Countercurrent protection device with double-balloon structure

Abstract

The utility model provides a double-balloon structure countercurrent protection device, which comprises a catheter main body, a near-end balloon body and a far-end balloon body, the near-end balloon body and the far-end balloon body are distributed left and right, and the near-end balloon body and the far-end balloon body are respectively connected to the surface of the catheter main body; the near-end balloon filling cavity and the far-end balloon filling cavity are arranged on the inner wall of the catheter main body, the near-end balloon filling cavity and the far-end balloon filling cavity are respectively arranged on the inner wall of the catheter main body, the near-end balloon filling cavity is communicated with the near-end balloon body, and the far-end balloon filling cavity is communicated with the far-end balloon body. By means of the double-balloon design of the near-end balloon body and the far-end balloon body, blood flow can be blocked at the two ends of a diseased region at the same time, and compared with a traditional single-balloon or filter screen type protection device, blood backflow can be more comprehensively and effectively prevented, and the risk that emboli enter cerebral vessels is reduced.

Description

TECHNICAL FIELD

[0001] The utility model relates to the field of medical apparatus and instruments, especially to a double-balloon structure reverse flow protection device. BACKGROUND

[0002] Carotid artery stenosis is one of the important causes of ischemic stroke, which seriously threatens human health. At present, carotid endarterectomy (CEA) and carotid artery stent implantation (CAS) are the main means for treating carotid artery stenosis. However, during the operation process, it is easy to cause the shedding of carotid atherosclerotic plaques, and these detached emboli can enter the cerebral blood vessels with the blood flow, leading to distal cerebral embolism, greatly increasing the risk of surgery and the incidence of postoperative complications.

[0003] The double-balloon structure reverse flow protection device is a technology applied in carotid artery interventional therapy, aiming to reduce the risk of cerebral embolism caused by blood clots, plaque shedding and other factors during the operation process. In the authorized Chinese utility model patent "Publication No. CN212308117U, Name: Cerebral protection system", the covered stent has filtering property and can intercept thrombus, that is, the above-mentioned application adopts a filtering type protection method. However, although it can intercept larger emboli to some extent, the filtering effect on small emboli is not good, and blockage is easy to occur, affecting hemodynamics. In the existing technology, some use a balloon blocking method, but it can only block at the proximal or distal end of the blood vessel, and cannot completely eliminate the possibility of blood reverse flow, still existing the risk of emboli escaping into the cerebral blood vessels. SUMMARY

[0004] The technical problem to be solved by the utility model is to overcome the poor protection effect of the existing technology in the treatment of carotid artery stenosis, and to provide a double-balloon structure reverse flow protection device.

[0005] The utility model solves the above technical problems through the following technical solutions:

[0006] The utility model provides a double-balloon structure reverse flow protection device, which comprises a catheter main body,

[0007] The proximal balloon body and the distal balloon body are distributed on the left and right sides, and the proximal balloon body and the distal balloon body are respectively connected to the surface of the catheter main body;

[0008] The proximal balloon inflation cavity and the distal balloon inflation cavity are respectively arranged on the inner wall of the catheter main body, and the proximal balloon inflation cavity is in communication with the proximal balloon body, and the distal balloon inflation cavity is in communication with the distal balloon body;

[0009] The three-way pipe base is connected with the proximal balloon body and the distal balloon body respectively.

[0010] The guide wire cavity is arranged through the whole length of the catheter body, and is used for guiding the guide wire body to pass through.

[0011] In the technical scheme, the double-balloon design of the proximal balloon body and the distal balloon body can block blood flow at both ends of the lesion site at the same time, compared with the traditional single-balloon or filter type protection device, can more comprehensively and effectively prevent blood backflow, and reduce the risk of emboli entering the cerebral blood vessels.

[0012] Preferably, one end of the catheter body is connected with the three-way pipe base, and the other end of the catheter body is connected with a catheter head.

[0013] In the technical scheme, the three-way pipe base can be used to charge and discharge the proximal balloon body and the distal balloon body.

[0014] Preferably, the catheter body is composed of an inner tube, an intermediate reinforcing layer and an outer tube.

