Disclosure of Invention
The present disclosure aims to provide a repair patch for reinforcing an anastomotic stoma, aiming at the technical problems in the related art. The specific scheme is as follows:
The embodiment of the disclosure provides an anastomotic stoma reinforcement repair sheet, which comprises a backing, a repair sheet, an end cap, a suture and a traction wire, wherein the backing is provided with a first surface and a second surface which are mutually deviated in the thickness direction, the backing is configured into an arc structure, a first end and a second end which are opposite in direction are arranged in the extending direction of the arc structure, the backing is used for assembling an anastomotic mechanism of an arc anastomat, the repair sheet is arranged on the first surface and is detachably connected with the backing and is provided with an arc structure matched with the backing, the end cap is arranged on the first surface of the backing, the arc end of the end cap is connected with the first end, the end cap is used for limiting the anastomotic stoma reinforcement repair sheet to be connected with the arc anastomat, the suture is arranged on the backing and is connected with the repair sheet and the end cap, the suture is arranged into a closed ring shape on the backing, and the traction wire is sleeved on the suture wire adjacent to the second end and drags the suture wire under the action of external force so as to drive the suture to separate from the backing.
In some embodiments, the radius length of the inner arc of the patch is r, the value range of r is 15mm-40mm, the width of the patch is w, the value range of w is 5mm-20mm, the central angle of the arc-shaped structure is θ, and the value range of θ is 80 ° -180 °.
In some embodiments, the suture comprises a first suture 311, wherein the first suture 311 is penetrated through the repair sheet and the back lining for a plurality of times, double-stranded wires are exposed on the first surface of the back lining and the repair sheet, the double-stranded wire sleeve forms a lasso structure, and single-stranded wires are exposed on the second surface of the back lining, and a second suture is penetrated through the lasso structure for a plurality of times, and is separated from the first suture 311 after being subjected to external force.
In some embodiments, the pull wire is connected to the second suture, and pulling the pull wire under an external force separates the second suture from the first suture 311.
In some embodiments, at least a portion of the pull wire connected to the suture is configured as a pull ring that encases the second suture.
In some embodiments, the patch and the backing have a first state in which at least a portion of the patch is connected, and a second state in which the patch and the backing are relatively independent, the pull wire being pulled by an external force to transition the patch and the backing from the first state to the second state.
In some embodiments, the patch extends in a direction of curvature of the backing, and at least a portion of the patch is housed inside the end cap.
In some embodiments, the backing includes a first arcuate structure that curves in a counterclockwise direction on a first side of the backing, and a second arcuate structure that curves in a clockwise direction on the first side of the backing, wherein the first arcuate structure and the second arcuate structure are configured as symmetrical structures on the first side of the backing.
In some embodiments, the suture thread is a closed loop extending along the edges of the first and second arcuate structures traversing both suture threads on the axes of symmetry of the first and second arcuate structures.
In some embodiments, the pull wire is sleeved with two sutures, and the pull wire is pulled under the action of external force so that the two sutures are separated from the back lining at the same time.
Compared with the related art, the scheme of the embodiment of the disclosure has at least the following beneficial effects:
The present disclosure provides a stoma reinforcement repair patch, comprising an arc-shaped backing, a repair patch matching the shape of the arc-shaped backing, a suture line, and a pull line. The suture line is arranged on the back lining in a closed ring shape, the traction line is sleeved on the suture line, and the traction line is dragged under the action of external force, so that the suture line can be driven to be separated from the back lining. The arc anastomat is applied to clinical operation, after the anastomat reinforcing repair patch is sleeved on the anastomat, the annular closed suture line can be separated from the backing only by dragging the traction line, so that a doctor can conveniently control the anastomat reinforcing repair patch, and the operation accuracy and timeliness are improved.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosure.
Detailed Description
For the purpose of promoting an understanding of the principles and advantages of the disclosure, reference will now be made in detail to the drawings, in which it is apparent that the embodiments described are only some, but not all embodiments of the disclosure. Based on the embodiments in this disclosure, all other embodiments that a person of ordinary skill in the art would obtain without making any inventive effort are within the scope of protection of this disclosure.
The terminology used in the embodiments of the disclosure is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. As used in this disclosure of embodiments and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise, the "plurality" generally includes at least two, other words similar.
