US20140121784A1 - Amputation residuum device and method of using the same - Google Patents
Amputation residuum device and method of using the same Download PDFInfo
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- US20140121784A1 US20140121784A1 US14/150,161 US201414150161A US2014121784A1 US 20140121784 A1 US20140121784 A1 US 20140121784A1 US 201414150161 A US201414150161 A US 201414150161A US 2014121784 A1 US2014121784 A1 US 2014121784A1
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- Prior art keywords
- shell
- residuum
- distal end
- opening
- slit
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
- A61F2/7812—Interface cushioning members placed between the limb stump and the socket, e.g. bandages or stockings for the limb stump
Definitions
- edema often occurs in the amputated region causing volume fluctuations in the residuum. It is often important to stabilize the residuum by apply compression to the residuum.
- the residuum may be placed in a splint or other device to manage swelling and protect the residuum.
- Current devices are formed from a continuous piece of plastic to form the posterior and anterior portions and a distal end, where the anterior and posterior portions are attached, such that variances in volume are not appropriately accommodated at the distal end of the residuum.
- the amputation residuum device comprises a posterior shell having longitudinal slits formed therein and a multidurometer, soft pre-tibial shell is provided.
- the residuum device provides for a limb volume and diameter variance accommodation via the floating pre-tibial shell and the flexible posterior shell.
- an apparatus for post amputation residuum maintenance includes: an elongated shell having a longitudinal axis and defining a hollow interior closed at a distal end, the shell having an opening extending from a proximal end and adapted to receive a residuum into the interior of the shell, and a longitudinal slit having a circular aperture at each end.
- the shell further includes a second slit extending parallel to at least a portion of the longitudinal slit.
- a distal end of the longitudinal slit is defined by the closed distal end of the shell.
- the shell has a second slit having a distal end defined by the closed distal end of the shell.
- the distal end of the longitudinal slit is positioned from about 0.5 inches to about 3 inches from the distal end of the second slit.
- the apparatus includes a second shell adapted to be positioned adjacent to the residuum, the second shell configured to cover at least a portion of the opening of the shell.
- the second shell has a longitudinal axis, and the second shell is substantially arcuate in a cross-section taken transverse to the longitudinal axis of the second shell.
- the apparatus further includes an inner foam layer comprising a soft material; and an outer foam layer comprising a rigid material, wherein the outer layer is positioned adjacent to the inner foam layer.
- the peripheral edge of the inner foam layer tapers outwardly.
- the peripheral edge of the outer foam layer tapers inwardly.
- the shell has a circumference, and the opening is about 40% of the circumference of the shell.
- the shell comprises a proximal portion and a distal portion, wherein the width of the opening defined by the distal portion is greater than the width of the opening defined by the proximal portion.
- the apparatus further includes at least one enclosure panel; and a means for securing that at least enclosure panel to the shell.
- the apparatus further includes a circular pad disposed in the interior of the shell adjacent the closed end.
- method for maintaining post amputation residuum maintenance includes: providing an elongated shell having a longitudinal axis and defining a hollow interior closed at a distal end, the shell having an opening extending from a proximal end and adapted to receive a residuum into the interior of the shell, and a longitudinal slit having a circular aperture at each end; and positioning a residuum in the interior of the shell via the opening.
- the method further includes the step of providing a second shell adapted to be positioned adjacent to the residuum, the second shell configured to cover at least a portion of the opening.
- the method further includes the step of adjusting the position of the second shell to fit against the residuum, wherein at least a portion of an edge of the first shell defining the opening partially overlaps the second shell. In further embodiments, the method further includes trimming a portion of the second shell to accommodate the residuum exposed through the opening in the shell.
- the shell has a second slit extending parallel to at least a portion of the longitudinal slit and a distal end of the longitudinal slit is defined by the closed distal end of the shell and wherein a distal end of the second slit is defined by the closed distal end of the shell.
- the method further includes the step of positioning an enclosure panel over at least a portion of the residuum exposed through the opening in the shell; and securing the enclosure panel to the shell.
- the method further includes the step of modifying the dimensions of the shell to accommodate the residuum by trimming a portion of the first shell
- FIG. 1A is an exploded perspective view of an amputation residuum device according to some embodiments
- FIG. 1B is a perspective view of a partially assembled residuum device as shown in FIG. 1A ;
- FIG. 2 is a front elevation view of a partially assembled residuum device as shown in FIG. 1A ;
- FIG. 3 is a rear perspective view of a portion of the residuum device according to some embodiments of the invention.
- FIG. 4 is a rear perspective view of another embodiment of the residuum device.
- FIG. 5 is a cross-sectional view of the pre-tibial shell in FIG. 1B according to some embodiments of the invention.
- FIG. 6 is another embodiment of a pre-tibial shell
- FIG. 7 is a cross-sectional view of the pre-tibial shell in FIG. 6 according to some embodiments of the invention.
- FIG. 8 is a top plan view of enclosure panels for a residuum device according to some embodiments of the invention.
- FIG. 9 is a rear plan view of the enclosure panels of FIG. 8 ;
- FIG. 10 is a perspective view of an enclosing means and a residuum device according to some embodiments of the invention.
- Embodiments described herein provide a device and method for amputation residuum maintenance.
- a device and method for stabilization of an amputation residuum while accommodating fluctuations in volume and diameter of the residuum are provided.
- the term “residuum” as used herein includes the remaining portion of an amputated body part, such as an amputated limb and, in particular, a leg. When used with a limb, such as a leg, the residuum device helps with knee range of motion preservation.
- the residuum device described herein may be used for human and animal residuum maintenance.
- FIGS. 1A-1B illustrate one embodiment of an amputation residuum device 100 .
- the residuum device 100 includes a posterior shell 110 , a pre-tibial shell 120 , enclosure panels 802 , 804 , and a circular pad 250 .
- the posterior shell 110 comprises a proximal portion 122 and a distal portion 124 that extend along a longitudinal axis L of the posterior shell 110 (see also, FIG. 2 ).
- the posterior shell 110 is generally cylindrical in shape and includes an open end 130 positioned at the proximal portion of the posterior shell 110 and a closed end 132 positioned at the distal portion of the posterior shell 110 . Although a closed distal end is shown and described herein, it will be understood that both ends may be open.
