WO2022237248A1 - 完全腹腔镜下绕肝带法二步切除病患侧肝的手术方法及其器械 - Google Patents

完全腹腔镜下绕肝带法二步切除病患侧肝的手术方法及其器械 Download PDF

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WO2022237248A1
WO2022237248A1 PCT/CN2022/075586 CN2022075586W WO2022237248A1 WO 2022237248 A1 WO2022237248 A1 WO 2022237248A1 CN 2022075586 W CN2022075586 W CN 2022075586W WO 2022237248 A1 WO2022237248 A1 WO 2022237248A1
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liver
hepatic
volume
patient
sleeve
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PCT/CN2022/075586
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English (en)
French (fr)
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蔡秀军
彭淑牖
王一帆
陆琛
陈鸣宇
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浙江大学
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12009—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
    • A61B17/12013—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
    • A61B17/1285—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/132—Tourniquets
    • A61B17/1322—Tourniquets comprising a flexible encircling member
    • A61B17/1325—Tourniquets comprising a flexible encircling member with means for applying local pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/132—Tourniquets
    • A61B17/1322—Tourniquets comprising a flexible encircling member
    • A61B17/1327—Tensioning clamps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00407—Ratchet means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B2017/12004—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument

Definitions

  • the invention relates to an operation method and an operation instrument for resecting the liver of the diseased side under complete laparoscope two-step method for liver cancer patients with severe liver cirrhosis or liver tumor.
  • Hepatitis B liver cirrhosis and liver cancer in the world.
  • Hepatitis B, liver cirrhosis, and liver cancer are closely related to different stages of disease development after hepatitis B virus infection.
  • Many patients with hepatitis B virus infection will eventually develop liver cancer.
  • According to public data nearly 100 million Chinese are among the 350 million hepatitis B virus carriers worldwide. China accounts for nearly half of the approximately 700,000 viral hepatitis-related deaths in the world each year.
  • Primary liver cancer is a common malignant tumor in China, and its mortality rate ranks second among malignant tumors.
  • liver resection is currently the most effective treatment, but not all patients can afford liver resection.
  • liver cancer patients with cirrhosis if the remaining liver volume is expected to be less than 40% after surgery, it is considered contraindicated for liver resection. For these patients, they can only give up surgery or wait patiently for liver transplantation. Due to the shortage of donor liver sources, most patients cannot wait for liver transplantation.
  • liver transection and portal vein ligation have gradually attracted the attention of the hepatobiliary surgery community.
  • This second surgery approach performs liver resection in patients who are considered unresectable.
  • the portal vein branch of the liver to be resected is cut off, and the left and right livers are cut and separated at the same time.
  • the volume of the retained liver will increase rapidly after surgery.
  • a second-stage surgery is then performed to remove the liver on one side of the lesion. Judging from the current experience, this surgical method can perform hepatic resection for patients with liver cancer who could not undergo hepatic resection before, and has achieved a good therapeutic effect.
  • the existing method can (1) reduce intraoperative bleeding; (2) reduce ischemia-reperfusion injury; (3) anatomical liver resection can protect remnant liver function; (4) reduce tumor dissemination.
  • this operation the most prominent of which is that the first operation needs to cut and separate the left and right livers to block the communication blood flow between the left and right hemi-livers.
  • the risk of bile leakage in the liver section is extremely high. Regensburg Hospital, Germany, the incidence of bile leakage in this operation is as high as 24%.
  • the interval between the two operations is too long, it will easily lead to increased adhesions in the abdominal cavity. A second surgery is performed.
  • the present invention overcomes the above-mentioned shortcomings of the prior art, and provides a laparoscopic two-step resection of the patient's side liver by encircling the liver band and its instruments.
  • the invention allows patients to perform the first-stage and second-stage operations completely under laparoscopy, so that the surgical wounds are greatly reduced, which is beneficial to postoperative recovery and liver regeneration.
  • a laparoscopic laparoscopic band-wrapping method for resection of the diseased side liver in two steps characterized in that the operation method is completed through two operations at intervals of 6-15 days, and the method is carried out according to the following steps:
  • the first operation the patient underwent laparoscopic surgery under general anesthesia, and the liver band was used to ligate the portal vein branch of the patient's liver to be resected. At the same time, the liver band was used to tighten the left and right liver The connecting part of the patient's liver to block the communication blood flow between the patient's liver to be resected and the hemi-liver to be preserved, a peritoneal drainage tube was placed in the hilum of the liver, and the abdomen was closed to complete the first operation;
  • the expected residual liver volume is preferably more than 40% of the standard liver volume, and when the patient is not cirrhotic, the expected residual liver volume is preferably more than 30% of the standard liver volume.
  • the present invention uses a band around the liver to fasten the connection between the left and right livers to block the communication blood flow between the left and right livers.
  • Step (1) of the present invention is recommended to be carried out as follows: under laparoscopy, free the perihepatic ligament, dissect the first hepatic hilum, separate the hepatic artery and portal vein on the affected side, and expose the right hepatic vein at the second hepatic hilum
  • the suprahepatic vein lacuna between the middle liver and the left hepatic vein free the retrohepatic inferior vena cava, ligate part of the short hepatic vein, expose the right inferior hepatic vein, ligate and cut off the hepatic vein on the patient side to be resected, and preserve it for protection Hepatic veins on the hepatic side of the liver, and then use a band around the liver to block the communication blood flow between the patient's liver to be resected and the hemi-liver to be preserved, and place a peritoneal drainage tube at the hilum of the liver, and then close the abdomen.
  • the enclosing part of the belt around the liver according to the present invention is preferably provided with a pressure-adjustable liver tightening device.
  • the pressure-adjustable liver tightening device is an elastic device that closely fits with the periphery after being surrounded by the liver band. In the state of non-action, the pressure-adjustable liver tightening device locks the liver belt tightly, so that the liver belt is fixed and tied around the liver. When the liver belt is pulled hard or loosened, the liver belt can be tied to the liver respectively. Tighten or relax, because the pressure-adjustable liver tightening device has strong elasticity, the binding length of the liver band around the outer circle of the liver can be fixed at any time.
  • the opening of the laparoscopic operation uses the same operating hole as the first laparoscopic poking hole.
  • the first operation in the step (1) is preferably carried out according to the following steps.
  • the intersection of the left rib margin around the patient’s liver and the midline of the left clavicle is used as the main operation hole.
  • Two auxiliary operation holes were used to separate the adhesions in the abdominal cavity, hepatic hilum, and the second hepatic hilum, and the proper hepatic artery, left hepatic artery, and left portal vein branch were dissected out, and the root of the left portal vein branch was ligated with silk thread before clipping with Hamlock. Use the Proline line to mark the left hepatic artery.
  • the coronary ligament and left triangular ligament are dissected to free the left hemi-liver; the left hepatic vein is dissected at the second hepatic hilum, and a nasal catheter
  • the gastric tube passes through the right side of the left hepatic vein, close to the surface of the liver and wraps backwards to the front of the left caudate lobe. After avoiding the left hepatic artery, it wraps around the root of the left hepatic pedicle to the front of the liver. Poke a hole in the abdominal wall of the right midclavian line and pull it out of the body, put on a No.
  • liver belt that is used as a liver belt
  • push in the outer tube and clamp it with a vascular forceps, and use intraoperative ultrasound before tightening On the affected side of the liver, a peritoneal drainage tube was placed in the hilum of the liver and the abdomen was closed.
  • the second operation of the step (3) is preferably performed as follows: take the first laparoscope to poke a hole into the abdomen, use a suction device to suck in the peritoneal fluid and push the adhesion to expose the hilum, Pull the abdominal wall around the liver band, first find the marked left hepatic artery at the hilum, clamp and cut off, and then use the laparoscopic Peng's Multifunctional Surgical Dissector (LPMOD) along the liver band to cut off the liver by scraping and aspiration , and use a cutting closer to assist in cutting off the liver. The left hepatic vein was clamped and then cut off. The patient's half of the liver was removed, and the bleeding was properly stopped in the abdominal cavity.
  • LMOD laparoscopic Peng's Multifunctional Surgical Dissector
  • the patient gradually resumes diet after the first postoperative period, and continues to tighten the band around the liver once on the 6th day after the first postoperative period.
  • the volume of the hemi-liver to be preserved is preferably increased to the expected residual liver volume of more than 60% of the standard liver volume within 6-15 days after the patient's first operation, and then the second operation is performed. If the operation time is too short, it is expected that the remaining liver volume may be too small. If the time is too long, it is easy to cause excessive adhesions in the abdominal cavity. Therefore, the appropriate time is 1-2 weeks, and it is usually not recommended to exceed 2 weeks.
  • the portal vein branch of the liver on the side to be resected is completely cut off under a laparoscope, and the band between the left and right livers is tightened with a band around the liver. Connecting parts to block the communication blood flow between the left and right livers. After surgery, the volume of the preserved liver will increase rapidly; then a second-stage operation is performed to remove the liver on the side of the lesion.
  • This method adopts laparoscopic technique, and the operation trauma is small, which reduces the impact on the body's immune system and the body's own anti-tumor ability, and the early recovery of the patient can enable the patient to receive other anti-tumor adjuvant therapy earlier .
  • This technique uses the band around the liver instead of cutting and separating the left and right livers to block the communication blood flow between the left and right livers, so that the complication of bile leakage in the postoperative liver section has been completely resolved.
  • the cost of the operation is 30% of the cost of conventional liver transplantation, which can reduce the financial burden of the patient's family.
  • the invention also includes a special instrument for implementing the two-step operation method of resection of the diseased side liver by the laparoscopic encircling liver band method, which is a pressure-adjustable liver tightening device.
  • the prior art still has the following disadvantages:
  • the tension force of the liver belt depends entirely on the experience of the doctor during installation, which is not easy to grasp, and it is prone to loose or If it is too tight, if it is too loose, it will not be able to completely block the communication blood flow between the left and right livers, and it will not be able to achieve the purpose of the operation.
  • the atrophy of the connection between the livers is relatively large.