It should be understood that although the terms first, second, third, etc. may be used in embodiments of the present disclosure to describe the terms. These terms are only used to distinguish. For example, the first..once again may be referred to as the second..once again, and similarly, the second..once again may be referred to as the first..once again without departing from the scope of the embodiments of the present disclosure. Furthermore, the terms "first," "second," "third," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
It should be understood that the term "and/or" as used herein is merely an association relationship describing the associated object, and means that there may be three relationships, e.g., a and/or B, and that there may be three cases where a exists alone, while a and B exist together, and B exists alone. In addition, the character "/" herein generally indicates that the front and rear associated objects are an "or" relationship. The singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.
It will be further understood that the terms "center," "longitudinal," "transverse," "front," "rear," "upper," "lower," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like, as used herein, are merely for convenience in describing the present embodiments and simplifying the description, and do not denote or imply that the devices or elements being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be construed as limiting the invention.
In the description of the present disclosure, unless explicitly stated and limited otherwise, the terms "connected" and "connected" are to be construed broadly, and for example, they may be fixedly connected, detachably connected, or integrally connected, mechanically connected, electrically connected, or indirectly connected through an intermediary. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
The words "if", as used herein, may be interpreted as "at" or "when" or "in response to a determination" or "in response to a detection", depending on the context. Similarly, the phrase "if determined" or "if detected (stated condition or event)" may be interpreted as "when determined" or "in response to determination" or "when detected (stated condition or event)" or "in response to detection (stated condition or event), depending on the context.
It should also be noted that the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a product or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such product or apparatus. Without further limitation, an element defined by the phrase "comprising one does not exclude the presence of additional like elements in a commodity or device comprising the element.
In the related art, the stoma reinforcing patch includes a backing, a patch, and a suture. The suture connects the backing and patch together so that the backing and patch are integral and the two sutures have a longer pull segment. When in use, the repair sheet is arranged on the anastomat, and then the front part of the anastomat is stretched into the body cavity to reach the focus. Closing the jaw of the anastomat to clamp the tissue to be anastomosed. The pulling section is then pulled to completely separate the patch from the backing. Because the suture and the backing have fixed connection points at the front end, the backing is pulled by the suture to be withdrawn. Then, the anastomat is fired, the tissue is cut by the anastomat, and an anastomotic stoma is formed, and the anastomat fixes the repairing sheet at the anastomotic stoma and cuts the repairing sheet into two parts at the same time of forming the anastomotic stoma. The stapler jaw is then released, the stapler is then withdrawn from the patient, and the pulling section is continued to be pulled and the backing removed. Thereby completing the operation and realizing the purpose of repairing the anastomotic stoma by the repairing piece.
The commonly used endoscopic anastomat is mainly used for the operation in the abdominal cavity, and the anastomat enters the abdominal cavity through the puncture outfit to reach the focus. The front end of the anastomat is of a linear structure. However, due to the narrow surgical space of some specific parts, such as rectal tumor surgery in the pelvis, a linear anastomat can enter the pelvis, but the cutting line is linear, so that the tumor can not be deeply cut in the pelvis. For such operations, particularly low-level rectal tumor operations, the arcuate stapler is used to excise the lesion, and there is a risk of bleeding and non-tight suturing of the stoma with the stapler.
In view of this, alternative embodiments of the present disclosure are described in detail below with reference to the drawings.
The disclosed embodiment provides a stoma reinforcement repair 200, comprising a backing 100, an end cap 103, a repair 200, a suture 310, and a pull wire 320.
The backing 100 has a first surface and a second surface facing away from each other in a thickness direction, the backing 100 is configured in an arc structure, as shown in fig. 1, a first end 101 and a second end 102 opposite to each other are disposed in an extending direction of the arc structure, and the backing 100 is used for assembling an anastomotic mechanism of an arc anastomat.
The repair sheet 200 is disposed on the first surface, is detachably connected to the backing 100, and has an arc structure matched with the backing 100.
When the anastomotic stoma reinforcement repairing sheet 200 is sleeved on the arc-shaped anastomat and applied to clinical practice, the arc-shaped anastomat with the repairing sheet 200 is inserted into a human body cavity, and the repairing sheet 200 with the arc-shaped structure is applied to the arc-shaped anastomat and can repair an anastomotic stoma in a narrow space so as to protect fragile tissues from being torn, thereby reinforcing the anastomotic stoma and reducing risks of bleeding, liquid seepage and the like of the anastomotic stoma.
The end cap 103 is disposed on the first surface of the backing 100, the arc end of the end cap 103 is fixedly connected with the first end 101 of the backing 100, the end cap 103 is foldable to enable the end cap 103 to coincide with the backing 100, and the end cap 103 is used for limiting the connection of the anastomotic stoma reinforcement repairing sheet 200 with the arc anastomat.
