U.S. patent application number 11/302753 was filed with the patent office on 2006-05-04 for prosthetic annular coupling socket adaptor with adjustable clamp.
Invention is credited to Damon Johncour, Steve Steinbarger.
Application Number | 20060095140 11/302753 |
Document ID | / |
Family ID | 29553262 |
Filed Date | 2006-05-04 |
United States Patent
Application |
20060095140 |
Kind Code |
A1 |
Steinbarger; Steve ; et
al. |
May 4, 2006 |
Prosthetic annular coupling socket adaptor with adjustable
clamp
Abstract
A method for custom fitting prosthetic devices, comprising the
steps of: (a) providing a unitary prosthetic coupling device
adapted to couple a prosthetic pylon to a second prosthetic limb
component, the coupling device having a cylindrical sheath
extending from a cavity adapted to receive at least a portion of
the second prosthetic limb component therein, the cylindrical
sheath adapted to interface with a prosthetic pylon, the
cylindrical sheath accommodating various depths of pylon insertion
to provide height adjustability with the second prosthetic limb
component, the coupling device further being designed for
day-to-day use; and (b) mounting the second prosthetic limb
component to the prosthetic coupling device and mounting the
prosthetic pylon to an interior surface of the cylindrical sheath
so as to provide a secure coupling between the prosthetic pylon and
the second prosthetic limb component enabling day-to-day use.
Inventors: |
Steinbarger; Steve;
(Willmington, OH) ; Johncour; Damon; (Raleigh,
NC) |
Correspondence
Address: |
TAFT, STETTINIUS & HOLLISTER LLP
SUITE 1800
425 WALNUT STREET
CINCINNATI
OH
45202-3957
US
|
Family ID: |
29553262 |
Appl. No.: |
11/302753 |
Filed: |
December 14, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10377289 |
Feb 28, 2003 |
6994732 |
|
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11302753 |
Dec 14, 2005 |
|
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60361427 |
Feb 28, 2002 |
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Current U.S.
Class: |
623/38 |
Current CPC
Class: |
A61F 2002/30433
20130101; A61F 2002/30817 20130101; A61F 2002/30495 20130101; A61F
2002/30224 20130101; A61F 2310/00047 20130101; A61F 2002/30359
20130101; A61F 2220/0033 20130101; A61F 2002/30492 20130101; A61F
2220/0025 20130101; A61F 2310/00023 20130101; A61F 2002/5018
20130101; A61F 2002/502 20130101; A61F 2002/30507 20130101; A61F
2/76 20130101; A61F 2220/0041 20130101; A61F 2230/0069
20130101 |
Class at
Publication: |
623/038 |
International
Class: |
A61F 2/62 20060101
A61F002/62 |
Claims
1. An adjustable prosthetic coupling comprising: a unitary coupling
adapter comprising: a pylon receiving end having an inner ring for
captively engaging a prosthetic pylon therein, and a prosthetic
component interface end for engaging and securing a prosthetic
component thereto; and an outer ring circumscribing the inner ring;
wherein the pylon receiving end accommodates varying depths of
insertion of the prosthetic pylon beyond the minimum required for
secured fitting, thereby enabling height adjustability.
2. The adjustable prosthetic coupling of claim 1, wherein the inner
ring includes at least two segments being constrictable.
3. The adjustable prosthetic component of claim 2, wherein the
outer ring facilitates restriction by forcing the at least two
segments toward one another to operatively adjust the inner ring
diameter.
4. The prosthetic coupling of claim 2, wherein the axial depth of
the inner ring does not exceed 2.5 inches.
5. The adjustable prosthetic component of claim 2, wherein the
prosthetic component interface end includes at least one concavity
adapted to accommodate a convex portion of the prosthetic component
mounted thereto.
6. The adjustable prosthetic component of claim 5, wherein the
prosthetic component interface end includes a prosthetic pyramid
having a frustropyramidal boss.
7. The prosthetic coupling of claim 2, wherein: the pylon receiving
end is manufactured, at least in part, from a metal; and the outer
ring is manufactured, at least in part, from a metal.
8. The prosthetic coupling of claim 7, wherein: the metal for the
pylon receiving end includes at least one of stainless steel and
titanium; and the metal for the outer ring includes at least one of
stainless steel, aluminum and titanium.
