Medical catheter assembly
By designing adjustable bend guide sheath assembly and puncture needle assembly, the precise positioning of room septum puncture is achieved using ring electrodes and magnetic positioning sensors, which solves the problems of inaccurate positioning and excessive radiation in the prior art, and improves the puncture Accuracy and safety.
Patent Information
- Application Number
- CN202420719349.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-04-09
- Publication Date
- 2025-02-07
- Estimated Expiration
- 2034-04-09
AI Technical Summary
The prior art is difficult to accurately locate the fossa position and puncture direction of the atrial septum puncture, resulting in errors in the puncture site, increasing patient pain and patient risk, and requiring a large amount of X-rays to cause radiation damage.
A medical catheter assembly is designed including an adjustable bend guide sheath assembly and a puncture needle assembly. The adjustable bend guide sheath assembly has a distal sheath, an adjustable bend section and a proximal body, equipped with ring electrodes and magnetic positioning sensors, and the puncture needle assembly is also equipped with positioning sensors for precise positioning and accurate puncture.
Through this technology, the accuracy and safety of atrial septum puncture can be significantly improved, the use of X-rays can be reduced, and the radiation risk of patients and doctors can be reduced.
Smart Images
Figure CN222426167U_ABST
Abstract
Description
Technical Field
[0001] The present disclosure relates to medical catheters and, more particularly, to magnetically positioned transseptal puncture assemblies. Background Art
[0002] Atrial septal puncture was first reported by Ross et al. in 1959. Brockenbrough and Mullins et al. later improved the puncture needle, sheath and puncture technique. At that time, it was mainly used for left heart catheter examination of valvular lesions. Now, with the increasing popularity of atrial fibrillation catheter ablation, atrial septal puncture has become a common clinical technique.
[0003] Atrial septal puncture can be used for left-sided accessory pathway ablation via the atrial septal approach, atrial fibrillation ablation, left atrial tachycardia ablation, and left atrial flutter ablation during catheter ablation surgery. At the same time, atrial septal puncture is also an alternative route and necessary supplement for the ablation of left ventricular arrhythmias.
[0004] The catheter of the percutaneous approach cannot reach the left atrium in an antegrade manner and needs to pass through the aortic valve and mitral valve. Both of these valves have a certain curvature, making it difficult for the catheter to reach them. Even if they can reach them, the catheter operation is very cumbersome.
[0005] The atrial septum is located between the left and right atria, and the oval fossa is the thinnest part of the atrial septum. Therefore, the oval fossa is the ideal location for atrial septal puncture to enter the left atrium. When performing atrial septal puncture, the location of the oval fossa must be determined first. In traditional surgery, since there is still potential at the oval fossa, it is difficult to determine its specific location simply from the electrophysiological signal, and puncture is mainly performed by radioanatomical positioning. By displaying the shape and position of the puncture system under the X-ray two-dimensional system, the head end of the guide component is moved on the atrial septum. Since the anatomical structure of the oval fossa is a concave nest, there will be a certain force feedback to the operator during the movement, thereby determining the location of the oval fossa. After determining the location of the oval fossa, it is also necessary to irradiate X-ray development at a certain angle to determine whether the puncture system is perpendicular to the atrial septum surface. If it is vertical, the puncture needle can be inserted for atrial septal puncture. The wrong puncture direction may cause danger.
[0006] In traditional atrial septal puncture, the positioning of the oval fossa and the determination of the puncture direction require good experience of the doctor. Even so, X-rays are still needed many times to display the shape of the heart and determine the position of the guide component and the puncture direction, which causes a lot of radiation to patients and doctors.
[0007] Therefore, there is an urgent need for a technology that can accurately locate the atrial septum puncture components in the heart and the relative positions of its components, so as to reduce the X-ray radiation to patients and doctors during atrial septum puncture. Utility Model Content
[0008] As mentioned above, the problems existing in the prior art include:
[0009] 1. It is difficult to accurately determine the exact location of the oval fossa during puncture.
[0010] 2. It is difficult for existing technologies to accurately locate the specific position of the sheath in the heart, and it is difficult to accurately determine whether the front end of the sheath is perpendicular to the atrial septum. These can easily lead to errors in the puncture site, causing great pain and risks to patients.
