Gastroesophageal valve and treatment device
By designing an adaptively deformable gastroesophageal valve, the problems of complex instruments and significant damage in existing technologies have been solved, achieving simplified operation and low-cost treatment of gastroesophageal reflux disease, and avoiding the use of rigid anastomotic devices.
Patent Information
- Application Number
- CN202511019677.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-07-23
- Publication Date
- 2025-11-18
AI Technical Summary
Existing treatments for gastroesophageal reflux disease (GERD) suffer from problems such as complex instrumentation, numerous operational steps, significant tissue damage, high costs, and cumbersome disassembly. Furthermore, existing devices require the use of a rigid stapler under endoscopic ultrasound guidance, which affects the ease of operation.
A gastroesophageal valve was designed, including a valve body, an extension edge, and a pressure foot edge. By utilizing a shape memory reset component and a hinge assembly, the valve can achieve adaptive deformation within the esophagus, avoiding folding of the esophagus and stomach fundus. Flexible suture fixation simplifies the operation and reduces damage.
It effectively prevents the reflux of gastric contents without altering the normal physiological and anatomical structure of the esophagus and gastric fundus. It involves minimal damage, is easy to operate, low in cost, and does not require ultrasound guidance or rigid staplers, making disassembly and replacement convenient.
Smart Images
Figure CN120959939A_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to the field of valve technology, in particular to a gastroesophageal valve and a treatment device comprising the same. BACKGROUND
[0002] Gastroesophageal reflux disease is a common digestive system disease, and its incidence rate has a trend of increasing year by year. Medical drug treatment can only alleviate local symptoms and cannot completely prevent reflux. During the treatment of gastroesophageal reflux disease by the first generation of surgical procedures (pioneering) and the second generation of surgical procedures (minimally invasive), the third generation of natural orifice procedures gradually emerged. The third generation of natural orifice procedures currently mainly includes Esophy of EndoGastric Solutions Company in the United States and Medigus ultrasonic surgical stapler (MUSE, Medigus Ultrasonic Surgical Endostapler) of Attikouris Medical Company in Cyprus, both of which are to fold the stomach wall tissue to reconstruct the structure of the gastric fundus and esophagus. The instruments are complex in composition, high in manufacturing cost, multiple in operation steps, greatly changed in the normal anatomical structure of the esophagus and the gastric fundus, not small in the range and degree of tissue damage, troublesome to disassemble and replace, and the folding of Esophyx needs to implant about 7 mm long 20 fasteners into the esophageal tissue and gastric fundus, and the folding of MUSE needs to use a hard stapler to punch in ≥15 titanium nails under the guidance of endoscopic ultrasound. SUMMARY
[0003] The technical problem to be solved by the present application is to solve the deficiencies in the prior art, and to provide a gastroesophageal valve and a treatment device comprising the same.
[0004] The technical solution adopted by the present application to solve the technical problem is: a gastroesophageal valve, comprising: a valve membrane body having an unfolded state when unfolded in the gastroesophageal tract; an extension edge arranged around the circumference of the valve membrane body and connected with the outer peripheral edge of the valve membrane body; and a pressure foot edge, the two ends of which are respectively connected with the two ends of the extension edge, the pressure foot edge being used for fixing on the inner wall of the gastroesophageal tract; the extension edge is a shape memory reset member; the extension edge is configured to locally or integrally swing towards the stomach body direction on the side away from the pressure foot edge when food flows in the forward direction and contacts the valve membrane body, and reset after the swing; the extension edge is further configured to bend and deform in response to the space at the valve membrane body in the gastroesophageal tract being reduced, and reset when the space at the valve membrane body in the gastroesophageal tract is restored.
[0005] Further, the extending edge is fixedly connected with or integrally formed with the valve body, the extending edge is an elastic extending edge, and the thickness of the extending edge is greater than the thickness of the valve body.
[0006] Further, the extending edge is a first spiral spring, and the axis of the first spiral spring is a curve extending around the outer peripheral edge of the valve body.
[0007] Further, the hinge assembly further comprises a plurality of hinge members connected in sequence in the circumferential direction of the valve body, and the hinge members are fixedly connected with the extending edge. The extending edge is used to promote the hinge assembly to restore to the preset state after the change in the state. The hinge member is provided with a limiting member, the limiting member is used to limit the outer limit position of the hinge member rotating towards the oral cavity, and the maximum rotation angle of the hinge member in the hinge assembly in the preset state towards the oral cavity is less than the maximum rotation angle of the hinge member in the hinge assembly in the preset state towards the stomach body.