- the posterior shell 110 may have any length and diameter, which may be adjusted to fit the amputation residuum. In some embodiments, the posterior shell 110 is about 18 inches in length and about 5.5 inches in diameter along its length.
- the posterior shell 110 may have any thickness and the thickness may vary along the length of the proximal shell 110 .
- the proximal portion 122 of the posterior shell 110 has a greater thickness in the proximal portion 122 than the distal portion 124 .
- the posterior shell defines an anterior opening 210 extending longitudinally from the proximal end for exposing the hollow interior of the posterior shell 110 .
- the width of the distal portion 124 of the anterior opening 210 defines a region that is about 40% of the circumference of the posterior shell 110 . It will be understood that the width of the distal portion 124 of the anterior opening 210 may be more or less than about 40% of the circumference of the posterior shell 110 based on the desired rigidity or size of the posterior shell 110 .
- the length of the anterior opening 210 in some embodiments, extends from the open end 130 to the closed end 132 along the longitudinal axis L of the posterior shell 110 .
- the proximal portion of the posterior shell 110 comprises a first ear 220 and a second ear 222 that extend circumferentially inwardly and are configured such that the width of the anterior opening 210 at the proximal portion 122 is less than the width of the anterior opening 210 at the distal portion 124 .
- the posterior shell 110 is formed from a semi-rigid polymer material that is shaped to comfortably accommodate the posterior of a thigh, knee, and trans-tibial residuum following amputation below the knee.
- the semi-rigid polymer material include thermoplastics; polyolefins; plastics; ethylene vinyl acetate, polypropylene, polyethylene, polyethylene terephthalate, styrene, vinyl acetate, acrylonitrile, polyvinyl chloride, polyamide, silicone, rubber, and carbohydrates polymers or copolymers; cross-linked polymers or copolymers; and combinations thereof.
- the posterior shell in some embodiments, is fabricated by thermo-forming the polymer material over a cylindrical model.
- the posterior shell is formed by injection molding.
- the posterior shell 110 may be formed in any color or opacity.
- the posterior shell 110 may be clear, slightly opaque, or completely opaque.
- the position of the floating pre-tibial shell 120 or any collecting fluids may be visible from the outside of the posterior shell 110 .
- anything positioned on the outside of the posterior shell 110 such as fabric fasteners 850 a - d , may be visible from the inside.
- the inner surface of the posterior shell 110 may be lined.
- the posterior shell 110 may include padding, wicking material, a gel layer, and the like.
- the circular pad 250 is disposed at the closed end of the proximal shell.
- the pad 250 may be formed from any soft, elastic, or conformable material. Examples of the material used in the pad 250 include sponge, plastazote, polypropylene terephthalate (PPT), foam, and the like.
- the slits 236 a , 236 b or 236 c, 236 d allow for limited deformation of the shell to accommodate volume and diameter variances of the residuum within the posterior shell 110 .
- the slits 236 a - d may be formed by cutting the posterior shell 110 using a knife, saw, blade, die, punch, or the like.
- the slits 236 a - d extend along the longitudinal axis of the posterior shell 110 .
- Each of the slits 236 a - d includes a first end and a second end, the slits 236 a - d having circular apertures 238 a - h at each end (see, e.g., FIGS. 2-4 ).
- the slits 236 a, 236 b and 236 c , 236 d, as shown in FIG. 3 and FIG. 4 are formed in the posterior shell 110 and are positioned in parallel.
- the slits 236 a and 236 c are positioned about 1 inch to about 5 inches from a first side edge 260 a and slits 236 b and 236 d are positioned about 1 inch to about 5 inches form a second side edge 260 b of the posterior shell 110 , where the side edges 260 a, 260 b extend along the longitudinal axis L of the posterior shell 110 (see, FIG. 2 ).
- the diameter of the circular apertures 238 a - 5 h allows the gaps formed by the slits 236 a - d to increase in width in response to an increase in residuum volume or diameter.
- the length of the slits and distance from the side edges may vary and any number of slits may be formed in the posterior shell 110 in accordance with the size of the residuum device 100 and volume and diameter fluctuations of the residuum.
- the first slit 236 a and the second slit 236 b are positioned about 3 inches from the first side edge 260 a and the second side edge 260 b of the posterior shell 110 , respectively.
- the slits 236 a, 236 b originate about 5 inches to about 12 inches from the open end 130 .
- the slits 236 a, 236 b are from about 2 inches to about 7 inches apart.
- the slits 236 a, 236 b are about 3 inches apart at the point of origin.
- the slits 236 a, 236 b terminate at a first point 304 a and a second point 304 b, respectively.
- the points 304 a, 304 b are positioned about 0.5 inches to about 3 inches apart at the closed end 132 of the posterior shell 110 . In some embodiments, the points 304 a, 304 b are positioned about 1.5 inches apart.
- the slits 236 c, 236 d are about 1.5 inches from the first side edge 260 a and the second side edge 260 b of the posterior shell 110, respectively.
- the slits 236 c, 236 d originate about 5 inches to about 12 inches from the open end 130 and terminate near the closed end 132 .
- the slits 236 c, 236 d run parallel along the longitudinal axis of the posterior shell 110 about 2 inches to about 7 inches apart.
- the pre-tibial shell 120 includes an inner foam layer 502 positioned adjacent to an outer foam layer 504 .
- the inner foam layer 502 is laminated to the outer foam layer 504 .
- the layers may be laminated using heat, adhesive, or a combination thereof.
- the laminated foam layers may then be cut to size, thermo-molded to a generally cylindrical model, and beveled along all edges.
- the pre-tibial shell 120 is formed through an injection-molding process.
- the inner foam layer 502 is positioned against the amputation residuum and, in some embodiments, comprises a soft material.
- the outer foam layer 504 comprises a rigid, high density material. This arrangement enhances the comfort and protection of the user's limb.
- the foam used in the pre-tibial shell 120 may be open cell foam, closed cell foam, polymer based foams, plant based foams, or combinations thereof. Examples of the inner foam layer 502 and outer foam layer 504 include: polyolefin, polyether, polyester, polyethylene, polypropylene, ethylene vinyl acetate, rubber, polyimide, vinyl chloride, polyurethane, styrene, carbon, soy, and cellulose based foams, and combinations thereof.
