Abstract:
A gastric/jejunal catheter comprises three major components, a triple lumen “Y” connector, a transitional “midport” bolus, and a single lumen jejunal tube with a jejunal tip. The midport bolus, in turn, comprises three lumens, a jejunal feeding lumen, a gastric relief lumen and an air lumen. The midport bolus also contains inflow and outflow ports communicating with said lumens. The bolus contains a key reinforcing arc that prevents the kinking, and resultant jejuna lumen occlusion, of the bolus.

Description:
RELATED APPLICATIONS 
       [0001]    This application is based on Provisional application Ser. No. 61/302,210 filed Feb. 8, 2010, and claims priority therefrom. The disclosure of this Provisional application is incorporated herein in its entirety by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to catheters for use in administering fluids to body cavities, irrigating the cavities and aspirating the cavities. It relates particularly to such catheters and the distal ends thereof that contain the opening(s) for fluid egress or ingress. 
       BACKGROUND OF THE INVENTION 
       [0003]    The use of Salem sump catheters in the US for the aspiration of gastric fluid, post-surgically in gastrointestinal surgery is well documented. About 10,000 of these catheters are used annually in the USA. 50% of sump catheter tube usage is in 18Fr tubes. 25% of the usage is in 16Fr tubes. The remaining usage is spread in decreasing amounts over 14fr, 12Fr, 10Fr and 9Fr tubes. The vast majority of these tubes utilize polyvinyl chloride as the tube material, commonly referred to as PVC. The use of PVC requires large wall thicknesses and therefore correspondingly large French (Fr) sizes to support internal lumens. The existing sump tubes also incorporate conventional, easily clogged, inflow ports that have not been changed since the early 1970&#39;s. All of the existing postsurgical sump tubes are contraindicated for enteral feeding because of flow port clogging. 
         [0004]    Recent clinical studies have shown that patients in the immediate post surgical intensive care units should be fed immediately after surgery. It is not possible to immediately enterally feed any of the patients now being given Salem sumps because none of these patients have peristalsis and cannot, therefore, empty their stomachs. Stomach contents must be continually be aspirated. These clinical studies show that if patients are fed immediately fed after surgery they are released 2.2 days earlier than patients not being fed. Immediate feeding also results in a 55% reduction rate in post-surgical infections. 
         [0005]    Many postsurgical patients, including all of those with impaired peristalsis, must be fed deep in the jejunum, not in the stomach. Clinical studies have also shown that feeding deep in the jejunum does not stimulate the secretion of enzymes in the duodenum. However, deep jejunal feeding does stimulate the secretion of gastric juices, hence the critical need to aspirate the stomach simultaneously while feeding into the jejunum. Deep jejunal feeding does not stimulate enzyme secretion in the duodenum and therefore deep jejunal feeding must be accomplished with predigested elemental diets, not the normal undigested polymeric diets. 
       SUMMARY OF THE INVENTION 
       [0006]    This invention is embodied in a new midport catheter that incorporates improved inflow and outflow ports in a midport bolus in the stomach. The catheter provides for much larger, effectively protected ports to prevent clogging and to maintain aspiration flow. The catheter also provides for the feeding of feeding formulas deep into the jejunum through a jejunal catheter lumen with an improved outflow port. 
         [0007]    The catheter invention covers all the size requirements of existing gastric sump devices as now represented by the size availability of Salem sumps. The size disclosed in this patent application is 18Fr. The invention will also cover 16Fr, 14Fr, 12Fr and 10Fr sizes, all of which have the same design configurations as the 18Fr version. Because of the catheter tube lumen designs and because of the utilization of stronger polyurethane, a midport catheter incorporating a third lumen for feeding in the jejunum can be constructed that provides the third lumen for feeding while at the same time providing larger air vent lumens and gastric aspiration lumens per French size than existing Salem sumps. The 18Fr tube has an outside diameter (OD) of 0.242″. The actual midport bolus has an OD of 0.278″ or 20Fr. This size differential between the tube and midport bolus is not important because the tube is initially inserted through the nose via a 12Fr jejunal tube. The most important portion of the tube is the portion of the 18Fr length that exits the patient&#39;s nose. The length of the midport bolus is 1.08 inches. Normal enteral feeding tubes for adult and juvenile use are 12Fr, 10Fr, 8Fr, and 6Fr. The jejunal tube leading from the midport bolus covers these sizes and are as follows: 18Fr midport bolus/12Fr jejunal line; 16Fr midport bolus/10Fr jejunal line; 14Fr midport bolus/9Fr jejunal line; 12Fr midport bolus/8Fr jejunal line; and 10Fr midport bolus 6Fr jejunal line. 
