Anastomotic reinforcement and repair assembly
By designing an anastomosis reinforcement repair assembly including reinforcement patches, backings and wires, the risk of anastomosis tear and complications in fragile tissue surgery is solved, and effective reinforcement and anti-pinching effects are achieved.
Patent Information
- Application Number
- CN201810418132.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2018-05-04
- Publication Date
- 2025-03-11
- Estimated Expiration
- 2038-05-04
AI Technical Summary
When performing surgery on certain fragile tissues, unprotected anastomosis lines are prone to full-line tearing, and the risk of complications such as anastomosis bleeding, air leakage, and fluid seepage is high. It is difficult for existing reinforcement and repair materials to effectively prevent the problem of clamping and nailing lines.
An anastomosis reinforcement repair assembly is designed, including a reinforcement repair piece, a backing and a wire, with the backing having an extension, the wire is disposed detachably on the extension, and the starting point of the traction section is not less than 5 mm, 7 mm or 10 mm from the edge of the reinforcement repair piece to avoid the wire being clamped.
It effectively increases the strength of fragile tissue, prevents tearing and bleeding of the anastomosis, reduces the risk of complications such as air leakage and fluid leakage, and avoids the problems of clamping and nailing lines, ensuring the stability and safety of the surgery.
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Figure CN110432942B_ABST
Abstract
Description
Technical Field
[0001] The present invention belongs to the technical field of medical devices, and specifically relates to an anastomotic stoma reinforcement and repair assembly, and more specifically relates to an anastomotic stoma reinforcement and repair assembly for a linear cutting stapler or a linear cutting stapler under laparoscopy. Background Art
[0002] Surgical staplers are widely used in surgical operations because they can quickly cut and seal tissues and organs in the patient's body at the same time. Compared with conventional surgery that first uses a scalpel / scissors to cut, they greatly reduce the risks of such surgical procedures and shorten the operation time. Generally, surgical reinforcement devices have a jaw structure, usually including two separate arms. One arm is a staple magazine arm, which has a staple magazine surface, including two or more staple lines, and the other arm is a staple anvil arm, which has a staple anvil surface. The surgical reinforcement device may be with or without a cutting device with a cutting function.
[0003] In some surgeries, it is feasible to use bare staples directly, that is, staples directly contact the patient's tissue. Because before healing, the patient's intact tissue itself can prevent the staples from detaching from the tissue and compensate for the cracks. However, for other surgeries, the tissues that need to be sutured are too fragile to fix the staples in the corresponding position. For example, in lung surgery, some lung tissues with special lesions require very fragile tissues to be anastomosed. In extreme cases, unprotected staple lines are prone to full-line tearing. With the increasing use of surgical reinforcement devices in surgery on diseased lung tissue, it has become increasingly important to take measures to protect fragile tissues from being torn by staples or being torn during surgical suturing. Furthermore, when using staplers, the problem of bleeding and exudation around staples also needs to be solved. For example, among the causes of early bleeding in gastrointestinal surgery, the most common cause is anastomotic bleeding, accounting for more than 90%; especially intraoperative bleeding during reconstruction of the anastomosis, and the bleeding sites are commonly found in the gastrointestinal anastomosis, gastric stump anastomosis, and duodenal stump. Bleeding from the anastomosis will greatly prolong the operation time and increase the patient's risk of surgical complications.
[0004] A known protective measure is to use reinforcing or strengthening materials. The working principle of such reinforcing or strengthening materials is to equip the stapler magazine and the anvil surface of the stapler with a layer of absorbable reinforcing material. While completing the cutting and stapling, the material is fixed on the anastomosis to protect the fragile tissue from being torn by the staples and to close the gap between the bare staples and the tissue or blood vessels, thereby reinforcing the anastomosis and reducing the risk of complications such as anastomotic bleeding, air leakage, and exudation.
