Nerve intervention balloon OCT catheter

Abstract

The invention relates to the technical field of medical apparatuses and instruments, and discloses a nerve intervention balloon OCT catheter which comprises a catheter body, and the catheter body is provided with a far end and a near end and is provided with a single rail, a catheter flushing opening, a side arm Luer connector and a flushing outlet in the length direction of the catheter body; a balloon is arranged at the far end of the catheter, and the balloon is used for expanding in a target blood vessel area; the catheter is provided with an OCT imaging element behind the near end of the balloon, and the OCT imaging element is used for imaging the inner wall of a blood vessel; the balloon and the OCT imaging element are arranged in series along the axial direction of the catheter, and are matched with an external guide wire through the monorail, so that the catheter can be conveyed to a target blood vessel area along the guide wire; by means of the design, the problems that in traditional step-by-step operation, due to the fact that a balloon catheter and an OCT catheter are repeatedly exchanged, operation time is prolonged, and complications such as plaque falling and blood vessel injury are caused are fundamentally avoided, and safety, accuracy and overall efficiency of the nerve interventional operation are remarkably improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically to a neurointerventional balloon OCT catheter. Background Technology

[0002] The descriptions in this section are intended only to provide background information for the implementation of this application and should not be construed as an admission or implication that they constitute prior art.

[0003] Optical coherence tomography (OCT) has become a key intravascular imaging diagnostic tool in the field of neurointervention due to its extremely high resolution. It plays a crucial role in the assessment and treatment of cerebrovascular diseases. For example, it can accurately assess arterial stenosis and plaque characteristics, monitor stent apposition in real time during stent implantation, and observe the neointimal formation process during aneurysm treatment. This assists physicians in developing and adjusting optimal treatment strategies, effectively reducing the occurrence of related complications.

[0004] However, in current neurointerventional surgery practice, the treatment of vascular stenosis or plaque usually requires a step-by-step procedure: first, a balloon catheter is used to dilate the lesion site, then the balloon catheter is withdrawn, and then an OCT catheter is reinserted along the guidewire for imaging evaluation to check the dilation effect, plaque nature, or presence of dissection, etc.

[0005] This repeated catheter exchange procedure has significant drawbacks: First, it significantly prolongs the operation time; second, and more importantly, repeatedly pushing and exchanging catheters in tortuous and fragile intracranial vessels greatly increases the risk of serious complications such as plaque detachment leading to secondary cerebral infarction, guidewire puncture causing intracranial hemorrhage, and vascular injury. Furthermore, for lesions with severe stenosis, traditional OCT catheters often struggle to reach the target area due to poor permeability; catheter jitter during imaging also affects image quality and stability. Therefore, we propose a neurointerventional balloon OCT catheter. Summary of the Invention

[0006] The purpose of this invention is to provide a neurointerventional balloon OCT catheter to overcome the above-mentioned shortcomings of the prior art.

[0007] In one aspect of this invention, a neurointerventional balloon OCT catheter is provided, comprising: a catheter having a distal end and a proximal end, and having a monorail, a catheter flushing port, a side arm Luer connector, and a flushing outlet along its length; a balloon at the distal end of the catheter for dilation in a target vascular region; an OCT imaging element disposed posterior to the proximal end of the catheter for imaging the vascular wall; the balloon and the OCT imaging element being arranged in series along the axial direction of the catheter, and cooperating with an external guidewire via the monorail, enabling the catheter to be delivered along the guidewire to the target vascular region.

[0008] In a preferred embodiment, the side-arm Luer connector is located at the proximal end of the conduit and is in fluid communication with the proximal end of the monorail cavity; and The proximal end of the catheter is also provided with a balloon Luer connector, which is provided in correspondence with the side arm Luer connector.

[0009] In a preferred embodiment, the catheter flushing port and the flushing outlet are in fluid communication with a flushing channel disposed inside the catheter for perfusing flushing fluid into the blood vessel during imaging.

