WO2012118423A1 - Device and method for the reduction of radius fractures - Google Patents

Device and method for the reduction of radius fractures Download PDF

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Publication number
WO2012118423A1
WO2012118423A1 PCT/SE2012/000020 SE2012000020W WO2012118423A1 WO 2012118423 A1 WO2012118423 A1 WO 2012118423A1 SE 2012000020 W SE2012000020 W SE 2012000020W WO 2012118423 A1 WO2012118423 A1 WO 2012118423A1
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WO
WIPO (PCT)
Prior art keywords
fracture
instrument
connecting device
arch
victim
Prior art date
Application number
PCT/SE2012/000020
Other languages
French (fr)
Inventor
Adrihan Hermann JANBAZ
Condrad Chris JANBAZ
Original Assignee
Janbaz Adrihan Hermann
Janbaz Condrad Chris
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 Janbaz Adrihan Hermann, Janbaz Condrad Chris filed Critical Janbaz Adrihan Hermann
Publication of WO2012118423A1 publication Critical patent/WO2012118423A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/01Orthopaedic devices, e.g. splints, casts or braces
    • A61F5/04Devices for stretching or reducing fractured limbs; Devices for distractions; Splints
    • A61F5/042Devices for stretching or reducing fractured limbs; Devices for distractions; Splints for extension or stretching
    • A61F5/048Traction splints
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/37Restraining devices for the body or for body parts, e.g. slings; Restraining shirts
    • A61F5/3715Restraining devices for the body or for body parts, e.g. slings; Restraining shirts for attaching the limbs to other parts of the body
    • A61F5/3723Restraining devices for the body or for body parts, e.g. slings; Restraining shirts for attaching the limbs to other parts of the body for the arms

Definitions

  • the present invention concerns a device and method for the reduction of radius fractures in accordance with the claims.
  • Hand and wrist fractures are some of the most common types of fractures and they particularly affect older individuals.
  • the incidence (number of injuries) of wrist fractures is estimated at 300 per 100 000 inhabitants each year.
  • the incidence rate is however estimated at 880 per 100 000 inhabitants each year.
  • Distal radius fractures are one of the most commonly reported areas where patients complain of unsatisfactory results in treatment of the fractures resulting in a high incidence of insurance claims.
  • a major problem with most types of fractures is the difficulty of bone reduction (setting) to its original position. This is particularly true of distal radius fractures. A number of factors affect the ability to successfully set a fracture. The first and most difficult medical problem affecting the end result is an axial shortening of the radius compared with the ulna where it is common that different types of displacement of various difficulties occur. Apart from this axial shortening there is also a dorsal displacement and tilt of the distal fragment as well as radial angulations of the wrist. In more than 60 corp of fracture cases an associated fracture of the ulnar styloid process is present as well.
  • the first problem is the most difficult to resolve in connection with a closed reduction.
  • the reason for this is that the problem is typically based on an insufficient axial traction (stretching of the forearm in the arm's axial direction), which is very essential for the reduction of the fracture and to achieve an adequate position and thus as good a prognosis as possible.
  • An inadequate treatment increases the risk of both short and long term complications of various degrees and type such as limited and impaired wrist function.
  • a third health care professional applies a supporting plaster splint over the back of the hand/wrist and forearm. While the plaster solidifies, the two afore mentioned health care professionals continue to hold the fracture affected limb in a stable/static position for a few minutes.
  • the time required varies widely, but typically the entire procedure takes between 30- 60 minutes. Time can increase significantly depending on how successful the first reduction attempt was. If several attempts are needed, the time may increase significantly.
  • the area In order to carry out a reduction the area must first be anesthetized, which is done in different ways depending on the treating physician's experience and method which he/she feels familiar with.
  • two methods are normally used.
  • anesthetic is applied by injection directly into the fracture site of the wrist. This method only anesthetizes the fracture site.
  • anesthetization is accomplished intravascularly (directly into a blood vessel in the hollow of the elbow) to numb the entire forearm.
  • Intravascular anesthetization is still regarded as advantageous because it increases
  • US20060200061 also impedes the ability to keep it clean and possibly even sterile.
  • the design according to its description also has the problem that plane of the elbow is positioned at a higher vertical position compared with the axial traction vector and
  • US7771378 describes a design which includes a function for the reduction of broken forearms.
  • the design has a number of deficiencies in comparison with the present design. For example, it has far too many parts and components compared with the present design that is in one piece and thus very easy to handle thanks to the fact that several of the components do not need to be unscrewed/screwed together for each treatment.
  • US7771378 also includes a support for the forearm that acts as fixation device that causes an obstruction when applying a cast up to the level of the elbow (because this component is in the way and will be under the cast). Moreover, different "straps" are used to fix the upper and forearm against the fixation device, which because of its small surface causes a high pressure over the underlying tissue with the risk for injury. This design also lacks the blood pressure cuff function included in the present patent application, which allows the use of different anesthesia methods. The design according to US7771378 allows bending of the wrist in only one plane at a time, which usually is not enough because a fracture consists of three components (axial shortening, backward bending and radial angulation which is an outward angle from the radius).
  • US7771378 lacks the ability to make the whole design mobile in a simple manner (for example, being able hang it around the fracture victims neck via straps/belts) in order to make the fracture victim more moveable for transport to different facilities (X-ray room, operating theater, recovery and others).
  • the main purpose of the present invention is to create a device that substantially improves the ability of health care providers in the reduction of forearm fractures with satisfactory results.
