U.S. patent application number 15/097184 was filed with the patent office on 2016-08-04 for lock and release implant delivery system.
The applicant listed for this patent is XENCO MEDICAL LLC. Invention is credited to Jason HAIDER, Gustavo R. PRADO.
Application Number | 20160220390 15/097184 |
Document ID | / |
Family ID | 52101620 |
Filed Date | 2016-08-04 |
United States Patent
Application |
20160220390 |
Kind Code |
A1 |
PRADO; Gustavo R. ; et
al. |
August 4, 2016 |
LOCK AND RELEASE IMPLANT DELIVERY SYSTEM
Abstract
Injection-molded devices and systems for graft or other tissue
delivery, methods for their single-use in delivery of an implant,
and kits for their sterile delivery to a practitioner are disclosed
herein. Systems for implant delivery comprise an injection moldable
implant body and an insertion device comprising: an inner and outer
shaft that form a locking mechanism that secures an implant body in
place and releases it upon placement within a patient. Systems are
configured to be manufactured by injection molding, such that they
can be cost-effectively manufactured and discarded after a single
use to avoid costs and risks associated with re-sterilization and
cleaning, but can in some cases optionally also be manufactured by
machining to be re-sterilized and reused.
Inventors: |
PRADO; Gustavo R.; (San
Diego, CA) ; HAIDER; Jason; (San Diego, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
XENCO MEDICAL LLC |
San Diego |
CA |
US |
|
|
Family ID: |
52101620 |
Appl. No.: |
15/097184 |
Filed: |
April 12, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14553748 |
Nov 25, 2014 |
9339395 |
|
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15097184 |
|
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|
61908733 |
Nov 26, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2002/30904
20130101; A61F 2002/4627 20130101; A61F 2002/30808 20130101; A61F
2/447 20130101; A61F 2002/30772 20130101; A61F 2002/4635 20130101;
A61F 2002/30172 20130101; A61F 2/4455 20130101; A61F 2/4611
20130101; A61F 2002/308 20130101; A61F 2002/30228 20130101; A61F
2002/30805 20130101; A61F 2/4601 20130101; A61F 2002/30261
20130101; A61F 2002/30593 20130101; A61F 2/4603 20130101 |
International
Class: |
A61F 2/46 20060101
A61F002/46; A61F 2/44 20060101 A61F002/44 |
Claims
1. An implant delivery system comprising: a) an implant body
comprising: an outer surface; a main slot indented into the outer
surface; a chamber indented from the main slot, the chamber being
deeper than the main slot; two side slots at the outer surface
proximal to the main slot; and an empty internal space passing
through the bottom to the top of the implant body; wherein the
implant body is substantially toroidal, the internal space is not
covered at a top cross section and a bottom cross section thereof
by the support structure, and the internal space is configured to
receive at least one graft material therewithin; and b) an implant
insertion device comprising: i) an inner shaft comprising: an inner
shaft body; a knob at a base of the inner shaft body, the knob
comprising a cam feature; an inner shaft tip at an insertion end of
the inner shaft body, wherein the inner shaft tip is not
substantially cylindrically circular and the inner shaft tip is
wider than the inner shaft body immediately adjacent thereto in at
least one dimension perpendicular to a plane of rotation of the
inner shaft tip; ii) an outer shaft configured to hold the inner
shaft body therein, the outer shaft comprising: a hollow outer
shaft body, wherein the outer shaft body is configured to
accommodate the inner shaft body therewithin; an outer face; an
outer shaft opening at the outer face of the outer shaft, the outer
shaft opening being configured to allow passage of the inner shaft
tip; two outer shaft tips at the outer face to fit the two side
slots of the implant body; a first surface at a base of the outer
shaft configured to receive the cam feature of the knob at a first
position; a second surface at the base of the outer shaft
configured to receive the cam feature of the knob at a second
position; a stopper at the base of the outer shaft configured to
stop the cam feature at the first or the second position; a ramp at
the base of the outer shaft, wherein the ramp connects the first
surface to the second surface, wherein the inner shaft is
configured to rotate within the outer shaft such that the cam
feature moves to the first position or the second position at the
base of the outer shaft, wherein the rotation of the inner shaft is
configured to transform into a linear movement of the inner shaft
along a direction perpendicular to a plane of the rotation of the
inner shaft tip, wherein the inner shaft tip is configured to fit
through the main slot of the implant body and rotate in the chamber
of the implant body so as to lock or unlock the implant body to the
inner shaft, and the two side slots of the implant body are
configured to fit the two outer shaft tips at the outer face of the
outer shaft so as to attach the implant body to the outer shaft,
and wherein the inner shaft is unlocked from the outer shaft at the
first position and the inner shaft is locked to the outer shaft at
the second position.
2. An implant delivery system comprising: an implant insertion
device comprising: i) an inner shaft comprising: an inner shaft
body; a knob at a base of the inner shaft body, the knob comprising
a first interface; an inner shaft tip at an insertion end of the
inner shaft body, wherein the inner shaft tip is not substantially
cylindrically circular; and ii) an outer shaft configured to hold
the inner shaft body therein, the outer shaft comprising: a hollow
outer shaft body, wherein the outer shaft body is configured to
accommodate the inner shaft body therewithin; an outer face; an
outer shaft opening at the outer face of the outer shaft; a first
complementary interface at a base of the outer shaft configured to
receive the first interface of the inner shaft; a second
complementary interface at the outer face to receive a second
interface of the implant body; wherein a rotation of the inner
shaft is configured to associate the first complementary interface
to the first interface at a first position or at a second position,
wherein the inner shaft tip is configured to fit through a main
slot of an implant body and rotate in a chamber of the implant body
so as to lock the implant body to the inner shaft.
3. The device of claim 2, wherein the implant delivery system
comprises an implant body comprising a support structure
comprising: an outer surface; a main slot indented into the outer
surface; a chamber indented from the main slot, the chamber being
deeper than the main slot; and a second interface at the outer
surface proximal to the main slot; wherein the implant body is
substantially toroidal, and the internal space is not covered at a
top cross section, a bottom cross section, or the top and bottom
cross sections thereof by the support structure, and the internal
space is configured to receive at least one graft material; and an
internal space configured to contain at least a graft material.
4. The device of claim 2, wherein the second interface of the
implant body is configured to fit the second complementary
interface at the outer face of the outer shaft so as to attach the
implant body to the outer shaft.
5. The device of claim 2, wherein the implant insertion device is
injection molded.
6. The device of claim 2, wherein the implant delivery system is
for one-time use only.
7. The device of claim 2, wherein the internal space of the implant
body is filled at least partly by at least one graft material.
8. The device of claim 2, wherein the inner shaft comprises at
least one material selected from carbon fiber-reinforced polymer,
carbon fiber-reinforced plastic, carbon fiber-reinforced
thermoplastic, glass fiber-reinforced polymer, glass
fiber-reinforced plastic, and polyarylamide.
9. The device of claim 2, wherein the inner shaft body is flexible
so as to fit in a curved outer shaft body.
10. The device of claim 2, wherein the inner shaft tip is
substantially rectangular cuboid or cylindrically elliptical.
11. The device of claim 2, wherein the first interface comprises a
cam feature.
12. The device of claim 2, wherein the inner shaft tip is
configured to fit and rotate in the chamber of the implant
body.
13. The device of claim 2, wherein the inner shaft tip is
configured to pass through the outer shaft opening.
14. The device of claim 2, wherein the first or the second
interface comprises a first surface and a second surface, wherein
the first surface and the second surface are connected by a
ramp.
15. The device of claim 14, wherein the first and the second
surface are displaced by a distance that the inner shaft tip is
capable of moving with respect to the outer shaft.
16. The device of claim 2, wherein the outer shaft body is
curved.
17. The device of claim 2, wherein the outer shaft comprises at
least one material selected from the list consisting of carbon
fiber-reinforced polymer, carbon fiber-reinforced plastic, carbon
fiber-reinforced thermoplastic, glass fiber-reinforced polymer,
glass fiber-reinforced plastic, and polyarylamide.
18. The device of claim 2, wherein the outer shaft is injection
moldable.
19. The device of claim 2, wherein the outer shaft opening is
configured to allow passage of the inner shaft tip.
20. The device of claim 2, wherein the linear movement of the inner
shaft body is determined by a height of the interface or the
complimentary interface and a rotation angle that the cam feature
rotates through from a predetermined location along a circumference
of the knob.
21. A method for delivering an implant body using an implant
insertion device comprising: a) locking the implant body to the
implant insertion device by rotating a knob of an inner shaft of
the implant insertion device in a manner such that the rotation of
the knob i) rotates an inner shaft tip within a chamber of the
implant body such that a major axis of a main slot and a major axis
of the inner shaft tip are not substantially parallel, ii) linearly
moves the implant body towards an insertion end of an outer shaft
of the implant insertion device so as to secure the implant body
against the insertion end of the outer shaft, b) delivering the
implant body into a subject using the implanting insertion device;
and c) reversely rotating the knob of the inner shaft of the
implant insertion device in a manner such that the reverse rotation
of the knob i) rotates the inner shaft tip within the main slot in
the implant body such that the major axis of the main slot and the
major axis of the inner shaft tip are substantially parallel, ii)
associates the first interface of the knob to the first
complimentary interface at the outer shaft at a second
position.
22. The method of claim 21 comprising removing the insertion device
from a sterile package prior to use.
23. The method of claim 21 comprising fitting at least one side
slot of the implant body to at least one outer shaft tip at the
insertion end of the outer shaft such that the implant body is
substantially locked to the insertion device.
24. The method of claim 21 comprising disposing the implant
insertion device after a single use.
25. The method of claim 21, wherein the first and the second
surfaces are displaced by a distance that the inner shaft tip is
capable of moving with respect to the outer shaft.
26. The method of claim 21, wherein the first and the second
surfaces are displace by a distance determined by a length and a
rising angle of the ramp.
27. The method of claim 21 comprises rotating the knob of an inner
shaft of the implant insertion device in a manner such that the
rotation of the knob linearly displaces the implant body from the
insertion end of the outer shaft of the implant insertion
device.
28. A sterile kit containing a single-use implant body insertion
device and a single use implant, the sterile kit comprising: a) a
sterile kit cover sealed to enclose at least one device tray, at
least one implant body, and at least one implant insertion device
therewithin, wherein the at least one implant body and the at least
one implant insertion device are configured for a single usage; b)
the at least one device tray configured to secure the at least one
implant insertion device; and the at least one implant body; c) the
at least one implant insertion device comprising: a shaft; a tip; a
first interface for locking the at least one implant body; a second
interface for locking the at least one implant body; a first
position; a second position; and d) the at least one implant body
comprising: an internal space, a slot for locking the at least one
implant body against the at least one implant insertion device at
the first position; a first complimentary interface for receiving
the interface of the at least one implant insertion device at the
first position or the second position; a second complimentary
interface for receiving the second interface of the at least one
implant insertion device at the first position.
29. The kit of claim 28 comprising a second sterile kit cover
sealed to enclose the sterile kit cover.
30. The kit of claim 28, wherein the device tray comprises a
compartment to secure at least one implant body to facilitate
loading at least one graft material to the internal space of the
implant body.
Description
[0001] This application claims priority to U.S. Provisional Patent
Application Ser. No. 61/908,733, filed Nov. 26, 2013, which is
explicitly incorporated herein by reference in its entirety.
BACKGROUND OF THE INVENTION
[0002] Traditionally, implant insertion device and spinal implant
are machined individually to accommodate the need of different
patient and different surgical procedures.
SUMMARY OF THE INVENTION
[0003] Machinable implant insertion devices and implants can be
individually tailored to the needs of the patient, practitioner
and/or the medical procedure. However, the cost of machining each
implant insertion device and implant with different materials and
sizes is significantly higher than molding an injection moldable
equivalent. The cost of these reusable devices and implants is
manifest in their manufacture but also in the expense of
professional device cleaning, autoclaving, sterilization,
transport, and maintenance. The risk of contamination rises with
the complex procedure for cleaning and transporting the devices and
implants between usages. There are also costs and risks associated
with dealing with infections caused by failure to clean and
sterilize.
[0004] Injection moldable implant insertion devices and implant
bodies can be molded using one or more durable materials at a lower
price than their machinable equivalents. In addition, the injection
moldable implant insertion devices and implant bodies are easily
made and can be deployed for single use only, so that the
contamination associated with the cleaning, autoclaving,
sterilization, transportation, or maintenance of the machined
equivalents are significantly reduced or completely eliminated.
Thus, the cost of the implant insertion device and implant body per
usage is significantly lower than the re-usable machined
equivalent, even if the devices are discarded after a single use.
Further, injection moldable implant insertion devices and implants
can be packed in sterile and peelably sealed kits to prevent
contamination and facilitate surgical needs in different medical
procedures.
[0005] In some aspects, disclosed herein are implant delivery
systems comprising: an implant body comprising a support structure
and an internal space, the support structure comprising: an outer
surface; a main slot indented into the outer surface; a chamber
indented from the main slot, the chamber being deeper than the main
slot; two side slots at the outer surface proximal to the main
slot; wherein the implant body is substantially toroidal, the
internal space is not covered at a top cross section and a bottom
cross section thereof by the support structure, and the internal
space is configured to receive at least one graft material
therewithin; and an implant insertion device comprising: an inner
shaft comprising: an inner shaft body; a knob at a base of the
inner shaft body, the knob comprising a cam feature; an inner shaft
tip at an insertion end of the inner shaft body, wherein the inner
shaft tip is not substantially cylindrically circular and the inner
shaft tip is wider than the inner shaft body immediately adjacent
thereto in at least one dimension perpendicular to a plane of
rotation of the inner shaft tip; an outer shaft configured to hold
the inner shaft body therein, the outer shaft comprising: a hollow
outer shaft body, wherein the outer shaft body is configured to
accommodate the inner shaft body therewithin; an outer face; an
outer shaft opening at the outer face of the outer shaft, the outer
shaft opening being configured to allow passage of the inner shaft
tip; two outer shaft tips at the outer face to fit the two side
slots of the implant body; a first surface at a base of the outer
shaft configured to receive the cam feature of the knob at a first
position; a second surface at the base of the outer shaft
configured to receive the cam feature of the knob at a second
position; a stopper at the base of the outer shaft configured to
stop the cam feature at the first or the second position; a ramp at
the base of the outer shaft, wherein the ramp connects the first
surface to the second surface, wherein the inner shaft is
configured to rotate within the outer shaft such that the cam
feature moves to the first position or the second position at the
base of the outer shaft, wherein the rotation of the inner shaft is
configured to transform into a linear movement of the inner shaft
along a direction perpendicular to a plane of the rotation of the
inner shaft tip, wherein the inner shaft tip is configured to fit
through the main slot of the implant body and rotate in the chamber
of the implant body so as to lock or unlock the implant body to the
inner shaft, and the two side slots of the implant body are
configured to fit the two outer shaft tips at the outer face of the
outer shaft so as to attach the implant body to the outer shaft,
and wherein the inner shaft is unlocked from the outer shaft at the
first position and the inner shaft is locked to the outer shaft at
the second position.
[0006] In some aspects, disclosed herein are implant delivery
systems comprising: an implant insertion device comprising: an
inner shaft comprising: an inner shaft body; a knob at a base of
the inner shaft body, the knob comprising a first interface; an
inner shaft tip at an insertion end of the inner shaft body,
wherein the inner shaft tip is not substantially cylindrically
circular; an outer shaft configured to hold the inner shaft body
therein, the outer shaft comprising: a hollow outer shaft body,
wherein the outer shaft body is configured to accommodate the inner
shaft body therewithin; an outer face; an outer shaft opening at
the outer face of the outer shaft; a first complementary interface
at a base of the outer shaft configured to receive the first
interface of the inner shaft; a second complementary interface at
the outer face to receive a second interface of the implant body;
wherein a rotation of the inner shaft is configured to associate
the first complementary interface to the first interface at a first
position or at a second position, wherein the inner shaft tip is
configured to fit through a main slot of an implant body and rotate
in a chamber of the implant body so as to lock the implant body to
the inner shaft.