  • Even with elastic rings the tightness of the liver bands will vary greatly, which cannot be kept at an optimal level, which will affect the realization of the purpose of surgery.
  • the bands around the liver are located at the Inside the human body, the degree of tension is difficult to be identified by the doctor, which affects the doctor's timely adjustment of the liver belt; fourth, the adjustment of the tightness of the liver belt after the first-stage operation depends on the doctor's personal experience and hand feeling, which cannot be accurately measured, and is blind. Therefore, in order to reduce the implementation difficulty of the surgical method of the present invention, it is necessary to improve its surgical instruments.
  • liver belt 5 made of flexible materials and the liver belt 5.
  • One end is a free end, and the other end is provided with a through hole, and the free end passes through the through hole to form a collar capable of tightening the liver 4; the side of the liver band 5 away from the liver is defined as the outside;
  • a first ratchet 51 is provided on the outside of the liver belt 5; the free end of the liver belt 5 passes through the through hole, the abdominal wall catheter 6, and the pressure control device 7 in sequence, and the abdominal wall catheter 6 passes through the patient's abdominal wall 2 ;
  • the pressure control device 7 includes a first sleeve 72 and a buckle 71, with the direction of the central axis of the first sleeve 72 as the longitudinal direction, and the first sleeve 72 is provided with a longitudinal first inner hole for passing around the liver band 5 721, the buckle 71 is arranged in the longitudinal guide groove 722 of the first sleeve 72, and can move longitudinally along the guide groove 722; the buckle 71 is provided with a second ratchet 711 extending into the first inner hole 721, When the liver band 5 passes through the first sleeve 72, the first ratchet 51 engages with the second ratchet 711; the second ratchet 711 allows the first ratchet 51 to slide forward to tighten the collar, and at the same time prevent the first ratchet 51 from sliding backward;
  • a spring 73 arranged longitudinally is arranged between the buckle 71 and the first sleeve 72;
  • the buckle 72 is provided with a vernier 714 for marking the tension of the liver belt 5
  • the first sleeve 72 is provided with a vernier scale 723 .
  • the buckle 71 is a second sleeve sleeved in the first sleeve 72, and the second sleeve is provided with a longitudinal second inner hole 712 for the band around the liver 5 to pass through;
  • the outer wall of the second sleeve is provided with a protrusion 713, and the protrusion 713 is slidably inserted into the longitudinal guide groove 722 on the wall surface of the first sleeve 72, and the protrusion 713 is provided with the above-mentioned cursor 714; the second sleeve
  • the inner wall of the second ratchet 711 is provided.
  • the other end of the liver belt 5 opposite to the free end is provided with a base 52, and the through hole is arranged on the base 52; under the pulling force of the liver belt 5, the first sleeve 72, the abdominal wall catheter 6, The base 52 is in conflict with each other in turn, so that the band 5 around the liver is positioned.
  • the first sleeve 72 , buckle 71 and spring 73 of the present invention set physical parameters according to the requirement of tightening force on the liver during the operation.
  • the vernier on the buckle is aligned with the scale of the first sleeve, and the surgeon performing the operation can fix the position of the liver belt, which can avoid Rely on the physician's personal experience.
  • the connecting part connecting the left and right liver lobes shrinks, and the tension around the liver band decreases.
  • the vernier and scale on the pressure control device 7 can directly reflect this change. Since the pressure control device 7 is located outside the body, the doctor can conveniently observe the change of the tension around the liver band 5 and make adjustments without opening the abdomen. Thus, the physician can conveniently maintain the tightening force of the liver belt 5 on the liver at an optimal value at any time.
  • the advantages of the present invention are: (1) The present invention uses a belt around the liver instead of cutting and separating the left and right livers to block the communication blood flow between the left and right livers, so that the complication of bile leakage in the postoperative liver section has been completely resolved. At the same time, the two operations were performed under laparoscopy. Compared with the previous open surgery, the surgical trauma is small, which reduces the impact on the body's immune system and the body's own anti-tumor ability. Moreover, the early recovery of the patient can enable the patient to receive other anti-tumor adjuvant therapy earlier.
  • the present invention uses the method of encircling the liver band under complete laparoscopy to perform two-stage liver resection on patients with liver cirrhosis and liver cancer who were considered inoperable in the past, completely resecting the liver tumor, and solving the problem that the estimated remaining liver volume is less than 40%
  • the difficult problem that the liver cancer patients with liver cirrhosis cannot be treated by surgery makes this part of patients get effective treatment.
  • this operation is not only a good news for liver cancer patients with severe liver cirrhosis who need extensive liver resection, but also solves the dilemma that most liver resections cannot be performed, and patients can be operated on without waiting for a liver source; it is also economical From a perspective, the cost of this operation is 30% of the cost of conventional liver transplantation, and it also greatly reduces the financial burden on the patient's family.
  • the present invention overcomes the problem of bile leakage on the hepatic section in the two-step hepatectomy, and solves the difficult problem that the liver cancer patients with cirrhosis whose expected remnant liver volume is less than 40% of the standard liver volume cannot be treated surgically, The patient recovers well after the operation and reduces the cost of treatment.
  • a pressure-adjustable liver tightening device that can adjust the tightness of the liver belt is provided at the surrounding area of the liver belt. Tighten around the liver belt enclosure.
  • the instrument scale can be used to determine the tightness of the liver belt to the liver, avoiding relying on the doctor's personal experience; the doctor can directly observe the tightening force of the liver belt outside the patient's body, and conveniently adjust the liver belt. With tightening force on the liver, avoid laparotomy.
  • FIG. 1 Schematic diagram of the traditional separation of left and right liver parenchyma
  • Fig. 2 is a schematic diagram of the implementation of the method of binding the left and right livers by using the belt around the liver in the present invention
  • Figure 3 Comparison of CT images before and after surgery in ALPPS patients: X part represents the right liver volume before placing the liver band, and Y part represents the liver volume after placing the liver band;
  • Fig. 4 is the intraoperative picture of the first stage operation of ALPPS in embodiment 1;
  • the white arrow points to the left branch of the portal vein, and the zebra-patterned arrow points to the left hepatic artery; in Figure 4b, the white arrow indicates the left hepatic vein; in Figure 4c, intraoperative ultrasonography is used to confirm that the tumor is located around the liver before tightening the tourniquet The left side of the tourniquet, and check the blood flow between the left and right livers;
  • Figure 4d shows the abdominal incision after the first stage operation, and the white arrow shows the outer part of the tourniquet around the liver, which is clamped with vascular clamps;
  • Fig. 5 is the intraoperative picture of the second phase operation of ALPPS in embodiment 1;
  • Figure 5a shows ulcers and adhesions on the surface of the left liver
  • Figure 5b shows the left hepatic artery marked during the first-stage operation
  • Figure 5c shows the cut-off of the liver by scraping and aspiration with LPMOD; Shows the stump of the left branch of the portal vein;
  • Fig. 6 is the liver sample after ALPPS in embodiment 1, with significant liver cirrhosis;
  • Fig. 7 is a schematic diagram of the working principle of an embodiment of the present invention.
  • Fig. 8a is a schematic diagram of a buckle according to an embodiment of the present invention.
  • Fig. 8b is a longitudinal sectional view of the buckle according to an embodiment of the present invention.
  • Fig. 9 is a schematic diagram of a first sleeve according to one embodiment of the present invention.
  • Fig. 10 is a schematic diagram of a pressure control device according to an embodiment of the present invention.
  • Fig. 11 is a longitudinal sectional view of a pressure control device according to an embodiment of the present invention.
  • Fig. 12 is a schematic view of the use state of an embodiment of the present invention.
  • the term "a” in the claims and the specification should be understood as “one or more”, that is, in one embodiment, the number of an element may be one, while in another embodiment, the number of the element Can be multiple. Unless it is clearly indicated in the disclosure of the present invention that there is only one element, the term “a” cannot be understood as unique or single, and the term “a” cannot be understood as a limitation on the number.
  • BW body weight in kg
  • BH height in cm
  • BSA body surface area in m 2
  • SLV standard liver volume in ml
  • the whole liver volume measured by CT was 1038mL (GEHC software, Volume Viewer 9.6.25b; workstation, Ge advantage Workstation, General Electric Medical), and the remaining liver volume was 387mL, accounting for 38.3% of the standard liver volume.
  • ALPPS is planned to be performed in patients with liver cirrhosis due to the requirement that the remaining liver volume should reach more than 40% in the future.
  • the first-stage surgery patient underwent total laparoscopic surgery under general anesthesia on May 14, 2014.
  • the main operation hole was made at the intersection of the left costal margin and the left midclavicular line.
  • two auxiliary operation holes were made in the right abdomen. Because of obvious intra-abdominal adhesions, the adhesions in the abdominal cavity, hilum and second hilum were patiently separated, and the proper hepatic artery, left hepatic artery, and left branch of the portal vein were dissected out (Fig. 2a).
  • a nasogastric tube with a guide core to pass through the right side of the left hepatic vein, stick to the surface of the liver and go back to the front of the left caudate lobe, avoiding the left liver
  • wrap around the root of the left hepatic pedicle to the front of the liver put the two tails of the band around the liver together, pull it out of the body from the abdominal wall at the right midclavian line, and put on a No. 36 chest catheter (as a pressure-applying outer tube). Tighten the band around the liver, push it into the outer cannula, and clamp it with a vascular clamp.
  • a pressure-adjustable liver tightening device around the liver band.
  • a peritoneal drainage tube was placed in the hilum of the liver and the abdomen was closed. The postoperative abdominal incision pictures are shown in (Fig. 2d).
  • the second-stage operation was performed on the 11th day (May 25) after the first-stage operation, and a laparoscopic left hemihepatectomy was performed. Take the original laparoscope and poke the hole into the abdomen, and see a little adhesion in the abdominal cavity, which is relatively loose, and multiple ulcers can be seen on the surface of the left liver under the surrounding liver band (Fig. 3a).
  • the operation time of the first stage was 290 minutes, the intraoperative blood loss was 100mL, and there was no intraoperative blood transfusion.
