Balloon assembly

Abstract

The present invention relates to a balloon assembly, comprising a balloon body having an opening of the balloon body; a balloon interface provided at the opening of the balloon body for allowing a filler to pass through and enter the balloon body; a sealing assembly provided on the balloon body and / or the balloon interface, including a sealing body which includes a sealing film for preventing the filler from flowing out of the balloon body; an outer catheter detachably connected to the balloon interface, and the filler enters the opening of the balloon body through the outer catheter. The present invention can simultaneously achieve the sealing of the balloon and the retraction of the catheter. The sealing body can maintain balance under the pressures inside and outside the balloon, and no debris will be left during the sealing process, making the entire sealing process simple to operate, highly safe, and effectively extending the service life of the implantable balloon.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to a balloon assembly. Background Art

[0002] A large amount of tendon tissue and cartilage tissue are attached to the joint connection, which can play a role in supporting the joint and maintaining joint stability. In addition, these tissues are also crucial for joint movement. The joint capsule is a kind of connective tissue distributed in the joint cavity, which can firmly connect two adjacent bones, and at the same time play a lubricating role to reduce wear during joint movement. Injuries at the joint will weaken and lose the function of supporting the bones and transmitting movement. For example, the injury of the rotator cuff will weaken or even lose the fulcrum function of maintaining the humeral head and the glenoid cavity, seriously affecting the function of the shoulder joint. The main function of the joint balloon is to be implanted in the joint cavity to play a supporting and lubricating role, ensuring smooth and frictionless movement between bones, and helping the organism recover the characteristics of the joint by replacing the damaged joint capsule or providing temporary support.

[0003] The implantable balloon is folded in the puncture cannula. After being positioned and released under direct vision of an arthroscope, physiological saline is injected through a catheter to fill the balloon. Then, the catheter is separated from the balloon and withdrawn, and at the same time, the balloon is sealed. Therefore, the design of the catheter needs to ensure that the connection is disconnected in time after the balloon is filled and the balloon does not leak after the catheter is withdrawn. At present, there are not many technologies in the market that can solve the above problems. Usually, after the catheter is withdrawn, a plug is forced into the opening of the balloon body to seal the implantable balloon.

[0004] Due to its small initial volume, the implantable balloon causes less trauma to the patient during the surgical operation and the patient recovers faster, and it has begun to be widely used to achieve specific medical purposes. However, in the common sealing method, on the one hand, the withdrawal of the catheter and the sealing of the balloon cannot be carried out simultaneously, which is easy to cause leakage of the filling liquid; on the other hand, when the plug is forced in for sealing, the plug at the sealing part is not firmly sealed and is easy to loosen under external force. More importantly, when the plug is forced into the opening of the balloon, the plug is easily worn. If debris enters the organism, such as into the blood vessels, it will bring more health hazards.

[0005] Therefore, it is necessary to design a balloon assembly with a simple structure and safe operation, which can seal the balloon while withdrawing the catheter after the balloon is filled. Summary of the Invention

[0006] Based on this, in view of the problems of balloon sealing and catheter withdrawal, a balloon assembly is provided.

[0007] A balloon assembly, comprising a balloon body provided with a balloon body opening; a balloon interface disposed at the balloon body opening for allowing a filler to pass through and enter the balloon body; a sealing assembly disposed on the balloon body and / or the balloon interface, including a sealing body which includes a sealing film for preventing the filler from flowing out of the balloon body; an outer catheter detachably connected to the balloon interface, and the filler enters the balloon body opening through the outer catheter.

[0008] Further, the sealing assembly includes an inner catheter which is disposed through the outer catheter to form a gap for the filler to pass through. One end of the inner catheter is connected to an inflatable inner balloon; the sealing film covers the surface of the inner balloon, and the inner balloon is inflated through the inner catheter and compresses the sealing film to seal the balloon.

[0009] Preferably, the cross-section of the sealing film and the area of the covered inner balloon in the axial direction of the inner catheter is in a U-shaped structure.

[0010] After the inflation of the balloon body is completed, gas, liquid or other substances are injected into the inner balloon through the inner catheter. As the inner balloon expands, the sealing film wrapped on its surface gradually adheres tightly and combines with the inner wall surface of the balloon interface, finally realizing the sealing of the balloon body.

[0011] Further, the sealing body is disposed inside the balloon body and extends from the inner wall of the balloon body, and at least part of the edge of the sealing body is not connected to the inner wall of the balloon body.

