Residual limb protector and methods of use

Abstract

The present invention is directed to a reusable residual limb protector that can be used with a knee immobilizer to protect a recent amputee patient from further injury and infection of the amputation site while preventing knee flexion contractures. In alternative embodiments, the residual limb protector is configured for use with one patient. A method of use of the residual limb protector is also disclosed herein.

Description

Residual Limb Protector and Methods of Use

[0001] All patents, patent applications, and publications cited herein are hereby incorporated by reference in their entirety. The disclosures of these publications in their entireties are hereby incorporated by reference into this application in order to more fully describe the state of the art as known to those skilled therein as of the date of the invention described and claimed herein.

[0002] This patent disclosure contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the U.S. Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights.CROSS REFERENCE TO RELATED APPLICATIONS

[0003] This international application claims the benefit of priority to U.S. Provisional Application No. 63 / 646,342, filed on May 13, 2024, entitled “RESIDUAL LIMB PROTECTOR AND METHODS OF USE.”GOVERNMENT INTERESTS

[0004] Not applicable.TECHNOLOGICAL FIELD

[0005] The present disclosure relates to a residual limb protector and methods for use thereof. Specifically, the residual limb protector disclosed herein is configured to receive and hold a knee immobilizer without contacting a dressing of a residual limb of a user and mitigate damage from a fall or other impact to a residual limb of a recently amputated user.BACKGROUND

[0006] This section is intended to introduce various aspects of the art, which may be associated with exemplary embodiments of the present disclosure. This discussion is believed to assist in providing a framework to facilitate a better understanding of aspects of the present disclosure. Accordingly, it should be understood that this section should be read in this light, and not necessarily as admissions of prior art.

[0007] Patients in an acute care hospital, inpatient rehabilitation hospital, and a community setting who have recently undergone a lower leg amputation (specifically including, any area above the ankle but below the knee, otherwise referred to as a “trans-tibial, amputation”) represent a subset of patient with a heightened susceptibility to falls. Patients with a recent amputation may reflexively attempt to stand, walk, or otherwise ambulate without considering the recent limb removal, which, consequently, leads to an increased risk of falling. For such patients, falls may cause a range of injuries, including bruises, lacerations, fractures, hematomas, wound dehiscence, and reopen or otherwise damage surgical wounds that may have an increased risk of infection or necessitate surgery to revise the amputation. In severe cases, these post-operative wound complications from falls can lead to recent amputee patients returning to the operating room for conversion surgery to an above-the-knee amputation. Aside from these physical effects, an amputee patient following a fall can develop a fear of future falls and social withdrawal. Following a fall, an amputee may face additional challenges with accepting or adapting to their prosthesis. Diabetic amputees, who often experience postural instability due to peripheral nerve damage that can impair lower limb proprioception, touch sensitivity, and sensing vibrations, have an even greater risk of falls.

[0008] Post-operatively, amputee patients have a reported incidence of falls at a rate of 16.5% in the acute care setting, about 35% in the in-patient rehabilitation hospital, and even higher in the community setting. Of transtibial amputee patients who fall, 3% require subsequent surgical procedures, and 47% of those individuals require conversion to an aboveknee amputation, resulting in poorer functional outcome for the patient. Falls also increase the length of the patient’s stay at an acute-care hospital by an average of 32.5 days. Given these risks for amputee patients, there is a strong need for a device that can be used post-operatively to protect the residual limb and the surgical site from impacts or falls.

[0009] Other post-operative devices for residual limbs of recent lower-limb amputee patients are not configured for use with a knee immobilizer. In addition, current post-operative devices can either interfere with the dressing on the amputation incision or cause surgeons or recovery care personnel to place the device in a manner that interferes with or otherwise contacts any soft dressing applied to the residual limb.

[0010] Following amputation, dressings are applied to the surgical site that can include sterile gauze, padding, elastic wrap, or any combinations thereof. Such compression dressings provide contouring of the residual limb to facilitate wound healing, prevent infection, prevent knee flexion contractures, reduce swelling, and prepare the amputee patient for a future prothesis by shrinking and shaping the residual limb. Dressings that are applied incorrectly orare displaced due to a device on the residual limb, can constrict circulation, cause skin irritations, or interfere with proper scar formation. In addition, these simple dressing offer minimal protection from trauma associated with a fall. In fact, there can be an increased likelihood of injury to the residual limb following falls or other impacts when the only protection to the post-operative site is a soft dressing.

[0011] Other post-operative tools for amputee patients include rigid dressings, which are multi-layered dressings made of gaze, bandages, stump socks, and a plaster of Paris cast, which are molded to a specific patient and, thus, not reusable. In addition, rigid dressings do not allow frequent observation of the healing surgical wound. Instead, a removable rigid dressing (RRD) can be used to allow inspection of the wound.

[0012] RRDs have certain disadvantages that reduce their practical use in clinical settings. RRDs can be costly, interfere with the surgical dressing, and require a specialized, professional prosthetist to fit the patient postoperatively. Whenever a dressing needs to be changed, such as for frequent observation and evaluation of the healing surgical incision, the RRD must be properly replaced, which either requires the prosthetist to return to the facility or the facility staff to undergo extensive training.SUMMARY OF THE INVENTION

[0013] Disclosed herein is a residual limb protector configured to be used with a knee immobilizer to protect a recent amputate from further injury and infection of the amputation site, while preventing knee contractures using the immobilizer.

[0014] In various aspects the residual limb protector comprises a substantially cylindrical body that is hollow, with a first end and a second end. The second end of the body can be connected to a dome. In embodiments, the dome comprises an apex end and a base end, an interior surface, and an exterior surface. The apex end of the dome can comprise an energyabsorbing structure. A circumferential channel can extend around at least a portion of the body. The residual limb protector can be configured to receive at least a portion of a knee immobilizer. In embodiments, the residual limb protector comprises at least one means for reversible attachment of the knee immobilizer thereto.

[0015] In certain embodiments, the energy-absorbing structure comprises at least one circumferential groove or notch extending across a portion thereof. The energy-absorbing structure can comprise a plurality of circumferential groves or notches. In embodiments, the energy-absorbing structure comprises at least one circumferential groove or notch. The energyabsorbing structure can comprise at least twenty circumferential grooves or notches. In variousembodiments, the dome has a thickness, and the at least one circumferential groove or notch of the energy-absorbing structure has a depth of between 10% and 80% of the thickness of the dome. The energy-absorbing structure can comprise an infill with a honeycomb matrix.

[0016] In one embodiment, the dome is elongated such that the length of the dome is greater than the width of the dome. The substantially cylindrical body of the residual limb protector can comprise a circumference, and the base end of the dome comprises an extended rim, the extended rim comprising a larger circumference than the circumference of the body. The circumferential channel can be laterally defined by the base end of the dome and medially defined by the body. In one embodiment, the circumferential channel is U-shaped. The circumferential channel can comprise a width that is sufficient to receive and hold a distal end of the knee immobilizer. In embodiments, the circumferential channel comprises a depth being defined by the height of an extended rim of the base end of the dome. The circumferential channel can be at least partially defined by a floor that continuously extends around the circumference of the body. In embodiments, the channel is at least partially defined by a floor, the floor further comprising a plurality of slots or discontinuous gaps therein.

[0017] The residual limb protector can further comprise a plurality of guidance grooves or notches disposed on the body, wherein the plurality of guidance grooves or notches are configured to guide at least one stay of a knee immobilizer into the channel. In embodiments, the residual limb protector comprises at least one projection or bump disposed on the body or a floor of the channel, wherein the at least one projection or bump is configured to guide at least one stay of a knee immobilizer into the channel.

[0018] The means for reversible attachment of a knee immobilizer can comprise at least one flange extending from a rim of the first end of the body. The at least one flange can comprises an upward- and outward-extending curvature from the rim. In certain embodiments, the rim of the first end of the body comprises at least two flanges. The rim of the first end of the body can comprise at least three flanges. In certain embodiments, the at least three flanges comprise a first flange, a second flange, and third flange; the first flange comprising a first length; the second flange comprising a second length; and the first length is shorter than the second length.

[0019] The residual limb protector can comprise a plurality of flanges, wherein each flange is spaced a defined distance from a neighboring flange. In embodiments, the rim has a substantially straight profile between each of the plurality of flanges. The rim can comprise an outwardly projecting curve between the plurality of flanges.

[0020] In various embodiments, the residual limb protector comprises at least one hole or opening in the apex end. The at least one hole or opening can be disposed in the center of the apex end.

[0021] The dome of the residual limb protector can comprise a semispherical shape. In embodiments, the means for attachment of a knee immobilizer comprises an attachable anchor disposed on the exterior surface dome. In certain embodiments, the body, the dome, or both comprise a single, continuous piece of substantially nonflexible material. The thickness of the nonflexible material can be up to about 5 mm. In various embodiments, the energy-absorbing structure comprises a first thickness; the base end of the dome comprises a second thickness; the body comprises a third thickness; and the first thickness is less than the second thickness, the third thickness, or both.

[0022] In certain embodiments, the residual limb protector comprises a first piece and a second piece, the first piece comprising the substantially cylindrical body with a neck or extension at a distal end of the substantially cylindrical body, and the second piece comprising the dome and the circumferential channel. The first piece and the second piece can comprise a means for attaching the first piece to the second piece. In embodiments, the first piece and the second piece are reversibly attached to one another. The first piece and the second piece can be integral with one another. In certain embodiments, the means for attaching the first piece to the second piece is comprised of a plurality of tabs or ridges on the second piece, which are shaped and positioned such that the plurality of tabs or ridges fit within a plurality of holes or gaps in the distal end of the body of the first piece. The internal surface of the dome of the second piece can have at least one vertical rib or gusset having a proximal end and a distal end, and the proximal end being closest to the circumferential seat or channel. In embodiments, the proximal end of the at least one vertical ridge or gusset comprises means for receiving the distal end of the body of the first piece. The means for receiving the distal end of the body of the first piece can be comprised of a notch or groove.

[0023] In various embodiments, the residual limb protector further comprises a knee immobilizer. The knee immobilizer can be reversibly connected to the residual limb protector. Alternatively, the knee immobilizer and the residual limb protector can be integral with one another such that the residual limb protector comprises a limb protector portion disposed at a proximal end of the residual limb protector and a knee immobilizer portion disposed at a distal end of the residual limb protector.

[0024] In embodiments, the residual limb protector is configured for use with one patient before being disposed. The residual limb protector can be reusable. In certain embodiments,the residual limb protector comprises a sterilizable material. The material can be capable of being cleaned with a liquid cleaning solution without negatively affecting the integrity of the residual limb protector.

[0025] In certain embodiments, the residual limb protector comprises a weight of up to about 800 grams. The body of the residual limb protector can comprise a vertical height that is sufficient to create a space between the distal end of a residual limb of a user without the residual limb protector contacting the user or a soft dressing on the user. The circumference of the substantially cylindrical body can comprise a diameter sufficient to receive and hold at least a portion of a knee immobilizer. The circumference of the substantially cylindrical body ranges from about 200 mm up to about 650 mm. In embodiments, the width of the circumferential channel can be between about 5 mm and about 80 mm.

[0026] Another aspect of the present disclosure relates to a method of protecting a distal end of a residual limb of a recently amputated user from further injury. In embodiments, the method comprises obtaining any of the various residual limb protectors disclosed herein. The method can further comprise inserting at least a portion of the distal end of the residual limb of the user into a knee immobilizer, which comprises a proximal end, a distal end, and a plurality of straps, strings, bands, cords, hook-and-loop straps, or a combination thereof; securing at least one of the straps, strings, bands, cords, hook-and-loop straps, or a combination thereof except the most distal straps, strings, bands, cords, hook-and-loop straps, or a combination thereof; positioning the proximal end of the residual limb protector within in the distal end of the knee immobilizer such that at least a portion of the proximal end of the substantially cylindrical body of the residual limb protector is inside of the knee immobilizer, with a space between the distal end of the residual limb of the user and the residual limb protector; centering a knee of the user between at least two flanges or projections on the rim of a proximal end of the body; placing the distal end of the knee immobilizer within the circumferential channel; and wrapping the strap, string, band, cord, hook-and-loop strap, or a combination thereof closest to the distal end of the knee immobilizer around an exterior surface of the substantially cylindrical body of the protector and underneath the flanges of the rim of the proximal end of the body.