  • the patient's body temperature was 36.2-37.7°C
  • heart rate was 81-104 beats/min
  • the daily abdominal drainage fluid was 200-1033 mL.
  • On the 1st day after the operation he got up and moved.
  • On the 4th day after the operation B-ultrasound showed pleural effusion, and he was placed for drainage.
  • the drainage volume was 350-911ml per day.
  • the hepatic belt was tightened down once.
  • the pressure-adjustable liver tightening device continued to tighten the hepatic belt after adjustment.
  • ALT peaked at 2998 U/L on the second day after surgery;
  • AST peaked at 2232 U/L on the first day after surgery;
  • total bilirubin gradually increased and reached a peak of 112.7 ⁇ mol/L on day four after surgery.
  • white blood cells and C-reactive protein peaked on the 2nd day and 4th day after surgery respectively, PT maintained at 13.9-25.0s, and APTT maintained at 36.1-44.6s.
  • the patient underwent CT examination on the 5th day after the operation, and the measured residual liver volume was 669mL, an increase of 72.9% compared with that before operation.
  • the remaining liver volume accounted for 74.6% of the standard liver volume, that is, the expected residual liver volume was 74.6% of the standard liver volume ( Figure 1).
  • the liver function basically returned to normal, there was no infection in the abdominal cavity, and the nutritional status was good. Safe resection of the liver was achieved. scope.
  • the operation time of the second stage operation is 160min, the intraoperative blood loss is 100mL, and the intraoperative transfusion of red blood cells is 2U.
  • Her body temperature was 35.8-37.6°C, her heart rate was 72-86 beats/min, and her blood pressure was stable.
  • White blood cells gradually decreased after a slight increase, ALT and AST continued to decrease in the next period, and total bilirubin continued to decrease after a transient increase the next day.
  • the daily abdominal drainage volume was 300-1100Ml, which gradually decreased to 24-64mL.
  • Postoperative pathological examination results Postoperative pathological sections showed: (left half) hepatocellular carcinoma, coagulation necrosis with hemorrhage, (hepatoduodenal ligament) lymph node no cancer metastasis (0/2).
  • approaches to promote hypertrophy of future residual liver volume include: (1) Makuuchi's portal vein embolization approach (1990); (Adam's (2000) two-stage hepatectomy; (3) Jaeck's (2004) two-stage hepatectomy Treatment of multiple left or right hemihepatic tumors; (4) Clavien's two-stage hepatectomy (2007), after resection of all left hemihepatic tumors using a combined wedge in the first-stage operation, ligation of the right portal vein, a few weeks later in the left Second-stage extended right hemihepatectomy is performed when the hemihepatic hyperplasia is sufficient.
  • the biggest disadvantage of these operations is: the time interval between the two operations is too long, with an average of >4 weeks, or even 4 months; during this period, the tumor can continue to progress; Adhesions caused by the first operation will make the second resection more difficult, and the remaining liver hyperplasia after operation is not ideal.
  • the characteristics of ALPPS are: the residual liver within 7 days Rapid and significant hyperplasia of the liver (74%-87%), the second-stage operation can be performed after a short wait of 1 week.
  • the incidence of complications in ALPPS surgery is as high as 74%, and the mortality rate has been reported as high as 12%-23%. Surgery The risk is relatively high.
  • the incidence of bile leakage and severe infection is as high as (20% to 25%), which is an important reason for high mortality.
  • the first stage of operation is to cut the liver parenchyma, the purpose is to block the The communicating branch of the portal vein promotes the rapid and significant proliferation of the remaining liver, but it may cause serious consequences of bile leakage. Is there any other method that can not only avoid liver detachment but also block the communicating branch of the portal vein on both sides to promote the rapid and significant proliferation of the remaining liver? Hyperplasia?
  • liver-wrapping band as a tourniquet can replace the liver parenchyma section in ALPPS to avoid liver cut-off and completely prevent bile leakage.
  • the tourniquet around the liver is also helpful for the operation of liver parenchyma in the second stage operation: we are accustomed to using the laparoscopic multifunctional surgical dissector LPMOD, which can be used when the liver is cut.
  • LPMOD laparoscopic multifunctional surgical dissector
  • the electrocoagulation is strengthened directly against the liver belt. Due to the insulating effect of the liver belt, there is no need to worry about injuring deep tissues, especially the retrohepatic inferior vena cava at the back, which makes the liver cutting process safe and reliable.
  • the placement of the tourniquet around the liver in this case is different from the traditional method.
  • the hepatic zone runs through the retrohepatic tunnel between the right hepatic vein and the middle hepatic vein.
  • a tourniquet around the liver had to be managed to pass between the left hepatic vein and the middle hepatic vein. Therefore, great care should be taken when dissecting at the superior border of the liver.
  • the method of implementation is to lower the hepatic hilum and let the tourniquet around the liver pass between the hepatic hilum and the surface of the liver, thereby separating the liver pedicle.
  • the choice of the surgical method in this case is indeed a dilemma, because although the tumor is small, it is close to the sagittal portion of the portal vein, and the risk of ablation is high, so the ablation of the tumor may not be complete; the patient's preoperative CT and MR showed liver cirrhosis , although the liver function belongs to ChildA grade, it is feasible to perform hepatectomy, but on the other hand, the remaining liver volume is only 38%, which is lower than the lower limit of 40% required for patients with liver cirrhosis, and left hemihepatectomy is also risky. Based on the above reasons, we chose the two-step liver resection. The postoperative recovery of this patient is very good. Both the first postoperative and the second postoperative got out of bed on the first day, which shows that the selected treatment method can bring benefits to this patient.
  • ALPPS can be performed safely under laparoscopy; for primary liver cancer with cirrhosis, ALPPS can also promote the rapid increase of the remaining liver volume in the short term; Banding is more difficult than liver transection, but the surgical trauma of banding around the liver is significantly smaller than that of transecting the liver, and the patient can obtain a second operation in a shorter time. At the same time, banding around the liver does not need to cut the liver parenchyma , can avoid complications such as bile leakage.
  • Liver tourniquet can replace liver parenchyma, with similar effect but greatly reduced complications; blocking the blood flow on the left and right sides, so that all the portal vein blood from the opposite side pours into the remaining liver is the main mechanism of rapid hyperplasia of the remaining liver in ALPPS .
  • ALPPS was performed completely laparoscopically and the hepatic parenchyma was replaced by a tourniquet around the liver.
  • the effect was good, and the liver increased rapidly in a short period of time, but it was only a preliminary practice and needs to be verified in more cases.
  • animal experiments are needed to further explore its mechanism. ground research.
  • the residual liver volume calculated by preoperative CT accounted for 35.6% of the standard liver volume. Because the remaining liver volume of cirrhotic patients is required to reach more than 40% in the future, it is planned to perform laparoscopic two-step hepatectomy around the liver band to remove the right hemi-liver.
  • the first phase of surgery was performed on May 22, 2014: no obvious metastatic nodules were found in the abdominal cavity during the operation, no ascites was formed, the texture of the liver showed nodular changes, bleeding was easy to touch, the left liver was small, and the right liver was hypertrophic. Ultrasound showed a mass with a diameter of about 5 cm in the segment VIII of the right liver, and a small lesion with a diameter of about 0.8 cm in the segment VI of the right liver. The size of the gallbladder is about 7*3cm, and stone formation can be seen in it.
  • the first phase of the operation went through: lying on the back, successful general anesthesia with air intubation, routine catheterization, and sterile drape.
  • 2. make a small incision in an arc 5 cm to the right of the umbilical cord, puncture the abdominal cavity with a Veress needle, and inflate carbon dioxide gas into a 15 mmHg pneumoperitoneum. Pull out the Veress needle, puncture the abdominal cavity with a trocar, pull out the inner core, insert a laparoscope, and check the abdominal cavity as seen during the operation. 3.
  • Multiple trocar punctures were performed under laparoscopic vision.
  • the main operation hole was 12mm Xcel Trocar, which was located under the right costal margin.
  • Two 5mm Trocars were placed on the right anterior axillary line and the midaxillary line as assistant operation holes. 4. Change the position of the head to the bottom of the foot, and use the ultrasonic knife to separate a small amount of adhesions in the abdominal cavity. Fully dissociate the right liver, pull the right liver to the left, separate the short hepatic vessels, suture and ligate them one by one, continue to separate upward, dissect the second hepatic porta, and separate the right hepatic vein. 5. The hepatoduodenal ligament was to be dissected and separated.
  • cholecystectomy was performed, and the dissection continued to separate the proper hepatic artery, left hepatic artery and right hepatic artery, and continued to separate the left portal vein.
  • branch, right branch, and caudate lobe branch the right portal branch was ligated with absorbable suture and clipped with Hamlock. 6.
  • use a nasojejunal nutrition tube with a guide core pass through the hiatus of the vena cava from the second hepatic hilum to the back of the liver, pass through the back of the right hepatic artery along the inferior vena cava, and reach the front of the liver.
  • the nutrition tubes converge and are placed into the No. 36 chest tube cavity with a length of about 10 cm. Together with the chest tube, it is poked out from the abdominal wall, the nutrition tube is tightened, and the vascular forceps with rubber sheaths are used to clamp and bind the left and right liver parenchyma.
  • a pressure-adjustable liver tightening device is installed around the liver band. 7.
  • ALT alanine aminotransferase
  • AST aspartate aminotransferase
  • a CT scan was performed to measure the remaining liver The volume is 670ml, an increase of 37.9% compared with preoperative. At this time, the remaining liver volume accounts for 49.1% of the standard liver volume, that is, the expected residual liver volume is 49.1% of the standard liver volume.
  • the second-stage operation was performed to remove the right hemi-liver.
  • the process of the second stage operation 1. Lying on the back, successful general anesthesia with air intubation, routine catheterization, and sterilized drape. 2. Take the original laparoscopic surgery incision and enter the abdomen, make an incision below the umbilical cord, puncture the abdominal cavity with a pneumoperitoneum needle, and inflate carbon dioxide gas into a 15mmHg pneumoperitoneum. Pull out the Veress needle, puncture the abdominal cavity with a trocar, pull out the inner core, insert a laparoscope, and check the abdominal cavity as seen during the operation. 3. Three more trocar punctures were performed under laparoscopic vision. The main operation hole was 12mm Xcel Trocar, which was located under the left costal margin.
