US20060276911A1 - Offset alignment device - Google Patents

Offset alignment device Download PDF

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Publication number
US20060276911A1
US20060276911A1 US11/504,906 US50490606A US2006276911A1 US 20060276911 A1 US20060276911 A1 US 20060276911A1 US 50490606 A US50490606 A US 50490606A US 2006276911 A1 US2006276911 A1 US 2006276911A1
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United States
Prior art keywords
piece
positioner
flange
opening
prosthetic device
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Abandoned
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US11/504,906
Inventor
Michael Curtis
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Individual
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Individual
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Priority to US11/504,906 priority Critical patent/US20060276911A1/en
Publication of US20060276911A1 publication Critical patent/US20060276911A1/en
Priority to US29/331,387 priority patent/USD620594S1/en
Abandoned legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/50Prostheses not implantable in the body
    • A61F2/76Means for assembling, fitting or testing prostheses, e.g. for measuring or balancing, e.g. alignment means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
    • A61F2002/30359Pyramidally- or frustopyramidally-shaped protrusion and recess
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30476Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
    • A61F2002/30507Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism using a threaded locking member, e.g. a locking screw or a set screw
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/50Prostheses not implantable in the body
    • A61F2002/5016Prostheses not implantable in the body adjustable
    • A61F2002/5021Prostheses not implantable in the body adjustable for adjusting a position by translation along an axis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/50Prostheses not implantable in the body
    • A61F2002/5016Prostheses not implantable in the body adjustable
    • A61F2002/5021Prostheses not implantable in the body adjustable for adjusting a position by translation along an axis
    • A61F2002/5023Prostheses not implantable in the body adjustable for adjusting a position by translation along an axis along two perpendicular axes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit

