Suturing device

Abstract

The present disclosure relates to a suturing device comprising: a first jaw element comprising a first needle locking device for holding and releasing a first end of a double ended needle; a second jaw element comprising a second needle locking device for holding and releasing a second end of the double ended needle, wherein the first jaw element and the second jaw element are movable relative to each other between an open position and a closed position; a needle transfer mechanism for alternatingly transferring the double ended needle from one of the jaw elements to the other when the first jaw and the second jaw are moved from the open position to the closed position, the needle transfer mechanism comprising: a first rotatable wheel connected to the first needle locking device; and a second rotatable wheel connected to the second needle locking device.

Description

[0001] This application is a divisional application of PCT International Patent Application No. 201980034906.6, filed May 23, 2019, entitled “SUTURING DEVICE”. TECHNICAL FIELD

[0002] The present invention relates to an improved suturing device, in particular to an automated or semi-automated disposable suturing device. Preferably, the device is a one-handed suturing device. BACKGROUND

[0003] Abdominal surgery requires access that can be achieved by open surgery or minimally invasive techniques. Open surgery is very common, with approximately 2 million procedures performed in the United States each year. After surgery, the abdominal wall must be closed. Experimental and clinical data can provide reliable information about the surgical techniques required to minimize postoperative abdominal wall complications. If a continuous suturing technique is used, and the length of the thread is four times the length of the incision, wound infection and incisional hernia are reduced. The knots should be small and placed closely. The suturing process is tedious and time consuming and difficult to achieve after a long and arduous surgical procedure. Operating room time is precious, and time savings can provide care for more patients. In addition, abdominal closure is the most common reason for needle injuries during surgery.

[0004] Existing suturing instruments have many drawbacks and inconveniences. They are often difficult to use, do not guarantee patient safety, lack precision and are often mechanically complex. Therefore, it is desirable to provide an instrument that will help the surgeon adhere to the correct abdominal closure method and reduce the time required to perform suturing. Preferably, such an instrument should also reduce the risk of needle sticks, simplify suturing placement and be mechanically simple and robust. SUMMARY

[0005] The present disclosure relates to an improved suturing device having a needle conveyor with built-in double-ended needles. The suturing device can be a one-handed device, wherein the conveyance of the needle between the jaws is preferably automatic, as the mechanism for opening / closing the jaws also controls or is mechanically synchronized with the conveyance of the needle, preferably without the need for additional switches for controlling the needle conveyance.

[0006] In a first embodiment, the suturing device comprises:

[0007] - a first jaw element comprising a first needle locking device for holding and releasing a first end of a double-ended needle;

[0008] - a second jaw element comprising a second needle locking device for holding and releasing a second end of a double-ended needle, - a needle conveyor comprising a first needle conveyor element and a second needle conveyor element, wherein the first needle conveyor element is arranged to convey the first end of the double-ended needle and the second needle conveyor element is arranged to convey the second end of the double-ended needle,

[0009] wherein the first and second jaw elements are movable relative to each other between an open position and a closed position;

[0010] - a needle transfer mechanism for transferring the double-ended needle from one of the jaw elements to the other alternately when the first and second jaws are moved from the open position to the closed position, said needle transfer mechanism comprising:

[0011] o a first rotatable wheel connected to the first needle locking device, said first rotatable wheel comprising a first wheel inner portion rigidly connected to a first wheel outer portion; and

[0012] o a second rotatable wheel connected to the second needle locking device, said second rotatable wheel comprising a second wheel inner portion rigidly connected to a second wheel outer portion,

[0013] wherein, when the first jaw element and the second jaw element are moved relative to each other from the open position to the closed position, a first force is propagated from the first jaw element to the second rotatable wheel, and wherein a second force is propagated from the second jaw element to the first rotatable wheel, thereby rotating the first and second rotatable wheels, wherein the rotation of the first and second rotatable wheels causes one of the needle locking devices to lock the double-ended needle while the other needle locking device releases the double-ended needle. The needle transfer mechanism can thereby be arranged such that a difference in rotation and / or a difference in rotation period (e.g. shift / offset) between the first rotatable wheel and the second rotatable wheel provides the transfer mechanism.

[0014] The suturing device with built-in needle transfer of the present disclosure provides a precise and robust design of a suturing device for improved, especially faster and more precise, surgical suturing, wherein the user can repeatedly push the jaws together with one hand to transfer the double-ended needle back and forth between the jaws. The process of releasing the needle from one jaw and locking the needle in the other jaw when the jaws are closed can be achieved by a sequence mechanism inside the tool. In a first embodiment, two wheels are turned in opposite directions when the jaws are closed, which allows alternately opening and closing the needle holding elements, such that the needle moves back and forth between the first jaw and the second jaw when the jaws are repeatedly opened and closed. In a second and alternative embodiment, the two wheels can be arranged oppositely to rotate in the same direction. However, if each wheel has an outer profile that engages with the needle locking device and controls the position of the needle locking elements in the axial direction of the corresponding jaw, a shift in the outer profile between the wheels can provide a mechanism for transferring the double-ended needle from one of the jaw elements to the other jaw element when the first and second jaws are moved from the open position to the closed position.

[0015] Preferably, the needle transfer mechanism is arranged to operate in a coordinated sequence of steps triggered by the angle between the jaws, which changes during the closing process. For example, two wheel drive mechanisms in the form of drive shafts can be engaged with the jaws and the wheels, such that during the closing process, when the angle between the jaws is less than a threshold angle, the wheels start to turn. Below this threshold, as the wheels start to turn as the jaws close, the outer profile of the wheels can define further steps, where each step can correspond to the configuration of the first and second needle locking devices. In one embodiment, each needle locking device comprises a wheel engagement element that moves axially back / forward with the jaws to hold / release the needle as the wheels rotate. This mechanism is further explained by way of example in the detailed description of the invention below.