[0011] 3. The existing technology cannot accurately determine the exact position relationship between the sheath and the catheter or the atrial septal puncture needle.
[0012] 4. During the existing puncture process, doctors need to use a large amount of X-rays, which brings different degrees of risk of radiation damage to the patient and the doctor.
[0013] The present disclosure designs a medical catheter assembly in view of the above problems. According to the embodiment of the present disclosure, the medical catheter assembly may include an adjustable bend guide sheath assembly and a puncture needle assembly. The adjustable bend guide sheath assembly may include a sheath distal end, an adjustable bend section and a proximal tube body. At least two ring electrodes for collecting cardiac electrophysiological signals are arranged on the distal end of the sheath. The adjustable bend section is connected to the distal end of the sheath. The distal end of the sheath is provided with a sheath distal end positioning sensor near the distal end of the adjustable bend section, and the proximal tube body is provided with a sheath proximal end positioning sensor near the proximal end of the adjustable bend section. Among them, the sheath distal end positioning sensors are two positioning sensors, which are respectively positioned radially below the ring electrodes and embedded in the two sides of the sheath distal end tube body and arranged at 180 degrees. The sheath proximal end positioning sensor and one of the two sheath distal end positioning sensors are located on the same side of the tube body. The puncture needle assembly includes a needle tube assembly and a sensor assembly. The sensor assembly is lined inside the needle tube assembly and can be plugged in and out separately. The sensor assembly cooperates with the needle tube assembly. The top end of the sensor component is located at the top end exit of the puncture needle, and a puncture needle positioning sensor is arranged at the top end of the sensor component.
[0014] Preferably, the medical catheter assembly according to the embodiment of the present disclosure is an atrial septal puncture assembly, and the puncture needle assembly is an atrial septal puncture needle assembly.
[0015] Preferably, one or more ring electrodes are also provided on the adjustable bending section.
[0016] Preferably, the distal end of the sheath is also provided with an exhaust hole, which is arranged 3-5 mm away from the farthest end of the sheath.
[0017] Preferably, the sheath distal end positioning sensor, the sheath proximal end positioning sensor and the puncture needle positioning sensor are all magnetic positioning coils.
[0018] Preferably, a metal braided layer is arranged outside the inner cavity channel of the adjustable bend guide sheath assembly, and an outer layer tube is arranged on the outermost side. A traction ring is arranged on the sheath distal end positioning sensor close to one end of the adjustable bend section and is installed on the metal braided layer. Two traction steel sheets are welded at an angle of 180° on the traction ring to form a traction assembly, and the double bend control of the adjustable bend section is realized by the control of the handle. The two traction steel sheets of the traction assembly and the sheath distal end positioning sensor are installed on the tube body at 90°.
[0019] Preferably, four inner cavity channels are provided through the adjustable bend and the proximal tube body sandwich, located in the axial direction of the sheath tube body, and each two channels form a group, which are 180° apart, and the angle between the two groups is 90°, which are respectively a wire channel group and a traction channel group. The ring electrode wire and the positioning sensor wire of the ring electrode pass through the wire channel group, and the traction steel sheet of the traction assembly passes through the traction channel group.
[0020] Preferably, a first groove and a second groove are respectively arranged at 180° symmetrical positions at the distal end of the sheath, and their arrangement positions are connected to the wire channel. A third groove is arranged at one end of the proximal tube body close to the adjustable bend section, and is on the same wire channel as the first groove. The three grooves are deep enough to pass through the metal braided layer but do not damage the inner cavity channel. The sheath distal end positioning sensor is embedded in the first groove and the second groove at the distal end of the sheath, and the sheath proximal end positioning sensor is embedded in the third groove of the proximal tube body.
[0021] According to the technology disclosed in the present invention, the ring electrode and positioning sensor on the sheath of the medical catheter assembly, the positioning assembly on the puncture needle assembly and other components are combined to make the implementation of punctures including atrial septal puncture more accurate, fast, safe and effective. At the same time, this technology can greatly reduce the amount of radiation during the puncture process and reduce the risk of radiation damage to patients and users. BRIEF DESCRIPTION OF THE DRAWINGS
[0022] The present disclosure will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which like elements are numbered in a similar manner, and in which:
[0023] Figure 1A Schematic diagram of an overall structure of an adjustable bend guide sheath assembly of a medical catheter assembly according to an embodiment of the present disclosure.
