CN217827913U

CN217827913U - Medical catheter and system

Info

Publication number: CN217827913U
Application number: CN202220622503.2U
Authority: CN
Inventors: 包俊伟; 何志华; 甘耀�; 其他发明人请求不公开姓名
Original assignee: Shenzhen Microport Trace Medical Equipment Co ltd
Current assignee: Shenzhen Microport Trace Medical Equipment Co ltd
Priority date: 2022-03-21
Filing date: 2022-03-21
Publication date: 2022-11-18
Anticipated expiration: 2032-03-21

Abstract

The utility model provides a medical catheter and system, medical catheter includes: a sheath assembly including a tube body having a distal end portion closed and a one-way passage formed on a distal side wall thereof, the tube body being configured such that the one-way passage is opened when a pressure in an inner cavity of the tube body is greater than or equal to a predetermined value and is closed when the pressure in the inner cavity of the tube body is less than the predetermined value; the inner core assembly comprises a flexible driving shaft and an imaging probe, the distal end of the flexible driving shaft is arranged in the inner cavity of the pipe body, and the flexible driving shaft is configured to move along the axial direction of the pipe body and rotate around the axis of the flexible driving shaft; the imaging probe is disposed at a distal end of the flexible drive shaft. The medical catheter can be used for intravascular imaging, and can simplify imaging operation, shorten operation time and improve safety.

Description

Medical catheter and system

Technical Field

The utility model relates to the technical field of medical equipment, concretely relates to medical catheter and system.

Background

Intravascular ultrasound Imaging (IVUS) is a novel diagnostic method combining noninvasive ultrasound examination with minimally invasive catheter interventional techniques. The IVUS can accurately describe the complex three-dimensional anatomical structure of a blood vessel wall in real time by placing a miniaturized ultrasonic probe in the blood vessel cavity for imaging through a catheter technology, evaluate the stenosis degree of the blood vessel cavity, and further check the vulnerability and the plaque load of atherosclerotic plaques, so that the IVUS is considered as a new 'gold standard' for blood vessel examination. Furthermore, IVUS can also be used to guide stent placement, assessment of stent intimal hyperplasia, investigation of causes of in-stent restenosis, detection of late-stage stent malapposition, in-stent thrombosis, and the like.

Intravascular ultrasound catheter among the prior art mainly includes sheath pipe subassembly and inner core subassembly, sheath pipe subassembly includes the body, be equipped with a through-hole on the distal end of body, the inner core subassembly includes flexible drive shaft and ultrasonic probe, flexible drive shaft partially wears to establish in the body so that the distal end of flexible drive shaft is located the body, ultrasonic probe sets up the distal end at the flexible drive shaft, this flexible drive shaft can follow the axial displacement of body and can also the rotation, axial displacement and the rotation that still carries on along the body are followed to drive ultrasonic probe. The using process of the intravascular ultrasonic catheter comprises the following steps: the method comprises the steps of firstly filling physiological saline into a tube body from a near end, wherein the physiological saline carries air in the tube body and is discharged from a through hole at the far end of the tube body, then enabling the far end of an intravascular ultrasonic catheter to enter a preset position in a blood vessel, driving a flexible driving shaft to move (namely retract) along the far end to the near end, driving the flexible driving shaft to rotate, simultaneously transmitting an ultrasonic signal by an ultrasonic probe, and acquiring image information of a blood vessel passing through a part. Because the through-hole on the body distal end is in open state all the time, in the use, especially when flexible drive shaft is withdrawing, blood extremely easily gets into the sheath pipe from the through-hole department, influences the continuity of formation of image effect and use, consequently executes the operation person toward still need pour into normal saline many times in order to discharge blood, leads to complex operation, extension operation time, increases the operation risk.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide a medical catheter and system, this medical catheter can be used to the intravascular imaging to can the simplified operation, shorten operation time, reduce the operation risk.

