A self-fixing vascular catheter for battlefield ex vivo tissue perfusion and preservation

Abstract

The present invention relates to the field of medical technology. The purpose is to provide a self-fixing vascular catheter for battlefield ex vivo tissue perfusion and preservation, comprising a catheter body with an insertion end at one end and a connection end at the other end, the connection end of the catheter body is provided with a pipe joint for connecting to a perfusion tube, and the outer surface of the middle section of the catheter body is provided with a closed water bag that can close the blood vessel after expansion; a water injection joint is also provided on the side wall of the catheter body between the closed water bag and the pipe joint, and the water injection joint is connected to the closed water bag through a water injection pipe. The present invention can be conveniently and quickly fixed on the blood vessels of ex vivo tissues so as to perform remote perfusion of preservation fluid on three-dimensional tissues, which can significantly improve the preservation time limit of ex vivo tissues and the subsequent replantation success rate.

Description

Technical Field

[0001] The invention relates to the field of medical technology, and in particular to a self-fixing vascular catheter used for battlefield ex vivo tissue perfusion and preservation. Background Art

[0002] In recent years, with the advancement of microsurgical techniques and equipment, the survival rate of ex vivo tissue replantation such as severed limbs has been continuously improved, but the time limit of severed limb preservation is the key to the successful replantation and recovery of limb function. Currently, the methods for preserving severed limbs include simple low-temperature preservation, organ preservation fluid immersion preservation, perfusion preservation, hyperbaric oxygen preservation, and temporary ectopic foster preservation. The latter three methods are still limited to animal experiments.

[0003] Currently, the most commonly used method in clinical practice is simple cryopreservation, that is, wrapping the severed limb with sterile gauze, putting it in a plastic bag and immersing it in an ice bath. Limbs containing a large amount of muscle tissue can be preserved for about 4 hours, and fingers and toes with only a small amount of muscle tissue can be preserved for up to 24 hours. Therefore, the clinical replantation time limit is generally 6 hours.

[0004] Organ transplantation is all carried out by perfusion preservation with preservation fluid. The main artery of the donor organ is freed and then cannulated. The proximal artery is ligated to allow the preservation fluid to be perfused to the distal end. This method can significantly increase the preservation time of the organ, but it is not suitable for the perfusion of ex vivo tissue. The arteries in the section of ex vivo tissue are usually relatively small, not fixed in position, and are not sufficiently free to be ligated using conventional methods. In order to address the problem that the time for battlefield evacuation and transportation far exceeds the current preservation time limit for severed limbs, the present invention designs a catheter that is inserted into the arterial blood vessel of the section of ex vivo tissue under the guidance of a guide wire. The catheter is fixed in the blood vessel by a water bag that expands after being injected with water, and the severed end of the blood vessel is sealed at the same time. After the preservation fluid is connected, the preservation fluid can be continuously perfused to the distal and deep parts of the tissue, achieving perfusion preservation of the ex vivo tissue, and increasing the preservation time limit for the ex vivo tissue and the subsequent replantation success rate. Summary of the invention

[0005] The object of the present invention is to provide a self-fixing vascular catheter for battlefield ex vivo tissue perfusion preservation, which can improve the ex vivo tissue preservation time limit and subsequent replantation success rate.

[0006] To achieve the above-mentioned purpose of the invention, the technical solution adopted by the present invention is: a self-fixing vascular catheter for battlefield ex vivo tissue perfusion and preservation, comprising a catheter body with an insertion end at one end and a connecting end at the other end, the connecting end of the catheter body is provided with a pipe joint for connecting to a perfusion tube, and the outer surface of the middle section of the catheter body is provided with a closed water bag capable of closing the blood vessel after expansion; a water injection joint is also provided on the side wall of the catheter body between the closed water bag and the pipe joint, and the water injection joint is connected to the closed water bag through a water injection pipe.

[0007] Preferably, the method further comprises a guide wire which is inserted into the catheter body and is used for guiding the catheter body to be inserted into the blood vessel.

[0008] Preferably, a marking line is provided on the catheter body between the closed water bag and the water injection joint.

[0009] Preferably, the distance between the marking line and the end of the insertion end of the catheter body is 2-3CM.

