A spherical binding basket catheter

Abstract

The application discloses a spherical bound net basket catheter and relates to the technical field of medical devices, which comprises a catheter main body, a control handle arranged at the proximal end of the catheter main body and a net basket electrode assembly arranged at the distal end of the catheter main body; further comprising an elastic metal wire, which is spirally arranged on the inner side of the net basket electrode assembly, and the control handle controls the net basket electrode assembly to be contracted into a shuttle shape or opened into a spherical shape through the elastic metal wire. The elastic metal wire is used for pulling the net basket, the net basket is tightly constrained in the storage state of the shuttle shape when the net basket is contracted, the whole net basket is conveniently put in and taken out, and the net basket is conveniently opened into a spherical shape, at the moment, the elastic metal wire is in a spiral shape, the opened net basket is maintained in a stable shape from the inner side, the uniformity is ensured, and the treatment is facilitated.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a spherical restraint basket catheter. Background Technology

[0002] In recent years, minimally invasive surgery has been increasingly used in the treatment of medical diseases due to its advantages such as smaller incisions. Cardiac interventional surgery, as a minimally invasive treatment method, plays an important role in the treatment of heart diseases. The most common type of cardiac interventional surgery is the basket catheter, which allows for cardiac ablation through electrodes on a basket.

[0003] Currently available interventional basket catheters consist of a catheter body and a basket electrode assembly. The basket electrode assembly is located at the distal end of the catheter and can be delivered to the target site within the body. The basket electrode assembly includes several ridged nickel-titanium plates and electrodes distributed on the nickel-titanium plates. The nickel-titanium plates can elastically bend and deform to allow the basket electrode assembly to unfold and retract. In the retracted state, the basket electrode assembly can easily pass through channels such as sheaths; in the unfolded state, the basket electrode assembly can contact the tissue at the target location.

[0004] However, most common baskets currently used achieve their deformation through a central push rod. The basket expands into a spherical shape or contracts into a spindle shape solely through the axial movement of the push rod. Since the force exerted by the push rod is axial, it provides no radial or inward clamping force. Therefore, when the nickel-titanium sheet in its contracted state, guided by the push rod, passes through a curved blood vessel or a narrow sheath, external forces can easily cause one of the sheets to deform and be hooked out, leading to jamming or even damage to the vessel. Conversely, when the nickel-titanium sheet in its expanded state contacts cardiac tissue, the tissue exerts forces on the basket in various directions due to heartbeats, blood flow, or the doctor's adjustments to the catheter. Lacking internal support, the individual nickel-titanium sheets are prone to overall tilting, local collapse, or asymmetrical deformation under external forces. This directly leads to unstable electrode-tissue contact pressure, affecting the quality of mapping signals and ablation effects. Specifically, in the contracted state, the nickel-titanium sheet may not adhere tightly to the catheter, potentially affecting its entry into the body; in the expanded state, the basket structure formed by the nickel-titanium sheet is not stable enough, potentially affecting mapping or ablation results. Therefore, it is very important to develop a basket guide tube that is very stable in both its unfolded and contracted forms and is easy to operate. Summary of the Invention

[0005] The purpose of this invention is to provide a spherical binding basket catheter to solve the technical problem that the existing basket catheter is not stable in shape when it is deployed and contracted, which affects the therapeutic effect.

[0006] The technical problem to be solved by this invention can be achieved through the following technical solution: A spherical confinement basket catheter includes a catheter body and a basket electrode assembly disposed at the distal end of the catheter body; it also includes an elastic metal wire; The elastic metal wire is spirally arranged inside the basket electrode assembly. The elastic metal wire is used to support the open basket electrode assembly or to pull the basket electrode assembly to close it.

[0007] Preferably, the basket electrode assembly includes nickel-titanium sheets and electrode components; an intermediate connecting tube is fixedly fitted at the distal end of the conduit body, and a connecting slide tube is slidably fitted on the inner side of the distal end of the conduit body; multiple nickel-titanium sheets are provided and are fitted between the distal end of the intermediate connecting tube and the connecting slide tube; the elastic metal wire is used to simultaneously pull all the nickel-titanium sheets together and adhere them to the intermediate connecting tube.