  • Two 5mm Trocars were placed on the right midaxillary line as assistant operation holes. 4. Change the position of the head to the bottom of the foot, use a suction device to separate the adhesions on the surface of the liver and the abdominal cavity, and then separate the preset right hepatic artery at the hilum, use absorbable clips to clamp both ends and then cut off. 5. At this time, lift the liver-wrapping band from the outside of the abdominal wall, and use the endoscopic Peng's multifunctional surgical dissector to cut the liver by scraping and aspiration. Because the liver parenchyma in the band around the liver is less and thin after banding, there are many pipeline structures. Then use EC60 to break the liver. The wound was completely hemostasis. 6.
  • This example introduces the special instrument for the two-step laparoscopic resection of the liver on the affected side according to the present invention, which is a pressure-adjustable liver tightening device.
  • FIG. 8-Fig. 13 Reference numerals among Fig. 8-Fig. 13 are: abdominal cavity 1, abdominal wall 2, extracorporeal 3, liver 4, belt around liver 5 (comprising first ratchet 51, base 52), abdominal wall catheter 6, pressure control device 7;
  • the control device 7 includes a buckle 71, a first sleeve 72, and a spring 73;
  • the buckle 71 includes a second ratchet 711, a second inner hole 712, a protrusion 713, and a cursor 714;
  • the first sleeve 72 includes a first inner hole 721, guide groove 722, scale 723.
  • liver belt 5 made of flexible materials and the liver belt 5.
  • One end is a free end, and the other end is provided with a through hole, and the free end passes through the through hole to form a collar capable of tightening the liver 4; the side of the liver band 5 away from the liver is defined as the outside;
  • a first ratchet 51 is provided on the outside of the liver belt 5; the free end of the liver belt 5 passes through the through hole, the abdominal wall catheter 6, and the pressure control device 7 in sequence, and the abdominal wall catheter 6 passes through the patient's abdominal wall 2 ;
  • the pressure control device 7 includes a first sleeve 72 and a buckle 71, with the direction of the central axis of the first sleeve 72 as the longitudinal direction, and the first sleeve 72 is provided with a longitudinal first inner hole for passing around the liver band 5 721, the buckle 71 is arranged in the longitudinal guide groove 722 of the first sleeve 72, and can move longitudinally along the guide groove 722; the buckle 71 is provided with a second ratchet 711 extending into the first inner hole 721, When the liver band 5 passes through the first sleeve 72, the first ratchet 51 engages with the second ratchet 711; the second ratchet 711 allows the first ratchet 51 to slide forward to tighten the collar, and at the same time prevent the first ratchet 51 from sliding backward;
  • a spring 73 arranged longitudinally is arranged between the buckle 71 and the first sleeve 72;
  • the buckle 71 is provided with a vernier 714 for marking the tension of the liver belt 5
  • the first sleeve 72 is provided with a vernier scale 723 .
  • the buckle 71 is a second sleeve sleeved in the first sleeve 72, and the second sleeve is provided with a longitudinal second inner hole 712 for the band around the liver 5 to pass through; the second sleeve
  • the outer wall is provided with a protrusion 713, and the protrusion 713 is slidably inserted into the longitudinal guide groove 722 on the wall surface of the first sleeve 72.
  • the protrusion 713 is provided with the above-mentioned cursor 714; the inner wall of the second sleeve is provided with There is said second ratchet 711 .
  • the other end of the liver belt 5 opposite to the free end is provided with a base 52, and the through hole is arranged on the base 52; under the pulling force of the liver belt 5, the bottom end of the first sleeve 72, the base
  • the upper end of 52 is close to the upper end and the lower end of the abdominal wall catheter 6 respectively, so that the first sleeve 72, the abdominal wall catheter 6, and the base 52 successively interfere with each other, so that the liver band 5 is positioned.
  • the liver band 5 in the first stage of operation, is tightened on the connecting part of the left and right liver lobes.