[0016] The two wheels can be shaped such that the process of transferring a needle from the first jaw to the second jaw is the same as when transferring a needle from the second jaw to the first jaw. This allows the user to operate the suturing device by pushing the two jaws together to transfer a needle from the first jaw to the second jaw, then opening the jaws relying on the force of the jaws' opening spring, then pushing the jaws together again to transfer the needle from the second jaw to the first jaw, and so on. Thus, the needle transfer mechanism can be automatic in the sense that there is no additional switch to control the transfer of the needle. BRIEF DESCRIPTION OF DRAWINGS

[0017] Figure 1 Embodiments of the suturing device of the present disclosure are shown, with a built-in needle transfer for double-ended needles, where two rotatable wheels are arranged to rotate in opposite directions to control the holding and release of two needle locking devices.

[0018] Figure 2 A perspective view of the suturing device of Figure 1 is shown.

[0019] Figure 3 Embodiments of the holding and release of one end of a needle are shown.

[0020] Figure 4 Embodiments of one of the rotatable wheels, with an inner part and an outer part, are shown, where at least the inner part has an outer profile with cam elements and engages with the needle locking device to control the position of the needle locking elements.

[0021] Figure 5A An example of a sequence of steps of the jaw closing process is shown, where each step corresponds to an angle between the jaw elements, explaining the sequence of the mechanism for transferring a double-ended needle from one jaw to the other.

[0022] Figure 6 Embodiments of a needle holding element are shown, with an opening for receiving and locking a needle and a needle pusher element.

[0023] Figure 7 Another embodiment of the stapling device of the present disclosure is shown with a built-in needle conveyor with a double-ended needle, wherein the two rotatable wheels are arranged to rotate in the same direction and the outer contours of the wheels are displaced relative to each other.

[0024] Figure 8 An embodiment of two jaw elements with two wheel engaging elements is shown.

[0025] Figure 9 Two rotatable wheels are shown arranged to rotate in the same direction, wherein the outer contours are displaced relative to each other and a common drive wheel connected to both rotating wheels. DETAILED DESCRIPTION

[0026] The invention relates to a suturing device with a needle passer having a double-ended needle, the suturing device comprising: a first jaw element comprising a first needle locking device for holding and releasing a first end of the double-ended needle; a second jaw element comprising a second needle locking device for holding and releasing a second end of the double-ended needle, wherein the first jaw element and the second jaw element are movable relative to each other between an open position and a closed position; and a needle passing mechanism for alternatingly passing the double-ended needle from one of the jaw elements to the other when the first jaw and the second jaw are moved from the open position to the closed position. More precisely, the double-ended needle is alternatingly passed from one needle locking device to the other needle locking device. The suturing device can be a suturing device for closing an abdomen. Typically, the jaw elements are pivotable relative to each other about a common pivot joint. Preferably, the needle passing mechanism comprises: a first rotatable wheel connected to the first needle locking device; and a second rotatable wheel connected to the second needle locking device. The first and second rotatable wheels can be arranged such that a rotational difference and / or displacement or offset between the first and second rotatable wheels causes one of the needle locking devices to lock the double-ended needle while the other needle locking device releases the double-ended needle when the first and second jaw elements are moved relative to each other from the open position to the closed position. In one embodiment, the first and second rotatable wheels are arranged to rotate simultaneously and / or synchronously, preferably at the same rotational speed, in order to provide a synchronized and / or coordinated release and holding of the two needle locking devices. The rotatable wheel based solution allows the user to pass the needle from one jaw to the other with one motion, for example by directly pushing the jaws together, or by pushing the two handles together, thereby pushing the jaws together. If the user then releases the jaws or handles, a spring coil or other solution providing the same functionality can force the jaws back to the open position. This mechanism can be provided by a jaw opening spring arranged between the first jaw element and the second jaw element. If the user then pushes the jaws together again, the needle passing mechanism can pass the double-ended needle from the second jaw back to the first jaw. This means that the user can repeatedly push the jaws together and then let the spring coil move them back to the open position in order to perform the suturing process.

[0027] In particular, the automatic or semi-automatic mechanism can allow for single-handed use. The device is robust, efficient and simple in construction. The mechanism is therefore suitable for a suturing device that can be used and then discarded.

[0028] A first embodiment of the suturing device of the present disclosure comprises two rotatable wheels, wherein the first and second rotatable wheels are arranged to rotate in opposite directions when the first and second jaw elements are moved relative to each other from an open position to a closed position, thereby causing one of the needle locking devices to lock the double ended needle while the other needle locking device releases the double ended needle. The rotation of the two rotatable wheels can be driven by a shaft connected to the jaw elements. When the jaw elements are closed towards each other, the shaft can push the wheels to rotate. The outer profiles of the wheels can thereby cause the needle locking devices to alternately lock and release the double ended needle.

[0029] A second embodiment of the suturing device of the present disclosure comprises two rotatable wheels, wherein the first and second rotatable wheels are arranged to rotate in the same direction, and wherein the outer profiles of the wheels are displaced relative to each other when the wheels rotate. In this embodiment, the displaced profiles can be arranged such that they control the needle locking devices to alternately lock and release the double ended needle.

