WO2017008109A1

WO2017008109A1 - A pelvic frame system for the substantial prevention of bedsores of double leg amputees

Info

Publication number: WO2017008109A1
Application number: PCT/AU2016/050602
Authority: WO
Inventors: Declan Brazil; Paul Smith
Original assignee: Signature Orthopaedics Europe Ltd
Priority date: 2015-07-11
Filing date: 2016-07-11
Publication date: 2017-01-19

Abstract

There is provided a pelvic frame system for the substantial prevention of bedsores of double leg amputees. The pelvic frame comprises at least one rod inserted into a pelvis of the amputee in use so as to provide at least one protruding end extending from the skin of the amputee; and at least one support engagement fastened to the least one protruding end, the at least one support engagement configured for engaging a support in use such that at least one rod bears at least some of the weight of the torso of the amputee so as to substantially reduce or eliminate bedsores causing pressure on tissue surrounding the pelvis of the amputee.

Description

A pelvic frame system for the substantial prevention of bedsores of double leg amputees

Field of the Invention

[1] The present invention relates to a pelvic frame system for the substantial prevention of bedsores of double leg amputees.

[2] The invention has been developed primarily for use with double leg amputees and will be described hereinafter with reference to this application. However, it will be appreciated that the invention is not limited to this particular field of use and has use for other applications within the purposive scope of the embodiments provided herein.

Background of the Invention

[3] Double leg amputees are prone to bedsores induced either from pressure caused during the use of a wheelchair or other mobility apparatus, while sleeping and the like.

[4] Indeed, double leg amputees experience poor quality of life from these bedsores often times requiring prolonged recovery periods in hospital, such as up to 7 months, for the treatment of bedsores.

[5] Furthermore, double leg amputees are oftentimes repeat patients for bed sore treatment such as, for example, requiring admission to hospital once a year.

[6] Existing treatment extend so far as to attempt to provide for the periodic release of pressure, such as by requiring the patient to move about within the mobility apparatus, or requiring nurses to turn patients periodically while sleeping during the night.

[7] However, these existing treatments are not only inconvenient and costly but also unable to prevent the recurrence of bedsores.

[8] The present invention seeks to provide a system, which will overcome or substantially ameliorate at least some of the deficiencies of the prior art, or to at least provide an alternative.

[9] It is to be understood that, if any prior art information is referred to herein, such reference does not constitute an admission that the information forms part of the common general knowledge in the art, in Australia or any other country.

Summary of the Disclosure

[10] According to one aspect, there is provided a pelvic frame system for the substantial prevention of bedsores of double leg amputees, the pelvic frame comprising: at least one rod inserted into a pelvis of the amputee in use so as to provide at least one protruding end extending from the skin of the amputee; and at least one support engagement fastened to the least one protruding end, the at least one support engagement configured for engaging a support in use such that at least one rod bears at least some of the weight of the torso of the amputee so as to substantially reduce or eliminate bedsores causing pressure on tissue surrounding the pelvis of the amputee.

[11] The at least one rod may comprise a laterally/medially orientated weight-bearing rod inserted through the pelvis of the amputee in use so as to provide opposite laterally protruding ends; and [12] the at least one support engagement may comprise a pair of support engagements each fastened to a respective one of the laterally protruding ends.

[13] The weight-bearing rod may be inserted substantially through the acetabula of the pelvis in use.

[14] The at least one rod may comprise at least one substantial anteriorly/posteriorly orientated stabilising rod inserted into the pelvis of the amputee so as to provide at least one anteriorly located protruding end from the skin of the amputee.

[15] The stabilising rod may comprise a length sufficient so as to extent posteriorly beyond the weight-bearing rod.

[16] The at least one stabilising rod may comprise at least two stabilising rods.

[17] The at least one stabilising rod may be inserted into the ilium of the pelvis in use.

[18] The at least one stabilising rod may be inserted into the anterior inferior iliac spine of the pelvis.

[19] The at least two stabilising rods are orientated in line with a portion of the ilium.

[20] The at least two stabilising rods are substantially coplanar.

[21] The at least two stabilising rods are superiorly located with respect to the weight-bearing rod.