[0007] In some cases, disclosed herein are implant delivery systems
comprising: an implant insertion device comprising: an inner shaft
comprising: an inner shaft body; a knob at a base of the inner
shaft body, the knob comprising a first interface; an inner shaft
tip at an insertion end of the inner shaft body, wherein the inner
shaft tip is not substantially cylindrically circular; an outer
shaft configured to hold the inner shaft body therein, the outer
shaft comprising: a hollow outer shaft body, wherein the outer
shaft body is configured to accommodate the inner shaft body
therewithin; an outer face; an outer shaft opening at the outer
face of the outer shaft; a first complementary interface at a base
of the outer shaft configured to receive the first interface of the
knob; a second complementary interface at the outer face; an
implant body comprising a support structure and an internal space,
the support structure comprising: an outer surface; a main slot
indented into the outer surface; a chamber indented from the main
slot and deeper than the main slot; a second interface at the outer
surface proximal to the main slot to fit the second complimentary
interface at the outer face; wherein the implant body is
substantially toroidal, the internal space is not covered at a top
cross section, a bottom cross section, or the top and the bottom
cross sections thereof by the support structure, and the internal
space is configured to receive at least one graft material, wherein
a rotation of the inner shaft is configured to associate the first
complementary interface to the first interface at a first position
or a second position, wherein the inner shaft tip is configured to
fit through a main slot of an implant body and rotate in a chamber
of the implant body so as to lock the implant body to the inner
shaft.
[0008] In some aspects, disclosed herein are methods for delivering
an implant body using an implant insertion device comprising:
locking the implant body to the implant insertion device by
rotating a knob of an inner shaft of the implant insertion device
in a manner such that the rotation of the knob: rotates an inner
shaft tip within a chamber of the implant body such that a major
axis of a main slot and a major axis of the inner shaft tip are not
substantially parallel, linearly moves the implant body towards an
insertion end of an outer shaft of the implant insertion device so
as to secure the implant body against the insertion end of the
outer shaft, delivering the implant body into a subject using the
implanting insertion device; reversely rotating the knob of the
inner shaft of the implant insertion device in a manner such that
the reverse rotation of the knob rotates the inner shaft tip within
the main slot in the implant body such that the major axis of the
main slot and the major axis of the inner shaft tip are
substantially parallel, associates the first interface of the knob
to the first complimentary interface at the outer shaft at a second
position. In some aspects the methods comprise inserting the
implant into an intervertebral space. In some aspects the
intervertebral space is lumbar. In some aspects the intervertebral
space is cervical. In some aspects intervertebral disk material is
removed from the intervertebral space prior to inserting the
implant. In some aspects the implant is inserted into the interior
of an intervertebral disk.
[0009] In some cases, disclosed herein are methods for delivering
an implant body using an implant insertion device comprising
releasing an implant body into an intervertebral space of a patient
comprising: rotating a knob of an inner shaft of the implant
insertion device in a manner such that a rotation of the knob
rotates an inner shaft tip within a main slot in the implant body
substantially in a coronal plane such that a major axis of the main
slot and a major axis of the inner shaft tip are substantially
parallel, and associates a first interface of the knob to a first
complimentary interface at an outer shaft at a unlocked position;
and depositing the implant body in an intervertebral space of the
patient. In some aspects the methods comprise inserting the implant
into an intervertebral space. In some aspects the intervertebral
space is lumbar. In some aspects the intervertebral space is
cervical. In some aspects intervertebral disk material is removed
from the intervertebral space prior to inserting the implant. In
some aspects the implant is inserted into the interior of an
intervertebral disk.
[0010] In some aspects, disclosed herein are sterile kits
containing a single-use implant body insertion device and a single
use implant, the sterile kit comprising: a sterile kit cover sealed
to enclose at least one device tray, at least one implant body, and
at least one implant insertion device therewithin, wherein the at
least one implant body and the at least one implant insertion
device are configured for a single usage; the at least one device
tray is configured to secure: the at least one implant insertion
device; the at least one implant body; the at least one implant
insertion device comprising: a shaft; a tip; a first interface for
locking the at least one implant body; a second interface for
locking the at least one implant body; a first position; a second
position; and the at least one implant body comprising: an internal
space; a slot for locking the at least one implant body against the
at least one implant insertion device at the first position; a
first complimentary interface for receiving the interface of the at
least one implant insertion device at the first position or the
second position; a second complimentary interface for receiving the
second interface of the at least one implant insertion device at
the first position. In some aspects, sterile kits may also contain
pre-assembled grafting material within the graft window of implant.
Grafting material may be packed allograft bone (demineralized or
not), packed biocompatible ceramics granules (beta-tricalcium
phosphate, hydroxyapatite, calcium sulfate, and equivalents) to
assume the graft volume shape, biocompatible ceramic granules held
by biocompatible matrix such as collagen with or without bioglass
and with or without hyaluronic acid.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1a shows an embodiment of the implant insertion device
and the implant body attached to the implant insertion device.
[0012] FIG. 1b shows an embodiment of the implant insertion
device.
[0013] FIG. 2 shows an embodiment of the implant insertion
device.
[0014] FIG. 3 shows an embodiment of the implant body.
[0015] FIG. 4 shows an embodiment of the implant body.
[0016] FIG. 5 shows a 3-part mold that is used to mold the
embodiment shown in FIG. 3
[0017] FIG. 6 shows an embodiment of the implant body.
[0018] FIG. 7 shows the embodiment of the inner shaft and outer
shaft of the implant insertion device in FIG. 2.
[0019] FIG. 8 shows an embodiment of the inner shaft tip.
[0020] FIG. 9 shows an embodiment of the base of the outer
shaft.
[0021] FIG. 10 shows an embodiment of the locking interface of the
inner shaft and the outer shaft.
[0022] FIG. 11 shows an embodiment of preventing the inner shaft
from being accidentally removed from the outer shaft.
[0023] FIG. 12 shows an embodiment of the implant insertion
device.
[0024] FIG. 13 shows molds to make the implant insertion device of
FIG. 12.
[0025] FIG. 14 shows an embodiment of the knob of the inner shaft
and the base of the outer shaft.
[0026] FIG. 15 shows an embodiment of the knob of the inner
shaft.
[0027] FIG. 16 shows an embodiment of the rotation of the inner
shaft and linear movement of the inner shaft with respect to the
outer shaft so as to lock the implant body to the implant insertion
device.
DETAILED DESCRIPTION OF THE INVENTION
[0028] Chronic spinal pain is a common issue among a large number
of people worldwide, and is a major health and quality of life
concern. Back pain can impair one's ability to work, concentrate
and exercise, thus having a substantial effect on one's quality of
life. Spinal pain, either in the neck or back, is often associated
with damage to one or more intervertebral discs. A herniated disc
may exude its soft, internal protective material (nucleus pulposus)
outside of the disc area. When this exuded material presses on the
nerves that run down the spine, the result can be a loss of range
of motion, sharp localized pain, and/or dull radiating pain to one
or more extremities. Secondary effects of spinal pain can include
depression, loss of work efficiency, and early cognitive
degeneration.
[0029] One effective approach to addressing spinal pain is fusion
of the adjacent vertebrae. Fusion of adjacent vertebrae can be
accomplished by introduction of graft tissue between the vertebrae,
such as into the herniated disc or into a space created by removal
of the herniated disc. Graft tissue, as used herein, may comprise
autologous patient tissue, such as bone tissue taken from elsewhere
in the patient during the procedure. Graft tissue may be
cadaverous, or cultured or synthetically produced from
differentiated or undifferentiated cell populations derived from
the patient or elsewhere. Graft tissue, if properly inserted and
protected, can lead to fusion of the adjacent vertebrae.
[0030] Stabilizing graft tissue is a major challenge. The spinal
column, particularly the lumbar spine and the cervical spine, must
sustain substantial pressures, and these pressures can easily
disrupt an unstabilized graft. The graft material must be delivered
into the intervertebral space with a minimum of damage to the
surrounding tissue.
[0031] In addition, contamination or infection of the graft
material or the insertion site during the procedure is a major
risk. Current methods and devices for insertion of graft material
involve reusable, machined materials that must be sterilized
between uses. Although this process allows re-use of the devices,
the sterilization process is costly and not without risk, as
unsuccessfully sterilized or unclean materials can lead to major
complications.
[0032] Injection-molded devices can be made out of materials that
are substantially less costly to produce, without loss in
single-use material durability. These injection molded devices can
be sterilely manufactured and packaged, so that they can be
delivered to an operating room without risk of contamination. Once
used, they are disposed of rather than being cleaned and
sterilized. This single-use aspect has both medical and economic
benefits: the risk of infection is greatly reduced relative to the
risk associated with multi-use devices; and the cost of
manufacturing injection-molded devices is substantially lower than
the cost of sterilizing devices for re-use.
[0033] Accordingly, the single-use, injection moldable devices and
methods disclosed herein are able to increase patient health,
reduce risk of infection and reduce health costs.
[0034] Disclosed herein, in certain embodiments, are implant
delivery systems comprising: an implant body comprising a support
structure and an internal space, the support structure comprising:
an outer surface; a main slot indented into the outer surface; a
chamber indented from the main slot, the chamber being deeper than
the main slot; two side slots at the outer surface proximal to the
main slot; wherein the implant body is substantially toroidal, the
internal space is not covered at a top cross section and a bottom
cross section thereof by the support structure, and the internal
space is configured to receive at least one graft material
therewithin; and an implant insertion device comprising: an inner
shaft comprising: an inner shaft body; a knob at a base of the
inner shaft body, the knob comprising a cam feature; an inner shaft
tip at an insertion end of the inner shaft body, wherein the inner
shaft tip is not substantially cylindrically circular and the inner
shaft tip is wider than the inner shaft body immediately adjacent
thereto in at least one dimension perpendicular to a plane of
rotation of the inner shaft tip; an outer shaft configured to hold
the inner shaft body therein, the outer shaft comprising: a hollow
outer shaft body, wherein the outer shaft body is configured to
accommodate the inner shaft body therewithin; an outer face; an
outer shaft opening at the outer face of the outer shaft, the outer
shaft opening being configured to allow passage of the inner shaft
tip; two outer shaft tips at the outer face to fit the two side
slots of the implant body; a first surface at a base of the outer
shaft configured to receive the cam feature of the knob at a first
position; a second surface at the base of the outer shaft
configured to receive the cam feature of the knob at a second
position; a stopper at the base of the outer shaft configured to
stop the cam feature at the first or the second position; a ramp at
the base of the outer shaft, wherein the ramp connects the first
surface to the second surface, wherein the inner shaft is
configured to rotate within the outer shaft such that the cam
feature moves to the first position or the second position at the
base of the outer shaft, wherein the rotation of the inner shaft is
configured to transform into a linear movement of the inner shaft
along a direction perpendicular to a plane of the rotation of the
inner shaft tip, wherein the inner shaft tip is configured to fit
through the main slot of the implant body and rotate in the chamber
of the implant body so as to lock or unlock the implant body to the
inner shaft, and the two side slots of the implant body are
configured to fit the two outer shaft tips at the outer face of the
outer shaft so as to attach the implant body to the outer shaft,
and wherein the inner shaft is unlocked from the outer shaft at the
first position and the inner shaft is locked to the outer shaft at
the second position.
Also disclosed herein, in certain embodiments, are implant delivery
systems comprising: an implant insertion device comprising: an
inner shaft comprising: an inner shaft body; a knob at a base of
the inner shaft body, the knob comprising a first interface; an
inner shaft tip at an insertion end of the inner shaft body,
wherein the inner shaft tip is not substantially cylindrically
circular; an outer shaft configured to hold the inner shaft body
therein, the outer shaft comprising: a hollow outer shaft body,
wherein the outer shaft body is configured to accommodate the inner
shaft body therewithin; an outer face; an outer shaft opening at
the outer face of the outer shaft; a first complementary interface
at a base of the outer shaft configured to receive the first
interface of the inner shaft; a second complementary interface at
the outer face to receive a second interface of the implant body;
wherein a rotation of the inner shaft is configured to associate
the first complementary interface to the first interface at a first
position or at a second position, wherein the inner shaft tip is
configured to fit through a main slot of an implant body and rotate
in a chamber of the implant body so as to lock the implant body to
the inner shaft. In some cases, the implant delivery system
comprises an implant body comprising a support structure and an
internal space, the support structure comprising: an outer surface;
a main slot indented into the outer surface; a chamber indented
from the main slot, the chamber being deeper than the main slot;
the second interface at the outer surface proximal to the main
slot; wherein the implant body is substantially toroidal, and the
internal space is not covered at a top cross section, a bottom
cross section, or the top and bottom cross sections thereof by the
support structure, and the internal space is configured to receive
at least one graft material; and an internal space configured to
contain at least a graft material. In some cases, the second
interface of the implant body is configured to fit the second
complementary interface at the outer face of the outer shaft so as
to attach the implant body to the outer shaft. In some cases, the
implant insertion device is disposable. In some cases, the implant
insertion device is for one-time use only. In some cases, the
implant insertion device is injection moldable. In some cases, the
implant delivery system is disposable. In some cases, the implant
delivery system is for one-time use only. In some cases, the second
interface comprises at least one side slot indented into the
implant body proximal to the main slot, wherein each side slot is
configured to receive an outer shaft tip. In some cases, the at
least one side slot is peripherally proximal to the main slot. In
some cases, the at least one side slot is shallower than the main
slot. In some cases, the main slot and the at least one side slot
are indented into the supporting structure. In some cases, wherein
the main slot is indented deeper into the wall of the implant body
than the two side slots along the insertion direction. In some
cases, the internal space of the implant body is filled at least
partly by at least one graft material. In some cases, the implant
body is substantially toroidal. In some cases, wherein a toroidal
shape is a shape with a plurality of cross sections stacked
together continuously, each cross section having an arbitrary two
dimensional empty area enclosed by a wall. In some cases, the
height of the implant body is non-uniform along the
anterior-to-posterior direction so as to accommodate the lordosis
angle of the spinal cord when the implant body is properly
inserted. In some cases, a toroidal shape is a shape comprising a
hole throughout an arbitrary three dimensional volume. In some
cases, the internal space is not covered at the top cross section,
bottom cross section, or top and bottom cross sections thereof by
the implant body. In some cases, the implant body enclosing the
internal space has a wall thickness of at least 1 millimeter but no
more than 3 centimeters. In some cases, the implant body comprises
at least one selected from polyether ether ketone (PEEK), carbon
fiber-reinforced polymer, carbon fiber-reinforced plastic, carbon
fiber-reinforced thermoplastic, glass fiber-reinforced polymer,
glass fiber-reinforced plastic, and polyaryletherketone (PEAK). In
some cases, the implant body is injection moldable. In some cases,
the implant body is machinable. In some cases, the implant body
comprises a saw tooth configured to allow unidirectional insertion
into a subject on an outer surface of the implant body. In some
cases, the saw tooth is further located on the longitudinal plane
of the implant body. In some cases, the saw tooth is configured to
prevent sliding back-out of an implant body after an insertion. In
some cases, the implant body comprises at least one space for
accommodating at least one detectable tag. In some cases, the at
least one detectable tag comprise a radio frequency detectable tag.