[0010] Preferably, a side hole is also provided on the side wall of the insertion end of the catheter body.

[0011] Preferably, there are two closed water bags, which are connected by short tubes.

[0012] Preferably, after the closed water bag is expanded, the opposing surfaces are in a relatively meshing serrated shape.

[0013] Preferably, the perfusion tube is provided with a perfusion valve for controlling the on-off of the perfusion tube.

[0014] Preferably, the water injection joint is provided with a one-way control valve which is connected in one direction toward the closed water bag.

[0015] Preferably, the closed water bag, water injection tube, short tube and water injection joint are all made of latex, and the catheter body is made of hard plastic.

[0016] Preferably, the method of use comprises the following steps:

[0017] A. Use sterile saline to rinse the ex vivo tissue, focusing on cleaning the ex vivo tissue section; soak the section in the preservation solution of the sterile preservation bag;

[0018] B. Identify the arterial stump under the surgical magnifying glass and insert the guide wire from the arterial stump to a depth of about 5 cm;

[0019] C. Insert the catheter body into the artery along the guide wire to a depth of about 2-3 cm;

[0020] D. Connect the syringe through the water injection connector, inject enough saline to expand the closed water bag, gently pull up the catheter body to ensure that the catheter body is fixed in the artery and does not fall out, and pull out the guide wire;

[0021] E. Connect one end of the perfusion tube to the liquid source of the preservation solution, open the perfusion valve on the perfusion tube, fill the other end of the perfusion tube with the preservation solution, exhaust the air in the perfusion tube, connect the perfusion tube to the pipe joint on the catheter body, and start perfusion;

[0022] F. When the preservation fluid flowing out of the ex vivo tissue section is basically clear, discard the liquid in the sterile preservation bag, continue to perfuse a sufficient amount of preservation fluid to completely immerse the ex vivo tissue, remove the perfusion tube, and continue to leave the catheter body in the artery for later use. Tie the opening of the sterile preservation bag, place it in an incubator and add ice cubes to store and transport it at 0-4℃.

[0023] The beneficial effects of the present invention are concentrated in: it can be conveniently and quickly fixed on the blood vessels of ex vivo tissues, so as to perform distal perfusion of preservation fluid on three-dimensional tissues, which can significantly improve the preservation period of ex vivo tissues and the subsequent replantation success rate. Specifically, during use, the present invention can use a closed water bag to quickly and stably fix the catheter body in the blood vessel, and the pipe joint can be ideally matched with the existing perfusion tube. It saves perfusion time, effectively perfuses the ex vivo tissue with preservation fluid, and improves the preservation period of ex vivo tissues and the subsequent replantation success rate. The preferably designed guide wire can guide the rapid insertion of the catheter body, and the double-closed water bag can improve the sealing effect, which is generally more convenient to use. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 It is a structural schematic diagram of the present invention;

[0025] Figure 2 It is a schematic diagram of the structure of the closed water bag of the present invention when it is expanded;

[0026] Figure 3 for Figure 2 Enlarged view of part A in the middle. DETAILED DESCRIPTION

[0027] like Figure 1-3 As shown, a self-fixing vascular catheter for battlefield ex vivo tissue perfusion and preservation comprises a catheter body 1 having an insertion end at one end and a connection end at the other end. The connection end of the catheter body 1 is provided with a pipe joint 2 for connecting with a perfusion tube 10. Figure 1 As shown in , the left end is the insertion end of the catheter body 1, and the right end is the connection end. The catheter body 1 (including the pipe joint 2) is generally made of medical grade hard plastic. The pipe joint 2 adopts a standard universal joint, which can be ideally adapted to the existing perfusion tube 10 on the market. Generally, the perfusion tube 10 is provided with a perfusion valve 11 for controlling the on and off of the perfusion tube 10. The perfusion valve 11 can be in the form of a one-way valve to prevent liquid reflux and improve the smoothness of perfusion. The perfusion valve 11 is generally directly arranged on the perfusion tube 10, and of course it can also be arranged on the connection end of the catheter body 1. The size of the catheter body 1, that is, its diameter, can also have different specifications to meet the needs of different blood vessels 0.

