Tissue spacing device

Abstract

The invention relates to a tissue spacing device. The tissue spacing device comprises an injection tube used for injecting filler into a bag; the near end of the pre-supporting structure is connected with the injection tube; the pre-supporting structure is provided with a compression configuration for conveying and a preset expansion configuration, and can be switched between the compression configuration and the expansion configuration through elastic deformation; wherein the injection tube and the pre-support structure extend into or out of the capsular bag through the inlet of the capsular bag, and when the injection tube and the pre-support structure are located in the capsular bag, the pre-support structure abuts against the inner surface of the capsular bag when the pre-support structure is in the expanded configuration, so that the capsular bag is pre-expanded. When the tissue spacing device is used, the injection tube drives the pre-supporting structure and the bag to move out of the conveying catheter together, and the pre-supporting structure abuts against the inner surface of the bag when the pre-supporting structure is in the expansion configuration, so that the bag is pre-expanded, preliminary positioning is achieved, and the position of the bag can be adjusted. And finally, filling materials can be injected into the bag through the injection tube, so that the bag is accurately fixed at a target position.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, in particular to a tissue spacer. Background Art

[0002] Cancer is a genetic disease caused by uncontrolled cell growth due to genetic defects or mutations and is a leading cause of death. Current treatments for cancer primarily involve surgery, chemotherapy, radiotherapy, or targeted therapies. Removing or treating diseased tissue, malignant tumors, benign tumors, or masses can be achieved through various energy-based treatments, and energy-based treatments are becoming increasingly popular. However, during procedures such as hyperthermia, cryotherapy, radiofrequency ablation, and radiotherapy, energy-based treatments carry the risk of damaging surrounding healthy tissue while treating the target tissue. For example, hyperthermia involves using a balloon filled with hot water or a thermal ablation catheter to thermally damage the target tissue, causing tissue necrosis. Cryotherapy utilizes freezing techniques such as liquid nitrogen or argon gas expansion to damage tissue, causing irreversible necrosis and ultimately removing diseased tissue. Radiofrequency ablation, on the other hand, uses high-energy radiofrequency energy to destroy tumors, rapidly eliminating them. These methods for treating tumors or cancer can be used independently or in combination, but all carry the risk of damaging healthy tissue to some extent while treating the target tissue.

[0003] In related technologies, a capsule is implanted between the target tissue to be treated and healthy tissue. A filler is then added to expand the capsule, allowing it to abut the target tissue and healthy tissue, respectively. This physically isolates the target tissue from the healthy tissue and protects the healthy tissue. However, the unexpanded capsule cannot be fixed after implantation. The expanded capsule, after being filled with the filler, abuts the target tissue and healthy tissue, making it difficult to adjust its position. This can easily lead to inaccurate placement of the capsule and the risk of secondary implantation. Summary of the Invention

[0004] Based on this, it is necessary to provide a tissue spacer to address the technical problem that when the energy device in the prior art treats the target tissue, the bag used to separate the target tissue from the healthy tissue is prone to inaccurate positioning.

[0005] A tissue spacer device, comprising: a pouch, an injection tube, and a pre-support structure.

[0006] The injection tube is used to inject filler into the pouch;

[0007] The proximal end of the pre-support structure is connected to the injection tube; the pre-support structure has a compressed configuration for delivery and a predetermined expanded configuration, and can be switched between the compressed configuration and the expanded configuration by elastic deformation;

[0008] In which, the injection tube and the pre-support structure extend into or out of the bag through the entrance of the bag, and when located in the bag, the pre-support structure abuts against the inner surface of the bag in the expanded configuration to pre-expand the bag.

[0009] In one embodiment, the pre-support structure includes a plurality of support bars, the plurality of support bars are sequentially arranged along a circumferential direction, and the proximal ends of the plurality of support bars are fixedly connected to the injection tube;

[0010] When the pre-support structure switches from the compressed configuration to the expanded configuration, distal ends of the plurality of support bars move away from each other, so that the plurality of support bars jointly pre-expand the balloon.

[0011] In one embodiment, the support strip is in sheet or wire form.

[0012] In one embodiment, the pre-support structure is made of shape memory metal material.

