Visceral artery in-situ windowing positioning mechanism

By designing an adjustable and recyclable visceral artery in situ window positioning mechanism, using an umbrella-shaped locator and shape memory wire for precise positioning, the problem of lack of precise marking methods during visceral artery reconstruction in the prior art is solved, and efficient and safe visceral artery reconstruction effect is achieved.

CN222566031UActive Publication Date: 2025-03-07SHANGHAI NINTH PEOPLES HOSPITAL SHANGHAI JIAO TONG UNIV SCHOOL OF MEDICINE
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Patent Information

Application Number
CN202420791697.8
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-04-17
Publication Date
2025-03-07
Estimated Expiration
2034-04-17

AI Technical Summary

Technical Problem

The lack of accurate labeling methods in the process of visceral artery reconstruction in the prior artery is a high difficulty and risk in the operation, and the existing methods have problems such as high cost, inaccurate positioning or relying on physician experience.

Method used

An adjustable and recyclable visceral artery in situ window positioning mechanism is designed, and the umbrella-shaped locator is used to accurately locate the shape memory wire and marking points, and vascular reconstruction is carried out through laser in situ window.

Benefits of technology

The precise marking of visceral arteries and laser in-situ windowing are achieved, reducing the difficulty and risk of surgery, improving the efficiency and success rate of surgery, and the equipment is recyclable and has a low cost.

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Abstract

The utility model provides a visceral artery in-situ windowing positioning mechanism. The positioning mechanism comprises an operating handle, a stress relieving pipe, a positioner conveying sheath, a positioner conveying part and an umbrella rib-shaped positioner, the positioner conveying part is arranged in the operating handle, the stress relieving tube and the positioner conveying sheath in a sliding manner, the front end of the positioner conveying part can extend outwards from the positioner conveying sheath, and an umbrella rib-shaped positioner is mounted at the front end of the positioner conveying part; the umbrella rib-shaped positioner comprises a positioner umbrella rib support composed of a plurality of shape memory metal wires, a far-end mark point and a near-end mark point are arranged at the front end and the rear end of each shape memory metal wire respectively, and each shape memory metal wire is further provided with a positioner anchoring hook at the far end of the far-end mark point. By means of the adjustable and recoverable visceral artery in-situ windowing positioning mechanism, marking of a target artery can be completed simply and conveniently, and therefore a doctor can carry out accurate laser in-situ windowing on an aorta covered stent conveniently.
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Description

Technical Field

[0001] The utility model relates to a surgical instrument for in-situ windowing of visceral arteries, in particular to an in-situ windowing positioning mechanism for visceral arteries. Background Art

[0002] The visceral arteries are the main blood vessels that supply blood to important organs in our body, including the celiac trunk artery, superior mesenteric artery, and bilateral renal arteries. These arteries play a vital role in maintaining our life activities. However, when the thoracic and abdominal aorta are diseased and these visceral arteries are involved, the treatment becomes extremely complicated and difficult.

[0003] For a long time, open surgery has been the first choice for treating visceral artery disease. Although this method can solve the problem to a certain extent, the problems such as large trauma, high incidence of postoperative complications, and high risk of perioperative death have always troubled doctors and patients. With the continuous advancement of medical technology, people have begun to look for safer and more effective treatment methods.

[0004] With the rapid development of endovascular technology, minimally invasive interventional procedures have brought new hope for the treatment of visceral artery lesions. Compared with traditional open surgery, minimally invasive interventional procedures have the advantages of less trauma, faster recovery, and fewer complications. Through minimally invasive interventional procedures, doctors can accurately locate the lesion site and perform precise vascular reconstruction, thereby restoring the normal function of the visceral arteries.

[0005] Although minimally invasive interventional surgery has many advantages, it still faces many challenges in the process of visceral artery reconstruction. The biggest challenge is how to achieve accurate reconstruction of visceral arteries. Since visceral arteries have many branches and complex structures, accurately locating and repairing lesions places extremely high demands on doctors' skills and experience.

