CN113893444B

CN113893444B - A medical device

Info

Publication number: CN113893444B
Application number: CN202010576014.3A
Authority: CN
Inventors: 朱清; 孙立忠; 刘金宏; 王丽文; 袁振宇; 王韶霞
Original assignee: Shanghai Minimally Invasive Heart Pulse Medical Technology Group Co ltd
Current assignee: Shanghai Minimally Invasive Heart Pulse Medical Technology Group Co ltd
Priority date: 2020-06-22
Filing date: 2020-06-22
Publication date: 2025-02-07
Anticipated expiration: 2040-06-22
Also published as: WO2021258772A1; AR122706A1; CN113893444A

Abstract

The invention relates to a medical device which comprises an infusion catheter, a blocking mechanism, a supporting mechanism and a supporting mechanism, wherein the blocking mechanism comprises a balloon and a catheter body, the balloon is arranged on the outer surface of the infusion catheter, the catheter body is communicated with the balloon and is used for infusing filling agent into the balloon, the supporting mechanism comprises a supporting body and a driving body, the supporting body is arranged on the outer surface of the infusion catheter and is positioned at the proximal end of the balloon, and the driving body is connected with the supporting body and is used for driving the supporting body to expand outwards or contract inwards along the radial direction of the supporting body. When the medical device is used for the operation treatment of aortic dissection, a clean operation field can be provided, the operation of doctors is convenient, the circulation stopping time is obviously reduced, and the damage to important organs of the lower body of a patient is reduced.

Description

Medical device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a medical device applied to aortic total arch replacement and stent trunk surgery.

Background

Aortic dissection refers to a true and false two-cavity separation state that blood in an aortic cavity enters an aortic media from an aortic intima tearing position to separate the media, and expands along the long axis direction of the aorta to form an aortic wall, and is an aortic disease with critical illness, rapid progress and high mortality rate. The dissection hematoma of the middle aortic layer can cause serious cardiovascular emergency, wherein 65% -70% of patients die in the acute phase due to cardiac tamponade, arrhythmia and the like, so that early treatment of aortic dissection is very necessary. At present, an aortic dissection is mainly treated by an operation, wherein a Stanford B-type dissection with a breach positioned in a descending aorta is generally treated by an interventional treatment, and a Stanford A-type dissection with a breach which affects the ascending aorta and an aortic arch is generally treated by combining an aortic total arch replacement operation with a stent trunk operation.

Trunk surgery refers to implantation of a free length of vascular prosthesis in the descending aorta during the ascending aortic and aortic arch replacement procedures, thereby eliminating the need for a deep cryogenic stop cycle during the secondary descending aortic surgery. The trunk operation shortens the aortic blocking time and reduces the risk of ischemic complications, but the traditional trunk operation is easy to cause the aortic wall to be torn due to limited visual field and difficult needle entering and exiting, and meanwhile, the postoperative brain complications are extremely easy to occur due to long circulation stopping time in the operation. The prior art sun's procedure is a classical procedure for treating Stanford type a dissection (i.e. aortic total arch replacement + stent trunk), which further simplifies the procedure, but which also needs to be performed under conditions of deep cryogenic stop-cycling.

In summary, the prior art has the following problems that the visual field of operation is difficult to show, the blood return of the descending aorta further influences the visual field definition, the operation needs to be carried out in an extracorporeal circulation state, when the descending aorta anastomosis is carried out, the close end of the trunk stent and the autologous blood vessel of a patient are often bad to be anastomosed due to various reasons, the anastomosis time is excessively long, the deep low temperature stop circulation time is prolonged, and the possibility that organs such as spinal cord, liver and stomach intestine are damaged by ischemia and hypoxia is increased, so that the postoperative recovery of the patient is not facilitated.

Disclosure of Invention

The invention aims to provide a medical device which is used for providing clear operation vision, can perform descending aorta anastomosis operation under the extracorporeal circulation condition, greatly shortens the time of deep low-temperature stop circulation, reduces ischemia and low-temperature damage to vital organs of the lower body of a patient, is beneficial to postoperative recovery of the patient, and particularly, improves the fitting property of a trunk support and a patient autologous blood vessel, facilitates anastomosis operation and shortens anastomosis time.