In some cases, the at least one space are in the wall of the
implant body. In some cases, the implant body comprises two spaces
for detectable tags, the two spaces being not greater than 5 mm in
their widest dimension. In some cases, the implant body comprises
two spaces for detectable tags, the two spaces being spatially
separated from each other. In some cases, the implant body
comprises four spaces for detectable tags, the four spaces being
spatially separated from each other. In some cases, the cross
section of the implant body along a longitudinal plane comprises a
closed contour formed by the implant body. In some cases, wherein
the closed contour encloses an area therewithin. In some cases, the
internal space is enclosed by closed contours in a plurality of
adjacent longitudinal planes. In some cases, the cross section of
the implant body along a longitudinal plane is a square, a
rectangle, a circle, an ellipse, a rhombus, a trapezoid, a
pentagon, or an arbitrary two dimensional shape enclosing an empty
two dimensional area in a closed contour by a wall. In some cases,
the cross section of the implant body along a longitudinal plane is
a two-dimensional shape similar to a cross section of the
intervertebral space to be inserted therein. In some cases, the
cross section of the implant body along a longitudinal plane is
comprises a closed contour with a non-uniform thickness along the
closed contour. In some cases, the non-uniform thickness along the
closed contour is filled with at least one selected from polyether
ether ketone (PEEK), carbon fiber-reinforced polymer, carbon
fiber-reinforced plastic, carbon fiber-reinforced thermoplastic,
glass fiber-reinforced polymer, glass fiber-reinforced plastic, and
polyaryletherketone (PEAK), In some cases, the chamber of the
implant body is connected to a slot indented from a top-most region
or a bottom-most region of the outer surface along the longitudinal
direction. In some cases, wherein the slot at the top-most region
or the bottom-most region of the support structure is configured to
facilitate injection molding of the chamber. In some cases, the
slot at the top-most region or the bottom-most of the support
structure is configured to enable visualization of the inner shaft
tip. In some cases, the inner shaft is disposable. In some cases,
the inner shaft is for one-time use only. In some cases, the inner
shaft comprises at least one selected from carbon fiber-reinforced
polymer, carbon fiber-reinforced plastic, carbon fiber-reinforced
thermoplastic, glass fiber-reinforced polymer, glass
fiber-reinforced plastic, and polyarylamide. In some cases, the
inner shaft comprises about 50% glass. In some cases, the inner
shaft comprises a glass content of at least 10% to no greater than
70%. In some cases, the inner shaft tip comprises at least one
metal. In some cases, the inner shaft body comprises at least one
metal. In some cases, the inner shaft is injection moldable. In
some cases, the inner shaft tip is injection moldable. In some
cases, the inner shaft body is injection moldable. In some cases,
the knob is injection moldable. In some cases, the inner shaft is
injection moldable and machinable. In some cases, the inner shaft
body is substantially cylindrical. In some cases, the inner shaft
body is flexible so as to fit in a curved outer shaft body. In some
cases, the inner shaft body is a cylinder. In some cases, the knob
of the inner shaft is not enclosed in the outer shaft. In some
cases, the inner shaft tip is not enclosed in the outer shaft. In
some cases, the inner shaft tip is connected to the inner shaft
body in a manner such that the inner shaft tip rotates
concentrically when the inner shaft body rotates. In some cases,
the inner shaft tip is attached to the inner shaft body such that
the center of the cross section of the inner shaft body overlaps
with the middle point of the two foci of the inner shaft tip. In
some cases, the linear movement draws the inner shaft tip towards
the two outer shaft tips. In some cases, the inner shaft tip is
substantially rectangular cuboid or cylindrically elliptical. In
some cases, the inner shaft comprises at least two protrusions
proximal to the inner shaft tip. In some cases, the at least two
protrusions are configured to ensure concentric rotation of the
inner shaft within the outer shaft. In some cases, the at least two
protrusions contact an inner surface of the outer shaft. In some
cases, the first or the second interface comprises a camping some
cases, the cam feature is semi-circular. In some cases, the cam
feature is substantially a circle sector, a triangle, a
quadrilateral, or a pentagon. In some cases, the cam feature is
substantially a circle sector with a central angle of at least 15
degrees to up to 275 degrees. In some cases, the cam feature is
substantially a triangle, a quadrilateral, or a pentagon with an
angle of at least 15 degrees to up to 150 degrees. In some cases,
the cam feature is attached to the knob of the inner shaft. In some
cases, the knob is substantially cylindrical. In some cases, the
cross section of the knob is greater than the cross section of the
inner shaft body. In some cases, the knob of the inner shaft is
configured to not fit into the outer shaft at the base of the outer
shaft. In some cases, the knob comprises at least one hump. In some
cases, the hump is configured to lock the inner shaft to the outer
shaft at the second position such that the inner shaft does not
rotate with respect to the outer shaft. In some cases, the inner
shaft tip is substantially rectangular cuboid or cylindrically
elliptical. In some cases, the inner shaft tip is configured to fit
and rotate in the chamber of the implant body. In some cases, the
inner shaft tip is configured to pass through the outer shaft
opening. In some cases, the inner shaft tip is configured to pass
through the outer shaft opening only when a major axis of the inner
shaft tip and a major axis of the outer shaft opening are
substantially parallel. In some cases, the first or the second
complimentary interface comprises a cam feature. In some cases, the
first or the second interface comprises a first surface and a
second surface, wherein the first surface and the second surface
are connected by a ramp. In some cases, the first and the second
surface are displaced by a distance that the inner shaft tip is
capable of moving with respect to the outer shaft. In some cases,
the first and the second surface are displaced by a distance, the
distance determined by a length and a rising angle of the ramp. In
some cases, the first or the second interface comprises at least
one slot. In some cases, the first or the second complimentary
interface comprises at least a slot. In some cases, the first or
the second interface comprises at least one tip. In some cases, the
outer shaft body is curved. In some cases, the outer shaft is
disposable. In some cases, the outer shaft is for one-time use
only. In some cases, the outer shaft comprises at least one
material selected from the list consists of carbon fiber-reinforced
polymer, carbon fiber-reinforced plastic, carbon fiber-reinforced
thermoplastic, glass fiber-reinforced polymer, glass
fiber-reinforced plastic, and polyarylamide. In some cases, the
outer shaft comprises about 50% glass. In some cases, the outer
shaft comprises a material having a glass content of at least 10%
to no greater than 70%. In some cases, the outer shaft is injection
moldable. In some cases, the outer shaft is injection moldable and
machinable. In some cases, the cross sectional area of the outer
shaft is monotonically non-increasing from a base of the outer
shaft to an insertion end of the outer shaft. In some cases, the
outer shaft opening is substantially circular. In some cases, the
outer shaft opening is configured to allow passage of the inner
shaft tip. In some cases, the outer shaft comprises a third
interface, wherein the third interface unlocks to the hump at the
first position and locks to the hump at the second position. In
some cases, the outer shaft comprises at least one insertion
stopper on the outer shaft to limit insertion depth into an
intervertebral space of the subject. In some cases, the outer shaft
comprises at least an insertion stopper attached to the outer
shaft. In some cases, the outer shaft comprises at least an
insertion stopper, the height of the insertion stopper being
greater than 0.2 millimeters but less than 2 centimeters. In some
cases, the outer shaft comprises at least a ramped protrusion to
prevent the inner shaft from sliding out while the inner shaft is
inserted therewithin. In some cases, the outer shaft comprises at
least a ramped protrusion so that the inner shaft only comes out of
the outer shaft when the implant body is not locked to an inner
shaft tip. In some cases, the outer shaft comprises at least a
ramped protrusion so that the inner shaft only comes out of the
outer shaft when the major axis of the inner shaft tip and the
major axis of the main slot of the implant body are substantially
perpendicular. In some cases, the outer shaft opening at the
insertion end of the outer shaft is further configured to allow
passage of the inner shaft tip only when the major axis of the
inner shaft tip and the major axis of the outer shaft opening are
substantially parallel. In some cases, the first complimentary
interface comprises a first surface and a second surface. In some
cases, the first surface and the second surface are semi-circular.
In some cases, the first surface and the second surface are a
portion of a circle sector. In some cases, the first surface and
the second surface are a portion of a circle sector with a central
angle of 45, 60, 90, 120, or 150 degrees. In some cases, the first
surface and the second surface are a portion of a circle sector
with a central angle of at least 15 degrees to up to 275 degrees.
In some cases, the first surface and the second surface are a
portion of a circle sector with a central angle of 65, 75, 85, 90,
95, 105, or 115 degrees. In some cases, the first or the second
complimentary interface comprises at least one tip. In some cases,
the at least one tip is substantially semi-rectangular cuboid or
semi-cylindrically elliptical. In some cases, the at least one tip
is peripherally proximal to the outer shaft opening at the
insertion end of the outer shaft. In some cases, the at least one
tip and another tip are symmetrically adjacent to the outer shaft
opening at the insertion end of the outer shaft, and on an
extension of the major axis of the outer shaft opening. In some
cases, the at least one tip is on the outer face of the outer
shaft. In some cases, each tip is substantially semi-rectangular
cuboid or semi-cylindrically elliptical. In some cases, each tip is
configured to fit in one side slot of the implant body when the
implant body is locked to the outer shaft. In some cases, the
locking the implant body to the inner shaft comprises that a major
axis of the main slot and a major axis of the inner shaft tip are
not substantially parallel. In some cases, not substantially
parallel comprises an angle of about 90 degrees between the major
axis of the main slot and a major axis of the inner shaft tip. In
some cases, the linear movement of the inner shaft body is
determined by a height of the interface or the complimentary
interface and a rotation angle that the cam feature rotates from a
predetermined location along a circumference of the knob.
Also disclosed herein, in certain embodiments, are implant delivery
systems comprising: an implant insertion device comprising: an
inner shaft comprising: an inner shaft body; a knob at a base of
the inner shaft body, the knob comprising a first interface; an
inner shaft tip at an insertion end of the inner shaft body,
wherein the inner shaft tip is not substantially cylindrically
circular; an outer shaft configured to hold the inner shaft body
therein, the outer shaft comprising: a hollow outer shaft body,
wherein the outer shaft body is configured to accommodate the inner
shaft body therewithin; an outer face; an outer shaft opening at
the outer face of the outer shaft; a first complementary interface
at a base of the outer shaft configured to receive the first
interface of the knob; a second complementary interface at the
outer face; an implant body comprising a support structure and an
internal space, the support structure comprising: an outer surface;
a main slot indented into the outer surface; a chamber indented
from the main slot and deeper than the main slot; a second
interface at the outer surface proximal to the main slot to fit the
second complimentary interface at the outer face; wherein the
implant body is substantially toroidal, the internal space is not
covered at a top cross section, a bottom cross section, or the top
and the bottom cross sections thereof by the support structure, and
the internal space is configured to receive at least one graft
material, wherein a rotation of the inner shaft is configured to
associate the first complementary interface to the first interface
at a first position or a second position, wherein the inner shaft
tip is configured to fit through a main slot of an implant body and
rotate in a chamber of the implant body so as to lock the implant
body to the inner shaft. In some cases, the implant delivery system
comprises an implant body comprising a support structure and an
internal space, the support structure comprising: an outer surface;
a main slot indented into the outer surface; a chamber indented
from the main slot, the chamber being deeper than the main slot;
the second interface at the outer surface proximal to the main
slot; wherein the implant body is substantially toroidal, and the
internal space is not covered at a top cross section, a bottom
cross section, or the top and bottom cross sections thereof by the
support structure, and the internal space is configured to receive
at least one graft material; and an internal space configured to
contain at least a graft material. In some cases, the second
interface of the implant body is configured to fit the second
complementary interface at the outer face of the outer shaft so as
to attach the implant body to the outer shaft. In some cases, the
implant insertion device is disposable. In some cases, the implant
insertion device is for one-time use only. In some cases, the
implant insertion device is injection moldable. In some cases, the
implant delivery system is disposable. In some cases, implant
delivery system for one-time use only. In some cases, the second
interface comprises at least one side slot indented into the
implant body proximal to the main slot, wherein each side slot is
configured to receive an outer shaft tip. In some cases, the at
least one side slot is peripherally proximal to the main slot. In
some cases, the at least one side slot is shallower than the main
slot. In some cases, the main slot and the at least one side slot
are indented into the supporting structure. In some cases, wherein
the main slot is indented deeper into the wall of the implant body
than the two side slots along the insertion direction. In some
cases, the internal space of the implant body is filled at least
partly by at least one graft material. In some cases, the implant
body is substantially toroidal. In some cases, wherein a toroidal
shape is a shape with a plurality of cross sections stacked
together continuously, each cross section having an arbitrary two
dimensional empty area enclosed by a wall. In some cases, the
height of the implant body is non-uniform along the
anterior-to-posterior direction so as to accommodate the lordosis
angle of the spinal cord when the implant body is properly
inserted. In some cases, a toroidal shape is a shape comprising a
hole throughout an arbitrary three dimensional volume. In some
cases, the internal space is not covered at the top cross section,
bottom cross section, or top and bottom cross sections thereof by
the implant body. In some cases, the implant body enclosing the
internal space has a wall thickness of at least 1 millimeter but no
more than 3 centimeters. In some cases, the implant body comprises
at least one selected from polyether ether ketone (PEEK), carbon
fiber-reinforced polymer, carbon fiber-reinforced plastic, carbon
fiber-reinforced thermoplastic, glass fiber-reinforced polymer,
glass fiber-reinforced plastic, and polyaryletherketone (PEAK). In
some cases, the implant body is injection moldable. In some cases,
the implant body is machinable. In some cases, the implant body
comprises a saw tooth configured to allow unidirectional insertion
into a subject on an outer surface of the implant body. In some
cases, the saw tooth is further located on the longitudinal plane
of the implant body. In some cases, the saw tooth is configured to
prevent sliding back-out of an implant body after an insertion. In
some cases, the implant body comprises at least one space for
accommodating at least one detectable tag. In some cases, the at
least one detectable tag comprise a radio frequency detectable tag.
In some cases, the at least one space are in the wall of the
implant body. In some cases, the implant body comprises two spaces
for detectable tags, the two spaces being not greater than 5 mm in
their widest dimension. In some cases, the implant body comprises
two spaces for detectable tags, the two spaces being spatially
separated from each other. In some cases, the implant body
comprises four spaces for detectable tags, the four spaces being
spatially separated from each other. In some cases, the cross
section of the implant body along a longitudinal plane comprises a
closed contour formed by the implant body. In some cases, wherein
the closed contour encloses an area therewithin. In some cases, the
internal space is enclosed by closed contours in a plurality of
adjacent longitudinal planes. In some cases, the cross section of
the implant body along a longitudinal plane is a square, a
rectangle, a circle, an ellipse, a rhombus, a trapezoid, a
pentagon, or an arbitrary two dimensional shape enclosing an empty
two dimensional area in a closed contour by a wall. In some cases,
the cross section of the implant body along a longitudinal plane is
a two-dimensional shape similar to a cross section of the
intervertebral space to be inserted therein. In some cases, the
cross section of the implant body along a longitudinal plane is
comprises a closed contour with a non-uniform thickness along the
closed contour. In some cases, the non-uniform thickness along the
closed contour is filled with at least one selected from polyether
ether ketone (PEEK), carbon fiber-reinforced polymer, carbon
fiber-reinforced plastic, carbon fiber-reinforced thermoplastic,
glass fiber-reinforced polymer, glass fiber-reinforced plastic, and
polyaryletherketone (PEAK). In some cases, the chamber of the
implant body is connected to a slot indented from a top-most region
or a bottom-most region of the outer surface along the longitudinal
direction. In some cases, wherein the slot at the top-most region
or the bottom-most region of the support structure is configured to
facilitate injection molding of the chamber. In some cases, the
slot at the top-most region or the bottom-most of the support
structure is configured to enable visualization of the inner shaft
tip. In some cases, the inner shaft is disposable. In some cases,
the inner shaft is for one-time use only. In some cases, the inner
shaft comprises at least one selected from carbon fiber-reinforced
polymer, carbon fiber-reinforced plastic, carbon fiber-reinforced
thermoplastic, glass fiber-reinforced polymer, glass
fiber-reinforced plastic, and polyarylamide. In some cases, the
inner shaft comprises about 50% glass. In some cases, the inner
shaft comprises a glass content of at least 10% to no greater than
70%. In some cases, the inner shaft tip comprises at least one
metal. In some cases, the inner shaft body comprises at least one
metal. In some cases, the inner shaft is injection moldable. In
some cases, the inner shaft tip is injection moldable. In some
cases, the inner shaft body is injection moldable. In some cases,
the knob is injection moldable. In some cases, the inner shaft is
injection moldable and machinable. In some cases, the inner shaft
body is substantially cylindrical. In some cases, the inner shaft
body is flexible so as to fit in a curved outer shaft body. In some
cases, the inner shaft body is a cylinder. In some cases, the knob
of the inner shaft is not enclosed in the outer shaft. In some
cases, the inner shaft tip is not enclosed in the outer shaft. In
some cases, the inner shaft tip is connected to the inner shaft
body in a manner such that the inner shaft tip rotates
concentrically when the inner shaft body rotates. In some cases,
the inner shaft tip is attached to the inner shaft body such that
the center of the cross section of the inner shaft body overlaps
with the middle point of the two foci of the inner shaft tip. In
some cases, the linear movement draws the inner shaft tip towards
the two outer shaft tips. In some cases, the inner shaft tip is
substantially rectangular cuboid or cylindrically elliptical. In
some cases, the inner shaft comprises at least two protrusions
proximal to the inner shaft tip. In some cases, the at least two
protrusions are configured to ensure concentric rotation of the
inner shaft within the outer shaft. In some cases, the at least two
protrusions contact an inner surface of the outer shaft. In some
cases, the first or the second interface comprises a camping some
cases, the cam feature is semi-circular. In some cases, the cam
feature is substantially a circle sector, a triangle, a
quadrilateral, or a pentagon. In some cases, the cam feature is
substantially a circle sector with a central angle of at least 15
degrees to up to 275 degrees. In some cases, the cam feature is
substantially a triangle, a quadrilateral, or a pentagon with an
angle of at least 15 degrees to up to 150 degrees. In some cases,
the cam feature is attached to the knob of the inner shaft. In some
cases, the knob is substantially cylindrical. In some cases, the
cross section of the knob is greater than the cross section of the
inner shaft body. In some cases, the knob of the inner shaft is
configured to not fit into the outer shaft at the base of the outer
shaft. In some cases, the knob comprises at least one hump. In some
cases, the hump is configured to lock the inner shaft to the outer
shaft at the second position such that the inner shaft does not
rotate with respect to the outer shaft. In some cases, the inner
shaft tip is substantially rectangular cuboid or cylindrically
elliptical. In some cases, the inner shaft tip is configured to fit
and rotate in the chamber of the implant body. In some cases, the
inner shaft tip is configured to pass through the outer shaft
opening. In some cases, the inner shaft tip is configured to pass
through the outer shaft opening only when a major axis of the inner
shaft tip and a major axis of the outer shaft opening are
substantially parallel. In some cases, the first or the second
complimentary interface comprises a cam feature. In some cases, the
first or the second interface comprises a first surface and a
second surface, wherein the first surface and the second surface
are connected by a ramp. In some cases, the first and the second
surface are displaced by a distance that the inner shaft tip is
capable of moving with respect to the outer shaft. In some cases,
the first and the second surface are displaced by a distance, the
distance determined by a length and a rising angle of the ramp. In
some cases, the first or the second interface comprises at least
one slot. In some cases, the first or the second complimentary
interface comprises at least a slot. In some cases, the first or
the second interface comprises at least one tip. In some cases, the
outer shaft body is curved. In some cases, the outer shaft is
disposable. In some cases, the outer shaft is for one-time use
only. In some cases, the outer shaft comprises at least one
material selected from the list consists of carbon fiber-reinforced
polymer, carbon fiber-reinforced plastic, carbon fiber-reinforced
thermoplastic, glass fiber-reinforced polymer, glass
fiber-reinforced plastic, and polyarylamide. In some cases, the
outer shaft comprises about 50% glass. In some cases, the outer
shaft comprises a material having a glass content of at least 10%
to no greater than 70%. In some cases, the outer shaft is injection
moldable. In some cases, the outer shaft is injection moldable and
machinable. In some cases, the cross sectional area of the outer
shaft is monotonically non-increasing from a base of the outer
shaft to an insertion end of the outer shaft. In some cases, the
outer shaft opening is substantially circular. In some cases, the
outer shaft opening is configured to allow passage of the inner
shaft tip. In some cases, the outer shaft comprises a third
interface, wherein the third interface unlocks to the hump at the
first position and locks to the hump at the second position. In
some cases, the outer shaft comprises at least one insertion
stopper on the outer shaft to limit insertion depth into an
intervertebral space of the subject. In some cases, the outer shaft
comprises at least an insertion stopper attached to the outer
shaft. In some cases, the outer shaft comprises at least an
insertion stopper, the height of the insertion stopper being
greater than 0.2 millimeters but less than 2 centimeters. In some
cases, the outer shaft comprises at least a ramped protrusion to
prevent the inner shaft from sliding out while the inner shaft is
inserted therewithin. In some cases, the outer shaft comprises at
least a ramped protrusion so that the inner shaft only comes out of
the outer shaft when the implant body is not locked to an inner
shaft tip. In some cases, the outer shaft comprises at least a
ramped protrusion so that the inner shaft only comes out of the
outer shaft when the major axis of the inner shaft tip and the
major axis of the main slot of the implant body are substantially
perpendicular. In some cases, the outer shaft opening at the
insertion end of the outer shaft is further configured to allow
passage of the inner shaft tip only when the major axis of the
inner shaft tip and the major axis of the outer shaft opening are
substantially parallel. In some cases, the first complimentary
interface comprises a first surface and a second surface. In some
cases, the first surface and the second surface are semi-circular.
