Patent Grant
7918510
This invention relates in general to a seating system for treating sit complaints and sit impairments, especially decubitus ulcers.
The body-weight functions as an acting force when lying down and sitting. This force is distributed over the contact area that the body has with the supporting surface. The quotient of force and contact area is pressure, as shown in
In sitting, the acting force (i.e., the body-weight) is not usually applied perpendicularly but at an angle to the supporting surface and therefore a shear force is generated, as shown in
The potential efficacy (i.e., a non critical load and adequate sit stability) of wheelchair seating systems can be derived from above mentioned biomechanical starting points of local deloading and stabilizing of the body in place. In general, patients with wheelchair sit-complaints/impairments are treated with a standard sit-cushion. When this treatment is not successful, unless some alternative treatment is applied, this leads to chronic recitative wheelchair sit complaints.
Standard sit-cushions and backrests are manufactured (in series) as off-the-shelve products. The following are characteristics/limitations of present standard sit cushions not anatomically (i.e., three dimensional) shaped, or limited anatomical shape; not specifically designed for/suitable for an unequal load distribution over the buttocks; not specifically designed to achieve pelvic stability; and not specifically designed to compensate sit pathology.
The characteristics/limitations of the present standard sit cushions frequently cause the situation that treatment of wheelchair sit complaints/impairments via standard sit cushions do not deliver a positive medical treatment result, in other words lead to chronic/recitative sit complaints/impairments.
A seating system comprises a three dimensional anatomically shaped that design is specifically designed for the range of three dimensional pelvic/trunk measures (i.e., sit-cushion and backrest measures), that is specifically designed for unequal and non-critical load distribution over the buttocks and back that is specifically designed for an adequate pelvic and trunk stability; and that is specifically designed to compensate present sit pathology.
Various aspects of this invention will become apparent to those skilled in the art from the following detailed description of the preferred embodiment, when read in light of the accompanying drawings.
Now with reference to the drawings, particularly
The most prevalent sit complaints may be complaints of pain, the feeling of instability, and tiredness or fatigue. The most prevalent sit impairments may be complaints related to the threat of decubitus ulcers, which may be apparent from red skin, decubitus ulcers, or sliding away, which may result from instability.
Sit complaints and impairments may be an expression of an abnormal magnitude and/or direction of a load when seated. The inability to change the seated position (e.g., in a wheelchair) often results in the experience of pain at those places or points where the bony parts of the skeleton of the sitting area (e.g., the tubera, trochantera and sacrum) and to a lesser extent the back (e.g., the scapula, processus spinosus, crista iliaca) are prominent (see
Not only may the magnitude of the load be influenced by sitting but also the direction of that loading. In general, the tendency may be to slide away as a consequence of instability. This may take place when a person is not able or is insufficiently able to correct a changing body posture. Corrections of the body posture are often attempted and often do not give the required result. These attempts require a lot of effort (i.e., energy) for the person and generate tiredness or fatigue.
Instability may present greater problems especially with users that are completely or nearly completely wheelchair-bound. Often these users have one of the following diagnoses: spinal cord lesion, severe stroke or contusio cerebri, cerebral palsy, congenital skeleton diseases, spina bifida, or neuromuscular or degenerative diseases.
Diagnostics of sit complaints of wheelchair users may be difficult because such users typically fail to mention pain they encounter when sitting, pain being an accompaniment to sit complaints or because they cannot feel pain (e.g. in spinal cord laesions). A doctor or seating expert frequently does not inquire specifically about a user's pain. For an abnormal sitting posture, the same holds true. This problem is also insufficiently recognized because it is not taken seriously.
When diagnosing wheelchair users, a consistent and accurate inquiry should be made about the kind of sit complaints or impairments the user endures. Most prevalent complaints or impairments may be pain, decubitus ulcers or a threat thereof, instability or tiredness. In connection with this inquiry, an inspection of the buttocks (e.g., for skin defects) and sitting posture (e.g., sliding away) may be performed. Last mentioned, palpation at the height of the bony prominent skeleton parts (e.g., putting a hand under a loaded buttock at the height of the tubera) may give possible insight into the differences of localized loading and can as such be an explanation, at least in part, for the sit complaints and impairments that are present.
