Abstract:
A medical delivery or extraction system comprising a needle assembly having a needle and a hub coupled to the needle. The hub includes a verification region or component. A syringe body rotatably coupled to the needle assembly includes at least one indicia on the outer surface thereof. When the indicia corresponds to the verification region, the user is provided with an indication that the syringe body is properly connected to the needle assembly. The system also includes a lever arm coupled to the needle assembly. The lever arm is sized and positioned to provide a user with a mechanism of easily securing the needle assembly to the syringe without the use of external tools.

Description:
This application is a continuation-in-part of U.S. patent application Ser. No. 10/113,680, filed Mar. 29, 2002. 
    
    
     FIELD OF THE INVENTION 
     The present invention is directed to a medical delivery/extraction system. More particularly, the present invention is related to a medical delivery/extraction system with a lever arm to easily and fully tighten a needle to the syringe. 
     BACKGROUND OF THE INVENTION 
     Syringe and needle assemblies have been used for a number of years for the purpose of injecting fluids into or withdrawing fluids from a body. These fluids may include medicine, blood or other types of biological materials. Due to the multitude of infectious diseases which may be carried by bodily fluids such as blood, it is extremely important that any potential leakage of fluid during an injection or withdrawal process be kept to an absolute minimum. 
     One location in a delivery/extraction system where bodily fluids and/or other substances may leak from the system is the connection area between the syringe and the needle assembly. Because syringes and needle assemblies are often marketed and/or manufactured separately, a doctor, nurse or other technician is required to properly connect the needle assembly to the syringe. If the needle assembly is not properly connected to the syringe, the possibility of a poor connection and accidental leakage of biological materials increases significantly. This correspondingly increases the risk of exposure to hazardous materials. 
     The type of fluid or other biological media being delivered to or from the syringe may also contain materials, components, or ingredients (hereinafter, “material”) that can separate at a poor connection when exposed to the injection pressures developed in the syringe. The material separation can cause further problems of injecting or extracting the full contents of the syringe through the needle. A needle assembly properly connected to the syringe would significantly reduce the possibility of material, component, or ingredient separation from occurring. 
     A variety of mechanisms have been developed to securely fasten needle assemblies to syringes, but each have their drawbacks. For example, a number of conventional mechanisms include a linear connection between the syringe and the needle assembly in the form of a track or groove, in which the needle assembly slides onto the syringe. Systems with linear connections often include o-ring type seals that are located a certain distance from the path of the fluid material. This distance between the seal and the material pathway may cause delivery and/or extraction problems for certain types of materials. Other types of conventional systems involve a rotational fitting between the needle assembly and the syringe. These systems allow for a line-to-line seal that is integral to the material path, but the systems are somewhat limited in their ability to indicate to the user when an adequate or proper connection has been achieved. Furthermore, some of these systems may be prone to being “overtightened” which can affect the functionality and/or safety of the completed assembly. Also, it often can be difficult to determine whether the needle assembly is properly connected to the syringe. In whichever case, an improperly made connection between the needle assembly and the syringe can have hazardous results and/or functional/operational problems. 
     Additionally, most conventional injection needles do not provide a mechanism for adequately tightening the needle to a standard luer syringe without the use of tools by the user. A few products currently available provide a double grip design in order to produce an increased leverage, but double grip designs typically expect that the user will rotate the needle relative to the syringe. Tightening the needle relative to syringe can cause additional tissue trauma if the needle is in the tissue. Some designs also do not permit for the repeated connection and disconnection of the needle with different syringes, as the needle&#39;s plastic luer threads tend to distort or wear under the required tightening force. Furthermore, some delivery and extraction systems do not provide a sufficiently tight seal between the syringe and needle luer connections or a connection that clears particles from the luer surface of the syringe. 
     SUMMARY OF THE INVENTION 
     It is therefore an object of the invention to provide an improved delivery or extraction system that provides a simple mechanism for ensuring a proper connection between components. 
     It is another object of the invention to provide an improved delivery or extraction system that includes a mechanism to indicate to a user that a proper connection has been achieved. 
     It is still another object of the invention to provide an improved delivery or extraction system that minimizes the incidence of fluids or other bio-material escaping from the system. 
     It is yet another object of the present invention to provide an improved delivery and extraction system that provides a visual indication of whether an adequate or proper connection has been made in the system. 
