RU2812597C1 - Method of temporary extracorporeal perfusion of limb - Google Patents

Abstract

FIELD: medicine; emergency limb surgery; transplantology.

SUBSTANCE: invention can be used to maintain perfusion of a limb deprived of main and collateral circulation. If the main arteries are damaged in the venous-arterial mode, puncture cannulation of the femoral or jugular vein is performed with a 12–15 Fr cannula and retrograde cannulation of the distal artery of the damaged limb with a 6–10 Fr cannula. If the lower extremity is injured, the posterior tibial artery is cannulated. If the upper limb is damaged, the radial or ulnar artery is cannulated. After cannulation, a perfusion circuit is connected, consisting of hollow connecting tubes, an oxygenator and a portable extracorporeal membrane oxygenation device. Through a 12–15 Fr cannula installed in the femoral or jugular vein, venous blood is collected and passed through a perfusion circuit at a rate of 0.4 l/min. Oxygenated blood is returned through a 6–10 Fr cannula into the posterior tibial or radial or ulnar artery and fills the arterial bed in a retrograde manner.

EFFECT: claimed method makes it possible to maintain the vital activity of the tissues of the injured limb for 10 hours or more, if necessary, until the patient’s condition is stabilized, which in turn ensures a more complete restoration of blood flow and the ischemic limb.

1 cl, 12 dwg, 2 ex

Description

The invention relates to medicine, in particular to the field of emergency limb surgery and transplantology, and can be used to maintain perfusion of a limb deprived of main and collateral circulation. Temporary extracorporeal perfusion of the limb in emergency surgery and transplantation has not been used previously.

The traditional option for restoring limb perfusion is surgery: thrombus/embolectomy, temporary artery replacement, lateral or circular suture, bypass surgery. Currently, in emergency surgery, there is a method to solve the problem of restoring perfusion using an amputee bag (Patent No.: EP0159209B1). In it, the limb is kept in sterile conditions and is subject to hypothermia. The state of hypothermia allows you to delay irreversible tissue ischemia caused by oxygen deficiency by reducing metabolism in the tissues of the limb. The amputated bag allows you to delay the time of replantation by 8-10 hours. However, the significant disadvantages of the amputated bag include an exclusively passive effect on the metabolism of the limb, which consists in suppressing oxidation mechanisms: reducing the activity of respiratory enzymes through dry sterile cooling of the limb segment separated from the human body. With prolonged hypoxia, oxidation products accumulate in the tissues of the limb, which during replantation can enter the general bloodstream and cause a toxic response, which can adversely affect the condition of the body as a whole and the restoration of the trophism of the severed limb after its replantation.

The invention is based on the task of creating a method for temporary extracorporeal perfusion of a limb, which provides a more complete restoration of blood flow in an ischemic limb.

The solution to this problem is ensured by the fact that in the method of temporary extracorporeal perfusion of a limb in case of damage to the main arteries, extracorporeal membrane oxygenation is carried out in the veno-arterial mode by puncture cannulation of the femoral vein of an intact (or damaged) limb or another main vein with a 12-15 Fr cannula and cannulation of the distal artery damaged limb (or the distal end of the damaged artery visualized in the wound), in this case, in the case of the lower limb, the posterior tibial artery is cannulated, in the case of the upper limb, the radial or ulnar artery is cannulated with a 6-10 Fr cannula, then a perfusion circuit consisting of hollow connecting tubes is connected, oxygenator and a portable extracorporeal membrane oxygenation device, then venous blood is taken through a 12-15 Fr cannula installed in the femoral vein, passed through a perfusion circuit at a rate of 0.4 l/min, then the oxygenated blood is returned through a 6-10 Fr cannula into the posterior tibial or radial or ulnar artery and fill the arterial bed retrogradely.

The advantages of the invention are associated with the fact that a temporary circulatory circuit is created in a limb deprived of main blood flow (severely ischemic), in which oxygenation of blood is performed outside the patient’s body. This method allows you to maintain the vital activity of the tissues of the injured limb for 10 hours or more, if necessary, until the patient’s condition is stabilized.

