CN220370290U - Saccule catheter capable of rapidly rescuing sudden cardiogenic shock in TAVR pre-expansion - Google Patents

Abstract

The utility model discloses a balloon catheter capable of rapidly rescuing sudden cardiac shock in TAVR pre-expansion, wherein a TAVR balloon pressure inner cavity catheter, a guide wire cavity catheter and an IABP helium inner cavity catheter jointly form a push rod; the front part of the pushing rod is fixedly provided with a TAVR pre-expansion balloon and an IABP balloon in an external sealing manner; the TAVR pre-dilation balloon is communicated with a TAVR balloon pressure inner cavity catheter, and the IABP balloon is communicated with an IABP helium inner cavity catheter; the rear end of the pushing rod is connected with a fixing piece, the fixing piece is connected with a connecting end, and an IABP helium inlet, a guide wire cavity, a pressure sensor inlet and a TAVR pre-expansion balloon pressure inlet are arranged on the connecting end. The utility model has reasonable design, no need of changing the original basic structures of the prior IABP and TAVR, no need of additional investment and training, and low learning cost and period.

Description

Saccule catheter capable of rapidly rescuing sudden cardiogenic shock in TAVR pre-expansion

Technical Field

The utility model belongs to the technical field of medical treatment, relates to a pre-expansion balloon catheter for rapidly rescuing patients suffering from sudden cardiogenic shock during pre-expansion in catheter aortic valve replacement, and particularly relates to a balloon catheter capable of rapidly rescuing patients suffering from sudden cardiogenic shock during TAVR pre-expansion.

Background

Aortic valve stenosis (Aortic Valve Stenosis) is a heart pathological condition in which the aortic valve is stenosed or calcified, resulting in a blocked blood flow, which increases myocardial load, leads to cardiac hypertrophy, heart failure, arrhythmia, affects coronary and systemic blood flow supply, severely reducing patient life and quality of life. While conventional aortic valve replacement Surgery (SAVR) requires open chest surgery, percutaneous aortic valve replacement (TAVR) is an interventional cardiac procedure that aims to restore the normal function and hemodynamics of the aortic valve by implanting a new prosthetic valve into the patient's heart via a percutaneous route without open chest.

Compared with the traditional aortic valve replacement operation of open chest operation, the TAVR operation performs valve pre-expansion and artificial valve implantation under the guidance of a guide wire, has the advantages of small trauma, quick recovery, low postoperative complication risk and the like, is suitable for elderly patients, patients with various complications or higher operation risks, can improve the survival rate of patients with severe aortic valve stenosis, has the advantages of no disadvantage of the aortic valve replacement operation in patients with high operation risk, has the advantages of minimally invasive operation, no need of open chest and cardiac arrest, quick recovery and the like, and gradually expands the indication and rapidly increases the clinical application quantity in China.

However, complications arising from any of the factors in TAVR surgery (especially during balloon pre-dilation) can rapidly lead to cardiogenic shock and it is difficult to predict the occurrence of such events. Especially, at present, most TAVR operations in China need balloon pre-expansion, and rapid pace-making of right ventricle is needed during expansion, so that interference of heart self-pulsation to balloon positioning and expansion processes is reduced, simultaneously, the balloon expansion effect, reflux condition and coronary artery perfusion condition are observed by assisting aortic root radiography, complications such as acute myocardial infarction, aortic root or valve annulus rupture, arrhythmia and valve massive reflux can be caused by slightly careless, and further, the function of an operation center is rapidly deteriorated, so that the life of a patient is endangered. This makes it possible for a significant portion of patients to require prophylactic (i.e., preplanned) or remedial use of mechanical circulation assistance devices (MCSs) during TAVR, which results in a very poor prognosis.