9. The adjustable prosthetic component of claim 2, wherein the
outer ring is a ring clamp.
10. The adjustable prosthetic component of claim 9, wherein the
ring clamp is integrated into the pylon receiving end.
11. The adjustable prosthetic component of claim 9, wherein the
ring clamp includes at least one screw for securing the prosthetic
pylon within the pylon receiving end.
12. The prosthetic coupling of claim 9, wherein the ring clamp is
mounted to the inner ring so as to inhibit unrestricted rotation of
the ring clamp about the inner ring.
13. An adjustable prosthetic coupling comprising: a pylon receiving
portion having a means for selectively securing a prosthetic pylon
therein; and a pyramid receiving portion including a means for
selectively securing a prosthetic pyramid thereto; wherein the
means for selectively securing the prosthetic pylon therein
includes a plurality of height adjustments between the prosthetic
pyramid and the prosthetic pylon, and wherein the means for
selectively securing the prosthetic pylon therein enables
day-to-day use.
14. A method for custom fitting prosthetic devices, comprising the
steps of: providing a unitary prosthetic coupling device adapted to
couple a prosthetic pylon to a second prosthetic limb component,
the coupling device having a cylindrical sheath extending from a
cavity adapted to receive at least a portion of the second
prosthetic limb component therein, the cylindrical sheath adapted
to interface with a prosthetic pylon, the cylindrical sheath
accommodating various depths of pylon insertion to provide height
adjustability with the second prosthetic limb component, the
coupling device further being designed for day-to-day use; and
mounting the second prosthetic limb component to the prosthetic
coupling device and mounting the prosthetic pylon to an interior
surface of the cylindrical sheath so as to provide a secure
coupling between the prosthetic pylon and the second prosthetic
limb component enabling day-to-day use.
15. The method of claim 14, further comprising the step of
adjusting the height between the second prosthetic limb component
and the prosthetic pylon for a proper fit.
16. The method of claim 15, wherein the adjusting step includes the
steps of: releasing a restrictive force associated with the
prosthetic coupling so as to enable vertical movement relative to
an interior surface of the prosthetic coupling and the exterior
surface of the prosthetic pylon; moving the prosthetic pylon
relative to the prosthetic coupling such that a proper distance is
achieved between a proximal end of the prosthetic coupling and a
distal end of the prosthetic pylon; and engaging the restrictive
force associated with the prosthetic coupling to inhibit vertical
movement relative to the interior surface of the prosthetic
coupling and the exterior surface of the prosthetic pylon.
17. The method of claim 14, wherein the secure coupling is
accomplished, at least in part, by a clamp manipulating a
restrictive force about the prosthetic pylon.
18. The method of claim 17, wherein the clamp is a ring clamp that
includes a screw torqued to approximately around 7.0 ft.lbs to
facilitate the secure coupling.
19. The method of claim 14, wherein the day-to-day use includes
time periods extending beyond initial fitting or adjustment.
20. The method of claim 14, wherein the concavity enables
prosthetic pylon insertion approximately between 1.375 and 1.875
inches.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of U.S. Nonprovisional
patent application Ser. No. 10/377,289, entitled "PROSTHETIC
ANNULAR COUPLING SOCKET ADAPTOR WITH ADJUSTABLE CLAMP," filed on
Feb. 28, 2003, now U.S. Pat. No. ______, which claimed the benefit
of U.S. Provisional Patent Application Ser. No. 60/361,427,
entitled, "PROSTHETIC ANNULAR COUPLING SOCKET ADAPTOR WITH
ADJUSTABLE CLAMP", filed on Feb. 28, 2002, the disclosures of which
are incorporated herein by reference.
BACKGROUND
[0002] 1. Field of the Invention
[0003] The present invention relates to prosthetic devices, and
more particularly, to prosthetic couplings having annular coupling
socket adapters (aka, "pyramid receivers") with adjustable height
tube clamps.
