WO2017064182A1 - Fixation device for a part of the body - Google Patents

Fixation device for a part of the body Download PDF

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Publication number
WO2017064182A1
WO2017064182A1 PCT/EP2016/074584 EP2016074584W WO2017064182A1 WO 2017064182 A1 WO2017064182 A1 WO 2017064182A1 EP 2016074584 W EP2016074584 W EP 2016074584W WO 2017064182 A1 WO2017064182 A1 WO 2017064182A1
Authority
WO
WIPO (PCT)
Prior art keywords
cushion
fixation device
chamber
carrier means
immobilization
Prior art date
Application number
PCT/EP2016/074584
Other languages
French (fr)
Inventor
Thomas Müller
Simon BÜRGI
Christoph Schröter
Original Assignee
Pearl Technology Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pearl Technology Ag filed Critical Pearl Technology Ag
Publication of WO2017064182A1 publication Critical patent/WO2017064182A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/04Positioning of patients; Tiltable beds or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/04Positioning of patients; Tiltable beds or the like
    • A61B6/0407Supports, e.g. tables or beds, for the body or parts of the body
    • A61B6/0421Supports, e.g. tables or beds, for the body or parts of the body with immobilising means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/54Control of apparatus or devices for radiation diagnosis
    • A61B6/541Control of apparatus or devices for radiation diagnosis involving acquisition triggered by a physiological signal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N2005/1092Details
    • A61N2005/1097Means for immobilizing the patient

Definitions

  • the present invention is directed to a fixation device for a part of the body, such as for limbs or inner organs.
  • a fixation device according to the invention may e.g. be used for immobilizing or positioning of human or animal patients during medical imaging or medical therapy, in particular radiotherapy.
  • a fixation device according to the present invention may also be used in order to restrict or suppress movements of inner organs in the abdominal region during respiration.
  • WO2009/155211 A1 was published on 23.1 2.2009 on behalf of CIVCO Medical Instruments Co., Inc. and shows a patient positioning system.
  • the document discloses dif- ferent types of devices in order to position and immobilize patients on a patient support panel for medical treatments, in particular for radiotherapy.
  • the document shows a pneumatically operated respiratory restriction device which comprises an inflatable bladder that is mounted on the underside of one of two sheets for engagement with the epigastric area of the patient. Said bladder is arranged to be inflated by a hand pump and the pressure within the bladder is measured by a pressure gauge. Thus the bladder can be inflated until it is at a desired pressure so that the appropriate degree of restriction of the patient's diaphragmatic excursions can be established.
  • the document disclos- es a plate connected to a bridge-like structure, said plate being able to be displaced with respect to the patient's epigastric area in order to compress the abdomen and hence restrict abdominal breathing.
  • EP2104477 B1 was published on 30.09.2009 on behalf of ETH Zurich and shows an immobilizing device for a part of the body, in particular a forearm.
  • This document discloses an immobilizing device which comprises a bag and an outer shell in which the bag is mounted. Between the outer shell and the bag, a hollow space is formed for receiving pressured air in order to produce a force on the bag for immobilizing a part of the body.
  • the bag is filled with granular material and adapted to be put over the part of the body.
  • WO2012/076199 A1 was published on 1 4.06.201 2 on behalf of Pearltec AG and shows a relatively small cushion with an elongated shape for immobilizing a part of the body.
  • the cushion disclosed comprises an air chamber and a chamber filled with granular material.
  • the two chambers are separated by a membrane.
  • a hand pump pressured air can be pumped in the air chamber, leading to an expansion of the air chamber.
  • the chamber filled with granular ma- terial is placed between the part of the body and a medical device - such as a M RI-coil or a CT holder.
  • the air chamber is filled with pressured air, causing the granular parts in the other chamber to become rigid, as well as a movement of the chamber filled with granular material is caused.
  • the chamber filled with granular material has a plurality of ventilation holes for the flux of air.
  • Such types of cushions are suited for immobilizing some parts of the body with respect to certain medical devices, like coils.
  • the document discloses an apparatus that is intended to be used as a collar/sleeve for injured parts of the body (such as broken limbs) or as seat rest.
  • the apparatus comprises a bag filled with a filling material which comprises a plurality of bodies that are movable relative to each other.
  • the bag can be evacuated using a vacuum pump, leading to a restriction of said movement leading to a dimensionally stable body.
  • a cushion layer is arranged which can be brought in a lasting extended state, like a bag filled with air.
  • the bag filled with a filling material has to be manually adjusted in order to fit the shape of the part of the body it has to be applied on.
  • the bag filled with filling material is evacuated, leading to shrinking of the bag and hence also to an improper alignment of the contour of the evacuated bag with respect to the body contour.
  • the bag arranged between the evacuated bag and the body is expanded, in order to fill the void space.
  • the disclosed bag filled with filling material has to be manually adjusted to the outer contour of the body and evacuated in order to form some kind of hard shell.
  • One object of the present invention is to provide an improved device for the immobilization of a part of the body which provides advanced stability during critical moments when doing medical imaging or therapy. Another object is to provide a carrier means for such a device. Another object is to provide a first and a second cushion for such a device. Another object is to provide a system for positioning a part of the body. Yet another object is to provide a method for the fixation of a part of the body and to provide a device and method to minimize diaphragmatic excursions during respiration.
  • the fixation device according to the present invention provides improved immobilization of a part of a body, which is not only important for single medical procedures, but also for series of medical procedures.
  • the fixation device also offers potential to increase the reproducibility of immobilizations, which according to at least some embodiments of the present invention is in particular important for follow-up immobilizations such as applied during radiotherapy courses, as will be explained in more details below.
  • a fixation device according to the present invention may be used in order to press a part of the body against a support board (e.g. a stretcher or surgical table).
  • a fixation device for the immobilization of a part of the body typically comprises a carrier means which provides a front face.
  • a carrier means which provides a front face.
  • it typically comprises a first cushion extending along the front face of the carrier means, and an inflatable second cushion arranged at least partially between the carrier means and the first cushion, foreseen to press the first cushion away from the carrier means against the part of the body to be immobilized.
  • the first cushion is designed to switch from a more deformable state to a less deformable state and thereby to support the immobilization effect.
  • the first cushion is designed to reversibly switch from a more deformable state to a less deformable state. Hence such a variation allows multiple use of the first cushion.
  • the first cushion comprises a first chamber which is at least partially filled with a filling material that can switch from a more deformable state to a less deformable state. Multiple use of the first cushion becomes possible if the filling material can reversibly switch from a more deformable state to a less deformable state.
  • the filling material may be a liquid or gel, such as non-Newtonian fluid, in particular it may be a dilatant fluid.
  • the filling material comprises an electrorheological fluid, in particular an electrorheological liquid.
  • an electrical field may be applied in order to switch the filling material to a less deformable state.
  • the filling material comprises a magnetorheological fluid, in particular a magnetorheological liquid.
  • a magnetic field may be applied in order to switch the filling material to a less deformable state.
  • the filling material is an interlockable material that when compressed interlocks and thereby achieves a less deformable state.
  • the filling material may be an interlockable material that interlocks and thereby achieves a less deformable state when the first chamber is evacuated.
  • the fixation device may comprise a pump in order to at least assist evacuating of fluid from the first chamber.
  • compaction of the first chamber can be supported by the pump if desired.
  • Good results may be obtained if the filling material is a granular material whose granules are configured to interlock with each other when being compressed.
  • the granules (granular base material) inside the first chamber are compressed against each other and hence interlock such that the first cushion forms some kind of rigid shell that closely aligns with the contour of the part of the body to be immobilized.
  • the first cushion forms some kind of rigid shell that closely aligns with the contour of the part of the body to be immobilized.
  • the kind of rigid shell formed by the first cushion that closely aligns with the contour of the body causes an effect of additional positive locking between fixation device and the part of the body.
  • fixation device according to the present invention helps to improve the compliance of the patients that undergo such radiotherapy courses. Consequently a fixation device according to the present invention may help to increase the success rate of certain medical procedures if compared to conventional devices.
  • the first cushion comprises a first chamber that is at least partially filled with a granular material which comprises granules that have an essentially spherical shape.
  • the granules can move easily relatively to each other.
  • Good adaptation to the outer contour of a part of the body to be immobilized may be obtained if the granules have a mean diameter of between 1 and 3 mm.
  • a particularly good adaptation to the outer contour can be obtained if the granules have a mean diam- eter of between 1 .2 and 2.2 mm.
  • the granule material is made from an expanded polystyrene (EPS).
  • EPS expanded polystyrene
  • the granular material may be at least partially made from expanded polypropylene (EPP).
  • the second cushion comprises a second chamber that can be filled with a fluid to inflate the second cushion.
  • a fluid may be a gas (e.g. air) or a liquid (e.g. water) or a gel.
  • the cushion may comprise an opening through which the fluid may be added to the second chamber or evacuated from the second chamber.