[0024] Figure 1B is a schematic diagram of the expander.
[0025] Figure 2A Schematic diagram of an overall structure of a transseptal puncture needle assembly of a medical catheter assembly according to an embodiment of the present disclosure.
[0026] Figure 2B is a schematic diagram of the puncture needle.
[0027] Figure 3A and Figure 3B It is a schematic diagram of the front end of the sheath.
[0028] Figure 4 It is a schematic cross-sectional view of the front end of the sheath tube and its sections along lines AA, BB, and CC according to an embodiment of the present disclosure.
[0029] Figure 5 It is a schematic diagram showing the front end of the sheath tube of the metal braided layer and an enlarged view of the positioning sensor according to an embodiment of the present disclosure.
[0030] Figure 6 is a schematic diagram of the transseptal puncture needle sensor assembly.
[0031] Figure 7 It is an overall schematic diagram of the atrial septal puncture needle assembly and the adjustable curved guide sheath assembly.
[0032] Figure 8 It is a schematic diagram of the steps of preparing for puncture in the method of using the atrial septal puncture assembly.
[0033] Fig. 9 It is a schematic diagram of the puncture steps in the method of using the atrial septal puncture assembly.
[0034] Fig.10 is a schematic diagram of the post-puncture steps in the method of using the atrial septal puncture assembly.
[0035] Description of Reference Numerals
[0036] 101 adjustable bends
[0037] 102 proximal tube
[0038] 103 handle knob
[0039] 104 handle
[0040] 105 hemostatic valve
[0041] 106 Tee
[0042] 107 sheath connector
[0043] 108 ring electrode
[0044] 109 Damage Prevention Section
[0045] 110 Exhaust Hole
[0046] 111 traction components
[0047] 112 Metal Braid
[0048] 113 traction steel sheet
[0049] 114 ring electrode wire
[0050] 115 positioning sensor wire
[0051] 116 wire channels
[0052] 117 Traction Channel
[0053] 118 First Groove
[0054] 119 Second groove
[0055] 120 Third groove
[0056] 121 Distal end of sheath
[0057] 201 expander
[0058] 301 atrial septal puncture needle
[0059] 302 puncture needle locator
[0060] 303 Atrial Septal Puncture Needle Handle
[0061] 304 puncture needle seat switch
[0062] 305 sensor assembly handle
[0063] 306 sensor assembly connector
[0064] 307 sensor assembly
[0065] M1 sheath distal end first magnetic positioning sensor
[0066] M2 sheath distal end second magnetic positioning sensor
[0067] M3 sheath proximal magnetic positioning sensor
[0068] M1 puncture needle positioning sensor DETAILED DESCRIPTION
[0069] Those skilled in the art should understand that although ordinal numbers such as "first" and "second" are used in the present disclosure to describe various regions, units, components or parts, these regions, units, components or parts should not be limited by these ordinal numbers. These ordinal numbers are only used to distinguish one region, unit, component or part from another region, unit, component or part. Therefore, the first region, unit, component or part described below can be interchangeably named as the second region, unit, component or part; similarly, the second region, unit, component or part can also be interchangeably named as the first region, unit, component or part, and such naming does not deviate from the teachings of the present disclosure and does not imply an actual necessary order unless explicitly specified in the text.
[0070] In addition, relative terms such as "upper", "lower", "top", "bottom", "far", "near", "front", "back" and the like are also used in the present disclosure to illustrate the relative relationship between a region, unit, component or part and another region, unit, component or part as shown in the figure. It should be understood by those skilled in the art that such relative terms are intended to include different orientations of regions, units, components or parts other than the orientations described in the figure. For example, if the region, unit, component or part in the figure is turned over, another region, unit, component or part originally described as being on the "upper" side of a certain region, unit, component or part will be located on the "lower" side of the region, unit, component or part. Therefore, based on the specific orientation of the accompanying drawings, the exemplary term "upper" can actually include the orientations of "lower" and "upper". Similarly, if an element in the figure is turned over, another element originally described as being "lower" of a certain element will be located "on" of the other element. Therefore, the exemplary term "lower" can also actually include the orientations of "upper" and "lower". Similarly, the relative relationships of "top" and "bottom", "far" and "near", "front" and "back" can be explained. In short, such relative terms do not imply absolute positional relationships unless clearly specified in the context.