  • the doctor pulls the liver band 5 upwards on the upper part of the second sleeve 72 outside the patient's body.
  • the twitching stops the first ratchet 51 meshes with the second ratchet 711 , and is positioned around the liver band 5 .
  • the tightening force of the liver belt 5 on the liver automatically reaches a preset value.
  • the tightening force of the liver belt 5 on the liver can be determined according to the design of the surgical instrument in advance, and no longer depends on the operator's personal feel and experience.
  • the hepatic belt needs to be tightened downward on the 6th day after the operation, no laparotomy is required, as long as the upper part of the second sleeve 72 outside the body is pulled upwards around the liver belt 5, when the cursor 714 is aligned with the first
  • the preset scale 723 is set on the sleeve 72, the twitching stops, and the liver band 5 can be positioned by itself.
  • the tightening force of the liver-wrapping belt 5 on the liver automatically reaches a preset value, which is convenient and quick, and is easy for doctors to operate and reduces pain for patients.

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Abstract

一种完全腹腔镜下绕肝带法二步切除病患侧肝的手术方法：（1）病人在全麻状态下行完全腹腔镜手术，用绕肝带法手术结扎，将待切除的病患侧肝的门静脉分支，同时使用绕肝带束紧左右肝之间的连接部位来阻断待切除的病患侧肝与需保留的半侧肝之间的交通血流，在肝门部留置1根腹腔引流管后关腹，完成第一次手术；（2）病人第一次手术后逐渐恢复饮食，休养6-15天，使需保留的半侧肝脏的体积增大至预期余肝体积，预期余肝体积为标准肝脏体积的30-40％以上；（3）待病人需保留的半侧肝脏的体积增大至预期余肝体积，然后进行第二次手术，在全麻下行完全腹腔镜手术，将病患半侧肝脏切除，休养至完全康复。还包括专用于完全腹腔镜下绕肝带法二步切除病患侧肝的手术方法的压力可调式肝脏束紧装置。

Description

完全腹腔镜下绕肝带法二步切除病患侧肝的手术方法及其器械 技术领域
本发明涉及用于为患有严重肝硬化或肝肿瘤的肝癌患者，在完全腹腔镜下二步法切除病患侧肝的手术方法及其手术器械。
背景技术
中国是世界上为乙肝、肝硬化和肝癌付出最多社会成本的国家。乙肝、肝硬化和肝癌是密切关联的乙肝病毒感染后病情发展的不同阶段，很多乙肝病毒感染的病人最后会发展为肝癌，公开数据显示，全球3.5亿乙肝病毒携带者中有近1亿中国人，全球每年大约70万病毒性肝炎相关死亡人群中中国占近半，原发性肝癌是中国常见的恶性肿瘤，死亡率在恶性肿瘤中居第2位。对肝癌患者，肝切除术是目前最有效的治疗方法，但并不是所有患者都能承受肝切除术。大多数肝癌患者都有长达数十年的乙肝病史，伴有严重的肝硬化，肝脏代偿能力差，难以承受一半以上的肝脏切除，勉强手术后出现肝功能衰竭以至于死亡的可能性非常大。医学上对于伴有肝硬化的肝癌患者，如果预计手术后剩余的肝脏体积小于40％，则被认为是肝切除术的禁忌。对于这些患者，只能放弃手术或耐心地等待肝移植，由于供体肝源的紧缺，大部分病人都无法等到肝移植。
近年来，联合肝脏离断和门静脉结扎的二步法肝切除术(ALPPS)逐渐受到肝胆外科界的关注。这种采用二次手术的方法对这类被认为无法实施肝切除的患者实施肝切除。第一期手术，切断所要切除侧肝 脏的门静脉分支，同时将左右两侧的肝脏切开分离，术后保留侧肝脏体积会迅速增大。然后进行二期手术，切除病灶一侧的肝脏。从目前的经验来看，这种手术方法能对以前无法行肝切除的肝癌患者实施肝切除，取得了较好的治疗效果。现有的这种方法能⑴减少术中出血；⑵减少缺血再灌注损伤；⑶解剖性肝切除，保护残肝功能；⑷减少肿瘤播散。但这种手术仍存在一些问题，其中最为突出的是第一次手术需要将左右两侧肝脏切断分离来阻断左右半肝之间的交通血流，肝切面发生胆漏的风险极大，在德国Regensburg医院，该手术胆漏的发生率高达24％。另外就是两次期手术间隔时间如果太长，容易导致腹腔内部粘连增加，但是如果两期手术间隔时间太短，由于病人进行一期手术时创面较大，本身的体力不能很好的恢复，就要进行第二期手术。
发明内容
本发明要克服现有技术的上述缺点，提供一种完全腹腔镜下绕肝带法二步切除病患侧肝的手术方法及其器械。
本发明让患者完全腹腔镜下施行第一期和第二期手术，这样手术创面大大减小，有利于术后恢复及肝再生。
一种腹腔镜下绕肝带法二步切除病患侧肝的手术方法，其特征在于所述的手术方法通过间隔6-15天的两次手术完成，所述的方法按如下步骤进行：
(1)第一次手术：病人在全麻状态下行全腹腔镜手术，用绕肝 带法手术结扎，将待切除的病患侧肝的门静脉分支，同时使用绕肝带束紧左右肝之间的连接部位来阻断待切除的病患侧肝与需保留的半侧肝之间的交通血流，在肝门部留置1根腹腔引流管后关腹，完成第一次手术；
(2)短期养肝：病人第一次手术后逐渐恢复饮食，休养6-15天，使需保留的半侧肝脏的体积增大至预期余肝体积，所述的预期余肝体积为标准肝脏体积的30-40％以上；所述的标准肝脏体积SLV＝706.2×BSA+2.4，BSA＝BW 0.425×BH 0.725×0.007184，其中：BW为体重(kg)，BH为身高(cm)，BSA为体表面积(m 2)，SLV：标准肝脏体积(ml)；
(3)第二次手术：在第一次手术后6-15天内待病人需保留的半侧肝脏的体积增大至所述的预期余肝体积后，进行第二次手术，在全麻下行完全腹腔镜手术，将病患半侧肝脏肝切除术，休养至完全康复。
通常当病人为肝硬化患者时，优选所述的预期余肝体积为标准肝脏体积的40％以上，当病人为非肝硬化患者时优选所述预期余肝体积为标准肝脏体积30％以上。
本发明使用绕肝带束紧左右肝之间的连接部位来阻断左右肝的交通血流。
本发明所述的步骤(1)推荐按如下方法进行：在腹腔镜下，游离肝周韧带，解剖第一肝门，分离出病患侧肝动脉及门静脉，第二肝门处显露肝右静脉与肝中、肝左静脉之间的肝上静脉陷窝，游离肝后下腔静脉，结扎部分肝短静脉，显露右下肝静脉结扎离断待切除的病 患侧肝的静脉，保护需保留的半侧肝脏静脉，再使用绕肝带阻断待切除的病患侧肝与需保留的半侧肝脏之间的交通血流，在肝门部留置1根腹腔引流管后关腹。
本发明所述的绕肝带围合处优选设有压力可调式肝脏束紧装置。
所述的压力可调式肝脏束紧装置是与绕肝带围合后的外周紧密配合的弹性装置。不动作的状态下，压力可调式肝脏束紧装置紧锁住绕肝带，使绕肝带固定捆扎在肝周围，使劲提拉或松动绕肝带时，分别可使绕肝带对肝的捆扎收紧或松弛，由于压力可调式肝脏束紧装置有较强的弹性，随时都能固定肝外圈的绕肝带的捆扎长度。
进一步，所述的第一次手术的腹腔镜开孔取左侧肋缘下与左锁骨中线交点作主操作孔，分离腹腔内粘连后，在右侧腹部取两个副操作孔。
再进一步，所述的第二次手术，行腹腔镜手术时的开孔使用与第一次腹腔镜戳孔相同的操作孔。
所述的步骤(1)第一次手术优选按如下步骤进行，在病人肝脏周围左侧肋缘下与左锁骨中线交点作主操作孔，使用超声刀分离腹腔内粘连后，在右侧腹部取两个副操作孔，分离腹腔内以及肝门部、第二肝门的粘连，解剖出肝固有动脉、左肝动脉以及门静脉左支，在门静脉左支根部使用丝线结扎后再使用Hamlock夹闭，在左肝动脉上使用Proline线作标记，第一肝门处理完毕，随后离断冠状韧带、左三角韧带游离左半肝；在第二肝门处解剖出左肝静脉，使用带导芯的鼻胃管经过左肝静脉右侧，紧贴肝表面向后绕到左侧尾状叶前方，避开左 肝动脉后，靠近左肝蒂根部绕到肝前面，将绕肝带两尾端并拢，自右锁骨中线腹壁戳孔拉出体外，套上36号胸引管，拉紧作为绕肝带的绕肝带，推入外套管后使用血管钳夹紧，拉紧前使用术中超声，明确患肝侧部位，在肝门部留置1根腹腔引流管后关腹。
更进一步，所述的步骤(3)第二次手术优选按如下步骤进行：取第一次腹腔镜戳孔进腹，使用吸引器吸进腹腔积液并推拨粘连暴露肝门部后，在腹壁提拉绕肝带，首先在肝门部找到标记的左肝动脉，夹闭并离断，随后沿着绕肝带使用腹腔镜彭氏多功能手术解剖器(LPMOD)采用刮吸法断肝，并使用切割闭合器协助断肝，至左肝静脉处确切夹闭后离断，移除病患半侧肝，腹腔内妥善止血并于断面留置腹腔引流管关腹。
具体的，所述的步骤(2)，第一次术后病人逐渐恢复饮食，在所述的第一次术后第6天时将绕肝带继续向下收紧1次。
所述的步骤(3)病人第一次手术后在6-15天内使需保留的半侧肝脏的体积优选增大到至预期余肝体积为标准肝脏体积的60％以上，再进行第二次手术，如时间太短预期余肝体积可能太小，时间太久，容易使腹腔内产生过多粘连，因此时间以1-2周为宜，通常不建议超过2周。
