Gastropuncture occlusion device and mold for facilitating deployment
By designing an easily deployable gastric perforation closure device, which is then deployed and fixed to the stomach wall using laparoscopic minimally invasive surgery, the shortcomings of suturing techniques and existing closure devices are overcome, enabling rapid sealing and repair of gastric perforations.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2023-05-05
- Publication Date
- 2026-03-31
AI Technical Summary
In current gastric perforation repair surgery, suturing techniques are prone to causing granulomas or gastric fluid leakage, and the sealing instruments are complex in structure, large in size, and difficult to deploy, which affects gastric recovery.
Design an easily deployable gastric perforation closure device, including a deployable component, a connector, a first sealing body, and a second sealing body. It can be deployed and fixed to the gastric wall through laparoscopic minimally invasive surgery. It utilizes protein denaturation and stem cell exosomes to achieve connection with the gastric wall, reducing the size and burden of the device.
It improves the ease of sealing gastric perforations, shortens the repair cycle, reduces the burden on the stomach and the risk of complications, and promotes the recovery of gastric function.
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Figure CN116849747B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical surgical instruments, and in particular to a gastric perforation closure device and mold that is easy to deploy. Background Technology
[0002] Gastric perforation is generally treated with open surgery and laparoscopic minimally invasive surgery. Current techniques for repairing gastric perforation include suturing the perforation using traditional suturing techniques and sealing the perforation with occluding instruments. When suturing a gastric perforation, there are two main issues: firstly, the sutures can easily irritate the stomach wall, leading to granulation tissue formation and hindering healing and repair; secondly, a gap is always unavoidable between the suture and the needle hole. If the suture tension is too low, the perforation will not be tightly closed, allowing gastric fluid to leak from both the perforation and the needle hole, preventing the surgery from achieving the desired repair. Conversely, if the suture tension is too high, the needle hole in the stomach wall will deform under the force of the suture, increasing the gap between the needle hole and the suture, allowing gastric fluid to leak out.
[0003] In existing technologies, repairing gastric perforations using sutures is a complex procedure, and improper operation can easily lead to granulomas or gastric leakage, severely impacting gastric recovery. When using occlusion devices to seal gastric perforations, two issues arise: firstly, to facilitate deployment, these devices often incorporate internal deployment structures such as shape-memory metals. These complex structures make it difficult to accommodate the device within the guide tube or to deploy it, resulting in high installation difficulty and cost; secondly, existing occlusion devices are often thick and bulky, increasing the burden on the stomach and affecting its normal function, thus hindering rapid recovery from the perforation. Summary of the Invention
[0004] This invention proposes an easy-to-deploy gastric perforation sealing device, which can improve the convenience of sealing gastric perforations and shorten the gastric perforation repair cycle.
[0005] To achieve the above objectives, the present invention proposes an easily deployable gastric perforation closure device, which has a first state and a second state. The easily deployable gastric perforation closure device includes a deployable component, a connector, a first sealing body, and a second sealing body. The connector is used to pass through the gastric perforation and has a first axis. The first sealing body is connected to one end of the connector along the first axis. In the first state, the first sealing body is contracted towards the first axis to allow placement of a surgical catheter. In the second state, the first sealing body is deployed away from the first axis to connect with the inner wall of the stomach to cover the gastric perforation, and the first sealing body restricts a first chamber. The second sealing body is connected to the other end of the connector along the first axis. In the first state, the second sealing body is contracted towards the first axis to allow placement of a surgical catheter. In the second state, the second sealing body is deployed away from the first axis to connect with the outer wall of the stomach. The connecting body and the second sealing body together define a second chamber with a first opening. The first opening is located on the side of the second sealing body opposite to the connecting body, and the first chamber communicates with the second chamber. In the first state, the unfolding member is positioned in the second chamber along a direction parallel to the first axis. In the second state, the end of the unfolding member near the first chamber is bent so that it can enter the first chamber and contact the side of the first sealing body near the connecting body, thereby allowing the unfolding member to unfold the first sealing body.
[0006] In some embodiments, the first sealing body includes a first fold portion, the first fold portion including a first portion and a second portion circumferentially distributed along a first axis. In a first state, the first portion and the second portion are stacked together. In a second state, the first portion and the second portion are circumferentially arranged along the first axis.
[0007] In some embodiments, the second sealing body includes a second fold portion, the second fold portion including a third portion and a fourth portion circumferentially distributed along a first axis. In a first state, the third portion and the fourth portion are stacked together, and in a second state, the third portion and the fourth portion are circumferentially arranged along the first axis.
[0008] In some embodiments, the first sealing body includes a plurality of first folds along the circumferential direction of the first axis.
[0009] In some embodiments, the second sealing body includes a plurality of second folds along the circumferential direction of the first axis.
[0010] In some embodiments, the connector has a first peripheral wall disposed around a first axis, the first peripheral wall being used to connect to the peripheral wall of a gastric perforation.
