CN116999670B - Medical catheter, positioning device and catheter system - Google Patents
Medical catheter, positioning device and catheter systemInfo
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- CN116999670B CN116999670B CN202210470082.0A CN202210470082A CN116999670B CN 116999670 B CN116999670 B CN 116999670B CN 202210470082 A CN202210470082 A CN 202210470082A CN 116999670 B CN116999670 B CN 116999670B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/1206—Generators therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0113—Mechanical advancing means, e.g. catheter dispensers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00404—Blood vessels other than those in or around the heart
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00577—Ablation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B2034/2046—Tracking techniques
- A61B2034/2051—Electromagnetic tracking systems
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- Health & Medical Sciences (AREA)
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- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
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- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
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Abstract
本发明提供一种医疗导管、定位设备及导管系统，所述导管系统包括所述医疗导管和所述定位设备，所述医疗导管的手柄外壳内设有集成电路模块，该集成电路模块用于感测手柄外壳的径向朝向及运动状态，并可将感测结果发送给所述定位设备，所述定位设备根据定位的所述医疗导管的末端的三维位置、所述医疗导管的导管属性参数以及所述医疗导管发送的所述感测结果判断所述医疗导管的末端的弯折方向。采用本发明提供的医疗导管、定位设备及导管系统，操作者可以通过导管末端的弯折方向实时地获取导管围绕不同轴向方向的旋转反馈，减少了手术过程中不必要的操作(如测试激发等)，从而减少手术时间和手术风险。
The present invention provides a medical catheter, positioning device, and catheter system. The catheter system includes the medical catheter and the positioning device. An integrated circuit module is installed within the handle housing of the medical catheter. The integrated circuit module is configured to sense the radial orientation and motion state of the handle housing and transmit the sensing results to the positioning device. The positioning device determines the bending direction of the distal end of the medical catheter based on the three-dimensional position of the distal end of the medical catheter, the catheter property parameters of the medical catheter, and the sensing results transmitted by the medical catheter. Using the medical catheter, positioning device, and catheter system provided by the present invention, an operator can obtain real-time feedback on the catheter's rotation around different axial directions based on the bending direction of the distal end of the catheter, thereby reducing unnecessary operations (such as test excitation) during surgery, thereby reducing surgical time and surgical risks.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a medical catheter, positioning equipment and a catheter system.
Background
Overactive nerves can adversely affect human organs or tissues, resulting in a range of diseases, common heart diseases, diseases of the blood circulation system (hypertension) or kidney diseases, which can be caused by overactivity of local sympathetic nerves. Chronic activation of, for example, the renal sympathetic nerve causes excessive secretion of one or more renins resulting in increased levels of sodium ion reabsorption by the kidneys or increased cardiac output and ultimately increased blood pressure. In addition, excessive hormone levels (e.g., norepinephrine) in some of the body caused by prolonged sympathetic overactivity may cause irreversible damage to the viscera. By inhibiting the activity level of local sympathetic nerves, such symptoms are given the opportunity to be treated to some extent.
Radio frequency ablation is a main nerve ablation mode, and uses radio frequency energy to generate high temperature to local tissues, selectively block the conduction function of sympathetic nerve fibers in an area, and reduce the excitement of the sympathetic nerves, thereby achieving the treatment effect of relieving symptoms (such as hypertension). For example, in the renal sympathetic denervation (RENAL SYMPATHETIC denervation, RDN) procedure for treating refractory hypertension, the afferent nerves are ablated to reduce the nerve impulses of the ascending central nerve, reduce the sympathetic excitability, thereby reducing heart rate, reduce myocardial contractility, reduce the blood output of the heart by reducing the amount of blood ejected per beat, thereby reducing blood pressure, and the efferent nerves are ablated to reduce the activity of the descending nerves, thereby increasing glomerular filtration rate, reducing the renal reabsorption capacity, reducing the reabsorption of sodium ions and water, causing more sodium ions and water to be expelled from the body, reducing blood volume, and reducing blood pressure.