[0004] 2. Description of the Related Art
[0005] As shown in FIG. 1, an example of an above-knee ("AK")
prosthetic limb 2 for a patient may include a prosthetic limb
socket 4 for receiving the wearer's residual limb, a knee joint
assembly 6, a first pylon 8 coupled between the prosthetic limb
socket 4 and the knee joint assembly 6, interconnection components
10 for coupling the first pylon 8 to the prosthetic limb socket 4,
interconnection components 12 for coupling the first pylon 8 to the
knee joint assembly 6, an ankle/foot assembly 14, and a second
pylon 16 coupled between the knee joint assembly 6 and the
ankle/foot assembly 14. The interconnection components 10 may
consist of a locking or suction assembly 18 (such as, for example,
a Shuttle Lock component commercially available from Prosthetic
Design, Inc.) positioned within a distal end of the prosthetic limb
socket 4, the conventional pyramidal link-plate 20, and a pyramid
receiver 22 for coupling the first pylon 8 to the distal boss 24 of
the pyramidal link-plate 20. Likewise, the interconnection
components 12 may consist of the conventional pyramidal link-plate
20 mounted to the knee joint assembly 6 and another pyramid
receiver 22 for coupling the first pylon 8 to the distal boss 24 of
the pyramidal link-plate 20. The plurality of set screws 26 are
tightened, thus securely mounting the pyramidal link-plate 20 to
the pyramid receiver 22.
[0006] As shown in FIG. 2, a prior art prosthetic pyramid receiver
22 includes a pyramid receiver portion 30 and a diametrically
restrictable tube portion 32. The tube portion 32 includes a
ring-clamp 34, a screw 36 and a washer 38. The pyramid receiver
portion 30 has a concave upper mouth 33 adapted to mate with the
domed structure 40 of a pyramid 42. Angled holes 44 extend from the
exterior surface and continue inward, thereafter extending into the
interior channel of the pyramid receiver portion 30. These holes 44
are adapted to receive set screws 46 for throughput. When tightened
to engage the surfaces 48 of the frustropyramidal boss 50, the
pyramid 42 is pulled toward the pyramid receiver portion 30 until
the domed structure 40 of the pyramid 42 engages the concave upper
mouth 33 of the pyramid receiver portion 30. Thereafter, further
movement between the domed structure 40 of the pyramid 42 and the
concave upper portion 33 of the pyramid receiver portion 30 is
minimal (collectively the elements). Further tightening of the set
screws 46 increases the amount of force required axially to move
the elements in relation to one another, eventually "locking" the
elements together for all intents and purposes.
[0007] In fitting prosthetic limbs to patients, it is often
necessary for the prosthetist to modify the lengths and/or
orientations of various prosthetic limb components with respect to
each other during initial fitting, or after the patient has worn
the prosthetic limb for a period of time. The prosthetist attempts
to maintain the alignment of the prosthetic components along the
TKA line; a line parallel to the trochanter, knee and ankle. A
pylon, in particular, is capable of being ground down or cut so as
to shorten the length of the pylon to accord proper fitting.
Problems sometimes arise when the pylon is ground down or cut,
thereby shortening its length beyond that which is required. This
necessitates the procurement of a completely new pylon.
Alternatively, if the original pylon is too short, the current
state of the art provides no alternative for the prosthetist other
than procuring another pylon having a greater length.
[0008] Accordingly, there is a need for a pyramid receiver and
associated tube clamp that provides axial height adjustability with
respect to pylon length. Alternatively, there is a need for a
system in which a prosthetist may simply exchange different height
spacers or bushings to be placed within the tube of the tube clamp,
between an axial shoulder in the tube and the end of the pylon, to
adjust the height of the pyramid receiver with respect to the
pylon.