[0011] In some embodiments, the deployable gastric perforation closure device has proteins and stem cell exosomes, and the proteins of the first seal are denatured to allow the first seal to connect with the inner wall of the stomach.
[0012] In some embodiments, the deployable gastric perforation closure device has proteins and stem cell exosomes, wherein the proteins of the second seal are denatured to allow the second seal to connect to the outer wall of the stomach.
[0013] In some embodiments, the easily deployable gastric perforation closure device further includes electrodes for conducting current to the first seal and the stomach, causing the proteins of the first seal to denature and connect with the proteins of the stomach lining.
[0014] In some embodiments, the easily deployable gastric perforation closure device further includes electrodes for conducting current to the second seal and the stomach, causing the proteins of the second seal to denature and connect with the proteins of the stomach lining.
[0015] On the other hand, the present invention also provides a mold comprising an intermediate body, a first end, and a second end. The intermediate body has a second axis. The first end is connected to one end of the intermediate body along the second axis, and the first end has a first molding cavity with an opening recessed towards the side closer to the intermediate body. Along a first direction, the projected area of the first molding cavity in a plane perpendicular to the first direction gradually decreases. The second end is connected to the other end of the intermediate body along the second axis, and the second end has a second molding cavity with an opening recessed towards the side closer to the intermediate body. Along the first direction, the projected area of the second molding cavity in a plane perpendicular to the first direction gradually increases. The direction from the first end to the second end is defined as the first direction.
[0016] In some embodiments, the first end is configured as a cone, having a first inner groove and a first outer groove extending parallel to the generatrix of the cone. The first inner groove and the first outer groove are arranged adjacent to each other around a second axis. The side of the first inner groove near the second axis communicates with a first molding cavity, and the side of the first outer groove opposite to the second axis has an opening, which is spaced apart from the first molding cavity. The second end is also configured as a cone, having a plurality of second inner grooves and second outer grooves extending parallel to the generatrix of the cone. The second inner grooves and the second outer grooves are arranged adjacent to each other around a second axis. The side of the second inner groove near the second axis communicates with a second molding cavity, and the side of the second outer groove opposite to the second axis has an opening, which is spaced apart from the second molding cavity.
[0017] Compared with the prior art, the beneficial effects of the present invention are:
[0018] The present invention provides a deployable gastric perforation closure device, which has a first state and a second state. The deployable gastric perforation closure device includes a deployable component, a connecting body, a first sealing body, and a second sealing body. In the first state, both the first and second sealing bodies can be contracted towards a first axis to allow placement within a surgical catheter, enabling easy application in laparoscopic minimally invasive surgery. In the second state, the first sealing body deploys and seals the gastric perforation on the inner wall of the stomach, preventing gastric fluid from flowing out through the perforation. The second sealing body deploys and connects to the outer wall of the stomach, allowing the deployable gastric perforation closure device to be stably fixed to the stomach wall. The first sealing body defines a first chamber, and the connecting body and the second sealing body together define a second chamber with a first opening, with the first and second chambers communicating. In the first state, the unfolding member can be disposed in the second chamber along a direction parallel to the first axis. In the second state, the end of the unfolding member near the first chamber is bent so that it can enter the first chamber and contact the side of the first sealing body near the connecting body, so that the unfolding member can unfold the first sealing body.
[0019] Existing technologies employ elastic elements and shape-memory metals to deploy occlusion devices. These deployment structures are housed within the occlusion device. However, these deployment structures are not only costly but also result in larger occlusion devices that are difficult to accommodate within a guide tube, significantly increasing the difficulty of use. In contrast, the present application's solution features a connected first and second chamber, through which the deployable component can pass, thereby enabling the deployment of the first sealing body. Since there is no need for additional auxiliary deployment devices within the easily deployable gastric perforation occlusion device, the present application's easily deployable gastric perforation occlusion device can have a smaller volume and a significantly reduced overall thickness, making it easier to place in the guide tube. Furthermore, the deployable component can be withdrawn from the first and second chambers after deploying the first sealing body, eliminating the need to leave it in the stomach. Meanwhile, the reduction in the thickness of the first and second sealing bodies, as well as the removal of the unfolding component, allows for a thinner and lighter gastric perforation closure device that is easier to unfold, thereby effectively reducing the burden on the stomach and improving the repair capability of gastric perforations. In conclusion, the technical solution of this application can greatly improve the convenience of sealing gastric perforations, while reducing the burden on the stomach, which is conducive to the repair of gastric perforations and shortens the repair cycle. Attached Figure Description
[0020] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.
[0021] Figure 1 This is a schematic diagram of the structure of a gastric perforation closure device in a first state according to an embodiment of the present invention;
[0022] Figure 2 This is a schematic diagram of the structure of a gastric perforation occlusion device placed in a surgical catheter in a first state according to an embodiment of the present invention.