The above mentioned subjective diagnostics (i.e., inquiry, inspection and palpation) can be objectified by carrying out a sit load analysis. A sit load analysis can give an objective insight into the magnitude and direction of the seated load and can make it possible to make a distinction between critical loading (i.e., accompanied by risk) and a non-critical loading (i.e., without risk). In a sit load analysis, specific clinical software can be applied to process pressure measurement data obtained via a protocolled pressure measurement in time in order to acquire relevant clinical outcome data. The sit load analysis program may calculate the seated load (e.g., of the seat and back) and determine the medical risks of seating. As such, sit complaints and impairments can be objectified.
The treatment of wheelchair sit complaints and impairments may exist out of the application of a load related wheelchair seating system. Starting from a load related treatment, the treatment of the excessive local overload at the buttocks and/or back should result in a local or regional pressure relief at the buttocks and/or back. A localized deloading can be achieved on the one hand, through the provision of a contact area that should be as large as possible between the seat and/or backrest and the body and on the other hand, through the realization of a redistribution of the load (at the level of the contact area) on the principle of a non-equal pressure and loading distribution. In practice, the latter may be with respect to the reduction of the load at the level of the bony prominent skeleton parts and the scar regions and a selective loading of soft tissues and body parts, which can endure more load (e.g., the dorsal side of the upper legs and the gluteus region).
In the treatment of instability, the seat should stabilize the pelvic base (i.e., the bottom view of the pelvis) directly or indirectly (in the frontal, the sagittal and the transversal planes (see
There may be a few bony and soft tissue structures available to stabilize the pelvic basis in the frontal and the sagittal planes. These may be supportive areas.
Pelvic stability can also be influenced via the back in the sagittal plane. Trunk stability can be influenced via the back in the frontal, sagittal and transversal planes. This can be accomplished, as in the pelvic base stabilization, by using certain loadable supportive areas. In the stabilization of the pelvis (i.e., pelvic base stabilization) and the trunk, not only the supportive areas are considered, but also an optimal contact area is considered.
Design Trajectory of the Sit-Cushion:
A. Inventory of three dimensional pelvic measures (e.g., prominent skeletal parts of the pelvic base). This may be done with the help of patient load analysis data (registration of three dimensional pelvic base measures), and using the measures of three dimensional experimental sit-cushions.
Result: Range of pelvic measures of prominent skeletal parts of the pelvic base may be in the frontal, sagittal and transversal planes.
B. Design (three dimensional drawing) of the basic sit cushion (models) may be in three measures: small, medium and large (S, M and L).
The basic three-dimensional shape of a sit-cushion module 210, which may be made up of a left bottom half 214 and a right bottom half 216, as shown in
To simplify the sit-cushion assortment, three different size models (sit shapes) may be described, namely small, medium, and large (S, M and L) size models. These sizes may be based on measures in the transversal, frontal and sagittal plane. That is to say, the width of the each size model may be based on the hip width of the user. For the three model sizes, the hip widths chosen, for example, may be:
The widths chosen may be based on the range of hip widths, derived from the patient load analysis data with pelvic base measures (see
Next, the width of the ischial tuberosities (IT) may be scheduled (see
The mean of the trochanter width may be, for example, 22.5 cm (i.e., central trochanter). This may be a design measure and should not be confused with a clinical outer trochanter measure. This may be scaled linearly with a total hip width. The average trochanter width (see
The distance of the IT to the rear end (i.e., the back of the seat) may vary, for example, between 13 and 15 cm (see
The distance between the pubis P and the sacrum S may vary (see
The mean of the sacrum pubis distance (SP) may be 18.5 cm.
Analyses of these measures may be derived form anthropometric data (e.g., physical measures of pelvises in place and pelvic measures derived from sit pressure measurements/sit load analyses of patients).
In the frontal plane, the depth position of the tubera, trochantera and sacrum may differ, as shown in
The distance tuber-sacrum (distal part of the sacrum) may vary, for example, from 4-6 cm (sitting in a relaxed position with a slight lumbar lordosis) and this may lead to the following sizes:
Starting with the above mentioned three dimensional pelvic measures, S, M and L basic sit-cushion models may be developed/built up.