本发明的腹腔镜下采用绕肝带捆扎的二步法肝切除术，第一期手术，在完全腹腔镜下切完全断所要切除侧肝脏的门静脉分支，使用绕肝带束紧左右肝之间的连接部位来阻断左右肝的交通血流。术后保留侧肝脏体积会迅速增大；然后进行二期手术，切除病灶一侧的肝脏。 这种方法采用了腹腔镜技术，手术创伤小，减少了对机体免疫系统的打击及机体自身的抗肿瘤能力的影响，而且患者的早期康复，能使患者更早的接受其它抗肿瘤的辅助治疗。这种技术使用绕肝带替代了左右侧肝脏切断分离来阻断左右肝的交通血流，使术后肝切面发生胆漏这一并发症得到了彻底解决。手术的费用是常规肝移植手术费用的30％，能够减轻了病患家庭的经济负担。
本发明还包括实施完全腹腔镜下绕肝带法二步切除病患侧肝的手术方法的专用器械，是一种压力可调式肝脏束紧装置。
虽然存在用弹性圈束紧绕肝带的先例，但是现有技术仍然有如下缺点：其一，绕肝带的束紧张力在安装时全靠医师的经验，不容易掌握，容易出现过松或过紧，过松则不能完全阻断左右肝的交通血流，不能达到手术目的，过紧则容易损伤肝脏组织；其二，一期手术与二期手术的间隔长达6～15天，左右肝之间的连接部的萎缩较大，即便带有弹性圈，绕肝带的松紧程度也有较大变化，不能一直保持在最佳的程度，影响手术目的的实现；其三，绕肝带位于人体内部，其张紧程度难以被医师识别，影响医师及时调节绕肝带；其四，一期手术之后绕肝带的松紧程度调节依靠医师个人经验和手感，无法准确计量，盲目性较大。因此，为了降低本发明的手术方法的实施难度，需要改善其手术器械。
实施完全腹腔镜下绕肝带法二步切除病患侧肝的手术方法的专用器械，一种压力可调式肝脏束紧装置，包括用柔性材料制成的绕肝带5，绕肝带5的一端是自由端，另一端设有一个通孔，所述的自由 端穿过所述的通孔形成一个能束紧肝脏4的套环；将绕肝带5背离肝脏的一侧定义为外侧；绕肝带5的外侧设有第一棘齿51；绕肝带5的自由端依次穿过所述的通孔、腹壁导管6、压力控制装置7，所述的腹壁导管6穿过病人腹壁2；
所述的压力控制装置7包括第一套筒72、卡扣71，以第一套筒72中心轴线方向为纵向，第一套筒72设有供绕肝带5穿过的纵向第一内孔721，卡扣71设置在第一套筒72的纵向导槽722内，并能沿导槽722纵向移动；卡扣71设有伸入所述的第一内孔721的第二棘齿711，绕肝带5穿过第一套筒72时第一棘齿51与第二棘齿711啮合；第二棘齿711允许第一棘齿51朝拉紧所述的套环的正向滑动，同时阻止第一棘齿51反向滑动；
卡扣71与第一套筒72之间设有沿纵向设置的弹簧73；
所述的卡扣72上设有用于标注绕肝带5张紧度的游标714，第一套筒72上设有游标的刻度723。
优选地，所述的卡扣71是套设在所述的第一套筒72内的第二套筒，第二套筒设有供绕肝5带穿过的纵向第二内孔712；第二套筒外壁设有突出部713，突出部713可滑动地穿设在第一套筒72的壁面上的纵向导槽722内，突出部713上设有所述的游标714；第二套筒的内壁设有所述的第二棘齿711。
绕肝带5的与所述的自由端相对的另一端设有底座52，所述的通孔设在底座52上；在绕肝带5拉力作用下，第一套筒72、腹壁导管6、底座52依次抵触，使绕肝带5定位。
本发明的第一套筒72、卡扣71和弹簧73，依照手术中对肝脏的束紧力的要求，进行物理参数的设置。在一期手术中，在绕肝带的张紧力达到预设值时，卡扣上的游标对准第一套筒的刻度，进行手术的医师即可固定绕肝带的位置，这样可以避免依靠医师的个人经验。
在一、二期手术之间，连接左右肝叶的连接部萎缩，绕肝带的张力下降，位于压力控制装置7的游标和刻度可以直接反映这个变化。由于压力控制装置7位于体外，医师可以方便地观察绕肝带5的张力的变化，并进行调整，无需开腹。由此，医师得以随时方便地将绕肝带5对肝脏的束紧力保持在最佳值。
本发明的优点是：(1)本发明通过使用绕肝带替代了左右侧肝脏切断分离来阻断左右肝的交通血流，使术后肝切面发生胆漏这一并发症得到了彻底解决。同时，两次手术是在腹腔镜下进行的，相较于以往的开腹手术，手术创伤小，减少了对机体免疫系统的打击及机体自身的抗肿瘤能力的影响。而且，患者的早期康复，能使患者更早的接受其它抗肿瘤的辅助治疗。(2)本发明在完全腹腔镜下使用绕肝带的方法对以往被认为无法手术的肝硬化肝癌患者实施了二期肝切除术，彻底切除了肝脏肿瘤，解决了预计剩余肝脏体积小于40％的伴有肝硬化的肝癌患者无法手术治疗的难题，使这一部分患者得到了有效的治疗。还值得一提的是，这个手术不仅是有严重肝硬化需要大范围肝切除的肝癌患者的治疗福音，破解了不能做大部分肝切除的困境，病人无需等待肝源就可以手术；而且从经济角度讲，该手术的费用是常规 肝移植手术费用的30％，也大大减轻了病患家庭的经济负担。(3)本发明克服了二步法肝切除术中肝切面发生胆漏的问题，解决了预期余肝体积为标准肝脏体积的小于40％的伴有肝硬化的肝癌患者无法手术治疗的难题，病人术后恢复好，降低治疗费用。(4)本发明方法在绕肝带围合处设有可调节绕肝带松紧的压力可调式肝脏束紧装置，可以方便在术手再提拉束紧绕肝带，在适当的时候可以固紧一下绕肝带围合处。
在一期手术中，可以用仪器刻度确定绕肝带对肝脏的束紧程度，避免依赖医师的个人经验；医师可以在病人体外直接观察绕肝带的束紧力大小，并方便地调节绕肝带对肝脏的束紧力，避免开腹。
附图说明
图1传统的左右肝实质分离原理图；
图2是本发明利用绕肝带对左右肝进行捆绑方法实施原理图；
图3行ALPPS病人手术前后CT图片对比：X部分表示放置绕肝带前右肝体积，Y部分表示放置绕肝带后肝脏体积；
图4为实施例1 ALPPS第一期手术术中图片；
图4a中白色箭头所指为门静脉左支，斑马纹箭头所指为左肝动脉；图4b白色箭头提示左肝静脉；图4c示拉紧绕肝止血带前使用术中超声确认肿瘤位于绕肝止血带左侧，并查看左右肝之间交通血流；图4d示第一期术后腹部切口情况，白色箭头所示为绕肝止血带体外部分，使用血管钳夹闭；
图5为实施例1 ALPPS第二期手术术中图片；
图5a示左肝表面溃疡以及粘连；图5b示第一期手术时作标记的左肝动脉；图5c示采用LPMOD刮吸法断肝；图5d斑马纹箭头示左肝动脉断端，白色箭头示门静脉左支断端；
图6为实施例1 ALPPS术后肝脏标本，显著肝硬化；
图7是本发明的一个实施例的工作原理示意图。
图8a是本发明的一个实施例的卡扣的示意图。
图8b是本发明的一个实施例的卡扣的纵向剖视图。
图9是本发明的一个实施例的第一套筒的示意图。
图10是本发明的一个实施例的压力控制装置的示意图。
图11是本发明的一个实施例的压力控制装置的纵剖面图。
图12是本发明的一个实施例的使用状态示意图。
具体实施方式
以下描述用于揭露本发明以使本领域技术人员能够实现本发明。以下描述中的优选实施例只作为举例，本领域技术人员可以想到其他显而易见的变型。在以下描述中界定的本发明的基本原理可以应用于其他实施方案、变形方案、改进方案、等同方案以及没有背离本发明的精神和范围的其他技术方案。
本领域技术人员应理解的是，在本发明的揭露中，术语“纵向”、“横向”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”“内”、“外”等指示的方位或位置关系是基于附图所示的方位或位置关系，其仅是为了便于描述本发明和简化描述，而不是指示或暗示 所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此上述术语不能理解为对本发明的限制。
在本发明中，权利要求和说明书中术语“一”应理解为“一个或多个”，即在一个实施例，一个元件的数量可以为一个，而在另外的实施例中，该元件的数量可以为多个。除非在本发明的揭露中明确示意该元件的数量只有一个，否则术语“一”并不能理解为唯一或单一，术语“一”不能理解为对数量的限制。
在本发明的描述中，需要理解的是，属于“第一”、“第二”等仅用于描述目的，而不能理解为指示或者暗示相对重要性。本发明的描述中，需要说明的是，除非另有明确的规定和限定，属于“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接或者一体地连接；可以是机械连接，也可以是电连接；可以是直接连接，也可以是通过媒介间接连接。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。
在本说明书的描述中，参考术语“一个实施例”、“一些实施例”、“示例”、“具体示例”、或“一些示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中，对上述术语的示意性表述不必须针对的是相同的实施例或示例。而且，描述的具体特征、结构、材料或者特点可以在任一个或多个实施例或示例中以合适的方式结合。此外，在不相互矛盾的情况下，本领域的技术人员可以将本说明书中描述的不同实施例或示例以及不同实施例或示例的特征进行结合和组合。
实施例1
1临床资料
患者，女性，61岁。因“发现AFP升高5d”入院。既往史：患慢性乙型病毒性肝炎30年，长期随访并服用拉米夫定和阿德福韦酯抗病毒治疗。2年前于外院行“开腹右肝结节切除+胆囊切除术”，术后病理提示：粗结节肝硬化，慢性萎缩性胆囊炎。入院查体：身高156cm，体重47kg。肝病面容，未见肝掌和蜘蛛痣，皮肤巩膜未见黄染。腹软，无压痛及反跳痛。入院后实验室检查AFP 39.94μg/L。肝功能Child分级A级。上腹部增强CT提示：肝II段占位性病变，首先考虑肝癌，肝硬化，脾大，胆囊缺如，肝内胆管稍扩张(见图1a)。MRCP提示：左肝内胆管轻度扩张，胆囊缺如。遂行经皮肝穿刺活检，病理提示：(左肝组织)高分化肝细胞性肝癌。拟行左半肝切除，测算标准肝脏体积：1010mL(标准肝脏体积SLV＝706.2×BSA+2.4，BSA＝BW 0.425×BH 0.725×0.007184)
，其中：BW为体重kg，BH为身高cm，BSA为体表面积m 2，SLV：标准肝脏体积ml；
CT测定全肝体积1038mL(GEHC软件，Volume Viewer 9.6.25b；工作站，Ge advantage Workstation,通用电器医疗)，剩余肝体积387mL，占标准肝体积的38.3％。因肝硬化病人未来剩余肝体积要求达到40％以上，拟行ALPPS。
2手术方法