The technique we offer for temporary perfusion of the limb is original due to the implementation of puncture cannulation of the femoral vein of the uninjured limb or another main vein with a 12-15 Fr cannula (item 2 of Fig. 1) and cannulation of the distal artery of the injured limb (item 8 of Fig. 1), with In this case, in the case of the lower limb, the posterior tibial artery is cannulated, in the case of the upper limb, the radial or ulnar artery is cannulated with a 6-10 Fr cannula, then a perfusion circuit is connected, consisting of hollow connecting tubes (item 3, item 6 of Fig. 1), an oxygenator ( item 5 of Fig.1) and a portable extracorporeal membrane oxygenation apparatus (item 4 of Fig.1), then through a 12-15 Fr cannula (item 2 of Fig.1) installed in the femoral vein, venous blood is taken and passed through perfusion circuit at a rate of 0.4 l/min, then oxygenated blood is returned through a 6-10 Fr cannula (item 8 of Fig. 1) into the posterior tibial or radial or ulnar artery and fills the arterial bed retrogradely and is intended to provide tissues of the extremities deprived main and collateral circulation, oxygen in case of damage to the main artery of the limb. The advantages of this method are its relative ease of use, the short time required to connect the perfusion circuit, and the complete restoration of blood flow in the limb.

The invention is illustrated in Figure 1, which shows a circuit diagram for connecting the circuit for temporary regional blood circulation of the limb and localization of cannulation of the great vessels to collect venous blood and return arterial (oxygenated) blood to the limb through the artery. Figure 2 shows an angiogram of the vessels of the pelvis and lower extremities of a sheep, performed during the experiment “Temporary extracorporeal perfusion of the limb”. A contrast agent was injected into the perfusion circuit (arterial cannula). Figure 3 shows extracorporeal perfusion of the limb of an experimental animal (sheep). Assessment of the quality of perfusion by oximetry of perfused soft tissues of the limb with the main blood flow blocked by a specialized apparatus. Figure 4 shows the implementation of open access to the posterior tibial artery. Figure 5 shows the selection of the posterior tibial artery. Figure 6 shows the installation of a cannula in the posterior tibial artery. Figure 7 shows the implementation of puncture access to the femoral vein of an uninjured limb. Figure 8 shows puncture cannulation of the femoral vein and its fixation by suturing to the skin. Figure 9 shows the assembled perfusion circuit (cannulas not connected). Figure 10 shows the process of collecting venous blood from the femoral vein. Fig. 11 shows the process of return of oxygenated blood to the posterior tibial artery (item 47. Fig. 11). Fig. 12 shows a graph of oximetry of a sheep limb using a regional oximetry sensor Somanetics INVOS 5100 Regional Oximeter (Medtronic, USA).

The structure of the invention is illustrated in Fig. 1, which shows a diagram of connecting the circuit for temporary regional blood circulation of the limb and localizing the cannulation of the great vessels to collect venous blood and return arterial (oxygenated) blood to the limb through the artery. Fig. 1 includes the following symbols:

1 - Femoral vein

2 - Intake cannula 12-15 Fr (venous)

3 - Connecting tube for the intake part of the circuit

4 - Portable ECMO device

5 - Oxygenator

6 - Connecting tube for the return part of the circuit

7 - Oxygen source

8 - Return cannula 6-10 Fr (arterial)

9 - Posterior tibial artery

10 - Femoral artery

11 - Area of damage (occlusion) of the femoral artery

The perfusion circuit includes:

Cannula 12-15Fr venous (intake) (item 2 Fig.1),

Cannula 6-10 Fr arterial (return) (item 8. Fig.1),

Connecting tubes with a diameter of 3/8 3 pcs. 60-100 cm long (item 3 of Fig. 1).

Oxygenator (item 5 fig.1)

Portable extracorporeal membrane oxygenation (ECMO) device (item 4.fig.1).

The invention is carried out as follows:

1) Cannulation of a large vein (for example, the femoral vein (FV) of a healthy (intact or damaged) limb, or the jugular vein) (item 1.fig.1) is carried out using a puncture or open access with a 12-15 Fr cannula (the diameter of the cannula is selected based on vein diameter) (item 2.fig.1), a clamp is applied to the distal part of the cannula while waiting for the circuit to be connected and the perfusion to start.

2) Cannulation of the posterior tibial artery (PTAA) (item 9.fig.1.) of the damaged (subject to perfusion) lower limb (or radial/ulnar artery - for the upper limb) is performed by puncture or openly with a 6-10 Fr cannula (the diameter of the cannula or catheter is selected based on the diameter of the artery) (item 8.fig.1), a clamp is applied to the distal part of the cannula while waiting for the circuit to be connected and the perfusion to start.

3) Under sterile conditions, the circuit is assembled in the following sequence: intake line (item 3 of Fig.1) - centrifuge (or roller) head (item 12 of Fig.1) - connecting line - oxygenator (item 5 of Fig.1) - return line (item 6 of Fig.1). Through the side port of the connector, sterile saline solution is poured into the formed circuit, and air is removed from the system.

4) The intake and return lines are separated and connected, respectively, to the intake (venous) (item 2 of Fig.1, item 23 of Fig.3) and the return (arterial) (item 8 of Fig.1, item 29. Fig.3) cannulas to prevent air bubbles from entering the system.

