Patent Publication Number: US-2022218387-A1

Title: Renal puncture sampling device

Description:
CROSS REFERENCE TO THE RELATED APPLICATIONS 
     This application is the national phase entry of International Application No. PCT/CN2020/109674, filed on Aug. 18, 2020, which is based upon and claims priority to Chinese Patent Application No. 202010786155.8, filed on Aug. 07, 2020, the entire contents of which are incorporated herein by reference. 
    
    
     TECHNICAL FIELD 
     The present invention relates to the technical field of medical appliances, and in particular to the technical field of a renal puncture sampling device. 
     BACKGROUND 
     Renal puncture is also known as renal biopsy or renal puncture biopsy. Kidney diseases come in various types, with complicated etiology and pathogenesis. Therefore, the clinical manifestations of many kidney diseases are not completely consistent with the histopathological changes of kidneys. For example, when the clinical manifestations indicate nephrotic syndrome (NS), there may be various pathological changes such as minimal pathological changes, minor pathological changes, mild mesangial hyperplasia, membranous nephropathy (MN), membranoproliferative glomerulonephritis (MPGN), or focal segmental glomerulosclerosis (FSGS), which vary considerably in the treatment plan and disease progression result. A kidney disease also manifests different histopathological changes in different developmental stages. For example, immunoglobulin A (IgA) nephropathy may have pathological manifestations including almost all developmental stages, from a developmental stage in which the kidney tissue is nearly normal to a developmental stage in which most glomeruli become sclerosis. Therefore, the understanding of histomorphological changes of kidneys provides an important basis for clinicians to judge the progression of a disease, treat the disease, and estimate the prognosis. Admittedly, the development of renal pathological examination marks a leap forward for the development of nephrology. Renal pathological examination results have become gold indicators for the diagnosis of kidney diseases. With renal puncture biopsy, the clinical diagnosis of more than one-third of patients can be corrected. 
     At present, renal puncture procedures are conducted typically by using disposable automatic ejection biopsy guns (where 18G or 16G biopsy needles for adults and 18G biopsy needles for children). In this case, needle guidance and biopsy are both conducted by sonographers, and a nephrologist will conduct biopsy under the ultrasound guidance performed by a sonologist. Generally, a guiding device with ultrasound is used to increase the biopsy accuracy. However, this method is difficult to accurately determine the puncture location, and thus cannot adjust the puncture location according to a specific patient. 
     SUMMARY 
     The present invention is intended to solve the problems in the prior art and provide a renal puncture sampling device that can be automatically adjusted to meet the puncture needs of patients with different ages and body weights. 
     In order to achieve the above objectives, the present invention provides a renal puncture sampling device, including a base, a sampler, a first pneumatic cylinder, a support frame, a second pneumatic cylinder, and a controller. The sampler includes a sample storage cylinder, a puncture needle, and a piston. The puncture needle is fixed at a left side of the sample storage cylinder; the piston is located in an inner cavity of the sample storage cylinder, and a piston rod passes through a right sidewall of the sample storage cylinder; an end of a telescopic rod of the first pneumatic cylinder is connected to the piston rod; the sampler and the first pneumatic cylinder are separately fixed at a center of a top surface of the support frame; the second pneumatic cylinder is fixed at a right side of a top surface of the base and drives the support frame to horizontally move left and right; a first position sensor is disposed on an inner wall of a left end of a puncture channel of the puncture needle to determine a first real-time position Wi; a second position sensor is disposed at a center of a left end of the support frame to determine a second real-time position W2; a first angle sensor and a second angle sensor are symmetrically disposed at a front side and a back side of the left end of the support frame respectively to determine a first real-time included angle A between the first angle sensor and a central line of the puncture channel and a second real-time included angle B between the second angle sensor and the central line of the puncture channel; a liquid level sensor is disposed inside the sample storage cylinder; the controller is electrically connected to the sampler, the first pneumatic cylinder, the support frame, and the second pneumatic cylinder, respectively; and the controller determines a corresponding specific puncture needle insertion length D, a specific maximum puncture needle angle deviation C, and specific sampling volume information Q according to input specific age information E and specific body weight information M of a specific patient, and then controls actions of the first pneumatic cylinder and the second pneumatic cylinder through a prebuilt specific sampling matrix F (E, M, D, C, Q). 
     Preferably, a sample outlet and a scale may be disposed on an outer wall of the sample storage cylinder; and a flared column may be disposed at a left end of the sample storage cylinder, and a soft pad may be disposed at a left side of the flared column. 
     Preferably, the support frame may include a straight rod body, a bent rod body, and inclined rod bodies; the straight rod body may be located at a right side of the bent rod body; an arc center of the bent rod body may be located at the right side of the bent rod body; a front end and a back end of the straight rod body may be connected respectively to a front end and a back end of the bent rod body through the inclined rod bodies; and the second position sensor, the first angle sensor, and the second angle sensor may be fixed on the bent rod body separately. 
     Preferably, the support frame may further include a reinforcing rod; the reinforcing rod may be located between the straight rod body and the bent rod body, and a front end and a back end of the reinforcing rod may be fixed to the inclined rod bodies, respectively; a plurality of slide rails may be horizontally disposed left and right on a top surface of the base; and a slide block may be slidably disposed on each of the slide rails, and a top end of the slide block may be connected to the reinforcing rod. 
     Preferably, a standard sampling matrix F 0  (E 0 , M 0 , D 0 , C 0 , Q 0 ) may be set in the controller, where E 0  represents standard age information, M 0  represents standard body weight information, and D 0 , C 0 , and Q 0  are a standard puncture needle insertion length, a maximum standard puncture needle angle deviation, and standard sampling volume information corresponding to E 0  and M 0 ,respectively. 
     Preferably, the specific puncture needle insertion length D may be calculated according to the following formula: 
     