  • the second cushion - respectively the walls enclosing the second chamber - may be made from a material that is essentially impermeable to the fluid used. Alternatively or in addition it/they may be coated by such a material.
  • the cushions may be made from a plastic film, in particular from thermoplastic polyurethane (TPU). Using TPU allows the cushions to be assembled mainly using plastic welding, as well as it offers good surface disinfection and cleaning.
  • the first and/or the second cushion is/are made from a plastic film that is interconnected by means of a high frequency welding process. Thus, highly durable and easy to assem ⁇ ble cushions can be obtained.
  • the cushions may also be coated with another material.
  • the cushions may comprise MRI markers and/or X-ray markers in order to be identifiable during medical imaging.
  • the front wall of the second cushion and the rear wall of the first cushion may be at least partially formed by one and the same membrane.
  • the membrane may e.g. be made from one of the materials mentioned above.
  • the first and the second cushion may be detachably interconnected by plastic welding and/or by an adhesive film and/or by a hook and loop fastener.
  • the first and the second cushion, as well as the carrier means may also be arranged in a sleeve, such as e.g. a single-use sanitary cover.
  • the carrier means comprises a rigid structure arranged to exert a force on a rear wall of the second cushion. Using such rigid structures allows to obtain good fixation of certain parts of the body in multiple spatial directions.
  • the rigid structure comprises a plate and/or a shell and/or a grid.
  • the force (and resulting stress) exerted on the part of the body in order to immobilize it can be distributed over a larger area, respectively the distribution of force can be controlled.
  • the rigid structure may be spatially curved.
  • the carrier device may be adapted to the part of the body to be immobilized - which in most cases will rather have a curved than a flat contour.
  • the device for fixation according to the invention allows to apply an at least almost evenly distributed force even on curved contours of parts of the body.
  • the carrier means may comprise an adjustable and interlockable joint which allows to rotate a first portion of the carrier means relatively to a second portion of the carrier means.
  • a joint may e.g. be a hinge or a ball joint.
  • the shape of the carrier means may be altered and adapted such that the fixation device can be used for various parts of the body or be adjusted to fit to the anatomy of specific patients.
  • the front face of the carrier means may be interconnected to a back face of the carrier means by an opening.
  • an opening may be used in order to get access to a rear wall of the second cushion, e.g. in order to add or evacuate fluid to/from a first and/or the second chamber (if present), as will be explained in more detail below.
  • the carrier means is at least partially made from a resilient material - hence be relatively flexible such that e.g. its shape can be easily adapted to the shape of the part of the body by the application of limited physical force.
  • a resilient material may be made from a fabric or a plastic film, as will be explained in more detail below.
  • the carrier means may comprise a stiffening means in order to stiffen the carrier means at least temporarily.
  • the shape of a resilient carrier may first be adapted to the outer contour of a part of the body and then be stiffened as soon as the desired shape of the carrier means is obtained.
  • the stiffening means comprises a third chamber, the third chamber being at least partially filled with a granular material and comprising a means for evacuating fluid from the third chamber in order to stiffen the third chamber and thus also the carrier means.
  • the stiffening means comprises a third chamber, the third chamber being at least partially filled with a granular material and comprising a means for evacuating fluid from the third chamber in order to stiffen the third chamber and thus also the carrier means.
  • the fixation device comprises a second chamber in which a connecting element mechanically interconnects the second chamber's front wall with its rear wall, restricting at least locally the distance between front wall and the rear wall when the sec- ond chamber is inflated by adding fluid.
  • the connecting element may comprise an adhesive or a plastic weld that connects the front and the rear wall (as will be explained in more detail below) .
  • Connecting elements may e.g. be formed as quilt-type baffles or box-type baffles.
  • the carrier means comprises a fastening means in order to mechanically interconnect the carrier means with e.g. an auxiliary structure that is mechanically interconnected with a support means for the part of the body to be immobilized.
  • the auxiliary structure may be a (mechanical) superstructure arranged at the support means, such as a bridge member that comprises two legs and a central section bridging the two legs, such that it surrounds the part of the body to be immobilized.
  • the fastening means may e.g. be mechanically interconnected with the central section.
  • the support means may e.g. be a support board or a stretcher.
  • the fastening means may comprise an adjustment means to adjust the distance and/or the relative orientation between the fixation device and an auxiliary structure and/or the part of the body to be immobilized, as will be described in more detail below.
  • an adjustment means may comprise e.g. a ball joint and/or a screwed connection and/or a linear actuator and/or a clamping connection
  • the auxiliary structure and/or the fastening member and/or the adjustment means may comprise a scale or other type of indicator which indicates positioning and/or orientation of the fixation device with respect to the part of the body and/or with respect to the support means.
  • the carrier means comprises a strap that can be interconnected with a support means.
  • a strap may be a belt-type strap.
  • the strap may be made from an X-ray transparent and/or MRI-compatible material in order to obtain a fixation device suited to be used for such types of medical imaging.
  • the strap may be made from materi- als that offer a good penetrability for most types of beams used in radiotherapy. Thus such embodiments offer great potential for being used in radiotherapy as they can easily be penetrated by the applied beams and can essentially be neglected when navigating the beam.
  • the first and/or the second cushion may comprise a pocket config- ured to receive a portion of the carrier means in order to fasten the first and/or the second cushion to the carrier means.
  • the pocket is made from an elastic material, such as a plastic film, in particular from a (TPU).
  • the carrier means may be mechanically interconnected with the second cushion by means of a permanent or a non-permanent adhesive film and/or a hook and loop fastener and/or a clamping mechanism.
  • the second cushion comprises a second chamber which is fluidically interconnected with a pump in order to pump a fluid into the second chamber and thus to inflate the second cushion.
  • the pump may be a hand pump or an automated pump. Good inflation of the second cushion can be obtained if the pump is fluidically interconnected with an opening in a rear wall of the second cushion. However, an opening may also be arranged at other walls of the cushion.
  • the second chamber may be interconnected with a pressure gauge for measuring the fluidic pressure in- side of the second chamber. The pressure gauge may be connected to a display that pro- vides information about said pressure. The pressure gauge may also be used in order to control an automated pump as described above.
  • the fixation device may also comprise means limit the maximum fluidic pressure inside of the second chamber, such as e.g. a pressure relief valve. Such a means may be used in order to restore a pressure setting of a previous immobilization and/or to prevent injuries due to mechanical overloading of the part of the body, as e.g. caused by suppression of blood flow.
  • the fixation device may also comprise a means to measure the mass and/or volume of the fluid that is added to the second chamber. Such an embodiment can be advantageous for certain applications, as explained in more detail below.
  • the first cushion comprises an orifice to exhaust fluid from the first chamber.
  • the walls of the first cushion may at least be partially made from a material which is permeable for a fluid which is inside of the first chamber (e.g. air).
  • the chamber may be made from a non-airtight fabric. A fixation device which is easy to clean and sterilize may be obtained if the orifice is arranged at a portion of the first cushion that is not intended to be pressed against the part of the body - e.g. not at the front wall of the first cushion.
  • the orifice does not get in direct contact with the part of the body to be immobilized and hence penetration of body liquids and/or germs from the part of the body via the orifice into the first chamber can be prevented.
  • the front wall of the first cushion can be cleaned easily without the danger of cleaning agent penetrating into the first chamber.
  • an orifice is arranged at a rear wall (directed to the carrier means) of the first cushion and positioned such that fluid exhausted from a first chamber inside of the first cushion can pass through a passageway arranged at the connecting element of the second chamber which interconnects the front wall with the rear wall of the second cushion.
  • the fixation device comprises a third cushion arranged adjacent to the front wall of the first cushion.
  • the third cushion may be at least partially filled with a liquid and/or a gel and/or a granular material.
  • the third cushion may comprise means to add and/or remove liquid and/or gel from inside of the third cushion and/or to measure and/or control temperature of the third cushion. Hence e.g. the temperature of the part of the body to be immobilized may be controlled.
  • the fixation device may comprise a single second cushion and multiple first cushions, as will be explained in further details below.
  • the fixation device may comprise a single first cushion and multiple second cushions.
  • Good results may be obtained if the fixation device comprises multiple second cushions, whereof at least two second cushions comprise second chambers that are fluidically interconnected with each other. Hence - if desired - isobar pressure may be obtained in multiple second cushions.
  • Good results for a large range of applications can be obtained if the first cushion in a non- loaded state has a thickness of between 5 and 20 mm, in particular of about 1 0 mm.
  • the second cushion can be inflated to a mean thickness of between 5 and 20 mm, in particular to about 1 0 mm.
  • the present invention is also directed to a carrier means for a fixation device, as well as to a first and a second cushion for a fixation device.
  • a system for the immobilization of a part of the body comprising a support means on which the part of the body can be positioned as well as an auxiliary structure that is mechanically interconnectable with the support means and that is at least partially surrounding the part of the body. Further the system comprises a fixation device as described above, the fixation device being mechanically interconnectable with the auxiliary structure.
