CN116271305A

CN116271305A - ECMO is with self-expanding backward flow intubate

Info

Publication number: CN116271305A
Application number: CN202310118341.8A
Authority: CN
Inventors: 陈增胜; 席一峰; 樊瑜波; 邓小燕
Original assignee: Beihang University
Current assignee: Beihang University
Priority date: 2023-01-30
Filing date: 2023-01-30
Publication date: 2023-06-23

Abstract

The utility model discloses a self-expanding reflux cannula for ECMO, which relates to the technical field of medical appliances and comprises the following components: the implantation tube comprises an inner tectorial membrane, an outer tectorial membrane and a self-expanding vascular stent, wherein the inner tectorial membrane is laid on the inner wall of the self-expanding vascular stent, and the outer tectorial membrane is laid on the outer wall of the self-expanding vascular stent; the self-expanding vascular stent is of a net tubular structure and can radially stretch, and the inner covering film and the outer covering film are tubular and can radially stretch along with the self-expanding vascular stent; a sleeve sleeved on the implant, the sleeve being separable from the implant, the sleeve being adapted to maintain the implant in a radially contracted state; one end of the connecting pipe is communicated with one end of the implantation tube, and the other end of the connecting pipe is used for being communicated with an arterial blood outlet of the ECMO system; the implantation tube, the sleeve and the connecting tube are all flexible tubes. The intubation tube can be adapted to various blood vessels with different sizes, can avoid arterial vascular injury caused by expanding the blood vessels, and can also supply blood to distal limbs.

Description

ECMO is with self-expanding backward flow intubate

Technical Field

The utility model relates to the technical field of medical instruments, in particular to a self-expanding reflux cannula for ECMO.

Background

The cannula is a key component in an extracorporeal membrane pulmonary oxygenation (ECMO) system, is directly connected with a human blood vessel, plays a role in connecting an extracorporeal circulation pipeline of the ECMO system with a human blood vessel bridge, and plays a vital role in normal function of the ECMO system. One ECMO system includes two cannulas, one cannula is for drawing venous blood of a human body and is also called a drainage tube, and the other cannula is for sending arterial blood after the ECMO system is oxygenated back to the blood vessel of the human body and is also called a return tube.

In clinical treatment with the ECMO system, venous-arterial (VA) catheterization is a common way to withdraw blood from the vein through a venous catheterization, and arterial blood after oxygenation by the ECMO system is returned from the vein to the body. Because ECMO system is often very high in flow rate when carrying out heart and lung failure patient support, if the intubate of internal diameter is less to the selection, can lead to blood perfusion resistance to increase, and the same volume of perfusing just needs higher blood pump rotational speed to realize, and this also leads to the blood damage that ECMO caused to also aggravate. Therefore, in general, when selecting a cannula, a cannula having a relatively large inner diameter is selected according to the size of an arterial blood vessel of a patient. While arterial cannulas (return lines) often require one or more vasodilation procedures to dilate the implanted vessel prior to implantation, such procedures often damage the vessel on the implanted side and cause complications such as bleeding, vascular rupture, etc.

Venous blood is led out through femoral vein, arterial blood after the oxygenation of ECMO is returned to human body through femoral artery cannula, and the method for assisting ECMO in first aid is established rapidly. In trans-femoral VA-ECMO, the arterial distal ischemic complications of the femoral artery often occur when oxygenated blood is returned to the femoral artery through an arterial cannula. Because the blood return direction of the intubation tube in the market at present is only one direction, after the femoral artery intubation tube is inserted into the femoral artery, blood can only be ensured to supply blood to the abdominal aorta, the aortic arch, the carotid artery and the like along the femoral artery, and the distal extremity of the femoral artery, such as the lower leg and the foot, can possibly have insufficient blood supply. Long-term support, for example, can lead to long-term ischemia of the lower extremities, and the lower leg and foot can be at risk of necrosis.

For femoral artery cannulas, there is no ECMO artery cannula capable of directly providing blood perfusion to the lower limb in clinic, so that a clinical doctor can only provide blood perfusion to the distal limb by adding a perfusion bypass to the distal limb at the cannulated site. This approach, while solving the problem of VA-ECMO femoral artery cannulation distal extremity ischemia, increases the complexity of the procedure. Setting up the perfusion bypass requires making an incision in the patient's lower limb vessel, inserting the bypass perfusion tube, allowing for inherently complex ECMO procedures, adding complexity and increasing patient pain.

