Abstract:
An apparatus for treating a tennis elbow by percutaneous intervention, includes:
       a body having an actuating element,   a fixing part arranged to fixably position the body,   a positioning device connected to the body, including a positioning part moveable by the actuating element,   a holder releasably connected to the positioning part, and including a top part for the releasable connection to the positioning part and a bottom part defining a support surface for supporting an elbow tendon region of a person to be treated, the support surface, the top and bottom parts being connected by one or more connecting members, the holder including a holder part with a number of penetration elements arranged thereon, wherein the top and bottom parts are spaced-apart at such a distance that, before penetration of the elbow tendon, the penetration tips of the penetration elements are covered by the bottom part.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to an apparatus for treating a tennis elbow by means of percutaneous intervention. 
       BACKGROUND OF THE INVENTION 
       [0002]    Approximately 1-3% of the general population is affected by a tennis elbow. In particular the age group between 35-54 years of age suffers from this complaint, with men and women both being affected to the same degree by this medical condition. Contrary to popular belief, a tennis elbow is not usually caused by playing tennis This cause only accounts for 5-10% of patients. 
         [0003]    It is known that a tennis elbow (medical term: epicondylitis lateralis) involves a degeneration of the tendon of the muscle known as “musculus extensor carpi radialis brevis” (ECRB). 
         [0004]    The object of treating a tennis elbow is to alleviate the pain in the elbow and to return the elbow to its normal function as soon as possible. To this day, it is not known which type of treatment is most effective. The most commonly used treatments of a tennis elbow are: physiotherapy, a brace, immobilisation by putting the elbow in plaster, surgery during which cuts are made in the affected tendon, and percutaneous interventions. The latter treatment is discussed in more detail below. 
         [0005]    In medical practice, it has been found that a treatment of the affected tendon in the case of a tennis elbow by means of various manual penetration operations of this tendon by means of a penetration means can be effective. Whether this so-called “percutaneous intervention” is more effective than surgery is not known, but it is less invasive which means that the patient can resume his/her activities after such an intervention much sooner than after surgery. These penetrations often are combined with injection of for instance corticosteroids, blood platelets, autologous blood, dextrose or hyaluronic acid. 
         [0006]    However, with a percutaneous intervention, it is a problem to determine the exact position of the needle with respect to the patient, in order to ensure that the correct tissue is pierced and a correct position of the penetration means with respect to the patient&#39;s arm is achieved. As of yet, this treatment is often performed by hand and without ultrasound guidance. 
         [0007]    In European patent publication EP 2,377,475, by the present applicant, an apparatus for treating tennis elbow is described for carrying out the percutaneous intervention of the elbow tendon in a much more convenient, standardized, fool-proof way. 
         [0008]    From Swiss patent publication CH 396,311 a device is known aimed at stimulating the blood circulation in the skin by stimulating the skin with needles. The device is unsuitable for carrying out a controlled percutaneous intervention, however. 
         [0009]    A drawback of the apparatus of EP 2,377,475 is that the positioning of the penetration means, both before and during penetration, requires a very high degree of accuracy. The known devices leave a lot to be desired in this respect. Another disadvantage of the known devices is that, before or after penetration, unwanted injuries can be sustained due to accidental touching of the sharp tips of the penetration means. 
         [0010]    It is an object of the present invention to provide an apparatus for the treatment of a tennis elbow by means of percutaneous intervention, wherein a very high degree of accuracy is provided when positioning the penetration means, both before and during penetration. A further object of the invention is to provide an abovementioned apparatus, wherein unwanted injuries, before or after penetration, due to accidental touching of the tips of the penetration means are prevented. 
       SUMMARY OF THE INVENTION 
       [0011]    To this end, the apparatus according to the invention comprises:
       a body having an actuating means for operating the apparatus,   a fixing part arranged to fixably position the apparatus body with respect to its surroundings,   a positioning device connected to the body, comprising a positioning part moveable upon actuation of the actuating means,   a holder releasably connected to the positioning part of the positioning device, wherein the holder comprises a top part for the releasable connection to the positioning part and a bottom part defining a support surface for being supported on an elbow tendon region of a person to be treated, the support surface during use at least partially extending along the elbow tendon region, the top part and the bottom part being spaced-apart and being connected by one or more connecting members, wherein the holder comprises a holder part with a number of penetration means arranged thereon in a pattern, wherein the top part and the bottom part are spaced-apart at such a distance that, before penetration of the elbow tendon, the penetration tips of the penetration means are covered by the bottom part,   the holder part being moveable along the connecting members upon actuation of the actuating means, in the direction of the bottom part, wherein the connecting members act as guidance members for the holder part, such that the penetration means are controllably moved towards the elbow tendon region for penetration of the elbow tendon.       