[0027] In embodiments wherein the residual limb protector obtained is one that is comprised of a first piece and a second piece, the method further comprises attaching the first piece to the second piece before positioning the proximal end of the residual limb protector within the distal end of the knee immobilizer. In such embodiments, the method can further comprise lining up the plurality of tabs or ridges of the second piece such that the plurality of tabs or ridges fitwithin a plurality of holes or gaps in the distal end of the body of the first piece when the first piece is attached to the second piece.

[0028] In another aspect the present disclosure relates to a method of protecting a distal end of a residual limb of a recently amputated user from further injury using a residual limb protector with an integrated knee immobilizer, wherein an internal space exists between the limb protector portion and the knee immobilizer portion of the residual limb protector. The method can comprise inserting at least a portion of the distal end of the residual limb of the user into the knee immobilizer portion of the residual limb protector, which comprises a plurality of straps, strings, bands, cords, hook-and-loop straps, or a combination thereof; positioning the distal end of the residual limb of the user within the knee immobilizer portion at a depth within the internal space such that the distal end of the residual limb of the user does not contact the apex end of the residual limb protector portion; and securing at least one of the straps, strings, bands, cords, hook-and-loop straps, or a combination thereof to the user.

[0029] Other objects and advantages of this invention will become readily apparent from the ensuing description.BRIEF DESCRIPTION OF THE FIGURES

[0030] Certain illustrations, charts, or flow charts are provided to allow for a better understanding of the present invention. It is to be noted, however, that the drawings illustrate only selected embodiments of the inventions and are therefore not to be considered limiting of scope. Additional and equally effective embodiments and applications of the present invention exist.

[0031] FIG. 1A shows an elevated left perspective view of the front of a residual limb protector under one embodiment.

[0032] FIG. IB shows an elevated right perspective view of the back of the residual limb protector of Figure 1 A.

[0033] FIG. 1C shows a side view of the residual limb protector of Figure 1 A. The residual limb protector is shown in an inverted state as compared to the orientation of Figure 1 A.

[0034] FIG. ID shows a back perspective of the bottom of the residual limb protector under the embodiment of Figure 1A.

[0035] FIG. IE shows a perspective view of the bottom of the residual limb protector of the residual limb protector of Figure 1A.

[0036] FIG. 2 shows an elevated front view a residual limb protector under another embodiment.

[0037] FIG. 3 shows a cross-sectional side view through the middle of the Figure 1A embodiment.

[0038] FIG. 4 shows a front view of a residual limb protector attached to a knee immobilizer in accordance with one embodiment.

[0039] FIG. 5 shows a front view of a residual limb protector being employed by a user while attached to a knee immobilizer in accordance with one embodiment.

[0040] FIG. 6A shows a back perspective of a residual limb protector under another embodiment.

[0041] FIG. 6B shows a side perspective, exploded view of the front of the residual limb protector of Figure 6 A, in a diagonal orientation.

[0042] FIG. 6C shows a cross-sectional and exploded view through the middle of the residual limb protector of Figure 6A.

[0043] FIG. 6D shows an elevated right perspective view of the back of the residual limb protector of Figure 6 A.

[0044] FIG. 6E shows a lower-right perspective view of the bottom of the residual limb protector of Figure 6 A.DETAILED DESCRIPTION OF THE INVENTIONAbbreviations and Definitions

[0045] Detailed descriptions of one or more embodiments are provided herein. It is to be understood, however, that the present invention can be embodied in various forms. Therefore, specific details disclosed herein are not to be interpreted as limiting, but rather as a basis for the claims and as a representative basis for teaching one skilled in the art to employ the present invention in any appropriate manner.

[0046] The singular forms “a,” “an,” and “the” include plural reference unless the context clearly dictates otherwise. The use of the word “a” or “an” when used in conjunction with the term “comprising” in the claims and / or the specification can mean “one,” but it is also consistent with the meaning of “one or more,” “at least one,” and “one or more than one.”

[0047] Wherever any of the phrases “for example,” “such as,” “including” and the like are used herein, the phrase “and without limitation” is understood to follow unless explicitly stated otherwise. Similarly, “an example,” “exemplary” and the like are understood to be nonlimiting.

[0048] The term “substantially” allows for deviations from the descriptor that do not negatively impact the intended purpose. Descriptive terms are understood to be modified by the term “substantially” even if the word “substantially” is not explicitly recited. Therefore, for example, the phrase “wherein the lever extends vertically” means “wherein the lever extends substantially vertically” so long as a precise vertical arrangement is not necessary for the lever to perform its function.

[0049] The terms “comprising” and “including” and “having” and “involving” (and similarly “comprises,” “includes,” “has,” and “involves”) and the like are used interchangeably and have the same meaning. Specifically, each of the terms is defined consistent with the common United States patent law definition of “comprising” and is therefore interpreted to be an open term meaning “at least the following,” and is also interpreted not to exclude additional features, limitations, aspects, etc. Thus, for example, “a process involving steps a, b, and c” means that the process includes at least steps a, b, and c. Wherever the terms “a” or “an” are used, “one or more” is understood, unless such interpretation is nonsensical in context.

[0050] As used herein the term “about” is used herein to mean approximately, roughly, around, or in the region of. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. In general, the term “about” is used herein to modify a numerical value above and below the stated value by a variance of 20 percent up or down (higher or lower).

[0051] For purposes of the present disclosure, it is noted that spatially relative terms, such as “up,” “down,” “right,” “left,” “beneath,” “below,” “lower,” “above,” “upper” and the like, can be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over or rotated, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the exemplary term “below” can encompass both an orientation of above and below. The device can be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0052] The terms “user,” “patient,” or “subject” as used herein include all members of the animal kingdom including, but not limited to, mammals, animals (e.g., cats, dogs, horses, swine, etc.) and humans.

[0053] The term “knee immobilizer,” as used herein can refer to any removable device that can be worn by a patient to maintain stability of the knee or restrict movement (such as contraction of flexion) of the knee joint. Knee immobilizer can refer to any tool used post- operatively for amputee patients to allow for safe patient movement in and out of bed and prevent knee flexion contractures, in an acute care hospital, inpatient rehabilitation hospital, and in a community setting. A knee immobilizer can refer to an off-the-shelf knee immobilizer or a custom fit or patient-specific knee immobilizer.Description of Selected Embodiments

[0054] Disclosed herein is a residual limb protector configured to receive a knee immobilizer, without contacting a soft dressing on a residual limb of a user, and prevent, or mitigate injury from, falls or other impacts to a patient’s healing surgical amputation incision and possible bone fractures or other injuries. In various embodiments, the residual limb protector disclosed herein can be repeatedly used with multiple patients. The residual limb protector can be readily cleaned and sanitized, before being reused with other patients. In alternative embodiments, the residual limb protector can be configured for use by a single patient. In various embodiments, the presently disclosed residual limb protector can comprise an attachable anchor that can further improve the strength of attachment between the protector and a knee immobilizer.

[0055] Figure 1A shows a front left view of a residual limb protector 100 under one exemplary embodiment. The residual limb protector 100 can be used with either the right or left leg of a patient who has had a transtibial amputation. In the embodiment of Figure 1A, the residual limb protector 100 comprises a substantially cylindrical body 102 that is hollow and has an internal space 104. The body 102 has a rim 106 on the first or proximal end of the body. The rim 106 can be curved in shape and can have one or more flanges or projections 108 extending therefrom. In embodiments, the limb protector 100 comprises a means for reversible attachment of a knee immobilizer; in some embodiments, this comprises plurality of flanges or projections 108 ,110. At least one of the flanges or projections 108, 110 can comprises a curvature that extends upwardly and outwardly to provide a point of attachment to a knee immobilizer. In certain embodiments, the curvature of the flanges or projections 108, 110 extends downwardly to provide a point of attachment to a knee immobilizer. In embodiments,the curvature of the flanges or projections 108, 110 can be configured to receive a strap, string, band, cord, hook-and-loop strap, or a combination thereof of the knee immobilizer around the circumference of the proximal end of the body 112 underneath the rim 106. In embodiments, the attachment point formed from the outwardly extending curvature of the flanges or projections 108, 110 prevents the residual limb protector 100 from dislodging from the knee immobilizer, or otherwise accidentally or unintentionally removed during use thereof. For example, the attachment point formed from the outwardly extending curvature of the one or more flanges or projections 108, 110 can serve as an anti-slip mechanism to prevent the knee immobilizer from sliding off the residual limb protector 100 during use or in the event of impact from a fall.

[0056] The substantially cylindrical shape of the body 102 allows for the strap, string, band, cord, hook-and-loop strap, or a combination thereof of the knee immobilizer to be wrapped or secured around the protector 100. In some embodiments, an insertion section can be used with the protector 100 that is configured so that the strap, string, band, cord, hook-and-loop strap, or a combination thereof of the knee immobilizer can be wrapped or secured onto the insertion section and leave the amputation incision free of pressure.

[0057] As shown in the Figure 1A embodiment, the residual limb protector 100 can have at least three flanges or projections 108, 110 wherein one flange or projection 108 is smaller than at least one of the other two flanges or projections 110. In embodiments, at least one of the flanges or projections 110 is substantially the same size as at least one other flange or projection 110. In operation or use of the protector 100, the smaller flange or projection 108 can be aligned with a kneecap of the user.

[0058] As shown in the Figure 1A embodiment, the length of the one or more flanges or projections 108, 110 can be sufficient to prevent or reduce movement of the strap, string, band, cord, hook-and-loop strap, or a combination thereof of the knee immobilizer. As shown in the Figure 1A embodiment, the smaller flange or projection 108 can measure about 60 mm in width. In embodiments, at least one of the larger flanges or projections 110 can measure about 100 mm in width. In various embodiments, the plurality of flanges or projections 108, 110 can measure about 30 mm in length. In certain embodiments, at least one of the flanges or projections 108, 110 is curved in shape. At least flanges or projections 108, 110 can have a central angle of about 2.85 radians.

[0059] As can be seen from Figure 1A, a spacing may exist between each of the flanges or protections 108, 110, wherein the spacing permits each of the flanges or projections to be disposed circumferentially at discrete locations around the rim 106. As shown in the exemplaryembodiment of Figure 1A, the smaller flange or projection 108 can be centered at about 0 degrees circumferentially (looking at the front view), while larger flanges or projections 110 can be centered at about 45 and about 315 degrees circumferentially. In other embodiments, the plurality flanges or projections 108, 110 are spaced equidistantly about the rim 106. The plurality of flanges or projections 108, 110 can be spaced at any distances about the rim 106.

[0060] In embodiments, the number, shape, or size of the flanges or projections 108, 110 can vary. In certain embodiments, an increased number, shape, or size of the flanges or projections 108, 110 can serve to increase the strength of the connection between the knee immobilizer and the protector 100 during use. Embodiments of the residual limb protector 100 comprises up to 10 flanges or projections. The residual limb protector can comprise two, three, four, five, six, seven, eight, nine, or ten flanges or projections 108, 110.

[0061] In addition, although embodiments are shown with curved flanges or projections 108, 110, it should be understood that at least one of the flanges or projections 108, 110 can comprise an alternate shape or form. For instance, at least one of the flanges or projections 108, 110 can be substantially straight or linear and extend laterally and upwardly from the distal- most portion of the body 102. In embodiment, the flanges or projections 108, 110 extend laterally at an angle between about 0 degrees and about 180 degrees.