[0071] The present disclosure provides a medical catheter assembly. More specifically, the medical catheter assembly of the present disclosure can be used for transseptal puncture. Therefore, in a preferred embodiment, the medical catheter assembly of the present disclosure is an atrial septal puncture assembly, and the puncture needle assembly described herein is an atrial septal puncture needle assembly.
[0072] Those skilled in the art should understand that, although the technical solution of the present disclosure is described through a preferred embodiment of an atrial septal puncture assembly, the medical catheter assembly claimed for protection in the present disclosure is also applicable to other solutions involving catheter puncture surgery, and similar to atrial septal puncture, can achieve better technical effects.
[0073] The technical solution of the present disclosure is further described in detail below through embodiments and in combination with the accompanying drawings, but the present disclosure is not limited to the following embodiments.
[0074] In the description of the present disclosure, "distal end" and "proximal end" are relative to the catheter operator, for example, the distal end may be the end closer to the human tissue, and the proximal end may be the end closer to the catheter operator. In addition, "front end" generally refers to the end in the "distal end" direction, and "rear end" generally refers to the end in the "proximal end" direction.
[0075] Figure 1A Schematic diagram of an overall structure of an adjustable bend guide sheath assembly of a medical catheter assembly according to an embodiment of the present disclosure. Figure 1B is a schematic diagram of the expander. Figure 2ASchematic diagram of an overall structure of a transseptal puncture needle assembly of a medical catheter assembly according to an embodiment of the present disclosure. Figure 2B is a schematic diagram of the puncture needle.
[0076] like Figure 1A , 1B As shown in Figures 2A and 2B, the atrial septal puncture assembly as a preferred embodiment of the medical catheter assembly disclosed herein mainly includes an adjustable curved guide sheath assembly and an atrial septal puncture needle assembly.
[0077] Simply put, if Figure 1A , 3A As shown in FIG. 3B , the adjustable bend guide sheath assembly includes at least a sheath distal end 121 , an adjustable bend section 101 and a proximal tube body 102 at the front end portion of the sheath.
[0078] In addition, if Figure 1A , 1B As shown in , 3A, 3B, 4, and 6, the adjustable bend guide sheath assembly may also include parts or components such as an anti-damage section 109 and a control handle 104. The handle knob 103 on the control handle 104 can be adjusted to control the adjustable bend section 101. Specifically, the handle knob 103 can be rotated clockwise and counterclockwise to control the adjustable bend section 101 to bend to more than 135° in two directions, which is the so-called double bend control. The structural implementation of double bend control will be described in more detail below. The inner cavity of the adjustable bend guide sheath is designed to be 8.5F, and the inner cavity channel is made of a polymer material with good self-lubricating properties. A metal braided layer 112 is provided on the outer side of the inner cavity channel of the adjustable bend guide sheath assembly, and an outer tube is provided on the outermost side. The outer tube is made of a polymer material containing a developer and has a certain strength. A tee 106 is provided at the tail of the adjustable bend guide sheath control handle for injection of drugs and other liquids. The hemostatic valve 105 is arranged at the tail of the handle and is coaxial with the sheath tube body, and is used for the passage of the catheter, the atrial septal puncture needle assembly, and the dilator 201. The tail of the adjustable curved guide sheath is provided with a sheath connector 107, which is used to connect the sensor signal and the electrophysiological signal collected by the ring electrode to the device.
[0079] like Figure 1A , 1BAs shown in Figures 3A, 3B, 4 and 5, two or more ring electrodes 108 are arranged on the distal end 121 of the sheath of the adjustable bend guide sheath assembly for measuring intracardiac electrophysiological signals. The adjustable bend section 101 is connected to the distal end 121 of the sheath. The distal end 121 of the sheath is provided with sheath distal end positioning sensors M1 and M2 near the distal end of the adjustable bend section 101. The proximal tube body 102 is provided with a sheath proximal end positioning sensor M3 near the proximal end of the adjustable bend section 101. The sheath distal end positioning sensors M1 and M2 are two positioning sensors, which are respectively positioned radially below the ring electrodes 108 (i.e., radially inside), and are embedded in the two sides of the sheath distal end 121 and arranged at 180°. The sheath proximal end positioning sensor M3 is located on the same side of the tube body as one of the two sheath distal end positioning sensors M1 and M2. According to Figure 3B , 5 As shown, the sheath tube proximal end positioning sensor M3 and the sheath tube distal end positioning sensor M1 are located on the same side of the tube body.