Disclosure of Invention

The utility model aims to provide a self-expanding reflux cannula for ECMO, which solves the problems in the prior art and avoids the defects that ECMO operation cannot be performed due to thin blood vessels and arterial vessel injury is caused by too thick expansion tube when the blood vessels are expanded before the cannula.

In order to achieve the above object, the present utility model provides the following solutions:

the utility model provides a self-expanding reflux cannula for ECMO, comprising:

the implant comprises an inner tectorial membrane, an outer tectorial membrane and a self-expanding vascular stent, wherein the inner tectorial membrane is laid on the inner wall of the self-expanding vascular stent, and the outer tectorial membrane is laid on the outer wall of the self-expanding vascular stent; the self-expanding vascular stent is of a net tubular structure and can radially stretch, and the inner covering film and the outer covering film are tubular and can radially stretch along with the self-expanding vascular stent;

a sleeve sleeved on the implant tube, wherein the sleeve can be separated from the implant tube and is used for maintaining the implant tube in a radial contracted state;

one end of the connecting pipe is communicated with one end of the implantation tube, and the other end of the connecting pipe is used for being communicated with an arterial blood outlet of the ECMO system; the implant tube, the cannula and the connecting tube are flexible tubes.

Preferably, the device further comprises a shunt structure, wherein the shunt structure comprises a cylindrical shunt membrane and a shunt hole arranged on the wall of the implant tube, and the shunt hole penetrates through the inner tectorial membrane, the self-expanding vascular stent and the outer tectorial membrane; the diameter of the cylindrical shunt membrane is gradually increased from one end to the other end, and the necking end of the cylindrical shunt membrane is fixedly connected with the outer wall of the implant; a gap is formed between the flaring end of the cylindrical shunt membrane and the outer wall of the implantation tube; the diversion hole is positioned between the necking end and the flaring end; and the flaring end is closer to the connecting pipe than the necking end.

Preferably, the number of the shunt holes is at least one.

Preferably, a protruding portion is arranged on the outer wall of the sleeve close to one end of the connecting pipe.

Preferably, the protruding portion is annular.

Preferably, the inner coating and the outer coating are biocompatible elastic films; the inner wall of the inner coating film and the outer wall of the outer coating film are coated with anticoagulant drugs.

Preferably, the surface of the end of the implant tube far from the connecting tube is rounded.

Preferably, a connecting ring is arranged at one end of the implant tube connected with the connecting tube, a plurality of convex rings are arranged on the outer wall of the connecting ring, a plurality of annular grooves are arranged on the inner wall of one end of the connecting tube connected with the implant tube, the annular grooves correspond to the convex rings one by one, and the annular grooves can be clamped with the corresponding convex rings; the connecting ring and the convex ring are made of elastic materials.

Preferably, the length of the sleeve is greater than or equal to the length of the implant tube, and the inner diameter of the sleeve is greater than the outer diameter of the connection tube.

Compared with the prior art, the utility model has the following technical effects:

the self-expanding reflux cannula for ECMO can be inserted into an arterial vessel on the premise of not expanding the arterial vessel, so that arterial vessel injury caused by expanding the vessel is avoided; since the implantation tube is maintained in a thin state under the action of the sleeve, the self-expanding reflux cannula for ECMO can be inserted into thin blood vessels, and can adapt to various blood vessels with different sizes from thick to thin. At present, different cannulas are required to be selected according to different blood vessels of different positions of different patients clinically, so that a plurality of cannulas with different sizes are required to be processed during production and processing, hundreds of cannulas with different sizes are available on the market at present, and the cannulas designed by the utility model can be adapted to the blood vessels with different sizes, and one cannula can replace a plurality of clinical reflux cannulas on the market at present.

Furthermore, the self-expanding reflux cannula for ECMO of the present utility model is used by guiding the implantation of the self-expanding reflux cannula into the artery through a guide wire, and does not need to be inserted into the expanding tube for multiple times to expand the arterial vessel.

Furthermore, the implantation tube in the self-expansion reflux cannula for ECMO has the characteristic of self-expansion tube diameter, the implantation tube is in a compressed state before implantation, the self-expansion vascular stent is stretched to expand the inner covering film and the outer covering film through the extraction of the cannula after implantation, a vascular access is formed, the implantation tube can be expanded until the outer covering film is attached to the inner wall of a blood vessel under the pressure of blood, the operation of expanding the blood vessel before the implantation of the ECMO cannula is reduced, and the risk of damaging the wall of the blood vessel at the implantation side due to the overlarge diameter of the cannula is reduced.