[0015] In the technical scheme, the inner tube is made of PTFE material, the intermediate reinforcing layer is made of stainless steel wire winding, and the outer tube is made of high polymer resin material.

[0016] Preferably, the outer tube is coated with a coating layer having an anticoagulant property on the outer surface.

[0017] Preferably, the proximal balloon body and the distal balloon body are both compliant balloons, and the distance between the proximal balloon body and the distal balloon body is 20-30mm.

[0018] In the technical scheme, the diameter of the proximal balloon body ranges from mm to mm, and the diameter of the distal balloon body ranges from mm to mm.

[0019] Preferably, the proximal balloon inflation cavity and the distal balloon inflation cavity are thin-walled tubes located between the intermediate reinforcing layer and the outer tube.

[0020] In the technical scheme, the proximal balloon inflation cavity and the distal balloon inflation cavity are respectively used for charging and discharging the proximal balloon body and the distal balloon body.

[0021] Preferably, an instrument working channel is arranged between the proximal balloon body and the distal balloon body, and the instrument working channel is arranged on the catheter body.

[0022] In the technical scheme, the instrument working channel is used to adapt to different types of surgical instruments.

[0023] Preferably, the tee seat comprises a first interface, a main interface and a second interface, the first interface is connected with the proximal balloon inflation cavity, the second interface is connected with the distal balloon inflation cavity, and the main interface is connected with an external pressure injector through a luer joint.

[0024] Preferably, the tube of the proximal balloon body and the distal balloon body is provided with a radiographic marker ring.

[0025] In the technical solution, the radiographic marker ring is radiopaque under X-ray during the operation, indicating the positions of the proximal balloon body and the distal balloon body.

[0026] Preferably, the connection between the proximal balloon inflation cavity and the proximal balloon body and the connection between the distal balloon inflation cavity and the distal balloon body are sealed by an adhesive.

[0027] In the technical solution, the adhesive is uniformly applied to the connection part, and after the adhesive is cured, a tight sealing layer is formed.

[0028] On the basis of common knowledge in the art, the above-mentioned preferred conditions can be combined arbitrarily, that is, the preferred examples of the utility model are obtained.

[0029] The positive progress effect of the utility model lies in:

[0030] The double-balloon design of the proximal balloon body and the distal balloon body can block blood flow at both ends of the lesion site at the same time, compared with the traditional single-balloon or filter type protection device, which can more comprehensively and effectively prevent blood backflow and reduce the risk of emboli entering the cerebral blood vessels.

[0031] The material selection and size design of the catheter main body, the proximal balloon body and the distal balloon body make them adapt to the carotid artery anatomical structure of different patients, have wide applicability, and at the same time, the flexibility and pushability of the catheter main body are good, facilitating the operation of doctors during the operation.

[0032] The proximal balloon body and the distal balloon body adopt materials with good biocompatibility, reducing the stimulation and damage to the blood vessel wall and reducing the risk of thrombus formation.

[0033] In addition, the double-balloon blood flow blocking mode of the proximal balloon body and the distal balloon body can provide a relatively clear and embolus-free operating environment for doctors during the operation, improving the safety and success rate of the operation. BRIEF DESCRIPTION OF DRAWINGS

[0034] Figure 1 It is a structure schematic view of the double-balloon structure reverse flow protection device of the embodiment of the utility model.

[0035] Figure 2 It is a structure schematic view of the double-balloon structure reverse flow protection device of the embodiment of the utility model. Figure 1The whole internal structure diagram of the double-balloon structure reverse flow protection device shown.

[0036] Figure 3 For Figure 1 The connection relationship internal structure diagram of the proximal balloon, the distal balloon and the catheter body of the double-balloon structure reverse flow protection device shown.

[0037] Figure 4 For Figure 1 The catheter body installation state structure diagram of the double-balloon structure reverse flow protection device shown.

[0038] Figure 5 For Figure 1 The internal structure diagram of the second embodiment of the double-balloon structure reverse flow protection device shown.

[0039] Figure 6 For Figure 1 The internal structure diagram of the third embodiment of the double-balloon structure reverse flow protection device shown.

