CN217286860U - Medical device - Google Patents

Abstract

The utility model provides a medical device, which comprises a perfusion catheter, a first balloon and a second balloon, wherein the perfusion catheter is provided with a perfusion cavity extending along the axial direction, and the far end of the perfusion catheter is provided with a perfusion hole which enables the perfusion cavity to be communicated with the outside; the first balloon and the second balloon are sleeved on the outer peripheral surface of the far end of the perfusion catheter, and the second balloon is positioned on the near end side of the first balloon; still be provided with the first full filling chamber and the second full filling chamber of mutual isolation on the medical device, first full filling chamber with first sacculus intercommunication, the second full filling chamber with second sacculus intercommunication. The medical device can be used in Sunshima surgery to treat aortic dissection with laceration involving the descending aorta, which can provide a clear view for the surgery.

Description

Medical device

Technical Field

The utility model relates to the technical field of medical equipment, concretely relates to medical device.

Background

The aortic dissection refers to a state that blood in an aortic lumen enters an aortic media from a torn part of the aortic intima to separate the media, and expands along the major axis direction of the aorta to form a true-false separation state of two lumens of the aortic wall, and is an aortic disease with critical illness state, rapid progress and high death rate. Dissection hematoma in the middle aorta can cause serious cardiovascular emergencies, and 65% -70% of patients die in the acute stage due to cardiac tamponade, arrhythmia and the like, so that early treatment of aortic dissection is very necessary. At present, the aortic dissection is mainly treated by an operation, wherein a Stanford B-type dissection with a break at a descending aorta is generally treated by an intervention, and a Stanford A-type dissection with a break involving an ascending aorta and an aortic arch is generally treated by a mode of combining an aortic total arch replacement operation and a stent trunk surgery.

The trunk operation is to implant one section of free artificial blood vessel in descending aorta during ascending aorta and aortic arch replacement, so that deep low temperature circulation stopping is not needed during second-stage descending aorta operation. The trunk operation shortens the aorta blocking time and reduces the risk of ischemic complications, but the traditional trunk operation is easy to cause the aorta wall to be torn due to limited visual field and difficult needle insertion and extraction, and meanwhile, the postoperative cerebral complications are easy to occur due to long in-operation stopping circulation time. The state-of-the-art Sunshire's surgery is the classic (i.e., total aortic arch replacement + stenting rhinoplasty) procedure for the treatment of Stanford type A dissections, which further simplifies the procedure, but it also requires a deep hypothermic arrest.

At present, the device for blocking the aorta in the grandson surgery on the market basically only aims at true lumen blood return, but in the case that the laceration of the aortic dissection is affected by descending aorta, the blood return at the laceration can not be prevented, and the blood return at the laceration can also influence the definition of the surgical visual field, which is not beneficial to shortening the anastomosis time.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide a medical device can be applied to the aorta intermediate layer that the broken mouth is tired to descending aorta, shortens the time of stopping the circulation, provides the clear simultaneously and is the operation field of vision.

In order to achieve the above object, the present invention provides a medical device, comprising a perfusion catheter, a first balloon and a second balloon, wherein the perfusion catheter is provided with a perfusion cavity extending along an axial direction, and a perfusion hole for communicating the perfusion cavity with the outside is formed at the distal end of the perfusion catheter; the first balloon and the second balloon are sleeved on the outer peripheral surface of the far end of the perfusion catheter, and the second balloon is positioned on the near end side of the first balloon; still be provided with the first sufficient chamber and the second of mutual isolation on the medical device and be full of the chamber, first sufficient chamber with first sacculus intercommunication, the second be full of the chamber with the second sacculus intercommunication.

Optionally, the first filling lumen and the second filling lumen are both disposed on the perfusion catheter and extend in an axial direction of the perfusion catheter, and are isolated from the perfusion lumen.

Optionally, the distal end of the perfusion lumen has an opening such that the opening of the distal end of the perfusion lumen constitutes the perfusion orifice.

Optionally, the side wall of the distal end of the perfusion catheter is provided with the perfusion hole.

Optionally, the perfusion catheter comprises a shaft and a head end portion, the head end portion is connected to the distal end of the shaft, and the outer diameter of the head end portion is gradually reduced along the proximal direction to the distal direction; the irrigation lumen extends from the proximal end of the shaft to the tip portion, and the first and second inflation lumens each extend within the shaft.

Optionally, the medical device further comprises a connector assembly connected to the proximal end of the perfusion catheter and comprising a first interface, a second interface and a third interface, the first interface being in communication with the perfusion lumen, the second interface being in communication with the first filling lumen, and the third interface being in communication with the second filling lumen.