Furthermore, the self-expanding backflow cannula for ECMO is provided with a diversion structure, one part of blood in the implantation tube always flows into an arterial vessel in the implantation tube, and the other part flows out through the diversion hole and flows into the arterial vessel in the other direction, so that the distal limb of the femoral artery is supplied with blood; can be used for solving the problem of ischemia at the distal end of the VA-ECMO femoral artery cannula, does not need to establish bypass perfusion, does not increase the complexity of operation, can supply oxygenated blood for the upper limb organ and simultaneously can supply blood for the distal end (lower leg, foot, etc.), does not need to additionally increase bypass perfusion operation, and is convenient to use.

Still further, the self-expanding reflux cannula for ECMO of the present utility model not only can solve the problem of the remote limb ischemia of the VA-ECMO femoral artery cannula, but also can be applied to the blood supply of other arterial vessels with the problem of the remote limb ischemia, such as common carotid artery, axillary artery, etc.; for example, the self-expanding reflux cannula for ECMO of the present utility model can be used to supply blood to the brain using a shunt structure when applied to the common carotid artery, and can be used to supply blood to the side branch when applied to the axillary artery. In summary, there are theoretically arterial vessels that need to be shunted that can be used with the self-expanding reflux cannulas for ECMO of the utility model, i.e., the applicability of the utility model is high.

Drawings

In order to more clearly illustrate the embodiments of the present utility model or the technical solutions of the prior art, the drawings that are needed in the embodiments will be briefly described below, it being obvious that the drawings in the following description are only some embodiments of the present utility model, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic view of a part of a self-expanding reflux cannula for ECMO according to the present utility model;

FIG. 2 is a schematic view of a portion of the self-expanding reflux cannula for ECMO according to the present utility model;

FIG. 3 is a schematic view of a portion of the self-expanding reflux cannula for ECMO according to the present utility model;

FIG. 4 is a schematic view of a portion of the self-expanding reflux cannula for ECMO according to the present utility model;

FIG. 5 is a schematic view of a portion of the self-expanding reflux cannula for ECMO according to the present utility model;

fig. 6 is a schematic view of the blood flow structure of the self-expanding reflux cannula for ECMO of the present utility model during operation.

Wherein, 1, an implantation tube; 101. an outer coating film; 102. self-expanding vascular stents; 103. an inner coating film; 104. a diversion aperture; 2. a sleeve; 201. a boss; 3. a cylindrical split-flow film; 4. a connecting pipe; 5. a connecting ring; 501. a convex ring.

Detailed Description

The following description of the embodiments of the present utility model will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present utility model, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the utility model without making any inventive effort, are intended to be within the scope of the utility model.

The utility model aims to provide a self-expanding reflux intubation tube for ECMO, which solves the problems of the prior art, such as incapability of performing ECMO operation due to thin blood vessels, arterial vessel injury caused by too thick expanded tube when the blood vessels are expanded before intubation, and distal limb ischemia caused after insertion of the ECMO reflux intubation tube.

In order that the above-recited objects, features and advantages of the present utility model will become more readily apparent, a more particular description of the utility model will be rendered by reference to the appended drawings and appended detailed description.

As shown in fig. 1 to 6, the present embodiment provides a self-expanding reflux cannula for ECMO, including an implant 1, a cannula 2, a connection tube 4, and a shunt structure.

Wherein, the implantation tube 1 comprises an inner coating 103, an outer coating 101 and a self-expanding vascular stent 102, wherein the inner coating 103 is laid on the inner wall of the self-expanding vascular stent 102, and the outer coating 101 is laid on the outer wall of the self-expanding vascular stent 102; the self-expandable vascular stent 102 is of a net tubular structure and can radially expand and contract, and the inner covering film 103 and the outer covering film 101 are tubular and can radially expand and contract along with the self-expandable vascular stent 102; the inner coating film 103 and the outer coating film 101 are biocompatible elastic films, and the contact surface of the elastic films and the blood vessel is smooth and does not damage the blood vessel; the inner wall of the inner coating 103 and the outer wall of the outer coating 101 are coated with an anticoagulant drug which serves to reduce the risk of thrombosis at the cannula.

