Invention (Patent): Purquerio BM,
Fortulan CA, Botega R, de Moraes TF. Prótese cirúrgica antiluxação e sistema artificial de ligamento redondo
da mesma. BR102015006381A2 (Antiluxation surgical prosthesis and artificial
round ligament system thereof, 2016). Translated from
Portuguese.
BR102015006381A2 Brazil
Inventors: Benedito De Moraes Purquerio, Renan Botega, Thiago Francisco De Moraes, Carlos Alberto Fortulan
Worldwide applications 2015 BR
Application BR102015006381-4A events:
2015-03-23 Application filed by Universidade De São Paulo - Usp.
2015-03-23 Priority to BR102015006381-4A
2016-09-27 Publication of BR102015006381A2
2023-04-11 Publication of BR102015006381B1
Antiluxation surgical
prosthesis and artificial round ligament system thereof
Benedito De Moraes Purquerio,
Renan Botega, Thiago Francisco De Moraes, Carlos Alberto Fortulan
Abstract
The present
invention relates to an anti-dislocation surgical prosthesis in ceramic and/or
polymeric materials, porous, multidense and in functional gradient for
orthopedic arthroplasty surgeries for resurfacing spheroid or condylar ends of
long bones, for example, the hip, of humans or animals. of any size, who
present any synovial joint diseases. Said prosthesis is made up of three parts:
the femoral head, which can be of various sizes, the femoral guide-pin in one
size or according to the femoral head, and the pelvic acetabulum, which may be
of various sizes in correspondence with the head. femoral. Due to its
versatility, such a prosthesis can be used in hospitals, orthopedic and
veterinary surgery clinics, or similar institutions.
Description
FIELD OF THE INVENTION
[1] The present invention is part of the field of medicine,
more specifically in the area of prostheses and surgical implants for
orthopedics, and describes an anti-dislocation surgical prosthesis in ceramic
and/or polymeric materials, porous multidense and in functional gradient for
orthopedic arthroplasty surgeries of hip resurfacing, as well as an artificial
round ligament system of the referred prosthesis.
[2] In general, this prosthesis can be used for recapping
spheroid or condylar ends of long bones in arthroplasty surgeries in humans or
animals of any size, which present any kind of synovial joint disease.
FUNDAMENTALS OF THE INVENTION
[3] Resurfacing arthroplasty (resurfacing) of long bones,
such as those of the hip, is a technique that provides excellent results in
young and active patients, in contrast to conventional long stem prostheses.
The choice for the resurfacing prosthesis has been made due to the great
advantage of greater post-surgery proximal bone preservation, resulting in
greater stability and better physiological movement.
[4] In the state of the art, there are still no consistent
records of anti-dislocation surgical prostheses for hip resurfacing in any type
of material, which makes the present invention enable safety against
dislocation of the prosthesis after arthroplasty surgery from the hip of humans
or animals.
[5] Although modern human resurfacing surgical hip
prostheses, now manufactured only in metallic materials (metal-on-metal), offer
the restoration of the function of the implanted patients, they also present
the great and constant risk of dislocation, unavoidable in this type of
prosthetic rehabilitation. Furthermore, numerous metallic prostheses used in
hip resurfacing arthroplasty are already known, but all of them, without
exception, are subject to potential accidental dislocation.
[6] Completely different, in terms of design, from existing
hip resurfacing prostheses, the anti-dislocation surgical hip resurfacing
prosthesis in ceramic or metallic or polymeric materials, porous multidense,
with functional gradient of the present invention presents innovative solutions
in relation to its concept of design and materials, as well as their
predictability and functional stability with regard to non-dislocation.
State of the art documents
[7] Patent document US2007276364 discloses a hip joint
anti-dislocation device and method to prevent displacement of hip arthroplasty
implants. The invention prevents displacement by maintaining a retaining
tension (coaptation force) on the implant throughout all joint movements.
Although this device is used in conventional hip arthroplasty prostheses with
the aim of eliminating dislocation in the postoperative period, it presents an
inventive concept that is totally different from the present invention, as this
document describes an artificial joint capsule as a joint stabilizing element,
while that the present invention describes a round ligament as a joint
coaptation element.
[8] ITFR990014 describes a post-surgical anti-dislocation
prosthesis that can be used bilaterally in hip replacement surgery with second
revision prostheses. This prosthesis used, although used in hip replacement,
uses the hyperispheric principle (ball-socket) as an anti-dislocation principle,
while the present invention describes a prosthesis with a system that allows
the replacement of the round ligament, preventing dislocation.
[9] Documents US3067740, EP0655230, EP0485311, FR2210909,
W0016960, are cited as a mere understanding of the problem presented, since
none of the devices presented are used in surgeries with conventional joint
replacement prostheses, and the present invention refers to a prosthesis of
joint resurfacing with a system that artificially mimics the functions of the
round ligament, when implanted.