C. Specification of Sit Pathology of the Buttocks Per Pelvic Half
The sit pathology of the buttocks (i.e., excessive local loading and/or instability) can be specified per pelvic half (left and right, respectively), using the patient load analyses data, whereby for example
The following regions or structures of the module (i.e., the left bottom half and the right bottom half), using patient load analyses data, can be used as loading options: the trochantera, the musculus glutei, the rami inferiores ossis pubis, and the dorsal side of the upper legs (see
D. Modification of the Designed Three Dimensional Basic Sit Cushion Model Per Pelvic Half
On the basis of the insight in the sit pathology (see C above), modifications may be applied in the design of the basic sit-cushion model half.
Modification of the basic sit-cushion model half (with standard loading) on behalf of the treatment of local overloading, may be, for example, as follows:
Modification of the basic pelvic sit module on behalf of the treatment of sit instability, may be, for example, as follows:
The above mentioned modifications of the three dimensional basic pelvic sit shape half have experimentally (from a bio-mechanical perspective) taken place and were judged on their effect on the local sit loading and sit stability by means of sit load analysis in a representative group of subjects. Guided by the results, sit loading profiles with a non critical load distribution over the buttocks and an adequate sit stability (loading less than 60 mm Hg, shift the center of pressure (COP), as it relates to pressure mapping (i.e., in the plane of the pressure map), such as in the pressure mapping systems available from Tekscan, Force Sensing Array (FSA) from Vista Medical, X-Sensor and Novell, over both axis less than 0.20 cm) have been accomplished.
To simplify the prescription, three basic half models may be sufficient. The three basic half models may be alike with respect the deloading of the tubera and the sacrum but may differ to the extent in which the musculi gluteï and the trochantera may be loaded, for example, as follows:
The modifications of the three dimensional sit-cushion model half may make it possible to achieve an unequal load distribution over the buttocks with a non-critical sit loading (i.e., treatment of local overload) and, at the same time, an adequate sit stability.
As far as a pelvic half model does not necessarily realize a non-critical load/adequate sit stability, the remaining overload/sit instability can be solved via an adaptation of the cushion. Material (e.g., foam) and construction of the cushion may be suitable for adaptation.
Based on the results of the sit analysis of a patient sitting on a preselected cushion shape, the cushion (e.g., foam base) can be adapted locally by grinding the foam base and/or adding specific inserts: a sacrum bridge (for deloading of the sacrum in the sagittal plane), a buttock bank (for deloading of the sacrum, stabilizing the pelvis in the sagittal plane), a hip endo/exo facilitator (for treatment of spasm), a hip endo/exo preventor (for treatment of hypotone thigh muscles), a sagittal wedge (for treatment of stability of the body in the sagittal plane), a frontal wedge, (for treatment of stability in the frontal plane), a diagonal wedge (for treatment of stability in the frontal and transversal plane simultaneously), and a rotation block (for treatment of the rotated pelvis in the transversal plane).
The pelvic half models are respectively illustrated, for example, in
Because a half model should be selected for per each pelvic half (i.e., the left bottom half and the right bottom half), there may be a total of nine different sit-cushion models, as set forth, for example, in the matrix that follows:
Three symmetric cushion models may be presented, for example, as set forth below:
Through the nine sit-cushion models (above), local overload of the tubera and sacrum can be treated. In the case of a trochanter overload, pelvic half model 3 may be applied. The extra gluteus load may provide sit stability in the sagittal plane (see
If the trochanter region can be loaded normally, pelvic half model 1 or 2 may be selected. In the case of gluteus hypotonus or atrophy and/or pelvic instability in the sagittal and frontal planes, the gluteus region can be loaded more, via pelvic half model 2. This may stabilize (see
In all three pelvic base half models, the rami inferiores ossis pubis and upper legs may be subjected to the same degree of loading. This may contribute to the pelvic base stability in the sagittal plane.
The combination of the nine pelvic half models, left and right (L and R), and the three sizes (S, M and L) of these models may result in twenty seven (3×9) pelvic half models (L and R).