[0012] When the balloon body is inflated, the sealing body can be pushed open under the action of an external force to open the balloon body opening, so that the filler can smoothly enter the balloon body. As the filler in the balloon body continuously increases, the internal pressure gradually increases. At the same time, after withdrawing the external force acting on the sealing body, the sealing body will seal the balloon body opening under the action of the internal pressure of the balloon body, thus realizing the sealing of the balloon body opening. The balloon sealing operation in this solution is simpler, can realize the synchronous filling and sealing, and at the same time the balloon body and the sealing body can be integrated, with a simple structure, which can effectively reduce the manufacturing cost.

[0013] Further, the sealing body is disposed inside the balloon body, and the sealing assembly includes an auxiliary tube detachably connected to the sealing body for pre-positioning the sealing body at the balloon body opening. By pushing and pulling the auxiliary tube, the sealing body opens or closes the balloon body opening.

[0014] Further, the surface of the sealing body in contact with the balloon body entirely or partially covers the sealing film.

[0015] Further, the sealing film includes incisions penetrating the sealing film. In this solution, the sealing film is preset in the balloon interface and integrated with the balloon interface, thereby sealing the balloon body. It includes incisions penetrating the sealing film and can communicate with the balloon body. Due to the characteristics of the material of the sealing film itself, the incisions can be closely adhered together without external force.

[0016] Preferably, the sealing film includes cross-shaped incisions.

[0017] Preferably, the incisions include at least two lips, and when the two lips come into contact, they seal the opening of the balloon body and / or the balloon interface.

[0018] Further, the outer catheter includes a needle-shaped head, and the needle-shaped head can pass through the incision into the balloon body to inject the filler into the balloon body.

[0019] The needle-shaped head of the outer catheter can extend into the balloon body through the incision to inject the filler. After inflation is completed, the outer catheter is withdrawn. Due to the characteristics of the material of the sealing film itself and the pressure of the biological tissue fluid from the periphery of the balloon interface, the incisions on the sealing film can be closely combined together, thereby sealing the balloon body.

[0020] For the balloon assembly of this solution, since the sealing film is cast in the balloon interface, there are no special requirements for the internal structure of the balloon body. Therefore, it is easier to process and manufacture in production, with lower costs, and can seal the balloon body while meeting the withdrawal of the outer catheter, thus having a wider market effect.

[0021] Further, the constituent materials of the balloon body, the balloon interface, and / or the sealing film include polyamide, polyester, polyurethane, polyamide-polyether block copolymer, polyethylene, polypropylene, polyimide, cross-linked polyethylene, cross-linked polyurethane, ionomer, PCL (polycaprolactone), PLA (polylactic acid), PLGA (poly(lactic acid-co-glycolic acid)), PLCL (poly(lactide-co-caprolactone)), plasticized starch material, polyelectrolyte complex, or copolymer or blend materials of multiple materials among the above materials.

[0022] For different application environments, if the role of the implantable balloon is to support and replace organs in the organism, such as the joint capsule, a material with biocompatibility is preferably selected. If the role of the implantable balloon is to provide temporary support during the recovery of the organism, such as during the healing period after a muscle tear at the joint, a biodegradable material is preferably selected. This type of implantable balloon will be gradually absorbed by the organism as the organism recovers.

[0023] Further, the sealing film includes a sticky sealing film.

[0024] Further, the connection between the outer catheter and the balloon interface includes, but is not limited to, interference connection, threaded connection or snap connection. For example, the outer wall of the outer catheter has a protruding portion, and the inner wall of the balloon interface has a matching recessed portion. When the outer catheter is inserted into the balloon interface, the protrusion and the recess can cooperate to snap the outer catheter onto the balloon interface. The function of the outer catheter is to fill the filler into the balloon body. Therefore, the connection between the outer catheter and the balloon interface should be tight to ensure no leakage during the filling process. Description of the Drawings

[0025] Figure 1 It is a schematic cross-sectional view of the balloon assembly of Embodiment 1 of the present application in the first state;

[0026] Figure 2 It is a schematic cross-sectional view of the balloon assembly of Embodiment 1 of the present application in the second state;

[0027] Figure 3 It is a schematic cross-sectional view of the balloon assembly of Embodiment 1 of the present application in the third state;

[0028] Figure 4 It is a schematic cross-sectional view of the balloon assembly of Embodiment 2 of the present application in the first state;

[0029] Figure 5 It is a schematic cross-sectional view of the balloon assembly of Embodiment 2 of the present application in the second state;

[0030] Figure 6 It is a schematic cross-sectional view of the balloon assembly of Embodiment 3 of the present application in the first state;

[0031] Figure 7 It is a schematic cross-sectional view of the balloon assembly of Embodiment 4 of the present application in the first state;

[0032] Figure 8 It is a schematic cross-sectional view of the sealing assembly of Embodiment 5 of the present application;

[0033] Figure 9 It is a side view of the sealing assembly of Embodiment 5 of the present application;

[0034] Figure 10 It is a schematic cross-sectional view of the balloon assembly of Embodiment 5 of the present application;

[0035] Figure 11 It is a schematic cross-sectional view of the sealing assembly of Embodiment 6 of the present application. Detailed Description of the Invention

[0036] The technical solutions in the embodiments of the present application will be further clearly and completely described below with reference to the accompanying drawings. It should be noted that the following embodiments are only some preferred embodiments of the present application and do not cover all the embodiments covered by the technical solutions of the present application.