 
         [0017]    By providing the holder with the above connecting members, the penetration means can be conveniently and controllably guided towards the bottom part and eventually the elbow tendon to be penetrated. The bottom part, suitable for being supported on the elbow tendon region and partially extending along the elbow tendon region, i.e. along the skin surface directly above the elbow tendon, provides further steady support during penetration. Furthermore, due to the top part and the bottom part being spaced-apart at such a distance that the penetration tips of the penetration means are covered by the bottom part, unwanted injuries due to accidental touching of the sharp tips of the penetration means are prevented. In the context of this patent application, the covering of the penetration means by the bottom part after penetration may be referred to as ‘recapping’. 
         [0018]    In an embodiment, the apparatus is provided with the bottom part of the holder comprising a number of through-openings, matching the pattern, for allowing the penetration means to pass there through during penetration. This provides even better stability and guidance of the penetration means during penetration. 
         [0019]    Moreover, the apparatus can be provided with the holder part and the top part being fixedly connected to each other and the top part being slideably arranged on the connecting members near an upper end of the connecting members and a lower end of the connecting members is fixedly connected to the bottom part, wherein the positioning part, the top part and the holder are slid towards the bottom part upon actuation of the actuating means. 
         [0020]    In an embodiment of the invention, the positioning part comprises a height adjustment device for adjusting the penetration depth of the penetration means with respect to the bottom part and the elbow tendon region, prior to operation of the actuating means. Thus, the penetration depth of the subsequent penetration can be set with a very high level of accuracy. 
         [0021]    To this end, the height adjustment device can comprise a height adjustment screw, having a head part and a threaded part, a lower end of the threaded part being connected to the upper end of one of the connecting members, the threaded part being aligned with the connecting member with its screw axis, such that the positioning part can slide along the threaded part and the connecting member in a single sliding movement, the thread of the threaded part engaging the positioning part, wherein, before operation of the actuating means, upon downward adjustment of the head part of the height adjustment screw, the penetration depth is decreased, due to the stroke of the sliding movement becoming shorter, whereas upon upward adjustment of the head of the height adjustment screw, the penetration depth is increased, due to the stroke of the sliding movement becoming longer. 
         [0022]    An embodiment relates to an abovementioned apparatus, wherein the positioning part further comprises a suspension device connected to the positioning part on the one hand and one of the connecting members on the other hand for damping sudden movements of the connecting member. This is especially useful for instance when a patient moves his arm against the bottom plate by accident. 
         [0023]    An embodiment relates to an abovementioned apparatus, wherein the holder part comprises one or more openings fluidly connected to one or more channels inside the holder part, the one or more channels being in fluid connection to a top part of the penetration means for allowing the injection of a fluid via the openings through the penetration means into the elbow tendon. Thus, during penetration, medications in fluid form can be injected into the elbow tendon. 
         [0024]    An embodiment relates to an abovementioned apparatus, wherein an upper surface of the top part and a lower surface of the bottom part of the holder comprise a sealing protecting film. In this manner, the holder can be kept safe and clean from dirt. Furthermore, the film can be used for initial connection of the top plate to an upper part of a connecting member. Upon removal of the film, a sliding movement of the top part along the connecting member can be realized. 
         [0025]    Another aspect of the invention concerns a holder suitable for releasable connection to the positioning part of the positioning device of the apparatus according to any one of the preceding claims, wherein the holder comprises a top part for the releasable connection to the positioning part and a bottom part defining a support surface for being supported on an elbow tendon region of a person to be treated, the support surface during use at least partially extending along the elbow tendon region, the top part and the bottom part being spaced-apart and being connected by one or more connecting members, wherein the holder comprises a holder part with a number of penetration means arranged thereon in a pattern, the holder part being moveable along the connecting members upon actuation of the actuating means, in the direction of the bottom part, wherein the connecting members act as guidance members for the holder part, such that the penetration means are controllably moved towards the elbow tendon region for penetration of the elbow tendon. 