To achieve the above object, the present invention provides a medical device comprising:

Perfusing the catheter;

a blocking mechanism comprising a balloon and a catheter body, the balloon being disposed on an outer surface of the infusion catheter, the catheter body being in communication with the balloon for infusing an inflation agent into the balloon, and

The support mechanism comprises a support body and a driving body, wherein the support body is arranged on the outer surface of the perfusion catheter and positioned at the proximal end side of the balloon, and the driving body is connected with the support body and is used for driving the support body to expand outwards or contract inwards along the radial direction of the support body.

Optionally, the driving body is sleeved on the outer surface of the perfusion catheter and can move along the axial direction of the perfusion catheter, the distal end of the supporting body is fixedly connected with the perfusion catheter, and the proximal end of the supporting body is fixedly connected with the distal end of the driving body;

the support mechanism is configured such that when the drive body is moved toward the distal end of the infusion catheter, the drive body drives the proximal end of the support body to move toward the distal end of the infusion catheter to deform and expand the support body, and when the drive body is moved toward the proximal end of the infusion catheter, the drive body drives the proximal end of the support body to move toward the proximal end of the infusion catheter to contract the support body.

Optionally, the support body is woven from a plurality of woven wires, and at least some of the woven wires are metal wires.

Optionally, the maximum diameter of the support body when expanded is 35mm-40mm.

Optionally, the support mechanism further comprises a first handle, wherein the first handle is arranged on the outer surface of the perfusion catheter and can move along the axial direction of the perfusion catheter, and the first handle is fixedly connected with the proximal end of the driving body.

Optionally, the support mechanism further comprises a locking assembly provided on the first handle for selectively connecting or disconnecting the perfusion catheter;

the support mechanism is configured to prevent axial movement of the first handle, the drive body, and the proximal end of the support body along the irrigation catheter when the locking assembly is coupled to the irrigation catheter, and to allow axial movement of the first handle, the drive body, and the proximal end of the support body along the irrigation catheter when the locking assembly is uncoupled from the irrigation catheter.

Optionally, the locking assembly comprises a locking part and a nut, wherein the locking part is arranged at the proximal end of the first handle and is of a hollow tubular structure, external threads are arranged on the locking part, a plurality of open slots are arranged at the proximal end of the locking part, and the nut is sleeved on the outer surface of the locking part and is in threaded connection with the locking part.

Optionally, the catheter body is threaded inside the perfusion catheter, and a distal end of the catheter body penetrates a distal tube wall of the perfusion catheter to communicate with the balloon.

Optionally, the blocking mechanism further comprises a syringe, the syringe is spirally coiled inside the first handle, and the distal end of the syringe extends into the perfusion catheter and is connected with the proximal end of the catheter body, and the proximal end of the syringe extends out of the first handle through the first handle;

when the first handle is moved toward the distal end of the infusion catheter, the proximal end of the syringe is moved synchronously with the first handle to stretch-deform the syringe.

Optionally, a second handle is also included, the second handle being disposed on an outer surface of the perfusion catheter and being located proximal to the first handle.

Optionally, the blocking mechanism further comprises a syringe, a distal end of the syringe extending into the infusion catheter and being connected to a proximal end of the catheter body, the proximal end of the syringe extending through the second handle to the outside of the second handle.

Optionally, the proximal end of the syringe is provided with a one-way valve.

Compared with the prior art, the medical device has the following advantages:

The medical device comprises an infusion catheter, a blocking mechanism and a supporting mechanism, wherein the blocking mechanism comprises a balloon and a catheter body, the balloon is arranged on the outer surface of the infusion catheter, the catheter body is communicated with the balloon and used for infusing filling agent into the balloon, the supporting mechanism comprises a supporting body and a driving body, the supporting body is arranged on the outer surface of the infusion catheter and located on the proximal end side of the balloon, and the driving body is connected with the supporting body and used for driving the supporting body to expand outwards or contract inwards along the radial direction of the supporting body. When the medical device is applied to aortic dissection operation treatment, the catheter body is used for filling agents into the balloon so that the balloon is filled to be attached to the inner wall of the trunk support, the inside of the trunk support is divided into two parts which are not communicated with each other, blood return of the descending aorta is blocked, blood in the descending aorta cannot enter the aortic arch and the ascending aorta in a countercurrent mode, clear vision is provided for an operation, the perfusion catheter is connected with an external circulating machine to perform blood perfusion on the lower half of a patient, anastomosis operation can be performed without deep low-temperature stop circulation, the deep low-temperature and stop circulation time in the operation process is remarkably shortened, damage to important organs of the lower half of the patient is reduced, and the postoperative recovery of the patient is facilitated.