[0023] Figure 3 This is a schematic diagram of the structure of a gastric perforation occlusion device in a second state according to an embodiment of the present invention;
[0024] Figure 4 This is a cross-sectional schematic diagram of a gastric perforation closure device in a second state according to an embodiment of the present invention;
[0025] Figure 5 This is a cross-sectional schematic diagram of a gastric perforation closure device disposed in the stomach in one embodiment of the present invention;
[0026] Figure 6 for Figure 5 A magnified view of a portion of point I;
[0027] Figure 7 This is a schematic diagram of the mold structure from a first perspective in one embodiment of the present invention;
[0028] Figure 8 This is a schematic diagram of the mold structure from a second perspective in one embodiment of the present invention.
[0029] Explanation of icon numbers:
[0030] 100 - Easily deployable gastric perforation closure device;
[0031] 110 - Connector; 111 - First axis; 112 - First peripheral wall; 113 - Second chamber;
[0032] 120 - First sealing body; 121 - First fold; 1211 - First part; 1212 - Second part; 122 - First housing; 123 - Second housing; 124 - First chamber;
[0033] 130 - Second sealing body; 131 - Second fold; 1311 - Third part; 1312 - Fourth part; 132 - First opening;
[0034] 140-Expandable parts;
[0035] 150-electrode;
[0036] 200-Mold;
[0037] 210 - Intermediate body; 211 - Second axis;
[0038] 220 - First end; 221 - First molding cavity; 222 - First inner groove; 223 - First outer groove;
[0039] 230 - Second end; 231 - Second forming cavity; 232 - Second inner groove; 233 - Second outer groove;
[0040] X - First direction;
[0041] 300 - Surgical catheter;
[0042] 400 - Stomach.
[0043] The realization of the objective, functional features and advantages of the present invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation
[0044] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.
[0045] It should be noted that if the embodiments of the present invention involve directional indications (such as up, down, left, right, front, back, etc.), the directional indications are only used to explain the relative positional relationship and movement of the components in a specific posture. If the specific posture changes, the directional indications will also change accordingly.
[0046] Furthermore, if the embodiments of this invention involve descriptions such as "first" or "second," these descriptions are for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first" or "second" may explicitly or implicitly include at least one of those features. Additionally, the use of "and / or," "and / or," or "and / or" throughout the text implies three parallel solutions. For example, "A and / or B" includes solution A, solution B, or a solution where both A and B are satisfied simultaneously. Furthermore, the technical solutions of the various embodiments can be combined with each other, but this must be based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or impossible to implement, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection claimed by this invention.
[0047] Gastric perforation is generally treated with open surgery and laparoscopic minimally invasive surgery. Current techniques for repairing gastric perforation include suturing the perforation using traditional suturing techniques and sealing the perforation with occluding instruments. When suturing a gastric perforation, there are two main challenges. First, the sutures can easily irritate the stomach wall, leading to granulation tissue formation and hindering healing and repair. Second, a gap is unavoidable between the suture and the needle hole. If the suture tension is too low, the perforation will not be tightly closed, allowing gastric fluid to leak from both the perforation and the needle hole, preventing the surgery from achieving its intended repair effect. If the suture tension is too high, the needle hole in the stomach wall will deform under the force of the suture, increasing the gap between the needle hole and the suture, allowing gastric fluid to leak out. Repairing gastric perforation using suturing is a complex procedure, and improper operation can easily lead to granulation tissue formation or gastric leakage, severely impacting gastric recovery. When using occlusion devices to seal gastric perforations, two main issues arise: firstly, most existing occlusion devices are complex in structure, difficult to deploy, and challenging to install; secondly, their thickness and size increase the burden on the stomach, affecting its normal function and hindering rapid recovery. To avoid granulation tissue or gastric leakage caused by sutures on the stomach wall, which could impede recovery, such as... Figures 1 to 6 As shown, this application provides a deployable gastric perforation closure device 100, which has a first state and a second state. The deployable gastric perforation closure device 100 includes a deployable member 140, a connector 110, a first sealing body 120, and a second sealing body 130.
[0048] like Figure 1 as well as Figure 5A connector 110 is used to pass through a perforation 400 in the stomach. The connector 110 has a first axis 111. A first sealing body 120 and a second sealing body 130 are disposed opposite each other at both ends of the connector 110. The connector 110 allows the first sealing body 120 and the second sealing body 130 to connect with each other, improving the stability of the easily deployable gastric perforation closure device 100 fixed to the stomach wall. In different embodiments, to provide connection to the first sealing body 120 and the second sealing body 130 and to ensure the repair of the gastric perforation, the connector 110 can be a cylinder with different diameters, and the surface of the connector 110 can also have different protruding structures for connecting with the stomach wall at the gastric perforation site. To improve the stability of the easily deployable gastric perforation closure device 100 after installation in the gastric perforation, preferably, the height of the connector 110 can be equal to the thickness of the stomach wall at the gastric perforation site.