[0008] Further, the hinge member is spherical, a first hole is formed through one end of the hinge member, and a second hole is formed through the other end of the hinge member. The first hole is formed with a closed portion at the position of the inner wall of the one end of the hinge member away from the center of the sphere, and the second hole is formed with an open portion at the position of the inner wall of the one end of the hinge member away from the center of the sphere. The limiting member is fixed in the second hole, the limiting member has at least one limiting groove matched with the closed portion, and the closed portion of one hinge member is inserted into the limiting groove of another hinge member to be connected in the universal direction. The hinge member reaches the outer limit position when the closed portion is in contact with the groove bottom of the limiting groove.
[0009] Further, the second hole is provided with an elastic member, and the elastic member is pressed against the outer wall surface of the closed portion in the second hole.
[0010] Further, the pressing foot edge is a second spiral spring, the extending edge is wrapped with an extending wrapping layer, and the pressing foot edge is wrapped with a pressing foot wrapping layer.
[0011] Further, the axis of the extending edge is a first circular arc, and the axis of the pressing foot edge is a second circular arc. The center of the second circular arc is located on the inner side of the first circular arc, the arc length of the first circular arc is greater than the arc length of the second circular arc, and the radius of the first circular arc is greater than the radius of the second circular arc.
[0012] Further, the fixing ring is further provided. The pressing foot edge is provided with at least one fixing ring. The fixed ring is integrally formed with the presser foot edge, or the fixed ring is connected to the presser foot edge through a clamping ring, and the fixed ring and the presser foot edge are both slidably arranged through the clamping ring.
[0013] Further, the valve membrane body is suspended near one side of the presser foot edge, and a window is formed between the presser foot edge.
[0014] The application also provides a treatment device comprising the above-mentioned gastroesophageal valve, and further comprising a valve clip storage, wherein the valve clip storage comprises an upper hinge, a fixed part storage and a lower hinge. The upper hinge is fixed to a distal end body of an endoscope suture device. One end of the fixed part storage is fixedly connected with the upper hinge, and the other end is hingedly connected with the lower hinge, and the lower hinge is located on one side of the distal end body, and a valve storage for accommodating the gastroesophageal valve is formed between the lower hinge and the distal end of the distal end body. The clip storage reset part is arranged between the upper hinge and the lower hinge, and the clip storage reset part is used for elastically pressing the lower hinge against the gastroesophageal valve.
[0015] The application has the advantages that: the valve membrane body which returns to a normal structure is used to prevent the reflux of gastric contents, the presser foot edge is fixed at the esophagus or the cardia, the valve membrane body can be turned towards the stomach body under the pushing of digestive tract food chyme, and can be curved and deformed along the situation when the gastroesophageal space is reduced, and the shape is reset when the gastroesophageal space is restored, so that the esophagus and the fundus of the stomach do not need to be folded, only the valve for blocking the reflux of gastric contents is added, the normal anatomical structure of the esophagus and the fundus of the stomach is almost unchanged, the fixation of the valve is simple and convenient by using flexible medical suturing thread, the damage range is small, the damage amplitude is small, the structure is simple, the manufacturing cost is low, the installation is simple, the operation steps are few, no ultrasonic guidance is needed, no hard anastomat is needed, no hard fastener is needed, and the disassembly and replacement are convenient.
[0016] Other features and advantages of the application will become apparent from the following detailed description of exemplary embodiments thereof, taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS
[0017] The application will be further described below in conjunction with the drawings and examples.
[0018] Figure 1A is a structural schematic view of a gastroesophageal valve; Figure 1B is Figure 1A is a structural schematic view from another perspective; Figure 2 is Figure 1A is an exploded schematic view of the valve clip storage; Figure 3 is a schematic view of using a first spiral spring as an extension edge; Figure 4is a schematic view of the second spiral spring as the foot edge; Figure 5A is a schematic view of the hinge with the elastic member inside; Figure 5B is a schematic view of the structure from another perspective; Figure 6A is a three-dimensional view of one side of the hinge without the elastic member inside; Figure 6B is a schematic view of one side of the hinge without the elastic member inside; Figure 6C is a three-dimensional view of the other side of the hinge without the elastic member inside; Figure 7A is a schematic view of the closure of the B ball entering the A ball through the insertion gap; Figure 7B is a schematic view of the clockwise rotation adjustment of the closure of the B ball after entering the A ball; Figure 7C is a schematic view of the closure of the B ball clamping into the limiting slot of the A ball; Figure 8A is a schematic view of the foot edge without the fixing ring; Figure 8B is a schematic view of the foot edge without the fixing ring; Figure 8A is a schematic view of the structure from another perspective; Figure 9A is a three-dimensional view of one side of the valve clip storage with the folding bar; Figure 9B is a three-dimensional view of the other side of the valve clip storage with the folding bar; Figure 10 is a three-dimensional view of the valve clip storage with the inner edge; Figure 11 is a schematic view of the valve clip storage with the folding bar installed on the distal body of a kind of endoscope suture device; Figure 12 is a schematic view of the gastric esophageal valve being loaded into the valve clip storage with the folding bar; Figure 13 is a schematic view of the valve clip storage with the inner edge installed on the distal body of another kind of endoscope suture device; Figure 14 is a schematic view of the gastric esophageal valve being loaded into the valve clip storage with the inner edge; Figure 15 is a schematic view of the gastric esophageal valve returning to the normal structure in the gastric esophagus; Figure 16 is a schematic view of the stretching edge being able to partially or wholly swing towards the stomach body when the food flows in the same direction and contacts the valve membrane; Figure 17 is a schematic diagram of the stretchable edge bending in response to the space reduction at the valve membrane body in the gastroesophageal tract; Figure 18 is a schematic diagram of the stretchable edge restoring shape in response to the space recovery at the valve membrane body in the gastroesophageal tract.
