Balloon type plugging device

Abstract

The utility model discloses a balloon type plugging device. The balloon type plugging device comprises a balloon and a shaft rod, the balloon has a full state, and in the full state, the balloon is configured to plug a target area; the shaft rod comprises an inner shaft rod and an outer shaft rod, and the outer shaft rod is arranged outside the inner shaft rod in a sleeving mode; the inner shaft rod is arranged in the balloon in a penetrating mode, and the outer shaft rod is connected with the balloon. The inner shaft rod is made of metal materials, and the outer shaft rod is made of macromolecule materials. The balloon type plugging device provided by the embodiment of the utility model can be adapted to a catheter sheath with a smaller diameter size; and a guide wire for guiding can be omitted, so that the operation time is saved, and the operation efficiency is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, and more particularly, to a balloon occlusion device. BACKGROUND

[0002] At present, severe postpartum hemorrhage, upper gastrointestinal hemorrhage, pelvic and abdominal cavity traumatic hemorrhage, ruptured abdominal aortic aneurysm and other external compression uncontrolled fatal hemorrhage can cause severe shock in a very short time, leading to decreased blood pressure, insufficient perfusion of important organs, and even death, so it is necessary to take quick and effective measures for resuscitation.

[0003] The most common treatment measure is intravascular balloon blocking technology, which uses a compliant or semi-compliant balloon to block the blood flow of the aorta at the proximal end of the damaged aortic rupture or the main artery branch supplying blood to the bleeding organ; while controlling blood loss, maintaining blood pressure at the proximal end, redistributing the limited blood volume of the shock patient, maintaining the blood supply of important organs such as heart and brain, and achieving the purpose of reducing blood loss and maintaining blood pressure in a short period after injury, effective anti-shock resuscitation, thereby providing opportunities for further surgery and supportive treatment.

[0004] At present, the occlusion balloon devices in the prior art mostly have the defects of large catheter size, long operation time, the need for image assistance, and large trauma to the patient's blood vessel access.

[0005] Therefore, it is necessary to provide a new technical solution to at least solve one of the above technical problems. CONTENT OF THE INVENTION

[0006] An object of the present application is to provide a new technical solution of a balloon occlusion device.

[0007] According to a first aspect of the present application, a balloon occlusion device is provided, comprising:

[0008] a balloon, the balloon having a full state, and in the full state, the balloon is configured to occlude a target region;

[0009] a shaft, the shaft comprising an inner shaft and an outer shaft, the outer shaft being sleeved outside the inner shaft; the inner shaft is provided in the balloon, and the outer shaft is connected with the balloon; the inner shaft is made of metal material, and the outer shaft is made of high polymer material.

[0010] Optionally, the material of the inner shaft is nickel-titanium alloy or stainless steel.

[0011] Optionally, the material of the outer shaft is one of polyamide, polyether block polyamide elastomer, polyvinyl chloride or polyurethane.

[0012] Optionally, the outer shaft rod comprises a first rod part and a second rod part, and the first rod part and the second rod part are connected to two ends of the balloon respectively.

[0013] Optionally, the balloon comprises a balloon body, a first connecting part and a second connecting part; one end of the first connecting part is connected to one end of the balloon body, and the other end of the first connecting part is connected to the distal end of the first rod part; one end of the second connecting part is connected to the other end of the balloon body, and the other end of the second connecting part is connected to the proximal end of the second rod part.

[0014] Optionally, the inner shaft rod is provided with a developing ring at a position close to the first connecting part and the second connecting part.

[0015] Optionally, the balloon occlusion device further comprises a bumper head, and the bumper head is connected to the distal end of the inner shaft rod; the bumper head has a head portion away from the inner shaft rod, and the head portion is curved.

[0016] Optionally, the head portion is provided with a developing structure.

[0017] Optionally, the inner shaft rod has a first cavity; the bumper head comprises a connecting rod and a head portion, the head portion is arranged at one end of the connecting rod, the other end of the connecting rod is connected to the distal end of the inner shaft rod, the connecting rod has a second cavity, the second cavity is in communication with the first cavity, and the connecting rod is provided with a communication hole close to the head portion, and the communication hole is in communication with the second cavity.

