METHODS FOR BONE STABILIZATION

Abstract

A method for reducing motion of a skeletal structure in a limb towards a wall of an interface is described. The interface comprises a plurality of compression areas that are longitudinally-shaped and oriented longitudinally along the length of limb. The method comprises selecting, during a process of creating the interface, a compression level for the compression areas that compresses soft tissue against the skeletal structure. The method also comprises donning the interface over the limb to apply a plurality of compressive forces that is sufficient to aid in suspension of the interface on the limb and reduce motion of the skeletal structure toward a wall of the interface.

Claims

1. A method for reducing motion of a skeletal structure in a limb towards a wall of an interface worn on the limb, wherein the interface comprises a plurality of compression areas, the method comprising: selecting, during a process of creating the interface, a compression level for each of the plurality of compression areas that compresses soft tissue of the limb against the skeletal structure when the interface is worn on the limb; wherein each of the plurality of compression areas is longitudinally-shaped and oriented longitudinally along the limb; donning the interface over the limb so that the plurality of compression areas applies a plurality of compressive forces to the limb; wherein the plurality of compressive forces is sufficient to aid in suspension of the interface on the limb and reduce motion of the skeletal structure toward a wall of the interface.

2. The method of claim 1, wherein the plurality of compression areas comprises at least three compression areas.

3. The method of claim 1, wherein the interface further comprises a plurality of open or low-compression relief areas, and wherein the plurality of compression areas and the plurality of relief areas are arranged in an alternating pattern.

4. The method of claim 1, wherein the interface has an encapsulating design.

5. The method of claim 1, wherein the interface has a strut-type configuration.

6. The method of claim 1, further comprising the step of donning an inner flexible membrane on the limb.

7. The method of claim 6, wherein the inner flexible membrane comprises a liner.

8. The method of claim 6, wherein the inner flexible membrane is donned on the limb prior to donning the interface.

9. The method of claim 6, wherein the inner flexible membrane provides an elastic force to the soft tissue.

10. The method of claim 1, wherein, when the interface is donned, the plurality of compressive forces reduces an uncompressed diameter of the limb by at least 20%.

11. The method of claim 1, wherein the step of selecting a compression level for each of the plurality of compression areas comprises determining a comfort level of the user.

12. The method of claim 1, wherein the step of selecting a compression level for each of the plurality of compression areas depends at least in part on body fat content of the limb.

13. The method of claim 1, wherein the plurality of compressive forces is sufficient such that redundant skeletal motion is minimized while retaining sufficient comfort to allow the user to withstand the compressive forces for a useable amount of time.

14. The method of claim 13, wherein the plurality of compressive forces allows adequate blood flow in the soft tissue for a useable amount of time.

15. The method of claim 1, wherein the step of selecting a compression level for each of the plurality of compression areas comprises ascertaining blood perfusion of the soft tissue using a sensor.

16. The method of claim 1, wherein the step of selecting a compression level for each of the plurality of compression areas comprises measuring an uncompressed diameter of the limb.

17. The method of claim 1, further comprising a step of creating the interface by applying a setting material to the limb and applying the plurality of compressive forces to the setting material as the material sets to produce a negative model.

18. The method of claim 17, further comprising the step of removing the negative model from the limb and allowing a material to set in the negative model to produce a positive model.

19. The method of claim 1, further comprising the step of creating the interface by scanning the limb to create a digital image of the limb and modifying the digital image to apply the plurality of compression areas to create a digital model.

20. The method of claim 19, further comprising the step of creating the interface by applying a plurality of compressive forces prior to scanning the limb.

