The present invention relates to a surgical soft tissue suturing device. The suturing device may be used after a surgical intervention to close two portions of a target soft tissue arranged at opposite sides of an incision. The suturing device may be used in combination with bio-resorbable or permanent suture material. The proposed surgical suturing device provides a surgeon with a tool to close incisions in a fast and secure manner with a high resistance to forces promoting wound dehiscence. The invention also relates to a surgical suturing tool assembly and to a surgical suture holder assembly comprising a suture and an attached shuttle for passing the suture.
After an invasive surgical intervention, often a longer incision needs to be closed. Most commonly sutures are used to close the muscle and the fascial layer, and sutures or metal staples are used to close the skin. Depending on the type of tissue layer to be closed, bioresorbable or permanent materials may be preferred. Longer skin incisions are frequently closed with staples. These staples are made of metal and clamp the skin together. These metal staples are removed after healing. These staples, which are placed in the outer tissue layer of the body, can generally be easily removed. The staples are bent backwards using a special tool, and then pulled out.
Metal staples are rarely used for deeper tissue layers, for instance because the removal would be too difficult, and a new incision would be needed. Furthermore, the staples are not configured to stay long in the body. For example, the staples can break due to stress. Therefore, in these body parts, most often sutures are used. Sutures are strong and can be chosen out of resorbable and non-resorbable materials. The disadvantage of sutures is that they are very time consuming to place.
Thus, in view of the above, there is a need for an improved tissue suturing device or tool that provides a surgeon with a fast and secure application or deployment technique to close longer and short incisions in the high-stress or deeper tissue layers, as well as in superficial skin layers. In other words, there is a need for a suturing device loaded with multiple suture strands that can be applied to a target incision and that provides increased security, reproducibility, and reduced surgery time.
It is an object of the present invention to overcome at least some of the problems associated with the closure of incisions in deeper soft tissue layers, such as the myofascial tissue layers, as well as superficial skin tissue layers. There is a need for a suturing device that provides the ability of quickly placing suture loops that are made of a bioresorbable material or alternatively of a non-resorbable material. The suture loops should be able to withstand higher stresses and safely close the target tissue.
According to a first aspect of the invention, there is provided a surgical suturing device as recited in claim 1.
According to a second aspect of the invention, there is provided a surgical suturing tool assembly for closing an incision or two layers of a target soft tissue, the suturing tool assembly comprising the suturing device according to the first aspect, and a set of suture holder assemblies.
The suturing tool assembly comprises a stack of suture holder assemblies or clips with suture loops, which can be passed through the target tissue. After a first suture holder assembly has been used, a second suture holder assembly is made available for the next suture passing. Furthermore, the suture is sized and shaped in such a manner that the suture passing automatically creates a suture loop through the target soft tissue. The suturing device and/or the suturing tool assembly is/are (a) single-use instrument(s). Thus, they may be disposable instruments. Such an instrument would typically be delivered in a sterile packaging, and it may be thrown away after use.
According to a third aspect of the invention, there is provided a suture holder assembly as recited in claim 23.
Other aspects of the invention are recited in the dependent claims attached hereto.
Other features and advantages of the invention will become apparent from the following description of non-limiting example embodiments, with reference to the appended drawings, in which:
An embodiment of the present invention will now be described in detail with reference to the attached figures. The embodiment is described in the context of a suturing device and two portions of a target soft tissue arranged at the opposite sides of an incision, which is to be closed after a surgical intervention. Although the invention is specifically described in this context, the teachings of the invention are not limited to this environment. When the words first and second are used to refer to different elements, it is to be understood that this does not necessarily imply or mean that the first and second elements are somehow structurally substantially different elements or that their dimensions are substantially different unless implicitly or explicitly stated. Moreover, the word “end” is understood not only to mean the actual end point of an element but to also cover an end region in the proximity of the actual end point of the respective element. Identical or corresponding functional and structural elements which appear in the different drawings are assigned the same reference numerals.
The suture holder assembly 30 comprises a holder 32, a suture strand 31 having a first suture strand end 33, a second suture strand end 34 and a suture central portion 35 therebetween, a shuttle 36 and a blade 37. The shuttle, which in this example is configured as an elongated tubular element, has a needle end 38, a suture attachment portion 39 (in this case in the central or middle region or portion of the shuttle) and a driving end 40. The first suture strand end 33 is attached to the suture attachment portion. The second suture strand end is attached or connected to a suture retention element or means 41. The suture retention element 41 comprises an opening or hole, which may be a central opening, to allow the shuttle 36 to pass through it (while still being connected to the second suture strand end 34) and thus to receive the suture strand 31 and so to form a suture loop 42. As described in greater detail later, a fit, such as a form fit, a friction fit, a hooking, or other retentive fit between the suture strand (and more specifically its second suture strand end) and the suture retention element will inhibit an unravelling or releasing of the suture loop 42. As the suture retention element 41 and the suture 31 remain attached to the target tissue once the suturing operation has been completed, they can be understood to form an element similar in function to a cable tie.