     It is another object of the present invention to provide an improved delivery and extraction system that is simple to use while still maintaining a high degree of safety. 
     It is another object of the invention to provide an improved delivery or injection system which provides a high degree of leverage when tightening the needle onto a syringe. 
     It is yet another object of the invention to provide an improved delivery and extraction system that permits sufficient tightening of the system without the use of external tools. 
     It is still another object of the invention to provide an improved delivery and extraction system that allows for the repeated connection and disconnection of the needle with different syringes. 
     It is another object of the present invention to provide an indicator means that provides accurate and concurrent positioning of both linear and angular orientation, ensuring indication of a proper connection. 
     In accordance with the above objects, a medical delivery and extraction system is provided. The system comprises, among other things, a needle assembly including a needle with a hub formed therein, the hub containing a lever arm. A syringe body is rotatably coupled to the needle assembly. The syringe body includes at least one indicia on a portion of the body, and the needle hub includes a verification region on a portion thereof. The indicia and verification region are arranged on the syringe body and needle hub, respectively, such that when the syringe body is properly fastened to the needle assembly, the indicia aligns with the verification region, giving the user an indication that the needle assembly is properly connected to the syringe body. The lever arm provides the user a high degree of leverage when tightening the needle onto the syringe without necessitating the use of external tools. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing advantages and features of the invention will become apparent upon reference to the following detailed description and the accompanying drawings, of which: 
         FIG. 1  is a side view of a medical delivery system according to one embodiment of the invention; 
         FIG. 2  is a detailed side view of a syringe according to one embodiment of the present invention; 
         FIG. 3  is a detailed side view of a needle assembly for mating with the syringe of  FIG. 2 ; 
         FIG. 4  is a detailed side view of a portion of the needle assembly of  FIG. 3  rotated ninety degrees about its central longitudinal axis; 
         FIG. 5  is a side view of a needle assembly and syringe before being fastened; 
         FIG. 6  is a side view rotated ninety degrees about the longitudinal axis of the needle assembly and syringe of  FIG. 5 ; 
         FIG. 7  is a side view of the needle assembly rotated ninety degrees and syringe of  FIG. 5  as the needle assembly is partially fastened to the syringe; 
         FIG. 8  is a side view of the needle assembly and syringe of  FIG. 5  as the needle assembly is properly connected to the syringe; 
         FIG. 9  is a side view rotated ninety degrees of the needle assembly and syringe of  FIG. 8  as the needle assembly is properly connected to the syringe; 
         FIG. 10  is a side view of a luer connection according to another embodiment of the invention; 
         FIG. 11  is another side view of the luer connection of  FIG. 10 ; 
         FIG. 12  is a side view of a modified luer connection according to still another embodiment of the invention; 
         FIG. 13  is a side view of a modified luer connection according to yet another embodiment of the invention; 
         FIG. 14  is a side view of a modified luer connection according to still another embodiment of the invention; 
         FIG. 15  is a side view of an unfastened medical delivery system including a protective sheath; 
         FIG. 16  is a side view rotated ninety degrees about the longitudinal axis of an unfastened medical delivery/extraction system including a cannula; 
         FIG. 17  is a side view of the needle assembly rotated ninety degrees and syringe of the medical delivery system of  FIG. 15  during the securing process; 
         FIG. 18  is a side view of the medical delivery system of  FIG. 15  when properly connected; 
         FIG. 19  is a side view rotated ninety degrees about the longitudinal axis of the medical delivery system of  FIG. 18  when properly connected; 
         FIG. 20A  is an alternate embodiment of the invention in which a beveled needle is connected to a tightening lever arm&#39;s luer fitting, and a cannula is connected to a linearly adjustable member with the needle in a retracted position; and  FIG. 20B  shows the needle of  FIG. 20A  with the needle in an open and injection position; and 
         FIG. 21A  is an alternate embodiment of the invention in which a pointed needle is connected to a tightening lever arm&#39;s luer fitting, and a cannula is connected to a linearly adjustable member with the needle in a retracted position; and  FIG. 21B  shows the needle of  FIG. 21A  with the needle in an open and injection position 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     A medical delivery or extraction system is shown generally at  100  in  FIGS. 1-4 . The medical delivery or extraction system  100  comprises a syringe  102  and a needle assembly  104 . The syringe  102  comprises a syringe body  110  coupled to an end-piece  112  (best seen in  FIG. 2 ). The syringe body  110  includes a plunger receiving end  114  and a needle assembly receiving end  116 . The plunger receiving end  114  is open such that it may accept a plunger  128  that is used to force fluid into or out of the syringe  102 . The syringe body  110  also includes a plurality of volume indicia  118  for measuring the amount of fluid inside the syringe  102  at any given moment. 
