CN215741268U

CN215741268U - Multifunctional catheter system with channel cavity

Info

Publication number: CN215741268U
Application number: CN202121109854.5U
Authority: CN
Inventors: 于波; 康维; 候静波; 贾海波; 赵晨; 徐晨阳
Original assignee: Panorama Scientific Co ltd; Harbin Medical University
Current assignee: Panorama Scientific Co ltd; Harbin Medical University
Priority date: 2021-05-21
Filing date: 2021-05-21
Publication date: 2022-02-08
Anticipated expiration: 2031-05-21

Abstract

The utility model discloses a multifunctional catheter system with a channel cavity, which belongs to the field of diagnosis; the method comprises the following steps: the conduit, the second cavity and the acute angle connecting part; wherein the catheter comprises: the guide wire opening part is arranged on the upper portion of the guide wire opening part, and the guide wire opening part is connected with the guide wire opening part through the acute angle connecting part. According to the utility model, the combined lumens enable the guide wire and the images in the blood vessel lumen to alternately use the common lumen, so that a larger catheter cross-sectional area caused by two lumens penetrating through the catheter system is avoided, and the catheter can be suitable for a narrower diseased blood vessel.

Description

Multifunctional catheter system with channel cavity

Technical Field

The utility model belongs to the technical field of diagnosis, and particularly relates to a multifunctional catheter system with a channel cavity.

Background

In Percutaneous Coronary Intervention (PCI) surgery, a guiding catheter is usually delivered to the coronary artery mouth to be dilated, then a balloon with a corresponding size is delivered to a stenotic segment along a guide wire, and the stenosis is dilated with proper pressure and time according to the characteristics of the lesion, so that the purpose of relieving the artery stenosis is achieved. Traditional treatment approaches include angioplasty or stent placement. For example, a physician may dilate a stenosis in an artery by placing an expandable balloon in the artery and applying pressure to the balloon. The physician may also place a stent as needed to reduce restenosis of the vessel. However, coronary calcified lesions increase the difficulty of interventional treatment, increase the incidence of immediate surgical complications and major adverse cardiovascular events in early and late stages. The reason for this is that calcified lesions are high-resistance lesions and the balloon requires very high pressure (sometimes up to 10 to 15 atm, even 30 atm). Such pressure will generally result in a significant increase in the probability of rebound stenosis, dissection, perforation, rupture of the vessel. Such surgical events are particularly severe in the case of eccentric calcified lesions, since the pressure of the balloon is acting on soft tissue without calcification.

Meanwhile, intravascular shock wave lithotripsy is an independent treatment means, and needs to rely on other methods to diagnose calcified lesions in advance and evaluate the efficacy of shock wave lithotripsy after lithotripsy. Common diagnostic means are coronary angiography, CT angiography, intravascular ultrasound or optical coherence tomography.

However, the balloon used in the shock wave lithotripsy needs to be guided by a vascular guide wire to be close to a lesion, so that the balloon needs to be provided with a guide wire cavity. When using an intraluminal imaging catheter, the catheter requires another catheter lumen. If the catheter has two lumens from the proximal end to the distal end, the cross-sectional area of the catheter must be large enough to not pass through the stenotic lesion of the blood vessel. Thereby causing a problem of compromise failure.

Aiming at the problem, a multifunctional catheter system with a channel cavity is provided, wherein two lumens are combined at the far end of the catheter, shock wave lithotripsy and images in a blood vessel cavity are combined on the same catheter, so that an operator can observe morphological structures in the blood vessel cavity before and after using the shock wave lithotripsy, prejudgment and effect visualization of the lithotripsy can be realized, the positioning accuracy of the lithotripsy is improved, and a clear treatment effect index is provided. And the cross-sectional area of the catheter near the balloon is reduced by pulling back the guidewire or the imaging probe. The catheter thus makes it easier to treat stenotic lesions.

SUMMERY OF THE UTILITY MODEL

In view of the problems of the background art, the present invention provides a multifunctional catheter system with a passageway cavity, comprising: the conduit, the second cavity and the acute angle connecting part; wherein the catheter comprises: the guide wire opening part is arranged on the upper portion of the guide wire opening part, and the guide wire opening part is connected with the guide wire opening part through the acute angle connecting part.

A guide wire penetrates through the common cavity, the guide wire opening part, the acute angle connecting part and the second cavity; the length of the second cavity is 30-100 mm.