In order to achieve the above object, the present invention provides a medical catheter, comprising:

a sheath assembly including a tube body having a closed distal end and a one-way channel formed on a distal side wall thereof and communicating with an inner cavity of the tube body, the tube body being configured such that the one-way channel is opened when a pressure in the inner cavity of the tube body is greater than or equal to a predetermined value and is closed when the pressure in the inner cavity of the tube body is less than the predetermined value; and

an inner core assembly comprising a flexible drive shaft and an imaging probe, a distal end of the flexible drive shaft being disposed within the lumen of the tubular body, the flexible drive shaft being configured to be axially movable along the tubular body and rotatable about an axis thereof; the imaging probe is disposed at a distal end of the flexible drive shaft.

Optionally, a predetermined area is provided on the distal sidewall of the tube body, the predetermined area is configured to have elasticity, and a slit is formed on the predetermined area, and the slit forms the one-way passage.

Optionally, the sheath assembly further comprises a guide head, the guide head is disposed at the distal end of the tube body, and a guide wire channel is disposed on the guide head, and an axis of the guide wire channel is inclined with respect to an axis of the tube body.

Optionally, the distance from the distal end of the cutting slit to the distal end of the guide head is 15 mm-25 mm; and/or the length of the cutting seam is 1 mm-3 mm.

Optionally, the material of the predetermined region is selected from any one of polyurethane, polyethylene, silicone, and block polyether amide elastomer.

Optionally, the flexible drive shaft includes a shaft body and a hydrophilic coating disposed on an outer surface of the shaft body.

Optionally, the sheath subassembly still includes first near-end connecting portion, adapter and flushing joint, the adapter sets up the near-end of body, first near-end connecting portion with the near-end of adapter is connected, just the inner chamber of first near-end connecting portion the inner chamber of adapter and the inner chamber of body communicates in proper order, the flushing joint sets up on the first near-end connecting portion, and with the inner chamber intercommunication of first near-end connecting portion.

Optionally, the inner core assembly further comprises a second proximal connecting portion at least partially disposed in the inner cavity of the first proximal connecting portion, a distal end of the second proximal connecting portion being connected to the flexible drive shaft, and a proximal end of the second proximal connecting portion being configured to be connected to an external driving device to transmit the driving force provided by the driving device to the flexible drive shaft.

Optionally, a sealing structure is disposed between the first proximal connecting portion and the second proximal connecting portion.

In order to achieve the above object, the present invention also provides a medical system, including:

a medical catheter as in any one of the preceding claims;

the driving device is connected with the flexible driving shaft and is used for driving the flexible driving shaft to move along the axial direction of the pipe body and driving the flexible driving shaft to rotate;

the imaging host is in communication connection with the imaging probe, and is used for sending an excitation signal to the imaging probe to drive the imaging probe to transmit an image acquisition signal, and receiving an imaging signal obtained by the imaging probe.

Compared with the prior art, the utility model discloses a medical catheter and system have following advantage:

the medical catheter comprises a sheath tube component and an inner core component; wherein the sheath assembly comprises a tube body, the distal end of the tube body is closed, and a one-way channel is formed on the distal side wall of the tube body, the tube body is configured to open when the pressure in the inner cavity of the tube body is greater than or equal to a predetermined value, and close when the pressure in the inner cavity of the tube body is less than the predetermined value; the inner core assembly comprises a flexible driving shaft and an imaging probe, the distal end of the flexible driving shaft is arranged in the inner cavity of the tube body, the flexible driving shaft is configured to move along the axial direction of the tube body and rotate around the axis of the flexible driving shaft, and the imaging probe is arranged at the distal end of the flexible driving shaft. The medical catheter can be used for intravascular imaging, when in use, physiological saline is firstly filled into the inner cavity of the tube body from the proximal end of the tube body, the pressure exerted on the tube body by the physiological saline is larger than the preset value, so that a one-way channel is opened, the physiological saline is exhausted out of the tube body from the one-way channel together with air in the tube body, the pressure in the tube body is not applied, and the one-way channel is closed; and then conveying the distal end of the medical catheter to a preset position in a blood vessel according to a conventional method, controlling the flexible driving shaft to move along the direction from the distal end to the proximal end, and controlling the flexible driving shaft to rotate around the axis of the flexible driving shaft so as to drive the imaging probe to rotate, wherein the imaging probe transmits an image acquisition signal and receives an imaging signal of a blood vessel wall. In the use process of the medical catheter, after the distal end of the medical catheter enters the blood vessel, the one-way channel is closed, blood can be prevented from entering the inner cavity of the tube body from the one-way channel, and further, the blood vessel entering the tube body does not need to be discharged by pouring normal saline for many times, so that the interference of the blood vessel on imaging can be avoided, the imaging can be continuously carried out, the imaging operation is simplified, the operation time is shortened, and the operation risk is reduced.

