Patent Publication Number: US-2022211535-A1

Title: Patient immobilization device, system and method for immobilizing a patient

Description:
The invention relates to a patient immobilization device and also to a system and a method for immobilizing a patient, in particular while a medical procedure is being carried out. 
     PRIOR ART 
     In many medical procedures, it is necessary that a patient does not move a part of the body on which the medical procedure is being carried out. Medical procedures that require immobilization of the patient include, for example, diagnostic and therapeutic radiology, radiation therapy, operative/surgical procedures, and pre- or post-operative care. 
     In the applicant&#39;s published patent application US 2017/0246024 A1, the disclosure of which is hereby incorporated by reference in its entirety, a simple device for immobilizing the human body or parts of the body is disclosed. The device has at least one immobilizing element that can be positioned on the body surface. The immobilizing element consists of a bonded, nonwoven fabric that can be fastened using a micro-hook and loop fastener. 
     The object of the invention is to make available an improved patient immobilization device in conjunction with a system and a method that allows even simpler and more flexible handling. 
     DISCLOSURE OF THE INVENTION 
     An improved patient immobilization device comprises a planar element made of nonwoven fabric. The planar element has an elongate middle part and a multiplicity of arms which extend laterally on both sides from the middle part. A particularly flexible and, if necessary, large-area immobilization of patients and parts of their body is made possible using a plurality of arms. A plurality or multiplicity of arms is to be understood here as numbering at least two arms on both sides of the middle part. 
     The patient immobilization device can be made available to the end user particularly advantageously in a folded state. In the folded state, each of the arms is folded laterally onto the elongate middle part. Parts of the elongate middle part, with the arms folded laterally thereon, are moreover preferably folded onto one another in the longitudinal direction. In addition, each arm can preferably also be folded laterally onto itself before being folded laterally onto the elongate middle part. Overall, the various folding options result in a compact package that is easy to handle even for large-area uses. 
     A system for immobilizing a patient comprises the patient immobilization device and a multiplicity of micro-hook fastening elements which are fastenable to the sides of a patient table. One or more arms of the patient immobilization device can be held by micro-hooks which are arranged on parts of the micro-hook fastening elements. 
     The micro-hook fastening elements preferably comprise a plate-shaped part with a multiplicity of micro-hooks arranged thereon. The micro-hook fastening element moreover comprises an upper web and a lower web. The upper web and the lower web are configured and spaced apart such that a rail of a patient table can be clamped between them. The lower web can include a channel, which is configured such that it receives a lower part of the rail of the patient table, and also a deformable rubber strip which is arranged in the channel. 
     In an advantageous development of the system according to the invention, provision is made that disposable patches can be arranged between the patient immobilization device and the micro-hook fastening elements. The disposable patches have fabric loops on the inner face and micro-hooks on the outer face. The disposable patches can be used in a sandwich structure between the micro-hook fastening elements and the planar element of nonwoven fabric of the patient immobilization device. 
     An alternative micro-hook fastening element comprises a keder cord and a micro-hook patch wrapped around the keder cord. The keder cord can have a lower part with a cross-sectional diameter greater than the diameter of a keder rail slot of a patient table, and an upper part with a width that is smaller than the diameter of the keder rail slot of the patient table. The upper part of the keder cord can optionally be bent between 45 and 90 degrees in its region guided through the keder rail slot. 
     Each of the micro-hook fastening elements can be provided with a removable disposable patch that engages in the micro-hooks of the micro-hook fastening elements. The removable disposable patch can be provided in order to protect the micro-hooks before use or to prevent direct contact between the micro-hooks and the patient. 
     A method for securing a patient on a patient table can be based on the provision of the patient immobilization device. The patient immobilization device is placed onto the patient, and two or more arms of the patient immobilization device are fastened to micro-hook fastening elements on opposite sides of the patient table. The method can moreover include selectively removing a part of the patient immobilization device in order to create an access opening for performing a medical intervention on the patient. For this purpose, the patient immobilization device preferably has perforations at which individual arms and/or parts of the middle part can be completely or partially separated. 