[0019] In the figure: 1, valve membrane body, 11, window; 2, stretchable edge, 21, stretchable wrapping layer; 3, presser foot edge, 31, presser foot wrapping layer, 32, fixing ring, 33, clamping ring, 34, pull rope; 4, hinge, 41, first hole, 411, closing part, 42, second hole, 422, opening part, 422a, short edge arm, 422b, long edge arm, 4221, insertion seam, 43, limiting part, 431, limiting groove, 431a, groove bottom, 44, elastic part, 441, arc part, 442, supporting part; 5, distal body, 51, needle outlet, 52, needle inlet, 53, suture needle; 6, valve clamp bin, 61, upper hinge, 62, fixing part bin, 63, lower hinge, 631, bin bottom surface, 64, clamp bin reset part, 65, folding column, 651, fixed column, 652, movable column, 66, outer guide edge, 67, inner guide edge, 68, valve bin. DETAILED DESCRIPTION
[0020] The application will now be described in further detail with reference to the drawings. These drawings are simplified schematic diagrams which only show the basic structure of the application in a schematic manner, and therefore only show the features relevant to the application, and the directions and references (e.g. upper, lower, left, right, etc.) can only be used to help describe the features in the drawings. Therefore, the following detailed description is not in a limiting sense, and the scope of the claimed subject matter is only defined by the appended claims and their equivalents.
[0021] As shown in Figure 1A , Figure 1B , Figure 2 , Figure 8A and Figure 8B , a gastroesophageal valve includes a valve membrane body 1, a stretchable edge 2, and a presser foot edge 3: The valve membrane body 1 has an unfolded shape when unfolded in the gastroesophageal tract, and the valve membrane body 1 can be a self-cleaning, corrosion-resistant, soft, and firm thin layer structure; The stretchable edge 2 is arranged around the circumference of the valve membrane body 1 and fixedly connected with the outer circumferential edge of the valve membrane body 1; The presser foot edge 3 has two ends respectively connected with the two ends of the stretchable edge 2, forming a closed loop structure, and the presser foot edge 3 is used for fixing on the inner wall of the gastroesophageal tract; The extending edge 2 is a shape memory reset member; As shown in Figure 16 The extending edge 2 is configured to swing locally or wholly towards the stomach body from the side of the extending edge 2 away from the pressure foot edge 3 when the food flows in the normal direction and contacts the valve membrane body 1, and reset after the swing; the end of the valve membrane body 1 away from the pressure foot edge 3 is a free end; As shown in Figure 17 The extending edge 2 is further configured to bend and deform in response to the space in the stomach esophagus at the valve membrane body 1 being reduced, and reset when the space in the stomach esophagus at the valve membrane body 1 is restored, as shown in Figure 18 The extending edge 2 bends and deforms in response to the space in the stomach esophagus at the valve membrane body 1 being reduced, which is equivalent to the area enclosed by the extending edge 2 changing in size to adapt to the state change of the stomach esophagus, and allows the food to flow over the valve membrane body 1 towards the stomach body in the form of the extending edge 2 and the valve membrane body 1 bending and deforming locally.
[0022] In this scheme, the valve membrane body 1 restored to the normal structure is used to prevent the reflux of the stomach contents, the pressure foot edge 3 is fixed at the esophagus or cardia, the valve membrane body 1 can be flipped towards the stomach body under the push of the food chyme in the digestive tract, and can also bend and deform in response to the reduction of the space in the stomach esophagus, and reset in shape when the space in the stomach esophagus is restored, so as to realize that the folded esophagus and the fundus of the stomach are not needed, only the valve for blocking the reflux of the stomach contents is added, the normal anatomical structure of the esophagus and the fundus of the stomach is almost unchanged, the fixation of the valve is also a simple suture with flexible medical sutures, the damage range is small, the damage amplitude is small, the structure is simple, the manufacturing cost is low, the installation is simple, the operation steps are few, no ultrasonic guidance is needed, no hard anastomat is needed, no hard fastener is needed, and the disassembly and replacement are convenient.