[0049] like Figure 1 , Figure 2 as well as Figure 3 As shown, the first sealing body 120 is connected to one end of the connecting body 110 along the first axis 111. In a first state, the first sealing body 120 is constricted towards the first axis 111 to allow placement in the surgical catheter 300. In a second state, the first sealing body 120 is extended away from the first axis 111 to connect with the inner wall of the stomach, thereby covering the gastric perforation. It can be understood that in the second state, the first sealing body 120 covers the gastric perforation, meaning that the first sealing body 120 seals and covers the gastric perforation on the inner side of the stomach wall, preventing gastric juice from flowing out of the perforation.
[0050] like Figure 1 , Figure 2 as well as Figure 3 As shown, the second sealing body 130 is connected to the other end of the connector 110 along the first axis 111. In the first state, the second sealing body 130 is contracted towards the first axis 111 to allow placement in the surgical catheter 300. In the second state, the second sealing body 130 is extended away from the first axis 111 to connect with the outer wall of the stomach. It is understood that since the first sealing body 120 already seals the gastric perforation from the inside of the stomach wall, the second sealing body 130, as an auxiliary sealing structure, can completely or partially cover the gastric perforation. When the first sealing body 120 covers the gastric perforation from the inside of the stomach wall, and the second sealing body 130 covers the gastric perforation from the outside of the stomach wall, both the inside and outside of the gastric perforation are sealed. This prevents further erosion of the gastric perforation by internal gastric juices and provides a favorable microenvironment for the repair of the stomach wall at the perforation site.
[0051] The first sealing body 120 defines a first chamber 124, while the connecting body 110 and the second sealing body 130 together define a second chamber 113 with a first opening 132. The first opening 132 is located on the side of the second sealing body 130 opposite to the connecting body 110, and the first chamber 124 communicates with the second chamber 113. In the first state, the unfolding member 140 is positioned in the second chamber 113 along a direction parallel to the first axis 111. In the second state, the end of the unfolding member near the first chamber 124 is bent so that it can enter the first chamber 124 and contact the side of the first sealing body 120 near the connecting body 110, so that the unfolding member 140 can unfold the first sealing body 120.
[0052] In gastric perforation repair surgery, laparoscopic minimally invasive surgery is less traumatic, does not interfere with gastrointestinal function, facilitates postoperative gastrointestinal function recovery, reduces the incidence of complications, and reduces surgical pain, thus improving the patient's quality of life. In the first state, both the first sealing body 120 and the second sealing body 130 can be contracted towards the first axis 111 to be placed in the surgical catheter 300, allowing the easily deployable gastric perforation closure device 100 of this application to be placed in the surgical catheter 300, thereby enabling its easy application in laparoscopic minimally invasive surgery. In the second state, the first sealing body 120 unfolds and seals the gastric perforation on the inner wall of the stomach, while the second sealing body 130 unfolds and connects to the outer wall of the stomach. That is, the first sealing body 120 and the second sealing body 130 are positioned opposite each other on both sides of the stomach wall, connected by the body, thereby allowing the easily deployable gastric perforation closure device 100 to be fixed to the stomach wall. The technical solution of this application connects the first chamber 124 to the second chamber 113. The unfolding member 140 can pass through both the first chamber 124 and the second chamber 113, thereby enabling the unfolding of the first sealing body 120 and greatly improving the convenience of sealing gastric perforations. Furthermore, due to the independent unfolding member 140, the thickness of the first sealing body 120 and the second sealing body 130 can be significantly reduced, effectively reducing the burden on the stomach and improving the repair capability of gastric perforations.
[0053] like Figure 1As shown, in different embodiments, in the first state, the first sealing body 120 and the second sealing body 130 can be converged in any suitable manner towards the first axis 111. In the second state, after unfolding, the first sealing body 120 and the second sealing body 130 can be laid flat on the stomach wall, or connected to the stomach wall in any other suitable manner. Specifically, in this embodiment, the first sealing body 120 includes a first folded portion 121, which includes a first portion 1211 and a second portion 1212 distributed circumferentially along the first axis 111. In the first state, the first portion 1211 and the second portion 1212 are stacked. That is, the first portion 1211 and the second portion 1212 can be stacked and rolled around the first axis 111. In the second state, the first portion 1211 and the second portion 1212 are arranged circumferentially along the first axis 111. Specifically, when unfolded, the first part 1211 and the second part 1212 can together form a flat plate, thereby allowing the first sealing body 120 to be laid flat on the stomach wall.
[0054] like Figure 1 As shown, in different embodiments, the second sealing body 130 may also include a second folded portion 131. The second folded portion 131 includes a third portion 1311 and a fourth portion 1312 distributed circumferentially along the first axis 111. In a first state, the third portion 1311 and the fourth portion 1312 are stacked. In a second state, the third portion 1311 and the fourth portion 1312 are arranged circumferentially along the first axis 111. Specifically, the contraction and expansion forms of the first sealing body 120 can be consistent with those of the first sealing body 120. Furthermore, to guide the first sealing body 120 and the second sealing body 130 to contract in the first state, different folding areas of the first sealing body 120 and the second sealing body 130 can be configured with different thicknesses, which will not be elaborated here.