[0010] In a preferred embodiment, the OCT imaging element includes a lens fixedly disposed inside the conduit and a lens mark disposed on the outer surface of the conduit and corresponding to the position of the lens, the lens mark being used to indicate the position of the lens under external imaging equipment.

[0011] In a preferred embodiment, the outer surface of the catheter is provided with an axis mark along its insertable length to indicate the depth of insertion of the catheter into the blood vessel.

[0012] In a preferred embodiment, the distal and proximal ends of the catheter are respectively provided with distal and proximal markers to indicate the working segment of the catheter and the position of the balloon under external imaging equipment.

[0013] In a preferred embodiment, the distal end of the monorail cavity terminates at a guidewire outlet located between the distal end of the OCT imaging element and the proximal end of the balloon.

[0014] In a preferred embodiment, the balloon and the OCT imaging element have a predetermined axial distance, and the balloon can be positioned at the imaged lesion location by pushing or pulling the catheter according to the axial distance.

[0015] In a preferred embodiment, the proximal end of the catheter is integrated with an electrically rotatable connector for connection to the fiber optic interface of an external OCT imaging engine.

[0016] In a preferred embodiment, the flushing channel formed between the flushing port and the flushing outlet of the catheter is linked to an external perfusion pump and configured to provide a pulsed flushing fluid flow when the OCT imaging element is in operation.

[0017] The main differences and effects of the embodiments of the present invention compared with the prior art are as follows: This invention provides a neurointerventional balloon OCT catheter that innovatively integrates a balloon for dilation and an OCT imaging element for high-definition imaging into a single catheter in series, achieving integrated diagnosis and treatment. During operation, the catheter is first delivered along a guidewire to the target vascular region. After precise positioning using multiple markers, blood interference is cleared through a built-in flushing channel, allowing the OCT imaging element to provide high-definition imaging of the vascular wall and accurately identify lesions. Subsequently, without exchanging instruments, the physician only needs to fine-tune the catheter according to the preset fixed distance between the balloon and the imaging element to ensure the balloon precisely covers the imaged lesion area and completes the dilation treatment. This design fundamentally avoids the prolonged operation time and complications such as plaque detachment and vascular damage caused by repeated exchanges of balloon and OCT catheters in traditional step-by-step procedures, significantly improving the safety, precision, and overall efficiency of neurointerventional surgery.

[0018] It should be understood that, within the scope of this invention, the above-described technical features of this invention and the technical features specifically described below (such as in the embodiments) can be combined with each other to form new or preferred technical solutions. Due to space limitations, they will not be described in detail here. Attached Figure Description

[0019] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1 This is a schematic diagram of the overall planar structure according to one embodiment of this application.

[0021] Figure 2 This is a schematic diagram of a three-dimensional split state according to one embodiment of this application.

[0022] Figure 3 This is a schematic diagram showing the extent of various structures in a portion of a catheter according to one embodiment of this application. Figure 3 (a) shows one of the length ranges. Figure 3 (b) shows another length range.

[0023] The labels in each of the attached figures are as follows: 1. Catheter irrigation port; 2. Side arm Luer connector; 3. Axis marking; 4. Insertable length; 5. Distal marking; 6. Monorail; 7. Guidewire exit; 8. Lens; 9. Lens marking; 10. Proximal marking; 11. Irrigation outlet; 12. Catheter; 13. Balloon; 14. OCT imaging element; 15. Balloon Luer connector Detailed Implementation

[0024] In the following description, many technical details are presented to help the reader better understand this application. However, those skilled in the art will understand that the technical solutions claimed in this application can be implemented even without these technical details and various variations and modifications based on the following embodiments.

[0025] To enable those skilled in the art to better understand the technical solution of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings.