In some cases, the first surface and the second surface are a
portion of a circle sector. In some cases, the first surface and
the second surface are a portion of a circle sector with a central
angle of 45, 60, 90, 120, or 150 degrees. In some cases, the first
surface and the second surface are a portion of a circle sector
with a central angle of at least 15 degrees to up to 275 degrees.
In some cases, the first surface and the second surface are a
portion of a circle sector with a central angle of 65, 75, 85, 90,
95, 105, or 115 degrees. In some cases, the first or the second
complimentary interface comprises at least one tip. In some cases,
the at least one tip is substantially semi-rectangular cuboid or
semi-cylindrically elliptical. In some cases, the at least one tip
is peripherally proximal to the outer shaft opening at the
insertion end of the outer shaft. In some cases, the at least one
tip and another tip are symmetrically adjacent to the outer shaft
opening at the insertion end of the outer shaft, and on an
extension of the major axis of the outer shaft opening. In some
cases, the at least one tip is on the outer face of the outer
shaft. In some cases, each tip is substantially semi-rectangular
cuboid or semi-cylindrically elliptical. In some cases, each tip is
configured to fit in one side slot of the implant body when the
implant body is locked to the outer shaft. In some cases, the
locking the implant body to the inner shaft comprises that a major
axis of the main slot and a major axis of the inner shaft tip are
not substantially parallel. In some cases, not substantially
parallel comprises an angle of about 90 degrees between the major
axis of the main slot and a major axis of the inner shaft tip. In
some cases, the linear movement of the inner shaft body is
determined by a height of the interface or the complimentary
interface and a rotation angle that the cam feature rotates from a
predetermined location along a circumference of the knob.
Also disclosed herein, in certain cases, are methods for delivering
an implant body using an implant insertion device comprising:
locking the implant body to the implant insertion device by
rotating a knob of an inner shaft of the implant insertion device
in a manner such that the rotation of the knob: rotates an inner
shaft tip within a chamber of the implant body such that a major
axis of a main slot and a major axis of the inner shaft tip are not
substantially parallel, linearly moves the implant body towards an
insertion end of an outer shaft of the implant insertion device so
as to secure the implant body against the insertion end of the
outer shaft, delivering the implant body into a subject using the
implanting insertion device; reversely rotating the knob of the
inner shaft of the implant insertion device in a manner such that
the reverse rotation of the knob rotates the inner shaft tip within
the main slot in the implant body such that the major axis of the
main slot and the major axis of the inner shaft tip are
substantially parallel, associates the first interface of the knob
to the first complimentary interface at the outer shaft at a second
position. In some cases, the methods comprising removing the
insertion device from a package. In some cases, the methods
comprising fitting a first interface of the knob to a first
complementary interface at the outer shaft at a first position. In
some cases, the package comprises a first kit cover, or a second
kit cover, or a first and a second kit covers. In some cases, the
methods comprises fitting a second interface of the implant body to
a second complimentary interface at the insertion end of the outer
shaft such that the implant body is substantially locked to the
insertion device. In some cases, the methods comprises fitting at
least one side slot of the implant body to at least one outer shaft
tip at the insertion end of the outer shaft such that the implant
body is substantially locked to the insertion device In some cases,
the methods comprises releasing at least one side slot of the
implant body from the at least one outer shaft tip at the insertion
end of the outer shaft. In some cases, the method comprises
disposing the implant insertion device after a single use. In some
cases, the implant insertion device is disposable. In some cases,
the implant insertion device is for one-time use only. In some
cases, the implant insertion device is injection moldable. In some
cases, the first interface comprises at least one side slot
indented into the implant body proximal to the main slot, wherein
each side slot is configured to receive an outer shaft tip. In some
cases, the at least one side slot is peripherally proximal to the
main slot. In some cases, the at least one side slot is shallower
than the main slot. In some cases, the main slot and the at least
one side slot are indented into the supporting structure. In some
cases, the main slot is indented deeper into the wall of the
implant body than the two side slots along the insertion direction.
In some cases, the internal space of the implant body is filled at
least partly by at least one graft material. In some cases, the
implant body is substantially toroidal. In some cases, the height
of the implant body along the anterior-to-posterior direction is
configured to accommodate the lordosis angle of the spinal cord
when the implant body is properly inserted. In some cases, a
toroidal shape is a shape with a plurality of cross sections
stacked together continuously, the cross sections being non-uniform
in height when properly deployed, and each cross section having an
arbitrary two dimensional empty area enclosed by a wall. In some
cases, a toroidal shape is a shape comprising a hole in an
arbitrary three dimensional volume. In some cases, the internal
space is not covered at the top cross section, bottom cross
section, or top and bottom cross sections thereof by the implant
body. In some cases, the implant body enclosing the internal space
has a wall thickness of at least 1 millimeter but no more than 3
centimeters. In some cases, the implant body comprises at least one
selected from polyether ether ketone (PEEK), carbon
fiber-reinforced polymer, carbon fiber-reinforced plastic, carbon
fiber-reinforced thermoplastic, glass fiber-reinforced polymer,
glass fiber-reinforced plastic, and polyaryletherketone (PEAK). In
some cases, the implant body is injection moldable. In some cases,
the implant body is machinable. In some cases, the implant body
comprises a saw tooth configured to allow unidirectional insertion
into a subject, the saw tooth being on an outer surface of the
implant body. In some cases, the saw tooth is further located on
the longitudinal plane of the implant body. In some cases, the saw
tooth is configured to prevent back-out after insertion of an
implant insertion direction. In some cases, the implant body
comprises at least one space for accommodating at least one
detectable tag. In some cases, the detectable tags comprise radio
frequency detectable tags. In some cases, the at least one space
are in the wall of the implant body. In some cases, the implant
body comprises at least two spaces for detectable tags, the at
least two spaces being not greater than 5 mm in their widest
dimension. In some cases, the implant body comprises at least two
spaces for detectable tags, the at least two spaces are spatially
separated from each other. In some cases, the implant body
comprises four spaces for detectable tags, spatially separated from
each other. In some cases, the cross section of the implant body
along the longitudinal plane comprises a closed contour formed by
the implant body. In some cases, the closed contour encloses an
area therewithin. In some cases, the internal space is enclosed by
closed contours in a plurality of adjacent longitudinal planes. In
some cases, the cross section of the implant body along a
longitudinal plane is a square, a rectangle, a circle, an ellipse,
a rhombus, a trapezoid, a pentagon, or an arbitrary two dimensional
shape enclosing an empty two dimensional area in a closed contour.
In some cases, the cross section of the implant body along a
longitudinal plane is a two-dimensional shape similar to a cross
section of the intervertebral space to be inserted therein. In some
cases, the cross section of the implant body along a longitudinal
plane is comprises a closed contour with a non-uniform thickness
along the closed contour. In some cases, the non-uniform thickness
along the closed contour is filled with at least one selected from
polyether ether ketone (PEEK), carbon fiber-reinforced polymer,
carbon fiber-reinforced plastic, carbon fiber-reinforced
thermoplastic, glass fiber-reinforced polymer, glass
fiber-reinforced plastic, and polyaryletherketone (PEAK). In some
cases, the chamber of the implant body is connected to a slot
indented from a top-most region or a bottom-most region of the
outer surface along a longitudinal direction. In some cases, the
slot indented from the top-most region or the bottom-most region of
the outer surface is configured to facilitate molding of a chamber
therewithin. In some cases, the slot is configured to enable
visualization of the inner shaft tip. In some cases, the inner
shaft is disposable. In some cases, the inner shaft is for one-time
use only. In some cases, the inner shaft comprises at least one
selected from carbon fiber-reinforced polymer, carbon
fiber-reinforced plastic, carbon fiber-reinforced thermoplastic,
glass fiber-reinforced polymer, glass fiber-reinforced plastic, and
polyarylamide. In some cases, the inner shaft comprises about 50%
glass. In some cases, the inner shaft comprises a material having a
glass content of at least 10% to no greater than 70%. In some
cases, the inner shaft tip comprises at least one metal. In some
cases, the inner shaft body comprises at least one metal. In some
cases, the inner shaft is injection moldable. In some cases, the
inner shaft tip is injection moldable. In some cases, the inner
shaft body is injection moldable. In some cases, the knob is
injection moldable. In some cases, the inner shaft is injection
moldable and machinable. In some cases, the inner shaft body is
substantially cylindrical. In some cases, the inner shaft body is
flexible so as to fit in a curved outer shaft body. In some cases,
the inner shaft body is a cylinder. In some cases, the knob of the
inner shaft is not enclosed in the outer shaft. In some cases, the
inner shaft tip is not enclosed in the outer shaft. In some cases,
the inner shaft tip is connected to the inner shaft body in a
manner such that the inner shaft tip rotates concentrically when
the inner shaft body rotates. In some cases, the inner shaft tip is
attached to the inner shaft body such that the center of the cross
section of the inner shaft body overlaps with the middle point of
the two foci of the inner shaft tip. In some cases, the linear
movement draws the inner shaft tip towards the two outer shaft
tips. In some cases, the inner shaft tip is substantially
rectangular cuboid or cylindrically elliptical. In some cases, the
inner shaft comprises at least two protrusions proximal to the
inner shaft tip to ensure concentric rotation of the inner shaft
within the outer shaft. In some cases, the at least two protrusions
are enclosed in the outer shaft. In some cases, the at least two
protrusions contact an inner surface of the outer shaft. In some
cases, the first interface comprises a cam feature. In some cases,
the cam feature is semi-circular. In some cases, the cam feature is
substantially a circle sector, a triangle, a quadrilateral, or a
pentagon. In some cases, the cam feature is substantially a circle
sector with a central angle of 45, 60, 90,120, or 150 degrees. In
some cases, the cam feature is substantially a circle sector with a
central angle of at least 15 degrees to up to 275 degrees. In some
cases, the cam feature is substantially a triangle, a
quadrilateral, or a pentagon with an angle of at least 15 degrees
to up to 150 degrees. In some cases, the cam feature is
substantially a triangle, a quadrilateral, or a pentagon with an
angle of 65, 75, 85, 95, 105, or 115 degrees. In some cases, the
cam feature is attached to the knob of the inner shaft. In some
cases, the knob is substantially cylindrical. In some cases, the
cross section of the knob is greater than the cross section of the
inner shaft body. In some cases, the knob of the inner shaft is
configured to not fit into the outer shaft at the base of the outer
shaft. In some cases, the knob comprises a hump. In some cases, the
hump is configured to unlock the inner shaft from the outer shaft
at the first position and lock the inner shaft to the outer shaft
at the second position. In some cases, the inner shaft tip is
substantially rectangular cuboid or cylindrically elliptical. In
some cases, the inner shaft tip is configured to fit and rotate in
the chamber of the implant body. In some cases, the inner shaft tip
is configured to pass through the outer shaft opening. In some
cases, the inner shaft tip is configured to pass through the outer
shaft opening only when a major axis of the inner shaft tip and a
major axis of the outer shaft opening are substantially parallel.
In some cases, the first or the second complimentary interface
comprises a cam feature. In some cases, the first or the second
interface comprises a first surface and a second surface. In some
cases, the first and the second surfaces are displaced by a
distance that the inner shaft tip is capable of moving with respect
to the outer shaft. In some cases, the first and the second
surfaces are displaced by a distance determined by a length and a
rising angle of the ramp. In some cases, the first or the second
interface comprises at least one slot. In some cases, the first or
the second complimentary interface comprises at least a slot. In
some cases, the first or the second interface comprises at least
one tip or at least two tips. In some cases, the outer shaft is
disposable. In some cases, the outer shaft is for one-time use
only. In some cases, the outer shaft comprises at least one
selected from carbon fiber-reinforced polymer, carbon
fiber-reinforced plastic, carbon fiber-reinforced thermoplastic,
glass fiber-reinforced polymer, glass fiber-reinforced plastic, and
polyarylamide. In some cases, the outer shaft comprises about 50%
glass. In some cases, the outer shaft comprises a glass content of
at least 10% to no greater than 70%. In some cases, the outer shaft
is injection moldable. In some cases, the outer shaft is injection
moldable and machinable. In some cases, the cross sectional area of
the outer shaft is monotonically non-increasing from a base of the
outer shaft to an insertion end of the outer shaft. In some cases,
the outer shaft opening is substantially circular. In some cases,
the outer shaft opening is configured to allow passage of the inner
shaft tip. In some cases, the outer shaft comprises a third
interface, wherein the third interface unlocks to the hump at the
first position and locks to the hump at the second position. In
some cases, the outer shaft comprises at least one insertion
stopper on the outer shaft to limit insertion depth into an
intervertebral space of the subject. In some cases, the outer shaft
comprises at least an insertion stopper attached to the outer
shaft. In some cases, the outer shaft comprises at least an
insertion stopper, the height of the insertion stopper being
greater than 0.2 millimeters but less than 2 centimeters. In some
cases, the outer shaft comprises at least a ramped protrusion to
prevent the inner shaft from sliding out while the inner shaft is
inserted therewithin. In some cases, the outer shaft comprises at
least a ramped protrusion so that the inner shaft only comes out of
the outer shaft when the implant body is not locked to an inner
shaft tip. In some cases, the outer shaft comprises at least a
ramped protrusion so that the inner shaft only comes out of the
outer shaft when the major axis of the inner shaft tip and the
major axis of the main slot of the implant body are substantially
perpendicular. In some cases, the outer shaft opening at the
insertion end of the outer shaft is further configured to allow
passage of the inner shaft tip only when the major axis of the
inner shaft tip and the major axis of the outer shaft opening are
substantially parallel. In some cases, the first or the second
complimentary interface comprises a first surface and a second
surface. In some cases, the first surface and the second surface
are semi-circular. In some cases, the first surface and the second
surface are a portion of a circle sector. In some cases, the first
surface and the second surface are a portion of a circle sector
with a central angle of at least 15 degrees to up to 275 degrees.