Drawings

The drawings are included to provide a better understanding of the invention and are not to be construed as unduly limiting the invention. Wherein:

fig. 1 is a schematic structural view of a medical catheter according to an embodiment of the present invention;

fig. 2 is a schematic view of a portion of a medical catheter according to an embodiment of the present invention, showing a one-way passage and the one-way passage closed;

fig. 3 is a partial schematic structural view of a medical catheter according to an embodiment of the present invention, showing a one-way passage, with the one-way passage open;

fig. 4 is a schematic partial view of a medical catheter according to an embodiment of the present invention, showing a guide tip and a guide wire channel;

fig. 5 is a schematic structural diagram of a medical system according to an embodiment of the present invention.

[ reference numerals are described below ]:

1-a medical system;

10-medical catheter, 100-sheath assembly, 110-tube body, 111-one-way channel, 112-proximal tube section, 113-distal tube section, 120-guide head, 121-guide wire channel, 130-first proximal end connecting part, 131-head, 132-joint tube, 140-adapter, 150-flushing joint, 200-inner core assembly, 210-flexible driving shaft, 211-shaft body, 212-hydrophilic coating, 220-imaging probe, 230-second proximal end connecting part and 300-sealing structure;

20-a drive device;

30-imaging host.

Detailed Description

The following description of the embodiments of the present invention is provided for illustrative purposes, and other advantages and effects of the present invention will be readily apparent to those skilled in the art from the disclosure herein. The present invention can be implemented or applied by other different specific embodiments, and various details in the present specification can be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the drawings provided in the present embodiment are only for illustrating the basic idea of the invention in a schematic manner, and only the components related to the invention are shown in the drawings rather than being drawn according to the number, shape and size of the components in actual implementation, and the form, quantity and proportion of the components in actual implementation may be changed at will, and the layout of the components may be more complicated.

Furthermore, each embodiment described below has one or more technical features, and this does not mean that all the technical features in any embodiment need to be implemented simultaneously by using the present invention, or that only some or all the technical features in different embodiments can be implemented separately. In other words, in the implementation of the present invention, based on the disclosure of the present invention, and depending on design specifications or implementation requirements, a person skilled in the art can selectively implement some or all of the technical features of any embodiment, or selectively implement a combination of some or all of the technical features of a plurality of embodiments, thereby increasing the flexibility in implementing the present invention.

As used in this specification, the singular forms "a", "an" and "the" include plural referents, and the plural forms "a plurality" includes more than two referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either fixedly connected, detachably connected, or integrally connected. Either mechanically or electrically. Either directly or indirectly through intervening media, either internally or in any other relationship. The specific meaning of the above terms in the present invention can be understood according to specific situations by those skilled in the art.

As used herein, the terms "proximal" and "distal" refer to the relative orientation, relative position, and orientation of elements or actions with respect to one another from the perspective of a clinician using the medical device, and although "proximal" and "distal" are not intended to be limiting, the term "proximal" generally refers to the end of the medical device that is closer to the clinician during normal operation, and the term "distal" generally refers to the end that is first introduced into a patient.

To make the objects, advantages and features of the present invention clearer, the present invention will be described in further detail with reference to the accompanying drawings. It should be noted that the drawings are in a very simplified form and are not to precise scale, which is only used for the purpose of facilitating and clearly explaining the embodiments of the present invention. The same or similar reference numbers in the drawings identify the same or similar elements.