  • a system for the immobilization of a part of the body which comprises a support means on which the part of the body can be positioned and a fixation device which comprises a strap that can be mechanically interconnected with the support means.
  • One aspect of the invention is directed to a method for the immobilization of a part of the body which comprises the steps of: Providing a system for the immobilization of a part of the body as described above; positioning the part of the body on the support means; po- sitioning the fixation device such that a front wall of the first cushion is at least partially aligned with the outer contour of the part of the body; displacing the carrier means towards the part of the body such that the first cushion gets into contact with the part of the body; inflating the second cushion.
  • the first cushion on the one hand forms a relatively stiff shell that aligns with the part of the body and on the other hand exerts a relatively evenly distributed force on the part of the body.
  • fluid may be added to a second chamber in the second cushion until the second chamber reaches a predefined volume and/or a predefined inner pressure.
  • a predefined volume may be advantageous in order to reproduce a specific positioning of the part of the body while being immobilized.
  • a predefined inner pressure may be advantageous in order to obtain a certain amount of pressure on the part of the body without a risk of mechanically injuring the part of the body.
  • Good and safe immobilization may be obtained if fluid is added to the second chamber until an inner pressure of between 3 and 1 0 kPA is obtained.
  • the displacement of the carrier means and/or the amount of inflation of the second cushion may be determined based on a feedback provided by the part of the body to be immobilized, respectively the patient it belongs to.
  • the feedback may include a measurement of blood circulation.
  • the feedback may be acoustic and/or optical signal given by the patient based on comfort, respectively discomfort caused by the fixation device.
  • the fixation device may e.g. be displaced towards the part of the body until the patient starts to feel uncomfortable - which will typically be caused by a local stress concentration at the interface between the part of the body and the front wall of the first cushion.
  • the second cushion may be inflated to a certain extent, causing an improvement in stress distribution at said interface, leading to better immobilization and an increased comfort for the patient.
  • the fixation device may be positioned at the abdomen, preferably at the region of the upper abdomen in order to compress the epigastric region. Hence diaphragmatic excursions which cause movements of internal organs in the chest and abdomen during respiration can be minimized. Hence, motion artifacts in medical imaging (CT, MRI) can be reduced and tracking of internal organs during radiation therapy can be improved. Good results may be obtained if the pressure inside of the second chamber is measured over time and used to control medical imaging or radiation therapy. In particular the measured pressure over time can be used for predicting and/or tracking motion of internal organs during a respiratory cycle.
  • Fig. 1 schematically shows a variation of a system for the immobilization of a part of the body in a perspective view
  • Fig. 2 shows detail D of Fig. 1 ;
  • Fig. 3 shows a variation of a first and second cushion in a first perspective view
  • Fig. 4 shows the variation of a first and second cushion of Fig. 3 in a second perspective view
  • Fig. 5 shows the fixation device of Fig. 2 in a front view
  • Fig. 6 schematically shows a variation of a fixation device
  • Fig. 7 schematically shows another variation of a fixation device
  • Fig. 8 schematically shows another variation of a fixation device
  • Fig. 9 schematically shows a first method step for the immobilization of a part of the body
  • Fig. 1 0 schematically shows a second method step
  • Fig. 1 1 schematically shows a third method step
  • Fig. 1 2 schematically shows a fourth method step
  • Fig. 1 3 schematically shows a variation of a fixation device in a first perspective view
  • Fig. 14 schematically shows a variation of a fixation device in a second perspective view
  • Fig. 1 5 schematically shows a variation of a system for the immobilization of a part of the body in a perspective view.
  • a fixation device 1 can e.g. be used in order to immobilize a part of the body 2.
  • the fixation device 1 is used in order to immobilize the upper abdominal region (respectively the epigastric region) of a patient in order to minimize diaphragmatic excursions during respiration. Therefore, the patient is positioned in a lying position on a support board 4.
  • a bridge member 3 which has two legs and a central section bridging the two legs is arranged on the support board 4, surrounding the part of the body 2.
  • this variation of a fixation device 1 comprises adjustment means 1 6a, 1 6b.
  • the first adjustment means 1 6a comprises a threaded section which allows to vary the distance between the fixation device 1 and the support means 4 (respectively the part of the body 2 lying on the support means 4).
  • the second adjustment means 1 6b comprises a ball joint which allows to rotate the fixation device 1 relatively to the support board 4, and hence to align the fixation device 1 with the contour of the upper abdomen 2 of the patient.
  • fixation device 1 shown in Figs. 1 to 5 is shaped such that it can be positioned close to the patient's chest, without interfering with the ribs. Therefore the fixation device 1 comprises two lateral recesses to receive the ribs (ribs not visible).
  • the fixation device 1 comprises a carrier means 1 0 to which a member comprising a second cushion 21 as well as three first cushions 31 is mechanical- ly interconnected.
  • the second cushion is in a non-inflated state.
  • This mechanical connection is established by means of three pockets 25 arranged at the second cushion 2 1 and configured to receive three portions of the carrier means 1 0, as shown in Fig. 2.
  • the carrier means 1 0 of the fixation device 1 shown comprises a plate-like structure 1 3 that is rigid and hence is able to exert a force on the part of the body 2 via the first and the second cushions 31 , 21 .
  • the rear face 1 2 and front face (not visible) of the carrier means 1 0 are interconnected by several openings 1 4 which decrease the weight of the carrier means 1 0 as well as they allow better access to the second cushion 21 .
  • a fluid line 7 e.g. a tube/hose
  • air can be pumped by an air pump 5 via the tube 7 into the second chamber 20 to inflate the second chamber 20, respectively second cushion 21 .
  • the fixation device 1 further comprises a pressure gauge 6 for measuring the fluidic pressure inside of the second chamber 21 . As shown in Fig.
  • a fluid connector 27 suited to be interconnected with tube 7 is arranged at the rear wall 23 of the second cushion 21 , posi- tioned such that when the second cushion 21 is mechanically interconnected with the carrier means 1 0, the fluid connector 27 and the tube 7 are arranged in an opening 1 4, as shown in Fig. 2.
  • the second cushion 21 comprises several connecting elements 24 which mechanically interconnect the second cushion's 21 front wall 22 with its rear wall 23.
  • the first and the second cushion 3 1 , 21 are made from a thermoplastic polyurethane (TPU) film and the connection means 24 are established by locally connecting the front and the rear wall (which are both made from a TPU film) by means of a local welding process.
  • TPU thermoplastic polyurethane
  • these connecting elements 24 are local welding spots having an essentially circular shape.
  • passageways 26 are arranged which are fluidicaliy interconnected with orifices (not visible) arranged in rear walls 33 of the first cushions 3 1 , as will be shown in more detail below with respect to Figs. 9 to 12.
  • three pockets 25 are arranged at the rear wall 23 of the second cushion, each pocket being made from a TPU film and being interconnected with the rear wall 23 by means of plastic welding.
  • the carrier means 1 0 may be spatially curved in order to better align with the contour of the part of the body 2. Therefore, the carrier means 1 0 comprises angled lateral portions (winglets).
  • the angled portions allow to improve the immobilization of the part of the body 2 in lateral (y) direction.
  • the first cushion 31 is divided into three parts that are separated from each other by gaps. Each of the three first cushions 31 encloses a first chamber 30 that has an orifice which is fluidically interconnected with one of the passageways 26, as indicated in Fig. 3.
  • Figs. 6 to 8 schematically show some variations of a fixation device 1 according to the invention.
  • the variation shown in Fig. 6 comprises a carrier means 1 0 that has a front face 1 1 on which a second cushion 21 (shown in an inflated state) is arranged.
  • the rear wall 23 of the second cushion is arranged on the front face 1 1 of the fixation device.
  • a connecting element 24 mechanically interconnects the front and the rear wall 22, 23 of the second cushion and thus restricts the distance between front wall 22 and the rear wall 23 when the second cushion 21 is inflated.
  • a first cushion 31 is arranged at the front wall.
  • the front wall 22 of the second cushion 21 is identical with the rear wall 33 of the first cushion 31 .
  • the first cushion 31 encloses a first chamber 30 which is partially filled with a granular material (not shown).
  • Fig. 7 schematically shows a variation of a fixation device 1 according to the present invention which comprises two second cushions 21 that are arranged between a single first cushion 31 and a single carrier means 1 0.
  • Fig. 8 schematically shows another variation of a fixation device 1 according to the present invention which comprises a single second cushion 21 that is arranged between a two first cushion 31 and a single carrier means 1 0.
  • Figs. 9 to 12 schematically show subsequent steps of a method to immobilize a part of the body 2 according to the present invention.
  • the fixation device 1 is positioned close to the part of the body 2, the second cushion 21 still being flat, as the second chamber 20 is not inflated yet.
  • the first chamber 30 is partially filled with a granular material 34 comprising spherical particles of expanded polystyrene. As the first cushion 3 1 is not loaded, the particles of the granular material 34 can easily move relatively to each other and thus the shape of the first cushion 3 1 can be altered easily.