         [0026]    An embodiment relates to an abovementioned holder, wherein the holder part comprises one or more openings fluidly connected to one or more channels inside the holder part, the one or more channels being in fluid connection to a top part of the penetration means for allowing the injection of a fluid via the openings through the penetration means into the elbow tendon. 
         [0027]    An embodiment relates to an abovementioned holder, wherein an upper surface of the top part or a lower surface of the bottom part of the holder comprise a sealing protecting film. 
         [0028]    Other aspects, features and details of the present invention will be readily understood by reference to the following detailed description of preferred embodiments of the apparatus and holder according to the invention, taken in conjunction with the drawings. 
     
    
     
       DETAILED DESCRIPTION 
         [0029]    The invention will be explained in more detail with reference to one or more embodiments by means of figures, in which: 
           [0030]      FIG. 1  shows a perspective view of an embodiment of an apparatus according to the invention in cross-section of, 
           [0031]      FIG. 2  shows a perspective view of an embodiment of a holder according to the invention, 
           [0032]      FIG. 3   a  shows a perspective bottom view of an embodiment of a positioning device according to the invention having a first and a second connecting plate in assembled state, and 
           [0033]      FIG. 3   b  shows a perspective view of n embodiment of a positioning device to the invention, wherein the second connecting plate is removed. 
       
    
    
       [0034]      FIG. 1  shows a perspective view of an apparatus according to the invention in cross-section, i.e. a cross-section along a vertical plane. In  FIG. 1  the apparatus  1  comprises an apparatus body  2  with a coupling part  3  which connects a vertical fixing rod  6  and a pair of horizontal rods  7  arranged perpendicular to the fixing rod  6 . The fixing rod  6  connects the apparatus  1  to its surroundings such as a treatment table  5 , or the like. Alternatively, the fixing rod  6  can be embodied to be connected to a wall in the treatment space. The coupling part  3  allows rotation of the rods  7  in a plane perpendicular to the fixing rod  6 . Of course, the coupling part  3  may be further adapted to provide height adjustment or rotation of the rods  7  in a vertical plane. Other translational or rotating movements are also conceivable for the coupling part  3 . One end of the rods  7  is connected to the coupling part  3  while an opposing end is connected to a mounting block  23 . A handle  4  is hingeably attached to the mounting block  23 . The handle  4  is rotatable in a vertical plane. As shown, it is conceivable to attach the handle  4  to the respective opposing end of one of the rods  7 . If desired, the rod  7  may rotate along with the handle  4  movement. The rods  6 ,  7  preferably have a circular cross-section. In a preferred embodiment, the construction with the fixing rod  6 , the coupling part  3  and the rods  7  is fully symmetrical with respect to the vertical cross-sectional plane. 
         [0035]    Preferably, the patient&#39;s arm is received in a special frame or plate arranged on the table  5  to allow the patient&#39;s arm to remain static during penetration. 
         [0036]    As stated,  FIG. 1  shows the handle  4  being mounted on a mounting block  23  extending. By means of example, the mounting block  23  may have a cubic, trapezoidal or similar shape. As illustrated, the mounting block  23  has a rear portion having a pair of horizontal through-holes the ends of the rods  7  are positioned. The handle  4  can be an L-shaped handle  4  wherein the short part of the ‘L’ is rotatably connected to one end of one of the horizontal rods  7 , while the long part of the ‘L’ can be grabbed by a person&#39;s hand for pushing or pulling. The length ratio of the short part versus the long part may for instance be 1:3-1:4. Thus, sufficient torque and, more importantly, downwards force is provided for penetrating the patient&#39;s elbow tendon (region) when pushing the handle  4  in a downwards direction. The above ratios also cause the amount of torque and downwards force to be well-controllable. 