Optionally, the connector assembly comprises a stress diffusion tube and a connector portion, the stress diffusion tube is connected to the proximal end of the perfusion catheter, the connector portion is connected to the stress diffusion tube, and the connector portion comprises the first interface, the second interface and the third interface.

Optionally, the inner diameter of the perfusion cavity is 4mm to 10 mm.

Optionally, the distance between the proximal end of the first balloon and the distal end of the second balloon in the axial direction of the perfusion catheter is 60mm to 220 mm.

Optionally, the first balloon is a compliant balloon.

Compared with the prior art, the utility model discloses a medical device has following advantage:

the medical device comprises a perfusion catheter, a first balloon and a second balloon, wherein a perfusion cavity extending along the axial direction is arranged on the perfusion catheter, and a perfusion hole for communicating the perfusion cavity with the outside is formed at the far end of the perfusion catheter; the first balloon and the second balloon are sleeved on the outer peripheral surface of the far end of the perfusion catheter, and the second balloon is positioned on the near end side of the first balloon; still be provided with the first sufficient chamber and the second of mutual isolation on the medical device and be full of the chamber, first sufficient chamber with first sacculus intercommunication, the second be full of the chamber with the second sacculus intercommunication. When the medical device is applied to the operation treatment of aortic dissection, an inflating agent is filled into the first balloon by using the first inflating cavity so that the first balloon is inflated to be attached to the inner wall of the trunk stent, so that the interior of the trunk stent is divided into two parts which are not communicated with each other, and the aortic blood return is blocked; the perfusion catheter is connected with an external circulator, and the lower half of the body can be perfused with blood by utilizing the perfusion cavity, so that anastomosis operation can be performed without deep low temperature stop circulation, the deep low temperature stop circulation time in the operation process is obviously shortened, the damage to important organs of the lower half of the body of a patient is reduced, and the postoperative recovery of the patient is facilitated. When the aorta interlayer lacerated opening is affected with descending aorta, the trunk support and the autologous blood vessel can be simply sutured at the lacerated opening, then the second balloon is filled with filling agent by utilizing the second filling cavity, so that the second balloon is filled and supports the trunk support at the lacerated opening, the trunk support is tightly attached to the autologous blood vessel, the lacerated opening is blocked, blood returning at the lacerated opening is blocked, a clear operation visual field is further provided, and on the other hand, the anastomosis operation of doctors is facilitated, and the operation time is further shortened.

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 diagram of a medical device according to an embodiment of the present invention;

fig. 2 is a longitudinal cross-sectional view of an infusion catheter of a medical device according to an embodiment of the present invention;

fig. 3 is a transverse cross-sectional view of an irrigation catheter of a medical device provided in accordance with an embodiment of the present invention;

fig. 4 is a schematic view of an application scenario of the medical device according to an embodiment of the present invention, illustrating a breach of the aortic dissection involving the descending aorta;

fig. 5 is a schematic view of an application scenario of the medical device according to an embodiment of the present invention, illustrating a laceration of the aortic dissection without affecting the descending aorta.

[ reference symbols are explained below ]:

10-a medical device;

100-perfusion catheter, 101-perfusion lumen, 102-perfusion hole, 103-inner tube layer, 104-supporting wire, 105-outer tube layer, 106-first filling hole, 107-second filling hole, 110-shaft, 120-tip, 200-first balloon, 300-second balloon, 400-first filling lumen, 500-second filling lumen, 600-connector assembly, 601-first interface, 602-second interface, 603-third interface, 610-stress diffusion tube, 620-connector portion;

20-trunk support;

30-a suture thread;

40-autologous blood vessels.

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 also be implemented or applied through 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 schematically illustrating the basic concept of the present invention, and the components related to the present invention are only shown in the drawings rather than drawn according to the number, shape and size of the components in actual implementation, and the type, amount and proportion of each component may be changed arbitrarily and the layout of the components may be more complicated.

Furthermore, each embodiment described below has one or more technical features, which does not mean that all technical features of any embodiment need to be implemented simultaneously by a person using the present invention, or that all technical features of 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 and include, for example, either a fixed connection or a releasable connection or an integral connection. 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.

The terms "proximal" and "distal" as used herein refer to the distance of various parts, elements, structures, actions of the medical device relative to the heart during actual use, 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 heart during normal operation, and the term "distal" refers to the end that is farther from the heart during normal operation. Unless the content clearly dictates otherwise.