     The following detailed description of the invention is of a purely illustrative nature and is not intended to limit the invention or the application and uses of the invention. There is also no intention to be bound to a theory presented in the preceding background of the invention or in the following detailed description of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows a flat view of a patient immobilization device, 
         FIG. 2  shows the folding-up of a patient immobilization device according to  FIG. 1 , 
         FIG. 3  shows the patient immobilization device according to  FIGS. 1 and 2  in the folded state, 
         FIG. 4  shows the patient immobilization device from  FIG. 1  in use on a patient lying on a patient table, 
         FIG. 5  shows a perspective front and side view of a micro-hook fastening element for a system for patient immobilization, which is fastened to a rail of a patient table, 
         FIG. 6  shows a perspective rear and side view of a micro-hook fastening element according to  FIG. 5 , 
         FIG. 7  shows a perspective rear and side view of an alternative fastening element, 
         FIG. 8  shows a perspective front and side view showing the alternative fastening element according to  FIG. 7  in use when inserted in a keder rail of a patient table, 
         FIG. 9  shows a rear and side view of an alternative fastening element according to  FIGS. 7 and 8 , 
         FIG. 10  shows cross sections of alternative configurations of keder cords that can be used in the alternative fastening elements according to  FIGS. 7 to 9 , 
         FIG. 11  shows cross sections of alternative embodiments of fastening elements within keder rails, and 
         FIG. 12  shows an exploded sectional view of a fastening element with an anchor patch, a disposable patch and the patient immobilization device. 
     
    
    
     EMBODIMENTS OF THE INVENTION 
     Referring to  FIG. 1 , a nonwoven fabric layer forming a planar element  105  is shaped to provide a patient immobilization device  100 . The immobilization device  100  has an elongate middle part  110 , from which two or more arms  120 ,  130  extend laterally on both sides of the middle part  110 . The fabric of the planar element  105 , or the non-woven fabric layer, can preferably be produced from nonwoven polypropylene with a thickness of approximately 1 mm, preferably of approximately 0.8 mm. To achieve the desired strength, the fabric should preferably have a tensile strength of more than 100 N per 50 mm fabric width. The fabric is radioparent and MR (magnetic resonance tomography) safe. It can be sterilized with steam or ethylene oxide according to the standards ISO 11135, ISO 10993-7 or EN 1422. 
     As is shown in  FIG. 4 , the patient immobilization device can be used to secure a patient P to a patient table  305  by placing the middle part  110  on the patient&#39;s torso and fastening the arms  120 ,  130  to micro-hook fastening elements  300 , which can be fastened on each side of the patient table  305 . Other uses of the patient immobilization device  100  are possible. These include immobilizing a body part of a patient P with the patient immobilization device  100  similarly to a bandage or a plaster cast, possibly together with one or more rigid, elongate elements, for example when splinting a bone fracture. 
     The elongate middle part  110  is preferably between 100 cm and 200 cm long and has a width of between 10 cm and 30 cm. The elongate middle part  110  may be suitable for covering a substantial part of the torso of a patient P, such that it is possible to apply uniform pressure to the torso without creating local pressure points. 
     The arms  120 ,  130  are preferably between 5 cm and 20 cm wide and between 50 cm and 150 cm long. The elongate middle part  110  is generally longer than the arms  120 ,  130  and often has approximately the same width as the arms  120 ,  130 . Longitudinal gaps  140  can be cut out between every two adjacent arms  120 ,  130 . The longitudinal gaps  140  can be between 1 cm and 10 cm wide. 
     The longitudinal gaps  140  can be cut out with semicircular transitions  150  which separate the arms  120 ,  130  at the middle part  110 . This reduces the risk of accidentally tearing the fabric sheet. 
     The arms  120 ,  130  can be arranged symmetrically, with a left arm  120  in each case being arranged on the middle part  110  symmetrically with respect to a right arm  130 . 
     The patient immobilization device  100  can have between five and fifteen arms  120 ,  130  which extend laterally on each side of the middle part  110 . 
     In use, each arm  120 ,  130  can be individually and separately fastened to a micro-hook fastening element  300 . In this case, the number of micro-hook fastening elements  300  that are used on each side of patient P is equal to the number of arms  120 ,  130  on that side of the patient P. Alternatively, an n:1 or 1:n relationship between arms  120 ,  130  and micro-hook fastening elements  300  can be used. That is to say, one fastening element  300  can be used to fasten two or more arms  120 ,  130 , or one arm  120 ,  130  can be fastened to two or more micro-hook fastening elements  300 . 