In some cases, the first or the second complimentary interface
comprises at least one or at least two tips. In some cases, each
tip is substantially semi-rectangular cuboid or semi-cylindrically
elliptical. In some cases, each tip is peripherally proximal to the
outer shaft opening at the insertion end of the outer shaft. In
some cases, the at least two tips are symmetrically adjacent to the
outer shaft opening at the insertion end of the outer shaft, and on
an extension of the major axis of the outer shaft opening. In some
cases, each tip is on the outer face of the outer shaft. In some
cases, each tip is substantially semi-rectangular cuboid or
semi-cylindrically elliptical. In some cases, each tip is
configured to fit in one side slot of the implant body when the
implant body is locked to the outer shaft. In some cases, the
locking the implant body to the inner shaft comprises that a major
axis of the main slot and a major axis of the inner shaft tip are
not substantially parallel. In some cases, not substantially
parallel comprises an angle of about 90 degrees between the major
axis of the main slot and a major axis of the inner shaft tip. In
some cases, the linear movement of the inner shaft body is
determined by a height of the interface or the complimentary
interface and a rotation angle that the cam feature rotates from a
predetermined location along a circumference of the knob. In some
cases, the methods comprises rotating the knob of an inner shaft of
the implant insertion device in a manner such that the rotation of
the knob linearly displaces the implant body from the insertion end
of the outer shaft of the implant insertion device. In some aspects
the methods comprise inserting the implant into an intervertebral
space. In some aspects the intervertebral space is lumbar. In some
aspects the intervertebral space is cervical. In some aspects
intervertebral disk material is removed from the intervertebral
space prior to inserting the implant. In some aspects the implant
is inserted into the interior of an intervertebral disk.
Also disclosed herein, in certain embodiments, are methods for
delivering an implant body using an implant insertion device
comprising releasing an implant body into an intervertebral space
of a patient comprising: rotating a knob of an inner shaft of the
implant insertion device in a manner such that a rotation of the
knob rotates an inner shaft tip within a main slot in the implant
body substantially in a coronal plane such that a major axis of the
main slot and a major axis of the inner shaft tip are substantially
parallel, and associates a first interface of the knob to a first
complimentary interface at an outer shaft at a unlocked position;
and depositing the implant body in an intervertebral space of the
patient. In some cases, the methods comprises locking the implant
body to the implant insertion device by a rotation of a knob of an
inner shaft of the implant insertion device in a manner such that
the rotation of the knob rotates an inner shaft tip within a
chamber of the implant body substantially in a coronal plane such
that a major axis of the main slot and a major axis of the inner
shaft tip are not substantially parallel, linearly moves the
implant body towards an insertion end of the outer shaft of the
implant insertion device so as to secure the implant body against
the insertion end of the outer shaft, and associates the first
interface of the knob to the first complementary interface at the
outer shaft at the first position. In some cases, the methods
comprising removing the insertion device from a package. In some
cases, the methods comprising fitting a first interface of the knob
to a first complementary interface at the outer shaft at a first
position. In some cases, the package comprises a first kit cover,
or a second kit cover, or a first and a second kit covers. In some
cases, the methods comprises fitting a second interface of the
implant body to a second complimentary interface at the insertion
end of the outer shaft such that the implant body is substantially
locked to the insertion device. In some cases, the methods
comprises fitting at least one side slot of the implant body to at
least one outer shaft tip at the insertion end of the outer shaft
such that the implant body is substantially locked to the insertion
device In some cases, the methods comprises releasing at least one
side slot of the implant body from the at least one outer shaft tip
at the insertion end of the outer shaft. In some cases, the method
comprises disposing the implant insertion device after a single
use. In some cases, the implant insertion device is disposable. In
some cases, the implant insertion device is for one-time use only.
In some cases, the implant insertion device is injection moldable.
In some cases, the first interface comprises at least one side slot
indented into the implant body proximal to the main slot, wherein
each side slot is configured to receive an outer shaft tip. In some
cases, the at least one side slot is peripherally proximal to the
main slot. In some cases, the at least one side slot is shallower
than the main slot. In some cases, the main slot and the at least
one side slot are indented into the supporting structure. In some
cases, the main slot is indented deeper into the wall of the
implant body than the two side slots along the insertion direction.
In some cases, the internal space of the implant body is filled at
least partly by at least one graft material. In some cases, the
implant body is substantially toroidal. In some cases, the height
of the implant body along the anterior-to-posterior direction is
configured to accommodate the lordosis angle of the spinal cord
when the implant body is properly inserted. In some cases, a
toroidal shape is a shape with a plurality of cross sections
stacked together continuously, the cross sections being non-uniform
in height when properly deployed, and each cross section having an
arbitrary two dimensional empty area enclosed by a wall. In some
cases, a toroidal shape is a shape comprising a hole in an
arbitrary three dimensional volume. In some cases, the internal
space is not covered at the top cross section, bottom cross
section, or top and bottom cross sections thereof by the implant
body. In some cases, the implant body enclosing the internal space
has a wall thickness of at least 1 millimeter but no more than 3
centimeters. In some cases, the implant body comprises at least one
selected from polyether ether ketone (PEEK), carbon
fiber-reinforced polymer, carbon fiber-reinforced plastic, carbon
fiber-reinforced thermoplastic, glass fiber-reinforced polymer,
glass fiber-reinforced plastic, and polyaryletherketone (PEAK). In
some cases, the implant body is injection moldable. In some cases,
the implant body is machinable. In some cases, the implant body
comprises a saw tooth configured to allow unidirectional insertion
into a subject, the saw tooth being on an outer surface of the
implant body. In some cases, the saw tooth is further located on
the longitudinal plane of the implant body. In some cases, the saw
tooth is configured to prevent back-out after insertion of an
implant insertion direction. In some cases, the implant body
comprises at least one space for accommodating at least one
detectable tag. In some cases, the detectable tags comprise radio
frequency detectable tags. In some cases, the at least one space
are in the wall of the implant body. In some cases, the implant
body comprises at least two spaces for detectable tags, the at
least two spaces being not greater than 5 mm in their widest
dimension. In some cases, the implant body comprises at least two
spaces for detectable tags, the at least two spaces are spatially
separated from each other. In some cases, the implant body
comprises four spaces for detectable tags, spatially separated from
each other. In some cases, the cross section of the implant body
along the longitudinal plane comprises a closed contour formed by
the implant body. In some cases, the closed contour encloses an
area therewithin. In some cases, the internal space is enclosed by
closed contours in a plurality of adjacent longitudinal planes. In
some cases, the cross section of the implant body along a
longitudinal plane is a square, a rectangle, a circle, an ellipse,
a rhombus, a trapezoid, a pentagon, or an arbitrary two dimensional
shape enclosing an empty two dimensional area in a closed contour.
In some cases, the cross section of the implant body along a
longitudinal plane is a two-dimensional shape similar to a cross
section of the intervertebral space to be inserted therein. In some
cases, the cross section of the implant body along a longitudinal
plane is comprises a closed contour with a non-uniform thickness
along the closed contour. In some cases, the non-uniform thickness
along the closed contour is filled with at least one selected from
polyether ether ketone (PEEK), carbon fiber-reinforced polymer,
carbon fiber-reinforced plastic, carbon fiber-reinforced
thermoplastic, glass fiber-reinforced polymer, glass
fiber-reinforced plastic, and polyaryletherketone (PEAK). In some
cases, the chamber of the implant body is connected to a slot
indented from a top-most region or a bottom-most region of the
outer surface along a longitudinal direction. In some cases, the
slot indented from the top-most region or the bottom-most region of
the outer surface is configured to facilitate molding of a chamber
therewithin. In some cases, the slot is configured to enable
visualization of the inner shaft tip. In some cases, the inner
shaft is disposable. In some cases, the inner shaft is for one-time
use only. In some cases, the inner shaft comprises at least one
selected from carbon fiber-reinforced polymer, carbon
fiber-reinforced plastic, carbon fiber-reinforced thermoplastic,
glass fiber-reinforced polymer, glass fiber-reinforced plastic, and
polyarylamide. In some cases, the inner shaft comprises about 50%
glass. In some cases, the inner shaft comprises a material having a
glass content of at least 10% to no greater than 70%. In some
cases, the inner shaft tip comprises at least one metal. In some
cases, the inner shaft body comprises at least one metal. In some
cases, the inner shaft is injection moldable. In some cases, the
inner shaft tip is injection moldable. In some cases, the inner
shaft body is injection moldable. In some cases, the knob is
injection moldable. In some cases, the inner shaft is injection
moldable and machinable. In some cases, the inner shaft body is
substantially cylindrical. In some cases, the inner shaft body is
flexible so as to fit in a curved outer shaft body. In some cases,
the inner shaft body is a cylinder. In some cases, the knob of the
inner shaft is not enclosed in the outer shaft. In some cases, the
inner shaft tip is not enclosed in the outer shaft. In some cases,
the inner shaft tip is connected to the inner shaft body in a
manner such that the inner shaft tip rotates concentrically when
the inner shaft body rotates. In some cases, the inner shaft tip is
attached to the inner shaft body such that the center of the cross
section of the inner shaft body overlaps with the middle point of
the two foci of the inner shaft tip. In some cases, the linear
movement draws the inner shaft tip towards the two outer shaft
tips. In some cases, the inner shaft tip is substantially
rectangular cuboid or cylindrically elliptical. In some cases, the
inner shaft comprises at least two protrusions proximal to the
inner shaft tip to ensure concentric rotation of the inner shaft
within the outer shaft. In some cases, the at least two protrusions
are enclosed in the outer shaft. In some cases, the at least two
protrusions contact an inner surface of the outer shaft. In some
cases, the first interface comprises a cam feature. In some cases,
the cam feature is semi-circular. In some cases, the cam feature is
substantially a circle sector, a triangle, a quadrilateral, or a
pentagon. In some cases, the cam feature is substantially a circle
sector with a central angle of 45, 60, 90,120, or 150 degrees. In
some cases, the cam feature is substantially a circle sector with a
central angle of at least 15 degrees to up to 275 degrees. In some
cases, the cam feature is substantially a triangle, a
quadrilateral, or a pentagon with an angle of at least 15 degrees
to up to 150 degrees. In some cases, the cam feature is
substantially a triangle, a quadrilateral, or a pentagon with an
angle of 65, 75, 85, 95, 105, or 115 degrees. In some cases, the
cam feature is attached to the knob of the inner shaft. In some
cases, the knob is substantially cylindrical. In some cases, the
cross section of the knob is greater than the cross section of the
inner shaft body. In some cases, the knob of the inner shaft is
configured to not fit into the outer shaft at the base of the outer
shaft. In some cases, the knob comprises a hump. In some cases, the
hump is configured to unlock the inner shaft from the outer shaft
at the first position and lock the inner shaft to the outer shaft
at the second position. In some cases, the inner shaft tip is
substantially rectangular cuboid or cylindrically elliptical. In
some cases, the inner shaft tip is configured to fit and rotate in
the chamber of the implant body. In some cases, the inner shaft tip
is configured to pass through the outer shaft opening. In some
cases, the inner shaft tip is configured to pass through the outer
shaft opening only when a major axis of the inner shaft tip and a
major axis of the outer shaft opening are substantially parallel.
In some cases, the first or the second complimentary interface
comprises a cam feature. In some cases, the first or the second
interface comprises a first surface and a second surface. In some
cases, the first and the second surfaces are displaced by a
distance that the inner shaft tip is capable of moving with respect
to the outer shaft. In some cases, the first and the second
surfaces are displaced by a distance determined by a length and a
rising angle of the ramp. In some cases, the first or the second
interface comprises at least one slot. In some cases, the first or
the second complimentary interface comprises at least a slot. In
some cases, the first or the second interface comprises at least
one tip or at least two tips. In some cases, the outer shaft is
disposable. In some cases, the outer shaft is for one-time use
only. In some cases, the outer shaft comprises at least one
selected from carbon fiber-reinforced polymer, carbon
fiber-reinforced plastic, carbon fiber-reinforced thermoplastic,
glass fiber-reinforced polymer, glass fiber-reinforced plastic, and
polyarylamide. In some cases, the outer shaft comprises about 50%
glass. In some cases, the outer shaft comprises a glass content of
at least 10% to no greater than 70%. In some cases, the outer shaft
is injection moldable. In some cases, the outer shaft is injection
moldable and machinable. In some cases, the cross sectional area of
the outer shaft is monotonically non-increasing from a base of the
outer shaft to an insertion end of the outer shaft. In some cases,
the outer shaft opening is substantially circular. In some cases,
the outer shaft opening is configured to allow passage of the inner
shaft tip. In some cases, the outer shaft comprises a third
interface, wherein the third interface unlocks to the hump at the
first position and locks to the hump at the second position. In
some cases, the outer shaft comprises at least one insertion
stopper on the outer shaft to limit insertion depth into an
intervertebral space of the subject. In some cases, the outer shaft
comprises at least an insertion stopper attached to the outer
shaft. In some cases, the outer shaft comprises at least an
insertion stopper, the height of the insertion stopper being
greater than 0.2 millimeters but less than 2 centimeters. In some
cases, the outer shaft comprises at least a ramped protrusion to
prevent the inner shaft from sliding out while the inner shaft is
inserted therewithin. In some cases, the outer shaft comprises at
least a ramped protrusion so that the inner shaft only comes out of
the outer shaft when the implant body is not locked to an inner
shaft tip. In some cases, the outer shaft comprises at least a
ramped protrusion so that the inner shaft only comes out of the
outer shaft when the major axis of the inner shaft tip and the
major axis of the main slot of the implant body are substantially
perpendicular. In some cases, the outer shaft opening at the
insertion end of the outer shaft is further configured to allow
passage of the inner shaft tip only when the major axis of the
inner shaft tip and the major axis of the outer shaft opening are
substantially parallel. In some cases, the first or the second
complimentary interface comprises a first surface and a second
surface. In some cases, the first surface and the second surface
are semi-circular. In some cases, the first surface and the second
surface are a portion of a circle sector. In some cases, the first
surface and the second surface are a portion of a circle sector
with a central angle of at least 15 degrees to up to 275 degrees.
In some cases, the first or the second complimentary interface
comprises at least one or at least two tips. In some cases, each
tip is substantially semi-rectangular cuboid or semi-cylindrically
elliptical. In some cases, each tip is peripherally proximal to the
outer shaft opening at the insertion end of the outer shaft. In
some cases, the at least two tips are symmetrically adjacent to the
outer shaft opening at the insertion end of the outer shaft, and on
an extension of the major axis of the outer shaft opening. In some
cases, each tip is on the outer face of the outer shaft. In some
cases, each tip is substantially semi-rectangular cuboid or
semi-cylindrically elliptical. In some cases, each tip is
configured to fit in one side slot of the implant body when the
implant body is locked to the outer shaft. In some cases, the
locking the implant body to the inner shaft comprises that a major
axis of the main slot and a major axis of the inner shaft tip are
not substantially parallel. In some cases, not substantially
parallel comprises an angle of about 90 degrees between the major
axis of the main slot and a major axis of the inner shaft tip. In
some cases, the linear movement of the inner shaft body is
determined by a height of the interface or the complimentary
interface and a rotation angle that the cam feature rotates from a
predetermined location along a circumference of the knob. In some
cases, the methods comprises rotating the knob of an inner shaft of
the implant insertion device in a manner such that the rotation of
the knob linearly displaces the implant body from the insertion end
of the outer shaft of the implant insertion device. In some aspects
the methods comprise inserting the implant into an intervertebral
space. In some aspects the intervertebral space is lumbar. In some
aspects the intervertebral space is cervical. In some aspects
intervertebral disk material is removed from the intervertebral
space prior to inserting the implant. In some aspects the implant
is inserted into the interior of an intervertebral disk.