Starting from the three basic pelvic half models (1, 2 and 3), one generic pelvic half model (in S, M and L) for the left (L) and the right (R) pelvic half may be developed (see
Using inserts (e.g., a trochanter insert for standard trochanter loading and a gluteus insert for extra gluteus loading), the three basic pelvic half models can be built up from the generic pelvic half model. Starting from the composed three pelvic half models, nine sit-cushion models can be made (in S, M and L). The composed sit-cushion models may be entrapped in an envelop, or container.
The complete generic sit-cushion assortment (GSA) may exist out of left and right generic pelvic half models in three sizes (S, M and L) with (in-size) accompanying inserts, an entrapping container, and a seat-pan.
The GSA may be a clinical toolkit. On the basis of an inventory of the sit complaints, treatment of the sit complaints may be performed by a test cushion, composed with the help of the GSA. Application of this test cushion may make it possible to clarify objectively if the existing sit complaints can be treated in a medically responsible manner.
Design Trajectory of the Backrest
E. Inventory of three dimensional back measures (e.g., prominent skeletal parts of the pelvic dorsum, the spine and the scapulae). This with the help of the patient load analysis data (registration of three dimensional back measures) and using the measures of three dimensional experimental backrests.
Result: Range of back measures of prominent skeletal parts of the back, for example, in the frontal, sagittal and transversal planes.
F. Design (Three Dimensional Drawing) of the Basic Backrest (Model) in Three Measures, for Example: Small, Medium and Large (S, M and L).
The basic three-dimensional shape of a backrest module 310, which may be made up of a right back half 314 and a left back half 316, as shown in
To simplify the backrest assortment, three different size models (back shapes) may be described, namely, for example, small, medium, and large (S, M and L) size models. These sizes may be based on measures, for example, in the transversal, frontal and sagittal planes. That is to say, the length of the each size model may be based on the chosen back length in sit (distance between seat surface and Th3) of the user minus the height of the seat cushion (i.e., about 7 cm). For the three model sizes, the back length (see
L 54 cm.
The length chosen may be based on the range of back lengths, derived, for example, from the patient load analysis data with back measures (see
Also, the width of the back may be scheduled (i.e., reduced to a matrix) (see
1. Crista Level
The widths determined may be:
2. Th-12 Level
The widths determined may be:
3. Th-7 Level
The widths determined may be:
The width on Th-7 level may determine the choice of the size of the model.
The depth of the lumbar lordosis (see
Starting with the above-mentioned back measures, S, M and L basic backrest concept models can be developed.
G. Specification of Sit Pathology of the Back Per Back Half
The sit pathology of the back—excessive local loading and/or sit instability can be clearly specified per back half (left and right respectively), using the patient load analyses data, whereby, for example,
The following regions or structures of the module (i.e., the left back half and the right back half), using patient load analyses data, can be used as loading options: the dorso lateral side of the thorax wall and the proximal part of the musculi glutei. These loading options may not only be useful within the framework of an unequal pressure and loading distribution of the back but also for the stabilization of the back in the frontal and the sagittal plane (via the musculi glutei and the thorax wall (see
H. Modification of the Designed Three Dimensional Basic Backrest Model Per Back Half
On the basis of the insight in the sit pathology (see G above), modifications can be applied in the design of the basic backrest model half.
Modification of the basic backrest model half (with standard loading) on behalf of the treatment of local overloading, for example:
Modification of the basic backrest module on behalf of the treatment of sit instability, for example:
The above mentioned modifications of the three dimensional basic back shape half (model) have experimentally (from a bio-mechanical perspective) taken place and were judged on their effect on the local sit loading and sit stability by means of sit (back) load analyses in a representative group of subjects. Guided by the results, sit (back) loading profiles with a non-critical load distribution over the back and an adequate sit stability (loading less than 60 mm Hg and shifting COP less than 0.20 cm) can be accomplished.
To simplify the prescription, four basic back half models may be sufficient. The backrest half models are illustrated, for example, in
The modifications of the three dimensional backrest model half may make it possible to achieve a specific unequal load distribution over the back with a non-critical sit loading (e.g., treatment of local overload) and at the same time an adequate sit stability.
In as much as a backrest half model does not realize a non-critical load/adequate sit stability, the remaining overload/sit instability can be solved via a manual adaptation of the material (e.g., foam) and construction of the backrest (which are suitable for adaptation).