[0040] Figure 7 For Figure 1 The cross-sectional structure diagram of the fourth embodiment of the double-balloon structure reverse flow protection device shown.

[0041] Figure 8 For Figure 1 The three-dimensional structure diagram of the fourth embodiment of the double-balloon structure reverse flow protection device shown.

[0042] Figure 9 For Figure 1 The cross-sectional structure diagram of the fifth embodiment of the double-balloon structure reverse flow protection device shown.

[0043] Figure 10 For Figure 1 The three-dimensional structure diagram of the fifth embodiment of the double-balloon structure reverse flow protection device shown.

[0044] Figure 11 For Figure 1 The connection relationship structure diagram between the catheter body and the filter cover of the double-balloon structure reverse flow protection device shown.

[0045] Explanation of reference numerals

[0046] 1, catheter body; 2, proximal balloon body; 3, distal balloon body; 4, proximal balloon filling cavity; 5, distal balloon filling cavity; 6, guide wire cavity; 7, instrument working channel; 8, three-way pipe base; 9, inner tube; 10, intermediate reinforcing layer; 11, outer tube; 12, first interface; 13, main interface; 14, second interface; 15, development mark ring; 16, catheter head end; 17, guide wire body; 18, filter cover. DETAILED DESCRIPTION

[0047] The utility model is further illustrated below by way of examples, but the utility model is not limited in the scope of the examples.

[0048] Figures 1 to 11 The structure schematic diagram of the embodiment of the double-balloon structure reverse flow protection device is shown.

[0049] Embodiment one

[0050] The double-balloon structure reverse flow protection device comprises a catheter main body 1, the inner cavity size of the catheter main body 1 is 0.085 inch to 0.115 inch, to adapt 6F / 8F guide catheter, and the outer diameter of the catheter main body 1 is 2.5-3.5 mm.

[0051] A proximal balloon body 2 and a distal balloon body 3 are distributed left and right, and the proximal balloon body 2 and the distal balloon body 3 are respectively connected to the surface of the catheter main body 1.

[0052] The surface of the proximal balloon body 2 and the distal balloon body 3 is provided with a hydrophilic coating, and the proximal balloon body 2 and the distal balloon body 3 are both made of ultra-thin, high-elastic and biocompatible polyurethane material.

[0053] A proximal balloon inflation cavity 4 and a distal balloon inflation cavity 5 are respectively arranged on the inner wall of the catheter main body 1, and the proximal balloon inflation cavity 4 is communicated with the proximal balloon body 2, and the distal balloon inflation cavity 5 is communicated with the distal balloon body 3.

[0054] A three-way pipe base 8 is connected with the corresponding interfaces on the three-way pipe base 8 at the end of the proximal balloon inflation cavity 4 away from the proximal balloon body 2 and the end of the distal balloon inflation cavity 5 away from the distal balloon body 3.

[0055] A guide wire cavity 6 penetrates through the whole length of the catheter main body 1, and the guide wire cavity 6 is used for guiding a guide wire body 17 to pass through.

[0056] In the technical scheme, the double-balloon design of the proximal balloon body 2 and the distal balloon body 3 can block blood flow at both ends of the lesion site at the same time, compared with the traditional single-balloon or filter type protection device, can more comprehensively and effectively prevent blood reverse flow, and reduce the risk of embolus entering the cerebral blood vessels.

[0057] One end of the catheter main body 1 is connected with the three-way pipe base 8, and the other end of the catheter main body 1 is connected with a catheter head end 16.

[0058] The catheter head end 16 is made of polyurethane or Pebax material with good flexibility.

[0059] In the technical solution, the three-way pipe base 8 can be used to charge and discharge the proximal balloon body 2 and the distal balloon body 3 respectively.

[0060] The catheter body 1 is composed of an inner tube 9, an intermediate reinforcing layer 10 and an outer tube 11.

[0061] The intermediate reinforcing layer 10 is made of stainless steel wire winding, the wire diameter is 0.025-0.05mm, the strength is 2000-3000MPa, and the winding gap is 0.01-0.05mm, so as to provide good support and flexibility.

