Abstract:
The invention relates to a PEG probe having a PEG tube, an outer holding plate, through which the PEG tube is fed and in which the PEG tube is fastened, and a funnel adapter, which is associated with an outer end region of the PEG tube. A tightly closing valve is arranged either in the PEG tube between the outer holding plate and the outer end region or on the outer end region of the PEG tube. The valve blocks the flow through the PEG tube in a closed position and allows said flow at least in the full cross-section of the PEG tube in an open position. The valve has a valve body and a valve housing. The valve body is connected to and movable by means of a handle accessible from outside. The valve body is supported in the valve housing.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a national stage application of international application no. PCT/EP2015/066781 filed Jul. 22, 2015, entitled “Peg Probe Having Protected Manual Valve Operation,” claiming benefit under 35 U.S.C. §§119(a)-(d) to German application no. DE 10 2014 115 340.5 filed Oct. 21, 2014, which are hereby expressly incorporated by reference as part of the present disclosure. 
     
    
     FIELD OF INVENTION 
       [0002]    The invention relates to a PEG tube
       with an inner retaining plate,   with a PEG hose having an inner end portion and an outer end portion, the inner end portion being firmly connected to the inner retaining plate and having an inner opening of the PEG hose there,   with an outer retaining plate through which the PEG hose is routed,   with a funnel adapter associated with the outer end portion,   with a tightly sealing valve disposed at the outer end portion of the PEG hose, the valve blocking the flow-through through the PEG hose in a closing position and unblocking it in an opening position, the valve comprising a valve body and a valve housing, the valve body being connected to a handling means accessible from the outside and being mounted in the valve housing so as to be movable between the permanent closing position and the permanent opening position.       
 
       BACKGROUND 
       [0008]    Such a PEG tube is known from WO 2006/036843 A1. Another tube is known from U.S. Pat. No. 4,666,433 A. PEG tubes, i.e. gastronomy feeding tubes offer access to the stomach at the location of a stoma. Such connections typically remain in position over extended periods of time and serve for feeding the patient and for administering medicaments. Several of the known PEG tubes have check valves that prevent the contents of the stomach from flowing back through the PEG hose and leaking from its outer opening; see, for example, US 2006/0079850 A1 and DE 101 54 864 A1. Thus, it is possible to prevent possibly acid stomach contents from leaking to the outside and causing damage there. 
         [0009]    In the previously known PEG tube of the type mentioned in the introduction, the funnel adapter is firmly connected to the outer end portion of the PEG hose, and a sealing plug is provided with which the outer end of the funnel adapter can be sealed. Such sealing caps can be found frequently in PEG tubes. They seal the PEG hose; they prevent the entrance of foreign substances into the PEG hose from the outside. However, they do not offer a permanent seal. 
         [0010]    Disengageable clamping seals are also known, which are generally also referred to as ratchet clamps and can be attached at any location of the PEG hose between the outer retaining plate and the outer end portion. Such a hose clamp is discussed in general terms in DE 100 51 593 A1. Such hose clamps are disadvantageous, however, in that they put great, excessive strain on the PEG hose in the long term and destroy it. When it is squeezed together it is put under excessive strain in the sharply bent corner areas of the hose that are formed at that time, and tends to form tears and, in the long term, to spring a leak. 
       SUMMARY 
       [0011]    Based on this, it is the object of at least some embodiments of the invention to further develop the PEG tube of the type mentioned in the introduction in such a way that a secure seal of the PEG hose is obtained that can be opened and closed any number of times, can be permanently kept in a partially opened position, which is designed in such a way that it can be simply and directly operated only by means of accessories, and therefore not by a patient, and which provides the conditions for configuring the parts of the PEG tube located outside the body in such a way that they are as small and easy to carry as possible. 