[0013] In one embodiment, the tissue spacer device also includes a self-sealing structure provided at the entrance of the pouch; the self-sealing structure includes two sealing sheets, which are connected to the pouch and located inside the entrance, and the two sealing sheets have a stacked portion for self-sealing the entrance when the pressure inside the pouch is greater than the external pressure.

[0014] In one embodiment, the tissue spacer device further comprises an injection portion for connecting to the proximal end of the injection tube to inject the filler into the injection tube.

[0015] In one embodiment, the injection unit includes: a main body, an output head and a driving unit.

[0016] The main body is provided with a plurality of parallel injection cavities, and a piston push rod is respectively provided in each of the plurality of injection cavities;

[0017] The output ends of the plurality of injection cavities are all connected to the output head, and the output port of the output head is connected to the proximal end of the injection tube;

[0018] One end of each of the plurality of piston push rods located outside the injection cavity is connected to the driving portion, so that the driving portion can push the plurality of piston push rods to move synchronously.

[0019] In one embodiment, the injection part is an injection gun, and the injection part further includes: a gripping part, an operating part, and an elastic member.

[0020] The gripping portion is fixedly connected to the main body;

[0021] The elastic force of the elastic member is used to drive the driving part to drive the piston push rod to perform a pulling motion;

[0022] The operating portion is configured to operably drive the driving portion to push the plurality of piston push rods to move synchronously.

[0023] In one embodiment, the pouch has a plurality of storage units, and the pouch has a separation line formed by heat pressing; adjacent storage units are separated by the corresponding separation lines.

[0024] In one embodiment, the pouch has a plurality of storage units, the plurality of storage units are interconnected, and the inlet is connected to any of the storage units.

[0025] In one embodiment, the pouch is made of a degradable material.

[0026] In one embodiment, the pouch has substance exchange pores, and the substance exchange pores are micropores or nanopores.

[0027] In one embodiment, the pouch has a plurality of storage units, which are arranged sequentially from the proximal end to the distal end of the pouch, are independent of each other, and each storage unit has an injection port;

[0028] The injection tube and the pre-support structure correspond to the storage unit at the proximal end of the sac, and extend from the injection port of the storage unit at the proximal end of the sac.

[0029] In one embodiment, the tissue spacer device further comprises a delivery catheter, and when the injection tube and the balloon are placed in the delivery catheter, the pre-support structure is located in the balloon and is in a compressed configuration.

[0030] To use the aforementioned tissue spacer, the distal end of the syringe and the pre-support structure are inserted through the inlet of the pouch and into the pouch. The tissue spacer is then delivered to the patient's body between the target tissue and healthy tissue using a delivery catheter. While the tissue spacer is within the delivery catheter, the pre-support structure is in a compressed configuration, while the pouch is also in a deflated state, allowing the pre-support structure and pouch to rest within the delivery catheter. The syringe is then distally moved, thereby moving the pre-support structure and pouch out of the delivery catheter. The pre-support structure then switches to an expanded configuration due to elastic restoring force. In the expanded configuration, the pre-support structure abuts against the inner surface of the pouch, pre-expanding the pouch. This allows the pouch to be pre-expanded before it is filled with a filler. After pre-expanding, the pouch can abut against the target tissue and healthy tissue, respectively, achieving initial positioning. Because the pre-expanded pouch has not yet been filled with a filler, the abutment forces between the pouch and the target tissue and healthy tissue are relatively low, allowing the pouch to be accurately adjusted to its target position. Finally, filler can be injected into the capsule through the injection tube to fully expand the capsule so as to achieve reliable contact with the target tissue and healthy tissue, thereby accurately fixing the capsule at the target position. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 Schematic diagram of the structure of a tissue spacer according to an embodiment.

[0032] Figure 2 Schematic diagram of a pre-support structure according to an embodiment.

[0033] Figure 3 Schematic diagram of the cooperation relationship between the injection tube and the self-sealing structure of one embodiment.

[0034] Figure 4 Schematic diagram of the connection relationship between the pouch, self-sealing structure and injection tube according to one embodiment.

[0035] Figure 5 Schematic diagram of the connection between the self-sealing structure and the pouch when closed according to one embodiment.

[0036] Figure 6 Schematic diagram of the structure of the injection part of one embodiment.

[0037] FIG7( a ) is a schematic structural diagram of a pouch according to an embodiment.

[0038] FIG7( b ) is a schematic structural diagram of a pouch according to another embodiment.