     The syringe  102  also includes an inner body  122  (shown in phantom in  FIG. 2 ) on the inside of the syringe  102 . The inner body  122  comprises a passageway through which the fluid primarily flows. The inner body  122  terminates at a connection portion  124 . In the area around the connection portion  124 , there are a plurality of threads  126  (shown in phantom) formed on the inside of the syringe body  110 . 
     An indicator mark  120  is also included at the needle assembly receiving end  116  of the syringe  102 . The indicator mark  120  is used to determine whether the syringe  102  is properly connected to the needle assembly  104 . The indicator mark  120  may take a variety of forms. In a preferred embodiment of the invention, the indicator mark  120  comprises a colored dot which is visible by a user. The indicator mark  120  can take a variety of other forms, however, including lines, figures, numbers, colored bands, etc. and a variety of conventional indicating methods including aligning lines or figures, compression rings, etc. Additionally, it is also possible for the indicator mark  120  simply to be a color opposite that of the surrounding portion of the syringe body  110  or to be reverse printed from that described in this embodiment. Furthermore, it is possible to have multiple color bands or other mechanisms for indicating varying degrees of making the connection. The indicator mark  120  is preferably imprinted on the outer surface of the syringe body  110  or imbedded inside the syringe body  110 . Furthermore, the indicator mark  120  can comprise a depression, ridge, or groove which mates with the needle assembly  104 . 
     The needle assembly  104  comprises a needle  130  (shown partially in phantom and full line in  FIGS. 3 and 4 ) coupled to a luer connection  132 . The luer connection  132  includes a hub  134  (shown in phantom) formed on the inside thereof. The hub  134  is hollow and runs from a first end  136  to a second end  138 . The hub  134  is sized to accept the needle  130  in a snug relationship. The hub  134 , in one embodiment of the invention, also includes a hub ridge  142  at the second end  138 . Alternatively, the hub  134  may include a plurality of hub threads  170 , shown best in  FIGS. 10-14 . As shown in  FIGS. 3 and 4 , the hub ridge  142  and/or the hub threads  170  are used to mate the needle assembly  104  with the syringe  102  shown in  FIGS. 1 and 2 . The luer connection  132  also includes a lever arm  146 . The lever arm  146  is used to fasten and unfasten the needle assembly  104  from the syringe  102 . 
     The luer connection  132  also includes a viewing region  144 . In a preferred embodiment of the invention, the viewing region  144  comprises a circular opening. It is also possible for the viewing region  144  to comprise a transparent material. The viewing region  144  is used to determine if the needle assembly  104  is properly connected to the syringe  102 . As is explained herein, when the indicator mark  120  of the syringe  102  is clearly visible through the viewing region  144 , then it is understood that the syringe  102  is properly connected to the needle assembly  104 . 
       FIGS. 10-14  show various example types of threaded sealing connections that may be incorporated into the present invention.  FIGS. 10 and 11  show a standard threaded luer connection  232 , including a strain relief portion  148  and a luer end  170 .  FIGS. 12-14  disclose modified luer connections  132 , including a modified luer connection  132  with the initial leading threads removed, (see  FIG. 12 ); a modified luer connection  132  with the initial leading thread removed, while the inner diameter begins straight at a diameter smaller than the standard luer  232  and tapers to a normal luer diameter (see  FIG. 13 ); and a modified luer connection  132  in which the initial diameter does not taper nor chamfer fully to the second diameter, but incorporates a ninety degree or less angled step between the two diameters to help push particulates off of the luer taper surface (see  FIG. 14 ). A variety of types of connections could also be used, as would be understood by one of ordinary skill in the art. 