[0062] The residual limb protector 100 is further configured to receive a distal end of a knee immobilizer, such as an off-the-shelf knee immobilizer, without touching the soft dressing of a residual limb of a user. Use of the protector 100 with a knee immobilizer provides protection to the residual limb of the user while also preventing knee contractures.

[0063] Knee immobilizers can comprise at least one stay, which is configured to add support to the structure of the immobilizer or further limit motion of the patient (i.e., preventing knee flexion). Each stay can comprise a proximal end and a distal end. In embodiments, the distal end refers to the end of the stay that is furthest from the user when being worn, while the proximal end is opposite thereto (i.e., closer to the hip of a user when worn). As shown in the Figure 1A embodiment, the protector 100 can comprise a means for receiving the at least one stay of the knee immobilizer. In certain embodiments, the means for receiving at least one stay can include a circumferential seat, recess, channel 114. The circumferential seat or recess or channel 114 can be configured to permit the distal end of the stay to reside therein. The circumferential seat or recess or channel 114 can be defined within or around the connection of the body 102 with a dome 116. For instance, the circumferential seat or recess or channel 114 can comprise a medial side 117 defined by an exterior wall of the body 102 and a lateral side 119 defined by an internal wall that extends upward toward the rim 122 of the dome 116with a floor extending therebetween. In embodiments, the circumferential seat or recess or channel 114 can comprise about a 90-degree angle 117 where the floor of the channel 114 meets the exterior wall of the body 102, about a 90-degree angle formed 119 between the floor of the channel 114 internal wall extending toward the rim 122 of the dome 116, or a combination thereof. In other embodiments, a curved angle can be formed at the edges of a U- shaped circumferential seat or recess or channel 114, where the floor of the channel 114 meets the exterior wall of the body 102, and where the floor of the channel 114 internal wall extends toward the rim 122 of the dome 116, or a combination thereof. In various embodiments, the seat or recess or channel 114 can assist with maintaining the position of the knee immobilizer and the stay(s) on a patient, especially during impact or falls. In addition, the channel 114 can be configured to prevent the end of the knee immobilizer and / or stay(s) from becoming caught on and / or tangled in an acute-care or rehabilitation setting, which can include, for example, medical lines like an intravenous or IV-line, bed rails, bed sheets, or other medical equipment.

[0064] The width of the circumferential seat or recess or channel 114 can be sufficient to receive and hold the distal end of the knee immobilizer or any portion thereof, including the end of any stays of the immobilizer, without touching the dressing on a residual limb of a user. In embodiments, the width of the circumferential seat or recess or channel 114 can be about 25 mm. In other embodiments, the width of the circumferential seat or recess or channel 114 can be between about 5 mm and 80 mm.

[0065] In some embodiments, as in Figure 1 A, the circumferential seat or recess or channel 114 can be continuous. In other embodiments, not pictured, the floor of the circumferential seat or recess or channel 114 can be discontinuous. The circumferential seat or recess or channel 114 can comprise a plurality of gaps that extend through the floor. In such embodiments, each of the gaps can be configured to receive the distal end of at least one stay of the knee immobilizer.

[0066] In still other embodiments, the circumferential seat or recess or channel 114 can be continuous with a one or more slots extending at least partially through the floor of the circumferential seat or recess or channel 114. The one or more slots can extend completely through at least a portion of the floor of the circumferential seat or recess or channel 114. In various embodiments, such slots can be configured to receive at least one stay of the knee immobilizer. In embodiments with slots, the slots can be wide enough to receive at least a portion of the distal end of at least one stay of the knee immobilizer. In some embodiments, the slots have a width of around 1 inch.

[0067] In various embodiments, such slots or gaps within the circumferential seat or recess or channel 114 prevent or reduce slipping or dislodgement of the residual limb protector 100 out of the knee immobilizer, adding greater stability during use of the residual limb protector 100 with the knee immobilizer.

[0068] In other embodiments not pictured, there may be at least one groove, notch, or other indicator around the body 102 that can guide a knee immobilizer into the proper positioning in the circumferential seat or recess or channel 114. In still other embodiments, there can be at least one proj ection or bump around the body 102, the floor of the channel 114, or both, wherein the projection or bump is configured to guide a knee immobilizer into the proper positioning in the circumferential seat or recess or channel 114.

[0069] The dome 116 has an apex end 118 and a base end 120, the base end having a rim 122 that is also the rim of the circumferential seat or recess or channel 114. The proximal end of the body 112 is opposite to the dome 116. The proximal end of the body 112 is the portion of the residual limb protector 100 that fits within the distal end of the knee immobilizer. When properly positioned, the proximal end of the body 112 is closest to the user’s residual limb, and the dome 116 is furthest from the user’s residual limb. The shape of the dome 116 can be generally the shape of a semi-sphere. In embodiments, the semispherical shape of the dome 116 is configured to protect an incision wound of an amputee patient from an impact or force from any direction. For instance, the generally spherical shape of the dome 116 permits the force of any impact, such as that which may occur from a fall, to be absorbed throughout the protector 100 or otherwise deflected from affecting the wound of a patient’s residual limb. In forming the circumferential seat or recess or channel 114, the circumference of the rim 122 of the base end of the dome is larger than the circumference of the substantially cylindrical body 102 and the body 102 sits within an internal space of the dome 116. The circumferential seat or recess or channel 114 can have a connection point 117 at about halfway up the height of the body 102. The apex end 118 of the dome can comprise an energy-absorbing structure 124, which is further described below with reference to Figure ID & IE.

[0070] As shown in the Figure 1A embodiment, the residual limb protector 100 can comprise a single, continuous piece of nonflexible material. The body 102 can comprise a height and width or diameter that are sufficient to fit within the distal end of the knee immobilizer, such that the residual limb protector 100 can be received and held within the distal end of the knee immobilizer without contacting a residual limb of a user. In such embodiments (and as more clearly shown in Figure 5), a space exists between the residual limb of the user and the residual limb protector 100. Thus, while in use, the residual limb protector 100 can beprevented from contacting or otherwise interacting directly with the user’s residual limb or any dressing disposed thereon. The space between the distal end of the residual limb and the apex end 118 of the protector 100 allows the dome 116 to absorb any impact or force and reduce, if not eliminate, any direct forces to an incision or wound on the residual limb of the user.

[0071] In various embodiments, the residual limb protector 100 comprises a shape that is designed to fit within a knee immobilizer and can comprise a variety of sizes. In certain embodiments, the residual limb protector 100 is configured to fit individuals with a calf size of a residual limb, in terms of circumference, between the 5thpercentile of females and the 95thpercentile of males, inclusive, according to any commonly referenced anthropometric standards.1In embodiments, the residual limb protector 100 can be configured for use with the residual limb of an average adult male. The residual limb protector 100 can be configured for use with the residual limb of an average adult female. In embodiments, the residual limb protector 100 can be configured for use with the residual limb of an average 12-year-old child. The residual limb protector 100 can be configured for use with the residual limb of an averagesized toddler. The residual limb protector 100 can be configured to protect the user when participating in activities of daily living after the amputation, such as standing up, transferring from one surface to another, walking, normal childhood playing, or rehabilitation exercises.

[0072] In certain embodiments, the body 102 has a circumference of about 480 mm. The circumference of the body 102 can range from about 200 mm to about 650 mm. The body 102 can range in vertical height from about 55 mm to about 335 mm. In embodiments, the dome 116 can have a vertical height of about 80 mm. The circumference of the dome can be about 640 mm. The dome 116 can range in vertical height from about 55 mm to about 335 mm. The circumference of the dome 116 can range from about 225 mm to about 750 mm.

[0073] Figure IB provides an elevated right perspective view of the back of the residual limb protector 100 of the Figure 1A embodiment. In this view, the residual limb protector 100 is rotated about 45° in the counterclockwise direction as compared to the Figure 1A orientation. Once again, a plurality of flanges or projections 108, 110 can be seen on the rim 106 of the proximal end of the body 102. One or more flanges or projections 108 can be smaller than the other flanges or projections 110. The top of the rim 106 can comprise a profile that is substantially straight within the spaces 125, 126 between the plurality of flanges or projections1A non-limiting example of an acceptable anthropometric standard is McDowell MA, Fryar CD, Ogden CL, Flegal KM, Anthropometric reference data for children and adults: United States: 2003-2006, National Center for Health Statistics, National Health Statistics Reports, no 10, at pages 36-38, Hyattsville, MD (October 22, 2008).108, 110. Alternatively, the rim 106 can comprise a profile that is curved (such as an outwardly extending curve) or angled within the spaces 125, 126 between the one or more flanges or projections 108, 110. As discussed above with respect to Figure 1A, the protector 100 can comprise a flange or projection 108, which can be centered in line with the user’s knee when in use. In embodiments, the flange or projection 108 configured to be disposed over the user’s knee is smaller than one or more of the other flanges or projections 110. As seen in the Figure IB embodiment, between the two larger flanges or projections 110, the curve 125 can be shaped like a wide “C’ (or open parenthesis on its back), to support a backside of the residual limb of the user when being worn. As seen in the Figure IB embodiment, the spacing along the rim 106 on either side of the smaller flange or projection 108 can comprise a means for receiving a knee immobilizer with at least one stay located on either, or both, side(s). In other embodiments, the rim 106 between the plurality of flanges or projections 108, 110 can be curved in a different manner to accommodate different types or locations of stays, or to accommodate no stays.

[0074] Figure 1C provides a side view of the residual limb protector 100 in an inverted position as compared to that of Figure 1A embodiment. The exterior surface of the dome 116 can be seen. In some embodiments, the nonflexible material that makes up the apex end 118 of the dome 116 can be thinner than the nonflexible material that makes up the remainder of the residual limb protector 100. In embodiments, this thinner portion of the dome 116 can comprise the energy-absorbing structure 124 as discussed in more detail below. The circumferential seat or recess or channel 114 is not visible in the view of Figure 1C, as the rim 122 of the dome 116 can be extended to form the outer wall of the seat or recess or channel 114.

[0075] Figure ID shows an elevated perspective of the front of the residual limb protector 100 of the Figure 1A embodiment. Once again, the circumferential seat or recess or channel 114 and the internal space 104 of the body 102 can be seen. In the elevated perspective of Figure ID, a distal or second end 128 of the body 102 can be seen within the interior surface of the dome 116. The second end 128 comprises the apex end 118 of the dome 116. The interior surface of the apex end 118 is shown, comprising the energy-absorbing structure 124. A one hole or opening 130 is shown at the distal -most portion of the dome apex end 118. In this embodiment, the hole or opening 130 is disposed at about the center of the apex end 118 of the dome 116. In other embodiments, the at least one hole or opening 130 can be off center. In other embodiments, there can be as many as 25 holes or openings 130. The at least one hole or opening 130 can be at least sufficiently wide enough to allow airflow into the residual limb protector 100 to reach the surgical wound. The hole or opening 130 can have a diameter ofabout 50 mm. In other embodiments, the at least one hole or opening 130 can have a diameter that is any value between about 1 mm to about 100 mm.

[0076] In various embodiments, the energy-absorbing structure 124 is comprised of a plurality of grooves or notches 132 extending from the outside rim of the at least one hole or opening 130 and connecting to the second end 128 of the body 102. In other embodiments, the plurality of grooves or notches 132 may not reach, or may extend beyond, the second end 128 of the body 102. Each of the one or more grooves or notches 132 can comprise a length of between about 5 to about 100 mm, inclusive. In other embodiments, the one or more grooves or notches 132 can comprise a length that can be between 5% and 75% of a surface distance of the dome 116; the surface distance of the dome 116 being the length from the center of the hole or opening 130 in the apex end 118 of the dome, following the curve down to the base of a rim 122 of the dome 116. In other embodiments, the one or more grooves or notches 132 can comprise a length that can be between 20% and 40% of a surface distance of the dome 116. The plurality of grooves or notches 132 can be disposed on the interior surface of the dome 116. In embodiments, the plurality of grooves or notches 132 are present on the interior surface of the dome 116, but do not extend entirely through to the exterior surface of the dome 116. In such embodiments, the plurality of grooves or notches 132 represent thinner or weaker points in the structure of the dome 116 that are configured to break, crack, or crumple to absorb or deflect at least a portion of any force exerted on the exterior surface of the residual limb protector 100 during a fall or other impact to a distal end of protector 100. These grooves or notches 132 can further act as a visual indicator of a fall or force exerted on the residual limb protector 100, wherein a break, crack, or crumple in the energy-absorbing structure 124 along the plurality of grooves or notches 132 indicates a prior occurrence of a fall or other impact.