For hemodynamic instability or critical illness patients receiving TAVR, ECMO (extracorporeal membrane oxygenation) is preferred in selecting MCS type according to relevant clinical path of China, and secondary IABP (intra-aortic balloon counterpulsation) is selected for assistance. However, while ECMO can perform work without depending on the heart of a patient, and provides a greater degree of hemodynamic support, ECMO has a low popularity in a medical environment in China, has extremely high requirements on hospital-related teams, has high cost, obviously makes it difficult to put it into large-scale use, and also greatly limits the use of ECMO. Meanwhile, considering that MCS use during TAVR is still mainly remedial implantation, the disease progress of patients is rapid, and the complex implantation procedure of ECMO cannot meet the rescue requirement. Although the advantages of economy, simplicity, high popularity and the like of the IABP are proved in clinical practice, the IABP is the most used MCS in China or even worldwide at present, and is the most used MCS in TAVR operation.

Further, implantation of MCS in association with TAVR is classified into both prophylactic and remedial cases. For the preventive implantation of MCS, the success rate of the operation can be improved and the prognosis of the patient can be improved compared with the remedial implantation; however, there is currently no guideline and consensus on when to pre-implant MCS, and more depending on the clinical experience of the operator, there is a likelihood of an unplanned occurrence of cardiogenic shock, and thus the use of TAVR-related MCS currently dominates remedial implants, resulting in poor patient survival, with hospitalization mortality of 29% and 1 year mortality of about 49% as counted by the PARTNER trial (Srenivas SS, lilly SM, szeto WY, et al Cardiopulmonary bypass and intra-aortic balloon pump use is associated with higher short and long term mortality after transcatheter aortic valve replacement: A PARTNER three sub-study Catheter Cardiovasc Interv; 86 (2): 316-322). Meanwhile, in the remedial MCS implantation process, the process of replacing with the ECMO or the IABP catheter is unavoidable, so that the exchange process of the IABP from the pre-dilation balloon to the IABP catheter may delay the optimal rescue opportunity of the patient, although the implantation process is economical and simple.

The problems are still to be solved at present, and the method has higher research value and clinical significance.

Disclosure of Invention

The utility model aims to provide a new medical instrument for rapidly rescuing patients suffering from sudden cardiogenic shock during the pre-expansion of TAVR, namely a balloon catheter capable of rapidly rescuing patients suffering from sudden cardiogenic shock during the pre-expansion of TAVR.

The utility model is realized by adopting the following technical scheme:

the balloon catheter capable of rapidly rescuing sudden cardiac shock during TAVR pre-expansion comprises a TAVR balloon pressure inner cavity catheter, a guide wire cavity catheter and an IABP helium inner cavity catheter, wherein the TAVR balloon pressure inner cavity catheter, the guide wire cavity catheter and the IABP helium inner cavity catheter jointly form a push rod. The front outer seal of the push rod is fixedly provided with a TAVR pre-expansion balloon and an IABP balloon; the TAVR pre-dilation balloon is communicated with a TAVR balloon pressure inner cavity catheter, and the IABP balloon is communicated with an IABP helium inner cavity catheter; the rear end (distal end) of the pushing rod is connected with a fixing piece, the fixing piece is connected with a connecting end, and an IABP helium gas inlet, a guide wire cavity, a pressure sensor inlet and a TAVR pre-expansion balloon pressure inlet are arranged on the connecting end; the IABP helium inlet is communicated with the IABP helium inner cavity catheter, the guide wire cavity and the pressure sensor inlet are communicated with the guide wire cavity catheter, and the TAVR pre-expanded balloon pressure inlet is communicated with the TAVR balloon pressure inner cavity catheter.

Further preferably, a TAVR pre-expansion balloon developing mark is arranged in the TAVR pre-expansion balloon; an IABP balloon developing mark is arranged in the IABP balloon and used for confirming the positions of the pre-expanded balloon and the IABP balloon under the X-ray in the operation, so that the IABP balloon can be conveniently and quickly positioned in an effect area.

Further preferably, the front end of the pushing rod forms a guide head, so that the balloon catheter can enter smoothly.