[0055] It should be noted that, for ease of manufacture and use, the easily deployable gastric perforation closure device 100 of this application may also have a third state. In the third state, the first sealing body 120 includes a first wall surface and a second wall surface circumferentially spaced along the first axis 111. The first wall surface is located inside the second wall surface. The first wall surface is recessed on the side near the connector. Taking the direction from the end of the first sealing body 120 away from the connector 110 to the other end of the first sealing body 120 near the connector 110 as the second direction, along the second direction, the first wall surface is recessed on the side near the second wall surface to form a first guide groove, and the second wall surface is recessed on the side near the first wall surface to form a second guide groove. The first guide groove and the second guide groove are used to guide the first sealing body 120 from the third state to the first state. Similarly, in the third state, the second sealing body 130 may include a third wall surface and a fourth wall surface that are circumferentially spaced along the first axis 111. The third wall surface is located inside the fourth wall surface and is recessed on the side near the connector. The direction from the end of the second sealing body 130 away from the connector 110 to the other end of the second sealing body 130 near the connector 110 is taken as the third direction. Along the third direction, the third wall surface is recessed with a third guide groove on the side near the fourth wall surface, and the fourth wall surface is recessed with a fourth guide groove on the side near the third wall surface. The third guide groove and the fourth guide groove are used to guide the second sealing body 130 from the third state to the first state. In other words, in the third state, the easily deployable gastric perforation occlusion device 100 is between the first state of being in a contracted state and the second state of being in an deployed state. Since the easily deployable gastric perforation occlusion device 100 is not fully contracted, both the first and third wall surfaces are recessed towards the side closer to the connector. Furthermore, the first and second sealing bodies have a first guide groove and a third guide groove with openings facing the first axis, and a second guide groove and a third guide groove with openings facing away from the first axis. This ensures that the easily deployable gastric perforation occlusion device 100 is not difficult to manufacture due to contraction and shrinkage. Moreover, the guide grooves make it easier for the easily deployable gastric perforation occlusion device 100 to be contracted from the third state to the first state, thus improving the convenience of using the easily deployable gastric perforation occlusion device 100.
[0056] like Figure 1As shown, in different embodiments, to improve the ease of unfolding the easily deployable gastric perforation closure device 100 and facilitate its installation on the stomach wall, the first sealing body 120 may include multiple first folds 121, and the second sealing body 130 may include multiple second folds 131, along the circumferential direction of the first axis 111. In different embodiments, taking the first sealing body 120 and the second sealing body 130 as a conical shell as an example, the first folds 121 and the second folds 131 can be wound circumferentially along the first axis 111. Since the same size first sealing body 120 and second sealing body 130 need to be contracted into the same diameter surgical catheter 300, the starting radius of a single fold is small and the number of winding layers is large. The multiple folds increase the winding radius and reduce the number of winding layers, thereby reducing the winding density of the first sealing body 120 and the second sealing body 130. This also reduces the difficulty of unfolding the first sealing body 120 and the second sealing body 130, making it easier to unfold and fix the gastric perforation sealing device 100 to the gastric perforation after it is delivered to the gastric perforation through the laparoscopic minimally invasive surgery system.
[0057] like Figure 4 as well as Figure 5 As shown, in different embodiments, to enhance the stability of the easily deployable gastric perforation closure device 100 fixed to the stomach wall and reduce the risk of gastric fluid leakage, the connector 110 can fit against the wall of the gastric perforation. Specifically, in this embodiment, the connector 110 has a first peripheral wall 112 arranged around a first axis 111, which is used to connect with the peripheral wall of the gastric perforation. That is, the connector 110 can be configured as a column, with the peripheral wall of the column fitting against the wall of the gastric perforation, thereby making the fixation of the easily deployable gastric perforation closure device 100 more stable and the sealing effect better.
[0058] like Figure 4As shown, in different embodiments, to facilitate the unfolding of the first sealing body 120 from the first state to the second state, the easily unfoldable gastric perforation occlusion device 100 may be provided with an unfolding channel extending into the interior of the first sealing body 120. Specifically, in this embodiment, the first sealing body 120 has a first housing 122 and a second housing 123, both of which are arranged around a first axis 111. One end of the first housing 122 is connected to the connector 110, and the other end is connected to the second housing 123. In the first state, the first housing 122 is constricted towards the first axis 111 to accommodate the surgical catheter 300, and the second housing 123 is located within the first housing 122 and recessed towards the connector 110. In the second state, the wall surface of the first housing 122 near the connector 110 is connected to the inner wall surface of the stomach, and the second housing 123 and the first housing 122 together define a first chamber 124. The connector 110 and the second sealing body 130 together define a second chamber 113 with a first opening 132. The first opening 132 is located on the side of the second sealing body 130 opposite to the connector 110. The first chamber 124 communicates with the second chamber 113. Specifically, the second chamber 113 can extend in a direction parallel to the first axis 111. In use, any suitable auxiliary instrument can be inserted into the first chamber 124 through the first opening 132 and extended into the second chamber 113. The first sealing body 120 is then placed against the stomach wall using the auxiliary instrument.