21. The method of claim 19, further comprising the step of sending the digital model to a carver or 3D printer to generate a physical model.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0054] FIG. 1 is a perspective view from an anterior position of a transhumeral high-fidelity interface device in accordance with a first preferred embodiment of the invention, where the device has an open cage or strut-type structure;

[0055] FIG. 2 is a perspective view from an anterior position of a transhumeral high-fidelity interface device in accordance with a second preferred embodiment of the invention, where the device has a closed structure;

[0056] FIG. 3 is a cutaway view from the top of the interface device of FIG. 2, showing an interior thereof;

[0057] FIG. 4 is a view of the device of FIG. 1 on a patient's left arm;

[0058] FIG. 5 is a perspective view from a medial position of a transradial high-fidelity radial interface device as a closed structure;

[0059] FIG. 6 is a perspective view from an anterior position of a transfemoral high-fidelity interface device in accordance with a fourth embodiment, where the device has a closed structure;

[0060] FIGS. 7a, 7b show an example of a jig design utilized for transfemoral cast taking in preparation for the creation of a transfemoral high-fidelity interface;

[0061] FIGS. 8a, 8b show the anterior and posterior perspectives of an exemplary transfemoral high-fidelity interface attached to prosthetic components;

[0062] FIG. 9 is a drawing showing a casting

[0063] FIG. 10 is a drawing showing a mold formed from the casting;

[0064] FIG. 11 is a flow chart showing steps in a process of an embodiment of the invention for making a high-fidelity interface for a prosthesis and limb, preferably a lower limb; and

[0065] FIG. 12 is a flow chart showing steps in an alternate process of another embodiment of the invention for making a high-fidelity interface for a prosthesis and limb, preferably an upper limb.

DETAILED DESCRIPTION

[0066] As shown in FIG. 1, a the transhumeral open-cage interface embodiment, there is an upper portion 1, which has both an anterior stabilizer 2 and a posterior stabilizer 3 and which extends in a proximal (in this case toward a patient's shoulder) and medial (toward a patient's midline) direction from a lower portion 4 to stabilize the interface on a patient's body. Although stabilizers 2 and 3 are not required, they are recommended to impart or enhance rotational stability. The lower portion 4 (below line 5) has an open-cage structure. Dashed horizontal line 5 demarcates the upper and lower portions. The lower portion 4 of this open-cage embodiment has multiple, e.g. three or four struts 6, which look like fingers that extend along the long axis of the residual limb and are designed to partially encompass the residual limb, allowing soft tissue to flow through windows 7.

[0067] As shown in FIG. 2, a transhumeral solid-body interface embodiment, there is an upper portion 1a, which has both an anterior stabilizer 2a and a posterior stabilizer 3a and which extends in a proximal (in this case toward the shoulder) and medial (toward the midline) direction from lower portion 8 to stabilize the interface on the body. Although stabilizers 2a and 3a are not required, they are recommended to impart or enhance rotational stability. In this embodiment, lower portion 8 is a solid body structure. A dashed horizontal line 5a demarcates the upper and lower portions. The lower portion of this solid-body embodiment has multiple, e.g. three or four, compression areas 9 and soft tissue relief areas 10 that extend along the long axis of the residual limb and are arranged circumferentially in an alternating compression-relief pattern as shown. Soft tissue relief areas 10 must have a volume sufficient to cleave displaced skin and other tissue from compression applied by compression areas 9.

[0068] In FIG. 3, an interior of the transhumeral solid-body interface embodiment is shown, with alternating compression areas 9 and relief areas 10 indicated.

[0069] In FIG. 4, a patient is shown wearing a transhumeral open-cage interface embodiment such as that of FIG. 1 with a suspension liner 30 of minimal thickness or of sufficient stretch to minimally restrict soft tissue flow through the relief windows. Struts 6 providing soft tissue compression and windows 7 allowing soft tissue flow are indicated.

[0070] In FIG. 5, a transradial solid-body interface is shown. In this embodiment, there is an upper portion 11, which comprises the area of the interface proximal to olecranon 12 and cubital fold 13. A lower portion 14 has multiple, e.g. three or four, compression areas 15 and soft tissue relief areas 16 that extend along the long axis of the residual limb and are arranged circumferentially in an alternating compression-relief pattern as shown.

[0071] In FIG. 6, a transfemoral solid-body interface is shown. This embodiment has multiple, e.g., three or four, compression areas 17 and soft tissue relief areas 18 that extend along the long axis of the residual limb and are arranged circumferentially in an alternating compression-relief pattern as shown.