SUMMARY OF THE INVENTION
[0009] In a first exemplary embodiment of the present invention, a
height-adjustable prosthetic coupling is provided that has an
annular coupling adapter (pyramid receiver) on one end and a
diametrically restrictable tube (tube clamp) on the opposing end,
which allows for height (axial) adjustment between the coupling and
a prosthetic pylon. The diametrically restrictable tube has an
internal depth which accommodates the insertion of a portion of the
pylon. Conventional pyramid-receiver tube clamps have a
diametrically restrictable tube of a minimal length sufficient to
provide enough surface area to securely lock the tube clamp onto
the pylon. One reason for minimizing this length is to reduce the
material costs for such components. The first exemplary embodiment
of the present invention, on the other hand, provides a
diametrically restrictable tube having an internal depth which can
accommodate more than the minimum length of the pylon necessary for
properly securing the pylon to the coupling. In other words, the
interior height of the tube is greater than prior art tubes. When
the patient requires the overall length between the tube clamp and
pylon to be adjusted, the prosthetist "frees up" the diametrically
restrictable tube so as to enable movement between the internal
surface of the tube and the exterior surface of the pylon. Once the
desired overall length is reached, the prosthetist restricts the
diametrically restrictable tube and prevents noticeable movement
between the pylon and tube; both in the vertical, and in the
rotational/axial direction. Thus, the present invention provides
for human errors in measuring and provides adjustability to meet
the patient's needs and may not require the procurement of a
plurality of pylons of varied lengths.
[0010] Likewise, the elements of the first exemplary embodiment may
be combined with bushings (or spacers) that fill any potential
axial void that may be present in the first exemplary embodiment
between the shoulder of the coupling extending radially into the
channel of the tube and the longitudinal end-surface of the pylon;
resulting in a second exemplary embodiment. The second exemplary
embodiment provides a plurality of variable-height axial bushings
that are insertable into the tube of the coupling before the pylon
is inserted. One or more of these bushings may be inserted to fill
any potential void between the coupling and the longitudinal
surface of the pylon. Thus, the adjustment of the prosthetic
components may be made easier for the prosthetist because the
weight of the tube clamp and associated prosthetic components may
be pressed onto the pylon without the fear of hampering the
measurements surrounding the proper depth of the pylon.
[0011] It is a first aspect of the present invention to provide an
adjustable prosthetic coupling comprising: (a) a unitary coupling
adapter comprising a pylon receiving end having an inner ring for
captively engaging a prosthetic pylon therein, and a prosthetic
component interface end for engaging and securing a prosthetic
component thereto; and (b) an outer ring circumscribing the inner
ring, where the pylon receiving end accommodates varying depths of
insertion of the prosthetic pylon beyond the minimum required for
secured fitting, thereby enabling height adjustability.
[0012] It is a second aspect of the present invention to provide An
adjustable prosthetic coupling comprising: (a) a pylon receiving
portion having a means for selectively securing a prosthetic pylon
therein; and (b) a pyramid receiving portion including a means for
selectively securing a prosthetic pyramid thereto, where the means
for selectively securing the prosthetic pylon therein includes a
plurality of height adjustments between the prosthetic pyramid and
the prosthetic pylon, and wherein the means for selectively
securing the prosthetic pylon therein enables day-to-day use
[0013] It is a third aspect of the present invention to provide a
method for custom fitting prosthetic devices, comprising the steps
of: (a) providing a unitary prosthetic coupling device adapted to
couple a prosthetic pylon to a second prosthetic limb component,
the coupling device having a cylindrical sheath extending from a
cavity adapted to receive at least a portion of the second
prosthetic limb component therein, the cylindrical sheath adapted
to interface with a prosthetic pylon, the cylindrical sheath
accommodating various depths of pylon insertion to provide height
adjustability with the second prosthetic limb component, the
coupling device further being designed for day-to-day use; and (b)
mounting the second prosthetic limb component to the prosthetic
coupling device and mounting the prosthetic pylon to an interior
surface of the cylindrical sheath so as to provide a secure
coupling between the prosthetic pylon and the second prosthetic
limb component enabling day-to-day use.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is a perspective view of a prior art prosthetic limb
assembly;
[0015] FIG. 2 is a perspective view of a prior art pyramid
receiver;
[0016] FIG. 3 is a perspective view of a first exemplary embodiment
of the present invention;
[0017] FIG. 4 is an exploded view of the first exemplary embodiment
of the present invention;
[0018] FIG. 5 is a frontal view of the first exemplary embodiment
of the present invention;
[0019] FIG. 6 is a left side view of the first exemplary embodiment
of the present invention;
[0020] FIG. 7 is an overhead view of the first exemplary embodiment
of the present invention; and
[0021] FIG. 8 is a cross sectional view of the first exemplary
embodiment of the present invention along lines 6-6 of FIG. 7.
