RU2781345C1 - Method for laser retrograde intrarenal lithotripsy - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to operative urology. A guide wire, a ureterorenoscope and a Khachin “inflated” basket are introduced into the renal cavity system. After that, the calculus is fixed inside the basket. Lithotripsy is performed and the operation is completed with the installation of a ureteral stent. In this case, after conducting the conductor string, a ureteral casing is passed along it. The conductor string is removed, a ureterorenoscope and a basket are passed along the ureteral casing. After fixing the calculus inside the basket, the ureterorenoscope is removed and inserted parallel to the fixing component of the basket along with the laser fiber. Then, the process of fragmentation of the calculus from the periphery is carried out with continuous irrigation of an isotonic solution cooled to 10-12°C, and the ureterorenoscope with laser fiber, the basket and the ureteral casing are removed. In this case, lithotripsy is carried out using a Fiberlase U2 apparatus, a 400 mcm laser fiber, with the apparatus settings in the “sputtering” mode, energy 1 J, frequency 30 Hz, power 30 watts.

EFFECT: method allows to increase the efficiency, reduce the time and reduce the trauma of treatment of patients with nephrolithiasis using lithotripsy.

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Description

The invention relates to medicine, namely to a method for performing transurethral (retrograde) intrarenal lithotripsy of urological stones.

Urolithiasis (UCD) is a popular disease with an estimated worldwide prevalence of 7.2–7.7% [K. Sakhaee. Nephrolithiasis as a systemic disorder. Curr Opin Nephrol Hypertens, 17 (2008), pp. 304-309; J.C. Lieske, L.S. Peña De La Vega, J.M. Slezak, et al. Renal stone epidemiology in Rochester, Minnesota: an update Kidney Int, 69 (2006), pp. 760-764]. The results of nationally representative statistics that were collected and published by the US National Health and Nutrition Survey (NHANES) program showed that approximately 10% of the US adult male population is diagnosed with KSD [C.D. Scales, A.C. Smith, J.M. Hanley, C.S. Saigal Prevalence of kidney stones in the United States. Eur Urol, 62 (2012), pp. 160-165]. Other evidence suggests that the prevalence of kidney stones increased in the last quarter of the 20th century among both sexes [V. Romero, H. Akpinar, D.G. Assimos Kidney stones: a global picture of prevalence, incidence, and associated risk factors Rev Urol, 12 (2010), pp. e86-96] Indeed, the health burden of this condition continues to grow, as the annual cost of urolithiasis in the US alone is about $2 billion [C.J. Boyce, P.J. Pickhardt, E.M. Lawrence, D.H. Kim, R.J. Bruce. Prevalence of urolithiasis in asymptomatic adults: objective determination using low dose noncontrast computerized tomography. J Urol, 183 (2010), pp. 1017-1021; Mohammad A, Prevalence and Trends in Kidney Stone Among Adults in the USA: Analyzes of National Health and Nutrition Examination Survey 2007–2018. European Urology Focus, Volume 7, Issue 6, 2021, Pages 1468-1475].

Open surgical surgery in clinical practice is currently practically not considered as the primary way to rid the patient of stones due to its high invasiveness. In the arsenal of a modern urologist clinician in the treatment of nephrolithiasis (calculi in the kidney cavity), there is an external shock wave lithotripsy (ESWL), percutaneous lithotripsy (PNL) and transurethral pyelo(calico) lithotripsy [Baylan, B., Sarı, S., Cakıcı, M.C., Selmi, V., Özdemir, H., Ozok, H.U., Karakoyunlu, A.N., Topaloglu, H., Sagnak, A.L., and Ersoy, H.. Is RIRS Safe and Efficient In Patients With Kidney Stones Who Had Previous Open, Endoscopic, or Percutaneous Kidney Stone Surgery? One Center Retrospective Study. Urology Journal 17, (2020), 228–231]. The latter is more commonly referred to as retrograde intrarenal surgery (we will also use this synonym as it reflects the concept of the method more broadly).