Conventional radio frequency ablation devices do not include any catheter movement or position feedback functionality, and catheter positioning during surgery is typically accomplished by additional positioning devices (e.g., magnetic field positioning devices, electric field positioning devices, etc.). However, due to the axially symmetrical shape of the catheter, it is difficult for conventional positioning devices to identify the bending direction of the catheter by its external features. The same is true for ablation devices of other energy sources, such as pulsed ablation, cryoablation. The conventional device usually needs an operator to test himself in the operation process and then adjust the bending direction of the catheter according to the test result, or marks the bending direction of the catheter at the handle to enable the operator to judge the bending direction of the catheter by identifying the relative positions of the device and the human body. Both of these different types of solutions require operators to perform different degrees of logic judgment or calculation to derive the direction of the bend of the catheter, increasing the difficulty of the procedure and the risk of mishandling to some extent.
Disclosure of Invention
The present invention is directed to a medical catheter, a positioning device and a catheter system that address one or more of the problems of the prior art.
In order to solve the technical problems, the invention provides a medical catheter, which comprises a catheter body and a handle, wherein the handle is connected with the proximal end of the catheter body,
The handle comprises a shell and an integrated circuit module arranged in the shell, the integrated circuit module comprises a first integrated circuit chip and a second integrated circuit chip, the first integrated circuit chip is used for sensing the radial direction of the shell to obtain a first sensing result, the second current collecting circuit chip is used for sensing the motion state of the shell to obtain a second sensing result, and the first sensing result and the second sensing result are used for combining the catheter attribute parameters of the medical catheter to obtain the radial direction of the tail end of the catheter body.
Optionally, in the medical catheter, the integrated circuit module further includes a fixing member, the fixing member has two mounting grooves, the first integrated circuit chip and the second integrated circuit chip are respectively accommodated in the two mounting grooves, and the upper surfaces of the first integrated circuit chip and the second integrated circuit chip are not beyond the outermost outer surface of the fixing member.
Optionally, in the medical catheter, the fixing member is a hollow cylindrical structural member, and at least part of an outer contour of the fixing member matches with an inner contour of the handle.
Optionally, in the medical catheter, the fixing piece has a first limiting structure, the housing has a second limiting structure, and the first limiting structure and the second limiting structure are connected in a matching way to limit the relative positions of the fixing piece and the housing.
Optionally, in the medical catheter, one of the first limit structure and the second limit structure is a limit groove, and the other is a protruding piece.
Optionally, in the medical catheter, the medical catheter further includes a torque sensor for sensing a torque value of the catheter body affected by the connected handle, and the torque value is used for combining a catheter attribute parameter of the medical catheter, the first sensing result and the second sensing result to obtain a radial direction of the distal end of the catheter body.
Optionally, in the medical catheter, the torque sensor is disposed at a connection point between the catheter body and the handle.
The invention also provides a positioning device for use with a medical catheter as described in any of the preceding claims, the positioning device comprising a signal processing unit and a positioning unit, wherein,
The signal processing unit is used for judging the radial direction of the tail end of the catheter body according to the first sensing result and the second sensing result fed back by the handle and the catheter attribute parameters of the medical catheter;
The positioning unit is used for positioning the three-dimensional position of the tail end of the catheter body and judging the bending direction of the tail end of the catheter body according to the three-dimensional position and the radial direction.
Optionally, in the positioning device, the positioning device further comprises a positioning display unit, wherein the positioning display unit is used for displaying a positioning simulation image of the catheter body in the target object, and marking the bending direction of the tail end of the catheter body on the displayed positioning simulation image according to the judging result of the positioning unit.
Optionally, in the positioning device, the positioning display unit has an interactive interface, the interactive interface is used for an operator to select a catheter type of the medical catheter, and the signal processing unit is further used for calling a pre-stored corresponding catheter attribute parameter according to the catheter type selected by the operator in the positioning display unit.
Optionally, in the positioning device, the signal processing unit is configured to determine a radial direction of the distal end of the catheter body according to the first sensing result and the second sensing result fed back by the handle, the catheter attribute parameter of the medical catheter, and a torque value of the catheter body affected by the connected handle.
The present invention also provides a catheter system comprising:
a medical catheter according to any one of the preceding claims, and
The positioning device of any of the preceding claims, the positioning device being electrically connected with the integrated circuit module of the medical catheter.
Optionally, in the catheter system, the catheter body includes a radio frequency electrode, and the catheter system further includes a radio frequency transmitter for transmitting a radio frequency signal to the radio frequency electrode.