         [0008]    To both reduce costs and to allow the midport bolus to be better secured to the thin walls of triple lumen tube, the midport bolus is formed by being overmolded directly to the tube that is cut at a 45 degree angle. The tip bolus of the jejunal tube is overmolded over a tube that is skived at a level slightly below the internal radius of the tube. The midport bolus incorporates a reinforcing arc which extends from the point on the bolus where the 45° skived gastric port begins and terminates at the point that the flow port recess in the bolus transitions up to the outside diameter of the bolus. 
         [0009]    An object of the invention is to provide a new and improved midport catheter bolus construction, a construction which allows for the elimination of bolus port side walls, where the gastric/air vent port is recessed with a port that has an effective recessed level of the full OD of the bolus. 
         [0010]    Another object of the invention is to provide a gastric/air vent port whereby both the gastric lumen and the air vent lumen of the triple lumen tube are terminated at the same point at the distal end of the tube so that increases in suction pressure are instantly relieved because of the proximity of aspiration lumen port and the vent line port. 
         [0011]    Another object is to maintain direct access between the terminus of the gastric lumen and the adjacent terminus of the air vent lumen. 
         [0012]    Yet another object of the invention is to provide a recessed portion for protection of outflow and inflow that extends around 270° of the circumference of the first bolus. 
         [0013]    Another object of the invention is to provide smooth recessed grooves in the distal bullet tip of the first bolus that create for flow channels in the tip which allow flow communication from the distal end of the bolus to the 270° recessed area so as to communicate with the gastric aspiration lumen and the air vent lumen. 
         [0014]    Another object of the invention is to provide a distal end 45° skiving of the three lumen tube to provide methodology for the overmolding of the main midport bolus to the thin walled tube which prevents leaking between lumens. 
         [0015]    Still another object of the invention is to provide a NGJ catheter that is the smallest size possible while at the same time providing adequate ingress and egress of fluid and air from both the stomach and the jejunum. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]    The invention, including its construction and method of operation, is illustrated more or less diagrammatically in the drawings, in which: 
           [0017]      FIG. 1  is a side view of the entire gastro/jejunal catheter, including a three port “Y” connector, the transitional gastric bolus and the jejunal bolus; 
           [0018]      FIG. 2  is a side view of a gastric/jejunal catheter including a gastric transitional bolus, showing the bolus connected to both the gastric and the jejunal tube; 
           [0019]      FIG. 3  is an opposite side view of a gastric/jejunal catheter including a gastric transitional bolus, showing the bolus connected to both the gastric and the jejunal tube; 
           [0020]      FIG. 4  Is a top plan view of the catheter of  FIG. 2 ; 
           [0021]      FIG. 5  is a bottom plan view of the catheter of  FIG. 2 ; 
           [0022]      FIG. 6  is a longitudinal view of the catheter taken along lines  6 - 6  of  FIG. 3 ; 
           [0023]      FIG. 7  is an enlarged view of a partial portion of  FIG. 6 . 