[0023] In some examples, the extending edge 2 is fixedly connected or integrally formed with the valve body 2, the extending edge 2 is an elastic extending edge 2, the thickness of the extending edge 2 is greater than the thickness of the valve body 1, after the valve membrane body 1 is flipped downwards or / and the valve membrane body 1 bends and deforms around, the extending edge 2 can use the elastic force of itself to prompt the valve membrane body 1 to reset immediately to block the reflux of the stomach contents, at the same time, the reflux of the stomach contents will also push the flipped downwards valve membrane body 1 upwards to assist the reset of the valve membrane body 1.
[0024] In some examples, as shown in Figure 2 and 3As shown, the stretching edge 2 is a first spiral spring, and the axis of the first spiral spring is a curve extending around the outer peripheral edge of the valve membrane 1. The axis of the first spiral spring can be, but is not limited to, a circular arc. The stretching edge 2 is formed by the first spiral spring, and after the valve membrane 1 is turned downward or / and deformed around the periphery, the stretching edge 2 can use its own elastic force to promote the valve membrane 1 to reset immediately to block the reflux of the stomach contents. At the same time, the reflux of the stomach contents can also push the downward turned valve membrane 1 upward to assist the reset of the valve membrane 1.
[0025] In some examples, a hinge assembly is further included, and the hinge assembly includes a plurality of hinge pieces 4 connected in sequence around the valve membrane 1 in a circumferential direction, and the hinge pieces 4 are fixedly connected with the stretching edge 2 and attached to the peripheral edge of the valve membrane 1. The stretching edge 2 is used to promote the hinge assembly to return to a preset state after a change in shape. The hinge piece 4 is provided with a limiting piece 43 for limiting the outer limit position of the hinge piece 4 rotating toward the oral cavity direction, so that the maximum rotation angle of the hinge piece 4 in the hinge assembly in the preset state toward the oral cavity direction is less than the maximum rotation angle of the hinge piece 4 in the hinge assembly in the preset state toward the stomach direction.
[0026] Through the design of the hinge assembly, the valve membrane 1 can swing toward the stomach direction and be deformed around the periphery, but the valve membrane 1 is prevented from being folded reversely, that is, the valve membrane 1 is prevented from being folded toward the oral cavity direction when reaching the outer limit position, so that the valve membrane 1 can play the expected function of blocking the reflux of the stomach contents. In addition, the strength of the peripheral edge of the valve membrane 1 can be significantly improved, and the risk of tearing the edge of the stretching edge 2 of the valve membrane 1 can be inhibited. At the same time, in order to further prevent the valve membrane 1 restored to the normal structure from being reversely rotated by the impact of the reflux of the stomach contents, the enclosed area of the stretching edge 2 of the valve membrane 1 restored to the normal structure can be greater than the cross-sectional area of the digestive tract lumen at the position. When the pressing foot edge 3 of the valve membrane 1 is fixed to the inner wall of the stomach esophagus, the reflux of the stomach contents impacts the valve membrane 1 upward, and the free end of the valve membrane 1 touches the digestive tract wall and is prevented from being reversely folded (toward the oral cavity direction) by the digestive tract lumen wall. Even if the stomach cavity contracts to push the stomach contents reversely to the esophagus, the lower end of the esophagus reflexively contracts or relaxes, the area of the stretching edge 2 is less than the cross-sectional area of the digestive tract lumen, and the valve membrane 1 approaches the state of the physiological normal cardiac lip or similar structure, the valve membrane 1 can also play the normal blocking reflux function, and at the same time, it does not completely block the stomach and intestinal contents from being vomited through the esophagus and oral cavity due to the relaxation of the esophagus, the strong reverse contraction of the proximal small intestine and gastric antrum, and the contraction of the abdominal muscles.
[0027] In some examples, asFigure 5A 、 5B , 6A, 6B and 6C, the hinge 4 is spherical, one end of the hinge 4 is penetrated by a first hole 41, and the other end is penetrated by a second hole 42; the axis of the first hole 41 and the axis of the second hole 42 can be, but are not limited to, perpendicular to each other, and the cross section of the first hole 41 and the second hole 42 can be, but is not limited to, circular; As shown in Figure 5A and 6C , the first hole 41 forms a closed part 411 at the position of the inner wall of one end of the hinge 4 away from the center of the sphere, and the second hole 42 forms an open part 422 at the position of the inner wall of one end of the hinge 4 away from the center of the sphere; As shown in Figure 6A and 7C , the open part 422 can be provided with a slit 4221, so that the closed part 411 of one hinge 4 can pass through the slit 4221 of another hinge 4 to reach the second hole 42, thereby achieving the assembly of the two hinges 4. Further, the slit 4221 can be located on one side of the open part 422, avoiding the middle part of the open part 422. In this way, the side of the open part 422 where the slit 4221 is located is the short side arm 422a, and the other side is the long side arm 422b. The arc length of the long side arm 422b is longer than that of the short side arm 422a, so the long side arm 422b is more flexible than the short side arm 422a. The second hole 42 is fixed with the limiting part 43, and the limiting part 43 has at least one limiting groove 431 matched with the closed part 411. The closed part 411 of one hinge 4 is inserted into the limiting groove 431 of another hinge 4 to be connected with each other. Due to the cooperation of the closed part 411 and the limiting groove 431, the closed part 411 is difficult to restore to the initial angle of installation and is difficult to disassemble. When the hinge 4 rotates to the position where the closed part 411 contacts the groove bottom 431a of the limiting groove 431, the hinge 4 reaches the outer limit position, as shown in Figure 7C .
