Background
There are two main types of existing contact-type extremely-high-density mapping catheters: one is a company's octopus duct and the other is a company's focusing duct. The two catheters can be matched with a three-dimensional mapping system to complete three-dimensional modeling of the endocardium structure and high-density mapping of an excitation point.
The mapping accuracy is not high due to limitations of electrode shape and structure. The mapping results obtained do not allow accurate localization of ectopic activation foci and direct guidance of radiofrequency ablation.
Disclosure of Invention
The embodiment of the invention provides a mapping catheter, which improves the structure of the catheter, is matched with a guide sheath to store a mapping electrode, is convenient to freely move in a target heart cavity, and improves the mapping effect of the catheter.
The embodiment of the invention provides a mapping catheter, which comprises a mapping electrode, a catheter and an operation part, wherein the mapping electrode is arranged on the catheter;
the mapping electrode is connected to the head end of the catheter, the mapping electrode is powered through a bundling wire connected with the mapping electrode, the operating part is connected to the tail end of the catheter and used for operating and bending the head end of the catheter, and at least one depth mark is arranged on the catheter;
the outer surface of the catheter tube body of the catheter is slidably sleeved with a guide sheath, and the mapping electrode can be contained in the guide sheath which is slid to the head end.
Optionally, the mapping electrode comprises a plurality of pairs of electrode arrays, and the electrode arrays are woven by guide wires.
Optionally, the electrode array is distributed according to a preset rule according to an array face center, and the guide wires are converged to the array face center and then connected to the bundling wires.
Optionally, the mapping electrodes are distributed in a hollow spherical surface in a natural state.
Optionally, the mapping catheter further includes a long sheath tube slidably disposed on the outer surface of the catheter on the side of the head end, and the guiding sheath may partially or completely extend into the lumen of the long sheath tube.
Optionally, the long sheath tube and the end opposite to the head end are provided with a first perfusion tube, and the first perfusion tube is communicated with the inner cavity of the long sheath tube.
Optionally, the operation portion comprises an operation handle and an operation sliding handle, the operation sliding handle is sleeved at the tail end of the catheter, the operation handle is sleeved on the operation sliding handle, and the operation handle can slide along the outer surface of the operation sliding handle.
Optionally, the operation portion further comprises a pulling steel wire, one end of the pulling steel wire is attached to the inner wall of the catheter on one side of the head end, and the other end of the pulling steel wire is connected to the operation sliding handle after being folded back in an inner cavity formed by the operation handle and the operation sliding handle.
Optionally, the operation portion is further provided with a second perfusion tube, and the second perfusion tube is communicated with the catheter inner cavity of the catheter through the inner cavity of the operation portion.
Optionally, the bundled conducting wire runs in the catheter inner cavity of the catheter, the bundled conducting wire is led out from the inner cavity of the operating part, and a conducting wire interface is arranged at the leading-out end of the bundled conducting wire.
The mapping electrode can be accommodated through the guide sheath, so that the mapping electrode can freely move in a target heart cavity, three-dimensional modeling and fixed-point mapping can be rapidly completed, and the mapping effect of the catheter is improved. In some embodiments, the electrode array can be woven by the guide wire, so that the density of the mapping electrode is greatly improved, the modeling density and effect of the catheter are improved, the endocardial special-shaped structure can be found more conveniently, and accurate positioning and direct lesion ablation can be realized.
The foregoing description is only an overview of the technical solutions of the present invention, and the embodiments of the present invention are described below in order to make the technical means of the present invention more clearly understood and to make the above and other objects, features, and advantages of the present invention more clearly understandable.
Detailed Description
Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.
A first embodiment of the present invention provides a mapping catheter, as shown in fig. 1, including a mapping electrode 1, a catheter, and an operation portion;
the mapping electrode 1 is connected to the head end of the catheter, the mapping electrode 1 is powered by a bundling wire 2 connected with the mapping electrode 1, the operating part is connected to the tail end of the catheter, the operating part is used for operating and bending the head end of the catheter, and at least one depth mark is arranged on the catheter;
the catheter tube 4 of the catheter is slidably sleeved with an introducer sheath 8, as shown in fig. 2, and the mapping electrode 1 can be received in the introducer sheath 8 slid to the tip.
The catheter in this embodiment can be made of polyurethane material, with a catheter lumen 3 in the center and braided guidewire reinforcement in the wall. In the present embodiment, the end of the catheter connected to the mapping electrode 1 is used as the tip of the catheter, and the end of the catheter connected to the operation portion is used as the tail of the catheter, wherein the tip of the catheter can be bent by a certain angle range, for example, 0-180 ° under the operation of the operation portion. Wherein the mapping electrode 1 comprises a plurality of pairs of electrode arrays, and the electrode arrays are woven by guide wires. At least one depth indicator, such as the depth indicators a, b, c, d on the catheter in fig. 1 and 2, may also be provided in this embodiment.