[0030] Pintle locking device mechanism

[0031] The first needle locking device is associated with the first jaw element, and the second needle locking device is associated with the second jaw element. The needle locking devices in the present disclosure can be referred to as complete mechanisms for holding and releasing one end of the double ended needle. The needle locking devices can thereby comprise a plurality of connected or engaged elements. The needle locking devices can be incorporated into the jaw elements. The needle locking devices can at one end be engaged or connected to one of the rotatable wheels, and extend via the jaw elements, preferably inside the jaw elements, while the other end can be able to hold and release one end of the needle, as will be explained in further detail. Preferably, the first rotatable wheel is engaged with the first needle locking device, and the second rotatable wheel is engaged with the second needle locking device. This can be achieved by wheel engagement elements engaged with the first and second rotatable wheels, respectively. As the wheels rotate, the outer profiles of the wheels can cause the wheel engagement elements to move axially forward and backward along the corresponding jaw elements in response to the rotation of the corresponding rotatable wheels. Forward means in the direction towards the free end of the jaw element. Thus, backward means the opposite direction, i.e. towards the wheel.

[0032] The wheel engagement elements can be engagement shafts. In order to maintain contact between the wheel engagement elements and the varying outer profiles of the rotatable wheels, each wheel engagement element can comprise a first spring coil configured to maintain a pressure from the wheel engagement element to the corresponding rotatable wheel.

[0033] As will be appreciated by the skilled person, there are different solutions for controlling the holding and release of the double ended needle based on the wheel engagement elements moving back and forth in the axial direction of each jaw element. Figure 1An embodiment is shown, wherein each wheel engagement element is connected to a needle holding element extending in the longitudinal direction of the corresponding jaw element. Each needle holding element can comprise an opening, which is preferably adjacent to the free end of the jaw element, where suturing is typically performed to accommodate the double ended needle. The opening can have a shape capable of locking the double ended needle. One mechanical solution for locking the needle comprises an opening having a wide cross section and a narrow cross section, for example, an opening substantially keyhole shaped. Thus, the double ended needle can have a narrower or thinner portion than the rest of the needle, which prevents the needle from moving in the longitudinal direction of the needle when this portion is introduced into the narrow portion, for example a groove or a slot, of the opening of the holding element. Both ends of the double ended needle can have such a groove or slot.

[0034] To prevent the needle from moving to the wide portion and falling down when locked in the narrow portion of the opening, each needle locking device can comprise a needle pusher element configured to push the double ended needle towards the body portion, as Figure 6 shown. The needle pusher element can be arranged to push the double ended needle backwards towards the body portion of the corresponding jaw element. The needle pusher connecting element can form part of the needle locking device and connect the wheel engagement element and the needle holding element. There can be a second spring configured to maintain the pressure on the needle pusher element towards the body portion.

[0035] In addition to the built-in mechanism for holding and releasing the needle, the suturing device of the present disclosure can comprise a manual needle release mechanism for manually releasing the needle from the jaw when needed. Each jaw can have its own manual needle release element. The manual needle release mechanism can be implemented as, for example, a pin, a clamp or a button on the jaw, which extends into the jaw and controls, for example, the needle locking device or an element of the needle locking device, for example the holding element or the wheel engagement element.

[0036] Arrangement of rotating wheels

[0037] As mentioned above, the needle transfer mechanism comprises a first rotatable wheel connected to a first needle locking device and a second rotatable wheel connected to a second needle locking device. The first and second rotatable wheels can be arranged such that upon movement of the first and second jaw elements relative to each other from the open position to the closed position, the rotational difference between the first and second rotatable wheels causes one of the needle locking devices to lock the double ended needle, while the other needle locking device releases the double ended needle.

[0038] A first embodiment of the suturing device of the present disclosure comprises two rotatable wheels, wherein the first and second rotatable wheels are arranged to rotate in opposite directions when the first and second jaw elements are moved relative to each other from an open position to a closed position, thereby causing one of the needle locking devices to lock the double ended needle while the other needle locking device releases the double ended needle. A second embodiment of the suturing device of the present disclosure comprises two rotatable wheels, wherein the first and second rotatable wheels are arranged to rotate in the same direction, and wherein the outer contours of the wheels are displaced relative to each other when the wheels are rotated.

[0039] The rotatable wheels can comprise a plurality of cam elements distributed along the outer contour or circumference of each wheel. It can be said that the distance from the wheel center to the wheel outer periphery determines the position of the corresponding wheel engagement element. Thus, when the wheels are rotated, the wheel engagement elements move back and forth in the axial direction of the jaw elements. This movement can be used in the mechanism for holding and releasing the double ended needle. Thus, the cam elements can be shaped such that the shape of the cam elements controls the backward and forward movement of the wheel engagement elements when the rotating wheels are rotated, to hold and release the corresponding end of the double ended needle.

[0040] Each cam element can have a front convex ridge and a back convex ridge. The back convex ridge can be steeper than the front convex ridge. The direction of rotation of the wheels is defined relative to the shape of the wheels and is exemplified in Figure 4 In the configuration of this figure, the second rotating wheel will be rotated clockwise, whereby the second wheel engagement element will contact and first move along the longer front convex ridge (30) of the cam element, and then drop over the back convex ridge (31). The latter can correspond to a locking mechanism. In one embodiment, the border part (32) between the front convex ridge and the back convex ridge (which can also be seen as a groove or notch) is configured to hold the wheel engagement element of one of the needle locking devices in a retracted position, thereby causing the needle locking device to be in a locked configuration. The raised part of each rotating wheel can be configured to hold the wheel engagement element of one of the needle locking devices in an extended position, thereby causing the needle locking device to be in a released configuration. Figure 4 The second rotating wheel is shown. The first rotating wheel can be mirrored relative to the second rotating wheel. Thus, the first rotating wheel can have the same shape as the second rotating wheel, and can be rotated clockwise from the opposite angle, i.e. from the opposite direction, when looking at the suturing device. Thus, the first rotating wheel and the second rotating wheel can be rotated in opposite directions.