[0005] For a linear cutting stapler or a laparoscopic linear cutting stapler, the reinforcement and repair materials used include a reinforcement and repair portion, a backing and a wire, wherein the wire is used to fix the reinforcement and repair portion and the backing in a detachable manner. Before the surgical operation, the anastomotic reinforcement and repair assembly is sleeved on the stapler magazine and the anvil of the stapler. After the stapler clamps the tissue, the stapler is activated, at which time the tissue is cut, and the reinforcement and repair pieces are fixed on both sides of the anastomosis by staples. Then, the wire is removed by pulling to separate the reinforcement and repair piece from the backing. Finally, the wire, the backing and the cut tissue are removed. In order to remove the wire, the wire is usually set to a certain length. However, due to the limitation of the surgical operation space, the stapler may clamp the wire and the staple line, and the surgical effect is affected. Summary of the invention
[0006] The technical problem to be solved by the present invention is to provide an anastomotic reinforcement and repair assembly, which can provide sufficient strength for the tissue to be treated, prevent tearing of the anastomotic stoma, and prevent bleeding, air leakage, and fluid exudation of the anastomotic stoma; at the same time, the implant material is degradable and has the function of actively inducing tissue regeneration. The anastomotic reinforcement and repair piece can further avoid the problem of clamping and nailing.
[0007] In order to solve one or more of the above problems, the present invention provides an anastomotic reinforcement and repair assembly, which can be used in conjunction with an anvil or a stapler of a stapler, and is characterized in that: the anastomotic reinforcement and repair assembly includes a reinforcement patch, a backing and a wire; the backing includes a backing body and an extension portion, the backing body at least partially overlaps the reinforcement patch, and the extension portion is connected to the backing body; at least a portion of the wire is arranged at two side edges of the backing body, for detachably connecting the reinforcement patch to the backing; at least a portion of the wire is also detachably arranged on the extension portion; the wire includes a traction section, and the starting point of the traction section is not less than 5 mm, not less than 7 mm or not less than 10 mm away from the edge of the reinforcement patch at the proximal end. In the reinforcement and repair assembly, the reinforcement patch and the backing are detachably fixed by the wire, and before the stapler is activated, the wire fixes the reinforcement patch and the backing to each other. After the stapler is activated, the reinforcement patch is fixed to the tissue incision by the stapler. At this time, by pulling the wire, the reinforcement patch is separated from the backing so that the backing can be removed. By using a backing with an extension, a part of the wire is detachably arranged on the extension of the backing, so that the extension of the backing guides the wire away from the anvil surface and the stapler magazine surface of the stapler, thereby preventing the wire from being clamped between the anvil surface and the stapler magazine surface of the stapler. At least a part of the wire is arranged on the extension of the backing, and the wire and at least a part of the extension are coupled to each other. At the proximal end of the reinforcement patch assembly, there is a coupling end point between the wire and the extension, and the wire segment from the coupling end point constitutes a traction segment, which is basically not coupled with the extension. The force of pulling the wire is applied to the traction segment of the wire. Therefore, the coupling end point can also serve as the starting point of the traction segment of the wire. The distance between the starting point and the anastomotic reinforcement patch is long enough to ensure that the wire is not clamped between the anvil surface and the stapler magazine surface. Or even if it is clamped, it can be easily discovered by the operator, thereby prompting the operator to adjust the position of the line to avoid the line being nailed or clamped, which is conducive to taking out the line by pulling.
[0008] The line includes a first line and a second line, at least a portion of the first line and at least a portion of the second line are respectively arranged at two side edges of the backing body, for detachably connecting the reinforcement patch to the backing; at least a portion of the first line is also detachably arranged on the extension portion, the first line includes a first traction segment; at least a portion of the second line is also detachably arranged on the extension portion, the second line includes a second traction segment; the starting point of the first traction segment and the starting point of the second traction segment are respectively not less than 5 mm, not less than 7 mm or not less than 10 mm away from the edge of the reinforcement patch at the proximal end. By setting the length of the sewing position, the guide line is away from the anvil surface and the stapler surface of the stapler to avoid line clamping.
[0009] The thread is detachably sewn on the extension portion, and the length of the thread at the sewing position on the extension portion is not less than 5 mm, not less than 7 mm or not less than 10 mm.