           [0024]      FIG. 8  is an enlarged end perspective view of  FIG. 2  taken along lines  8 - 8 ; 
           [0025]      FIGS. 9 ,  10 ,  11 ,  12 ,  13   14  and  15  sectional views taken along lines  9 - 9 ,  10 - 10 ,  11 - 11 ,  12 - 12 ,  13 - 13 ,  14 - 14 , and  15 - 15  of  FIG. 3 ; 
           [0026]      FIG. 16  is the side view of  FIG. 2  and the sectional view of  FIG. 9  showing the “phantom” flow path of the jejunal lumen through the catheter; 
           [0027]      FIG. 17  is the top plan view of  FIG. 4  and the sectional view of  FIG. 9  showing the “phantom” flow path of the jejunal lumen through the catheter; 
           [0028]      FIG. 18  is the side view of  FIG. 2  and the sectional view of  FIG. 9  showing the “phantom” flow path of the gastric aspiration lumen through the catheter; 
           [0029]      FIG. 19  is the top plan view of  FIG. 4  and the sectional view of  FIG. 9  showing the “phantom” flow path of the gastric aspiration lumen through the catheter; 
           [0030]      FIG. 20  is the side view of  FIG. 2  and the sectional view of  FIG. 9  showing the “phantom” flow path of the gastric vent lumen through the catheter; 
           [0031]      FIG. 21  is the top plan view of  FIG. 4  and the sectional view of  FIG. 9  showing the “phantom” flow path of the gastric vent lumen through the catheter; 
           [0032]      FIGS. 22 ,  23 ,  24 ,  25  and  26  are sectional views of  FIG. 9  showing the 18fr, 16fr, 14FR 12FR and 10fr showing relative dimensions. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0033]    Referring now to the drawings (especially  FIGS. 1 ,  2 ,  3 ,  4  and  5 ), in  FIG. 1  the three major components of a gastric/jejunal catheter  10  are shown. The catheter  10  comprises a triple lumen “Y” connector  18 , a multiple lumen tube  20 , a transitional (midport) bolus  16 , a single lumen jejunal tube  32  and a jejunal tip  14 . 
         [0034]    In  FIG. 2  an 18Fr triple lumen tube is shown at  20 . This segment of tube for adult or juvenile uses can be either 36″ or 42″ long, depending on the size of the patient. The goal is to place the bolus in close proximity to the pylorus so that the stomach can be aspirated at its emptying point. 
         [0035]    The tube  20  size disclosed is an 18Fr, triple lumen, tube with an outside diameter of 0.242.″ The midport bolus  16  is 1.08″ in length. The jejunal tube  32  exiting the distal end of bolus  16  is a 12Fr, single lumen tube, with an outside diameter (OD) of 0.164″. Its length is 42′. Therefore, the full length is either 76″ or 80.″ Other sizes are 16/10Fr, 14/9Fr, 12Fr/8Fr and 10/6Fr. 
         [0036]    The outside diameter of the bolus  16  is 0.278″, reflecting over-molding walls of 0.018″ shown at over molding area  23  in  FIG. 2 . The lowest portion of ramp  21 , as calculated from the outside diameter of bolus  16 , is recessed 0.124″ or slightly more than the radius 0.121″ of multi lumen tube  30 . The side ramp  26  is recessed 0.080″ from the 0.278″ outside diameter of bolus  16 . The cross-sectional view of the approximate lowest recessed level of ramp  21  is shown in  FIG. 12 . The 0.080″ deepest recess level of side ramp  26  is shown in  FIG. 13 . 
         [0037]    In  FIG. 2  the socket area  23  encloses the triple lumen tube  20  where it is overmolded on the tube. The top of the ramp  21  leading from first gastric aspiration lumen  38  leads to distal end bolus tip  34 . The bottom, recessed groove level, of air vent lumen  48  is shown at  22 . The continuation of side recess area is shown at  26 . 
         [0038]    As shown in  FIGS. 2 ,  3 ,  4  and  5 , this recess  26  continues the full side of the bolus  16 . The grooved side flow channels in distal tip  34  are shown at  28  and  30 . The leading top edge of the gastric lumen  38  is seen at  25 . 
         [0039]      FIG. 3  shows a side view of the bolus  16  opposite to that shown in  FIG. 2 .  FIG. 4  shows a tip view of the bolus  16 . The lower edge of the vent port is shown at  22 . The recessed area of the bolus blends from  22  and is shown at  26 .  FIG. 5  shows the bottom of the bolus  16 . The recess on the side of the bolus is shown at  26 . 