[0028] In order to achieve stable self-fixation of the catheter body 1, the outer surface of the middle section of the catheter body 1 of the present invention is provided with a closed water bag 3 that can close the blood vessel 0 after expansion; a water injection joint 4 is also provided on the side wall of the catheter body 1 between the closed water bag 3 and the pipe joint 2, and the water injection joint 4 is connected to the closed water bag 3 through the water injection pipe 5. Liquid can be injected into the closed water bag 3 through the water injection joint 4 and the water injection pipe 5, so that the closed water bag 3 expands and realizes automatic closure of the blood vessel 0. Generally, the closed water bag 3, the water injection pipe 5, the short pipe 9 and the water injection joint 4 are all latex, with good flexibility and biocompatibility. Of course, in order to prevent the injected liquid from flowing out, the present invention can be provided with a one-way control valve 12 that is one-way connected to the closed water bag 3 on the water injection joint 4. When the catheter body 1 needs to be withdrawn, the water injection joint 4 can be cut off. Alternatively, the present invention can directly provide an end cap at the end of the water injection joint 4, and it is also feasible to directly achieve closure using the end cap.

[0029] The specific shapes of the closed water bag 3 are various, and they can be disc-shaped, cone-shaped, cylindrical, etc. The closed water bag 3 can be provided alone, or two or more can be provided, depending on the stable fixation. As shown in the figure, there are two closed water bags 3, and the closed water bags 3 are connected by a short tube 9. On this basis, in order to further improve the sealing stability of the closed water bag 3, the relative surfaces of the closed water bag 3 after expansion can also be relatively meshed serrated. Through the serrated structure, after expansion, it is easier to clamp the blood vessel wall between the two, so that the overall fixation is more stable.

[0030] During use, the present invention can use the closed water bag 3 to quickly and stably fix the catheter body 1 in the blood vessel 0, and the pipe joint 2 can be ideally matched with the existing perfusion tube 10. The perfusion time is saved, and the ex vivo tissue is effectively perfused with the preservation solution, which can improve the preservation time of the ex vivo tissue and the subsequent replantation success rate.

[0031] In order to improve the convenience of inserting the catheter body 1, the present invention may further include a guide wire 6 that is inserted into the catheter body 1 and used to guide the catheter body 1 to be inserted into the blood vessel 0. When in use, the guide wire 6 is first inserted, and then the inserted catheter body 1 is guided by the guide wire 6. After the guiding is completed, the guide wire 6 can be withdrawn.

[0032] In addition, in order to accurately control the depth of the catheter body 1 inserted into the blood vessel 0, a marking line 7 is provided on the catheter body 1 between the closed water bag 3 and the water injection joint 4. Generally, the distance between the marking line 7 and the end of the insertion end of the catheter body 1 is 2-3CM, which can meet the insertion requirements. During the perfusion process, the preservation solution can usually flow out directly from the end of the catheter body 1, but in order to improve the perfusion efficiency, a side hole 8 can also be provided on the side wall of the insertion end of the catheter body 1.

[0033] The method of using the present invention comprises the following steps:

[0034] A. Use sterile saline to rinse the ex vivo tissue, focusing on cleaning the ex vivo tissue section, and removing the detached tissue and impurities covering the section; soak the section in the preservation solution of the sterile preservation bag;

[0035] B. Identify the arterial stump under the surgical magnifying glass and insert the guide wire 6 from the arterial stump to a depth of about 5 cm;

[0036] C. Insert the catheter body 1 into the artery along the guide wire 6 to a depth of about 2-3 cm, based on the marking line 7;

[0037] D. Connect the syringe through the water injection connector 4, inject a sufficient amount of physiological saline to expand the closed water bag 3, gently pull up the catheter body 1, ensure that the catheter body 1 is fixed in the artery and does not fall out, and pull out the guide wire 6;

[0038] E. Connect one end of the perfusion tube 10 to the liquid source of the preservation solution. The liquid source can be a bagged preservation solution. Open the perfusion valve 11 on the perfusion tube 10 to fill the other end of the perfusion tube 10 with the preservation solution to discharge the air in the perfusion tube 10. Of course, when there is a lot of air in the catheter body 1, it should also be discharged. Then connect the perfusion tube 10 to the pipe joint 2 on the catheter body 1 and start perfusion.