The foam material of the selected backrest model can be adapted locally by, for example, grinding the foam and/or adding specific inserts: a gluteus insert (for extra loading to treat instability in the sagittal plane), a low thoracal wall insert (for extra loading to compensate instability of the trunk in the frontal plane) and a high thoracal wall insert for extra loading to compensate instability of the trunk in the frontal plane).
Not every theoretical combination (see matrix below) of each half model needs to be selected. Only six backrest models may have a clinical relevant meaning in treating sit pathology. Clinically relevant may be the backrest models which can correct/stabilize the stance of the trunk/pelvis in patients with a sit instability.
With a stance impairment, or a reduced functional control over pelvis and/or trunk (i.e., sit pathology), and/or sit instability in patients with a central neurological disease with a high muscle tone (spascisticy)/spasm there may be an indication for model 1/1 (see
Symmetrical sit pathology/sit instability on the basis of a neurological disease, without manifest spasticity/spasm, may require the application of backrest model 2/2 (see
In all backrest models, a standard deloading may take place of the sacrum, the crista iliaca, the spina iliaca posterior superior, the proc. spinae, the lower two ribs (i.e., the floating ribs) and the scapulae.
The combination of the six backrest half models and the three sizes (S, M and L) of these models may result in eighteen (3×6) backrest models.
Starting with the six backrest models (1/1, 2/1, 1/2, 2/2, 3/4, 4/3) a generic backrest model (see
This generic backrest may characterize itself by:
Through the application of, for example, inserts (for extra loading at the location of the gluteii, the lower and higher thoracic wall), the clinically relevant backrest can be built up and tested on a patient. In this manner, the prescription for the specific model and size (to treat the sit complaints/impairments medically justified) can be verified and made definite.
The complete generic backrest assortment (GBA) may exist out of a generic backrest model in three sizes (S, M and L) with, in the right size, the accompanying inserts and a back pan.
Prescription Procedure
I. Inventory of Sit Complaints/Impairments
To prescribe a seating system, an inventory of sit complaints and impairments may be taken by considering, for example:
In relation to 1 and 2 above, investigation of sit complaints can be performed subjectively or objectively by application of the method of sit load analysis.
II. Selection of the Sit-Cushion and/or Backrest Model
Seat Cushion:
The pelvic half models may be selected for each pelvic half (i.e., left and right) based on the inventory of the sit complaints or impairments and accompanying pathology characteristics, by considering, for example, the following:
Based on the foregoing prescription, the appropriately left and right pelvic half models may be selected. The left and right half models may form the selected seat cushion model. The size of the model (S, M and L) may be determined by the measure of the hip width.
Backrest
For sit instability and/or stance impairments, or decreased functional control over the spine due to a symmetrical central neurological disease (symmetrical high tone/spasm), backrest model 1/1 may be indicated.
For sit instability and/or stance impairment, or a decreased functional control over pelvis/spine due to an asymmetrical central neurological disease (asymmetrical high tone/spasm, for example, CVA), backrest model 1/2 or 2/1 may be indicated.
For sit instability and/or stance impairments, or decreased functional control over the spine due to a symmetrical neurological disease with a normal/low tone (left and right), backrest model 2/2 may be indicated.
For sit instability and/or stance impairments, or decreased functional control over the spine due to an asymmetrical neurological disease with normal/hypotone or orthopedic disease (e.g., scoliosis), backrest 3/4 or 4/3 may be indicated.
The size of the model is determined by the measure of the Th-7 width.
The basic sit-cushion and/or backrest module may need individual adaptation to the user, as described above.
It should be appreciated that half models of a seating system (i.e., a sit-cushion and a back) can be formed from a single piece of material, by cutting (e.g., by computer numerical control or other cutting method), molding or other suitable manner, rather than being formed from separate pieces that a joined together. That is to say, the sit-cushion and back do not have to be formed from physically separate pieces that are joined together, but rather can be formed from or into a single piece.
The principle and mode of operation of this invention have been explained and illustrated in its preferred embodiment. However, it must be understood that this invention may be practiced otherwise than as specifically explained and illustrated without departing from its spirit or scope.
This application claims the benefit of U.S. Provisional Patent Application No. 60/836,292, filed on Aug. 8, 2006.
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