  • the first and the second chamber 30, 20 are separated by a single membrane which forms the front wall 22 of the second cushion 21 and at the same time the rear wall 33 of the first cushion 31 .
  • the carrier means 1 0 is moved towards the part of the body 2 (indicated by the arrows) until the front wall 32 of the first cushion 31 gets into contact with the surface of the part of the body 2.
  • the front wall 32 of the first cushion 31 starts to align with the part of the body 2, respectively starts to displace and deform. Consequently the shape of the first cushion 31 , respectively the first chamber 30 is changed, leading to moving and compressing of the granular material 34, as shown in Fig. 1 1.
  • the front wall 32 of the first cushion 3 1 starts to exert a distributed force (indicated by the small arrows) on the part of the body 2.
  • All walls of the first and of the second cushion 3 1 , 21 are made from a fluid-tight material. Consequently - as the volume of the first chamber 30 decreases - the fluid pressure inside of the first chamber 30 increases, causing an airflow outside of the first chamber 31 through the orifice 35, respectively the passageway 26 and the opening 14 in the carrier means 1 0 (indicated by the slim dotted arrows).
  • the second cushion 2 1 is inflated by adding fluid (e.g. air) to the second chamber 20, which causes an increase of the mean thickness of the second cushion 21 and thus to a further compaction of the first cushion 31 .
  • Fig. 13 and 14 show another embodiment of a fixation device 1 which comprises a carrier means 1 0 that is made from a relatively flexible fabric.
  • a first and a second cushion 31 , 21 are arranged, whereby a second chamber 20 in the second cushion 21 is fluidically interconnected with the tube 7 arranged at the rear face 1 2 of the carrier means 1 9.
  • the carrier means 1 0 comprises two straps 1 7 which comprise hook and loop fasteners (not shown in detail) that allow to establish a mechanical connection between the fixation device 1 and e.g. a support means 4 for a part of the body, as schematically shown in Fig. 15.
  • a system for the immobilization 40 of a part of the body 2 can be obtained, which allows good transmission of radiation.

Abstract

The invention is directed to a fixation device (1) for the immobilization of a part of the body (2). The immobilization device (1) comprises a carrier means (10) that provides a front face (11) and a first cushion (31 ) that extends along the front face (11) of the carrier means (10). Furthermore, the fixation device (1) comprises an inflatable second cushion (21) arranged at least partially between the carrier means (10) and the first cushion (31), foreseen to press the first cushion (31) away from the carrier means (10) against the part of the body (2) to be immobilized. The first cushion (31) is designed to switch from a more deformable state to a less deformable state and thereby to support the immobilization effect.

Description

FIXATION DEVICE FOR A PART OF THE BODY
FIELD OF THE INVENTION
The present invention is directed to a fixation device for a part of the body, such as for limbs or inner organs. A fixation device according to the invention may e.g. be used for immobilizing or positioning of human or animal patients during medical imaging or medical therapy, in particular radiotherapy. A fixation device according to the present invention may also be used in order to restrict or suppress movements of inner organs in the abdominal region during respiration. BACKGROUND OF THE INVENTION
In order to position and/or at least partially immobilize patients during medical procedures, such as radiotherapy and/or medical imaging, different approaches are known.
WO2009/155211 A1 was published on 23.1 2.2009 on behalf of CIVCO Medical Instruments Co., Inc. and shows a patient positioning system. The document discloses dif- ferent types of devices in order to position and immobilize patients on a patient support panel for medical treatments, in particular for radiotherapy. The document shows a pneumatically operated respiratory restriction device which comprises an inflatable bladder that is mounted on the underside of one of two sheets for engagement with the epigastric area of the patient. Said bladder is arranged to be inflated by a hand pump and the pressure within the bladder is measured by a pressure gauge. Thus the bladder can be inflated until it is at a desired pressure so that the appropriate degree of restriction of the patient's diaphragmatic excursions can be established. In addition, the document disclos- es a plate connected to a bridge-like structure, said plate being able to be displaced with respect to the patient's epigastric area in order to compress the abdomen and hence restrict abdominal breathing.
Similar devices are known from the documents DE202015101 579 U1 on behalf of Dornier MedTech, US20080250565 on behalf of Indiana University, US201201 1653 on behalf of Qfix Systems and WO2010125218 on behalf of Fundacion Analuz.
EP2104477 B1 was published on 30.09.2009 on behalf of ETH Zurich and shows an immobilizing device for a part of the body, in particular a forearm. This document discloses an immobilizing device which comprises a bag and an outer shell in which the bag is mounted. Between the outer shell and the bag, a hollow space is formed for receiving pressured air in order to produce a force on the bag for immobilizing a part of the body. According to said patent, the bag is filled with granular material and adapted to be put over the part of the body.
WO2012/076199 A1 was published on 1 4.06.201 2 on behalf of Pearltec AG and shows a relatively small cushion with an elongated shape for immobilizing a part of the body. The cushion disclosed comprises an air chamber and a chamber filled with granular material. The two chambers are separated by a membrane. By means of e.g. a hand pump pressured air can be pumped in the air chamber, leading to an expansion of the air chamber. In order to immobilize a part of the body, the chamber filled with granular ma- terial is placed between the part of the body and a medical device - such as a M RI-coil or a CT holder. Subsequently the air chamber is filled with pressured air, causing the granular parts in the other chamber to become rigid, as well as a movement of the chamber filled with granular material is caused. In order to allow this movement, the chamber filled with granular material has a plurality of ventilation holes for the flux of air. Such types of cushions are suited for immobilizing some parts of the body with respect to certain medical devices, like coils.
DE4423755 A1 was published on behalf of GDW Genossenschaft der Werkstatten fur Behinderte eG and shows an apparatus for the fixation and positioning of a part of the body. The document discloses an apparatus that is intended to be used as a collar/sleeve for injured parts of the body (such as broken limbs) or as seat rest. The apparatus comprises a bag filled with a filling material which comprises a plurality of bodies that are movable relative to each other. The bag can be evacuated using a vacuum pump, leading to a restriction of said movement leading to a dimensionally stable body. Between said bag and the part of the body to be fixed - respectively positioned - a cushion layer is arranged which can be brought in a lasting extended state, like a bag filled with air. In order to apply the apparatus, in a first step the bag filled with a filling material has to be manually adjusted in order to fit the shape of the part of the body it has to be applied on. After that, the bag filled with filling material is evacuated, leading to shrinking of the bag and hence also to an improper alignment of the contour of the evacuated bag with respect to the body contour. Subsequently, the bag arranged between the evacuated bag and the body is expanded, in order to fill the void space. Thus, the apparatus is directed to provide comfortable fixation over longer periods of time, such as during fracture healing. The disclosed bag filled with filling material has to be manually adjusted to the outer contour of the body and evacuated in order to form some kind of hard shell. This hard shell typically causes pain to the patients when being used over extended periods of time, as it is very hard and does not really align with the contour of the part of the body due to the shrinkage caused by the evacuation. Therefore, the document describes that the shell has to be cushioned by the other bag. SUMMARY OF THE INVENTION
One object of the present invention is to provide an improved device for the immobilization of a part of the body which provides advanced stability during critical moments when doing medical imaging or therapy. Another object is to provide a carrier means for such a device. Another object is to provide a first and a second cushion for such a device. Another object is to provide a system for positioning a part of the body. Yet another object is to provide a method for the fixation of a part of the body and to provide a device and method to minimize diaphragmatic excursions during respiration.
The fixation device according to the present invention provides improved immobilization of a part of a body, which is not only important for single medical procedures, but also for series of medical procedures. The fixation device also offers potential to increase the reproducibility of immobilizations, which according to at least some embodiments of the present invention is in particular important for follow-up immobilizations such as applied during radiotherapy courses, as will be explained in more details below. A fixation device according to the present invention may be used in order to press a part of the body against a support board (e.g. a stretcher or surgical table).
In order to solve at least one of the aforementioned problems, a fixation device for the immobilization of a part of the body according to the present invention typically comprises a carrier means which provides a front face. As well it typically comprises a first cushion extending along the front face of the carrier means, and an inflatable second cushion arranged at least partially between the carrier means and the first cushion, foreseen to press the first cushion away from the carrier means against the part of the body to be immobilized. The first cushion is designed to switch from a more deformable state to a less deformable state and thereby to support the immobilization effect. In a variation of the invention, the first cushion is designed to reversibly switch from a more deformable state to a less deformable state. Hence such a variation allows multiple use of the first cushion.
In one embodiment of the invention, the first cushion comprises a first chamber which is at least partially filled with a filling material that can switch from a more deformable state to a less deformable state. Multiple use of the first cushion becomes possible if the filling material can reversibly switch from a more deformable state to a less deformable state.