Fig. 1 shows a schematic structural diagram of a medical catheter 10 according to an embodiment of the present invention, and fig. 2 and 3 show a schematic partial structural diagram of the medical catheter 10. As shown in fig. 1 to 3, the medical catheter 10 includes a sheath assembly 100 and an inner core assembly 200. The sheath assembly 100 includes a tube body 110, a distal end of the tube body 110 is closed, and a one-way channel 111 is formed on a distal side wall of the tube body 110. The tube 110 is configured such that when the pressure in the inner cavity of the tube 110 is greater than or equal to a predetermined value, the one-way passage 111 is opened to communicate the inner cavity with the outside (as shown in fig. 3), and when the pressure in the inner cavity of the tube 110 is less than the predetermined value, the one-way passage 111 is closed (as shown in fig. 2). The inner core assembly 200 includes a flexible drive shaft 210 and an imaging probe 220. The distal end of the flexible driving shaft 210 is disposed in the inner cavity of the tube body 110, and the flexible driving shaft 210 is configured to be capable of moving in the axial direction of the tube body 110 and rotating on its axis. The imaging probe 220 is disposed at the distal end of the flexible drive shaft 210.

The medical catheter 10 may be used for intravascular imaging, and as such, the imaging probe 220 may be an ultrasound transducer. The use process of the medical catheter 10 comprises the following steps:

step S1: the inner cavity of the tube body 110 is filled with physiological saline from the proximal end of the tube body 110, the physiological saline generates fluid pressure in the inner cavity of the tube body 110, when the fluid pressure is greater than the predetermined value, the one-way passage 111 is opened, the physiological saline is discharged out of the tube body 110 from the one-way passage 111, and the physiological saline also carries air in the tube body 110 away from the tube body 110 during the discharge. It is understood that this step is performed outside the patient's body.

Step S2: the distal end of the medical catheter 10 is delivered to a predetermined location within a blood vessel along a guidewire previously introduced into the blood vessel.

And step S3: the flexible drive shaft 210 is controlled to move in a distal-to-proximal direction, and the flexible drive shaft 210 is controlled to rotate about its own axis, such that the imaging probe 220 moves with the flexible drive shaft 210 in a distal-to-proximal direction and rotates about the axis of the flexible drive shaft 210. Meanwhile, the imaging probe 220 also transmits an image acquisition signal and receives an image signal, which is used for acquiring intravascular image information.

Here, when the distal end of the medical catheter 10 enters the blood vessel, the saline injection into the tube 110 is stopped, so that the pressure in the tube 110 is lost, the one-way passage 111 is closed, and thus blood can be prevented from entering the inner cavity of the tube 110 from the one-way passage 111, and the interference of blood on the imaging process can be avoided, and the saline injection for flushing the tube repeatedly is not needed, so that the operation steps of the imaging process can be simplified, the continuity of the imaging process can be improved, the operation time can be shortened, and the operation safety can be improved.

Optionally, the distal sidewall of the tube body 110 is provided with a predetermined region configured to have elasticity, and the predetermined region is formed with a slit. When the pressure in the inner cavity of the pipe body 110 is greater than or equal to the predetermined value, the predetermined region is deformed and stores elastic potential energy so that the slit is opened, and when the pressure in the pipe body 110 is less than the predetermined value, the predetermined region releases the elastic potential energy and restores the deformation so that the slit is closed. In other words, in the present embodiment, the slits constitute the one-way passage 111. The material of the predetermined region is selected from any one of polyurethane, polyethylene, silica gel and block polyether amide elastomer (Pebax).

The slit extends in the axial direction of the pipe body 110 such that the slit has opposite proximal and distal ends in the axial direction of the pipe body 110. It is understood that the slit may be parallel to the axis of the pipe body 110, or may be inclined with respect to the axis of the pipe body 110, which is not limited in this embodiment. The predetermined value is related to the size of the slit, the length of the slit cannot be too large or too small, if the length of the slit is too large, the closing of the slit is not facilitated, and if the length of the slit is too small, the predetermined value is too large. Optionally, the length of the cutting slit is 1mm to 3mm, and the predetermined value is 20Kpa to 35Kpa correspondingly. In addition, the slit should be formed as close to the distal end of the tube body 110 as possible, so that the gas in the entire axial length of the tube body 110 can be completely discharged by using the saline solution.