       
         
           
             
               D 
               = 
               
                 
                   [ 
                   
                     
                       ( 
                       
                         1 
                         - 
                         
                           
                              
                             
                               E 
                               - 
                               
                                 E 
                                 0 
                               
                             
                              
                           
                           
                             E 
                             0 
                           
                         
                       
                       ) 
                     
                     + 
                     
                       ( 
                       
                         
                            
                           
                             
                               M 
                               0 
                             
                             - 
                             M 
                           
                            
                         
                         
                           M 
                           0 
                         
                       
                       ) 
                     
                   
                   ] 
                 
                 × 
                 
                   D 
                   0 
                 
               
             
             . 
           
         
       
     
     Preferably, the specific sampling volume information Q may be calculated according to the following formula: 
     
       
         
           
             
               Q 
               = 
               
                 
                   [ 
                   
                     
                       ( 
                       
                         1 
                         - 
                         
                           
                              
                             
                               E 
                               - 
                               
                                 E 
                                 0 
                               
                             
                              
                           
                           
                             E 
                             0 
                           
                         
                       
                       ) 
                     
                     + 
                     
                       ( 
                       
                         1 
                         - 
                         
                           
                              
                             
                               
                                 M 
                                 0 
                               
                               - 
                               M 
                             
                              
                           
                           
                             M 
                             0 
                           
                         
                       
                       ) 
                     
                   
                   ] 
                 
                 × 
                 
                   Q 
                   0 
                 
               
             
             . 
           