To make the objects, advantages and features of the present invention more apparent, the present invention will be described in detail with reference to the accompanying drawings. It should be noted that the drawings are in simplified form and are not to precise scale, and are provided for convenience and clarity in order to facilitate the description of the embodiments of the present invention. The same or similar reference numbers in the drawings identify the same or similar elements.

Referring to fig. 1-3, the medical device 10 includes an irrigation catheter 100, a first balloon 200, and a second balloon 300. The perfusion catheter 100 is provided with a perfusion cavity 101 extending along the axial direction, and the perfusion catheter 100 is provided with a perfusion hole 102 for communicating the perfusion cavity 101 with the outside. The first balloon 200 and the second balloon 300 are sleeved on the outer peripheral surface of the distal end of the perfusion catheter 100, and the second balloon 300 is located on the proximal end side of the first balloon 200. The medical device 10 is further provided with a first filling cavity 400 and a second filling cavity 500 which are isolated from each other, the first filling cavity 400 is communicated with the first balloon 200, and the second filling cavity 500 is communicated with the second balloon 300.

Referring to fig. 4, the medical device 10 is used in conjunction with an ivory stent for the surgical treatment of aortic dissections, such as those involved in descending aorta with laceration in Sun's surgery.

In operation, the trunk stent 20 is first placed in the descending aorta, and then the distal end of the medical device 10 is placed in the lumen of the trunk stent 20, wherein the first balloon 200 is located at the distal end of the lumen of the trunk stent 20, and the second balloon 300 is located at the proximal end of the lumen of the trunk stent 20 and may be located at the distal side of the laceration. Next, the operator performs a simple suture of the subject nasal stent 20 with the native blood vessel 40 at the proximal end of the laceration using the suture 30, and then injects a filling agent into the second balloon 300 through the second filling lumen 500 to fill the second balloon 300. Then, the medical device 10 is pulled in the distal-to-proximal direction, so that the proximal end of the second balloon 300 reaches the position where the trunk stent 20 is sutured with the autologous blood vessel 40, and the trunk stent 20 is supported at the sutured position, so that the outer wall of the trunk stent 20 is tightly attached to the autologous blood vessel 40, and the lacerations are blocked, and blood is prevented from flowing back to the proximal end of the descending aorta from the false lumen through the lacerations, and further prevented from flowing back to the aortic arch and ascending aorta. Then, the first balloon 200 is filled with the filling agent through the first filling lumen 400, so that the first balloon 200 fills and supports the trunk stent 20, and the first balloon 200 prevents the backflow of blood from the distal end of the true lumen of the descending aorta to the lumen of the trunk stent 20, and thus prevents the backflow of blood to the aortic arch and ascending aorta. The operator may then connect the perfusion catheter 100 to an extracorporeal circulation machine for extracorporeal circulation to perfuse the lower body of the patient with blood. That is, when the sun's surgery is performed on the aortic dissection with the lacerated descending aorta, the first balloon 200 and the second balloon 300 can be used to block blood flow, so as to achieve the purpose of providing a clear surgical field, and the perfusion catheter 100 is used to establish extracorporeal circulation to reduce the time of deep hypothermia.

Therefore, the grandson's surgery for aortic dissection with laceration involving the descending aorta can be performed according to the following procedure: building extracorporeal circulation, and maintaining the selective antegrade perfusion of brain when the nasopharyngeal temperature reaches 25-28 deg.c; then stopping circulation, opening the aortic arch, trimming the distal anastomosis stoma of the aortic arch part, and then placing the trunk support 20 and the medical device 10; then blocking the blood flow of the false lumen at the laceration with the second balloon 300 and the blood flow of the main artery with the first balloon 200; then the circulation is recovered, and finally the anastomosis operation and other operations are carried out. That is, when the medical device 10 is used to perform surgical treatment on aortic clamping involving the descending aorta, on the one hand, the body temperature of the patient does not need to be lowered too low, so that the visceral function and the blood coagulation function of the patient are effectively protected, the damage of relevant organs of the patient due to long-term ischemia and hypoxia is avoided, and the complications caused by postoperative blood coagulation dysfunction are reduced. On the other hand, the anastomosis process can still carry out blood circulation during the operation, thereby reducing the pressure of the operator caused by overlong anastomosis time. On the other hand, the arrangement of the two balloons can effectively block the backflow of blood to the aortic arch and ascending aorta, and a clear visual field is provided for the operation. After the operation is finished, the first balloon 200 and the second balloon 300 are contracted along the radial direction by discharging the filling agent in the first balloon 200 and the second balloon 300, so that the outer diameter of the medical device 10 is reduced, the medical device 10 is conveniently withdrawn out of the body, and the problem that the medical device 10 cannot be withdrawn after end-to-end anastomosis is avoided.