- the inner foam layer 502 and outer foam layer 504 may further include any number of additives or topical treatments such as antimicrobials, water resistant additives, coloring agents, and the like. Although two foam layers are illustrated in FIG. 5 , it will be understood that the pre-tibial shell 120 may include only a single layer or any number of layers including additional foam layers or layers of other materials. For example, the pre-tibial shell 120 may include plastic, gel, fabric, and the like.
- the pre-tibial shell 120 is configured to accommodate the shape of the amputation resdiuum and provide a secure and comfortable fit. As shown in FIG. 5 , the thickness of the pre-tibial shell 120 varies. In some embodiments, the inner foam layer 502 has a beveled edge, tapering as it extends to the outer side edges of the pre-tibial shell 120 . In other embodiments, the inner foam layer 502 tapers as it extends to the outer proximal and distal edges. As further shown in FIG. 5 , the inner foam layer 502 has a greater thickness than the outer foam layer 504 .
- the inner foam layer 502 and outer foam layer 504 may have any thickness as long as the pre-tibial shell 120 fits securely against the amputation residuum.
- an upper portion adjacent the proximal end of the pre-tibial shell 120 The upper portion defines an inner indentation for receiving a knee of the user limb when a leg is amputated below the knee.
- FIG. 6 illustrates another embodiment of a pre-tibial shell 600 of the residuum device 100 , which may be used in conjunction with the posterior shell 110 .
- the pre-tibial shell 600 can be included in the residuum device 100 and may be used in conjunction with the posterior shell 110 .
- the pre-tibial shell 600 includes a fastener strip 850 e that is positioned on at least a portion of an outer foam layer 704 .
- the pre-tibial shell 600 comprises an inner foam layer 702 and an outer foam layer 704 .
- the outer foam layer 704 tapers inwardly as it extends toward the outer edges of the pre-tibial shell 120 such that only the inner foam layer 702 extends along the outer perimeter of the pre-tibial shell 600 .
- the width of the upper portion adjacent the proximal end of the pre-tibial shell 600 is wider than the lower portion adjacent the distal end of the pre-tibial shell 600 .
- Both embodiments of the pre-tibial shell 120 , 600 may be modified in any way.
- the pre-tibial shell 120 , 600 may be easily trimmed or cut with scissors to better fit the user's limb.
- FIGS. 8 and 9 illustrate an enclosing means 800 for enclosing an amputation residuum within the interior of the posterior shell 110 .
- the enclosing means 800 includes a first enclosure panel 802 , and optionally, a second enclosure panel 804 .
- the enclosure panels 802 , 804 may be formed in any shape. In the illustrated embodiments, the first enclosure panel 802 is rectangular and the second enclosure panel 804 is trapezoidal.
- the rear portions of the enclosure panels 802 , 804 comprise soft fuzzy or a “loop” type of fabric such that the rear potions may adhere to the fastener strips 850 a - e ( FIG. 9 ).
- the enclosure panels 802 , 804 may come in any color, size, shape, width, length, area, and thickness. In the illustrated embodiments, the enclosure panels 802 , 804 are rectangular in shape. In other embodiments, the enclosure panels 802 , 804 are 11 inches by 20 inches. The dimensions of enclosure panels 802 , 804 may be modified by trimming the panels. Although two enclosure panels 802 , 804 are illustrated, it will be understood that a single enclosure panel or additional panels may be provided. The enclosure panels 802 , 804 are placed over the fastener strips 850 a - e to keep the enclosing means 800 in place.
- the enclosure panels 802 , 804 include one or more layers of fabric, foam, padding, rubber, neoprene, elastic material, and the like.
- the enclosure panels 802 , 804 may be formed by cutting, die-cutting, or stamping the panels from a roll of material.
- Other types of fastening systems may also be used with the residuum device 100 such as clamps, straps, belts, tapes, and the like.
- the residuum device 100 is further illustrated including the enclosing means 800 .
- One or more of the enclosure panels 802 , 804 are positioned across the patella to enhance control over knee flexion.
- the enclosure panels 802 , 804 and the fastener strips 850 a - e comprise fabric made of fastening material, such as hook and loop type fasteners (e.g., “Velcro”).
- the fastener strips 850 a - d are positioned on at least a portion of the outer surface of the posterior shell 110 .
- the fastener strips 850 a and 850 c are positioned on the first ear 220 and the second ear 222 , respectively.
- the fastener strips 850 b and 850 d are positioned on the outer surface of the posterior shell 110 in the distal portion 124 .
- the second embodiment the pre-tibial shell 600 may also include a fastener strip 850 e that is positioned on the outer surface of the pre-tibial shell 120 .
- the residuum device 100 can be used to accommodate an amputation residuum.
- the posterior shell 110 is applied to the posterior of a patient's thigh and residual limb by positioning at least a portion of the residuum into the hollow interior of the posterior shell 110 .
- the residuum device 100 will complete a three point pressure configuration comprised of posterior thigh, anterior patella, and posterior tibia in order to provide a knee extension load.
- the proximal potion 122 extends along at least a portion of the user's thigh and the distal portion 124 extends along at least a portion of the user's tibia.
- the posterior shell 110 may, for example, be trimmed at the open end 130 .
- the residual limb may be further accompanied by postoperative dressings.
- the relative position of the posterior shell 110 to the residuum is such that the distal end of the residuum engages a pad placed in the closed end 132 of the residuum device 100 .
- the slits 236 a , 236 b or 236 c, 236 d formed in the posterior shell 110 are configured to expand to avoid over-compressing an often painful postoperative residuum.
- the circular apertures 238 a - h positioned at the ends of the longitudinal slits 236 a - d cause the slits 236 a - d formed in the posterior shell 110 to widen in response to volume and diameter variations in the amputation residuum.
- the residuum device 100 may be used with or without the pre-tibial shell 120 , 600 depending on the needs or condition of the patient.
- the pre-tibial shell 120 or 600 is positioned in the anterior opening 210 of the posterior shell 110 such that the pre-tibial shell 120 , 600 comes in contact with the anterior aspect of the amputation residuum.
