Suturing device
11806007 · 2023-11-07
Assignee
Inventors
- Gabriel Börner (Ramlösa, SE)
- Mats Christensson (Staffanstorp, SE)
- Rickard Norenstam (Löddeköpinge, SE)
Cpc classification
A61B2017/0609
HUMAN NECESSITIES
A61B2017/06019
HUMAN NECESSITIES
International classification
Abstract
A suturing device with built-in needle-transfer of a double-ended needle has a first jaw element with a first needle lock device for retaining and releasing a first end of the needle; a second jaw element with a second needle lock device, wherein the jaw elements are movable between an open and closed position; and a needle-transferring mechanism for alternately transferring the needle from one of the jaw elements to the other when the jaws are moved from the open to the closed position. The needle-transferring mechanism includes a first rotatable wheel connected to the first needle lock device, the first wheel having a first wheel inner portion rigidly connected to a first wheel outer portion and a second rotatable wheel connected to the second needle lock device, said second rotatable wheel comprising a second wheel inner portion rigidly connected to a second wheel outer portion.
Claims
1. A suturing device with a needle-transfer of a double-ended needle, the suturing device comprising: a first jaw element comprising a first needle lock device for retaining and releasing a first end of the double-ended needle; a second jaw element comprising a second needle lock device for retaining and releasing a second end of the double-ended needle, wherein the first and second jaw elements are movable in relation to each other between an open position and a closed position; a needle-transferring mechanism for alternately transferring the double-ended needle from one of the first and second jaw elements to the other when the first and second jaw elements are moved from the open position to the closed position, said needle-transferring mechanism comprising: a first rotatable wheel connected to the first needle lock device, said first rotatable wheel comprising a first wheel inner portion rigidly connected to a first wheel outer portion, wherein the first wheel inner portion and the first wheel outer portion have separate cam element profiles; and a second rotatable wheel connected to the second needle lock device, said second rotatable wheel comprising a second wheel inner portion rigidly connected to a second wheel outer portion, wherein the second wheel inner portion and the second wheel outer portion have separate cam element profiles, wherein 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 when the first and second jaw elements are moved in relation to each other from the open position to the closed position, thereby causing the first and second rotatable wheels to rotate, wherein the first and second rotatable wheels are arranged such that a rotation of the first and second rotatable wheels causes one of the first and second needle lock devices to lock the double-ended needle and the other of the first and second needle lock devices to release the double-ended needle.
2. The suturing device according to claim 1, wherein the first and second rotatable wheels are arranged to rotate in opposite directions when the first and second jaw elements are moved in relation to each other from the open position to the closed position, thereby causing one of the first and second needle lock devices to lock the double-ended needle and the other of the first and second needle lock devices to release the double-ended needle.
3. The suturing device according to claim 1, wherein the first and second rotatable wheels are arranged to rotate in the same direction, wherein outer profiles of the first and second rotatable wheels are shifted in relation to each other when the first and second rotatable wheels rotate.
4. The suturing device according to claim 1, further comprising a first wheel drive mechanism engaging with the second wheel outer portion.
5. The suturing device according to claim 1, further comprising a second wheel drive mechanism engaging with the first wheel outer portion.
6. The suturing device according to claim 1, wherein the first and second rotatable wheels are arranged to rotate simultaneously and/or synchronized, preferably with the same rotational speed.
7. The suturing device according to claim 1, wherein the first needle lock device comprises a first wheel engagement element engaging with the first rotatable wheel, and wherein the second needle lock device comprises a second wheel engagement element engaging with the second rotatable wheel.
8. The suturing device according to claim 7, wherein the first wheel engagement element engages with the first wheel inner portion.
9. The suturing device according to claim 7, wherein the second wheel engagement element engages with the second wheel inner portion.