[0062] In the technical solution, the inner tube 9 is made of PTFE material, the intermediate reinforcing layer 10 is made of stainless steel wire winding, and the outer tube 11 is made of high polymer resin material.

[0063] The outer tube 11 is a multi-section high polymer resin tube hot melt welded and laminated to combine with the inner tube PTFE lining tube, the high polymer resin tube is gradually softened from the proximal end to the distal end, and the Pebax hardness is gradually softened from the proximal end to the distal end, like the model numbers of Pebax7233, Pebax6333, Pebax5533, Pebax4033, Pebax, Pebax3533, and the TPU hardness is gradually softened from the proximal end to the distal end, like the resin model numbers of Penethan80A, Tecoflex70A and lower hardness resin such as 60A or 50A, and the size is wall thickness 0.025-0.075mm.

[0064] The lengths of the resins with different hardnesses are different, so as to gradually soften from the proximal end to the distal end, and to support, navigate and pass through tortuous blood vessels during the operation.

[0065] The outer surface of the outer tube 11 is coated with a coating with anticoagulant properties.

[0066] The proximal balloon body 2 and the distal balloon body 3 are both compliant balloons, and the distance between the proximal balloon body 2 and the distal balloon body 3 is 20-30mm.

[0067] In the technical solution, the diameter of the proximal balloon body 2 ranges from 4mm to 12mm, and the diameter of the distal balloon body 3 ranges from 2mm to 8mm.

[0068] The proximal balloon inflation cavity 4 and the distal balloon inflation cavity 5 are thin-walled tubes located in the interlayer of the intermediate reinforcing layer 10 and the outer tube 11.

[0069] The size of the proximal balloon inflation cavity 4 and the distal balloon inflation cavity 5 is inner cavity 0.1-0.25mm, wall thickness 0.00025-0.0008inch, and the material is PET, PI or Pebax.

[0070] In the technical solution, the proximal balloon inflation cavity 4 and the distal balloon inflation cavity 5 are respectively used for inflating and deflating the proximal balloon body 2 and the distal balloon body 3.

[0071] The position between the proximal balloon body 2 and the distal balloon body 3 is provided with an instrument working channel 7, and the instrument working channel 7 is arranged on the catheter main body 1.

[0072] The width of the instrument working channel 7 is 1.5-2.5mm, which is suitable for different types of surgical instruments.

[0073] The 1.5mm inner diameter is suitable for small diameter instruments such as guide wires and microcatheters;

[0074] The 2.5mm inner diameter can meet the passing requirements of larger diameter balloon dilatation catheters, stent delivery systems and other instruments.

[0075] In the technical solution, the instrument working channel 7 is used to adapt to different types of surgical instruments.

[0076] The three-way pipe base 8 includes a first interface 12, a main interface 13 and a second interface 14, the first interface 12 is connected with the proximal balloon inflation cavity 4, the second interface 14 is connected with the distal balloon inflation cavity 5, and the main interface 13 is connected with an external pressure injector through a luer joint.

[0077] The inflation and deflation of the proximal balloon body 2 and the distal balloon body 3 are realized by accurately controlling the amount of contrast agent or normal saline injected or extracted by the pressure injector;

[0078] The proximal balloon body 2 and the distal balloon body 3 form a seal after being inflated, which can effectively prevent blood backflow.

[0079] The tube body of the proximal balloon body 2 and the distal balloon body 3 is provided with a developing mark ring 15.

[0080] In the technical solution, the developing mark ring 15 is used to be radiopaque under X-ray during the operation, indicating the position of the proximal balloon body 2 and the distal balloon body 3.

[0081] The connection between the proximal balloon inflation cavity 4 and the proximal balloon body 2, and the connection between the distal balloon inflation cavity 5 and the distal balloon body 3 are sealed by adhesive.

[0082] In the technical solution, the adhesive is evenly applied at the connection site, and after the adhesive is cured, a tight sealing layer is formed.