- the pre-tibial shell 120 , 600 is positioned such that the distal end of the posterior shell 110 is adjacent the distal end of the residuum and extending upwardly to the patella.
- the pre-tibial shell 120 , 600 may be trimmed for removing material from its distal end such that the pre-tibial shell 120 , 600 is positioned more distally.
- the pre-tibial shell 120 , 600 is tucked into the posterior shell in order to appropriately accommodate for volume loss secondary to edema reduction within the residuum.
- at least a portion of the posterior shell 110 defining the anterior opening 210 overlaps at least a portion of the peripheral edges of the pre-tibial shell 120 , 600 .
- the posterior shell 110 when expanding or contracting in response to volume and diameter variances in the amputation residuum, to move relative to outer foam layer 504 of the pre-tibial shell 120 , 600 .
- the pre-tibial shell 120 , 600 When the pre-tibial shell 120 , 600 is adjacent to the amputation residuum exposed through the anterior opening 210 , the pre-tibial shell 120 , 600 floats to accommodate the amputation residuum as it expands and contracts while it simultaneously stabilizes the amputation residuum.
- the user's residuum is enclosed in the proximal portion 122 of the posterior shell 110 by fastening the first enclosure panel 802 to the posterior shell 110 over the anterior of the patient's thigh. And the user's residuum is enclosed in the distal portion 124 of the posterior shell 110 by fastening the second enclosure panel 804 to the distal portion 124 of the posterior shell 110 and over the pre-tibial shell 120 , 600 that has been appropriately applied to the anterior of the user's residuum.
- the residuum device 100 can be used in conjunction with any number of additional items such as foam padding, a prosthetic sock or prosthetic shrinker, straps, strapping apparatus and belt (e.g., fork strap and suspension belt), and the like.
- the strapping apparatus and belt is useful when a user is upright, standing, or ambulating, and the prosthetic sock can be used to further protect the residuum and accommodate volume variance within the residuum.
- a kit is provided.
- the kit comprises one or more of the posterior shells 110 , pre-tibial shells 120 , 600 , and enclosure panels 802 , 804 .
- the kit comprise packaging, a container, instructions, labels, foam padding, a prosthetic sock or prosthetic shrinker, straps, a strapping apparatus, and the like.
Abstract
An apparatus and method for post amputation residuum maintenance and for preserving motion of the knee are provided. The apparatus includes an elongated shell having a longitudinal axis and defining a hollow interior closed at a distal end, the shell having an opening extending from a proximal end and adapted to receive a residuum into the interior of the shell, and a longitudinal slit having a circular aperture at each end.
Description
- This application is a continuation application of U.S. patent application Ser. No. 13/398,521 entitled “Amputation Residuum Device and Method of Using the Same,” filed Feb. 16, 2012, which claims priority to U.S. Provisional Application No. 61/443,552 entitled “Post Amputation Residuum Maintenance and Knee Range of Motion Preservation Apparatus,” filed on Feb. 16, 2011, the entire contents of both of which are incorporated by reference herein.
- Following amputation, edema often occurs in the amputated region causing volume fluctuations in the residuum. It is often important to stabilize the residuum by apply compression to the residuum. The residuum may be placed in a splint or other device to manage swelling and protect the residuum. Current devices are formed from a continuous piece of plastic to form the posterior and anterior portions and a distal end, where the anterior and posterior portions are attached, such that variances in volume are not appropriately accommodated at the distal end of the residuum.
- For all these reasons and others, there is a need for an improved user-friendly device and method for accommodating residuum volume fluctuations.
- Embodiments an amputation residuum device and method of using the same are described herein which address these and/or other. In some embodiments, the amputation residuum device comprises a posterior shell having longitudinal slits formed therein and a multidurometer, soft pre-tibial shell is provided. The residuum device provides for a limb volume and diameter variance accommodation via the floating pre-tibial shell and the flexible posterior shell.
- In some embodiments, an apparatus for post amputation residuum maintenance is provided. The apparatus includes: an elongated shell having a longitudinal axis and defining a hollow interior closed at a distal end, the shell having an opening extending from a proximal end and adapted to receive a residuum into the interior of the shell, and a longitudinal slit having a circular aperture at each end.
- In some embodiments of the apparatus, the shell further includes a second slit extending parallel to at least a portion of the longitudinal slit. In other embodiments, a distal end of the longitudinal slit is defined by the closed distal end of the shell. In still other embodiments, the shell has a second slit having a distal end defined by the closed distal end of the shell. In some embodiments, the distal end of the longitudinal slit is positioned from about 0.5 inches to about 3 inches from the distal end of the second slit. In some embodiments, the apparatus includes a second shell adapted to be positioned adjacent to the residuum, the second shell configured to cover at least a portion of the opening of the shell. In some embodiments of the apparatus, the second shell has a longitudinal axis, and the second shell is substantially arcuate in a cross-section taken transverse to the longitudinal axis of the second shell.
- In other embodiments, the apparatus further includes an inner foam layer comprising a soft material; and an outer foam layer comprising a rigid material, wherein the outer layer is positioned adjacent to the inner foam layer. In still other embodiments, the peripheral edge of the inner foam layer tapers outwardly. In further embodiments, the peripheral edge of the outer foam layer tapers inwardly.
- In some embodiments of the apparatus, the shell has a circumference, and the opening is about 40% of the circumference of the shell. In other embodiments, the shell comprises a proximal portion and a distal portion, wherein the width of the opening defined by the distal portion is greater than the width of the opening defined by the proximal portion. In further embodiments, the apparatus further includes at least one enclosure panel; and a means for securing that at least enclosure panel to the shell. In other embodiments, the apparatus further includes a circular pad disposed in the interior of the shell adjacent the closed end.
- In some embodiments, method for maintaining post amputation residuum maintenance is provided. The method includes: providing an elongated shell having a longitudinal axis and defining a hollow interior closed at a distal end, the shell having an opening extending from a proximal end and adapted to receive a residuum into the interior of the shell, and a longitudinal slit having a circular aperture at each end; and positioning a residuum in the interior of the shell via the opening. In other embodiments, the method further includes the step of providing a second shell adapted to be positioned adjacent to the residuum, the second shell configured to cover at least a portion of the opening. In still other embodiments, the method further includes the step of adjusting the position of the second shell to fit against the residuum, wherein at least a portion of an edge of the first shell defining the opening partially overlaps the second shell. In further embodiments, the method further includes trimming a portion of the second shell to accommodate the residuum exposed through the opening in the shell.