And the second support body is formed by braiding a plurality of braiding wires, and at least part of the braiding wires are metal wires. That is, the support body is mainly made of a metal material, so that the support body is ensured to have enough strength to effectively support the proximal end of the trunk stand, and the proximal end of the trunk stand is expanded again to be attached to the inner wall of the autologous blood vessel.

Third, supporting mechanism includes first handle, first handle sets up on the surface of perfusion catheter, and can follow the axial displacement of perfusion catheter, just first handle with the proximal end fixed connection of the drive body makes things convenient for the operator to hold in order to push the drive body is followed the axial displacement of perfusion catheter. Further, the support mechanism also includes a locking assembly disposed on the first handle for selectively connecting and disconnecting the irrigation catheter. When the locking component is disconnected with the perfusion catheter, the first handle, the driving body and the proximal end of the supporting body are allowed to move along the axial direction of the perfusion catheter so that the supporting body can be expanded, and when the supporting body is expanded to a proper degree so as to support the proximal end of the trunk stent to be closely attached to the inner wall of an autologous blood vessel, the locking component is connected with the perfusion catheter so as to prevent the first handle, the driving body and the proximal end of the supporting body from moving along the axial direction of the perfusion catheter, thereby achieving the aim of locking the supporting body in an expanded state and facilitating anastomosis operation by an operator.

Drawings

FIG. 1 is a schematic view of a medical device according to an embodiment of the present invention;

FIG. 2 is a schematic view of the medical device of FIG. 1 in use;

FIG. 3 is a schematic view of a support body of a medical device according to an embodiment of the present invention when expanded;

FIG. 4 is a schematic view of a driving body of a supporting mechanism of a medical device according to an embodiment of the present invention;

FIG. 5 is a schematic view of a locking assembly of a support mechanism of a medical device according to an embodiment of the present invention, the locking portion being shown separated from the nut;

FIG. 6 is a schematic view of a medical device according to another embodiment of the present invention;

FIG. 7 is an enlarged schematic view of the medical device shown in FIG. 6 at A;

fig. 8 is a schematic view of the medical device of fig. 6 in use.

Reference numerals are described as follows:

10-a medical device;

100-perfusing a catheter;

200-blocking mechanism;

210-a balloon, 220-a catheter body, 230-a syringe, 240-a one-way valve;

300-a supporting mechanism;

310-a support;

320-a driver;

321-inner tube, 322-support wire, 323-outer tube;

330-a first handle;

340-a locking assembly;

341-locking part, 341 a-open slot, 341 b-snap;

342-a nut;

400-a second handle;

20-trunk stent.

Detailed Description

Other advantages and effects of the present invention will become apparent to those skilled in the art from the following disclosure, which describes the embodiments of the present invention with reference to specific examples. The invention may be practiced or carried out in other embodiments that depart from the specific details, and the details of the present description may be modified or varied from the spirit and scope of the present invention. It should be noted that, the illustrations provided in the present embodiment merely illustrate the basic concept of the present invention by way of illustration, and only the components related to the present invention are shown in the drawings and are not drawn according to the number, shape and size of the components in actual implementation, and the form, number and proportion of the components in actual implementation may be arbitrarily changed, and the layout of the components may be more complex.

In addition, each embodiment of the following description has one or more features, respectively, which does not mean that the inventor must implement all features of any embodiment at the same time, or that only some or all of the features of different embodiments can be implemented separately. In other words, those skilled in the art can implement some or all of the features of any one embodiment or a combination of some or all of the features of multiple embodiments selectively, depending on the design specifications or implementation requirements, thereby increasing the flexibility of the implementation of the invention where implemented as possible.

As used in this specification, the singular forms "a", "an", and "the" include plural referents, the plural form "the plural" 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, as well as being either fixedly connected, detachably connected, or integrally connected, for example. It may be a mechanical connection that is made, or may be an electrical connection. Can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.

In this context, the terms "proximal" and "distal" refer to the relative orientation, relative position, direction of the elements or actions relative to each other from the perspective of the physician using the medical device, although "proximal" and "distal" are not limiting, "proximal" generally refer to the end of the medical device that is closest to the physician during normal operation, and "distal" generally refers to the end that enters the patient first. Unless the context clearly indicates otherwise.