Also disclosed herein, in certain cases, are sterile kits
containing a single-use implant body insertion device and a single
use implant, the sterile kit comprising: a sterile kit cover sealed
to enclose at least one device tray, at least one implant body, and
at least one implant insertion device therewithin, wherein the at
least one implant body and the at least one implant insertion
device are configured for a single usage; the at least one device
tray is configured to secure: the at least one implant insertion
device; the at least one implant body; the at least one implant
insertion device comprising: a shaft; a tip; a first interface for
locking the at least one implant body; a second interface for
locking the at least one implant body; a first position; a second
position; and the at least one implant body comprising: an internal
space; a slot for locking the at least one implant body against the
at least one implant insertion device at the first position; a
first complimentary interface for receiving the interface of the at
least one implant insertion device at the first position or the
second position; a second complimentary interface for receiving the
second interface of the at least one implant insertion device at
the first position. In some cases, the kit comprises a second kit
cover sealed to enclose the sterile kit cover. In some cases, the
second kit cover is sterile. In some cases, the device tray
comprises a compartment to secure at least one implant body to
facilitate loading at least one graft material to the internal
space thereof. In some cases, the kits comprising removing the
insertion device from a package. In some cases, the kits comprising
fitting a first interface of the knob to a first complementary
interface at the outer shaft at a first position. In some cases,
the package comprises a first kit cover, or a second kit cover, or
a first and a second kit covers. In some cases, the kits comprises
fitting a second interface of the implant body to a second
complimentary interface at the insertion end of the outer shaft
such that the implant body is substantially locked to the insertion
device. In some cases, the kits comprises fitting at least one side
slot of the implant body to at least one outer shaft tip at the
insertion end of the outer shaft such that the implant body is
substantially locked to the insertion device In some cases, the
kits comprises releasing at least one side slot of the implant body
from the at least one outer shaft tip at the insertion end of the
outer shaft. In some cases, the kit comprises disposing the implant
insertion device after a single use. In some cases, the implant
insertion device is disposable. In some cases, the implant
insertion device is for one-time use only. In some cases, the
implant insertion device is injection moldable. In some cases, the
first interface comprises at least one side slot indented into the
implant body proximal to the main slot, wherein each side slot is
configured to receive an outer shaft tip. In some cases, the at
least one side slot is peripherally proximal to the main slot. In
some cases, the at least one side slot is shallower than the main
slot. In some cases, the main slot and the at least one side slot
are indented into the supporting structure. In some cases, the main
slot is indented deeper into the wall of the implant body than the
two side slots along the insertion direction. In some cases, the
internal space of the implant body is filled at least partly by at
least one graft material. In some cases, the implant body is
substantially toroidal. In some cases, the height of the implant
body along the anterior-to-posterior direction is configured to
accommodate the lordosis angle of the spinal cord when the implant
body is properly inserted. In some cases, a toroidal shape is a
shape with a plurality of cross sections stacked together
continuously, the cross sections being non-uniform in height when
properly deployed, and each cross section having an arbitrary two
dimensional empty area enclosed by a wall. In some cases, a
toroidal shape is a shape comprising a hole in an arbitrary three
dimensional volume. In some cases, the internal space is not
covered at the top cross section, bottom cross section, or top and
bottom cross sections thereof by the implant body. In some cases,
the implant body enclosing the internal space has a wall thickness
of at least 1 millimeter but no more than 3 centimeters. In some
cases, the implant body comprises at least one selected from
polyether ether ketone (PEEK), carbon fiber-reinforced polymer,
carbon fiber-reinforced plastic, carbon fiber-reinforced
thermoplastic, glass fiber-reinforced polymer, glass
fiber-reinforced plastic, and polyaryletherketone (PEAK). In some
cases, the implant body is injection moldable. In some cases, the
implant body is machinable. In some cases, the implant body
comprises a saw tooth configured to allow unidirectional insertion
into a subject, the saw tooth being on an outer surface of the
implant body. In some cases, the saw tooth is further located on
the longitudinal plane of the implant body. In some cases, the saw
tooth is configured to prevent back-out after insertion of an
implant insertion direction. In some cases, the implant body
comprises at least one space for accommodating at least one
detectable tag. In some cases, the detectable tags comprise radio
frequency detectable tags. In some cases, the at least one space
are in the wall of the implant body. In some cases, the implant
body comprises at least two spaces for detectable tags, the at
least two spaces being not greater than 5 mm in their widest
dimension. In some cases, the implant body comprises at least two
spaces for detectable tags, the at least two spaces are spatially
separated from each other. In some cases, the implant body
comprises four spaces for detectable tags, spatially separated from
each other. In some cases, the cross section of the implant body
along the longitudinal plane comprises a closed contour formed by
the implant body. In some cases, the closed contour encloses an
area therewithin. In some cases, the internal space is enclosed by
closed contours in a plurality of adjacent longitudinal planes. In
some cases, the cross section of the implant body along a
longitudinal plane is a square, a rectangle, a circle, an ellipse,
a rhombus, a trapezoid, a pentagon, or an arbitrary two dimensional
shape enclosing an empty two dimensional area in a closed contour.
In some cases, the cross section of the implant body along a
longitudinal plane is a two-dimensional shape similar to a cross
section of the intervertebral space to be inserted therein. In some
cases, the cross section of the implant body along a longitudinal
plane is comprises a closed contour with a non-uniform thickness
along the closed contour. In some cases, the non-uniform thickness
along the closed contour is filled with at least one selected from
polyether ether ketone (PEEK), carbon fiber-reinforced polymer,
carbon fiber-reinforced plastic, carbon fiber-reinforced
thermoplastic, glass fiber-reinforced polymer, glass
fiber-reinforced plastic, and polyaryletherketone (PEAK). In some
cases, the chamber of the implant body is connected to a slot
indented from a top-most region or a bottom-most region of the
outer surface along a longitudinal direction. In some cases, the
slot indented from the top-most region or the bottom-most region of
the outer surface is configured to facilitate molding of a chamber
therewithin. In some cases, the slot is configured to enable
visualization of the inner shaft tip. In some cases, the inner
shaft is disposable. In some cases, the inner shaft is for one-time
use only. In some cases, the inner shaft comprises at least one
selected from carbon fiber-reinforced polymer, carbon
fiber-reinforced plastic, carbon fiber-reinforced thermoplastic,
glass fiber-reinforced polymer, glass fiber-reinforced plastic, and
polyarylamide. In some cases, the inner shaft comprises about 50%
glass. In some cases, the inner shaft comprises a material having a
glass content of at least 10% to no greater than 70%. In some
cases, the inner shaft tip comprises at least one metal. In some
cases, the inner shaft body comprises at least one metal. In some
cases, the inner shaft is injection moldable. In some cases, the
inner shaft tip is injection moldable. In some cases, the inner
shaft body is injection moldable. In some cases, the knob is
injection moldable. In some cases, the inner shaft is injection
moldable and machinable. In some cases, the inner shaft body is
substantially cylindrical. In some cases, the inner shaft body is
flexible so as to fit in a curved outer shaft body. In some cases,
the inner shaft body is a cylinder. In some cases, the knob of the
inner shaft is not enclosed in the outer shaft. In some cases, the
inner shaft tip is not enclosed in the outer shaft. In some cases,
the inner shaft tip is connected to the inner shaft body in a
manner such that the inner shaft tip rotates concentrically when
the inner shaft body rotates. In some cases, the inner shaft tip is
attached to the inner shaft body such that the center of the cross
section of the inner shaft body overlaps with the middle point of
the two foci of the inner shaft tip. In some cases, the linear
movement draws the inner shaft tip towards the two outer shaft
tips. In some cases, the inner shaft tip is substantially
rectangular cuboid or cylindrically elliptical. In some cases, the
inner shaft comprises at least two protrusions proximal to the
inner shaft tip to ensure concentric rotation of the inner shaft
within the outer shaft. In some cases, the at least two protrusions
are enclosed in the outer shaft. In some cases, the at least two
protrusions contact an inner surface of the outer shaft. In some
cases, the first interface comprises a cam feature. In some cases,
the cam feature is semi-circular. In some cases, the cam feature is
substantially a circle sector, a triangle, a quadrilateral, or a
pentagon. In some cases, the cam feature is substantially a circle
sector with a central angle of 45, 60, 90,120, or 150 degrees. In
some cases, the cam feature is substantially a circle sector with a
central angle of at least 15 degrees to up to 275 degrees. In some
cases, the cam feature is substantially a triangle, a
quadrilateral, or a pentagon with an angle of at least 15 degrees
to up to 150 degrees. In some cases, the cam feature is
substantially a triangle, a quadrilateral, or a pentagon with an
angle of 65, 75, 85, 95, 105, or 115 degrees. In some cases, the
cam feature is attached to the knob of the inner shaft. In some
cases, the knob is substantially cylindrical. In some cases, the
cross section of the knob is greater than the cross section of the
inner shaft body. In some cases, the knob of the inner shaft is
configured to not fit into the outer shaft at the base of the outer
shaft. In some cases, the knob comprises a hump. In some cases, the
hump is configured to unlock the inner shaft from the outer shaft
at the first position and lock the inner shaft to the outer shaft
at the second position. In some cases, the inner shaft tip is
substantially rectangular cuboid or cylindrically elliptical. In
some cases, the inner shaft tip is configured to fit and rotate in
the chamber of the implant body. In some cases, the inner shaft tip
is configured to pass through the outer shaft opening. In some
cases, the inner shaft tip is configured to pass through the outer
shaft opening only when a major axis of the inner shaft tip and a
major axis of the outer shaft opening are substantially parallel.
In some cases, the first or the second complimentary interface
comprises a cam feature. In some cases, the first or the second
interface comprises a first surface and a second surface. In some
cases, the first and the second surfaces are displaced by a
distance that the inner shaft tip is capable of moving with respect
to the outer shaft. In some cases, the first and the second
surfaces are displaced by a distance determined by a length and a
rising angle of the ramp. In some cases, the first or the second
interface comprises at least one slot. In some cases, the first or
the second complimentary interface comprises at least a slot. In
some cases, the first or the second interface comprises at least
one tip. In some cases, the outer shaft is disposable. In some
cases, the outer shaft is for one-time use only. In some cases, the
outer shaft comprises at least one material selected from carbon
fiber-reinforced polymer, carbon fiber-reinforced plastic, carbon
fiber-reinforced thermoplastic, glass fiber-reinforced polymer,
glass fiber-reinforced plastic, and polyarylamide. In some cases,
the outer shaft comprises about 50% glass or 50% glass. In some
cases, the outer shaft comprises a glass content of at least 10% to
no greater than 70%. In some cases, the outer shaft is injection
moldable. In some cases, the outer shaft is injection moldable and
machinable. In some cases, the cross sectional area of the outer
shaft is monotonically non-increasing from a base of the outer
shaft to an insertion end of the outer shaft. In some cases, the
outer shaft opening is substantially circular. In some cases, the
outer shaft opening allows passage of the inner shaft tip. In some
cases, the outer shaft comprises a third interface, wherein the
third interface unlocks to the hump at the first position and locks
to the hump at the second position. In some cases, the outer shaft
comprises at least one insertion stopper on the outer shaft to
limit insertion depth into an intervertebral space of the subject.
In some cases, the outer shaft comprises at least an insertion
stopper attached to the outer shaft. In some cases, the outer shaft
comprises at least an insertion stopper, the height of the
insertion stopper being greater than 0.2 millimeters but less than
2 centimeters. In some cases, the outer shaft comprises at least a
ramped protrusion to prevent the inner shaft from sliding out while
the inner shaft is inserted therewithin. In some cases, the outer
shaft comprises at least a ramped protrusion so that the inner
shaft only comes out of the outer shaft when the implant body is
not locked to an inner shaft tip. In some cases, the outer shaft
comprises at least a ramped protrusion so that the inner shaft only
comes out of the outer shaft when the major axis of the inner shaft
tip and the major axis of the main slot of the implant body are
substantially perpendicular. In some cases, the outer shaft opening
at the insertion end of the outer shaft is further configured to
allow passage of the inner shaft tip only when the major axis of
the inner shaft tip and the major axis of the outer shaft opening
are substantially parallel. In some cases, the first or the second
complimentary interface comprises a first surface and a second
surface. In some cases, the first surface and the second surface
are semi-circular. In some cases, the first surface and the second
surface are a portion of a circle sector. In some cases, the first
surface and the second surface are a portion of a circle sector
with a central angle of at least 15 degrees to up to 275 degrees.
In some cases, the first or the second complimentary interface
comprises at least one or at least two tips. In some cases, each
tip is substantially semi-rectangular cuboid or semi-cylindrically
elliptical. In some cases, each tip is peripherally proximal to the
outer shaft opening at the insertion end of the outer shaft. In
some cases, the at least two tips are symmetrically adjacent to the
outer shaft opening at the insertion end of the outer shaft, and on
an extension of the major axis of the outer shaft opening. In some
cases, each tip is on the outer face of the outer shaft. In some
cases, each tip is substantially semi-rectangular cuboid or
semi-cylindrically elliptical. In some cases, each tip is
configured to fit in one side slot of the implant body when the
implant body is locked to the outer shaft. In some cases, the
locking the implant body to the inner shaft comprises that a major
axis of the main slot and a major axis of the inner shaft tip are
not substantially parallel. In some cases, not substantially
parallel comprises an angle of about 90 degrees between the major
axis of the main slot and a major axis of the inner shaft tip. In
some cases, linear movement of the inner shaft body is determined
by a height of the interface or the complimentary interface and a
rotation angle that the cam feature rotates from a predetermined
location along a circumference of the knob. In some cases, the
methods comprise rotating the knob of an inner shaft of the implant
insertion device in a manner such that the rotation of the knob
linearly displaces the implant body from the insertion end of the
outer shaft of the implant insertion device.
[0040] Certain Terminologies:
[0041] Unless otherwise defined, all technical terms used herein
have the same meaning as commonly understood by one of ordinary
skills in the art to which this invention belongs. As used in this
specification and the appended claims, the singular forms "a,"
"an," and "the" include plural references unless the context
clearly dictates otherwise. Any reference to "or" herein is
intended to encompass "and/or" unless otherwise stated.
[0042] Overview:
[0043] The systems, methods, devices, and kits disclosed herein
includes injection moldable implant insertion devices and implant
bodies can be injection molded using one or more durable materials
at a lower price than their machinable equivalents. In addition,
the injection moldable implant insertion devices and implant bodies
are easily made and can be deployed for single use only, so that
the contamination associated with cleaning, autoclaving,
sterilization, transportation, or maintenance of the machined
equivalents are significantly reduced or completely eliminated. The
cost of the implant insertion device and implant body per usage is
significantly lower than the machined equivalent. Further,
injection moldable implant insertion devices and implants can be
packed in sterile and peelably sealed kit to prevent contamination
and facilitate surgical needs in different medical procedures.
Further, the he systems, methods, devices, and kits disclosed
herein includes at least one secure locking mechanism that locks
the implant body to both the inner shaft and the outer shaft of the
implant delivery device. Such locking mechanism greatly reduces
undesired release or breakage of the implant body from the
insertion device. Additional sawtooth features on the implant body
also assist the unidirectional insertion during implant delivery.
Further, the implant body has a supporting structure that is
durable and compatible with biomaterial delivery and anchoring in
the patient.
[0044] FIG. 1a shows a non-limiting exemplary embodiment of an
implant insertion device with an implant body properly locked
thereon. The implant body has an outer shaft 20 and an inner shaft
30 with a knob at the base of the insertion device. The outer shaft
20 has an insertion stopper 21 close to the insertion end of the
device. The implant body 10 is locked to the inner shaft 30 and
attached to the outer shaft 20. The inner shaft has an internal
space 11 and a support structure 12 enclosing the internal space.
In some cases, the outer shaft 20 is a rod shape with non-uniform
cross sectional areas along its longest direction. In some cases,
the outer shaft is a curved or bent shaft. In some cases, the outer
shaft is flexible. In some cases, the outer shaft is deformable and
allows user-defined shaping of its curvature. In some cases, the
inner shaft 30 is partly enclosed in the outer shaft 20. In some
cases, the knob and the inner shaft tip is not enclosed in the
outer shaft 20. In some cases, the inner shaft is flexible. In some
cases, the inner shaft body rotates concentrically or
non-concentrically in the outer shaft. In some cases, the implant
body 10 comprises an arbitrary three-dimensional shape that fits
into an intervertebral space of a subject. In some cases, the
interface of the implant body 10 to the implant insertion device is
on any part of the outer surface of the support structure 12, the
interface being configured to lock and/or attached the implant body
to the inner shaft 30 and/or outer shaft 20. The insertion stopper
21 is an optional feature of the outer shaft 20. In some cases, the
insertion stopper 21 facilitates implant insertion at certain
insertion angles with respect to the spinal cord of the
patient.