[0010] At least a portion of the thread is sewn at a side edge of the extension portion, or a sewing position of at least a portion of the thread is contracted toward a center line of the backing.
[0011] At least a portion of the extension portion forms a channel through which the wire passes. The wire is guided to a position away from the anvil surface and the nail magazine surface by setting a guide channel to avoid wire clamping. The channel has a channel wall and two ends are openings. The wire enters from one opening and exits from the other opening, thereby passing through the channel. The channel wall can be made of the same or different material as the backing.
[0012] At least a portion of the extension portion forms a first channel and a second channel, and the first wire and the second wire pass through the first channel and the second channel respectively. Separate channels can be provided for the first wire and the second wire to guide the wires away from the anvil surface and the nail magazine surface respectively.
[0013] The backing also includes a fixing portion, which can be sleeved to the end of the stapler anvil or staple magazine. The fixing portion can be sleeved with the end of the stapler anvil arm or the end of the stapler magazine arm to prevent the stoma reinforcement repair assembly from shifting when entering the body cavity through the puncture device, and to prevent the edge from rolling up. At least a part of the fixing portion can be integrated with the backing, and the material used for the first fixing portion can be reserved at one time by using the backing material; the reserved material forms the fixing portion. Alternatively, a fixing portion similar to a sleeve structure that can be sleeved at the end of the stapler is formed by arranging materials such as wires, belts, and sheets on the reserved material. The fixing portion and the backing can also be separated, in which case different materials can be selected for the fixing portion and the backing, and the fixing portion and the backing are connected by sewing, bonding, or hot pressing.
[0014] The reinforcement patch is a polymer material or a biomaterial that can be degraded in vivo. The material of the reinforcement patch is a non-immunogenic and in vivo degradable material, having a three-dimensional mesh porous structure, capable of reinforcing the anastomosis, and used in conjunction with an anastomosis device, such as a polymer material or a biomaterial. The degradable polymer material can be polylactic acid, polyethylene glycol acid, a copolymer of polyethylene glycol acid and lactic acid, a copolymer of lactic acid and caprolactone, a copolymer of polyethylene glycol acid and caprolactone, polycaprolactone, polydioxanone, or a mixture thereof. The degradable biomaterial comprises a sheet-like antigen-free animal-derived extracellular matrix material of non-cross-linked collagen fibers, mucopolysaccharides, growth factors, and glycoproteins.
[0015] The reinforced patch comprises dermal matrix, pericardium, peritoneum, bladder submucosa or small intestinal submucosa treated with immunogen removal, preferably comprises decellularized small intestinal submucosa matrix material.
[0016] A portion of the thread is non-detachably connected to the backing. When the thread includes a first thread and a second thread, a portion of the first thread and / or a portion of the second thread is non-detachably connected to the backing. By non-detachably connecting a portion of the thread to the backing or the fixing portion, the backing can be removed from the body by pulling the thread.
[0017] The anastomotic stoma reinforcement and repair assembly of the present invention can be applied to staplers of different models and is also applicable to the case where the staple cartridge surface and / or the staple anvil surface are non-planar. BRIEF DESCRIPTION OF THE DRAWINGS
[0018] Figure 1A is a schematic diagram of an anastomotic reinforcement and repair assembly according to a first embodiment of the present invention;
[0019] Figure 1B is a top view of the anastomotic reinforcement and repair assembly according to the first embodiment of the present invention;
[0020] Figure 2A is a schematic diagram of an anastomotic reinforcement and repair assembly according to a second embodiment of the present invention;
[0021] Figure 2B is a top view of an anastomotic reinforcement and repair assembly according to a second embodiment of the present invention;
[0022] Figure 3 is a schematic diagram of an anastomotic reinforcement and repair assembly according to a third embodiment of the present invention;
[0023] Figure 4 is a schematic diagram of an anastomotic reinforcement and repair assembly according to a fourth embodiment of the present invention;
[0024] Figure 5 4 is a schematic diagram of an anastomotic reinforcement and repair assembly according to a fifth embodiment of the present invention. DETAILED DESCRIPTION
[0025] The present invention is further described below in conjunction with a specific implementation method. The accompanying drawings are only used for exemplary description and are only schematic diagrams, and cannot be understood as limiting the present invention; in order to better illustrate the implementation methods of the present invention, some parts of the accompanying drawings may be omitted, enlarged or reduced, and do not represent the size of the actual product.