The invention aims to provide a medical device which comprises an infusion catheter, a blocking mechanism and a supporting mechanism. Wherein, blocking mechanism includes sacculus and catheter body, the sacculus sets up on the surface of perfusion catheter, the catheter body with the sacculus intercommunication is used for to the sacculus is filled with filling agent. The support mechanism comprises a support body and a driving body, wherein the support body is arranged on the outer surface of the perfusion catheter and is positioned at the proximal side of the balloon. The driving body is connected with the supporting body and is used for driving the supporting body to expand outwards or contract inwards along the radial direction of the supporting body.

The medical device is used in combination with a trunk stent for surgical treatment of aortic dissection, for example in Sun's surgery. Specifically, the perfusion catheter is connected with the trunk support at first during operation, so that the medical device is fixed in the aorta, wherein the balloon is positioned in the middle of the inner cavity of the trunk support, and the supporting body is positioned in the inner cavity of the proximal end of the trunk support. And filling agent into the balloon by utilizing the catheter body, so that the balloon is filled to be attached to the inner wall of the trunk support, the interior of the trunk support is divided into two parts which are not communicated with each other, namely, the balloon is utilized to expand to block blood return of the descending aorta, and blood in the descending aorta is prevented from flowing back into the aortic arch and the ascending aorta, so that a clear view is provided for operation. Then, the operator controls the driving body to drive the supporting body to expand so as to support the proximal end of the trunk support, so that the proximal end of the trunk support is expanded again until the proximal end of the trunk support is tightly attached to the inner wall of the autologous blood vessel, on one hand, blood return between the outer wall of the trunk support and the proximal end breach of the descending aorta can be blocked, a clean operation field is further provided, on the other hand, the doctor can conveniently perform anastomosis operation subsequently, and anastomosis time is shortened. The perfusion catheter is then connected to an extracorporeal circulation machine for extracorporeal circulation. Finally, the surgeon performs anastomosis and other surgical procedures. That is, the medical device provided by the invention provides a clean operation field through the combined action of the balloon and the support body, the extracorporeal circulation is established by using the perfusion catheter, the time of cryogenic stop circulation is reduced, and the anastomosis operation is facilitated through the action of the support body, so that the operation is facilitated.

Thus, surgical treatment of aortic dissection may be performed by maintaining selective antegrade perfusion of the brain when the extracorporeal circulation temperature reaches around 28 ℃, then stopping circulation, opening the aortic arch, implanting the trunk stent and the medical device, then blocking aortic blood flow with the balloon of the blocking mechanism, then resuming circulation, and finally performing anastomosis and other operations. That is, when the medical device is used for the operation treatment of aortic dissection, on one hand, the body temperature of a patient does not need to be reduced to be too low, so that the visceral function and the blood coagulation function of the patient are effectively protected, the damage of related organs of the patient due to long-time ischemia and hypoxia is avoided, and the complications caused by postoperative blood coagulation dysfunction are reduced. On the other hand, blood circulation can be performed in the anastomosis process, so that the pressure of an operator caused by overlong anastomosis time is reduced. Particularly, the perfusion catheter is also provided with the supporting mechanism, and the proximal end of the trunk support is supported by the supporting mechanism, so that the proximal end of the trunk support is tightly attached to the inner wall of the autologous blood vessel of the patient, the anastomosis is convenient, and the operation time is further shortened.

Preferably, the support body is mainly made of metal materials, so that the support body can provide enough radial supporting force when supporting the proximal end of the trunk support, and the proximal end of the trunk support is ensured to be re-expanded and closely attached to the inner wall of the autologous blood vessel.

The invention will be further described in detail with reference to the accompanying drawings, in order to make the objects, advantages and features of the invention more apparent. It is to be noted that the drawings are in a very simplified or schematic form and are to non-precise proportions, merely for convenience and clarity in aiding in the description of embodiments of the invention. The same or similar reference numbers in the drawings refer to the same or similar parts. It should also be understood that the following description is only of the preferred structure of the various components of the medical device, but is not the only implementation and should not be taken as limiting the invention.

Fig. 1 is a schematic view showing a structure of a medical device according to a preferred embodiment of the present invention, and fig. 2 is a schematic view showing a state of use of the medical device.

Referring to fig. 1, the medical device 10 includes an infusion catheter 100, a blocking mechanism 200, and a support mechanism 300. Wherein the perfusion catheter 100 is a hollow structure. The blocking mechanism 200 includes a balloon 210 and a catheter body 220, the balloon 210 is sleeved on the outer surface of the perfusion catheter 100, and the catheter body 220 is communicated with the balloon 210 for perfusing the balloon 210 with the filling agent. The support mechanism 300 includes a support body 310 and a driving body 320, wherein the support body 310 is sleeved on the outer surface of the perfusion catheter 100 and is located at the proximal end of the balloon 210. The driving body 320 is connected to the supporting body 310, and is used for driving the supporting body 310 to expand or contract inwards along the radial direction thereof.