[0041] The rotatable wheels can have separate parts for being driven to rotate and for controlling the needle locking device. This can be implemented in the form of an inner part and an outer part, where the inner part and the outer part are rigidly connected. The inner part of the first rotatable wheel can be referred to as a first wheel inner part. The inner part of the second rotatable wheel can be referred to as a second wheel inner part. The outer part of the first rotatable wheel can be referred to as a first wheel outer part. The outer part of the second rotatable wheel can be referred to as a second wheel outer part. The inner part and the outer part can have separate cam elements. An example of such an arrangement is shown in Figure 4 The outer part of each rotating wheel can be engaged with the wheel drive mechanism of one of the jaw elements. As can be seen from the example of Figure 4 The shape of the outer part can thus be adapted to this purpose. The inner part of the rotating wheel can be engaged with the wheel engagement element of the same jaw element. The inner part and the outer part do not necessarily have to have these configurations, as the inner part can alternatively be driven to rotate the wheel and the outer part in order to facilitate control of the needle locking device.

[0042] The stapling device can further comprise a reverse locking mechanism to prevent the wheels from rotating backwards when the jaw elements are moved from the closed position to the open position. A first reverse locking mechanism can be arranged to prevent the first rotatable wheel from rotating backwards when the first and second jaw elements are moved from the closed position to the open position. A second reverse locking mechanism can be arranged to prevent the second rotatable wheel from rotating backwards when the first and second jaw elements are moved from the closed position to the open position. As shown in Figure 4 The reverse locking mechanism can be implemented in the form of a hook element (23) that can hook around an edge or ridge of the rotating wheel, for example around the edge of the outer part of the wheel as shown in the example.

[0043] Wheel drive arrangement

[0044] Several embodiments are possible for driving the rotating wheels to rotate.

[0045] In one embodiment, such as a one-handed embodiment, the user can hold the jaw elements in one hand and push the jaw elements together. In such embodiments, the jaw elements can comprise elements that engage with the rotating wheels and transmit force to the wheels to cause the wheels to rotate when the stapling device is closed. The stapling device can comprise a first wheel drive mechanism for rotating the second rotating wheel and a second wheel drive mechanism for rotating the first rotating wheel. The first wheel drive mechanism can be a first wheel drive shaft and the second wheel drive mechanism can be a second wheel drive shaft. The first wheel drive mechanism can be configured to transmit force from the first jaw element to the second rotating wheel such that when the first and second jaws are moved from an open position to a closed position, the second rotating wheel rotates in a first direction (forward). The second wheel drive mechanism can operate in the same manner. In one embodiment, the stapling device of the present disclosure comprises a jaw opening control element that allows the user to manually control the rotatable wheels. There can also be two jaw opening control elements, one for each rotatable wheel, to enable separate control of the wheels. The jaw opening control element can be implemented, for example, as an extension of the rotatable wheel. The rotatable wheel can thus have a first mechanical part that is not normally directly exposed to the user. This part can comprise the inner part and the outer part of the rotatable wheel. These mechanical parts are normally placed behind the housing of the stapling device. The jaw opening control element can be the exposed part of the rotatable wheel, preferably comprising a clamp or a handle. The user can then manually control the locking and release of the needle by applying force to the jaw opening control element.

[0046] In a second embodiment, the wheels can be driven by a handle, as shown in the example of Figure 7 . The handle can drive the opening / closing of the rotating wheels and the jaw elements. Several embodiments are possible as long as the two mechanisms are synchronized so that the closing of the jaw elements corresponds to the sequence of the mechanism for holding and releasing the double-ended needle. In the example of Figure 7 , there are three control elements that extend along the device, as also shown in Figure 8 . The jaw opening control element (27) in the form of a shaft (27) controls the opening and closing of the jaw elements (3, 4), preferably assisted by a spring. The needle holding element (12) is controlled by two wheel engagement elements (9, 10) in the form of two further shafts (9, 10). These mechanisms are preferably synchronized in the sense that a handle (35) controls them.

[0047] Detailed description of the drawings

[0048] The present invention will be described in more detail below with reference to the accompanying drawings. These drawings are exemplary and are intended to show some of the features of the stapling device of the present disclosure and should not be interpreted as limiting the invention of the present disclosure.