[0026] Please see Figures 1-2 This invention provides a technical solution: a neurointerventional balloon OCT catheter, comprising: a catheter 12 having a distal end and a proximal end, and a monorail 6, a catheter flushing port 1, a side arm Luer connector 2, and a flushing outlet 11 along its length; a balloon 13 is provided at the distal end of the catheter 12, the balloon 13 being used for dilation in the target vascular region; an OCT imaging element 14 is provided behind the proximal end of the catheter 12 for imaging the vascular wall; the balloon 13 and the OCT imaging element 14 are arranged in series along the axial direction of the catheter 12, and cooperate with an external guidewire via the monorail 6, allowing the catheter 12 to be delivered to the target vascular region along the guidewire; this series arrangement allows for precise imaging using the OCT imaging element 14 after guidewire delivery and guidance, and then the balloon 13 is moved to the identified lesion area for dilation treatment by pushing and pulling the catheter 12.

[0027] Figure 1 In the provided embodiments, a preferred range of lengths is defined, wherein the insertable length 4 is preferably 135 cm, the shaft mark 3 is preferably 10 cm, the outer diameter is 3.5 Fr, the length of the connected portion of the catheter is preferably 90 cm, and the length of the portion of the catheter from the proximal mark 10 to the tip is preferably 17 cm, with an outer diameter ≤ 3.0 Fr. Specifically, the length from the proximal mark 10 to the tip includes a length of 82 mm from the proximal mark 10 to the lens mark 9, a length of 20 mm from the lens 8 to the distal mark 5, a length of 3 mm from the distal mark 5 to the tip, and a length of 17 mm from the guidewire outlet 7 to the tip, with an outer diameter ≤ 2.7 Fr.

[0028] In another embodiment of the present invention, preferably, the side-arm Luer connector 2 is disposed at the proximal end of the catheter 12, and the side-arm Luer connector 2 is in fluid communication with the proximal end of the monorail cavity; the proximal end of the external guidewire can pass through the monorail 6 and be led out from the side-arm Luer connector 2, which facilitates the establishment of a monorail system to assist delivery and provides a fluid channel for possible auxiliary flushing. The proximal end of the catheter 12 is also provided with a balloon Luer connector 15, which is disposed correspondingly to the side-arm Luer connector 2.

[0029] The balloon Luer connector 15 is used to connect to and inflate the balloon 13. It can also serve as an external interface for receiving a pressure pump, allowing the pressure pump to press contrast agent into the inner cavity of the balloon 13 through the balloon Luer connector 15.

[0030] In another embodiment of the present invention, preferably, the catheter flushing port 1, the flushing outlet 11 and the flushing channel provided inside the catheter 12 are in fluid communication for perfusing flushing fluid into the blood vessel during the imaging process; the flushing fluid introduced through the catheter flushing port 1 flows out from the flushing outlet 11 through the internal channel, which can flush away the blood in the target imaging area and create conditions for the OCT imaging element 14 to obtain a clear image.

[0031] In another embodiment of the present invention, preferably, the OCT imaging element 14 includes a lens 8 fixedly disposed inside the catheter 12, and a lens mark 9 disposed on the outer surface of the catheter 12 and corresponding to the position of the lens 8. The lens mark 9 is used to indicate the position of the lens 8 under external imaging equipment. Under the fluoroscopy of external imaging equipment such as X-ray, the doctor can directly determine the specific position of the OCT imaging element 14 and the lens 8 in the blood vessel by observing the lens mark 9.

[0032] In another embodiment of the present invention, preferably, the outer surface of the catheter 12 is provided with an axis mark 3 along its insertable length 4 to indicate the depth of the catheter 12 inserted into the blood vessel; when the doctor pushes the catheter 12, by observing the number or position change of the axis mark 3 passing through the blood vessel puncture point, the doctor can intuitively judge the approximate depth of the catheter 12 inserted, and assist in the initial positioning.

[0033] In another embodiment of the present invention, preferably, distal marker 5 and proximal marker 10 are respectively provided at the distal and proximal ends of the catheter 12, which are used to indicate the working segment of the catheter 12 and the position of the balloon 13 under external imaging equipment; when the catheter 12 is delivered to the vicinity of the target area, under X-ray fluoroscopy, distal marker 5 and proximal marker 10 can help doctors quickly identify the working segment range of the catheter 12 and estimate the relative position of the balloon 13, and perform preoperative large-scale positioning.