In this example the holder 32 has a crescent-shaped or C-shaped holder body 43 of an average thickness “T” (measured orthogonally to the holder body's longitudinal axis). The holder body 43 comprises a first holder end or side 44 and a second holder end or side 45, a soft tissue clearance 46 between the first and second ends. The soft tissue clearance 46 is a clearance or gap, in which upon operation of the suturing tool assembly 1, the target soft tissue 70 is being arranged. As explained in greater detail later, upon operation of the suturing tool assembly 1, the shuttle 36 with an attached suture strand 31 is passed across or through this soft tissue clearance 46, and thereby forced through the soft tissue 70. The soft tissue clearance 46 is located in a central portion or section 47 of the holder 32. As depicted in the cross-sectional view of
In this example the shuttle receiving channel 49 has a curved shaped, more specifically a curved shape of a substantially constant radius. The shuttle receiving channel 49 comprises a shuttle end fixture 50. As explained in greater detail later, the shuttle end fixture 50 is configured to hold the shuttle 36 after it has passed through the soft tissue 70 and thus its purpose is to inhibit the shuttle 36 from inadvertently travelling back towards the soft tissue clearance 46. In this example, the end fixture is a narrowed channel section, i.e. a section with a smaller channel cross section than the cross section of the remainder of the shuttle receiving channel 49. The holding effect of the fixtures can be generated by friction, form fit, etc. In this example, the holding force is a friction-based holding force.
The holder 32 further comprises a blade 37 at the second holder end 45. The blade 37 intersects the shuttle receiving channel 49. The blade 37 comprises an opening or passage 51, which overlaps the shuttle receiving channel 49. The passage 51 is sized and shaped in such a manner that the shuttle 36 can pass through the passage 51 upon operation of the suturing tool assembly 1. The blade 37 comprises a cutting edge 52 which is directed towards the shuttle receiving channel 49 (or its centre). The cutting edge 52 has the purpose of cutting off a remaining piece of the suture strand 31, after a suture stitch or suture loop 42 has been placed, as depicted in
At the second holder end 45, adjacent to the soft tissue clearance 46, the holder body comprises a suture retention means or fixture 53 or a suture end fixture 54. The suture retention fixture 53 is configured to hold the second suture strand end 34 in such a manner that it will receive the suture strand 31 as soon as the shuttle 36 has passed through the suture retention fixture 53. In this example, the suture retention fixture 53 intersects the shuttle receiving channel 49. Therefore, the second suture strand end 34 overlaps the shuttle receiving channel 49. In this example, the suture retention fixture 53 holds the suture retention element 41 by means of a friction fit.
As depicted in greater detail in
In this example, the needle 16 is movably coupled to the housing 11 and can travel along a defined path. For this purpose, the suturing device 10 may comprise a groove or device channel 58 such that the needle 16 can be received in the groove or device channel and travel therein during the operation of the suturing device 10. More specifically, the needle 16 is rotatably coupled to the housing by an arm 18, which can also be understood to be part of the shuttle driving mechanism 14, and can rotate about a first axis A1 and therefore travels along a substantially semi-circular path in the present example. Therefore, in this example, the needle path has a substantially constant radius. The needle 16 is directly or indirectly actuated by the lever 12. In this example, the lever 12 is directly coupled to the shuttle driving mechanism 14 and more specifically to the arm 18 by a meshed cogwheel arrangement comprising at least two cogwheel sections, namely a first cogwheel or tooth section 20 and a second cogwheel or tooth section 21. In this example, the first cogwheel section 20 is in unity with the shuttle driving mechanism 14 (i.e. the shuttle driving mechanism can be understood to comprise the first cogwheel section), and the second cogwheel section 21 is in unity with the lever 12 (i.e. the lever can be understood to comprise the second cogwheel section). In other words, the shuttle driving mechanism 14 comprises at one of its ends the first cogwheel section 20, which in this example is configured as an entire cogwheel, while the lever 12 comprises at one of its ends the second cogwheel section 21. The lever 12 defines a second axis A2, which forms a pivot axis for the lever 12. In this example, the first and second axes are parallel or substantially parallel to each other. The second cogwheel section 21 has a greater diameter than the first cogwheel section 20, and therefore a specific angular rotation of the lever 12 will initiate a greater angular rotation of the shuttle driving mechanism 14.
The housing 11 further comprises a soft tissue window 22 which overlaps the soft tissue clearance 46 and an ejection window 23 which is sized an shaped to let the suture holder assembly 30 pass through. In this example, the soft tissue window is configured as an opening or recess, for example at the bottom of the suturing device. The ejection window is also configured in this example as an opening at the bottom of the suturing device. As shown for example in
While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive, the invention being not limited to the disclosed embodiment. Other embodiments and variants are understood, and can be achieved by those skilled in the art when carrying out the claimed invention, based on a study of the drawings, the disclosure and the appended claims. New embodiments or variants may be obtained by combining any of the above teachings.
The above-described suturing device is a manually powered and operated for serving a suturing purpose. It should be noted that alternative actuation mechanisms and methods can achieve the same purpose. These actuation mechanisms do not need to be actuated by manually applied forces, but they may instead be motor-driven or magnet-driven mechanisms. For example, the shuttle driver 13 could be arranged over a motorised spindle, which actuates the rotational movement. Equally, the stack of suture holder assemblies may be actuated to translate by means of a motor. An example translation mechanism may be a conveyor belt. Furthermore, the described example suturing device comprises a shuttle driving mechanism that is configured to rotate about an axis. Alternatively, translational movements could pass the shuttle across the soft tissue clearance and achieve the same result.
In the claims, the word “comprising” or “including” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. The mere fact that different features are recited in mutually different dependent claims does not indicate that a combination of these features cannot be advantageously used. Any reference signs in the claims should not be construed as limiting the scope of the invention.
Number | Date | Country | Kind |
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00099/21 | Feb 2021 | CH | national |
Filing Document | Filing Date | Country | Kind |
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PCT/IB2021/061124 | 11/30/2021 | WO |