When in use, according to guidelines and clinical experience of an operator, the balloon catheter can be selected in advance for pre-expanding an aortic valve for patients with high hemodynamic collapse risk during operation or for preventing unexpected emergencies. If the patient is not experiencing cardiogenic shock during pre-dilation, the patient may be assessed for the dilation and decide to continue further pre-dilation, or to retract the TAVR pre-dilation balloon and withdraw the balloon catheter.

Once the patient is found to develop cardiogenic shock during the pre-dilation, immediately retracting the TAVR pre-dilation balloon and retracting the balloon catheter until the IABP balloon reaches the working area. And the IABP host is further connected, so that the implantation of the emergency IABP is completed after the IABP saccule enters a working state, and other necessary rescue measures are selected according to the illness state of a patient.

After the patient has hemodynamic recovery, depending on the patient's condition, whether to continue using the IABP balloon is determined, and if the patient has not had an IABP to assist in the circulation of blood, the balloon catheter may be withdrawn. If the patient still needs to continue with the IABP assistance, the balloon catheter cannot be used for a long time, and the existing IABP balloon catheter is replaced by the balloon catheter to prevent thrombus from being generated on the TAVR pre-expanded balloon, so that other complications are caused.

Compared with the prior art, the technical scheme provided by the utility model has the following advantages:

1. the balloon catheter disclosed by the utility model avoids the high expense cost and complex preparation flow related to the preventive implantation of MCS, saves the cost expenditure of patients and medical centers, and can reserve precious ECMO kits for other critical patients.

2. The balloon catheter can be used for treating cardiac shock which occurs out of plan, and the IABP and TAVR pre-expanded balloons are almost in place at the same time, so that the effect equivalent to preventive implantation of the IABP is achieved, and the survival rate of patients is improved.

3. Changing the pre-dilation balloon generally requires valuable surgical time, and the application of the balloon catheter of the utility model can begin providing the IABP support by directly retracting the catheter to the working area of the IABP balloon, thereby saving the time for exchanging the pre-dilation balloon to the IABP catheter, minimizing the time and interference in the exchanging process and achieving the first-aid purpose.

4. The balloon catheter disclosed by the utility model is compatible with the existing IABP and TAVR equipment, and does not need to be radically modified or replaced, so that medical institutions and doctors can adopt the balloon catheter on the basis of the existing equipment without additional investment or training, the operation is high-speed and simple and convenient, and the efficiency and the success rate of rescuing patients are increased.

The utility model has reasonable design, no need of changing the original basic structures of the prior IABP and TAVR, no need of additional investment and training, low learning cost and period, and good practical application and popularization value.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the utility model and together with the description, serve to explain the principles of the utility model.

In order to more clearly illustrate the embodiments of the present utility model or the technical solutions in the prior art, the drawings that are required to be used in the description of the embodiments or the prior art will be briefly described below, and it will be obvious to those skilled in the art that other drawings can be obtained from these drawings without inventive effort.

Fig. 1 shows a schematic view of a balloon catheter according to the present utility model in an expanded state as a TAVR pre-expanded balloon.

Fig. 2 shows a schematic view of a balloon catheter according to the present utility model in an emergency rescue mode as an IABP.

Reference numerals in the drawings: 1-IABP helium inlet, 2-wire lumen and pressure sensor inlet, 3-TAVR pre-dilation balloon pressure inlet, 4-TAVR balloon pressure lumen catheter, 5-wire lumen catheter, 6-IABP helium lumen catheter, 7-IABP balloon in a non-working state (hugging state), 8-TAVR pre-dilation balloon in a working state (expanding state), 9-guide head, 10-wire (having entered the wire lumen), 11-IABP pressure connector connected with helium, 12-pressure sensor connector (having withdrawn the wire and connected with IABP host), 13-TAVR pre-dilation balloon in a working state (expanding state), 14-TAVR pre-dilation balloon in a non-working state (hugging state), 15-TAVR pre-dilation balloon development marker, 16-IABP balloon development marker, 17-fixing piece, 18-connection end.

Detailed Description

In order that the above objects, features and advantages of the utility model will be more clearly understood, a further description of the utility model will be made. It should be noted that, without conflict, the embodiments of the present utility model and features in the embodiments may be combined with each other.