Referring to fig. 2, the procedure for aortic dissection surgical treatment using the medical device and trunk stent is as follows:

First, extracorporeal circulation is established, selective antegrade perfusion to the brain is maintained, and then circulation is stopped.

Next, the patient's aortic arch is opened and the trunk stent 20 is implanted in the descending aortic region of the patient's aorta, the trunk stent 20 expanding to support the descending aortic wall.

Next, the medical device 10 is placed into the aorta with the distal end of the infusion catheter 100 connected to the trunk stent 20, with the balloon 210 disposed in the medial lumen of the trunk stent 20 and the support 310 disposed in the proximal lumen of the trunk stent 20. As is well known to those skilled in the art, the distal end of the infusion catheter 100 may extend from the distal end of the balloon 210 for ease of connection.

Next, the balloon 210 is inflated with an inflation agent using the catheter body 220 to inflate the balloon 210 to conform to the inner wall of the trunk stent 20. The balloon 210 fills and separates the lumen of the trunk stent 20 into two portions that are not in communication with each other, thereby blocking blood circulation in the aorta so that blood in the descending aorta cannot flow back into the aortic arch and aorta.

Then, the driving body 320 is used to drive the support body 310 to expand, and the expanded support body 310 supports the proximal end of the trunk stent 20, so that the proximal end of the trunk stent 20 is tightly attached to the inner wall of the autologous blood vessel of the patient, and blood return between the outer side of the trunk stent 20 and the proximal end breach of the descending aorta is blocked.

Next, the perfusion catheter 100 is connected to an extracorporeal circulation machine, and extracorporeal circulation is resumed.

Finally, anastomosis and other surgical procedures are performed.

That is, in the medical device according to the embodiment of the present invention, the balloon 210 is used to block the aortic blood flow to avoid aortic blood return, and the support 310 is used to support the proximal end of the trunk stent 20 to block the blood return between the trunk stent 20 and the proximal breach of the descending aorta, thereby providing a clean and clear surgical field at the aortic arch and the ascending aorta. The perfusion catheter 100 can be used to restore extracorporeal circulation, thereby reducing the time of circulatory arrest, avoiding the need to lower the body temperature of the patient to be too low, effectively protecting the visceral function and the blood coagulation function of the patient, and greatly reducing complications caused by blood coagulation dysfunction after operation. In addition, the proximal end of the trunk stand 20 is supported by the support 310, so that the trunk stand 20 is attached to the inner wall of the autologous blood vessel, which is convenient for the doctor to perform the anastomosis operation, and facilitates the operation, shortens the anastomosis time, and further shortens the operation time.

In this embodiment, the perfusion catheter 100 is used for performing blood perfusion on the lower body of the patient, so that the perfusion catheter 100 is made of a flexible medical polymer tubing with bending resistance, so that the perfusion catheter 100 can enter any angle of the descending aorta and supply blood for circulation. In this embodiment, the infusion catheter 100 has a diameter of 8mm-12mm. The balloon 210 may be a compliant balloon, which may be expanded according to the size of the trunk stent 20 until it is tightly attached to the inner wall of the trunk stent 20, so as to block the blood return of the descending aorta.

The support body 310 has an expanded state and a contracted state, and the operator switches the support body 310 between the expanded state and the contracted state by driving the proximal end of the support body 310 along the axial direction of the perfusion catheter 100 by the driving body 320. Specifically, the driving body 320 is sleeved on the outer surface of the perfusion catheter 100 and can move along the axial direction of the perfusion catheter 100. The distal end of the support body 310 is fixedly connected with the perfusion catheter 100, such that the distal end of the support body 310 and the perfusion catheter 100 remain relatively stationary, and the proximal end of the support body 310 is fixedly connected with the distal end of the driving body 320, so that the proximal end of the support body 310 can move synchronously with the driving body 320. The support mechanism 300 is configured such that when the drive body 320 is moved toward the distal end of the infusion catheter 100, the proximal end of the support body 310 moves synchronously with the drive body 320 toward the distal end of the infusion catheter 100 to deform the support body 310 to the expanded state. When the driving body 320 moves toward the proximal end of the perfusion catheter 100, the proximal end of the supporting body 310 moves toward the proximal end of the perfusion catheter 100 in synchronization with the driving body 320, so that the shape of the supporting body 310 is restored to the contracted state.