[0008] Preferably, one end of the elastic metal wire is fixedly connected to the far end of the intermediate connecting tube, and the other end is connected to the control handle; each nickel-titanium sheet has an FPC board for electrically connecting the electrode attached to its inner surface; each nickel-titanium sheet is connected to the elastic metal wire through the FPC board.

[0009] Preferably, each of the nickel-titanium sheets has holes on its FPC plate, and the elastic metal wire moves sequentially through the holes on each of the FPC plates.

[0010] Preferably, each of the nickel-titanium sheets has a hollow spherical protrusion on its FPC plate, and an elastic metal wire moves sequentially through the hollow spherical protrusion on each of the FPC plates.

[0011] Preferably, the basket guide tube further includes a control handle disposed at the proximal end of the guide tube body. The control handle includes a handle housing, a control slider, and a magnetic connector. The handle housing is fixedly connected to the proximal end of the guide tube body, and the control slider is slidably disposed on the outer wall of the handle housing. The control slider is connected to the proximal end of the elastic metal wire through the magnetic connector.

[0012] Preferably, the magnetic connector includes a solenoid and a metal post. The solenoid is disposed inside the handle housing and is connected to the control slider. The metal post is connected to the proximal end of an elastic metal wire and is inserted into the solenoid. The metal post is made of a material that readily generates magnetism.

[0013] Preferably, the solenoid is slidably disposed within the handle housing, and the solenoid is fixedly connected to the control knob.

[0014] Preferably, the solenoid is fixedly disposed inside the handle housing, and a sliding electrical contact that engages with the conductive coil on the solenoid is fixedly connected to the control knob.

[0015] Preferably, a limiting block for restricting the stroke of the metal column is fixedly connected inside the solenoid.

[0016] The beneficial effects of this invention are: 1. This invention uses a spiral elastic metal wire to pull the basket, which makes it easy to tightly restrain the basket in a shuttle-shaped storage state when it is tightened, making it easy for the entire basket to enter and exit. At the same time, when the basket is unfolded into a spherical shape, the spiral elastic metal wire maintains the shape stability of the unfolded basket from the inside, ensuring its uniformity and making it convenient for treatment use.

[0017] 2. The spiral elastic metal wire provided in this invention can also restrict the position of the balloon that is set inside the basket, preventing the balloon from being squeezed out from between the adjacent nickel-titanium plates of the basket and exceeding the diameter range of the basket when it inflates, thus affecting the contact between the basket and the tissue and making it impossible to perform effective treatment. At the same time, it can also prevent the operator from incorrectly inflating the balloon, causing it to fail.

[0018] 3. The control knob of this invention relies on the magnetic force generated between the energized solenoid and the metal column to pull the elastic metal wire, avoiding mechanically pulling the elastic metal wire, which could lead to wire breakage or breakage of the nickel-titanium sheet of the basket, resulting in damage to the basket. Attached Figure Description

[0019] Figure 1 This is a three-dimensional structural diagram of the mesh basket electrode assembly and the conduit body of the present invention in cooperation and connection. Figure 2 This is a front view of the mesh basket electrode assembly and the catheter body in this invention in cooperation and connection. Figure 3 yes Figure 2 A magnified schematic diagram of the partial structure at point A in the middle; Figure 4 This is a partial structural diagram of the connection between the elastic metal wire and the FPC plate on the nickel-titanium sheet in this invention through the engagement of hollow spherical protrusions. Figure 5 This is a top view schematic diagram of the connection between the elastic metal wire and the nickel-titanium sheet in this invention; Figure 6 This is a partial structural diagram of the connection between the sliding tube, the intermediate connecting tube, and the main body of the conduit in this invention; Figure 7 This is a schematic diagram of the control handle in this invention; Figure 8 This is a schematic diagram of one embodiment of the present invention in which the solenoid is disposed inside the handle housing; Figure 9 This is a schematic diagram of another embodiment of the present invention in which the solenoid is disposed inside the handle housing; Figure 10This is a schematic diagram of the structure in which the metal column and the solenoid are connected in this invention.