[0028] For example, among two adjacent and matched hinges 4, the left hinge 4 is an A ball, and the right hinge 4 is a B ball. The closed part 411 of the B ball enters the second hole 42 of the A ball from the slit 4221 of the open part 422 of the A ball. During the specific installation, the hinge 4 as the A ball is placed horizontally along the center line of the closed part 411 to the open part 422, i.e., the closed part 411 of the A ball is on the left side, and the open part 422 of the A ball is on the right side. The hinge 4 as the B ball is placed vertically along the center line of the closed part 411 to the open part 422, i.e., the closed part 411 of the B ball is on the lower side, and the open part 422 of the B ball is on the upper side. Then, the closed part 411 of the B ball is translated in the horizontal direction and then enters the second hole 42 of the A ball through the slit 4221 of the A ball, as shown in Figure 7A . Then, the B ball is rotated clockwise by about 90°, as shown inFigure 7B As shown, the closing part 411 of the B ball is gradually adjusted during rotation until the B ball is also placed horizontally along the center connecting line from the closing part 411 to the opening part 422, at which time the closing part 411 of the B ball is constrained in the limiting groove 431 of the A ball, and the universal connection of the two is achieved, as shown in Figure 7C As shown, the closing part 411 and the limiting groove 431 are matched in the embodiment, for example, the closing part 411 and the limiting groove 431 are both curved into a spherical or approximately spherical part; or, the outer side surface of the closing part 411 is a part of a spherical surface, the groove wall opposite to the outer side surface of the closing part 411 is a part of a spherical surface, and the inner side surface of the closing part 411 can also be a cylindrical surface, so that when the valve membrane 1 swings locally or integrally in the stomach body direction, the long arm 422b of the closing part 411 or / and the opening part 422 is easy to elastically deform slightly and can be elastically restored.
[0029] In some examples, as shown in Figure 5B , Figure 7C As shown, the second hole 42 is provided with an elastic member 44, which is pressed against the outer wall surface of the closing part 411 in the second hole 42; thus, by elastically pressing the closing part 411 through the elastic member 44, the closing part 411 can be inhibited from coming out of the limiting groove 431, which is beneficial to the restoration of the hinge assembly.
[0030] The elastic member 44 can be, but is not limited to, a coil spring, a disc spring, a torsion spring, etc., and can also be a spring sheet, for example, the spring sheet includes an arc-shaped part 441 and two bent supporting parts 442; The two ends of the arc-shaped part 441 are connected with the two supporting parts 442 respectively, and the end of the supporting part 442 away from the arc-shaped part 441 is fixedly connected with the second hole 42. The supporting part 442 can be V-shaped, so that the supporting part 442 can better elastically stretch and contract. The tip of the V-shaped supporting part 442 can be inward, and the two V-shaped supporting parts 442 are symmetrical to each other. The arc-shaped part 441 is elastically pressed against the outer wall surface of the closing part 411 in the second hole 42. The contact area between the arc-shaped part 441 of the elastic member 44 and the closing part 411 of the hinge member 4 is large, and the degree of fit is high. Therefore, the arc-shaped part 441 of the spring sheet can exert a larger elastic pressing force on the closing part 411, but does not hinder the rotation of the closing part 411 with the hinge member 4.
[0031] In some examples, the pressure foot edge 3 is a second coil spring, so that the pressure foot edge 3 can be flexibly deformed in response to the expansion of the inner wall at the position of the pressure foot edge 3 in the esophagus and stomach, and can be reset when the inner wall at the position of the pressure foot edge 3 in the esophagus and stomach restores. The pressure foot edge 3 can also extend along the trend when the esophagus and stomach wall expands laterally, and can restore the shape when the esophagus and stomach wall restores. The extending edge 2 is coated with an extending coating layer 21, which coats the extending edge 2 and the four peripheral edges of the valve membrane 1 to form protection; the presser edge 3 is coated with a presser coating layer 31, which can form protection for the presser edge 3.
