WO2003017893A1

WO2003017893A1 - Pelvic immobilizer

Info

Publication number: WO2003017893A1
Application number: PCT/IL2002/000717
Authority: WO
Inventors: Yona Kosashvili; Yaron Bar Ziv
Original assignee: Yona Kosashvili; Yaron Bar Ziv
Priority date: 2001-08-30
Filing date: 2002-08-29
Publication date: 2003-03-06
Also published as: IL145205A0

Abstract

The present invention is primarily directed to a pelvic immobilizer comprising a wide band constructed of a material that is essentially non-elastic in a horizontal direction, characterized in that said wide band comprises a posterior portion that is continuous at its two ends with two lateral portions, wherein each of said lateral portions bears an anatomically-shaped cushion on its inner surface, said cushion approximating in size and shape to the human iliac wing, and wherein one or more connecting straps are attached to the exterior surface of each of said lateral portions, said connecting straps extending anteriorly and medially from the anterior free margin of each of said lateral portions.

Description

PELVIC IMMOBILIZER

Field of the Invention

The present invention relates to a device for use in immobilizing the pelvis in cases of traumatic and non- traumatic pelvic disorders. More specifically, the present invention discloses a device that provides pelvic stabilization in a non-invasive manner, and that may be used in both pre-hospital and hospital settings for pelvic fractures, and ambulatory and hospital use in cases of non- traumatic pelvic disorders such as symphysiolysis and sacroileitis .

Background of the Invention

Pelvic trauma presents a particular set of challenges to the medical and paramedical team, in view of the need to provide both immediate stabilization of the skeletal structures and to arrest the profuse bleeding often associated with such conditions. A further complicating factor that frequently arises is the need to provide the initial treatment under difficult_/ non-hospital conditions, such as at the site of road-traffic accidents or on the battlefield. Moreover, by the very nature of the situations in which pelvic fracture occurs, the patient may often also be suffering from serious injury to other parts of the body, including fractures of the spinal column, cranium and limbs, each of which may be associated with serious or life-threatening soft-tissue damage and blood loss. Finally, there are other medical disorders, in which pelvic instability causes discomfort, such as symphysiolysis and sacroileitis .

There is thus a need for a device for stabilizing pelvic fractures that may be easily, rapidly and comfortably applied to the patient in the field, and which can exert optimally-directed compressive forces sufficient to provide both stabilization of fractured bones and significant reduction in blood loss in pelvic trauma, as well as stabilization of the pelvic ring in other pelvic disorders such as symphysiolysis and sacroileitis in order to relieve pain.

The prior art has suggested several methods for stabilizing the pelvic ring structures in cases of trauma. These are essentially of two different types: external fixators comprising metal pins inserted into the iliac crest connected to an externally placed frame or clamp, and non- invasive devices for providing compression and/or stabilization of the fractured pelvis.

US 6/240,923 discloses a pelvic fracture immobilizer consisting of a wide band of firm material such as canvas and a plurality of straps, each having a ratcheting buckle. Compressive force is applied by wrapping the band around the affected area and closing and tightening the dynamic buckles. 09719658 discloses a device for stabilizing unstable pelvic fractures comprising a belt for fitting around the pelvis of a subject, means in connection with the belt for securing it in a tightened state against the victim of accident, and at least two first expandable means arranged so as to press against the posterior side of the pelvic ring opposite the pelvic sockets upon expansion and to further tighten the belt.

US6066109 describes a method for anatomical reduction of pelvic fractures involving the use of a narrow belt having at least two inflatable bladders slidingly positionable along the belt. Operationally, the device is positioned to encircle the hips of a patient with a bladder positioned over each of the patient's hip bones. The belt is fastened in place by means of a clasp, and a pump is used to selectively inflate each of the bladders.

It is a purpose of the present invention to provide a non- invasive pelvic immobilization device for use in the management of pelvic trauma.

It is a further purpose of the invention to provide a pelvic immobilization device that may be easily and safely applied to the traumatized or otherwise structurally -or functionally compromised pelvis of a subject in need of such treatment.

A further object of the invention is to provide a pelvic immobilization device of robust design that permits movement of the patient under difficult circumstances (such as at accident sites and in the battlefield) without compromising the effectiveness of said device.

It is yet a further object of the invention that the device disclosed therein ^"may be used at all stages of the management of pelvic trauma: from the accident site or battlefield to the hospital emergency room or operating suite .

It is yet a further object of the invention that the device disclosed therein will be used for stabilizing the pelvis in non-traumatic disorders such as symphysiolysis and sacroileitis .