In addition, the tube body 110 may include a proximal tube segment 112 and a distal tube segment 113 that are axially connected, the proximal tube segment 112 having a hardness greater than the hardness of the distal tube segment 113 to provide the medical catheter 10 with better pushability. The slit is provided on the distal tube section 113.

As shown in fig. 1 and 4, the sheath assembly 100 further includes a guide head 120, the guide head 120 is disposed at a distal end of the tube 110, a guide wire channel 121 is disposed on the guide head 120, and an axis of the guide wire channel 121 is inclined with respect to an axis of the tube 110. Thus, in the step S2, the sheath assembly 100 is sleeved on the guide wire through the guide wire channel 121, and the distal end of the tube body 110 can reach a predetermined position in the blood vessel under the guidance of the guide wire. The distance from the distal end of the seeker 120 to the distal end of the slit is preferably 15mm to 25mm.

Optionally, the guiding head 120 is further provided with a visualization element (not shown in the figures), and the visualization element is used for displaying the position of the guiding head 120 in the blood vessel, so as to facilitate the operator to judge the position of the distal end of the tube body 110 in the blood vessel.

Further, the sheath assembly 100 further includes a first proximal connection 130, an adapter 140, and a flush adapter 150. The adapter 140 connects the body 110 to the first proximal connection 130. The first proximal connection portion 130 includes a head portion 131 and a joint tube 132, the head portion 131 is disposed at a proximal end of the joint tube 132, the adapter 140 specifically connects a distal end of the joint tube 132 and a proximal end of the tube body 110, and two different pieces of tubing can be firmly joined together by disposing the adapter 140. The inner cavity of the first proximal end connecting portion 130, the inner cavity of the adapter 140, and the inner cavity of the tube body 110 are sequentially communicated. The flush adapter 150 is disposed on the first proximal connection 130, specifically on the head 131, and is in communication with the lumen of the tube 110. The flush connector 150 is, for example, a luer connector, which is used to connect with an external perfusion mechanism for perfusing the tube body 110 with physiological saline. Optionally, a check valve is further disposed on the flush joint 150 to prevent the reverse flow of saline.

Further, the flexible driving shaft 210 includes a shaft body 211 and a hydrophilic coating 212 disposed on an outer surface of the shaft body 211. By providing the hydrophilic coating 212 on the outer surface of the shaft body 211, the physiological saline can quickly infiltrate the outer surface of the flexible driving shaft 210 when the physiological saline is poured, so as to reduce air bubbles attached to the flexible driving shaft 210, and to discharge air in the tube body 110 as much as possible. The hydrophilic coating 212 may be polyvinylpyrrolidone (PVP) or any other suitable hydrophilic coating. The shaft body 211 is preferably a three-dimensional spiral spring structure having sufficient flexibility and capable of maintaining rigidity required for rotation.

Further, referring back to fig. 1, the inner core assembly 200 further includes a second proximal connecting portion 230, the second proximal connecting portion 230 is disposed at a proximal end of the flexible driving shaft 210, and a proximal end of the second proximal connecting portion 230 is used for connecting with an external driving device 20 (as shown in fig. 5) so as to transmit a driving force provided by the driving device 20 to the flexible driving shaft 210, so as to drive the flexible driving shaft 210 to move along the axial direction of the tube body 110, and simultaneously drive the flexible driving shaft 210 to rotate.