[0077] Figure IE provides a perspective view of the bottom of the residual limb protector 100 of the Figure 1A embodiment. Once again, the at least one hole or opening 130 in the apex end 118 of the dome 116 can be seen. In embodiments, the at least one hole or opening 130 provides airflow and allows for visualization of a wound or of a soft dressing covering an amputation incision on an end of a residual limb of a user. In embodiments, the residual limb protector 100 does not contact the wound or the soft dressing on the wound of the residual limb of the user. A space (as more clearly shown at 510 of Figure 5) can exist between the residual limb and the residual limb protector 100. Airflow to the incision, through the hole or opening 130, the space 510 between the residual limb and the residual limb protector 100, or both can promote wound healing. Visualization of the soft dressing through the at least one hole or opening 130 can allow medical professionals to quickly and easily evaluate the integrity of thedressing, the healing progress of the wound, or both. For example, allowing visualization of the presence, or lack thereof, of any drainage or bleeding from the incision, seeping into a soft dressing, wound dehiscence, or other wound complications. In the event of a fall or other impact, the at least one hole or opening 130 can allow for quick visualization of the incision to determine signs of any injury to incision that may require urgent care, such as active bleeding seeping into the soft bandages that can indicate the wound reopening.

[0078] In some embodiments, the notches or grooves 132 on the interior surface of the apex end 118 of the dome 116 that make up the energy-absorbing structure 124 can be superficial enough in depth that the notches or grooves 132 are not seen on the exterior surface of the dome 116, as shown in Figure IE. In other embodiments, the notches or grooves 132 can comprise a depth such that the notches or grooves 132 can be observed from the exterior surface of the dome 116.

[0079] Figure 2 provides a top view of a residual limb protector 200 according to another embodiment. Once again, the internal space 204 of the body 202 and at least one hole or opening 230 in the apex end 218 of the dome 216 can be seen. The plurality of grooves or notches 232 withing the energy-absorbing structure 224 are shown on the interior surface of the protection 200 extending from the hole or opening 230 toward the body 202. In this embodiment, eight grooves or notches 232 can be seen within the energy-absorbing structure 224. Some embodiments comprise as few as 1 notch or groove 232. Alternative embodiments comprise up to 50 groove(s) or notch(es) 232 in the energy-absorbing structure 224.

[0080] In the Figure 2 embodiment, the residual limb protector 200, comprises two flanges or projections 210 that are about the same size. In other embodiments, the two flanges or projections 210 can be different sizes. The plurality of flanges or protections 210 can be spaced far enough apart to permit the tethering of a securing a strap, string, band, cord, hook-and-loop strap, or a combination thereof of a knee immobilizer thereto. As shown in the Figure 2 embodiment, the two flanges or projections 210 can be spaced circumferentially around the rim 206, with the center of one flange or projection 210 at around 50 degrees, and the center of the other flange or projection 210 at around 325 degrees. In other embodiments, the at least two flanges or projections 210 can be spaced equidistantly. In the Figure 2 embodiment, the portion of the rim 206 between at least two flanges or projections 210 can be shaped like wide “C’ (or open parenthesis on its back). The smaller portion of the rim 226 can be configured to be positioned over the front of a knee of a user, while the larger portion of the curved rim 225 can be centered over a backside of the knee of the user, to support a backside of a residual limb of a user while within the residual limb protector 200. In embodiments that employ or areotherwise adjoined with a knee immobilizer that includes a posterior stay, this posterior stay can sit in the circumferential seat or recess or channel 214 wen in use. In use of such embodiments, the posterior stay can be in line with the wide-C-shaped curve 225.

[0081] Figure 3 shows a cross-sectional view of the residual limb protector 100 of the Figure 1A embodiment. The cross-section is made halfway through the residual limb protector 100, bisecting two of the flanges or projections 110 making on the rim 106 of the body 102. Once again, the distal or second end 128 of the body 102 that sits within the dome 116 can be seen.

[0082] Figure 3 offers another view of the circumferential seat or recess or channel 114 disposed between the body 102 and the dome 116. As shown, the medial connection point 117 exists between the body 102 and the floor of the recess or channel 114, and the lateral connection point 119 exists between an internal wall of the dome 116 and the floor of the recess or channel 114. The medial connection point can be disposed about around halfway up the height of the body 102. As seen in the Figure 3 embodiment, the circumferential seat or recess or channel 114 can comprise about a 90-degree angle 117 formed between the floor of the circumferential seat or recess or channel 114 and the body 102. An angle of about 90 degrees 119 can also be formed between a medial portion of the channel floor 114 and the internal wall that extends toward the rim 122 of the dome 116. In other embodiments not pictured, a curved angle is formed at the edges of the circumferential seat or recess or channel 114, between the floor of the circumferential seat or recess or channel 114 and the body 102 and / or between a medial portion of the channel floor 114 and the internal wall that extends toward the rim 122 of the dome 116. In forming the circumferential seat or recess or channel 114, the circumference of the extended rim 122 of the base end 120 of the dome 116 is larger than the circumference of the substantially cylindrical body 102 and the body 102 sits within an interior space of the dome 116.

[0083] As seen in the cross-sectional view of Figure 3, the body 102 comprises an internal space 104 configured to create a space between the residual limb protector 100 and a patient’s residual limb. The dome 116 can comprise a thickened wall or thickened portion 304. In embodiments this thickened wall 304 can be disposed in the portion of the dome 116 that is immediately below the circumferential channel 114 and immediately above the energyabsorbing portion 124. This thickened portion 304 can be substantially solid or can comprise a pattern of internal support structures to create an infill. In embodiments, the infill is configured to strengthen the protective features of the dome 116. The infill can comprise a structure of pattern that is configured to evenly distribute a load or impact throughout the structure of thedome 116. In embodiments, the infill can be a grid infill, a triangular infill, a honeycomb infill, a rectilinear infill, a concentric infill, a gyroid infill or any combination thereof. Similarly, in certain embodiments, the energy-absorbing structure 124 can comprise an infill 302 that is configured to provide increased strength, force absorption, or both to the apex end 118 of the dome 116. In embodiments, the infill 302 of the energy-absorbing structure 124 comprises a grid infill, a triangular infill, a honeycomb infill, a rectilinear infill, a concentric infill, a gyroid infill or any combination thereof. The infill 302 of the energy-absorbing structure 124 can comprise a different pattern than that of the infill for the thickened wall 304 of the dome 116. In alternative embodiments, the infill 302 of the energy-absorbing structure 124 comprise the same pattern as that of the infill for the thickened wall 304 of the dome 116.

[0084] Figure 4 shows a view of the front of the residual limb protector 100 attached to a distal end of a knee immobilizer 402 in accordance with one embodiment. As can be seen, the knee immobilizer 402 can comprise stays 406 extending longitudinally along a least a portion thereof. The circumferential seat or recess or channel 114 is shown, in which at least one stay 406 of the distal end of the knee immobilizer 402 can be received and held. The Figure 4 embodiment of the residual limb protector 100 can be used with a knee immobilizer without stays. For instance, such use can be accomplished by placing the distal end of the knee immobilizer in the circumferential seat or recess or channel 114. A strap, string, band, cord, hook-and-loop strap, or a combination thereof of the knee immobilizer can be wrapped around the body 102, underneath the rim 106 formed by the plurality of flanges or projections 108, 110 to secure the residual limb protector 100 to the knee immobilizer 402. As shown in Figure 4, the most distal hook-and-loop strap 404 of the knee immobilizer 402 can be wrapped around the body 102. A user’s knee can be contained in a hole or opening 408 in the middle of the knee immobilizer 402, which can be centered over the smaller flange or protection 108.

[0085] Figure 5 shows a view of the front of the residual limb protector 502 being worn by a user 504 while attached to a knee immobilizer 506 in accordance with one embodiment.

[0086] When worn by a user, the end of a residual limb of a user can be contained within a middle portion of the knee immobilizer 506, and a knee of the user is contained within a hole or opening 508 in the knee immobilizer 506; the residual limb protector 100, 502 can be disposed at the distal-most end of the knee immobilizer such that a space 510 exists between the residual limb of the user and the residual limb protector 100, 502 to prevent the residual limb from contacting or otherwise interacting with the residual limb protector 100, 502. Thus, when worn, no portion of the distal end of the residual limb of the user can be directly exposed to any forces or impacts. As shown, in the embodiment of Figure 5, the residual limb protector100, 502 does not contact the wound or the soft dressing on the wound of the residual limb of the user, due, at least in part, to the presence of a spacing 510 disposed between the residual limb and the residual limb protector 100, 502. In some embodiments, the space 510 between the residual limb of the user and the residual limb protector 100, 502 can range between 2 inches to 24 inches. The space 510, and the corresponding lack of contact with the soft dressing or residual limb, allows for greater use of the residual limb protector 100, 502, as surgeons may choose to use any configuration of soft dressings. Allowing surgeons to use various configuration of soft dressings allows providers to optimize healing for each patient while still using the residual limb protector 100, 502 without interfering with various different configurations of dressings. The space 510 between the residual limb and the residual limb protector 100, 502 can also provide additional airflow to the surgical incision to optimize healing and allow for easy, unobstructed wound inspection of a user’s residual limb.

[0087] In addition, if the user were to fall onto the residual limb, or if any force were exerted toward the residual limb of the user, the energy-absorbing structure 124, the shape of the dome 116, and the space 510 between the residual limb and the residual limb protector 100, 502 can mitigate, if not entirely remove, the forces felt upon the surgical wound in the residual limb of the user. For example, the residual limb protector 100, 502 can be configured to absorb such forces to protect the residual limb of the user or the amputation wound site. The distal end of the residual limb of the user, contained within a soft dressing, can be positioned within a knee immobilizer 506 such that the distal end of the residual limb does not touch nor otherwise interact with the residual limb protector 100. In such embodiments, if the energy-absorbing structure 124 cracks or breaks along the plurality of notches or grooves 132, the broken or cracked notch(es) or groove(s) 132 remain within the space 510 between the residual limb protector 100, 502 and do not contact the end of the residual limb of the user. In addition, the notch(es) or groove(s) 132 in the energy-absorbing structure 124 can be configured to absorb forces exerted on the end of the residual limb of the user, provide a visual indicator of a user’s fall to monitoring medical professionals, or a combination thereof. Such a configuration permits effective protection of the residual limb of the user from any force or impact due to a fall. In addition, the additional weight and visual presence of the residual limb protector 100 serves as a visual and kinesthetic reminder to the recently amputated patient of the amputation and to be careful when moving, reducing the risk of such patients falling.