In summary, the medical catheter, the positioning device and the catheter system provided by the invention, the catheter system comprises the medical catheter and the positioning device, an integrated circuit module is arranged in a handle shell of the medical catheter, the integrated circuit module is used for sensing the radial direction and the motion state of the handle shell, and after the sensing result is sent to the positioning device, the positioning device judges the bending direction of the tail end of the medical catheter according to the three-dimensional position of the tail end of the positioned medical catheter, the catheter attribute parameters of the medical catheter and the sensing result sent by the medical catheter. By adopting the medical catheter, the positioning equipment and the catheter system provided by the invention, an operator can acquire the rotation feedback of the catheter around different axial directions in real time through the bending direction of the tail end of the catheter, so that unnecessary operations (such as test excitation and the like) in the operation process are reduced, and the operation time and the operation risk are reduced.
Drawings
FIG. 1 is a schematic view of a catheter rotating about an X-axis, a Y-axis, and a Z-axis;
FIG. 2 is a schematic illustration of the anatomy of a handle provided in an embodiment of the present invention;
FIG. 3 is an assembled schematic view of a handle according to an embodiment of the present invention;
FIG. 4 is a schematic cross-sectional view of a handle in the area A-A in FIG. 3 according to an embodiment of the present invention;
FIG. 5 is a schematic diagram of an integrated circuit module according to an embodiment of the invention;
FIG. 6 is a schematic diagram of the composition of a catheter system according to an embodiment of the present invention;
FIG. 7 is a schematic view showing the relationship between the radial direction of the distal end of the catheter and the radial direction of the catheter handle according to an embodiment of the present invention;
FIG. 8 is a flow chart illustrating operation of a catheter system in accordance with an embodiment of the present invention;
FIG. 9 is a schematic view showing the effect of handle rotation on the bending direction of a catheter according to an embodiment of the present invention;
FIG. 10 is a schematic view showing the effect of handle rotation on the direction of bending of a catheter in the case of bending of the catheter according to an embodiment of the present invention;
wherein, each reference sign is explained as follows:
1-handle, 2-main section, 3-bendable section, 4-electrode;
The system comprises a 5-radio frequency transmitter, a 6-signal processing unit, a 7-positioning display unit and an 8-positioning unit, wherein the 7-positioning display unit is connected with the antenna;
A 9-positioning device, a 10-medical catheter;
11-an integrated circuit module 12-a housing;
13-hollow structural features;
14a, 14 b-mounting slots;
15a, 15 b-first limit structure, 16-fixing piece;
17-a first integrated circuit chip, 18-a second integrated circuit chip;
29-push rod, 30-bending direction, 31-right kidney and 32-renal artery.
Detailed Description
The invention will be described in detail with reference to the drawings and the embodiments, in order to make the objects, advantages and features of the invention more apparent. It should be noted that the drawings are in a very simplified form and are not drawn to scale, merely for convenience and clarity in aiding in the description of embodiments of the invention. Furthermore, the structures shown in the drawings are often part of actual structures. In particular, the drawings are shown with different emphasis instead being placed upon illustrating the various embodiments. It should be further understood that the terms "first," "second," "third," and the like in this specification are used merely for distinguishing between various components, elements, steps, etc. in the specification and not for indicating a logical or sequential relationship between the various components, elements, steps, etc., unless otherwise indicated.
In the present document, "proximal" and "distal/tip" are relative orientations, relative positions, directions of elements or actions relative to each other from the perspective of a physician using the medical device, although "proximal" and "distal/tip" are not limiting, "proximal" generally refers to an end of the medical device that is proximal to the physician during normal operation, and "distal/tip" generally refers to an end that first enters the patient.