[0037] Unless otherwise specified, the first state described in the present application refers to the state before the start of balloon filling.

[0038] Attached Figures 1-3 Shows a schematic diagram of Embodiment 1 of the present application in different working states. As Figure 1 Shown is a cross-sectional schematic diagram of the balloon assembly in the first state. The balloon assembly includes a balloon body 1 and a balloon interface 2 provided at the opening of the balloon body 1; the sealing assembly includes an inner bladder 5, a sealing film 3 covering the surface of the inner bladder 5, and an inner catheter 6 connected to the inner bladder 5. Among them, the inner bladder 5 is arranged in the balloon interface 2, and the outer catheter 4 is detachably connected to the balloon interface 2. The inner catheter 6 passes through the outer catheter 4 and forms an annular gap for the filler to pass through. The filler can enter the balloon body 1 through the above-mentioned annular gap and the gap between the inner bladder 5 and the balloon interface 2.

[0039] Specifically, as Figure 2 Shown, after the balloon body 1 is filled, the inner bladder 5 is inflated through the inner catheter 6 and presses the sealing film 3 on its surface to gradually adhere tightly to the inner wall of the balloon interface 2, thereby closing the balloon body 1. Among them, the sealing film 3 and the inner bladder 5 are used in combination. Preferably, the cross-section of the area of the sealing film 3 and the covered inner bladder 5 along the axial direction of the inner catheter 6 is in a U-shaped structure, but this is not all the styles of the combination of the sealing film 3 and the inner bladder 5. Other forms of combination that can achieve the above sealing structure are allowed.

[0040] Further, by withdrawing other fillers in the inner catheter 6, the inner bladder 5 can retract due to its own elasticity and release the sealing film 3. Due to the material properties of the sealing film 3, it can maintain a tightly fitting state with the inner wall of the balloon interface 2, specifically as Figure 3 Shown. Then, the outer catheter 4 is removed, and the inner catheter 6 and the inner bladder 5 connected thereto are withdrawn from the organism together.

[0041] Adopting the technical solution provided in Embodiment 1, the balloon assembly is used in a set. The sealing assembly is pre-arranged in the balloon interface 2 in advance. After the balloon body 1 is filled, pressure is applied to the sealing film 3 to press or bond the sealing film 3 to the inner wall of the balloon interface 2. The operation is simple. After sealing, the sealing film 3 can maintain stability under internal and external pressures. At the same time, no wear will occur during the entire sealing process, and no other hidden dangers will be brought to the biological body. Therefore, it has better application prospects.

[0042] Figure 4The figure shows a cross-sectional schematic diagram of the balloon assembly of Example 2 of the present application in the first state, which includes a balloon body 7 and a balloon interface 8 connected to the balloon body 7. The sealing body 9 is located inside the balloon body 7 and extends out from the inner wall of the balloon body 7. At least part of the edge of the sealing body 9 is not connected to the inner wall of the balloon body 7. The sealing body 9 covers the opening of the balloon body 7. Figure 4 As shown, under the action of the outer catheter 10 , the sealing body 9 is pushed open so that the filling material can enter the balloon body 7 .

[0043] In a preferred embodiment, the material of the sealing body 9 can be different from that of the balloon body 7, and the two are bonded, welded or otherwise combined together. The rigidity of the sealing body 9 is greater than that of the balloon body 7, so the sealing body 9 is more easily separated from the inner surface of the balloon body 7 under the action of the outer catheter 10, so that the filler can enter the balloon body 7.

[0044] Figure 5 What is shown is a schematic diagram of the balloon assembly of Example 2 in the second state, that is, a sealing state diagram of the balloon assembly after filling is completed. At this time, the sealing body 9 is squeezed and fitted to the inner wall of the balloon body 7 due to the gradual increase of the filling material inside the balloon body 7. Since the surface area of ​​the sealing body 9 is larger than the area of ​​the opening of the balloon body 7, it can completely cover the opening of the balloon body 7. After the filling is completed, the outer catheter 10 is gradually withdrawn, and the sealing body 9 can automatically fit under the action of the internal pressure of the balloon body 7, so that the withdrawal of the outer catheter 10 and the sealing of the balloon body 7 can be carried out simultaneously.