         [0037]    As can be seen, the long part of the ‘L’ comprises a groove  31  extending along its downward edge. The groove  31  has a length of approximately ¼-½, such as ⅓, of the length of the long part. An upper end of a vertical, elongated force transfer member  19  is slideably arranged in the groove  31 . The force transfer member  19  is vertically slideably arranged in the mounting block  23 . The upper end of the force transfer member  19  projects from an upper surface of the mounting block  23 . The length of the force transfer member  19  and the length of the groove  31 , with which the force transfer member  19  cooperates, are preferably designed in such a way as to control and limit the downward movement of the handle  4  (and ultimately the vertical stroke of the penetration means, which will be explained later) when pushed downwards. In a preferred embodiment, a pair of such force transfer members  19  can be provided, each force transfer member  19  being arranged near a corner of the mounting block  23 , i.e. each on one side of the cross-sectional plane as to achieve a symmetrical force transfer arrangement. The top ends of the pair of force transfer members  19  can be connected by a horizontally arranged, elongated member (not shown) that receives the force from the handle  4  and transfers the force to the two force transfer members  19  to obtain an even force distribution. Preferably, the elongated member has a cylindrical shape. The design of the groove  31  is to be adapted accordingly. 
         [0038]    In the exemplary embodiment of  FIG. 1 , the mounting block  23  is connected to a positioning device comprising a positioning block  8  by means of a pair of retaining means (of which only one is shown since  FIG. 1  shows a cross-section) embodied as spring members  32 , provided at each side of the force transfer member  19 . The spring members  32  each comprise a central, vertical part, protruding through the mounting block  23  in downwards direction and connecting to the positioning block  8 . The outer part of the central, vertical part is provided with a coil spring extending downwards along the central, vertical part and arranged between a top part of the central part and the upper surface of the mounting block  23 . The spring members  32  allow the positioning block  8  to move downwards with respect to the mounting block  23 . With increasing downwards movement/stroke, the spring force will increase, causing the positioning block  8  to have an increasing ‘urge’ to move upwards back to the mounting block  23 . The spring tension of the spring members  32  is preferably adjustable, e.g. by adjusting the vertical position of the top part of the central part with respect to the mounting block  23 . 
         [0039]    The positioning block  8  comprises several vertical through-holes in which further devices, parts or equipment can be inserted, for instance to cooperate with the holder  10  arranged at a lower side of the positioning block  8 . As illustrated, one of the through-holes of the positioning block  8  is provided with a height adjustment device  18 . The respective through-hole has a sideways opening such that the height adjustment device  18  can be manipulated or otherwise operated. The height adjustment device  18  comprises a threaded part being inserted into the mentioned through-hole of the positioning block  8 , while the top part or head part has a serrated outer surface for providing better rip upon rotation of the head part, as best seen in  FIGS. 3   a  and  3   b . The head part functions as a travel limiter for the sliding movement and thus the penetration depth, i.e. blocks the positioning block  8  from moving further upwards along the connection member  16  and the threaded part of the height adjustment device  18  when the desired penetration depth is achieved. 
         [0040]    Moreover, next to the longitudinal aperture wherein the height adjustment device  18  is located, the positioning device  8  is provided with height indication marks  33  along one of its external side walls. 
         [0041]    The positioning block  8  further comprises a suspension device  20  located in one of its through holes. As illustrated, the suspension device  20  comprises an elongated rod  34  having a spring element  36  arranged along its outer surface  34 , and a closing element  35  in a form of a screw nut. The suspension device  20  dampens movements of a bottom part (end cap)  12  of the holder  10  with respect to the positioning block  8 , in vertical direction (for instance when the patient accidentally bumps upwards against the bottom plate  12  with his or her arm). 
         [0042]    Furthermore, the embodiment of the apparatus illustrated in  FIG. 1  comprises a holder  10  which is releasably connected to the positioning block  8 . As shown, the holder  10  comprises a top part  10  and a bottom part  12  being connected to each other by means of a couple of connecting members  16  in the form of rods. A holder part  13  is connected to the lower surface of the top part  11 . The holder part  13  comprises a number of penetration means  14  in the form of needles  14  arranged in a pattern, such as in a number of rows, for instance 2 or 3 rows of 4 or 5 needles each. The needles can be arranged with their upper ends in a solid, preferably block-shaped element, for instance made of plastic. The holder part  13  further comprises a number of (sideways) openings  30  which connect to internal holder channels, which in turn are in fluid connection to the needles  14  and their (hollow) penetration tips. A syringe can for instance be plugged into the openings  30  for injecting medications, such as steroids, pain killers, anti-inflammatories, et cetera. However, it is conceivable that only one opening  30  will actually be used for receiving a syringe, whereas the other openings are closed-off. Thus, sufficient build-up of fluid pressure is achieved within the internal holder channels. Optionally, the internal holder channels are aligned with and fluidly connected to one or more of the openings  30  to allow both the respective internal holder channel and the respective opening to be drilled in a single drilling action. 