[10] Other documents, such as CN202015270 and CN201939550
present orthopedic devices, such as orthoses for use in the postoperative
period of hip arthroplasty with the function of preventing dislocation with the
use of these devices. These documents presented in the state of the art
contribute to the demonstration of the inefficiency of the devices currently
used with the purpose of anti-dislocation in the postoperative period.
[11] Therefore, the present invention presents an inventive
concept based on a joint biomechanical study, which replaces the functions of
the round ligament in order to mimic the joint coaptation force performed under
normal physiological conditions.
Advantages of the Invention
[12] The anti-dislocation surgical prosthesis for
resurfacing the hip in multidense porous ceramic with functional gradient
described in the present invention is an alternative for hip arthroplasty also
for patients who have metal allergy problems. Metals in the human body, as is
known, in addition to promoting a constant increase in the level of metallic
ions in the blood by up to 10 times more in individuals with implants compared
to the levels found in individuals without metallic implants, they also cause
adverse reactions in patients with allergies. to metals.
[13] Aiming to solve the currently unresolved inconveniences
and uncertainties related to the quality of the human body's immune response,
as observed in the mentioned documents that use metallic prostheses that can
make the two most important parameters that guarantee the success of surgical
prostheses in general and , in particular, surgical hip resurfacing prostheses,
i.e., predictability and stability, and thus offer alternatives and innovative
techniques for the design and manufacture of anti-dislocation surgical
prostheses for hip resurfacing in non-metallic materials, was developed at hip
in multidense porous ceramic with functional gradient.
[14] The referred anti-dislocation surgical prosthesis of
hip resurfacing in multidense porous ceramic with functional gradient appears
as a new technology for orthopedic surgeries of hip resurfacing arthroplasty,
where its functional safety characteristics eliminate the common negative
situations offered by metallic prostheses similar ones found on the market
today, regarding situations where the immune response of debilitated
individuals who are candidates for hip arthroplasty puts the post-surgical
stability of the prosthesis at risk.
[15] In addition, the new Functional Gradient Multidense
Porous Ceramic Hip Resurfacing Anti-Dislocation Surgical Prosthesis for Human
Hip Arthroplasty, which is also suitable for animals of any size, is designed
to be fabricated from non-metallic materials: ceramics and ceramic composites
and/or polymeric and polymeric composites.
BRIEF DESCRIPTION OF THE INVENTION
[16] The present invention relates to an anti-dislocation
surgical prosthesis in ceramic and/or polymeric, porous and multidense
materials and in functional gradient for the recapping of spheroid or condylar
ends of long bones; more specifically, it deals with a prosthesis that does not
contain metallic materials, capable of lining the ends of bones, such as those
of the hip or shoulder of children, young people, adults and the elderly, as
well as hip arthroplasty of animals of any size, that present any diseases of
these synovial joints, which may, in any case, be used in hospitals, orthopedic
and veterinary surgery clinics, or similar institutions; due to its
anti-dislocation versatility.
[17] This prosthesis is made up of three parts: the femoral
head, which can have different sizes, the femoral pin-guide rod in one size or
according to the femoral head, and the pelvic acetabulum, which can have
different sizes in correspondence. with the femoral head. The femoral head and
the pelvic acetabulum are made of ceramic, porous, multidense and functional
gradient materials. The femoral guide-pin rod is made of ceramic or polymeric
materials, porous, multidense and in a functional gradient. The femoral head
has its outer ceramic part dense and polished and its inner ceramic part, which
comes into contact with the bone tissue at the end of the bone, porous,
multidense and in a functional gradient. The pelvic acetabulum has its inner
ceramic part dense and polished and its outer ceramic part, which comes into
contact with the bone tissue of the hip, porous, multidense and in a functional
gradient. The femoral guide-pin rod that is inserted into the hole at the end
of the bone in hip arthroplasty has a dense core and a multidense porous
surface in a functional gradient that is in contact with the bone tissue. This
rod in polymeric material can be reinforced or not with carbon fibers.
BRIEF DESCRIPTION OF THE FIGURES
[18] Fig. 1 is a graphical representation of the multidense
functional gradient porous ceramic hip resurfacing implanted into a human
synovial joint.
[19] Fig. 2 is a graphical representation of the frontal
cutaway view of the antidislocation surgical prosthesis for hip resurfacing in
multidense porous ceramic with functional gradient implanted in a canine
synovial joint.
[20] Fig. 3A is a cross-sectional graphical representation
of the acetabulum of the anti-dislocation surgical prosthesis for hip
resurfacing in multidense porous ceramic with functional gradient.
[21] Fig. 3B is a cross-sectional graphical representation
of the head of the antidislocation surgical prosthesis for hip resurfacing in
multidense porous ceramic with functional gradient.