  • Another purpose of the present invention is to provide a device by which the reduction of a forearm fractures may be performed by one health care professional thereby freeing healthcare resources to be used in other treatments.
  • It is a further purpose of the present patent application to allow X-ray examination of the fracture, to verify an adequate fracture reduction, without the need for the device to be removed from the treated fracture victim.
  • a still further purpose is to minimize unsatisfactory results depending on the skill levels of health care professionals and maximize the possibility of standardized treatment.
  • a yet still further purpose of the present invention is to provide a method for using the device.
  • Fig. 1 shows a first embodiment of the present invention.
  • Fig. 2 shows a first alternate embodiment of the present invention.
  • Fig. 3 shows a first embodiment of the included positioning device.
  • Fig. 4 shows an alternate embodiment of the positioning device.
  • Fig. 5 shows a cross-sectional view of the positioning device according to Fig. 4.
  • an exemplary form of an instrument (device) 1 for the reduction of bone fractures such as preferably fractures of the forearm 2 is shown schematically.
  • the instrument 1 has at least one first connecting device 3, at least one second connecting device 4 and at least one intermediate structure 5.
  • the first connecting device 3 is intended to be connected to the fracture victim's upper arm 6.
  • the second connecting device 4 is connected to the hand, the fingers or the like at at least one position which is positioned beyond the fracture relative to the first connecting device 3.
  • the second connecting device 4 is via at least one traction device 7 connected to the structure 5.
  • the instrument 1 includes at least one positioning device 8 which is intended to be used to adjust the position of the forearm 2 in relation to the hand.
  • the first connecting device 3 includes at least one supporting connection part 9 with which the device abuts against the front of the upper arm 6.
  • the first connecting device 3 further includes at least one first connecting member 10 with the connecting device 3 is temporarily connected to the upper arm 6 of the fracture victim whose fracture is to be reduced.
  • the first connecting device 3 includes at least one first connecting member 10 and at least one second connecting member 11.
  • the connecting member 10 consists of at least one first cuff (sleeve) 12 and the second connecting member 11 of at least one second cuff (sleeve) 13.
  • the cuffs 12 and 13 are preferably of some type of blood pressure cuffs. In alternative embodiments, the cuffs 12 and 13 consist of other types of sleeves.
  • the connecting member 10 and connecting member 1 1 may be of various types of straps or other suitable for the purpose of connecting members with which the connecting device 3 may be temporarily connected to the upper arm 6.
  • the cuff 12 and cuff 13 are connected to the upper arm 6. Each cuff 12 and 13 are
  • cuffs 12 and 13 make it possible to adjust the shape of the connecting device 3 relative to the upper arm 6.
  • the cuffs 12 and 13 are provided with, or connected to, at least one pressure gauge or other type of indicator that shows the pressure in each cuff 12 and 13.
  • an anesthetized area may be achieved by injection of anesthetic directly into the fracture site of the wrist, which only numbs the area around the fracture.
  • the present instrument may also be used in connection with anesthetic given intravascularly (directly into a blood vessel in the hollow of the elbow), whereby the whole forearm is put under sedation.
  • the design of the instrument allows for intravascular anesthesia to be achieved with a substantially reduced risk of the anesthetic following a vein to the heart and causing heart rhythm disturbances.
  • the solution to this problem is achieved by the design including two cuffs 12 and 13 which are used according to the following procedure. Initially, the first cuff 12 is connected and pressurized. Pressurization of the first cuff 12 takes place in an area of the upper arm that is not anesthetized which allows the fracture victim to usually feel some pain in this area. The anesthesia is then intravascularly administered in the vein in the arm. The pressurization of the first cuff (upper arm cuff) 12 reduces the risk that the administered anesthesia follows the vein to the heart and thereby affecting heart rhythm.
  • the instrument (device) 1 for the reduction of fractures also includes at least one second connecting device 4.
  • the second connecting device 4 includes at least one connecting member 14 which is connected to the fracture victim's wrist affected and/or fingers beyond the position of the fracture. In alternative embodiments, the connection of the connecting member 14 may occur at another suitable for the purpose position on the hand, wrist or the like.
  • the connecting member 14 may consist of a so-called Chinese finger trap, also known as a Chinese finger puzzle or Chinese handcuffs.
  • a Chinese finger trap also known as a Chinese finger puzzle or Chinese handcuffs.
  • the connecting member 14 consists of a Chinese finger trap or the like, preferably several Chinese finger traps are used and are connected to several fingers of the hand.
  • the connecting member 14 consists of a cuff or the like which is connected to the wrist. It is further conceivable that the connecting member 14 consists of a glove or similar.
  • the frame 5 includes at least one back arch 15.
  • the back arch 15 includes at least one first arch section 16 and at least one second arch section 17.
  • the back arch 15 includes at least one first arch section 16, at least one second arch section 17 and at least one third arch section 18.
  • the first arch section 16 is connected to the supporting connection part 9.
  • the first arch section 16 is pivotally arranged relative to the supporting connection part 9 via at least one articulation (joint) 19.
  • the first arch section's 16 point of attachment relative to the supporting connection part 9 may be adjusted in the vertical direction.
  • the supporting connection part 9 may include a number of attachment points 20 with which a stepwise (incremental) positioning of the first arch section 16 may occur in relation to the supporting connection part 9.
  • the adjustment of the first arch section 16 and the supporting connection part 9 are non-incrementally (infinitely, variably) adjustable.
  • the first arch section 16 connects to the second arch section 17 via at least one first articulation (joint) 21.