The mapping electrode can be accommodated through the guide sheath, so that the mapping electrode can freely move in a target heart cavity, and three-dimensional modeling and fixed-point mapping can be rapidly completed. In the embodiment, the electrode array can be woven by the guide wire, so that the density of the mapping electrode is greatly improved, the modeling density and effect of the catheter are improved, the discovery of the special-shaped structure of the endocardium is facilitated, and the accurate positioning and the direct guidance of lesion ablation are realized.
Optionally, the electrode array is distributed according to a preset rule according to an array face center, and the guide wires are converged to the array face center and then connected to the bundling wires 2.
The radial linear electrode ring in the prior art has the potential risk of winding with endocardial structures, and the electrode ring is easy to hook, wind and damage the endocardial structures when rotating in a reverse clock direction. In this embodiment, in order to complete three-dimensional modeling of an endocardial structure and high-density mapping of an activation point, the arranged electrode arrays may be distributed according to a preset rule according to the array surface center, and meanwhile, the mapping electrode 1 is in a hollow flat state in a natural state, and the mapping electrode 1 is woven by a flexible self-expanding material, as shown in fig. 2, and may be put into the guide sheath 8 to be in a linear state, and be in a self-expanding state after leaving the guide sheath 8. Of course, the specific array arrangement may be various, such as an ellipsoid, a sphere or other surface. The mapping catheter adopts the flexibly-woven mapping electrode with the self-expansion function, and the balloon electrode can be freely recovered and released by matching with the sheath tube.
Optionally, the mapping electrodes 1 are distributed in a hollow spherical surface in a natural state.
In the prior art, the total number of the electrodes is less, so that the efficiency of completing three-dimensional modeling and performing extremely-high-density mapping is not high. Due to the fact that mapping fineness is not enough, a special-shaped structure with diagnosis and treatment significance on the target endocardium is difficult to find. The basic principle of contact-based very high density mapping is: under the precondition of satisfying the in vitro minimally invasive intervention control and bearable target cardiac cavity volume, the bipolar detection electrode pairs are distributed in the unit space as much as possible so as to achieve the purposes of efficiently completing three-dimensional modeling and fixed-point ultrahigh-density mapping in unit time and unit space range. As shown in fig. 1, in an alternative embodiment of the present invention, the mapping electrodes 1 are distributed in a hollow spherical shape in a natural state, that is, the mapping electrodes 1 are in a hollow flat spherical shape in a natural state. An alternative weaving mode can be specifically that more than 30 pairs of miniature detection electrode arrays are selected, the miniature detection electrode arrays are respectively and symmetrically arranged on the inner side surface and the outer side surface of the balloon according to the condition that the maximum gap between the woven guide wires is not more than 5mm, the inner side electrode array and the outer side electrode array are arranged in a circumferential mode from the center to the periphery, the electrode arrays are in pairwise correspondence, the inner side is a negative electrode, and the outer side is a positive electrode. The electrode wires may run along with the braided guide wire and join in the inner cavity of the catheter to form a bundled wire 2, as shown in fig. 3, that is, in this embodiment, the bundled wire 2 is formed by the braided guide wire after converging to the spherical surface center of the mapping electrode 1. By greatly improving the electrode array number of pairs on the mapping electrode 1, high-fineness contact mapping can be realized, discovery of special-shaped structures of endocardium is facilitated, accurate positioning is realized, and lesion ablation is directly guided.
As shown in fig. 4, the miniature detection electrode in this embodiment may include an electrode main body 103, the electrode main body 103 includes an electrode cavity 106, a positive electrode 104 and a negative electrode 105 are embedded on the electrode main body 103, a positive lead 102 and a negative lead 101 are respectively connected with the positive electrode 104 and the negative electrode 105, and the positive lead 102 and the negative lead 101 are extended out of the electrode cavity 106.
Optionally, the bundled conducting wire 2 runs in the catheter lumen 3 of the catheter, the bundled conducting wire 2 is led out from the lumen of the operating part, and a conducting wire interface 15 is arranged at the leading end of the bundled conducting wire 2.
As shown in fig. 1, 2 and 3, in an alternative embodiment of the present invention, the electrode wires are merged into the catheter lumen 3 along with the traveling of the braided guide wire to form a bundled wire 2, the bundled wire 2 travels in the catheter lumen 3 of the catheter, then the bundled wire 2 passes through the catheter lumen 3 and is led out from the lumen of the operating part, the extension wire 13 of the led bundled wire 2 can be connected to a wire interface 15, which is convenient for accessing a power supply connector in the later use process, and of course, the wire interface 15 can also be matched with an extension wire connector 16, an extension wire handle 17 and an extension wire 18 to realize the extension of the power supply of the bundled wire 2.