Definitions

  • the present invention relates to an offset alignment device and more particularly an alignment device that is adjustable in both the lateral or medial direction and the anterior or posterior direction, and also rotatably connectable, at a single interface between the two pieces of the present invention.
  • a limb 6 amputated The amputated limb 6 terminates in a stump 7 .
  • a prosthetic component such as a socket 10 can be formed for a particular stump 7 .
  • Sockets 10 are well known in the art, and each socket 10 has an end 11 and a central axis 12 .
  • the present invention relates to endoskeletal prosthetic limbs. That is, limbs comprised of structural components and an optional aesthetic outer shell.
  • FIG. 1 the components of a typical prosthetic limb setup 30 are shown.
  • a conventional four hole adapter 20 having a central axis 21 that runs centrally through the component is shown.
  • the four hole adapter 20 cannot be positioned centrally upon the socket 10 .
  • the central axis 21 of the adapter 20 is parallel to the central axis 12 of the socket 10 , it is offset there from.
  • the adapter central axis 21 can be offset from the socket central axis 12 in the lateral or medial direction 15 and 16 as well as in the anterior or posterior direction 18 or 19 by a total offset distance delta.
  • a conventional pylon 25 with a fixed receiver 26 and central axis 27 is also provided.
  • the pylon central axis 27 be centrally aligned with the socket central axis 12 , to ensure maximum comfort and stability of the prosthetic limb. This alignment is further preferred because a person's gait may be adversely affected if the pylon central axis 27 is out of central alignment with the socket central axis 12 and the person may experience unnecessary muscle strain and fatigue. Yet, as shown, it can be impossible to achieve this preferred socket central axis 12 and pylon central axis 27 alignment when the conventional four hole adapter 20 is offset from the socket.
  • the adapter 35 is exemplary of the adapter shown in U.S. Pat. No. RE 36,521 to Hiemisch.
  • the modified four hole adapter 35 has a pyramid with an alignment axis 36 running there through.
  • Adapter 35 also has a central axis 37 .
  • the alignment axis 36 and central axis 37 are parallel and offset from one another by a fixed distance and orientation.
  • the four holes are arranged in a square pattern, such that the adapter 35 can align with its adjacent component in one of four positions by rotating the adapter 35 around its central axis 37 in relation to the adjacent component. Therefore, the alignment axis 36 can be selectively oriented to one of four distinct orientations relative to the central axis or its adjacent component.
  • the modified adapter 35 of the Hiemisch patent may work well for its intended purposes, it is not without drawbacks.
  • the component is capable of being reoriented with respect to an adjacent component, there are only a limited number of possible orientations. Specifically, only four orientations are possible.
  • the adapter 35 is only useful when the offset amount delta is at an appropriate distance and angle from the socket central axis 12 in a plane defined by the lateral or medial direction 15 and 16 and the anterior or posterior direction 17 and 18 .
  • the end of the socket 11 is not offset by an amount that can be overcome with adapter 35 . Therefore, incorporation of the adapter 35 into the prosthetic limb may not work to fully realize its intended results.
  • the first component is a four hole plate with a male dovetail protruding there from along a first axis.
  • the second component is an adapter with a female dovetail receiver for mating with the male dovetail of the first component, and with a male dovetail that is on the opposed side of the adapter and that is aligned generally perpendicular to the female dovetail receiver.
  • the third component has a female dovetail receiver on its first side for mating with the male dovetail of the second component and a standard pyramid on the opposed side.
  • Each side shift screw has a head with a rib that rests in a groove in the female dovetail section.
  • the threaded end of the screw is received within a hole in the male dovetail section.
  • the screw head remains laterally stationary relative to the female dovetail section as the screw is twisted.
  • the male dovetail section translates towards or away from the screw head as the screw is twisted, depending on which way the screw is twisted.
  • Three screws and ball bearings are shown to guide the male end within the female end.
  • the ball bearings are anti-friction devices that reduce friction between the female and male dovetail sections, which encourage movement of the male end within the female end when the side shift screw is twisted.
  • the structural integrity of the dovetail connection is determined solely by the strength of the ribs on the screw head. If the screw head fails, the entire component could fail. These components may therefore be less than optimally strong. Also, given that three components are necessary to effectuate the intended adjustment, this system is undesirably overly complicated.
  • This patent is entitled system for assembling two components of a prosthesis in a plurality of adjustable positions.
  • the Vera system has a projecting part integral with one of the components, and a hollow part formed into the second component.
  • the projecting part of the first component is not able to fully move within the hollow part of the second component. This is because the screws would engage the base of the hollow part instead of the lateral flanks of the projecting part after the projecting part moves a short distance from center and prior to the projecting part moving near the side walls of the hollow part.
  • an embodiment is shown where the projecting part can be twisted and held in place with a screw, as shown in FIG. 11 . Such an arrangement is less structurally secure than an integrally formed component.
  • the present invention relates to an offset alignment device that is adjustable in the lateral or medial direction and the anterior or posterior direction, and is also rotatably connectable, at a single interface between the two pieces of the present invention.
  • first piece having a body with a central axis through the body.
  • the body has two sides.
  • a positioner is on the first side of the body.
  • a dome with a pyramid is on the second side of the body.
  • a second piece, having a central axis and a flange is also provided. Four walls upstand from the flange to define an opening.
  • the first and second pieces of the present invention are selectably offsetable at a single interface in both the lateral or medial direction and in the anterior or posterior direction.
  • the first piece and second piece co-act so that the positioner can be selectably received and positioned within the opening.
  • the body of the first piece rests on the top of the walls of the second piece to provide stability and ensure that the central axis of the first piece remains parallel to the central axis of the second piece.
  • the positioner has more than four faces so that the first piece can be rotated and locked in place relative to the second piece in less than ninety degree increments.
  • the positioner has a generally round profile so that the first piece can be rotated and locked in place relative to the second piece in an infinite number of positions.
  • a further goal of the present invention is to provide maximum comfort and stability to a person with a prosthetic limb. This is accomplished by allowing the prosthetic limb to be properly aligned to enable the person to have a correct gait.
  • a still further goal of the present invention is to provide a prosthetic component that is strong enough to withstand daily stresses that it is subject to. This is accomplished in the preferred embodiments by having the body of the first piece rest on the wall or walls of the second piece to ensure proper alignment of the first piece central axis and the second piece central axis, and by having multiple screws to forceably keep the positioner within the opening.
  • FIG. 1 is an exploded side view of existing prosthetic components.
  • FIG. 2 is a top view of an existing rigid and offset four hole adapter.
  • FIG. 3 is a side view of an embodiment of the present invention.
  • FIG. 4 is an exploded side view of the embodiment shown in FIG. 3
  • FIG. 5 is a top view of an embodiment of a piece of the present invention.
  • FIG. 6 is a side view of the piece shown in FIG. 5 .
  • FIG. 7 is a bottom view of the piece shown in FIG. 5 .
  • FIG. 8 is a cross-sectional view of the piece shown in FIG. 5 taken along line 8 - 8 in FIG. 5 .
  • FIG. 9 is a top view of an embodiment of a second piece of the present invention.
  • FIG. 10 is a side view of the piece shown in FIG. 9 .
  • FIG. 11 is a cross-sectional view of the piece shown in FIG. 9 taken along line 11 - 11 in FIG. 9 .
  • FIG. 12 is a side view of an embodiment of the present invention similar to FIG. 3 , but instead showing the first piece and second piece in an offset alignment.
  • FIG. 13 is a cross-sectional view of the embodiment shown in FIG. 12 taken along line 13 - 13 in FIG. 12 .
  • FIG. 14 is a top view of the embodiment shown in FIG. 12 .
  • FIG. 15 is an exploded side view of an embodiment of the present invention in relation to other prosthetic components.
  • FIG. 16 is a side view of an embodiment of the present invention where the first and second pieces are offset to overcome a natural offset of the remainder of the prosthetic components.
  • FIG. 17 is a side view of an alternative embodiment of the present invention.
  • FIG. 18 is an exploded side view of the alternative embodiment shown in FIG. 17 .
  • FIG. 19 is a side view of a piece of the alternative embodiment shown in FIG. 17 .
  • FIG. 20 is a cross-sectional view of the piece shown in FIG. 19 taken along line 20 - 20 .
  • FIG. 21 is a bottom view of a second piece of the alternative embodiment shown in FIG. 17 .
  • FIG. 22 is a side view of the piece shown in FIG. 21 .
  • FIG. 23 is a cross-sectional view of the piece shown in FIG. 22 taken along line 23 - 23 .
  • FIG. 24 is a side view of the embodiment shown in FIG. 17 , but showing the first piece and second piece in an offset alignment.
  • FIG. 25 is cross-sectional view of the embodiment shown in FIG. 24 taken along line 25 - 25 .
  • FIG. 26 is a top view of the embodiment shown in FIG. 24 .