[22] The length of the at least one stabilising rod may be less than the length of the weight-bearing rod.

[23] The at least one rod may comprise at least one substantial anteriorly/posteriorly orientated ancillary rod.

[24] The at least one ancillary rod may be inserted into the anterior superior iliac spine of the pelvis in use.

[25] The at least one rod may comprise at least one circumferential bone growth enhancing surface.

[26] The least one bone growth enhancing surface may comprise two spaced apart circumferential bone growth enhancing surfaces.

[27] The at least one rod may be modular.

[28] The at least one rod may comprise a rod portion and a rod engaging portion. [29] The offset of the rod engaging portion with respect to the rod portion are configurable so as to allow for the length adjustment of the rod.

[30] The support engagements are configured for engaging a substantially V shaped support in use.

[31] The support engagements comprise a waist configured for sitting within a notch of the V shaped support.

[32] Other aspects of the invention are also disclosed. Brief Description of the Drawings

[33] Notwithstanding any other forms which may fall within the scope of the present invention, a preferred embodiments of the disclosure will now be described, by way of example only, with reference to the accompanying drawings in which:

[34] Figure 1 shows a top perspective view of a pelvic frame system for the substantial prevention of bedsores of double leg amputees in accordance with embodiments of the present disclosure;

[35] Figure 2 shows a top perspective view of the pelvic frame system of Figure 1 in situ in accordance with embodiments of the present disclosure;

[36] Figure 3 shows a top plan view of the pelvic frame system of Figure 1 in situ in accordance with embodiments of the present disclosure;

[37] Figure 4 shows a side elevation view of the pelvic frame system of Figure 1 in situ in accordance with embodiments of the present disclosure;

[38] Figure 5 shows a top exploded perspective view of the pelvic frame system of Figure 1 in situ when the system comprises modular rods in accordance with embodiments of the present disclosure;

[39] Figure 6 shows a top exploded view of the pelvic frame system of Figure 1 in situ when the system comprises modular rods in accordance with embodiments of the present disclosure;

[40] Figure 7 shows a side elevation view of the pelvic frame system of Figure 1 in situ prior to the insertion of the rods in accordance with embodiments of the present disclosure;

[41] Figure 8 shows a top plan view of the pelvic frame system of Figure 1 in accordance with embodiments of the present disclosure; and

[42] Figure 9 shows a side elevation view of the pelvic frame system of Figure 1 in accordance with embodiments of the present disclosure.

Description of Embodiments

[43] For the purposes of promoting an understanding of the principles in accordance with the disclosure, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended. Any alterations and further modifications of the inventive features illustrated herein, and any additional applications of the principles of the disclosure as illustrated herein, which would normally occur to one skilled in the relevant art and having possession of this disclosure, are to be considered within the scope of the disclosure.

[44] Before the structures, systems and associated methods relating to the pelvic frame system are disclosed and described, it is to be understood that this disclosure is not limited to the particular configurations, process steps, and materials disclosed herein as such may vary somewhat. It is also to be understood that the terminology employed herein is used for the purpose of describing particular embodiments only and is not intended to be limiting since the scope of the disclosure will be limited only by the claims and equivalents thereof.

[45] In describing and claiming the subject matter of the disclosure, the following terminology will be used in accordance with the definitions set out below.

[46] It must be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[47] As used herein, the terms "comprising," "including," "containing," "characterised by," and grammatical equivalents thereof are inclusive or open-ended terms that do not exclude additional, unrecited elements or method steps.

[48] It should be noted in the following description that like or the same reference numerals in different embodiments denote the same or similar features.

[49] Turning now to the accompanying figures, there is shown a pelvic frame system 1 for the substantial prevention of bedsores of double leg amputees. As will become apparent from the ensuing description, the pelvic frame system 1 is configured to support the pelvis of the amputee so as to be able to bear at least some of the weight of the torso so as to substantially reduce or eliminate bedsore inducing pressure. As will furthermore be described in further detail below, the pelvic frame system may be configured also for engaging a mobility support, such as a wheelchair or the like, and additionally or alternatively used while the amputee is sleeping in bed.

