U.S. patent application number 16/278541 was filed with the patent office on 2019-06-20 for implantable connector.
The applicant listed for this patent is SeaSpine Orthopedics Corporation. Invention is credited to Michael Di Lauro.
Application Number | 20190183539 16/278541 |
Document ID | / |
Family ID | 65322607 |
Filed Date | 2019-06-20 |
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United States Patent
Application |
20190183539 |
Kind Code |
A1 |
Di Lauro; Michael |
June 20, 2019 |
Implantable Connector
Abstract
A rotational connector insertable into a surgical incision onto
a top of a pedicle screw in a first orientation and rotated into a
second orientation to engage a primary fusion rod. The rotational
connector may include a revision rod coupled to one end
thereof.
Inventors: |
Di Lauro; Michael;
(Carlsbad, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SeaSpine Orthopedics Corporation |
Carlsbad |
CA |
US |
|
|
Family ID: |
65322607 |
Appl. No.: |
16/278541 |
Filed: |
February 18, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15436308 |
Feb 17, 2017 |
10206718 |
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16278541 |
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62296260 |
Feb 17, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/7007 20130101;
A61B 17/7004 20130101; A61B 17/7052 20130101; A61B 2017/867
20130101; A61B 17/7032 20130101; A61B 17/8665 20130101; A61B
2017/564 20130101 |
International
Class: |
A61B 17/70 20060101
A61B017/70; A61B 17/86 20060101 A61B017/86 |
Claims
1. An implantable connector system comprising: a rotational
connector having a first end, a second end, and a middle portion,
wherein said middle portion includes a through opening that has a
central axis, wherein said first end and said second end extend
outwardly from said middle portion transversely to said central
axis, wherein said first end is configured to rotate from a first
orientation to a second orientation, wherein in said first
orientation said middle portion of said rotational connector is top
loaded onto a head of an existing pedicle screw wherein said
through opening receives a head of an existing pedicle screw head
and in said second orientation said first end of said rotational
connector receives an outer surface of a primary fusion rod, and
wherein said second end includes a receptacle; a revision rod
having a first end and a second end, wherein said first end is
matingly received in said receptacle of said second end of said
rotational connector; a connector set screw configured to
threadingly engage a set screw opening in said first end of said
rotational connector; and a revision rod set screw configured to
threadingly engage a set screw opening in said second end of said
rotational connector.
2. The implantable connector system of claim 1 wherein said
rotational connector includes a bottom having a receiving slot
configured to receive an existing pedicle screw and a primary
fusion rod.
3. The implantable connector system of claim 2 wherein said
receiving slot is a vertical first slot intersecting a horizontal
second slot.
4. The implantable connector system of claim 3 wherein said
horizontal second slot is substantially in line with said revision
rod when said first end of said revision rod is matingly received
in said receptacle of said second end of said rotational
connector.
5. The implantable connector system of claim 1 wherein said first
end of said revision rod and said receptacle of said second end of
said rotational connector is a ball-and-socket joint.
6. The implantable connector system of claim 1 wherein said first
end of said revision rod and said receptacle of said second end of
said rotational connector each have corresponding vertical teeth
positioning said revision rod at an angle relative to said
rotational connector.
7. The implantable connector system of claim 1 wherein said first
end of said revision rod or said receptacle of said second end of
said rotational connector includes one or more protrusions received
in one or more channels of the other one of said first end of said
revision rod or said receptacle of said second end of said
rotational connector.
8. An implantable connector system comprising: a revision rod
having a first end and a second end; a rotational connector having
a first end, a second end, and a middle portion, said middle
portion having a through opening extending from a bottom of said
rotational connector wherein said first end and said second end
extend radially outward from said through opening of said middle
portion; said rotational connector having a bottom with a first
slot extending inwardly to a second slot, wherein said second slot
is transverse to and intersects said first slot, wherein said
second slot extends into said first end of said rotational
connector; at least one first set screw threadingly engaging said
first end of said revision rod to said second end of said
rotational connector; and at least one second set screw threadingly
engaging said first end of rotational connector and extending into
said second slot in said first end of said rotational
connector.
9. The implantable connector system of claim 8 wherein said first
end of said rotational connector includes a top member, a bottom
member, and a side member interconnecting said top member to said
bottom member, and wherein said top member, said bottom member, and
said side member define said second slot in said first end of said
rotational connector.
10. The implantable connector system of claim 8 wherein said
revision rod is axially aligned with said second slot when said
revision rod is coupled with said rotational connector.
11. The implantable connector system of claim 8 wherein said
revision rod is not axially aligned with said second slot when said
revision rod is coupled with said rotational connector.
12. The implantable connector system of claim 8 wherein said
revision rod and said rotational connector are coupled by a
ball-and-socket joint.
13. The implantable connector system of claim 8 wherein said second
slot extends into said second end of said rotational connector.
14. The implantable connector system of claim 8 wherein said
revision rod is spaced at a higher elevation than said second slot.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to and benefit from under
35 U.S.C. .sctn. 120 to copending U.S. patent application Ser. No.
15/436,308, filed on Feb. 17, 2017, which claims priority to U.S.
Provisional Application No. 62/296,260, filed Feb. 17, 2016, the
entire contents of aforementioned applications are herein
incorporated by reference in their entirety.
FIELD
[0002] The present disclosure is directed to methods and apparatus
for implantable connection to a rod, such as a spinal rod.
BACKGROUND
[0003] Surgery, whether of the spine or other areas of the body, is
often complex and routinely involves the need for highly
experienced medical staff, in addition to well-designed and
well-manufactured implants, made to exacting specifications. Often
the implants take the form of various types of hardware. In the
area of spinal fixation, for example, various spinal fixation
devices have been developed in the art. Some examples of such
fixation devices include spinal rods, plates, corpectomy cages, and
intervertebral discs, to name but a few. Spinal fixation rods are
fixation devices configured to fix adjacent vertebrae of a spine
relative to each other. The rods provide stabilization of the spine
till fusion occurs. The spinal fixation rods are often used in
spinal surgeries to repair spinal abnormalities, whether related to
injury or otherwise. The spinal rods are configured to attach to
the vertebrae using, for example, anchoring devices like pedicle
screws and hooks.