10. The suturing device according to claim 7, wherein: the first wheel engagement element is configured to move backwards and forwards in an axial direction of the first jaw element in response to the rotation of the first rotatable wheel and wherein a movement backwards and forwards of the first wheel engagement element causes the first needle lock device to retain and release the first end of the double-ended needle, respectively; and the second wheel engagement element is configured to move backwards and forwards in an axial direction of the second jaw element in response to the rotation of the second rotatable wheel and wherein a movement backwards and forwards of the second wheel engagement element causes the second needle lock device to retain and release the second end of the double-ended needle, respectively.
11. The suturing device according to claim 7, wherein each of the first rotatable wheel and the second rotatable wheel have cam elements shaped such that when rotated, the shape of the cam elements controls the movement backwards and forwards of the first and second wheel engagement elements to retain and release corresponding respective ends of the double-ended needle.
12. The suturing device according to claim 11, wherein each cam element has a front ridge and a back ridge, wherein the back ridge is steeper than the front ridge.
13. The suturing device according to claim 12, wherein a border section between the front ridge and the back ridge is configured to hold the wheel engagement element of one of the first and second needle lock devices in a retracted position causing the one of the first and second needle lock devices to be in a locked configuration.
14. The suturing device according to claim 12, wherein: an elevated section of the first rotatable wheel is configured to hold the first wheel engagement element of the first needle lock device in an extended position causing the first needle lock device to be in a release configuration; and an elevated section of the second rotatable wheel is configured to hold the second wheel engagement element of the second needle lock device in an extended position causing the second needle lock device to be in a release configuration.
15. The suturing device according to claim 1, further comprising a jaw opening control element for manually controlling the first and/or second rotatable wheels to open the first and second jaw elements.
16. The suturing device according to claim 15, wherein the jaw opening control element is rigidly connected to one of the first rotatable wheel or the second rotatable wheel.
17. The suturing device according to claim 15, comprising a further jaw opening control element, wherein the jaw opening control element and further jaw opening control element are arranged to control the first and second rotatable wheels individually.
18. A suturing device with a needle-transfer of a double-ended needle, the suturing device comprising: a first jaw element comprising a first needle lock device for retaining and releasing a first end of the double-ended needle; a second jaw element comprising a second needle lock device for retaining and releasing a second end of the double-ended needle, wherein the first and second jaw elements are movable in relation to each other between an open position and a closed position; a needle-transferring mechanism for alternately transferring the double-ended needle from one of the first and second jaw elements to the other when the first and second jaw elements are moved from the open position to the closed position, said needle-transferring mechanism comprising: a first rotatable wheel connected to the first needle lock device, said first rotatable wheel comprising a first rotation axis and a first wheel inner portion rigidly connected to a first wheel outer portion; and a second rotatable wheel connected to the second needle lock device, said second rotatable wheel comprising a second rotation axis coaxially aligned with the first rotation axis and a second wheel inner portion rigidly connected to a second wheel outer portion, wherein 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 when the first and second jaw elements are moved in relation to each other from the open position to the closed position, thereby causing the first and second rotatable wheels to rotate, wherein the first and second rotatable wheels are arranged such that a rotation of the first and second rotatable wheels causes one of the first and second needle lock devices to lock the double-ended needle and the other of the first and second needle lock devices to release the double-ended needle.
19. The suturing device according to claim 18, wherein the first needle lock device comprises a first wheel engagement element engaging with the first rotatable wheel, and wherein the second needle lock device comprises a second wheel engagement element engaging with the second rotatable wheel.
20. The suturing device according to claim 19, wherein each of the first rotatable wheel and the second rotatable wheel have cam elements shaped such that when rotated, the shape of the cam elements controls the movement backwards and forwards of the first and second wheel engagement elements to retain and release corresponding respective ends of the double-ended needle.