The catheter has 6 degrees of freedom of movement in the human body, and the conventional positioning device can determine the linear movement of the catheter body in the X, Y, Z direction and the rotational movement of the catheter body around the Y axis and the Z axis (two types of rotational movement of the catheter body and the Y axis shown in fig. 1) by capturing the appearance characteristics of the catheter, but the single appearance judgment is insufficient to distinguish the rotational movement of the catheter around the X axis (the Pitch type rotational movement shown in fig. 1) due to the axially symmetrical shape characteristics of the catheter body around the X axis. In the actual operation process, the bending direction of the distal end of the catheter is completely controlled by the rotation of the catheter around the X-axis direction, and a single positioning system through the appearance characteristics of the catheter cannot recognize the rotation movement of the catheter around the X-axis direction, so that an operator cannot obtain effective feedback at the movement input end. Therefore, under the condition of using the traditional positioning system, an operator is usually required to judge whether the catheter is bent towards the target direction or not by continuously exciting the handle push rod, the operation difficulty is high, and the misoperation risk is high.
Accordingly, the present invention is directed to a catheter system capable of automatically determining a bending direction of a catheter tip, which comprises a catheter itself and a positioning device.
Embodiments of the present invention provide a medical catheter comprising a catheter body and a handle connected to a proximal end of the catheter body. As shown in fig. 2-5, the handle includes a housing 12 and an integrated circuit module 11 disposed in the housing 12, the integrated circuit module 11 includes a first integrated circuit chip 17 and a second integrated circuit chip 18, the first integrated circuit chip 17 is configured to sense a radial direction of the housing 12 to obtain a first sensing result, the second integrated circuit chip 18 is configured to sense a movement state of the housing 12 to obtain a second sensing result, and the first sensing result and the second sensing result are configured to combine a catheter attribute parameter of the medical catheter to obtain a radial direction of a distal end of the catheter body.
Based on the same idea, please refer to fig. 6, an embodiment of the present invention further provides a positioning device 9, where the positioning device 9 is used with the medical catheter 10 provided by the embodiment of the present invention, the positioning device 9 includes a signal processing unit 6 and a positioning unit 8, where the signal processing unit 6 is configured to determine a radial direction of the distal end of the catheter body according to the first sensing result and the second sensing result fed back by the handle 1 and a catheter attribute parameter of the medical catheter 10, and the positioning unit 8 is configured to position a three-dimensional position of the distal end of the catheter body and determine a bending direction of the distal end of the catheter body according to the three-dimensional position and the radial direction of the distal end of the catheter body.
In addition, as shown in fig. 6, the embodiment of the present invention further provides a catheter system, which includes the medical catheter 10 and the positioning device 9 provided in the embodiment of the present invention, where the positioning device 9 is electrically connected to the integrated circuit module 11 of the medical catheter 10.
When the medical catheter 10 and the positioning device 9 provided in the embodiment of the present invention are used in combination, after the integrated circuit module 11 disposed in the handle housing 12 of the medical catheter 10 sends the sensed radial direction and the motion state of the handle housing 12 to the positioning device 9, the positioning device 9 determines the bending direction of the distal end of the medical catheter 10 according to the three-dimensional position of the distal end of the medical catheter 10, the catheter attribute parameters of the medical catheter 10, and the data sent by the medical catheter 10. By adopting the medical catheter 10, the positioning device 9 and the catheter system provided by the embodiment of the invention, an operator can acquire the rotation feedback of the catheter around different axial directions in real time through the bending direction of the tail end of the catheter, so that unnecessary operations (such as test excitation and the like) in the operation process are reduced, and the operation time and the operation risk are reduced.
The medical catheter 10, the positioning device 9 and the catheter system provided by the embodiments of the present invention are described in further detail below.
As mentioned above, the first integrated circuit chip 17 is used for sensing the radial direction of the housing 12, specifically, the first integrated circuit chip 17 may be a gravity sensing chip, a gyroscope, etc., but the application is not limited thereto, the second integrated circuit chip 18 is used for sensing the movement state of the housing 12, where the movement state refers to the movement direction, the speed, the acceleration of the housing 12, and the second integrated circuit chip 18 may be an acceleration sensing chip, etc., but the application is not limited thereto.