It should be noted that, the self-expandable vascular stent 102 is made of a titanium-nickel shape memory alloy, which has good biocompatibility and corrosion resistance, especially has peculiar super-elasticity and memory property, and the alloy wire is softer at 0-10 ℃, can be deformed into a shape which is easy to be placed into a thinner catheter, and is sent into a predetermined narrow position in the body through the catheter, and the stent is quickly restored to the original shape at body temperature, at this time, the material is hardened, and a continuous soft restoring force is generated, so as to achieve the expanding supporting function. The support is in a super-elastic state in vivo for a long time, the elasticity is not increased along with the increase of the deformation quantity, the recoverable deformation quantity is large, the deformation resistance is moderate, and the fatigue performance is good, which is incomparable with other materials. The self-expanding stent 102 is a mature product, such as the patent of 201480040823.5, 200420022330.2 and 200620057977.8; the specific structure of the self-expanding stent 102 will not be described in detail.

Since the inner and

outer covers

103, 101 need to expand and contract radially with the self-expanding stent 102, elastic membranes are required for both the inner and outer covers.

The shunt structure comprises a cylindrical shunt membrane 3 and two shunt holes 104 arranged on the wall of the implant tube 1, wherein the shunt holes 104 penetrate through the inner tectorial membrane 103, the self-expanding vascular stent 102 and the outer tectorial membrane 101; the tubular split-flow film 3 is sleeved on the implantation tube 1, and the diameter of the tubular split-flow film is gradually increased from one end to the other end, namely, the smaller end of the tubular split-flow film 3 is a necking end, and the larger end is a flaring end; the necking end of the cylindrical shunt membrane 3 is fixedly connected with the outer wall of the implantation tube 1; a gap is reserved between the flaring end of the cylindrical shunt membrane 3 and the outer wall of the implantation tube 1; the tap hole 104 is positioned between the necking end and the flaring end; and the flared end is closer to the connecting tube 4 than the necked end.

The sleeve 2 is sleeved on the implantation tube 1, the sleeve 2 can be separated from the implantation tube 1, namely, the sleeve 2 and the implantation tube 1 are not connected together, and the sleeve 2 is used for maintaining the implantation tube 1 in a radial contracted state; when the sleeve 2 is sleeved on the implant 1, the cylindrical shunt membrane 3 in the shunt structure is clamped between the sleeve 2 and the implant 1.

In this embodiment, an annular protruding portion 201 is disposed on the outer wall of the sleeve 2 near one end of the connecting tube 4, and the annular protruding portion 201 can facilitate the doctor to exert force on the sleeve 2 when withdrawing the sleeve 2. The length of the sleeve 2 is greater than or equal to the length of the implant 1, and the inner diameter of the sleeve 2 is greater than the outer diameter of the connection tube 4.

One end of the connecting tube 4 is communicated with one end of the implantation tube 1, and the other end of the connecting tube 4 is used for communicating with an arterial blood outlet of the ECMO system, namely, the implantation tube 1 is used for communicating with the arterial blood outlet of the ECMO system through the connecting tube 4.

In this embodiment, a connecting ring 5 is disposed at one end of the implant tube 1 connected with the connecting tube 4, a plurality of convex rings 501 are disposed on the outer wall of the connecting ring 5, a plurality of annular grooves are disposed on the inner wall of one end of the connecting tube 4 connected with the implant tube 1, the annular grooves correspond to the convex rings 501 one by one, and the annular grooves can be clamped with the corresponding convex rings 501; the connecting ring 5 and the convex ring 501 are made of elastic materials; make implant 1 and connecting pipe 4 pass through bulge loop 501 and annular joint, can conveniently connect to improve the connection speed, because go-between 5 and bulge loop 501 all adopt elastic material to make so when connecting, go-between 5 and bulge loop 501 can produce certain deformation, thereby conveniently insert go-between 5 in connecting pipe 4, also make things convenient for bulge loop 501 card into in the annular that corresponds.

In this embodiment, the implantation tube 1, the sleeve 2 and the connection tube 4 are all flexible tubes, and the flexible tubes can meet the requirements of the surgical environment.

In this embodiment, the surface of the end of the implant tube 1 far from the connecting tube 4 is smooth, so as to avoid damage to the arterial vessel caused by the existence of the tip when the implant tube 1 is implanted into the arterial vessel.