[50] Specifically, referring to figure 1, the pelvic frame system 1 comprises at least one rod configured for insertion into a pelvis of the amputee. Figure 2 shows the pelvic frame system 1 inserted into the pelvis 10. The remaining drawings show various views of the pelvic frame system 1 either in isolation or once having been inserted into the pelvis 10 of which some will be described in further detail below.

[51] Now, the pelvic frame system 1 comprises at least one rod configured for insertion into the pelvis 10 of the amputee so as to provide at least one protruding end extending beyond the skin of the amputee.

[52] To this protruding end is fastened a support engagement 11. [53] The support engagement 11 is configured for engaging a support 9 in use such that the at least one rod is configured to bear at least some of the weight of the torso of the amputee so as to substantially reduce or eliminate bedsore causing pressure on tissue surrounding the pelvis 10 of the amputee.

[54] Now, in a preferred embodiment, the at least one rod comprises a laterally/medially orientated weight-bearing rod 2 configured for insertion through the pelvis of the amputee so as to provide oppositely located lateral protruding ends beyond the skin of the amputee.

[55] It should be noted that the nomenclature "weight-bearing" (and that of "stabilising" and "ancillary"as used in further detail below) is utilised primarily for illustrative convenience in differentiating the types of rods utilised by the frame system 1. It should be noted that all rods utilised by the system 1 serve at least some sort of weight-bearing and/or support capabilities and therefore no technical limitation should necessarily be imputed to the embodiments described herein utilising such nomenclature accordingly.

[56] As such, two support engagements 11 may be fastened to either end of the weight-bearing rod 2. In embodiments, the weight-bearing rod 2 may be inserted through the acetabular of the pelvis 10.

[57] As can be appreciated, the weight-bearing rod 2 is configured to bear substantially the majority of the weight of the pelvis 10, especially where the amputee is seated. As such, the weight- bearing rod 2 may comprise sufficient strength, dimensions and the like so as to be suited for bearing such weight.

[58] It should be noted that while in the embodiment shown the weight-bearing rod 2 is configured for insertion entirely through the pelvis 10, in embodiments, the weight-bearing rod 2 may comprise two separate rods each configured for the separate and oppositely located medial insertion into the pelvis 10. However, the use of a single rod 2 provides for strength advantages, greater support for the pelvis 10 and the like as opposed to utilising separate weight-bearing rods.

[59] Now, as can be appreciated, the utilisation of the weight-bearing rod 2, provides only two points of contact for a support. Ideally, at least three points of contact would be required by a support so as to be able to balance the pelvis 10 in use.

[60] As such, in a preferred embodiment, the at least one rod comprises at least one substantially anteriorly/posteriorly orientated stabilising rod 4 configured for insertion into the pelvis 10 of the amputee so as to provide at least one anteriorly located end extended beyond the skin of the amputee.

[61] It should be noted that in other embodiments (not shown) the other end of each stabilising rod 4 may protrude posteriorly also. [62] As alluded to above, whereas at least three points of contact would be required for adequate stability, given the geometry of the pelvis 10, in a preferred embodiment, two stabilising rods 4 are provided. In this embodiment, the stabilising rods 4 may be inserted into the ilium of the pelvis 10 and specifically the anterior inferior iliac spine of the pelvis 10.

[63] As is also shown, the two stabilising rods 4 are anteriorly outwardly orientated so as to substantially lie in line with a portion ilium for adequate insertion therein. Furthermore, the stabilising rods 2 may be substantially coplanar.

[64] Now, as figure 1 shows a top perspective view of the pelvic frame system 1, as can be appreciated, the stabilising rods 3 may be superiorly located within the pelvis 10 with respect to the weight-bearing rod 2. Such respective locations are chosen such that the weight-bearing rod 2 may be configured for insertion through the acetabular of the pelvis 10 and the stabilising rods 4 configured for insertion through the ilium of the pelvis 10 as described above.

[65] In a preferred embodiment, the length of the at least one stabilising rod 4 is less than the length of the weight-bearing rod 2 such that the pelvic frame system 1 can take on the configuration as substantially shown in figure 1.