[0088] Figure 6A shows a back perspective view of a residual limb protector 600 under another exemplary embodiment. In the embodiment of Figure 6A, the residual limb protector 600 comprises a substantially cylindrical body 602 that is hollow and has an internal space 604.The body 602 has a rim 606 on the first or proximal end of the body. The rim 606 can be curved in shape and can have one or more flanges or projections 608 extending therefrom. In embodiments, the limb protector 600 comprises a means for reversible attachment of a knee immobilizer; in some embodiments, this comprises plurality of flanges or projections 608, 610. At least one of the flanges or projections 608, 610 can comprise a curvature that extends upwardly and outwardly to provide a point of attachment to a knee immobilizer. In certain embodiments, the curvature of the flanges or projections 608, 610 extends downwardly to provide a point of attachment to a knee immobilizer. In embodiments, the curvature of the flanges or projections 608, 610 can be configured to receive a strap, string, band, cord, hook- and-loop strap, or a combination thereof of the knee immobilizer around the circumference of the proximal end of the body 612 underneath the rim 606. In embodiments, the attachment point formed from the outwardly extending curvature of the flanges or projections 608, 610 prevents the residual limb protector 600 from dislodging from the knee immobilizer, or otherwise accidentally or unintentionally removed during use thereof. For example, the attachment point formed from the outwardly extending curvature of the one or more flanges or projections 608, 610 can serve as an anti-slip mechanism to prevent the knee immobilizer from sliding off the residual limb protector 600 during use or in the event of impact from a fall.

[0089] The substantially cylindrical shape of the body 602 allows for the strap, string, band, cord, hook-and-loop strap, or a combination thereof of the knee immobilizer to be wrapped or secured around the protector 600. In some embodiments, an insertion section can be used with the protector 600 that is configured so that the strap, string, band, cord, hook-and-loop strap, or a combination thereof of the knee immobilizer can be wrapped or secured onto the insertion section and leave the amputation incision free of pressure.

[0090] As shown in the Figure 6A embodiment, the residual limb protector 600 can have at least three flanges or projections 608, 610 wherein one flange or projection 608 is smaller than at least one of the other two flanges or projections 610. In embodiments, at least one of the flanges or projections 610 is substantially the same size as at least one other flange or projection 610. In operation or use of the protector 600, the smaller flange or projection 608 can be aligned with a kneecap of the user.

[0091] As shown in the Figure 6A embodiment, the length of the one or more flanges or projections 608, 610 can be sufficient to prevent or reduce movement of the strap, string, band, cord, hook-and-loop strap, or a combination thereof of the knee immobilizer. As can be seen from Figure 6A, a spacing may exist between each of the flanges or protections 608, 610,wherein the spacing permits each of the flanges or projections to be disposed circumferentially at discrete locations around the rim 606.

[0092] In embodiments, the number, shape, or size of the flanges or projections 608, 610 can vary. In certain embodiments, an increased number, shape, or size of the flanges or projections 608, 610 can serve to increase the strength of the connection between the knee immobilizer and the protector 600 during use. Embodiments of the residual limb protector 600 comprises up to 10 flanges or projections. The residual limb protector can comprise two, three, four, five, six, seven, eight, nine, or ten flanges or projections 608, 610.

[0093] In addition, although embodiments are shown with curved flanges or projections 608, 610, it should be understood that at least one of the flanges or projections 608, 610 can comprise an alternate shape or form. For instance, at least one of the flanges or projections 608, 610 can be substantially straight or linear and extend laterally and upwardly from the distal- most portion of the body 602. In embodiments, the flanges or projections 608, 610 extend laterally at an angle between about 0 degrees and about 180 degrees.

[0094] The residual limb protector 600 is further configured to receive a distal end of a knee immobilizer, such as an off-the-shelf knee immobilizer, without touching the soft dressing of a residual limb of a user. Use of the protector 600 with a knee immobilizer provides protection to the residual limb of the user while also preventing knee contractures.

[0095] As shown in the Figure 6A embodiment, the protector 600 can comprise a means for receiving the at least one stay of the knee immobilizer. In certain embodiments, the means for receiving at least one stay can include a circumferential seat, recess, channel 614. The circumferential seat or recess or channel 614 can be configured to permit the distal end of the stay to reside therein. The circumferential seat or recess or channel 614 can be defined within or around the connection of the body 602 with an elongated dome 616. As shown in Fig. 6A, a curved angle can be formed at the edges of a U-shaped circumferential seat or recess or channel 614, where the floor of the channel 614 meets the exterior wall of the body 602, and where the floor of the channel 614 internal wall extends toward the rim 622 of the elongated dome 616, or a combination thereof. In various embodiments, the seat or recess or channel 614 can assist with maintaining the position of the knee immobilizer and the stay(s) on a patient, especially during impact or falls. In addition, the channel 614 can be configured to prevent the end of the knee immobilizer and / or stay(s) from becoming caught on and / or tangled in an acutecare or rehabilitation setting, which can include, for example, medical lines like an intravenous or IV-line, bed rails, bed sheets, or other medical equipment.

[0096] In some embodiments, as in Figure 6A, the circumferential seat or recess or channel 614 can be continuous. In other embodiments, not pictured, the floor of the circumferential seat or recess or channel 614 can be discontinuous. The circumferential seat or recess or channel 614 can comprise a plurality of gaps that extend through the floor. In such embodiments, each of the gaps can be configured to receive the distal end of at least one stay of the knee immobilizer.

[0097] In still other embodiments, the circumferential seat or recess or channel 614 can be continuous with a one or more slots extending at least partially through the floor of the circumferential seat or recess or channel 614. The one or more slots can extend completely through at least a portion of the floor of the circumferential seat or recess or channel 614. In various embodiments, such slots can be configured to receive at least one stay of the knee immobilizer. In embodiments with slots, the slots can be wide enough to receive at least a portion of the distal end of at least one stay of the knee immobilizer. In some embodiments, the slots have a width of around 1 inch.

[0098] In various embodiments, such slots or gaps within the circumferential seat or recess or channel 614 prevent or reduce slipping or dislodgement of the residual limb protector 600 out of the knee immobilizer, adding greater stability during use of the residual limb protector 600 with the knee immobilizer.

[0099] In other embodiments not pictured, there may be at least one groove, notch, or other indicator around the body 602 that can guide a knee immobilizer into the proper positioning in the circumferential seat or recess or channel 614. In still other embodiments, there can be at least one proj ection or bump around the body 602, the floor of the channel 614, or both, wherein the projection or bump is configured to guide a knee immobilizer into the proper positioning in the circumferential seat or recess or channel 614.

[0100] The elongated dome 616 has an apex end 618 and a base end 620, the base end having a rim 622 that is also the rim of the circumferential seat or recess or channel 614. The elongated dome 616 can comprise a shape that is elongated as compared to the embodiment of Figure 1A. The elongated dome 616 can have dimensions such that the length 618, 620 of the elongated dome 616 is elongated in comparison to the width 621 of the elongated dome 616, where the elongated dome 616 has a narrower apex end 618 than base end 620. In some embodiments, the elongated dome 616, together with the circumferential seat or recess or channel 614, can form the shape of a bell that has been inverted, where the circumferential seat or recess or channel 614 forms the lip of the bottom of the bell shape and the elongated dome616 forms the portion of the rest of the bell shape.

[0101] The proximal end of the body 612 is opposite to the elongated dome 616. When properly positioned, the proximal end of the body 612 is closest to the end of the user’s residual limb, and the elongated dome 616 is furthest from the end of the user’s residual limb. The shape of the elongated dome 616 can be generally the shape of an elongated semi-sphere that has a longer length than it does width. In embodiments, the elongated shape of the elongated dome 616 provides for additional space between the apex end 618 and the user’s residual limb to avoid any further injury to the residual limb in the event of a fall. In other embodiments (as shown in Figure 1A), the dome 616 may not be elongated and form the general shape of a semi-sphere. In embodiments, the elongated semispherical shape of the elongated dome 616 is configured to protect an incision wound of an amputee patient from an impact or force from any direction. For instance, the generally spherical shape of the elongated dome 616 permits the force of any impact, such as that which may occur from a fall, to be absorbed throughout the protector 600 or otherwise deflected from affecting the wound of a patient’s residual limb. In forming the circumferential seat or recess or channel 614, the circumference of the rim 622 of the base end 620 of the elongated dome 616 is larger than the circumference of the substantially cylindrical body 602 and the distal end of the body 602 sits within an internal space of the circumferential seat or recess or channel 614.

[0102] The apex end 618 of the dome can comprise an energy-absorbing structure 624. The energy-absorbing structure 624 can be formed using at least one circumferential groove or notch 632 in the elongated dome 616. In such embodiments, the at least one circumferential groove or notch 632 represents a thinner or weaker point in the exterior structure of the elongated dome 616 that is configured to break, crack, or crumple to absorb or deflect at least a portion of any force exerted on the exterior surface of the residual limb protector 600 during a fall or other impact to a distal end of protector 600. The at least one circumferential groove or notch 632 can further act as a visual indicator of a fall or force exerted on the residual limb protector 600, wherein a break, crack, or crumple in the energy-absorbing structure 624 along the at least one circumferential groove or notch 632 indicates a prior occurrence of a fall or other impact. In a fall, the at least one circumferential groove or notch 632 may not break or come loose.

[0103] In other embodiments not pictured, the at least one circumferential groove or notch 632 can be disposed on the interior surface of the elongated dome 616. In other embodiments, the at least one circumferential groove or notch 632 is present on the interior surface of the elongated dome 616 but does not extend entirely through to the exterior surface of the elongated dome 616 to be visible from the exterior surface of the elongated dome 616. In still otherembodiments not pictured, there can be a plurality of circumferential grooves or notches 632, up to twenty circumferential grooves or notches 632, which form the energy-absorbing structure. In yet other embodiments, also not pictured, the at least one circumferential groove or notch 632 may not be a continuous groove or notch 632 around the circumference of the apex end 618 of the dome. While the embodiment pictured in Figure 6A is an embodiment with an elongated dome 616, it should be appreciated that any embodiment consistent with the disclosure of this application can have an energy-absorbing structure 624 comprised of the at least one circumferential groove or notch 632. In other embodiments of the residual limb protector 100, 600 not pictured, the energy-absorbing structure 624 of the distal end of the dome 116 or elongated dome 616 may be comprised of both at least one circumferential groove or notch 632 or the plurality of notches or grooves 132 in the energy-absorbing structure 124.

[0104] The measurements of the Figure 6A embodiment can be similar to that of the Figure 1A embodiment, other than the elongated dome 616. The elongated length of the elongated dome 616 can allow for a greater space between the residual limb of the user and the residual limb protector 600. Thus, while in use, the residual limb protector 600 can be prevented from contacting or otherwise interacting directly with the user’s residual limb or any dressing disposed thereon. The space between the distal end of the residual limb and the apex end 618 of the protector 600 allows the elongated dome 616 to absorb any impact or force and reduce, if not eliminate, any direct forces to an incision or wound on the residual limb of the user.

[0105] As more clearly shown in the embodiment of Figures 6B-6C, the residual limb protector 100, 600 can comprise at least two pieces 600A, 600B made up of nonflexible material, the first piece 600A being comprised of the body 102, 602 the second piece 600B being comprised of the dome 116, 616 and the connection point of the two pieces being the circumferential seat or recess or channel 114, 614.

[0106] Figure 6B shows a side perspective view of the front of the residual limb protector 600 of Figure 6A. The residual limb protector 600 is shown in a diagonal state as compared to the orientation of Figure 6A and shows the residual limb protector 600 in two separate pieces 600A, 600B rather than joined together as in Figure 6A. At the distal end of the body 602, the first piece 600A can comprise a neck or extension 628 that is dimensioned to fit within the proximal end of the second piece 600B. The proximal end of the body 612 can be the portion of the residual limb protector 600 that fits within the distal end of the knee immobilizer. A space (as more clearly shown at 510 of Figure 5) can exist between the residual limb and the residual limb protector 600.

[0107] The second piece 600B can have a plurality of ribs or gussets 634 in the internal space of the elongated dome 616. The plurality of ribs or gussets 634 may be vertically oriented and can provide additional strength or reinforcement to the elongated dome 616 such that when a force is applied to the energy-absorbing structure 624, a portion of the force can be absorbed by the plurality of ribs or gussets 634, further protecting a residual limb of a user from direct force or impacts. The plurality of ribs or gussets 634 can provide this additional strength or reinforcement to the elongated dome 616 without adding significant weight to the residual limb protector 600. Such embodiments can permit the residual limb protector 600 to be sufficiently light such as not to interfere or otherwise disrupt the user’ s movement while wearing the same. In embodiments, the plurality of ribs or gussets 634 may be made of steel or other metals that are safe for contact with the human body. As shown in the embodiment of Figure 6B, the plurality of ribs or gussets 634 may be steel safe and made from the same or similar material as the rest of the elongated dome 616.