  • FIG. 27 is an exploded side view of an additional alternative embodiment of the present invention.
  • FIG. 28 a cross-sectional view of the piece shown in FIG. 27 taken along line 28 - 28 .
  • FIG. 29 is a bottom view of the second piece of the embodiment shown in FIG. 27 .
  • FIG. 30 is a cross-sectional view of the piece shown in FIG. 31 taken along line 30 - 30 .
  • a four hole alignable device 50 is provided.
  • the device, or prosthetic component is connectable to an adjacent prosthetic component, such as a socket 10 or a lower knee joint.
  • the device 50 is also connectable to a prosthetic component, such as a conventional pylon 25 or other type of component having a pyramidal receiver.
  • a prosthetic component such as a conventional pylon 25 or other type of component having a pyramidal receiver.
  • the four hole alignable device 50 of the present invention is preferably made of Titanium alloy. However, other materials may be used without departing from the broad aspects of the present invention.
  • the present invention is preferably made in a Computer Numerical Controlled machining process.
  • the four hole alignable device 50 is comprised of two major pieces 60 and 90 , respectively.
  • the first piece 60 is shown in further detail in FIGS. 5-8 .
  • the first piece 60 has a body 61 .
  • Body 61 is preferably a flat flange that lies in a plane and that is disk shaped.
  • Body 61 has a first side 65 and an opposed second side 75 .
  • a central axis 80 runs through the first piece in a direction generally perpendicular to the body 61 .
  • a positioner 66 is on the first side 65 of the body 61 .
  • the positioner 66 is preferably a protrusion that is formed integral with the first side.
  • the positioner 66 preferably has the shape of a four sided pyramid with faces 67 , 68 , 69 and 70 . Face 67 opposes face 69 , and face 68 opposed face 70 .
  • the pyramid has an outer surface that lies in a plane that is generally parallel to the plane of the body.
  • a dome 76 with a pyramid 77 is preferably on the second side 75 of the body 61 of the first piece 60 .
  • the dome 76 and pyramid 77 are preferably conventional in nature, and are adapted to be connected to an adjacent prosthetic component.
  • the dome 76 and pyramid 77 are formed integral with the body 61 . It is understood that an alternative connector can be used without departing from the broad aspects of the present invention.
  • the second piece 90 has a flange 91 .
  • the flange 91 is preferably flat, and lies in a plane.
  • the perimeter of the flange 91 is preferably square shaped.
  • Four walls 95 , 97 , 99 and 101 upstand from the flange 91 , preferably at the perimeter of the flange.
  • Wall 95 is opposed to wall 99
  • wall 97 is opposed to wall 101 .
  • the four walls 95 , 97 , 99 and 101 are preferably integral with the flange 91 and preferably each lie in a plane generally perpendicularly to the flange plane.
  • the walls 95 , 97 , 99 and 01 define an opening 110 , discussed in further detail below.
  • a central axis 120 extends through the second piece 90 .
  • the central axis 120 is generally perpendicular to the flange plane and generally parallel to plane of each wall 95 , 97 , 99 and 101 , respectively.
  • a hole 96 extends through wall 95 .
  • a second hole 98 extends through wall 97 .
  • a third hole 100 extends through wall 99 .
  • a fourth hole 102 extends through wall 101 .
  • Each hole 96 , 98 , 100 and 102 preferably has a respective hole axis that intersects the flange plane at a location inward of the respective wall, as best shown in FIG. 11 .
  • Holes 96 , 98 , 100 and 102 are adapted to receive screws 103 . The screws 103 can be selectively turned into or out of the respective holes 96 , 98 , 100 and 102 .
  • Holes 105 , 106 , 107 and 108 extend through the second piece 90 at the intersection of adjacent walls 95 , 97 , 99 and 101 .
  • Hole 105 is located at the intersection of walls 95 and 97 .
  • Hole 106 is located at the intersection of walls 97 and 99 .
  • Hole 107 is located at the intersection of walls 99 and 101 .
  • Hole 108 is located at the intersection of walls 101 and 95 .
  • the holes are generally perpendicular to the flange plane. The hole are preferably used to connect the second piece to an adjacent prosthetic component in the conventional manner.
  • the walls 95 , 97 , 99 and 101 define an opening 110 , as best shown in FIG. 9 .
  • the opening is preferably a square shaped opening, having a depth equal to the wall height.
  • the opening has four sides 111 , 112 , 113 and 114 .
  • Side 111 is comprised of the inside of wall 95 .
  • Side 112 is comprised of the inside of wall 97 .
  • Side 113 is comprised of the inside of wall 99 .
  • Side 114 is comprised of the inside of wall 101 .
  • Side 111 is opposed to side 113
  • side 112 is opposed to side 114 .
  • FIGS. 12-14 an example of the co-action between the first piece 60 and second piece 90 is shown.
  • the positioner 66 of the first piece 60 is received within the opening 110 of the second piece 90 .
  • the body 61 rests atop the top of the walls 95 , 97 , 99 and 101 .
  • Screws 103 received within walls 95 , 97 , 99 and 101 penetrate the opening 110 to engage the positioner 66 .
  • the screw 103 through hole 96 engages face 67 of the pyramidal positioner 66 .
  • Screw 103 through hole 98 engages face 68 of the pyramidal positioner 66 .
  • Screw 103 through hole 100 engages face 69 of the pyramidal positioner 66 .
  • Screw 103 through hole 102 engages face 70 of the pyramidal positioner 66 .
  • the walls 95 , 97 , 99 and 101 have a height that allows a screw 103 to penetrate the opening to engage the positioner to effectuate the maximum offset amount without contacting the flange 91 .
  • the central axis 80 of the first piece 60 and the central axis 120 of the second piece 90 can be offset by an offset amount beta.
  • the offset amount beta is comprised of any combination of components from the lateral or medial direction 15 or 16 , respectively, and from the anterior or posterior direction 17 or 18 , respectively. Described another way, the offset amount beta is comprised of a linear amount at a certain angle from the anterior direction 15 (or any other reference direction). Adjustment of the present invention to achieve a desired offset amount beta occurs at a single interface.
  • the central axis 80 of the first piece 60 and the central axis 120 of the second piece are generally parallel, even when offset by offset amount beta.
  • this parallel alignment is maintained and the overall component is structurally strengthened by having the body 61 of the first piece 60 rest atop the walls 95 , 97 , 99 and 101 of the second piece.
  • the body 61 is preferably a disk shaped flange to ensure that a large portion of the body 61 contacts the walls while also minimizing the overall weight of the component.
  • the preferred disk shape as shown in FIGS. 12 and 13 , also acts to prevent any screws 103 extending out from the second piece 90 from being hit, knocked or otherwise damaged.
  • the preferred geometry of the positioner 66 a pyramid, is shown being engaged by screws in FIG. 13 .
  • the screws 103 force the positioner 66 to remain within the opening due to the pyramidal geometry by forcing the body 61 to be more tightly held atop the walls 95 , 97 , 99 and 101 of the second piece 90 .
  • the tighter the screws 103 engage the positioner 66 the stronger the component 50 is and the greater the component's ability to maintain the preferred parallel alignment between the first piece central axis 80 and the second piece central axis 120 .
  • FIGS. 15 and 16 show one application of the present invention used to overcome an offset amount between a socket central axis 12 and the central axis of a component attached thereto by an offset amount delta. Even though FIG. 15 only shows two dimensions, the offset amount delta is comprised of a distance in both the lateral or medial direction 15 or 16 , respectively, and the anterior or posterior direction 17 or 18 , respectively. In FIG. 15 , the first piece 60 of the present invention is attached to the socket 10 .
  • the second piece 90 In order for the central axis 27 of the pylon 25 to be centrally aligned with the central axis 12 of the socket 10 , the second piece 90 must be offset from the first piece by an offset amount beta that is equal and opposite of the offset amount delta between the socket 10 and the first piece 60 .
  • Such adjustment is made at a single interface between the first piece 60 and the second piece 90 of the present invention. This is accomplished in the preferred embodiment by selectively positioning the positioner 66 within the opening 110 by selectively turning selected screws a selected amount into the opening 110 and turning the opposed screw a selected amount out of the wall to move or reposition the positioner to a selected orientation. This process can be enacted between both sides 111 and 113 and sides 112 and 114 to obtain the desired offset amount in both the lateral or medial direction 15 or 16 and the anterior or posterior direction 17 or 18 , respectively.
  • FIGS. 17-26 a second embodiment 150 is shown having two major pieces 160 and 190 , respectively.
  • the first piece 160 is shown in further detail in FIGS. 18-20 .
  • the first piece 160 has a body 161 .
  • Body 161 is preferably a flat flange that lies in a plane and that is disk shaped.
  • Body 161 has a first side 165 and an opposed second side 175 .
  • a central axis 185 runs through the first piece 160 in a direction generally perpendicular to the body 161 .
  • a positioner 166 is on the first side 165 of the body 161 .
  • the positioner 166 is preferably a protrusion that is formed integral with the first side.
  • the positioner 166 preferably has an inside surface 167 and an outside surface 168 .
  • the outside surface 168 has more than four faces 169 , and in a preferred embodiment has thirty-two faces.
  • Each face is generally planar, with a top at the flange, two sides and a bottom remote from the top.
  • the top, bottom and two sides define a generally rectangular face.
  • Each face is preferably angled approximately 7.5 degrees outward away from the central axis 185 .
  • a connector 176 is integral with the second side 175 of the flange.
  • the illustrated connector 176 is a receiver 177 .
  • the receiver 177 preferably has in inside 178 and an outside 179 . Holes 180 are through the receiver 177 between the inside 178 and outside 179 for receiving screws. The screws allow for a protrusion of an adjacent component to be locked within the receiver.