2.1第一期手术病人于2014-05-14行全麻下行全腹腔镜手术。在左侧肋缘下与左锁骨中线交点作主操作孔，使用超声刀分离腹腔内粘 连后，在右侧腹部取两个副操作孔。因腹腔内粘连明显，遂耐心分离腹腔内以及肝门部、第二肝门的粘连，解剖出肝固有动脉、左肝动脉以及门静脉左支(图2a)，在门静脉左支根部使用丝线结扎后再使用Hamlock夹闭，在左肝动脉上使用Proline线作标记，第一肝门处理完毕，随后离断冠状韧带、左三角韧带游离左半肝。在第二肝门处解剖出左肝静脉(图2b)，使用带导芯的鼻胃管经过左肝静脉右侧，紧贴肝表面向后绕到左侧尾状叶前方，避开左肝动脉后，靠近左肝蒂根部绕到肝前面，将绕肝带两尾端并拢，自右锁骨中线腹壁戳孔拉出体外，套上36号胸引管(作为施压外套管)。拉紧绕肝带，推入外套管后使用血管钳夹紧，在拉紧后绕肝带围合处装上压力可调式肝脏束紧装置，拉紧前使用术中超声，明确肿瘤位于绕肝带左侧(图2c)。在肝门部留置1根腹腔引流管后关腹。术后腹部切口图片见(图2d)。
2.2第二期手术在第一期手术后第11天(5月25日)行第二期手术，行腹腔镜左半肝切除术。取原腹腔镜戳孔进腹，见腹腔内少许粘连，较疏松，紧贴绕肝带下面左肝表面可见多发溃疡形成(图3a)，腹腔内中等量淡血性腹水，使用吸引器吸进腹腔积液并推拨粘连暴露肝门部后，助手在腹壁提拉绕肝带，首先在肝门部找到标记的左肝动脉(图3b)，夹闭并离断，随后沿着绕肝带使用腹腔镜彭氏多功能手术解剖器(LPMOD)采用刮吸法断肝(图3c)，并使用切割闭合器协助断肝，至左肝静脉处确切夹闭后离断，移除标本。腹腔内妥善止血并于断面留置腹腔引流管关腹(图3d)。因左肝标本体积巨大，约21cm×16cm，无法自腹壁戳孔取出，遂取原右上腹肋缘下小切口进腹取出标本(图4)。手术过程顺利。
3结果
3.1第一期手术时间290min，术中出血量100mL，无术中输血。 第一期手术后病人体温36.2～37.7℃，心率81～104次/min，每日腹腔引流液200～1033mL。术后1天起床活动，术后第4天B超提示胸腔积液，予以置管引流，引流量每日350～911ml。术后病人逐渐恢复饮食，在术后第6天时将绕肝带继续向下收紧1次，压力可调式肝脏束紧装置调节后对绕肝带继续起张紧作用。术后第2天ALT即达到峰值，为2998U/L；术后第1天AST即达峰值，为2232U/L；总胆红素逐渐上升，在术后4天达到高峰为112.7μmol/L，随后逐渐回落；白细胞以及C反应蛋白分别在术后第2天以及术后第4天达到峰值，PT维持在13.9-25.0s，APTT维持在36.1～44.6s。病人在术后第5天行CT检查，测得剩余肝脏体积为669mL，较术前增加72.9％，在术后第9天时复查CT测量剩余肝脏体积为753.7mL，较术前增加94.8％。此时，剩余肝脏体积占标准肝脏体积的74.6％，即预期余肝体积为标准肝脏体积的74.6％(图1)肝功能基本恢复正常，腹腔内无感染，营养状况佳，达到安全切除肝脏的范围。
3.2第二期手术手术时间160min，术中出血100mL，术中输红细胞2U。术后次日即下床活动、恢复饮食，体温35.8～37.6℃，心率72～86次/min，血压稳定。白细胞在轻度上升后逐渐下降，ALT以及AST进一期持续下降，总胆红素在次日一过性上升后持续下降。每日腹腔引流量300-1100Ml,逐渐降至24～64mL。
3.3术后病理检查结果术后病理切片提示：(左半)肝细胞肝癌，凝固性坏死伴出血，(肝十二指肠韧带)淋巴结未见癌转移(0/2)。
传统上，促进未来剩余肝脏体积增生的方法包括：(1)Makuuchi的门静脉栓塞方法(1990)；(Adam(2000)的二期肝切除术；(3)Jaeck(2004)的二期肝切除术治疗多发左或右半肝肿瘤；(4)Clavien的二期肝切除术(2007)，在第一期手术中使用联合楔 形切除所有左半肝的肿瘤后，结扎右门静脉，数周后在左半肝增生足够时行第二期扩大右半肝切除术。这些手术的最大缺点是：两次手术的时间相距太长，平均>4周，甚至4个月；在此期间肿瘤可继续进展；第1次手术引致粘连会使第2次切除手术更困难等，而且术后剩余肝脏增生不够理想。与2～8周增生10％～46％相比之下，ALPPS的特点在于：7d内剩余肝脏急速显著增生(74％～87％)，短暂等待1周后就可进行第二期手术。然而，ALPPS手术并发症发生率高达74％，而病死率有报告高达12％～23％。手术风险相对较大。发生胆漏，伴严重感染的发生率高达(20％～25％)这是造成高死亡率的重要原因。第一期手术进行肝实质离断，目的在于通过阻断两侧门静脉的交通支从而促进剩余肝脏急速显著增生，然而却可能带来胆漏的严重的后果。有没有其他方法，既能避免断肝又能阻断两侧门静脉的交通支从而促进剩余肝脏急速显著增生？我们根据在各种肝切除术中大量使用绕肝提拉法的经验，认为将绕肝带作为止血带可以取代ALPPS中的肝实质离断从而避免断肝，彻底防止胆漏。查阅文献发现，Campos也有类似设想并于2011、2013年各施行1例，但均为开腹手术。
国内已有腹腔镜辅助联合肝脏离断和门静脉结扎的报告，取得较好结果。但是，完全腹腔镜施行ALPPS的报告在国际上报告很少，只有两例由于具有完全腹腔镜施行肝切除以及使用绕肝提拉法的经验，我们将二者结合应用取得了良好效果。
绕肝止血带除了起到阻断左右两侧的血流的作用，还有助于第二期手术肝实质离断时的操作：我们习惯使用腹腔镜多功能手术解剖器LPMOD，断肝时可直接对着绕肝带加强电凝，由于绕肝带的绝缘作用，不必担心伤及深部组织，尤其是后面的肝后下腔静脉，这样就使断肝过程安全可靠。
本例绕肝止血带的安置与传统的方法有所不同。通常绕肝带是在肝右静脉和肝中静脉之间穿行于肝后隧道。为了把肝中静脉在二期断肝时留给剩余肝以期更好地保护肝功能，只好设法让绕肝止血带在肝左静脉和肝中静脉之间穿行。因此，在肝上缘进行解剖时需要倍加小心。
关于ALPPS剩余肝脏急速增生的机制，有人提出4种可能。通过绕肝止血带的应用结果表明，阻断左右两侧的血流的交通，使对侧的门静脉血全部涌入剩余肝才是最主要的因素。本例的治疗效果也表明了ALPPS对伴有肝硬化的原发性肝癌也同样能起作用。由于第一期手术无需离断肝实质，没有肝创面，也就得以避免严重的胆漏并发症及其带来的感染。
本例绕肝止血带上提束紧时，虽然避开了肝动脉，却压到了左肝蒂，以至术后黄疸上升。这样也许有助于剩余肝脏急速增生，但是对肝功能会有不良影响。因此衡量得失，以避开肝蒂为佳。实施的方法是，将肝门板下降，让绕肝止血带从肝门板和肝表面之间穿出，从而隔开肝蒂。
关于手术适应证，本例术式的选择确实两难，因为肿瘤虽然较小，但紧靠近门静脉矢状部，消融消融风险较大，因而可能消融肿瘤不彻底；患者术前CT、MR提示肝硬化，尽管肝功能属于ChildA级，有行肝切除的可行性，但是另一方面，剩余肝脏体积仅为38％，低于肝硬化病人要求40％的下限，行左半肝切除也有风险。综合上述原因，我们选择了二步法肝切除。此患者术后恢复非常好，第一次术后及第二次术后均在第1天就下床活动，说明所选用的治疗方法，能给该患者带来好处。
总之，通过临床实践，我们认为，ALPPS两期手术均能在腹腔镜下安全实施；对伴有肝硬化的原发性肝癌ALPPS同样能够促使未来剩余肝脏体积在短期内迅速增大；虽然绕肝带实施难度较肝离断大，但采用绕肝带方法的手术创伤明显小于肝离断的方法，患者可以在更短时间内获得二 次手术的机会，同时绕肝带方法不需要切割肝实质，可以避免胆漏等并发症的发生。绕肝止血带可以取代肝实质离断，效果相似而并发症大大减少；阻断左右两侧的血流的交通，使对侧的门静脉血全部涌入剩余肝是ALPPS剩余肝脏急速增生的主要机制。
本例完全腹腔镜施行ALPPS并以绕肝止血带取代肝实质离断效果良好，短期内肝脏迅速增大，但只是初步实践，有待更多病例的验证，同时需要动物实验研究对其机理作深入地研究。
实施例2
患者2年前于北京某医院因肝癌行“肝脏射频消融术”，术后无明显不适主诉，每3月复查甲胎蛋白，结果均正常。2月前入我科行TACE，术后至今感右上腹不适，无其他明显异常，今为求进一步治疗，来我院就诊，门诊拟“肝癌，TACE术后”收住入院。患者患慢性乙肝史16年，阿德福韦片1片QD。
术前CT计算余肝体积占标准肝体积的35.6％。因肝硬化病人未来剩余肝体积要求达到40％以上，拟行腹腔镜下绕肝带法二步肝切除术切除右半肝。
2014.5.22行第一期手术：术中探查腹腔内未见明显转移性结节，无腹水形成，肝脏质地呈结节状改变，触碰易出血，左肝不大，右肝肥厚，术中超声提示右肝内VIII段直径约5cm肿块，右肝VI段亦可见直径约0.8cm小病灶。胆囊大小约7*3cm，内可见结石形成。
第一期手术经过：平卧，气插全麻成功，常规导尿，消毒铺巾。2.于脐右侧5cm作弧行小切口，以气腹针穿刺入腹腔，充入二氧化碳气体成15mmHg气腹。拔出气腹针，以套管针穿刺腹腔，拔出内芯，插入腹腔镜，检查腹腔如术中所见。3.腹腔镜明视下再作多个 套管针穿刺，主操作孔为12mm Xcel Trocar，位于右肋缘下。右侧腋前线、腋中线各置二个5mmTrocar，作为助手操作孔。4.改头高脚底位，使用超声刀分离腹腔内少量粘连。充分游离右肝，将右肝向左侧牵拉，分离出肝短血管，逐一缝扎结扎，继续向上分离，解剖第二肝门，分离出处右肝静脉。5.拟解剖分离肝十二指肠韧带，因患者合并胆囊结石且胆囊阻挡视线，遂行胆囊切除，继续解剖，分离出肝固有动脉，左肝动脉以及右肝动脉，继续向后分离处门静脉左支，右支以及尾状叶分支，使用可吸收线结扎门脉右支并使用Hamlock夹闭。6.此时使用带导芯鼻空肠营养管，自第二肝门穿过腔静脉裂孔干绕到肝后，沿着下腔静脉，穿过肝右动脉的后方，到达肝前方，与前方的营养管汇合，置入长约10cm的36号胸管腔内，连同胸管自腹壁戳出，收紧营养管，使用带橡皮套的血管钳夹闭，捆绑左右肝实质，在拉紧后绕肝带围合处装上压力可调式肝脏束紧装置。7.再次冲洗腹腔，探查无活动性出血后，于肝门部留置腹腔引流管1根。逐个缝合切口并固定引流管。术毕。7.手术过程顺利，出血量约100ml，术中病人生命体征稳定，麻醉效果满意，病人送PACU。
患者术后第一天下床活动。术后第1天谷丙转氨酶(ALT)及谷草转氨酶(AST)即达到峰值，分别为1520U/L和1460U/L。在术后第6天时将绕肝带继续向下收紧1次，压力可调式肝脏束紧装置调节后对绕肝带继续起张紧作用，术后第10天行CT检查，测得剩余肝脏体积为670ml，较术前增加37.9％，此时，剩余肝脏体积占标准肝脏体积的49.1％，即预期余肝体积为标准肝脏体积的49.1％。第一期手术第12天行第二期手术切除右半肝。