[0004] Patients often experience extreme and debilitating pain
because of spinal column injuries or from spinal column disorders
such as spondylolisthesis and scoliosis. Pain may be attributed to
issues of the spine as related to degeneration, deformity, and/or
injury. Often a typical course of treatment involves surgical
spinal fixation utilizing spinal fixation rods that mechanically
immobilize areas of the spine causing, ideally, the eventual fusion
of the treated vertebrae.
[0005] Sometimes additional surgical procedures, known as revision
surgeries, become necessary. Several causes exist for the need for
revision surgeries. For example, pseudarthrosis (failure to achieve
solid fusion) may have occurred, which can be due to various causes
such as poor tissue healing, improper implant placement or
securement, implant failure, or to patient-related factors.
Sometimes revision surgeries are indicated even after successful
initial surgeries, given that the function and shape of the spine
can deteriorate with age. Also, after prolonged use, the spinal
fixation rods may move or become dislodged or unstable, or even
bend or break.
[0006] Revision surgery is also required to treat adjacent segment
disease ("ASD"). Spinal fusion recipients may be at risk for
developing ASD, a condition in which the motion segments adjacent
to the fused vertebral segments experience higher rates of
degeneration or deterioration due to an increase in vertebral
loading, higher intradiscal pressures, increased range of motion,
and increased facet motion. Treatment options for ASD begin with
determining whether the primary fusion is intact. If so, then a
revision surgery with a revision connector is a likely course of
action.
[0007] When considering spinal fusion revision surgery options, a
few revision connectors are known, such as the "Revere Addition
Revision System" and the "Expedium Universal Connector". However,
these connectors suffer from various drawbacks. First, these prior
connectors are difficult to connect to the spinal level above the
targeted level. This may be due to scar tissue or fusion mass that
has developed in the lateral "gutters" across the transverse
process. Second, such connectors add significant profile to the
implant, both laterally and in height. Increased height can cause
problems post-surgery when patients can feel the implants under
their skin. Sometimes this leads to deep superficial pain. Third,
prior art revision connectors do not achieve adequate stability
in-line with the primary rod. Fourth, some prior art connectors are
not ideal for minimally invasive surgical implantation
techniques.
[0008] What is needed is a universal revision connector that is
easy to install, with minimal profile, and that can sit in-line,
nearly in-line, and/or at desired angles with the primary fusion
rod. The connector ideally minimizes the disruption of the previous
fusion mass and limposes less violation of the scar tissue. The
stabilization may be extended to the next level above or below the
fusion. Additional benefit is also achieved with a connector that
can be inserted percutaneously. Ideally, a connector is desired
that is not only suitable for revision surgeries, but also for
primary fusion surgeries. The present connector provides vast
improvement over such existing revision connectors.
SUMMARY
[0009] The disclosure herein is directed to an apparatus, system,
and method for use in primary or revision surgeries. The system or
implantable connector system would typically include at least a
rotational connector, a connector set screw, a connector rod, and a
connector rod set screw in some embodiments. The rotational
connector is inserted in a "twist and lock" fashion.
[0010] In some embodiments of the invention, for example, an
implantable connector system may include a rotational connector.
The rotational connector may have a first end and a second end. In
some embodiments, the first end may be configured to rotate from a
first orientation to a second orientation, wherein in the first
orientation the rotational connector may be top loaded onto a head
of an existing pedicle screw. In some embodiments, when in the
second orientation the first end of the rotational connector may
receive an outer surface of a primary fusion rod. The second end
may include a receptacle in some embodiments. In various
embodiments, the implantable connector system may include a
revision rod. The revision rod may have a first end and a second
end. The first end may be matingly received in the receptacle of
the second end of the rotational connector. Moreover in some
embodiments, the implantable connector system may include a
connector set screw. The connector set screw may be configured to
threadingly engage a set screw opening in the first end of the
rotational connector. In various embodiments, the implantable
connector system may include a revision rod screw such as a set
screw. The revision rod set screw may be configured to threadingly
engage a set screw opening in the second end of the rotational
connector.
[0011] In some embodiments, the rotational connector may include a
middle portion top loaded onto a head of an existing pedicle screw.
In various embodiments, the rotational connector may include a
bottom having a receiving slot configured to receive an existing
pedicle screw and a primary fusion rod. Further in some
embodiments, the receiving slot may be a vertical first slot
intersecting a horizontal second slot. Moreover in some
embodiments, the horizontal second slot may be substantially in
line with the revision rod when the first end of the revision rod
is matingly received in the receptacle of the second end of the
rotational connector. In various embodiments, the first end of the
revision rod and the receptacle of the second end of the rotational
connector may be a ball-and-socket joint. In some embodiments, the
first end of the revision rod and the receptacle of the second end
of the rotational connector may each have corresponding vertical
teeth positioning the revision rod at an angle relative to the
rotational connector. Moreover, in various embodiments, the first
end of the revision rod or the receptacle of the second end of the
rotational connector may include one or more protrusions received
in one or more channels of the other one of the first end of the
revision rod or the receptacle of the second end of the rotational
connector.
[0012] In various embodiments, an implantable connector system may
include a revision rod. The revision rod may have a first end and a
second end. In some embodiments, the implantable connector system
may include a rotational connector. Moreover in some embodiments,
the rotational connector may have a first end, a second end, and a
middle portion connecting the first end and the second end. Further
in some embodiments, the middle portion may have a through opening
extending from a bottom of the rotational connector. In some
embodiments, the rotational connector may have a bottom with a
first slot extending inwardly to a second slot. In some
embodiments, the second slot may be transverse to and intersects
the first slot. In various embodiments, the second slot may extend
into the first end of the rotational connector. In various
embodiments, the implantable connector system may include at least
one first set screw. The first set screw may threadingly engage the
first end of the revision rod to the second end of the rotational
connector. In various embodiments, the implantable connector system
may include at least one second set screw. The second set screw may
threadingly engage the first end of rotational connector and extend
into the second slot in the first end of the rotational
connector.
[0013] In addition, in various embodiments, the first end of the
rotational connector may include a top member, a bottom member, and
a side member interconnecting the top member to the bottom member.