The diameter of the support body 310 in the contracted state is 9mm-13mm, and the maximum diameter of the support body 310 can reach 35mm-40mm when the support body 310 is in the expanded state, the support body 310 having a diameter sufficient to support the proximal end of the trunk stand 20 so as to be in contact with the inner wall of the patient's own blood vessel. Further, the support body 310 is mainly made of a metal material, so that when the support body 310 is in the expanded state, sufficient supporting force can be provided for the proximal end of the trunk stand 20, so that the proximal end of the trunk stand 20 is attached to the inner wall of the autologous blood vessel of the patient.

To achieve the above object, in an alternative embodiment, as shown in fig. 3, the support body 310 is formed by braiding a plurality of braided wires, and at least part of the braided wires are metal wires, preferably all of the braided wires are metal wires. The wire is made of a shape memory alloy such as nickel titanium alloy, and the deformation and recovery of the support body 310 can be achieved by using the high elasticity of the shape memory alloy, thereby switching the support body 310 between the expanded state and the contracted state. As shown in fig. 3, when the support body 310 is in the expanded state, the support body 310 is in a cage-like structure, and as shown in fig. 1, when the support body 310 is in the contracted state, the support body 310 is in a pipe network-like structure. In this embodiment, the distal end of the support body 310 may be fixedly connected to the perfusion catheter 100 through a clip, and the proximal end of the support body 310 may be fixedly connected to the distal end of the driving body 320 through a clip.

The driving body 320 is required to have both good flexibility and good supporting force along the axial direction of the perfusion catheter 100, so that the driving body 320 can push the proximal end of the supporting body 310 to move while following the bending of the perfusion catheter 100, so that the supporting body 310 is switched from the contracted state to the expanded state. Accordingly, as shown in fig. 4, the driving body 320 preferably includes an inner tube 321, a supporting wire 322, and an outer tube 323. The inner tube 321 and the outer tube 323 are polymer tubes, the supporting wire 322 is spirally wound on the outer surface of the inner tube 321, and the outer tube 323 is sleeved on the inner tube 321 to cover the supporting wire 322. The flexibility of the driving body 320 is improved by using the polymer tubes of the inner and outer layers, and the supporting force is improved by using the supporting wires 322, so that the balance effect between the driving body and the supporting wire is achieved.

Further, referring back to fig. 1, the support mechanism 300 further includes a first handle 330, the first handle 330 has an inner cavity passing through axially, and the perfusion catheter 100 movably passes through the inner cavity of the first handle 330, so that the first handle 330 is sleeved on the outer surface of the perfusion catheter 100 and can move along the axial direction of the perfusion catheter 100. The first handle 330 is fixedly connected to the proximal end of the driving body 320. The operator holds the first handle 330, and pushes the first handle 330 to move along the axial direction of the perfusion catheter 100, so as to move the driving body 320, thereby facilitating the operation.

Still further, with continued reference to fig. 1, the support mechanism 300 further includes a locking assembly 340, the locking assembly 340 being disposed on the first handle 330 for selectively connecting and disconnecting the perfusion catheter 100. When the locking assembly 340 is coupled to the infusion catheter 100, the proximal ends of the first handle 330, the driver 320, and the support 310 are prevented from moving axially of the infusion catheter 100. When the locking assembly 340 is disconnected from the infusion catheter 100, the first handle 330, the drive body 320, and the proximal end of the support body 310 are allowed to move in the axial direction of the infusion catheter 100. That is, the locking assembly 340 may be used to lock the state of the support body 310 such that when the support body 310 is in the expanded state and the proximal end of the trunk stent 20 is tightly adhered to the inner wall of the patient's own vessel, the locking assembly 340 is connected to the perfusion catheter 100 to maintain the support body 310 in the expanded state, thereby continuously blocking the blood return between the trunk stent 20 and the lacerations of the proximal end of the descending aorta during the operation, and facilitating the convenient and rapid anastomosis operation by the operator.