As shown in fig. 2 to 5, the first integrated circuit chip 17 and the second integrated circuit chip 18 may be fixed in the housing 12 by a fixing member 16. Preferably, as shown in fig. 3, the fixing member 16 has two mounting grooves 14a, 14b, and the two mounting grooves 14a, 14b are used for respectively accommodating the first integrated circuit chip 17 and the second integrated circuit chip 18, so that the upper surfaces of the first integrated circuit chip 17 and the second integrated circuit chip 18 do not exceed the outermost outer surface of the fixing member 16, and the term "outermost outer surface" refers to an outer surface of the fixing member 16 farthest from the central axis of the fixing member 16 in the radial direction, and the upper surfaces of the first integrated circuit chip 17 and the second integrated circuit chip 18 are closer to the central axis of the fixing member 16 than the outermost outer surface. The first integrated circuit chip 17 and the second integrated circuit chip 18 may be fixed to the fixing member 16 by nylon screws, or the first integrated circuit chip 17 and the second integrated circuit chip 18 may be fixed to the fixing member 16 by dispensing. The arrangement of the two mounting slots 14a, 14b prevents the first integrated circuit chip 17 and the second integrated circuit chip 18 from being squeezed and disturbed by the housing 12, thereby making the monitored data more accurate. The relative positions of the two mounting grooves 14a, 14b are not particularly limited in the present application, in this embodiment, the two mounting grooves 14a, 14b may be disposed on two opposite sides of the fixing member 16, and in other embodiments, the two mounting grooves 14a, 14b may be disposed in parallel. The positions of the mounting grooves 14a, 14b may be adjusted according to the shape of the fixing member 16 and the connection manner between the fixing member 16 and the housing 12.
The accommodating dimensions of the two mounting grooves 14a, 14b may be respectively matched with the dimensions of the first integrated circuit chip 17 and the second integrated circuit chip 18, where the matching means that the groove bottom area of the mounting grooves 14a, 14b is equal to the area of the first integrated circuit chip 17 and the second integrated circuit chip 18, or the groove bottom area of the mounting grooves 14a, 14b is larger than the area of the first integrated circuit chip 17 and the second integrated circuit chip 18. The mounting slots 14a, 14b may be grooves surrounding the first and second integrated circuit chips 17, 18, or, as shown in fig. 5, the mounting slots 14a, 14b may have only one side wall. In summary, the mounting grooves 14a, 14b may be disposed such that the upper surfaces of the first integrated circuit chip 17 and the second integrated circuit chip 18 do not protrude beyond the outermost outer surface of the mount 16.
It is further preferred that, as shown in fig. 2 to 5, the fixing member 16 is a hollow tubular structure, having a hollow structural feature 13, and at least part of the outer contour of the fixing member 16 matches the inner contour of the handle 1, for example, one end of the fixing member 16 is provided with a tubular boss having a circular outer contour (in this embodiment, the circular outer contour includes the outermost outer surface), and the handle 1 has a circular inner contour matching the circular outer contour. When the outer contour of at least part of the fixing member 16 matches the inner contour of the handle 1, the connection strength and connection stability between the fixing member 16 and the handle 1 can be improved, and the hollow structural feature 13 of the fixing member 16 can be used for wires, pipes, cooling liquid conveying pipes and the like to pass through without affecting the arrangement of structural members of the pipes.
Further, the fixing member 16 has a first limiting structure, the housing 12 has a second limiting structure, and the first limiting structure and the second limiting structure are connected in a mating manner to define a relative position of the fixing member 16 and the housing 12. The number and the positions of the first limiting structures can be designed according to the arrangement of the mounting grooves, and the number and the positions of the second limiting structures are matched with those of the first limiting structures. In a preferred embodiment, as shown in fig. 5, the two mounting grooves 14a and 14b are located on two opposite sides of the fixing member 16 along a first direction (a groove depth direction), the number of the first limiting structures is two, the two first limiting structures 15a and 15b are located on two other opposite sides of the fixing member 16 along a second direction, the first direction and the second direction are intersected, and in order to facilitate the arrangement of each structural unit, the first direction and the second direction are preferably two directions perpendicular to each other, but the application is not limited thereto, for example, in other embodiments, the number of the first limiting structures may be only 1, and the two mounting grooves 14a and 14b may be located on two sides of the first limiting structures respectively.
In addition, preferably, one of the first limiting structure and the second limiting structure is a limiting groove, and the other one is a protruding member, when the protruding member is inserted into the limiting groove, a stable connection between the housing 12 and the fixing member 16 is achieved. When this structural combination design is employed, the difficulty of connecting the fastener 16 to the housing 12 can be reduced.