[0006] Currently, there are several types of technical methods for reconstructing visceral arteries in a completely minimally invasive manner:

[0007] (1) Parallel support technology

[0008] These techniques include the chimney, periscope, octopus and sandwich techniques. These techniques do not require marking of visceral arteries for operation and have simple technical requirements, but have obvious disadvantages. The incidence of postoperative endoleak and re-intervention rates are very high. Currently, the guidelines formulated by many professional organizations do not recommend them as routine surgical methods and only recommend them as backup options in emergency situations.

[0009] (2) Window / branch support technology

[0010] The fenestration / branching stent technology refers to pre-punching and marking holes on the stent according to the location of the visceral artery opening before surgery, or sewing the internal branch or external branch according to the type of lesion. The advantage of the fenestration / branching stent technology in reconstructing the visceral artery is that the structure is more in line with physiological anatomy, but when dealing with the origin of the visceral artery false lumen, local stenosis and torsion of the aorta, and displacement of the inner membrane of the dissection, the window position is prone to inaccurate, and the visceral artery cannot be superselected, resulting in surgical failure. The commercial customized stents used in this technology require a long waiting time and are not suitable for patients in urgent need of treatment; physician-made fenestration / branching stents also require a long modification time and are extremely dependent on the physician's treatment experience and operational proficiency, making large-scale promotion and application difficult.

[0011] (3) In-situ window opening technology

[0012] In situ fenestration means that after the position of the visceral artery is marked in advance, the main stent is directly and completely released, and then a window is opened at the marked position of the visceral artery through tools such as lasers and puncture needles. This technology is the closest method to the anatomical reconstruction of the visceral artery. The core point of this technology lies in the precise marking of the visceral artery. There are currently two methods for marking visceral arteries in clinical practice. One is to implant a stent in the visceral artery in advance for marking. This method has accurate positioning, but increases the cost (reference Le Houérou, Thomas et al. "In Situ Antegrade Laser Fenestrations During Endovascular Aortic Repair." European journal of vascular and endovascular surgery: the official journal of the European Society for Vascular Surgery vol.56,3(2018):356-362.).

[0013] The second method is image fusion technology, which is easy to operate, but this method can only mark the opening position of the visceral artery, and respiratory movement will affect the marking effect, reducing the positioning accuracy (reference Leger, Thomas et al. "Image Fusion Guidance for In Situ Laser Fenestration of Aortic Stent graft for Endovascular Repair of Complex Aortic Aneurysm: Feasibility, Efficacy and Overall Functional Success." Cardiovascular and interventional radiology vol. 42, 10 (2019): 1371-1379.).

[0014] At present, the in situ fenestration technology of visceral arteries is not yet mature. The core problem is the lack of a relatively complete and accurate marking method for visceral arteries. Both of the current methods have obvious technical defects:

[0015] 1) Stent labeling method: The stents used are not specially designed for visceral arteries, are non-retrievable, and are very expensive.

[0016] 2) Image fusion method: It only marks the opening position of the visceral artery, and cannot provide the physician with a stereoscopic view of the marked artery, and the fused image is affected by the patient's respiratory movement. Utility Model Content

[0017] The utility model provides an adjustable and recyclable visceral artery in situ fenestration positioning mechanism, with the help of which the target artery can be marked simply and conveniently, so that the physician can perform accurate laser in situ fenestration on the aortic stent graft. The specific scheme is as follows:

[0018] A visceral artery in situ fenestration positioning mechanism, the visceral artery in situ fenestration positioning mechanism comprises an operating handle, a stress relief tube, a positioner delivery sheath, a positioner delivery part, and the umbrella-shaped positioner;

[0019] The operating handle, the stress relief tube and the positioner delivery sheath are all tubular, the stress relief tube is installed between the operating handle and the positioner delivery sheath, the positioner delivery part is slidably arranged in the operating handle, the stress relief tube and the positioner delivery sheath, and the front end can extend outward from the positioner delivery sheath, and the rib-shaped positioner is installed at the front end of the positioner delivery part;

[0020] The rib-shaped locator comprises a locator rib bracket composed of a plurality of shape memory metal wires, a locator distal end marking point and a locator proximal end marking point are respectively arranged at the front and rear ends of each of the shape memory metal wires, and each of the shape memory metal wires is also provided with a locator anchor hook;

[0021] The operating handle is provided with a positioner adjustment roller, and the positioner adjustment roller and the positioner conveying part are rolling and frictionally matched to drive the positioner conveying part to slide in the operating handle, the stress relief tube and the positioner conveying sheath.