         
       
     
     Preferably, when the puncture needle is at an initial position, if |A 1 −B 1 |=0, the puncture needle may be in a standard insertion state; 
     when the puncture needle is at the initial position, if |A 1 −B 1 |&gt;0, the puncture needle has a certain angle deviation during insertion; 
     the specific maximum puncture needle angle deviation C may be calculated according to the following formula: 
     when D&gt;D 0 , 
     
       
         
           
             
               C 
               = 
               
                 
                   
                      
                     
                       
                         A 
                         1 
                       
                       - 
                       
                         B 
                         1 
                       
                     
                      
                   
                   × 
                   
                     ( 
                     
                       1 
                       - 
                       
                         
                            
                           
                             D 
                             - 
                             
                               D 
                               0 
                             
                           
                            
                         
                         
                           D 
                           0 
                         
                       
                     
                     ) 
                   
                 
                 + 
                 
                   
                      
                     
                       
                         A 
                         1 
                       
                       - 
                       
                         B 
                         1 
                       
                     
                      
                   
                   × 
                   
                     ( 
                     
                       1 
                       - 
                       
                         
                            
                           
                             Q 
                             - 
                             
                               Q 
                               0 
                             
                           
                            
                         
                         
                           Q 
                           0 
                         
                       
                     
                     ) 
                   
                 
               
             
             , 
           
         
       
     
     and 
     when D&lt;D 0 , 
     
       
         
           
             
               C 
               = 
               
                 
                   
                      
                     
                       
                         A 
                         1 
                       
                       - 
                       
                         B 
                         1 
                       
                     
                      
                   
                   × 
                   
                     ( 
                     
                       1 
                       + 
                       
                         
                            
                           
                             D 
                             - 
                             
                               D 
                               0 
                             
                           
                            
                         
                         
                           D 
                           0 
                         
                       
                     
                     ) 
                   
                 
                 + 
                 
                   
                      
                     
                       
                         A 
                         1 
                       
                       - 
                       
                         B 
                         1 
                       
                     
                      
                   
                   × 
                   
                     ( 
                     
                       1 
                       - 
                       
                         
                            
                           
                             Q 
                             - 
                             
                               Q 
                               0 
                             
                           
                            
                         
                         
                           Q 
                           0 
                         
                       
                     
                     ) 
                   
                 
               
             
             ; 
           
         
       
     
     where |A 1 −B 1 | represents an initial angle deviation, and A 1  and B 1  represent a first initial included angle between the first angle sensor and the central line of the puncture channel and a second initial included angle between the second angle sensor and the central line of the puncture channel at an initial position, respectively. 
     Preferably, when the second pneumatic cylinder drives the sampler and the support frame to move towards the left until the first position sensor has a distance of W 11  from a patient and the second position sensor has a distance of W 12  from the patient, the sampling device may be at the initial position. 
     Preferably, during a puncture of the puncture needle, if |A−B|&gt;C, the second pneumatic cylinder may drive the support frame and the puncture needle to return to the initial position, and sampling is stopped; and after an angle of the puncture needle is adjusted, sampling may be restarted; 
     during a puncture of the puncture needle, if |A−B|&lt;C, the first pneumatic cylinder may pull the piston to sample until there is a sample volume of Q in the sample storage cylinder; 
     where |A−B| is a real-time angle deviation. 
     Beneficial effects of the present invention include the following: a specific puncture needle insertion length D, a specific maximum puncture needle angle deviation C, and specific sampling volume information Q can be automatically adjusted according to specific conditions of patients with different ages and body weights, such as to adapt to the puncture needs of different patients. A scale is disposed on an outer wall of the sample storage cylinder, such that sampling conditions can be clearly observed. A flared column with a soft pad is disposed at a left end of the sample storage cylinder to enable the comfort of a patient in contact with the device. 
     The features and advantages of the present invention are described in detail through examples with reference to accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         FIG. 1  is a top view of the renal puncture sampling device of the present invention; 
         FIG. 2  is a top view of a sampler of the renal puncture sampling device of the present invention; and 
         FIG. 3  is a top view of a support frame of the renal puncture sampling device of the present invention. 
       In the figures:  1  represents a base,  11  represents a slide rail,  12  represents a slide block,  2  represents a sampler,  21  represents a sample storage cylinder,  211  represents a sample outlet,  212  represents a liquid level sensor,  213  represents a scale,  214  represents a flared column,  215  represents a soft pad,  22  represents a puncture needle,  221  represents a puncture channel,  222  represents a first position sensor,  23  represents a piston,  231  represents a piston rod,  3  represents a first pneumatic cylinder,  4  represents a support frame,  41  represents a straight rod body,  42  represents a bent rod body,  421  represents a second position sensor,  422  represents a first angle sensor,  423  represents a second angle sensor,  43  represents an inclined rod body,  44  represents a reinforcing rod,  5  represents a second pneumatic cylinder, and  6  represents a controller. 
     
