Abstract:
A surgical apparatus has connected strips that are configured to surround an organ, such as a kidney. The surgical apparatus at least partially mechanically occludes fluid flow into, out of or within part of the organ. Each strip is individually inflatable. Tubes deliver fluid to the strips. Each of the tubes is connected to one of the strips.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to U.S. Provisional Application No. 62/054,115, filed on Sep. 23, 2014, now pending, the disclosure of which is incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to a device used during surgery and, more particularly, to a device used during partial nephrectomy (PN) kidney surgery. 
       BACKGROUND OF THE INVENTION 
       [0003]    In the field of urology surgery, partial nephrectomy (PN) surgeries are performed to remove renal tumors while sparing as much of the remaining kidney as possible. As kidneys are highly vascular structures, receiving roughly 22% of the cardiac output with many branches of veins and arteries, operations on the kidneys are at risk for major blood loss without appropriate preventative methods. 
         [0004]    In a typical open PN surgery, the surgeon directly accesses the kidney by way of an incision. The renal hilum (renal artery, renal vein, and urethra) is clamped and the whole organ is cooled to preserve the organ for as long as possible thereby reducing postoperative damage. 
         [0005]    PN surgery may also be performed using minimally-invasive surgery techniques where the surgeon makes small incisions in the patient and the kidney is handled indirectly with long instruments inserted through the incisions. The instruments have ergonomically designed handles operable by the surgeon for controlling movement of distal ends that have surgical instruments (scissors, graspers, etc.) Among urologists, minimally-invasive PN surgery is gaining popularity due to the reduced risk for infection, less pain, and shortened hospital stays. A method employed in minimally-invasive procedures is to reduce blood flow to and from the kidney by clamping the renal hilum, which creates a mostly bloodless surgical field. Placing and retrieving ice slush inside the patient&#39;s body to cool the kidney is difficult and rarely attempted, so the time window to perform the entire surgery is shortened to avoid renal injury or eventual failure due to ischemia. 
         [0006]    A range of studies has been performed to examine the relationships between clamping (fully or partially), ischemia time (cold or warm), tumor sizes, blood loss, acute renal failure, and renal injury. Some results indicate the longer the kidneys are without blood flow after a certain time (such as, for example, roughly  30  minutes), the higher the risk of postoperative renal injury or failure. If the patient has a solitary kidney, this time is shortened even further. There are other variables (age, gender, body mass index, etc.) that could affect the risk, but the general trend in PN studies is that the longer the kidney experiences ischemia, the greater the risk to patient outcome. Due to these trends, there is a need for a device and method to create a relatively bloodless surgical field without clamping the renal hilum to avoid the potential injury to or failure of the kidney caused by the clamping. 
       BRIEF SUMMARY OF THE INVENTION 
       [0007]    A pressurized anatomical compressor for kidney device (“PACK&#39;D” or “device”) is disclosed. This device can be used during open, laparoscopic, robotic, or other types of PN kidney surgeries. The device can be used in surgery to remove the need to perform arterial occlusion via clamping of the renal artery and vein. 
         [0008]    The device disclosed herein at least partially mechanically occludes fluid flow into, out of, or within a controlled part of an organ. The organ may be a kidney, though the device disclosed herein also could be used with other human or animal organs. 
         [0009]    The device may be embodied as an adjustable cage that fits around an organ, such as a kidney. In general, the device has a cage with inflatable strips connected to a tubing system that is controlled by a valve system and a pump. The adjustable cage, which may be loose and not adjusted for a specific kidney, has several connecting strips that form a cavity for the kidney. Each strip may be configured as a long strip that passes over or around the external curve of the kidney with the ends of the strip on the internal curve of the kidney. The ends of a strip also may be on the external curve of the kidney. There may be strips connected to the strips near the ends of the kidney between the external and internal curves of the kidney and that wrap around those ends. These strips can be flexible, structured with one end for each side, or rigid. 
         [0010]    The ends of the strips may be designed for adjustability and a non-slip fastener can hold the ends of each strip together. The mode of fastening is compatible to the standard minimally-invasive surgical devices as well as simple to fasten in open surgeries. The fastener may be a ring that encloses the ends and can slide along the ends for adjustability. 
         [0011]    The strips can create at least two divided portions of the kidney or other organ. One portion has reduced blood flow or fluid flow compared to the other portion or portions. One portion may or may not be symmetrical to the other portion or portions. One portion may or may not be the same size as the other portion or portions. 