[0039] F. When the preservation fluid flowing out of the ex vivo tissue section is basically clear, discard the liquid in the sterile preservation bag, continue to perfuse a sufficient amount of preservation fluid to completely immerse the ex vivo tissue, remove the perfusion tube 10, and continue to leave the catheter body 1 in the artery for later use. Tie the opening of the sterile preservation bag, place it in an incubator and add ice cubes to store and transport it at 0-4℃.

Claims

1. A self-fixating vascular catheter for battlefield ex vivo tissue perfusion and preservation, characterized in that: The catheter body (1) comprises an insertion end at one end and a connection end at the other end, the connection end of the catheter body (1) being provided with a pipe joint (2) for connecting to an irrigation tube (10), and a sealing water bag (3) being provided on the outer surface of the middle section of the catheter body (1) and capable of sealing a blood vessel (0) after expansion; a water injection joint (4) is also provided on the side wall of the catheter body (1) between the sealing water bag (3) and the pipe joint (2), and the water injection joint (4) is connected to the sealing water bag (3) via a water injection pipe (5); The number of the closed water bags (3) is two, and the closed water bags (3) are connected via a short tube (9); After the closed water bag (3) is expanded, the opposing surfaces are in a mutually meshing sawtooth shape; After the two closed water bags (3) are expanded, they can clamp the blood vessel wall between the two closed water bags (3).

2. The self-fixating vascular catheter for battlefield ex vivo tissue perfusion and preservation according to claim 1, characterized in that: It also includes a guide wire (6) which is inserted into the catheter body (1) and is used to guide the catheter body (1) to be inserted into the blood vessel (0).

3. The self-fixating vascular catheter for battlefield ex vivo tissue perfusion and preservation according to claim 2, characterized in that: A marking line (7) is provided on the catheter body (1) between the closed water bag (3) and the water injection joint (4).

4. The self-fixating vascular catheter for battlefield ex vivo tissue perfusion and preservation according to claim 3, characterized in that: The distance between the marking line (7) and the insertion end of the catheter body (1) is 2-3 cm.

5. The self-fixating vascular catheter for battlefield ex vivo tissue perfusion and preservation according to claim 4, characterized in that: A side hole (8) is also provided on the side wall of the insertion end of the catheter body (1).

6. The self-fixating vascular catheter for battlefield ex vivo tissue perfusion and preservation according to claim 5, characterized in that: The perfusion pipe (10) is provided with a perfusion valve (11) for controlling the on / off state of the perfusion pipe (10).

7. The self-fixating vascular catheter for battlefield ex vivo tissue perfusion and preservation according to claim 6, characterized in that: The water injection joint (4) is provided with a one-way control valve (12) which is connected in one direction toward the closed water bag (3).

8. The self-fixating vascular catheter for battlefield ex vivo tissue perfusion and preservation according to claim 7, characterized in that: The method of use includes the following steps: A. Use sterile saline to rinse the ex vivo tissue, focusing on cleaning the ex vivo tissue section; soak the section in the preservation solution of the sterile preservation bag; B. Identify the arterial stump under the surgical magnifying glass and insert the guide wire (6) from the arterial stump to a depth of about 5 cm; C. Insert the catheter body (1) into the artery along the guide wire (6) to a depth of 2-3 cm; D. Connect the syringe through the water injection connector (4), inject a sufficient amount of saline to expand the closed water bag (3), gently pull up the catheter body (1), ensure that the catheter body (1) is fixed in the artery and does not fall out, and remove the guide wire (6); E. Connect one end of the perfusion tube (10) to a liquid source of the preservation solution, open the perfusion valve (11) on the perfusion tube (10), fill the other end of the perfusion tube (10) with the preservation solution, exhaust the air in the perfusion tube (10), connect the perfusion tube (10) to the pipe joint (2) on the catheter body (1), and start perfusion; F. When the preservation solution flowing out of the ex vivo tissue section is basically clear, discard the liquid in the sterile preservation bag and continue to perfuse a sufficient amount of preservation solution to completely immerse the ex vivo tissue. Remove the perfusion tube (10), and continue to leave the catheter body (1) in the artery for later use. Tie the opening of the sterile preservation bag, place it in an incubator and add ice cubes to store and transport it at 0-4 ℃.

Images