Description
DESCRIPTION OF DRAWINGS
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DETAILED DESCRIPTION OF THE INVENTION
(10) The present disclosure relates to a suturing device with a needle-transfer of a double-ended needle, the suturing device comprising: a first jaw element comprising a first needle lock device for retaining and releasing a first end of the double-ended needle; a second jaw element comprising a second needle lock device for retaining and releasing a second end of the double-ended needle, wherein the first and second jaw elements are movable in relation to each other between an open position and a closed position; and a needle-transferring mechanism for alternately transferring the double-ended needle from one of the jaw elements to the other when the first and second jaws are moved from the open position to the closed position. More precisely the double-ended is alternately transferred from one needle lock device to the other needle lock device. The suturing device may be a suturing device for closing the abdomen. Typically, the jaw elements are pivotable in relation to each other around a common pivot joint. Preferably, the needle-transferring mechanism comprises: a first rotatable wheel connected to the first needle lock device; and a second rotatable wheel connected to the second needle lock device. The first and second rotatable wheels may be arranged such that a rotation, such that a difference in rotation and/or a shift or offset, between the first and second rotatable wheels causes one of the needle lock devices to lock the double-ended needle and the other needle lock device to release the double-ended needle when the first and second jaw elements are moved in relation 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 synchronized, preferably with the same rotational speed in order to provide a synchronized and/or coordinated release and retention of the two needle lock devices. The rotatable wheel based solution allows the user to transfer the needle form one jaw to the other in one movement, for example by pushing the jaws together directly or by pushing two handles together, thereby pushing the jaws together. If the user then releases the jaws or handles, a spring coil, or another solution providing the same functionality may force the jaws to return to an open position. This mechanism may be provided by means of 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-transferring mechanism may cause the double-ended needle to transfer back from the second jaw 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 to perform a suturing process.
(11) In particular this automatic or semi-automatic mechanism may allow for one-handed use. The device is robust, efficient and relatively simple in its construction. The mechanism is hence suitable for a disposable suturing device.
(12) A first embodiment of the presently disclosed suturing device 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 in relation to each other from the open position to the closed position, thereby causing one of the needle lock devices to lock the double-ended needle and the other needle lock device to release the double-ended needle. The rotation of two rotatable wheels may be driven by shafts connected to the jaw elements. When the jaw elements are closed towards each other, the shafts may push the wheels to rotation. Outer profiles of the wheels may thereby cause the needle lock devices to lock and release the double-ended needle alternately.
(13) A second embodiment of the presently disclosed suturing device comprises two rotatable wheels, wherein the first and second rotatable wheels are arranged to rotate in the same direction, and wherein outer profiles of the wheels are shifted in relation to each other when the wheel rotates. In this embodiment the shifted profiles may be arranged such that they control the needle lock devices to lock and release the double-ended needle alternately.
(14) Needle Lock Device Mechanisms
(15) A first needle lock device is associated with the first jaw element and a second needle lock device is associated with the second jaw element. A needle lock device within the present disclosure may be referred to as a complete mechanism for retaining and releasing one end of a double-ended needle. The needle lock device may thereby comprise a number of connected or engaging elements. A needle lock device may be incorporated into a jaw element. A needle lock device may engage or connect to one of the rotatable wheels in one end, and extend via, preferably inside, the jaw element, whereas the other end may be able to retain and release one end of the needle as explained in further detail below. Preferably, the first rotatable wheel engages with the first needle lock device and the second rotatable wheel engages with the second needle lock device. This can be achieved by wheel engagement elements engaging with the first and second rotatable wheels, respectively. As the wheel rotate, the outer profile of the wheels may move the wheel engagement elements backwards and forwards in the axial direction of the corresponding jaw element in response to a rotation of the corresponding rotatable wheel. Forwards has the meaning in the direction towards the free end of a jaw element. Consequently, backwards means the opposite direction, i.e. towards the wheels.
(16) The wheel engagement elements may 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 may comprise a first spring coil configured to maintain a pressure from the wheel engagement element to the corresponding rotatable wheel.
(17) As a person skilled in the art would understand, there are different solutions for controlling the retention and release of the double-ended needle based on the movement of the wheel engagement elements back and forth in the axial direction of each jaw element.