[0032] In some examples, the axis of the extending edge 2 is a first circular arc, and the axis of the presser edge 3 is a second circular arc; The center of the second circular arc is located inside the first circular arc, the arc length of the first circular arc is greater than that of the second circular arc, and the radius of the first circular arc is greater than that of the second circular arc; As shown in Figure 1A , Figure 1B , Figure 8A and Figure 8B , the valve membrane 1 is suspended on the side close to the presser edge 3 and forms a window 11 with the presser edge 3, and a part of the edge of the valve membrane 1 is free on the side close to the presser edge 3, which can be stretched with the peristalsis of the stomach and esophagus.
[0033] In some examples, a fixing ring 32 is further included; At least one fixing ring 32 is arranged on the presser edge 3; The fixing ring 32 is integrally formed with the presser edge 3, or the fixing ring 32 is connected to the presser edge 3 through a clamping ring 33, the fixing ring 32 and the presser edge 3 can slide through the clamping ring 33, and the fixing ring 32 is sutured to the inner wall of the stomach and esophagus; Specifically, the fixing ring 32 is two and located at the two ends of the presser edge 3 respectively; at least one fixing ring 32 is provided with a pull rope 34.
[0034] By arranging the clamping ring 33, the fixing of the fixing ring 32 can be adjusted in movement or / and rotation on the extending edge according to different folds in the digestive tract.
[0035] For example, two clamping rings 33 are arranged on the presser edge 3, and the clamping ring 33 can be a soft and inelastic sheet-shaped ring, which can slide on the presser edge 3, so that after the fixing ring 32 is sutured, the position of the presser edge 3 and the valve membrane 1 can still be adjusted, which can adapt to patients of different body types and different suture positions.
[0036] Even if the presser edge 3 is turned down around the clamping ring 33 to make the valve membrane 1 collapse, the stomach contents will lift the valve membrane 1.
[0037] In some examples, as shown in Figure 10 A treatment device can be used in cooperation with an endoscope suture device, which comprises the above-mentioned gastroesophageal valve and further comprises a valve clip bin 6, the valve clip bin 6 comprising an upper hinge 61, a fixing part bin 62 and a lower hinge 63; The upper hinge 61 is fixed to the distal end body 5 of the endoscope stapler; The fixed part box 62 is fixedly connected with the upper hinge 61 at one end, and is hingedly connected with a lower hinge 63 at the other end. The lower hinge 63 can be arc-shaped, and the distal end body 5 of the endoscope stapler can also be arc-shaped. The lower hinge 63 and the distal end body 5 can be coaxially arranged. The lower hinge 63 is located on one side of the distal end body 5, and a valve warehouse 68 for accommodating a gastroesophageal valve is formed between the lower hinge 63 and the distal end of the distal end body 5, as shown in Figure 11 、 Figure 12 、 Figure 13 and Figure 14 ; As shown in Figure 9A 、 9B , the specific construction scheme of the valve warehouse 68 can be that the side surface of the lower hinge 63 close to the distal end body 5 is a warehouse bottom surface 631, the inner side wall of the lower hinge 63 is provided with a folding column 65 with adjustable arc length, and the outer side wall of the lower hinge 63 is provided with an outer edge 66. The outer edge 66 can extend from one end of the lower hinge 63 to the other end. The folding column 65 and the outer edge 66 both protrude from the warehouse bottom surface 631 towards the distal end body 5, and the valve warehouse 68 is formed between the warehouse bottom surface 631, the folding column 65, the outer edge 66 and the distal end body 5. The folding column 65 can have a fixed column 651 and a movable column 652. The movable column 652 is slidingly connected to the fixed column 651. The arc length of the folding column 65 can be adjusted by moving the movable column 652. After adjusting the arc length of the folding column 65, the movable column 652 can be fastened to the fixed column 651 by a fastener. The design of the folding column 65 can change the limiting effect on the gastroesophageal valve in the valve warehouse 68 and allow the gastroesophageal valve to smoothly exit the warehouse from the side of the folding column 65 of the valve warehouse 68.
[0038] As shown in Figure 10 , the specific construction scheme of the valve warehouse 68 can also be: The side surface of the lower hinge 63 close to the distal end body 5 is a warehouse bottom surface 631. The inner side wall of the lower hinge 63 is provided with an inner edge 67. The outer side wall of the lower hinge 63 is provided with an outer edge 66. The outer edge 66 and the inner edge 67 can both extend from one end of the lower hinge 63 to the other end. The outer edge 66 and the inner edge 67 both protrude from the warehouse bottom surface 631 towards the distal end body 5. The valve warehouse 68 is formed between the warehouse bottom surface 631, the inner edge 67, the outer edge 66 and the distal end body 5. The height of the inner edge 67 protruding from the warehouse bottom surface 631 can be lower than the height of the outer edge 66 protruding from the warehouse bottom surface 631, which facilitates the gastroesophageal valve to smoothly exit the warehouse from the side of the inner edge 67 of the valve warehouse 68.