ESWL is a relatively sparing method of lithotripsy, but only in relation to stones of low density and small sizes, while with inversely proportional stones, the method loses its relevance. PNL has proven itself well for large calculi (more than 2 cm) and high density, but the disadvantage of the method lies in its high invasiveness, which lies in the peculiarity of the manipulation technique. In the presence of stones up to 2 cm, it is recommended to perform RIRS (retrograde intrarenal surgery). The density of the calculus with a rational approach is not a contraindication for performing lithotripsy. [Clinical recommendations "Urolithiasis" (approved by the Ministry of Health of Russia), 2020].

One of the main requirements for surgical treatment is the complete disposal of the patient from stones from the kidney, since the presence of a stone a priori indicates the inferiority of the provision of medical care to the patient. [W. Wang, G. Shi, J. He, Natural History of Post-Treatment Kidney Stone Fragments: A Systematic Review and Meta-Analysis. letter. Journal of Urology. 207 (2022), pp. 244–245]. The calculus or its fragments further greatly increase the likelihood of recurrent urolithiasis. In a meta-analysis (the presence of residual stones in 2096 patients) conducted under the guidance of Brain E. et al. shows that reoperations for fragments with a diameter of ≤ 4 mm range from 19% (20 months) to 22% (50 months), and for fragments with a diameter of > 4 mm from 22% to 47%. Comparative analysis by size ratio showed the following results: reoperation rate at > 4 mm (versus ≤ 4 mm): OR=1.50 (95% CI 0.70-2.30), p<0.001, I2=67, 6%, tau2=0.48, Cochrane Q=11.4 (p=0.02) and Egger regression: z=3.11, p=0.002. Recurrence rate at >4 mm: OR=0.06 (95% CI -0.98-1.10), p=0.91, I2=53.0%, tau2=0.57, Cochrane Q=7 .11 (p=0.07) and Egger regression: z=-0.75, p=0.45. The results obtained confirm the data that larger residual fragments are much more likely to require further treatment, especially in the long term [E. Brain, R. M. Geraghty, C. E. Lovegrove, B. Yang, B. K. Somani, Natural History of Post-Treatment Kidney Stone Fragments: A Systematic Review and Meta-Analysis. The Journal of Urology. 206, 526–538 (2021)].

The presence or absence of fragments is usually assessed as an indicator of the Stone-free Rate (SFR), which is conventionally translated into Russian as “an indicator of the absence of a stone”. Obviously, the closer the result of the method to 100%, the higher the quality of lithotripsy [B. K. Somani, M. Desai, O. Traxer, S. Lahme, Stone-free rate (SFR): A new proposal for defining levels of SFR. Urolithiasis. 42 (2014), p. 95].

A study by Danilovic et al. shows that the SFRs in the ESWL group were lower than in the RIRS group (24.2% vs. 58.3%, p = 0.007 in the postoperative stage and 30.3% vs. 72.2%, p = 0.004 90 days after the manipulation ) [Danilovic, A., Torricelli, F.C.M., Marchini, G.S., et al. Residual Stone Fragments after Percutaneous Nephrolithotomy: Shockwave Lithotripsy vs Retrograde Intrarenal Surgery. Journal of Endourology 35, (2021), 609–614]. If we take into account stones larger than 1 cm and with a density above 800 Hounsfield units, then the lithotripsy technique becomes completely unrecommended to the best of its specificity.

Companion RIRS in the aspect of lithotripsy of large stones with high density is PNL. In clinical practice, PNL is very common, as it greatly facilitates the task of the clinician to remove the calculus due to the simplicity of the technique compared to RIRS. Along with its advantages, the technique is accompanied by a large number of frequent intra and postoperative complications. In a study by G. H. Jung et al., intraoperative bleeding and hospital stay were significantly higher in the PCNL group. The SFR scores were almost the same and without statistical significance. In terms of the number of complications, PCNL prevailed over RIRS (15.9% versus 4.5%, p = 0.157). [G. H. Jung et al., Comparison of retrograde intrarenal surgery versus a single-session percutaneous nephrolithotomy for lower-pole stones with a diameter of 15 to 30 mm: A propensity score-matching study. Korean Journal of Urology. 56, 525–532 (2015)].

RIRS is applicable for any kidney stones, regardless of density and size. Despite its advantages, the technology is not without disadvantages, the main of which are:

- migration of fragments;

- thermal burn of the parenchyma due to heating of the calculus;

- mechanical damage due to active pulsation of the calculus;

- lack of fixation of the calculus in one position.