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
     As shown in  FIG. 1 ,  FIG. 2 , and  FIG. 3 , the present invention provides a renal puncture sampling device, including a base  1 , a sampler  2 , a first pneumatic cylinder  3 , a support frame  4 , a second pneumatic cylinder  5 , and a controller  6 . The sampler  2  includes a sample storage cylinder  21 , a puncture needle  22 , and a piston  23 . The puncture needle  22  is fixed at a left side of the sample storage cylinder  21 ; the piston  23  is located in an inner cavity of the sample storage cylinder  21 , and a piston rod  231  passes through a right sidewall of the sample storage cylinder  21 ; an end of a telescopic rod of the first pneumatic cylinder  3  is connected to the piston rod  231 ; the sampler  2  and the first pneumatic cylinder  3  are separately fixed at a center of a top surface of the support frame  4 ; the second pneumatic cylinder  5  is fixed at a right side of a top surface of the base  1  and drives the support frame  4  to horizontally move left and right; a first position sensor  222  is disposed on an inner wall of a left end of a puncture channel  221  of the puncture needle  22  to determine a first real-time position W 1 ; a second position sensor  421  is disposed at a center of a left end of the support frame  4  to determine a second real-time position W 2 ; a first angle sensor  422  and a second angle sensor  423  are symmetrically disposed at a front side and a back side of the left end of the support frame  4  respectively to determine a first real-time included angle A between the first angle sensor  422  and a central line of the puncture channel  221  and a second real-time included angle B between the second angle sensor  423  and the central line of the puncture channel  221 ; a liquid level sensor  212  is disposed inside the sample storage cylinder  21 ; the controller  6  is electrically connected to the sampler  2 , the first pneumatic cylinder  3 , the support frame  4 , and the second pneumatic cylinder  5 , respectively; and the controller  6  determines a corresponding specific puncture needle insertion length D, a specific maximum puncture needle angle deviation C, and specific sampling volume information Q according to input specific age information E and specific body weight information M of a specific patient, and then controls actions of the first pneumatic cylinder  3  and the second pneumatic cylinder  5  through a prebuilt specific sampling matrix F (E, M, D, C, Q). 
     A sample outlet  211  and a scale  213  may be disposed on an outer wall of the sample storage cylinder  21 ; and a flared column  214  may be disposed at a left end of the sample storage cylinder  21 , and a soft pad  215  may be disposed at a left side of the flared column  214 . 
     The support frame  4  may include a straight rod body  41 , a bent rod body  42 , and inclined rod bodies  43 ; the straight rod body  41  may be located at a right side of the bent rod body  42 ; an arc center of the bent rod body  42  may be located at the right side of the bent rod body  42 ; a front end and a back end of the straight rod body  41  may be connected respectively to a front end and a back end of the bent rod body  42  through the inclined rod bodies  43 ; and the second position sensor  421 , the first angle sensor  422 , and the second angle sensor  423  may be fixed on the bent rod body  42  separately. 
     The support frame  4  may further include a reinforcing rod  44 ; the reinforcing rod  44  may be located between the straight rod body  41  and the bent rod body  42 , and a front end and a back end of the reinforcing rod may be fixed to the inclined rod bodies  43 , respectively; a plurality of slide rails  11  may be horizontally disposed left and right on a top surface of the base  1 ; and a slide block  12  may be slidably disposed on each of the slide rails  11 , and a top end of the slide block  12  may be connected to the reinforcing rod  44 . 
     During a working process, the second pneumatic cylinder  5  pushes the support frame  4  to move towards the left along the slide rail  11 , which drives the sampler  2  located on the support frame  4  to move towards the left, such that the puncture needle  22  is gradually inserted into a patient&#39;s body and stays at a preset position. Subsequently, the first pneumatic cylinder  3  pulls the piston  23  to move towards the right, thereby sucking a sample into the sample storage cylinder  21 . After the sample suction is completed, the second pneumatic cylinder  5  drives the support frame  4  and the sampler  2  to return to the original position. The medical staff can take out the sample through the sample outlet  211 . 
     A standard sampling matrix F 0  (E 0 , M 0 , D 0 , C 0 , Q 0 ) may be set in the controller  6 , where E 0  represents standard age information, M 0  represents standard body weight information, and D 0 , C 0 , and Q 0  are a standard puncture needle insertion length, a maximum standard puncture needle angle deviation, and standard sampling volume information corresponding to E 0  and M 0 , respectively. 
     The specific puncture needle insertion length D and the specific sampling volume information Q are determined according to the specific age information E and specific body weight information M of a patient. 
     The specific puncture needle insertion length D may be calculated according to the following formula: 
     