The size of the axial length of the strip-shaped opening is 3-10 mm, the size of the width of the strip-shaped opening is 0.4-0.6 mm, and the included angle between the acute-angle connecting part and the guide pipe is 3-10 degrees.

The near-end of pipe installs pars contractilis, and the near-end shell is installed to the near-end of pars contractilis.

The near-end shell is provided with a stamping opening, and the stamping opening is connected with a balloon arranged outside the middle part of the common cavity through a stamping channel arranged on the inner side of the catheter; two groups of far-end electrodes are arranged outside the middle part of the common cavity, and the saccule covers the far-end electrodes.

An imaging channel connector and a shock wave electrode connector are arranged in the near-end shell, and the imaging channel connector and the shock wave electrode connector are respectively connected with an imaging engine and a power supply; the imaging channel and the lead group pass through the first cavity together, and the lead group passes through the inner cavity of the imaging channel; the imaging channel connector at the near end of the imaging channel is connected with the imaging probe at the far end through the imaging channel, and the shock wave electrode connector at the near end of the shock wave electrode is connected with the far end electrode at the far end through the lead group; the near-end shell is provided with a liquid flushing port.

And a torque transmission part is arranged on the outer side of the imaging channel, the near end of the torque transmission part is fixedly connected with the imaging channel connector, and the far end of the torque transmission part is fixedly connected with the imaging probe.

The far end of the common cavity is provided with an ultra-soft end, and the inner cavity of the common cavity extends to the inner cavity of the ultra-soft end.

The pipe wall of the common cavity is provided with a concave marking part, and the marking part is a layer of substance with strong scattering permeating on the pipe wall.

The substance with strong scattering of the layer penetrated by the mark part is metal titanium, the depth of the mark part is 30-100 micrometers, and the thickness of the pipe wall of the shared cavity is 100-150 micrometers.

The utility model has the beneficial effects that:

1. through merging the lumens, images in the guide wire and the blood vessel cavity can alternately use the common lumen, so that the larger catheter cross-sectional area caused by the fact that the two lumens penetrate through the catheter system all the time is avoided, and the catheter can be suitable for narrower diseased blood vessels.

2. Determining the relative position of the imaging probe and the catheter before and after each vibration through a marking part arranged on the wall of the catheter, thereby judging whether deviation occurs; and corrects the position of the imaging probe when the offset is generated.

Drawings

FIG. 1 is a schematic structural view of an embodiment of a multi-functional catheter system with a channel lumen of the present invention when the imaging probe is used for optical coherence tomography;

FIG. 2 is a schematic view of a catheter in accordance with an embodiment of the present invention pushing a balloon around a lesion along a conventional guidewire;

FIG. 3 is a schematic view of an image forming apparatus according to an embodiment of the present invention;

FIG. 4 is a schematic view of a structure of an embodiment of the present invention in the vicinity of a balloon;

FIG. 5 is a cross-sectional view taken along line A-A' of FIG. 4;

FIG. 6 is a schematic view of a structure in the vicinity of a balloon when imaging is performed according to an embodiment of the present invention.

Wherein: 100-catheter, 101-proximal housing, 102-fluid flushing port, 103-telescoping part, 104-first cavity, 105-common cavity, 106-second cavity, 107-balloon, 108-imaging channel connector, 109-shock wave electrode connector, 110-imaging channel, 111-imaging probe, 112-lead set, 113-distal electrode, 114-ultra-soft end, 115-lead opening, 116-strip opening, 118-punching port, 119-punching channel, 200-acute angle connecting part, 203-lead, 300-marking part, 301-torque transmission part, 403-first electrode, 404-second electrode.

Detailed Description

The present invention will be described in further detail with reference to the accompanying drawings.

The embodiment of the present invention shown in fig. 1 to 3 includes: catheter 100, lead set 112, distal electrode 113, ultra-soft tip 114, imaging channel 110, torque transmitting component 301, proximal housing 101, balloon 107, imaging probe 111, guidewire 203, telescoping portion 103, and second lumen 106, wherein catheter 100 comprises: a first cavity 104, a guide wire opening part 115 and a common cavity 105 which are integrally formed from a near end to a far end, wherein the far end of the common cavity 105 is provided with an ultra-soft end 114, and the inner cavity of the common cavity 105 extends to the inner cavity of the ultra-soft end 114; a second cavity 106 arranged in parallel with the first cavity 104 is arranged on one side of the first cavity, and the second cavity 106 serving as a guide wire channel is connected with a strip-shaped opening 116 on a guide wire opening part 115 through an acute angle connecting part 200 so as to be communicated into the catheter 100; a balloon 107 and two groups of distal electrodes 113 are arranged outside the middle part of the common cavity 105, and the balloon 107 covers the distal electrodes 113; the far and near ends of the telescopic part 103 are respectively connected with the near end shell 101 and the near end of the catheter 100 in a mechanical coupling mode, one side of the near end shell 101 is provided with a liquid flushing port 102 and a punching port 118, and the punching port 118 is connected with the balloon 107 through a punching channel 119 arranged on the inner side of the catheter 100; the guide wire 203 passes through the second cavity 106, the acute angle connecting part 200, the guide wire opening part 115 and the common cavity 105;