Optionally, the operation portion includes an operation handle 10 and an operation sliding handle 9, the operation sliding handle 9 is sleeved on the tail end of the catheter, the operation handle 10 is sleeved on the operation sliding handle 9, and the operation handle 10 can slide along the outer surface of the operation sliding handle 9.
As shown in fig. 1 and 2, the operation portion includes an operation handle 10 and an operation sliding handle 9, the operation sliding handle 9 is sleeved on the tail end of the catheter, the operation handle 10 is sleeved on the operation sliding handle 9, the operation handle 10 can slide along the outer surface of the operation sliding handle 9, and the operation sliding handle 9 can be fixed with the tail end of the catheter. A handle cavity 11 is formed between the operating handle 10 and the operating slider 9 after the operating handle 10 can slide along the outer surface of the operating slider 9 to a certain distance.
Optionally, the medical catheter further comprises a pulling steel wire 5, one end of the pulling steel wire 5 is attached to the inner wall of the catheter on one side of the head end, and the other end of the pulling steel wire 5 is folded back in an inner cavity formed by the operating handle 10 and the operating sliding handle 9 and then connected to the operating sliding handle 9.
In another embodiment of the present invention, as shown in fig. 1 and 2, the operation part operates the tip end of the catheter by pulling the wire 5, so that the tip end of the catheter bends downward by a certain angle, for example, 0-180 °. Wherein the head end of the traction steel wire 5 is attached to the inner wall of the catheter at one side of the head end of the catheter, and the distance between the attachment point and the head end of the catheter is not less than 2 cm. The tail end of the traction guide wire 5 slides and turns back at the bottom of the handle cavity 11, and then is attached to the tail part of the sliding handle of the operation sliding handle 9, and a traction steel wire sliding point 12 is formed at the sliding and turning position of the bottom of the inner cavity of the operation handle.
In this embodiment, the introducer sheath 8 can be pre-assembled near the operating slider 9, and the introducer sheath 8 can slide back and forth with an inner diameter greater than the catheter outer diameter by 0.5F. In order to completely store the mapping electrode 1, the length of the guide sheath 8 is 5mm greater than the recovery length of the mapping electrode 1, so that the mapping electrode 1 can be recovered in vitro, and preparation is made for the forward balloon to enter the tail of the sheath tube.
In this embodiment, the operation portion can be used to realize in-vitro control, and the mapping electrode 1 can freely move in the target cardiac chamber, thereby rapidly completing three-dimensional modeling and fixed-point mapping.
Optionally, the operation portion is further provided with a second perfusion tube 14, and the second perfusion tube 14 is communicated with the catheter lumen 3 of the catheter through the lumen of the operation portion.
Second infusion tube 14 in this embodiment is used to deliver heparin saline to flush the catheter lumen.
In conclusion, the invention adopts the flexible self-expanding woven mapping electrode array to realize the extremely high-density mapping. The extremely-high-density mapping function of the woven mapping electrode array can simultaneously realize three-dimensional modeling, accurate mapping, abnormal structure detection and direct radio frequency ablation. The flexible self-expanding mapping electrode can be freely recovered and released, and can be repeatedly used in the same operation. The depth mark of the catheter body can directly guide an operator to send the braided balloon to a set position.
Example two
In addition to the first embodiment, the present embodiment further provides a mapping catheter, in which the mapping catheter further includes an elongated sheath 19, the elongated sheath 19 is slidably disposed on an outer surface of the catheter on the side of the head end, and the guiding sheath 8 can partially or completely extend into the lumen of the elongated sheath 19.
Specifically, as shown in fig. 5 and 6, in the present embodiment, a structure of the long sheath 19 used in combination with the measuring catheter in the first embodiment is proposed, wherein the long sheath 19 is slidably sleeved on the outer surface of the catheter on the side of the head end, the guiding sheath 8 can partially or completely extend into the inner cavity of the long sheath 19, an optional implementation manner is that the inner diameter of the guiding sheath 8 is larger than the outer diameter of the catheter tube 4, the inner diameter of the long sheath 19 is larger than the outer diameter of the guiding sheath 8, and the specific size matching can be set according to actual needs, so that the guiding sheath 8 can partially or completely extend into the inner cavity of the long sheath 19. During use, the long sheath 19 is first introduced into the center of a predetermined cardiac chamber, blood is withdrawn, and the introducer sheath 8 carrying the mapping electrode 1 is advanced through the long sheath 19, so that the head of the introducer sheath 8 enters a predetermined position at the tail of the long sheath 19.
In an alternative embodiment, as shown in fig. 5, a first perfusion tube 7 is further disposed on the end of the long sheath 19 opposite to the head end of the catheter, and the first perfusion tube 7 is communicated with the inner cavity of the long sheath 19.