       
         
           
             D 
             = 
             
               
                 [ 
                 
                   
                     ( 
                     
                       1 
                       - 
                       
                         
                            
                           
                             E 
                             - 
                             
                               E 
                               0 
                             
                           
                            
                         
                         
                           E 
                           0 
                         
                       
                     
                     ) 
                   
                   + 
                   
                     ( 
                     
                       
                          
                         
                           
                             M 
                             0 
                           
                           - 
                           M 
                         
                          
                       
                       
                         M 
                         0 
                       
                     
                     ) 
                   
                 
                 ] 
               
               × 
               
                 D 
                 0 
               
             
           
         
       
     
     The standard age information E 0  represents an intermediate age, such as an age of 30 to 40. When the specific age information E of a patient is too large or too small, that is, when the patient is an elderly or a child, |E−E 0 | is large, and a small specific puncture needle insertion length D is selected, which can avoid harm to the human body. 
     The standard body weight information M 0  is set to a small value. If the specific weight information M of a patient is large, |M−M 0 | is large, and a large specific puncture needle insertion length D is selected to ensure the full suction of a sample; otherwise, a small puncture needle insertion length D is selected to avoid damage to the human body. 
     The specific sampling volume information Q may be calculated according to the following formula: 
     
       
         
           
             Q 
             = 
             
               
                 [ 
                 
                   
                     ( 
                     
                       1 
                       - 
                       
                         
                            
                           
                             E 
                             - 
                             
                               E 
                               0 
                             
                           
                            
                         
                         
                           E 
                           0 
                         
                       
                     
                     ) 
                   
                   + 
                   
                     ( 
                     
                       1 
                       - 
                       
                         
                            
                           
                             
                               M 
                               0 
                             
                             - 
                             M 
                           
                            
                         
                         
                           M 
                           0 
                         
                       
                     
                     ) 
                   
                 
                 ] 
               
               × 
               
                 Q 
                 0 
               
             
           
         
       
     
     When a patient is an elderly or a child (|E−E 0 | is large) or when a patient has a large or small body weight (|M 0 −M| is large), small specific sampling volume information Q is selected to avoid harm to the human body; and on the contrary, when |E−E 0 | or |M 0 −M| is small, large sampling volume information Q is selected, such that the optimal sampling volume can be adopted for patients with different ages and body weights. 
     When the puncture needle  22  is at an initial position, if |A 1 −B 1 |=0, the puncture needle  22  is in a standard insertion state. 
     When the puncture needle  22  is at the initial position, if |A−B 1 |&gt;0, the puncture needle  22  has a certain angle deviation during insertion. 
     The specific maximum puncture needle angle deviation C may be calculated according to the following formula: 
     When D&gt;D 0 , 
     