     Depending upon the nature and type of threads  126 , the number of indicator marks  120  on the syringe body  110  may also vary. For example, if a single lead thread is used, only one of the indicator marks  120  is required on the syringe body  110 . If a double lead thread is used, however, two of the indicator marks  120  should be incorporated onto the syringe body  110 , each being approximately 180° from the other. In this case, the medical delivery or extraction system  100  would be properly connected when either of the indicator marks  120  is aligned with the viewing region  144 . If a triple lead thread is used, three indicator marks  120  would be used with each of the indicator marks  120  being approximately 120° from the other indicator marks  120 . In general, the number of the indicator marks  120  needed would correlate to the number of thread leads used. 
     The operation of the medical delivery or extraction system  100  is generally as follows. As shown in  FIGS. 5 and 6 , the needle assembly  104  is separable from the syringe  102 . If the user desires to couple the needle assembly  104  to the syringe  102 , the user brings the second end  138  of the luer connection  132  towards the needle assembly receiving end  116  of the syringe body  110 . When the second end  138  of the luer connection  132  comes into contact with the needle assembly receiving end  116  of the syringe body  110 , the user either twists the lever arm  146  of the luer connection  132  or grips the lever arm  146  of the luer connection  132  and twists the syringe body  110 . The mating action of the threads  126  with the hub threads  170  (see  FIG. 4 ) causes the luer connection  132  to couple to the syringe body  110 . As is shown in  FIGS. 7-9 , the connection between the luer connection  132  and the syringe body  110  becomes more pronounced as the luer connection  132  is twisted relative to the syringe body  110 . As is shown in  FIG. 8 , when the luer connection  132  is only partially upon the syringe body  110 , the indicator mark  120  is not yet shown or visible through the viewing region  144 . As the user continues to twist the luer connection  132 , the indicator mark  120  ultimately aligns with the viewing region  144 , as best shown in  FIG. 9 . At this position a proper connection has been achieved between the needle assembly  104  and the syringe  102 , and the user is given an indication that additional tightening is not necessary. The user is then able to perform the particular procedure using the medical delivery or extraction system  100 . When the user desires to remove the needle assembly  104  from the syringe  102 , the user simply rotates the luer connection  132  in the opposite direction using the lever arm  146 . 
     The delivery or extraction system  100  of the present invention can be used in virtually any situation that requires an indication and assurance of a proper connection for rotationally connected medical delivery or extraction devices. Such environments range from sterile hospital suites to non-sterile doctors&#39; offices. The system  100  could be used at ambient conditions in addition to hot or below freezing conditions and dry or humid conditions. The system  100  can also be packaged and sterilized using conventionally known methods and can be provided and used for non-sterile applications. The individual components can all be manufactured using conventionally known techniques resulting in a relatively low cost. 
     As mentioned previously, a variety of indicia can be used for indicating that the syringe  102  is properly connected to the needle assembly  104 . For example, a variety of visual indicators could be used, and it is also possible to have an audible indication of a proper connection. This can be accomplished using a form of snap fitting in a mechanical design, an electronic computer chip in an electrical design, or other design systems. A combination of visual and audio indications could also be used. Furthermore, a number of the individual components can be replaced and/or modified depending upon the particular needs. For example, the syringe  102  could be in the form of a container such as a cartridge, vial or bottle, while the needle assembly  104  could be replaced with a different type of mechanism or device. Different types of seal interfaces, such as tapered seals, face seals, etc., could be used to ensure a secure connection, and connections other than luer connections could be used. For example, a variety of types of threads or a twist locking mechanism could be incorporated into the system  100 . 
     The present invention also provides for an extended, single torque lever arm  146 . The lever arm  146  can be used for many applications where a delivery or extraction system  100  including a needle  130  is used and requires a very tight seal, such as during the delivery of particle laden and/or high viscosity materials. The lever arm  146  provides a mechanism for adequately tightening the needle assembly  104  to a standard syringe luer fitting by an operator without the need for ancillary tools or other assistance. The lever arm  146  provides the operator with greater leverage and reduced hand force for tightening and, by virtue of the increased tightness, a greater seal pressure. The lever arm  146  therefore allows for the easier connection and disconnection of the needle assembly  104  to the syringe. The lever arm  146  also provides a comfortable grasp for the user. 