[0039] The clamping warehouse reset member 64 is arranged between the upper hinge 61 and the lower hinge 63, and the clamping warehouse reset member 64 is used to make the lower hinge 63 elastically press the gastroesophageal valve. The clamping warehouse reset member 64 can be, but is not limited to, a torsional spring.
[0040] The gastroesophageal valve installation process is as follows: 1) As shown in Figure 11 and 12 , the valve clamping warehouse 6 is installed at the distal end of the endoscope suture device 5; 2) The open lower hinge 63 wraps the gastroesophageal valve longitudinally and pushes it into the valve warehouse 68 (the open lower hinge 63 of the valve warehouse 68, that is, the top of the stretching edge 2 is pushed to the center of the valve membrane 1 (in this way, there are four edges side by side; the presser foot edge 3 can not be inserted and exposed, and the valve warehouse 68 is wide enough), and the arc length of the folding column 65 of the lower hinge 63 is adjusted according to the actual situation; 3) Two fixed rings 32 are respectively a first fixed ring and a second fixed ring, the pull rope 34 on the second fixed ring is inserted into the pull rope hole of the fixed member box 62 and is pulled out, and the end of the pull rope 34 is set with a ring knot after being pulled out; 3) The first fixed ring is inserted into the fixed member box 62 of the valve warehouse 68, and attention should be paid not to block the end of the reserved knot of the suture line. The suture needle 53 is installed in the distal end body 5 with rotation, and one end of the distal end body 5 is the needle outlet 51, and the other end is the needle inlet 52; 4) When suturing, the needle tip of the suture needle 53 is rotated out of the needle outlet 51 and is rotated into the needle inlet 52 of the distal end body 5, and the suture needle 53 is rotated in a cycle of 360°. In the cycle process, the needle tip of the suture needle 53 passes through the first fixed ring 32 and enters the needle inlet 52 of the distal end body 5.
[0041] The gastroesophageal valve operation steps can be referred to as follows: The gastroscope reaches the fundus of the stomach, and the reverse gastroscope confirms that the labium of the cardia is visible; the gastroscope is adjusted (direct vision), and is withdrawn to the distal end of the dentate line; the first grabber grabs one side of the tissue at the distal end of the dentate line; the needle is inserted, the suture needle 53 on the distal end body 5 of the endoscopic suture device passes through the target suture site and the first fixed ring 32, and the suture needle 53 enters the needle channel groove inside the distal end body 5; after the suture needle 53 completely enters the needle channel groove, the suture line is pulled; the second grabber is on the left side of the suture device, and gently pulls the suture line to the right to pull out the first fixed ring from the fixing member box 62 of the valve clamp warehouse 6, or directly clamps the first fixed ring to pull it out; after being pulled out, the suture line is threaded and knotted by using the grabber and the knot pushing tube; during the knotting process, the grabber adjusts the position of the first fixed ring from the distal end of the tissue to be fixed to the proximal end of the tissue to be fixed (if the reverse gastroscope is operated, it is directly fixed to the proximal end of the tissue to be fixed), so as to avoid the slip knot; in order to facilitate the knotting operation of the second fixed ring later, the suture line does not need to be cut off; when the first fixed ring is pulled out of the fixing member box 62 of the valve clamp warehouse 6, the valve membrane 1 can be taken out of the valve warehouse 68, or it can not be taken out, depending on the proficiency and operation state; after the first fixed ring 32 is fixed and knotted, the grabber hooks the pull rope 34 (the pull rope 34 on the second fixed ring) outside the pull rope hole on the side of the fixing member box 62, and pulls to pull the second fixed ring 32 into the fixing member box 62, and waits for fixation (suture).
[0042] The grabber grabs the other side of the tissue at the distal end of the dentate line; the needle is inserted, the suture needle 53 passes through the target suture site and the second fixed ring 32, and the suture needle 53 enters the needle channel groove of the distal end body 5 of the endoscopic suture device; after the suture needle 53 completely enters the needle channel groove, the suture line is pulled; the second grabber is on the left side of the suture device, hooks the suture line to the right, and gently pulls the second fixed ring out of the fixing member box 62 of the valve clamp warehouse 6, or directly clamps the second valve fixing member to pull it out. The suture line is threaded and knotted by using the grabber and the knot pushing tube; during the knotting process, the grabber adjusts the position of the second valve fixing member from the distal end of the tissue to be fixed to the proximal end of the tissue to be fixed, so as to avoid the slip knot; the suture line between the first fixed ring and the second fixed ring and the pull rope are cut off by using the wire scissors (and are taken out).
[0043] The gastroscope is withdrawn, and the suture device is taken out, and the operation is completed.
[0044] The above is the ideal embodiment according to the present application, and through the above description, relevant personnel can make various changes and modifications without deviating from the technical idea of the present application. The technical scope of the present application is not limited to the content in the specification, and must be determined according to the scope of claims.