[0022] FIG. 9 is an underneath view of an alternate exemplary
embodiment of the present invention having two integrated tube
clamps.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0023] The exemplary embodiments of the present invention are
described and illustrated below as prosthetic limb couplings, for
mounting a first prosthetic component to a second pylon component,
that include height-adjustable tube clamps for mating with pylon
components. The various orientational or positional terms used to
describe the elements of the inventions are therefore used
according to this frame of reference. Of course, it will be
apparent to those of ordinary skill in the art that the preferred
embodiments may also be used in combination with one or more
prosthetic components to function as a complete prosthetic
assembly. In such a case, the orientational or positional terms may
be different. However, for clarity and precision, only a single
orientational or positional reference will be utilized; and,
therefore it will be understood that the positional and
orientational terms used to describe the elements of the exemplary
embodiments of the present invention are only used to describe the
elements in relation to one another. For example, a pylon will have
two opposing longitudinal surfaces; one being characterized as
proximal, while the other is characterized as distal. Yet, the
pylon may be rotated in space, thereafter transforming the proximal
end into the distal end and vice versa without departing from the
scope and spirit of the present invention.
[0024] As shown in FIGS. 3-8, a first exemplary embodiment of the
present invention 52 provides a prosthetic coupling 52 having a
titanium pyramid receiver 54 on the proximal end, and a titanium
tube 56 on the distal end with an aluminum ring clamp 58 mounted
thereto. The pyramid receiver 54 has a proximal opening with a
mouth 60 having a conical interior surface 61 that is machined or
molded to mate with a "male" prosthetic limb component such as, for
example, a conventional prosthetic pyramid 62. The pyramid receiver
54 also includes at least two diametrically opposed holes 64 angled
distally in relation to an imaginary planar surface parallel to the
proximal end of the pyramid receiver 54. Each angled hole 64 may be
machined or molded to house a single set screw 66; the set screws
may be 5/16-18 socket head set screws.
[0025] Referencing FIG. 2, the pyramid 42 includes a
frustropyramidal, four-sided boss 50 projecting from a domed
shaped, or spherically convex base 40 (hereafter domed portion).
The pyramid 42 is secured to another prosthetic component with four
screws (a standard industry design). These four screws attach the
pyramid 42 firmly to a prosthetic component (not shown) and provide
structural support at the proximal end for connection between the
prosthetic pyramid 42 and the prosthetic pyramid receiver 54.
[0026] Mounting the pyramid 42 to the pyramid receiver 54 begins by
placing the frustropyramidal boss 50 within the concave mouth 60 of
the pyramid receiver proximal opening so as to enable the set
screws 66 to engage the faces 48 of the frustropyramidal boss 50.
Concurrently, as the set screws 66 are engaging the faces 48 of the
frustropyramidal boss 50, the domed portion 40 of the pyramid 42 is
being moved closer to the concave mouth 60 of the pyramid receiver
54. As the pyramid 42 comes in close proximity to the pyramid
receiver's 54 interior conical surface 62, the exterior surface of
the domed portion 40 abuts the conical interior surface 62 of the
pyramid receiver 54 and a friction fit results. The tighter the set
screws 66 push against the faces 48 of the frustropyramidal boss
50, the relatively better the friction fit. In other words, the
higher the force the set screws 66 exert against the faces 48 of
the frustropyramidal boss 50, thus pushing the pyramid 42 against
the pyramid receiver 54, the greater the amount of force required
to unseat the pyramidal receiver's 54 interior conical surface 62
from the domed portion 40 of the pyramid 42. This results in
relatively no movement between the two elements in either the
vertical or rotational direction when the set screws 66 are
sufficiently tightened.
[0027] As shown in FIG. 4, the tube 56 includes two discontinuities
in the form of channels 78 extending therethrough and upward from a
distal end thereof, which separate at least two circumferential
portions of the tube 56 from one another. The channels 78 terminate
with the formation of a stress riser 80 to dissipate stress and
inhibit the formation or a stress crack at the point of
termination. These channels 78 are in part what provides the
flexibility of the tube 56 to conform to a plurality of internal
diameters, thereby supplemented by the adjustable aluminum ring
clamp 58 which provides the restrictive force. The exterior of the
tube 56 includes a lip or shoulder 82 extending radially from the
tube 56 that is adapted to abut the proximal surface of the
ring-clamp 58. Extending distally from the lip 82, the outer
circumferential surface of the tube 56 is recessed to mate with the
inner diameter of the ring clamp 58.