     The lever arm design is sized to provide an easy grip point between the user&#39;s thumb and finger to encourage holding the needle assembly  104  steady while twisting the syringe  102  onto the needle assembly  104 . Conventional designs such as double wing, no wing, and short single arm designs encourage the user to hold the syringe  102  and twist the needle assembly  104  onto the syringe  102 . The design of the present invention discourages this practice, providing a distinct advantage for procedures in which the needle  130  is required to be left in place and not twisted while the syringe  102  is removed and/or attached and while the syringe  102  or component exchanges occur at the luer connection  132 . 
     For a single torque form of the lever arm  146 , the needle assembly  104  is connected to the mating syringe  102  by holding the lever arm  146  and rotating the syringe  102  onto the needle assembly  104  until a tight connection has been made. The lever arm  146  provides significant leverage for the operator, reducing the force normally required to tighten the needle assembly  104 . Removal of the syringe  102  is achieved by simply holding the injection needle torque lever arm  146  and rotating the syringe  102  in the opposite direction as when tightened. A syringe change-out occurs by removing an existing form of the syringe  102  and connecting a new form of the syringe  102  as detailed previously. 
     The extraction or delivery system  100  according to the present invention may also include an adjustable outer sheath  137  that covers the needle  130  and needle tip  135  or cannula  133  that tapers and/or blends into the needle tip  135  during part of the injection procedure. Examples of these embodiments are shown in  FIGS. 15 ,  16 ,  20 A-B and  21 A-B. The delivery or extraction system  100  may also include a modified luer design that provides a means of wiping the mating luer&#39;s outer diameter surface while the parts are being connected together. 
     Types of styles which may be used include a modified full thread luer connection  132  that has a straight and smaller than normal lead-in diameter, shown in  FIG. 13  or a standard luer lead-in diameter which quickly changes to a long, continuous diameter that is approximately equal to the smallest luer diameter, shown in  FIG. 14 . These modified styles provide the needle  130  a means of the pushing material located on the syringe luer sealing surface off that surface. The designs promote a proper and tight seal between the sealing surfaces of the luer fittings without the injection material being trapped or sandwiched between, preventing a tight seal from forming. These designs could include a modified full luer thread that has some of the lead-in threads removed (as shown in  FIG. 13 ). This feature combined with the other modifications described herein would further allow the leading edge of the needle luer to grip snuggly around the smallest diameter of the mating syringe luer and distort or flare outward as the needle assembly  104  is tightened fully onto the luer fitting. The material of construction is pliable and flexible to allow distortion of the lead-in diameter. 
       FIGS. 15-16 ,  20 A- 2 B and  21 A- 21 B show that the invention may include a controlled mechanism for adjusting and locking-in-place a sheath  137  or cannula  133 , placed over a needle  130 , while the needle  130  remains in position. In this particular embodiment, the outer sheath  137  or the cannula  133  is connected to a linearly adjustable member  154  which is integral and connected to the tightening lever arm&#39;s  146  luer fitting. The needle  130  could be replaced with a stylet while still allowing use of the system in a manner similar to that described or allowing removal of the stylet altogether once placed in its desired location. 
     In one embodiment of the invention and as shown in  FIG. 15 , the needle  130  is connected to the tightening lever arm&#39;s  146  luer fitting and the protective sheath  137  is connected to the linearly adjustable member. In a second embodiment and as shown in  FIGS. 16 ,  21 A,  21 B,  22 A and  22 B, the beveled or pointed needle  130  is connected to the tightening lever arm&#39;s  146  luer fitting, and the cannula  133  is connected to the linearly adjustable member. In this particular embodiment of the invention, a preferred form of the needle  130  is a side discharge needle that has a solid metal point. With this design, the needle opening  164  is initially covered by the outer cannula  133 , thus acting as a stylet when first introduced into the body. Once in place, the cannula  133  is retracted by use of the linear adjustable member, and the needle opening  164  is exposed. The needle tip  135  remains in the original injection position as the cannula  133  is retracted. After injection, the cannula  133  can be slid back over the exposed needle opening  164  and the entire needle assembly  104  withdrawn from the site. This alternative design is preferred over standard and non-coring needles for applications where the needle  130  must puncture through tough membranes such as cartilage or scar tissues, as standard and non-coring needles can core when pushed through these tissues. 