5) A source of 100% oxygen (item 7 of Fig. 1) (centralized oxygen distribution, oxygen cylinder, oxygen concentrator) with a volumetric flow rate of about 1 l/min is connected to the oxygenator (item 5.fig. 1).

6) The ECMO device is turned on (item 4 of Fig. 1), perfusion parameters are entered. The rate of volumetric flow of perfusate (autoblood) is 0.4-0.8 l/min and is regulated by increasing/decreasing the number of revolutions per minute of the centrifuge head (item 12 of Fig. 1) of the ECMO device.

Perfusion of the ischemic limb is provided with autologous blood. Autologous blood sampling is carried out through an access that was carried out by cannulation of the femoral vein from the contralateral (intact) side (cannulation of the veins of the neck and upper limb is acceptable) with a 12-15 Fr sampling cannula (item 2 of Fig. 1) (preferably using puncture access). Next, the perfusate (autoblood), passing through the perfusion circuit, moves to a 6-10 Fr cannula (item 8 of Fig.1), installed in the posterior tibial artery (item 9 of Fig.1). Blood saturation with oxygen occurs in the oxygenator (item 5 of Fig. 1), thanks to a source of 100% oxygen connected to it (item 7 of Fig. 1.). Blood circulation in the created circuit is provided by a portable device for extracorporeal membrane oxygenation (PA-ECMO) Ex-Stream (Transbiotek, Russia) or an analogue (item 4 of Fig. 1), which collects perfusate from the venous bed. Providing blood sampling for isolated limb perfusion is carried out from the pool of a large vein of the upper or lower intact (or damaged) limb (item 1 of Fig. 1). Percutaneous (puncture) access to the main vein is performed and using a set for percutaneous cannulation according to the Seldinger technique, a cannula is installed into the venous bed of the femoral (or other main) vein. To supply the perfusate to the ischemic limb, cannulation of the STBA (or radial/ulnar artery) (item 9 of Fig. 1) is carried out on the injured limb, as the most suitable for access. The perfusate is supplied to the 3BA (radial/ulnar artery) retrogradely. Due to the system of arterial collaterals, the oxygenated perfusate nourishes the tissues of the injured limb, entering the distal parts of the leg and foot through the system of the anterior tibial and peroneal arteries (and through the system of collaterals of the upper limb - into the arteries of the forearm and hand). Fig. 1 explains the tactics of isolated perfusion of a limb deprived of main blood flow using the example of the arteries of the lower limb.

This invention was tested during an experiment on 8 large biological objects (male sheep), with an average weight of 41 kg. Modeling of arterial occlusion was carried out by blocking the main blood flow in the distal aorta 2-3 cm above the bifurcation (item 12 of Fig. 2) for a period of 6 hours. Figure 2 shows the following symbols:

14. Balloon in the distal abdominal aorta of an experimental animal (sheep)

15. Aortic bifurcation zone (sheep)

16. Right common iliac artery (sheep)

17. Left common iliac artery (sheep)

18. Right internal iliac artery (sheep)

19. Left internal iliac artery (sheep)

20. Right external iliac artery (sheep)

21. Left external iliac artery (sheep)

22. Right femoral artery (sheep)

23. Right deep femoral artery (sheep)

Intraoperatively, limb perfusion was monitored by angiography of the perfused limb (Figure 2). A contrast agent was added to the perfusion circuit, after which the contrast of all arteries was determined fluoroscopically (right deep femoral artery (item 23 of Fig.2), right femoral artery (item 22 of Fig.2), left external iliac artery (item 21 of Fig. 2), right external iliac artery (item 20 of Fig.2), left internal iliac artery (item 19 of Fig.2), right internal iliac artery (item 18 of Fig.2), left common iliac artery (item 17 Fig.2), right common iliac artery (item 16 of Fig.2), area of the aortic bifurcation (item 14 of Fig.2) with visualization of the balloon in the lumen of the aorta at a level of 2-3 cm proximal to the aortic bifurcation (item 15 of Fig. 2)) perfused limb of the animal.