  • the articulation 21 includes a feature with which the articulation 21 may be temporarily locked in specific position.
  • the articulation 21 consists of a ball joint.
  • the second arch section 17 may be formed in one piece or alternatively may include at least one first portion 22 and at least one second portion 23 which are interconnected with each other.
  • the interconnection of the first portion 22 and the second portion 23 may be accomplished by the first portion 22 being inserted into the second portion 23, or vice versa, and that they are mutually lockable by a locking function.
  • the length of the second arch section 17 may be adjusted and locked to a specific length.
  • the mutual length adjustment may occur stepwise (incrementally) or non-incrementally
  • adjustment of the second arch section's 17 length occurs incrementally (stepwise).
  • the stepwise adjustment of the length of the arch section 17 is accomplished by the first portion 22 and the second portion 23 being provided with a series of holes 24.
  • the first arch portion 22 and the second arch portion 23 are connected together with each other by a pin 25 or the like being passed through a hole in the series of holes in the first portion 22 and through a hole in the series of holes in the second portion 23.
  • the adjustment feature allows the adjustment of the instrument's length in proportion to the fracture victim's arm size.
  • the second arch section 17 is in its other end connected to the third arch section 18 via at least one second articulation (joint) 26 or the like.
  • the articulation 26 includes a function with which the articulation 26 may be locked in specific positions.
  • the articulation 26 consists of a ball joint.
  • the third arch section 18 has a curved, bent or otherwise suitable form which changes the direction of the frame 5 back towards the fracture victim.
  • the third arch section 18 may for example be U-shaped or of another suitable shape for the purpose.
  • Arch sections 16, 17 and 18 consist preferably of tubes, profiles or the like.
  • the design is made of a very light but resilient and strong material, which allows, as required, a relatively high, stable and concentrated traction strength, while providing opportunities for the transport of the fracture victim with little effort.
  • the material of the arch sections may be of metal, polymeric material or other suitable material for the purpose, or combinations of different materials.
  • the traction device 7 includes at least one line 27, rope, wire, cable, strip or similar which in its one end is connected to at least one tensioning device 28 which is connected to the arch. The position of the placement of the tensioning device 28 may vary within the scope of the present patent application. With the tensioning device 28, traction via the line 27 and the connecting device 4 may be applied to the fracture victim's forearm and hand allowing for traction (reduction) of the fracture in the forearm to occur.
  • the Incorporated in the traction device is preferably at least one gauge, scale, tensionometer or the like which detects the instantaneous force with which the arm is pulled. This is essentially as good as mandatory and a prerequisite for a physician to keep a record, evaluate, quality assure and possibly reproduce the treatment and outcomes.
  • the positioning device 8 in Fig. 1 consists of at least one from the "arch" extending strip 29 or the like. In order to enable fastening of the strip 29 or strips, one of the arch sections has at least one loop 30 or the like in which one or more strips 29 is connected.
  • the positioning device 8, makes it possible to apply traction to the forearm so that the different parts of the wrist may be affected by the traction vector in different directions (the purpose of this is to solve the three, in the background described, fracture components).
  • the present instrument 1 includes at least one positioning device 8.
  • a second embodiment of the positioning device 8 is shown.
  • the positioning device 8 is connected to the second arch section 17.
  • the positioning device's 8 position may be fixed or adjustably arranged along the length of the second arch section 17.
  • the positioning device 8 is arranged to be foldable via at least one third articulation (joint) 31. With this articulated function, the positioning device 8 may be folded in and folded out, in relation to the second arch section 17.
  • the positioning device 8 is further preferably arranged to be rotatable relative to the second arch section 17 around a pivot axis in the second arch section's essentially transverse direction.
  • the positioning device 8 includes a first portion 32 and a second portion 33 which are interconnected with each other.
  • the first portion 32 and second portion 33 insertable into one another and mutually lockable.
  • Mutual locking may be achieved by the portions 32 and 33 including a series of holes which may be locked together by at least one pin. It is further conceivable that portions 32 and 33 are telescopically adjustable and locked by a snap lock of the previously known type.
  • the positioning device 8 also includes a connector 34 against which the fracture victim's forearm is laid against. The connector 34 is connected to the positioning device's second portion 33.
  • the connector 34 is rotatably and displaceably arranged relative to the second portion 33.
  • the connector 34 includes at least one first contact surface 35, one second contact surface 36 and one third contact the 37.
  • the positioning device 8 includes a strap 38 or other tensioning member with which the arm is temporarily fixed to the connector 34.
  • Fig. 2 shows a third embodiment of the positioning device 8.
  • the positioning device includes at least one first foldable appendage 39 from the arch.
  • the positioning device 8 also includes at least one first foldable side arch 40 and at least one second foldable side arch 41 which are connected on each side of the arch's second part.
  • the foldable side arches 40 and 41 include brackets in which straps or the like may be connected to the forearm 2 and used to pull the arm in the various desired directions.
  • the instrument 1 preferably includes at least one first support 42 to which the first connecting device 3 may be supported against an underlying surface.
  • the support 42 is exemplified in Fig. 2.
  • the support 42 in the exemplifying figure, is preferably pivotally arranged so that it may be folded out and folded in.
  • the instrument also includes a second support the 43.
  • the second support 43 is connected to the instrument's 1 third arch section 18.
  • the second support 43 is also preferably pivotally arranged so that it can be folded out and folded in towards the third arch section 18.