In fig. 5, the second limiting structure is a rib disposed along the axial direction of the fixing member 16, and the first limiting structures 15a and 15b are elongated limiting grooves disposed along the axial direction of the fixing member 16, but it should be understood that fig. 5 does not constitute a limitation of the present application.
In addition, in the medical catheter 10 provided by the embodiment of the present invention, the catheter body adopts a common catheter body structure, as shown in fig. 6, the catheter body includes a main body section 2, a bendable section 3 and an electrode section 4 sequentially connected from a proximal end to a distal end (tip), the bending direction of the distal end of the catheter is the bending direction of the distal end of the bendable section 3, and the proximal end of the main body section 2 is connected with the handle 1. The electrode segment 4 may include one or more electrodes and/or one or more sensors, and the shape of the electrode segment 4 is not limited to a linear shape, but may be a spiral shape, a ring shape or other shapes, and for a non-linear electrode segment such as a spiral shape, a ring shape or the like, the electrode segment is linear before entering the target area, and returns to a non-linear working state after being positioned. In view of the fact that the catheter tube is long and the elastic coefficient of the catheter tube is small, the torque existing between the catheter tube and the handle will have a certain influence on the radial direction of the final catheter end, therefore, preferably, the medical catheter 10 further comprises a torque sensor (not shown) for sensing the torque value of the catheter body affected by the connected handle, so as to improve the accuracy of the final judgment result, and preferably, the torque sensor is arranged at the connection part of the main body section 2 and the handle 1. The sensing data of the torque sensor may also be used for determining the radial direction of the distal end of the catheter body, and the detailed description is omitted herein.
In the positioning device 9 provided by the embodiment of the present invention, the positioning unit 8 may position the three-dimensional position of the catheter in the target object during the operation by using a magnetic field and/or an electric field.
Preferably, as shown in fig. 6, the positioning device 9 provided in the embodiment of the present invention further includes a positioning display unit 7, where the positioning display unit 7 is configured to display a positioning analog image of the catheter body in the target object, so that an operator can observe the state of the catheter body in the target object in real time.
In addition, in this embodiment, preferably, the positioning display unit 7 has an interactive interface, the interactive interface is used for an operator to select a catheter type of the medical catheter 10, in addition, the positioning simulation image may also be displayed through the interactive interface, for example, the interactive interface may have a plurality of windows, including a catheter type selection window, an image display window, etc., and the signal processing unit 6 is further used for calling the prestored corresponding catheter attribute parameters according to the catheter type selected by the operator on the positioning display unit 7. That is, in embodiments of the present invention, the catheter type of the catheter is selected by the operator.
In yet other embodiments, a catheter identification unit may be provided for automatically identifying the catheter type of the medical catheter 10 and generating catheter attribute parameters for recall by the signal processing unit 6 after the medical catheter 10 has established a connection. However, because of the additional arrangement of the catheter identification unit, which leads to an increase in hardware costs, it is preferred in this embodiment to design the positioning display unit 7 with an interactive interface so that the operator can directly select the catheter type. In addition, preferably, the positioning display unit 7 is further configured to mark the bending direction of the distal end of the catheter body on the displayed positioning simulation image according to the determination result of the positioning unit 8, so as to facilitate the confirmation of the operator.
In the embodiment of the invention, the catheter attribute parameters can comprise a length L, a radius r, a rigidity coefficient G, a quality M and the like. The signal processing unit 6 determines an algorithm formula from the invoked catheter attribute parameters. In an exemplary embodiment, as shown in fig. 7, the algorithm formula is, for example: Wherein the rotational inertia J of the catheter, the damping coefficient C of the catheter in the blood vessel (fixed value built-in according to experimental parameters) and the elastic coefficient k of the catheter (for example, in one of the cases Wherein the method comprises the steps ofIs the polar moment of inertia of the section of the catheter) is constant, the catheter attribute parameter is called according to the catheter type, and then calculated, T represents the torque value (if higher accuracy is not required, the T value may also be taken as 0 to participate in calculation), as previously described, it may be measured by providing a torsion sensor at the junction of the main body section 2 of the medical catheter and the handle 1, in other embodiments, it may also be measured in other ways, which will not be described here again,Representing the speed (including magnitude and direction) of movement of the housing 12 as measured by the second integrated circuit chip 18,Representing the acceleration (including magnitude and direction) of the housing 12 measured by the second integrated circuit chip 18, Δθ, which is the difference between the radial direction of the catheter tip θ tip and the radial direction of the catheter handle θ handle, can be calculated according to the above calculation formula, and where the radial direction of the catheter handle θ handle is known, the radial direction of the catheter tip θ tip can be obtained.