[22] Fig. 3C is a graphical representation of the front
sectional view of the guide pin-rod of the anti-dislocation surgical prosthesis
for hip resurfacing in multidense porous ceramic with functional gradient.
[23] Fig. 3D is a graphical representation of the frontal
cutaway view of the anti-dislocation surgical prosthesis for hip resurfacing in
multidense porous ceramic with functional gradient, showing its three
components, the femoral head, the femoral pin-rod and the hip pelvic
acetabulum.
[24] Fig. 4 is a graphical perspective representation of the
anti-dislocation surgical prosthesis for hip resurfacing in multidense porous
ceramic with functional gradient, showing its three components, the femoral
head, the femoral guide-pin rod and the pelvic acetabulum of the hip, in a
synovial joint human.
[25] Fig. 5 is a graphical perspective representation of the
anti-dislocation surgical prosthesis for hip resurfacing in multidense porous
ceramic with functional gradient, showing its three components, the femoral
head, the femoral guide-pin rod and the pelvic acetabulum of the hip, in a
synovial joint canine.
[26] Fig. 6A is a cross-sectional graphic representation
showing the insertion of the artificial round ligament system (anti-dislocation
lock and suture threads) into the perforation of the acetabular cavity of the
pelvis for the fixation of the anti-dislocation surgical prosthesis for hip
resurfacing in multidense porous ceramic with functional gradient, using the
thin end of the tool specially designed to carry out this operation and
drilling the anchor or fixing lock.
[27] Fig. 6B is a cross-sectional graphical representation
showing the positioning and locking of the anchor or anti-dislocation lock of
the artificial round ligament system (anti-dislocation lock and sutures) behind
the drilling of the acetabular cavity of the pelvis for the fixation of the
anti-dislocation surgical prosthesis for hip resurfacing in multidense porous
ceramics with functional gradient, using the thick end of the tool specially
designed to carry out this operation.
[28] Fig. 6C is a cross-sectional graphic representation
showing the anti-dislocation surgical prosthesis for hip resurfacing in
functional gradient porous multidense ceramic, positioned and locked or
anchored through the artificial round ligament system (anti-dislocation lock
and sutures) in the acetabular cavity of the pelvis.
DETAILED DESCRIPTION OF THE INVENTION
[29] The present invention relates to an anti-dislocation
surgical prosthesis in ceramic and/or polymeric materials, multidense porous
and in functional gradient for orthopedic surgeries of arthroplasty of
resurfacing of spheroid or condylar ends of long bones, for example, the hip,
of humans or animals. As can be seen in Figs. 1 and 2, and 4 and 5,
respectively, said prosthesis comprises the following elements: a femoral head
(7), (8), a femoral guide-pin rod (9), (10) and a pelvic acetabulum (13 ),
(14). The prosthesis was designed with geometry to be used in recapping
arthroplasty of spheroid ends of human femurs (1) or animals (2) in hip or
shoulder arthroplasty surgeries in young, adult and elderly patients, as well
as in hip arthroplasty in animals of any size, as can be seen, respectively, in
Fig. 1, for human femurs (1) and Fig. 2 for canine femurs (2).
[30] In Figs. 1 and 2, which illustrate human (1) and canine
(2) femurs, respectively, the respective drilling (11) or (12), in turn, where
the guide-pin rod (9) or (10) is inserted of the prosthesis and the end modeled
in cylindrical shape (5) or (6), respectively, where the femoral head (7) or
(8) of the prosthesis is coupled, are similar for any size of prosthesis for
humans or animals.
[31] Preparation operations for seating the resurfacing
prosthesis are performed with special tools on the bone ends of human femurs (1)
and canine femurs (2), and are necessary to safely couple and position the
surgical resurfacing prosthesis and accuracy.
Femoral Head of Anti-dislocation Surgical Prosthesis for
Humans
[32] The femoral head (7) of the surgical resurfacing
prosthesis for humans, as shown in Figs. 1, 3B, 3D and 4, has a dense ceramic
structure (21) and its spherical outer surface (23) is polished with high
dimensional and shape accuracy. Its inner surface (24), which is in contact
with the surface of the modeled bone (5), is porous, multidense and in a
functional gradient. The interior porous surface (24) of the femoral head (7)
which has a thickness between 0.5 to 2.0 mm can contain, since the
manufacturing process, osteoinductive materials such as 45S5 bioglass and hydroxyapatite
and bone growth factors such as morphogenetic proteins such as BMP (bone
morphogenetic protein) and similar and/or live bone and/or cartilaginous tissue
cultures precultured in co-culture of these tissues. The femoral head (7) has a
housing or cylindrical hole (25) for coupling the femoral guide pin-rod (9) and
also chamfers (27) or internal and external finishing rounding.
[33] The femoral head (7) of the resurfacing
anti-dislocation surgical prosthesis has a manufacturing process involving two
ceramic processes in co-pressing: uniaxial pressing in two stages at 50.0 MPa
and isostatic pressing at 200.0 MPa.