Figure 3 shows the following symbols:

2. 15 Fr sampling cannula in the femoral vein

13. Connecting tube for the intake part of the circuit

12. Centrifuge head

5. Oxygenator

25. Control panel of a portable ECMO device

7. Oxygen source (circuit from oxygen concentrator to oxygenator)

6. Connecting tube of the return part of the circuit

8. Return cannula 10 Fr (arterial)

10. Femoral artery

14. Balloon catheter for endovascular balloon occlusion

24. Somanetics INVOS 5100 Regional Oximeter (Medtronic, USA)

To stop blood flow in the lower extremities, the method of balloon occlusion of the aorta was used with an endovascular aortic balloon, which was inserted above the aortic bifurcation (item 14 of Fig. 3). To restore blood flow in the extremities, a perfusion circuit was used in the experiment, which included: a 15 Fr sampling cannula installed in the femoral vein (item 1 of Fig. 3), a connecting tube for the intake part of the circuit (item 13 of Fig. 3), a centrifuge head (item .12 of Fig.3), oxygenator (item 5 of Fig.3), control panel of the ECMO device (item 25 of Fig.3), oxygen source (oxygen concentrator) (item 7 of Fig.3), connecting tube of the return part of the circuit (item 6 of Fig.3), return cannula 10 Fr (item 8 of Fig.3). During testing of the invention, it was revealed that the developed new method of temporary isolated perfusion of a limb in case of damage to the main artery (item 30 of Fig. 3) is feasible and allows for long-term perfusion of the limb. When the aorta is occluded (item 14 of Fig.2), the oximetry index measured by the regional oximetry device Somanetics INVOS 5100 Regional Oximetr (Metronic, USA) with patch-on sensors (item 24 of Fig.3) decreased to zero (item 29 of Fig.12) , while at the start of perfusion, oximetry values obtained from the lower extremities returned to the original normal values (item 30 of Fig. 12). Within 30 minutes between the stage of complete occlusion of the aorta and the start of perfusion (item 29 of Fig. 12), the oximetry graph (Fig. 12) shows the complete absence of perfusion below the level of balloon occlusion of the aorta (item 29 of Fig. 12). All perfused limbs were viable at the end of the experiment.

Also, this invention was tested on a human limb in an intensive care unit (Figures 4, 5, 6, 7, 8, 9, 10, 11) with the aim of temporarily maintaining blood flow in the limb to preserve it. According to the medical history, the patient received a shrapnel wound to the left knee joint with complete intersection and thrombosis of the popliteal artery. Reconstructive surgery on the popliteal artery was not performed at the previous stages of medical evacuation, as a result of which the patient was delivered to the trauma center, where isolated perfusion was performed, with signs of uncompensated (threatening) ischemia of the left leg (distal to the wound site). Due to low hemoglobin and platelet counts, full arterial reconstruction was postponed, and this invention was used for temporary perfusion of the limb, which made it possible to delay the main intervention by three hours. The invention was applied as follows: a typical open access to the posterior tibial artery was performed (item 26 of Fig.4), after isolating the posterior tibial artery, cannulation of the posterior tibial artery was performed (item 9 of Fig.6) with a return arterial cannula (item 8 of Fig.6 ). After cannulation of the posterior tibial artery, a clamp was applied to the cannula. Next, puncture access to the femoral vein was performed using the Seldinger method (item 1 of Fig. 7) with insertion of an endovascular guide into the lumen of the femoral vein (item 27 of Fig. 7), through which a 15 Fr venous (sampling) cannula was inserted into the vein (item 2 Fig. 8). After cannulation, a clamp was also placed on the collection cannula while the perfusion circuit was assembled. The assembled perfusion circuit is presented in Fig. 9 and consisted of: a connecting tube for the intake part of the circuit (item 3 of Fig. 9), a centrifuge head of a portable ECMO device (item 12 of Fig. 9), an oxygenator (item 5 of Fig. 9) and a connecting tubes of the return part of the circuit (item 6, Fig.9). After starting the portable ECMO device, autologous blood (perfusate) was collected through the sampling cannula (item 3 of Fig. 10), passing it along the perfusion circuit and returning to the posterior tibial artery (item 9 of Fig. 11).

Claims (1)

A method of temporary extracorporeal perfusion of a limb in case of damage to the main arteries by performing extracorporeal membrane oxygenation in the venous-arterial mode, characterized in that puncture cannulation of the femoral or jugular vein is performed with a 12-15 Fr cannula and cannulation of the distal artery of the damaged limb retrogradely with a 6-10 Fr cannula, with In this case, if the lower limb is damaged, the posterior tibial artery is cannulated, if the upper limb is damaged, the radial or ulnar artery is then connected, then a perfusion circuit consisting of hollow connecting tubes, an oxygenator and a portable extracorporeal membrane oxygenation device is connected, then through a 12-15 Fr cannula installed in the femoral or jugular vein, venous blood is collected, passed through a perfusion circuit at a rate of 0.4 l/min, then oxygenated blood is returned through a 6-10 Fr cannula into the posterior tibial, or radial, or ulnar artery and the arterial bed is filled retrogradely.