[0039] FIG7( c ) is a schematic structural diagram of a pouch according to another embodiment.

[0040] FIG7( d ) is a schematic structural diagram of a pouch according to yet another embodiment.

[0041] Description of reference numerals:

[0042] 10. Delivery catheter; Z, first direction; X, second direction; Y, third direction;

[0043] 100, pouch; 101, entrance; 110, storage unit; 120, dividing line;

[0044] 200, injection tube; 210, threaded connector;

[0045] 300, support bar;

[0046] 400, sealing piece;

[0047] 500, injection part; 510, main body; 511, injection chamber; 512, piston push rod; 520, output head; 530, drive part; 540, grip part; 550, operating part. DETAILED DESCRIPTION

[0048] To make the above-mentioned objects, features, and advantages of the present invention more readily apparent, specific embodiments of the present invention are described in detail below with reference to the accompanying drawings. The following description sets forth numerous specific details to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways than those described herein, and those skilled in the art may make similar modifications without departing from the scope of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0049] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like to indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the present invention.

[0050] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.

[0051] In the present invention, unless otherwise specified or limited, the terms "installed," "connected," "connect," "fixed," etc. should be understood in a broad sense. For example, they can refer to fixed connection, detachable connection, or integration; mechanical connection, electrical connection; direct connection, or indirect connection through an intermediate medium; internal communication between two components, or interaction between two components, unless otherwise specified. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0052] In the present invention, unless otherwise expressly specified or limited, when a first feature is "above" or "below" a second feature, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediary. Furthermore, when a first feature is "above," "above," or "above" a second feature, it may mean that the first feature is directly above or diagonally above the second feature, or simply means that the first feature is at a higher level than the second feature. When a first feature is "below," "below," or "below" a second feature, it may mean that the first feature is directly below or diagonally below the second feature, or simply means that the first feature is at a lower level than the second feature.

[0053] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be an intermediate element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be an intermediate element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only implementation methods.

[0054] In the embodiments of the present application, the terms "distal end" and "proximal end" are used, wherein the proximal end is the end of the components of the tissue spacer device close to the operator, and the distal end refers to the other end opposite to the proximal end.

[0055] Please refer to Figure 1 One embodiment of the present application provides a tissue spacer device, which includes: a pouch 100, an injection tube 200 and a pre-support structure, wherein the injection tube 200 is used to inject a filler into the pouch 100. The proximal end of the pre-support structure is connected to the injection tube 200. The pre-support structure has a compression configuration for delivery and a predetermined expansion configuration, and can switch between the compression configuration and the expansion configuration through elastic deformation. The injection tube 200 and the pre-support structure can extend into or exit the pouch 100 through the entrance of the pouch 100. And when the injection tube 200 and the pre-support structure are located in the pouch 100, the pre-support structure abuts against the inner surface of the pouch 100 in the expansion configuration to pre-expand the pouch 100.

[0056] When the above-mentioned tissue spacer device is in use, the distal end of the injection tube 200 and the pre-support structure are first extended into the pouch 100 through the entrance of the pouch 100, and the tissue spacer device is delivered to between the target tissue and the healthy tissue in the patient's body by the delivery catheter 10. Among them, when the tissue spacer device is located in the delivery catheter 10 (the delivery catheter of this embodiment can be an independent sheath or an instrument channel of an endoscope), the pre-support structure is in a compressed configuration, and the pouch 100 is also in a contracted state, so that the pre-support structure and the pouch 100 are placed in the delivery catheter 10. Then, the injection tube 200 is moved in the distal direction, so that the injection tube 200 drives the pre-support structure and the pouch 100 to move out of the delivery catheter 10 together. At this time, the pre-support structure can be switched to an expanded configuration (such as Figure 1 State shown). The pre-support structure abuts against the inner surface of the pouch 100 in the expanded configuration to pre-expand the pouch 100. In this way, the pouch 100 is pre-expanded before the pouch 100 is filled with the filler, and the pre-expanded pouch 100 can abut against the target tissue and healthy tissue respectively to achieve preliminary positioning. Since the pre-expanded pouch 100 has not yet been filled with the filler, the abutment force between the pouch 100 and the target tissue and healthy tissue is relatively small, so that the position of the pouch 100 can also be adjusted so that the pouch 100 is accurately adjusted to the target position. Finally, the filler can be injected into the pouch 100 through the injection tube 200, so that the pouch 100 is fully expanded, so as to achieve reliable abutment with the target tissue and healthy tissue, thereby accurately fixing the pouch 100 at the target position.