[0022] Furthermore, an opening is provided on the upper side wall of the operating handle, and the locator adjustment roller is rotatably installed in the opening. The lower edge of the locator adjustment roller is rollingly frictionally engaged with the locator conveying part in the operating handle, and the upper edge of the locator adjustment roller protrudes from the operating handle by 0.5 to 0.75 cm.

[0023] Furthermore, the outer diameter of the positioner adjustment roller is provided with a rubber ring or a rack distributed along the thickness direction.

[0024] Furthermore, the positioner delivery sheath and the positioner delivery portion are both made of flexible materials.

[0025] Furthermore, the outer wall of the operating handle is provided with anti-slip stripes or protrusions.

[0026] Furthermore, the distal marking point of the locator and the proximal marking point of the locator are both spheres with a diameter greater than the diameter of the shape memory metal wire.

[0027] Furthermore, a stress relief hole cooperating with the positioner conveying part is provided in the stress relief tube.

[0028] The advantages of the utility model are:

[0029] 1) A recyclable rib-shaped locator is used. By accurately releasing the rib-shaped locator to the specified position of the blood vessel, the distal and proximal marking points on each branch of the rib-shaped locator can be observed during intraoperative imaging. The marking points are used for positioning and laser in situ windowing, reducing the difficulty and risk of the operation.

[0030] 2) Unique design and easy operation improve the surgical efficiency and success rate.

[0031] 3) Shape memory metal wire is used as an umbrella-shaped locator, which has good biocompatibility and stability. After release, it can be fixed to the inner wall of the target artery through the elastic outward expansion force of the shape memory metal wire and the locator anchor hook to keep its position fixed, while facilitating observation by the surgical imaging system.

[0032] 4) The positioner adjusting roller can accurately control the conveying of the positioner conveying part to ensure positioning accuracy.

[0033] 5) The outer wall of the operating handle is provided with anti-slip stripes or bumps, which improves the comfort and safety of operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0035] Figure 1 This is a front view of the in-situ window opening positioning mechanism in the example of the utility model (unreleased state);

[0036] Figure 2 It is a side view of the in-situ window opening positioning mechanism in the example of the utility model (unreleased state);

[0037] Figure 3 This is a front view of the in-situ window opening and positioning mechanism in the example of the utility model (released state);

[0038] Figure 4 It is a side view of the in-situ window opening and positioning mechanism in the example of the utility model (after release);

[0039] Figure 5 It is a schematic diagram of the structure of the in-situ window positioner after the umbrella part is released in the example of the utility model;

[0040] Figure 6 It is a schematic diagram of the guide wire and vascular sheath superselecting the target artery in the example of the utility model;

[0041] Figure 7 It is a schematic diagram of the positioning device in the example of the present utility model being delivered along the vascular sheath to the target artery;

[0042] Figure 8 It is a schematic diagram of the umbrella-shaped locator in the example of the utility model being released and fixed to the target artery;

[0043] Fig. 9 This is a schematic diagram of an example of the utility model after the conveying and positioning mechanism is removed;

[0044] Fig.10 It is a schematic diagram of the locator recovery in the example of the utility model. DETAILED DESCRIPTION

[0045] In the following description, a large number of specific details are given to provide a more thorough understanding of the utility model. However, it is obvious to those skilled in the art that the utility model can be implemented without one or more of these details. In other examples, in order to avoid confusion with the utility model, some technical features known in the art are not described.

[0046] In order to thoroughly understand the present invention, detailed steps and detailed structures will be presented in the following description to illustrate the technical solution of the present invention. The preferred embodiments of the present invention are described in detail below, but in addition to these detailed descriptions, the present invention may also have other implementations.

[0047] Reference Figure 1-Figure 4 As shown, the utility model provides a visceral artery in situ fenestration positioning mechanism, which includes an operating handle 1, a stress relief tube 3, a positioner delivery sheath 4, a positioner delivery part 5, and an umbrella-shaped positioner 6.