The filling material may be a liquid or gel, such as non-Newtonian fluid, in particular it may be a dilatant fluid. In a variation of the invention, the filling material comprises an electrorheological fluid, in particular an electrorheological liquid. For such a variation of the invention, an electrical field may be applied in order to switch the filling material to a less deformable state. In another variation of the invention, the filling material comprises a magnetorheological fluid, in particular a magnetorheological liquid. For such a variation of the invention, a magnetic field may be applied in order to switch the filling material to a less deformable state.
In an embodiment of the invention the filling material is an interlockable material that when compressed interlocks and thereby achieves a less deformable state. For some applications the filling material may be an interlockable material that interlocks and thereby achieves a less deformable state when the first chamber is evacuated. For some applica- tions, the fixation device may comprise a pump in order to at least assist evacuating of fluid from the first chamber. Thus, compaction of the first chamber can be supported by the pump if desired. Good results may be obtained if the filling material is a granular material whose granules are configured to interlock with each other when being compressed. In such an embodiment of a fixation device, the granules (granular base material) inside the first chamber are compressed against each other and hence interlock such that the first cushion forms some kind of rigid shell that closely aligns with the contour of the part of the body to be immobilized. On the one hand, thus a more even stress distribution on a larger area of the part of the body's surface, if compared to the conventional fixation devices for immo¬ bilization can be obtained. Thus, local stress concentration within the part of the body can be decreased. On the other hand, the kind of rigid shell formed by the first cushion that closely aligns with the contour of the body causes an effect of additional positive locking between fixation device and the part of the body. This leads to significantly increased immobilization which at the same time feels much more comfortable for the patient if compared to conventional fixation devices. Therefore, the improved comfort provided by the fixation device according to the present invention also helps to improve the compliance of the patients that undergo such radiotherapy courses. Consequently a fixation device according to the present invention may help to increase the success rate of certain medical procedures if compared to conventional devices.
An embodiment of a fixation device that adapts particularly easily even to parts of bodies with various geometries can be obtained if the first cushion comprises a first chamber that is at least partially filled with a granular material which comprises granules that have an essentially spherical shape. Thus the granules can move easily relatively to each other. Good adaptation to the outer contour of a part of the body to be immobilized may be obtained if the granules have a mean diameter of between 1 and 3 mm. A particularly good adaptation to the outer contour can be obtained if the granules have a mean diam- eter of between 1 .2 and 2.2 mm. For some applications good stiffening of the first cushion as well as good distribution of contact stress between the first cushion and the part of the body can be obtained if the granule material is made from an expanded polystyrene (EPS). For some applications where an increased cushioning effect is required, the granular material may be at least partially made from expanded polypropylene (EPP).
In an embodiment, the second cushion comprises a second chamber that can be filled with a fluid to inflate the second cushion. Thus, an evenly distributed force can be applied on the first cushion. A fluid may be a gas (e.g. air) or a liquid (e.g. water) or a gel. The cushion may comprise an opening through which the fluid may be added to the second chamber or evacuated from the second chamber. The second cushion - respectively the walls enclosing the second chamber - may be made from a material that is essentially impermeable to the fluid used. Alternatively or in addition it/they may be coated by such a material.
A variation of fixation device that can be produced at relatively low costs can be obtained if the first and/or the second cushion are/is at least partially made from a film and/or a fabric. The cushions may be made from a plastic film, in particular from thermoplastic polyurethane (TPU). Using TPU allows the cushions to be assembled mainly using plastic welding, as well as it offers good surface disinfection and cleaning. In an embodiment, the first and/or the second cushion is/are made from a plastic film that is interconnected by means of a high frequency welding process. Thus, highly durable and easy to assem¬ ble cushions can be obtained. The cushions may also be coated with another material. As well, the cushions may comprise MRI markers and/or X-ray markers in order to be identifiable during medical imaging. For some applications the front wall of the second cushion and the rear wall of the first cushion may be at least partially formed by one and the same membrane. The membrane may e.g. be made from one of the materials mentioned above. Thus the number of com¬ ponents necessary to assemble/produce the fixation device can be reduced. For some applications the first and the second cushion may be detachably interconnected by plastic welding and/or by an adhesive film and/or by a hook and loop fastener. The first and the second cushion, as well as the carrier means may also be arranged in a sleeve, such as e.g. a single-use sanitary cover.
In an embodiment, the carrier means comprises a rigid structure arranged to exert a force on a rear wall of the second cushion. Using such rigid structures allows to obtain good fixation of certain parts of the body in multiple spatial directions.
Good results may be obtained if the rigid structure comprises a plate and/or a shell and/or a grid. Thus the force (and resulting stress) exerted on the part of the body in order to immobilize it can be distributed over a larger area, respectively the distribution of force can be controlled. For some applications the rigid structure may be spatially curved. Thus, the carrier device may be adapted to the part of the body to be immobilized - which in most cases will rather have a curved than a flat contour. In contrast to devices conventionally used for the immobilization of parts of the body, the device for fixation according to the invention allows to apply an at least almost evenly distributed force even on curved contours of parts of the body.
The carrier means may comprise an adjustable and interlockable joint which allows to rotate a first portion of the carrier means relatively to a second portion of the carrier means. A joint may e.g. be a hinge or a ball joint. Thus, the shape of the carrier means may be altered and adapted such that the fixation device can be used for various parts of the body or be adjusted to fit to the anatomy of specific patients.
In one embodiment, the front face of the carrier means may be interconnected to a back face of the carrier means by an opening. Thus the amount of material needed to produce the carrier means can be decreased, leading to a decrease in weight and material costs. As well, such an opening may be used in order to get access to a rear wall of the second cushion, e.g. in order to add or evacuate fluid to/from a first and/or the second chamber (if present), as will be explained in more detail below.
In an embodiment the carrier means is at least partially made from a resilient material - hence be relatively flexible such that e.g. its shape can be easily adapted to the shape of the part of the body by the application of limited physical force. In particular, it may be made from a fabric or a plastic film, as will be explained in more detail below. For some applications, the carrier means may comprise a stiffening means in order to stiffen the carrier means at least temporarily. Thus the shape of a resilient carrier may first be adapted to the outer contour of a part of the body and then be stiffened as soon as the desired shape of the carrier means is obtained. Good results may be obtained if the stiffening means comprises a third chamber, the third chamber being at least partially filled with a granular material and comprising a means for evacuating fluid from the third chamber in order to stiffen the third chamber and thus also the carrier means. Hence a somehow stiff/rigid carrier means can be obtained, which for some applications provides improved stress distribution in, and immobilization of a part of the body.
In an embodiment the fixation device comprises a second chamber in which a connecting element mechanically interconnects the second chamber's front wall with its rear wall, restricting at least locally the distance between front wall and the rear wall when the sec- ond chamber is inflated by adding fluid. Thus the degree of deformation of the second cushion when being inflated can be controlled. The connecting element may comprise an adhesive or a plastic weld that connects the front and the rear wall (as will be explained in more detail below) . Connecting elements may e.g. be formed as quilt-type baffles or box-type baffles.
In an embodiment the carrier means comprises a fastening means in order to mechanically interconnect the carrier means with e.g. an auxiliary structure that is mechanically interconnected with a support means for the part of the body to be immobilized. The auxiliary structure may be a (mechanical) superstructure arranged at the support means, such as a bridge member that comprises two legs and a central section bridging the two legs, such that it surrounds the part of the body to be immobilized. The fastening means may e.g. be mechanically interconnected with the central section. Thus a particularly good immobilization of the part of the body can be obtained. The support means may e.g. be a support board or a stretcher. For some purposes the fastening means may comprise an adjustment means to adjust the distance and/or the relative orientation between the fixation device and an auxiliary structure and/or the part of the body to be immobilized, as will be described in more detail below. Such an adjustment means may comprise e.g. a ball joint and/or a screwed connection and/or a linear actuator and/or a clamping connection, in an embodiment, the auxiliary structure and/or the fastening member and/or the adjustment means may comprise a scale or other type of indicator which indicates positioning and/or orientation of the fixation device with respect to the part of the body and/or with respect to the support means. Thus it becomes possible to keep records on the settings used for an immobilization and consequently the same type of settings can be reproduced for follow-up immobilizations. Alternatively or in addition also electronic sensors may be used in order to determine positioning and/or orientation of the fixation device. In an embodiment the carrier means comprises a strap that can be interconnected with a support means. A strap may be a belt-type strap. The strap may be made from an X-ray transparent and/or MRI-compatible material in order to obtain a fixation device suited to be used for such types of medical imaging. As well, the strap may be made from materi- als that offer a good penetrability for most types of beams used in radiotherapy. Thus such embodiments offer great potential for being used in radiotherapy as they can easily be penetrated by the applied beams and can essentially be neglected when navigating the beam.
For some applications the first and/or the second cushion may comprise a pocket config- ured to receive a portion of the carrier means in order to fasten the first and/or the second cushion to the carrier means. Hence an easy to establish as well as reversible connection between the carrier means and the first and/or the second cushion can be obtained. Good results may be obtained if the pocket is made from an elastic material, such as a plastic film, in particular from a (TPU). Alternatively or in addition, the carrier means may be mechanically interconnected with the second cushion by means of a permanent or a non-permanent adhesive film and/or a hook and loop fastener and/or a clamping mechanism.