[0034] In another embodiment of the present invention, preferably, the distal end of the single-track cavity terminates at the guidewire outlet 7, which is located between the distal end of the OCT imaging element 14 and the proximal end of the balloon 13. The guidewire outlet 7 is positioned after the imaging element 14 and before the balloon 13, so that when the catheter 12 travels along the guidewire, the foremost balloon 13 and the subsequent imaging element 14 can reach the distal end of the lesion without obstruction through the path guided by the guidewire, and the guidewire support section covers the treatment area.

[0035] In another embodiment of the present invention, preferably, there is a predetermined axial distance between the balloon 13 and the OCT imaging element 14. By pushing and pulling the catheter 12 according to the axial distance, the balloon 13 can be positioned at the location of the lesion that has been imaged. After the OCT imaging element 14 completes the precise imaging of the lesion, the doctor knows the fixed distance between the two. The doctor only needs to move the catheter 12 to the distal or proximal end of the predetermined distance to make the balloon 13 accurately cover the lesion that has just been imaged and confirmed.

[0036] In another embodiment of the present invention, preferably, the proximal end of the catheter 12 is integrated with an electrical rotary connector for connecting to the fiber optic interface of an external OCT imaging engine; after the electrical rotary connector is connected, stable transmission of electrical and optical signals can be achieved, ensuring that the OCT imaging element 14 can receive instructions from the external imaging engine and transmit back the acquired optical interference data of the blood vessel wall for real-time imaging processing.

[0037] In another embodiment of the present invention, preferably, the flushing channel formed between the catheter flushing port 1 and the flushing outlet 11 can be linked with an external perfusion pump and configured to provide a pulsed flushing fluid flow when the OCT imaging element is working; by linking with the external perfusion pump, the flow rate and timing of flushing can be controlled as needed. In particular, by adopting the pulsed flushing mode, a brief and clear transparent window can be formed at the moment when the OCT imaging element 14 acquires an image, effectively eliminating blood interference, while reducing the total amount of flushing fluid used, and making the operation more controllable.

[0038] Figure 3 In the provided embodiments, preferred range lengths of each structure in the catheter in two preferred embodiments are defined, wherein Figure 3 In (a), the length from the near end mark 10 to the lens mark 9 is 82 mm, the length from the lens 8 to the far end mark 5 is 20 mm, and the length from the far end mark 5 to the tip is 3 mm; Figure 3 In (b), the length from the near end mark 10 to the lens mark 9 is 50 mm, the length from the lens 8 to the far end mark 5 is 23 mm, and the length from the far end mark 5 to the tip is 3 mm. Figure 3The diagram also shows a quick-change interface and a proximal marker on the balloon. The quick-change interface is a dedicated opening and channel structure on the catheter for quick insertion and withdrawal of the guidewire, used for rapid guidewire exchange. The length from the proximal marker to the distal marker 5 of the balloon reflects the distance between the imaging markers at both ends of the balloon 15, used to accurately determine the coverage area of ​​the balloon in the blood vessel, facilitating positioning.

[0039] During operation, preoperative preparation is first performed. The proximal electrical rotary connector of catheter 12 is connected to the external OCT imaging engine, and the catheter flushing port 1 and flushing outlet 11 are connected to the external perfusion pump. Next, delivery and positioning are performed. After the external guidewire is advanced to the target area, catheter 12 is delivered along the guidewire via the monorail system 6. The insertion depth is controlled by the axis marker 3, and the distal marker 5, proximal marker 10, and lens marker 9 are observed through the external imaging equipment to accurately locate the OCT imaging element 14 in the target vessel segment. Imaging is then performed. The perfusion pump is activated, and blood in the imaging area is cleared by a pulsed flushing flow. Simultaneously, the OCT imaging element 14 provides high-resolution imaging of the vessel wall to identify lesions. Treatment positioning and dilation are then completed. Based on the preset axial distance between balloon 13 and OCT imaging element 14, the position of catheter 12 is finely adjusted so that balloon 13 is accurately aligned with the imaged lesion area and dilated. Finally, balloon 13 is depressurized, flushing and imaging are stopped, and catheter 12 is withdrawn. This procedure integrates imaging, irrigation, and balloon dilation functions, and achieves precise localization and treatment of neurovascular lesions through tandem design and multiple marking.