[34] The femoral head (7) has a central hole (41), with
external countersunk (42) and rounded edges, for the passage of surgical suture
threads (19) that simulate and/or replace the round ligament of the joint ,
which prevent dislocation of the prosthesis. The central hole (41) countersunk
in the femoral head (7) coincides with the hole (48) in the pelvic acetabulum
(13) for both to allow the passage of surgical threads (19) which constitute a
system functionally equivalent to that of the round ligament.
Anti-Dislocation Surgical Prosthesis Femoral Guide-Pin for
Humans
[35] The femoral guide-pin rod (9), as shown in Figs. 1, 3C,
3D and 4, has a dense structure (28), and its external surface (29), which is
in contact with the internal surface of the hole (11) of the femoral bone (1),
is porous, multidense and in functional gradient. The external porous surface
(29) of the femoral guide-pin rod (9), which has a thickness between 0.3 to 1.0
mm, may contain, from the manufacturing process, osteoinductive materials such
as 45S5 bioglass and hydroxyapatite and bone growth factors such as
morphogenetic proteins such as BMP and the like and/or live bone and/or
cartilaginous tissue cultures precultured in co-culture of these tissues. The
femoral guide-pin rod (9) is assembled and cemented in the femoral head (7), in
the housing or cylindrical hole (25), to form the femoral assembly of the
resurfacing anti-dislocation surgical prosthesis, using adhesives or commercial
biological cements. The femoral set of the resurfacing surgical
anti-dislocation prosthesis for humans, as described, can be manufactured in a
single piece formed by the femoral guide pin-rod (9) and the femoral head (7),
eliminating the use of adhesives.
[36] The femoral guide-pin rod (9), with a dense body (28)
and a multidense porous surface (29) with a functional gradient, as shown in
Figs. 1, 3C, 3D and 4 can be manufactured with ceramic or polymeric materials,
such as PMMA or similar, reinforced or not with carbon fibers if manufactured
with polymeric materials or can be isostatically pressed if manufactured with
ceramic materials. In both possibilities, the femoral guide-pin rod (9) of the
total surgical resurfacing prosthesis has a dense core (28) and a porous
surface (29), multidense in a functional gradient.
[37] The femoral guide-pin rod (9) has a central hole (46),
which allows the passage of surgical suture threads (19) that simulate and/or
replace the round ligament and that prevent dislocation of the prosthesis. The
central hole (46) of the femoral guide-pin (9) coincides with the hole (41) of
the femoral head (7) and, in this way, allows the passage of the surgical
threads (19) for locking the complete prosthesis ( acetabulum, femoral head and
guide rod) through the anchor or latch (17) of the pelvis and the anchor or
latch (18) of the femur, with adequate surgical mooring (20) of the surgical
threads, after passing through the hole (15) output of the femur, using
conventional suture needles (52), thus performing the function of the
artificial round ligament system, which positions the prosthesis in its joint
function and prevents its accidental dislocation.
Pelvic Acetabulum of Total Resurfacing Surgical Prosthesis
for Humans
[38] The pelvic acetabulum (13) illustrated in Figs. 1, 3A,
3D and 4, has a dense ceramic structure (30) and its inner surface (32) is
polished with high dimensional and shape accuracy. On the other hand, its
external surface (31), which is in contact with the acetabular bone surface of
the human hip (3), as shown in Fig. 1, is porous, multidense and functionally
gradient. The external porous surface (31) of the pelvic acetabulum (13) has a
thickness between 0.5 and 2.0 mm and may contain, since the manufacturing
process, osteoinductive materials, such as 45S5 bioglass, hydroxyapatite and
bone growth factors , such as morphogenetic proteins such as BMP and the like
and/or live bone and/or cartilaginous tissue cultures precultured in co-culture
of these tissues. The pelvic acetabulum (13) may present on its external porous
surface, indentations or circular pits with a greater porous thickness and with
a concentration of osteoinductive materials also greater, to emulate its
fixation, through accelerated osseointegration in these sites of contact with
the bone host (3). The pelvic acetabulum (13) has chamfers (33) or internal and
external finishing rounding.
[39] The pelvic acetabulum (13) has a manufacturing process
involving two ceramic processes in co-pressing: uniaxial pressing in two stages
at 50.0 MPa and isostatic pressing at 200.0 MPa.
[40] In addition, the pelvic acetabulum (13) has a central
hole (48), countersunk (50) internally with rounded edges, for the passage of
surgical suture threads (19) that simulate and/or replace the round ligament,
which prevent dislocation of the prosthesis. The central hole (48) of the
pelvic acetabulum (13) coincides with the hole (16) of the pelvic bone (3) and
both allow the passage and locking of the anchor or latch (17) for fixing the
round ligament system constituted by the surgical threads (19).