[0108] At the proximal end of the at least one rib or gusset 634 can be a means for supporting the neck or extension 628 of the distal end of the body 602 of the first piece 600A. In some embodiments, the means for supporting the neck or extension 628 of the distal end of the body 602 can be comprised of a groove or notch 636. The neck or extension 628 of the body 602 of the first piece 600A can fit within the internal space of the elongated dome 616 by resting the most distal edge of the neck or extension 628 within the groove or notch 636 of the plurality of ribs or gussets 634. The groove or notch 636 at the proximal end of each of the plurality of ribs or gussets 634 can support the neck or extension 628 of the body 602 of the first piece 600A; this additional support can reinforce the integrity of the residual limb protector 600 when it is comprised of two separate pieces 600A, 600B that are reversibly or permanently attached.

[0109] In addition, the residual limb protector 600 can have a means for attaching the first piece 600A to the second piece 600 B. In some embodiments, this means for attaching the first piece 600A to the second piece 600B can be comprised of a plurality of tabs or ridges 638 that fit within a plurality holes or gaps 640 (as better seen in Figure 6C) that are dimensioned to receive and hold the tabs or ridges 638 therein. The plurality of tabs or ridges 638 can be disposed at or near the point where the circumferential seat or recess or channel 614 meets the exterior wall of the elongated dome 616 at a point 617. Alternatively, or in addition to the plurality of tabs or ridges 638 that fit within the plurality of holes or gaps 640, the means for attaching the first piece 600A to the second piece 600B can be glue or other solvent bonds.

[0110] FIG. 6C shows a cross-sectional view through the middle of the residual limb protector 600 of Figure 6A. The residual limb protector is shown exploded into two separate pieces, like in Figure 6B, rather than joined together as in Figure 6A.

[0111] As shown in Figure 6C, at the distal end of the body 602 and at or near the connection point between the body 602 and the neck or extension 628 can be a plurality of holes or gaps 640 that are configured to receive the plurality of tabs or ridges 638 of the second piece 600B. The plurality of holes or gaps 640 of the first piece 600A can be in the location that is correlated with or otherwise aligned with the plurality of tabs or ridges 638 on the second piece 600B. The plurality of holes or gaps 640 can comprise a similar shape and size as, the plurality of tabs or ridges 638 of the second piece 600B, such that when a user fits the first piece 600A together with the second piece 600B to form the residual limb protector 600, the plurality of tabs or ridges 638 fit within the plurality of holes or gaps 640. Similarly, the plurality of tabs or ridges 638 can be snap fit tabs. Furthermore, the number of the plurality of holes or gaps 640 of the first piece 600A can be the same number as the plurality of tabs or ridges 638 of the second piece 600B. For example, as a cross-sectional view of the residual limb protector 600 of Figure 6A, Figure 6C shows four tabs or ridges 638 and four corresponding holes or gaps 640 that can be the same size and shape and in a location that that is correlated with or otherwise aligned with the holes or gaps 640 when the first piece 600A is fit together with the second piece 600B. Under such embodiments, the residual limb protector 600 can comprise eight tabs or ridges 638 and eight corresponding holes or gaps 640.

[0112] Similarly, Figure 6C shows four ribs or gussets 634, so the embodiment of Figure 6A has eight ribs or gussets 634 total. While the exemplary embodiment pictured in Figures 6A-6C has eight, each, of tabs or ridges 638, holes or gaps 640, and ribs or gussets 634, it should be appreciated that other embodiments not pictured can have as little as at least one of each structure or as many as twenty of each structure. Furthermore, while the exemplary embodiment pictured in Figures 6A-6C has a number of ribs or gussets 634 that matches the number of tabs or ridges 638 and holes or gaps 640, it should be appreciated that other embodiments not pictured may have a number of ribs or gussets 634 that does not match the number of tabs or ridges 638 and holes or gaps 640. Similarly, while the exemplary embodiment pictured in Figures 6A-6C has the plurality of ribs or gussets 634 spaced equidistantly from each other and aligned with the plurality of tabs or ridges 638, it should be appreciated that other embodiments not pictured can have these two structures unaligned and spaced such that they are not equidistant from each other.

[0113] As can be better seen in Figure 6C, in embodiments where the energy-absorbing structure 624 comprises at least one circumferential groove or notch 632, the at least one circumferential groove or notch 632 can be disposed at the distal end of the plurality of ribs or gussets 634, closer to the distal-most portion of the apex end 618 of the elongated dome 616. Furthermore, there can be at least one hole or opening 630 in the energy-absorbing structure 624 at the distal-most portion of the apex end 618 of the elongated dome 616.

[0114] Although the residual limb protector 100, 600 comprises at least two pieces 600A, 600B, a patient can use the residual limb protector 100, 600 when it is reversibly attached into one piece. While the embodiment pictured in two separate pieces in Figure 6B-6C is an embodiment with an elongated dome 616, it should be appreciated that any embodiment consistent with the disclosure of this application can be comprised of two pieces 600A, 600B that are reversibly or permanently attached into one piece. In embodiments, the number, shape, or size of the tabs or ridges 638 and the reciprocal holes or gaps 640 can vary. In certain embodiments, an increased number or size (width, length, or depth) of the tabs or ridges 638 and the reciprocal holes or gaps 640 can serve to increase the strength of the connection between the first piece 600A to the second piece 600B of the residual limp protector 600 when in use.

[0115] Figure 6D shows an elevated right perspective view of the back of the residual limb protector of Figure 6A, where the two pieces 600A, 600B are shown fit together into one piece for use by a patient. A plurality of tabs or ridges 638 can be seen extending through a corresponding plurality holes or gaps 640. Furthermore, the neck or extension 628 of the body 602 can rest within the plurality of grooves or notches 636 at the proximal end of each of the plurality of ribs or gussets 634. Also, the circumferential seat or recess or channel 614 can comprise a medial side 617 defined by an exterior wall of the body 602 and a lateral side 619 defined by an internal wall that extends upward toward the rim 622 of the elongated dome 616 with a floor extending therebetween. In embodiments not pictured, the circumferential seat or recess or channel 614 can comprise about a 90-degree angle 617 where the floor of the channel 614 meets the exterior wall of the body 602, about a 90-degree angle formed 619 between the floor of the channel 614 internal wall extending toward the rim 622 of the elongated dome 616, or a combination thereof.

[0116] Figure 6E shows a lower-right perspective view of the bottom of the residual limb protector of Figure 6A. The residual limb protector is shown in a diagonal state as compared to the orientation of Figure 6A. Again, at least one hole or opening 630 can be seen in the energy-absorbing structure 624 at the distal-most portion of the apex end 618 of the elongateddome 616. Through the at least one hole or opening 630 is a view of the internal space of the elongated dome 616, in which one of the plurality of ribs or gussets 634 can be seen, along with the notch or groove 636 in the most proximal end of the rib or gusset 634; the most distal end of the neck or extension 628 can be seen resting within the notch or groove 636.

[0117] As the first piece 600 A is fit together with the second piece 600 B in Figure 6E, the bottom of the plurality of tabs or ridges 638 of the second piece 600B can be seen from this view, along the medial side 617 of the circumferential seat or channel 614.

[0118] In yet another embodiment, not pictured, the residual limb protector 100 is integral with the knee immobilizer such that the residual limb protector 100 and the knee immobilizer are one piece.

[0119] In yet another embodiment, the means for reversible attachment of a knee immobilizer to the residual limb protector 100 comprises an attachable anchor that is configured to attach a knee immobilizer to the protector 100. In embodiments, the attachable anchor comprises at least one hook-and-loop strap that is configured to extend around at least a portion of the exterior surface of the body 102, the rim 106, or a combination thereof. The attachable anchor can be disposed on the knee immobilizer, the residual limb protector 100, or both. The attachable anchor can comprise at least two hook-and-loop straps. In embodiments, the at least two hook-and-loop straps are in the shape of an X or substantially parallel to one another. The attachable anchor can comprise a plurality of hook-and-loop straps. Such plurality of hook-and-loop straps can be provided in the shape of a star or flower. In embodiments, the plurality of hook-and-loop straps are disposed on the body 102, the rim 106, the dome 116, or a combination thereof. The present disclosure further includes additional or alternate shapes or configurations of the at least one hook-and-loop strap of the attachable anchor. In various embodiments, the attachable anchor permits a plurality of attachment points between the immobilizer and the protector 100 to further strengthen the connection therebetween.

[0120] In other embodiments not pictured, the residual limb protector 100 comprise two or more holes, gaps, notches, or eyelets configured to assist with reversible attachment of the knee immobilizer thereto. By way of example, two or more holes, gaps, notches, or eyelets can be disposed on the body 102 of the protector 100 between the rim 106 and a circumferential seat, recess, channel 114. Such holes, gaps, notches, or eyelets can be configured to receive one or more anchors (such as straps or other attachments means including, but not limited to a string, band, cord, hook-and-loop strap, or a combination thereof) of the knee immobilizer such that the one or more straps on the knee immobilizer can pass through the one or more holes, gaps, notches, or eyelets to provide a reversible connection between the residual limb protector 100and the knee immobilizer. In embodiments each of the at least two holes, gaps, notches, or eyelets are substantially co-planar with at least one another hole, gap, notch or eyelet to permit an interlocking attachment of the knee immobilizer around the circumference of the body 112. In one exemplary embodiment, the means for reversible attachment of the knee immobilizer to the protector 100 comprises an interlocking strap system (such as that disclosed in U.S. patent No. 5724707, the entirety of which is hereby incorporated by reference) or a similar system or mechanism for forming a reversible, interlocking connection between the knee immobilizer and the residual limb protector 100. In embodiments with the at least two holes, gaps, notches, or eyelets, serves as an anti-slip mechanism to prevent the knee immobilizer from sliding off the residual limb protector 100 during use or in the event of impact from a fall.

[0121] Another aspect of the present invention includes a method of a protecting a distal end of a residual limb of a recently amputated user from further injury using the residual limb protector 100 in accordance with any embodiment disclosed herein or otherwise apparent from the descriptions herein. In embodiments, such as the one displayed in exemplary Figure 4, a knee immobilizer with or without stays is attached to a residual limb of a user. In embodiments, the residual limb can be contained or wrapped within a soft dressing. The immobilizer containing the residual limb of the user is then positioned into the residual limb protector 100 such that the distal end of the immobilizer rests or sits in the circumferential seat or recess or channel 114 and at least a portion of the distal end of the residual limb of the user sits inside the interior space 104 of the body 102.

[0122] If the residual limb protector 100 has at least two flanges or projections 110, the knee immobilizer can be positioned such that its back (and any posterior stay) rests in the wide-C- shaped curve 125 between the at least two flanges or projections 110 of the rim 106. If the residual limb protector 100 has at least three flanges or projections 108, 110 wherein one flange or projection 108 is smaller than the other two flanges or projections 110, then the smaller flange or projection 108 can be aligned with a kneecap of the user.

[0123] At least one strap, string, band, cord, hook-and-loop strap, or a combination thereof can be secured around the exterior surface of the body 102 such that the strap, string, band, cord, hook-and-loop strap, or a combination thereof reversibly attaches the distal end of the knee immobilizer around the proximal end 112 of the body 102 underneath the lip formed by the plurality of flanges or projections 108, 110. In alternative embodiments involving an attachable anchor, at least one strap, string, band, cord, hook-and-loop strap, or a combination thereof of the immobilizer can be secured onto the at least one-hook-and-loop straps of the attachable anchor.