(18) In order to prevent that the needle, when locked in the narrow section of the opening, moves to the wide section and falls off, each needle lock device may comprise a needle pusher element configured to push the double-ended needle against a body part as shown in
(19) In addition to the built-in mechanism for retaining and releasing the needle the presently disclosed suturing device may comprise a manual needle release mechanism for manually releasing the needle from the jaw if needed. Each jaw may have its own manual needle release element. The manual needle release mechanism may be implemented as for example a pin, grip or button on the jaw, extending into the jaw and controlling for example the needle lock device or an element of the needle lock device, such as the retention element or the wheel engagement element.
(20) Arrangements of Rotatable Wheels
(21) As stated above, the needle-transferring mechanism comprises: a first rotatable wheel connected to the first needle lock device; and a second rotatable wheel connected to the second needle lock device. The first and second rotatable wheels may be arranged such that a difference in rotation between the first and second rotatable wheels causes one of the needle lock devices to lock the double-ended needle and the other needle lock device to release the double-ended needle when the first and second jaw elements are moved in relation to each other from the open position to the closed position.
(22) A first embodiment of the presently disclosed suturing device 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 in relation to each other from the open position to the closed position, thereby causing one of the needle lock devices to lock the double-ended needle and the other needle lock device to release the double-ended needle. A second embodiment of the presently disclosed suturing device comprises two rotatable wheels, wherein the first and second rotatable wheels are arranged to rotate in the same direction, and wherein outer profiles of the wheels are shifted in relation to each other when the wheel rotates.
(23) The rotatable wheels may comprise a number of cam element distributed along an outer profile or contour of the each wheel. The distance from the center of the wheel to the outer periphery of the wheel can be said to determine the position of the corresponding wheel engagement element. Hence, when a wheel rotates the wheel engagement element moves back and forth in an axial direction of the jaw element.
(24) This movement can be used in a mechanism to retain and release the double-ended needle. The cam elements may therefore be shaped such that when the rotation wheels rotate, the shape of the cam elements control the movement backwards and forwards of the wheel engagement elements to retain and release the corresponding end of the double-ended needle.
(25) Each cam element may have a front ridge and a back ridge. The back ridge may be steeper than the front ridge. The rotational direction of the wheels are defined in relation to the shape of the wheel and exemplified in
(26) The rotatable wheels may have separate portions for being driven to rotate and for controlling the needle lock devices. This may be implemented in the form of an inner portion and an outer portion, wherein the inner and outer portions are rigidly connected. The inner portion of the first rotatable wheel may be referred to as the first wheel inner portion. The inner portion of the second rotatable wheel may be referred to as the second wheel inner portion. The outer portion of the first rotatable wheel may be referred to as the first wheel outer portion. The outer portion of the second rotatable wheel may be referred to as the second wheel outer portion. The inner portion and the outer portion may have separate cam elements. An example of such an arrangement is shown in
(27) The suturing device may further comprise reverse lock mechanisms to prevent the wheels from rotation backwards when the jaw elements are moved from a closed to an open position. A first reverse lock mechanism may be arranged to prevent the first rotatable wheel to rotate backwards when the first and second jaw elements are moved from the closed position to the open position. A second reverse lock mechanism may be arranged to prevent the second rotatable wheel to rotate backwards when the first and second jaw elements are moved from the closed position to the open position. The reverse lock mechanism may be implemented in the form of hook elements (23), as shown in
(28) Wheel Driving Arrangements
(29) Several embodiments for driving the rotation of the rotation wheels are possible.
(30) In one embodiment, such as a one-handed embodiment, the user may hold the jaw elements in one hand and push the jaw elements together. In such an embodiment the jaw elements may comprise elements which engage with the rotation wheel and transfer a force to the wheels when the suturing device is being closed such that the wheels rotate. The suturing device may comprise a first wheel drive mechanism for rotation of the second rotation wheel and a second wheel drive mechanism for rotation of the first rotation wheel. The first wheel drive mechanism may be a first wheel drive shaft and the second wheel drive mechanism may be a second wheel drive shaft. The first wheel drive mechanism may be configured to propagate a force from the first jaw element to the second rotation wheel such that the second rotation wheel rotates in a first direction (forward) when the first and second jaws are moved from the open position to the closed position. The second wheel drive mechanism may operate in the same way. In one embodiment the presently disclosed suturing device comprises a jaw opening control element, which allows the user the manually control the rotatable wheels. There may also be two jaw opening control elements, one for each rotatable wheel, in order to be able to control the wheels individually. The jaw opening control element may be implemented, for example, as an extension of the rotatable wheels. The rotatable wheels may thereby have a first mechanical portion that is typically not directly exposed to the user. This portion may comprise the inner and outer portions of the rotatable wheel. This mechanical parts are typically placed behind a casing of the suturing device. The jaw opening control element may be an exposed part of the rotatable wheel, preferably comprising a grip or handle. The user can then control the locking and releasing of the needle manually by applying a force to the jaw opening control element.