[0080] One or more other ring electrodes 108 may be provided on the adjustable curved section 101 for collecting electrophysiological signals and assisting in positioning. The distal end 121 of the sheath is provided with an exhaust hole 110 at the top to reduce air bubbles during the suction operation. More specifically, the exhaust hole 110 may be provided 3-5 mm from the distal end of the sheath.
[0081] The traction ring is arranged on the end of the sheath tube distal positioning sensors M1 and M2 close to the adjustable bending section 101 and is installed on the metal braided layer 112. There are two traction steel sheets 113 on the traction ring, which are welded at an angle of 180° to form a traction assembly 111, and the double bending control of the adjustable bending section 101 is achieved by the control of the handle. The two traction steel sheets 113 of the traction assembly 111 and the sheath tube distal positioning sensors M1 and M2 are installed on the tube body at 90°.
[0082] More specifically, four inner cavity channels are provided in the interlayer between the adjustable curved section 101 and the proximal tube body 102, and are located in the axial direction of the sheath tube body. Each two channels form a group, and are 180° apart. The angle between the two groups is 90°, and they are a group of wire channels 116 and a group of traction channels 117. The ring electrode wire 114 and the positioning sensor wire 115 of the ring electrode 108 pass through the wire channels 116 of the same group, and the traction steel sheet 113 of the traction assembly 111 passes through the traction channels 117 of another group.
[0083] like Figure 3A , 3BAs shown in Figures 4 and 5, the top of the anti-damage section 109 is provided with an exhaust hole 110 and two ring electrodes 108 in sequence. The sheath positioning sensors M1 and M2 are located below the two ring electrodes 108 (symmetrically embedded on both sides of the tube body). The traction ring and other ring electrodes 108 are located in the adjustable bend section 101. The magnetic positioning sensor M3 is arranged on the proximal tube body 102, specifically near the junction with the adjustable bend section 101. The exhaust hole 110 is arranged at a distance of 3 to 5 mm from the top. The first groove 118 and the second groove 119 are respectively arranged at the 180° symmetrical position of the distal end 121 of the sheath tube, and their arrangement positions are connected to the wire channel 116. The third groove 120 is arranged at one end of the proximal tube body 102 close to the adjustable bend section 101, and is on the same wire channel 116 as the first groove 118. The three grooves 118, 119, and 120 are deep enough to pass through the metal braided layer 112 but do not damage the inner cavity channel. The sheath distal end positioning sensors M1 and M2 are respectively embedded in the first groove 118 and the second groove 119 of the sheath distal end 121 . The sheath proximal end positioning sensor M3 is embedded in the third groove 120 of the proximal tube body 102 .
[0084] According to a preferred embodiment of the present disclosure, the sheath distal end positioning sensors M1 and M2 and the sheath proximal end positioning sensor M3 are magnetic positioning coils. The magnetic positioning coils can induce different magnetic fluxes at different positions of the magnetic field, thereby indirectly obtaining their spatial coordinate positions.
[0085] The proximal tube body 102 and the tube body of the adjustable bend section 101 are both provided with a metal braided layer 112 for enhancing the rigidity and torque of the tube body. The metal braided layer 112 is integrally provided on the inner cavity channel of the sheath tube.