[0045] FIG. 1b shows a non-limiting exemplary embodiment of an
implant insertion device without an implant body properly locked
thereon. The implant body has an outer shaft 20 and an inner shaft
30 with a knob 36 at the base of the insertion device. The inner
shaft 30 is partly enclosed in the outer shaft, the inner shaft tip
31 is not enclosed in the outer shaft 20 when it is properly
inserted therewithin. The inner shaft tip 31 is in an unlocked
position with respect to an implant body that can be loaded
thereon. The outer shaft includes a plurality of windows 213 on its
outer surface. In some cases, the outer shaft 20 is a rod shape
with non-uniform cross sectional areas along its longest direction.
In some cases, the outer shaft is a curved or bent shaft. In some
cases, the outer shaft is flexible. In some cases, the outer shaft
is deformable and allows user-defined shaping of its curvature. In
some cases, the inner shaft 30 is partly enclosed in the outer
shaft 20. In some cases, the knob and the inner shaft tip is not
enclosed in the outer shaft 20. In some cases, the inner shaft 30
is flexible. In some cases, the inner shaft body rotates
concentrically or non-concentrically in the outer shaft 20.
[0046] Referring to FIG. 2, in a particular embodiment, an implant
insertion device is shown with no implant body attached thereon.
The outer shaft 20 has an insertion stopper 21 close to the
insertion end of the device. The inner shaft fits through the
hollow space of the outer shaft and the inner shaft tip 31 and the
knob at the base of the inner shaft 30 is not enclosed within the
outer shaft 20.
[0047] Implant Shapes:
[0048] In some embodiments, the implant body has a cylindrical
shape. In some cases, the implant body has a cylindrical shape with
cross section of a trapezoid. In other embodiment, the implant body
has a cuboid shape. In other embodiment, the implant body has a
rectangular cuboid shape. In some cases, the implant body has a
cylindrically elliptical shape. In some cases, the implant body is
properly shaped to endure the force, pressure, or wear after
insertion for a pre-determined period of time. In some cases, the
implant body is properly shaped in three spatial dimensions so that
it fits into an intervertebral space. In some cases, the implant
body has a toroidal shape. In some cases, the support structure has
a toroidal shape. A toroidal shape is an arbitrary three
dimensional volume having a hole or a three dimensional empty space
therethrough. In some cases, a toroidal shape is an arbitrary three
dimensional volume having a hole or empty passage therethrough. In
some cases, a toroidal shape is a three dimensional ring with some
of the circular shapes of the ring replaced by arbitrary two
dimensional shapes. In some cases, a toroidal shape is a shape with
a plurality of two dimensional cross sections stacked together
continuously, the cross sections being non-uniform in height, and
each cross section having an arbitrary two dimensional empty area
enclosed by a wall. In some cases, the wall has a closed contour
and a non-uniform radial thickness along its contour.
[0049] In some embodiments, the height of the implant body in
uniform. In other cases, the height of the implant body is
non-uniform. In some cases, the height of the implant body is
non-uniform along the anterior-to-posterior direction when the
implant body is properly inserted. In some cases, the non-uniform
height of the implant body is structured to accommodate the height
difference in an intervertebral space caused by a lordosis angle or
kyphosis angle of the spinal column. In some cases, the height of
the implant body is smaller at the anterior side of the implant
body than the posterior side of the implant body when the implant
body is properly inserted. In some cases, the height gradually
decreases from the posterior side to the anterior side of the
implant body when properly deployed. In other cases, the height
gradually increases from the posterior side to the anterior side of
the implant body when properly deployed. In some cases, the height
of the implant body includes the height of at least one sawtooth.
In some cases, the height of the implant body excludes the height
of all the sawteeth. In some cases, the sawtooth prevents the
implant body from backing out. In some cases, the sawtooth prevents
the implant body from sliding or moving after it is properly
inserted or located. In some cases, the sawteeth are located on the
top-most surface of the support structure and/or the bottom-most
surface of the support structure. In exemplary cases, the hole or
empty passage is configured to accommodate graft tissue to be
inserted therewith.
[0050] Referring to FIG. 3, in a particular embodiment, an implant
body 10 is shown. Image on the left is a top view of the implant
body. Image on the right is a bottom view of the implant body. The
implant body includes sawteeth 16 on the top and the bottom
surfaces. The implant body has a main slot 13 indented from the
side of the support structure. Two side slots 14 are symmetrically
located proximal to the main slot 13 and shallower than the main
slot 13 on the side wall of the implant body 10. The implant body
has an internal space 11 that can be filled by graft materials.
Spatially separated empty spaces 15 are located in the support
structure to enclose detectable tags, such as RF tags therewithin.
A top slot 17 connects to the chamber that is accessible from the
main slot 13. The implant body has a non-uniform height. In some
cases, the side slots 14 are immediately adjacent to the main slot
13. In some cases, the side slots 314 are spatially separated from
the main slot 13. In some cases, the implant body 10 has a ring
shape. In some cases, the implant body 10 has a donut shape. In
some cases, the implant body is toroidal. In some cases, the
implant body 10 has a three-dimensional volume with an internal
space enclosed in the volume, the internal space accessible from
the outer surface of the volume. In some cases, the main slot 13 of
the implant body is a cylindrical shape. In some cases, a cross
section of the main slot 13 is an ellipse. In some cases, a cross
section of the main slot is rectangular. In some cases, a cross
section of the main slot is rhombus. In some cases, a cross section
of the main slot is triangular. In some cases, the cross section of
the main slot is a parallelogram. In some cases, a cross section of
the main slot is a cross. In some cases, a main slot of the implant
body is indented from an outer surface of the implant body. In some
cases, a main slot is indented from an outer surface towards an
inner surface of the implant body in a direction that is parallel
to the proper implant insertion direction. In some cases, the
implant body has no empty spaces 15. In some cases, the implant
body has at least one empty spaces 15.
[0051] Referring to FIG. 4, in a particular embodiment, an implant
body is shown. The implant body has a support structure 12 that
encloses an internal space 11 that can be filled by graft
materials. The implant body has a main slot 13 indented from the
side of the support structure. Two side slots 14 are symmetrically
located proximal to the main slot 13 on the side wall of the
implant body 10. A top slot 17 connects to the chamber that is
accessible from the main slot 13. The implant body 10 includes
sawteeth 16 on the top and the bottom surfaces. The implant body
has a non-uniform height. The wall thickness of the support
structure is not uniform in order to accommodate the lordosis angle
of the human spine.
[0052] Injection Molded:
[0053] As used herein, `injection molded` refers to being
manufactured by a process involving injection or pressure-driven
introduction of a non-solid material into a cavity formed by a mold
such that, when solidified, the material assumes to form defined by
the cavity of the mold. Similarly, `injection moldable` means
capable of being manufactured by such a process. In some cases the
terms are used interchangeably. In various cases, the implant
insertion devices and implant bodies disclosed herein are injection
molded. In some cases, the implant insertion device is injection
molded separately. In some cases, the inner shaft of the implant
insertion device and the outer shaft of the implant insertion
device are injection molded separately. In some cases, the parts of
the inner shaft of the implant insertion device are molded
separately, wherein the parts includes an inner shaft body, an
inner shaft knob, an inner shaft tip. In some cases, the parts of
the outer shaft of the implant insertion device are molded
separately, wherein the parts includes two outer shaft tips, an
outer shaft body excluding the outer shaft tips.
[0054] Referring to FIG. 5, in a particular embodiment, a 3-part
mold with parts 40, 41, and 42 are used to mold the implant body in
FIG. 3. The mold part 42 slides and out of the mold parts 40 and 41
to form the slots cavity. The mold part 40 includes a U shaped
protruding feature 47 to create the cavity of the chamber. The mold
part 40 includes a cylindrical protruding feature 45 to create an
empty space to load at least a detectable tag. The mold parts 40
and 41 include a feature 46 to create sawteeth on the top and
bottom surfaces of the implant body.
[0055] Single Use:
[0056] As used herein, `single use` refers to use once only, or in
a single procedure on a single patient, or in a single operation.
`Single use` implies that the object does not need to be
re-sterilized or reused, as it is discarded rather than being used
in a second procedure that may require sterilization prior to use.
Single use implies use for delivery of a single implant, or use in
delivery of an insert such as an insert comprising graft material
in a single intervertebral space, or rarely use in delivery of a
first insert comprising a first graft to a first intervertebral
space and a second insertion comprising a second graft into a
second intervertebral space of a single individual in a single
operation. In some cases, implant insertion devices and implant
bodies disclosed herein are disposable. In some cases, implant
insertion devices and implant bodies disclosed herein are for
one-time use only. In some cases, implant insertion devices and
implant bodies disclosed herein are not for reuses. In some cases,
implant insertion devices and implant bodies disclosed herein are
not to be autoclaved. In some cases, implant insertion devices and
implant bodies disclosed herein are not for sterilization. Rather
devices disclosed herein may in some cases be made cheaply enough
that they may be used a single time and disposed of rather than
being re used. In some cases, the cost of manufacturing a device
herein is less than the cost of sterilization of a machine
manufactured device.
[0057] In many cases, the material is injection moldable such at
the device can be made by injecting the material into a mold.
[0058] Materials:
[0059] In some embodiments, the implant insertion device or the
implant body is made of at least one non-metal material. In some
cases, the implant insertion device or the implant body is made of
at least one metal material. In some cases, the implant insertion
device or the implant body is made of at least one plastic
material. In some cases, the implant insertion device or the
implant body is made of at least one durable material. In some
cases, the implant body is made of one or more durable materials so
that the implant body functionally last for at least one year, 1.5
year, or 2 years. In some cases, the implant insertion device or
the implant body is made of at least one material that is
compatible with one or more medical imaging modalities. In some
cases, the one or more medical imaging modalities includes: MRI,
X-ray, CT, PET, SPECT, and ultrasound. In some cases, the inner
shaft body and the inner shaft tip is made of at least one metal.
In some cases, the at least one metal increases reduces unwanted
breakage of the inner shaft during implant insertion.
[0060] In some embodiments, the implant body is made of at least
one selected from: polyether ether ketone (PEEK), carbon
fiber-reinforced polymer, carbon fiber-reinforced plastic, carbon
fiber-reinforced thermoplastic, glass fiber-reinforced polymer,
glass fiber-reinforced plastic, and polyaryletherketone (PEAK).
[0061] In some embodiments, the inner shaft, the outer shaft, or
the inner shaft and the outer shaft is made of one selected from:
at least one selected from carbon fiber-reinforced polymer, carbon
fiber-reinforced plastic, carbon fiber-reinforced thermoplastic,
glass fiber-reinforced polymer, glass fiber-reinforced plastic,
Ixef, and polyarylamide (PARA), or any commercially available
polymer of a similar nature. In some cases, the inner shaft or the
outer shaft comprises about 50% glass in its material. In some
cases, the inner shaft or the outer shaft comprises a material
having a glass content of at least 10% to no greater than 70%. In
other cases, the inner shaft or the outer shaft includes a material
having a glass content of at least one selected from 5%, 6%, 7%,
8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%,
22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%,
35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%,
48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%,
61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, or 70%.
[0062] In some cases, the implant is made of titanium. In some
cases, the inner shaft body, the inner shaft, or the outer shaft is
made of nitinol, stainless steel, titanium, or other similar
metals.
[0063] In some embodiments, the inner shaft is made of a flexible
material such as a material that maintains integrity if bent
laterally. In some cases, the inner shaft is flexible such that it
can be threaded into a curved outer shaft.
[0064] Implant devices and systems as disclosed herein are used to
deliver graft material to a number of patient locations. Exemplary
locations include intervertebral spaces, such as lumbar
intervertebral spaces, cervical intervertebral spaces, or other
intervertebral spinal spaces. In some cases, the devices and
methods disclosed herein are used to deliver a graft or inert to a
non-vertebral space of a patient, such as a bone exterior or
interior, or a soft tissue.
[0065] Sizes:
[0066] In some cases, the implant body is properly sized in three
spatial dimensions so that it fits into an intervertebral space
that needs to be inserted. In some cases, the implant body is
properly is sized to endure the force, pressure, or worn after
insertion for a pre-determined period of time.
[0067] In some cases, when the height, length, or width is not
uniform, the height, length, and width here indicate the minimal
height, length, or width. In other cases, when the height, length,
or width is not uniform, the height, length, and width here
indicate the average height, length, or width.
[0068] In some embodiments, the implant body has a height of no
less than 1 mm and no more than 3 cm. In some cases, the height of
the implant body is in the head-to-toe direction when it is
properly inserted. In some cases, the implant body has a width of
no less than 5 mm and no more than 8 cm. In some cases, the width
of the implant body is in the left-to-right direction when it is
properly inserted. In some cases, the implant body has a length of
no less than 5 mm and no more than 8 cm. In some cases, the length
of the implant body is in the anterior-to-posterior direction, when
it is properly inserted. In some cases, the internal space has a
height of no less than 1 mm and no more than 3 cm. In some cases,
the height of the internal space is in the head-to-toe direction
when it is properly inserted. In some cases, the internal space has
a width of no less than 5 mm and no more than 8 cm. In some cases,
the width of the internal space is in the left-to-right direction
when it is properly inserted. In some cases, the internal space has
a length of no less than 5 mm and no more than 8 cm. In some cases,
the length of the internal space is in the anterior-to-posterior
direction, when it is properly inserted. In some cases, the wall
thickness of the supporting structure is no less than 1 mm and no
more than 3 cm.
[0069] In some embodiments, the main slot of the implant body has a
height of no less than 2 mm and no greater than 5 cm. In some
cases, the main slot has a width and a length of no less than 2 mm
and no greater than 5 cm. In some cases, the main slot has a
height, width or length of one selected from: 1 mm, 1.5 mm, 2 mm, 3
mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm,
14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 10 mm, 21 mm, 22 mm, 23
mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, 30 mm, 31 mm, 32 mm,
33 mm, 34 mm, 35 mm, 36 mm, 37 mm, 38 mm, 39 mm, 40 mm, 41 mm, 42
mm, 43 mm, 44 mm, or 45 mm.
[0070] In some cases, the chamber of the implant body has a U
shape. In some cases, the bottom part of the U shape is a half
circle. In some cases, the diameter of the half circle is the
length or width of the chamber. In some cases, the diameter is one
selected from: 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm,
13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 10 mm, 21 mm, 22
mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, 30 mm, 31 mm,
32 mm, 33 mm, 34 mm, 35 mm, 36 mm, 37 mm, 38 mm, 39 mm, 40 mm, 41
mm, 42 mm, 43 mm, 44 mm, 45 mm, 46 mm, 47 mm, 48 mm, 49 mm, and 50
mm.
[0071] In some cases, the depth of the chamber, i.e., the indented
depth from the edge of the main slot to the opposite side of the
chamber, is slighter greater than the depth of the inner shaft tip
so that it allows the inner shaft tip to be fully enclosed in the
chamber and rotate therewithin. The depth of the chamber is no less
than 1 mm to no greater than 2 cm. In some cases, the depth of the
chamber or the inner shaft tip is selected from 1 mm, 1.2 mm, 1.5
mm, 1.8 mm, 2 mm, 2.2 mm, 2.5 mm, 2.8 mm, 3 mm, 5 mm, 6 mm, 7 mm, 8
mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm,
18 mm, 19 mm, 10 mm, 21 mm, 22 mm, 23 mm, 24 mm, and 25 mm. In some
cases, the depth of the inner shaft tip is perpendicular to the
rotation plane of the inner shaft.
[0072] In some cases, each side slot has an arbitrary
three-dimensional shape. In some cases, each side slot has a three
dimensional volume smaller than the main slot. In some cases, each
of the outer shaft tips has an arbitrary three dimensional shape
that fit in a matching side slot.
[0073] In some cases, the inner shaft tip has a shape that is
substantially similar and slightly smaller than the main slot so
that it can pass through the main slot by keeping the main axis of
the inner shaft tip and the main axis of the main slot
substantially parallel.