[0026] Figure 1A is a schematic diagram of an anastomotic reinforcement and repair assembly according to a first embodiment of the present invention, Figure 1B1 is a top view of an anastomotic reinforcement and repair assembly according to a first embodiment of the present invention. The anastomotic reinforcement and repair assembly 10 includes an anastomotic reinforcement patch sheet 11, a backing 12, and a thread 13. The two sides of the reinforcement patch sheet 11 and the backing 12 are sewed together using the thread 13, and the sew (for example, by sewing equipment or manual sewing) enables a detachable connection between the reinforcement patch sheet 11 and the backing 12. The backing 12 includes a backing main body portion overlapping the reinforcement patch sheet 11 and an extension portion 121, and the thread 13 is further arranged on the extension portion 121, for example, by a detachable sewing method. The sewing relationship between the thread 13 and the extension portion 121 enables the thread 13 to be fixed to the extension portion, and guides the thread 13 away from the stapler staple cartridge surface and the staple anvil surface to prevent the thread 13 from being clamped. At the proximal end 102, the portion of the thread 13 that leaves the sewing position is a traction section 131, which is used to provide a traction position for the operator. By grasping the traction section 131, a pulling force can be provided to the thread 13 to achieve the loosening of the thread 13. That is, in a normal state, the thread 13 fixes the reinforcement patch 11 and the backing 12 to each other, and when the traction section 131 of the thread 13 is pulled at the proximal side 102 of the anastomotic reinforcement and repair assembly 10, the thread 13 is loosened, so that the fixed patch 11 is separated from the backing 12, thereby ensuring that the reinforcement patch is retained at the anastomotic stoma on the one hand, and the backing 12 can be removed on the other hand.
[0027] Furthermore, the thread 13 can be sewed to the distal end 101 of the reinforcement patch assembly 10 in an undetachable manner, and sewed in a detachable manner at other positions. That is, when the thread 13 is pulled, the thread 13 begins to loosen, so that the reinforcement patch sheet 11 and the backing 12 are separated from each other, and the thread 13 does not separate from the backing 12 at the distal end 101 (at this time, the reinforcement patch sheet 11 and the backing 12 are completely separated), so the backing 12 can be removed by continuing to pull the thread 13. In addition, the thread 13 can also be completely separated from the reinforcement patch sheet 11 and the backing 12.
[0028] The number of threads 13 may be one or two. When there are two threads 13, both threads may be connected to the backing 12 at the distal end 101 in an undetachable manner, or any one of the two threads may be connected to the backing 12 at the distal end 101 in an undetachable manner. In either case, by pulling the thread 13, the reinforcement patch 11 and the thread 13 are separated, and the reinforcement patch 11 is separated from the backing 12. Such a structure can ensure that the backing 12 can be removed smoothly after the stapler is activated. The method used for sewing the thread includes machine sewing or manual sewing. The thread 13 can be set at both sides of the backing 12 and the reinforcement patch.