[0040] It should be noted that in the claims and description of this patent, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, meaning that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one" does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0041] All documents mentioned in this invention are incorporated herein by reference as if each document were individually incorporated by reference. Furthermore, it should be understood that after reading the foregoing teachings of this invention, those skilled in the art can make various alterations or modifications to this invention, and these equivalent forms also fall within the scope defined by the appended claims.

Claims

1. A neurointerventional balloon OCT catheter, characterized in that, include: The catheter (12) has a distal end and a proximal end, and is provided with a monorail (6), a catheter flushing port (1), a side arm Luer connector (2), and a flushing outlet (11) along its length; the distal end of the catheter (12) is provided with a balloon (13), which is used to expand in the target vascular region; the catheter (12) is provided with an OCT imaging element (14) behind the proximal end of the balloon for imaging the inner wall of the vascular vessel; the balloon (13) and the OCT imaging element (14) are arranged in series along the axial direction of the catheter (12), and cooperate with an external guidewire through the monorail (6) so that the catheter (12) can be delivered to the target vascular region along the guidewire.

2. The neurointerventional balloon OCT catheter according to claim 1, characterized in that, The side-arm Luer connector (2) is located at the proximal end of the conduit (12), and the side-arm Luer connector (2) is in fluid communication with the proximal end of the monorail cavity; and The proximal end of the catheter (12) is also provided with a balloon Luer connector (15), which is provided in correspondence with the side arm Luer connector (2).

3. The neurointerventional balloon OCT catheter according to claim 1, characterized in that, The flushing port (1) and the flushing outlet (11) of the catheter are in fluid communication with the flushing channel located inside the catheter (12) for perfusing flushing fluid into the blood vessel during the imaging process.

4. The neurointerventional balloon OCT catheter according to claim 1, characterized in that, The OCT imaging element (14) includes a lens (8) fixedly disposed inside the conduit (12) and a lens mark (9) disposed on the outer surface of the conduit (12) and corresponding to the position of the lens (8). The lens mark (9) is used to indicate the position of the lens (8) under external imaging equipment.

5. The neurointerventional balloon OCT catheter according to claim 1, characterized in that, The outer surface of the catheter (12) is provided with an axis mark (3) along its insertable length (4) to indicate the depth of insertion of the catheter (12) into the blood vessel.

6. The neurointerventional balloon OCT catheter according to claim 1, characterized in that, The distal end and proximal end of the catheter (12) are respectively provided with a distal end marker (5) and a proximal end marker (10) to indicate the working section of the catheter (12) and the position of the balloon (13) under external imaging equipment.

7. The neurointerventional balloon OCT catheter according to claim 2, characterized in that, The distal end of the monorail cavity terminates at the guidewire outlet (7), which is located between the distal end of the OCT imaging element (14) and the proximal end of the balloon (13).

8. The neurointerventional balloon OCT catheter according to claim 1, characterized in that, The balloon (13) and the OCT imaging element (14) have a predetermined axial distance. By pushing and pulling the catheter (12) according to the axial distance, the balloon (13) can be positioned at the location of the imaged lesion.

9. The neurointerventional balloon OCT catheter according to claim 1, characterized in that, The proximal end of the catheter (12) is integrated with an electrical rotary connector for connecting to the fiber optic interface of an external OCT imaging engine.

10. The neurointerventional balloon OCT catheter according to claim 1, characterized in that, The flushing channel formed between the flushing port (1) and the flushing outlet (11) of the conduit can be linked with an external perfusion pump and configured to provide a pulsed flushing fluid flow when the OCT imaging element is working.

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