[0072] In FIGS. 7a and 7b, there is shown a tool for use in imaging (and particularly helpful for the lower limb), which tool optionally may be used with various embodiments of the invention. Imaging is a process to render a model of the limb using plaster bandage, laser scanning or other such technique. Imaging of a limb under compression may be done to create the model. This tool is essentially a connected set of adjustable bars attached to screws which in turn are connected to a circumferential or partially circumferential ring that allows this tool to be placed over the limb either before, during or after the imaging process and that applies the appropriate compression to the soft tissues of the limb in desired target areas while allowing redundant soft tissue to flow through the areas between the struts unhindered.

[0073] More specifically, the jig consists of a multiplicity of paddles 101 for pushing inward against the limb remnant of an amputee. For most purposes, four paddles preferably are used. For the configuration shown, eight sectors 110 are assembled into two rings. Eight screws are used at locations 111 to assemble the rings.

[0074] In FIG. 7b, a screw (not shown) is inserted into clearance hole 112 to secure the turnbuckle holder 108 to the sector 110. Until the screw is tight, the holder is free to rotate with respect to the sector. The turnbuckle rod 106 is threaded with an eyelet 113 on the far end to connect to paddle holder 105. A pin attaching these two parts is inserted into hole 114. Paddles 101 each have a channel 103 into which a slider 102 is captured. This slider has two threaded bosses 104 which are secured to paddle holder 105 by nuts (not shown). By loosening these two nuts the slider may be repositioned along the paddle.

[0075] To adjust the position of the paddle, a threaded wheel 107 is turned. In the configuration shown, there are a total of eight turnbuckle assemblies to position the paddles in contact with the amputee's limb. Preferably, the paddles are made from a rigid, inexpensive plastic that can be trimmed to a width and length suitable to the individual amputee fitting. All of the other components are preferably reusable.

[0076] As shown in FIGS. 8a (an anterior perspective) and 8b (a posterior perspective), an exemplary prosthetic component set 22 is attached to one device 23. Various prosthetic components may be attached to the device by any one of various methods currently available or available in the future. The device may have at a proximal end any one of various support structures known in the art or developed in the future.

[0077] In a method in accordance with an embodiment of the invention, an interface device with open-cage or strut-type is fitted onto a person.

[0078] First, it is determined whether a patient needs a transradial (radial level) device, a transhumeral (humeral level) device, a transtibial (tibial level) device or a transfemoral (femoral level) device. The patient or prosthetist may select a closed device or an open cage strut-type high-fidelity device.

[0079] Second, the patient's limb radius is determined at one or more locations. Third, the device is essentially crimped during modification or creation of the device until sufficient compression from the at rest radius of the patient's limb at the cage or strut region of the device is at a desired amount. The desired amount of compression will depend in part on the patient's bone size, body fat, and other tissue parameters at the area of the cage or strut. The compression generally is at least 20% or at least 30% from the at rest radius of the limb. Typically, compression will be from 20% to 70% or 30% to 70%. The amount of compression is sufficient such that there is minimum redundant tissue between the maximum point of compression and the target bone contained within the interface such that motion capture of the bone is maximized while retaining sufficient comfort to allow the wearer to withstand the compression for a useable amount of time and to ensure adequate blood flow over time, which can be ascertained through the use of a blood perfusion sensor and monitor. The blood perfusion sensor can be utilized during casting, diagnostic interface assessment or in the definitive socket.

[0080] However, compression can be lower than 20% or higher than 70% depending upon bone size, body fat and other tissue parameters, and the prosthetician and/or physician will use the blood perfusion sensor and monitor and make a determination of the safety and effectiveness of the particular amount of compression for the particular patient.

[0081] Fourth, the modified or rectified high-fidelity device with an inner radius or inner radii of size that can be fit over the distal (free) end of the patient's limb (for fitting with a prosthesis) is selected, and applied to the patient's limb, e.g., by sliding onto the limb.

Creation and Fabrication of High-Fidelity Interface

[0082] In a method in accordance with an embodiment of the invention, an interface device with open-cage (strut-type) or solid-body configuration is fitted onto a person.