Specifically, at least a portion of the end cap 103 is fixedly connected with the end portion of the backing 100, and the end cap 103 is sleeved with an arc-shaped anastomat, so as to wrap the end portion of the arc-shaped anastomat and prevent the end portion of the arc-shaped anastomat from directly contacting human tissues.
The suture 310 is disposed on the backing 100 for connecting the backing 100 with the patch 200 and the end cap 103, as shown in fig. 2, the suture 310 being disposed in a closed loop on the backing 100.
In some embodiments, at least a portion of the suture 310 is coupled to the end cap 103 to avoid a gap between the end cap 103 and the patch 200 exposing the stapler. Wherein the suture 310 removably connects the endcap 103 and the patch 200 to the backing 100.
Specifically, the end cap 103 and the backing 100 have an unfolded state and a folded state, as shown in fig. 1 and 2, when the end cap 103 is not sewn to the backing 100 by the suture thread 310, the end cap 103 and the backing 100 are in the unfolded state, the end of the end cap 103 is connected to the first section of the backing 100, the end cap 103 is supplemented to the backing 100, and when the end cap 103 and the backing 100 are sewn by the suture thread 310, the end cap 103 is overlapped with the first end 101 of the backing 100, and the end cap 103 and the backing 100 are in the folded state.
The end cap 103 has at least a single side opening facing the direction of the second end 102, the end cap 103 is used for accommodating the end of the arc-shaped anastomat, so that the end of the arc-shaped anastomat is abutted with the end cap 103 and wrapped in the end cap 103, the end of the arc-shaped anastomat is prevented from directly contacting human tissues, and simultaneously, the repairing sheet 200 is prevented from being turned over due to touching the inner cavity wall when the arc-shaped anastomat works in a narrow space.
It should be noted that the use of a stoma-strengthening repair patch with end cap 103 helps to accurately fix the position of repair patch 200 and prevents repair patch 200 from rolling over. For an open surgical stapler with a more sufficient operation space, the stoma reinforcement repair sheet without the cap 103 may be used. This is because, for open surgery, the working space is large, and a stoma-reinforcing repair sheet with or without the cap 103 can be used.
In some embodiments, the patch 200 extends in the direction of curvature of the backing 100, and at least a portion of the patch 200 is housed inside the end cap 103.
Specifically, the repair sheet 200 is disposed on the first surface of the backing 100, and the suture thread 310 is used to suture the repair sheet 200 to the backing 100, so that the repair sheet 200 is detachably connected to the backing 100. The first end 101 of the backing 100 is provided with an end cap 103 for receiving at least a portion of the repair sheet 200.
In some embodiments, one end of suture 310 is non-detachably sutured to the backing for attachment to backing 100 after suture 310 is detached, thereby pulling backing 100 from within the body cavity to the outside of the body. If suture 310 is completely separated from backing 100, backing 100 may be removed from the body by other medical devices, such as medical forceps or clamps.
In some embodiments, at least a portion of the suture 310 is coupled to the end cap 103, and at least a portion of the repair sheet 200 extends into the interior of the end cap 103 for guiding an arcuate stapler into the end cap 103. Wherein the suture 310 removably positions the end cap 103 on the backing 100. When the suture 310 is removed, the suture connection of the end cap 103 to the backing 100 can be released, thereby releasing the sleeved arcuate stapler end.
In some embodiments, the stoma reinforcement repair 200 further includes a pull wire 320, wherein the pull wire 320 is sleeved on the suture thread 310 adjacent to the second end 102, and the pull wire 320 is pulled under an external force to drive the suture thread 310 to separate from the backing 100.
Specifically, pulling the pull wire 320 under external force may disengage the suture 310 from the backing 100, and further, transition the end cap 103 from the folded state to the unfolded state, and the repair sheet 200 is separated from the backing 100. At this time, the repair patch 200 and the end cap 103 are in the unfolded state, the repair patch 200 is independent from the backing 100, the anastomotic stoma reinforcement repair patch 200 is repaired to the affected part of the patient, and the backing 100 and the arc anastomat can be withdrawn out of the patient.
In some embodiments, as shown in fig. 3, two sides of the curved extension direction of the arc-shaped repairing piece 200 have the same circle center and central angle, and in practical application, parameters of the repairing piece 200 are defined to enable the repairing piece 200 to have a higher matching degree with the arc-shaped anastomat.