Fig. 5 shows a schematic view of an alternative locking assembly 340. As shown in fig. 5, the locking assembly 340 includes a locking part 341 and a nut 342, and the locking part 341 may be fixedly disposed at the proximal end of the first handle 330. The locking part 341 is a hollow tubular structure and is sleeved on the outer surface of the perfusion catheter 100. An external thread is provided on an outer surface of the locking part 341, and a plurality of open grooves 341a are provided at a proximal end of the locking part 341 to divide a proximal side wall of the locking part 341 into a plurality of snaps 341b. The nut 342 is sleeved on the outer surface of the locking portion 341 and is in threaded connection with the locking portion 341, and the nut 342 is screwed down, so that the nut 342 radially extrudes the buckle 341b, and the buckle 341b compresses the outer surface of the infusion catheter 100, so that connection with the infusion catheter 100 is achieved.

Typically, the support 310 is in the contracted state prior to use of the medical device 10. Thus, during a procedure using the medical device 10, the operator drives the drive body 320 by pushing the first handle 330 toward the distal end of the infusion catheter 100 to move the proximal end of the support body 310 toward the distal end of the infusion catheter 100, deforming the support body 310 to the expanded state to support the proximal end of the trunk stent 20. The operator then connects the locking assembly 340 to the infusion catheter 100 by rotating the nut 342 to lock the support 310, after which the operator performs an anastomosis procedure.

Referring back to fig. 1, in the present embodiment, the outer diameter of the catheter body 220 is smaller than the inner diameter of the perfusion catheter 100, and preferably the catheter body 220 is disposed in the perfusion catheter 100, and the distal end of the catheter body 220 is communicated with the balloon 210 after penetrating the distal sidewall of the perfusion catheter 100. In other words, in this embodiment, the catheter body 220, the perfusion catheter 100 and the driving body 320 are nested, so that the medical device 10 is compact and is prevented from being entangled.

With continued reference to fig. 1, the medical device 10 further includes a second handle 400, the second handle 400 being fixedly disposed on the infusion catheter 100 and located proximal to the first handle 330. The blocking mechanism 200 further includes a syringe 230, wherein a distal end of the syringe 230 extends into the infusion catheter 100 through a sidewall of the infusion catheter 100 and is connected to a proximal end of the catheter body 220, and a proximal end of the syringe 230 extends out of the second handle 400. Filling agent is infused into the balloon 210 by connecting the syringe 230 to a syringe to fill the balloon 210. The second handle 400 is provided to facilitate injection operations. Further, the proximal end of the syringe 230 is provided with a one-way valve 240, and when the balloon 210 is inflated to a proper size, the inflation agent is prevented from being discharged from the balloon 210 by the one-way valve 240. The check valve 240 may be attached to the proximal end of the syringe 230 by UV glue.

In other embodiments, the syringe 230 is a helical configuration. Referring to fig. 6 to 8, the first handle 330 is hollow, the syringe 230 is spirally wound inside the first handle 330, and the distal end of the syringe 230 penetrates through the sidewall of the infusion catheter 100, then extends into the infusion catheter 100, and is connected to the proximal end of the catheter body 220. The proximal end of the syringe 230 extends out of the first handle 330 to the outside of the first handle 330. A one-way valve 240 is provided on the proximal end of the syringe 230. In this embodiment, the syringe 230 is made of medical grade PVC material that is stretch deformable such that when the operator drives the first handle 330 toward the distal end of the infusion catheter 100, the proximal end of the syringe 230 stretches and deforms as the first handle 330 moves simultaneously, while the junction of the distal end of the syringe 230 and the catheter body 220 remains relatively stationary, and the syringe 230 springs back when the operator drives the first handle 330 toward the proximal end of the infusion catheter 100. Further, it should be appreciated that for the syringe 230, distal refers to the end that is connected to the catheter body 220 and proximal refers to the end that is remote from the catheter body 220.

The medical device provided by the embodiment of the invention comprises an infusion catheter, a blocking mechanism and a supporting mechanism. The blocking mechanism comprises a balloon and a catheter body, the balloon is sleeved on the outer surface of the perfusion catheter, and the catheter body is communicated with the balloon and is used for perfusing filling agent into the balloon. The support mechanism comprises a support body and a driving body, wherein the support body is sleeved on the outer surface of the perfusion catheter and is positioned at the proximal end of the saccule, and the driving body is connected with the support body and is used for driving the support body to expand outwards or contract inwards along the radial direction of the support body. When the operation treatment of aortic dissection is carried out, the medical device utilizes the saccule to block blood return of the descending aorta, and utilizes the supporting body to re-expand the proximal end of the trunk support so as to block blood return between the outer wall of the trunk support and the breach of the proximal end of the descending aorta, thereby providing clean and clear operation vision. The perfusion catheter is utilized for extracorporeal circulation, so that the deep low-temperature stop circulation time is shortened, the possibility that the important organs of the lower body of the patient are damaged due to low temperature and ischemia is reduced, and the postoperative recovery of the patient is facilitated. In addition, under the effect of the support body, the proximal end of the trunk support is tightly attached to the inner wall of the autologous blood vessel of the patient, so that a doctor can conveniently perform anastomosis operation, and the operation time can be shortened. That is, the medical device can reduce organ damage to a patient, facilitate operation of an operator, and reduce pressure of the operator when applied to surgical treatment of aortic dissection.