[0124] In embodiments, the residual limb protector 100 is compatible with a soft dressing, which can be employed by medical providers during postoperative care of amputee patients without requiring a revised method or use of the soft dressing or a change in the type of incision used in the amputation. Furthermore, the ability to use compressive soft dressings with the protector 100, 200 can help contour the residual limb in preparation for future prosthetic fittings and reduce the sensations of phantom pain in a residual limb.

[0125] The residual limb protector 100 can be comprised of various materials or combinations of nonflexible materials. In embodiments, the residual limb protector 100 comprises a nonflexible material that permits cleaning or sterilization without altering the structural or chemical properties of the protector. In certain embodiments, the residual limb protector 100 comprises a hydrophobic nonflexible material. The residual limb protector 100 can comprise a waterproof nonflexible material. The residual limb protector 100 can be comprised of materials that do not adversely affect human health. In embodiments, the nonflexible material can comprise a non-toxic, 3-D printed material. In other embodiments, the nonflexible material can comprise a non-toxic, thermoformed plastic material. In still further embodiments, the nonflexible material can be injection molded. In other embodiments, the nonflexible material can comprise a non-toxic, expanded polystyrene. In still other embodiments, the nonflexible material can comprise a non-toxic, expanded polyethylene foam. The material can comprise carbon fiber.

[0126] The residual limb protector 100 can be made of light-weight material. The thickness of the nonflexible material at the body 102 of the protector 100 can be less than 1 mm thick. In embodiments, the body 102 has a thickness of up to 5 mm. The material in the apex end 118 of the dome 116 can be thinner than the material of the rest of the residual limb protector 100. The thinner apex end 118 and / or the plurality of notches or grooves 132 in the energy-absorbing structure 124 allows the residual limb protector 100 to better protect an incision on an end of a residual limb of a user. In embodiments, the thinner areas can absorb forces or impacts by breaking easier than the rest of the stronger structure of the protector. Similarly, the depth of each notch or groove 132 can range from less than 1 mm to the thickness of the dome apex end 118. The width of each notch or groove 132 can vary from 5 to 30 mm. The thin and lightweight material allows the residual limb protector 100 to be light enough to allow a user to have as little impediment to move as possible, but still have sufficient weight to serve as a kinesthetic reminder to the amputee patient of a missing limb and to exercise caution when moving, further preventing, if not eliminating, falls. In embodiments, the residual limb protector 100 weighs about 310 grams. Other embodiments of the protector can weigh as littleas about 100 grams or as much as about 800 grams. The residual limb protector 100 can weigh as much as about 2,000 grams. In certain embodiments, the residual limb protector 100 weighs up to 1,500 grams. The residual limb protector 100 can weigh up to about 1,000 grams. The protector can be a noticeable color, for example red or orange, to serve as a visual reminder to the user of the missing limb. In embodiments, the residual limb protector 100 can serve as both a visual reminder and a kinesthetic reminder to the user of the amputated limb to help prevent and reduce the instance of falls. In addition, the structure and function of the residual limb protector 100 can reduce injury to the residual limb of the user if any impact or forces are exerted on the residual limb if such a fall or other event occurs.

[0127] The residual limb protector 100 can be used with a knee immobilizer to help prevent knee contractures without changing the incision made by surgeons, or the configuration of a soft dressing. In embodiments, attachment of a knee immobilizer to the limb protector 100 can be accomplished by securing the residual limb protector 100 to the knee immobilizer such as by wrapping a strap, string, band, cord, hook-and-loop strap, or a combination thereof around the proximal end 112 of the body 102 and underneath the lip formed by the plurality of flanges or projections 108, 110. In various embodiments, residual limb protector 100 is configured for be used by anyone, ranging from a surgeon, to the postoperative support staff, to the patient themselves, and may not require the presence or assistance of a prosthetist or other specially trained medical professional. In various embodiments, the residual limb protector 100 is configured to permit easy removal and reattachment, such as with routine dressing change or wound inspection.

[0128] In embodiments, the residual limb protector 100 is configured to protect the distal end of the user’s residual limb from injury due to trauma or force. Without being bound by theory, the residual limb protectors disclosed herein can reduce the risk that the surgical incision reopens (dehiscence), which, in turn, promotes wound healing. Such a promotion of wound healing decreases wound healing time\ and minimizes the risk for infection. Use of the residual limb guard 100 can prevent or mitigate impacts to the end of the residual limb, which can decrease pain to the patient. Preventing a patient with a newly amputated limb from falling using the residual limb protector 100 not only protects the patient’s physical health, but also their emotional and mental health by preventing the development of negative feelings around the amputation and prosthesis that can develop after a fall. By way of example, an amputated patient with greater visual or kinesthetic awareness of their amputated limb using the added presence and weight of the residual limb protector 100 can avoid falling during the postoperative period, which can reduce fear, frustration, embarrassment, or difficulty inadapting to activities of daily living after the amputation. Use of the residual limb protector 100 as disclosed herein can also be employed as a method for reducing the length and number of stays in an acute care hospital, inpatient rehabilitation, or community setting.EXAMPLES

[0129] Examples are provided below to facilitate a more complete understanding of the invention. The following examples illustrate the exemplary modes of practicing the invention. However, the scope of the invention is not limited to specific embodiments disclosed in these Examples, which are for purposes of illustration only, since alternative methods can be utilized to obtain similar results.EXAMPLE 1

[0130] Lower limb amputation can be defined as the removal of part or parts of the lower limb. Although there is some discrepancy in the published medical literature, there is general agreement that major limb amputations include those at or proximal to the ankle. Approximately 2 million people in the USA are living with limb loss and an estimated 185,000 major limb amputations occur annually.

[0131] Hospital-acquired falls remain a recalcitrant public health problem in the USA. The World Health Organization (WHO) defines a fall as an unexpected event in which the participants come to rest on the ground, floor, or lower level. Thirty to fifty percent of hospital falls result in a range of injuries, varying from severe bruises, lacerations, broken bones, and reopened surgical wounds. These hospital-acquired falls that are a common occurrence are especially so for lower limb amputees. The reported incidence of falls is 16.5% for amputees in the acute care setting post-operatively. Within inpatient rehabilitation facilities, the reported amputee fall-incidence ranges from 20.5 to 35%. The consequences of amputee inpatient falls can include fear of falling, reduced prosthetic acceptance and social withdrawal. Trauma to the residual limb can also cause hematomas, wound dehiscence, and increase the risk of wound infection. Perhaps more serious and certainly more immediate consequences of an amputee inpatient fall are the limb fracture and damage to the surgical wound. Evidence demonstrates that post-operative wound complications from falls in this already debilitated population lead to a return to the operating room for an above the knee conversion, resulting in worse functional outcomes.

[0132] Transtibial amputation patients have the highest fall rate of any subset of patient in both the acute care hospital (16.5%) and inpatient rehabilitation hospitals (20.5-35%). Additional studies demonstrate approximately 3% of transtibial amputees fall hard enough to require a return to the operating room for revision surgery and 47% have an above-knee amputation as a final outcome. A removable rigid dressing or protective device during the postoperative acute care stay mitigates potential damage that occurs during falls. Preventing sever damage due to falls can allow for progression of rehabilitation and a return to activities of daily living.

[0133] Post operative, pre-prosthetic care prepares the residual limb for a more successful prosthetic fitting and ambulation.

[0134] Post operative dressing can include the use of sterile gauze, padding and covering with an elastic wrap to provide compression and provide limb contouring. The “standard of care” relating to the application of the elastic wrap can be as follows: compression wrapping the residual limb after amputation prepares it for fitting artificial limbs (prothesis). Compression wrapping shrinks and shapes the residual limb. To wrap, begin with a dry rolled compression bandage. The residual limb should also be dry. The bandage should be worn at all times.

[0135] Exemplary procedure for Treating Below the Knee Amputations1. Clinicians can make figure 8s with the compression bandage starting near the end of the residual limb. The compression wrap can be pulled diagonally, in an upward direction to secure the wrap in place upon itself. The compression bandage can then be wrapped, making all turns in a diagonal direction, forming a crisscross pattern. The clinician should avoid circular turns as they tend to constrict circulation and should avoid wrinkles as they may cause skin irritations.2. Clinicians should not encircle the end of the residual limb with one turn because it may cause the skin to crease over the scar. Instead, they can cover the inside, then the outside end of the residual limb with each turn.3. Then continue making diagonal turns while applying firm pressure over the end of the residual limb.4. Compression bandage pressure can become less and less as clinicians wrap higher toward the thigh.5. The wrap can be extended above the knee and there can be at least one turn above the kneecap.6. The compression bandage can be anchored with tape or safety pins. The residual limb can be wrapped multiple times per day.

[0136] The post operative dressing objective is to cleanly cover the fresh surgical incision, maintain compression on the residual limb, prevent knee flexion contractures, reduce edema, provide consistent contouring of the residual limb, protect against external trauma from fall, or a combination thereof.

[0137] In 1979, the removable rigid dressing (RRD) was designed to address many of the complications associated with a soft dressing applied to a below-knee amputation. The RRD can provide faster healing times, reduced limb edema, improved residual limb contouring in preparation for prosthetic fitting, prevented knee contractures and reduced trauma to the limb. An additional benefit of the RRD is protection of the residual limb when an amputee experiences a fall.

[0138] However, the adoption of the RRD is limited in clinical practice due to interference with the surgical dressing, the lack of consensus in clinical practice regarding dressing selection for the management of transtibial amputation, and the relative high cost. Also hindering clinical adoption of the RRD is that it is operationally cumbersome. The hospital must credential and call in an allied health professional (prosthetist) to fit the RRD while the patient is in the Operating or Recovery Room and often return for routine dressing changes or provide extensive training for the hospital staff. An RRD also contacts the soft dressing on a residual limb of a user and can interfere with the configuration of the soft dressing or limit the type of dressings that a surgeon can apply to a patient’s surgical incision on a residual limb.

[0139] One purpose of the presently disclosed residual limb protector is to prevent or mitigate damage to the residual limb from in-patient falls while the trans-tibial amputee is in the acute care hospital setting without requiring the operating surgeon to change their customary surgical wound and / or compression bandage dressing while allowing for easy and frequent wound inspection. Additionally, the disclosed residual limb protector can prevent or mitigate damage to the residual limb from falls in various settings - from amputation until the time of definitive prosthetic use - including inpatient rehabilitation centers or within acommunity setting. In various embodiments, the presently disclosed residual limb protector is designed to interface with a knee immobilizer applied to prevent knee flexion contractures, while protecting the surgical wound from serious injury resulting from falls.

[0140] Below the knee amputation (BKA) is a surgical procedure centered on the removal of leg by a surgeon. A soft dressing can be applied in the operating or recovery room with primary objectives of preventing wound infection and providing contouring of the residual limb in preparation of eventual prosthetic fitting. The soft dressing can be removed and replaced multiple times per day to evaluate the recovery of the wound.

[0141] In addition to the soft dressing, a knee immobilizer can be used to prevent knee flexion contractures, and to allow for safe patient movement in and out of a bed in an acute care hospital, inpatient rehabilitation hospital, and in a community setting. The knee immobilizer can include multiple (3 in many cases) stays to prevent knee flexion, padding for patient comfort and straps (such as hook-and-loop straps) to attach the immobilizer to the residual limb.

[0142] The presently disclosed residual limb protector, can comprise a shield designed to attached to the distal end of the knee immobilizer by capturing each of the stays in a groove / channel at the top of the shield. Once captured, the distal strap of the immobilizer can be wrapped around the top of the shield, tightened down, and held firmly in place by the lip of the shield. The presently disclosed residual limb protector can be designed to remain in place during impact of a patient fall - deflecting and reducing the force of the fall away from the wound, while indicating the occurrence of a fall with either shield discoloration or cracking. In embodiments, the presently disclosed residual limb protector is constructed with a large opening at the distal end to provide air flow to the soft dressing to encourage surgical wound healing. In embodiments, the presently disclosed residual limb protector is placed without any interface with the post-operative dressing, and thus interference with limb contouring. It can be placed by the same surgical assistant or nurse that is placing the knee immobilizer. The presently disclosed residual limb protector can be easily removed and replaced without any interference with the soft dressing or need for additional or reconfiguration of the immobilizer. Additionally, the presently disclosed residual limb protector can be removed and replaced as the knee immobilizer and soft dressing are removed for routine wound inspection.