[0029] The wire 13 is coupled to the extension part 121 by sewing, and the coupled end point can be used as the starting point of the traction section 131. Based on the structure of the linear cutting stapler and the nail magazine and anvil of the linear cutting stapler under laparoscopy, the distance d between the starting point and the edge of the reinforcement patch 11 in the proximal end 102 direction is not less than 5 mm, not less than 7 mm, and not less than 10 mm; thereby ensuring that the wire 13 is away from the nail anvil surface and the nail magazine surface of the stapler. Or even if it is clamped, it can be easily found by the operator, thereby prompting the operator to adjust the position of the wire to avoid the wire being nailed or clamped, thereby facilitating the removal of the wire by pulling. The proximal side of the nail magazine and the nail anvil of the linear cutting stapler is provided with a handle, and the surface of the handle protrudes from the outer contour of the nail anvil and the nail magazine, which is not conducive to the arrangement of other structures, so the existing reinforcement repair assembly does not provide an extension part. This structure causes the starting point of the traction section of the wire to be close to the junction of the nail magazine and the nail anvil, so that the wire is easily clamped and is not easy to be found by the operator. The backing extension of the anastomotic reinforcement and repair assembly of the present invention exceeds the anvil surface and the stapler surface of the stapler, and the length extends to the handle surface. At this time, the starting point of the traction section of the wire is located above the handle surface, away from the anvil surface and the stapler surface, and the wire clamping situation is not easy to occur; and even if the wire clamping problem occurs, it is easy to find and solve. For the laparoscopic linear cutting stapler, in the process of activating the stapler, the anvil and the stapler are close to each other and closed. At this time, for the anastomotic reinforcement patch without an extension part, the starting point of the traction section of the wire is also close to or located at the junction of the stapler and the anvil. When the closing and stapling action occurs, the wire is also easily clamped or nailed. In addition, since the laparoscopic surgery is to observe the surgical situation through a camera in the abdominal cavity, it is more difficult to find the wire clamping, and the wire is more difficult to be removed. It can be seen that by setting the starting point of the traction section of the wire at a position away from the stapler and the anvil by setting the extension part, the wire clamping problem can be fundamentally solved.
[0030] Although Figure 1A and 1B The pulling section 131 of the thread is shown as being located on the same side of the backing 12 as the reinforcing patch 11, but in fact, the two may also be located on different sides of the backing 12. The thread 13 may be sewn in a manner that can be released by pulling.
[0031] Figure 2A is a schematic diagram of an anastomotic reinforcement and repair assembly according to a second embodiment of the present invention; Figure 2B2 is a top view of an anastomotic reinforcement and repair assembly according to a second embodiment of the present invention. The anastomotic reinforcement and repair assembly 20 includes an anastomotic reinforcement patch sheet 21, a backing 22, and a thread 23. The two sides of the reinforcement patch sheet 21 and the backing 22 are sewed together by the thread 23, and the sew (for example, by sewing equipment or manual sewing) makes the reinforcement patch sheet 21 and the backing 22 detachably connected. The backing 22 includes a backing main body portion overlapping the reinforcement patch sheet 21 and an extension portion 221, and the thread 23 is further arranged on the extension portion 221, for example, by a detachable sewing method. The sewing relationship between the thread 23 and the extension portion 221 fixes the thread 23 on the extension portion, guides the thread 23 away from the stapler staple cartridge surface and the staple anvil surface, and prevents the thread 23 from being clamped. At the proximal end 202, the portion of the thread 23 that leaves the sewing position is a traction section 231, which is used to provide a traction position for the operator. By grasping the traction section 231, a pulling force can be provided to the thread 23 to achieve the loosening of the thread 23. That is, in a normal state, the thread 23 fixes the reinforcement patch 21 and the backing 22 to each other, and when the traction section 231 of the thread 23 is pulled at the proximal side 202 of the anastomotic reinforcement and repair assembly 20, the thread 23 is loosened, so that the fixed patch 21 is separated from the backing 22, thereby ensuring that the reinforcement patch is retained at the anastomotic stoma on the one hand, and the backing 22 can be removed on the other hand.
[0032] Further, the thread 23 can be sewed to the distal end 201 of the backing 22 at the distal end 101 of the reinforcement and repair assembly 20 in an undetachable manner, and sewed in a detachable manner at other positions. The thread 23 can be one or two. When there are two threads 23, both threads can be connected to the backing 22 at the distal end 201 in an undetachable manner, or any one of the two threads can be connected to the backing 22 at the distal end 201 in an undetachable manner.