[0048] The operating handle 1, the stress relief tube 3 and the positioner delivery sheath 4 are all tubular, the stress relief tube 3 is installed between the operating handle 1 and the positioner delivery sheath 4, the positioner delivery part 5 is slidably arranged in the operating handle 1, the stress relief tube 3 and the positioner delivery sheath 4, and the front end can extend outward from the positioner delivery sheath 4, and an umbrella rib-shaped positioner 6 is installed at the front end of the positioner delivery part 5. The umbrella rib-shaped positioner 6 is in a compressed and retracted state in the positioner delivery sheath 4. The physician pushes the umbrella rib-shaped positioner 6 to a predetermined position (the junction of the visceral artery and the aorta) by adjusting the pulley 2 to complete the release of the umbrella rib-shaped positioner 6.

[0049] The stress relief tube 3 plays the role of uniformly distributing stress. A stress relief hole matching the locator conveying part 5 is provided inside the stress relief tube 3. The diameter of the stress relief hole is slightly larger than the diameter of the locator conveying part 5, so that the internal stress can be eliminated when the locator conveying part 5 passes through the stress relief hole and moves.

[0050] The main body of the rib-shaped locator 6 is a rib bracket 6.1, which is composed of 6 shape memory wires 6.5. A locator distal marking point 6.3 and a locator proximal marking point 6.2 are respectively provided at the front and rear ends of each shape memory wire 6.5, and a locator anchor hook 6.4 is also provided at the distal end of each shape memory wire 6.5. The locator distal marking point 6.3 and the locator proximal marking point 6.2 can be clearly displayed under X-rays to assist physicians in determining the opening position and blood vessel direction of the target artery. After being released, the rib-shaped locator 6 can be fixed to the inner wall of the target artery through the elastic outward expansion force of the shape memory wire and the locator anchor hook 6.4.

[0051] An opening is provided on the upper side wall of the operating handle 1, and a locator adjustment roller 2 is rotatably installed in the opening. The upper edge of the locator adjustment roller 2 is exposed outside the operating handle 1, and the lower edge of the locator adjustment roller 2 is rollingly frictionally matched with the locator conveying part 5 in the operating handle 1. By toggling the locator adjustment roller 2, the locator conveying part 5 can be driven to slide in the operating handle 1, the stress relief tube 3 and the locator conveying sheath 4.

[0052] In an optional embodiment, in order to increase the friction between the locator adjustment roller 2 and the locator conveying part 5, a rubber ring or a rack distributed along the thickness direction can be provided on the outer diameter of the locator adjustment roller 2 to finely adjust the implantation position of the rib-shaped locator 6.

[0053] The locator delivery sheath 4 is made of a bendable flexible material and can freely shuttle to a designated position in the blood vessel.

[0054] In an optional embodiment, the operating handle is 9 to 13 cm long and 2 to 3 cm in outer diameter, and the upper edge of the positioner adjusting roller 2 protrudes from the operating handle by 0.5 to 0.75 cm. In addition, the outer wall of the operating handle 1 is provided with anti-skid stripes or convex points to play an anti-skid effect.

[0055] In an optional embodiment, both the locator distal end marking point 6.3 and the locator proximal end marking point 6.2 are spheres with a diameter larger than the diameter of the shape memory wire 6.5, so as to facilitate clear imaging of the surgical imaging system.

[0056] The implementation steps of the present invention are as follows:

[0057] 1) Implantation of the positioning device into the visceral artery

[0058] Puncture the femoral artery or upper limb artery, place a vascular sheath, and selectively superselect and indwell a catheter in the visceral artery according to the patient's condition. Introduce the visceral artery positioning device into the target artery through the catheter.

[0059] The positioning device includes: a handheld operating handle 1 located proximal to the in-situ window positioning mechanism, which is constructed to facilitate holding and manipulation of a distal locator delivery sheath 4; a delivery assembly connected to the operating handle 1, including a stress relief tube 3, a locator delivery sheath 4; a positioning device assembly connected to the delivery assembly, including an umbrella-shaped locator 6 (which can be fixed to the target artery after release to mark the opening position of the target artery) and a locator delivery portion (the delivery position of the umbrella portion can be adjusted).

[0060] The rib-shaped locator 6 is in an unreleased state in the locator delivery sheath 4. When the head end of the locator delivery sheath 4 enters the predetermined position of the target artery, the locator adjustment roller 2 is operated to gradually push out the rib-shaped locator 6 until it is completely released. After being completely released, the rib-shaped locator 6 adheres to the wall of the target artery, completing the positioning of the device.