(31) In a second embodiment the wheels may be driven by a multidrive element (35), for example a handle, as shown in the example of
DETAILED DESCRIPTION OF DRAWINGS
(32) The invention will in the following be described in greater detail with reference to the accompanying drawings. The drawings are exemplary and are intended to illustrate some of the features of the presently disclosed suturing device, and are not to be construed as limiting to the presently disclosed invention.
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LIST OF ELEMENTS IN FIGURES
(42) 1—suturing device 2—double-ended needle 3—first jaw element 4—second jaw element 5—first needle lock device 6—second needle lock device 7—first rotatable wheel 8—second rotatable wheel 9—first wheel engagement element 10—second wheel engagement element 11—first spring 12—needle retention element 13—needle pusher element 14—second spring 15—needle pusher connecting element 16—first wheel drive mechanism 17—second wheel drive mechanism 18—cam element 19—inner portion 20—outer portion 21—first reverse lock mechanism 22—second reverse lock mechanism 23—hook 24—pivot joint 25—jaw opening spring 26—needle pusher grip element 27—jaw opening control element 28—wide section (of needle retention element) 29—narrow section (of needle retention element) 30—front ridge (of cam element) 31—back ridge (of cam element) 32—border section between the front ridge and the back ridge 33—elevated section (of cam element) 34—common drive wheel 35—multidrive element 36—body part (of the jaw element)
Further Details of the Invention 1. A suturing device with a needle-transfer of a double-ended needle, the suturing device comprising: a first jaw element comprising a first needle lock device for retaining and releasing a first end of the double-ended needle; a second jaw element comprising a second needle lock device for retaining and releasing a second end of the double-ended needle, wherein the first and second jaw elements are movable in relation to each other between an open position and a closed position; a needle-transferring mechanism for alternately transferring the double-ended needle from one of the jaw elements to the other when the first and second jaws are moved from the open position to the closed position, said needle-transferring mechanism comprising: a first rotatable wheel connected to the first needle lock device; and a second rotatable wheel connected to the second needle lock device, wherein the first and second rotatable wheels are arranged such that a rotation of the first and second rotatable wheels causes one of the needle lock devices to lock the double-ended needle and the other needle lock device to release the double-ended needle when the first and second jaw elements are moved in relation to each other from the open position to the closed position. 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 an second wheel inner portion rigidly connected to a second wheel outer portion. 3. The suturing device according to item 2, wherein 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 when the first and second jaw elements are moved in relation to each other from the open position to the closed position, thereby causing the first and second rotatable wheels to rotate 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 in relation to each other from the open position to the closed position, thereby causing one of the needle lock devices to lock the double-ended needle and the other needle lock device to release the double-ended needle. 5. The suturing device according to item 1, wherein the first and second rotatable wheels are arranged to rotate in the same direction, wherein outer profiles of the wheels are shifted in relation to each other when the wheel rotates. 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 synchronized, preferably with the same rotational speed. 7. The suturing device according to any of the preceding items, wherein each needle lock device comprises a wheel engagement element engaging with the first and second rotatable wheels, respectively. 8. The suturing device according to item 7, wherein each wheel engagement element is configured to move backwards and forwards in the axial direction of the corresponding jaw element in response to a rotation of the corresponding rotatable wheel. 9. The suturing device according to item 8, wherein a movement backwards and forwards of each wheel engagement element causes the corresponding needle lock device to retain and release the corresponding end of the double-ended needle, respectively. 10. The suturing device according to item 9, wherein each wheel engagement element is an engagement shaft. 11. The suturing device according to any of items 2-10, wherein each wheel engagement element comprises a first spring configured to maintain a pressure from the wheel engagement element to the corresponding rotatable wheel. 