  • the instrument 1 includes at least one first strap 44, belt, strip or similar stabilizing member which prevents a vertical displacement of the connecting device 3 downwards in relation to the upper arm. In alternative embodiments, it is
  • the instrument 1 include at least one second strap 45, belt, strip or similar stabilizing member which prevents a vertical displacement of the connecting device 3 upwards in relation to the upper arm.
  • the instrument 1 includes at least one strap 46, belt, strip or the like which is hung around the neck of the fracture victim (such as a sling), which in turn enables the transport and makes the instrument mobile.
  • the instrument 1 may be held in place by one or more suspension devices 47 or the like.
  • two suspension devices 47 are shown in the form of straps 48 and 49 which support the device and unburdens the fracture victim.
  • the suspension device 47 (or suspension devices 47) may consist of another for the purpose suitable suspension devices.
  • any of the details such as supports, belts, straps, foldable side arches or other details may be transferred from the second embodiment to the first embodiment.
  • the instrument include at least one timer (not shown in the figures).
  • the timer may for example be used to record time for one of the procedures that the device is intended to perform. For example, the time period for how long the forearm is exposed to traction may be measured.
  • the design is lightweight.
  • a further advantage is that the device may be used by a single healthcare professional, which in turn frees medical recourses to be used for other health needs.
  • the present device offers good accessibility to the area that needs treatment. The simplicity (from several perspectives) is very helpful during treatment procedures.
  • the design has the further advantage that it is easy to clean.
  • the design is also stable during use.
  • the device and method also result in reproducible reduction results.
  • the design also allows treatment result to be more independent of the skills of treating health care professionals, that is to say less dependent on who is carrying out the treatment.

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Abstract

The invention relates to an instrument (1), intended for use in the reduction of radial fractures, including at least one first connecting device (3) and at least one second connecting device (4) with at least one intermediate frame (5). The first connecting device (3) is intended to be connected to the fracture victim's upper arm (6) and the second connecting device (4) is intended to be connected to the hand, fingers or the like at least one position which is positioned beyond the fracture relative to the first connecting device (3). The instrument (1) includes at least one first traction device (tensioning device) with which a change in distance between the first connecting device (3) and the second connecting device (4) may take place and hence a traction of the forearm may be performed. Unique to the present invention is that the instrument (1) includes at least one positioning device (8) with which the forearm's (2) position relative to the hand may be adjusted.

Description

Device and Method for the Reduction of Radius Fractures Field of the Invention
The present invention concerns a device and method for the reduction of radius fractures in accordance with the claims. Background of the Invention
Hand and wrist fractures (distal radius fractures) are some of the most common types of fractures and they particularly affect older individuals. The incidence (number of injuries) of wrist fractures is estimated at 300 per 100 000 inhabitants each year. For women between the ages of 50 and 69, the incidence rate is however estimated at 880 per 100 000 inhabitants each year. Distal radius fractures are one of the most commonly reported areas where patients complain of unsatisfactory results in treatment of the fractures resulting in a high incidence of insurance claims.
A major problem with most types of fractures is the difficulty of bone reduction (setting) to its original position. This is particularly true of distal radius fractures. A number of factors affect the ability to successfully set a fracture. The first and most difficult medical problem affecting the end result is an axial shortening of the radius compared with the ulna where it is common that different types of displacement of various difficulties occur. Apart from this axial shortening there is also a dorsal displacement and tilt of the distal fragment as well as radial angulations of the wrist. In more than 60 procent of fracture cases an associated fracture of the ulnar styloid process is present as well.
Of the mentioned problems, the first problem is the most difficult to resolve in connection with a closed reduction. The reason for this is that the problem is typically based on an insufficient axial traction (stretching of the forearm in the arm's axial direction), which is very essential for the reduction of the fracture and to achieve an adequate position and thus as good a prognosis as possible. An inadequate treatment increases the risk of both short and long term complications of various degrees and type such as limited and impaired wrist function.
As a rule people with fractures seek out an emergency room. Today it is known that emergency rooms are often overcrowded with people with many different types of illnesses. It is not uncommon for fractures to occur during late hours or weekends when there are fewer health care professionals on-duty. The consequences of this are that waiting times for treatment may be unfortunately long, which does not favor a satisfactory result in treatment.
Since all on-call physicians and other needed health care professionals have varying degrees of experience, technical know-how for reduction and even strength, this may result in the outcome of fracture treatment being dependent on various independent and to some extent non-controllable factors. Thus, it is not unreasonable to conclude that a fracture victim arriving at the "right" time and meeting the "right" physician and other heath care workers will have a much better treatment/prognosis than a fracture victim with worse "luck". As a result, the outcomes of treatment will be dependent on the current method established in a country's various emergency and orthopedic clinics and also on the treating physician and thus the quality of treatment will vary.
In way that these fractures are currently treated they require, in addition to the fracture victim himself, at least three other health care professionals (of which at least one is a doctor) in order to accomplish a reduction. This brings with it the disadvantage that all involved health care professionals must do exactly the right thing at the right time in the steps of the treatment process to fully heal the fracture victim. This requires extensive experience and training. A health care provider usually has the task of keeping the fracture victim's upper arm in a stable position, whilst the doctor, for several minutes, manually pulls the fracture victims hand/fingers. Furthermore, it is very difficult to maintain a static and stable traction in the axial direction while at the same time manually trying to push the other distal and proximal fracture parts into place to obtain a satisfactory positioning/alignment of the distal and proximal fracture parts without losing a portion of the axial traction that is very essential for reduction. A third health care professional applies a supporting plaster splint over the back of the hand/wrist and forearm. While the plaster solidifies, the two afore mentioned health care professionals continue to hold the fracture affected limb in a stable/static position for a few minutes. The time required varies widely, but typically the entire procedure takes between 30- 60 minutes. Time can increase significantly depending on how successful the first reduction attempt was. If several attempts are needed, the time may increase significantly.