  • the second piece 190 has a body 191 shaped as a flange.
  • the flange 191 is preferably flat, and lies in a plane.
  • the perimeter of the flange 191 is preferably round shaped.
  • the flange 191 has a first side 195 and a second side 205 .
  • a receiver 196 is preferably integral with the first side 195 of the body 191 .
  • a preferred receiver 196 is a sidewall 197 that upstands from the flange 191 , preferably at the perimeter of the flange.
  • the wall 197 preferably lies in a plane generally perpendicularly to the flange plane.
  • the sidewall 197 has an inside surface 198 and an outside surface 199 .
  • the inside surface 198 preferably has a round geometry with a preferred diameter of approximately 1.5 inches, and defines the perimeter of an opening 203 .
  • the sidewall 197 terminates at an end that lies in a plane generally parallel to the flange 191 .
  • the opening preferably has a depth equal to the wall height, which is preferably 0.375 inches.
  • a central axis 215 extends through the second piece 190 .
  • the central axis 215 is generally perpendicular to the flange plane.
  • inside surface 198 can alternatively have more than four faces, thirty-two for example, rather than a generally round geometry without departing from the broad aspects of the present invention.
  • holes 200 are through the sidewall 197 .
  • six holes 200 extend through the circular sidewall 197 , and are spaced equidistant apart.
  • Each screw hole 200 preferably has an opposite hole half way around the inside perimeter of the opening 203 defined by in the inside surface 198 .
  • Screws 201 are provided for being received within the holes 200 for being selectively turned into or out of the holes.
  • Each hole preferably has a hole axis that is generally perpendicular to the sidewall and generally parallel to the flange 191 .
  • the second piece 190 also has a second side 205 .
  • a connector 206 is integral with the second side 205 of the flange.
  • the illustrated connector 206 is a receiver 207 .
  • the receiver 207 preferably has in inside 208 and an outside 209 . Holes 210 are through the receiver 207 between the inside 208 and outside 209 for receiving screws. The screws allow for a protrusion of an adjacent component to be locked within the receiver.
  • FIGS. 24-26 an example of the co-action between the first piece 160 and second piece 190 is shown.
  • the positioner 166 of the first piece 160 is received within the receiver opening 203 of the second piece 190 .
  • the body 161 rests atop the top of end of the sidewall 197 .
  • Screws 201 received within holes 200 though the sidewall 197 penetrate the opening 203 to engage the positioner 166 and lock it into place.
  • Opposed screws can be turned in or out, respectively, to lock the positioner 166 in its desired position.
  • the positioner 166 can fully move anywhere within the opening 203 defined by the inside surface 198 of the sidewall.
  • the screws 200 will not contact the flange 191 regardless of the location of the positioner 166 within the opening 203 .
  • the central axis 185 of the first piece 160 and the central axis 215 of the second piece 190 can be offset by an offset amount.
  • the offset amount beta is comprised of any combination of components from the lateral or medial direction 15 or 16 , respectively, and from the anterior or posterior direction 17 or 18 , respectively. Described another way, the offset amount is comprised of a linear amount at a certain angle from the anterior direction 15 (or any other reference direction). Adjustment of the present invention to achieve a desired offset amount beta occurs at a single interface.
  • the central axis 185 of the first piece 160 and the central axis 215 of the second piece 190 are generally parallel, even when offset by the offset amount. In the preferred embodiment, this parallel alignment is maintained and the overall component is structurally strengthened by having the body 161 of the first piece 160 rest atop the sidewall 197 of the second piece 190 .
  • the body 161 is preferably a disk shaped flange to ensure that a large portion of the body 161 contacts the sidewall 197 . It is further seen that the flange 161 of the first piece 160 is generally parallel to the flange 191 of the second piece 190 .
  • the positioner 166 is held in place in a selected rotatable orientation within the opening 203 of the second piece 190 .
  • the fist piece 160 can be rotated in increments less than 90 degrees relative the second piece 190 .
  • the pieces can be adjusted in increments at least as small as 11.25 degrees. It is appreciated that as the number of faces 169 increase, the size of the increments decreases while still maintaining a strong lock on the positioner.
  • the screws 201 are able to lock the positioner in place. It is found that three sets of opposing screws, six total, provides acceptable stability. However, it is understood that more or less screws 201 could be used without departing from the broad aspects of the present invention.
  • FIGS. 27-30 a third embodiment 250 is shown having two major pieces 260 and 290 , respectively.
  • the first piece 260 is shown in further detail in FIGS. 27-28 .
  • the first piece 260 has a body 261 .
  • Body 261 is preferably a flat flange that lies in a plane and that is disk shaped.
  • Body 261 has a first side 265 and an opposed second side 275 .
  • a central axis 285 runs through the first piece 260 in a direction generally perpendicular to the body 261 .
  • a positioner 266 is on the first side 265 of the body 261 .
  • the positioner 266 is preferably a protrusion that is formed integral with the first side.
  • the positioner 266 preferably has an inside surface 267 and an outside surface 268 .
  • the outside surface 168 has a preferably round perimeter dimension.
  • the outside surfaced 268 is preferably angled approximately 7.5 degrees outward away from the central axis 285 .
  • a connector 276 is integral with the second side 275 of the flange.
  • the illustrated connector 276 has a dome 277 and a pyramid 278 . Yet, it is understood that other connectors can be used without departing from the broad aspects of the present invention so long as is adapted to be connected to an adjacent prosthetic component.
  • the second piece 290 has a body 291 shaped as a flange.
  • the flange 291 is preferably flat, and lies in a plane.
  • the perimeter of the flange 291 is preferably square shaped.
  • the flange 291 has a first side 295 and a second side 305 .
  • a receiver 296 is preferably integral with the first side 295 of the body 291 .
  • a preferred receiver 296 is a sidewall 297 that upstands from the flange 291 , preferably at the perimeter of the flange.
  • the wall 297 has an end that preferably lies in a plane generally perpendicularly to the flange plane.
  • the sidewall 297 has an inside surface 298 and an outside surface 299 .
  • the outside surface 299 can have a generally square geometry.
  • the inside surface 298 preferably has a round geometry with a preferred diameter of approximately 1.5 inches, and defines the perimeter of an opening 303 .
  • the sidewall 297 terminates at an end that lies in a plane generally parallel to the flange 291 .
  • the opening preferably has a depth equal to the wall height, which is preferably 0.375 inches.
  • a central axis 315 extends through the second piece 290 .
  • the central axis 315 is generally perpendicular to the flange plane.
  • holes 300 are through the sidewall 297 .
  • four holes 300 extend through the sidewall 297 , and are spaced equidistant apart.
  • Each screw hole 300 preferably has an opposite hole half way around the inside perimeter of the opening 303 defined by in the inside surface 298 .
  • Screws 301 are provided for being received within the holes 300 for being selectively turned into or out of the holes.
  • the second piece 290 also has a second side 305 .
  • a connector 306 is integral with the second side 305 of the flange.
  • the illustrated connector 306 is a flat surface with four holes 307 there through forming a four-hole adapter. The holes are at the corners of the flange 261 and sidewall 297 .
  • the positioner 266 of the first piece 260 is received within the receiver opening 303 of the second piece 290 .
  • the body 261 rests atop the top of end of the sidewall 297 .
  • Screws received within holes 300 though the sidewall 297 penetrate the opening 303 to engage the positioner 266 and lock it into place.
  • Opposed screws can be turned in or out, respectively, to lock the positioner 266 in its desired position.
  • the positioner 266 can move anywhere within the opening 303 defined by the inside surface 298 of the sidewall. The screws will not contact the flange 291 regardless of the location of the positioner 266 within the opening 303 .
  • the central axis 285 of the first piece 260 and the central axis 315 of the second piece 290 can be offset by an offset amount.
  • the offset amount is comprised of any combination of components from the lateral or medial direction 15 or 16 , respectively, and from the anterior or posterior direction 17 or 18 , respectively. Described another way, the offset amount is comprised of a linear amount at a certain angle from the anterior direction 15 (or any other reference direction). Adjustment of the present invention to achieve a desired offset amount occurs at a single interface.
  • the central axis 285 of the first piece 260 and the central axis 315 of the second piece 290 are generally parallel, even when offset by the offset amount. In the preferred embodiment, this parallel alignment is maintained and the overall component is structurally strengthened by having the body 261 of the first piece 260 rest atop the sidewall 297 of the second piece 290 .
  • the body 261 is preferably a disk shaped flange to ensure that a large portion of the body 261 contacts the sidewall 297 .
  • the flange 261 of the first piece 260 is generally parallel to the flange 291 of the second piece 290 .
  • the positioner 266 is held in place in a selected rotatable orientation within the opening 303 of the second piece 290 .
  • the round outside surface 268 of the fist piece 260 can be rotated in infinitely small increments relative the second piece 290 .
  • the screws are able to lock the positioner 266 in place. It is found that four screws are able to provide acceptable stability. However, it is understood that more or less screws could be used without departing from the broad aspects of the present invention.