the imaging channel 110 and the lead group 112 pass through the first cavity 104 together, the imaging channel connector 108 at the proximal end of the imaging channel 110 is connected with the imaging probe 111 at the distal end through the imaging channel 110, and the shock wave electrode connector 109 at the proximal end of the shock wave electrode is connected with the distal end electrode 113 at the distal end through the lead group 112; an imaging channel connector 108 and a shockwave electrode connector 109 disposed within the proximal housing 101 are connected to an imaging engine (not shown) and a power source (not shown), respectively.

In the embodiment, the length of the second cavity 106 is 30mm to 100mm, the axial length of the strip-shaped opening 116 is 3mm to 10mm, and the width of the strip-shaped opening is 0.4mm to 0.6 mm.

In the present embodiment, the axial length of the common cavity 105 is 20mm to 50mm, the outer diameter of the common cavity 105 is 0.6mm to 1.2mm, and the outer diameters of the first cavity 104 and the common cavity 105 are equal.

In the present embodiment, the acute angle connection portion 200 and the conduit 100 form an angle of 3-10 °.

In this embodiment, the telescopic portion 103 is composed of a distal outer sleeve and a proximal inner sleeve, the inner sleeve extends into the outer sleeve, a leakage-proof ring is arranged between the outer sleeve and the inner sleeve, and the inner sleeve moves along the axis relative to the outer sleeve by a distance of 3 mm-20 mm.

As shown in fig. 2 and 3, the common lumen 105 at the distal end of the catheter 100 of the first lumen 104 and the second lumen 106 merge into a common distal lumen, reducing the cross-sectional area of the catheter at the balloon, thereby allowing the balloon to access the stenosis; in the first lumen there is an imaging channel 110 connected to an imaging probe 111 and the second lumen has an inner diameter through which a vascular guidewire may be passed. When the imaging probe is pulled back to exit the common distal lumen completely, the vascular guidewire can enter and pass completely through the common distal lumen; conversely, when the vascular guidewire is pulled back to exit the common distal lumen completely, the imaging probe can enter the common distal lumen; the imaging probe 111 can be rotated along a longitudinal axis to perform scanning imaging after the proximal housing 101 is inserted into the common lumen 105.

When flushing is required prior to imaging, the injection of a fluid (e.g., but not limited to, saline) into the fluid flushing port 102 can pre-vent air from the catheter system, reducing air bubbles that may be carried into the blood as the catheter enters the blood vessel. In an exemplary embodiment, the choice of the rinsing liquid may also be selected according to the requirements of the imaging technique.

When a fixation site is desired prior to vibration, the fluid injected into the low durometer balloon 107 through the punch channel 119 via the punch port 118 is a conductive fluid (e.g., but not limited to, saline), and the fluid injected into the balloon is at a pressure between three and ten standard atmospheres, preferably about five atmospheres, which allows the balloon to be fixed to the inner wall of a blood vessel.

In this embodiment, the distal electrode 113 is ring-shaped to avoid interfering with the passage of the guidewire 202 through the lumen of the distal common lumen 105.

The distal electrode 113 shown in fig. 4 is wound around and fixed to the outer wall of the sleeve 410, and the distal electrode 113 is a pair of discharge electrodes consisting of a first electrode 403 and a second electrode 404. The first electrode 403 has a recess and the second electrode 404 has a corresponding protrusion. The conductive material at the location of both the pair of grooves and protrusions is exposed to the conductive fluid in balloon 107 and they are sufficiently close to but not touching to form a spark gap. This spark gap can produce arcing when a high voltage is applied to the electrodes. The sleeve material in the vicinity of the spark gap on the sleeve 410 may be hollowed out to allow the shock wave to propagate sufficiently. In an exemplary embodiment, multiple sets of electrodes may be placed on the cannula 410 in sequence to increase the intensity of the shock wave.