Claims
1. A gastroesophageal valve, characterized by: The valve membrane body (1) has an expanded shape when deployed in the esophagus; The extension edge (2) is provided around the circumference of the valve membrane body (1) and is connected to the outer peripheral edge of the valve membrane body (1); The pressure foot edge (3) is connected to both ends of the extension edge (2), and the pressure foot edge (3) is used to fix on the inner wall of the esophagus; The extension edge (2) is a shape memory reset member; The extension edge (2) is configured to locally or completely swing towards the stomach direction when the food flows in contact with the valve membrane body (1), and the extension edge (2) returns to the original position after swinging; The extension edge (2) is also configured to deform in response to the space at the valve membrane body (1) in the esophagus being reduced, and returns to the original position when the space at the valve membrane body (1) in the esophagus is restored. The extension edge (2) is fixedly connected or integrally formed with the valve body (2), the extension edge (2) is an elastic extension edge (2), and the thickness of the extension edge (2) is greater than the thickness of the valve body (1).
2. The gastroesophageal flap valve of claim 1, wherein: The extension edge (2) is a first spiral spring, and the axis of the first spiral spring is a curve extending around the outer peripheral edge of the valve membrane body (1).
3. The gastroesophageal flap valve of Claim 1, wherein: Further comprising a hinge assembly, the hinge assembly comprises a plurality of hinge members (4) connected in sequence around the circumference of the valve membrane body (1), and the hinge members (4) are fixedly connected with the extension edge (2); 4. The gastroesophageal flap valve of Claim 1, wherein: The extension edge (2) is used to promote the hinge assembly to return to the preset state after the shape changes; The hinge member (4) is provided with a limiting member (43), the limiting member (43) is used to limit the outer limit position of the hinge member (4) rotating towards the oral cavity direction, and the maximum rotation angle of the hinge member (4) in the preset state towards the oral cavity direction is less than the maximum rotation angle of the hinge member (4) in the preset state towards the stomach direction. The hinge member (4) is spherical, one end of the hinge member (4) penetrates the first hole (41), and the other end penetrates the second hole (42); 5. The gastroesophageal flap valve of Claim 4, wherein: The first hole (41) forms a closed part (411) at the position of the inner wall of one end away from the ball center of the hinge member (4), and the second hole (42) forms an open part (422) at the position of the inner wall of one end away from the ball center of the hinge member (4); The second hole (42) is fixedly provided with the limiting member (43), the limiting member (43) has at least one limiting groove (431) matched with the closed part (411), and the closed part (411) of one hinge member (4) is inserted into the limiting groove (431) of another hinge member (4) to be connected in a universal manner; The hinge member (4) rotates to the outer limit position when the closed part (411) contacts the groove bottom (431a) of the limiting groove (431). The second hole (42) is provided with an elastic member (44), and the elastic member (44) abuts against the outer wall surface of the closed part (411) in the second hole (42).
6. The gastroesophageal flap valve of Claim 5, wherein: The pressure foot edge (3) is a second spiral spring, the extension edge (2) is wrapped with an extension wrapping layer (21), and the pressure foot edge (3) is wrapped with a pressure foot wrapping layer (31).
7. The gastro-esophageal valve according to any of claims 1-6, characterized in that: 8. The gastroesophageal flap valve of Claim 7, wherein: The axis of the stretching edge (2) is a first circular arc, and the axis of the presser foot edge (3) is a second circular arc; The center of the second circular arc is located inside the first circular arc, the arc length of the first circular arc is greater than that of the second circular arc, and the radius of the first circular arc is greater than that of the second circular arc; Further comprising a fixing ring (32); At least one fixing ring (32) is arranged on the presser foot edge (3); The fixing ring (32) is integrally formed with the presser foot edge (3), or the fixing ring (32) is connected to the presser foot edge (3) through a clamping ring (33), and the fixing ring (32) and the presser foot edge (3) can slide through the clamping ring (33).
9. The gastro-esophageal flap valve of claim 1, wherein: The valve membrane (1) is suspended on the side close to the presser foot edge (3) and forms a window (11) with the presser foot edge (3).
10. A treatment device comprising the gastroesophageal valve of any one of claims 1-9, characterized in that: Further comprising a valve clamp bin (6), the valve clamp bin (6) comprises an upper hinge (61), a fixing part bin (62) and a lower hinge (63); The upper hinge (61) is fixed to the distal end body (5) of the endoscope suture device; One end of the fixing part bin (62) is fixedly connected with the upper hinge (61), and the other end is hingedly connected with the lower hinge (63), the lower hinge (63) is located on one side of the distal end body (5), and the lower hinge (63) and the distal end of the distal end body (5) form a valve bin (68) for accommodating the gastroesophageal valve; The clamp bin reset part (64) is arranged between the upper hinge (61) and the lower hinge (63), and the clamp bin reset part (64) is used for elastically pressing the lower hinge (63) to the gastroesophageal valve.