Abstract

The present invention relates to an offset alignment device that is adjustable in the lateral or medial direction, the anterior or posterior direction and rotatably adjustable at a single interface between the two pieces of the present invention. A first piece is provided having a body with a central axis. A positioner is on the first side of the body. A second piece is provided having a central axis and a flange. A side wall upstands from the flange to define an opening. The positioner can be selectably received within the opening while the central axis of the first piece remains parallel to the central axis of the second piece. The pieces are lockable in place with respect to each other at the selected offset alignment and rotational orientation.

Description

  • This application is a continuation in part application of pending United States patent application filed on Jun. 25, 2004 and having application Ser. No. 10/876,349, the contents of which are hereby incorporated herein by reference.
  • BACKGROUND OF THE INVENTION
  • 1. The present invention relates to an offset alignment device and more particularly an alignment device that is adjustable in both the lateral or medial direction and the anterior or posterior direction, and also rotatably connectable, at a single interface between the two pieces of the present invention.
  • 2. Description of the Related Art
  • Sometimes, due to accidents, health problems, birth defects, etc., people 5 need to have a limb 6 amputated. The amputated limb 6 terminates in a stump 7. In general, a prosthetic component such as a socket 10 can be formed for a particular stump 7. Sockets 10 are well known in the art, and each socket 10 has an end 11 and a central axis 12.
  • Fortunately for people requiring a prosthetic limb, much advancement has been made in the field of prosthetic limbs. Patients now have many choices, including endoskeletal and exoskeletal prosthetic limbs. The present invention relates to endoskeletal prosthetic limbs. That is, limbs comprised of structural components and an optional aesthetic outer shell.
  • Turning now to FIG. 1, the components of a typical prosthetic limb setup 30 are shown. A conventional four hole adapter 20 having a central axis 21 that runs centrally through the component is shown. In some situations, the four hole adapter 20 cannot be positioned centrally upon the socket 10. Even though the central axis 21 of the adapter 20 is parallel to the central axis 12 of the socket 10, it is offset there from. Specifically, the adapter central axis 21 can be offset from the socket central axis 12 in the lateral or medial direction 15 and 16 as well as in the anterior or posterior direction 18 or 19 by a total offset distance delta. A conventional pylon 25 with a fixed receiver 26 and central axis 27 is also provided. It is preferable that the pylon central axis 27 be centrally aligned with the socket central axis 12, to ensure maximum comfort and stability of the prosthetic limb. This alignment is further preferred because a person's gait may be adversely affected if the pylon central axis 27 is out of central alignment with the socket central axis 12 and the person may experience unnecessary muscle strain and fatigue. Yet, as shown, it can be impossible to achieve this preferred socket central axis 12 and pylon central axis 27 alignment when the conventional four hole adapter 20 is offset from the socket.
  • Similar problems also arise when the prosthetic components are attached to the lower knee joint (not shown) as opposed to a socket 10.
  • Turning now to FIG. 2, a modified four hole adapter 35 is shown. The adapter 35 is exemplary of the adapter shown in U.S. Pat. No. RE 36,521 to Hiemisch. The modified four hole adapter 35 has a pyramid with an alignment axis 36 running there through. Adapter 35 also has a central axis 37. The alignment axis 36 and central axis 37 are parallel and offset from one another by a fixed distance and orientation. The four holes are arranged in a square pattern, such that the adapter 35 can align with its adjacent component in one of four positions by rotating the adapter 35 around its central axis 37 in relation to the adjacent component. Therefore, the alignment axis 36 can be selectively oriented to one of four distinct orientations relative to the central axis or its adjacent component.
  • Even though the modified adapter 35 of the Hiemisch patent may work well for its intended purposes, it is not without drawbacks. For example, while the component is capable of being reoriented with respect to an adjacent component, there are only a limited number of possible orientations. Specifically, only four orientations are possible. Further, the adapter 35 is only useful when the offset amount delta is at an appropriate distance and angle from the socket central axis 12 in a plane defined by the lateral or medial direction 15 and 16 and the anterior or posterior direction 17 and 18. In many prosthetic limbs, the end of the socket 11 is not offset by an amount that can be overcome with adapter 35. Therefore, incorporation of the adapter 35 into the prosthetic limb may not work to fully realize its intended results.
  • A further existing product is made by Hosmer Dorrance Corporation under the name Spectrum Alignment System. To make adjustments in both the lateral or medial direction and also the anterior or posterior direction, a minimum of three major components is required. The first component is a four hole plate with a male dovetail protruding there from along a first axis. The second component is an adapter with a female dovetail receiver for mating with the male dovetail of the first component, and with a male dovetail that is on the opposed side of the adapter and that is aligned generally perpendicular to the female dovetail receiver. The third component has a female dovetail receiver on its first side for mating with the male dovetail of the second component and a standard pyramid on the opposed side.
  • To make adjustments with the Spectrum Alignment System, side shift screws are provided. Each side shift screw has a head with a rib that rests in a groove in the female dovetail section. The threaded end of the screw is received within a hole in the male dovetail section. The screw head remains laterally stationary relative to the female dovetail section as the screw is twisted. However, the male dovetail section translates towards or away from the screw head as the screw is twisted, depending on which way the screw is twisted. Three screws and ball bearings are shown to guide the male end within the female end. The ball bearings are anti-friction devices that reduce friction between the female and male dovetail sections, which encourage movement of the male end within the female end when the side shift screw is twisted.
  • The structural integrity of the dovetail connection is determined solely by the strength of the ribs on the screw head. If the screw head fails, the entire component could fail. These components may therefore be less than optimally strong. Also, given that three components are necessary to effectuate the intended adjustment, this system is undesirably overly complicated.
  • A still further existing system is shown in U.S. Pat. No. 5,549,710 to Vera et al. This patent is entitled system for assembling two components of a prosthesis in a plurality of adjustable positions. The Vera system has a projecting part integral with one of the components, and a hollow part formed into the second component. As shown in FIGS. 2 and 3 of the Vera patent, the projecting part of the first component is not able to fully move within the hollow part of the second component. This is because the screws would engage the base of the hollow part instead of the lateral flanks of the projecting part after the projecting part moves a short distance from center and prior to the projecting part moving near the side walls of the hollow part. Further, an embodiment is shown where the projecting part can be twisted and held in place with a screw, as shown in FIG. 11. Such an arrangement is less structurally secure than an integrally formed component.
  • A still further device yet is shown in UK patent application 2,141,345 with applicant Landstingens Inkopscentral LIC (Sweden) entitled “An adjustable connection for connecting adjoining parts of an artificial limb.” Screws are provided for locking first and second coupling components together. The first and second coupling components bear directly against each other along mutually co-acting support surfaces. The screws are arranged in an annular flange one element that encircles the other coupling element. Yet, the annular flange does not directly contact the second coupling element.
  • Thus there exists a need for an offset alignment device that solves these and other problems.
  • SUMMARY OF THE INVENTION
  • The present invention relates to an offset alignment device that is adjustable in the lateral or medial direction and the anterior or posterior direction, and is also rotatably connectable, at a single interface between the two pieces of the present invention.
  • This is accomplished in one embodiment by providing a first piece having a body with a central axis through the body. The body has two sides. A positioner is on the first side of the body. A dome with a pyramid is on the second side of the body. A second piece, having a central axis and a flange is also provided. Four walls upstand from the flange to define an opening.
  • The first and second pieces of the present invention are selectably offsetable at a single interface in both the lateral or medial direction and in the anterior or posterior direction. The first piece and second piece co-act so that the positioner can be selectably received and positioned within the opening. The body of the first piece rests on the top of the walls of the second piece to provide stability and ensure that the central axis of the first piece remains parallel to the central axis of the second piece.
  • In a second embodiment, the positioner has more than four faces so that the first piece can be rotated and locked in place relative to the second piece in less than ninety degree increments. In a third embodiment, the positioner has a generally round profile so that the first piece can be rotated and locked in place relative to the second piece in an infinite number of positions.
  • It is a goal of the present invention to have only limited complexity. This is accomplished by having only two major pieces that are adjustable in both the lateral or medial direction and the anterior or posterior direction at a single interface.
  • It is a further goal of the present invention to have a prosthetic component that is precisely adjustable. This is accomplished by incorporating screws in the preferred embodiment that can precisely adjust alignment of the pieces in both the lateral or medial direction and in the anterior or posterior direction, and also by allowing one piece to be rotatably lockable relative to the second piece.
  • A further goal of the present invention is to provide maximum comfort and stability to a person with a prosthetic limb. This is accomplished by allowing the prosthetic limb to be properly aligned to enable the person to have a correct gait.
  • A still further goal of the present invention is to provide a prosthetic component that is strong enough to withstand daily stresses that it is subject to. This is accomplished in the preferred embodiments by having the body of the first piece rest on the wall or walls of the second piece to ensure proper alignment of the first piece central axis and the second piece central axis, and by having multiple screws to forceably keep the positioner within the opening.
  • It is a goal of some embodiments of the present invention to allow the first component to be rotated relative to the second component in less than ninety degree increments, and in some embodiments an infinite number of increments.
  • Other advantages, benefits, and features of the present invention will become apparent to those skilled in the art upon reading the detailed description of the invention and studying the drawings.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 is an exploded side view of existing prosthetic components.
  • FIG. 2 is a top view of an existing rigid and offset four hole adapter.
  • FIG. 3 is a side view of an embodiment of the present invention.
  • FIG. 4 is an exploded side view of the embodiment shown in FIG. 3
  • FIG. 5 is a top view of an embodiment of a piece of the present invention.
  • FIG. 6 is a side view of the piece shown in FIG. 5.
  • FIG. 7 is a bottom view of the piece shown in FIG. 5.