[0057] After the pouch 100 is accurately fixed at the target position, the syringe 200 can be moved proximally so that the syringe 200 exits from the inlet 101 of the pouch 100 into the delivery catheter 10. During the withdrawal of the syringe 200, the pre-support structure can be driven to move, causing the pre-support structure to elastically deform, thereby causing the pre-support structure to also exit from the inlet 101 of the pouch 100 into the delivery catheter 10. The pre-support structure and the syringe 200 are then removed from the patient's body through the delivery catheter 10 for subsequent treatment of the target tissue.

[0058] The pouch 100 can be made of a biodegradable material, allowing for easy absorption by the human body and eliminating the need for removal from the patient's body. The filler can be saline, gel, or the like. When saline is used as the filler, a contrast agent can be added to the saline to allow for imaging of the pouch 100's position.

[0059] The shape of the capsule bag 100 can be butterfly-shaped, pear-shaped, peach-shaped, apple-shaped, triangular, flat, irregular, disc-shaped, etc., and can be designed according to the space of its implantation location.

[0060] Please refer to Figure 1In one embodiment, the tissue spacer device further comprises a delivery catheter 10, which in this embodiment is a separate sheath. When the syringe 200 and the pouch 100 are placed in the delivery catheter 10, the pre-support structure is located in the pouch 100 and is in a compressed configuration, facilitating delivery of the pouch 100, syringe 200, and pre-support structure into the patient's body using the delivery catheter 10.

[0061] Please refer to Figure 1 In one embodiment, the pre-support structure abuts against the inner surface of the bag 100 when in the expanded configuration so that when the bag 100 is pre-expanded, the distal end of the injection tube 200 extends to the distal end of the internal space of the bag 100, thereby allowing the filler to be directly injected into the deepest part of the bag 100, facilitating faster expansion of the bag 100.

[0062] Combine Figure 1 and Figure 2 In one embodiment, the pre-support structure includes a plurality of support bars 300, and the plurality of support bars 300 are arranged in sequence along a circumferential direction, and the proximal ends of the plurality of support bars 300 are fixedly connected to the injection tube 200. When the pre-support structure switches from a compression configuration to an expansion configuration, the distal ends of the plurality of support bars 300 move away from each other, so that the plurality of support bars 300 jointly pre-expand the pouch 100. The support bars 300 may be filamentous or sheet-like. In this embodiment, the distal ends of the plurality of support bars 300 are movable ends and may be close to or away from each other. When the distal ends of the plurality of support bars 300 move close to each other and gather together, the pre-support structure switches to a compression configuration.

[0063] After the filler is injected into the pouch 100 to fully expand the pouch 100 and the pouch 100 is in contact with the target tissue and healthy tissue, the pre-support structure is withdrawn from the pouch 100 and enters the delivery catheter 10. The portions of the multiple support bars 300 near the delivery catheter 10 gradually move closer together, allowing each of the multiple support bars 300 to penetrate the filler. The multiple support bars 300 do not interfere with each other during the penetration process, making it easier to penetrate the filler and withdraw from the pouch 100. The number of support bars 300 can be two, three, four, etc., and the number can be selected based on the internal space of the pouch 100.

[0064] Combine Figure 1 and Figure 2 In one embodiment, the proximal ends of the plurality of support bars 300 surround the outside of the injection tube 200. The proximal ends of the plurality of support bars 300 are parallel to each other and fixed to the outer surface of the injection tube 200. When the pre-support structure switches to the compressed configuration, the distal ends of the plurality of support bars 300 may also be parallel to each other.

[0065] In one embodiment, the pre-support structure is made of a shape memory metal material. The shape memory metal material has good support properties and is easily detected by ultrasound, CT and other equipment, thereby facilitating the observation of the position of the pouch 100 .

[0066] Combine Figures 3 to 5 In one embodiment, the tissue spacer further comprises a self-sealing structure provided at the inlet 101 of the pouch 100. The self-sealing structure comprises two sealing sheets 400, which are connected to the pouch 100 and located inside the inlet 101 of the pouch 100. The two sealing sheets 400 have overlapping portions for self-sealing the inlet 101 of the pouch 100 when the pressure inside the pouch 100 is greater than the external pressure.

