PATIENT IMMOBILIZATION DEVICE, SYSTEM AND METHOD FOR IMMOBILIZING A PATIENT

The invention relates to a patient immobilization apparatus (100) comprising a planar element (105) made of a non-woven fabric. The planar element (105) has an elongate middle section (110) and a plurality of arms (120; 130), which extend out laterally on both sides of the middle section (110). The patient immobilization apparatus (100) can be provided to the end user, preferably in a folded state. In the folded state, each of the arms (120; 130) is folded laterally on the elongate middle section (110). Parts of the elongate middle section (110), having the arms (120; 130) folded laterally thereon, are advantageously additionally foldable onto each other in the longitudinal direction. Each arm (120; 130) can be folded laterally in part on itself before it is folded laterally on the elongate middle section (110).

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'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.

EMBODIMENTS OF THE INVENTION

Referring toFIG. 1, a nonwoven fabric layer forming a planar element105is shaped to provide a patient immobilization device100. The immobilization device100has an elongate middle part110, from which two or more arms120,130extend laterally on both sides of the middle part110. The fabric of the planar element105, 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 inFIG. 4, the patient immobilization device can be used to secure a patient P to a patient table305by placing the middle part110on the patient's torso and fastening the arms120,130to micro-hook fastening elements300, which can be fastened on each side of the patient table305. Other uses of the patient immobilization device100are possible. These include immobilizing a body part of a patient P with the patient immobilization device100similarly 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 part110is preferably between 100 cm and 200 cm long and has a width of between 10 cm and 30 cm. The elongate middle part110may 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 arms120,130are preferably between 5 cm and 20 cm wide and between 50 cm and 150 cm long. The elongate middle part110is generally longer than the arms120,130and often has approximately the same width as the arms120,130. Longitudinal gaps140can be cut out between every two adjacent arms120,130. The longitudinal gaps140can be between 1 cm and 10 cm wide.

The longitudinal gaps140can be cut out with semicircular transitions150which separate the arms120,130at the middle part110. This reduces the risk of accidentally tearing the fabric sheet.

The arms120,130can be arranged symmetrically, with a left arm120in each case being arranged on the middle part110symmetrically with respect to a right arm130.

The patient immobilization device100can have between five and fifteen arms120,130which extend laterally on each side of the middle part110.

In use, each arm120,130can be individually and separately fastened to a micro-hook fastening element300. In this case, the number of micro-hook fastening elements300that are used on each side of patient P is equal to the number of arms120,130on that side of the patient P. Alternatively, an n:1 or 1:n relationship between arms120,130and micro-hook fastening elements300can be used. That is to say, one fastening element300can be used to fasten two or more arms120,130, or one arm120,130can be fastened to two or more micro-hook fastening elements300.

The arms120,130and the corresponding micro-hook fastening elements300are 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 arms120,130can remain unsecured or can even be separated from the central portion110, so as to create an accessible region while a medical intervention is being performed. The nonwoven fabric of the planar element105of the patient immobilization device100can be cut, for example, with a safety cutting device having a blade located in a narrow slot into which an arm120,130of the patient immobilization device100can be inserted, but which is inaccessible to a human finger or another body part.

Perforations112,113can be formed within the middle part110in order to make the middle parts110of the patient immobilization device100easy to separate. As is shown, the perforations112can run perpendicular to the longitudinal axis of the middle part110between two arms120,130. The perforations112preferably extend parallel to the holding force of the patient immobilization device along the arms120,130. As a result, the perforations112,113do not weaken the ability of the device to hold a patient P securely. However, the perforations112,113offer an additional safety mechanism in the event that an arm120,130has been fixed wrongly or with too high a tensile force, for example by being wrongly clamped. In this case, the loose arm120,130can be pulled in any direction, without the risk of the remaining arms120,130being accidentally removed. The central portion110, also referred to as the middle part110, tears along the perforations112,113, such that no force exerted on an individual arm120,130, regardless of its direction, can cause the detachment of an adjacent arm120,130.

To promote this safety aspect, the perforations113in the middle part110of the patient immobilization device100can run tangentially from the arms120,130in an X-shaped pattern over the middle part110.

The patient immobilization device100is preferably shipped in the folded state101, as shown inFIG. 3, and made available for use by medical personnel at the place of use. As is shown inFIG. 2, the folded state101can be obtained by folding each arm120,130onto itself one or more times, as is indicated by the arrows201,202and203,204. The arm120,130, pre-folded in this way, is then folded onto the middle part110. As is indicated by arrows209,219, the folded arms120,130, and a part of the central part110lying correspondingly under them, can then be folded, according to the arrow209, onto the next arms120,130, which are pre-folded according to the arrows211,212or213,214, and the adjacent part of the middle part110. The longitudinal fold can preferably coincide here with the perforations112. The folding process allows the medical personnel to easily place the folded patient immobilization device101centrally onto the torso of the patient P and then to unfold it there, as is shown inFIG. 4. During the unfolding, the medical personnel can fasten the arms120,130to corresponding micro-hook fastening elements300, which can be easily fastened on both sides of the patient P to a bed or patient table305. 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 element300is shown inFIGS. 5 and 6. The micro-hook fastening element300has a body with a generally flat, plate-shaped front body portion310, which is also referred to as a plate part310. A micro-hook patch312with micro-hooks314arranged thereon is fastened to the front body part310. The micro-hook fastening element300is configured such that it easily latches into place on a rail301of a patient table305or 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 element300comprises an upper side web332, which extends approximately perpendicularly from the rear face of the front body part310. A channel350is provided in a lower web340, which extends at a distance from and in parallel under the upper lateral web332. The channel350is approximately 1 cm wide, in order to receive a lower part of the rail301. The lower web340extends along a lower end of the front body part310and can have a generally V-shaped cross-sectional shape. The upper lateral web332can be arranged at a distance of approximately 3 cm from the bottom surface of the channel350. The lower web340and the upper web332are configured such that they can receive frequently used rails301, 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 patch312with micro-hooks314, which is fastened to the front body part310, can engage around a lower V-shaped end of the micro-hook fastening element300and cover a part of the lower web340. In order to achieve the desired strength, the use of a micro-hook patch312with approximately between 250 and 350 micro-hooks per cm2, in particular with approximately 300 micro-hooks per cm2, has proven advantageous. The micro-hooks314can particularly preferably be made of polyamide or polypropylene. The micro-hooks314preferably have a height of approximately 0.5 mm, e.g. 0.4 mm. The micro-hook patch312can be affixed to the micro-hook fastening element300using an adhesive layer313advantageously formed from polyurethane.