In some embodiments the top member, the bottom member, and the side
member may define the second slot in the first end of the
rotational connector. In some embodiments, the revision rod may be
axially aligned with the second slot when the revision rod is
coupled with the rotational connector. In various embodiments, the
revision rod may not be axially aligned with the second slot when
the revision rod is coupled with the rotational connector. Moreover
in some embodiments, the revision rod and the rotational connector
may be coupled by a ball-and-socket joint. In some embodiments, the
second slot may extend into the second end of the rotational
connector. In various embodiments, the revision rod may be spaced
at a higher elevation than the second slot.
[0014] Other embodiments may include a method of implanting a
rotational connector. In some embodiments the rotational connector
may have a first end and a second end. In various embodiments, the
method may include opening a first surgical site in a patient to
access a primary fusion site. Moreover, in some embodiments, the
primary fusion site may include a primary fusion rod having a
longitudinal rod axis and a first end and a second end, and a
pedicle screw engaged in a vertebra. The first end of the primary
fusion rod may terminate at a first distance away from an outer
surface of the pedicle screw measured in a first direction in some
embodiments. Further in some embodiments, the first direction may
be generally parallel to the longitudinal rod axis. In some
embodiments, the method may include inserting the rotational
connector in a first orientation through the first surgical site
and onto the pedicle screw in a second direction, the second
direction may be generally perpendicular to the first direction. In
various embodiments, the first orientation may be disposed at an
angle to the longitudinal rod axis. In some embodiments, the method
may include rotating the rotational connector from the first
orientation to a second orientation, wherein in the second
orientation the first end of the rotational connector matingly
receives therewithin the second end of the primary fusion rod. In
some embodiments, the method may include inserting a set screw into
the first end of the rotational connector to secure the rotational
connector to the primary fusion rod. In various embodiments, the
method may include inserting a first end of a revision rod into the
second end of the rotational connector. In some embodiments, the
method may include inserting a set screw into the second end of the
rotational connector to secure the rotational connector to the
revision rod.
[0015] In addition, in some embodiments, the step of rotating the
rotational connector from the first orientation to the second
orientation may include wherein in the second orientation the
second end of the rotational connector matingly receives
therewithin the first end of the primary fusion rod. In various
embodiments, the method may include the step of positioning the
revision rod at an angle relative to the second end of the
rotational connector. Moreover, in various embodiments, the step of
position the revision rod at the angle relative to the second end
of the rotational connector may include spherical angulation. In
some embodiments, the step of rotating the rotational connector
from the first orientation to the second orientation may include
rotating the rotational connector about a screw head of the pedicle
screw after the pedicle screw is inserted into the rotational
connector. In some embodiments, the method may include the step of
axial alignment of the revision rod and the primary fusion rod. In
some embodiments, the step of rotating the rotational connector
from the first orientation to the second orientation may include
rotating an acute angle between the first orientation and the
second orientation. Further, in some embodiments the acute angle
may be 30 degrees.
DESCRIPTION OF DRAWINGS
[0016] In the drawings, like reference characters generally refer
to the same parts throughout the different views. Also, the
drawings are not necessarily to scale, emphasis instead generally
being placed upon illustrating the principles of the invention
[0017] FIG. 1 is a top perspective view of an embodiment of a
system.
[0018] FIG. 2 is a top perspective view of the rotational connector
of FIG. 1 illustrating top loading in a first orientation relative
to a pedicle screw system.
[0019] FIG. 3 is a top perspective view of the rotational connector
of FIG. 1 illustrating a second orientation or neutral position
relative to the pedicle screw system with the set screws engaging
the primary fusion rod.
[0020] FIG. 4 is a top perspective view of the rotational connector
of FIG. 1 illustrating the top loading of an embodiment of the
revision rod.
[0021] FIG. 5 is a top perspective view of the revision rod of FIG.
4 illustrating an in-line position of the revision rod fastened by
a set screw in the rotational connector.
[0022] FIG. 6 is a top perspective view of the rotational connector
of FIG. 1.
[0023] FIG. 7 is a bottom perspective view of the rotational
connector of FIG. 6.
[0024] FIG. 8 is a perspective view of the set screw of FIG. 1 for
securing the primary fusion rod.
[0025] FIG. 9 is a perspective view of the revision rod of FIG.
1.
[0026] FIG. 10 is a perspective view of the connector rod set screw
of FIG. 3 for securing the revision rod.
[0027] FIG. 11 is a top perspective view of another embodiment of a
system, illustrating a rotational connector in a second orientation
or neutral position relative to the pedicle screw system with a set
screw engaging the primary fusion rod and a revision rod being top
loaded onto the rotational connector.
[0028] FIG. 12 is a top view of the embodiment of FIG. 11,
illustrating a set screw positioning the revision rod at an angle
relative to the rotational connector and/or primary fusion rod.
[0029] FIG. 13 is a top perspective view of the rotational
connector of FIG. 11.
[0030] FIG. 14 is a top view of the rotational connector of FIG.
13.
[0031] FIG. 15 is a perspective view of the set screw for the
rotational connector of FIG. 11 for engaging the primary fusion
rod.
[0032] FIG. 16 is a bottom perspective view of the revision rod of
FIG. 11 for use with the rotational connector opposite the primary
fusion rod.
[0033] FIG. 17 is a perspective view of the set screw for the
revision rod of FIG. 11.
[0034] FIG. 18 is top perspective view third embodiment of a system
engaging a pedicle screw system, illustrating the rotational
connector in the second orientation with the set screw engaging the
primary fusion rod removed.
[0035] FIG. 19 is top perspective view of the system of FIG. 18
with the set screw of the ball-and-socket engagement of the
rotational connector and revision rod exploded away therefrom.
[0036] FIG. 20 is a side view of the system of FIG. 18.
[0037] FIG. 21 is a side sectional view of the system of FIG. 18
taken along line 21-21.
[0038] FIG. 22 is a top perspective view of the rotational
connector of FIG. 18.
[0039] FIG. 23 is a perspective view of the revision rod of FIG. 18
for use with the rotational connector.
[0040] FIG. 24 is a perspective view of the set screw of FIG. 18
for engaging the revision rod.
[0041] FIG. 25 is a bottom perspective view of a fourth embodiment
of a rotational connector.
[0042] FIG. 26 is a side view of another embodiment of a system
engaging a pedicle screw system.
[0043] FIG. 27 is a bottom view of the system engaging a pedicle
screw system of FIG. 26.