     The arms  120 ,  130  and the corresponding micro-hook fastening elements  300  are preferably configured such that they withstand a tensile force of at least 40 N. 
     In order to permit access to a specific body part of a patient P, one or more arms  120 ,  130  can remain unsecured or can even be separated from the central portion  110 , so as to create an accessible region while a medical intervention is being performed. The nonwoven fabric of the planar element  105  of the patient immobilization device  100  can be cut, for example, with a safety cutting device having a blade located in a narrow slot into which an arm  120 ,  130  of the patient immobilization device  100  can be inserted, but which is inaccessible to a human finger or another body part. 
     Perforations  112 ,  113  can be formed within the middle part  110  in order to make the middle parts  110  of the patient immobilization device  100  easy to separate. As is shown, the perforations  112  can run perpendicular to the longitudinal axis of the middle part  110  between two arms  120 ,  130 . The perforations  112  preferably extend parallel to the holding force of the patient immobilization device along the arms  120 ,  130 . As a result, the perforations  112 ,  113  do not weaken the ability of the device to hold a patient P securely. However, the perforations  112 ,  113  offer an additional safety mechanism in the event that an arm  120 ,  130  has been fixed wrongly or with too high a tensile force, for example by being wrongly clamped. In this case, the loose arm  120 ,  130  can be pulled in any direction, without the risk of the remaining arms  120 ,  130  being accidentally removed. The central portion  110 , also referred to as the middle part  110 , tears along the perforations  112 ,  113 , such that no force exerted on an individual arm  120 ,  130 , regardless of its direction, can cause the detachment of an adjacent arm  120 ,  130 . 
     To promote this safety aspect, the perforations  113  in the middle part  110  of the patient immobilization device  100  can run tangentially from the arms  120 ,  130  in an X-shaped pattern over the middle part  110 . 
     The patient immobilization device  100  is preferably shipped in the folded state  101 , as shown in  FIG. 3 , and made available for use by medical personnel at the place of use. As is shown in  FIG. 2 , the folded state  101  can be obtained by folding each arm  120 ,  130  onto itself one or more times, as is indicated by the arrows  201 ,  202  and  203 ,  204 . The arm  120 ,  130 , pre-folded in this way, is then folded onto the middle part  110 . As is indicated by arrows  209 ,  219 , the folded arms  120 ,  130 , and a part of the central part  110  lying correspondingly under them, can then be folded, according to the arrow  209 , onto the next arms  120 ,  130 , which are pre-folded according to the arrows  211 ,  212  or  213 ,  214 , and the adjacent part of the middle part  110 . The longitudinal fold can preferably coincide here with the perforations  112 . The folding process allows the medical personnel to easily place the folded patient immobilization device  101  centrally onto the torso of the patient P and then to unfold it there, as is shown in  FIG. 4 . During the unfolding, the medical personnel can fasten the arms  120 ,  130  to corresponding micro-hook fastening elements  300 , which can be easily fastened on both sides of the patient P to a bed or patient table  305 . In this way, the patient is quickly and increasingly immobilized without the need for any complicated cuts to be made in the fabric. 
     An example of a micro-hook fastening element  300  is shown in  FIGS. 5 and 6 . The micro-hook fastening element  300  has a body with a generally flat, plate-shaped front body portion  310 , which is also referred to as a plate part  310 . A micro-hook patch  312  with micro-hooks  314  arranged thereon is fastened to the front body part  310 . The micro-hook fastening element  300  is configured such that it easily latches into place on a rail  301  of a patient table  305  or the like. In connection with this specification and the preceding claims, any structure that supports a patient is designated as “patient table”  305 . These include operating tables, beds, MRI/CT support surfaces and the like. 
     The micro-hook fastening element  300  comprises an upper side web  332 , which extends approximately perpendicularly from the rear face of the front body part  310 . A channel  350  is provided in a lower web  340 , which extends at a distance from and in parallel under the upper lateral web  332 . The channel  350  is approximately 1 cm wide, in order to receive a lower part of the rail  301 . The lower web  340  extends along a lower end of the front body part  310  and can have a generally V-shaped cross-sectional shape. The upper lateral web  332  can be arranged at a distance of approximately 3 cm from the bottom surface of the channel  350 . The lower web  340  and the upper web  332  are configured such that they can receive frequently used rails  301 , which can have a customary rectangular cross-sectional shape and dimensions of, for example, 25 mm×10 mm, 28.5 mm×9.5 mm or 31 mm×7 mm. 