Round Ligament Equivalent System of Total Resurfacing
Surgical Prosthesis for Humans
[41] The artificial system of the round ligament, consisting
of two anchors or anti-dislocation locks, the pelvic (17) and the femoral (18)
and suture threads (19) of the anti-dislocation surgical prosthesis of
resurfacing, as shown in Fig. 1, performs the anti-dislocation function that
characterizes the surgical prosthesis of the present invention. The artificial
system of the round ligament, as tested on bench models, limits the axial
displacement between the acetabulum (13) and the femoral head (7) of the
surgical prosthesis within design and functional standards, allowing, however,
all other movements joints in the normal range of motion (ROM) of the hip, that
is, flexion, extension, medial rotation and lateral rotation, safely and
naturally.
[42] For the insertion of the round ligament artificial
system, consisting of two anchors or anti-dislocation locks, the pelvic (17)
and the femoral (18) and suture threads (19) of the anti-dislocation surgical
prosthesis for resurfacing, a tool is used (53) specially designed to perform
this operation, which has two ends with different diameters, a thin one (54) to
perform the insertion of the anchor or pelvic lock (17) of the system that
carries the surgical threads (19), as shown in the figure. Fig. 6A, and a
thicker one (55), which positions the pelvic anchor or latch (17), as shown in
Fig. 6B, after passing through the hole (16) in the pelvic bone, locking the
system equivalent in terms of function to that of the round ligament of the
animal hip joint.
[43] Once locked in the pelvis, the artificial round ligament
system, through the pelvic anchor or lock (17) and the suture threads (19) of
the resurfacing anti-dislocation surgical prosthesis, performs the passage of
these suture threads (19) through the femoral head (7) and guide-pin rod (9),
already cemented together (glued and forming a single component), through their
respective holes (41, 46), using the appropriate conventional surgical needle
(52) to this function. The resurfacing anti-dislocation surgical prosthesis,
together with the artificial system of the round ligament, is therefore housed
in the hole (11) existing in the femur (1), with its porous surface (24)
internal to the head coupled to the cylindrical neck (5), already modeled of
the femur (1), and its external porous surface (29) of the rod-guide-pin in the
femoral hole (11), in a precise and stable fit.
[44] The suture threads (19) are led by the surgical needle
(52) through the femur exit hole (15), where it passes through the femoral
anchor or lock (18) that receives the external surgical mooring (20),
performing thus the function of the round ligament equivalent system, which
positions and stabilizes the prosthesis and prevents its accidental
dislocation.
Femoral Head of Anti-dislocation Surgical Prosthesis for
Dogs and Animals of Any Size
[45] The femoral head (8) of the surgical resurfacing
prosthesis for animals of any size, as shown in Figs. 2, 3B, 3D and 5, has a
dense ceramic structure (22) and its spherical outer surface (34) is polished
with high dimensional and shape accuracy. Its inner surface (35), which is in
contact with the surface of the modeled bone (6), is porous, multidense and in
a functional gradient. Furthermore, the inner porous surface (35) of the
femoral head (8) which has a thickness between 0.5 to 2.0 mm can contain, since
the manufacturing process, osteoinductive materials such as 45S5 bioglass and
hydroxyapatite; and bone growth factors such as morphogenetic proteins such as
BMP and the like and/or live bone and/or cartilaginous tissue cultures
precultured in co-culture of these tissues. The femoral head (8) has a housing
or cylindrical hole (26) for coupling the femoral guide pin-rod (10) and also
chamfers (27) or internal and external finishing rounding.
[46] The femoral head (8) has a manufacturing process
involving two ceramic processes in co-pressing: uniaxial pressing in two stages
at 50.0 MPa and isostatic pressing at 200.0 MPa.
[47] In addition, it has a central hole (43), countersunk
externally (44) with rounded edges, for the passage of surgical suture threads
(19) that simulate and/or replace the round ligament, which prevent dislocation
of the prosthesis . The reamed central hole of the femoral head (8) coincides
with the hole (49) of the pelvic acetabulum (14) for both to allow the passage
of surgical threads (19) that constitute a functional system equivalent to that
of the round ligament.
Anti-dislocation Surgical Prosthesis Femoral Guide-Pin for
Dogs and Animals of Any Size
[48] The femoral guide pin-rod (10), as shown in Figs. 2,
3C, 3D and 5, has a dense structure (36) ceramic or polymeric or composite and
its external surface (37), which is in contact with the internal surface of the
hole (12) of the canine femur (2) or animal , is porous, multidense and in a
functional gradient. The external porous surface (37) of the femoral guide
pin-rod (10) which has a thickness between 0.3 to 1.0 mm can contain, from the
manufacturing process, osteoinductive materials such as 45S5 bioglass and
hydroxyapatite; and bone growth factors such as morphogenetic proteins such as
BMP and the like and/or live bone and/or cartilaginous tissue cultures
precultured in co-culture of these tissues.