         [0012]    This object is achieved by a PEG tube
       with an inner retaining plate,   with a PEG hose having an inner end portion and an outer end portion, the inner end portion being firmly connected to the inner retaining plate and having an inner opening of the PEG hose there,   with an outer retaining plate through which the PEG hose is routed and in which it is fixed,   with a funnel adapter associated with the outer end portion,   with a tightly sealing valve disposed at the outer end portion of the PEG hose, wherein the valve blocks the flow-through through the PEG hose in a closing position, partially unblocks it in an intermediate position, and unblocks it at least over the full cross section of the PEG hose in an opening position, wherein the valve comprises a valve body and a valve housing, the valve body is connected to a handling means accessible from the outside and is mounted in the valve housing so as to be movable between the permanent closing position and the permanent opening position, wherein the handling means has a multi-part configuration, a first part of the handling means is permanently disposed on the valve body and a second part of the handling means is disposed on the funnel adapter separately from the valve and, when the valve and the funnel adapter are plugged together, automatically engages the first part of the handling means, and the second part of the handling means comprises a tool cooperating with a matching tool counterpart of the first part, wherein the PEG hose is located only on an inner side of the valve, the valve is connected on the inner side to the end portion of the PEG hose and has at its other, outer side a coupling portion, the funnel adapter has a coupling counterpart matched to the coupling portion, and that the coupling portion and the coupling counterpart can be mechanically connected to and detached from each other in a tight manner       
 
         [0018]    The valve is disposed directly at the outer end portion of the PEG hose. This valve can be adjusted to any intermediate position between a closing position and an opening position. All end and intermediate positions can be set permanently. At least in the opening position, the valve has a free flow-through cross section that corresponds to that of the PEG hose or is greater. The valve has a handling means; the valve body is moved by the handling means; it can thus be moved back and forth between its two end positions. The movement can be a shifting movement along the longitudinal axis of the PEG hose, a rotary movement about the longitudinal axis of the PEG hose as an axis and a rotary movement transverse to the longitudinal axis and about an axis of the valve body. In the latter case, the advantage is realized that only a rotary movement is required to move the valve body. Thus, sealing from the inside towards the outside is simple. 
         [0019]    The PEG hose is located only on one side of the valve; the funnel adapter is detachably connected to the valve. The funnel adapter is detachably placed and removed at the end of the valve facing away from the PEG hose. A coupling portion is provided on the valve; the funnel adapter has a coupling counterpart. The two coupling portions can be tightly connected to each other and then form a mechanically firm unit. In this way, the funnel adapter, which has an increasing volume over time due to various developments, and also due to a standardization that is to be expected, need not be constantly taken along. It can also be easily replaced with another model, with which medicaments can administered more easily, for example. 
         [0020]    The valve can be cleaned well because its housing is manufactured from at least two sections. If they are separated from each other, the valve body is free and can thus be cleaned. This also applies to the parts of the valve body. In the assembled state of the two sections, they retain the valve body between them, preferably in an elastic manner 
         [0021]    The handling means has a multi-part configuration. In this case, a first part is permanently disposed on the valve body. Without using a tool, however, the valve body cannot be moved with this first part. Only the second part provides the required accessory or tool for being able to move the first part with the valve body located thereon. The second part is disposed on the funnel adapter in such a way that an operation of the valve body is only possible if the funnel adapter is placed on the valve. The connection between the funnel adapter and the valve is configured in such a way that the funnel adapter can only be detached from the valve if the valve is located in the closing position. It is thus ensured that the valve is closed when the funnel adapter is removed. A patient without an accessory is unable to simply open the valve without the funnel adapter. 
         [0022]    When the valve and funnel adapter are plugged together, the second part of the handling means connected to the funnel adapter automatically engages the first part or is coupled with it in another manner, so that the first part can be operated by means of the second part. The second part comprises a tool; the first part has a matching tool counterpart. When the two are engaged, an operation of the valve body is manually possible with simple means. For this purpose, a grip of the second part is manually moved, for example rotated. Without the second part, the valve body can only be moved using special tools and not, in any case, with manual means, for example with the fingers of the patient. 