[0045] Furthermore, if Figure 6 The cross-sectional schematic diagram of the balloon assembly in the first state of Example 3 of the present application is shown. The outer catheter 10 can also have another alternative, including a sleeved outer catheter 10 and an inner tube 11, one end of the outer catheter 10 is detachably connected to the balloon interface 8; the inner tube 11 is inserted into the outer catheter 10 to form an annular gap. At this time, the outer catheter 10 is connected to the balloon interface 8, but it is not necessary to require the outer catheter 10 to act on the sealing body 9 to open the balloon body 7. When filling, the inner tube 11 is pushed axially toward the balloon body 7, thereby pressing the sealing body 9 in the balloon body 7 to open; and after the filling is completed, the inner tube 11 and the outer catheter 10 are withdrawn together, and the sealing body 9 can achieve sealing of the balloon body 7 under the internal pressure of the balloon body 7.

[0046] Figure 7The following is a schematic cross-sectional view of the balloon assembly in the first state of Embodiment 4 of the present application. Among them, the sealing assembly includes a sealing body 9 built into the balloon body 7 and an auxiliary tube 11 detachably connected to the sealing body 9. Through the auxiliary tube 11, the sealing body 9 can be positioned and covered on the balloon interface 8. Before the filling starts, the auxiliary tube 11 is pre-connected to the sealing body 9, and then the outer catheter 10 is connected to the balloon interface 8. When the filling starts, the auxiliary tube 11 is pushed to push the sealing body 9 to open the cavity of the balloon body 7, and the balloon body 7 is filled through the annular gap between the outer catheter 10 and the auxiliary tube 11. After the filling is completed, the sealing body 9 is pressed against its opening under the pressure inside the balloon body 7. At this time, the outer catheter 10 and the auxiliary tube 11 are removed and withdrawn from the living body, and the sealing of the balloon body 7 can be achieved simultaneously.

[0047] Further, for the balloon assemblies involved in Embodiments 2, 3, and 4, the surface of the sealing body 9 in contact with the balloon body 7 may completely or partially cover a sealing film, and the sealing film at least completely covers the opening of the balloon body 7, or the sealing film completely surrounds the opening of the balloon body 7.

[0048] For the balloon assemblies involved in Embodiments 2, 3, and 4, the sealing body 9 is pre-set in the balloon body 7, and the sealing is completed by relying on the pressure inside the balloon body 7 and / or the material properties of the sealing body 9. The balloon is filled by providing an outer catheter 10 outside the balloon, and the sealing can be achieved while withdrawing the outer catheter 10. The structure is simple, the manufacturing cost is low, and it can well meet the requirement of synchronously performing the sealing and withdrawal of this type of product.

[0049] Figure 8 、 Figure 9 Shown are the cross-sectional view and side view of the sealing assembly of Embodiment 5 of the present application. As Figure 8 shown, the sealing film 14 is located at the balloon interface 13 and can seal the balloon interface 13. A cut 15 is provided on the sealing film 14. In one embodiment, the sealing film 14 has a certain thickness, and the cut 15 penetrates through the entire sealing film 14 to communicate with the balloon body 12. As Figure 9 shown, the cut 15 is a cross-shaped cut. Due to the material properties of the sealing film 14, the cut portions of the cut 15 can be adhered together without external force, realizing the sealing of the balloon body 12.

[0050] Figure 10 Shown is a balloon assembly of Embodiment 5 of the present application. The outer catheter 16 is detachably connected to the balloon interface 13. Further, one end of the outer catheter 16 has a needle-shaped head 17, which can penetrate through the cross-shaped cut 15 and extend into the balloon body 12 to fill it. After the filling is completed, the outer catheter 16 is withdrawn, and the cross-shaped cut 15 can be adhered together, thereby realizing the sealing of the balloon body 12. Specifically, as Figure 8 、Figure 9 as shown

[0051] Figure 11 Shown is a cross-sectional view of the sealing assembly according to Embodiment 6 of the present application. In this embodiment, the incision 15 of the sealing film 14 is a straight incision, and the incision 15 includes a lip 151. The upper and lower lips 151 can be fitted together to achieve the sealing of the balloon body 12.

[0052] It should be noted that in Embodiments 5 and 6 of the present application, the shape of the incision 15 on the sealing film 14 is preferably linear, but incisions 15 of other shapes are also applicable as long as it can ensure that the sealing film 14 can seal the balloon body 12 without external force.