[0086] like Figure 1A , 1B As shown in Figures 3A, 3B, 4, and 5, the positioning sensors M1 and M3 are respectively located at the distal straight section and the front end of the proximal tube body 102, and the bending shape of the adjustable bending section 101 can be displayed in real time during the bending. In the natural straight state, the positions of the two sheath positioning sensors are respectively recorded as P1 (X1, Y1, Z1) and P3 (X3, Y3, Z3). The spatial distance between the two is P1-P3. The actual length of the adjustable bending section 101 between the two sheath positioning sensors is certain. When the bending is adjusted, the spatial distance between the two sheath positioning sensors changes. Therefore, the shape of the bending section can be indirectly calculated by integral conversion. Positioning sensors M1 and M2 are respectively embedded on both sides of the tube body and arranged at 180°. The spatial distance between the two positions P1 (X1, Y1, Z1) and P2 (X2, Y2, Z2) is P1-P2, which is the distance of the sheath lumen. In actual use, the position of the straight section of the front end of the tube body and the position of the lumen of the tube body can be determined, and the puncture needle positioning sensor m1 (such as Figure 2A , 6 , 7) in the tube body, thereby indirectly determining the position of the needle tip of the atrial septal puncture needle.
[0087] like Figure 1A , 1B As shown in Figures 4, 5, and 7, the ring electrode 108 at the top of the adjustable curved guide sheath can detect cardiac electrophysiological signals in real time, which is used to determine the position of the top of the adjustable curved guide sheath in the heart chamber. The basic principle is that there are differences in electrophysiological signals between the right atrium and the left atrium of the heart. When the adjustable curved guide sheath contacts the oval fossa before atrial septal puncture, the electrophysiological signal detected by the ring electrode 108 is a right atrium signal; when it passes from the oval fossa to the left atrium, the electrophysiological signal detected is a left atrium signal. By comparing the difference between the two electrophysiological signals, it can be determined whether the tip of the adjustable curved guide sheath passes from the right atrium through the oval fossa and enters the left atrium.
[0088] like Figure 2A , 2B As shown in Figure 6, the atrial septal puncture needle assembly comprises at least a needle tube assembly 301 and a sensor assembly 307. The sensor assembly 307 is lined inside the needle tube assembly 301 and can be plugged in and out separately. The sensor assembly 307 cooperates with the needle tube assembly 301, and the top of the sensor assembly 307 is located at the top exit of the puncture needle. The top of the sensor assembly 307 is provided with a puncture needle positioning sensor m1, and the tail is provided with a sensor assembly connector 306.
[0089] According to a preferred embodiment of the present disclosure, the puncture needle positioning sensor m1 is a magnetic positioning coil. As described above, the magnetic positioning coil can induce different magnetic fluxes at different positions in the magnetic field, thereby indirectly obtaining its spatial coordinate position. The sensor signal generated thereby is transmitted to the device through the sensor assembly connector 306, thereby indirectly obtaining the spatial coordinate position of the puncture needle assembly. By comparing with the collected position information of the adjustable curved guide sheath, the relative positions of the components of the atrial septum puncture assembly are obtained. The atrial septum puncture needle is marked with a scale near the handle, which can be used to determine the position of the needle tip and the top of the sheath when matched with the adjustable curved guide sheath. After the puncture needle assembly passes through the atrial septum, the sensor assembly can be withdrawn, and whether the puncture needle is located in the left atrium can be verified by observing the type of blood returning from the puncture needle.
[0090] like Figure 8 , 9As shown in Figure 10, the distal straight sections at both ends of the adjustable curved section 101 of the adjustable curved guide sheath and the front end of the proximal tube body 102 are embedded with positioning sensors, and more than two ring electrodes 108 are respectively arranged on the top of the adjustable curved guide sheath and the body of the adjustable curved section 101. When modeling the heart, the two positioning sensors can mark the absolute position of the adjustable curved section 101 of the sheath, and the ring electrodes 108 collect the electric field information in the heart, and the relative positions of each component can be calculated. The accurate position of the adjustable curved guide sheath in the heart cavity can be calculated through the magnetic field and electric field position information, and a physical model of the heart can be established to find the oval fossa. When the head end of the atrial septal puncture assembly enters the right atrium, the matching dilator 201 is located in the adjustable curved guide sheath, the atrial septal puncture needle assembly is located in the dilator 201, and the needle tip is located inside the dilator 201 and is not exposed. The sensor assembly in the atrial septal puncture needle assembly is located at the top of the dilator 201, and transmits the position information of the needle tip in the atrial septal puncture assembly and the heart model in real time. Operate the adjustable curved guide sheath, and when the top of the tube is perpendicular to the plane of the oval fossa, push the atrial septal puncture needle assembly to puncture the oval fossa to reach the left atrium, and withdraw the puncture needle sensor assembly. If the blood returning through the needle tube is venous blood, it proves that the puncture position is correct. Fix the atrial septal puncture needle assembly to ensure that the needle tip does not continue to penetrate into the left atrium, and push the adjustable curved guide sheath forward. When the electrophysiological signal collected by the sheath ring electrode 108 changes from the right atrial signal to the left atrial signal, stop pushing the adjustable curved guide sheath, and the accurate position of the sheath head end can also be displayed in the physical model of the heart. At this time, the atrial septal puncture has been completed, the atrial septal puncture needle assembly and dilator 201 are withdrawn, and the atrial septal channel is constructed.