Currently, methods are patented that eliminate one or two of the disadvantages indicated above. These include a method for protecting the kidney parenchyma from thermal burns [Patent No. 2016118264, "method for protecting the mucous membrane of the pelvis and calyces of the kidney in the process of laser transurethral nephrolithotripsy" priority dated 11.05.2016, Podoynitsyn A.A. et al.] by introducing a pre-cooled isotonic solution from +4°C to +10°C. This technique allows in general to reduce the overall temperature of the surface of the kidney, which has a beneficial effect on the kidney parenchyma. The temperature of the calculus, despite the performed manipulations, continues to remain the same or slightly decreases, which in turn will continue to cause thermal damage to the area in which it is located. The technique also increases the risk of migration of fragments of a fragmented calculus, since the authors recommend the introduction of an isotonic solution under excessive pressure (but not more than 60-70 cm of water column). Another serious drawback of this method is what the authors themselves point out, namely, with an increase in intrapelvic pressure above 60-70 cm of the water column, there is a risk of pyelovenous reflux, which in turn threatens with serious complications, up to sepsis. The technique, in addition to trying to prevent the rise in temperature, does not solve the remaining shortcomings of the method.

Sokolov A.A. and co-authors propose [Patent No. 2011108250/14, "device for preventing the migration of stone and its fragments during contact lithotripsy" priority dated 03/04/2011, Sokolov A.A. et al.] use a permeable collagen-based spongy material with the ability to increase its volume when placed in a water-containing environment. This technology is valid for ureteral calculi. The effectiveness of the technology is reduced or lost altogether in the case of calculi in the kidney cavity, since the space for the migration of the calculus is still large and it is impossible to place the sponge material in all cups. There is another method [Patent No. 2014122775/14, "Method of controlling the disintegration of kidney stones during remote lithotripsy in children" priority dated 06/04/2014, Zorkin S.N. et al.] preventing stone migration during ESWL. EFFECT: method makes it possible to increase the accuracy of control of the disintegration of the kidney calculus by assessing its structural density, which makes it possible to reduce the traumatization of the renal parenchyma and reduces the likelihood of complications. Given the technical features, despite the positive properties, the method cannot be used in RIRS.

Known methods of using various baskets [Patent No. RU2604800C2 "Method of contact lithotripsy" priority from 02/06/2015, Bredikhin V.I. et al.], which have their own advantages as a prevention of fragment migration. There are such technological support as a tool - extractor "Capture with a channel" and Cobra Richard Wolf. The latter allows simultaneous lithotripsy of the calculus in the fixed Dormia basket. The disadvantage of the tool is its high cost, in the size of the working channels (3.3 Sh each). In the tool - extractor "Capture with a channel" the maximum internal diameter of the channel is 1.0 mm, which does not allow to pass through it a probe of a larger diameter, which is necessary for effective lithotripsy of dense stones.

In practice, there is no comprehensive information on the use of the basket during lithotripsy of kidney stones, except for one method [Patent No. RU 2687593C1, "Method of treating patients with nephrolithiasis with dense stones" priority dated 08/02/2018, Komyakov B.K. et al.], which was chosen by us as a prototype.

The method specified in the prototype is performed as follows: Under endotracheal anesthesia after transurethral introduction of the ureterorenoscope into the cavitary system of the kidney, a lithoextractor is carried out, a basket of Khachin 4 x16 "inflated", with a diameter of 20 mm (5 Fr). The stone is fixed in the basket, then the ureterorenoscope is removed and then it is passed in parallel to the renal cavity system together with the lithotripter. Lithotripsy is performed using an intracorporeal contact lithotripter (Lithoclast) with an ultrasonic probe 1.5 mm long 573 mm at an ultrasound power of 80-100% with a duty cycle of 100%. Lithotripsy is carried out to finely dispersed fragments, which are washed through the working stroke of the ureterorenoscope. If it is impossible to fix the stone in the basket due to its size from 2 to 3 cm, a lithotripsy session is performed in the center of the stone in order to obtain fragments, followed by their capture in the basket and lithotripsy according to the above method. The operation is completed with the installation of a ureteral stent Ch No. 4.8. On the 3-5th day, the ureteral stent is removed.