[0018] Optionally, a gap cavity in communication with the inside of the balloon is arranged between the inner shaft rod and the outer shaft rod; the balloon occlusion device further comprises a handle part, and the handle part is connected to the proximal end of the first rod part and in communication with the gap cavity; the balloon further has a contracted state, and the handle part is configured to connect an external device via the handle part to switch the balloon between the inflated state and the contracted state.

[0019] Optionally, the outer shaft rod is provided with a position marker.

[0020] The balloon occlusion device provided by the embodiments of the present application can be adapted to a catheter sheath with a smaller diameter size, and can be used without a guide wire, thereby saving operation time and improving operation efficiency.

[0021] Other features and advantages of the present application will become apparent from the following detailed description of exemplary embodiments thereof, taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0022] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the application and, together with the description, serve to explain the principles of the application.

[0023] Figure 1 is a schematic diagram of the overall structure of a balloon occlusion device according to an embodiment of the present application;

[0024] Figure 2 is a schematic diagram of the structure of a balloon in a balloon occlusion device according to an embodiment of the present application;

[0025] Figure 3 is a schematic diagram of the structure of a bumper in a balloon occlusion device according to an embodiment of the present application.

[0026] BRIEF DESCRIPTION OF DRAWINGS

[0027] 1. balloon occlusion device; 11. balloon; 110. balloon body; 111. first connecting portion; 112. second connecting portion; 12. shaft; 121. inner shaft; 122. outer shaft; 1221. first shaft portion; 1222. second shaft portion; 1220. position marker; 13. bumper; 131. head portion; 132. connecting rod; 130. communication hole; 14. handle portion; 15. three-way valve. DETAILED DESCRIPTION

[0028] Various exemplary embodiments of the present application will now be described in detail with reference to the accompanying drawings. It should be noted that the relative arrangement of the components and steps set forth in the embodiments, numerical expressions, and numerical values are not limiting to the scope of the present application unless specifically stated otherwise.

[0029] The following description of at least one exemplary embodiment is merely illustrative in nature and is in no way limiting to the scope of the application or its applications or uses.

[0030] Techniques, methods, and devices known to those of ordinary skill in the relevant art can not be discussed in detail herein. However, the techniques, methods, and devices should be considered part of the specification, if appropriate.

[0031] In all of the examples shown and discussed herein, any specific values should be interpreted as illustrative only and not as a limitation. Thus, other examples of the exemplary embodiments can have different values.

[0032] It should be noted that like reference numerals and letters refer to like items throughout the drawings, and as a result, further discussion of such items is unnecessary in subsequent drawings.

[0033] SUMMARY Figures 1-3As shown, according to one embodiment of the present application, a balloon occlusion device 1 is provided. The balloon occlusion device 1 comprises a balloon 11 having a filled state, and in the filled state, the balloon 11 is configured to occlude a target region; and a shaft 12 comprising an inner shaft 121 and an outer shaft 122, the outer shaft 122 being sleeved outside the inner shaft 121; the inner shaft 121 being sleeved in the balloon 11, and the outer shaft 122 being connected with the balloon 11; the inner shaft 121 being made of metal material, and the outer shaft 122 being made of polymer material.

[0034] The balloon occlusion device 1 provided by the embodiments of the present application can be used for arterial occlusion and surgical operation, etc., and is used for temporarily occluding blood vessels and cavities to quickly occlude blood vessels, maintain blood pressure, ensure blood supply of important organs such as heart and brain, and avoid shock. The balloon occlusion device 1 generally enters the patient's body through the femoral artery, and can also enter the patient's body through the carotid artery, radial artery or clavicular artery.

[0035] For the balloon occlusion device 1 provided by the embodiments of the present application, when the blood vessel occlusion operation is performed, the balloon 11 reaches the target region, and the balloon 11 is in the filled state, so that the balloon 11 in the filled state occludes the blood vessels of the target region.