         [0040]      FIG. 6  shows a cross-section of the bolus  16  at section  6 .  42  is the cross section of the central septum separating gastric lumen  38  and jejunal lumen  40 . The 45° skived leading edge of multi-lumen tube  20  is shown at  25 . Shown at  52  is the jejunal lumen in the bolus  16 . Shown at  40  is the round jejunal lumen in the 12Fr single lumen jejunal line  32 . 
         [0041]      FIG. 7  is an expanded view of the area  23  of  FIG. 6 . A slight overmolding  46  assists in the adhesion of the bolus  16  to the septum  42 .  FIG. 8  shows the slight overmolding  46  in both the gastric lumen  38  and the air lumen  40 . 
         [0042]      FIGS. 9-15  show cross-sections of the catheter  10  seen in  FIG. 3 .  FIG. 13  also shows the air lumen bottom portion  22  as it transitions distally.  FIG. 13  shows the transition of the recess  26  where it forms a full 180° recess  26  on the side of the bolus. Note the full transition of side recess  26  to tip recess/ramp  21  forming a full 270° recess. 
         [0043]    The  FIGS. 6 and 7  illustrate positioning the reinforcing arc  36 . This element is critical because it prevents the entire overmolded bolus  16  from kinking and occluding the jejuna lumen  40 . It is also important that this bolus does not add effective outside diameter to the bolus. Why is that true? Because in  FIGS. 6 and 7  the proximal end of the bolus originates at points  67  where the recess  69  begins. As the bolus is inserted through the mucosa of the nose, nasopharynx and eosophagus, the tissue is not stretched beyond the overall outside diameter of the largest OD of the bolus. At its distal end the reinforcing arc ends at the point  68  where it meets the portion of the OD of the leading portion of the bolus  16 . It is because the part would become weaker if the reinforcing begins or terminates before the OD of the bolus. The length of the reinforcing arc  36  extends from the point on the first bolus where the recessed ramp begins at the top of the 45 degree skived gastric port and extends to the point where the ramp meets the leading portion of the bolus at the outside diameter of the bolus as defined by the portion of the bolus that is over molded over the three lumens of the three lumen tube at its distal end; ( FIGS. 6 ,  67  to  68 ). Without the reinforced arc the tube will kink at the point  63 . Because of the 45 degree skive the arc can begin before point  63  without actually making the effective OD of the bolus larger. The arc  36  is protecting from bending the single lumen portion of the bolus. 
         [0044]    Another feature is the fact that we describe that the deepest part of the recess is slightly larger than the radius of the actual three lumen tube. The configuration of the triple lumen extrusion and the reinforcing arc allows this depth. 
         [0045]      FIGS. 12 ,  13 , and  14  are also instructive. The reinforced arc  36  is enlarged beyond its shape defined by the ramp  21  because the portion of the bolus that contains the air vent lumen  48  is utilized as an additional side portion of the overall reinforced arc, basically expanding the arc beyond the approximate 180 degrees.  FIG. 12  shows the recessed space at 210 degrees. The recess tapers to 216 degrees in  FIG. 13 . In  FIG. 14  the bottom taper of the leading portion  34  of the bolus  16  tapers away from the reinforcing arc  36 , essentially creating a 270-degree recession. 
         [0046]    The grooved side flow channels  28  and  30  provide for flow access from the front, distal end of the bolus  16  to the recessed space that communicates with the gastric lumen  38  and the air vent lumen  48 . Flow to the recessed space is from the top, sides and front of the bolus. The recessed area transitions from 210 degrees around bolus  16  at the point where the gastric and air vent lumens access the recessed area in cross section  12 - 12  to 270 degrees at the point where the distal end of the bolus meets the two flow channels  28  and  30  that provide flow access from the leading distal portion of the bolus  16 . 
         [0047]    Now referring to  FIGS. 16 ,  17 ,  18 ,  19   20  and  21 . All of these FIGs. utilize the tube cross section of multi-lumen tube  20  that is shown in  FIG. 9 . This tube cross section is matched with the side and top plan views of  FIGS. 2 and 3  to show “phantom” flow through the bolus, and in the case of the jejunal line, through the bolus  16  and the jejunal single lumen tube  32 . 