The prototype, on the one hand, exhausts all of these disadvantages of the traditional RIRS method, but on the other hand, it has a number of disadvantages, namely:

- the use of a rigid ureterorenoscope, which limits the view;

- the impossibility of lithotripsy of calculi of the lower cups;

- the need to use a large amount of energy to fragment the calculus;

- long time of surgical intervention;

- the likelihood of injury to the ureter.

The technical problem is the need to develop an effective and convenient method of laser retrograde intrarenal lithotripsy, devoid of the above disadvantages.

The technical result consists in increasing the efficiency, reducing the time and reducing the trauma of the treatment of patients with nephrolithiasis using lithotripsy.

The technical result is achieved by the fact that in the method of laser retrograde intrarenal lithotripsy in patients with high-density calculi, during which a guide wire, a ureterorenoscope and a Khachin “inflated” basket are inserted into the kidney cavity system, after which the calculus is fixed inside the basket, lithotripsy is performed and the end surgery to install a ureteral stent. According to the invention, after leading the conductor string, a ureteral casing is passed along it, along which a ureterorenoscope is further passed and a basket is passed along the working course of which, and after fixing the calculus inside the basket, the ureterorenoscope is removed and inserted parallel to the fixing component of the basket along with the laser fiber, then the fragmentation process is carried out calculus from the periphery with continuous irrigation of an isotonic solution cooled to 10-12°C, which washes out fragments of the calculus and removes the ureterorenoscope with laser fiber, the basket and the ureteral casing.

The above technique provides increased efficiency, reduced time and reduced trauma in the treatment of patients with nephrolithiasis using lithotripsy. This provides access to all cups, reducing the constant contact of the calculus with the kidney parenchyma (reducing the likelihood of mechanical and thermal damage), permanent fixation of the calculus (which eliminates the migration of fragmenting particles of the calculus), greater crushing efficiency (compared to the prototype), the use of a ureteral casing reduces trauma to the ureter during repeated passage of instruments and maintaining a low temperature of the irrigation fluid, which helps to reduce thermal damage during lithotripsy.

The inventive method is carried out as follows.

In 14-20 days, we install a ureteral stent (see Figure 1: stage 1-2) and carry out antibacterial and anti-inflammatory therapy. After preparing the kidney, under anesthesia, we perform retrograde ureterorenography with the installation of a guide wire in the kidney. Then we introduce the ureteral (ureteral) sheath into the kidney along the guide wire, remove the guide wire and mandrel of the casing (stage 3). We start the ureterorenoscope along the casing into the kidney and along the working course the basket of Khachin. We move the calculus inside the basket, fix it (stage 4). We take out the ureterorenoscope and insert it parallel to the fixing component of the basket together with the laser fiber. We carry out the process of fragmentation of the calculus in the basket from the periphery, controlling the fixation (stage 5). Rinse with a current of irrigation fluid (during the manipulation, we continuously irrigate with a pre-cooled isotonic solution up to 10-12 degrees). Upon completion of complete fragmentation, we remove all instruments and the ureteral sheath. Surgical intervention ends with the installation of a ureteral stent (stage 6). The figure sequentially displays the stages of surgical intervention: 1. Hydronephrosis; 2. Installation of a stent; 3. Installation of the casing; 4. Moving the stone into the pelvis and fixing it in the basket; 5. Lithotripsy process; 6. Installation of the stent.

For flexible (fibro-) nephrolithotripsy, a flexible (fibro-) ureterorenoscope with a tip size of 7.7 F and 9.5 F OD is used (LithoVue™ Single-Use Digital Flexible Ureteroscope specifications from Boston Scientific). The working channel of the instrument is 3.6 F and can be used to pass instruments up to 3 F in size. The active tip bending system allows active controlled bending of the tip up to 270° in two planes.

The use of the Khachin 4x16 "inflated" basket provides the best protection against rupture compared to similar devices. At the same time, this basket is quite reliable, including due to the special interweaving of the strings, which makes it possible to fix the stone with maximum radial force and perform lithotripsy without the risk of breaking the strings of the basket. The shape of the "parachute" type basket excludes perforation of the kidney during insertion, unlike other types that have an external stop at the distal end of the basket [Patent No. Khachin V.N. et al.].