A still further purpose of the invention is to provide a pelvic stabilization device that overcomes the problems and shortcomings of previous devices.

Further objects and advantages of the present invention will become apparent as the description proceeds.

Summary of the Invention

It has now been unexpectedly found that it is possible to provide stabilization and compression of the fractured or otherwise compromised pelvic ring, in hospital, pre- hospital and ambulatory settings, by means of an externally placed, non-invasive immobilization device, wherein the compressive forces are directed towards anatomically- relevant portions of said pelvic ring by means of anatomically-shaped elements located within said device. The presence of these anatomically-shaped elements obviates the need for the use of delicate, easily-damaged components such as inflatable bags for providing the primary, directed compressive force on the traumatized or otherwise- compromised pelvis, thus permitting its effective use under field conditions. The ease of use afforded by these structural features also permits the effective use of the device of the present invention by non-specialist operators, such as paramedic and first-aid workers.

The pelvic immobilizer device disclosed immediately hereinabove is intended for use in the stabilization and compression of pelvic fractures as well as to provide pelvic stabilization in non-traumatic conditions in which the pelvic ring may be structurally or functionally compromised, such as symphysiolysis and sacroileitis, in which said stabilization would cause relief of pain and discomfort.

The term "iliac wing" as used hereinabove and hereinbelow, is used to describe the portion of the human ileum that is superior to the inferior gluteal line, including the iliac crest, iliac tuberosity and iliac fossa.

The term "anatomically-shaped cushion" as used herein, is intended to indicate a structural element constructed of a firm but deformable material (e.g. canvas), said element having a size and shape approximating to that of the human iliac wing.

In one preferred embodiment of the invention, up to three connecting straps are attached to each of the lateral portions .

In a preferred embodiment of the invention, each of the one or more connecting straps on one side of the immobilizer is fitted with the male half of a dynamic buckle, and wherein each of the connecting straps on the other side is fitted with the corresponding female half of said dynamic buckle.

In a preferred embodiment of the present invention, the pelvic fracture immobilizer further comprises a pair of pneumatic airbags, each of which is attached to the inner surface of one of the cushions. In another preferred embodiment of the invention, the inner surface of each of the cushions is lined with a deformable material. In a more preferred embodiment, the deformable material is a silicon-based material.

In yet another preferred embodiment, the pelvic immobilizer may be fitted with a particularly delicate set of cushions for use in the management of symphysiolysis in pregnancy.

In another aspect, the present invention is also directed to a method for immobilizing the pelvis in a patient presenting with a traumatic or non-traumatic pelvic disorder, comprising wrapping a wide band around the pelvic region of a patient in need of such treatment, wherein said band bears a pair of anatomically-shaped cushions attached to the antero-lateral portions of its inner surface, and wherein said band is placed such that said cushions are located over the iliac wings, fastening said band in place by means of anteriorly connecting pairs of straps attached to the exterior surface of said band, said straps being fitted with means for dynamic tensioning, and applying the desired degree of tension by pulling the free ends of the connected straps through said dynamic tensioning means.

The term "desired degree of tension" refers to the amount of tension on the connecting straps that the operator determines to be necessary in order to produce the optimal compressive forces on the pelvic ring. Optimal compressive forces are those that provide maximum stabilization of the pelvic ring whilst causing minimal soft tissue trauma. In a preferred embodiment of the method of the invention, the means for dynamic tensioning are dynamic buckles.

In another preferred embodiment, the method of the invention further comprises the controlled inflation of airbags that are attached to the inner surface of the anatomically-shaped cushions. The inflated airbags are of use inter alia in preventing the formation of decubitis ulcers, thus substantially prolonging the length of time in which the immobilizer may be comfortably used to periods of days and weeks.

In one preferred embodiment of the abovementioned method, the pelvic disorder is a traumatic pelvic disorder. In a particularly preferred embodiment, the traumatic pelvic disorder comprises one or more fractures of the pelvic ring.

In another preferred embodiment of the method of the invention, the pelvic disorder is a non-traumatic disorder. In one particularly preferred embodiment, the non-traumatic pelvic disorder is symphysiolysis. In another particularly preferred embodiment, the non-traumatic pelvic disorder is sacroileitis .

In another aspect, the pelvic immobilizer disclosed hereinabove is provided for use in the management of traumatic pelvic disorders. In a preferred embodiment, the traumatic pelvic disorder to be managed comprises one or more fractures of the pelvic ring. The present invention also provides a pelvic immobilizer, as disclosed and described hereinabove, for use in the management of non-traumatic pelvic disorders. In one preferred embodiment of this aspect of the invention, the non-traumatic pelvic disorder to be managed is symphysiolysis. In another preferred embodiment, the non- traumatic pelvic disorder to be managed is sacroileitis.