[0036] In the balloon occlusion device 1 provided by the embodiments of the present application, the shaft 12 for supporting and connecting the balloon 11 comprises two layers of inner and outer shafts, i.e., the inner shaft 121 and the outer shaft 122 sleeved outside the inner shaft 121; wherein the inner shaft 121 is made of metal material, has high strength, and can provide good support for the balloon 11; the inner shaft 121 has the characteristics of high strength and high elasticity, and can provide good mechanical transmission and conveying capacity; the outer shaft 122 is made of polymer material, has high elasticity, has good flexibility, and provides excellent pushing capacity. The shaft 12 combines the strength and support performance of the inner shaft 121 and the elasticity of the outer shaft 122, which is beneficial to the balloon occlusion device 1 to quickly penetrate and reach the occlusion position in the winding and tortuous blood vessels; at the same time, the soft characteristic of the outer shaft 122 also ensures that the inner wall of the blood vessel will not be damaged in the penetration process. The shaft 12 with the above structure can directly enter the expansion position in the blood vessel after puncture, avoiding the process that the balloon occlusion expansion needs a guide wire to first pass through the occlusion position and then the balloon catheter enters along the guide wire, saving the time of catheter placement, improving the operation efficiency and operation adaptability. In addition, the shaft 12 with the above structure has high strength and good flexibility, and can save the guide wire, so as to reduce the structure size of the shaft, and the size of the catheter sheath matched with the shaft is also reduced, for example, the diameter of the catheter sheath is reduced from 10 Fr to 7 Fr.

[0037] In one embodiment, the inner shaft 121 is made of nickel-titanium alloy or stainless steel.

[0038] In this specific example, the inner shaft 121 is made of nickel-titanium alloy or stainless steel, which not only has good supporting ability, but also has high elasticity, which is conducive to the passage of the shaft 12 in the blood vessel.

[0039] In one embodiment, the outer shaft 122 is made of one or a mixture of at least two of polyamide, polyether block polyamide elastomer, polyvinyl chloride or polyurethane.

[0040] In this specific example, the outer shaft 122 is made of a high molecular material, which is extruded by polyamide, polyether block polyamide elastomer, polyvinyl chloride or polyurethane, etc. The outer shaft 122 has high elasticity, can provide good pushing ability and synchronous performance with the inner shaft 121; and its forming process is relatively simple and saves production cost.

[0041] Referring to Figure 1 In one embodiment, the outer shaft 122 includes a first shaft portion 1221 and a second shaft portion 1222, and the first shaft portion 1221 and the second shaft portion 1222 are respectively connected to the two ends of the balloon 11.

[0042] In this specific example, the outer shaft 122 is a two-segment split structure, one segment is the first shaft portion 1221 connected to the proximal end of the balloon 11, and the other segment is the second shaft portion 1222 connected to the distal end of the balloon 11. The first part of the inner shaft 121 is arranged in the first shaft portion 1221, the second part is arranged in the balloon 11, and the third part is arranged in the second shaft portion 1222. The three parts of the inner shaft 121 are integrated.

[0043] Referring to Figure 1 , Figure 2 In one embodiment, the balloon 11 includes a balloon body 110, a first connecting portion 111 and a second connecting portion 112; one end of the first connecting portion 111 is connected to one end of the balloon body 110, and the other end of the first connecting portion 111 is connected to the distal end of the first shaft portion 1221; one end of the second connecting portion 112 is connected to the other end of the balloon body 110, and the other end of the second connecting portion 112 is connected to the proximal end of the second shaft portion 1222.

[0044] In this specific example, the balloon body 110 of the balloon 11 is used to occlude the blood vessel of the target region in the inflated state; and the first connecting portion 111 and the second connecting portion 112 of the balloon 11 are respectively used to connect the first rod portion 1221 and the second connecting portion 112 of the outer shaft 122. The first connecting portion 111 and the second connecting portion 112 are provided to facilitate the connection between the balloon 11 and the outer shaft 122.

[0045] The balloon body 110, the first connecting portion 111 and the second connecting portion 112 are of an integrated structure; the balloon 11 is made of elastic materials such as polyurethane, silicone rubber, latex, etc., and has good compliance so that the balloon body 110 can better fit the inner diameter of the blood vessel after inflation and expansion, thereby achieving complete occlusion of the blood vessel lumen.

[0046] Referring to Figure 2 In one embodiment, the inner shaft 121 is provided with a developing ring at a position close to the first connecting portion 111 and the second connecting portion 112.