[0067] In this embodiment, when the injection tube 200 and the pre-support structure extend into or out of the pouch 100 through the inlet 101, they can pass between the two sealing sheets 400, thereby passing through the inlet 101. When the injection tube 200 injects filler into the pouch 100 to fully expand the pouch 100 so as to achieve contact with the target tissue and healthy tissue, the injection tube 200 and the pre-support structure are passed through the two sealing sheets 400 and withdrawn from the pouch 100. At this time, the pressure provided by the filler in the pouch 100 is greater than the external pressure, so that the overlapping parts of the two sealing sheets 400 are tightly attached, achieving automatic sealing between the two sealing sheets 400, that is, self-sealing the inlet 101 of the pouch 100, without the need for additional sealing accessories or manual sealing, which is convenient and quick.

[0068] It can be understood that the sealing sheet 400 should be made of a material with a certain degree of flexibility so that the injection tube 200 and the pre-support structure can pass between the two sealing sheets 400, and when the pressure provided by the filler in the bag 100 is greater than the external pressure, the two sealing sheets 400 can be tightly attached.

[0069] like Figure 3 As shown, in one embodiment, the two sealing sheets 400 are fixed on both sides along the second direction X (they can be fixed by hot pressing, bonding, etc.). The middle of the two sealing sheets 400 along the second direction X allows the injection tube 200 and the pre-support structure to pass through. Figure 3 and Figure 4 As shown, the injection tube 200 and the pre-support structure pass through between the two sealing sheets 400 along the first direction Z.

[0070] After the syringe 200 injects filler into the pouch 100, causing the pouch 100 to fully expand and contact the target tissue and healthy tissue, the syringe 200 and the pre-support structure are then passed through the two sealing sheets 400 along the first direction Z and withdrawn from the pouch 100. At this point, the pressure provided by the filler in the pouch 100 is greater than the external pressure, causing the two sealing sheets 400 to adhere tightly along the third direction Y, thereby achieving self-sealing of the inlet 101.

[0071] The third direction Y is the thickness direction of the sealing sheet 400. The second direction X, the first direction Z, and the third direction Y are perpendicular to each other. The first direction Z is along the length direction of the injection tube 200.

[0072] In other embodiments, other sealing structures may be used to seal the pouch. For example, an elastic member (e.g., rubber) may be positioned at the pouch entrance. The injection tube and pre-support structure can pass through the elastic member to enter or exit the pouch. After the injection tube and pre-support structure pass through the elastic member and exit the pouch, the elastic member recovers its deformation, thereby preventing the pouch filling from leaking out.

[0073] In one embodiment, the material of the sealing sheet 400 is the same as that of the pouch 100 , and the sealing sheet 400 and the pouch 100 can be fixed by heat pressing, bonding, or the like.

[0074] In other embodiments, the sealing sheet and the pouch may also be made of different materials.

[0075] Please refer to Figure 6 In one embodiment, the tissue spacer device further includes an injection portion 500, which is connected to the proximal end of the injection tube 200. The injection portion 500 facilitates the injection of filler into the injection tube 200. The injection portion 500 can be a syringe, an injection gun, or the like.

[0076] Please refer to Figure 1 In one embodiment, a threaded connector 210 is provided at the proximal end of the injection tube 200 , and the threaded connector 210 is used to be threadedly connected to the injection part 500 , thereby facilitating the connection between the injection tube 200 and the injection part 500 .

[0077] Please refer to Figure 6 In one embodiment, the injection unit 500 includes a main body 510, an output head 520, and a driving unit 530. The main body 510 is provided with a plurality of mutually parallel injection chambers 511, each of which is provided with a piston push rod 512. The output ends of the plurality of injection chambers 511 are all connected to the output head 520, and the output port of the output head 520 is connected to the proximal end of the syringe 200. The ends of the plurality of piston push rods 512 located outside the injection chamber 511 are all connected to the driving unit 530, so that when the driving unit 530 moves, it can drive the plurality of piston push rods 512 to move synchronously.