Specifically, the centers of the two circular arcs on the patch 200 are spatially named as (a, b), the radius length of the inner circular arc of the patch 200 is r, r=15 mm-40mm, the width of the patch 200 is w, w=5 mm-20mm, the central angle of the arc structure is θ, θ=80° -180 °, and for example, the central angle θ may be 90 °, 100 °, 110 °, 120 °, 130 °, 140 °,150 °, 160 ° or 170 °. The repair sheet 200 can meet the standard of the matching precision with the arc anastomat under the multi-use scene under the limitation, is convenient for a doctor to control the anastomotic stoma reinforcement repair sheet 200 in clinical practice, and improves the accuracy and timeliness of the operation.
In some embodiments, the suture 310 includes a first suture 311 and a second suture 312.
The first suture line 311 is repeatedly threaded through the repair sheet 200 and the backing 100, as shown in fig. 4, the first suture line 311 exposes a plurality of sections of double-strand sleeves on the first surface of the backing 100 and the repair sheet 200, a lasso structure is formed between the double-strand sleeves, a plurality of sections of single-strand wires are exposed on the second surface of the backing 100, the second suture line 312 is repeatedly threaded through the lasso structure, the lasso structure can be untied when the second suture line 312 is pulled, and after the lock sleeve structure is untied, the first suture line 311 is separated from the second suture line 312.
Specifically, when the repair sheet 200 and the backing 100 are in the first state, the external force pulls the free end of the traction section of the second suture 312, the second suture 312 is pulled out of the lasso structure, and at the same time, the lasso structure of the first suture 311 is released. The connection state of the patch 200 to the backing 100 is changed from the first state to the second state, i.e., the backing 100 is separated from the patch 200.
In some embodiments, the pull wire 320 is connected to the second suture line 312, and pulling the pull wire 320 under an external force may separate the second suture line 312 from the first suture line 311. As shown in fig. 1, at least a portion of the pull wire 320 connected to the suture 310 is configured as a pull ring 321, and the pull ring 321 is sleeved with the second suture 312.
In some embodiments, the patch 200 and the backing 100 have a first state in which at least a portion of the patch 200 is connected, and a second state in which the patch 200 is independent of the backing 100, and an external force pulls the pull wire 320 to transition the patch 200 and the backing 100 from the first state to the second state.
Specifically, when the repair sheet 200 and the backing 100 are in the first state, the repair sheet 200 is connected to at least a portion of the backing 100, and the stoma reinforcement repair sheet 200 is sleeved on the arc-shaped anastomat or at least a portion of the repair sheet is wrapped around the arc-shaped anastomat.
When the repair patch 200 and the back 100 are in the second state, the repair patch 200 and the back 100 are relatively independent, the anastomotic stoma reinforcing repair patch 200 is repaired to the affected part of the patient, and the back 100 and the arc anastomat can be withdrawn out of the patient.
When the patch 200 and the backing 100 are in the first state, the traction wire 320 is pulled by an external force, so that the connection state of the patch 200 and the backing 100 can be switched from the first state to the second state.
In some embodiments, the backing 100 includes a first arcuate structure 110 and a second arcuate structure 120.
As shown in fig. 5, the first arc structures 110 are curved in a counterclockwise direction on the first side of the backing 100, and the second arc structures 120 are curved in a clockwise direction on the first side of the backing 100, wherein the first arc structures 110 and the second arc structures 120 are configured in a symmetrical structure on the first side of the backing 100.
The first arc-shaped structure 110 and the second arc-shaped structure 120 are respectively provided with a first repairing piece 210 and a second repairing piece 200, the first repairing piece 210 is bent towards the anticlockwise direction on the first surface of the backing 100, and the second repairing piece 200 is bent towards the clockwise direction on the first surface of the backing 100. The first repair sheet 210 and the second repair sheet 200 are configured in a symmetrical structure on the first face of the backing 100.
In clinical practice, the first arc-shaped structure 110 and the second arc-shaped structure 120 are respectively sleeved on two anastomotic forceps of the arc-shaped anastomat, and when the two anastomotic forceps are meshed, the back lining 100 with the first arc-shaped structure 110 and the second arc-shaped structure 120 is folded in half along the symmetry axis, so that the arc-shaped anastomotic stoma repair operation in the long and narrow space is realized.
In some embodiments, the suture lines 310 are closed loops extending along the edges of the first and second arcuate structures 110, 120, the axes of symmetry of the first and second arcuate structures 110, 120 traversing the two suture lines 310. The pull wire 320 is sleeved with two sutures 310 on the symmetry axis, and the pull wire 320 is pulled under the action of external force, so that the two sutures 310 are separated from the backing 100 at the same time.