An inadequate reduction may lead to the fracture victim being forced to undergo an operation to position the fracture in its proper place. This will result in excessive costs due to such needs as for example several more health care professionals (anesthesiologists, nurses and others) and the need for surgical resources and recovery. Not at all insignificant with such an operation are the surgical risks for the fracture victim, which arise in connection with anesthesia and the subsequent risk of infection.
In order to carry out a reduction the area must first be anesthetized, which is done in different ways depending on the treating physician's experience and method which he/she feels familiar with. In particular, two methods are normally used. In the first method anesthetic is applied by injection directly into the fracture site of the wrist. This method only anesthetizes the fracture site. With the second method anesthetization is accomplished intravascularly (directly into a blood vessel in the hollow of the elbow) to numb the entire forearm. When using this method, it is very important and essential that the doctor makes sure that the anesthetic (which can be very hazardous if this spreads to the heart) remains in the forearm. Intravascular anesthetization is still regarded as advantageous because it increases
significantly the comfort of the fracture victim. To combat the spread of anesthesia, a system of blood pressure cuffs is used to stop the flow of blood in the direction of the heart during treatment. Current blood pressure cuffs are not designed for the treatment of wrist fractures or to existing equipment used to treat wrist fractures, which complicates the use of intravascular anesthetization. There is a need for instruments and methods that are capable of both intravascular anesthesia and reduction of fractures.
The current method of treatment for wrist fractures is not very productive because it requires the involvement of so many parties and is very dependent on each person's abilities and skills. If a fracture victim as a result of fracture treatment receives an unsatisfactory result, costs may be very high and suffering may be lifelong. A simpler and safer way to treat wrist fractures is needed.
Prior Art
Devices intended for use in the reduction and traction of fractures are previously known. An example of these is shown and described in US20060200061. The design according to its description has a number of shortcomings in relation to the design in accordance with the present patent application. For example, the design according to its description is substantially more cumbersome and has a substantially lesser mobility than the design in accordance with the present patent application. Further, the design entails that it is virtually impossible to add a cast and x-ray the arm, and at the same time maintain an adequate traction and a stable position, which is essential for good results. Further, the design in accordance with
US20060200061 also impedes the ability to keep it clean and possibly even sterile. The design according to its description also has the problem that plane of the elbow is positioned at a higher vertical position compared with the axial traction vector and
simultaneously it fixates the upper arm with a "relatively narrow" band at the front. These factors will lead to the pulling force on the fingers/wrist in turn lifting the elbow from the underlying surface and increase the angle of the elbow more than 90 degrees, which in turn leads to the upper arm being pulled down out of the fastening device while the soft tissues (skin, biceps muscle and the surrounding vessels and nerves) receive an unwanted traction.
US7771378 describes a design which includes a function for the reduction of broken forearms. The design has a number of deficiencies in comparison with the present design. For example, it has far too many parts and components compared with the present design that is in one piece and thus very easy to handle thanks to the fact that several of the components do not need to be unscrewed/screwed together for each treatment. The design according to
US7771378 also includes a support for the forearm that acts as fixation device that causes an obstruction when applying a cast up to the level of the elbow (because this component is in the way and will be under the cast). Moreover, different "straps" are used to fix the upper and forearm against the fixation device, which because of its small surface causes a high pressure over the underlying tissue with the risk for injury. This design also lacks the blood pressure cuff function included in the present patent application, which allows the use of different anesthesia methods. The design according to US7771378 allows bending of the wrist in only one plane at a time, which usually is not enough because a fracture consists of three components (axial shortening, backward bending and radial angulation which is an outward angle from the radius). This causes the fracture gap to once again lose its position after the doctor has reduced one component while trying to change the device's settings in order to reduce the second component. The present invention has solved this problem in a way where the design may achieve traction in all directions and dimensions at one and the same time (this means that the doctor does not need to release traction until the entire procedure is completed). Unlike the design of the present patent application, US7771378 lacks the ability to make the whole design mobile in a simple manner (for example, being able hang it around the fracture victims neck via straps/belts) in order to make the fracture victim more moveable for transport to different facilities (X-ray room, operating theater, recovery and others). Brief Description of the Invention Concept
The main purpose of the present invention is to create a device that substantially improves the ability of health care providers in the reduction of forearm fractures with satisfactory results. Another purpose of the present invention is to provide a device by which the reduction of a forearm fractures may be performed by one health care professional thereby freeing healthcare resources to be used in other treatments. It is a further purpose of the present patent application to allow X-ray examination of the fracture, to verify an adequate fracture reduction, without the need for the device to be removed from the treated fracture victim. A still further purpose is to minimize unsatisfactory results depending on the skill levels of health care professionals and maximize the possibility of standardized treatment. A yet still further purpose of the present invention is to provide a method for using the device.
Brief Description of the Drawings
In the following detailed description of the present invention, reference and references to the following figures will occur. Each figure is briefly described in the following figure list. Note that the figures are schematic and details may thus be omitted in these. The exemplifying embodiments in the figures are not limiting for the scope of protection of the present patent application.