     The micro-hook patch  312  with micro-hooks  314 , which is fastened to the front body part  310 , can engage around a lower V-shaped end of the micro-hook fastening element  300  and cover a part of the lower web  340 . In order to achieve the desired strength, the use of a micro-hook patch  312  with approximately between 250 and 350 micro-hooks per cm 2 , in particular with approximately 300 micro-hooks per cm 2 , has proven advantageous. The micro-hooks  314  can particularly preferably be made of polyamide or polypropylene. The micro-hooks  314  preferably have a height of approximately 0.5 mm, e.g. 0.4 mm. The micro-hook patch  312  can be affixed to the micro-hook fastening element  300  using an adhesive layer  313  advantageously formed from polyurethane. 
     An elastically deformable rubber strip, in particular a silicone rubber strip  355 , can be arranged within the channel  350 . When the micro-hook fastening element  300  is fastened to the rail  301 , a lower part of the rail  301  is received within the channel  350 , while an upper part of the rail  301  is pressed against the upper lateral web  332  by means of the silicone rubber strip  355 . The silicone rubber strip  355  is elastically deformed in the process and provides the required clamping force for securely holding the micro-hook fastening element  300  on the rail  301 . 
     The channel  350  is formed along an upper side of the lower web  340  between the plate part  310  and a parallel wall  339 . A groove  338  can be formed within a bottom of the channel  350 . The deformable silicone rubber strip  355  can have a generally D-shaped hollow cross section, wherein a flat part of the D-shaped cross section rests on a bottom of the channel  350 , and a convex part of the D-shaped cross section points upward toward the rail  301 . 
     An anchor part  357  can extend vertically into the groove  338  centrally from the flat part of the D-shaped cross section. The deformable silicone rubber strip  355  resembles a D-shaped door sealing strip. 
     Referring to  FIGS. 7 to 11 , alternative embodiments to the micro-hook fastening elements  300  are now shown. The alternative fastening element  400  shown includes a micro-hook patch  420 , which is wrapped around a keder cord  410 . The fastening element  400  can be inserted into a keder rail  450  of a patient table  305 . The keder rail  450  runs in the longitudinal direction on the sides of the patient table  305 . The keder rail  450  contains at least one groove-shaped cavity  452  (see  FIG. 11 ), which is accessible through an upwardly or laterally directed slot  453 . The slot  453  is wide enough to accommodate the thin micro-hook patch  420  in a double layer, and narrow enough to hold its end, wrapped around the keder cord  410 , in the groove-shaped cavity  452 . 
     As is shown in  FIG. 10 , the keder cord  410  can have various cross-sectional shapes. For example, it can have a polygonal, round, oval or D-shaped cross section. A trapezoidal cross section  411  and a generally D-shaped cross section  412  are shown in  FIG. 10 . 
     As is shown in  FIG. 11 , the keder cord  410  can comprise a generally circular lower part, which is held in the cavity  452  of the keder rail  450 , and a thinner upper part, which extends through the slot  453  of the keder rail  450 . The upper part of the keder cord  410  can be bent in order to align the micro-hook patch  420  at a defined angle relative to the keder rail  450 . As is shown in  FIG. 11 , a keder cord  413  bent by approximately 90° or a keder cord  414  bent by approximately 45° can be used. Of course, other angles are also possible. 
       FIG. 8  shows the fastening element  400  with a disposable patch  365  arranged on the inside. Such a disposable patch  365  can be used for various purposes and in combination with any type of fastening element  300  or  400 . For example, the disposable patch  365  can be used to protect the micro-hooks  314  of the fastening element  300  or  400  from dirt when not in use. In this case, the fastening element  300 ,  400  can be supplied together with a disposable patch  365 . The disposable patch  365  protects the micro-hooks  314  during transport and is only removed shortly before use. 
     Alternatively, as is shown in  FIG. 8 , the disposable patch  365  can also be used on the patient-side face of the fastening element  400 , in order to prevent direct contact between the micro-hooks and a patient. 