[0047] In this specific example, the inner shaft 121 is provided with a developing ring made of metal materials such as stainless steel, platinum, gold, platinum-iridium alloy, etc. at positions corresponding to the first connecting portion 111 and the second connecting portion 112 of the balloon 11, so that the developing ring can be developed under X-ray, indicating the balloon spacing and accurately displaying the occlusion position. Moreover, the operator can observe the front end of the balloon occlusion device 1 and the balloon position in real time under X-ray, so as to confirm that the balloon 11 is located at the aortic occlusion and expansion position.

[0048] Referring to Figure 1 , Figure 3 In one embodiment, the balloon occlusion device further comprises a bumper head 13 connected to the distal end of the inner shaft 121; the bumper head 13 has a head portion 131 away from the inner shaft 121, and the head portion 131 is curved.

[0049] In this specific example, the bumper head 13 is provided to facilitate the balloon occlusion device 1 to freely enter the winding and tortuous blood vessels, avoiding scratching the inner wall of the blood vessels during the penetration process. The bumper head 13 can be made of elastic materials such as polyurethane, polyether block polyamide, silicone rubber, etc.; the bumper head 13 can be elastically deformed during the delivery process of the balloon occlusion device 1, thereby reducing the frictional resistance and buffering the contact force of the head portion 131 of the bumper head 13 colliding with the blood vessels, avoiding the risk of puncturing the tissue and damaging the blood vessel lumen. For example, the head portion 131 of the bumper head 13 is curved into a U shape, and the head portion 131 can also be provided in a protective shape such as a round shape, a pigtail shape, etc. to absorb the impact and scratches on the inner wall of the blood vessels and the lumen during the introduction of the balloon occlusion device 1, thereby avoiding the risk of penetration injury.

[0050] In one embodiment, the head 131 is provided with a developing structure.

[0051] In this specific example, the head 131 of the anti-collision head is provided with a developing structure, such as a developing structure added with compounds of barium, bismuth, tungsten oxide or salt, etc. The developing structure can show the balloon occlusion device 1 under the action of x-ray, thereby guiding the balloon 11 to enter the expansion position for occlusion expansion.

[0052] Referring to Figure 3 In one embodiment, the inner shaft 121 has a first cavity; the anti-collision head 13 includes a connecting rod 132 and a head 131, the head 131 is arranged at one end of the connecting rod 132, the other end of the connecting rod 132 is connected with the distal end of the inner shaft 121, the connecting rod 132 has a second cavity, the second cavity is in communication with the first cavity, and the connecting rod 132 is provided with a communication hole 130 in communication with the second cavity at a position close to the head 131.

[0053] In this specific example, the inner shaft 121 is a hollow structure with a first cavity, so that a guide wire can be arranged inside the inner shaft 121 when needed. Although the balloon occlusion device 1 can enter the blood vessel along the catheter without the guide of the guide wire, the inner shaft 121 is arranged as a hollow structure to make it more flexible to choose whether to use the guide wire. When the guide wire is needed, the guide wire is first arranged to enter the blood vessel along the catheter, and then the proximal end of the guide wire is arranged to enter the second cavity of the connecting rod 132 through the communication hole 130 of the connecting rod 132 of the anti-collision head 13, and then to enter the first cavity of the inner shaft 121, so that the balloon occlusion device 1 can enter the blood vessel along the catheter under the guide of the guide wire.

[0054] Referring to Figure 1 In one embodiment, the inner shaft 121 and the outer shaft 122 are provided with a gap cavity in communication with the inside of the balloon 11; the balloon occlusion device further includes a handle 14 connected to the proximal end of the first rod 1221 and in communication with the gap cavity; the balloon 11 further has a contracted state, and the handle 14 is configured to connect an external device via the handle 14 to switch the balloon 11 between the inflated state and the contracted state.

[0055] In this specific example, the gap cavity between the inner shaft 121 and the outer shaft 122 is used to provide a path for inflating or deflating the balloon 11. For example, the handle 14 can be connected to a three-way valve 15, which in turn is connected to an external device, so that the balloon 11 can be inflated by using a mixture of contrast agent and saline. After the occlusion procedure is completed, the balloon is deflated by using the external device to switch the balloon from an inflated state to a deflated state, so that the balloon occlusion device 1 can be withdrawn. The external device can be, for example, a pressure pump.