[0143] In various embodiments, the light weight of the presently disclosed residual limb protector allows ease of movement, while also providing a kinesthetic reminder of limb loss so the patient exhibits extreme awareness and caution when entering or exiting abed in acute care hospital, inpatient rehabilitation hospital, or a community setting.

[0144] No other device or dressing to postoperatively protect a residual limb has been designed that is compatible for use with knee immobilizers while also providing protection for an amputation surgical wound using an energy-absorbing structure without interfering with any soft dressing on the wound. The presently disclosed residual limb protector can be used with simple instructions. In various embodiments, the weight of the protector is sufficiently light so as not to impede the movement of the patient during use, while providing sufficient heft such that the protector serves as a visual and kinesthetic reminder of the amputated limb to promote awareness and caution in the patient while moving, reducing the risk of falling, and having wound complications, after the amputation.EXAMPLE 2

[0145] Non-Limiting Exemplary Instructions for Use of the Residual Limb Protector in One Embodiment

[0146] Step #1 : Obtain the residual limb protector.

[0147] Step #2: Apply a soft dressing to the distal end of a patient’s residual limb.

[0148] Step #3: Insert the dressed residual limb into a knee immobilizer and secure all straps or hook-and-loop straps of the knee immobilizer except the most distal strap.

[0149] Step #4: Position the residual limb protector into the distal end of the knee immobilizer until the stays sit within the circumferential seat / recess / channel.

[0150] Step #5: Wrap the most distal strap of the knee immobilizer around the body of the residual limb protector and underneath the flanges / proj ections of the protector before securing it to the knee immobilizer.EQUIVALENTS

[0151] Those skilled in the art will recognize, or be able to ascertain, using no more than routine experimentation, numerous equivalents to the specific substances and procedures described herein. Such equivalents are considered to be within the scope of this invention and are covered by the following claims.

Claims

What is claimed:

1. A residual limb protector comprising: a substantially cylindrical body that is hollow, with a first end and a second end; the second end of the body connected to a dome, the dome comprising an apex end and a base end, and an interior surface and an exterior surface; the apex end of the dome comprising an energy-absorbing structure; a circumferential channel extending around at least a portion of the body; configured to receive at least a portion of a knee immobilizer; and at least one means for reversible attachment of the knee immobilizer thereto.

2. The residual limb protector of claim 1, wherein the energy-absorbing structure comprises at least one circumferential groove or notch extending across a portion thereof.

3. The residual limb protector of claim 2, wherein the energy-absorbing structure comprises a plurality of circumferential groves or notches.

4. The residual limb protector of claim 2, wherein the energy-absorbing structure comprises at least one circumferential groove or notch.

5. The residual limb protector of claim 2, wherein the energy-absorbing structure comprises at least twenty circumferential grooves or notches.

6. The residual limb protector of claim 2, wherein the dome has a thickness, and the at least one circumferential groove or notch of the energy-absorbing structure has a depth of between 10% and 80% of the thickness of the dome.

7. The residual limb protector of claim 2, wherein the energy-absorbing structure comprises an infill with a honeycomb matrix.

8. The residual limb protector of claim 1, wherein the dome is elongated such that the length of the dome is greater than the width of the dome.

9. The residual limb protector of claim 1, wherein the substantially cylindrical body comprises a circumference, and the base end of the dome comprises an extended rim, the extended rim comprising a larger circumference than the circumference of the body.

10. The residual limb protector of claim 1, wherein the circumferential channel is laterally defined by the base end of the dome and medially defined by the body.

11. The residual limb protector of claim 1, wherein the circumferential channel is U- shaped.

12. The residual limb protector of claim 1, wherein the circumferential channel comprises a width that is sufficient to receive and hold a distal end of the knee immobilizer.

13. The residual limb protector of claim 1, wherein the circumferential channel comprises a depth being defined by the height of an extended rim of the base end of the dome.

14. The residual limb protector of claim 1, wherein the circumferential channel is at least partially defined by a floor that continuously extends around the circumference of the body.

15. The residual limb protector of claim 1, wherein the channel is at least partially defined by a floor, the floor further comprising a plurality of slots or discontinuous gaps therein.

16. The residual limb protector of claim 1, further comprising a plurality of guidance grooves or notches disposed on the body, wherein the plurality of guidance grooves or notches are configured to guide at least one stay of a knee immobilizer into the channel.

17. The residual limb protector of claim 1, further comprising at least one projection or bump disposed on the body or a floor of the channel, wherein the at least one projection or bump is configured to guide at least one stay of a knee immobilizer into the channel.

18. The residual limb protector of claim 1, wherein the means for reversible attachment of a knee immobilizer comprises at least one flange extending from a rim of the first end of the body.

19. The residual limb protector of claim 18, wherein the at least one flange comprises an upward- and outward-extending curvature from the rim.

20. The residual limb protector of claim 19, wherein the rim of the first end of the body comprises at least two flanges.

21. The residual limb protector of claim 20, wherein the rim of the first end of the body comprises at least three flanges.

22. The residual limb protector of claim 21, wherein the at least three flanges comprise a first flange, a second flange, and third flange; the first flange comprising a first length; the second flange comprising a second length; and the first length is shorter than the second length.

23. The residual limb protector of claim 18, comprising a plurality of flanges, wherein each flange is spaced a defined distance from a neighboring flange.

24. The residual limb protector of claim 23, wherein the rim has a substantially straight profile between each of the plurality of flanges.

25. The residual limb protector of claim 23, wherein the rim comprises an outwardly projecting curve between the plurality of flanges.

26. The residual limb protector of claim 1, comprising least one hole or opening in the apex end.

27. The residual limb protector of claim 26, wherein the at least one hole or opening is disposed in the center of the apex end.

28. The residual limb protector of claim 1, wherein the dome comprises a semispherical shape.

29. The residual limb protector of claim 1, wherein the means for attachment of a knee immobilizer comprises an attachable anchor disposed on the exterior surface dome.

30. The residual limb protector of claim 1, wherein the body, the dome, or both comprise a single, continuous piece of substantially nonflexible material.

31. The residual limb protector of claim 30, wherein the thickness of the nonflexible material is up to about 5 mm.

32. The residual limb protector of claim 31, wherein the energy-absorbing structure comprises a first thickness; the base end of the dome comprises a second thickness; the body comprises a third thickness; and the first thickness is less than the second thickness, the third thickness, or both.

33. The residual limb protector of claim 1, wherein the protector comprises a first piece and a second piece, the first piece comprising the substantially cylindrical body with a neck or extension at a distal end of the substantially cylindrical body, and the second piece comprising the dome and the circumferential channel.

34. The residual limb protector of claim 33, wherein the first piece and the second piece have a means for attaching the first piece to the second piece before use by a user.

35. The residual limb protector of claim 33, wherein the first piece and the second piece are reversibly attached to one another.

36. The residual limb protector of claim 33, wherein the first piece and the second piece are integral with one another.

37. The residual limb protector of claim 34, wherein the means for attaching the first piece to the second piece is comprised of a plurality of tabs or ridges on the second piece, which are shaped and positioned such that the plurality of tabs or ridges fit within a plurality of holes or gaps in the distal end of the body of the first piece.

38. The residual limb protector of claim 33, wherein the internal surface of the dome of the second piece has at least one vertical rib or gusset having a proximal end and a distal end, and the proximal end being closest to the circumferential seat or channel.

39. The residual limb protector of claim 38, wherein the proximal end of the at least one vertical ridge or gusset comprises means for receiving the distal end of the body of the first piece.

40. The residual limb protector of claim 39, wherein the means for receiving the distal end of the body of the first piece is comprised of a notch or groove.

41. The residual limb protector of claim 1, further comprising a knee immobilizer.

42. The residual limb protector of claim 41, wherein the knee immobilizer is reversibly connected to the residual limb protector.

43. The residual limb protector of claim 41, wherein the knee immobilizer and the residual limb protector are integral with one another such that the residual limb protector comprises a limb protector portion disposed at a proximal end of the residual limb protector and a knee immobilizer portion disposed at a distal end of the residual limb protector.

44. The residual limb protector of claim 1, wherein the protector is configured for use with one patient before being disposed.

45. The residual limb protector of claim 1, wherein the protector is reusable.

46. The residual limb protector of claim 1, wherein the protector comprises a sterilizable material.

47. The residual limb protector of claim 46, wherein the material is capable of being cleaned with a liquid cleaning solution without negatively affecting the integrity of the residual limb protector.

48. The residual limb protector of claim 1, wherein the protector comprises a weight of up to about 800 grams.

49. The residual limb protector of claim 1, wherein the body comprises a vertical height that is sufficient to create a space between the distal end of a residual limb of a user without the residual limb protector contacting the user or a soft dressing on the user.

50. The residual limb protector of claim 1, wherein the circumference of the substantially cylindrical body comprises a diameter sufficient to receive and hold at least a portion of a knee immobilizer.

51. The residual limb protector of claim 50, wherein the circumference of the substantially cylindrical body ranges from about 200 mm up to about 650 mm.

52. The residual limb protector of claim 51, wherein a width of the circumferential channel is between about 5 mm and about 80 mm.

53. A method of protecting a distal end of a residual limb of a recently amputated user from further injury, the method comprising: obtaining the residual limb protector of any one of claims 1-31, 41-42, and 44- 52; inserting at least a portion of the distal end of the residual limb of the user into a knee immobilizer, which comprises a proximal end, a distal end, and a plurality of straps, strings, bands, cords, hook-and-loop straps, or a combination thereof; securing at least one of the straps, strings, bands, cords, hook-and-loop straps, or a combination thereof except the most distal straps, strings, bands, cords, hook- and-loop straps, or a combination thereof; positioning the proximal end of the residual limb protector within in the distal end of the knee immobilizer such that at least a portion of the proximal end of the substantially cylindrical body of the residual limb protector is inside of the knee immobilizer, with a space between the distal end of the residual limb of the user and the residual limb protector;centering a knee of the user between at least two flanges or projections on the rim of a proximal end of the body; placing the distal end of the knee immobilizer within the circumferential channel; and wrapping the strap, string, band, cord, hook-and-loop strap, or a combination thereof closest to the distal end of the knee immobilizer around an exterior surface of the substantially cylindrical body of the protector and underneath the flanges of the rim of the proximal end of the body.

54. The method of claim 53, wherein the residual limb protector obtained is one that is comprised of a first piece and a second piece as in any one of claims 32-38, and the method further comprises attaching the first piece to the second piece before positioning the proximal end of the residual limb protector within in the distal end of the knee immobilizer.

55. The method of claim 54, wherein the method further comprises lining up the plurality of tabs or ridges of the second piece such that the plurality of tabs or ridges fit within a plurality of holes or gaps in the distal end of the body of the first piece when the first piece is attached to the second piece.

56. A method of protecting a distal end of a residual limb of a recently amputated user from further injury, the method comprising: obtaining the residual limb protector of claim 43, wherein an internal space exists between the limb protector portion and the knee immobilizer portion; inserting at least a portion of the distal end of the residual limb of the user into the knee immobilizer portion of the residual limb protector, which comprises a plurality of straps, strings, bands, cords, hook-and-loop straps, or a combination thereof;positioning the distal end of the residual limb of the user within the knee immobilizer portion at a depth within the internal space such that the distal end of the residual limb of the user does not contact the apex end of the residual limb protector portion; and securing at least one of the straps, strings, bands, cords, hook-and-loop straps, or a combination thereof to the user.

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