In the description, it should be noted that the terms "first," "second," and "second" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. It should be noted that, unless explicitly stated or limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the terms described above will be understood by those of ordinary skill in the art as the case may be.

In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present utility model, but the present utility model may be practiced otherwise than as described herein; it will be apparent that the embodiments in the specification are only some, but not all, embodiments of the utility model.

Specific embodiments of the present utility model will be described in detail below with reference to the accompanying drawings.

A balloon catheter capable of rapidly rescuing sudden cardiac shock in TAVR pre-expansion, as shown in figures 1 and 2, comprises a TAVR balloon pressure inner cavity catheter 4, a guide wire cavity catheter 5 and an IABP helium inner cavity catheter 6, wherein the TAVR balloon pressure inner cavity catheter 4, the guide wire cavity catheter 5 and the IABP helium inner cavity catheter 6 jointly form a push rod.

As shown in fig. 1 and 2, a TAVR pre-expansion balloon and an IABP balloon are fixedly arranged at the outer seal of the front part of the push rod; the TAVR pre-dilation balloon is in communication with a TAVR balloon pressure lumen catheter 4 and the IABP balloon is in communication with an IABP helium lumen catheter 6.

As shown in fig. 1 and 2, the front end of the push rod forms a guide head 9. The rear end of the pushing rod is connected with a fixing piece 17, the fixing piece 17 is connected with a connecting end head 18, and the connecting end head 18 is provided with an IABP helium gas inlet 1, a guide wire cavity, a pressure sensor inlet 2 and a TAVR pre-expansion balloon pressure inlet 3; the IABP helium inlet 1 is communicated with an IABP helium inner cavity catheter 6, the guide wire cavity and pressure sensor inlet 2 is communicated with a guide wire cavity catheter 5, and the TAVR pre-expansion balloon pressure inlet 3 is communicated with a TAVR balloon pressure inner cavity catheter 4.

As shown in fig. 1 and 2, a TAVR pre-expansion balloon developing mark 15 is arranged in the TAVR pre-expansion balloon; an IABP balloon development marker 16 is disposed within the IABP balloon.

In specific implementation, the length of the TAVR pre-expanded balloon is 40-50 mm (40 mm is generally preferred to meet the actual operation requirement), and the length of the IABP balloon is 180-240 mm (in actual operation, a proper balloon catheter can be selected according to the height and the aortic valve size of a patient, and various specifications, such as 180mm, 210mm or 240mm, and the like, can be manufactured).

The distance between the right end of the TAVR pre-dilation balloon and the left end of the IABP balloon is 90-100 mm (90 mm is generally preferred to meet the actual operation requirements).

The TAVR pre-expanded balloon is prepared from polyurethane or nylon, and the IABP balloon is prepared from polyurethane or nylon. The softness and hardness of the TAVR pre-expansion balloon and the IABP balloon are determined according to actual requirements, and the TAVR pre-expansion balloon and the IABP balloon belong to the prior art.

When the balloon catheter is specifically used, according to guidelines and clinical experience of an operator, for patients with high hemodynamic collapse risk during operation or for preventing unexpected emergency, the balloon catheter can be selected in advance to perform a pre-expansion process on an aortic valve, and the use state is shown in fig. 1, wherein the IABP balloon is in a non-working state (hugging state) and the TAVR pre-expansion balloon is in a working state (expansion state). If the patient is not experiencing cardiogenic shock during pre-dilation, the patient may be assessed for the dilation and decide to continue further pre-dilation, or to retract the TAVR pre-dilation balloon and withdraw the balloon catheter.

Once the patient is found to develop cardiogenic shock during the pre-dilation, immediately retracting the TAVR pre-dilation balloon and retracting the balloon catheter until the IABP balloon reaches the working area. The use state is shown in fig. 2, the IABP balloon is in an operating state (expanded state), and the TAVR pre-dilation balloon is in a non-operating state (hugging state). The device is further connected with an IABP host (an IABP helium inlet 1 is provided with an IABP pressure joint 11 connected with helium, a guide wire cavity and a pressure sensor inlet 2 are withdrawn from the guide wire and are connected with a pressure sensor joint 12 of the IABP host), so that the IABP balloon is in a working state, emergency IABP implantation is completed, and other necessary rescue measures are selected according to the illness state of a patient.