[66] In a yet further embodiment, the pelvic frame system 1 may further comprise at least one ancillary rod 5. The ancillary rod 5 may be suited for applications requiring additional or alternative securement points. As such, referring to figure 1, there is shown the system 1 comprising the at least one ancillary rod 5.

[67] In a similar manner as described with respect to the stabilising rods 4, the system 1 may comprise two ancillary rods 5. As can be seen, the proximal ends of the ancillary rods 5 may comprise attachment points 12 to which support engagements 11 may be selectively fastened when required.

[68] In a preferred embodiment, the ancillary rods 5 may be configured for insertion into the anterior superior iliac spine of the pelvis 10. In this manner, the ancillary rods 5 are dimensioned (especially with regard to length) and orientated so as to suit insertion into the anterior superior iliac spine of the pelvis 10.

[69] In a preferred embodiment, the rods are preferably smooth so as to facilitate the insertion through the pelvis 10. In a yet further embodiment, the rods comprise biocompatible bone growth enhancing surfaces 3 so as to encourage the growth of bone surrounding the rods so as to securely fasten the rods within the pelvis 10. In a preferred embodiment, each rod comprises two spaced apart circumferential bone growth enhancing surfaces 3. In embodiments, substantially the entire circumferential surface of the rods may comprise such bone growth enhancing surfaces 3.

[70] Now, referring to figure 5, in a preferred embodiment, the at least one rod is modular. Specifically, each rod may comprise a rod portion 13 and a rod engaging portion 6. In this manner, during insertion, the rod portion 13 may be inserted first whereafter the rod engaging portions 6 are subsequently fastened utilising suitable mechanical fastener.

[71] In a preferred embodiment, the offset of the rod portion 13 with respect to the rod rod engaging portion 6 is configurable so as to allow for differing lengths of rods depending on the geometry of the pelvis of differing amputees.

[72] As is further provided in figure 5, the system 10 may comprise suitable faster 14 for fastening the support engagements 11 to the supports 9.

[73] Referring again to figure 1, in a preferred embodiment, the support engagement 11 is configured for engaging a substantially V shaped support 9 as is shown. In this manner, the support engagements 11 may comprise an hourglass profile comprising a waist configured to rest within the notch of the V shape support 9. In this manner, the supports 9 may be engaged by the lowering of the support engagements 9. In this manner, when climbing into a wheelchair, the amputee may simply transition downwardly so as to engage the supports 9. As is also shown, each support 9 may comprise a fastener aperture 8 which may be elongate in embodiments to provide lateral movement tolerance during installation.

[74] In another embodiment, the supports 9 may comprise latches or the like so as to latch the support engagements 9 in place so as to substantially prevent the inadvertent disengagement of the support engagements 11 from the supports 9.

[75] It should be appreciated that a subset of the support engagements 11 may be utilised depending on the application. Specifically, while the amputee a sleeping, only the support engagements 11 of the weight-bearing rod 2 may be required, whereas, when the amputee is seated in a wheelchair or other mobility support, the support engagements 11 of the stabilising rods 4 may be required also.

Interpretation

Embodiments:

[76] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment, but may. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments.

[77] Similarly it should be appreciated that in the above description of example embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the Detailed Description of Specific Embodiments are hereby expressly incorporated into this Detailed Description of Specific Embodiments, with each claim standing on its own as a separate embodiment of this invention.

[78] Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.

Different Instances of Objects

[79] As used herein, unless otherwise specified the use of the ordinal adjectives "first", "second", "third", etc., to describe a common object, merely indicate that different instances of like objects are being referred to, and are not intended to imply that the objects so described must be in a given sequence, either temporally, spatially, in ranking, or in any other manner.

Specific Details

[80] In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the invention may be practiced without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description. Terminology

[81] In describing the preferred embodiment of the invention illustrated in the drawings, specific terminology will be resorted to for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar technical purpose. Terms such as "forward", "rearward", "radially", "peripherally", "upwardly", "downwardly", and the like are used as words of convenience to provide reference points and are not to be construed as limiting terms.

Comprising and Including

[82] In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word "comprise" or variations such as "comprises" or "comprising" are used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

[83] Any one of the terms: including or which includes or that includes as used herein is also an open term that also means including at least the elements/features that follow the term, but not excluding others. Thus, including is synonymous with and means comprising.