[0091] The use process of the atrial septal puncture assembly described in the present disclosure in atrial septal puncture is as follows:
[0092] Step 1: Vascular puncture: Place the adjustable curved guide sheath into the right atrium.
[0093] Step 2: Use the sheath positioning sensor and the ring electrode 108 on the adjustable curved guide sheath to manipulate the sheath to construct a right atrium physical model.
[0094] Step 3: Determine the location range of the oval fossa based on the established physical model.
[0095] Step 4: insert the atrial septal puncture needle assembly and dilator 201.
[0096] Step 5: Use the positioning sensors on the adjustable curved guide sheath and puncture needle assembly to determine the relative positions of the components. The puncture needle tip cannot extend out of the sheath. At the same time, the scale on the position of the puncture needle handle can assist in determining the relative positions of the puncture needle and sheath.
[0097] Step 6: Adjust and manipulate the adjustable curved guide sheath so that the needle tip of the atrial septal puncture needle is perpendicular to the plane of the oval fossa.
[0098] Step 7: Atrial septal puncture, push the atrial septal puncture needle until the needle tip passes through the oval fossa. Withdraw the atrial septal puncture needle positioning sensor assembly and observe the blood return from the needle tube assembly. If the blood return is bright red arterial blood, it proves that the puncture is successful.
[0099] Step 8: Fix the atrial septal puncture needle assembly to ensure that the needle tip does not continue to penetrate the left atrium. Push the adjustable curved guide sheath along the puncture direction of the puncture needle perpendicular to the position of the oval fossa, and the top of the sheath passes through the oval fossa. Observe the electrophysiological signal collected by the sheath ring electrode 108. If the electrophysiological signal changes from the right atrial signal to the left atrial signal, it can be proved that the sheath tip has passed through the oval fossa. Remove the atrial septal puncture needle assembly and dilator 201, the atrial septal channel is constructed, and the electrophysiological catheter is inserted to continue the operation.
[0100] In the technical solution disclosed in the present invention, positioning sensors are arranged at both ends of the adjustable bend of the sheath to determine the precise shape of the sheath and its relative position to the catheter. Two or more ring electrodes are added to the top of the sheath to collect cardiac electrophysiological signals. The changes in electrophysiological signals before and after the top of the sheath passes through the oval fossa are compared. After the sheath enters the heart cavity, the heart cavity modeling can be completed without the need for a magnetic positioning catheter. A positioning sensor is added to the atrial septal puncture needle to determine the position of the puncture needle tip and its relative position to other components.
[0101] The combination of the ring electrode and positioning sensor on the sheath of the atrial septal puncture assembly, the positioning assembly on the atrial septal puncture needle assembly and other components makes atrial septal puncture more accurate, fast, safe and effective. At the same time, this technology can greatly reduce the amount of radiation during the puncture process and reduce the risk of radiation damage to patients and users.
[0102] In addition, in the technical solution disclosed in the present invention, two magnetic positioning sensors are arranged at the distal end of the sheath and embedded in the sheath on both sides of the distal tube body at 180 degrees, and one magnetic positioning sensor is arranged on the proximal end, and a puncture needle positioning sensor is arranged at the top of the sensor assembly, so that the heart cavity modeling can be completed more easily, and the position of the puncture needle tip and its relative position with other components can be determined.
[0103] The implementation methods of the present disclosure are not limited to the above-mentioned embodiments. Without departing from the spirit and scope of the present disclosure, ordinary technicians in this field can make various changes and improvements to the present disclosure in form and details, and these are considered to fall within the protection scope of the present disclosure.