         [0023]    Preferably, the tool located on the second part of the handling means is guided in a groove when the funnel adapter and the valve are plugged together. This makes a certain alignment of the funnel adapter and the valve relative to one another compulsory; the two can only be plugged together if the tool fits into the groove. When they are pushed together, the groove guides the tool in such a way that the tool engages or is coupled in another manner with the tool counterpart of the first part. A rib may also be provided instead of a groove. It is possible to configure the groove with an inclined portion so that the tool is lifted in the radial direction when the funnel adapter and the valve are joined. Thus, the tool is lifted and can click or latch into the counterpart tool once the final position has been reached. 
         [0024]    In another embodiment, the second part of the handling means is flexibly connected to the funnel adapter, e.g. by a string or a flexible tab. The second part is available if the funnel adapter is in the vicinity, particularly if it is connected to the valve. 
         [0025]    Preferably, the valve body is a geometrically simple item. Spherical valve bodies, conical or cylindrical valve bodies and disk-shaped valve bodies suggest themselves. 
         [0026]    In any case, the valve is connected on one side to the PEG hose. Compression fittings as they are known from the prior art can be used for connecting the valve and the PEG hose, see, for example US 2006/0079850 A1, which, however, does not show a clamping union nut. 
     
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         [0027]    Other advantages and features of the invention become apparent from the other claims as well as from the following description of exemplary embodiments of the invention, which are to be understood not to be limiting and which will be explained below in more detail with reference to the drawing. In the drawing: 
           [0028]      FIG. 1  shows a perspective illustration of a PEG tube according to a first exemplary embodiment, 
           [0029]      FIG. 2  shows an axial sectional view through a valve with a two-part valve housing, 
           [0030]      FIG. 3  shows a top view of a valve that can be coupled to a funnel adapter, 
           [0031]      FIG. 4  shows a top view of a funnel adapter that matches the valve according to  FIG. 3  and that can be connected with it, 
           [0032]      FIG. 5  shows a section through the valve according to  FIG. 3  along the section line V-V, 
           [0033]      FIG. 6  shows a sectional view through the funnel adapter according to  FIG. 4  along the section line VI-VI in  FIG. 4 , and 
           [0034]      FIG. 7  shows a schematic view of a valve and a funnel adapter that can be coupled to it; a tab on which a second part of the handling means is flexibly disposed is provided on the funnel adapter. 
       
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
       [0035]      FIG. 1  shows a first exemplary embodiment.  FIG. 2  shows a second exemplary embodiment,  FIGS. 3 to 6  show a third exemplary embodiment, and a fourth exemplary embodiment is shown in  FIG. 7 . Only the first exemplary embodiment shows an entire PEG tube; the other exemplary embodiments show parts thereof. 
         [0036]    From  FIG. 1 , a PEG tube with an inner retaining plate  20  is apparent, which is also referred to as “bumper”. A PEG hose  22  is firmly connected to it. The PEG hose  22  has an inner end portion  24  and an outer end portion  26 . The inner end portion  24  is firmly connected to the inner retaining plate  20  and has an inner opening  28 . From that, a substance can be introduced into a stomach (not shown, see U.S. Pat. No. 4,666,433 A,  FIG. 3 ), e.g. for feeding or treatment with medicaments. A hose according to the prior art is used as a PEG hose  22 . It is preferably as transparent as glass, flexible, and has a free internal cross section of 2 to 5 mm; the cross section is round. 
         [0037]    Furthermore, the PEG tube comprises an outer retaining plate  30 . The PEG hose  22  is routed through that. It is fixed in the outer retaining plate  30 ; in this case, it may be positioned at any location by means of a clamping device of the outer retaining plate  30 . This is the prior art. In this manner, the distance between the inner retaining plate  20  and the outer retaining plate  30  can be adjusted to the respective patient. 
         [0038]    Finally, the PEG tube has a funnel adapter  32  at the outer end portion  26 . In the exemplary embodiment shown, it is connected to the outer end portion  26  by means of a compression fitting. The funnel adapter  32  shown is the prior art. It comprises a sealing cap. 