Fig. 1 shows a first embodiment of the present invention. Fig. 2 shows a first alternate embodiment of the present invention. Fig. 3 shows a first embodiment of the included positioning device. Fig. 4 shows an alternate embodiment of the positioning device. Fig. 5 shows a cross-sectional view of the positioning device according to Fig. 4. Detailed Description of the Invention
With reference to the figures, an exemplary form of an instrument (device) 1 for the reduction of bone fractures such as preferably fractures of the forearm 2 is shown schematically. The instrument 1 has at least one first connecting device 3, at least one second connecting device 4 and at least one intermediate structure 5. The first connecting device 3 is intended to be connected to the fracture victim's upper arm 6. The second connecting device 4 is connected to the hand, the fingers or the like at at least one position which is positioned beyond the fracture relative to the first connecting device 3. The second connecting device 4 is via at least one traction device 7 connected to the structure 5. Preferably, the instrument 1 includes at least one positioning device 8 which is intended to be used to adjust the position of the forearm 2 in relation to the hand. In the preferred embodiment, the first connecting device 3 includes at least one supporting connection part 9 with which the device abuts against the front of the upper arm 6.
The first connecting device 3 further includes at least one first connecting member 10 with the connecting device 3 is temporarily connected to the upper arm 6 of the fracture victim whose fracture is to be reduced. In the preferred embodiments of the present invention the first connecting device 3 includes at least one first connecting member 10 and at least one second connecting member 11. In the preferred embodiments, the connecting member 10 consists of at least one first cuff (sleeve) 12 and the second connecting member 11 of at least one second cuff (sleeve) 13. The cuffs 12 and 13 are preferably of some type of blood pressure cuffs. In alternative embodiments, the cuffs 12 and 13 consist of other types of sleeves. The connecting member 10 and connecting member 1 1 may be of various types of straps or other suitable for the purpose of connecting members with which the connecting device 3 may be temporarily connected to the upper arm 6.
The cuff 12 and cuff 13 are connected to the upper arm 6. Each cuff 12 and 13 are
individually inflatable (pressurizable). The function of cuffs 12 and 13 makes it possible to adjust the shape of the connecting device 3 relative to the upper arm 6. Preferably, the cuffs 12 and 13 are provided with, or connected to, at least one pressure gauge or other type of indicator that shows the pressure in each cuff 12 and 13.
The use of at least two cuffs 12 and 13 provides the attending health care professional with the opportunity to make use of the two, without a doubt, most common and widely accepted methods for applying anesthetic which to varying degrees, depending on experience and practice, are practiced in different medical centers throughout the world. For example, an anesthetized area may be achieved by injection of anesthetic directly into the fracture site of the wrist, which only numbs the area around the fracture. The present instrument may also be used in connection with anesthetic given intravascularly (directly into a blood vessel in the hollow of the elbow), whereby the whole forearm is put under sedation. The design of the instrument allows for intravascular anesthesia to be achieved with a substantially reduced risk of the anesthetic following a vein to the heart and causing heart rhythm disturbances. The solution to this problem is achieved by the design including two cuffs 12 and 13 which are used according to the following procedure. Initially, the first cuff 12 is connected and pressurized. Pressurization of the first cuff 12 takes place in an area of the upper arm that is not anesthetized which allows the fracture victim to usually feel some pain in this area. The anesthesia is then intravascularly administered in the vein in the arm. The pressurization of the first cuff (upper arm cuff) 12 reduces the risk that the administered anesthesia follows the vein to the heart and thereby affecting heart rhythm. After the anesthetic takes affect in the arm, the second (lower) cuff 13 is then pressurized. Since the area below the upper cuff 12 is numbed by the anesthetic, the fracture sufferer who is being treated essentially feels no pain in the arm associated with the pressurization of the second cuff 13. The pressure in the first cuff 12 may then be lessened without risk of the anesthetic following the vein to the heart. The instrument (device) 1 for the reduction of fractures also includes at least one second connecting device 4. The second connecting device 4 includes at least one connecting member 14 which is connected to the fracture victim's wrist affected and/or fingers beyond the position of the fracture. In alternative embodiments, the connection of the connecting member 14 may occur at another suitable for the purpose position on the hand, wrist or the like.
The connecting member 14 may consist of a so-called Chinese finger trap, also known as a Chinese finger puzzle or Chinese handcuffs. In those embodiments where the connecting member 14 consists of a Chinese finger trap or the like, preferably several Chinese finger traps are used and are connected to several fingers of the hand. In alternative embodiments, it is conceivable that the connecting member 14 consists of a cuff or the like which is connected to the wrist. It is further conceivable that the connecting member 14 consists of a glove or similar.
With reference to Fig. 2, a second embodiment of the present instrument 1 is shown. In this embodiment the frame 5 includes at least one back arch 15. The back arch 15 includes at least one first arch section 16 and at least one second arch section 17. In the exemplifying embodiment, the back arch 15 includes at least one first arch section 16, at least one second arch section 17 and at least one third arch section 18. The first arch section 16 is connected to the supporting connection part 9. Preferably, the first arch section 16 is pivotally arranged relative to the supporting connection part 9 via at least one articulation (joint) 19. In the embodiment shown in Fig. 2, the first arch section's 16 point of attachment relative to the supporting connection part 9 may be adjusted in the vertical direction. The figure shows that the supporting connection part 9 may include a number of attachment points 20 with which a stepwise (incremental) positioning of the first arch section 16 may occur in relation to the supporting connection part 9. In alternative embodiments, it is conceivable that the adjustment of the first arch section 16 and the supporting connection part 9 are non-incrementally (infinitely, variably) adjustable. In the embodiment shown in Fig. 2 the first arch section 16 connects to the second arch section 17 via at least one first articulation (joint) 21. The articulation 21 includes a feature with which the articulation 21 may be temporarily locked in specific position. In a preferred embodiment of the present instrument, the articulation 21 consists of a ball joint.