It is recommended to use laser lithotripters for the disintegration of calculi. In our case, lithotripsy is performed using the Fiberlase U2 device, 400 μm laser fiber, with the device settings in the “sputtering” mode, energy 1 J, frequency 30 Hz, power 30 watts.

To perform multiple retrograde approaches to the stone, requiring frequent ureterorenoscopy, systems are used along the urethra and ureter to ensure constant access to the stone - the ureteral (ureteral) casing.

The claimed method is illustrated by examples.

Example 1

A 47-year-old patient came to us with complaints of pain and a feeling of heaviness in the right lumbar region. According to the DECT data, a calculus of the pelvis with dimensions of 1.8x1.6 cm was diagnosed. The density of the calculus was 1274 HU. The diagnosis was made: ICD. Stone of the right kidney. The results of laboratory parameters (general blood count, biochemical parameters and urine) were within the reference values. No significant urodynamic disturbances were detected by ultrasound. After a detailed acquaintance of the patient with the proposed method of endoscopic surgical treatment and obtaining her consent, preoperative preparation was started. The patient was placed 16 days before surgery with a 5 F ureteral stent to ensure adequate urine outflow and dilatation of the ureter and reduce the risk of complications during ureteral sheath insertion.

The day before surgery, the patient was examined and consulted by an anesthesiologist-resuscitator.

After the introduction of endotracheal anesthesia (ETN), after removal of the ureteral stent, a ureterorenoscope was inserted into the kidney along with a guidewire. During ureterorenoscopy, a calculus was visualized in the projection of the pelvis. After installation of the ureteral casing, the conductor string was removed. A 4x16 "inflated" basket of Khachin was inserted through the ureteral sheath along with a ureterorenoscope and a laser lithotripter. The stone was fixed inside Khachin's basket, lithotripsy was performed using a Fiberlase U2 device, a 400 μm laser fiber, with the device settings in the "spray" mode, energy 1 J, frequency 30 Hz, power 30 watts. Irrigation was performed with a pre-cooled isotonic solution up to 10-12 degrees. Surgical treatment was completed with the installation of a 5 F DOUBLE-J ureteral stent. No technical difficulties or complications were recorded during the surgical intervention. The time of endoscopic manipulation, taking into account the installation of a ureteral stent, took 42 minutes. In the postoperative period, the patient received conventional therapy. The next day, low-dose computed tomography was performed to check the location of the ureteral stent, confirm the removal of the calculus and the absence of residual particles. Urination without features. In the postoperative period, the patient had no complaints. Discharged on the 3rd day of the postoperative period. By the 14th day of the postoperative period, the ureteral stent was removed to the patient. After 6 months, the patient underwent an ultrasound of the kidneys and bladder, no evidence of the presence of stones was found. According to the general analysis of blood and urine, there were also no deviations. It is recommended that ultrasound monitoring of the kidneys be observed by a urologist at a polyclinic in dynamics 1 time within 6 months.

Example 2

Patient I., 57 years old, came to the clinic with complaints of periodic pain and discomfort in the right lumbar region. ICD has been suffering for the past 20 years. He connects his disease with the peculiarity of his professional activity (operator of metal-working furnaces). From the anamnesis it is known that the patient underwent PNL on the right side 7 years ago. According to the words, during the year there were repeated attacks of renal colic, which he independently stopped by taking antispasmodic drugs. Medical documentation was not provided. In the right lumbar region, a p / o scar with a size of 2 cm is visualized. The patient underwent ultrasound of the kidneys. Diffuse changes in the parenchyma with thinning up to 0.7 cm, a calculus with an acoustic shadow in the projection of the middle calyces and pelvis measuring 1.5x1.4 cm were revealed. According to the general blood test, the patient has leukocytosis 10.7*109. According to the results of a biochemical blood test - creatinine 116 µmol/l, urea 7.2 mmol/l, CRP 5 mg/l, other indicators were within the reference values. According to the general analysis: cloudy color, leukocytes 15-20, erythrocytes 5-10 in the field of view. According to the microbiological analysis of urine, Escherichia coli was detected in the amount of 1 * 105 CFU. Complex conservative therapy was prescribed. After 30 days, a control analysis of clinical and biochemical blood parameters, a general urinalysis with tank culture. Indicators within the reference values. Performed CT of the urinary system with contrast. According to the CT scan, a calculus measuring 1.5x1.6 cm with indistinct boundaries and a density of 1582 HU, relatively hindering the excretory function of the middle group of calyces during contrasting. The patient's consent to treatment was obtained, a ureteral stent was placed for 14 days in order to prepare the kidney for the next stage of treatment.

