle is to allow surgeon to identify the exact position that that needle is going to take its "bite". This can be done easily by loading the needle with the desired exposure or partially trigger the device to expose the needle at the needle outlet.

On a contrary, this device can also be use with the needle hidden in the device. The benefits of this feature are to prevent needle stick injury and to prevent accidental penetration of undesired tissue. This is relevant especially in a bowel surgery where accidental penetration of tissue will lead to bowel leakage.

Another advantage of the present invention is the usage of conventional curved suturing needles with no modification to the needles required. Hence, in the event where manual suturing technique is required, in for example a surgery, the needle can be easily removed from the device and suture can be continued using a manual technique.

Finally, the present invention has a relatively simple design and is made up of only a hand full of mechanical parts, making the device cost effective and reliable.

Unless the context clearly requires otherwise, throughout the description, the words "comprise", "comprising", and the like, are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense, that is to say, in the sense of "including, but not limited to". Although this invention has been described by way of example and with reference to possible embodiments thereof, it is to be understood that modifications or improvements may be made thereto without departing from the scope of the invention. The invention may also be said broadly to consist in the parts, elements and features referred to or indicated in the specification of the application, individually or collectively, in any or all combinations of two or more of said parts, elements or features. Furthermore, where reference has been made to specific components or integers of the invention having known equivalents, then such equivalents are herein incorporated as if individually set forth. Any discussion of the prior art throughout the specification should in no way be considered as an admission that such prior art is widely known or forms part of common general knowledge in the field.

Claims

Claims:

1. A suturing device comprising:

2. A suturing device comprising:

3. A suturing device of claim 1 or 2 wherein the connection between the at least one elongate member and the needle driver is a pivoting connection.

4. A suturing device of claim 3 wherein the pivoting connection enables the needle driver to at least be aligned to the elongate member at any one of or all of 0 degrees, 45 degrees and 90 degrees.

5. A suturing device of any one of claims 1 to 4 wherein the at least one elongate member two forceps like arms.

6. A suturing device of claim 5 where in use, the forceps like arms are pinched together by a user's thumb and forefingers, so as to activate the user activated member and move the needle.

7. A suturing device of any one of claims 1 to 6 wherein the user activated member is a rack and pinion, operatively connected to the arms and the needle driver.

8. A suturing device of claim 7 wherein the rack and pinion is connected to a set of arms within the needle driver, such that upon application of the force to the rack and pinion a gearing system causes the arms to move the needle within the needle recess.

9. A suturing device of claim 7 or 8 wherein the arms engage and disengage the needle in a guided manner.

10. A suturing device of any of claims 1 to 3 wherein the at least one elongate member is a handle connected to the needle driver.

11. A suturing device of claim 8 wherein the user activated member is operatively connected to the handle.

12. A suturing device of claim 1 to 6 wherein the user activated member is a rotatable dial operatively connected to a gearing mechanism, which is operatively connected to the needle driver and causes the needle to move in a forward and backward movement through the needle driver.

13. A suturing device of claim 12 wherein the gearing mechanism is a belt and plurality of rods, where when the user activated member is actioned, a cog causes the belt to move through a plurality of rods, the belt connecting to the needle, thereby moving it within the needle recess.

14. A suturing device of any one of claims 1 to 13 wherein the needle advancement is a moment to moment control and movement by the fingers and thumb of the user, so as to provide high precision movement of the needle in use.

15. A method of suturing a tissue with a series of interrupted or continuous stitching comprising the steps of: a. placing the suturing device of claim 1 or 2 near the tissue to be sutured, b. activating the suturing device to thereby advance the needle to pierce the tissue, c. pull the suturing device away from the tissue allowing the suture to pull be pulled through the tissue making a stitch,

d. repeating steps a to c until the tissue suture is completed.

16. A suturing device as herein described with reference to the accompanying figures.

17. A method of suturing as herein described with reference to the accompanying figures.