When assembling the medical catheter 10, the sheath assembly 100 may be assembled first, then the core assembly 200 is assembled, and then the distal end of the flexible drive shaft 210 is inserted into the catheter body 110, such that the second proximal connection portion 230 is at least partially disposed in the inner cavity of the first proximal connection portion 130, specifically the head portion 131, and a sealing structure 300 is disposed between the first proximal connection portion 130 and the second proximal connection portion 230 to prevent air from entering the catheter body 110 from the first proximal connection portion 130. Moreover, when the medical catheter 10 is assembled, the imaging probe 220 should be as close as possible to the distal end of the tube body 110, so that when the flexible driving shaft 210 drives the imaging probe 220 to move in the tube body 110 along the distal end to the proximal end, the moving distance of the imaging probe 220 in the axial direction of the tube body 110 is as large as possible, and further, the moving distance of the imaging probe 220 in the axial direction of the blood vessel is as large as possible, thereby achieving the effect of increasing the imaging range of the blood vessel.

Further, as shown in fig. 5, the embodiment of the present invention further provides a medical system 1, where the medical system 1 includes the medical catheter 10, the driving device 20, and the imaging host 30 as described above. The driving device 20 is connected to the proximal end of the flexible driving shaft 210 and is used to drive the flexible driving shaft 210 to move along the axial direction of the tube body 110 and to drive the flexible driving shaft 210 to rotate around its axis. The imaging host 30 is communicatively connected to the imaging probe 220, the imaging host 30 is configured to send an excitation signal to the imaging probe 220 to drive the imaging probe 220 to transmit an image acquisition signal, and the imaging host 30 is further configured to receive an imaging signal obtained by the imaging probe 220. It can be understood that when the imaging probe 220 is an ultrasonic transducer, the image acquisition signal is an ultrasonic wave, and the imaging signal is an electrical signal obtained by the imaging host 30 according to a wave signal returned by a blood vessel wall.

Although the present invention is disclosed above, it is not limited thereto. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims and their equivalents, the present invention is also intended to include such modifications and variations.

Claims

1. A medical catheter, comprising:

a sheath assembly including a tube body having a closed distal end and a one-way channel formed on a distal side wall thereof and communicating with an inner cavity of the tube body, the tube body being configured such that the one-way channel is opened when a pressure in the inner cavity of the tube body is greater than or equal to a predetermined value and is closed when the pressure in the inner cavity of the tube body is less than the predetermined value; and the number of the first and second groups,

2. The medical catheter as claimed in claim 1, wherein the distal end of the tubular body has a predetermined region formed on a sidewall thereof, the predetermined region being configured to have elasticity, and the predetermined region has a slit formed thereon, the slit constituting the one-way passage.

3. The medical catheter of claim 2, wherein the sheath assembly further comprises a guide head disposed at the distal end of the tube body, and wherein a guide wire channel is disposed on the guide head, the axis of the guide wire channel being inclined relative to the axis of the tube body.

4. A medical catheter as in claim 3, wherein the distance from the distal end of the slit to the distal end of the introducer is 15mm to 25mm; and/or the length of the cutting seam is 1 mm-3 mm.

5. The medical catheter of claim 2, wherein the material of the predetermined region is selected from any one of polyurethane, polyethylene, silicone, and block polyether amide elastomer.

6. The medical catheter of claim 1, wherein the flexible drive shaft comprises a shaft body and a hydrophilic coating disposed on an outer surface of the shaft body.

7. The medical catheter of claim 1, wherein the sheath assembly further comprises a first proximal connection portion, an adapter, and a flush joint, the adapter being disposed at the proximal end of the catheter body, the first proximal connection portion being connected to the proximal end of the adapter, and the inner lumen of the first proximal connection portion, the inner lumen of the adapter, and the inner lumen of the catheter body being in communication in sequence, the flush joint being disposed on the first proximal connection portion and in communication with the inner lumen of the first proximal connection portion.

8. The medical catheter of claim 7, wherein the inner core assembly further comprises a second proximal connection at least partially disposed within the lumen of the first proximal connection, a distal end of the second proximal connection being coupled to the flexible drive shaft, and a proximal end of the second proximal connection being adapted to be coupled to an external drive device to transfer the drive force provided by the drive device to the flexible drive shaft.

9. A medical catheter according to claim 8, wherein a sealing structure is provided between the first proximal connection and the second proximal connection.

10. A medical system, comprising:

the medical catheter of any one of claims 1-9;