- In some embodiments of the method, the shell has a second slit extending parallel to at least a portion of the longitudinal slit and a distal end of the longitudinal slit is defined by the closed distal end of the shell and wherein a distal end of the second slit is defined by the closed distal end of the shell. In other embodiments, the method further includes the step of positioning an enclosure panel over at least a portion of the residuum exposed through the opening in the shell; and securing the enclosure panel to the shell. In still other embodiments, the method further includes the step of modifying the dimensions of the shell to accommodate the residuum by trimming a portion of the first shell
- Having thus described embodiments of the invention in general terms, reference will now be made the accompanying drawings, wherein:
-
FIG. 1A is an exploded perspective view of an amputation residuum device according to some embodiments; -
FIG. 1B is a perspective view of a partially assembled residuum device as shown inFIG. 1A ; -
FIG. 2 is a front elevation view of a partially assembled residuum device as shown inFIG. 1A ; -
FIG. 3 is a rear perspective view of a portion of the residuum device according to some embodiments of the invention; -
FIG. 4 is a rear perspective view of another embodiment of the residuum device; -
FIG. 5 is a cross-sectional view of the pre-tibial shell inFIG. 1B according to some embodiments of the invention; -
FIG. 6 is another embodiment of a pre-tibial shell; -
FIG. 7 is a cross-sectional view of the pre-tibial shell inFIG. 6 according to some embodiments of the invention; -
FIG. 8 is a top plan view of enclosure panels for a residuum device according to some embodiments of the invention; -
FIG. 9 is a rear plan view of the enclosure panels ofFIG. 8 ; and -
FIG. 10 is a perspective view of an enclosing means and a residuum device according to some embodiments of the invention. - Embodiments of the present invention will now be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all, embodiments of the invention are shown. Indeed, the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Where possible, any terms expressed in the singular form herein are meant to also include the plural form and vice versa, unless explicitly stated otherwise. Like numbers refer to like elements throughout.
- Embodiments described herein provide a device and method for amputation residuum maintenance. A device and method for stabilization of an amputation residuum while accommodating fluctuations in volume and diameter of the residuum are provided. It will be understood that the term “residuum” as used herein includes the remaining portion of an amputated body part, such as an amputated limb and, in particular, a leg. When used with a limb, such as a leg, the residuum device helps with knee range of motion preservation. The residuum device described herein may be used for human and animal residuum maintenance.
- Referring now to the figures,
FIGS. 1A-1B illustrate one embodiment of anamputation residuum device 100. Theresiduum device 100 includes aposterior shell 110, apre-tibial shell 120,enclosure panels circular pad 250. - The
posterior shell 110 comprises aproximal portion 122 and adistal portion 124 that extend along a longitudinal axis L of the posterior shell 110 (see also,FIG. 2 ). Theposterior shell 110 is generally cylindrical in shape and includes anopen end 130 positioned at the proximal portion of theposterior shell 110 and aclosed end 132 positioned at the distal portion of theposterior shell 110. Although a closed distal end is shown and described herein, it will be understood that both ends may be open. Theposterior shell 110 may have any length and diameter, which may be adjusted to fit the amputation residuum. In some embodiments, theposterior shell 110 is about 18 inches in length and about 5.5 inches in diameter along its length. Theposterior shell 110 may have any thickness and the thickness may vary along the length of theproximal shell 110. For example, in some embodiments, theproximal portion 122 of theposterior shell 110 has a greater thickness in theproximal portion 122 than thedistal portion 124. - Referring now to
FIG. 2 the posterior shell defines ananterior opening 210 extending longitudinally from the proximal end for exposing the hollow interior of theposterior shell 110. In some embodiments, the width of thedistal portion 124 of theanterior opening 210 defines a region that is about 40% of the circumference of theposterior shell 110. It will be understood that the width of thedistal portion 124 of theanterior opening 210 may be more or less than about 40% of the circumference of theposterior shell 110 based on the desired rigidity or size of theposterior shell 110. The length of theanterior opening 210, in some embodiments, extends from theopen end 130 to theclosed end 132 along the longitudinal axis L of theposterior shell 110. In some embodiments, the proximal portion of theposterior shell 110 comprises afirst ear 220 and asecond ear 222 that extend circumferentially inwardly and are configured such that the width of theanterior opening 210 at theproximal portion 122 is less than the width of theanterior opening 210 at thedistal portion 124. - In some embodiments, the
posterior shell 110 is formed from a semi-rigid polymer material that is shaped to comfortably accommodate the posterior of a thigh, knee, and trans-tibial residuum following amputation below the knee. Examples of the semi-rigid polymer material include thermoplastics; polyolefins; plastics; ethylene vinyl acetate, polypropylene, polyethylene, polyethylene terephthalate, styrene, vinyl acetate, acrylonitrile, polyvinyl chloride, polyamide, silicone, rubber, and carbohydrates polymers or copolymers; cross-linked polymers or copolymers; and combinations thereof. The posterior shell, in some embodiments, is fabricated by thermo-forming the polymer material over a cylindrical model. In other embodiments, the posterior shell is formed by injection molding. Theposterior shell 110 may be formed in any color or opacity. For example, theposterior shell 110 may be clear, slightly opaque, or completely opaque. In the case where theposterior shell 110 is clear or slightly opaque, the position of the floatingpre-tibial shell 120 or any collecting fluids may be visible from the outside of theposterior shell 110. Similarly, anything positioned on the outside of theposterior shell 110, such as fabric fasteners 850 a-d, may be visible from the inside. To enhance the comfort of the user, the inner surface of theposterior shell 110 may be lined. For example, theposterior shell 110 may include padding, wicking material, a gel layer, and the like. - Further shown in
FIG. 2 is thecircular pad 250 is disposed at the closed end of the proximal shell. Thepad 250 may be formed from any soft, elastic, or conformable material. Examples of the material used in thepad 250 include sponge, plastazote, polypropylene terephthalate (PPT), foam, and the like. - Referring now to