         [0012]    The strips may be connected to each other at various locations of the organ, such as, for example, at the centerline of the kidney or other organ. For example, there may be one strip on each side of the centerline of the kidney. The strips can be perpendicular to the strips they are connecting. The strips may form obtuse angles on one side of the strips to be connected. The strips also may be above or below the standard centerline of the organ. 
         [0013]    In an example, there may be two strips with one connector between the strips and another strip on the end perpendicular to each of the strips. In another example, there are four strips with three connecting strips and no strips at the ends. In yet another example, there are more or less than four strips. There also may be no strips at the ends or the device may be designed such that not all of the neighboring strips are connected to one another. 
         [0014]    There may be no supplementary material between each strip. In other embodiments, there may be material, such as mesh, fabrics, or plastics, between some or all of the strips. 
         [0015]    The device may be fabricated of biocompatible materials. For example, the device may be fabricated of silicone. 
         [0016]    There may be inflatable components (i.e., bladders) embedded in or otherwise connected to each strip. The inflatable components can be connected to a tube system that carries air or other fluid for inflating the corresponding bladder. The inflatable components can expand into the cavity containing the organ. The outer surfaces of the strips (e.g., surfaces of the strips opposite of the kidney surface, not contacting the kidney surface, or not facing the kidney surface) may be rigid or semi-rigid to contain or direct the inflatable components. The inflatable components may be curved or have other cross-strips. In an example, inner inflatable components can be divided into smaller interconnected parts that each has a shaped face (such as square or rectangular) contacting the surface. 
         [0017]    The inflatable components of the strips may be separated into two parts: one part that covers the external curve to the center of the strip on both sides and the other part covers the internal curve to the center of the strip on both sides. Each component may be defined as a strip and since the internal curve may contain the ends, there are two sub-strips in the internal curve component with one on each side of the kidney. The external curve component may have one connecting point with the tube system since it is continuous while the internal curve component may have two connectors since it is discontinuous. The fasteners around the ends on the internal curve strips can block unnecessary inflating of the strip (or sub-strip) or the part of the strip not in contact with the kidney. 
         [0018]    In an example, there can be a tubing system having a tube in fluid communication with each inflatable strip and having a control system. There may be one tube for each inflatable strip along the internal and external curves and one tube branches into two for each sub-strip of the internal curve strips due to the discontinuity. 
         [0019]    In another example, there is at least one small tube for each inflatable strip. The tube for each strip is collected into a bundle leading to the control system. The bundle may have a sheath which may enclose all of the tubes over a portion of the lengths of the tubes. 
         [0020]    The tubes may collect at any location convenient to the requirements of the particular organ and/or surgery. For example, the tubes may collect into a bundle at an end of a center strip. The location where the tubes collect on the cage can be at the center of the center connecting strip, though the collection point on the cage can be at any intersection. There may be a location where the tubes are configured to collect on both sides of the organ and the tubes from either side collect into a bundle at a distance from the cage. 
         [0021]    The location where the tubes collect may be at a distance from the cage sufficient for the branches to be moved to different sides of the organ depending on the preference of the surgeon or the desired field of view. 
         [0022]    The control system may be a valve system with controls for selectably inflating the strips. The control system can have different shapes and manners of arrangement. In an example, a series of stopcocks form a manifold. The manifold may comprise a stopcock corresponding to each inflatable component of the device. In another example, the control system comprises a plurality of stopcocks arranged in a circular manner. In yet another example, a circular device with a valve system controls the fluid flow into and out of the device. 
         [0023]    Some or all of the stopcocks can be 4-way stopcocks for total control of the air or fluid flow. 3-way, 2-way, or other stopcocks can be used. Each stopcock or valve can correspond to an inflatable component. Color-coded or other indications may show the corresponding valve or stopcock and inflatable component. The indications may be visual, tactile, or other types of indication and combinations of such types. 
         [0024]    The manifold can be connected to a pump that inputs and removes the air or other fluid from the inflatable strips. This pump can be a handheld pump, a machine pump, or other type of pump. 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0025]    For a fuller understanding of the nature and objects of the invention, reference should be made to the following detailed description taken in conjunction with the accompanying drawings, in which: 
           [0026]      FIG. 1  is a perspective view of a device on a kidney according to an embodiment of the disclosure; 
           [0027]      FIGS. 2A-2B  are perspective views of a device on a kidney showing various tube collection locations; 
           [0028]      FIGS. 3A-3B  are perspective views of an example of a system with the device and shaded strips illustrating corresponding tubes; 
           [0029]      FIG. 4  is a perspective view of an example of an external component; 
           [0030]      FIG. 5  is a perspective view of another example of an external component; and 
           [0031]      FIG. 6  is a perspective of the device on a kidney during a procedure. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0032]    Although claimed subject matter will be described in terms of certain embodiments, other embodiments, including embodiments that do not provide all of the benefits and features set forth herein, are also within the scope of this invention. Various structural, logical, process step, and electronic changes may be made without departing from the scope of the invention. 