All the above and other characteristics and advantages of the present invention will be further understood from the following illustrative and non-limitative examples of preferred embodiments thereof.

Brief Description of the Drawings

Fig. 1 illustrates an anterior view of one embodiment of the device of the invention.

Fig. 2 illustrates a posterior view of the device depicted in Fig. 1.

Fig. 3 depicts an anterior view of a further embodiment of the device of the invention.

Fig. 4 illustrates the pelvic immobilizing device of the invention in use. Detailed Description of Preferred Embodiments

Referring to Figs. 1 and 2, one embodiment of the pelvic immobilizer, indicated generally as 10, comprises a wide posterior band 11 made of a material that is essentially non-elastic in a horizontal direction (e.g. canvas or a synthetic material such as Cordora) , the lateral edges of which are connected to left and right lateral wing-shaped bands 12 and 13. In cases in which the pelvic immobilizer is used in the management of non-traumatic conditions, its inner layer will be covered with a smooth fabric such as silk, thus enabling the use of said immobilizer for extended periods of time.

Said lateral bands 12 and 13 approximately conform in both size and shape to the pelvic iliac wings. Firm cushions 14 and 15 are attached to the inner surfaces of lateral bands 12 and 13, respectively. Said cushions may be constructed of any suitable firm but resilient material, such as canvas, and are of a similar size and shape as lateral bands 12 and 13, which as stated hereinabove, are designed to conform to the size and shape of the iliac wings.

By means of the anatomically-shaped cushions, the device, when in use, provides optimal compression of the pelvic ring. The attachment of cushions 14 and 15 to lateral bands 12 and 13 may be achieved by any suitable permanent means, including gluing, stapling and stitching, or by any suitable removable means, including the use of Velcro® tape. The use of removable attachment means such as Velcro® tape is particularly advantageous, as it allows anterior-posterior re-positioning of the cushions in relation to the lateral bands, thus permitting the immobilizing device to be used with a wide range of different-sized pelvic rings. A plurality of connecting straps 16 are attached to the anterior surfaces of the lateral bands 12 and 13 in proximity to their free anterior margins. Straps 16 may be fitted with any suitable fasteners for ease of securing each strap with its contralateral counterpart. In the embodiment shown in Fig. 1, the fasteners are dynamic buckles, each of which consists of a male element 17 and a female element 18. Each of the straps 16 has a free end 19 for the purposes of providing horizontally-directed tension in the device following closure of said dynamic buckles 17, 18, each of which is fitted with a friction device to prevent slippage of the straps 16 therethrough.

Fig. 3 depicts an alternative embodiment of the device of the invention. In addition to all of the elements described hereinabove and illustrated in Figs. 1 and 2, this embodiment of the device also includes inflatable airbags 20 and 21 that are attached to the inner surface of each of the anatomically-shaped cushions 14 and 15. The inflatable airbags may be made of any suitable material such as rubber, or any other airtight, deformable material, such as is well-known to the skilled artisan in the field.

Said airbags may be attached to the cushions by any suitable means, including, but not limited to gluing, stitching, stapling and the use of Velcro® tape. Each of the airbags is provided with a one-way valve having an opening on the anterio-superior surface thereof. These valves are shown in fig. 3 as valves 22 and 23, and are used for inflating and deflating said airbags. Inflation may be performed by the use of any suitable inflating device, including manual pumps, pneumatic compressors, and mouth tubes. By means of inflating the airbags, fine adjustments may be made to the amount of compressive force applied to the pelvic structures. In addition, controlled inflation of the airbags may prevent damage to the skin and subcutaneous tissues by lowering pressure on said tissues over bony prominences. Moreover, use of the above- described controlled inflation of the airbags may assist in preventing the formation of decubitus ulcers, particularly when the immobilizer is to be used for prolonged periods of time .

Fig. 4 illustrates a pelvic immobilization device as disclosed and described hereinabove, in use on a subject. It may be seen from this figure that the lateral bands 12 and 13 and anatomically-shaped cushions 14 and 15 are positioned over the iliac wings, thus directing the compressive forces generated by the tensed connecting straps towards the largest elements of the bony pelvic ring, said elements (i.e. the iliac wings) being those that provide the largest contribution to the mechanical stability of the pelvis. In order to use the immobilizing devices of invention, the device 10 is first wrapped around the pelvic region of the patient, ensuring that the anatomically-shaped cushions 14 and 15 are correctly placed over the iliac wings. The device is then loosely secured anteriorly by means of connecting each of the connecting straps 16 to its contralateral counterpart, by means of uniting the male and female halves 17 and 18 of the dynamic buckles . The desired compression of the traumatized or otherwise compromised pelvis is then achieved by sequentially tightening each connecting strap by means of pulling its free end 19. In the preferred embodiment of the device of the invention illustrated in fig. 3 and described hereinabove, the degree of local pressure over the iliac wings may then be adjusted by controlled inflation of the airbags 20 and 21, by way of valves 22 and 23.