[0028] The restrictable aspect of the ring clamp 58 includes a
radial projection 84 that takes on a pyramidal shape which exhibits
an apex in exterior diameter at the axial center of the clamp and
diminishes proportionally in the vertical and radial directions
accordingly, thus providing an outer surface 86 which slopes in the
axial as well as distal and proximal directions. A break 88
effectively bisects the radial projection of the ring clamp 58,
providing complimentary, mirror image planar surfaces 90 parallel
to the TKA line. Perpendicular to the break 88 of the ring clamp 58
is a hole 92 which extends through the pyramid shaped radial
projection 94 of the ring clamp 58. The hole 92 extends through the
complimentary parallel planar surfaces 90 created by the break 88.
This hole 92 may be machined or molded so as to accept a threaded
device such as a screw 94; the screw may be a #10-32 socket head
cap screw. The screw 94 facilitates the restrictive force necessary
to bring the parallel surfaces 90 of the ring clamp 58 closer
together than compared to equilibrium without the screw 94, such
that the internal diameter of the tube 56 at the distal end becomes
variable; generally smaller in diameter when restrictive force is
applied.
[0029] It is preferred, but not necessary, that the adjustable
aluminum ring clamp 58 be mounted on the distal end of the hollow
titanium tube 56. One example of how this might be accomplished is
by way of a retention pin 96 that is friction fit within a hole 98
radially bored through the ring clamp 58 and the tube 56. When the
retention pin 96 is in place, free rotation and axial separation of
the ring clamp 58 from the tube 56 is inhibited. In any such
mounting technique, it is preferred, but not necessary, to align
the break 88 with at least one channel 78.
[0030] An inner concavity 100 of the tube 56 provides a "female"
interface between the coupling 52 and a second prosthetic component
such as, for example, a graphite pylon. The interior surface of the
tube 56 which makes contact with the exterior surface of the pylon
(not shown) may be smooth or of non-uniform texture and include a
taper approximating its distal end to effectively provide a maximum
axial depth for insertion of the pylon. In this exemplary
embodiment, the maximum axial depth is one-half inch longer than
the minimum depth necessary to provide sufficient surface area to
achieve secure locking (as required by the ISO 10328 torque test)
between the coupling 52 and the pylon. This additional one-half
inch depth of the tube 56 provides height adjustability for the
component as will be discussed further below.
[0031] The pylon is generally a cylindrical shaft having a uniform
circular cross section. The pylon has two longitudinal end surfaces
which make up the respective distal and proximal ends of the pylon.
Assembly of the pylon into the tube 56 of the coupling 52 begins by
inserting the proximal end of the pylon into the tube 56 until the
pylon abuts the shoulder 102 inside of the tube 56. Using a paint
marker, the exposed portion of the pylon immediately adjacent to
the ring-clamp is marked. The pylon may then be withdrawn from the
tube 56 up to one-half inch by sliding the coupling 52 away from
the pylon; all the while providing at least the minimum pylon
insertion depth. This minimal pylon insertion depth being the depth
at which enough of the exterior surface of the pylon is in
potential contact with enough of the interior surface of the tube
56 such that a resulting friction fit between the two elements will
disallow substantial rotational and/or vertical movement between
the two during day-to-day use of the prosthetic limb by the
patient. Thereafter, the ring clamp 58 is restricted by use of the
screw 94. An application of Loctite.RTM. may be applied before
tightening the screw to help maintain the proper restrictive
force.
[0032] Alternatively, to adjust the pylon to coupling 52 distance,
the prosthetist may simply measure down from the proximal
longitudinal surface of the pylon and mark the exterior surface of
the pylon corresponding to the minimum insertion depth. Thereafter,
the prosthetist may make vertical adjustments of the pylon so long
as the marked exterior surface of the pylon is inserted into the
tube 56.
[0033] Additionally, the prosthetist may adjust the pylon length
after the initial fitting of the patient's prosthetic components.