[0059] like Figure 2 as well as Figure 6 As shown, in the above embodiment, to facilitate the deployment of the first sealing body 120, the easily deployable gastric perforation closure device 100 may include a deployable member 140. Specifically, in the first state, the deployable member 140 is disposed in the second chamber 113 along a direction parallel to the first axis 111. In the second state, the end of the deployable member 140 near the first chamber 124 is bent so that it can enter the first chamber 124 and contact the second housing 123, thereby allowing the deployable member 140 to deploy the first sealing body 120. In the first state, the deployable member 140 is disposed in the second chamber 113. Since the first chamber 124 and the second chamber 113 are connected, in the second state, the deployable member 140 directly enters the second chamber 113 from the first chamber 124, reducing the difficulty of deploying the first sealing body. In the second state, after the deployable member 140 deploys the first sealing body 120, it can be withdrawn by the surgical catheter 300 without affecting the repair of the gastric perforation by the first sealing body 120, the second sealing body 130, and the connecting body 110. In different embodiments, for ease of operation, the unfolding member 140 can be placed as a whole with the electrode 150 into the first chamber 124 and the second chamber 113.
[0060] A certain number of proteins exist in the intercellular spaces of active tissues. When tissue is cut, these proteins are exposed at the cut wound. By denaturing these proteins—either straightening, entanglement, or coagulation—the damaged tissue can be repaired and bonded. Therefore, in some embodiments, to facilitate the connection between the easily deployable gastric perforation closure device 100 and the stomach wall, the easily deployable gastric perforation closure device 100 may be loaded with proteins (not shown in the figure). The co-denaturation of proteins between the easily deployable gastric perforation closure device 100 and the stomach wall tissue allows for a sealed connection between the easily deployable gastric perforation closure device 100 and the stomach wall. To improve biocompatibility, the easily deployable gastric perforation closure device 100 of this application may also be loaded with stem cell exosomes (not shown in the figure).
[0061] Specifically, in this embodiment, the easily deployable gastric perforation occlusion device 100 contains proteins and stem cell exosomes. The proteins loaded in the first sealing body 120 are denatured to allow the first sealing body 120 to connect with the inner wall of the stomach. The proteins in the second sealing body 130 are denatured to allow the second sealing body 130 to connect with the outer wall of the stomach. In different embodiments, the easily deployable gastric perforation occlusion device 100 can be entirely loaded with proteins, or it can be configured as a multi-layered structure with an outer layer for contact with the stomach wall, the outer layer being loaded with proteins that denature to allow the easily deployable gastric perforation occlusion device 100 to connect with the stomach wall. Specifically, the easily deployable gastric perforation occlusion device 100 can be made by electrospinning, with the electrospinning needle being a double-layered needle. The inner needle conducts a polymer solution, specifically polyvinyl alcohol, polylactic acid, polycaprolactone, polylactic acid, glycolic acid, or polyurethane, etc., and the solvent can be purified water or hexafluoroisopropanol, etc. Depending on the specific application, the concentration of the polymer solution can be any value from 0.5% to 10%. Specifically, the polymer solution concentration can be 0.5%, 1%, 2%, 5%, or 10%. The outer needle guides a protein suspension, which, depending on the application, may include collagen and polyvinyl alcohol (PVA) solution. Depending on the specific application, the PVA solution concentration can be any value from 0.2% to 10%. Specifically, the PVA solution concentration can be 0.2%, 0.5%, 1%, 2%, 5%, 7%, or 10%. It is understood that the protein suspension may also include stem cell exosomes, with a concentration of 1×10⁻⁶. 9 The number of units per ml is not limited here.
[0062] In different embodiments, different methods can be used to denature proteins. Specifically, methods such as laser welding, ultrasonic welding, and high-frequency current welding can be used to denature proteins. In this embodiment, high-frequency current welding is used to denature proteins. Specifically, the easily deployable gastric perforation closure device 100 also includes an electrode 150, which is used to conduct current to the first sealing body 120 and the stomach, causing the proteins in the first sealing body 120 to denature and connect with the proteins on the inner wall of the stomach. In some embodiments, the electrode 150 is used to conduct current to the second sealing body 130 and the stomach, causing the proteins in the second sealing body 130 to denature and connect with the proteins on the inner wall of the stomach. Understandably, depending on the specific welding requirements, the frequency of high-frequency current tissue welding can be any suitable frequency from 300KHz to 500KHz, and the voltage can be any suitable voltage value from 100V to 300V. This effectively protects the nerves of human tissues and organs from electrical stimulation, while also ensuring that, under safe voltage conditions, the current can provide sufficient energy to denature and connect the easily deployable gastric perforation closure device 100 and the proteins on the stomach wall.