In an embodiment the second cushion comprises a second chamber which is fluidically interconnected with a pump in order to pump a fluid into the second chamber and thus to inflate the second cushion. The pump may be a hand pump or an automated pump. Good inflation of the second cushion can be obtained if the pump is fluidically interconnected with an opening in a rear wall of the second cushion. However, an opening may also be arranged at other walls of the cushion. For some applications, the second chamber may be interconnected with a pressure gauge for measuring the fluidic pressure in- side of the second chamber. The pressure gauge may be connected to a display that pro- vides information about said pressure. The pressure gauge may also be used in order to control an automated pump as described above. Thus the quality of the fixation may be assessed; respectively pressure settings may be reproduced in subsequent immobiliza¬ tions. Hence the inner pressure may be measured and used as an additional parameter (additional to positioning and orientation of the fixation device as mentioned above) to obtain highly reproducible immobilizations. Such high reproducibility is in particular important for follow-up immobilizations during radiation therapy, where a consistent im¬ mobilization of internal organs has to be guaranteed during a radiotherapy course which may last up to several weeks or months. The fixation device may also comprise means limit the maximum fluidic pressure inside of the second chamber, such as e.g. a pressure relief valve. Such a means may be used in order to restore a pressure setting of a previous immobilization and/or to prevent injuries due to mechanical overloading of the part of the body, as e.g. caused by suppression of blood flow.
Alternatively or in addition to a pressure gauge to measure the fluidic pressure inside of the second chamber, the fixation device may also comprise a means to measure the mass and/or volume of the fluid that is added to the second chamber. Such an embodiment can be advantageous for certain applications, as explained in more detail below.
In an embodiment the first cushion comprises an orifice to exhaust fluid from the first chamber. Thus good alignment of the first cushion to the contour of a part of the body can be achieved . Alternatively or in addition the walls of the first cushion may at least be partially made from a material which is permeable for a fluid which is inside of the first chamber (e.g. air). For example, the chamber may be made from a non-airtight fabric. A fixation device which is easy to clean and sterilize may be obtained if the orifice is arranged at a portion of the first cushion that is not intended to be pressed against the part of the body - e.g. not at the front wall of the first cushion. Thus the orifice does not get in direct contact with the part of the body to be immobilized and hence penetration of body liquids and/or germs from the part of the body via the orifice into the first chamber can be prevented. As well, in such an embodiment the front wall of the first cushion can be cleaned easily without the danger of cleaning agent penetrating into the first chamber.
In an embodiment an orifice is arranged at a rear wall (directed to the carrier means) of the first cushion and positioned such that fluid exhausted from a first chamber inside of the first cushion can pass through a passageway arranged at the connecting element of the second chamber which interconnects the front wall with the rear wall of the second cushion.
In an embodiment, the fixation device comprises a third cushion arranged adjacent to the front wall of the first cushion. The third cushion may be at least partially filled with a liquid and/or a gel and/or a granular material. For some applications, the third cushion may comprise means to add and/or remove liquid and/or gel from inside of the third cushion and/or to measure and/or control temperature of the third cushion. Hence e.g. the temperature of the part of the body to be immobilized may be controlled.
For some purposes the fixation device may comprise a single second cushion and multiple first cushions, as will be explained in further details below. For other applications, the fixation device may comprise a single first cushion and multiple second cushions. Good results may be obtained if the fixation device comprises multiple second cushions, whereof at least two second cushions comprise second chambers that are fluidically interconnected with each other. Hence - if desired - isobar pressure may be obtained in multiple second cushions. Good results for a large range of applications can be obtained if the first cushion in a non- loaded state has a thickness of between 5 and 20 mm, in particular of about 1 0 mm. The same holds true if the second cushion can be inflated to a mean thickness of between 5 and 20 mm, in particular to about 1 0 mm. The present invention is also directed to a carrier means for a fixation device, as well as to a first and a second cushion for a fixation device.
According to an aspect of the invention a system for the immobilization of a part of the body is provided, the system comprising a support means on which the part of the body can be positioned as well as an auxiliary structure that is mechanically interconnectable with the support means and that is at least partially surrounding the part of the body. Further the system comprises a fixation device as described above, the fixation device being mechanically interconnectable with the auxiliary structure.
According to a further aspect of the invention a system for the immobilization of a part of the body is provided which comprises a support means on which the part of the body can be positioned and a fixation device which comprises a strap that can be mechanically interconnected with the support means.
One aspect of the invention is directed to a method for the immobilization of a part of the body which comprises the steps of: Providing a system for the immobilization of a part of the body as described above; positioning the part of the body on the support means; po- sitioning the fixation device such that a front wall of the first cushion is at least partially aligned with the outer contour of the part of the body; displacing the carrier means towards the part of the body such that the first cushion gets into contact with the part of the body; inflating the second cushion. Thus the first cushion on the one hand forms a relatively stiff shell that aligns with the part of the body and on the other hand exerts a relatively evenly distributed force on the part of the body. Hence, stress concentration in the body part to be immobilized can be reduced, which makes the immobilization much more comfortable for the patient. Depending on the application, fluid may be added to a second chamber in the second cushion until the second chamber reaches a predefined volume and/or a predefined inner pressure. A predefined volume may be advantageous in order to reproduce a specific positioning of the part of the body while being immobilized. A predefined inner pressure may be advantageous in order to obtain a certain amount of pressure on the part of the body without a risk of mechanically injuring the part of the body. Good and safe immobilization may be obtained if fluid is added to the second chamber until an inner pressure of between 3 and 1 0 kPA is obtained.
The displacement of the carrier means and/or the amount of inflation of the second cushion may be determined based on a feedback provided by the part of the body to be immobilized, respectively the patient it belongs to. The feedback may include a measurement of blood circulation. In case of patient measurements, the feedback may be acoustic and/or optical signal given by the patient based on comfort, respectively discomfort caused by the fixation device. The fixation device may e.g. be displaced towards the part of the body until the patient starts to feel uncomfortable - which will typically be caused by a local stress concentration at the interface between the part of the body and the front wall of the first cushion. Subsequently the second cushion may be inflated to a certain extent, causing an improvement in stress distribution at said interface, leading to better immobilization and an increased comfort for the patient. The fixation device may be positioned at the abdomen, preferably at the region of the upper abdomen in order to compress the epigastric region. Hence diaphragmatic excursions which cause movements of internal organs in the chest and abdomen during respiration can be minimized. Hence, motion artifacts in medical imaging (CT, MRI) can be reduced and tracking of internal organs during radiation therapy can be improved. Good results may be obtained if the pressure inside of the second chamber is measured over time and used to control medical imaging or radiation therapy. In particular the measured pressure over time can be used for predicting and/or tracking motion of internal organs during a respiratory cycle. BRIEF DESCRIPTION OF THE DRAWINGS
The herein described invention will be more fully understood from the detailed description of the given herein below and the accompanying drawings, which should not be considered as limiting to the invention described in the appended claims.
Fig. 1 schematically shows a variation of a system for the immobilization of a part of the body in a perspective view;
Fig. 2 shows detail D of Fig. 1 ;
Fig. 3 shows a variation of a first and second cushion in a first perspective view;
Fig. 4 shows the variation of a first and second cushion of Fig. 3 in a second perspective view;
Fig. 5 shows the fixation device of Fig. 2 in a front view;
Fig. 6 schematically shows a variation of a fixation device;
Fig. 7 schematically shows another variation of a fixation device;
Fig. 8 schematically shows another variation of a fixation device; Fig. 9 schematically shows a first method step for the immobilization of a part of the body;
Fig. 1 0 schematically shows a second method step;
Fig. 1 1 schematically shows a third method step;
Fig. 1 2 schematically shows a fourth method step;
Fig. 1 3 schematically shows a variation of a fixation device in a first perspective view; Fig. 14 schematically shows a variation of a fixation device in a second perspective view; Fig. 1 5 schematically shows a variation of a system for the immobilization of a part of the body in a perspective view.
DETAILED DESCRIPTION OF THE INVENTION
The foregoing summary, as well as the following detailed description of the preferred embodiments, is better understood when read in conjunction with the appended drawings. For the purposes of illustrating the invention, an embodiment that is presently preferred, in which like numerals represent similar parts throughout the several views of the drawings, it being understood, however, that the invention is not limited to the specific methods and instrumentalities disclosed.