第二期手术术中见：腹腔内未见明显转移结节，微量腹水，肝脏质地呈结节状改变，左肝体积较前增大，表面未见明显脓苔形成，原 第一步手术中的绕肝捆绑带在位，肝门部预置的右肝动脉结扎线在位，予行右半肝切除术，取出标本可见右肝VIII段下有一直径约1.5cm左右肿块，肿块切面呈灰白色。其余脏器未见明显异常。
第二期手术经过：1.平卧，气插全麻成功，常规导尿，消毒铺巾。2.取原腔镜手术切口进腹，于脐下切口，以气腹针穿刺入腹腔，充入二氧化碳气体成15mmHg气腹。拔出气腹针，以套管针穿刺腹腔，拔出内芯，插入腹腔镜，检查腹腔如术中所见。3.腹腔镜明视下再作三个套管针穿刺，主操作孔为12mm Xcel Trocar，位于左肋缘下。右侧腋中线置二个5mmTrocar，作为助手操作孔。4.改头高脚底位，使用吸引器分离肝脏表面以及腹腔内的粘连，随后分离出肝门部预置的右肝动脉，使用可吸收夹两端夹闭后离断。5.此时从腹壁外提起绕肝捆绑带，使用腔镜彭氏多功能手术解剖器采用刮吸法断肝，因捆绑后绕肝带内肝实质较少且薄，存在较多管道结构，遂使用EC60断肝。创面彻底止血。6.因右肝体积巨大，无法自腔镜戳孔取出，遂取上腹部剑突下小切口取标本。7.取出标本后肝断面以及腹腔内妥善止血，并予术中造影，可见胆总管及左肝内胆管显影清晰，无明显充盈缺损及胆漏等，探查无活动性出血及胆瘘后，于肝断面置腹腔引流管2根。逐个缝合切口并固定引流管。术毕。8.手术过程顺利，出血量约300ml，术中病人生命体征稳定，麻醉效果满意，术后安返PACU。
患者术后恢复良好，术后第一天即下床活动，术后病理诊断：肝癌。
实施例3
本实施例介绍本发明的完全腹腔镜下绕肝带法二步切除病患侧肝的手术方法的专用器械，是一种压力可调式肝脏束紧装置。
图8-图13中的附图标记是：腹腔1、腹壁2、体外3、肝脏4、绕肝带5(包括第一棘齿51、底座52)、腹壁导管6、压力控制装置7；压力控制装置7包括卡扣71、第一套筒72、弹簧73；卡扣71包括第二棘齿711、第二内孔712、突出部713、游标714；第一套筒72包括第一内孔721、导槽722、刻度723。
实施完全腹腔镜下绕肝带法二步切除病患侧肝的手术方法的专用器械，一种压力可调式肝脏束紧装置，包括用柔性材料制成的绕肝带5，绕肝带5的一端是自由端，另一端设有一个通孔，所述的自由端穿过所述的通孔形成一个能束紧肝脏4的套环；将绕肝带5背离肝脏的一侧定义为外侧；绕肝带5的外侧设有第一棘齿51；绕肝带5的自由端依次穿过所述的通孔、腹壁导管6、压力控制装置7，所述的腹壁导管6穿过病人腹壁2；
所述的压力控制装置7包括第一套筒72、卡扣71，以第一套筒72中心轴线方向为纵向，第一套筒72设有供绕肝带5穿过的纵向第一内孔721，卡扣71设置在第一套筒72的纵向导槽722内，并能沿导槽722纵向移动；卡扣71设有伸入所述的第一内孔721的第二棘齿711，绕肝带5穿过第一套筒72时第一棘齿51与第二棘齿711啮合；第二棘齿711允许第一棘齿51朝拉紧所述的套环的正向滑动，同时阻止第一棘齿51反向滑动；
卡扣71与第一套筒72之间设有沿纵向设置的弹簧73；
所述的卡扣71上设有用于标注绕肝带5张紧度的游标714，第一套筒72上设有游标的刻度723。
所述的卡扣71是套设在所述的第一套筒72内的第二套筒，第二套筒设有供绕肝5带穿过的纵向第二内孔712；第二套筒外壁设有突出部713，突出部713可滑动地穿设在第一套筒72的壁面上的纵向导槽722内，突出部713上设有所述的游标714；第二套筒的内壁设有所述的第二棘齿711。
绕肝带5的与所述的自由端相对的另一端设有底座52，所述的通孔设在底座52上；在绕肝带5拉力作用下，第一套筒72的底端、底座52的上端分别紧靠腹壁导管6的上端和下端，使第一套筒72、腹壁导管6、底座52依次抵触，使绕肝带5定位。
本实施例在第一期手术中将绕肝带5束紧在左右肝叶的连接部上，医师在病人体外的第二套筒72的上部向上抽动绕肝带5，当游标714对准第一套筒72上预设的刻度723时，停止抽动，第一棘齿51与第二棘齿711啮合，绕肝带5定位。此时，绕肝带5对肝脏的束紧力自动达到预设值。由此，绕肝带5对肝脏的束紧力可以按照事先对手术器械的设计而定，不再依赖于手术医师个人的手感和经验。
本实施例在术后第6天时需要将绕肝带继续向下收紧时，无需开腹，只要在体外的第二套筒72的上部向上抽动绕肝带5，当游标714对准第一套筒72上预设的刻度723时，停止抽动，绕肝带5即可自行定位。此时，绕肝带5对肝脏的束紧力自动达到预设值，方便快捷，便于医师操作，减少病人痛苦。

Claims (9)

  1. 一种完全腹腔镜下绕肝带法二步切除病患侧肝的手术方法，其特征在于所述的手术方法通过间隔6-15天的两次手术完成，所述的方法按如下步骤进行：
    1)第一次手术：病人在全麻状态下行完全腹腔镜手术，用绕肝带法手术结扎，将待切除的病患侧肝的门静脉分支，同时使用绕肝带束紧左右肝之间的连接部位来阻断待切除的病患侧肝与需保留的半侧肝之间的交通血流，在肝门部留置(1)根腹腔引流管后关腹，完成第一次手术；
    2)短期养肝：病人第一次手术后逐渐恢复饮食，休养6-15天，使需保留的半侧肝脏的体积增大至预期余肝体积，所述的预期余肝体积为标准肝脏体积的30-40％以上；所述的标准肝脏体积SLV＝706.2×BSA+2.4，BSA＝BW 0.425×BH 0.725×0.007184，其中：BW为体重kg，BH为身高cm，BSA为体表面积m 2，SLV：标准肝脏体积ml；
    3)第二次手术：在第一次手术后6-15天内待病人需保留的半侧肝脏的体积增大至预期余肝体积，然后进行第二次手术，在全麻下行完全腹腔镜手术，将病患半侧肝脏切除，休养至完全康复。
  2. 如权利要求1所述的手术方法，其特征在于所述的步骤1)按如下方法进行：在腹腔镜下，游离肝周韧带，解剖第一肝门，分离出病患侧肝动脉及门静脉，第二肝门处显露肝右静脉与肝中、肝左静脉之间的肝上静脉陷窝，游离肝后下腔静脉，结扎部分肝短静脉，显露右下肝静脉结扎离断待切除的病患侧肝的静脉，保护需保留的半侧肝脏静脉，再使用绕肝带束紧左右肝之间的连接部位来阻断待切除的病患 侧肝与需保留的半侧肝脏之间的交通血流，在肝门部留置(1)根腹腔引流管后关腹。
  3. 如权利要求1所述的手术方法，所述的第一次手术的腹腔镜开孔取左侧肋缘下与左锁骨中线交点作主操作孔，分离腹腔内粘连后，在右侧腹部取两个副操作孔；所述的第二次手术，行腹腔镜手术时的开孔使用与第一次腹腔镜戳孔相同的操作孔。
  4. 如权利要求1所述的手术方法，当病人为肝硬化患者时，所述的预期余肝体积为标准肝脏体积的40％以上，当病人为非肝硬化患者时所述预期余肝体积为标准肝脏体积30％以上。
  5. 如权利要求1所述的手术方法，所述的步骤1)第一次手术按如下步骤进行，在病人肝脏周围左侧肋缘下与左锁骨中线交点作主操作孔，使用超声刀分离腹腔内粘连后，在右侧腹部取两个副操作孔，分离腹腔内以及肝门部、第二肝门的粘连，解剖出肝固有动脉、左肝动脉以及门静脉左支，在门静脉左支根部使用丝线结扎后再使用Hamlock夹闭，在左肝动脉上使用Proline线作标记，第一肝门处理完毕，随后离断冠状韧带、左三角韧带游离左半肝；在第二肝门处解剖出左肝静脉，使用带导芯的鼻胃管经过左肝静脉右侧，紧贴肝表面向后绕到左侧尾状叶前方，避开左肝动脉后，靠近左肝蒂根部绕到肝前面，将绕肝带两尾端并拢，自右锁骨中线腹壁戳孔拉出体外，套上36号胸引管，拉紧作为绕肝带的绕肝带，推入外套管后使用血管钳夹紧，拉紧前使用术中超声，明确患肝侧部位，在肝门部留置1根腹腔引流管后关腹。
  6. 如权利要求1所述的手术方法，所述的步骤3)第二次手术按如下步骤进行：取第一次腹腔镜戳孔进腹，使用吸引器吸进腹腔积液并推拨粘连暴露肝门部后，在腹壁提拉绕肝带，首先在肝门部找到标记的左肝动脉，夹闭并离断，随后沿着绕肝带使用腹腔镜彭氏多功能手术解剖器(LPMOD)采用刮吸法断肝，并使用切割闭合器协助断肝，至左肝静脉处确切夹闭后离断，移除病患半侧肝，腹腔内妥善止血并于断面留置腹腔引流管关腹。
  7. 用于实施权利要求1所述的一种完全腹腔镜下绕肝带法二步切除病患侧肝的手术方法的器械，包括用柔性材料制成的绕肝带(5)，绕肝带(5)的一端是自由端，另一端设有一个通孔，所述的自由端穿过所述的通孔形成一个能束紧肝脏(4)的套环；将绕肝带(5)背离肝脏的一侧定义为外侧；其特征在于：绕肝带(5)的外侧设有第一棘齿(51)；绕肝带(5)的自由端依次穿过所述的通孔、腹壁导管(6)、压力控制装置(7)，所述的腹壁导管(6)穿过病人腹壁(2)；
    所述的压力控制装置(7)包括第一套筒(72)、卡扣(71)，以第一套筒(72)中心轴线方向为纵向，第一套筒(72)设有供绕肝带(5)穿过的纵向第一内孔(721)，卡扣(71)设置在第一套筒(72)的纵向导槽(722)内，并能沿导槽(722)纵向移动；卡扣(71)设有伸入所述的第一内孔(721)的第二棘齿(711)，绕肝带(5)穿过第一套筒(72)时第一棘齿(51)与第二棘齿(711)啮合；第二棘齿(711)允许第一棘齿(51)朝拉紧所述的套环的正向滑动，同时 阻止第一棘齿(51)反向滑动；
    卡扣(71)与第一套筒(72)之间设有沿纵向设置的弹簧(73)；
    所述的卡扣(72)上设有用于标注绕肝带(5)张紧度的游标(714)，第一套筒(72)上设有游标的刻度(723)。
  8. 如权利要求7所述的器械，其特征在于：所述的卡扣(71)是套设在所述的第一套筒(72)内的第二套筒，第二套筒设有供绕肝(5)带穿过的纵向第二内孔(712)；第二套筒外壁设有突出部(713)，突出部(713)可滑动地穿设在第一套筒(72)的壁面上的纵向导槽(722)内，突出部(713)上设有所述的游标(714)；第二套筒的内壁设有所述的第二棘齿(711)。
  9. 如权利要求8所述的器械，其特征在于：绕肝带(5)的与所述的自由端相对的另一端设有底座(52)，所述的通孔设在底座(52)上；在绕肝带(5)拉力作用下，第一套筒(72)、腹壁导管(6)、底座(52)依次抵触，使绕肝带(5)定位。
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