An elastically deformable rubber strip, in particular a silicone rubber strip355, can be arranged within the channel350. When the micro-hook fastening element300is fastened to the rail301, a lower part of the rail301is received within the channel350, while an upper part of the rail301is pressed against the upper lateral web332by means of the silicone rubber strip355. The silicone rubber strip355is elastically deformed in the process and provides the required clamping force for securely holding the micro-hook fastening element300on the rail301.

The channel350is formed along an upper side of the lower web340between the plate part310and a parallel wall339. A groove338can be formed within a bottom of the channel350. The deformable silicone rubber strip355can have a generally D-shaped hollow cross section, wherein a flat part of the D-shaped cross section rests on a bottom of the channel350, and a convex part of the D-shaped cross section points upward toward the rail301.

An anchor part357can extend vertically into the groove338centrally from the flat part of the D-shaped cross section. The deformable silicone rubber strip355resembles a D-shaped door sealing strip.

Referring toFIGS. 7 to 11, alternative embodiments to the micro-hook fastening elements300are now shown. The alternative fastening element400shown includes a micro-hook patch420, which is wrapped around a keder cord410. The fastening element400can be inserted into a keder rail450of a patient table305. The keder rail450runs in the longitudinal direction on the sides of the patient table305. The keder rail450contains at least one groove-shaped cavity452(seeFIG. 11), which is accessible through an upwardly or laterally directed slot453. The slot453is wide enough to accommodate the thin micro-hook patch420in a double layer, and narrow enough to hold its end, wrapped around the keder cord410, in the groove-shaped cavity452.

As is shown inFIG. 10, the keder cord410can have various cross-sectional shapes. For example, it can have a polygonal, round, oval or D-shaped cross section. A trapezoidal cross section411and a generally D-shaped cross section412are shown inFIG. 10.

As is shown inFIG. 11, the keder cord410can comprise a generally circular lower part, which is held in the cavity452of the keder rail450, and a thinner upper part, which extends through the slot453of the keder rail450. The upper part of the keder cord410can be bent in order to align the micro-hook patch420at a defined angle relative to the keder rail450. As is shown inFIG. 11, a keder cord413bent by approximately 90° or a keder cord414bent by approximately 45° can be used. Of course, other angles are also possible.

FIG. 8shows the fastening element400with a disposable patch365arranged on the inside. Such a disposable patch365can be used for various purposes and in combination with any type of fastening element300or400. For example, the disposable patch365can be used to protect the micro-hooks314of the fastening element300or400from dirt when not in use. In this case, the fastening element300,400can be supplied together with a disposable patch365. The disposable patch365protects the micro-hooks314during transport and is only removed shortly before use.

Alternatively, as is shown inFIG. 8, the disposable patch365can also be used on the patient-side face of the fastening element400, in order to prevent direct contact between the micro-hooks and a patient.

FIG. 12shows a cross-sectional view of a fastening element300in an exploded view. A micro-hook patch312with micro-hooks314is fastened to the front body part310of the micro-hook fastening element300. Here, the micro-hook patch312is affixed to the front body part310of the micro-hook fastening element300by an adhesive layer313. The micro-hooks314are formed on an opposite, outwardly facing side of the micro-hook patch312. The micro-hooks314can generally be mushroom-shaped elements that are suitable for engaging in loops160of the nonwoven fabric of the patient immobilization device100and for clamping themselves firmly therein.

The micro-hook patch312can be permanently affixed to the front body part310of the micro-hook fastening element300and can then also be designated as an anchor patch312. The micro-hook patch312is 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 patch360is shown inFIG. 12. The disposable patch360has, on its inner face, a layer of microfiber loops361, similar to those of the patient immobilization device100,101. The disposable patch360has a micro-hook layer362on its outer face, the micro-hooks corresponding to those of the anchor patch312.

The disposable patch360can thus form an intermediate layer between the anchor patch312and the patient immobilization device100. More than one disposable patch360can be used in order to form a sandwich structure in which several disposable patches360are arranged between the anchor patch312of the micro-hook fastening element300and the patient immobilization device100. After each use, the patient immobilization device100and the outermost disposable patch360can 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 device100,101to 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 element105with its multiple arms120,130can be brought into engagement directly with the micro-hooks314on the micro-hook fastening element300, on the micro-hook patch or anchor patch312or420, and fixed. Since the aforementioned fastening elements having the micro-hooks314are displaceable as required on the rail301or on the groove-shaped cavity452of a patient table305, 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