Scope of Invention

[84] Thus, while there has been described what are believed to be the preferred embodiments of the invention, those skilled in the art will recognize that other and further modifications may be made thereto without departing from the spirit of the invention, and it is intended to claim all such changes and modifications as fall within the scope of the invention. For example, any formulas given above are merely representative of procedures that may be used. Functionality may be added or deleted from the block diagrams and operations may be interchanged among functional blocks. Steps may be added or deleted to methods described within the scope of the present invention.

[85] Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms.

Industrial Applicability

[86] It is apparent from the above, that the arrangements described are applicable to the orthopaedic industries.

Claims

1. A pelvic frame system for the substantial prevention of bedsores of double leg amputees, the pelvic frame comprising:

at least one rod inserted into a pelvis of the amputee in use so as to provide at least one protruding end extending from the skin of the amputee; and

at least one support engagement fastened to the least one protruding end, the at least one support engagement configured for engaging a support in use such that at least one rod bears at least some of the weight of the torso of the amputee so as to substantially reduce or eliminate bedsores causing pressure on tissue surrounding the pelvis of the amputee.

2. A pelvic frame system as claimed in claim 1, wherein:

the at least one rod comprises a laterally/medially orientated weight-bearing rod inserted through the pelvis of the amputee in use so as to provide opposite laterally protruding ends; and the at least one support engagement comprises a pair of support engagements each fastened to a respective one of the laterally protruding ends.

3. A pelvic frame system as claimed in claim 2, wherein the weight-bearing rod is inserted substantially through the acetabula of the pelvis in use.

4. A pelvic frame system as claimed in claim 1, wherein the at least one rod comprises at least one substantial anteriorly/posteriorly orientated stabilising rod inserted into the pelvis of the amputee so as to provide at least one anteriorly located protruding end from the skin of the amputee.

5. A pelvic frame system as claimed in claim 4, wherein the stabilising rod comprises a length sufficient so as to extent posteriorly beyond the weight-bearing rod.

6. A pelvic frame system as claimed in claim 4, wherein the at least one stabilising rod comprises at least two stabilising rods.

7. A pelvic frame system as claimed in claim 4, wherein the at least one stabilising rod is inserted into the ilium of the pelvis in use.

8. A pelvic frame system as claimed in claim 4, wherein the at least one stabilising rod is inserted into the anterior inferior iliac spine of the pelvis.

9. A pelvic frame system as claimed in claim 7, wherein the at least two stabilising rods are orientated in line with a portion of the ilium.

10. A pelvic frame system as claimed in claim 6, wherein the at least two stabilising rods are substantially coplanar.

11. A pelvic frame system as claimed in claim 10, wherein the at least two stabilising rods are superiorly located with respect to the weight-bearing rod.

12. A pelvic frame system as claimed in claim 4, wherein the length of the at least one stabilising rod is less than the length of the weight-bearing rod.

13. A pelvic frame system as claimed in claim 1, wherein the at least one rod comprises at least one substantial anteriorly/posteriorly orientated ancillary rod.

14. A pelvic frame system as claimed in claim 13, wherein the at least one ancillary rod is inserted into the anterior superior iliac spine of the pelvis in use.

15. A pelvic frame system as claimed in claim 1, wherein the at least one rod comprises at least one circumferential bone growth enhancing surface.

16. A pelvic frame system as claimed in claim 15, wherein the least one bone growth enhancing surface comprises two spaced apart circumferential bone growth enhancing surfaces.

17. A pelvic frame system as claimed in claim 1, wherein the at least one rod is modular.

18. A pelvic frame system as claimed in claim 17, wherein the at least one rod comprises a rod portion and a rod engaging portion.

19. A pelvic frame system as claimed in claim 18, wherein the offset of the rod engaging portion with respect to the rod portion are configurable so as to allow for the length adjustment of the rod.

20. A pelvic frame system as claimed in claim 1, wherein the support engagements are configured for engaging a substantially V shaped support in use.

21. A pelvic frame system as claimed in claim 20, wherein the support engagements comprise a waist configured for sitting within a notch of the V shaped support.