[49] The femoral guide-pin rod (10) is assembled and
cemented into the femoral head (8), in the cylindrical housing (26) , to form
the femoral set of the anti-dislocation surgical prosthesis for resurfacing
animals of any size, using adhesives or commercial biological cements. The
femoral set of the anti-dislocation surgical prosthesis for resurfacing animals
of any size, as described, can be manufactured in a single piece formed by the
femoral guide-pin rod (10) and the femoral head (8), eliminating the use of
adhesives.
[50] The femoral guide-pin rod (10), with a dense body (36)
and a multidense porous surface (37) with a functional gradient, as shown in
Figs. 2, 3C and 3D can be manufactured from ceramic or polymeric materials and
can be molded with or without carbon fiber reinforcements if manufactured from
polymeric materials or will be isostatically pressed if manufactured from
ceramic materials. In both possibilities, the femoral guide-pin rod (10) has a
dense core (36) and a porous surface (37), multidense in a functional gradient.
[51] In addition, the femoral guide-pin rod (10) has a
central hole (47), which allows the passage of surgical suture threads (19)
that simulate and/or replace the round ligament, preventing dislocation of the
prosthesis. The central hole of the femoral guide-pin (10) coincides with the
hole (43) of the femoral head (8) and, thus, both allow the passage of surgical
threads (19) for locking the complete prosthesis (acetabulum, femoral head and
guide-pin rod) through the anchor or latch (17) of the pelvis and the anchor or
latch (18) of the femur, with adequate surgical mooring (20), after passing
through the hole (15) for exiting the femur ( 2), using suture needles (52),
thus performing the function of an artificial round ligament system, which
positions the prosthesis and prevents its accidental dislocation.
Pelvic Acetabulum of Total Surgical Resurfacing Prosthesis
for Dogs and Animals of Any Size
[52] The pelvic acetabulum (14) of the resurfacing
anti-dislocation surgical prosthesis illustrated in Figs. 2 and 3A have a dense
ceramic structure (38) and its inner surface (40) is polished with high
dimensional and shape accuracy. Its outer surface (39), which is in contact
with the bone surface of the canine or animal hip (2), as shown in Fig. 2, is
porous, multidense and functionally gradient. The external porous surface (39)
of the pelvic acetabulum (14) has a thickness between 0.5 to 2.0 mm and may
contain, since the manufacturing process, osteoinductive materials such as 45S5
bioglass and hydroxyapatite; and bone growth factors such as morphogenetic
proteins such as BMP and the like and/or with live bone and/or cartilaginous
tissue cultures precultured in co-culture of these tissues.
[53] The pelvic acetabulum (14) may present on its external
porous surface, indentations or circular pits with a greater porous thickness
and with a concentration of osteoinductive materials also greater, to emulate
its fixation, through accelerated osseointegration in these contact sites with
the host bone (2) . In addition, the pelvic acetabulum (14) has chamfers (33)
or internal and external rounding for finishing and has a manufacturing process
involving two ceramic processes in co-pressing: uniaxial pressing in two stages
at 50.0 MPa and isostatic pressing at 200.0 MPa.
[54] The pelvic acetabulum (14) has a central hole (49),
countersunk (51) internally with rounded edges, for the passage of surgical
suture threads (19) that simulate and/or replace the round ligament, which
prevent the prosthesis dislocation. The central hole of the pelvic acetabulum
(14) coincides with the hole (45) of the pelvic bone (4) and both allow the
passage and locking of the anchor or lock (17) for fixing the round ligament
system constituted by the surgical threads (19) .
Total Surgical Resurfacing for Dogs and Animals of Any Size
[55] The artificial system of the round ligament, consisting
of two anchors or anti-dislocation locks, the pelvic (17) and the femoral (18)
and suture threads (19) of the anti-dislocation surgical prosthesis of
resurfacing, as shown in Figs. 2 and 6C, perform the anti-dislocation function
that characterizes the surgical prosthesis of the present invention. The
artificial system of the round ligament, as tested on bench models, limits the
axial displacement between the acetabulum (14) and the femoral head (8) of the
surgical prosthesis within design and functional standards, allowing, however,
all other movements joints in the normal range of motion (ROM) of the hip, that
is, flexion, extension, medial rotation and lateral rotation, safely and
naturally.
[56] For the insertion of the round ligament artificial system,
consisting of two anchors or anti-dislocation locks, the pelvic (17) and the
femoral (18) and suture threads (19) of the surgical prosthesis, a tool (53) is
used. specially designed to carry out this operation, which has two ends with
different diameters, a thin one (54) to perform the insertion of the anchor or
pelvic lock (17) of the system that carries the surgical threads (19), as shown
in Fig. 6A, and a thicker one (55), which positions the pelvic anchor or latch
(17), as shown in Fig. 6B, after passing through the hole (45) in the animal
pelvic bone, locking the system equivalent in terms of function to the round
ligament of the animal hip joint.