     One method of sheath or cannula adjustment is shown in the  FIGS. 15-19  where a multi-slotted arm on the tightening lever arm  146  end mates with a correspondingly tabbed adjustment member  147  that can be rotated about ninety degrees to lock into place. This design allows for secure multiple position adjustment of the outer sheath  137  or cannula  133  with respect to the inner needle  130 . A second adjustment method comprises a channeled (and optionally detented) arm on the tightening lever arm end that mates with a corresponding tab and tightening screw or optional plunger (not shown) on the adjustment member  147 . This design permits secure multiple position adjustment of the outer sheath  137  or the cannula  133  without requiring rotation of one member with respect to the other. 
     The addition of a modified luer connection  132  does not change the connection and removal methods for the needle  130 , but simply adds a wiping element on the needle luer fitting as shown in  FIGS. 13 and 14 . The wiping element presses immediately against the smallest diameter of the syringe luer connection  124  and expands against the mating luer&#39;s taper as the luer fittings are drawn together and the connection tightened. Removal of the needle assembly  104  allows its luer fitting to return to its normal shape while ensuring the syringe&#39;s luer surface is wiped of any debris or particulate matter. 
     An integrated adjustment member may also be used to provide a controlled mechanism for adjusting and locking-in-place the sheath  137  or the cannula  133  placed over the needle or stylet  130  while the needle or stylet  130  remains in position. In one embodiment of the invention and as shown in  FIG. 15 , a sheathed form of the needle  130  is connected to the syringe. The needle&#39;s sheath  137  is slid over the needle tip  135 , and the covered needle assembly  104  is inserted. Once the needle sheath  137  protrudes out of the scope, the sheath  137  is retracted and the needle  130  placed into the tissue location desired. Upon completion of the procedure, the needle  130  is removed from the injection site, the sheath  137  pushed over the needle tip  135 , and the entire needle assembly  104  is pulled out of the scope. The sheath  137  allows the needle  130  to be placed through a scope with no damage to the scope channel 
     In an alternative embodiment of the invention and as shown in  FIG. 16 , the adjustable cannula  133  is connected to the syringe  102 , and the cannula  133  is slid over the needle tip  135  to cover and seal the needle opening  164  of the side discharge needle  130 . The needle  130  is placed into the tissue location desired, and the cannula  133  is retracted. The injection occurs and the entire needle assembly  104  is pulled out of the injection site. The cannula  133  is slid over the needle opening  164  again, and the needle  130  placed into another tissue location. The cannula  133  is again retracted and a new injection occurs. The process is repeated until all injections desired are completed. The sliding cannula  133  allows penetration into tough or fibrous tissue that may core a regular needle  130  during its penetration. 
     The present invention can be used in conjunction with virtually any environment and procedure which requires assurance of a tight connection using only the operators hand strength. Environments ranging from sterile hospital suites to non-sterile offices primarily at ambient conditions are acceptable, although the invention may be used in environments ranging from hot and humid conditions to dry and below freezing conditions. The types of materials used may range from 100% plastic to 100% metal, or a combination of the two materials. An elastomeric compound could also be added and used for the sealing and/or wiping applications. 
     The lever arm  146  for the invention can be molded using standard injection molding and insert molding techniques. Differences in the shape, size, and/or profile of the lever arm  146  can also be made to further ergonomically enhance the lever arm&#39;s  146  characteristics. Additionally, the lever arm  146  or other components of the injection needle  130  could be color coded to an industry standard, indicating the needle gauge of the product. The plastic tubing used can be manufactured from readily available extruded tubing known to those in the art. The needles  130  and respective cannulas  133  can be produced by current extrusion and fabrication methods such as grinding, drilling, cutting, milling, and polishing. The assembly of the extraction or delivery system  100  can be completed with standard assembly, forming, bonding, printing, and molding operations. The system can be packaged and sterilized using currently available methods, with Ethylene Oxide (EtO) being the preferred sterilization method. 
     It should be understood that the above description of the invention and specific examples and embodiments, while indicating the preferred embodiments of the present invention, are given by demonstration and not limitation. For example, although a luer type thread is discussed in detail, the invention can easily be used with any device that uses a “twist-to-tighten” connection (i.e. devices that use threads, ¼ turn connections, etc.) Many changes and modifications within the scope of the present invention may therefore be made without departing from the spirit thereof and the present invention includes all such changes and modifications.