[0044] FIG. 28 is a top perspective view of the system engaging a
pedicle screw system of FIG. 26 exploded away from each other.
[0045] FIG. 29 is a side view of FIG. 28.
[0046] FIG. 30 is a top perspective view of the rotational
connector of FIG. 26 in a first orientation relative to the pedicle
screw system.
[0047] FIG. 31 is a top perspective view of the rotational
connector of FIG. 26 in a second orientation relative to the
pedicle screw system illustrating the set screws engaging the
primary fusion rod.
[0048] FIG. 32 is a top perspective view of the rotational
connector of FIG. 26 in a second orientation relative to the
pedicle screw system illustrating the top loading of the revision
rod.
[0049] FIG. 33 is a top perspective view of another embodiment of a
system engaging a pedicle screw system.
[0050] FIG. 34 is a top perspective view of the system engaging a
pedicle screw system of FIG. 33 exploded away from each other.
[0051] FIG. 35 is a top view of the system engaging a pedicle screw
system of FIG. 33.
[0052] FIG. 36 is a side view of the system engaging a pedicle
screw system of FIG. 33.
[0053] FIG. 37 is a bottom view of the system engaging a pedicle
screw system of FIG. 33.
[0054] FIG. 38 is a top perspective view of another embodiment of a
system engaging a pedicle screw system.
[0055] FIG. 39 is a top perspective view of the system engaging a
pedicle screw system of FIG. 38 exploded away from each other.
[0056] FIG. 40 is a top view of the system engaging a pedicle screw
system of FIG. 38.
[0057] FIG. 41 is a side view of the system engaging a pedicle
screw system of FIG. 38.
[0058] FIG. 42 is a bottom view of the system engaging a pedicle
screw system of FIG. 38.
DETAILED DESCRIPTION
[0059] FIG. 1 shows a first embodiment of the implantable connector
system 20 and/or rotational connector 30. In the embodiments
described herein, the context of a revision surgery will be used as
an example, it being understood that the principles, methods, and
structures involved are equally suited in the context of primary
surgery as well. For example, in the context of a revision surgery,
the embodiments describe the rod that is connected to the "primary
fusion rod" to be a "revision rod". However, in primary fusion
surgeries using the apparatus herein, the "revision rod" is more
generically referred to as a secondary fusion rod.
[0060] In a first embodiment as shown in FIGS. 1-10, the apparatus
includes a top-loading, rotatable, in-line rotational connector 30
for coupling a revision rod 40, or secondary rod, to a primary
(pre-existing, if in a revision surgery) fusion rod 2 of a pedicle
screw system 1. The rotational connector 30 is a top loaded "twist
connect" design that fits over an existing pedicle screw 3, or more
specifically in some embodiments the screw head, and then twists
into an in-line position (FIG. 3) with a first end 30a of the
rotational connector 30 cradling an end 2a of an existing primary
fusion rod 2. The rotational connector 30 is then secured to the
end 2a of the primary fusion rod 2 with one or more set screws 50.
A first end 40a of a revision rod 40 is then inserted into the
second end 30b of the rotational connector 30, and secured with one
or more set screws 60.
[0061] As shown in the embodiment of FIGS. 1-10, the rotational
connector 30 may include a receiving slot 31 to engage the pedicle
screw 3 and the primary fusion rod 2. In the embodiment shown, the
receiving slot 31 may include a first slot 32 intersecting a second
slot 33 to receive the pedicle screw 3 and the primary fusion rod
2. The first slot 32 may extend upwardly from a bottom 34 of the
rotational connector 30 for a first distance allowing the screw
head 4 and primary fusion rod 2, on one or both sides of the screw
head, to be received within the first slot 32 of the rotational
connector 30 when in the first orientation (FIG. 2). The screw head
4 and/or primary fusion rod 2 may be substantially vertically
inserted into the first slot 32 for the first distance. As such the
rotational connector 30 may be vertically coupled to the screw head
4 and/or the primary fusion rod 2 when in the first orientation
(FIG. 2). The first slot 32 may be described in some embodiments as
being in a substantially vertical first plane P1. The second slot
33 is transverse to and intersects the first slot 32 (i.e.
perpendicular to the first slot). The second slot 33 may be
described as being in a second plane P2 transverse to the first
plane. The second slot 33 may extend within the second plane P2
from the first plane P1 or first slot 32 passing through the
central axis C of the rotational connector 30, (i.e. the central
axis of the screw head 4), and may extend in opposite rotational
angles A from the first plane P1 about the central axis C. The
second slot 33 and/or first slot 32 do not have to be symmetric
and/or similar in shape or size (length, width, and/or height)
about the central axis C in some embodiments. For example although
the second slot 33 is shown as extending through both rotational
connector ends from the central axis C and/or portions of the first
slot 32, it should be understood that that second slot may not
extend into the second end 30b in some embodiments such as when the
primary fusion rod is not present or of a reduced distance/length
on one side of the screw head 4 adjacent the revision rod 40. The
second slot 33 may be generally described as increasing in width
along the second plane P2 in opposing directions from the central
axis C, or towards the first end 30a and opposing second end 30b of
the rotational connector 30. The second slot 33 may extend through
opposing lateral sides 35, 36 of the rotational connector 30,
thereby creating open faces at the respective first end 30a and
second end 30b of the rotational connector 30. When the rotational
connector 30 has been vertical positioned (i.e. downwardly) for a
the first distance within the first slot 32 in the first
orientation (FIG. 2), these open faces or openings adjacent one or
more of the connector ends allow the primary fusion rod 2
projecting from the screw head 4 in at least one direction to pass
through and continue into the remaining portion of the second slot
33. As such, at least the primary fusion rod 2 travels or rotates
within the second slot 33 for a second distance or angle on one or
both sides of the screw head 4 and/or middle portion 30c. Thereby
when positioning the rotational connector 30 from the first
orientation (FIG. 2) to the second orientation (FIGS. 1 and 3-5),
the rotational connector 30 further rotates for an angle A relative
to the primary fusion rod 2 and the screw head 4 traveling within
the second slot 33. It should be understood that one or more slots
may be used to vertically insert and/or rotate the rotational
connector 30 relative to the pedicle screw 3 and/or primary fusion
rod 2. For example, a helical slot extending upwardly from the
bottom 34 of the rotational connector may provide for the vertical
and rotational movement of the rotational connector relative to the
pedicle screw and rod.