[0078] In this embodiment, the filler can be a cross-linked gel formed by cross-linking multiple different components. Multiple injection cavities 511 can each accommodate these different components. The drive unit 530 simultaneously pushes the multiple piston push rods 512, causing them to synchronously push the components within their respective injection cavities 511. This stabilizes the delivery rate of each component and allows the multiple components to fully mix and react to form a gel.

[0079] exist Figure 6 In the illustrated embodiment, there are two injection cavities 511 , which can be used to inject two components so that the two components are cross-linked to form a gel.

[0080] In other embodiments, the number of injection cavities may be three or more.

[0081] Please refer to Figure 6 In one embodiment, the injection unit 500 is an injection gun and further includes a gripping portion 540, an operating portion 550, and an elastic member (not shown). The gripping portion 540 is fixedly connected to the main body 510 for the operator to grasp. The elastic force of the elastic member is used to drive the driving unit 530 to move the piston push rods 512 in a pulling and retracting motion. The operating portion 550 is configured to operably drive the driving unit 530 to push the multiple piston push rods 512 in synchronous motion.

[0082] The operator holds the grip portion 540 and operates the operating portion 550, thereby driving the driving portion 530 to push the multiple piston push rods 512 to move synchronously. In this way, the operator can operate the operating portion 550 with a single button, conveniently performing the injection. After the injection is completed, the operating portion 550 is released, and the elastic force of the elastic member can drive the driving portion 530 to pull the multiple piston push rods 512 to move, thereby resetting the multiple piston push rods 512. It can be understood that in the process of the operating portion 550 driving the driving portion 530 to push the multiple piston push rods 512 to move synchronously, the external force applied to the operating portion 550 directly or indirectly overcomes the elastic force of the elastic member.

[0083] Please refer to Figure 6 In one embodiment, the driving portion 530 is slidably connected to the main body 510, and the sliding connection direction between the two is parallel to the movement direction of the piston push rod 512. The end of the driving portion 530 away from the piston push rod 512 is rotationally connected to the operating portion 550. The operating portion 550 is also rotationally connected to the grip portion 540.

[0084] When the operator grasps the grip portion 540 and presses the operating portion 550, the operating portion 550 rotates relative to the grip portion 540, thereby driving one end of the driving portion 530 to push the multiple piston push rods 512 to move synchronously. After releasing the operating portion 550, the restoring force of the elastic member drives the driving portion 530 to move the multiple piston push rods 512 in a pulling and extending motion.

[0085] The elastic member may be connected between the operating portion 550 and the grip portion 540, for example, a torsion spring disposed at the rotational connection between the operating portion 550 and the grip portion 540. The elastic member may also be connected between the driving portion 530 and the operating portion 550, for example, a torsion spring disposed at the rotational connection between the driving portion 530 and the operating portion 550. The elastic member may also be connected between the driving portion 530 and the main body 510, for example, a compression spring disposed between the driving portion 530 and the main body 510.

[0086] In other embodiments, the injection portion may also have only one injection cavity for injecting a filler of one component.

[0087] In one embodiment, the pouch 100 can be made of a polymer film. For example, two layers of film can be stacked and then secured at their circumferential edges by heat welding or bonding. This creates a cavity between the two layers, forming the interior space of the pouch 100. The pouch 100 can also be made of a single layer of film, which is folded in half to form two layers of film. The edges of the two layers (excluding the folded edge) are then secured by heat welding or bonding. Alternatively, the pouch 100 can be directly manufactured through blow molding, electrospinning, or dipping and casting.

[0088] The surface of the pouch 100 may be smooth, or may have a concave-convex structure, or other surface with a certain degree of roughness.

[0089] 7( a ) to 7 ( d ), in some embodiments, the pouch 100 has a plurality of storage units 110 , and the pouch 100 has separation lines 120 formed by heat pressing. Adjacent storage units 110 are separated by corresponding separation lines 120 .

[0090] Referring to FIG. 7( a ), in some embodiments, the pouch 100 includes multiple storage units 110 . These storage units 110 are independent of each other (i.e., not interconnected) and arranged sequentially from the proximal end to the distal end of the pouch 100 . Each storage unit 110 has an injection port. The injection tube 200 and pre-support structure correspond to the storage units 110 at the proximal end of the pouch 100 , extending from the injection port of the proximal storage unit 110 . In the expanded configuration, the pre-support structure abuts the inner surface of the proximal storage unit 110 of the pouch 100 , thereby pre-expanding the proximal storage unit 110 of the pouch 100 . The remaining storage units 110, excluding the proximal storage unit 110 of the pouch 100 , can be injected and filled using an injection tube without a pre-support structure, or using the injection tube 200 and pre-support structure described in the above embodiments.