In the positioning device 9 provided in the embodiment of the present invention, the positioning unit 8, the signal processing unit 6, and the positioning display unit 7 may be combined in one device to implement, or any one of the units may be split into a plurality of sub-functional units, or at least part of functions of one or more units of the positioning unit 8, the signal processing unit 6, and the positioning display unit 7 may be combined with at least part of functions of other units and implemented in one functional unit. For example, in an alternative embodiment, the signal processing unit 6 in the positioning device 9 provided by the embodiment of the present invention may be disposed outside the medical catheter 10, or the signal processing unit 6 is disposed on the handle 1 of the medical catheter, after the first integrated circuit chip 17 and the second collecting circuit chip 18 send respective sensing data to the signal processing unit 6, the signal processing unit 6 sends the processing result to the positioning unit 8 outside the medical catheter 10, where the signal processing unit 6 may also be considered as a part of the medical catheter 10, and in another alternative embodiment, the signal processing unit 6 is disposed outside the medical catheter 10, and the sensing data of the first integrated circuit chip 17 and the second collecting circuit chip 18 are processed outside the medical catheter 10.
For the catheter system, when the electrode section 4 of the distal end of the medical catheter 10 is provided with a radio frequency electrode, the catheter system may further comprise a radio frequency generator 5 for transmitting radio frequency signals to the radio frequency electrode. When the electrode segment 4 of the distal end of the medical catheter 10 is provided with a blood pressure sensor, the catheter system may further comprise a blood pressure monitoring device for monitoring the blood pressure level of the blood pressure sensor. When the electrode section 4 at the distal end of the medical catheter 10 is provided with both a radio frequency electrode and a blood pressure sensor, the catheter system may comprise both a radio frequency generator 5 and a blood pressure monitoring device, i.e. the composition of the catheter system may be adjusted according to the type of the electrode section 4 of the medical catheter 10. Although the remaining structural features of the medical catheter 10 are not described in detail in the present embodiment, it is understood that the medical catheter 10 in the present embodiment includes some structural features of the conventional catheter, such as a push rod, a saline delivery tube for delivering saline, a pull wire for adjusting the bend shape of the bendable section 3, and the like.
FIG. 8 depicts a workflow of a catheter system employing an embodiment of the invention, including the steps of:
s10, reading the radial direction of the catheter handle shell;
S11, reading the motion state (motion direction, speed and acceleration) of the catheter handle shell;
s12, after an operator selects a catheter used in surgery, calling catheter attribute parameters of the selected catheter;
S20, calculating the radial direction of the tail end of the catheter by combining the radial direction and the motion state of the handle shell of the catheter and the attribute parameters of the catheter;
S21, reading the three-dimensional position of the tail end of the catheter;
s30, combining the three-dimensional position and the radial direction of the tail end of the catheter to obtain the bending direction of the catheter at the position;
S40, marking the bending direction of the tail end of the catheter on the real-time positioning simulation image of the catheter.
The execution sequence of steps S10, S11, S12 is not sequential, and the execution sequence of steps S20, S21 is not sequential.
Steps S10, S11 are implemented by the first integrated circuit chip 17 and the second integrated circuit chip 18, respectively. The selection of the catheter type in step S20 is performed by the operator' S interactive interface operation on the positioning display unit 7, i.e. the operator may manually select the catheter used for the surgery in the positioning display unit 7 before starting the surgery operation, and then call the catheter attribute parameters according to the selected catheter type through the signal processing unit 6. Step S20 is implemented by the signal processing unit 6. Step S21 and step S30 are implemented by the positioning unit 8, and step S40 is implemented by the positioning display unit 7. Of course, as in the previous embodiment, step S11 may further comprise sensing a torque value of the catheter body affected by the attached handle, and step 20 may further comprise calculating a radial orientation of the catheter tip in combination with the radial orientation of the catheter handle housing, the motion state, the catheter attribute parameter, and the torque value of the catheter body affected by the attached handle.