In some embodiments, the suture lines 310 may be provided with two sets, as shown in fig. 6 and 7, where the two sets of suture lines 310 extend along the edges of the first and second arcuate structures 110 and 120, respectively, to form two closed loop structures. The pulling wire 320 is sleeved on one end of the two sutures 310 on two sides of the symmetry axis, which is far away from the end cap 103, and the pulling wire 320 is pulled under the action of external force, so that the two sutures 310 are separated from the backing 100 at the same time.
Because the suture lines 310 are closed loop-shaped, when the pulling lines 320 are pulled by an external force, the two groups of closed loop-shaped suture lines 310 have the same force trend, and the pulling section is pulled to switch the backing 100 and the repair sheet 200 from the first state to the second state.
It should be noted that when pulling the pull wire 320, the pulling force applied to the two sutures 310 is substantially the same due to the pull ring 321. This is because, when the traction wire 320 is pulled, the traction wires 320 located on both sides are pulled at the same time, but are individually stressed, and the lengths of the traction wires 320 located on the inner and outer arcs are different, so that the dismantling speeds are also different, which tends to cause uneven stress on both sides of the patch. Through the arrangement of the traction ring 321, the traction wires 320 on two sides can be stressed simultaneously, and the traction wires 320 on two sides of the repairing sheet 200 are sleeved with the traction ring 321 though the disassembling speeds are different, so that the traction wires 320 on the fast disassembling side can be compensated for the traction wires 320 on the slow disassembling side, and the traction wires 320 are pulled simultaneously and stressed uniformly. Therefore, when the pulling wire 320 is pulled to drive the suture line 310 to be separated from the backing 100, the stability of the connection between the repair sheet 200 and the anastomat can be ensured, and the accurate positioning of the repair sheet 200 on the anastomat is prevented from being affected due to uneven detachment stress.
In some embodiments, the repair 200 is provided with a knife slot. The guide groove extends along the length direction of the repair sheet 200, and is substantially in the shape of a bar, and an orthographic projection on a plane parallel to a horizontal plane is substantially in the shape of a rectangle, but is not limited thereto, and in other examples, the orthographic projection may be in the shape of a chamfered rectangle or other polygonal shapes. The foregoing is illustrative only and is not to be construed as limiting the invention.
The knife guiding groove is used for being matched with a cutting assembly of the anastomat, and the cutting position of the cutting assembly in cutting treatment of tissues to be treated and the like is limited through the knife guiding groove.
Specifically, after the repair sheet 200 contacts with the anastomotic stoma, the cutting assembly inside the anastomat can cut the repair sheet 200 into two parts along the extending direction of the guiding knife groove, and the guiding knife groove can ensure that the cutting assembly cuts off the repair sheet 200 completely, and simultaneously ensure that the repair sheet 200 is anastomosed with the anastomotic stoma completely, without using an additional cutting tool, thereby realizing the convenience of operation in practical application.
The biomaterial used for the patch 200 for the stoma reinforcement patch product of the present application is selected from a degradable polymer material or a degradable animal-derived biomaterial. Preferably, the degradable animal-derived biomaterial comprises an immunogen-removed dermal matrix, pericardium, peritoneum, urinary bladder submucosa or small intestine submucosa, or a combination of these materials, such as obtained by lamination, braiding, inlaying, and the like. Preferably comprises decellularized intestinal submucosa matrix material. The degradable polymeric material may be selected from PGA, PLA or PLGA, or a combination of these materials, for example obtained by lamination, braiding, inlaying or the like.
The specific structure, working principle and beneficial effects of the anastomotic stoma reinforcement repair patch 200 provided in the embodiments of the present disclosure may refer to the anastomotic stoma reinforcement repair patch 200 described in any of the foregoing embodiments, and will not be described herein.
Finally, it should be noted that, in the present specification, each embodiment is described in a progressive manner, and each embodiment is mainly described by differences from other embodiments, and identical and similar parts between the embodiments are only required to be mutually referred. The system or the device disclosed in the embodiments are relatively simple in description, and the relevant points refer to the description of the method section because the system or the device corresponds to the method disclosed in the embodiments.
The foregoing embodiments are merely for illustrating the technical solutions of the present disclosure, and not for limiting the same, and although the present disclosure has been described in detail with reference to the foregoing embodiments, it will be understood by those skilled in the art that modifications may be made to the technical solutions described in the foregoing embodiments or equivalents may be substituted for some of the technical features thereof, and such modifications or substitutions do not depart from the spirit and scope of the technical solutions of the embodiments of the present disclosure in essence.