         [0033]    Directional terms are used in the following description to indicate relative reference only, and should not impose any limitations on how any apparatus or components are to be manufactured or positioned during use. Here and throughout, for clarification and reference purpose only, the external curve of the kidney is the curve opposite of the renal hilum while the internal curve of the kidney includes the renal hilum. 
         [0034]      FIG. 1  is a perspective view of a device  102  on a kidney  100  according to an embodiment of the disclosure. The device  102  comprises a plurality of strips  103 ,  104 ,  106 ,  109 ,  111 ,  112 ,  113 , each of which may be connected to one or more of the other strips. The connected strips of the device may be considered as forming a cage having a cavity configured to encompass an organ. For example, device  102  is illustrated with a kidney  100  within the cavity defined by the strips  103 ,  104 ,  106 ,  109 ,  111 ,  112 , and  113 . While only one side of the device  102  and the kidney  100  is shown in  FIG. 1 , the device  102  may have a similar arrangement on the opposite side of the kidney  100 . The device  102  comprises a plurality of tubes  117  for delivering fluid to the strips. Each tube of the plurality of tubes  117  is in fluid communication with a corresponding strip. 
         [0035]    The device  102  may be configured such that the renal hilum  101 , comprising the renal artery, renal vein, and urethra, protrudes from the cavity of the device  102  when a kidney  100  is contained in the device  102 . Two strips  103  and  104  are shown below the renal hilum  101  and connected to an intersection  108 . On the external curve relative to the renal hilum  101 , strip  103  is continuous from the intersection  108  to a corresponding intersection (not shown) on the opposite side of the kidney  100 . On the internal curve relative to the renal hilum  101 , strip  104  is discontinuous, separating into two sub-strips  105  from the intersection  108 . This strip  104  contains two sub-strips  105 , one on each side of the kidney  100 , with the sub-strips  105  fastened together against the surface of the kidney  100  by a fastener  107 . On the bottom half of the kidney  100 , there is another strip  106  that accommodates the end curve of the kidney  100 . Strip  106  is configured with two sub-strips (similar to strip  104 ) with the sub-strips fastened together by a fastener. Strip  106  may be connected to intersection  108  on either side of the kidney  100 . At the opposite end of the kidney  100 , a structure similar to that of strips  103 ,  104 , and  106  connected by intersection  108  is present with strips  111 ,  112  and  113  connected by intersection  110 . A fastener  114  fastens the sub-strips of strip  113  to one another. 
         [0036]    Connecting these two sets of strips is a strip  109 , connecting intersection  108  to intersection  110  on both sides of the kidney  100 . This strip  109  may provide reinforcement to prevent the device  102  from undesired separation from the kidney  100 . On either end of the strip  109 , intersections  108  and  110  can control the position of the inflatable strips or the tubing. A tubing system (not illustrated in  FIG. 1 ) is connected to a bundle of tubes  117  leading away from the device  102  and the kidney  100 . Each tube may be directly or indirectly connected to a corresponding strip such that the strip is in fluid communication with the tube. For example, each tube may end at an intersection  108 ,  110 . The tubes of the device  102  may not be arranged symmetrically on the two sides of intersections  108  and  110 . The strips  103  and  111  can require one tube to feed the inflatable portion. The strips  104 ,  112  and strips  106 ,  113  can require two tubes, one for each side of the kidney  100 . The strip  109  may be fed from only intersection  110  and intersection  108  can serve solely as an anchor at strip  109 . Therefore, at intersection  110  there can be three tubes feeding into specific strips at intersection  108 . On the opposite intersection of intersection  110 , there can be two tubes feeding into the opposite side of strip  104  and strip  106 . At intersection  110  on one side, there can be a total of four tubes feeding each of the connecting bands. On the opposite intersection  110 , there can be three tubes feeding the opposite side of the strip  112 , strip  113 , and strip  109 . Intersection  110  may serve as the collection point of all the tubes in the device  102 . The intersection  110  and its opposite intersection exist on both sides of the device  102  and extends away from the kidney  100  in sub-bundles  115  and  116 . The sub-bundles  115 ,  116  combine into one larger bundle of tubes  117 . This bundle of tubes  117  leads to the external component of the device  102 . 