  • FIG. 8 is a cross-sectional view of the piece shown in FIG. 5 taken along line 8-8 in FIG. 5.
  • FIG. 9 is a top view of an embodiment of a second piece of the present invention.
  • FIG. 10 is a side view of the piece shown in FIG. 9.
  • FIG. 11 is a cross-sectional view of the piece shown in FIG. 9 taken along line 11-11 in FIG. 9.
  • FIG. 12 is a side view of an embodiment of the present invention similar to FIG. 3, but instead showing the first piece and second piece in an offset alignment.
  • FIG. 13 is a cross-sectional view of the embodiment shown in FIG. 12 taken along line 13-13 in FIG. 12.
  • FIG. 14 is a top view of the embodiment shown in FIG. 12.
  • FIG. 15 is an exploded side view of an embodiment of the present invention in relation to other prosthetic components.
  • FIG. 16 is a side view of an embodiment of the present invention where the first and second pieces are offset to overcome a natural offset of the remainder of the prosthetic components.
  • FIG. 17 is a side view of an alternative embodiment of the present invention.
  • FIG. 18 is an exploded side view of the alternative embodiment shown in FIG. 17.
  • FIG. 19 is a side view of a piece of the alternative embodiment shown in FIG. 17.
  • FIG. 20 is a cross-sectional view of the piece shown in FIG. 19 taken along line 20-20.
  • FIG. 21 is a bottom view of a second piece of the alternative embodiment shown in FIG. 17.
  • FIG. 22 is a side view of the piece shown in FIG. 21.
  • FIG. 23 is a cross-sectional view of the piece shown in FIG. 22 taken along line 23-23.
  • FIG. 24 is a side view of the embodiment shown in FIG. 17, but showing the first piece and second piece in an offset alignment.
  • FIG. 25 is cross-sectional view of the embodiment shown in FIG. 24 taken along line 25-25.
  • FIG. 26 is a top view of the embodiment shown in FIG. 24.
  • FIG. 27 is an exploded side view of an additional alternative embodiment of the present invention.
  • FIG. 28 a cross-sectional view of the piece shown in FIG. 27 taken along line 28-28.
  • FIG. 29 is a bottom view of the second piece of the embodiment shown in FIG. 27.
  • FIG. 30 is a cross-sectional view of the piece shown in FIG. 31 taken along line 30-30.
  • DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
  • While the invention will be described in connection with several preferred embodiments, it will be understood that it is not intended to limit the invention to those embodiments. On the contrary, it is intended to cover all alternatives, modifications and equivalents as may be included within the spirit and scope of the invention as defined by the appended claims.
  • According to one embodiment of the present invention, a four hole alignable device 50 is provided. The device, or prosthetic component, is connectable to an adjacent prosthetic component, such as a socket 10 or a lower knee joint. The device 50 is also connectable to a prosthetic component, such as a conventional pylon 25 or other type of component having a pyramidal receiver. However, it will be understood that these adjacent prosthetic components are exemplary in nature, and that the present invention is not limited for use therewith. The four hole alignable device 50 of the present invention is preferably made of Titanium alloy. However, other materials may be used without departing from the broad aspects of the present invention. The present invention is preferably made in a Computer Numerical Controlled machining process.
  • Turning now to FIGS. 3 and 4, it is shown that the four hole alignable device 50 is comprised of two major pieces 60 and 90, respectively.
  • The first piece 60, or component, is shown in further detail in FIGS. 5-8. The first piece 60 has a body 61. Body 61 is preferably a flat flange that lies in a plane and that is disk shaped. Body 61 has a first side 65 and an opposed second side 75. A central axis 80 runs through the first piece in a direction generally perpendicular to the body 61.
  • A positioner 66 is on the first side 65 of the body 61. The positioner 66 is preferably a protrusion that is formed integral with the first side. Further, the positioner 66 preferably has the shape of a four sided pyramid with faces 67, 68, 69 and 70. Face 67 opposes face 69, and face 68 opposed face 70. The pyramid has an outer surface that lies in a plane that is generally parallel to the plane of the body.
  • A dome 76 with a pyramid 77 is preferably on the second side 75 of the body 61 of the first piece 60. The dome 76 and pyramid 77 are preferably conventional in nature, and are adapted to be connected to an adjacent prosthetic component. In the preferred embodiment, the dome 76 and pyramid 77 are formed integral with the body 61. It is understood that an alternative connector can be used without departing from the broad aspects of the present invention.
  • Turning now to FIGS. 9-11, a second piece 90 is shown in further detail. The second piece 90, or component, has a flange 91. The flange 91 is preferably flat, and lies in a plane. The perimeter of the flange 91 is preferably square shaped. Four walls 95, 97, 99 and 101 upstand from the flange 91, preferably at the perimeter of the flange. Wall 95 is opposed to wall 99, and wall 97 is opposed to wall 101. The four walls 95, 97, 99 and 101 are preferably integral with the flange 91 and preferably each lie in a plane generally perpendicularly to the flange plane. The walls 95, 97, 99 and 01 define an opening 110, discussed in further detail below. A central axis 120 extends through the second piece 90. The central axis 120 is generally perpendicular to the flange plane and generally parallel to plane of each wall 95, 97, 99 and 101, respectively.
  • A hole 96 extends through wall 95. A second hole 98 extends through wall 97. A third hole 100 extends through wall 99. A fourth hole 102 extends through wall 101. Each hole 96, 98, 100 and 102 preferably has a respective hole axis that intersects the flange plane at a location inward of the respective wall, as best shown in FIG. 11. Holes 96, 98, 100 and 102 are adapted to receive screws 103. The screws 103 can be selectively turned into or out of the respective holes 96, 98, 100 and 102.
  • Holes 105, 106, 107 and 108 extend through the second piece 90 at the intersection of adjacent walls 95, 97, 99 and 101. Hole 105 is located at the intersection of walls 95 and 97. Hole 106 is located at the intersection of walls 97 and 99. Hole 107 is located at the intersection of walls 99 and 101. Hole 108 is located at the intersection of walls 101 and 95. The holes are generally perpendicular to the flange plane. The hole are preferably used to connect the second piece to an adjacent prosthetic component in the conventional manner.
  • The walls 95, 97, 99 and 101 define an opening 110, as best shown in FIG. 9. The opening is preferably a square shaped opening, having a depth equal to the wall height. The opening has four sides 111, 112, 113 and 114. Side 111 is comprised of the inside of wall 95. Side 112 is comprised of the inside of wall 97. Side 113 is comprised of the inside of wall 99. Side 114 is comprised of the inside of wall 101. Side 111 is opposed to side 113, and side 112 is opposed to side 114.
  • It is understood that there may be a different number of walls upstanding from the flange. Specifically, there may be three walls that form a triangular opening. There may also be more than four walls. Further, there may be only one circular wall. Yet, it has been found that having four walls defining a square opening allows for the preferable combination of high adjustability with minimal weight.
  • Turning now to FIGS. 12-14, an example of the co-action between the first piece 60 and second piece 90 is shown. The positioner 66 of the first piece 60 is received within the opening 110 of the second piece 90. The body 61 rests atop the top of the walls 95, 97, 99 and 101. Screws 103 received within walls 95, 97, 99 and 101 penetrate the opening 110 to engage the positioner 66. In the preferred embodiment shown, the screw 103 through hole 96 engages face 67 of the pyramidal positioner 66. Screw 103 through hole 98 engages face 68 of the pyramidal positioner 66. Screw 103 through hole 100 engages face 69 of the pyramidal positioner 66. Screw 103 through hole 102 engages face 70 of the pyramidal positioner 66. The walls 95, 97, 99 and 101 have a height that allows a screw 103 to penetrate the opening to engage the positioner to effectuate the maximum offset amount without contacting the flange 91.
  • The central axis 80 of the first piece 60 and the central axis 120 of the second piece 90 can be offset by an offset amount beta. The offset amount beta is comprised of any combination of components from the lateral or medial direction 15 or 16, respectively, and from the anterior or posterior direction 17 or 18, respectively. Described another way, the offset amount beta is comprised of a linear amount at a certain angle from the anterior direction 15 (or any other reference direction). Adjustment of the present invention to achieve a desired offset amount beta occurs at a single interface.
  • It is further seen that the central axis 80 of the first piece 60 and the central axis 120 of the second piece are generally parallel, even when offset by offset amount beta. In the preferred embodiment, this parallel alignment is maintained and the overall component is structurally strengthened by having the body 61 of the first piece 60 rest atop the walls 95, 97, 99 and 101 of the second piece. The body 61 is preferably a disk shaped flange to ensure that a large portion of the body 61 contacts the walls while also minimizing the overall weight of the component. The preferred disk shape, as shown in FIGS. 12 and 13, also acts to prevent any screws 103 extending out from the second piece 90 from being hit, knocked or otherwise damaged.
  • The preferred geometry of the positioner 66, a pyramid, is shown being engaged by screws in FIG. 13. The screws 103 force the positioner 66 to remain within the opening due to the pyramidal geometry by forcing the body 61 to be more tightly held atop the walls 95, 97, 99 and 101 of the second piece 90. The tighter the screws 103 engage the positioner 66, the stronger the component 50 is and the greater the component's ability to maintain the preferred parallel alignment between the first piece central axis 80 and the second piece central axis 120.
  • FIGS. 15 and 16 show one application of the present invention used to overcome an offset amount between a socket central axis 12 and the central axis of a component attached thereto by an offset amount delta. Even though FIG. 15 only shows two dimensions, the offset amount delta is comprised of a distance in both the lateral or medial direction 15 or 16, respectively, and the anterior or posterior direction 17 or 18, respectively. In FIG. 15, the first piece 60 of the present invention is attached to the socket 10.
  • In order for the central axis 27 of the pylon 25 to be centrally aligned with the central axis 12 of the socket 10, the second piece 90 must be offset from the first piece by an offset amount beta that is equal and opposite of the offset amount delta between the socket 10 and the first piece 60.
  • Such adjustment is made at a single interface between the first piece 60 and the second piece 90 of the present invention. This is accomplished in the preferred embodiment by selectively positioning the positioner 66 within the opening 110 by selectively turning selected screws a selected amount into the opening 110 and turning the opposed screw a selected amount out of the wall to move or reposition the positioner to a selected orientation. This process can be enacted between both sides 111 and 113 and sides 112 and 114 to obtain the desired offset amount in both the lateral or medial direction 15 or 16 and the anterior or posterior direction 17 or 18, respectively.
  • Turning now to FIGS. 17-26, a second embodiment 150 is shown having two major pieces 160 and 190, respectively.
  • The first piece 160, or component, is shown in further detail in FIGS. 18-20. The first piece 160 has a body 161. Body 161 is preferably a flat flange that lies in a plane and that is disk shaped. Body 161 has a first side 165 and an opposed second side 175. A central axis 185 runs through the first piece 160 in a direction generally perpendicular to the body 161.
  • A positioner 166 is on the first side 165 of the body 161. The positioner 166 is preferably a protrusion that is formed integral with the first side. Further, the positioner 166 preferably has an inside surface 167 and an outside surface 168. The outside surface 168 has more than four faces 169, and in a preferred embodiment has thirty-two faces. Each face is generally planar, with a top at the flange, two sides and a bottom remote from the top. The top, bottom and two sides define a generally rectangular face. Each face is preferably angled approximately 7.5 degrees outward away from the central axis 185.