As schematically shown in Fig. 1 and 2, a fixation device 1 according to the invention can e.g. be used in order to immobilize a part of the body 2. In the example shown in Fig. 1 and 2, the fixation device 1 is used in order to immobilize the upper abdominal region (respectively the epigastric region) of a patient in order to minimize diaphragmatic excursions during respiration. Therefore, the patient is positioned in a lying position on a support board 4. Serving as auxiliary structure, a bridge member 3 which has two legs and a central section bridging the two legs is arranged on the support board 4, surrounding the part of the body 2. At the central section a fastening means 1 5 is fastened, which me- chanically interconnects a carrier means 1 0 of the fixation device 1 with the bridge member 3. The lower ends of the two legs are mechanically interconnected with the support board 4. As shown e.g. in Fig. 2, this variation of a fixation device 1 comprises adjustment means 1 6a, 1 6b. The first adjustment means 1 6a comprises a threaded section which allows to vary the distance between the fixation device 1 and the support means 4 (respectively the part of the body 2 lying on the support means 4). The second adjustment means 1 6b comprises a ball joint which allows to rotate the fixation device 1 relatively to the support board 4, and hence to align the fixation device 1 with the contour of the upper abdomen 2 of the patient. The variation of a fixation device 1 shown in Figs. 1 to 5 is shaped such that it can be positioned close to the patient's chest, without interfering with the ribs. Therefore the fixation device 1 comprises two lateral recesses to receive the ribs (ribs not visible).
As shown in Figs. 2 to 5, the fixation device 1 comprises a carrier means 1 0 to which a member comprising a second cushion 21 as well as three first cushions 31 is mechanical- ly interconnected. In Figs. 1 to 5 the second cushion is in a non-inflated state. This mechanical connection is established by means of three pockets 25 arranged at the second cushion 2 1 and configured to receive three portions of the carrier means 1 0, as shown in Fig. 2. The carrier means 1 0 of the fixation device 1 shown comprises a plate-like structure 1 3 that is rigid and hence is able to exert a force on the part of the body 2 via the first and the second cushions 31 , 21 . The rear face 1 2 and front face (not visible) of the carrier means 1 0 are interconnected by several openings 1 4 which decrease the weight of the carrier means 1 0 as well as they allow better access to the second cushion 21 . As shown in Figs. 1 and 2, a fluid line 7 (e.g. a tube/hose) may be arranged in such an opening 1 4 to supply fluid to a second chamber 20 arranged in the second cushion 2 1 . In the variation shown, air can be pumped by an air pump 5 via the tube 7 into the second chamber 20 to inflate the second chamber 20, respectively second cushion 21 . The fixation device 1 further comprises a pressure gauge 6 for measuring the fluidic pressure inside of the second chamber 21 . As shown in Fig. 3 a fluid connector 27 suited to be interconnected with tube 7 is arranged at the rear wall 23 of the second cushion 21 , posi- tioned such that when the second cushion 21 is mechanically interconnected with the carrier means 1 0, the fluid connector 27 and the tube 7 are arranged in an opening 1 4, as shown in Fig. 2. As well, the second cushion 21 comprises several connecting elements 24 which mechanically interconnect the second cushion's 21 front wall 22 with its rear wall 23. In the variation shown, the first and the second cushion 3 1 , 21 are made from a thermoplastic polyurethane (TPU) film and the connection means 24 are established by locally connecting the front and the rear wall (which are both made from a TPU film) by means of a local welding process. In the variation shown e.g. in Fig. 3 these connecting elements 24 are local welding spots having an essentially circular shape. As well, in the center of the connecting elements 24 passageways 26 are arranged which are fluidicaliy interconnected with orifices (not visible) arranged in rear walls 33 of the first cushions 3 1 , as will be shown in more detail below with respect to Figs. 9 to 12. As can also be seen in Fig. 3, three pockets 25 are arranged at the rear wall 23 of the second cushion, each pocket being made from a TPU film and being interconnected with the rear wall 23 by means of plastic welding. As shown in Fig. 5, the carrier means 1 0 may be spatially curved in order to better align with the contour of the part of the body 2. Therefore, the carrier means 1 0 comprises angled lateral portions (winglets). The angled portions allow to improve the immobilization of the part of the body 2 in lateral (y) direction. In order to prevent buckling -which else may occur due to the curved shape - the first cushion 31 is divided into three parts that are separated from each other by gaps. Each of the three first cushions 31 encloses a first chamber 30 that has an orifice which is fluidically interconnected with one of the passageways 26, as indicated in Fig. 3.
Figs. 6 to 8 schematically show some variations of a fixation device 1 according to the invention. The variation shown in Fig. 6 comprises a carrier means 1 0 that has a front face 1 1 on which a second cushion 21 (shown in an inflated state) is arranged. The rear wall 23 of the second cushion is arranged on the front face 1 1 of the fixation device. By means of an opening, respectively a fluid connector 27 arranged at this opening, fluid can be inflated to - respectively exhausted from - a second chamber 20 that is arranged in the second cushion 21 . A connecting element 24 mechanically interconnects the front and the rear wall 22, 23 of the second cushion and thus restricts the distance between front wall 22 and the rear wall 23 when the second cushion 21 is inflated. At the front wall, a first cushion 31 is arranged. In the variation shown, the front wall 22 of the second cushion 21 is identical with the rear wall 33 of the first cushion 31 . The first cushion 31 encloses a first chamber 30 which is partially filled with a granular material (not shown).
Fig. 7 schematically shows a variation of a fixation device 1 according to the present invention which comprises two second cushions 21 that are arranged between a single first cushion 31 and a single carrier means 1 0. Fig. 8 schematically shows another variation of a fixation device 1 according to the present invention which comprises a single second cushion 21 that is arranged between a two first cushion 31 and a single carrier means 1 0.
Figs. 9 to 12 schematically show subsequent steps of a method to immobilize a part of the body 2 according to the present invention. As indicated in Fig. 9, the fixation device 1 is positioned close to the part of the body 2, the second cushion 21 still being flat, as the second chamber 20 is not inflated yet. The first chamber 30 is partially filled with a granular material 34 comprising spherical particles of expanded polystyrene. As the first cushion 3 1 is not loaded, the particles of the granular material 34 can easily move relatively to each other and thus the shape of the first cushion 3 1 can be altered easily. The first and the second chamber 30, 20 are separated by a single membrane which forms the front wall 22 of the second cushion 21 and at the same time the rear wall 33 of the first cushion 31 . In a second method step, as shown in Fig. 10, the carrier means 1 0 is moved towards the part of the body 2 (indicated by the arrows) until the front wall 32 of the first cushion 31 gets into contact with the surface of the part of the body 2. At this point, the front wall 32 of the first cushion 31 starts to align with the part of the body 2, respectively starts to displace and deform. Consequently the shape of the first cushion 31 , respectively the first chamber 30 is changed, leading to moving and compressing of the granular material 34, as shown in Fig. 1 1. At the same time, the front wall 32 of the first cushion 3 1 starts to exert a distributed force (indicated by the small arrows) on the part of the body 2. All walls of the first and of the second cushion 3 1 , 21 are made from a fluid-tight material. Consequently - as the volume of the first chamber 30 decreases - the fluid pressure inside of the first chamber 30 increases, causing an airflow outside of the first chamber 31 through the orifice 35, respectively the passageway 26 and the opening 14 in the carrier means 1 0 (indicated by the slim dotted arrows). As soon as a certain degree of displacement of the carrier means 1 0 (respectively deformation of the first cushion 3 1 ) is obtained, the second cushion 2 1 is inflated by adding fluid (e.g. air) to the second chamber 20, which causes an increase of the mean thickness of the second cushion 21 and thus to a further compaction of the first cushion 31 . This causes an improved alignment of the first cushion 3 1 to the outer contour of the part of the body 1 as well as a further compaction of the granular material 34, leading to a more even distribu- tion of force on the part of the body 2. By this, the granular material 34 becomes more compacted, the friction between its particles increases (due to higher contact stresses and increased deformation of the particles), resulting in a stiffening of the first cushion 31 , as shown in Fig. 12.
Fig. 13 and 14 show another embodiment of a fixation device 1 which comprises a carrier means 1 0 that is made from a relatively flexible fabric. On the front face 1 1 of the car- rier means 1 0 a first and a second cushion 31 , 21 (not shown in detail) are arranged, whereby a second chamber 20 in the second cushion 21 is fluidically interconnected with the tube 7 arranged at the rear face 1 2 of the carrier means 1 9. The carrier means 1 0 comprises two straps 1 7 which comprise hook and loop fasteners (not shown in detail) that allow to establish a mechanical connection between the fixation device 1 and e.g. a support means 4 for a part of the body, as schematically shown in Fig. 15. Thus a system for the immobilization 40 of a part of the body 2 can be obtained, which allows good transmission of radiation.