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, it is intended that the present invention also include such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims

1. A medical device, comprising:

Irrigation catheter;

The blocking mechanism comprises a balloon and a catheter body; the balloon is arranged on the outer surface of the perfusion catheter; the catheter body is connected with the balloon and is used to perfuse a filling agent into the balloon; and,

The support mechanism comprises a support body and a driving body, wherein the driving body comprises an inner tube body, a supporting wire, and an outer tube body which are sequentially arranged from the inside to the outside; the driving body is sleeved on the outer surface of the perfusion catheter and can move along the axial direction of the perfusion catheter; the support body is arranged on the outer surface of the perfusion catheter and is located at the proximal end side of the balloon; the distal end of the support body is fixedly connected to the perfusion catheter, and the proximal end of the support body is fixedly connected to the distal end of the driving body;

The support mechanism is configured as follows: when the driving body moves toward the distal end of the perfusion catheter, the driving body drives the proximal end of the support body to move toward the distal end of the perfusion catheter, so that the support body is deformed and expands radially outward; when the driving body moves toward the proximal end of the perfusion catheter, the driving body drives the proximal end of the support body to move toward the proximal end of the perfusion catheter, so that the support body contracts radially inward.

2 . The medical device according to claim 1 , wherein the support body is woven from a plurality of braided wires, and at least part of the braided wires are metal wires.

3. The medical device according to claim 1 or 2, characterized in that the maximum diameter of the support body when expanded is 35mm-40mm.

4. The medical device according to claim 1 is characterized in that the supporting mechanism further comprises a first handle, which is arranged on the outer surface of the perfusion catheter and can move axially along the perfusion catheter, and the first handle is fixedly connected to the proximal end of the driving body.

5. The medical device according to claim 4, characterized in that the support mechanism further comprises a locking assembly, the locking assembly being arranged on the first handle and used for selectively connecting or disconnecting with the irrigation catheter;

The support mechanism is configured to: when the locking assembly is connected to the perfusion catheter, prevent the first handle, the driving body and the proximal end of the support body from moving axially along the perfusion catheter; when the locking assembly is disconnected from the perfusion catheter, allow the first handle, the driving body and the proximal end of the support body to move axially along the perfusion catheter.

6. The medical device according to claim 5 is characterized in that the locking assembly includes a locking part and a nut; the locking part is arranged at the proximal end of the first handle and is a hollow tubular structure, the locking part is provided with an external thread, and the proximal end of the locking part is provided with a plurality of open grooves; the nut is used to be sleeved on the outer surface of the locking part and is threadedly connected to the locking part.

7. The medical device according to claim 4, characterized in that the catheter body is inserted into the interior of the perfusion catheter, and the distal end of the catheter body penetrates the distal end wall of the perfusion catheter and is communicated with the balloon.

8. The medical device according to claim 7, characterized in that the blocking mechanism further comprises an injection tube, the injection tube is spirally coiled inside the first handle, and the distal end of the injection tube extends into the perfusion catheter and is connected to the proximal end of the catheter body, and the proximal end of the injection tube penetrates the first handle and extends to the outside of the first handle;

When the first handle moves toward the distal end of the perfusion catheter, the proximal end of the injection tube moves synchronously with the first handle to stretch and deform the injection tube.

9. The medical device according to claim 7, further comprising a second handle, wherein the second handle is disposed on the outer surface of the irrigation catheter and is located at the proximal end of the first handle.

10. The medical device according to claim 9 is characterized in that the blocking mechanism also includes an injection tube, the distal end of the injection tube extends into the perfusion catheter and is connected to the proximal end of the catheter body, and the proximal end of the injection tube passes through the second handle and extends to the outside of the second handle.

11. The medical device according to claim 8 or 10, characterized in that a one-way valve is provided at the proximal end of the injection tube.