[0020] Explanation of reference numerals in the attached figures: 1. Catheter body; 11. Intermediate connecting tube; 12. Connecting slide tube; 2. Basket electrode assembly; 21. Nickel-titanium sheet; 22. Electrode component; 23. FPC board; 231. Hole; 3. Control handle; 31. Handle housing; 32. Control knob; 321. Sliding electrical contact; 33. Magnetic connector; 331. Solenoid; 332. Metal column; 34. Limiting block; 4. Elastic metal wire; 5. Balloon. Detailed Implementation

[0021] The specific embodiments of the present invention will be described in detail below, but it should be understood that the scope of protection of the present invention is not limited to the specific embodiments.

[0022] like Figures 1-10 As shown, a spherical restraint basket catheter is used in interventional surgery in medical treatment. The catheter includes a catheter body 1, a control handle 3 located at the proximal end of the catheter body 1, and a basket electrode assembly 2 located at the distal end of the catheter body 1. The basket electrode assembly 2 can be opened to form a spherical shape, which facilitates electrode contact with the corresponding human tissue location for discharge ablation treatment; at the same time, the basket electrode assembly 2 can also be retracted to facilitate entry and exit within the channel formed by the matching sheath; the control handle 3 is convenient for the operator to hold and perform treatment operations.

[0023] The conduit also includes an elastic metal wire 4, which is spirally arranged inside the basket electrode assembly 2. The control handle 3 controls the basket electrode assembly 2 to close into a spindle shape or open into a spherical shape by pulling or releasing the elastic metal wire 4. When the basket electrode assembly 2 is in the open state, the spiral elastic metal wire 4 provides auxiliary support inside, keeping the open shape of the basket electrode assembly 2 stable. When the elastic metal wire 4 is pulled or pulled, the entire basket electrode assembly 2 can be closed and kept in a stable closed shape.

[0024] In some specific implementations, the elastic metal wire 4 is a nickel-titanium alloy wire, which is a shape memory alloy material that can be pre-shaped into a spiral shape and is suitable for interventional medical catheters.

[0025] In some specific implementation schemes, refer to Figure 1 , Figure 2 as well as Figure 6As shown, the net basket electrode assembly 2 includes a nickel-titanium sheet 21 and an electrode 22; a middle connecting tube 11 is fixedly fitted at the distal end of the catheter body 1. The middle connecting tube 11 can be hollow and used to pass through a guide wire. It can also be fitted with a balloon 5. The side wall of the middle connecting tube 11 can be distributed with tubes for inflating or deflating the balloon 5, which facilitates the control of the balloon 5's expansion or contraction. The expanded balloon 5 can easily support the opened net basket; one end of the middle connecting tube 11 extends through the catheter body 1 and is inserted into the catheter body 1. A certain distance is maintained between the outer wall of the middle connecting tube 11 and the inner wall of the catheter body 1. A connecting slide tube 12 is slidably provided on the inner side of the distal end of the catheter body 1. The connecting slide tube 12 can cooperate between the catheter body 1 and the middle connecting tube 11. In the gap, the inner diameter of the connecting slide tube 12 is equal to the outer diameter of the intermediate connecting tube 11, and the outer diameter of the connecting slide tube 12 is smaller than the inner diameter of the conduit body 1. The connecting slide tube 12, the intermediate connecting tube 11, and the conduit body 1 are all coaxially distributed. Multiple nickel-titanium sheets 21 are provided and are equidistantly distributed around the intermediate connecting tube 11. The distal end of each nickel-titanium sheet 21 is fixedly connected to the distal end of the intermediate connecting tube 11 through existing conduit matching components, and the proximal end of the nickel-titanium sheet 21 is fixedly connected to the connecting slide tube 12, which can be fixed by adhesive bonding. An FPC board 23, i.e., a flexible circuit board, is bonded to the inner surface of each nickel-titanium sheet 21. Multiple electrode components 22 are provided and are evenly distributed on the nickel-titanium sheet 21, and are connected to the cable near the control handle 3 through the FPC board 23 for easy power supply. Each nickel-titanium sheet 21 is connected to an elastic metal wire 4 via an FPC plate 23. One end of the elastic metal wire 4 is fixedly connected to the distal end of the intermediate connecting tube 11, and the other end passes through the connecting slide tube 12 and into the control handle 3 for connection. A through hole for the elastic metal wire 4 to pass through can be opened on the connecting slide tube 12. When the nickel-titanium sheets 21 in the basket are in the unfolded state, the elastic metal wire 4 is in the initial spiral shape. By pulling the proximal end of the elastic metal wire 4 in the control handle 3, the spiral elastic metal wire 4 can be deformed into a taut state, which makes it easier to pull all the nickel-titanium sheets 21 to retract. The proximal end of the nickel-titanium sheets 21 slides into the guide tube body 1 by relying on the connecting slide tube 12, so that the nickel-titanium sheets 21 retract and stick to the intermediate connecting tube 11. Releasing the proximal end of the elastic metal wire 4 can also retract the nickel-titanium sheets 21 and the elastic metal wire 4 itself, i.e., the circumferentially distributed nickel-titanium sheets 21 form a spherical shape, and the elastic metal wire 4 returns to the spiral shape. In addition, even if the balloon 5 is fully inflated and contacts the inner wall of the basket formed by the nickel-titanium sheet 21, the elastic metal wire 4 will constrain the shape of the balloon 5, preventing the balloon 5 from over-inflating and being squeezed out of the gap between adjacent nickel-titanium sheets 21 and exceeding the maximum outer diameter of the basket formed by the nickel-titanium sheet 21, which would affect the contact tissue of the electrode 22 on the nickel-titanium sheet 21 and affect the discharge function; at the same time, the spiral elastic metal wire 4 also protects the balloon 5, preventing the operator from incorrectly inflating it and causing the balloon 5 to fail.