Claims
1. A medical catheter assembly, characterized in that: It includes an adjustable curved guide sheath assembly and a puncture needle assembly. The adjustable curved guide sheath assembly comprises a sheath distal end (121), an adjustable curved section (101) and a proximal tube body (102); At least two ring electrodes (108) for collecting cardiac electrophysiological signals are arranged on the distal end (121) of the sheath tube; The adjustable bend (101) is connected to the sheath tube distal end (121), and the sheath tube distal end positioning sensors (M1, M2) are arranged at the sheath tube distal end (121) near the distal end of the adjustable bend (101), and the proximal tube body (102) is provided with a sheath tube proximal end positioning sensor (M3) near the proximal end of the adjustable bend (101); wherein the sheath tube distal end positioning sensors (M1, M2) are two positioning sensors, which are respectively positioned radially below the ring electrode (108), embedded in the sheath tube distal end (121) on both sides of the tube body and arranged at 180 degrees, and the sheath tube proximal end positioning sensor (M3) and one of the two sheath tube distal end positioning sensors (M1, M2) are located on the same side of the tube body; The puncture needle assembly includes a needle tube assembly (301) and a sensor assembly (307). The sensor assembly (307) is lined inside the needle tube assembly (301) and can be plugged in and out separately. The sensor assembly (307) cooperates with the needle tube assembly (301). The top of the sensor assembly (307) is located at the top outlet of the puncture needle. A puncture needle positioning sensor (m1) is provided at the top of the sensor assembly (307).
2. The medical catheter assembly according to claim 1, characterized in that: The medical catheter assembly is a transseptal puncture assembly, and the puncture needle assembly is a transseptal puncture needle assembly.
3. The medical catheter assembly according to claim 1, characterized in that: One or more ring electrodes (108) are arranged on the adjustable bending section (101).
4. The medical catheter assembly according to claim 1, characterized in that: The distal end (121) of the sheath tube is provided with an exhaust hole (110), and the exhaust hole (110) is arranged 3-5 mm away from the distal end of the sheath tube.
5. The medical catheter assembly according to claim 1, characterized in that: The sheath distal end positioning sensor (M1, M2), the sheath proximal end positioning sensor (M3) and the puncture needle positioning sensor (m1) are all magnetic positioning coils.
6. The medical catheter assembly according to claim 1, characterized in that: A metal braided layer (112) is arranged on the outside of the inner cavity channel of the adjustable bend guide sheath tube assembly, and an outer tube is arranged on the outermost side; a traction ring is arranged at one end of the sheath tube distal end positioning sensor (M1, M2) close to the adjustable bend section (101) and installed on the metal braided layer (112); two traction steel sheets (113) are welded at an angle of 180 degrees on the traction ring to form a traction assembly (111); double bend control of the adjustable bend section (101) is achieved by control of a handle; the two traction steel sheets (113) of the traction assembly (111) and the sheath tube distal end positioning sensor (M1, M2) are installed on the tube body at 90 degrees.
7. The medical catheter assembly according to claim 6, characterized in that: Four inner cavity channels are provided in the interlayer between the adjustable bend (101) and the proximal tube body (102), and are located in the axial direction of the sheath tube body. Each group of two channels is 180 degrees apart, and the angle between the two groups is 90 degrees. They are a wire channel (116) group and a traction channel (117) group. The ring electrode wire (114) and the positioning sensor wire (115) of the ring electrode (108) pass through the wire channel (116) group, and the traction steel sheet (113) of the traction assembly (111) passes through the traction channel (117) group.
8. The medical catheter assembly according to claim 7, characterized in that: A first groove (118) and a second groove (119) are respectively arranged at 180° symmetrical positions of the distal end (121) of the sheath tube, and their arrangement positions are connected to the wire channel (116); a third groove (120) is arranged at one end of the proximal tube body (102) close to the adjustable bend section, and is on the same wire channel (116) as the first groove (118); the three grooves (118, 119, 120) are deep enough to pass through the metal braided layer (112) but do not damage the inner cavity channel, the sheath tube distal end positioning sensor (M1, M2) is embedded in the first groove (118) and the second groove (119) of the distal end (121) of the sheath tube, and the sheath tube proximal end positioning sensor (M3) is embedded in the third groove (120) of the proximal tube body (102).