       
         
           
             C 
             = 
             
               
                 
                    
                   
                     
                       A 
                       1 
                     
                     - 
                     
                       B 
                       1 
                     
                   
                    
                 
                 × 
                 
                   ( 
                   
                     1 
                     + 
                     
                       
                          
                         
                           D 
                           - 
                           
                             D 
                             0 
                           
                         
                          
                       
                       
                         D 
                         0 
                       
                     
                   
                   ) 
                 
               
               + 
               
                 
                    
                   
                     
                       A 
                       1 
                     
                     - 
                     
                       B 
                       1 
                     
                   
                    
                 
                 × 
                 
                   
                     ( 
                     
                       1 
                       - 
                       
                         
                            
                           
                             Q 
                             - 
                             
                               Q 
                               0 
                             
                           
                            
                         
                         
                           Q 
                           0 
                         
                       
                     
                     ) 
                   
                   . 
                 
               
             
           
         
       
     
     When the specific puncture needle insertion length D is large, the specific maximum puncture needle angle deviation C needs to be reduced, such that excessive deviation is avoided when the puncture needle  22  is inserted too long, which may cause damage to the human body. Moreover, when the specific sampling volume information Q is large, the specific maximum puncture needle angle deviation should also be reduced, such that the puncture needle  22  can aim at the optimal position as accurately as possible. 
     
       
         
           
             C 
             = 
             
               
                 
                    
                   
                     
                       A 
                       1 
                     
                     - 
                     
                       B 
                       1 
                     
                   
                    
                 
                 × 
                 
                   ( 
                   
                     1 
                     + 
                     
                       
                          
                         
                           D 
                           - 
                           
                             D 
                             0 
                           
                         
                          
                       
                       
                         D 
                         0 
                       
                     
                   
                   ) 
                 
               
               + 
               
                 
                    
                   
                     
                       A 
                       1 
                     
                     - 
                     
                       B 
                       1 
                     
                   
                    
                 
                 × 
                 
                   
                     ( 
                     
                       1 
                       - 
                       
                         
                            
                           
                             Q 
                             - 
                             
                               Q 
                               0 
                             
                           
                            
                         
                         
                           Q 
                           0 
                         
                       
                     
                     ) 
                   
                   . 
                 
               
             
           
         
       
     
     When D&lt;D 0 , 
     When the specific puncture needle insertion length D is small, the specific maximum puncture needle angle deviation C is allowed to increase appropriately to provide a large adjustment space. 
     |A 1 −B 1 | represents an initial angle deviation, and A 1  and B 1  represent a first initial included angle between the first angle sensor  422  and the central line of the puncture channel  221  and a second initial included angle between the second angle sensor  423  and the central line of the puncture channel  221  at an initial position, respectively. 
     When the second pneumatic cylinder  5  drives the sampler  2  and the support frame  4  to move towards the left until the first position sensor  222  has a distance of W 11  from a patient and the second position sensor  421  has a distance of W 12  from the patient, the sampling device may be at the initial position. 
     During a puncture of the puncture needle  22 , if |A−B|&gt;C, the second pneumatic cylinder  5  drives the support frame  4  and the puncture needle  22  to return to the initial position, and sampling is stopped; and after an angle of the puncture needle  22  is adjusted, sampling is restarted. If |A−B|&lt;C, the first pneumatic cylinder  3  pulls the piston  23  to sample until there is a sample volume of Q in the sample storage cylinder  21 . |A−B| is a real-time angle deviation. 
     The above examples are provided to illustrate the present invention, but not to limit the present invention. Any solution obtained by making a simple modification to the present invention shall fall within the protection scope of the present invention.