[0091] In the embodiment shown in FIG7( a ), there are two storage units 110 and one dividing line 120 . The two storage units 110 are independent of each other. One of the two storage units 110 is located at the proximal end of the pouch 100 , and the other storage unit 110 is located at the distal end of the pouch 100 .

[0092] During actual use of the tissue spacer, the distal end of the syringe 200 extends into the storage unit 110 at the proximal end of the pouch 100, and the pre-support structure is located within the storage unit 110 at the proximal end of the pouch 100. After the syringe 200 drives the pre-support structure and the pouch 100 out of the delivery catheter 10, the expanded configuration of the pre-support structure can abut against the inner surface of the storage unit 110 at the proximal end of the pouch 100, causing the storage unit 110 at the proximal end of the pouch 100 to pre-expand. After the pre-expanded storage unit 110 at the proximal end of the pouch 100 abuts against the target tissue and healthy tissue, respectively, achieving preliminary positioning of the pouch 100 and allowing for adjustment of its position. A filler is then injected into the storage unit 110 at the proximal end of the pouch 100 through the syringe 200, causing the storage unit 110 at the proximal end of the pouch 100 to fully expand, abutting against the target tissue and healthy tissue, thereby fixing its position. Finally, filler is injected into the injection port of the storage unit 110 at the distal end of the pouch 100 , so that the storage unit 110 at the distal end of the pouch 100 is fully expanded, thereby achieving full expansion of the entire pouch 100 .

[0093] In some optional technical solutions, the pouch may also have three or more storage units, with adjacent storage units separated by corresponding dividing lines and independent of each other. The injection tube and the pre-support structure extend into the storage unit at the proximal end of the pouch. Similar to the embodiment shown in FIG7 (a), the pre-support structure can be used to pre-expand the storage unit at the proximal end of the pouch to achieve preliminary positioning of the pouch, and filler can be injected into the storage unit at the proximal end of the pouch through the injection tube to fully expand the storage unit at the proximal end of the pouch so that it abuts against the target tissue and healthy tissue and thus fixes the position. Afterwards, filler is injected into the injection ports of other storage units (except the storage unit at the proximal end of the pouch) to fully expand the other storage units, thereby achieving full expansion of the entire pouch.

[0094] As shown in Figures 7(b) to 7(d), in other embodiments, the pouch 100 has multiple storage units 110, and the multiple storage units 110 may be interconnected. In this way, after the filler is injected into the pouch 100 through the injection tube 200, the filler can enter each storage unit 110 respectively.

[0095] In the embodiments shown in FIG. 7 ( b ) to FIG. 7 ( d ), the dividing line 120 is located within the area enclosed by the plurality of support bars 300 , so that the plurality of support bars 300 are staggered with the dividing line 120 to prevent interference.

[0096] In the embodiments shown in Figures 7(a) to 7(d) above, since the pouch 100 has a plurality of storage units 110, each storage unit 100 can store fillers separately, so that each storage unit 100 can separately divide the pressure of the pouch 100 as a whole. Each storage unit 100 can be deformed separately during the process of contact with the tissue in the patient's body, thereby (compared to the pouch 100 with a single storage space) being more easily adapted to the implantation space in the patient's body, reducing pressure on the tissue and improving the patient's comfort.

[0097] It can be understood that the separation line 120 is formed by heat pressing two opposite surfaces of the pouch 100. The heat pressing mark is a linear structure, so it is called the separation line 120. The position of the separation line 120 can be set according to the setting requirements of the storage unit 110.

[0098] As shown in Figures 7(b) to 7(d), the pouch 100 includes multiple dividing lines 120, thereby dividing the pouch 100 into multiple storage units 110. In the embodiment shown in Figure 7(b), the multiple dividing lines 120 are straight and parallel to each other. In the embodiment shown in Figure 7(c), the multiple dividing lines 120 are curved. In the embodiment shown in Figure 7(d), multiple pairs of dividing lines 120 are provided, with the two dividing lines 120 in each pair intersecting each other.