[0062] The rotational connector 30 may include a variety of
structure to define the receiving slot 31 that allows axial and
rotational engagement with the pedicle screw system 1 between the
first orientation and second orientation (i.e. screw head 4 and
primary fusion rod 2). In the embodiment shown in FIGS. 1-10, the
rotational connector 30 may include a first end 30a, second end
30b, and a middle portion 30c between the first end 30a and second
end 30b in some embodiments. The middle portion 30c may include a
cylindrical wall defining a through opening 37 to receive or slip
over a top portion of the screw head 4. The through opening 37 may
be a portion of the first slot 32 and/or second slot 33. The first
end 30a and second end 30b project in opposing directions from the
outer periphery of the wall of the middle portion 30c. The first
end 30a of the rotational connector 30 receives an outer surface of
the primary fusion rod 2. The first end 30a may be generally
described as U-shaped or a C-channel extending from the middle
portion 30c. The first end 30a of the rotational connector includes
a top member 38a and bottom member 38b connected by a side member
38c. The top and bottom members 38a, 38b are separated by the
second slot 33 and define the open face of the first end 30a within
the lateral side 36. In some embodiments, the bottom member 38b may
include a tapered edge 38d defining the first slot 32 for
substantial vertical insertion from the bottom 34. The open face
extends from the lateral side 36 to a distal free end 38e. The side
member 38c, opposite the open face, may be an abutment to the
primary fusion rod 2 in its neutral position in the second
orientation (FIG. 3) of the rotational connector 30. The first end
30a of the rotational connector 30 may include one or more set
screw openings 50a, 50b. In the embodiment shown, the top member
38a of the first end 30a includes one or more set screw openings
50a and 50b to receive one or more connector set screws 50. The
connector set screws 50 may compress the primary fusion rod 2
against the bottom member 38b to secure the rotational connector 30
in the second orientation. The second end 30b of the rotational
connecter 30 may couple adjacent ends of the primary fusion rod 2
and the revision rod 40. The second end 30b of the rotational
connector 30 may include a receptacle 70 configured to receive a
first end 40a of the revision rod 40. On embodiment of the
receptacle 70 of the second end 30b opposite the first end 30a may
include a top member 71 and a depending side member 72. The top
member 71 and/or side member 72 may define a portion of the second
slot 33 and the open face in the opposite facing direction or
lateral side 35 of the first ends' open face on the lateral side
36. The open face extends from the lateral side 35 to the distal
free end 73 in some embodiments. The open faces of the first and
second ends 30a and 30b face in the same rotational direction (i.e.
clockwise direction), towards the second orientation. The side
member 72 of the second end 30b may be a rotational stop of the
primary fusion rod 2, if the side member and/or primary fusion rod
end is present. In some embodiments, side members 72 may not be
used or saddle the primary fusion rod. Further in some embodiments,
the middle portion 30c and the first end 30a may define the
receiving slot 31 to receive the screw head 4 and primary fusion
rod 2 therein (see FIGS. 26-42). Although not shown, a bottom
member may be used in the second end 30b if desired. In some
embodiments, the second end 30b may not include a portion of the
second slot 33 and/or receiving slot 31. The one or more lateral
sides 35 and 36 of the second end 30b or receptacle 70 may include
a protrusion 74, or alternatively a recess in some embodiments, to
interlock with a revision rod 40 in some embodiments. The
interlocking of the second end 30b or receptacle 70 (i.e. outer
periphery and/or inner periphery) and the revision rod 40 may
reduce separation. In the embodiment shown, the protrusion 74 is a
vertical rib projecting from each lateral side 35, 36 of the second
end 30b. As such the revision rod engagement would have a
corresponding engagement feature. The revision rod 40 in the
embodiment shown in FIGS. 1, 4, 5, and 9 may include a vertical
recess or channel 41 to slidingly receive the vertical rib or
protrusion 74 of the rotational connector 30. The second end 30b of
the rotational connector 30 may include one or more set screw
openings 60a to receive a revision rod set screw 60 to couple the
revision rod 40 to the rotational connector 30. The first end 40a
of the revision rod includes an opening 42 receiving the revision
rod set screw 60. In the embodiment shown, the top member 71 of the
second end 30b includes the set screw opening 60a.
[0063] As shown in FIGS. 1, 4, 5, and 9, the revision rod 40 may
couple to the second end 30b of the rotational connector 30. As
shown in the embodiment of FIG. 1, the first end 40a of the
revision rod 40 couples to the second end 30b or receptacle 70 of
the rotational connector 30. The first end 40a of the revision rod
40 includes an inner periphery 43 sliding over the outer periphery
of the second end 30b of the rotational connector 30. The revision
rod set screw 60 threadingly engages the revision rod 40 to the
second end 30b of the rotational connector 30. When the rotational
connector 30 is in the second orientation, the revision rod 40 is
substantially aligned. In the embodiment shown in FIG. 5, the
revision rod 40 may be substantially co-axial (i.e. substantially
vertically and horizontally aligned with the primary fusion rod 2).
It should be understood that a variety of embodiments of the
rotational connector 30, receptacle 70, and/or revision rod 40 may
be used to orientate and/or position the revision rod in a variety
of angles and/or heights relative to the rotational connector 30
for a particular application. It should also be understood that the
receptacle 70 engaging the revision rod 40 may be of a variety of
shapes, sizes, quantities, and constructions and still position the
revision rod for an application.
[0064] The rotational connector 30 may be described as having a
"twist connect" design. The rotational connector 30, or more
specifically the middle portion 30c, is adapted to fit a variety of
screw sizes. The through openings 37 may be sized in diameter
and/or height to correspondence to a variety of screw head 4 or
pedicle screw 3 designs. The height of the rotational connector 30
may not extend vertically above the existing screw head in some
embodiments. Moreover, the revision rod may not extend above the
vertical extent of the rotational connector, or portions thereof.