[0033] The difference between the second embodiment and the first embodiment is that the arrangement of the thread 23 on the extension portion 221 is such that the sewing position of the thread can include a portion gradually approaching the central axis of the backing 23. By sewing in this way, the thread 23 can be further guided away from the anvil surface and the stapler surface of the stapler to avoid the occurrence of thread clamping. Moreover, the distance d between the starting point of the traction section 231 of the thread 23 and the edge of the reinforcement patch 21 at the proximal end 202 is not less than 5 mm, not less than 7 mm, and not less than 10 mm.
[0034] Figure 33 is a schematic diagram of an anastomotic reinforcement and repair assembly according to a third embodiment of the present invention. The anastomotic reinforcement and repair assembly 30 includes an anastomotic reinforcement patch sheet 31, a backing 32 and a thread 33. The two sides of the reinforcement patch sheet 31 and the backing 32 are sewed together by thread 33, and the sew (for example, by sewing equipment or manual sewing) makes the reinforcement patch sheet 31 and the backing 32 detachably connected. The backing 32 includes a backing main body portion overlapping the reinforcement patch sheet 31 and an extension portion 321, and the thread 33 is further arranged on the extension portion 321, for example, by a detachable sewing method. The sewing relationship between the thread 33 and the extension portion 321 fixes the thread 33 on the extension portion, guides the thread 33 away from the stapler staple cartridge surface and the staple anvil surface, and prevents the thread 33 from being clamped. At the proximal end 302, the portion of the thread 33 that leaves the sewing position is a traction section 331, which is used to provide a traction position for the operator. By grasping the traction section 331, a pulling force can be provided to the thread 33 to achieve the loosening of the thread 33. That is, in a normal state, the thread 33 fixes the reinforcement patch 31 and the backing 32 to each other, and when the traction section 331 of the thread 33 is pulled at the proximal side 302 of the anastomotic reinforcement and repair assembly 30, the thread 33 is loosened, so that the fixed patch 31 is separated from the backing 32, thereby ensuring that the reinforcement patch is retained at the anastomotic stoma on the one hand, and the backing 32 can be removed on the other hand.
[0035] Figure 3 The backing 32 of the anastomotic reinforcement and repair assembly 30 shown also includes a fixing portion 34, which is used to be sleeved to the end of the nail anvil or nail magazine used in conjunction with the anastomotic reinforcement and repair assembly 30, so that the anastomotic reinforcement and repair assembly 30 is relatively fixedly arranged on the corresponding nail anvil or nail magazine to prevent the reinforcement and repair assembly from displacement and rolling. The fixing portion 34 can be a sleeve-shaped structure formed by the extension of the backing 32 in the direction of the distal end 301, can be a sleeve-shaped or mesh-shaped structure formed by the wire 33 at the distal end 301, or a sleeve-shaped structure formed by the backing 32 and the wire 33 at the distal end 301, which can be sleeved to the end of the nail anvil or nail magazine.
[0036] Figure 44 is a schematic diagram of an anastomotic reinforcement and repair assembly according to a fourth embodiment of the present invention. The anastomotic reinforcement and repair assembly 40 includes an anastomotic reinforcement patch 41, a backing 42, a thread 43 and a fixing portion 44. The reinforcement patch 41 and the two sides of the backing 42 are sutured by the thread 43, and the suture (for example, by sewing equipment or manual sewing) makes the reinforcement patch 41 and the backing 42 detachably connected. The backing 42 includes a backing main body portion overlapping with the reinforcement patch 41 and an extension portion 421, and the thread 43 is further arranged on the extension portion 421, for example, a channel structure 422 is arranged on the extension portion 421, and the thread 43 passes through the channel 422 to form a traction section 431 in the direction of the distal end 402. The channel structure 422 can be a cylindrical channel formed on the extension portion 421 using the same or different material as the backing 42, and the two ends of the channel structure 422 are provided with openings for the thread 43 to pass through. The channel structure 422 can be realized by sewing, heat pressing, etc.