In this embodiment, the power source can provide a pulse-type high voltage to the electrodes to generate arc discharge between the two electrodes, so as to generate a shock wave in the local blood vessel. The shock wave propagates through the liquid in the balloon to the inner wall of the vessel. Typically, a balloon may be placed near the calcified plaque. The calcified plaque is distorted and even broken after absorbing the energy of shock wave, and the cross-sectional area of the blood vessel where the calcified plaque is located can be conveniently expanded by using the non-compliant balloon. In an exemplary embodiment, the power supply provides at least one high voltage between 500 volts and 10000 volts, preferably 2000 volts to 4000 volts, to the electrodes; the duration is between 0.05 and 5 microseconds, preferably 1 microsecond to 2 microseconds.

In the present embodiment, the imaging probe 111 is selected according to the function of optical imaging or acoustic imaging, and specifically, the imaging probe 111 is used for optical coherence tomography or intravascular ultrasound imaging;

when the imaging probe 111 is used for intravascular ultrasound Imaging (IVUS), the imaging channel 110 may optionally be, but not limited to, a set of wires, and the imaging probe 111 may optionally be, but not limited to, an acoustic transducer assembly, and may convert excitation voltages into acoustic waves that are transmitted to the tissue to be imaged and convert signal-carrying echoes reflected from the tissue into electrical signals.

In this embodiment, the imaging probe 111 may be ultimately connected to an IVUS imaging engine via a lead set to complete IVUS imaging.

When the imaging probe 111 is used for Optical Coherence Tomography (OCT), the imaging channel 110 can be, but is not limited to, an Optical fiber, and the imaging probe 111 can be, but is not limited to, a lens assembly, which focuses light propagating from the Optical fiber onto the tissue to be imaged and transmits signal-carrying light reflected from the tissue back to the Optical fiber. The imaging probe 111 may also be rotated by the torque transmission member 301 to complete scanning imaging. The outer side of the imaging channel 110 is provided with a torque transmission part 301, the imaging channel 110 penetrates through the inner cavity of the torque transmission part 301, the proximal end of the torque transmission part 301 is fixedly connected with the imaging channel connector 108, the distal end of the torque transmission part 301 is fixedly connected with the imaging probe 111, and the torque transmission part 301 drives the imaging probe 111 and the imaging channel 110 to rotate together; the torque transmission member 301 may be a torque coil or a hypotube. In this embodiment, the imaging probe 111 can be finally connected to an OCT imaging engine through an optical fiber to complete OCT imaging.

As shown in fig. 4 to 6, in the common lumen 105, a concave mark portion 300 is disposed on the tube wall between two sets of distal electrodes 113, the mark portion 300 is a layer of substance with strong scattering permeating on the tube wall, specifically, the mark portion 300 is disposed on the outer side of the tube wall in a permeating manner, and the proximal end has a larger circumferential dimension, and due to the existence of the mark portion 300, when the imaging probe 111 selects a lens assembly for optical coherence tomography; this layer of material, although visible on OCT, does not affect mechanical properties. The image near the marker 300 is brighter than the other positions of the catheter by judging the width of the marker region image generated by imaging; the width of the high-brightness area can be used for judging whether the front and back positions of the OCT probe and the catheter are changed; further, the displacement of the OCT probe is detected, and the imaging probe 111 is moved back to its original position.

Therefore, the problem that the imaging position of the OCT probe is possibly displaced after each pulse due to the vibration of the shock wave emitted by the distal electrode 113 in the shock wave treatment process, and the data judgment is influenced due to different imaging positions is solved.

In this embodiment, the marking portion 300 is a right triangle, and two right-angled sides respectively share the cavity 105 and are parallel to the radial plane and the axis;

in the present embodiment, the material with strong scattering of the layer penetrated by the mark portion 300 is metal titanium, the depth of the mark portion 300 is 30 micrometers to 100 micrometers, and the wall thickness of the common cavity 105 is 100 micrometers to 150 micrometers.