In the embodiment shown in FIGS. 2-5, the first end 40a of the
revision rod 40 is received in a recessed or lower surface 75 of
the second end 30b creating a substantially planar top surface of
the combined revision rod 40 and rotational connector 30. The
recessed surface 75 may include the top member 71 at a lower
elevation than the top surface of the middle portion 30c. When
combined as shown in FIG. 5, the revision rod 40 is substantially
in line with the existing primary fusion rod 2. The rotational
connector 30 may allow the revision rod 40 to be inserted sub
muscularly in some embodiments. The rotational connector is top
loaded onto the pedicle screw (i.e. vertical movement) (see FIGS. 2
and 3). The rotational connector 30 may be rotated from a first
orientation (FIG. 2) wherein the screw head is engaged at a
vertical or down position and the primary fusion rod 2 is
disengaged to a second orientation (FIG. 3) wherein the screw head
4 and one or more of the opposing ends of the primary fusion rod 2
extending away from the screw head is engaged. The rotational
connector 30 may be placed by rotating an acute angle between the
first orientation to the second orientation. In some embodiments,
the angle may be a variety of angles between the orientations (i.e.
obtuse angle). In the embodiment shown, the rotational connector 30
travels about 30 degrees between the first orientation and the
second orientation. When the rotational connector is rotated to the
second orientation, or neutral position, one or more set screws 50
may lock the rotational connector 30 to the primary fusion rod 2.
The revision rod 40 may be top loaded upon rotational connector 30
and axially aligned with the primary fusion rod 2 and secured to
the rotational connector 30 by one or more screws 60. The revision
rod 40 may not be axially aligned in some embodiments.
[0065] The end of the existing fusion rod can protrude beyond the
pedicle screw in a range of distances, which are typically not
known ahead of time since it was a result of the previous surgeon's
work. The rotational connector herein is designed to be placed
in-line over the existing rod with enough room to accommodate for
nearly any amount of protrusion by the existing rod. Typically
surgeons like to leave at least some amount of rod protruding
beyond the screw to ensure that there is a guarantee that the rod
is completely in the saddle of the screw for grip strength. The
rotational connector herein is designed so that surgeons never need
to adjust the pre-existing rod or construct because the goal is to
leave the original fusion rod/construct untouched if possible, to
minimize the risk of compromising fusion, as well as to eliminate
the need to simply replace the existing fusion rod construct and
the screws at the existing level when proceeding to build up to the
next levels during revision surgery.
[0066] The revision rod can be as long as desired. Theoretically,
the surgeon could run the revision rod all the way up the spine if
desired, though this would not be typical. Usually, surgeons will
elect to cut the revision rod to the desired length during revision
surgery; thus, the revision rod herein can begin as long as
desired, and then can be cut by the surgeon.
[0067] The set screws are prevented from backing out via their
standard, well-known set screw thread design. This is the same
mechanical principle that applies to a pedicle screw with a locking
set screw: once a recommended torque on the set screws is achieved,
the set screws are secure.
[0068] In this first embodiment shown in FIGS. 2-4, 6, and 7, one
or more ridges, tongues, or protrusions 74 are provided on the
external surface of the second end 30b of the rotational connector
30. These protrusions 74 mate with corresponding grooves inside the
first end 40a of the revision rod head portion. These protrusions
74 are designed to interface to carry the load between the two
components. This way the set screw 60 does not have to sustain the
full load in some embodiments. In other embodiments they could be
replaced by a single spherical surface (as, e.g., in a second
embodiment described below) or by a rod that has a female spherical
ball end that drops into a mating spherical cavity of the
rotational connector shown and described in an embodiment below.
The purpose of these alternatives is to prevent separation and
allows the rod to be angulated in order to accommodate less than
perfectly placed pedicle screws. This allows for a more secure
connection while allowing for some variation in placement.
[0069] The rotational connector 30 that accepts the existing rod is
designed to have a geometric shape that adds structural stability
to the rotational connector as shown in FIG. 3. The material of the
rotational connector 30 creates a tall wall or side member 38c on
one side of the existing rotational connector 30. The rotational
connector can accept most commonly used rods (such as, e.g., 5.5 mm
rods), but obviously can be easily dimensioned to fit on larger or
small diameter rods as desired. The rotational connector itself has
an inner diameter and surface that defines the through opening 37
and accommodates the many sizes of pedicle screws used by many
manufacturers throughout the years.
[0070] The rotational connector 30 can be inserted into a patient
in a standard open procedure, or can be inserted sub-muscularly or
percutaneously. In this fashion, the rotational connector 30 can be
categorized as an MIS connector.
[0071] As shown in FIG. 2, in one embodiment for one example
application (spinal fusion revision surgery), the rotational
connector 30 fits around the head of an existing, previously
implanted screw, and then rotates into an in-line position with an
existing, previously implanted fusion rod. The rotational connector
30, at the angle of the first orientation, slides over the screw
head 4 vertically to a position or down position within the first
slot 32 of the receiving slot 31 and subsequently rotates within
the second slot 33 of the receiving slot 31 to the second angle of
the second orientation.
[0072] Several options are used to accommodate pedicle screws 3
from various manufacturers, including multiple sizes of through
openings 37 in the rotational connector in order to ensure a tight
fit therearound.
[0073] In a second embodiment show in FIGS. 11-17, the implantable
connector system 120 may provide adjustability for the relative
angle of the revision rod 140 relative to the rotational connector
130. Another embodiment of the second end 130b of the rotational
connector is shown in FIGS. 11 and 14. The rotational connector 130
includes external serrations or teeth 174 on the outer surface of
the revision rod receiving end or receptacle 170. The second end
130b includes external vertical serrations 174 on the outer
periphery (i.e. the lateral sides and interconnecting distal free
end). The outer periphery of the second end 130b may by arcuate in
shape. The first end 140a of the revision rod may have a
corresponding shape to engage the second end 130b. The inner
periphery of the first end 140a of the revision rod 140 includes
serrations 141 at least in the upper portion of the cavity. The
corresponding serrations 141 and 174 between the structures may
interlock or interfere with relative rotation therebetween. In the
embodiment shown in FIG. 12, when the revision rod 140 is
positioned at the desired angle B relative to the second end 130b
of the rotational connector 130, the revision rod is vertically
coupled. The revision rod set screw 60 as shown in FIG. 17 is then
threadingly engaged. The revision rod 140 may be in substantially
the same horizontal plane of the primary fusion rod 2 and still be
a variety of angular positions (i.e. angle B) relative to the
second end 130b of the rotational connector 130. Moreover, the
rotational connector 130 includes another embodiment of the first
end 130a. The first end 130a of the rotational connector 130
includes a single set screw opening 150a for threadingly engaging a
corresponding connector set screw 150.