[0083] When in use, the guide wire body 17 is pushed to the target position of the external carotid artery under the real-time monitoring of the angiography device, the distal opening of the double-balloon structure reverse flow protection device is sleeved on the guide wire body 17, and the catheter body 1 is slowly and smoothly sent into the blood vessel along the guide wire body 17; during the pushing process, the position of the catheter body 1 is continuously observed by means of the angiography device to ensure that the catheter body 1 smoothly passes through the complex blood vessel path; when the catheter body 1 approaches the carotid bifurcation, special attention should be paid to the angle and direction of the catheter body 1, so that the catheter body 1 can accurately enter the external carotid artery and the common carotid artery.

[0084] When the distal balloon body 3 reaches the predetermined occlusion position of the external carotid artery, an appropriate amount of filling liquid is injected into the distal balloon through a syringe; during the injection process, the angiography is used to confirm that the distal balloon body 3 has tightly adhered to the wall of the external carotid artery and effectively blocked the blood flow of the external carotid artery, and then the injection is stopped; at this time, the blood flow of the external carotid artery is successfully cut off, preventing emboli from flowing back to the intracranial through the external carotid artery.

[0085] The proximal balloon body 2 is filled with filling liquid through a syringe; due to the larger diameter of the common carotid artery and the higher blood flow pressure, more filling liquid is usually needed to make the pressure in the proximal balloon body 2 reach a higher preset range; during the injection process, the angiography image is continuously observed to ensure that the balloon tightly adheres to the wall of the common carotid artery and completely blocks the blood flow of the common carotid artery; at this time, the blood flow of the entire carotid artery is effectively blocked, creating a stable blood flow-free environment for surgical operation.

[0086] When the proximal balloon body 2 and the distal balloon body 3 successfully complete the occlusion, surgical instruments such as balloon dilatation catheters and stent delivery systems can smoothly enter the blood vessel through the instrument working channel of the catheter body 1 and reach the lesion site of the carotid artery; due to the reasonable design and smooth inner wall of the instrument working channel, the surgical instruments can smoothly pass through, reducing the instrument jamming and operation resistance; during the instrument entering process, attention should be paid to avoid collision between the instrument and the wall of the catheter body 1 to ensure the safety of the instrument to the lesion site.

[0087] The doctor uses the corresponding surgical instruments to treat the lesion site of the carotid artery according to the specific condition of the patient; for example, if the patient has carotid stenosis, a balloon dilatation catheter can be used to dilate the stenosis site to restore the patency of the blood vessel; if a stent needs to be placed, the stent is accurately placed at the lesion site through the stent delivery system to support the blood vessel wall and prevent the blood vessel from restenosis; during the entire operation process, the doctor can inject contrast agent through the instrument working channel as needed, and real-time observe the key information such as the vascular morphology, instrument position and operation effect of the surgical site by means of the angiography device, to ensure the precision and safety of the surgical operation.

[0088] After the operation is completed, the filling liquid in the proximal balloon body 2 and the distal balloon body 3 is slowly extracted through the syringe; during the extraction process, the contraction of the proximal balloon body 2 and the distal balloon body 3 is closely observed to ensure that the proximal balloon body 2 and the distal balloon body 3 gradually separate from the blood vessel wall without causing damage to the blood vessel wall; when the pressure in the proximal balloon body 2 and the distal balloon body 3 is close to zero, and it is confirmed that the proximal balloon body 2 and the distal balloon body 3 have completely shrunk, the suction is stopped.

[0089] Subsequently, the entire double-balloon structure reverse flow protection device is slowly and smoothly withdrawn from the patient's body; during the withdrawal process, attention should be paid to avoid friction and collision between the catheter body 1 and the blood vessel wall to prevent blood vessel damage.

[0090] Example Two

[0091] As shown in Figure 5 , the cross section of the proximal balloon filling cavity 4 and the distal balloon filling cavity 5 is circular, and the circular structure is easier to produce and manufacture.

[0092] Example Three

[0093] As shown in Figure 6 , the cross section of the proximal balloon filling cavity 4 and the distal balloon filling cavity 5 is elliptical, and the elliptical proximal balloon filling cavity 4 and the distal balloon filling cavity 5 can have a larger cross-sectional area, facilitating higher flow perfusion.

[0094] Example Four

[0095] As shown in Figure 7 and Figure 8 , the catheter head 16 is a rounded nipple type, and the head "X" opening facilitates the smooth passage of the guide wire body 17, effectively blocks blood flow, and prevents emboli from flowing backward.