  • A connector 176 is integral with the second side 175 of the flange. The illustrated connector 176 is a receiver 177. Yet, it is understood that other connectors can be used without departing from the broad aspects of the present invention so long as is adapted to be connected to an adjacent prosthetic component. The receiver 177 preferably has in inside 178 and an outside 179. Holes 180 are through the receiver 177 between the inside 178 and outside 179 for receiving screws. The screws allow for a protrusion of an adjacent component to be locked within the receiver.
  • Turning now to FIGS. 21-23, a second piece 190 is shown in further detail. The second piece 190, or component, has a body 191 shaped as a flange. The flange 191 is preferably flat, and lies in a plane. The perimeter of the flange 191 is preferably round shaped. The flange 191 has a first side 195 and a second side 205.
  • A receiver 196 is preferably integral with the first side 195 of the body 191. A preferred receiver 196 is a sidewall 197 that upstands from the flange 191, preferably at the perimeter of the flange. The wall 197 preferably lies in a plane generally perpendicularly to the flange plane. The sidewall 197 has an inside surface 198 and an outside surface 199. The inside surface 198 preferably has a round geometry with a preferred diameter of approximately 1.5 inches, and defines the perimeter of an opening 203. The sidewall 197 terminates at an end that lies in a plane generally parallel to the flange 191. The opening preferably has a depth equal to the wall height, which is preferably 0.375 inches. A central axis 215 extends through the second piece 190. The central axis 215 is generally perpendicular to the flange plane.
  • It is understood that the inside surface 198 can alternatively have more than four faces, thirty-two for example, rather than a generally round geometry without departing from the broad aspects of the present invention.
  • Several holes 200 are through the sidewall 197. Preferably, six holes 200 extend through the circular sidewall 197, and are spaced equidistant apart. Each screw hole 200 preferably has an opposite hole half way around the inside perimeter of the opening 203 defined by in the inside surface 198. Screws 201 are provided for being received within the holes 200 for being selectively turned into or out of the holes. Each hole preferably has a hole axis that is generally perpendicular to the sidewall and generally parallel to the flange 191.
  • The second piece 190 also has a second side 205. A connector 206 is integral with the second side 205 of the flange. The illustrated connector 206 is a receiver 207. Yet, it is understood that other connectors can be used without departing from the broad aspects of the present invention so long as is adapted to be connected to an adjacent prosthetic component. The receiver 207 preferably has in inside 208 and an outside 209. Holes 210 are through the receiver 207 between the inside 208 and outside 209 for receiving screws. The screws allow for a protrusion of an adjacent component to be locked within the receiver.
  • Turning now to FIGS. 24-26, an example of the co-action between the first piece 160 and second piece 190 is shown. The positioner 166 of the first piece 160 is received within the receiver opening 203 of the second piece 190. The body 161 rests atop the top of end of the sidewall 197. Screws 201 received within holes 200 though the sidewall 197 penetrate the opening 203 to engage the positioner 166 and lock it into place. Opposed screws can be turned in or out, respectively, to lock the positioner 166 in its desired position. The positioner 166 can fully move anywhere within the opening 203 defined by the inside surface 198 of the sidewall. The screws 200 will not contact the flange 191 regardless of the location of the positioner 166 within the opening 203.
  • The central axis 185 of the first piece 160 and the central axis 215 of the second piece 190 can be offset by an offset amount. The offset amount beta is comprised of any combination of components from the lateral or medial direction 15 or 16, respectively, and from the anterior or posterior direction 17 or 18, respectively. Described another way, the offset amount is comprised of a linear amount at a certain angle from the anterior direction 15 (or any other reference direction). Adjustment of the present invention to achieve a desired offset amount beta occurs at a single interface.
  • It is further seen that the central axis 185 of the first piece 160 and the central axis 215 of the second piece 190 are generally parallel, even when offset by the offset amount. In the preferred embodiment, this parallel alignment is maintained and the overall component is structurally strengthened by having the body 161 of the first piece 160 rest atop the sidewall 197 of the second piece 190. The body 161 is preferably a disk shaped flange to ensure that a large portion of the body 161 contacts the sidewall 197. It is further seen that the flange 161 of the first piece 160 is generally parallel to the flange 191 of the second piece 190.
  • The positioner 166 is held in place in a selected rotatable orientation within the opening 203 of the second piece 190. By having more than four faces 169, the fist piece 160 can be rotated in increments less than 90 degrees relative the second piece 190. With preferably thirty-two faces, the pieces can be adjusted in increments at least as small as 11.25 degrees. It is appreciated that as the number of faces 169 increase, the size of the increments decreases while still maintaining a strong lock on the positioner. Regardless of the rotational orientation of the positioner 166 within the opening 203, the screws 201 are able to lock the positioner in place. It is found that three sets of opposing screws, six total, provides acceptable stability. However, it is understood that more or less screws 201 could be used without departing from the broad aspects of the present invention.
  • It is appreciated that the lateral-medial, anterior-posterior, and rotational adjustments are made at a single interface between the first and second pieces, 160 and 190, respectively.
  • Turning now to FIGS. 27-30, a third embodiment 250 is shown having two major pieces 260 and 290, respectively.
  • The first piece 260, or component, is shown in further detail in FIGS. 27-28. The first piece 260 has a body 261. Body 261 is preferably a flat flange that lies in a plane and that is disk shaped. Body 261 has a first side 265 and an opposed second side 275. A central axis 285 runs through the first piece 260 in a direction generally perpendicular to the body 261.
  • A positioner 266 is on the first side 265 of the body 261. The positioner 266 is preferably a protrusion that is formed integral with the first side. Further, the positioner 266 preferably has an inside surface 267 and an outside surface 268. The outside surface 168 has a preferably round perimeter dimension. The outside surfaced 268 is preferably angled approximately 7.5 degrees outward away from the central axis 285.
  • A connector 276 is integral with the second side 275 of the flange. The illustrated connector 276 has a dome 277 and a pyramid 278. Yet, it is understood that other connectors can be used without departing from the broad aspects of the present invention so long as is adapted to be connected to an adjacent prosthetic component.
  • Turning now to FIGS. 29 and 30, a second piece 290 is shown in further detail. The second piece 290, or component, has a body 291 shaped as a flange. The flange 291 is preferably flat, and lies in a plane. The perimeter of the flange 291 is preferably square shaped. The flange 291 has a first side 295 and a second side 305.
  • A receiver 296 is preferably integral with the first side 295 of the body 291. A preferred receiver 296 is a sidewall 297 that upstands from the flange 291, preferably at the perimeter of the flange. The wall 297 has an end that preferably lies in a plane generally perpendicularly to the flange plane. The sidewall 297 has an inside surface 298 and an outside surface 299. The outside surface 299 can have a generally square geometry. The inside surface 298 preferably has a round geometry with a preferred diameter of approximately 1.5 inches, and defines the perimeter of an opening 303. The sidewall 297 terminates at an end that lies in a plane generally parallel to the flange 291. The opening preferably has a depth equal to the wall height, which is preferably 0.375 inches. A central axis 315 extends through the second piece 290. The central axis 315 is generally perpendicular to the flange plane.
  • Several holes 300 are through the sidewall 297. Preferably, four holes 300 extend through the sidewall 297, and are spaced equidistant apart. Each screw hole 300 preferably has an opposite hole half way around the inside perimeter of the opening 303 defined by in the inside surface 298. Screws 301 are provided for being received within the holes 300 for being selectively turned into or out of the holes.
  • The second piece 290 also has a second side 305. A connector 306 is integral with the second side 305 of the flange. The illustrated connector 306 is a flat surface with four holes 307 there through forming a four-hole adapter. The holes are at the corners of the flange 261 and sidewall 297.
  • The positioner 266 of the first piece 260 is received within the receiver opening 303 of the second piece 290. The body 261 rests atop the top of end of the sidewall 297. Screws received within holes 300 though the sidewall 297 penetrate the opening 303 to engage the positioner 266 and lock it into place. Opposed screws can be turned in or out, respectively, to lock the positioner 266 in its desired position. The positioner 266 can move anywhere within the opening 303 defined by the inside surface 298 of the sidewall. The screws will not contact the flange 291 regardless of the location of the positioner 266 within the opening 303.
  • The central axis 285 of the first piece 260 and the central axis 315 of the second piece 290 can be offset by an offset amount. The offset amount is comprised of any combination of components from the lateral or medial direction 15 or 16, respectively, and from the anterior or posterior direction 17 or 18, respectively. Described another way, the offset amount is comprised of a linear amount at a certain angle from the anterior direction 15 (or any other reference direction). Adjustment of the present invention to achieve a desired offset amount occurs at a single interface.
  • It is further seen that the central axis 285 of the first piece 260 and the central axis 315 of the second piece 290 are generally parallel, even when offset by the offset amount. In the preferred embodiment, this parallel alignment is maintained and the overall component is structurally strengthened by having the body 261 of the first piece 260 rest atop the sidewall 297 of the second piece 290. The body 261 is preferably a disk shaped flange to ensure that a large portion of the body 261 contacts the sidewall 297. It is further seen that the flange 261 of the first piece 260 is generally parallel to the flange 291 of the second piece 290.
  • The positioner 266 is held in place in a selected rotatable orientation within the opening 303 of the second piece 290. The round outside surface 268 of the fist piece 260 can be rotated in infinitely small increments relative the second piece 290. Regardless of the rotational orientation of the positioner 266 within the opening 303, the screws are able to lock the positioner 266 in place. It is found that four screws are able to provide acceptable stability. However, it is understood that more or less screws could be used without departing from the broad aspects of the present invention.
  • It is appreciated that the lateral-medial, anterior-posterior, and rotational adjustments are made at a single interface between the first and second pieces, 260 and 290, respectively.
  • Thus it is apparent that there has been provided, in accordance with the invention, a four hole offset alignment device that fully satisfies the objects, aims and advantages as set forth above. While the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art in light of the foregoing description. Accordingly, it is intended to embrace all such alternatives, modifications, and variations as fall within the spirit and broad scope of the appended claims.