The robustness of the device coupled with its simplicity of use and lack of dependence on air pressure for its primary pressure-generating source facilitates its use under difficult situations such as on the battlefield or at the site of a road-traffic accident. Once applied to the patient as described hereinabove, the patient may then be moved to the hospital setting with the immobilizer securely in place. Visual and manual access to pelvic and lower abdominal structures (as may be required during ambulance transportation or in the hospital emergency room) may be gained by releasing the tension on one, and even two, of the connecting straps and opening the dynamic buckle attached thereto, without compromising the immobilizing effect achieved by the device. In addition, all of the components of the device of the invention may be made of radiolucent materials, thus permitting the use of imaging techniques with the device in situ . These features thus permit the use of the immobilization device of the invention at all stages of management of pelvic trauma from the initial site of the accident to the operating table.

While specific embodiments of the invention have been described for the purpose of illustration, it will be understood that the invention may be carried out in practice by skilled persons with many modifications, variations and adaptations, without departing from its spirit or exceeding the scope of the claims.

Claims

Clai s

1. A pelvic immobilizer comprising a wide band constructed of a material that is essentially non-elastic in a horizontal direction, characterized in that said wide band comprises a posterior portion that is continuous at its two ends with two lateral portions, wherein each of said lateral portions bears an anatomically-shaped cushion on its inner surface, said cushion approximating in size and shape to the human iliac wing, and wherein one or more connecting straps are attached to the exterior surface of each of said lateral portions, said connecting straps extending anteriorly and medially from the anterior free margin of each of said lateral portions.

2. A pelvic immobilizer according to claim 1, wherein up to three connecting straps are attached to each of the lateral portions .

3. A pelvic immobilizer according to claim 1, wherein each of the one or more connecting straps on one side of said immobilizer is fitted with the male half of a dynamic buckle, and wherein each of the connecting straps on the other side is fitted with the corresponding female half of said dynamic buckle.

4. A pelvic immobilizer according to claim 1, further comprising a pair of pneumatic airbags, each of which is attached to the inner surface of one of the cushions.

5. A pelvic immobilizer according to claim 1, wherein the inner surface of each of the cushions is lined with a deformable material.

6. A pelvic immobilizer according to claim 5, wherein the deformable material is a silicon-based material.

7. A method for immobilizing the pelvis in a patient presenting with a traumatic or non-traumatic pelvic disorder, comprising wrapping a wide band around the pelvic region of a patient in need of such treatment, wherein said band bears a pair of anatomically-shaped cushions attached to the antero-lateral portions of its inner surface, and wherein said band is placed such that said cushions are located over the iliac wings, fastening said band in place by means of anteriorly connecting pairs of straps attached to the exterior surface of said band, said straps being fitted with means for dynamic tensioning, and applying the desired degree of tension by pulling the free ends of the connected straps through said dynamic tensioning means.

8. A method according to claim 7, wherein the means for dynamic tensioning are dynamic buckles.

9. A method according to claim 7, further comprising the controlled inflation of airbags that are attached to the inner surface of the anatomically-shaped cushions.

10. A method according to any one of claims 7 to 9, wherein the pelvic disorder is a traumatic pelvic disorder.

11. A method according to claim 10, wherein the traumatic pelvic disorder comprises one or more fractures of the pelvic ring.

12. A method according to any one of claims 7 to 9, wherein the pelvic disorder is a non-traumatic pelvic disorder.

13. A method according to claim 12, wherein the non- traumatic pelvic disorder is symphysiolysis.

14. A method according to claim 12, wherein the non- traumatic pelvic disorder is sacroileitis.

15. A pelvic immobilizer according to claim 1 for use in the management of a traumatic pelvic disorder.

16. A pelvic immobilizer for use according to claim 15, wherein the traumatic pelvic disorder comprises one or more fractures of the pelvic ring.

17. A pelvic immobilizer according to claim 1 for use in the management of a non-traumatic pelvic disorder.

18. A pelvic immobilizer for use according to claim 17, wherein the non-traumatic pelvic disorder is symphysiolysis .

19. A pelvic immobilizer for use according to claim 17, wherein the non-traumatic pelvic disorder is sacroileitis.