         [0043]    The bottom part  12  of the holder  10  has the form of a (bottom) plate  12  comprising a number of openings  15  matching the pattern of the needles  14  for allowing the needles  14  to pass through the openings  15  during penetration of an elbow tendon underneath the bottom plate  12 . It should be noted that before use, i.e. before the holder  10  is installed in the positioning block  8 , the upper ends of the connecting members  16  are fixedly connected to the top plate  11 , e.g. via the use of a sticky foil or film arranged over the top surface of the top plate  11 . The lower ends of the connecting members  16  are fixedly attached to the bottom plate  12 , before as well as during use. 
         [0044]    During use (for instance after removing the aforementioned sticky foil), the top plate  11  and the rest of the holder  10  can slide in vertical direction along the connecting members  16 . It should furthermore be noted that the aforementioned suspension device  20  as well as the height adjustment device  18  are vertically aligned with both connecting members  16  to facilitate the sliding movement. Furthermore, at the respective contact points between the upper parts of the connecting members  16  and the lower ends of both the suspension device  20  and the height adjustment device  18 , the positioning block  8 , both the connecting members  16 , the suspension device  20  and the height adjustment device  18  are designed in such a way (especially with respect to their diameter) that the holder  10  (especially the top plate  11 ) can effortlessly slide up and down along the connecting members  16  past the contact points. 
         [0045]    The holder  10  is releasably connected to the positioning block  8  by means of a first connecting plate  24  and a second connecting plate  25  which can be best illustrated and explained with reference to  FIGS. 3   a  and  3   b.    
         [0046]      FIG. 2  shows the holder  10  according to the invention in detail, wherein the top and bottom plates  11 ,  12  comprise a sealing protecting film  38  for protecting the exposed surfaces of the plates  11 ,  12  before the use of the holder  10 . As illustrated, the sealing protecting film  38  comprises a protruding tap for easy removal of said sealing protecting film  38 . As can be seen, the top plate  11  comprises a top surface having a symmetrical structure, with a rectangular shape and rounded corners. On both sides of the longitudinal edges of the top plate  11 , a groove  28  can be found. Advantageously, the top surface may be provided with a pair of breaking lines  39 . After use of the holder  10 , the holder  10  can only be removed from the connecting plate  24  by breaking the top plate  11 , along one end of the top plate  11 , along the respective breaking line  39 . In this way, accidental re-use is prevented. Of course, other options are also conceivable, such as causing the bottom plate  12  to ‘lock’ after the penetration. In a preferred embodiment, the bottom plate  12  is provided with an additional blocking plate  41 , having a base plate  43  connected to the bottom plate  12  and/or the connecting members  16 , and extending in the same plane as the bottom plate  12 . The opposing horizontal ends of the base plate  43  are provided with foldable parts  42 , foldable around a horizontal axis. In a first (inward) folding position I, the foldable parts  42  prevent the holder  10  from moving downwards as the free ends of the foldable parts  42  block such movement. In a second (outward) folding position II, the holder  10  can move up and down freely. The second folding position II will be the default position when the penetration is carried out. After the penetration, the foldable parts  42  will be folded to the first position I to block further movement of the holder  10 . Thus, re-use is prevented and the penetration means or needles  14  are ‘recapped’ preventing injuries from occurring due to accidental touching of the needle tips. 
         [0047]    On the bottom plate  12 , another sealing protecting film  38  is provided, which can be removed before or after connecting the holder  10  to the positioning block  8  of the apparatus  1 . When the user sees that a certain holder  10  does not comprise the sealing protecting film  38 , the user knows (in a visual way) that the holder  10  has already been used before. 