         [0039]    A valve  34  is located in the PEG hose  22 ; it is disposed between the outer retaining plate  30  and the outer end portion  26 . In this case, a piece of the PEG hose  22  is located on both sides of the valve  34 . The valve  34  is connected on each of both sides to the adjacent piece of PEG hose  22 , for example by means of a compression fitting as it is used for the funnel adapter  32 . 
         [0040]    The valve  34  has a two-part valve housing  36 , i.e. a first section  38  and a second section  40 . Furthermore, it comprises a handling means  42 , which is configured as a circular disk with an operating slot  44  in the exemplary embodiment shown. It is located between the two sections  38 ,  40 . 
         [0041]      FIG. 2  shows in a sectional view a valve  34  as it can be used in the PEG tube according to  FIG. 1 . In turn, the valve  34  has a two-part valve housing  36  with a first section  38  and a second section  40 , which are tightly connected in the state shown; they are mechanically connected to each other. This is done by suitable means as they are known from the prior art, for example by means of a plugging or latching connection. Each section  38 ,  40  has on its outer side a conical region; there, the PEG hose  22  can be pushed on. It is retained by means of suitable devices as they are formed, for example, on the funnel adapter  32 . In particular, this is done by means of a union nut  41 . 
         [0042]    Between them, the two sections  38 ,  40  define a spherical cavity filled by a valve body  46  in the shape of a sphere with a diametral bore  48 . This valve body  46  is connected to a short cylindrical portion that extends radially and is part of a handling means  42 , which furthermore has a disk that is located outside the two sections  38 ,  40  and in which an operating slot  44  is provided. The valve  34  according to  FIG. 2  is shown in the blocking state. It can be seen that the diameter of the bore  48  corresponds to the diameter of passages in the two sections  38 ,  40 . If the valve body  46  is pivoted by 90° about an axis situated in the paper plane by means of the handling means  42 , a continuous channel with a constant cross section is formed. 
         [0043]    The valve according to  FIG. 2  can be cleaned by separating the two sections  38 ,  40  from each other. Then, the valve body  46 , together with the handling means  42  connected therewith, is free; it can be cleaned just like the sections  38 ,  40 . 
         [0044]    In the third exemplary embodiment according to the  FIGS. 3 to 6 , and also in the fourth exemplary embodiment according to  FIG. 7 , the PEG hose  22  is located on only one side, namely the left side of the valve  34  in the drawing. One coupling portion  50 , respectively, is provided on the other side of the valve  34 . It cooperates with a coupling counterpart  52  formed on the funnel adapter  32 . In the third exemplary embodiment, the funnel adapter forms a sleeve which reaches over the cylindrical outer shell of the valve  34  in the plugged-together state of the valve  34  and the funnel adapter  32 . A collar  56  is provided which radially protrudes all around from the outer shell and is located in the vicinity of a free front edge of the sleeve  54  if the valve  34  and the funnel adapter  32  are plugged together. A collar can be omitted. Particularly if the sleeve  54  is made to be so long in its free inner space that it reaches over the valve housing  36  in its entirety. 
         [0045]    In turn, the valve body  46  is formed by a sphere. Similar to the second exemplary embodiment according to  FIG. 2 , it is connected to a handling means  42 . 
         [0046]    In the third and fourth exemplary embodiments, the handling means  42  is configure of two parts. A first part  58  of the handling means  42  is permanently connected to the valve body  46 , just as in the second exemplary embodiment. This first part  58  is sufficient for operating the valve body  46  if one has a suitable tool. This suitable tool is formed by a second part  60  of the handling means  42 . In principle, however, the valve  34  could also already be operated without this second part. The intention is that the first part has an operating slot  44  or a depression, a projection or a hole pattern, i.e. an key arrangement for operation, whereby it is necessary that the first part  58  can be moved only by means of a matching, special tool. In no case should the first part  58  be operable only by means of the fingers. The key arrangement, and also the effort, required for operating the valve body  46  are set such that a patient is not able to operate the valve  34  with means normally available to him 
         [0047]    The valve  34  can be operated manually and without any other tools if the second part  60  cooperates with the first part  58 . This takes place when, in the third exemplary embodiment, the funnel adapter  32  and the valve  34  are pushed together in the direction of the arrow  62  up to the stop. The second part  60  is rotatably mounted in the sleeve  54 . It is rotatable about a radial axis. It forms a tool on its lower edge, e.g. a rib  64 , which can also be described as a blade. The narrow rib  64  protrudes into the free cavity of the sleeve  54 , as can also be seen in  FIG. 6 . 