In this case, the prosthetist begins by loosening the ring clamp 58
around the tube 56, thus enabling vertical and/or rotational
movement between the coupling 52 and the pylon. Next, the
prosthetist simply pulls a portion of the pylon out from the tube
56, up to one-half inch until the proper measurements are met if
the distance is too short; conversely, the prosthetist simply
pushes a portion of the pylon into the tube 56, up to one-half inch
until the proper measurements are met if the distance is too great;
all the while keeping the minimum amount of exterior pylon surface
in potential contact with the minimum amount of interior surface of
the tube 56 such that a friction fit between the two elements will
be maintained with proper tightening of the ring clamp 58. While
the prosthetist is adjusting the length between the distal end of
the pylon and the proximal end of the coupling 52, it will be
recognized by one of ordinary skill in the art that other concerns
may be addressed by the prosthetist such as alignment retention of
the prosthetic components attached to either the distal end of the
pylon, or the proximal end of the coupling 52. Finally, the
prosthetist tightens the ring clamp 58 by torquing the screw 94 to
the setting recommended by the manufacturer and the adjustment is
complete.
[0034] As a caveat to the aforementioned procedure for
adjustability, it will also be recognized by one of ordinary skill
in the art that if the amount of the pylon inserted into the tube
is the minimum amount necessary for a proper friction fit,
adjustability to a greater length may require: the procurement of
another pylon having a longer length; adjusting the prosthetic
component mounted to the distal end of the pylon; or, exchanging a
coupling 52 having a greater tube 56 height.
[0035] It will be apparent to those of ordinary skill that the
one-half inch extension of the tube of the tube clamp provided in
the first exemplary embodiment is not limiting, and it is within
the scope of the invention to provide extensions having longer or
shorter lengths as desired.
[0036] The ring clamp 58 may be of the same or a similar material
or of an alloy comprising one or more of the materials of the tube
56 and/or pyramid receiver 54. Materials suitable for use in the
fabrication of the tube 56, the pyramid receiver 54, and the
ring-clamp include elemental metals, alloys of elemental metals,
composites, and any other similar materials. It is preferred that
the material chosen for the tube 56 inhibits any permanent
deformation attributable to the ring clamp 58.
[0037] It is likewise within the scope and spirit of the invention
to provide grooves on the outer circumferential surface of the tube
56 that mate with corresponding grooves in the ring clamp 58 to
align the ring-clamp 98 to the proper exterior surface of the tube
56, thus maintaining the ring clamp's 58 axial position around the
tube 56 when the ring clamp 58 is not sufficiently tightened.
[0038] In the first exemplary embodiment 52, the clamp is separate
from the manufacture of the tube 56. However, it is within the
scope and spirit of the present invention to provide a titanium
ring clamp 58 incorporated into the tube 56 and/or pyramid receiver
54.
[0039] It is also within the scope and spirit of the present
invention to provide a set of bushings or spacers having
incremental axial height and uniform circular cross section. In
this embodiment, these bushings may be inserted into the tube 56
whenever the measurements taken by the prosthetist indicate that
the proximal end of the pylon will not abut the shoulder 102 within
the tube 56. The prosthetist begins by making a measurement of the
overall length desired as measured from the distal end of the pylon
to the proximal end of the coupling 52. Next, the prosthetist marks
or measures how much of the pylon will be inserted into the tube 56
for proper fitting. If this measurement is less than the height of
the tube 56 available for pylon insertion, the prosthetist simply
chooses a bushing having a height to make up the difference. It
will be understood by those of ordinary skill in the art that the
bushings do not act to provide a friction fit between the pylon and
the tube 56, but simply occupy a space or void that would normally
be vacant. It is also within the scope of the invention that all or
some of the spacers have equal height and are designed to be
stackable upon one another.
[0040] Another exemplary embodiment of the present invention
provides a plurality of couplings 52 having incremental tube
heights. This "set" of tube clamps, being interchangeable, provides
a prosthetist flexibility regarding adjustments to the length
between the proximal end of the coupling and the distal end of the
pylon (overall length). As characterized above, this flexibility in
tube height does not negate the requirement of a minimum pylon
insertion depth for proper friction fitting. The set of couplings
may be manufactured with any tube height for pylon insertion, so
long as the set as a whole provides incremental adjustment of the
overall length at least ranging one-half inch.