[0049] Figure 1One embodiment of a suturing device (1) of the present disclosure is shown with a needle transporter of built-in double-ended needles (2), where two rotatable wheels (7, 8) are arranged to rotate in opposite directions to control the holding and release of two needle locking devices (5, 6). Two jaw elements (3, 4) are pivotable relative to each other around a common pivot joint (24). After a user pushes the jaw elements (3, 4) together to transport a double-ended needle (2), a jaw opening spring (25) moves the jaws back to an open position. A first jaw element (3) has a first needle locking device (5). A second jaw element (4) has a second needle locking device (6). A first rotatable wheel (7) has a first wheel inner portion (19) and a first wheel outer portion (not visible). A second rotatable wheel (8) has a second wheel inner portion (19’) and a second wheel outer portion (20’). A first wheel engagement element (9) as part of the first needle locking device (5) engages with the outer profile of the inner portion (19) of the first rotatable wheel (7). A second wheel engagement element (10) as part of the second needle locking device (6) engages with the outer profile of the inner portion (19’) of the second rotatable wheel (8). A first spring (11) keeps pressure from the wheel engagement elements (9, 10) to the corresponding rotatable wheels (7, 8). The needle locking devices (5, 6) each comprise a needle holding element (12) and a needle pusher element (13) configured to push a double-ended needle (2) backwards, i.e. towards the wheels. Each needle locking device (5, 6) comprises a needle pusher connection element (15) and a second spring (14) for keeping pressure on the needle pusher element (13). Each needle locking device (5, 6) comprises a needle pusher clamp element (26) for limiting axial movement between the needle pusher connection element (15) and the corresponding wheel engagement element (9, 10). Force from a first wheel drive mechanism (16) in the first jaw element (3) rotates the second rotatable wheel (8). Force from a second wheel drive mechanism (17) in the second jaw element (4) rotates the first rotatable wheel (7). Each rotatable wheel (7, 8) has a plurality of cam elements (18) distributed on the circumference. The suturing device (1) of this example comprises a first reverse locking mechanism (21) and a second reverse locking mechanism (22), each with a hook (23). A jaw opening control element (27) is rigidly connected to one of the rotatable wheels. The jaw opening control element is arranged for manual control of one of the first and second rotatable wheels to open the jaws (3, 4). Another jaw opening control element can be connected to the other of the rotatable wheels.

[0050] Figure 2 One embodiment of a suturing device (1) of the present disclosure is shown with a needle transporter of built-in double-ended needles (2), where two rotatable wheels (7, 8) are arranged to rotate in opposite directions to control the holding and release of two needle locking devices (5, 6). Two jaw elements (3, 4) are pivotable relative to each other around a common pivot joint (24). After a user pushes the jaw elements (3, 4) together to transport a double-ended needle (2), a jaw opening spring (25) moves the jaws back to an open position. A first jaw element (3) has a first needle locking device (5). A second jaw element (4) has a second needle locking device (6). A first rotatable wheel (7) has a first wheel inner portion (19) and a first wheel outer portion (not visible). A second rotatable wheel (8) has a second wheel inner portion (19’) and a second wheel outer portion (20’). A first wheel engagement element (9) as part of the first needle locking device (5) engages with the outer profile of the inner portion (19) of the first rotatable wheel (7). A second wheel engagement element (10) as part of the second needle locking device (6) engages with the outer profile of the inner portion (19’) of the second rotatable wheel (8). A first spring (11) keeps pressure from the wheel engagement elements (9, 10) to the corresponding rotatable wheels (7, 8). The needle locking devices (5, 6) each comprise a needle holding element (12) and a needle pusher element (13) configured to push a double-ended needle (2) backwards, i.e. towards the wheels. Each needle locking device (5, 6) comprises a needle pusher connection element (15) and a second spring (14) for keeping pressure on the needle pusher element (13). Each needle locking device (5, 6) comprises a needle pusher clamp element (26) for limiting axial movement between the needle pusher connection element (15) and the corresponding wheel engagement element (9, 10). Force from a first wheel drive mechanism (16) in the first jaw element (3) rotates the second rotatable wheel (8). Force from a second wheel drive mechanism (17) in the second jaw element (4) rotates the first rotatable wheel (7). Each rotatable wheel (7, 8) has a plurality of cam elements (18) distributed on the circumference. The suturing device (1) of this example comprises a first reverse locking mechanism (21) and a second reverse locking mechanism (22), each with a hook (23). A jaw opening control element (27) is rigidly connected to one of the rotatable wheels. The jaw opening control element is arranged for manual control of one of the first and second rotatable wheels to open the jaws (3, 4). Another jaw opening control element can be connected to the other of the rotatable wheels. Figure 1A perspective view of the suture device (1). From this perspective view it can be seen that the second rotatable wheel (8) has an inner part (19') and an outer part (20'). The inner part (19') has a cam profile which can be used to move the wheel engaging element (10) of the second jaw element (4) axially forward and backward. The first wheel drive mechanism (16) is arranged to push the outer and smaller part (20') to make the wheel rotate. The perspective view also shows the needle pusher clamping element (26) in the form of a screw (26) which is arranged in a hole which is slightly wider than the screw (26). The jaw opening control element (27) is rigidly connected to one of the rotatable wheels and is arranged for manual control of the second rotatable wheel (8) to control the locking and release of the jaws and / or the needle. Another jaw opening control element can be connected to the other of the rotatable wheels.

[0051] Figure 3 An embodiment showing the holding and release of one end of the double ended needle (2). The needle holding element (12) has a wider part (28) and a narrower part (29). If the narrower part of the needle (2) or a recess in the needle (2) is arranged in the narrow part (29), the needle (2) is in the locked position. The figure also discloses the needle pusher element (13) which pushes the needle (2) backwards.

[0052] Figure 4 An embodiment showing one of the rotatable wheels with an inner part (19) and an outer part (20), where at least the inner part (19) has an outer profile with a number of cam elements (18) and engages with the needle locking device to control the position of the needle locking element. Each cam element (18) of the inner part (19) comprises a steep back ridge (31) and a curved front ridge (30). The boundary part (32) between the front ridge (30) and the back ridge (31) corresponds to the second wheel engaging element (10) being in its leftmost position in the figure, corresponding to the needle locking device (6) being in the holding position. On the front ridge (30), which is the longer curved surface between the two back ridges (31), there is a raised part (33). When the second wheel engaging element (10) is placed on the raised part (33), the needle locking device (6) is in the release configuration. The jaw opening control element (27) is rigidly connected to the outer part (20) of the rotatable wheel. Another jaw opening control element can be connected to the other of the rotatable wheels.