FIGS. 3 and 4 , formed in theposterior shell 110 are afirst slit 236 a and asecond slit 236 b as shown inFIG. 3 , and slits 236 c and 236 d shown inFIG. 4 . Theslits posterior shell 110. The slits 236 a-d may be formed by cutting theposterior shell 110 using a knife, saw, blade, die, punch, or the like. The slits 236 a-d extend along the longitudinal axis of theposterior shell 110. - Each of the slits 236 a-d includes a first end and a second end, the slits 236 a-d having circular apertures 238 a-h at each end (see, e.g.,
FIGS. 2-4 ). Theslits FIG. 3 andFIG. 4 , are formed in theposterior shell 110 and are positioned in parallel. Theslits first side edge 260 a and slits 236 b and 236 d are positioned about 1 inch to about 5 inches form asecond side edge 260 b of theposterior shell 110, where the side edges 260 a, 260 b extend along the longitudinal axis L of the posterior shell 110 (see,FIG. 2 ). The diameter of the circular apertures 238 a-5 h allows the gaps formed by the slits 236 a-d to increase in width in response to an increase in residuum volume or diameter. The length of the slits and distance from the side edges may vary and any number of slits may be formed in theposterior shell 110 in accordance with the size of theresiduum device 100 and volume and diameter fluctuations of the residuum. - In
FIG. 3 , at least a portion of thefirst slit 236 a and thesecond slit 236 b are positioned about 3 inches from thefirst side edge 260 a and thesecond side edge 260 b of theposterior shell 110, respectively. Theslits open end 130. At the point of origin, theslits slits slits first point 304 a and asecond point 304 b, respectively. Thepoints closed end 132 of theposterior shell 110. In some embodiments, thepoints - In
FIG. 4 , theslits first side edge 260 a and thesecond side edge 260 b of theposterior shell 110, respectively. Theslits open end 130 and terminate near theclosed end 132. Theslits posterior shell 110 about 2 inches to about 7 inches apart. - Referring now to
FIG. 5 , thepre-tibial shell 120 includes aninner foam layer 502 positioned adjacent to anouter foam layer 504. In some embodiments, theinner foam layer 502 is laminated to theouter foam layer 504. The layers may be laminated using heat, adhesive, or a combination thereof. The laminated foam layers may then be cut to size, thermo-molded to a generally cylindrical model, and beveled along all edges. In other embodiments, thepre-tibial shell 120 is formed through an injection-molding process. - The
inner foam layer 502 is positioned against the amputation residuum and, in some embodiments, comprises a soft material. Theouter foam layer 504 comprises a rigid, high density material. This arrangement enhances the comfort and protection of the user's limb. The foam used in thepre-tibial shell 120 may be open cell foam, closed cell foam, polymer based foams, plant based foams, or combinations thereof. Examples of theinner foam layer 502 andouter foam layer 504 include: polyolefin, polyether, polyester, polyethylene, polypropylene, ethylene vinyl acetate, rubber, polyimide, vinyl chloride, polyurethane, styrene, carbon, soy, and cellulose based foams, and combinations thereof. Theinner foam layer 502 andouter foam layer 504 may further include any number of additives or topical treatments such as antimicrobials, water resistant additives, coloring agents, and the like. Although two foam layers are illustrated inFIG. 5 , it will be understood that thepre-tibial shell 120 may include only a single layer or any number of layers including additional foam layers or layers of other materials. For example, thepre-tibial shell 120 may include plastic, gel, fabric, and the like. - The
pre-tibial shell 120 is configured to accommodate the shape of the amputation resdiuum and provide a secure and comfortable fit. As shown inFIG. 5 , the thickness of thepre-tibial shell 120 varies. In some embodiments, theinner foam layer 502 has a beveled edge, tapering as it extends to the outer side edges of thepre-tibial shell 120. In other embodiments, theinner foam layer 502 tapers as it extends to the outer proximal and distal edges. As further shown inFIG. 5 , theinner foam layer 502 has a greater thickness than theouter foam layer 504. It will be understood, however, that theinner foam layer 502 andouter foam layer 504 may have any thickness as long as thepre-tibial shell 120 fits securely against the amputation residuum. As best shown inFIGS. 1A and 1B , an upper portion adjacent the proximal end of thepre-tibial shell 120. The upper portion defines an inner indentation for receiving a knee of the user limb when a leg is amputated below the knee. -
FIG. 6 illustrates another embodiment of apre-tibial shell 600 of theresiduum device 100, which may be used in conjunction with theposterior shell 110. Thepre-tibial shell 600 can be included in theresiduum device 100 and may be used in conjunction with theposterior shell 110. Thepre-tibial shell 600 includes afastener strip 850 e that is positioned on at least a portion of anouter foam layer 704. - Referring to
FIG. 7 , thepre-tibial shell 600 comprises aninner foam layer 702 and anouter foam layer 704. In some embodiments, theouter foam layer 704 tapers inwardly as it extends toward the outer edges of thepre-tibial shell 120 such that only theinner foam layer 702 extends along the outer perimeter of thepre-tibial shell 600. In other embodiments, the width of the upper portion adjacent the proximal end of thepre-tibial shell 600 is wider than the lower portion adjacent the distal end of thepre-tibial shell 600. - Both embodiments of the
pre-tibial shell pre-tibial shell -
FIGS. 8 and 9 illustrate an enclosing means 800 for enclosing an amputation residuum within the interior of theposterior shell 110. The enclosing means 800 includes afirst enclosure panel 802, and optionally, asecond enclosure panel 804. Theenclosure panels first enclosure panel 802 is rectangular and thesecond enclosure panel 804 is trapezoidal. The rear portions of theenclosure panels FIG. 9 ). Theenclosure panels enclosure panels enclosure panels enclosure panels enclosure panels enclosure panels enclosure panels enclosure panels residuum device 100 such as clamps, straps, belts, tapes, and the like. - In
FIG. 10 , theresiduum device 100 is further illustrated including the enclosing means 800. One or more of theenclosure panels enclosure panels FIGS. 1A and 1B , the fastener strips 850 a-d are positioned on at least a portion of the outer surface of theposterior shell 110. The fastener strips 850 a and 850 c are positioned on thefirst ear 220 and thesecond ear 222, respectively. The fastener strips 850 b and 850 d are positioned on the outer surface of theposterior shell 110 in thedistal portion 124. As described herein above, the second embodiment thepre-tibial shell 600 may also include afastener strip 850 e that is positioned on the outer surface of thepre-tibial shell 120. - The