[0026] In a further specific implementation plan, refer to Figure 3 As shown, each nickel-titanium sheet 21 has a hole 231 on its FPC plate 23. The elastic metal wire 4 moves through the hole 231 on each FPC plate 23 in sequence. By operating the handle 3, the elastic metal wire 4 is pulled, so that the elastic metal wire 4 can be stably and effectively controlled to close or open the entire basket when it is stretched or deformed.

[0027] In other specific implementation plans, refer to Figure 4 As shown, hollow spherical protrusions can be provided on the FPC plate 23 of each nickel-titanium sheet 21, and the elastic metal wire 4 moves through the hollow spherical protrusions on each FPC plate 23 in sequence.

[0028] Of course, a guide sleeve or ring for the elastic metal wire 4 to pass through can also be fixed directly on each nickel-titanium sheet 21.

[0029] In some specific implementation schemes, refer to Figure 7 and Figure 8 As shown, the control handle 3 includes a handle housing 31, a control knob 32, and a magnetic connector 33. The handle housing 31 is fixedly connected to the proximal end of the guide tube body 1. The control knob 32 is slidably disposed on the outer wall of the handle housing 31. Specifically, a long strip-shaped sliding opening can be opened on the surface of the handle housing 31. The control knob 32 is slidably connected to the sliding opening. An extension extends from the side of the control knob 32 facing the inside of the handle housing 31 into the inside of the handle housing 31, so that the control knob 32 can be connected to the proximal end of the elastic metal wire 4 through the magnetic connector 33. By sliding the control knob 32, the elastic metal wire 4 is pulled, which facilitates the opening and closing of the net basket.

[0030] In a further specific implementation plan, refer to Figure 8 and Figure 10 As shown, the magnetic connector 33 includes a solenoid 331 and a metal post 332. The solenoid 331 is disposed inside the handle housing 31 and is connected to the control slider 32. The metal post 332 is connected to the proximal end of the elastic metal wire 4 and is inserted into the solenoid 331. It should be noted that the solenoid 331 consists of a tubular body and a conductive coil spirally wound around the outside of the tubular body. The metal post 332 is made of a material that is easy to magnetize and demagnetize, such as magnetic metals such as iron, cobalt, and nickel. That is, the solenoid 331 and the metal post 332 form an electromagnet. When the solenoid 331 is energized, the coil generates a magnetic force and a magnetic attraction occurs between it and the metal post 332. One implementation of the above solution is described in reference to... Figure 8As shown, the solenoid 331 can be slidably disposed inside the handle housing 31, and the solenoid 331 is fixedly connected to the control knob 32. When the solenoid 331 is energized and generates magnetic force, the control knob 32 drives the solenoid 331 to slide towards the near end position. Then, the metal column 332 can be driven to move synchronously by magnetic attraction. The metal column 332 then pulls the spiral elastic metal wire 4, causing it to pull the nickel-titanium sheet 21 of the basket to close and stick tightly to the intermediate connecting tube 11.