REFERENCE NUMERALS
1 Fixation device 20 Second chamber
2 Part of the body (patient's body) 21 Second cushion
3 Auxiliary structure 22 Front wall (of the second cushion)
5 4 Support means (support board) 20 23 Rear wall (of the second cushion)
5 Pump 24 Connecting element
6 Pressure gauge 25 Pocket
7 Tube (hose) 26 Passageway
1 0 Carrier means 27 Fluid connector
1 0 1 1 Front face (of the carrier means) 25 30 First chamber
1 2 Rear face (of the carrier means) 31 First cushion
1 3 Rigid structure 32 Front wall (of the first cushion)
14 Opening 33 Rear wall (of the first cushion)
1 5 Fastening means 34 Granular material
1 5 1 6a, b Adjustment means 30 35 Orifice
1 7 Strap 40 System for positioning

Claims

WHAT IS CLAIMED IS:
1. A fixation device ( 1 ) for the immobilization of a part of the body (2) comprising a. a carrier means ( 1 0) providing a front face ( 1 1 ) and b. a first cushion (31 ) extending along the front face ( 1 1 ) of the carrier means ( 1 0), and c. an inflatable second cushion ( 21 ) arranged at least partially between the carrier means ( 1 0) and the first cushion ( 31 ), foreseen to press the first cushion (31 ) away from the carrier means ( 1 0) against the part of the body ( 2 ) to be immobilized, d. wherein the first cushion (31 ) is designed to switch from a more deform- able state to a less deformable state and thereby to support the immobilization effect.
2. The fixation device ( 1 ) according to claim 1 , wherein the first cushion (31 ) comprises a first chamber (30) which is at least partially filled with a filling material (34) that can switch from a more deformable state to a less deformable state.
3. The fixation device ( 1 ) according to claim 2, wherein the filling material (34) is an interlockable material that when compressed interlocks and thereby achieves a less deformable state.
4. The fixation device ( 1 ) according to claim 2, wherein the filling material (34) is an interlockable material that interlocks and thereby achieves a less deformable state when the first chamber (30) is evacuated.
5. The fixation device ( 1 ) according to one of claims 3 or 4, wherein the filling material (34) is a granular material whose granules are configured to interlock with each other when being compressed.
6. The fixation device ( 1 ) according to one of the preceding claims, wherein the second cushion ( 21 ) comprises a second chamber (20) that can be filled with a fluid to inflate the second cushion ( 21 ).
7. The fixation device ( 1 ) according to one of the preceding claims, wherein the first and/or the second cushion (31 , 21 ) are/is at least partially made from a film and/or from a fabric.
8. The fixation device ( 1 ) according to one of the preceding claims, wherein a front wall (22 ) of the second cushion (21 ) and a rear wall (33 ) of the first cushion (31 ) are at least partially formed by one and the same membrane.
9. The fixation device ( 1 ) according to one of the preceding claims, wherein the carrier means ( 1 0) comprises a rigid structure ( 1 3 ) arranged to exert a force on a rear wall ( 23) of the second cushion (21 ) .
10. The fixation device ( 1 ) according to claim 9, wherein the rigid structure ( 1 3 ) is a plate and/or a shell and/or grid.
11. The fixation device (1 ) according to claim 9 or 10, wherein the rigid structure (13) is spatially curved.
12. The fixation device ( 1 ) according to one of the preceding claims, wherein the carrier means (10) comprises an adjustable and interlockable joint which allows to rotate a first portion of the carrier means (10) relatively to a second portion of the carrier means ( 1 ) to adjust the shape of the carrier means ( 10) to the shape of the part of the body (2).
13. The fixation device ( 1 ) according to one of the preceding claims, wherein the front face (11) of the carrier means (10) is interconnected to a back face (12) of the carrier means (10) by an opening (14).
14. The fixation device ( 1 ) according to one of the preceding claims, wherein the second cushion (21) comprises a connecting element (24) that mechanically interconnects a front wall (22) with a rear wall (23) of a second chamber (20) arranged in the second cushion (21 ), restricting at least locally the distance between front wall (22) and the rear wall (23) when the second chamber (20) is being inflated.
15. The fixation device ( 1 ) according to one of the preceding claims, wherein the carrier means (10) comprises a fastening means (15) in order to mechanically interconnect the carrier means (10) with an auxiliary structure (3) that is mechanically interconnected with a support means (4) for the part of body (2) to be immobilized.
16. The fixation device according to claim 1 5, wherein the fastening means ( 1 5) comprises an adjustment means ( 1 6a, 1 6b) to adjust the distance and /or the relative orientation between the fixation device ( 1 ) and the auxiliary structure (3).
17. The fixation device ( 1 ) according to one of the preceding claims, wherein the carrier means ( 1 0) comprises a strap ( 1 7) that can be interconnected with a support means (4) where the part of the body (2 ) can be positioned on.
18. The fixation device ( 1 ) according to any of the preceding claims, wherein the first and/or the second cushion (31 , 21 ) comprises a pocket (25 ) configured to receive a portion of the carrier means ( 1 0) in order to fasten the first and/or the second cushion (31 , 21 ) to the carrier means ( 1 0) .
19. The fixation device ( 1 ) according to one of claims 6 to 1 8, wherein the second chamber (20) is fluidically interconnected with a pump (5) to pump a fluid into the second chamber ( 20) in order to inflate the second cushion (21 ).
20. The fixation device ( 1 ) according to one of claims 6 to 1 9, wherein the second chamber ( 20) is interconnected with a pressure gauge ( 6) for measuring the fluidic pressure inside of the second chamber (20).
21. The fixation device ( 1 ) according to one of claims 2 to 20, wherein the first cushion (31 ) comprises an orifice (35) to exhaust fluid from the first chamber ( 30).
22. The fixation device ( 1 ) according to claim 21 , wherein the orifice (35) is arranged at a portion of the first cushion (31 ) that is not intended to be pressed against the part of the body (2).
23. The fixation device ( 1 ) according to claim 22 and claim 14, wherein the orifice (35 ) is arranged at a rear wall (33 ) of the first cushion (31 ) and positioned such that fluid exhausted from the first chamber (30) can pass through a passageway ( 26) arranged at the connecting element (24) of the second chamber ( 20) which interconnects the front wall (22) with the rear wall (23 ) of the second cushion (21 ).
24. The fixation device ( 1 ) according to one of the preceding claim, wherein the granular material (34) comprises granules that have an essentially spherical shape.
25. The fixation device ( 1 ) according to one of the preceding claims, wherein the fixation device ( 1 ) comprises multiple first cushions (31 ).
26. The fixation device ( 1 ) according to claim 25, wherein the fixation device ( 1 ) comprises multiple second cushions ( 21 ), whereof at least two second cushions (21 ) comprise second chambers (20) that are fluidically interconnected with each other.
27. The fixation device ( 1 ) according to one of the claims 1 to 24, wherein the fixation device ( 1 ) comprises a single first chamber (30) and multiple second chambers ( 20).
28. The fixation device ( 1 ) according to one of the preceding claims, wherein the first cushion (31 ) in a non-loaded state has a thickness of between 5 and 20 mm.
29. The fixation device ( 1 ) according to one of the preceding claims, wherein the second cushion ( 21 ) can be inflated to a mean thickness of between 5 and 20 mm.
30. A carrier means ( 1 0) for a fixation device ( 1 ) according to one of the preceding claims.
31. A first and a second cushion (31 , 21 ) for a fixation device ( 1 ) according to one of the claims 1 to 29.
32. A system (40) for the immobilization of a part of the body ( 2), comprising a. a support means (4) to position the part of the body ( 2 ) on and b. an auxiliary structure (3 ) i. that is mechanically interconnectable with the support means (4) and ii. that is at least partially surrounding the part of the body (2), c. a fixation device ( 1 ) according to one of claims 1 to 29, the fixation device ( 1 ) being mechanically interconnectable with the auxiliary structure (3).
33. A system (40) for the immobilization of a part of the body (2), comprising a. a support means (4) to position the part of the body ( 2) on and b. a fixation device ( 1 ) according to claim 1 7.
34. A method for the immobilization of a part of the body ( 2) comprising the steps of a. providing a system for the immobilization (40) of a part of the body (2 ) according to one of claims 32 or 33; b. positioning the part of the body (2) on the support means (4); c. positioning the fixation device ( 1 ) such that a front wall (32 ) of the first cushion (31 ) is at least partially aligned with the outer contour of the part of the body (2); d. Displacing the carrier means ( 1 0) towards the part of the body ( 2) such that the first cushion (31 ) gets into contact with the part of the body (2); e. inflating the second cushion (21 ).
35. The method according to claim 34, wherein the second cushion (21 ) comprises a second chamber (20) and fluid is added to the second chamber (20) until the second chamber ( 20) reaches a predefined volume and/or a predefined inner pressure.
36. The method according to one of claims 34 or 35, wherein the amount of inflation of the second cushion ( 21 ) is determined by a feedback provided by the patient, the part of the body (2 ) to be immobilized belongs to.
37. The method according to one of claims 34 to 36, wherein the fixation device ( 1 ) is positioned at the abdomen, preferably at the region of the upper abdomen to minimize diaphragmatic excursions during respiration. The method according to one of claims 35 to 37, wherein the internal pressure inside of the second chamber ( 20) is measured over time and used to control a process of medical imaging and/or a process of radiation therapy.
PCT/EP2016/074584 2015-10-16 2016-10-13 Fixation device for a part of the body WO2017064182A1 (en)

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CH14982015 2015-10-16

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