In this embodiment, the first perfusion tube 7 is disposed at the position of the long sheath tail 6, and the similar first perfusion tube 7 and the second perfusion tube 14 can also be used for delivering the running heparin saline to flush the inner cavity of the long sheath 19.
In conclusion, the invention adopts the flexible self-expanding woven mapping electrode array to realize the extremely high-density mapping. The extremely-high-density mapping function of the woven mapping electrode array can simultaneously realize three-dimensional modeling, accurate mapping, abnormal structure detection and direct radio frequency ablation. The flexible self-expanding mapping electrode can be freely recovered and released, and can be repeatedly used in the same operation. The depth mark of the catheter body part can directly guide an operator to send the braided balloon to a set position by matching with the long sheath.
EXAMPLE III
A third embodiment of the present invention provides an implementation of the mapping catheter of the second embodiment, and in this embodiment, the mapping electrode 1 is exemplified as a self-expanding flexible braided balloon electrode, and the specific process is as follows.
The long sheath tube 19 is sent to the center of the target heart cavity, blood is pumped back, the first perfusion tube 7 is connected with a saline flushing tube, and air is fully exhausted.
The tail wire of the braided balloon catheter is connected by the lead interface 15, and the second perfusion tube 14 is connected with the joint of the saline flushing tube for fully exhausting.
The introducer sheath 8 is advanced until its head contacts the inside surface of the braided balloon.
The head ends of the braided balloon and the guide sheath 8 are soaked in heparin saline to remove air bubbles.
The operator holds the head of the guide sheath 8 with his left hand, retracts the catheter with his right hand, and withdraws the woven balloon into the guide sheath 8, where the woven balloon is in a linear state and the end position of the balloon electrode tip is adjusted to be flush with the head end of the guide sheath.
The operator holds the tail of the long sheath tube 19 with the left hand, that is, the end of the long sheath tube 19 far away from the braided balloon is the tail, and forwards sends the guide sheath 8 loaded with the braided balloon with the right hand, so that the head end of the guide sheath 8 enters the tail of the long sheath tube 19 for a set distance, for example, 5 mm.
The tail part of the long sheath tube 19 and the guide sheath 8 are fixed at the same time, and the b mark of the catheter body part which is sent to the catheter body part separately is close to the tail part of the guide sheath 8. At this time, the braided balloon in a linear state completely enters the tail of the long sheath 8.
The introducer sheath 8 is withdrawn to the vicinity of the operating slider 9.
The tail of the long sheath 19 is fixed and the catheter is advanced until the c-mark of the catheter body approaches the tail of the long sheath 19. At this time, the tip of the braided balloon is flush with the tip of the long sheath tube 19.
The catheter is advanced until the d-tag of the catheter body approaches the tail of the long sheath 19. At this time, the braided balloon fully extends out of the long sheath tube 19 and restores the hollow sphere surface state.
Under the guidance of a three-dimensional mapping system, the ultrahigh-density modeling, the excitation point mapping and positioning and the radio frequency ablation guidance of a target heart cavity are completed.
The catheter is released from bending, the tail part of the long sheath 19 is fixed, and the catheter is withdrawn until the d mark of the catheter body part is exposed out of the tail part of the long sheath 19. At this time, the braided balloon is just outside the tip of the long sheath tube 19.
The tail of the long sheath 19 is fixed, and the catheter is continuously withdrawn until the c mark of the catheter body is exposed out of the tail of the long sheath 19. At this point, the braided balloon is straightened and fully retracted into the tip of the long sheath 19.
The tail part of the long sheath 19 is fixed, and the catheter is continuously withdrawn until the b mark of the catheter body part is exposed out of the tail part of the long sheath 19. At this point, the straightened tail of the braided balloon is just at the tail end of the long sheath 19.
The tail part of the long sheath tube 19 is fixed and the guide sheath 8 is sent forwards until the head end of the guide sheath 8 enters the tail part of the long sheath tube 19 by 5 mm.
And simultaneously fixing the tail part of the long sheath tube 19 and the guide sheath 8, and independently withdrawing the catheter until the mark a of the catheter body part is exposed out of the tail part of the guide sheath 8. At this time, the braided balloon in a linear state is completely recovered into the guide sheath 8.
The guide sheath 8 loaded with the braided balloon is removed, the side tube of the long sheath tube 19 is withdrawn, and the heparin saline is flushed.
The guide sheath 8 is withdrawn in heparin saline to release the braided balloon and to purge the remaining blood.
While the present invention has been described with reference to the embodiments shown in the drawings, the present invention is not limited to the embodiments, which are illustrative and not restrictive, and it will be apparent to those skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope of the invention as defined in the appended claims.