         [0048]    During the plugging process in the direction of the arrow  62 , the rib  64  ends up in a furrow  66  in the valve body  46  and then in the operating slot  44  of the first part  58 . In the fully plugged-together state, it is no longer situated in the furrow  66 , but only in the operating slot  44 . If the second part  60  is now rotated, the first part  58  also rotates with it, and accordingly, also the valve body  46 . 
         [0049]    In the position shown in the  FIGS. 3 and 5 , the valve body  46  is in the closing state; the passage through the valve housing  36  is fully blocked. In this state, it is possible to pull off the funnel adapter  32  from the valve  34  in the direction opposite to the arrow  62 . In any other rotational position, even in an intermediate position, this is not possible. 
         [0050]    If a patient twists the first part  58  or the second part  60  starting from the above-mentioned position, it is not possible to plug them together in the direction of the arrow  62 . This is possible only when the two parts  58 ,  60  are in the state in which they are shown in the  FIGS. 3 to 6 . 
         [0051]      FIGS. 4 and 6  show a grip of the second part  60  orientated in the axial direction. This grip should better be disposed twisted by 90° about the rotary axis of the second part  60  in order to directly show the state of the valve body  46 . In the transverse position of this grip, the valve is closed. In the longitudinal position, as shown in  FIG. 4 , but in contrast to this Figure, the valve  34  is opened. 
         [0052]    Other configurations are possible. For example, a tool in the shape of a polygon can replace the rib  64 , which protrudes in a pin-shaped manner The furrow  66  can be configured in a rising manner, so that the polygon is lifted and arrives on the top side of the first part  58 . When the process of pushing together is continued, it then drops into a recess that corresponds to the polygon and replaces the operating slot  44 . The second part  60  has to be pulled up during detachment. 
         [0053]    Finally,  FIG. 7  shows an exemplary embodiment in which the plugging process of the funnel adapter  32  and the valve  34  and the joining of the first part  58  and the second part  60  of the handling means  42  do not take place simultaneously and are independent of one another. The second part  60  is now disposed on a flexible tab  68  that is firmly connected to the funnel adapter  32 . The second part  60  is attached to the free end of the tab. It has a gripping portion and, on the other side of the tab, a tool that corresponds to the rib  64 , for example in the shape of a tool or key in an arbitrary form. A fitting recess  70  replacing the operating slot  44  is provided in the first part  58 . The tool is pushed into the recess  70 ; then, the valve body  46  can be operated by means of the gripping portion. 
         [0054]    The PEG tube comprises a PEG hose  22 , an outer retaining plate  30  through which the PEG hose  22  is routed and in which it is fixed, and a funnel adapter  32  associated with the outer end portion  26  of the PEG hose  22 . A tightly sealing valve  34  is disposed either in the PEG hose  22  between the outer retaining plate  30  and the outer end portion  26  or at the outer end portion  26  of the PEG hose  22 . In a closing position, the valve  34  blocks the flow-through through the PEG hose  22 , and in an opening position unblocks it at least over the full cross section of the PEG hose  22 . The valve  34  comprises a valve body  46  and a valve housing  36 . The valve body  46  is connected to a handling means  42  accessible from the outside and is movable; it is mounted in the valve housing  36 . Preferably, the handling means  42  comprises an operating slot or a corresponding projection or a corresponding depression that permit an operation by means of a matching separate tool, but not by means of human fingers or a simple accessory.