The second arch section 17 may be formed in one piece or alternatively may include at least one first portion 22 and at least one second portion 23 which are interconnected with each other. The interconnection of the first portion 22 and the second portion 23 may be accomplished by the first portion 22 being inserted into the second portion 23, or vice versa, and that they are mutually lockable by a locking function. By way of this design, the length of the second arch section 17 may be adjusted and locked to a specific length. For example, the mutual length adjustment may occur stepwise (incrementally) or non-incrementally
(variably), with for example, a telescopic function. In the exemplifying embodiment, shown in Fig. 2, adjustment of the second arch section's 17 length occurs incrementally (stepwise). The stepwise adjustment of the length of the arch section 17 is accomplished by the first portion 22 and the second portion 23 being provided with a series of holes 24. The first arch portion 22 and the second arch portion 23 are connected together with each other by a pin 25 or the like being passed through a hole in the series of holes in the first portion 22 and through a hole in the series of holes in the second portion 23. The adjustment feature allows the adjustment of the instrument's length in proportion to the fracture victim's arm size.
The second arch section 17 is in its other end connected to the third arch section 18 via at least one second articulation (joint) 26 or the like. The articulation 26 includes a function with which the articulation 26 may be locked in specific positions. In a preferred embodiment of the present instrument, the articulation 26 consists of a ball joint. The third arch section 18 has a curved, bent or otherwise suitable form which changes the direction of the frame 5 back towards the fracture victim. The third arch section 18 may for example be U-shaped or of another suitable shape for the purpose.
Arch sections 16, 17 and 18 consist preferably of tubes, profiles or the like. The design is made of a very light but resilient and strong material, which allows, as required, a relatively high, stable and concentrated traction strength, while providing opportunities for the transport of the fracture victim with little effort. The material of the arch sections may be of metal, polymeric material or other suitable material for the purpose, or combinations of different materials. The traction device 7 includes at least one line 27, rope, wire, cable, strip or similar which in its one end is connected to at least one tensioning device 28 which is connected to the arch. The position of the placement of the tensioning device 28 may vary within the scope of the present patent application. With the tensioning device 28, traction via the line 27 and the connecting device 4 may be applied to the fracture victim's forearm and hand allowing for traction (reduction) of the fracture in the forearm to occur.
Incorporated in the traction device is preferably at least one gauge, scale, tensionometer or the like which detects the instantaneous force with which the arm is pulled. This is essentially as good as mandatory and a prerequisite for a physician to keep a record, evaluate, quality assure and possibly reproduce the treatment and outcomes. The positioning device 8 in Fig. 1 consists of at least one from the "arch" extending strip 29 or the like. In order to enable fastening of the strip 29 or strips, one of the arch sections has at least one loop 30 or the like in which one or more strips 29 is connected. The positioning device 8, makes it possible to apply traction to the forearm so that the different parts of the wrist may be affected by the traction vector in different directions (the purpose of this is to solve the three, in the background described, fracture components).
In order to reduce bone fragments in directions other than the longitudinal direction of the arm, the present instrument 1 includes at least one positioning device 8. With reference to Fig. 2, a second embodiment of the positioning device 8 is shown. In this embodiment, the positioning device 8 is connected to the second arch section 17. The positioning device's 8 position may be fixed or adjustably arranged along the length of the second arch section 17. Preferably, the positioning device 8 is arranged to be foldable via at least one third articulation (joint) 31. With this articulated function, the positioning device 8 may be folded in and folded out, in relation to the second arch section 17.
The positioning device 8 is further preferably arranged to be rotatable relative to the second arch section 17 around a pivot axis in the second arch section's essentially transverse direction. The positioning device 8 includes a first portion 32 and a second portion 33 which are interconnected with each other. Preferably, the first portion 32 and second portion 33 insertable into one another and mutually lockable. Mutual locking may be achieved by the portions 32 and 33 including a series of holes which may be locked together by at least one pin. It is further conceivable that portions 32 and 33 are telescopically adjustable and locked by a snap lock of the previously known type. The positioning device 8 also includes a connector 34 against which the fracture victim's forearm is laid against. The connector 34 is connected to the positioning device's second portion 33. It is conceivable that the connector 34 is rotatably and displaceably arranged relative to the second portion 33. The connector 34 includes at least one first contact surface 35, one second contact surface 36 and one third contact the 37. Further, the positioning device 8 includes a strap 38 or other tensioning member with which the arm is temporarily fixed to the connector 34.
Fig. 2 shows a third embodiment of the positioning device 8. In this third embodiment of the positioning device, the positioning device includes at least one first foldable appendage 39 from the arch. In the embodiment shown in the figures, the positioning device 8 also includes at least one first foldable side arch 40 and at least one second foldable side arch 41 which are connected on each side of the arch's second part. The foldable side arches 40 and 41 include brackets in which straps or the like may be connected to the forearm 2 and used to pull the arm in the various desired directions.