       FIG. 12  shows a cross-sectional view of a fastening element  300  in an exploded view. A micro-hook patch  312  with micro-hooks  314  is fastened to the front body part  310  of the micro-hook fastening element  300 . Here, the micro-hook patch  312  is affixed to the front body part  310  of the micro-hook fastening element  300  by an adhesive layer  313 . The micro-hooks  314  are formed on an opposite, outwardly facing side of the micro-hook patch  312 . The micro-hooks  314  can generally be mushroom-shaped elements that are suitable for engaging in loops  160  of the nonwoven fabric of the patient immobilization device  100  and for clamping themselves firmly therein. 
     The micro-hook patch  312  can be permanently affixed to the front body part  310  of the micro-hook fastening element  300  and can then also be designated as an anchor patch  312 . The micro-hook patch  312  is not easily exchangeable in this case. 
     For some uses, it is preferable to use disposable patches that do not need to be cleaned. Such a disposable patch  360  is shown in  FIG. 12 . The disposable patch  360  has, on its inner face, a layer of microfiber loops  361 , similar to those of the patient immobilization device  100 ,  101 . The disposable patch  360  has a micro-hook layer  362  on its outer face, the micro-hooks corresponding to those of the anchor patch  312 . 
     The disposable patch  360  can thus form an intermediate layer between the anchor patch  312  and the patient immobilization device  100 . More than one disposable patch  360  can be used in order to form a sandwich structure in which several disposable patches  360  are arranged between the anchor patch  312  of the micro-hook fastening element  300  and the patient immobilization device  100 . After each use, the patient immobilization device  100  and the outermost disposable patch  360  can be discarded, as a result of which a clean and possibly also immediately sterile environment is created for the next patient. 
     The invention allows a patient immobilization device  100 ,  101  to be handled in a simple and uncomplicated manner, which is very advantageous in the clinical or medical field. By virtue of its material properties, the planar element  105  with its multiple arms  120 ,  130  can be brought into engagement directly with the micro-hooks  314  on the micro-hook fastening element  300 , on the micro-hook patch or anchor patch  312  or  420 , and fixed. Since the aforementioned fastening elements having the micro-hooks  314  are displaceable as required on the rail  301  or on the groove-shaped cavity  452  of a patient table  305 , the conditions for immobilizing a patient or individual parts of the body of a patient can be variably established in an extremely short time. 
     Although the present invention has been described with reference to illustrative embodiments, it will be readily apparent to a person skilled in the art that the invention is not limited to the disclosed or depicted embodiments, but on the contrary is intended to cover numerous other modifications, substitutions, variations and far-reaching equivalents contained within the spirit and scope of the following claims. In particular, all of the illustrated and described details of the various embodiments can be combined or interchanged with one another as desired. 
     LIST OF REFERENCE SIGNS 
     
         
           100  patient immobilization device 
           101  patient immobilization device (in folded state) 
           105  (planar) element 
           110  elongate middle part 
           112  perforation 
           113  perforation 
           120  left arm 
           130  right arm 
           140  longitudinal gap (between  120  or  130 ) 
           150  transition (to  140 ) 
           160  loops (on  100 ,  101 ) 
           201  arrow 
           202  arrow 
           203  arrow 
           204  arrow 
           209  part (of  110 ) 
           211  part (of  120 ) 
           212  part (of  120 ) 
           213  part (of  130 ) 
           214  part (of  130 ) 
           219  part (of  110 ) 
           300  micro-hook fastening element 
           301  rail 
           305  patient table 
           310  front body part/plate part 
           312  micro-hook patch/anchor patch 
           313  adhesive layer 
           314  micro-hook 
           332  upper lateral web 
           338  groove 
           339  wall 
           340  lower web 
           350  channel 
           355  rubber strip/silicone rubber strip 
           357  anchor part 
           360  disposable patch 
           361  microfiber loops 
           362  micro-hook layer 
           365  disposable patch 
           400  fastening element 
           410  keder cord 
           411  cross section (trapezoidal) 
           412  cross section (D-shaped) 
           413  keder cord (bent 90°) 
           414  keder cord (bent 45°) 
           420  micro-hook patch 
           450  keder rail 
           452  cavity/keder groove 
           453  slot 
         P patient