[0053] Figure 5A -H shows an example of the sequence of steps of the jaw closing process, where each step corresponds to an angle between the jaw elements, explaining the sequence of the mechanism for transferring the double ended needle from one jaw to the other. Figure 5AAt 2.3° between the jaw elements, the second wheel drive mechanism (17) starts to engage with the outer part (20). The same happens at the first rotatable wheel. Figure 5B 1.53°: The wheel drive mechanisms (16, 17) now drive the rotatable wheels in opposite directions. The first wheel engagement element (9) starts to move towards the double-ended needle (2), thus starting the opening process of the first needle locking device (5). Figure 5C 1.1°: The double-ended needle (2) enters the needle holding element of the second jaw element. Figure 5D 1.0°, showing the first needle holding element (12) about to lose its grip on the double-ended needle (2). Figure 5E At 0.7°, the first wheel engagement element (9) and the inner part (19) of the first rotatable wheel (7) are shown. The first wheel engagement element (9) is about to enter the curved part of the cam element. In this position, the needle is released from the needle holding element (12) of the first needle locking device (5). Figure 5F At 0.2°, the second wheel engagement element (10) is about to go down the back convex ridge (31) of the cam element (18) of the second rotatable wheel (8). Figure 5G 0.12°: The second wheel engagement element (10) passes the back convex ridge (31), thus locking the double-ended needle (2) in the holding element (12) of the second needle locking device (6). Figure 5H 0°: In this position, the double-ended needle (2) is locked in the holding element (12) of the second needle locking device (6).

[0054] Figure 6 An embodiment of a needle holding element (12) with an opening for receiving and locking a needle (2) with a wide part (28) and a narrow part (29) is shown. The needle holding element (12) is configured in a locked position. A needle pushing element (13) is arranged to push the needle (2) backwards against the body part (36) of the jaw element.

[0055] Figure 7 Another embodiment of the stapling device (6) of the present disclosure with a built-in needle conveyor with a double-ended needle (2) is shown, where the two rotatable wheels (7, 8) are arranged to rotate in the same direction and the outer contours of the wheels are displaced relative to each other. This embodiment comprises a multi-drive element (35) for driving the opening / closing of the jaw elements (3, 4) and the two rotatable wheels (7, 8). This mechanism is further described in Figures 7-8 .

[0056] Figure 8An embodiment with two jaw elements (3, 4) with two wheel engaging elements (9, 10) is shown. A jaw opening control element (27) in the form of a shaft (27) controls the opening and closing of the jaw elements (3, 4), preferably by means of a spring. A needle holding element (12) is controlled by two wheel engaging elements (9, 10) in the form of two further shafts (9, 10). The first engaging element (9) controls the holding and release of the first jaw element (3). The second engaging element (10) controls the holding and release of the second jaw element (4). If the outer contours of the wheels are displaced relative to each other upon wheel rotation, the shafts will move forward and backward in the axial direction of the device to control the fixation and release of the double-ended needle.

[0057] Figure 9 An embodiment with two rotatable wheels (7, 8) arranged to rotate in the same direction is shown, wherein the outer contours are displaced relative to each other and a common drive wheel (34) connected to both rotating wheels (7, 8).

[0058] List of elements in the drawings

[0059] 1 - suturing device

[0060] 2 - double-ended needle

[0061] 3 - first jaw element

[0062] 4 - second jaw element

[0063] 5 - first needle locking device

[0064] 6 - second needle locking device

[0065] 7 - first rotatable wheel

[0066] 8 - second rotatable wheel

[0067] 9 - first wheel engaging element

[0068] 10 - second wheel engaging element

[0069] 11 - first spring

[0070] 12 - needle holding element

[0071] 13 - needle pusher element

[0072] 14 - second spring

[0073] 15 - needle pusher connecting element

[0074] 16 - first wheel drive mechanism

[0075] 17 - second wheel drive mechanism

[0076] 18 - cam element

[0077] 19 - inner part

[0078] 20 - outer part

[0079] 21 - first counter locking mechanism

[0080] 22 - second counter locking mechanism

[0081] 23 - hook

[0082] 24 - pivot joint

[0083] 25 - jaw opening spring

[0084] 26 - needle pusher clamping element

[0085] 27 - jaw opening control element

[0086] 28 - wide part (of the needle holding element)

[0087] 29 - narrow part (of the needle holding element)

[0088] 30 - front cam ridge (of the cam element)

[0089] 31 - rear cam ridge (of the cam element)

[0090] 32 - border part between the front cam ridge and the rear cam ridge

[0091] 33 - raised part (of the cam element)

[0092] 34 - common drive wheel

[0093] 35 - multiple drive element

[0094] 36 - body part (of the jaw element)

[0095] Further details of the invention

[0096] 1. A suturing device with a needle transfer of a double ended needle, the suturing device comprising:

[0097] - a first jaw element comprising a first needle locking device for holding and releasing a first end of the double ended needle;

[0098] - a second jaw element comprising a second needle locking device for holding and releasing a second end of the double ended needle,

[0099] wherein the first jaw element and the second jaw element are movable relative to each other between an open position and a closed position;

[0100] - a needle transfer mechanism for alternatingly transferring the double-ended needle from one to the other of the jaw elements when the first and second jaws are moved from the open position to the closed position, said needle transfer mechanism comprising:

[0101] o a first rotatable wheel connected to the first needle locking device; and

[0102] o a second rotatable wheel connected to the second needle locking device,

[0103] wherein the first and second rotatable wheels are arranged such that when the first and second jaw elements are moved relative to each other from the open position to the closed position, rotation of the first and second rotatable wheels causes one of the needle locking devices to lock the double-ended needle while the other needle locking device releases the double-ended needle.