Claims (20)

1. A prosthetic device comprising:
a first piece having a central axis and comprising:
a flange with a first side and a second side;
a positioner integral with said first side of said flange, said positioner having an outside surface with a perimeter geometry with one of more than four faces and round and having a positioner size; and
a connector on said second side of said body for connecting said first piece to a first prosthetic component, and
a second piece connectable to a second prosthetic component, said second piece having a central axis and comprising:
a flange lying in a plane; and
a sidewall upstanding from said flange, said sidewall defining an opening for receiving said positioner, said opening having an opening size larger than said positioner size,
wherein said flange of said first piece contacts said sidewall of said second piece when said positioner is received within said opening, and
wherein with respect to said second piece, said first piece is selectively and adjustable in all directions within said opening while maintaining a parallel relationship of said central axis of said first piece and said central axis of said second piece, and also rotatably adjustable at increments less than 90 degrees.
2. The prosthetic device of claim 1 wherein said outside surface of said positioner is comprised of more than four faces.
3. The prosthetic device of claim 2 wherein said outside surface of said positioner is comprised of thirty-two faces.
4. The prosthetic device of claim 1 wherein said outside surface of said positioner is comprised of a round face.
5. The prosthetic device of claim 1 wherein said positioner has an inside surface defining a hollow portion of said positioner.
6. The prosthetic device of claim 1 wherein said sidewall has a generally round interior dimension.
7. The prosthetic device of claim 6 wherein said sidewall has six holes therethrough for receiving screws to lock said positioner within said opening.
8. The prosthetic device of claim 1 wherein said flange of said first piece is generally parallel to said flange of said second piece.
9. A prosthetic device comprising:
a first piece having a central axis and comprising:
a flange with a first side and a second side and defining a plane;
a positioner integral with said first side of said flange, said positioner having a positioner geometry with one of more than four faces and round and having a positioner size; and
a connector on said second side of said body for connecting said first piece to a first prosthetic component, and
a second piece connectable to a second prosthetic component, said second piece having a central axis and comprising:
a flange lying in a plane; and
a sidewall upstanding from said flange, said sidewall defining an opening for receiving said positioner, said opening having an opening size larger than said positioner size,
wherein said flange of said first piece contacts said sidewall of said second piece when said positioner is received within said opening, and
wherein with respect to said second piece, said first piece is selectively and adjustable in all directions within said opening and rotatably adjustable at increments less than 90 degrees, and said plane of said flange of said first piece remains generally parallel to and equally offset from said flange of said second piece during said adjustments.
10. The prosthetic device of claim 9 wherein said outside surface of said positioner is comprised of more than four faces.
11. The prosthetic device of claim 10 wherein said outside surface of said positioner is comprised of thirty-two faces.
12. The prosthetic device of claim 9 wherein said outside surface of said positioner is comprised of a round face.
13. The prosthetic device of claim 9 wherein said positioner has an inside surface defining a hollow portion of said positioner.
14. The prosthetic device of claim 9 wherein said sidewall has a generally round interior dimension.
15. The prosthetic device of claim 14 wherein said sidewall has six holes therethrough for receiving screws to lock said positioner within said opening.
16. The prosthetic device of claim 9 wherein said flange of said first piece is generally parallel to said flange of said second piece.
17. A prosthetic device comprising:
a first piece having a central axis and comprising:
a flange with a first side and a second side and defining a plane;
a positioner integral with said first side of said flange, said positioner having an external surface with more than four faces along an external perimeter; and
a connector on said second side of said body for connecting said first piece to a first prosthetic component, and
a second piece connectable to a second prosthetic component, said second piece having a central axis and comprising:
a flange lying in a plane; and
a sidewall upstanding from said flange, said sidewall defining an opening for receiving said positioner, said opening having an opening size larger than said external perimeter of said positioner,
wherein said flange of said first piece contacts said sidewall of said second piece when said positioner is received within said opening, and
wherein with respect to said second piece, said first piece is selectively and adjustable in all directions within said opening and rotatably adjustable at increments less than 90 degrees, and said plane of said flange of said first piece remains generally parallel to and equally offset from said flange of said second piece during said adjustments.
18. The prosthetic device of claim 17 wherein said positioner has thirty-two faces.
19. The prosthetic device of claim 18 wherein said positioner has an interior surface defining a hollow interior of said positioner.
20. The prosthetic device of claim 17 wherein said sidewall has six holes therethrough for receiving screws to lock said positioner within said opening.
US11/504,906 2004-06-25 2006-08-16 Offset alignment device Abandoned US20060276911A1 (en)

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US11/504,906 US20060276911A1 (en) 2004-06-25 2006-08-16 Offset alignment device
US29/331,387 USD620594S1 (en) 2004-06-25 2009-01-24 Offset alignment device

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US10/876,349 US7267695B2 (en) 2004-06-25 2004-06-25 Four hole offset alignment device
US11/504,906 US20060276911A1 (en) 2004-06-25 2006-08-16 Offset alignment device

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US29/331,387 Continuation-In-Part USD620594S1 (en) 2004-06-25 2009-01-24 Offset alignment device

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US20090093813A1 (en) * 2007-10-04 2009-04-09 Ebi, L.P. Alignment device for locking nail
US20100036506A1 (en) * 2008-08-08 2010-02-11 Ya-Ping Wang Position Deviation Adjustment Apparatus For Prosthesis
US20100061796A1 (en) * 2006-09-22 2010-03-11 Medi GmbH & Co., KG Rotatable connection adapter

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USD733884S1 (en) * 2012-05-11 2015-07-07 Otto Bock Healthcare Gmbh Adjustable adapter
US20140005801A1 (en) * 2012-06-27 2014-01-02 Ossur Hf Alignment adapter for prosthetic sport feet
EP2866747B1 (en) 2012-06-28 2017-02-22 Össur HF Adjustable prosthetic limb system
US9962273B2 (en) 2015-05-13 2018-05-08 Ossur Iceland Ehf Adjustable socket system
US10779962B2 (en) * 2016-03-02 2020-09-22 Amputech Shower-safe base foot
WO2018144973A1 (en) 2017-02-06 2018-08-09 Ossur Iceland Ehf Adjustable socket system
US11419740B2 (en) 2017-02-06 2022-08-23 Ossur Iceland Ehf Adjustable socket system
US10940028B2 (en) 2017-02-06 2021-03-09 Ossur Iceland Ehf Adjustable socket system
EP3813736B1 (en) * 2018-06-26 2024-03-13 Ossur Iceland EHF Adjustable socket system
WO2022051251A1 (en) 2020-09-04 2022-03-10 Ossur Iceland Ehf Interchangeable distal end for a prosthetic socket system

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US5290313A (en) * 1992-11-23 1994-03-01 Zimmer, Inc. Offset prosthetic stem extension
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US20100061796A1 (en) * 2006-09-22 2010-03-11 Medi GmbH & Co., KG Rotatable connection adapter
US20090093813A1 (en) * 2007-10-04 2009-04-09 Ebi, L.P. Alignment device for locking nail
US8273091B2 (en) * 2007-10-04 2012-09-25 Ebi, Llc Alignment device for locking nail
US20100036506A1 (en) * 2008-08-08 2010-02-11 Ya-Ping Wang Position Deviation Adjustment Apparatus For Prosthesis

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WO2006004666A2 (en) 2006-01-12
US7267695B2 (en) 2007-09-11
WO2006004666A3 (en) 2006-10-05
US20050288798A1 (en) 2005-12-29

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