         [0037]    One or more strips may comprise an inflatable component, such as, for example, a bladder. In one example, the strip is a bladder. In another example, the inflatable component is positioned between the strip and the kidney surface. In another example, the inflatable component is positioned in the strip against the kidney surface. The strip may be rigid or semi-rigid to enable or direct expansion of the inflatable component or strip against the kidney surface. In another example, one or more strips includes the inflatable component and the strip itself inflates. 
         [0038]      FIGS. 2A-2B  are perspective views of a device  201  or device  204  on a kidney showing different tube collection points. In  FIG. 2A , the structure of the strips are the same as  FIG. 1 , but another position for the collection point  202  is illustrated. Instead of a collection point at the intersection above the renal hilum  200 , the collection point  202  is below the renal hilum  200 . Intersection  202  of  FIG. 2A  may be the same as intersection  110  in  FIG. 1  and intersection  108  in  FIG. 1  may be the same as intersection  203  in  FIG. 2A  in terms of the amount of tubing feeding at the respective intersections and how the collection point of the tubing is arranged. 
         [0039]    In  FIG. 2B , the structure of the strips may be the same as presented in  FIG. 1 . The collection point  205 , at the center of the middle strip  206 , is presented in  FIG. 2B . The middle strip  206  is anchored to intersections  207  and  208 . The tubing system may be changed accordingly. For example, at intersections  207  and  208  on one side, there are three tubes at each intersection feeding into the corresponding strips. On the opposite side of the device, there are two tubes at each intersection. The strip  206  is fed air or other fluid at collection point  205  on either side of the device  204 . The collection points lead outward to sub-bundles  209 ,  210  and combine into one bundle of tubes  211  that leads to the external component of the device  204 . 
         [0040]      FIGS. 3A-3B  are perspective views of an example of a system with the device  301  and shaded strips illustrating corresponding pipes. The device  301  on the kidney  300  may be similar to that illustrated in  FIG. 1  or  FIG. 2A . Strips to be inflated on the device  301  on the kidney  300  are selected by an operator (e.g., a surgeon) and each of the valves  304  on the control system  303  is adjusted to block or allow airflow. The handheld pump  302  pumps air into the control system  303 . The air flows through the unblocked valves  304  and into the corresponding tubes  305 . The tubes  305  are collected into a sheathed bundle  306  and the bundle  306  is divided at split point  307  into the sub-bundles connecting to either side of intersection  308  of the device  301 . 
         [0041]    In  FIG. 3B , each valve  309  with shaded strips illustrates its corresponding strip  310 . 
         [0042]      FIG. 4  is a perspective view of an example of an external component. There is a control system  403  connected to a hand-held pump  401  by a pump tube  402 . The control system  403  comprises are seven valves switches  404  that allow an operator to control whether air flows into a corresponding tube  405 . The position of the valve switches  404  can either allow or block flow of air or other fluid. Each valve switch  404  has a corresponding tube  405  and the tubes  405  are collected into a bundle  406  leading away from the control system  403 . This bundle  406  can make insertion into the patient and operation easier during a surgery because fewer tubes  405  are loose or free to be moved proximate or inside the patient. Each tube  405  corresponds to one strip on the device. 
         [0043]      FIG. 5  is a perspective view of another example of an external component. There is a series of seven stopcocks  503 ,  505  connected to a hand-held pump  501  by a pump tube  502  between the manifold and the pump  501 . Each stopcock  503 ,  505  has a tube connector  504  extending from the manifold system. Each stopcock  503  with the exception of the last stopcock  505  in the series leading away from the pump  501  may be a 3-way stopcock. Turning the handle on the stopcocks  503 ,  505  controls the flow of air or other fluid. 
         [0044]    For example, when the handle on the stopcock  503  is pointed toward the tube connector  504 , fluid flows through the manifold and into the corresponding tube connector  504 . When the handle on the stopcock  503  is pointed in the opposite direction of the tube connector  504 , the fluid flows through the manifold at that strip without flowing into the tube connector  504 . When the handle on the stopcock  503  is pointed toward the pump  501 , the fluid flows from the manifold and into the respective tube connector  504  without flowing to the rest of the manifold system downstream of the stopcock  503  pointed toward the pump  501 . When the handle on the stopcock  503  is pointed toward the end of the manifold opposite the pump  501 , the fluid flow is blocked from the rest of the manifold and the respective tube connector  504 . 