[0104] 2. The suturing device according to item 1, wherein the first rotatable wheel comprises a first wheel inner portion rigidly connected to a first wheel outer portion, and wherein the second rotatable wheel comprises a second wheel inner portion rigidly connected to a second wheel outer portion.

[0105] 3. The suturing device according to item 2, wherein a first force is transmitted from the first jaw element to the second rotatable wheel when the first and second jaw elements are moved relative to each other from the open position to the closed position, and wherein a second force is transmitted from the second jaw element to the first rotatable wheel, thereby causing the first and second rotatable wheels to rotate.

[0106] 4. The suturing device according to any of the preceding items, wherein the first and second rotatable wheels are arranged to rotate in opposite directions when the first and second jaw elements are moved relative to each other from the open position to the closed position, thereby causing one of the needle locking devices to lock the double-ended needle while the other needle locking device releases the double-ended needle.

[0107] 5. The suturing device according to item 1, wherein the first and second rotatable wheels are arranged to rotate in the same direction, wherein the outer contours of the wheels are displaced relative to each other when the wheels rotate.

[0108] 6. The suturing device according to any of the preceding items, wherein the first and second rotatable wheels are arranged to rotate simultaneously and / or synchronously, preferably at the same rotational speed.

[0109] 7. The suturing device according to any of the preceding items, wherein each needle locking device comprises a wheel engagement element that is engaged with the first and second rotatable wheels, respectively.

[0110] 8. The suturing device according to item 7, wherein each wheel engagement element is configured to move axially forward and backward along the corresponding jaw element in response to rotation of the corresponding rotatable wheel.

[0111] 9. The suturing device according to item 8, wherein the forward and backward movement of each wheel engagement element causes the corresponding needle locking device to hold and release, respectively, the corresponding end of the double ended needle.

[0112] 10. The suturing device according to item 9, wherein each wheel engagement element is an engagement axle.

[0113] 11. The suturing device according to any one of items 2 to 10, wherein each wheel engagement element comprises a first spring configured to maintain a pressure from the wheel engagement element to the corresponding rotatable wheel.

[0114] 12. The suturing device according to any one of items 2 to 11, wherein each wheel engagement element is connected to a needle holding element, the needle holding element extending in the longitudinal direction of the corresponding jaw element.

[0115] 13. The suturing device according to item 12, wherein each needle holding element comprises an opening for accommodating the double ended needle, wherein the opening has a shape capable of locking the double ended needle.

[0116] 14. The suturing device according to item 13, wherein the opening has a wide portion and a narrow portion, wherein the narrow portion of the double ended needle can be locked in the narrow portion.

[0117] 15. The suturing device according to any one of the preceding items, wherein each needle locking device comprises a needle pusher element configured to push the double ended needle backwards towards the body portion of the corresponding jaw element.

[0118] 16. The suturing device according to item 15, wherein each needle locking device further comprises a needle pusher connection element and a second spring configured to maintain a pressure on the needle pusher element towards the body portion.

[0119] 17. The suturing device according to any one of the preceding items, further comprising a first wheel drive mechanism for the rotation of the first rotatable wheel and a second wheel drive mechanism for the rotation of the second rotatable wheel.

[0120] 18. The suturing device according to item 17, wherein the first wheel drive mechanism is a first wheel drive axle and the second wheel drive mechanism is a second wheel drive axle.

[0121] 19. The suturing device according to any one of items 17 to 18, wherein the first wheel drive mechanism is configured to propagate a force from the first jaw element to the second rotatable wheel such that the second rotatable wheel rotates in a first direction when the first and second jaws are moved from the open position to the closed position.

[0122] 20. The suturing device of item 19, wherein the second wheel drive mechanism is configured to propagate force from the second jaw element to the first rotating wheel such that the first rotating wheel rotates in a second direction opposite the first direction when the first and second jaws are moved from the open position to the closed position.

[0123] 21. The suturing device of any of the preceding items, wherein each rotating wheel has a cam element.

[0124] 22. The suturing device of item 21, wherein the cam element is shaped such that as the rotating wheel rotates, the shape of the cam element controls forward and rearward movement of the wheel engagement element to hold and release the corresponding end of the double-ended needle.

[0125] 23. The suturing device of any of items 21-22, wherein each cam element has a forward convex ridge and a rear convex ridge, wherein the rear convex ridge is steeper than the forward convex ridge.

[0126] 24. The suturing device of item 23, wherein a boundary portion between the forward convex ridge and the rear convex ridge is configured to hold the wheel engagement element of one of the needle locking devices in a retracted position, thereby placing the needle locking device in a locked configuration.

[0127] 25. The suturing device of any of items 23-24, wherein an elevated portion of each rotating wheel is configured to hold the wheel engagement element of one of the needle locking devices in an extended position, thereby placing the needle locking device in a released configuration.

[0128] 26. The suturing device of any of the preceding items, wherein each rotatable wheel comprises an inner portion and an outer portion, wherein the inner and outer portions are rigidly connected.

[0129] 27. The suturing device of item 26, wherein the inner portion and the outer portion have separate cam elements.

[0130] 28. The suturing device of any of items 26-27, wherein the outer portion of each rotating wheel is engaged with the wheel drive mechanism of one of the jaw elements, and the inner portion of each rotating wheel is engaged with the wheel engagement element of the same jaw element.