residuum device 100 can be used to accommodate an amputation residuum. In use, theposterior shell 110 is applied to the posterior of a patient's thigh and residual limb by positioning at least a portion of the residuum into the hollow interior of theposterior shell 110. As the posterior aspect of theposterior shell 110 is a continuous shell, theresiduum device 100 will complete a three point pressure configuration comprised of posterior thigh, anterior patella, and posterior tibia in order to provide a knee extension load. In some embodiments, theproximal potion 122 extends along at least a portion of the user's thigh and thedistal portion 124 extends along at least a portion of the user's tibia. Depending on the length of the amputation residuum, theposterior shell 110 may, for example, be trimmed at theopen end 130. - The residual limb may be further accompanied by postoperative dressings. The relative position of the
posterior shell 110 to the residuum is such that the distal end of the residuum engages a pad placed in theclosed end 132 of theresiduum device 100. Theslits posterior shell 110 are configured to expand to avoid over-compressing an often painful postoperative residuum. The circular apertures 238 a-h positioned at the ends of the longitudinal slits 236 a-d cause the slits 236 a-d formed in theposterior shell 110 to widen in response to volume and diameter variations in the amputation residuum. - It will be understood that the
residuum device 100 may be used with or without thepre-tibial shell pre-tibial shell anterior opening 210 of theposterior shell 110 such that thepre-tibial shell pre-tibial shell posterior shell 110 is adjacent the distal end of the residuum and extending upwardly to the patella. - For a shorter trans-tibial residuum, the
pre-tibial shell pre-tibial shell pre-tibial shell posterior shell 110 defining theanterior opening 210 overlaps at least a portion of the peripheral edges of thepre-tibial shell posterior shell 110, when expanding or contracting in response to volume and diameter variances in the amputation residuum, to move relative toouter foam layer 504 of thepre-tibial shell pre-tibial shell anterior opening 210, thepre-tibial shell - In some embodiments, the user's residuum is enclosed in the
proximal portion 122 of theposterior shell 110 by fastening thefirst enclosure panel 802 to theposterior shell 110 over the anterior of the patient's thigh. And the user's residuum is enclosed in thedistal portion 124 of theposterior shell 110 by fastening thesecond enclosure panel 804 to thedistal portion 124 of theposterior shell 110 and over thepre-tibial shell - The
residuum device 100 can be used in conjunction with any number of additional items such as foam padding, a prosthetic sock or prosthetic shrinker, straps, strapping apparatus and belt (e.g., fork strap and suspension belt), and the like. In particular, the strapping apparatus and belt is useful when a user is upright, standing, or ambulating, and the prosthetic sock can be used to further protect the residuum and accommodate volume variance within the residuum. In some embodiments, a kit is provided. The kit comprises one or more of theposterior shells 110,pre-tibial shells enclosure panels - While certain exemplary embodiments have been described and shown in the accompanying drawings, it is to be understood that such embodiments are merely illustrative of, and not restrictive on, the broad invention, and that this invention not be limited to the specific constructions and arrangements shown and described, since various other changes, combinations, omissions, modifications and substitutions, in addition to those set forth in the above paragraphs, are possible. Those skilled in the art will appreciate that various adaptations and modifications of the just described embodiments can be configured without departing from the scope and spirit of the invention. For example, while the
residuum device 100 is described herein for use with a leg, it will be understood that theresiduum device 100 may also be used for an arm or other body part. Therefore, it is to be understood that, within the scope of the appended claims, the invention may be practiced other than as specifically described herein.
Claims (23)
1. An apparatus for post amputation maintenance of a residuum having a posterior portion, the apparatus comprising:
an elongated shell having a longitudinal axis extending from a proximal end to a distal end and defining a hollow interior closed at the distal end, the shell having an opening into the interior extending from the proximal end and adapted to receive the posterior portion of the residuum into the interior of the shell, and the shell having a longitudinal slit having a circular aperture at each end and extending substantially parallel to the longitudinal axis.
2. The apparatus of claim 1 , wherein the shell has a second slit extending substantially parallel to at least a portion of the longitudinal slit.
3. The apparatus of claim 1 , wherein a distal end of the longitudinal slit is defined by the closed distal end of the shell.
4. The apparatus of claim 3 , wherein the shell has a second slit having a distal end defined by the closed distal end of the shell.
5. The apparatus of claim 4 , wherein the distal end of the longitudinal slit is positioned from about 0.5 inches to about 3 inches from the distal end of the second slit.
6. The apparatus of claim 1 , further comprising a second shell adapted to be positioned adjacent to the residuum, the second shell configured to cover at least a portion of the opening of the shell.
7. The apparatus of claim 6 , wherein the second shell has a longitudinal axis, and the second shell is substantially arcuate in a cross-section taken transverse to the longitudinal axis of the second shell.
8. The apparatus of claim 6 ,
wherein the second shell comprises:
an inner foam layer comprising a soft material; and
an outer foam layer comprising a rigid material, wherein the outer layer is positioned adjacent to the inner foam layer.
9. The apparatus of claim 8 , wherein the peripheral edge of the inner foam layer tapers outwardly.
10. The apparatus of claim 8 , wherein the peripheral edge of the outer foam layer tapers inwardly.
11. The apparatus of claim 1 , wherein the shell comprises a proximal portion including the proximal end of the shell, and a distal portion including the distal end of the shell, wherein a first width of the opening defined by the distal portion is greater than a second width of the opening defined by the proximal portion such that the width of the opening tapers inwardly from the proximal end of the shell to the distal end of the shell.
12. The apparatus of claim 1 , wherein the shell has a circumference, and the opening is about 40% of the circumference of the shell.
13. The apparatus of claim 1 , further comprising:
at least one enclosure panel; and
a means for securing the at least one enclosure panel to the shell.
14. The apparatus of claim 1 , further comprising a circular pad disposed in the interior of the shell adjacent to the closed distal end of the shell.