[0041] Still another exemplary embodiment of the present invention
is shown in FIG. 9. This exemplary embodiment provides two
integrated clamps 104, 106 as part of the tube portion of the
coupling. Each clamp includes a set screw 108, 110 that provides
the restrictive force necessary to diminish the gaps 112 in the
coupling conform the tube portion around a pylon thereby providing
a friction fit sufficient to enable day-to-day use of the coupling
by a patient. It is also within the scope of the invention to
provide a set of couplings embodying such a dual clamp
configuration that may be manufactured with any tube height for
pylon insertion, so long as the set as a whole provides incremental
adjustment of the overall length at least ranging one-half
inch.
[0042] Adjustability typically requires that the prior art tube
clamp be loosened by the prosthetist enabling vertical and/or
rotational movement between the pylon and tube clamp, so that
measurement can be made to adjust the length/height of the pylon.
However, using a set of couplings having incremental pylon
insertion depths, the pylon is not adjusted. A prosthetist would
remove the pylon and replace the coupling with another coupling
having a different pylon insertion depth so as to provide the
proper overall length for the patient. The pylon is thereafter
inserted into the tube 56 until the proximal longitudinal end of
the pylon abuts the shoulder on the inside of the tube. If
applicable, other prosthetic components are reattached, all the
while cognizant of proper alignment before final attachment and
tightening of the screw. Generally, it is envisioned that this set
be used without using the bushings as described above. However, it
is within the scope and spirit of the present invention to also
utilize the bushings if found advantageous by the prosthetist.
[0043] If the prosthetist utilizes the set, bushings may be used in
lieu of, or in addition to, the next or greater incremental sized
coupling in the set. Here, adjustability starts with the
prosthetist simply pulling a portion of the pylon out from the tube
until the proper measurements are established if the current
distance has been determined as being too short. All the while
keeping the minimum amount of exterior pylon surface in potential
contact with the minimum amount of interior surface (not shown) of
the tube such that a friction fit between the two elements will be
maintained with proper tightening of the screw. While the
prosthetist is adjusting the length between the distal end of the
pylon and the proximal end of the coupling, it will be recognized
by one of ordinary skill in the art that other concerns may
additionally be addressed such as alignment retention of the
prosthetic components attached to either the distal end of the
pylon, or the proximal end of the coupling. Once the proper
distance is determined and/or marked, the pylon is removed from the
tube. A bushing is inserted into the tube to accord the proper
distance. Next, the pylon is inserted into the tube to abut the
bushing which abuts the shoulder in the tube. Finally, the
prosthetist tightens the clamp by tightening the screw to the
proper torque setting recommended by the manufacturer and the
adjustment is complete. As a caveat to the aforementioned procedure
for adjustability, it will also be recognized by one of ordinary
skill in the art that if the amount of the pylon inserted into the
tube is the minimum amount necessary for a proper friction fit,
adjustability to a greater length will not be possible without the
procurement of another pylon having a longer length, or adjusting
the prosthetic component attached to the distal end of the pylon,
or switching couplings where the second coupling has a longer
height tube. In addition, should the prosthetist desire to exchange
couplings and utilize bushings, the procedure is analogous with
that enunciated above, but begins with removal of the old coupling
and insertion of a new coupling from the set.
[0044] Following from the above description and invention
summaries, it should be apparent to those of ordinary skill in the
art that, while the methods and apparatuses herein described
constitute exemplary embodiments of the present invention, it is to
be understood that the inventions contained herein are not limited
to these precise embodiments and that changes may be made to them
without departing from the scope of the inventions as defined by
the claims. Additionally, it is to be understood that the invention
is defined by the claims and it not intended that any limitations
or elements describing the exemplary embodiments set forth herein
are to be incorporated into the meanings of the claims unless such
limitations or elements are explicitly listed in the claims.
Likewise, it is to be understood that it is not necessary to meet
any or all of the identified advantages or objects of the invention
disclosed herein in order to fall within the scope of any claims,
since the invention is defined by the claims and since inherent
and/or unforeseen advantages of the present invention may exist
even though they may not have been explicitly discussed herein.
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