[0031] Another implementation method, see reference Figure 9 As shown, the solenoid 331 can be fixedly installed inside the handle housing 31. A sliding contact 321, which engages with the conductive coil on the solenoid 331, is fixedly connected to the control knob 32. Here, the conductive coil has a conductive exposed point on each turn, and all the conductive exposed points are aligned on a line. This allows the sliding contact 321 to switch between different contact positions as the control knob 32 slides, thereby controlling the effective length of the conductive coil and facilitating control of the magnetic force on the metal post 332. Specifically, one end of the conductive coil can be connected to the positive terminal of the power supply, while the other end remains unconnected. The sliding contact 321 is connected to the negative terminal of the power supply. Thus, relying on the sliding contact... The effective connection length of the conductive coil is controlled by changing the contact position of the exposed conductive point on the conductive coil. When the basket is in the unfolded state, the metal post 332 is located at the far end of the solenoid 331, and the exposed conductive point contacted by the sliding contact 321 is also located near the far end of the solenoid 331. When the sliding contact 321 is moved towards the near end of the solenoid 331 by the control knob 32, the connection length of the conductive coil on the solenoid 331 gradually increases. Since the area with the strongest magnetic field is located at the geometric center of the conductive coil segment, the metal post 332 can be moved towards the near end of the solenoid 331 by magnetic force, thereby pulling the elastic metal wire 4.

[0032] Alternatively, an electromagnet can be directly fixed to the control slider 32, with the electromagnet inside the handle housing 31. The metal post 332 can then be slidably mounted inside the handle housing 31 via a guide rail or groove, with the metal post 332 positioned to one side of the electromagnet. The electromagnet can then be energized to attract the metal post 332 and drive it to slide.

[0033] In some specific implementation schemes, refer to Figure 10As shown, in the scheme of fixing the solenoid 331, a limiting block 34 for limiting the stroke of the metal column 332 can also be fixedly connected inside the solenoid 331. Specifically, the limiting block 34 can be fixedly set on the side of the solenoid 331 close to the guide tube body 1, effectively limiting and blocking the ideal stroke boundary of the metal column 332, and the length of the solenoid 331 is greater than the moving distance of the control slider 32.

[0034] To facilitate understanding of the embodiments of this solution by those skilled in the art, the working principle of this solution will now be briefly explained in conjunction with specific application scenarios: When the nickel-titanium sheet 21 controlling the basket is retracted, if the solenoid 331 is set in a sliding manner, and if the nickel-titanium sheet 21 needs to be retracted and attached to the intermediate connecting tube 11, the solenoid 331 is energized, and its coil generates magnetic force and magnetic attraction between it and the metal column 332. When the operator slides the solenoid 331 towards the proximal position by controlling the slider 32, the metal column 332 moves synchronously due to magnetic attraction. The metal column 332 then pulls the spiral elastic metal wire 4, causing it to pull and retract the circumferentially distributed nickel-titanium sheets 21 of the basket electrode assembly 2 to stably close and adhere to the intermediate connecting tube 11, facilitating the insertion of the entire basket conduit into the corresponding position on the human body. Then, by pushing back the slider 32, the metal column 332 moves towards the distal end. At this time, the elastic metal wire 4 gradually releases and loosens the nickel-titanium sheets 21 of the basket, causing the entire basket to unfold, and the electrodes distributed on the nickel-titanium sheets 21... 22 can then be attached to the corresponding tissue, and at this time the elastic metal wire 4 returns to a spiral shape, which facilitates the support of the entire basket from the inside, keeping it stable in the unfolded state for use. At the same time, when the balloon 5 is inflated, the spiral elastic metal wire 4 can also constrain the shape of the balloon 5, preventing the balloon 5 from over-inflating and being squeezed out of the gap between the adjacent nickel-titanium plates 21 and exceeding the maximum outer diameter of the basket formed by the nickel-titanium plates 21, affecting the contact of the electrode 22 on the nickel-titanium plates 21 with the tissue and affecting the discharge function. At the same time, the spiral elastic metal wire 4 also protects the balloon 5, preventing the operator from incorrectly inflating it and causing the balloon 5 to fail.