15. A method for maintaining a post amputation residuum including a posterior portion, the method comprising:
providing an elongated shell having a longitudinal axis extending from a proximal end of the shell to a distal end of the shell and defining a hollow interior closed at the distal end, the shell having an opening into the interior extending from the proximal end and adapted to receive the residuum into the interior of the shell, and the shell having a longitudinal slit having a circular aperture at each end and extending parallel to the longitudinal axis; and
positioning the posterior portion of the residuum in the interior of the shell via the opening.
16. The method of claim 15 , further comprising the step of providing a second shell adapted to be positioned adjacent to the residuum, the second shell configured to cover at least a portion of the opening.
17. The method of claim 16 , further comprising the step of positioning the second shell over at least a portion of the residuum exposed through the opening in the shell.
18. The method of claim 16 , further comprising the step of:
adjusting the position of the second shell to fit against the residuum, wherein at least a portion of an edge of the first shell defining the opening partially overlaps the second shell.
19. The method of claim 16 , further comprising the step of:
trimming a portion of the second shell to accommodate the residuum exposed through the opening in the shell.
20. The method of claim 15 , wherein the shell has a second slit extending parallel to at least a portion of the longitudinal slit.
21. The method of claim 20 , wherein a distal end of the longitudinal slit is defined by the closed distal end of the shell and wherein a distal end of the second slit is defined by the closed distal end of the shell.
22. The method of claim 15 , further comprising the steps of:
providing an enclosure panel;
positioning the enclosure panel over at least a portion of the residuum exposed through the opening in the shell; and
securing the enclosure panel to the shell.
23. The method of claim 15 , further comprising the step of:
modifying the dimensions of the shell to accommodate the residuum by trimming a portion of the shell.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US14/150,161 US20140121784A1 (en) | 2011-02-16 | 2014-01-08 | Amputation residuum device and method of using the same |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US201161443552P | 2011-02-16 | 2011-02-16 | |
US13/398,521 US8679193B2 (en) | 2011-02-16 | 2012-02-16 | Amputation residuum device and method of using the same |
US14/150,161 US20140121784A1 (en) | 2011-02-16 | 2014-01-08 | Amputation residuum device and method of using the same |
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US13/398,521 Continuation US8679193B2 (en) | 2011-02-16 | 2012-02-16 | Amputation residuum device and method of using the same |
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US20140121784A1 true US20140121784A1 (en) | 2014-05-01 |
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US14/150,161 Abandoned US20140121784A1 (en) | 2011-02-16 | 2014-01-08 | Amputation residuum device and method of using the same |
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US13/398,521 Active 2032-04-13 US8679193B2 (en) | 2011-02-16 | 2012-02-16 | Amputation residuum device and method of using the same |
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USD752819S1 (en) * | 2014-08-22 | 2016-03-29 | Robert Magri | Protective barrier element |
US20160058634A1 (en) * | 2014-09-02 | 2016-03-03 | Top Shelf Manufacturing, Llc | Rigid removable dressing |
USD788375S1 (en) * | 2015-08-27 | 2017-05-30 | Easton Baseball/Softball Inc. | Panel for a leg guard |
US10524937B2 (en) * | 2015-08-28 | 2020-01-07 | Cobblestone, Llc | Post-operative support apparatus for a patients residual limb |
US11464656B2 (en) | 2015-08-28 | 2022-10-11 | Cobblestone, Llc | Post-operative support apparatus for a patient's residual limb |
DE102016108631A1 (en) * | 2016-05-10 | 2017-11-16 | Otto Bock Healthcare Gmbh | Prosthesis stem and method for controlling an adjustment of an inner circumference of a prosthesis stem |
USD912907S1 (en) * | 2018-08-28 | 2021-03-09 | Nico Hawk LaRosa | Arm and wrist guard |
US11737926B2 (en) * | 2019-10-16 | 2023-08-29 | Limbguard, LLC | Apparatus and method for suspending a residuum protection device |
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US3945046A (en) | 1974-08-09 | 1976-03-23 | Lawrence Thompson Stromgren | Flexible knee support |
US4139002A (en) | 1977-09-12 | 1979-02-13 | Almedia Manuel J | Universal knee orthosis |
GB2103490B (en) | 1981-08-14 | 1984-08-08 | Blatchford & Sons Ltd | Artificial limb socket |
FR2512666A1 (en) | 1981-09-16 | 1983-03-18 | Arche Assoc Gestion Ctre Reada | Stump pocket for artificial leg - using complementary rigid walls with adjustable straps for a comfortable fit |
US4872879A (en) | 1987-09-22 | 1989-10-10 | Prosthetic Consultants Inc. | Prosthetic device for above-knee amputation |
US4842608A (en) | 1988-01-27 | 1989-06-27 | Ortho-Bionics Laboratory, Inc. | Fluctuating volume adjustable preparatory below knee prosthetic socket |
US4981132A (en) | 1990-04-30 | 1991-01-01 | Andrew Chong | Orthosis for the treatment of tibial torsion in children |
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US5211667A (en) | 1992-04-22 | 1993-05-18 | Danforth Michael B | Guard for residuum after amputation |
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US5507722A (en) | 1994-12-09 | 1996-04-16 | Richardson; James V. | Amputation cylinder dressing |
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US5529575A (en) | 1995-04-10 | 1996-06-25 | Southern Illinois Prosthetic And Orthotic Ltd. | Prefabricated therapeutic prosthesis for below-knee amputees |
US5653766A (en) | 1996-02-23 | 1997-08-05 | Michigan Orthopedic Services, Llc | Post-operative prosthetic device |
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US6991657B1 (en) | 2004-07-08 | 2006-01-31 | James B. Price, Jr. | Adjustable prosthetic socket |
ES2308593T3 (en) | 2004-12-22 | 2008-12-01 | Oped Ag | PROTESICAL DEVICE. |
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US7488349B2 (en) * | 2006-03-24 | 2009-02-10 | Ossur Hf | Ventilated prosthesis system |
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- 2012-02-16 US US13/398,521 patent/US8679193B2/en active Active
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2014
- 2014-01-08 US US14/150,161 patent/US20140121784A1/en not_active Abandoned
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US8679193B2 (en) | 2014-03-25 |
US20120209404A1 (en) | 2012-08-16 |
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