[0053] For the sealing assemblies provided in Embodiments 5 and 6, in the manufacturing process, the sealing film 14 can be directly poured into the cavity of the balloon interface 13 and sealed. It is necessary to open an incision 15 penetrating the sealing film 14 on the sealing film 14 and fill it with a matching outer catheter 16. After filling is completed, the outer catheter 16 can be withdrawn. Therefore, this kind of sealing structure is simple, easy to manufacture, and will be more widely used in the market.

[0054] The constituent materials of the balloon body, balloon interface, and / or sealing film listed in the above embodiments include, but are not limited to, polyamide, polyester, polyurethane, polyamide-polyether block copolymer, polyethylene, polypropylene, polyimide, cross-linked polyethylene, cross-linked polyurethane, ionomer, PCL (polycaprolactone), PLA (polylactic acid), PLGA (poly(lactic acid-co-glycolic acid)), PLCL (poly(lactide-co-caprolactone)), plasticized starch material, polyelectrolyte complex, or copolymer or blend materials of multiple materials among the above materials. The sealing film can be attached to the inner wall of the balloon interface or balloon body through biological binding forces such as hydrogen bond binding, electrostatic attraction, van der Waals force, and hydrophobic interaction to achieve sealing. The materials of the sealing film are preferably PLCL (poly(lactide-co-caprolactone)), PLA (polylactic acid), plasticized starch material, polyelectrolyte complex, etc. These materials involve biocompatible or biodegradable materials, which can be optimally matched according to their different application environments. For example, an implantable balloon needs to replace an organ in the body, and a biocompatible material is preferably used. If the implantable balloon provides an auxiliary role during the recovery period after biological damage, a biodegradable material is preferably used.

[0055] It should be noted that in order to further ensure the sealing effect, the constituent materials of the sealing film also include a viscous sealing film, including but not limited to adding a viscous spray coating on its surface to make the bonding of the sealing film more firm.

[0056] For the balloon assembly provided in the above embodiments, the balloon body and the balloon interface can be integrally formed or separately processed and then connected together, including but not limited to bonding. However, it should be noted that after the balloon body and the balloon interface are connected, it must be ensured that there is no leakage during the filling process of the balloon body, and at the same time, the use performance of the balloon body in different application environments can be satisfied. The mating connection between the outer catheter and the balloon interface should be tight and leak-free, and at the same time, the outer catheter can be disassembled from the balloon interface after filling. Therefore, this kind of mating connection is a detachable tight connection, including but not limited to snap connection, screw connection, interference fit, etc.

[0057] The balloon assembly provided in the present application can be used not only to manufacture a rotator cuff balloon, but also can be manufactured into other types of balloons according to different applicable parts or diseases, such as a gastric balloon.

[0058] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope described in this specification.

[0059] The above-described embodiments only represent several implementation manners of the present invention, and the description is relatively specific and detailed, but it cannot be understood as a limitation on the scope of the invention patent. It should be pointed out that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the invention patent should be subject to the appended claims.

Claims

1. A balloon assembly, characterized in that, comprising: a balloon body having a balloon body opening thereon; a balloon interface provided at the balloon body opening for allowing a filler to pass through and enter the balloon body; a sealing assembly provided at the balloon body and / or the balloon interface, including a sealing body, the sealing body including a sealing film for preventing the filler from flowing out of the balloon body; an outer catheter detachably connected to the balloon interface, the filler entering the balloon body opening through the outer catheter; the sealing assembly includes: an inner catheter passing through the outer catheter to form a gap for the filler to pass through, one end of the inner catheter being connected to an inflatable inner balloon; the sealing film covers the surface of the inner balloon, the inner balloon is inflated through the inner catheter and compresses the sealing film to seal the balloon; the cross-section of the sealing film and the covered area of the inner balloon in the axial direction of the inner catheter is in a U-shaped structure; when the inner balloon retracts, the sealing film is released, and the sealing film can maintain close contact with the inner wall of the balloon interface.

2. The balloon assembly according to claim 1, characterized in that, the constituent materials of the balloon body, the balloon interface and / or the sealing film include polyamide, polyester, polyurethane, polyamide-polyether block copolymer, polyethylene, polypropylene, polyimide, cross-linked polyethylene, cross-linked polyurethane, ionomer, PLGA, PLCL, plasticized starch material, polyelectrolyte complex or copolymer or blend materials of multiple materials among the above materials.

3. The balloon assembly according to claim 1, characterized in that, the sealing film includes a sticky sealing film.

4. The balloon assembly according to claim 1, characterized in that, the connection between the outer catheter and the balloon interface includes interference connection, threaded connection or snap connection.

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