The specific use procedure of the self-expanding reflux cannula for ECMO provided in this example is as follows:

firstly, a connecting ring 5 at the end part of an implant tube 1 is plugged into one end of a connecting tube 4 provided with a ring groove, so that each convex ring 501 is clamped in the corresponding ring groove; then the tubular split-flow film 3 is stuck to the outer wall of the implantation tube 1, the sleeve 2 is sleeved on the implantation tube 1 from one end of the implantation tube 1 far away from the connecting tube 4 to the other end, and the implantation tube 1 is in a contracted state under the action of the sleeve 2; then, the end of the implant tube 1 far away from the connecting tube 4 is penetrated into the femoral artery of the patient, and then the sleeve 2 is withdrawn, and then the connecting tube 4 is communicated with the arterial blood outlet of the ECMO system;

after the cannula 2 is extracted and arterial blood in the ECMO system is pumped into the self-expanding reflux cannula for ECMO in the embodiment, the self-expanding vascular stent 102 in the implant 1 is self-expanded under the action of blood pressure, meanwhile, the inner coating 103 and the outer coating 101 are expanded along with the self-expanding vascular stent 102, the inner coating 103 forms a smooth blood flow path, and simultaneously, the implant 1 can be expanded until the outer coating 101 is attached to the inner wall of a blood vessel under the pressure of blood;

one part of blood in the implantation tube 1 always flows into the femoral artery blood vessel in the implantation tube 1, the other part flows out through the shunt hole 104 (see fig. 6), the tubular shunt membrane 3 is opened under the action of blood flow to form a shunt passage, so that the blood vessel can not block the shunt hole 104 on one hand, and the direct damage of blood impact to the blood vessel can be reduced on the other hand; then flows into the femoral artery vessel at the distal extremity through the other direction, thereby supplying blood to the distal extremity of the femoral artery; when the embodiment is adopted to provide the self-expanding reflux cannula for the reflux perfusion of the lower limb femoral artery of the VA-ECMO, the bi-directional blood supply can be carried out, the cylindrical shunt membrane 3 can effectively prevent the blood vessel from blocking the shunt hole 104, and can provide blood perfusion for the distal limb end (lower leg, foot and the like) while meeting the requirement of the oxygenation arterial blood perfusion of the upper limb organ, thereby avoiding additional bypass perfusion operation, reducing the complexity of the operation and relieving the pain of patients.

The principles and embodiments of the present utility model have been described in detail with reference to specific examples, which are provided to facilitate understanding of the method and core ideas of the present utility model; also, it is within the scope of the present utility model to be modified by those of ordinary skill in the art in light of the present teachings. In view of the foregoing, this description should not be construed as limiting the utility model.

Claims

1. A self-expanding reflux cannula for ECMO comprising:

2. The self-expanding reflow cannula for ECMO of claim 1, wherein: the device also comprises a shunt structure, wherein the shunt structure comprises a cylindrical shunt membrane and a shunt hole arranged on the wall of the implant tube, and the shunt hole penetrates through the inner tectorial membrane, the self-expanding vascular stent and the outer tectorial membrane; the diameter of the cylindrical shunt membrane is gradually increased from one end to the other end, and the necking end of the cylindrical shunt membrane is fixedly connected with the outer wall of the implant; a gap is formed between the flaring end of the cylindrical shunt membrane and the outer wall of the implantation tube; the diversion hole is positioned between the necking end and the flaring end; and the flaring end is closer to the connecting pipe than the necking end.

3. The self-expanding reflow cannula for ECMO of claim 2, wherein: the number of the shunt holes is at least one.

4. The self-expanding reflow cannula for ECMO of claim 1, wherein: the sleeve is provided with a protruding part on the outer wall of one end of the connecting pipe.

5. The self-expanding reflow cannula for ECMO of claim 4, wherein: the protruding portion is annular.

6. The self-expanding reflow cannula for ECMO of claim 1, wherein: the inner coating film and the outer coating film are biocompatible elastic films; the inner wall of the inner coating film and the outer wall of the outer coating film are coated with anticoagulant drugs.

7. The self-expanding reflow cannula for ECMO of claim 1, wherein: the surface of one end of the implant tube far away from the connecting tube is smooth.

8. The self-expanding reflow cannula for ECMO of claim 1, wherein: the implant comprises an implant body, a connecting pipe, a plurality of annular grooves, a plurality of convex rings, a plurality of connecting rings and a plurality of connecting rods, wherein the connecting ring is arranged at one end of the implant body, connected with the connecting pipe, the convex rings are arranged at the other end of the connecting pipe, the annular grooves are in one-to-one correspondence with the convex rings, and the annular grooves can be clamped with the corresponding convex rings; the connecting ring and the convex ring are made of elastic materials.

9. The self-expanding reflow cannula for ECMO of claim 1, wherein: the length of the sleeve is greater than or equal to the length of the implant tube, and the inner diameter of the sleeve is greater than the outer diameter of the connecting tube.