[57] Once the artificial round ligament system is locked in
the animal pelvis through the pelvic anchor or lock (17) and the suture threads
(19) of the resurfacing anti-dislocation surgical prosthesis, the passage of
these suture threads is performed (19) through the femoral head (8) and
guide-pin rod (10), already cemented (glued and forming a single component),
through their respective holes (43, 47), using a surgical needle (52) suitable
for this function.
[58] The resurfacing anti-dislocation surgical prosthesis,
together with the artificial round ligament system, is therefore housed in the
hole (12) existing in the animal femur (2), with its porous surface (35)
internal to the femoral head coupled to the neck cylindrical (6), already
modeled from the animal femur (2), and with the outer surface (37) of the
femoral guide-pin attached to the femoral hole (12), in a precise and stable
fit.
[59] The suture threads (19) of the resurfacing
anti-dislocation surgical prosthesis are guided by the surgical needle (52)
through the femur exit hole (15), where it passes through the femoral anchor or
lock (18) that receives the mooring ( 20) external surgery, thus performing the
function of the round ligament equivalent system, which positions and
stabilizes the prosthesis and prevents its accidental dislocation.
[60] As can be seen, all the porous surfaces of the components
of the anti-dislocation surgical prosthesis in ceramic, polymeric, metallic,
composite and similar materials for orthopedic surgeries of hip resurfacing
arthroplasty have a functional gradient, inherent to their manufacture and can
receive compositions of bioglass, hydroxyapatite, or similar bone growth
accelerators and/or live bone and/or cartilaginous tissue cultures
pre-cultivated in co-culture of these tissues, which guarantee their mechanical
behavior and their biological integration in the form of a multidense porous
matrix to maintain its stability as a resurfacing hip prosthesis.
[61] Its multidense porous surfaces with functional gradient
have a porous structure with active pores with dimensions between 50.0µm to
400.Oµm to ensure bone integration through its adhesion to the site of bone
repair, allowing cell growth depending on the their pores have characteristics
and dimensions recommended by the literature. Therefore, the choice of
materials in this patent is confirmed, which combine properties of
biocompatibility, dimensional and functional stability, chemical stability and
mechanical resistance, such as those inherent to ceramics or polymers or
metals, objects of the present invention.
[62] Although the invention has been widely described, it is
obvious to those skilled in the art that various changes and modifications can
be made to improve the design without said changes falling outside the scope of
the invention.
Claims:
1.
Anti-dislocation surgical prosthesis for use in humans or animals of any size
comprising a femoral head (7, 8), femoral guide-pin rod (9, 10) and pelvic
acetabulum (13, 14), characterized by the fact that the femoral head (7, 8) has
a central hole (41, 43), with an external countersunk (42, 44) and rounded
edges, has a dense ceramic structure (21, 22) and its outer surface (23, 34) is
spherical and polished with high dimensional and shape precision and its
interior surface (24, 35) is porous, multidense and in a functional gradient,
such head (7, 8) being coupled respectively to the end modeled in the
cylindrical shape (5, 6); a femoral guide pin-rod (9, 10) with a dense
structure (28, 36) and external surface (29, 37) porous, multidense and in a
functional gradient, which is in contact with the internal surface of the hole
(11, 12 ) of the femoral bone (1, 2), which has a central hole (46) that
coincides with the hole (41) of the femoral head (7) for the passage of
surgical suture threads (19) in order to promote locking through of the anchor
or latch (17) of the pelvis and the anchor or latch (18) of the femur, with
surgical mooring (20) of the surgical threads after passing through the hole
(15) at the exit of the femur using conventional suture needles (52) and a
pelvic acetabulum (13, 14) that has a dense ceramic structure (30, 38), an
external surface (31, 39) porous, multidense and in functional gradient that is
in contact with the acetabular bone surface of the hip (3, 2 ) and an internal
structure (32, 40) polished with high dimensional and shape accuracy.
2.
Prosthesis, according to claim 1, characterized by the fact that the central
hole (41, 43) reamed of the femoral head (7, 8) coincides with the hole (48,
49) of the pelvic acetabulum (13, 14).
3.
Prosthesis, according to claim 1, characterized in that the inner porous
surface (24, 35) of the femoral head (7, 8) has a thickness between 0.5 to 2.0
mm and contains, from the process manufacture, osteoinductive materials such as
45S5 bioglass and hydroxyapatite and bone growth factors such as morphogenetic
proteins such as BMP (bone morphogenetic protein) and similar and/or live bone
and/or cartilaginous tissue cultures precultured in coculture of these
tissues.
4.