[0056] Referring to Figure 1 In one embodiment, the outer shaft 122 is provided with position markers 1220, as shown.

[0057] In this specific example, the position markers 1220 provided on the outer shaft 122 can indicate the depth of the balloon occlusion device 1 into the human body, which is convenient for the operator to observe.

[0058] It should be understood that the distal end refers to the end of the balloon occlusion device 1 that is farther away from the operator when it enters the human body, and the proximal end refers to the end of the balloon occlusion device 1 that is closer to the operator when it enters the human body.

[0059] The above embodiments mainly describe the differences between the various embodiments, and the different optimization features between the various embodiments can be combined to form a more optimal embodiment as long as they are not contradictory. In view of the brevity of the writing, further description will not be repeated here.

[0060] Although some specific embodiments of the present application have been described in detail through examples, those skilled in the art should understand that the above examples are only for illustration and are not intended to limit the scope of the present application. Those skilled in the art should understand that the above embodiments can be modified without departing from the scope and spirit of the present application. The scope of the present application is defined by the appended claims.

Claims

1. A balloon occlusion device, characterized in that, The balloon occlusion device comprises: a balloon (11) having a filled state, and in the filled state, the balloon (11) is configured to occlude a target region; a shaft (12) comprising an inner shaft (121) and an outer shaft (122), the outer shaft (122) being sleeved outside the inner shaft (121); the inner shaft (121) is sleeved in the balloon (11), and the outer shaft (122) is connected with the balloon (11); the inner shaft (121) is made of metal material, and the outer shaft (122) is made of polymer material.

2. The balloon occlusion device of claim 1, wherein, The material of the inner shaft (121) is nickel-titanium alloy or stainless steel.

3. The balloon occlusion device of claim 1, wherein, The material of the outer shaft (122) is one of polyamide, polyether block polyamide elastomer, polyvinyl chloride or polyurethane.

4. The balloon occlusion device of claim 1, wherein, The outer shaft (122) comprises a first shaft portion (1221) and a second shaft portion (1222), and the first shaft portion (1221) and the second shaft portion (1222) are respectively connected to two ends of the balloon (11).

5. The balloon occlusion device of claim 4, wherein, The balloon (11) comprises a balloon body (110), a first connecting portion (111) and a second connecting portion (112); one end of the first connecting portion (111) is connected to one end of the balloon body (110), and the other end of the first connecting portion (111) is connected to the distal end of the first shaft portion (1221); one end of the second connecting portion (112) is connected to the other end of the balloon body (110), and the other end of the second connecting portion (112) is connected to the proximal end of the second shaft portion (1222).

6. The balloon occlusion device of claim 5, wherein, The inner shaft (121) is provided with a developing ring at a position close to the first connecting portion (111) and the second connecting portion (112).

7. The balloon occlusion device of claim 5, wherein, The balloon occlusion device further comprises a collision head (13) connected to the distal end of the inner shaft (121); the collision head (13) has a head portion (131) away from the inner shaft (121), and the head portion (131) is curved.

8. The balloon occlusion device of claim 7, wherein, The head portion (131) is provided with a developing structure.

9. The balloon occlusion device of claim 7, wherein, The inner shaft (121) has a first cavity; the collision head (13) comprises a head portion (131) and a connecting rod (132), the head portion (131) is arranged at one end of the connecting rod (132), the other end of the connecting rod (132) is connected to the distal end of the inner shaft (121), the connecting rod (132) has a second cavity, the second cavity is in communication with the first cavity, and the connecting rod (132) is provided with a communication hole (130) close to the head portion (131) and communicating with the second cavity.

10. The balloon occlusion device of claim 5, wherein, A gap cavity communicating with the interior of the balloon (11) is arranged between the inner shaft (121) and the outer shaft (122); the balloon occlusion device further comprises a handle portion (14) connected to the proximal end of the first shaft portion (1221) and communicating with the gap cavity; the balloon (11) further has a contracted state, and the handle portion (14) is configured to connect an external device via the handle portion (14) to switch the balloon (11) between the inflated state and the contracted state.

11. The balloon occlusion device of claim 1, wherein, The outer shaft (122) is provided with a position marker (1220).

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