[0096] Example Five

[0097] As shown in Figure 9 and Figure 10 , the catheter head 16 is an overall flat and gradually narrowing on both sides of the axe type, with a length of 0.3-0.4mm, which can be compatible with the 0. The guide wire body 17 passes through the second interface 140, which can effectively block blood flow and prevent emboli from flowing backward.

[0098] Example Six

[0099] As shown in Figure 11 , the proximal balloon body 2 and the distal balloon body 3 are provided with a filter cover 18 on the same side, and the two filter covers 18 are arranged on the surface of the catheter body 1, and the cross section of the filter cover 18 is a tapered structure with a larger left side and a smaller right side.

[0100] The filter cover 18 can collect larger emboli and carry them out.

[0101] Although the specific embodiments of the present application are described above, those skilled in the art should understand that this is only an example, the protection scope of the present application is defined by the appended claims. Those skilled in the art can make various changes or modifications to these embodiments without departing from the principles and essence of the present application, but these changes and modifications all fall within the protection scope of the present application.

Claims

1. A double-balloon backflow protection device, comprising a catheter body (1), characterized in that, The dual-balloon structure backflow protection device further includes: a proximal balloon (2) and a distal balloon (3), the proximal balloon (2) and the distal balloon (3) being distributed left and right, and the proximal balloon (2) and the distal balloon (3) being connected to the surface of the catheter body (1) respectively; The proximal balloon filling chamber (4) and the distal balloon filling chamber (5) are respectively disposed on the inner wall of the catheter body (1), and the proximal balloon filling chamber (4) is connected to the proximal balloon body (2), and the distal balloon filling chamber (5) is connected to the distal balloon body (3). The three-way tube seat (8) has the end of the proximal balloon inflation cavity (4) away from the proximal balloon body (2) and the end of the distal balloon inflation cavity (5) away from the distal balloon body (3) connected to the corresponding interface on the three-way tube seat (8); The guidewire lumen (6) extends through the entire length of the catheter body (1) and is used to guide the guidewire (17) through.

2. The double-balloon backflow protection device as described in claim 1, characterized in that: One end of the catheter body (1) is connected to the three-way tube seat (8), and the other end of the catheter body (1) is connected to the catheter tip (16).

3. The double-balloon backflow protection device as described in claim 1, characterized in that: The main body of the catheter (1) is composed of an inner tube (9), an intermediate reinforcing layer (10) and an outer tube (11).

4. The double-balloon backflow protection device as described in claim 3, characterized in that: The outer surface of the outer tube (11) is coated with a coating that has anticoagulant properties.

5. The double-balloon backflow protection device as described in claim 1, characterized in that: Both the proximal balloon (2) and the distal balloon (3) are compliant balloons, and the distance between the proximal balloon (2) and the distal balloon (3) is 20-30 mm.

6. The double-balloon backflow protection device as described in claim 1, characterized in that: The proximal balloon inflation cavity (4) and the distal balloon inflation cavity (5) are thin-walled tubes located between the intermediate reinforcing layer (10) and the outer tube (11).

7. The double-balloon backflow protection device as described in claim 1, characterized in that: A device working passage (7) is provided between the proximal balloon body (2) and the distal balloon body (3), and the device working passage (7) is provided on the catheter body (1).

8. The double-balloon backflow protection device as described in claim 1, characterized in that: The three-way connector (8) includes a first interface (12), a main interface (13), and a second interface (14). The first interface (12) is connected to the proximal balloon inflation chamber (4), and the second interface (14) is connected to the distal balloon inflation chamber (5). The main interface (13) is connected to an external pressure injector via a Luer connector.

9. The double-balloon backflow protection device as described in claim 1, characterized in that: The proximal balloon (2) and distal balloon (3) are provided with radiopaque marking rings (15).

10. The double-balloon backflow protection device as described in claim 1, characterized in that: The connection between the proximal balloon inflation cavity (4) and the proximal balloon body (2), and the connection between the distal balloon inflation cavity (5) and the distal balloon body (3) are all sealed with adhesive.

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