[0035] If the solenoid 331 is fixed, it slides directly on the control knob 32. When the control knob 32 drives the sliding contact 321 to slide towards the near end of the solenoid 331, the effective connection length of the conductive coil is controlled by the change in the contact position between the sliding contact 321 and the exposed conductive point on the conductive coil. Since the area with the strongest magnetic field is located at the geometric center of the conductive coil segment, the metal column 332 can be made to slide towards the near end of the solenoid 331 by magnetic force, thereby pulling the elastic metal wire 4.

[0036] The above-disclosed embodiments are merely a few specific examples of the present invention. However, the embodiments of the present invention are not limited thereto, and any variations that can be conceived by those skilled in the art should fall within the protection scope of the present invention.

Claims

1. A spherical confinement basket catheter, comprising a catheter body (1) and a basket electrode assembly (2) disposed at the distal end of the catheter body (1); characterized in that, It also includes elastic metal wire (4); The elastic metal wire (4) is spiral-shaped and is spirally arranged inside the basket electrode assembly (2). The elastic metal wire (4) is used to support or pull the open basket electrode assembly (2) to retract it.

2. The spherical binding basket guide tube according to claim 1, characterized in that, The basket electrode assembly (2) includes nickel-titanium sheets (21) and electrode components (22); the distal end of the conduit body (1) is fixedly fitted with an intermediate connecting tube (11), and the inner side of the distal end of the conduit body (1) is also slidably fitted with a connecting slide tube (12). Multiple nickel-titanium sheets (21) are provided and are fitted between the distal end of the intermediate connecting tube (11) and the connecting slide tube (12). The elastic metal wire (4) is used to simultaneously pull all the nickel-titanium sheets (21) together and attach them to the intermediate connecting tube (11).

3. The spherical binding basket conduit according to claim 2, characterized in that, One end of the elastic metal wire (4) is fixedly connected to the far end of the intermediate connecting tube (11), and the other end is connected to the control handle (3); each nickel-titanium sheet (21) has an FPC plate (23) for electrically connecting the electrode (22) bonded to its inner surface; each nickel-titanium sheet (21) is movably connected to the elastic metal wire (4) through the FPC plate (23).

4. The spherical binding basket conduit according to claim 3, characterized in that, Each of the nickel-titanium sheets (21) has holes (231) on its FPC plate (23), and the elastic metal wire (4) moves through the holes (231) on each of the FPC plates (23) in sequence.

5. A spherical binding basket conduit according to claim 3, characterized in that, Hollow spherical protrusions are provided on the FPC plate (23) of each nickel-titanium sheet (21), and elastic metal wires (4) move through the hollow spherical protrusions on each FPC plate (23) in sequence.

6. The spherical binding basket conduit according to claim 1, characterized in that, It also includes a control handle (3) located at the proximal end of the catheter body (1); the control handle (3) includes a handle housing (31), a control knob (32) and a magnetic connector (33), the handle housing (31) is fixedly connected to the proximal end of the catheter body (1), and the control knob (32) is slidably disposed on the outer wall of the handle housing (31); the control knob (32) is connected to the proximal end of the elastic metal wire (4) through the magnetic connector (33).

7. A spherical binding basket conduit according to claim 6, characterized in that, The magnetic connector (33) includes a solenoid (331) and a metal post (332). The solenoid (331) is located inside the handle housing (31) and is connected to the control slider (32). The metal post (332) is connected to the proximal end of the elastic metal wire (4) and is inserted into the solenoid (331). The metal post (332) is made of a material that is prone to magnetization.

8. A spherical binding basket conduit according to claim 7, characterized in that, The solenoid (331) is slidably disposed inside the handle housing (31), and the solenoid (331) is fixedly connected to the control knob (32).

9. A spherical binding basket conduit according to claim 7, characterized in that, The solenoid (331) is fixedly installed inside the handle housing (31), and a sliding electrical contact (321) that engages with the conductive coil on the solenoid (331) is fixedly connected to the control knob (32).

10. A spherical binding basket conduit according to claim 9, characterized in that, The solenoid (331) is internally fixedly connected to a limiting stop (34) for limiting the travel of the metal column (332).

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