[0099] In one embodiment, the pouch 100 is made of a perforated membrane having material exchange pores (not shown) on its surface. The material exchange pores are micropores or nanopores. The perforated membrane with material exchange pores in the pouch 100 allows for material exchange between the inside and outside of the pouch 100. For example, tissue from the patient's body can grow into the pouch 100 through the material exchange pores, further securing the pouch 100 and eliminating the need for multiple pre-treatment guidance and positioning procedures. Human tissue fluid, degradative enzymes, and the like can enter the pouch 100 through the material exchange pores, accelerating the degradation of the pouch 100 and its internal filler. Simultaneously, the filler within the pouch 100 can flow out through the material exchange pores, thereby preventing ischemia in the compressed tissue.

[0100] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0101] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A tissue spacer device, characterized in that: include: The capsule, injection tube and pre-support structure, The injection tube is used to inject filler into the pouch; The proximal end of the pre-support structure is connected to the injection tube; the pre-support structure has a compressed configuration for delivery and a predetermined expanded configuration, and can be switched between the compressed configuration and the expanded configuration by elastic deformation; In which, the injection tube and the pre-support structure extend into or out of the bag through the entrance of the bag, and when located in the bag, the pre-support structure abuts against the inner surface of the bag in the expanded configuration to pre-expand the bag.

2. The tissue spacer according to claim 1, wherein: The pre-support structure includes a plurality of support bars, the plurality of support bars are sequentially arranged along a circumferential direction, and the proximal ends of the plurality of support bars are fixedly connected to the injection tube; When the pre-support structure switches from the compressed configuration to the expanded configuration, distal ends of the plurality of support bars move away from each other, so that the plurality of support bars jointly pre-expand the balloon.

3. The tissue spacer according to claim 2, wherein: The support strips are in sheet or wire form.

4. The tissue spacer according to claim 1, wherein: The pre-support structure is made of shape memory metal material.

5. The tissue spacer according to claim 1, wherein: It also includes a self-sealing structure arranged at the entrance of the pouch; the self-sealing structure includes two sealing sheets, which are connected to the pouch and located inside the entrance, and the two sealing sheets have a stacked portion for self-sealing the entrance when the pressure inside the pouch is greater than the external pressure.

6. The tissue spacer according to claim 1, wherein: It also includes an injection part, which is used to connect with the proximal end of the injection tube and inject the filler into the injection tube.

7. The tissue spacer according to claim 6, characterized in that The injection unit includes: a main body, an output head and a driving unit. The main body is provided with a plurality of parallel injection cavities, and a piston push rod is respectively provided in each of the plurality of injection cavities; The output ends of the plurality of injection cavities are all connected to the output head, and the output port of the output head is connected to the proximal end of the injection tube; One end of each of the plurality of piston push rods located outside the injection cavity is connected to the driving portion, so that the driving portion can push the plurality of piston push rods to move synchronously.

8. The tissue spacer according to claim 7, characterized in that The injection part is an injection gun, and the injection part further includes: a gripping part, an operating part and an elastic member. The gripping portion is fixedly connected to the main body; The elastic force of the elastic member is used to drive the driving part to drive the piston push rod to perform a pulling motion; The operating portion is configured to operably drive the driving portion to push the plurality of piston push rods to move synchronously.

9. The tissue spacer according to claim 1, wherein: 1) The pouch has a plurality of storage units, and the pouch has separation lines formed by heat pressing; adjacent storage units are separated by corresponding separation lines; or, 2) The pouch has a plurality of storage units, the plurality of storage units are interconnected, and the inlet is connected to any of the storage units; or, 3) The pouch is made of a degradable material; or 4) The pouch has material exchange pores, which are micropores or nanopores.

10. The tissue spacer according to claim 1, wherein: The pouch has a plurality of storage units arranged in sequence from the proximal end to the distal end of the pouch, the plurality of storage units are independent of each other, and each storage unit has an injection port; The injection tube and the pre-support structure correspond to the storage unit at the proximal end of the sac, and extend from the injection port of the storage unit at the proximal end of the sac.

11. The tissue spacer according to claim 1, wherein: A delivery catheter is also included. When the injection tube and the balloon are placed in the delivery catheter, the pre-support structure is located in the balloon and is in a compressed configuration.

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