         [0045]    The last stopcock  505  is a 2-way stopcock. When the handle on the stopcock  505  is pointed toward the tube connector  504 , fluid flows from the manifold into the tube connector  504 . When the handle on the stopcock  505  is pointed away from the tube connector  504 , the fluid flow is blocked from the tube connector  504  and does not pass through the stopcock  505 . 
         [0046]    At each stopcock  503 ,  505 , a tube is connected to the tube connector  504  and each tube corresponds to a strip of the PACK&#39;D. Strips are selected to be inflated by adjusting each stopcock  503 ,  505  depending on the position on the manifold and the desired inflation of PACK&#39;D. 
         [0047]      FIG. 6  is a perspective of the device  602  on a kidney  600  during a procedure. In  FIG. 6 , there is a tumor  603  on the kidney  600  and the appropriate strip  604  and strip  605  are inflated to restrict blood flow into that portion of the kidney  600 . It should be noted that, in this embodiment, the ends of the sub-strips  606  of strip  605  are not inflated due to the ring fastener  607 . 
         [0048]    In the example of  FIG. 6 , the tumor  603  is on the external curve toward one end of the kidney  600 . The patient may be prepared for a laparoscopic PN surgery. When all the necessary ports are placed in the patient, the surgeon can introduce the instruments to begin the surgical procedure and the device  602  is inserted into the body via cannula and opened to its loosened structure. The kidney  600  is inserted into the cavity of the device  602  with half of the strips of the device  602  on either side of the renal hilum  601  and the fasteners  607  on the internal curve relative to the renal hilum  601 . The positioning of device  602  is adjusted based on where the tumor  603  is and the strips are tightened against the kidney  600  to secure the device  602 . Because the tumor  603  is on the external curve toward the end of the kidney  600 , the surgeon turns off all valves with the exception of those for the strip  604  and strip  605  next to the tumor  603 . This prevents fluid flow to all strips of the device  602  except strip  604  and strip  605  surrounding the tumor  603 . The surgeon pumps fluid into the strips  604 ,  605  with a pump until the strips reach an effective pressure, which can depend on the patient&#39;s blood pressure or other factors. The valves may be set so that fluid cannot flow into or out of strips  604 ,  605 , thereby maintaining the fluid pressure within those strips. The surgeon may make a small incision to observe the blood flow in the blood-restricted portion of the kidney  600  with the tumor  603 . After confirming the restriction of blood flow, the surgeon can proceed with performing the PN surgery. At the conclusion of the procedure, the surgeon will turn the valve or valves to let the fluid out of the inflated strips  604 ,  605  and loosen the fasteners  607  from the strips having such fasteners. The device  602  will be slipped off the kidney  600  and be removed from the body. Closing procedure will follow to conclude the operation. 
         [0049]    While a particular arrangement of strips is described herein, more or fewer strips may be used. The strips may be arranged (e.g., interconnected) in other configurations. For example, additional strips may be provided to narrow the regions of the kidney where blood flow is restricted or occluded. In another example, the device has only two strips. This may be used with, for example, exophytic tumors. 
         [0050]    In an embodiment, the part of the device inserted into the patient can be compacted into a cylinder-like volume or some other shape and be inserted via port in minimally invasive procedures. 
         [0051]    In an embodiment, the inflatable strips or strip can include sensors for blood flow or pressure. 
         [0052]    In an embodiment, the inflatable strips or connectors between the tubes connecting the inflatable strips may be airtight or otherwise fluid-tight. 
         [0053]    In an embodiment, the fasteners may be clips, slip-type fasteners, or any other fastener. 
         [0054]    The PACK&#39;D may not completely block blood flow to the portion of the kidney or other organ being operated on. 
         [0055]    The dimensions of the PACK&#39;D can vary for different patients, organ sizes, or types of organs. The dimensions of the strips also can vary. In an example, the strips are approximately 4 cm to 6 cm in length. 
         [0056]    The PACK&#39;D reduces or eliminates the need for clamping the renal artery by restricting blood flow to certain parts of a kidney. The remainder of the kidney receives blood. This may reduce renal injuries during and after a surgery. This also may lengthen time available for a surgeon to operate on a kidney without damaging the kidney. 
         [0057]    Although the present disclosure has been described with respect to one or more particular embodiments, it will be understood that other embodiments of the present disclosure may be made without departing from the spirit and scope of the present disclosure.