Hospitalized with a diagnosis of ICD. Stone of the right kidney. Concomitant diseases: prostatic hyperplasia, arterial hypertension 2/2 degree, risk of cardiovascular complications 3, chronic pyelonephritis, no exacerbation. The patient was examined by a therapist, resuscitator, whose recommendations were taken into account at the preoperative stage.

After providing anesthesia in the amount of ETN, surgical treatment was started according to the proposed method. Ureterorenoscopy with the installation of a guide wire. After removing the ureterorenoscope, a 14 Fr urethral sheath is installed through the installed conductor. Conductor string removed. Using a ureterorenoscope and a lithoextractor, the calculus was moved to a convenient position for capture in the Khachin basket. The laser lithotripter mentioned in the previous clinical example performed lithotripsy of a fixed calculus in Khachin's basket. Fragmented fragments were easily removed by a lithoextractor, the remaining small fragments were washed with a pre-cooled current of isotonic irrigation liquid (10-12 degrees). Upon completion of lithotripsy, instruments were removed, including the ureteral sheath, and a DOUBLE-J 5 F ureteral stent was placed. Control examination (computed tomography) revealed no pathological formations, including residual calculi. In the postoperative period, the patient received infusion-detoxification therapy. On the 5th day, the patient was discharged under the supervision of a urologist at the polyclinic at the place of residence. A year later, an X-ray of the MVS was performed, data for calculi were not revealed.

The above clinical cases clearly show an example of how it is possible, through an individual, rational approach to the treatment of a patient with kidney calculi, to avoid unwanted intraoperative damage and postoperative complications, which in turn are most often the trigger for exacerbation of infectious and inflammatory processes. In the last decade, the importance of focusing on the density of calculi has been more often mentioned in domestic and foreign clinical guidelines. This close attention is due to the dependence of the density and success of endoscopic stone removal when choosing a method. There are multicenter studies with more than 10,000 patients in which the authors also suggest that intra- and postoperative complications may depend on the wrong choice of method for ridding patients of urinary system calculi [Guven S. [et al.]. Retrograde intrarenal surgery of renal stones: a critical multi-aspect evaluation of the outcomes by the Turkish Academy of Urology Prospective Study Group (ACUP Study) // World Journal of Urology. 2020. No. 0123456789. P. 6–11].

The results of treatment of 24 patients aged 19 to 73 years old, in whom the proposed method for the treatment of patients with dense kidney calculi was tested, were studied. All operations were completed without complications, and the proposed method provided effective treatment of patients with dense kidney stones.

Claims (2)

A method for laser retrograde intrarenal lithotripsy in patients with high-density calculi, during which a guide wire, a ureterorenoscope, and a Khachin “inflated” basket are inserted into the renal cavity system, after which the calculus is fixed inside the basket, lithotripsy is performed and the operation is completed with the installation of a ureteral stent, characterized in that that after the insertion of the guide wire, a ureteral casing is passed along it, the guide wire is removed, a ureterorenoscope and a basket are passed along the ureteral casing, and after fixing the calculus inside the basket, the ureterorenoscope is removed and inserted parallel to the fixing component of the basket together with the laser fiber, then the fragmentation process is carried out calculus from the periphery with continuous irrigation of an isotonic solution cooled to 10-12 ° C and the ureterorenoscope with laser fiber, the basket and the ureteral casing are removed, while lithotripsy is performed using the Fiberlase U2 apparatus, 400 μm laser fiber, at setting x apparatus in the "spray" mode, energy 1 J, frequency 30 Hz, power 30 watts. 2. The method according to claim 1, characterized in that a 14 Fr ureteral sheath is used.

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