After the patient has hemodynamic recovery, depending on the patient's condition, whether to continue using the IABP balloon is determined, and if the patient has not had an IABP to assist in the circulation of blood, the balloon catheter may be withdrawn.

If the patient still needs to continue with the IABP assistance, the balloon catheter cannot be used for a long time, and the existing IABP balloon catheter is replaced by the balloon catheter to prevent thrombus from being generated on the TAVR pre-expanded balloon, so that other complications are caused.

The application of the balloon catheter avoids the high cost and complex preparation process related to the preventive implantation of MCS; can be used for treating the cardiac shock which occurs out of the plan, achieves the effect equivalent to the preventive implantation of IABP, and improves the survival rate of patients; the IABP support can be provided by directly retracting the catheter to the working area of the IABP saccule, so that the time for exchanging the IABP catheter after the pre-expanded saccule is withdrawn is saved, the first-aid purpose is achieved, and the operation is high-speed and simple and convenient.

The foregoing is only a specific embodiment of the utility model to enable those skilled in the art to understand or practice the utility model. Although described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the embodiments, and they should be construed as covering the scope of the appended claims.

Claims (6)

1. The utility model provides a sacculus pipe that can salvage fast TAVR in pre-dilatation burst heart shock which characterized in that: the device comprises a TAVR balloon pressure inner cavity catheter (4), a guide wire cavity catheter (5) and an IABP helium inner cavity catheter (6), wherein the TAVR balloon pressure inner cavity catheter (4), the guide wire cavity catheter (5) and the IABP helium inner cavity catheter (6) jointly form a pushing rod;

the front outer seal of the push rod is fixedly provided with a TAVR pre-expansion balloon and an IABP balloon; the TAVR pre-dilation balloon is communicated with a TAVR balloon pressure inner cavity catheter (4), and the IABP balloon is communicated with an IABP helium inner cavity catheter (6);

the rear end of the pushing rod is connected with a fixing piece (17), the fixing piece (17) is connected with a connecting end head (18), and an IABP helium gas access port (1), a guide wire cavity, a pressure sensor access port (2) and a TAVR pre-expansion balloon pressure access port (3) are arranged on the connecting end head (18); the IABP helium gas access port (1) is communicated with the IABP helium gas inner cavity catheter (6), the guide wire cavity and pressure sensor access port (2) is communicated with the guide wire cavity catheter (5), and the TAVR pre-expanded balloon pressure access port (3) is communicated with the TAVR balloon pressure inner cavity catheter (4).

2. The balloon catheter for rapid rescue of sudden cardiac shock in a TAVR pre-dilatation of claim 1, wherein: a TAVR pre-expansion sacculus developing mark (15) is arranged in the TAVR pre-expansion sacculus; an IABP balloon developing mark (16) is arranged in the IABP balloon.

3. The balloon catheter for rapid rescue of sudden cardiac shock in a TAVR pre-dilatation of claim 2, wherein: the front end of the pushing rod forms a guide head (9).

4. The balloon catheter for rapid rescue of sudden cardiac shock in a TAVR pre-dilatation of claim 1, wherein: the length of the TAVR pre-expansion balloon is 40-50 mm, and the length of the IABP balloon is 180-240 mm.

5. The balloon catheter for rapid rescue of sudden cardiac shock in a TAVR pre-dilatation of claim 4, wherein: the distance between the right end of the TAVR pre-expansion balloon and the left end of the IABP balloon is 90-100 mm.

6. The balloon catheter for rapid rescue of sudden cardiac shock in a TAVR pre-dilatation of claim 5, wherein: the TAVR pre-expanded balloon is made of polyurethane or nylon, and the IABP balloon is made of polyurethane or nylon.