[0061] 2) In-situ window opening

[0062] After positioning is completed, the vascular sheath and the positioning device delivery assembly are withdrawn. The aortic stent is delivered to the predetermined position and released, and then the laser optical fiber is delivered to the visceral window opening area. The umbrella-shaped positioning device 6 has 6 branches (i.e., the shape memory metal wire 6.5), each of which has a marking point at the proximal end and the distal end, and can be opened to show a clear black image under X-ray. According to the indication of the marking point, laser in-situ window opening is performed.

[0063] 3) Recycling locator

[0064] After the fenestration is completed, the guide wire of the delivery part of the locator is inserted into the delivery sheath, and the umbrella part is retracted into the delivery sheath to complete the recovery of the locator. 4) Visceral branch stent implantation

[0065] 4) The guidewire and catheter are passed through the opening on the aortic stent graft, the target artery is super-selected, and the branch stent is implanted to complete the treatment.

[0066] The above describes the preferred embodiments of the utility model. It should be understood that the utility model is not limited to the above-mentioned specific implementation methods, and the devices and structures that are not described in detail should be understood to be implemented in a common manner in the art; any technician familiar with the art can use the above-disclosed methods and technical contents to make many possible changes and modifications to the technical solutions of the utility model without departing from the scope of the technical solution of the utility model, or modify them into equivalent embodiments of equivalent changes, which does not affect the essential content of the utility model. Therefore, any simple modification, equivalent change and modification made to the above embodiments based on the technical essence of the utility model without departing from the content of the technical solution of the utility model still falls within the scope of protection of the technical solution of the utility model.

Claims

1. A visceral artery in situ window positioning mechanism, characterized in that: The visceral artery in situ window positioning mechanism comprises an operating handle (1), a stress relief tube (3), a positioner delivery sheath (4), a positioner delivery part (5), and an umbrella-shaped positioner (6); The operating handle (1), the stress relief tube (3) and the positioner delivery sheath (4) are all tubular, the stress relief tube (3) is installed between the operating handle (1) and the positioner delivery sheath (4), the positioner delivery part (5) is slidably arranged in the operating handle (1), the stress relief tube (3) and the positioner delivery sheath (4) and the front end can extend outward from the positioner delivery sheath (4), and the rib-shaped positioner (6) is installed at the front end of the positioner delivery part (5); The rib-shaped locator (6) comprises a locator rib bracket (6.1) composed of a plurality of shape memory metal wires (6.5), a locator distal end marking point (6.3) and a locator proximal end marking point (6.2) are respectively provided at the front and rear ends of each of the shape memory metal wires (6.5), and each of the shape memory metal wires (6.5) is also provided with a locator anchor hook (6.4); The operating handle (1) is provided with a positioner adjustment roller (2), and the positioner adjustment roller (2) and the positioner conveying part (5) are rollingly and frictionally matched to drive the positioner conveying part (5) to slide.

2. The visceral artery in situ window positioning mechanism according to claim 1, characterized in that: An opening is provided on the upper side wall of the operating handle (1), and the positioner adjustment roller (2) is rotatably installed in the opening. The lower edge of the positioner adjustment roller (2) is rollingly frictionally engaged with the positioner conveying part (5) in the operating handle (1), and the upper edge of the positioner adjustment roller (2) protrudes from the operating handle (1) by 0.5 to 0.75 cm.

3. The visceral artery in situ window positioning mechanism according to claim 2, characterized in that: The outer diameter of the positioner adjustment roller (2) is provided with a rubber ring or racks distributed along the thickness direction.

4. The visceral artery in situ window positioning mechanism according to claim 1, characterized in that: The outer wall of the operating handle (1) is provided with anti-slip stripes or protrusions.

5. The visceral artery in situ window positioning mechanism according to claim 1, characterized in that: The distal end marking point (6.3) of the locator and the proximal end marking point (6.2) of the locator are both spheres with a diameter greater than the diameter of the shape memory metal wire (6.5).

6. The visceral artery in situ window positioning mechanism according to claim 1, characterized in that: The stress relief tube (3) is provided with a stress relief hole which matches the positioner conveying part (5).