[0037] The wire 43 is coupled to the extension 421 at the channel structure 422, and the coupled edge is located at the edge of the channel structure 422 in the direction of the proximal end 402, so the point of the wire 43 at the edge can be regarded as the starting point of the traction segment 431, and the distance d between the starting point of the traction segment 431 and the reinforcement patch is greater than 5mm, preferably greater than 7mm, or greater than 10mm. The relationship between the wire 43 and the extension 421 allows the wire 43 to be bound in the channel 422 of the extension 421 to a certain extent, so that the extension 421 guides the wire 43 away from the stapler cartridge surface and the staple anvil surface to prevent the wire 43 from being clamped.
[0038] At the proximal end 402, the portion of the wire 43 that leaves the channel structure 422 is a traction section 431, which is used to provide a traction position for the operator. By applying a pulling force to the traction section 431, a pulling force can be provided to the wire 43 as a whole, thereby achieving the loosening of the wire 43. That is, in a normal state, the wire 43 fixes the reinforcement patch 41 and the backing 42 to each other, and when the traction section 431 of the wire 43 is pulled at the proximal side 402 of the anastomotic reinforcement and repair assembly 40, the wire 43 is loosened, so that the fixed patch 41 is separated from the backing 42, thereby ensuring that the reinforcement patch is retained at the anastomotic stoma on the one hand, and the backing 42 can be removed on the other hand.
[0039] Figure 5Schematic diagram of an anastomotic reinforcement and repair assembly according to a fifth embodiment of the present invention. The anastomotic reinforcement and repair assembly 50 includes an anastomotic reinforcement patch 51, a backing 52 and a thread 53. The reinforcement patch 51 and the backing 52 are sewn together on both sides by the thread 53, and the sewing (for example, by sewing equipment or manual sewing) makes the reinforcement patch 51 and the backing 52 detachably connected. The backing 52 includes a backing main body portion overlapping with the reinforcement patch 51 and an extension portion 521, and the thread 53 is further arranged on the extension portion 521, for example, by arranging a channel structure 522 on the extension portion 521. Since there can be two threads 53, the channel structure 522 can also include two channels correspondingly, and the two threads can pass through the two channels of the channel structure 522 respectively. The channel structure 522 can be a cylindrical channel formed on the extension portion 521 using the same or different material as the backing 52, and the two ends of the channel structure 522 are provided with openings for the thread 53 to pass through.
[0040] The wire 53 passes through the channel 522 to form a traction section 531 in the direction of the distal end 502. The distance d between the starting point of the traction section 531 and the reinforcement patch is greater than 5 mm, preferably greater than 7 mm, or greater than 10 mm. The relationship between the wire 53 and the extension 521 allows the wire 53 to be constrained in the channel 522 of the extension 521 to a certain extent, so that the extension 521 guides the wire 53 away from the stapler cartridge surface and the staple anvil surface to prevent the wire 53 from being clamped. At the proximal end 502, the part of the wire 53 leaving the channel structure 522 is the traction section 531, which is used to provide a traction position for the operator. By grasping the traction section 531, a pulling force can be provided to the wire 53 to achieve the loosening of the wire 53. That is, under normal conditions, the wire 53 fixes the reinforcement patch 51 and the backing 52 to each other, and when the traction section 531 of the wire 53 is pulled at the proximal side 502 of the anastomotic reinforcement patch assembly 50, the wire 13 loosens, separating the fixed patch 51 from the backing 52, thereby ensuring that the reinforcement patch remains at the anastomosis on the one hand, and allowing the backing 52 to be removed on the other hand.
[0041] The anastomotic reinforcement patch can be made of degradable polymer materials. The anastomotic reinforcement patch can also be made of extracellular matrix treated with immunogen removal, such as dermal matrix, pericardium, peritoneum, bladder submucosa or small intestinal submucosa. The small intestinal submucosa is preferably a pig or bovine small intestinal submucosa matrix. The backing can be made of one or more combinations of medical fabrics or medical non-woven fabrics, synthetic polymer materials, Tyvek paper, and medical synthetic paper. The thread can be sterilized thread, and medical sutures can be selected.