In the operation of the present embodiment,

the doctor firstly sends the guide wire 203 to the vicinity of the focus from the blood vessel; after the guide wire 203 is in place, the proximal end of the guide wire 203 outside the body is sent to the vicinity of the guide wire opening part 115 along the ultra-soft end 114, and because the proximal end of the guide wire 203 has certain hardness, a user breaks a button 200 to make the strip-shaped opening 116 offset to be opposite to the proximal end of the guide wire 203, and then pushes the catheter 100 to make the guide wire 203 pass through the acute angle connecting part 200 and the second cavity 106 from the strip-shaped opening 116 in sequence and finally extend out from the distal end of the second cavity 106; the catheter 100 continues to push the balloon 107 along the conventional guidewire 203 to the vicinity of the lesion and pulls away from the guidewire 203; in this process, the imaging probe 111 is received into the first cavity 104 (as shown in fig. 2); then, sequentially carrying out flushing, stamping, balloon fixing and imaging; pushing the imaging probe 111 into the common lumen 105 prior to imaging (as shown in fig. 3); the imaging probe 111 with a stable position can better provide an endoscopic image of a blood vessel, and can help a doctor to accurately judge the position and the form of a focus, so that the treatment parameters of the shock wave lithotripsy can be determined. After the shock wave lithotripsy is completed, the medical imaging probe can help a doctor to evaluate the treatment effect, so that a next operation plan is made.

Claims

1. A multi-functional catheter system with an access lumen, comprising: a conduit (100), a second cavity (106), and an acute angle connection (200); wherein the catheter (100) comprises: the guide wire opening part comprises a first cavity (104) integrally formed from a near end to a far end, a guide wire opening part (115) and a common cavity (105), wherein a second cavity (106) which is arranged side by side with the first cavity is arranged on one side of the first cavity (104), and the second cavity (106) is connected with a strip-shaped opening (116) on the guide wire opening part (115) through an acute angle connecting part (200).

2. The multifunctional catheter system with an access lumen as set forth in claim 1, wherein a guide wire (203) is passed through the common lumen (105), the guide wire opening portion (115), the acute angle connecting portion (200), and the second lumen (106); the length of the second cavity (106) is 30 mm-100 mm.

3. The multifunctional catheter system with the channel cavity is characterized in that the axial length of the strip-shaped opening (116) is 3-10 mm, the width of the strip-shaped opening is 0.4-0.6 mm, and the included angle between the acute-angle connecting part (200) and the catheter (100) is 3-10 degrees.

4. A multifunctional catheter system with an access lumen as claimed in any one of claims 1 to 3, wherein the proximal end of the catheter (100) is provided with a telescopic part (103), and the proximal end of the telescopic part (103) is provided with a proximal housing (101).

5. The multifunctional catheter system with the channel cavity is characterized in that a stamping opening (118) is formed in the proximal end shell (101), and the stamping opening (118) is connected with a balloon (107) arranged outside the middle part of the common cavity (105) through a stamping channel (119) arranged on the inner side of the catheter (100); two groups of distal electrodes (113) are arranged outside the middle part of the common cavity (105), and the balloon (107) covers the distal electrodes (113).

6. The multifunctional catheter system with a channel cavity as claimed in claim 4, wherein an imaging channel connector (108) and a shockwave electrode connector (109) are arranged in the proximal housing (101), and the imaging channel connector (108) and the shockwave electrode connector (109) are respectively connected with an imaging engine and a power supply; the imaging channel (110) and the lead group (112) pass through the first cavity (104) together, and the lead group (112) passes through the inner cavity of the imaging channel (110); an imaging channel connector (108) at the proximal end of the imaging channel (110) is connected with an imaging probe (111) at the distal end through the imaging channel (110), and a shock wave electrode connector (109) at the proximal end of the shock wave electrode is connected with a distal end electrode (113) at the distal end through a lead group (112); the near-end shell (101) is provided with a liquid flushing port (102).

7. The multifunctional catheter system with the channel cavity as claimed in claim 6, wherein a torque transmission component (301) is arranged outside the imaging channel (110), a proximal end of the torque transmission component (301) is fixedly connected with the imaging channel connector (108), and a distal end of the torque transmission component (301) is fixedly connected with the imaging probe (111).

8. The multifunctional catheter system with an access lumen as claimed in claim 1, wherein the distal end of the common lumen (105) is provided with an ultra-soft tip (114), and the lumen of the common lumen (105) extends to the lumen of the ultra-soft tip (114).

9. The multifunctional catheter system with the channel cavity as claimed in claim 1, wherein the wall of the common cavity (105) is provided with a concave mark part (300), and the mark part (300) is a layer of highly scattering substances permeated on the wall of the catheter.

10. The multifunctional catheter system with the channel cavity as claimed in claim 9, wherein the highly scattering material penetrated by the marker (300) is metallic titanium, the depth of the marker (300) is 30 to 100 microns, and the wall thickness of the common cavity (105) is 100 to 150 microns.