The instrument 1 preferably includes at least one first support 42 to which the first connecting device 3 may be supported against an underlying surface. The support 42 is exemplified in Fig. 2. The support 42, in the exemplifying figure, is preferably pivotally arranged so that it may be folded out and folded in. In the exemplifying embodiment shown in Fig. 2, the instrument also includes a second support the 43. In the exemplifying embodiment, the second support 43 is connected to the instrument's 1 third arch section 18. The second support 43 is also preferably pivotally arranged so that it can be folded out and folded in towards the third arch section 18. In the embodiment shown in Fig. 2, the instrument 1 includes at least one first strap 44, belt, strip or similar stabilizing member which prevents a vertical displacement of the connecting device 3 downwards in relation to the upper arm. In alternative embodiments, it is
conceivable that the instrument 1 include at least one second strap 45, belt, strip or similar stabilizing member which prevents a vertical displacement of the connecting device 3 upwards in relation to the upper arm.
The instrument 1 includes at least one strap 46, belt, strip or the like which is hung around the neck of the fracture victim (such as a sling), which in turn enables the transport and makes the instrument mobile. The instrument 1 may be held in place by one or more suspension devices 47 or the like. In the embodiment shown in Fig. 2, two suspension devices 47 are shown in the form of straps 48 and 49 which support the device and unburdens the fracture victim. In alternative embodiments, the suspension device 47 (or suspension devices 47) may consist of another for the purpose suitable suspension devices.
In alternative embodiments, it is conceivable that the various components and features of the second embodiment are combined with the first embodiment. Thus, a plurality of
combinations of the first embodiment and second embodiment may be reasonable to use. For example, any of the details such as supports, belts, straps, foldable side arches or other details may be transferred from the second embodiment to the first embodiment.
In the detailed description of the present invention, design details may have been omitted which are apparent to persons skilled in the art in the area of the method and device. Such obvious design details and methods are included to the extent necessary so that the proper and full performance and function of the present method and device is achieved.
Even if certain preferred embodiments have been described in more detail, variations and modifications of the device and method in accordance with the present patent application may become apparent for specialists in the field. All such variations and modifications are regarded as falling within the scope of the following claims. In an alternative embodiment it is conceivable that the instrument include at least one timer (not shown in the figures). The timer may for example be used to record time for one of the procedures that the device is intended to perform. For example, the time period for how long the forearm is exposed to traction may be measured. Advantages of the Invention
It is possible to achieve several advantages with the present invention. The most substantial being that an improved device and method with which reduction of a fractured forearm may be achieved more efficiently has been accomplished. Further, the design is lightweight. A further advantage is that the device may be used by a single healthcare professional, which in turn frees medical recourses to be used for other health needs. It is a further advantage that the present device offers good accessibility to the area that needs treatment. The simplicity (from several perspectives) is very helpful during treatment procedures. The design has the further advantage that it is easy to clean. The design is also stable during use. The device and method also result in reproducible reduction results. The design also allows treatment result to be more independent of the skills of treating health care professionals, that is to say less dependent on who is carrying out the treatment.

Claims

Claims
1. Instrument (device) (1), intended for use in the reduction of radial fractures, including at least one first connecting device (3) and at least one second connecting device (4) with at least one intermediate frame (5), said first connecting device (3) intended to be connected to the fracture victim's upper arm (6) and said second connecting device (4) intended to be connected to the hand, fingers or the like at at least one position located beyond the fracture relative to the first connecting device (3), and that the instrument (1) includes at least one first traction device (tensioning device) with which a change in distance between the first connecting device (3) and the second connecting device (4) may be achieved and hence a traction of the forearm may be performed, and that the instrument (1) includes at least one positioning device (8) with which the proximal and the distal bone fragments may be aligned (adjusted) in relation to the fracture characterized by that the first connecting device (3) includes at least one first connecting member (10) and at least one second connecting member(l 1) which are connected around the fracture victim's upper arm, and also that the first connecting member (10) consists of at least one first cuff (12) preferably in the form of one first blood pressure cuff and that the second connecting member(l 1) consists of at least one second cuff (13) preferably in the form of one second blood pressure cuff.
2. Instrument (1) according to claim 1 characterized by that the frame (5) consists of at least one back arch (15) which includes at least one first arch section (16) which is connected to the first connecting device (3) and at least one second arch section (17).
3. Instrument (1) according to claim 1 characterized by that the positioning device (8) includes at least one strap which is connected to the back arch (15) and the forearm, with which traction may be asserted in at least one direction separate from the fractured arm's axial direction.
4. Instrument (1) according to one or more of the previous claims characterized by that the positioning device (8) includes at least one strap which is connected to the instruments back arch (15) and the fracture victim's arm.
5. Instrument (1) according to one or more of the previous claims characterized by that the positioning device (8) consists of a device with which pressure and traction may be asserted in at least one direction separate from the arm's axial direction.
6. Instrument (1) according to one or more of the previous claims characterized by that the frame (5) consists of at least one back arch (15) which includes at least one first arch section (16), at least one second arch section (17) and at least one third arch section (18).
7. Instrument (1) according to one or more of the previous claims characterized by that the second connecting device (4) is connected to the fracture victim's fingers by way of a connecting member in the form of at least one Chinese finger trap.
8. Instrument (1) according to one or more of the previous claims characterized by that the positioning device (8) consists of at least one appendage (39) that is connected in a foldable manner to at least one of the arch sections and from which a strap may be connected between the foldable appendage (39) and the fracture victim's forearm.
PCT/SE2012/000020 2011-02-28 2012-02-27 Device and method for the reduction of radius fractures WO2012118423A1 (en)

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SE1100136A SE1100136A1 (en) 2011-02-28 2011-02-28 Device and method for repairing radius fractures
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