Prosthesis, according to claim 1, characterized by the fact that the femoral
head (7, 8) has a housing or cylindrical hole (25, 26) and chamfers (27) or
internal and external rounding.
5.
Prosthesis, according to claim 1, characterized in that the external porous
surface (29, 37) of the femoral guide-pin rod (9, 10) has a thickness between
0.3 and 1.0 mm and contains , from the manufacturing process, osteoinductive
materials such as 45S5 bioglass and hydroxyapatite; and bone growth factors
such as morphogenetic proteins such as BMP and the like and/or live bone and/or
cartilaginous tissue cultures precultured in coculture of these tissues.
6.
Prosthesis, according to claim 1, characterized by the fact that the femoral
guide-pin rod (9, 10) is manufactured with polymeric or polymeric ceramic
materials.
7.
Prosthesis, according to claim 6, characterized by the fact that the femoral
guide-pin rod (9, 10) when manufactured with polymeric materials is reinforced
with carbon fibers.
8.
Prosthesis, according to claim 6, characterized by the fact that the femoral
guide-pin rod (9, 10) when manufactured with ceramic materials is isostatically
pressed.
9.
Prosthesis, according to claim 1, characterized in that the femoral guide
pin-rod (9, 10) has a central hole (46, 47) that coincides with the hole (41,
43) of the femoral head ( 7, 8).
10. Prosthesis,
according to claim 1, characterized in that the external porous surface (31,
39) of the pelvic acetabulum (13, 14) has a thickness between 0.5 and 2.0 mm
and contains, from the process manufacturing, osteoinductive materials, such as
45S5 bioglass, hydroxyapatite; and bone growth factors, such as morphogenetic
proteins such as BMP and the like and/or live bone and/or cartilaginous tissue
cultures precultured in coculture of these tissues.
11.
Prosthesis, according to claim 1, characterized by the fact that the external
porous surface (31) of the pelvic acetabulum (13, 14) presents indentations or
circular pits with a greater porous thickness and with a concentration of
osteoinductive materials also greater.
12.
Prosthesis, according to claim 1, characterized by the fact that the pelvic
acetabulum (13, 14) has chamfers (33) or internal and external finishing
rounding.
13.
Prosthesis, according to claim 1, characterized in that the pelvic acetabulum
(13, 14) has a central hole (48, 49), internally countersunk (50, 51) with
rounded edges, which coincides with the hole ( 16, 45) of the pelvic bone (3,
4).
14.
Artificial round ligament system of the prosthesis as defined in any one of
claims 1 to 13, characterized in that it comprises the pelvic (17) and femoral
(18) anti-dislocation anchors or locks (18), suture threads (19) and a tool (
53) with a thin end (54) and a thick end (55).
15. System
according to claim 14, characterized in that it limits the axial displacement
between the acetabulum (13, 14) and the femoral head (7, 8) of the surgical
prosthesis and allows normal hip joint movements.
16. System,
according to claim 14, characterized in that the suture threads (19) are
conducted by a conventional surgical needle (52) (52) through the femoral head
(7, 8) and guide-pin rod (9 , 10) already cemented together through their
respective holes (41, 43, 46, 47).
17. System,
according to claim 14, characterized in that the suture threads (19) are led by
the surgical needle (52) through the hole (15) at the exit of the femur, where
it passes through the femoral anchor or lock (18 ) that receives the external
surgical tie (20).
18. System according to any one of claims 14 to 17, characterized in that together with the surgical prosthesis it is housed in the hole (11, 12) in the femur (1, 2), with a porous surface (24, 35 ) inside the head coupled to the cylindrical neck (5, 6), already modeled from the femur (1, 2), and its external porous surface (29, 37) of the guide-pin rod in the femoral hole (11, 12), in accurate and stable adjustment.
External links
Purquerio BM, Fortulan CA, Botega R, de Moraes TF. Prótese cirúrgica antiluxação e sistema artificial de ligamento redondo da mesma [Antiluxation surgical prosthesis and artificial round ligament system thereof]. BR102015006381A2 March 23, 2015. 2016. patents.google
Publications
of invention
BR102015006381 (А2)
BR102015006381 (B1)
2016PurquerioBM_deMoraesTF
Authors & Affiliations
Benedito De Moraes Purquerio –
De São Paulo, BR
Renan Botega – De São Paulo,
BR
Thiago Francisco De Moraes –
De São Paulo, BR
Carlos Alberto Fortulan – De
São Paulo, BR
Keywords
ligamentum capitis femoris, ligamentum teres, ligament of head of femur, endoprosthesis, prosthesis, invention, bipolar, total
NB! Fair practice / use: copied for the purposes of criticism, review, comment, research and private study in accordance with Copyright Laws of the US: 17 U.S.C. §107; Copyright Law of the EU: Dir. 2001/29/EC, art.5/3a,d; Copyright Law of the RU: ГК РФ ст.1274/1.1-2,7
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