[0063] Specifically, when using the easily deployable gastric perforation closure device 100 of this application, the first step is to roll and fold the first sealing body 120 and the second sealing body 130 to a first state, and place the easily deployable gastric perforation closure device 100 inside the surgical catheter 300 of the laparoscope. The second step is to use the laparoscopic surgical device to deliver the easily deployable gastric perforation closure device 100 to the designated position through the gastric perforation channel. The third step is to push the first sealing body 120 from the surgical catheter 300 to the inner side of the stomach wall, whereby the first sealing body 120 first unfolds and covers the inner side of the stomach wall, thereby sealing the gastric perforation. The fourth step is to push the easily deployable gastric perforation closure device 100 out of the surgical catheter 300, so that the connector 110 passes through the gastric perforation, and the second sealing body 130 unfolds on the outer side of the stomach wall and covers the gastric perforation. The fifth step involves fixing the first sealing body 120 and the second sealing body 130 to the stomach wall using high-frequency current welding technology, thus completing the repair of the stomach perforation.
[0064] like Figures 7 to 8 As shown, this application also provides a mold 200 for manufacturing an easily deployable gastric perforation closure device 100. The mold 200 includes an intermediate body 210, a first end 220, and a second end 230.
[0065] like Figure 7 As shown, the intermediate body 210 has a second axis 211, and the intermediate body 210 can be made into a connector 110 of the gastric perforation closure device 100 that is easy to deploy.
[0066] like Figure 7As shown, the first end 220 is connected to one end of the intermediate body 210 along the second axis 211. The first end 220 is recessed into a first molding cavity 221 with an opening on the side closer to the intermediate body 210. Taking the direction from the first end 220 to the second end 230 as the first direction X, the projected area of the first molding cavity 221 in a plane perpendicular to the first direction gradually decreases along the first direction X. The first end 220 can form the first sealing body 120.
[0067] like Figure 8 As shown, the second end 230 is connected to the other end of the intermediate body 210 along the second axis 211. The second end 230 is recessed into a second molding cavity 231 with an opening on the side closer to the intermediate body 210. Along the first direction X, the projected area of the second molding cavity 231 in the plane perpendicular to the first direction gradually increases. The second end 230 can form the second sealing body 130.
[0068] Mold 200 is used for demolding the easily deployable gastric perforation closure device 100. Specifically, during manufacturing, firstly, an outer model of the easily deployable gastric perforation closure device 100 is printed using 3D printing technology according to different usage requirements. Then, purified water is injected into the inner cavity of the outer model, and the outer model and purified water are frozen together. After the purified water solidifies, the outer model is removed to obtain mold 200. Finally, the easily deployable gastric perforation closure device 100 is fabricated on mold 200 using an electrospinning process. After the electrospinning process is completed, the fabricated easily deployable gastric perforation closure device 100 and mold 200 are simultaneously dried and thawed. The ice mold melts to obtain the easily deployable gastric perforation closure device 100 without causing any damage to the repair device. After fabrication, the removal of the ice mold is simple and efficient, and will not cause any damage to the formed easily deployable gastric perforation closure device 100.
[0069] Electrospinning is a process in which a polymer solution or melt is jet-spun into fibers under a strong electric field. The principle is that under the influence of a strong electric field, the droplet at the needle tip changes from a spherical shape to a conical shape, forming a Taylor cone. The droplet extends from the tip of the cone to form a fine fiber. The needle tip is connected to a positive high voltage power supply, and the copper wire in the mold is grounded, thus creating a potential difference between the needle tip and the mold. This allows the fine fiber to be efficiently deposited at a specific location through guidance. In different embodiments, to obtain a gastric perforation closure device 100 that is easy to deploy using electrospinning, a copper wire may be provided in the mold 200. The copper wire can be inserted into the mold 200 along a direction parallel to the second axis 211.
[0070] like Figure 7As shown, in different embodiments, to obtain a gastric perforation occlusion device 100 that is easy to retract and unfold, the first end portion 220 and the second end portion 230 can define grooves that guide folding. Specifically, in this embodiment, the first end portion 220 is configured as a cone, having a first inner groove 222 and a first outer groove 223 extending parallel to the generatrix of the cone. The first inner groove 222 and the first outer groove 223 are arranged adjacent to each other circumferentially around the second axis 211. The side of the first inner groove 222 near the second axis 211 communicates with the first forming cavity 221, and the side of the first outer groove 223 opposite to the second axis 211 has an opening, spaced apart from the first forming cavity 221. Figure 8 As shown, the second end portion 230 is configured as a cone shape, and has multiple second inner grooves 232 and second outer grooves 233 extending parallel to the generatrix of the cone shape. The second inner grooves 232 and second outer grooves 233 are arranged adjacent to each other circumferentially around the second axis 211. The side of the second inner groove 232 near the second axis 211 communicates with the second forming cavity 231, and the side of the second outer groove 233 opposite to the second axis 211 has an opening, and the side of the second outer groove 233 near the second axis 211 is spaced apart from the second forming cavity 231. When the mold 200 of this application manufactures a gastric perforation occlusion device 100 that is easy to unfold, it is possible to obtain a gastric perforation occlusion device 100 with different folds that is easy to unfold, which is beneficial to the convergence of the gastric perforation occlusion device 100 that is easy to unfold.