[0131] 29. The suturing device of any of the preceding items, further comprising a first backstop mechanism and a second backstop mechanism, the first backstop mechanism configured to prevent the first rotatable wheel from rotating rearward when the first and second jaw elements are moved from the closed position to the open position; the second backstop mechanism configured to prevent the second rotatable wheel from rotating rearward when the first and second jaw elements are moved from the closed position to the open position.

[0132] 30. The suturing device according to any of the preceding items, further comprising a jaw opening control element for manually controlling the first and / or second rotatable wheel to open the jaws.

[0133] 31. The suturing device according to any of the preceding items, wherein the needle delivery mechanism is automatic.

[0134] 32. The suturing device according to any of the preceding items, wherein the jaw elements are pivotable relative to each other about a common pivot joint.

[0135] 33. The suturing device according to any of the preceding items, further comprising a jaw opening spring arranged between the first jaw element and the second jaw element.

[0136] 34. The suturing device according to any of the preceding items, wherein the suturing device is disposable.

Claims

1. A suturing apparatus (1) having a needle feeder with double-ended needles (2), the suturing apparatus (1) comprising: - First jaw element (3), the first jaw element includes a first needle locking device (5) for holding and releasing the first end of the double-ended needle (2); - Second jaw element (4), the second jaw element includes a second needle locking device (6) for retaining and releasing the second end of the double-ended needle (2), The first jaw element and the second jaw element (3,4) are movable relative to each other between an open position and a closed position; - A needle conveying mechanism, the needle conveying mechanism being used to alternately convey a double-ended needle (2) from one jaw element to the other when the first jaw and the second jaw (3,4) move from the open position to the closed position, the needle conveying mechanism comprising: ο The first rotatable wheel (7) is connected to the first pin locking device (5); and The second rotatable wheel (8) is connected to the second pin locking device (6). Wherein, when the first jaw element and the second jaw element (3,4) move from the open position to the closed position relative to each other, the first rotatable wheel and the second rotatable wheel (7,8) are arranged such that rotation of the first rotatable wheel and the second rotatable wheel (7,8) causes one of the needle locking devices (5,6) to lock the double-ended needle (2), while the other needle locking device (5,6) releases the double-ended needle (2), characterized in that The suturing device further includes a jaw opening control element (27) for manually controlling the first rotatable wheel and / or the second rotatable wheel (7,8) to open the jaws (3,4). The jaw opening control element (27) includes a manually operable clamp or handle rigidly connected to the respective first rotatable wheel and / or second rotatable wheel (7,8). The jaw opening control element (27) is an exposed portion of one of the first rotatable wheel (7) and the second rotatable wheel (8).

2. The suturing device (1) according to claim 1, further comprising a jaw opening control element, wherein, The jaw opening control element (27) and the other jaw opening control element are arranged to independently control the first rotatable wheel and the second rotatable wheel (7,8).

3. The suturing device (1) according to any one of the preceding claims further includes a first reverse locking mechanism and a second reverse locking mechanism, the first reverse locking mechanism being configured to prevent the first rotatable wheel (7) from rotating backward when the first jaw element and the second jaw element (3,4) move from the closed position to the open position, and the second reverse locking mechanism being configured to prevent the second rotatable wheel (8) from rotating backward when the first jaw element and the second jaw element (3,4) move from the closed position to the open position.

4. The suturing device (1) according to any one of the preceding claims, wherein, Each of the rotatable wheels (7, 8) has a cam element (18).

5. The suturing device (1) according to claim 4, wherein, The cam element (18) is shaped such that when the rotatable wheel (7,8) rotates, the shape of the cam element (18) controls the forward and backward movement of the wheel engagement element (9,10) to hold and release the corresponding ends of the double-ended needle (2).

6. The suture device (1) according to claim 4 or 5, wherein, Each cam element (18) has a front ridge (30) and a rear ridge (31), wherein the rear ridge (31) is steeper than the front ridge (30).

7. The suturing device (1) according to any one of the preceding claims, wherein, Each wheel engagement element (9, 10) is connected to a needle holding element that extends in the longitudinal direction of the corresponding jaw element (3, 4).

8. The suturing device (1) according to claim 7, wherein, Each needle retaining element includes an opening for receiving a double-ended needle (2), wherein the opening has a shape capable of locking the double-ended needle (2).

9. The suturing device (1) according to claim 8, wherein, The opening has a wide portion and a narrow portion, wherein the narrow portion of the double-ended needle (2) can be locked in the narrow portion.

10. The suturing device (1) according to any one of the preceding claims, wherein, The first rotatable wheel (7) includes a first wheel inner portion rigidly connected to the outer portion of the first wheel; and wherein the second rotatable wheel (8) includes a second wheel inner portion rigidly connected to the outer portion of the second wheel.

11. The suturing device according to claim 10, wherein, When the first jaw element and the second jaw element (3,4) move from the open position to the closed position relative to each other, a first force is transmitted from the first jaw element (3) to the second rotatable wheel (8), and a second force is transmitted from the second jaw element (4) to the first rotatable wheel (7), thereby causing the first rotatable wheel and the second rotatable wheel (7,8) to rotate.

12. The suturing device (1) according to any one of the preceding claims, wherein, Each needle locking device includes a needle pusher element (13) configured to push the double-ended needle (2) rearward toward the body portion (36) of the corresponding jaw element (3,4).

13. The suturing device (1) according to claim 12, wherein, Each needle locking device also includes a needle pusher connecting element (15) and a second spring (14) configured to maintain pressure on the needle pusher element (15) toward the body portion (36).

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