[0074] Any number and type, size, and design of serrations 174 are
possible. These serrations 174 allow a surgeon to place the
revision rod 140 at an angle B with respect to the pre-existing
fusion rod 2. While the figures shows an example angle B of ten
degrees per side, this is just an example, and any number of angles
are possible from zero to approximately 90 degrees per side,
depending on the fit between the revision rod 140 and the
rotational connector 130, and where the construct is to be
implanted in the patient. The rounded second end 130b of the
rotational connector 130 may allow for medial/lateral revision rod
140 rotation.
[0075] In this embodiment, as in all the embodiments, any number of
set screws or screws can be utilized, depending on the size and
shape of the construct required. Often, surgeons desire the
smallest profile possible from an implant that does not compromise
strength. In some embodiments as shown in FIGS. 12 and 15, a single
larger set screw 150 will have a smaller profile than two set
screws 50 of FIG. 3, for example.
[0076] In a third embodiment of the implantable connector system
220 shown in FIGS. 18-24, another engagement between a revision rod
240 and rotational connector 230 may be used in a variety of
applications. The rotational connector second end 230b or
receptacle 270 that receives the first end 240a of the revision rod
240 is fitted with a socket 276 to receive a "ball" end 244 of the
revision rod 240, as shown in FIGS. 19 and 21. As shown in this
embodiment, the second end 230b or receptacle 270 of the rotational
connector 230 may positon the first end 240a of the revision rod
240 in a different vertical position or another horizontal plane
relative to the primary fusion rod 2. However, the adjacent ends of
the rods 240 and 2 may be substantially in the same horizontal
plane, or along the longitudinal axis, of the rotational connector
230 in some embodiments (See FIG. 25). The top surface of the
second end 230b of the rotational connector 230 may be at a higher
elevation or horizontal plane relative to the remaining portions of
the rotational connector (i.e. middle portion 230c and/or first end
230a). For example, the top surface of the second end 230b may be
0.2 inches or 5 mm above top surface of the middle portion 230c of
the rotational connector in some embodiments.
[0077] In the embodiment shown in FIGS. 18-24, angulation of the
revision rod 240 can be achieved via the ball-and-socket joint, 276
and 244. Once the desired angle is achieved by the surgeon, a
revision rod set screw 260 is tightened against to hold the angle.
This is akin to the polyaxial nature of many pedicle screws; here
the set screw contacts the spherical head of the revision rod
directly. There may be increased strength (i.e. torsion, F/E,
compression) between the revision rod interface. Moreover, the
spherical angulation between the revision rod 240 and the
rotational connector 230 may increase variability and ease of
insertion with adjacent levels.
[0078] Other options exist for achieving, and then holding, the
desired angulation, including the use of compression collets around
the spherical head of the revision rod, as described in commonly
owned U.S. Pat. No. 8,197,517, the disclosure of which is
incorporated by reference herein. Such a friction collet provides a
means to grip and secure the rod at the desired position once
placed and the set screw is tightened to the recommended tightening
torque. Another option is the use of a set screw that is integrally
formed within a body that has a saddle-shaped blocking mechanism.
The saddle has a post at its central axis around which the set
screw rotates. The saddle block could be designed to lock certain
angulations. For example, one saddle might be a zero angle saddle,
wherein each side of the saddle is of equal size and shape, and it
fits down over the revision rod. A different saddle might have one
"leg" larger or thicker than the other, which would lock in a
particular angle. Another option is having the bottom of the
locking set screw for the rod have a spherical underbody with
spherical shaped ridges to increase grip strength to secure the rod
in position once placed. This locking set screw has a spherical
cavity much like the concept of the collet.
[0079] Another embodiment of the rotational connector 330 is shown
in FIG. 25. The rotational connector 330 may include an embodiment
of a second end 330b that positions the first end 240a of the
revision rod substantially in the same horizontal plane, along the
longitudinal axis, of the rotational connector or primary revision
rod 2. The revision rod may be axially aligned with the second slot
or primary fusion rod in some embodiments. The receptacle 370 or
ball-and-socket joint (i.e. socket 376) may be adjacent the end of
the primary fusion rod or lower in elevation than the
ball-and-socket joint in FIG. 20. Another embodiment of the second
end 330b as shown in FIG. 25 includes a distal free end 373 that
may cover at least a portion of the axial end of the primary fusion
rod 2. As such the second slot 333 may not extend through the
distal free end 373 of the second end 330b in some embodiments. The
inside surface of the distal free end 373 may abut against the
axial end of the primary fusion rod 2 or be spaced from the inside
surface of the distal free end 373.
[0080] Another embodiment of the implantable connector system 420
is shown in FIGS. 26-33. The rotational connector 430 includes a
receiving slot 431 not extending through the second end 430b. The
first and second slots 432 and 433 extend upwardly into the middle
portion 430c and the first end 430a. The through opening 437 may be
enclosed by the wall of the middle portion 430c. Therefore the end
of the primary fusion rod 2 may not extend radial past the through
opening 437 from the screw head 4 to allow the rotation of the
rotational connector 430 from the first orientation (FIG. 30) to
the second orientation (FIGS. 31-33). Moreover in the embodiment
shown in FIG. 26, the top surface of the second end 430b is
substantially planar with the top surface of the middle portion
430c. As best shown in FIGS. 26 and 27, the second end 430b
positions the revision rod 40 in a spaced elevation, or different
horizontal plane, from the axis of the primary fusion rod 2.
However it should be understood that a recessed surface 75 may be
used with this embodiment. If a recess is used in an embodiment the
revision rod 40 may be horizontally and vertically aligned with the
primary fusion rod 2.
[0081] Another embodiment of the implantable connector system 520
is shown in FIGS. 34-37. Generally similar to the embodiment of the
implantable connector system 120, however the rotational connector
530 includes a receiving slot 531 not extending through the second
end 530b. The first and second slots 532 and 533 extend upwardly
into the middle portion 530c and the first end 530a. The through
opening 537 may be enclosed by the wall of the middle portion 530c.