[0083] First, it is determined whether a patient needs a wrist disarticulation device, a transradial device, a transhumeral device, a symes device, a transtibial device, a knee disarticulation device, a transfemoral device or a hip disarticulation device. The patient or prosthetist may select a closed or open cage strut-type high-fidelity device as disclosed herein.

[0084] Second, the patient's limb radius is determined at one or more locations along the limb where the interface device will be fit.

[0085] Third, the interface is created using one of several different methods, all of which require modification by the prosthetist to complete fitting of such a final socket.

[0086] One method commonly employed is to cast the patient's limb utilizing a plaster bandage. This casting allows the prosthetist or clinician to add compression forces to the plaster wrap and hence to the limb in the target areas that will hold this compression and allow for subsequent tissue relief between these compression areas as the plaster sets.

[0087] The cast, which will function as a negative model or mold, is removed and filled with liquid plaster.

[0088] The liquid plaster is allowed to set in the mold.

[0089] Once the liquid plaster has solidified, the plaster bandage (mold) surrounding the solid (positive) model is removed. The positive model is now revealed to which the prosthetist or clinician applies additional compression to the target areas by carving directly on the model. Carving on the positive model creates a pressure or compression point on the target areas because the negative model (the socket being molded from the positive model) will now have a larger inwardly facing compression area.

[0090] Another way to generate the limb shape to be modified is to use a scanner to obtain the image shape and then modify the digital image accordingly using well known software, e.g., on a computer such as a laptop. This digital model (as modified to apply targeted compression and relief) can then be sent to a carver or 3d printer to generate a physical positive model over which a negative model (mold) can be created for fitting or additional fabrication.

[0091] In order to determine appropriate compression levels, the device is essentially crimped during modification or creation of the device until sufficient compression from the at rest radius of the patient's limb at the cage or strut region of the device is at a desired amount. The desired amount of compression will depend in part on the patient's bone size, body fat, and other tissue parameters at the area of the cage or strut. The compression generally is at least 20% from the at rest radius of the limb. Typically, compression will be from 20% to 70%, or at least 30% to 70%. For certain patients, such as very muscular, or those having calcification, the minimum compression to achieve the advantages of the inventive method may be a little below the above minimum ranges, and for certain patients, such as obese patients or others with extremely fleshy skin, a higher than 70% compression may be appropriate. However, comfort and medical safety can dictate the final appropriate amount of compression for any particular patient.

[0092] The amount of compression is sufficient such that there is minimum redundant tissue between the maximum point of compression and the target bone contained within the interface such that motion capture of the bone is maximized while retaining sufficient comfort to allow the wearer to withstand the compression for a useable amount of time.

[0093] Fourth, the decision is made whether a diagnostic interface (transparent thermoplastic socket for analysis of fit and function prior to creating the definitive model) or a definitive interface, typically consisting of a laminated framework, is to be created.

[0094] Over the now modified or crimped model, in order to create the diagnostic interface, a thermoplastic material is heated and draped or blister-formed, preferably under vacuum, to render a new negative model. Once the thermoplastic has cooled and become rigid, the plaster is then removed from within the thermoplastic interface and the interface is trimmed and smoothed and is of sufficient stiffness and transparency to allow the clinician to don it on the patient and judge the fit and pressures acting on the limb. This model can be removed from the patient's limb and trimmed or heated to change its boundaries or perimeter and shape, including the amount of compression or relief that is applied to the limb based on what is observed and comments from the wearer.

[0095] In order to create the definitive interface, an acrylic laminate (with or without stiffeners such as carbon fiber, Kevlar, i.e., para-aramid synthetic fiber, etc.) or similar can be vacuum formed directly over the model or in the case of a frame style interface with a flexible liner and rigid frame, over an inner flexible liner that has been previously vacuum-formed over the same model.