         [0048]      FIGS. 16 and 17  show the flow and direction of the jejunal flow. In  FIG. 16  the semi-D lumen  40  tapers to become larger in this view as it tapers to a circular shape in tube  32 . In the top view of  FIG. 17 , the flow taper becomes more restricted as it tapers to a full circular shape. This flow channel is formed by a molding pin that enters the distal end of bolus  16  and extends the full length of the bolus and into the jejunal lumen  40 . At this point the molding forms a socket  62  for the jejunal single lumen tube  32 . In normal molding this molding pin (not shown) would present an “undercut” and the pin could not be removed from the part. However in this case the pin can easily be removed from the part because the taper pulls easily through and from the flexible part without damaging it. 
         [0049]      FIGS. 18 and 19  illustrate the internal and exterior flow in phantom of the gastric line. The flow through the flow grooves  28  and  30  communicate with the flow from gastric port  38 .  FIGS. 20 and 21  show the phantom flow through air lumen  40 . 
         [0050]    Now referring to  FIGS. 22 ,  23 ,  24 ,  25  and  26 . These FIGs. show the dimensions of the five multiple lumen tube sizes for the midport bolus  16 .  FIG. 22  shows the 18fr tube described in this application. The configurations of the other sizes are smaller versions of the 18Fr tube  20 . The “line”  60  is a tangent extending from the center of tube at the middle of internal septum  42 . Therefore these lines are true tangents. These lines form tangents that are at 45° from the center of the tube. All of the arcs forming the air vent lumen  40  and separating it from lumens  38  and  40  fall inside the width of the septums  42  where they meet and attach to the outside wall of the tube  32 . This combination of the septum arc forming the air vent lumen  48  form a strengthening “member” inside the main tube that assists in preventing the tube from collapsing or kinking. In addition, the fact that all three of the internal septum points of joining the outside wall of tube are at 45° angles minimize the amount of normal “filling” that occurs at the junctures of internal septums and the outer wall of a tube. This filling reduces the size of the internal lumens. It is virtually impossible to extrude polyurethane to form a true unfillited juncture of an internal septum and the outer wall. 
         [0051]    To review the functional aspects of the present inventions, they embody an enteral catheter that provides access to both the stomach and the deep jejunum for feeding, aspiration and decompression. The catheter includes a triple lumen tube that joins to a triple lumen “Y” connector at the proximal end of the tube. The connector serves the three lumens as a source for venting air, for fluid aspiration and for fluid infusion. The gastric aspiration lumen, the jejunal feeding lumen and the air vent lumen all connect to a transitional midport connector bolus in the stomach at the distal end of the three lumen tube. 
         [0052]    The gastric lumen and the air vent lumen both open into the stomach through a common gastric port. The jejunal lumen communicates with jejunal lumen in the midport bolus. Midport jejunal lumen transitions from a modified “D” shape to a full circle shape. The latter provides for the attachment of a smaller, round single lumen tube that extends to the jejunum. The gastric lumen and the air vent line terminate at the same point, side-by-side, into the common gastric port. The gastric port is recessed to the level of its full internal lumen, thereby providing a recess for maximum protection against occlusion and maximum area for outflow. This recessed level is at the top of the mid-tube septum that separates the gastric tube lumen and the jejunal lumen and is therefore recessed to almost the internal radius of the triple lumen tube. This septum transitions to become the ramp of the recessed port that serves both the gastric port and the air vent port. The air vent lumen continues distally in its same shape until it transitions into another recess on the side of the midport bolus that also provides protection against occlusion and is source of flow. This side recess extends around the full 180 degree side of the midport bolus. The gastric lumen, the vent lumen, the top recess and the side recess all communicate with each other, thus providing 270 degree access to the gastric and air vent lumen for flow in or out of the main three lumen tube and also flow in or out from the loading distal portion of the bolus  10  through flow channels  28  and  30 . 
         [0053]    It is intended that the foregoing detailed description be regarded as illustrative, rather than limiting. It is to be understood that it is the following claims, including all equivalents, that are intended to define the spirit and scope of this invention.