The second end 530b does not include a sidewall depending from the
top member 571 with serrations 574. Moreover in this embodiment,
the second end 530b does not include a recessed surface 75 as in
FIG. 3. However, a recess may be used. As shown in FIGS. 33 and 35,
the revision rod 140 is positioned at an angle B, being zero
degrees in the application shown.
[0082] Another embodiment of the implantable connector system 620
is shown in FIGS. 38-42. The rotational connector 630 includes a
receptacle 670 positioning the revision rod 240 substantially in
line with the primary fusion rod 2. The receptacle 670 of the
second end 630b includes a ball-and-socket joint as described
above. The receptacle 670 is substantially in line with the primary
fusing rod 2, similar to the embodiment in FIG. 25. Further, the
first end 630a of the rotational connector 630 illustrates a single
set screw 50 being used. Although two or more set screws are
contemplated. The set screw 50 and/or opening 50a is offset within
the top member 638a from the axis of the primary fusion rod 2 or
spaced from the side member 638c. Moreover, the set screw 50 is not
positioned over the bottom member 638b. Stated alternatively, the
first and second slots 632 and 633 of the receiving slot 631 are
defined by a variety of surfaces and/or structure. For example,
when the rotational connector 630 is top loaded upon the screw head
4, the bottom 634 of the middle portion 630c does not substantially
extend downwardly past the upper extent of the primary fusion rod
2.
[0083] While several embodiments have been described and
illustrated herein, those of ordinary skill in the art will readily
envision a variety of other means and/or structures for performing
the function and/or obtaining the results and/or one or more of the
advantages described herein, and each of such variations and/or
modifications is deemed to be within the scope of the embodiments
described herein. More generally, those skilled in the art will
readily appreciate that all parameters, dimensions, materials, and
configurations described herein are meant to be exemplary and that
the actual parameters, dimensions, materials, and/or configurations
will depend upon the specific application or applications for which
the teachings is/are used. Those skilled in the art will recognize,
or be able to ascertain using no more than routine experimentation,
many equivalents to the specific embodiments described herein. It
is, therefore, to be understood that the foregoing embodiments are
presented by way of example only and that, within the scope of the
appended claims and equivalents thereto, embodiments may be
practiced otherwise than as specifically described and claimed.
Embodiments of the present disclosure are directed to each
individual feature, system, article, material, kit, and/or method
described herein. In addition, any combination of two or more such
features, systems, articles, materials, kits, and/or methods, if
such features, systems, articles, materials, kits, and/or methods
are not mutually inconsistent, is included within the scope of the
present disclosure.
[0084] All definitions, as defined and used herein, should be
understood to control over dictionary definitions, definitions in
documents incorporated by reference, and/or ordinary meanings of
the defined terms.
[0085] The indefinite articles "a" and "an," as used herein in the
specification and in the claims, unless clearly indicated to the
contrary, should be understood to mean "at least one."
[0086] The phrase "and/or," as used herein in the specification and
in the claims, should be understood to mean "either or both" of the
elements so conjoined, i.e., elements that are conjunctively
present in some cases and disjunctively present in other cases.
Multiple elements listed with "and/or" should be construed in the
same fashion, i.e., "one or more" of the elements so conjoined.
Other elements may optionally be present other than the elements
specifically identified by the "and/or" clause, whether related or
unrelated to those elements specifically identified. Thus, as a
non-limiting example, a reference to "A and/or B", when used in
conjunction with open-ended language such as "comprising" can
refer, in one embodiment, to A only (optionally including elements
other than B); in another embodiment, to B only (optionally
including elements other than A); in yet another embodiment, to
both A and B (optionally including other elements); etc.
[0087] As used herein in the specification and in the claims, "or"
should be understood to have the same meaning as "and/or" as
defined above. For example, when separating items in a list, "or"
or "and/or" shall be interpreted as being inclusive, i.e., the
inclusion of at least one, but also including more than one, of a
number or list of elements, and, optionally, additional unlisted
items. Only terms clearly indicated to the contrary, such as "only
one of" or "exactly one of," or, when used in the claims,
"consisting of," will refer to the inclusion of exactly one element
of a number or list of elements. In general, the term "or" as used
herein shall only be interpreted as indicating exclusive
alternatives (i.e. "one or the other but not both") when preceded
by terms of exclusivity, such as "either," "one of," "only one of,"
or "exactly one of." "Consisting essentially of," when used in the
claims, shall have its ordinary meaning as used in the field of
patent law.
[0088] As used herein in the specification and in the claims, the
phrase "at least one," in reference to a list of one or more
elements, should be understood to mean at least one element
selected from any one or more of the elements in the list of
elements, but not necessarily including at least one of each and
every element specifically listed within the list of elements and
not excluding any combinations of elements in the list of elements.
This definition also allows that elements may optionally be present
other than the elements specifically identified within the list of
elements to which the phrase "at least one" refers, whether related
or unrelated to those elements specifically identified. Thus, as a
non-limiting example, "at least one of A and B" (or, equivalently,
"at least one of A or B," or, equivalently "at least one of A
and/or B") can refer, in one embodiment, to at least one,
optionally including more than one, A, with no B present (and
optionally including elements other than B); in another embodiment,
to at least one, optionally including more than one, B, with no A
present (and optionally including elements other than A); in yet
another embodiment, to at least one, optionally including more than
one, A, and at least one, optionally including more than one, B
(and optionally including other elements); etc.
[0089] It should also be understood that, unless clearly indicated
to the contrary, in any methods claimed herein that include more
than one step or act, the order of the steps or acts of the method
is not necessarily limited to the order in which the steps or acts
of the method are recited.
[0090] In the claims, as well as in the specification above, all
transitional phrases such as "comprising," "including," "carrying,"
"having," "containing," "involving," "holding," "composed of," and
the like are to be understood to be open-ended, i.e., to mean
including but not limited to. Only the transitional phrases
"consisting of" and "consisting essentially of" shall be closed or
semi-closed transitional phrases, respectively, as set forth in the
United States Patent Office Manual of Patent Examining Procedures,
Section 2111.03.
[0091] The foregoing description of several embodiments of the
invention has been presented for purposes of illustration. It is
not intended to be exhaustive or to limit the invention to the
precise steps and/or forms disclosed, and obviously many
modifications and variations are possible in light of the above
teaching. It is intended that the scope of the invention and all
equivalents be defined by the claims appended to the application
once filed as a non-provisional application.
* * * * *