         [0048]    The top plate  11  further comprises a series of openings  40  in which the connecting members  16  are slideably arranged (provided the foil  38  is removed). As illustrated, the connecting members  16  comprise a bolt head having a hexagonal cross-section. Moreover, the holder part  13  as shown comprises a number of openings  29  which are meant to inject fluids that can be provided via the needles  14  when treating the elbow tendon of a patient. 
         [0049]    In the illustrated exemplary embodiment, the bottom plate  12  comprises openings  15  matching the pattern of the needles  14 . The openings  15  can act as guiding mechanism for guiding the needles through them. The shape of the openings  15  may advantageously correspond to the length and/or width of a row of needles. E.g. when using 3 rows of 4 needles, there may be 3 (parallel, elongated) openings  15 , each opening  15  having a length of approximately the distance between the first and last needle in the row. Therein, the surface area affected by the needles/penetration means may advantageously have dimensions of 5-20 mm, such as 8-15 mm, by 20-30 mm to treat a tendon area large enough for effectively inciting the tendon to heal. The dimensions of the bottom plate  12  are, for example, set to a length of about 5-15 cm, such as 10 cm and a width of 2-7 cm, such as 5 cm, with the thickness being less important. It should be noted that the thickness is primarily important for giving the bottom plate  12  sufficient stiffness. 
         [0050]      FIG. 3   a  shows a perspective bottom view of the positioning block  8  having the first connecting plate  24  and the second connecting plate  25  in assembled state. The first connecting plate  24  is sandwiched in-between the second connecting plate  25  and the lower surface of the positioning block  8 . Both connecting plates  24 ,  25  have a U-shape. As illustrated, a pair of opposing spring locking elements  26  protrude inward from the inside of the U&#39;s legs (of the first connecting plate  24 ) to engage the grooves  28  of the top plate  11 , as to retain the holder  10  for performing the percutaneous intervention. The holder  10  can not be removed without breaking the top plate  11  along the respective breaking line  39 . The base part of the U-shape of the first connecting plate  24  is provided with a spring element  27  to provide spring counter-pressure when sliding the top plate  11  into the U-shaped connecting plate  24 . 
         [0051]      FIG. 3   b  shows a perspective bottom view of the positioning block  8  of  FIG. 3   a  wherein the second connecting plate  25  is removed for clarity. 
         [0052]    Thus, the invention has been described by reference to the embodiments discussed above. It will be recognized that these embodiments are susceptible to various modifications and alternative forms well known to those of skill in the art without departing from the spirit and scope of the invention. Accordingly, although specific embodiments have been described, these are examples only and are not limiting upon the scope of the invention. 
       REFERENCE NUMERALS 
       [0053]      1 . Apparatus 
         [0054]      2 . Apparatus body 
         [0055]      3 . Connector part 
         [0056]      4 . Handle 
         [0057]      5 . Treatment table 
         [0058]      6 . — 
         [0059]      7 . Horizontal rod 
         [0060]      8 . Positioning device 
         [0061]      9 . — 
         [0062]      10 . Holder 
         [0063]      11 . Top part 
         [0064]      12 . Bottom part 
         [0065]      13 . Holder part 
         [0066]      14 . Penetration means 
         [0067]      15 . Openings 
         [0068]      16 . Connecting members 
         [0069]      17 . — 
         [0070]      18 . Height adjustment device 
         [0071]      19 . Force transfer member 
         [0072]      20 . Suspension device 
         [0073]      21 . — 
         [0074]      22 . — 
         [0075]      23 . Mounting block 
         [0076]      24 . First connecting plate 
         [0077]      25 . Second connecting plate 
         [0078]      26 . Spring locking element 
         [0079]      27 . Spring element 
         [0080]      28 . Groove section 
         [0081]      29 . Openings 
         [0082]      30 . Channels 
         [0083]      31 . Groove 
         [0084]      32 . Threaded screw 
         [0085]      33 . Serrated marks 
         [0086]      34 . Rod 
         [0087]      35 . Closing element 
         [0088]      36 . Spring element 
         [0089]      37 . — 
         [0090]      38 . Sealing protecting film 
         [0091]      39 . — 
         [0092]      40 . Openings 
         [0093]      41 . Blocking plate 
         [0094]      42 . Foldable part of blocking plate 
         [0095]      43 . Base part of blocking plate