[0042] The above is an explanation of the preferred embodiments of the present invention, but it cannot be understood as a limitation of the claims. The present invention is not limited to the above embodiments, and its specific structure is allowed to be changed. All changes made within the scope of protection of the independent claims of the present invention are within the scope of protection of the present invention.
Claims
1. An anastomotic stoma reinforcement and repair assembly, which can be used in conjunction with an anvil or a stapler of a stapler, and is characterized by: The anastomotic reinforcement and repair assembly includes a reinforcement patch, a backing and a wire; the backing includes a backing body and an extension portion, the backing body at least partially overlaps the reinforcement patch, and the extension portion is connected to the backing body; at least a portion of the wire is arranged at two side edges of the backing body for detachably connecting the reinforcement patch to the backing; at least a portion of the wire is also detachably arranged on the extension portion; the wire includes a traction segment, and the starting point of the traction segment is not less than 5 mm, not less than 7 mm or not less than 10 mm away from the edge of the reinforcement patch at the proximal end.
2. The anastomotic reinforcement and repair assembly according to claim 1, characterized in that: The wire includes a first wire and a second wire, at least a portion of the first wire and at least a portion of the second wire are respectively arranged at two side edges of the backing body, for detachably connecting the reinforcement patch to the backing; at least a portion of the first wire is also detachably arranged on the extension portion, and the first wire includes a first traction segment; at least a portion of the second wire is also detachably arranged on the extension portion, and the second wire includes a second traction segment; the starting point of the first traction segment and the starting point of the second traction segment are respectively not less than 5 mm, not less than 7 mm or not less than 10 mm away from the edge of the reinforcement patch at the proximal end.
3. The anastomotic reinforcement and repair assembly according to claim 1, characterized in that: The thread is detachably sewn on the extension portion, and the length of the thread at the sewing position on the extension portion is not less than 5 mm, not less than 7 mm or not less than 10 mm.
4. The anastomotic reinforcement and repair assembly according to claim 2, characterized in that: The thread is detachably sewn on the extension portion, and the length of the thread at the sewing position on the extension portion is not less than 5 mm, not less than 7 mm or not less than 10 mm.
5. The anastomotic reinforcement and repair assembly according to any one of claims 1 to 4, characterized in that: At least a portion of the thread is sewn at a side edge of the extension portion, or a sewing position of at least a portion of the thread is contracted toward a center line of the backing.
6. The anastomotic reinforcement and repair assembly according to claim 1 or 2, characterized in that: At least a portion of the extension defines a channel through which the wire passes.
7. The anastomotic reinforcement and repair assembly according to claim 2, characterized in that: At least a portion of the extension portion encloses a first channel and a second channel, and the first wire and the second wire pass through the first channel and the second channel, respectively.
8. The anastomotic reinforcement and repair assembly according to any one of claims 1 to 4, characterized in that: The backing further comprises a fixing portion, which can be sleeved onto the end of the stapler anvil or the staple cartridge.
9. The anastomotic reinforcement and repair assembly according to any one of claims 1 to 4, characterized in that: The reinforcement patch is made of a biodegradable polymer material or a biodegradable biological material.
10. The anastomotic reinforcement and repair assembly according to any one of claims 1 to 4, characterized in that: The reinforcement patch comprises dermal matrix, pericardium, peritoneum, bladder submucosa or small intestinal submucosa treated to remove immunogens.
11. The anastomotic reinforcement and repair assembly according to any one of claims 1 to 4, characterized in that: The reinforcement patch includes a decellularized small intestinal submucosa matrix material.
12. The anastomotic reinforcement and repair assembly according to any one of claims 1 to 4, characterized in that: A portion of the thread is non-detachably connected to the backing.
13. The anastomotic reinforcement and repair assembly according to claim 2 or 4, characterized in that: A portion of the first thread and / or a portion of the second thread is non-detachably connected to the backing.
Citation Information
Patent Citations
Anastomotic stoma reinforcing and repairing assembly
CN209236256U