It is to be understood that the medical device 10 may also be used in conjunction with the trunk support 20 to perform surgical procedures on aortic dissection without involvement of the descending aorta, as shown in fig. 5. In operation, the trunk stent 20 is first placed in the descending aorta, and then the distal end of the medical device 10 is placed in the lumen of the trunk stent 20, wherein the first balloon 200 is located at the distal end of the lumen of the trunk stent 20. Then, the first balloon 200 is filled with the filling agent through the first filling lumen 400, so that the first balloon 200 fills and supports the trunk stent 20, and the first balloon 200 can prevent the blood from flowing back from the true lumen of the descending aorta to the lumen of the trunk stent 20, and further prevent the blood from flowing back to the aortic arch and the ascending aorta. That is, in this case, the second balloon 300 may not be inflated.

In this embodiment, the perfusion catheter 100 has a flexible and kink-resistant property, such that the distal end of the perfusion catheter 100 can enter the lumen of the trunk stent 20 at any suitable angle and communicate with the portion of the descending aorta on the distal side of the first balloon 200 for blood circulation and extracorporeal circulation. To achieve this, as shown in fig. 2, the perfusion catheter 100 may include an inner tube layer 103, a support wire 104, and an outer tube layer 105, wherein the inner tube layer 103 and the outer tube layer 105 are polymer structural layers, the support wire 104 is spirally wound on the outer surface of the inner tube layer 103, and the outer tube layer 105 covers the support wire 104. Such a configuration may improve the flexibility of the irrigation catheter 100 while also ensuring that the irrigation catheter 100 does not deform or break when bent.

With continued reference to fig. 1 and 2, the irrigation catheter 100 includes a shaft 110 and a tip 120. The tip portion 120 is connected to the distal end of the tube body 110, and preferably the tip portion 120 is tapered with an outer diameter that decreases in a proximal direction to a distal direction to facilitate introduction of the distal end of the perfusion catheter 100 into the lumen of the trunk support 20.

The infusion lumen 101 may extend along the proximal end of the shaft 110 to the distal end of the head portion 120 such that the infusion lumen 101 extends axially through the infusion catheter 100. In this way, extracorporeal circulation can be performed using the opening of the distal end of the perfusion chamber 101 as the perfusion orifice 102. Furthermore, a plurality of pouring holes 102 may be additionally formed in the sidewall of the head portion 120 to increase the pouring amount of the pouring cavity 101. Of course, in alternative implementations, the distal end of the perfusion chamber extends to the head end, but the distal end of the perfusion chamber is closed, and only the side wall of the head end is provided with perfusion holes (not shown). Optionally, the inner diameter of the perfusion cavity 101 may be 4mm to 10mm, specifically set according to the perfusion amount.

Further preferably, referring to fig. 1 to 3, the first filling lumen 400 and the second filling lumen 500 are both disposed on the perfusion catheter 100, so that the medical device 10 has a smaller outer diameter when the first balloon 200 and the second balloon 300 are in the contracted state, thereby facilitating the delivery and reducing the damage to the native blood vessel 40. The first filling lumen 400 and the second filling lumen 500 extend in the axial direction of the perfusion catheter 100 and are isolated from the perfusion lumen 101. Generally, the first filling cavity 400 and the second filling cavity 500 extend only in the tube body 110, a first filling hole 106 and a second filling hole 107 are formed in the tube body 110, the first filling hole 106 is used for communicating the first filling cavity 400 with the first balloon 200, so that the filling agent can enter the first balloon 200 from the first filling cavity 400 through the first filling hole 106, and further expand the first balloon 200; the second filling aperture 107 is used to communicate the second filling lumen 500 with the second balloon 300, so that the filling agent can be infused from the second filling lumen 500 to the second balloon 300 through the second filling aperture 107, thereby expanding the second balloon 300. The filling agent may be a gas or a liquid such as physiological saline or the like.

In an alternative implementation, the medical device comprises a first infusion tube and a second infusion tube independent of the infusion catheter, the lumen of the first infusion tube constituting the first filling lumen and the second infusion tube constituting the second filling lumen (not shown in the figures).

In this embodiment, the first balloon 200 may be a compliant balloon, and the material thereof includes, but is not limited to, TPU or silicone. When the first balloon 200 is inflated, the maximum outer diameter thereof may be 26mm to 42 mm. The first balloon 200 may be hermetically connected to the outer peripheral surface of the distal end of the perfusion catheter 100 by means of heat fusion or laser welding.