Fig. 9 and 10 illustrate the manner in which catheter handle 11 controls the direction of catheter bending during two different situations of surgery. Taking fig. 9 as an example, the bending direction of the catheter in the renal artery 32 (the right kidney 31 is shown on the left side for image mirror image reasons), is marked as 30, and is displayed in a three-dimensional model in real time by the positioning display unit 7, the initial bending direction of the catheter is towards the right (the initial bending direction of the catheter is determined by the position of the distal end of the catheter relative to the handle 1 when the catheter is installed), and the positioning device 9 can display the bending direction of the distal end of the catheter by real-time displaying the parameters such as gravity and angle of the handle 1 of the catheter and the corresponding relation between the handle 1 of the catheter and the bending direction of the catheter, and control the catheter to rotate anticlockwise by 180 degrees so that the bending direction of the catheter is towards the left. The catheter tip is advanced into the right renal artery (target) by activating the push rod 29 after confirming that the catheter bending direction 30 marked by the positioning display unit 7 coincides with the target bending direction. Similarly, as shown in fig. 10, after the catheter is subjected to one bending, the initial bending direction of the catheter is downward, and the catheter is controlled to rotate anticlockwise by 180 degrees so that the bending direction of the catheter is upward. The catheter electrode section 4 is attached to the upper wall of the right renal artery by activating the push rod 29 after confirming that the catheter bending direction 30 marked by the positioning display unit 7 is consistent with the target direction.
In summary, the medical catheter, the positioning device and the catheter system provided by the invention, the catheter system comprises the medical catheter and the positioning device, an integrated circuit module is arranged in a handle shell of the medical catheter, the integrated circuit module is used for sensing the radial direction and the motion state of the handle shell and sending the sensing result to the positioning device, and the positioning device judges the bending direction of the tail end of the medical catheter according to the three-dimensional position of the tail end of the positioned medical catheter, the catheter attribute parameters of the medical catheter and the sensing result sent by the medical catheter. By adopting the medical catheter, the positioning equipment and the catheter system provided by the invention, an operator can acquire the rotation feedback of the catheter around different axial directions in real time through the bending direction of the tail end of the catheter, so that unnecessary operations (such as test excitation and the like) in the operation process are reduced, and the operation time and the operation risk are reduced.
It should also be appreciated that while the present invention has been disclosed in the context of a preferred embodiment, the above embodiments are not intended to limit the invention. Many possible variations and modifications of the disclosed technology can be made by anyone skilled in the art without departing from the scope of the technology, or the technology can be modified to be equivalent. Therefore, any simple modification, equivalent variation and modification of the above embodiments according to the technical substance of the present invention still fall within the scope of the technical solution of the present invention.
Claims (13)
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| CN217724304U (en) * | 2022-04-28 | 2022-11-04 | 上海鸿电医疗科技有限公司 | Medical catheter |
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| US8257302B2 (en) * | 2005-05-10 | 2012-09-04 | Corindus, Inc. | User interface for remote control catheterization |
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| US20110238010A1 (en) * | 2008-12-31 | 2011-09-29 | Kirschenman Mark B | Robotic catheter system input device |
| EP2711676B1 (en) * | 2012-09-20 | 2020-10-07 | VascoMed GmbH | Fiber-optic force sensor, force measurement device and catheter |
| US10383542B2 (en) * | 2013-03-14 | 2019-08-20 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Device, system, and method for intracardiac diagnosis or therapy with localization |
| WO2021211310A1 (en) * | 2020-04-17 | 2021-10-21 | University Of Washington | Control system for robotic catheter |
| CN111537121B (en) * | 2020-06-24 | 2021-07-06 | 中国航空工业集团公司北京长城计量测试技术研究所 | Sine torque device system parameter online testing method and system |
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| CN114007685A (en) * | 2019-06-18 | 2022-02-01 | 阿比奥梅德欧洲股份有限公司 | System and method for preparing a catheter prior to use |
| CN217724304U (en) * | 2022-04-28 | 2022-11-04 | 上海鸿电医疗科技有限公司 | Medical catheter |
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