12. The suturing device according to any of items 2-11, wherein each wheel engagement element is connected to a needle retention element, the needle retention element extending in the longitudinal direction of the corresponding jaw element. 13. The suturing device according to item 12, wherein each needle retention element comprises an opening for receiving the double-ended needle, wherein the opening has a shape capable of locking the double-ended needle. 14. The suturing device according to item 13, wherein the opening has a wide section and narrow section, wherein a narrow portion of the double-ended needle can be locked in the narrow section. 15. The suturing device according to any of the preceding items, wherein each needle lock device comprises a needle pusher element configured to push the double-ended needle backwards towards a body part of the corresponding jaw element. 16. The suturing device according to item 15, wherein each needle lock device further comprises a needle pusher connecting element and a second spring configured to maintain a pressure on the needle pusher element towards the body part. 17. The suturing device according to any of the preceding items, further comprising a first wheel drive mechanism for rotation of the first rotation wheel and a second wheel drive mechanism for rotation of the second rotation wheel. 18. The suturing device according to item 17, wherein first wheel drive mechanism is a first wheel drive shaft and the second wheel drive mechanism is a second wheel drive shaft. 19. The suturing device according to any of items 17-18, wherein the first wheel drive mechanism is configured to propagate a force from the first jaw element to the second rotation wheel such that the second rotation wheel rotates in a first direction when the first and second jaws are moved from the open position to the closed position. 20. The suturing device according to item 19, wherein the second wheel drive mechanism is configured to propagate a force from the second jaw element to the first rotation wheel such that the first rotation wheel rotates in a second direction opposite to the first direction when the first and second jaws are moved from the open position to the closed position. 21. The suturing device according to any of the preceding items, wherein each of the rotation wheels have cam elements. 22. The suturing device according to item 21, wherein the cam elements are shaped such that when the rotation wheels rotate, the shape of the cam elements control the movement backwards and forwards of the wheel engagement elements to retain and release the corresponding end of the double-ended needle. 23. The suturing device according to any of items 21-22, wherein each cam element has a front ridge and a back ridge, wherein the back ridge is steeper than the front ridge. 24. The suturing device according to item 23, wherein a border section between the front ridge and the back ridge is configured to hold the wheel engagement element of one of the needle lock devices in a retracted position causing the needle lock device to be in a locked configuration. 25. The suturing device according to any of items 23-24, wherein an elevated section of each rotation wheel is configured to hold the wheel engagement element of one of the needle lock devices in an extended position causing the needle lock device to be in a release configuration. 26. The suturing device according to any of the preceding items, wherein each of the rotatable wheels comprises in inner portion and an outer portion, wherein the inner and outer portions are rigidly connected. 27. The suturing device according to item 26, wherein the inner portion and the outer portion have separate cam elements. 28. The suturing device according to any of items 26-27, wherein the outer portion of each rotation wheel engages with the wheel drive mechanisms of one of the jaw elements and the inner portion of each rotation wheel engages with the wheel engagement element of the same jaw element. 29. The suturing device according to any of the preceding items, further comprising a first reverse lock mechanism configured to prevent the first rotatable wheel to rotate backwards when the first and second jaw elements are moved from the closed position to the open position, and a second reverse lock mechanism configured to prevent the second rotatable wheel to rotate backwards when the first and second jaw elements are moved from the closed position to the open position. 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 wheels to open the jaws. 31. The suturing device according to any of the preceding items, wherein the needle-transferring mechanism is automatic. 32. The suturing device according to any of the preceding items, wherein the jaw elements are pivotable in relation to each other around a common pivot joint. 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. 34. The suturing device according to any of the preceding items, wherein the suturing device is disposable.