[0096] The now compressed negative socket, whether in diagnostic or definitive form can be donned by either a push-in or pull-in method, with the latter being preferred due to the high levels of compression applied to the limb. This compression imparts friction on the skin during donning and hence makes it more difficult to get all the limb tissue down in the interface unless a donning sock or similar is used to pull the tissue in. The pull-in method utilizes a donning sock or similar such device that surrounds the limb and is pulled through a distal aperture at the distal end or bottom of the interface. As the wearer pulls down on the end of the donning sock and pulls it through the aperture, the limb is pulled down into the interface until fully seated.

[0097] In FIG. 9, an example of a casting 240, e.g., for an upper limb, is shown.

[0098] In FIG. 10, a socket 202 having compression regions 209 and relief regions 210 is shown on a patient's limb, e.g., an upper limb.

[0099] FIG. 11 is a flow chart showing steps in a process of an embodiment of the invention for making a high-fidelity interface for a prosthesis and limb, preferably a lower limb, the lower limbs being the ones that will be bearing weight of the wearer's body; and

[0100] FIG. 12 is a flow chart showing steps in an alternate process of another embodiment of the invention for making a high-fidelity interface for a prosthesis and limb, preferably an upper limb.

[0101] In FIG. 11, in a step 221, a technician will locate biomechanically, anatomically and physiologically appropriate location of compression bars to be applied to an upper limb during casting or scanning such that there are alternating fields of compression and relief arranged longitudinally along shaft of long bone.

[0102] In step 222, a technician will, if casting, preferably use a casting jig as shown in FIG. 7a or 7b both before and after the plaster bandage is applied to the limb in order to identify the locations described above and to apply appropriate compression to the limb underweight bearing conditions after the plaster wrap is applied respectively. If scanning, the technician will identify locations for compression bars such that they are retained in the modification software after scan is complete.

[0103] In step 223, a technician will create positive model from negative model created above and modify such that the longitudinal compression areas correspond to at least a 20% (or 30%) (up to 70%) diameter reduction as compared to the uncompressed measurement if anatomically and physically appropriate. In some cases, compression below 20% or above 70% may be acceptable.

[0104] In step 224, a technician will create a diagnostic, negative model from the positive model above including longitudinally extending compression regions corresponding to the amount of compression determined above, and relief regions adjacent and in between the compression regions for receiving at least a volume of the patient's fleshy portions on the remaining limb that are to be displaced by the compression regions. The relief/release regions can be enclosed or completely open provided there is minimal restriction to soft tissue flow.

[0105] In step 225, which is optional, one preferably will put on al sock or sleeve to facilitate donning by pulling the limb down into the socket more completely.

[0106] In the process of FIG. 12, in step 231, a technician will locate biomechanically, anatomically and physiologically appropriate location of compression bars to be applied to (lower) limb during casting or scanning such that there are alternating fields of compression and relief arranged longitudinally along shaft of long bone.

[0107] In step 232, the technician will, if casting, apply a plaster bandage to limb and over this apply compression bars in the predetermined locations above. If scanning, the technician will identify locations for compression bars such that they are retained in the modification software after scan is complete.

[0108] In step 233, the technician will, create positive model from negative model created above and modify such that the longitudinal compression areas correspond to at least a 20% (or 30%) (up to 70%) diameter reduction as compared to the uncompressed measurement if anatomically and physically appropriate. In some cases, compression below 20% or above 70% may be acceptable.

[0109] In step 234, the technician will create a diagnostic, negative model from the positive model above including longitudinally extending compression regions corresponding to the amount of compression determined above, and relief regions adjacent and in between the compression regions for receiving at least a volume of the patient's fleshy portions on the remaining limb that are to be displaced by the compression regions. The relief/release regions can be enclosed or completely open provided there is minimal restriction to soft tissue flow.

[0110] In step 235, which is optional, one preferably will put on al sock or sleeve to facilitate donning by pulling the limb down into the socket more completely.

[0111] Although the invention has been described using specific terms, devices, and/or methods, such description is for illustrative purposes of the preferred embodiment(s) only. Changes may be made to the preferred embodiment(s) by those of ordinary skill in the art without departing from the scope of the present invention, which is set forth in the following claims. In addition, it should be understood that aspects of the preferred embodiment(s) generally may be interchanged in whole or in part.