[0071] The above are merely preferred embodiments of the present invention and do not limit the scope of the patent. Any equivalent structural transformations made using the contents of the specification and drawings of the present invention under the inventive concept of the present invention, or direct / indirect applications in other related technical fields, are included within the scope of patent protection of the present invention.
Claims
1. A gastric perforation closure device that facilitates deployment, comprising: The easy-to-deploy gastric perforation closure device has a first state and a second state, and comprises: a deployment member; a connecting body for being arranged in a gastric perforation, the connecting body having a first axis; a first sealing body connected to one end of the connecting body along the first axis, in the first state, the first sealing body is contracted towards the first axis to be capable of being arranged in a surgical catheter, in the second state, the first sealing body is deployed away from the first axis to be capable of being connected to an inner wall of the stomach to cover the gastric perforation, the first sealing body defines a first chamber; a second sealing body connected to the other end of the connecting body along the first axis, in the first state, the second sealing body is contracted towards the first axis to be capable of being arranged in the surgical catheter, in the second state, the second sealing body is deployed away from the first axis to be capable of being connected to an outer wall of the stomach; wherein the connecting body and the second sealing body jointly define a second chamber having a first opening, the first opening is arranged on the side of the second sealing body away from the connecting body, the first chamber and the second chamber are in communication; in the first state, the deployment member is arranged in the second chamber along a direction parallel to the first axis, in the second state, the deployment member is bent near one end of the first chamber to be capable of entering the first chamber to contact the side of the first sealing body near the connecting body, so that the deployment member deploys the first sealing body.
2. The easy-to-deploy gastric perforation closure device according to claim 1, wherein: the first sealing body comprises a first folding part, the first folding part comprises a first portion and a second portion distributed circumferentially along the first axis, in the first state, the first portion and the second portion are arranged in a stacked manner, in the second state, the first portion and the second portion are arranged circumferentially along the first axis; and / or, the second sealing body comprises a second folding part, the second folding part comprises a third portion and a fourth portion distributed circumferentially along the first axis, in the first state, the third portion and the fourth portion are arranged in a stacked manner, in the second state, the third portion and the fourth portion are arranged circumferentially along the first axis.
3. The easy-to-deploy gastric perforation closure device according to claim 2, wherein: along the circumferential direction of the first axis, the first sealing body comprises a plurality of first folding parts; and / or, along the circumferential direction of the first axis, the second sealing body comprises a plurality of second folding parts.
4. The easy-to-deploy gastric perforation closure device according to claim 1, wherein: the connecting body has a first peripheral wall arranged around the first axis, the first peripheral wall is used to be connected to a peripheral wall of the gastric perforation.
5. The easy-to-deploy gastric perforation closure device according to claim 1, wherein: the easy-to-deploy gastric perforation closure device has proteins and stem cell exosomes; and wherein, The protein of the first sealing body can be denatured to connect the first sealing body with the inner wall of the stomach; and / or, The protein of the second sealing body can be denatured to connect the second sealing body with the outer wall of the stomach.
6. The facilitated deployment gastric perforation closure instrument of claim 5, wherein, The gastric perforation closure device further comprises: an electrode for conducting electric current to the first sealing body and the stomach, so that the protein of the first sealing body and the protein of the inner wall of the stomach are denatured and connected; and / or, an electrode for conducting electric current to the second sealing body and the stomach, so that the protein of the second sealing body and the protein of the inner wall of the stomach are denatured and connected.
7. A mold for processing the easily-deployable gastric perforation closure device according to any one of claims 1 to 6, characterized in that, comprises: an intermediate body having a second axis; a first end connected to one end of the intermediate body along the second axis, the first end recessed towards the side of the intermediate body to have a first shaped cavity with an opening, and the projection area of the first shaped cavity in a plane perpendicular to the first direction gradually decreases in the first direction; a second end connected to the other end of the intermediate body along the second axis, the second end recessed towards the side of the intermediate body to have a second shaped cavity with an opening, and the projection area of the second shaped cavity in a plane perpendicular to the first direction gradually increases in the first direction; wherein the direction of the first end pointing to the second end is the first direction.
8. The mold of claim 7, wherein: the first end is configured as a conical body having a first inner groove extending along the direction parallel to the generatrix of the conical body and a first outer groove, the first inner groove and the first outer groove are arranged adjacent to each other around the second axis, the first inner groove is in communication with the first shaped cavity on the side close to the second axis, and the first outer groove is provided with an opening on the side away from the second axis, and the first outer groove is spaced from the first shaped cavity on the side close to the second axis; the second end is configured as a conical body having a plurality of second inner grooves extending along the direction parallel to the generatrix of the conical body and a plurality of second outer grooves, the second inner grooves and the second outer grooves are arranged adjacent to each other around the second axis, the second inner grooves are in communication with the second shaped cavity on the side close to the second axis, and the second outer grooves are provided with an opening on the side away from the second axis, and the second outer grooves are spaced from the second shaped cavity on the side close to the second axis.
Citation Information
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