The second balloon 300 may be a compliant balloon, a semi-compliant balloon, or a non-compliant balloon, and the material thereof includes but is not limited to any one of TPU, PVC, PA, silicone, nylon, Pebax, and polyurethane. When the second balloon 300 is inflated and expanded, the maximum outer diameter of the second balloon 300 is 16mm to 40 mm. The second balloon 300 may be hermetically connected to the outer peripheral surface of the distal end of the perfusion catheter 100 by means of heat fusion or laser welding.

In addition, the distance between the distal end of the second balloon 300 and the proximal end of the first balloon 200 in the axial direction of the perfusion catheter 100 is 60mm to 220mm, and the distance is configured according to the length of the trunk stent 20, and the configuration is based on the standard that when the second balloon 300 is located at the proximal edge of the inner cavity of the trunk stent 20, the first balloon 200 is located at the distal end of the inner cavity of the trunk stent 20 without extending out of the trunk stent 20, so that the risk that the first balloon 200 damages the inner membrane of the autologous blood vessel does not occur.

Referring to fig. 1, 4 and 5, the medical device 10 further includes a connector assembly 600. The connector assembly 600 is connected to the proximal end of the perfusion catheter 100 and comprises a first interface 601, a second interface 602 and a third interface 603. Wherein the first interface 601 is communicated with the perfusion cavity 101, and is used for communicating with an external circulator to perform extracorporeal circulation. The second port 602 communicates with the first filling chamber 400 for communication with a syringe-like device for filling the first filling chamber 400 with the filling agent or for draining the filling agent from the first filling chamber 400. The third port 603 communicates with the second filling lumen 500 for communication with a syringe-like device for filling the second filling lumen 500 with the filling agent or for draining the filling agent from the second filling lumen 500.

Further, the connector assembly 600 includes a stress diffusion tube 610 and a connector portion 620, the stress diffusion tube 610 is connected to the proximal end of the perfusion catheter 100, the connector portion 620 is connected to the proximal end of the stress diffusion tube 610, and the connector portion 620 includes the first connector 601, the second connector 602, and the third connector 603. By providing the stress diffusion tube 610 between the joint part 620 and the perfusion catheter 100, stress at the distal end of the joint part 620 and at the proximal end of the perfusion catheter 100 can be diffused, avoiding stress concentration.

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 (10)

1. A medical device is characterized by comprising a perfusion catheter, a first balloon and a second balloon, wherein the perfusion catheter is provided with a perfusion cavity extending along the axial direction, and the far end of the perfusion catheter is provided with a perfusion hole which enables the perfusion cavity to be communicated with the outside; the first balloon and the second balloon are sleeved on the outer peripheral surface of the far end of the perfusion catheter, and the second balloon is positioned on the near end side of the first balloon; still be provided with the first full filling chamber and the second full filling chamber of mutual isolation on the medical device, first full filling chamber with first sacculus intercommunication, the second full filling chamber with second sacculus intercommunication.

2. The medical device of claim 1, wherein the first and second filling lumens are each disposed on the infusion catheter and extend axially of the infusion catheter and are isolated from the infusion lumen.

3. The medical device of claim 1, wherein the distal end of the perfusion lumen has an opening such that the opening of the distal end of the perfusion lumen constitutes the perfusion orifice.

4. The medical device of claim 1 or 3, wherein the distal sidewall of the irrigation conduit is provided with the irrigation hole.

5. The medical device of claim 2, wherein the irrigation catheter comprises a shaft and a tip portion, the tip portion being connected to a distal end of the shaft, and an outer diameter of the tip portion gradually decreasing in a proximal to distal direction; the perfusion lumen extends from the proximal end of the shaft to the tip portion, the first and second filling lumens both extending within the shaft.

6. The medical device of claim 2, further comprising a connector assembly connected to the proximal end of the perfusion catheter and including a first port in communication with the perfusion lumen, a second port in communication with the first filling lumen, and a third port in communication with the second filling lumen.

7. The medical device of claim 6, wherein the connector assembly comprises a stress spreader tube connected to a proximal end of the infusion catheter and a connector portion connected to the stress spreader tube, the connector portion comprising the first, second, and third interfaces.

8. The medical device of claim 1, wherein the inner diameter of the perfusion lumen is between 4mm and 10 mm.

9. The medical device of claim 1, wherein the distance between the proximal end of the first balloon and the distal end of the second balloon in the axial direction of the perfusion catheter is 60mm to 220 mm.

10. The medical device of claim 1, wherein the first balloon is a compliant balloon.

Images