[0074] In some cases, the inner shaft body has a length or a size
of the longest dimension selected from about 4.5 inches, about 5
inches, about 5.5 inches, about 6 inches, about 6.5 inches, about 7
inches, about 7.5 inches, about 8 inches, about 8.5 inches, about 9
inches, about 9.5 inches about 10 inches, about 10.5 inches, about
11 inches, about 11.5 inches, about 12 inches, or about 12.5
inches. In some cases, the outer shaft has a length or a size of
the longest dimension of one selected from about 4.5 inches, about
5 inches, about 5.5 inches, about 6 inches, about 6.5 inches, about
7 inches, about 7.5 inches, about 8 inches, about 8.5 inches, about
9 inches, about 9.5 inches about 10 inches, about 10.5 inches,
about 11 inches, about 11.5 inches, about 12 inches, or about 12.5
inches. In some cases, the implant insertion device has a longest
dimension selected from about 4.5 inches, about 5 inches, about 5.5
inches, about 6 inches, about 6.5 inches, about 7 inches, about 7.5
inches, about 8 inches, about 8.5 inches, about 9 inches, about 9.5
inches about 10 inches, about 10.5 inches, about 11 inches, about
11.5 inches, about 12 inches, or about 12.5 inches.
[0075] In some embodiments, the cross section along the longest
dimension of the outer shaft monotonically decreases from the base
to the insertion end of the insertion device. The greatest cross
section of the implant insertion device or the outer shaft, i.e.,
the bottom-most cross section, perpendicular to the longest
dimension of the outer shaft has a width or a length of no less
than 5 mm and no greater than 8 cm. The top-most cross section of
the inner shaft body or the outer shaft has a width or a length of
no less than 2 mm and no greater than 2 cm.
[0076] In some embodiments, part of the knob of the inner shaft
fits into the outer shaft. In some cases, part of the knob does not
fit into the outer shaft. The at least one hump fits into the outer
shaft. The size of the hump has an area of no less than 1 mm
cm.sup.2 and no greater than 1 cm.sup.2.
[0077] In some embodiments, the outer face of the outer shaft is a
flat two dimensional surface. In other cases, the outer face is a
concave surface or a convex surface. In some cases, the outer face
includes a circular opening. In other cases, the outer face
includes an arbitrary two dimensional shape opening that allows
passage of the inner shaft tip.
[0078] In some cases, the inner shaft comprises a cam feature at
the base of the inner shaft. In some cases, the cam feature has a
height of no less than 0.2 mm and no greater than 1 cm. In some
cases, the insertion stopper has a height of no less than 0.2 mm
and no greater than 2 cm.
[0079] Graft tissue, as used herein, may comprise autologous
patient tissue, such as bone tissue taken from elsewhere in the
patient during the procedure. Graft tissue may also be cadaverous,
or may be cultured or synthetically produced from cultured
differentiated or undifferentiated cell populations derived from
the patient or elsewhere. Grafting material may be packed allograft
bone (demineralized or not), packed biocompatible ceramics granules
(beta-tricalcium phosphate, hydroxyapatite, calcium sulfate, and
equivalents) to assume the graft volume shape, biocompatible
ceramic granules held by biocompatible matrix such as collagen with
or without bioglass and with or without hyaluronic acid.
[0080] Insertion bodies, i.e., implant bodies, as disclosed herein,
are used to deliver graft tissue to an intervertebral space of a
patient in some case. Insertion bodies may also be used in the
absence of graft tissue, such as to deliver an artificial structure
to the internal space of a patient. In some cases an insertion
device is used to deliver an insert to the interior of a patient
that is distinct from the spine, such as a joint, bone graft
location, or bone reconstruction location. In some cases an
insertion device delivers an insert that does not comprise an
internal space, or that is configured for a use other than to
stabilize a graft between two vertebrae. Accordingly, both spinal
interventions and non-spinal interventions are contemplated herein,
and implant bodies consistent with the respective intervention are
similarly contemplated.
[0081] Cylindrical Shapes:
[0082] In some embodiments, the claimed devices, methods, or kits
involve a cylindrical shape, a substantially cylindrical shape or
use of the same. In some cases, a cylindrical shape is a
three-dimensional (3D) shape. In some cases, a cylindrical shape
has a cross section of an arbitrary two-dimensional (2D) shape
formed by a closed contour, and the cylindrical shape is formed by
a stack of a finite number of cross sections of the same arbitrary
two dimensional shape placed adjacent to each other.
[0083] In some cases, a cylindrical shape has a cross section of a
trapezoid formed by a closed contour, and the cylindrical shape is
formed by a stack of identical trapezoids placed adjacent to each
other. In some cases, a cylindrical shape has an elliptical cross
section formed by a closed contour, and the cylindrical shape is
formed by a stack of identical ellipses placed adjacent to each
other. In some cases, a cylindrical shape has a rectangular cross
section formed by a closed contour, and the cylindrical shape is
formed by a stack of identical rectangles placed adjacent to each
other.
[0084] In some embodiments, a cylindrical shape is a group of
parallel lines placed continuously adjacent to each other. In some
cases, this group of parallel lines is of a uniform height. In
other embodiment, these parallel lines are of different height.
[0085] In some cylindrical shapes, all parallel cross sections are
of equal area, while in other embodiments, parallel cross sections
vary in surface area, for example, by monotonically increasing or
decreasing in a `tapered cylindrical shape`.
[0086] Rectangular Cuboid:
[0087] In some embodiments, the claimed devices, methods, or kits
involve a rectangular cuboid, a cuboid, or use of the same. In some
cases, a rectangular cuboid is a three dimensional shape. In some
cases, a rectangular cuboid has a cross section of a two
dimensional rectangle formed by a closed contour, and a rectangular
cuboid is formed by a stack of a finite number of cross sections of
the same two dimensional rectangle shape placed adjacent to each
other. Similarly, in some cases, a cuboid has a cross section of a
two dimensional rectangle formed by a closed contour, and a cuboid
is formed by a stack of a finite number of cross sections of the
same two dimensional rectangle shape placed adjacent to each
other.
[0088] Cylindrically Elliptical:
[0089] In some cases, a cylindrically elliptical shape has a cross
section of an ellipse formed by a closed contour, and the
cylindrically elliptical shape is formed by a stack of identical
ellipses placed adjacent to each other.
[0090] Internal Spaces:
[0091] In some embodiments, the internal space of the implant body
is partly enclosed by the implant body in three dimensional space.
In some cases, the internal space is not covered in its top-most
cross section. In some cases, the internal space is not covered in
its bottom-most cross section. In some cases, the internal space is
not covered in its top-most cross section and bottom-most cross
section. In some cases, the internal space is not covered in its
top and bottom faces. In some cases, the internal space is a three
dimensional hole throughout one dimension of the support structure.
In some cases, the internal space is a three dimensional hole
throughout one dimension of the support structure and covered by a
wall of the support structure in other directions.
[0092] Slots:
[0093] In some embodiments, an implant body has a main slot
indented into a wall of the implant body. In some cases, the inner
shaft tip fits through a main slot when a major axis of the main
slot and a major axis of the inner shaft tip are substantially
parallel. In some cases, substantially parallel includes an acute
intersecting angle of the major axis of the main slot and the major
axis of the inner shaft tip, wherein the intersecting angle less
than 10 degrees. In some cases, substantially parallel includes an
acute intersecting angle of the major axis of the main slot and the
major axis of the inner shaft tip, wherein the intersecting angle
less than 5 degrees. In some cases, substantially parallel includes
an acute intersecting angle of the major axis of the main slot and
the major axis of the inner shaft tip, wherein the angle less than
15 degrees. In some cases, the inner shaft tip fits through a main
slot when the inner shaft is rotated to a second position and the
top or bottom-most outer surface of the implant body is
substantially parallel to the major axis of the main slot. In some
cases, the inner shaft tip fits through a main slot when the inner
shaft is rotated to a second position and the top or bottom-most
outer surface of the implant body is substantially parallel to the
major axis of a cross section of the main slot. In some cases, the
cross section is substantially perpendicular to the top or
bottom-most outer surface of the implant body.
[0094] In some embodiments, a slot is a two dimensional shape with
a close contour with a negligible size in the third dimension. In
some cases, a negligible size is at least 10 times smaller than any
other two dimensions. In other cases, a negligible size is at least
50 times smaller than any other two dimensions. In other cases, a
negligible size is at least 100 times smaller than any other two
dimensions. In other cases, a negligible size is at least 200 times
smaller than any other two dimensions.
[0095] In some embodiments, the main slot of the implant body
allows rotation of the inner shaft tip therewithin. In some cases,
the main slot allows rotation of the inner shaft tip therewithin
through at least 60 degrees. In some cases, the main slot allows
rotation of the inner shaft tip therewithin through at least 70
degrees. In some cases, the main slot allows rotation of the inner
shaft tip therewithin through at least 80 degrees. In some cases,
the main slot allows rotation of the inner shaft tip therewithin
through at least 90 degrees. In some cases, the main slot allows
rotation of the inner shaft tip therewithin so that the inner shaft
tip is locked to the implant body. In some cases, the main slot
allows rotation of the inner shaft tip therewithin so that the
inner shaft is locked to the implant body. In some cases, the main
slot allows rotation of the inner shaft tip therewithin in a manner
such that the implant body is locked to the inner shaft. In some
cases, the main slot allows rotation of the inner shaft tip
therewithin in a manner such that the implant body is not separable
from the inner shaft by any linear movement.
[0096] In some embodiments, a main slot of the implant body is a
cylindrical shape. In some cases, a cross section of the main slot
is an ellipse. In some cases, a cross section of the main slot is a
rectangle. In some cases, a cross section of the main slot is a
rhombus shape. In some cases, a cross section of the main slot is a
triangle. In some cases, the cross section of the main slot is a
parallelogram.
[0097] In some embodiments, a main slot of the implant body is
indented from an outer surface of the implant body. In some cases,
a main slot is indented from an outer surface towards an inner
surface of the implant body in a direction that is parallel to the
proper implant insertion direction. In some cases, the bottom cross
section of the main slot is on the outer surface of the implant
body.
[0098] In some embodiments, an implant body has two side slots
indented into a wall of the implant body. In some cases, an implant
body has two side slots indented into the same wall of the main
slot of the implant body. In some cases, two side slots are
indented from an outer surface of the implant body. In some cases,
two side slots are indented from an outer surface towards an inner
surface of the implant body in a direction that is parallel to the
proper implant insertion direction. In some cases, the bottom cross
sections of two side slots are on the outer surface of the implant
body. In some cases, the bottom cross sections of two side slots
are symmetrically adjacent to the bottom cross section of the main
slot. In some cases, the bottom cross sections of two side slots
are symmetric with respect to the mid-point or center of the bottom
cross section of the main slot. In some cases, the bottom cross
sections of two side slots are symmetric with respect to the minor
axis of the bottom cross section of the main slot. In some cases,
the bottom cross sections of two side slots are symmetric with
respect to the major axis of the bottom cross section of the main
slot. In some cases, the bottom cross sections of two side slots
are symmetric with respect to the longest axis of the bottom cross
section of the main slot. In some cases, the bottom cross sections
of two side slots are symmetric with respect to a diagonal of the
bottom cross section of the main slot. In some cases, the bottom
cross sections of two side slots are symmetric with respect to the
width of the bottom cross section of the main slot. In some cases,
each of the two side slots fits to one of the two outer shaft tips
when the implant body is properly locked to the outer shaft. In
some cases, the fitting of each of the two side slots to one of the
two outer shaft tips when the implant body the implant body is
properly locked to the outer shaft is configured to hold the
implant body against the implant insertion device. In some cases,
the properly locking of the implant body to the outer shaft is
configured to attach the side slots to the tips. In some cases, the
properly attachment of the implant body to the outer shaft prevent
the implant body from accidental rotation during implant insertion.
In some cases, the properly attachment of the implant body to the
outer shaft prevent the implant body from accidental rotation
around the inner shaft body during implant insertion. In some
cases, the properly attachment of the implant body to the outer
shaft prevent the implant body from accidental rotation around the
direction of insertion during implant insertion. In some cases, the
proper locking of the implant body to the outer shaft is configured
to facilitate reduction of pressure on the implant body during
insertion. In some cases, the proper locking of the implant body to
the outer shaft is configured to reduce unwanted implant release
from the implant insertion device during insertion. In some cases,
the proper locking of the implant body to the outer shaft is
configured to increase the area of interaction between the implant
body and the implant insertion device. In some cases, the proper
locking of the implant body to the outer shaft is configured to
increase the area of interaction with the implant body so that the
force on the implant body is partly transferred to the implant
insertion device. In some cases, the proper locking of the implant
body to the outer shaft is configured to decrease the risk of
implant breakage. In some cases, the proper locking of the implant
body to the outer shaft is configured to decrease the risk of
unwanted implant detachment from the implant insertion device. In
some cases, proper locking holds the implant body in place such
that it can be more accurately placed into an intervertebral space
of a patient.
[0099] In some embodiments, two side slots are each of a
semi-cylindrical shape. In some cases, a cross section of each of
the two side slots is a semi-ellipse. In some cases, a cross
section of each of the two side slots is a rectangle. In some
cases, a cross section of each of the two side slots is a
semi-rectangle. In some cases, a cross section of each of the two
side slots is a triangle. In some cases, a cross section of each of
the two side slots is a circle sector. In some cases, a cross
section of each of the two side slots is a circle. In some cases, a
cross section of each of the two side slots is a trapezoid. In some
cases, a cross section of each of the two side slots is a pentagon
or a rhombus. In some cases, the cross section of each of the two
side slots is a parallelogram. In some cases, a cross section of
each of the two side slots is an arbitrary two dimensional
shape.
[0100] In some cases, the implant body includes a slot at the top
or the bottom cross section of the implant body. In some cases, the
slot is indented from a top-most region or a bottom-most region of
the outer surface along the longitudinal direction. In some cases,
this slot is connected to the chamber of the implant body. In some
cases, this slot facilitates the molding of the chamber. In some
cases, the slot enables visualization of the inner shaft tip within
the chamber. In some embodiments, the slot has a width
substantially identical to the width of the chamber. In other
embodiments, the slot has a width substantially identical to the
diameter of the chamber.
[0101] In some embodiments, the main slot faces anterior,
posterior, left, right, head, or toe side of the patient when the
implant body is properly deployed in the patient. In some
embodiments, the main slot is located on any face of the support
structure. In some cases, the presence of the slot does not affect
the locking of the implant body to the insertion device.
[0102] Referring to FIG. 6, in a particular embodiment, an implant
body is shown. The implant body 10 has a support structure 12 that
encloses an internal space 11 that can be filled by graft
materials. The implant body has a main slot 13 indented from the
side of the support structure. Two side slots 14 are symmetrically
located proximal to the main slot 13 on the side wall of the
implant body 10. A top slot 17 connects to the chamber that is
accessible from the main slot 13. In some embodiments, the size of
side slots 14 is smaller than the main slot 13. In some
embodiments, each side slot 314 is optional. In some embodiments,
the main slot is threaded to fit a threaded inner shaft tip
therewithin by threading.
[0103] Supporting Structures:
[0104] In some embodiments, the implant body contains a supporting
structure. In some embodiments, the supporting structure is made of
at least one injection moldable material. In some embodiments, a
supporting structure is equivalent to an implant body. In some
embodiments, the implant body comprises a supporting structure, an
internal space for holding at least one graft material, and at
least one space for holding at least one medical imaging tag. In
some embodiments, the at least one space for holding at least one
medical imaging tag is in an edge of the supporting structure. In
some embodiments, the at least one space for holding at least one
medical imaging tag is located to facilitate the recognition of the
implant body with at least one medical imaging modalities. In some
embodiments, the at least one medical imaging modality includes one
or more selected from: MRI, CT, X-ray, PET, microPET, micro-SPECT,
OCT, and ultrasound.
[0105] Chambers: In some embodiments, the implant body includes a
chamber. In some embodiments, a chamber is sized so that an inner
shaft tip can rotate within a chamber to assume at least two
positions. In some embodiments, the first position in the chamber
is a locked position so that the inner shaft tip cannot be
withdrawn from the chamber without a rotation of the inner shaft
tip in the coronal or sagittal plane to a second position. In some
embodiments, the second position in the chamber is an unlocked
position so that the inner shaft tip can be withdrawn from the
chamber only with linear movement of the inner shaft tip. In some
embodiments, the linear movement is along the insertion direction
toward the base of the implant insertion device.
[0106] In some embodiments, the implant body only accesses the
chamber via movement through the main slot. In some cases, the
chamber is indented deeper in the wall of the implant body than the
main slot. In some embodiments, the chamber is connected to at
least one slot. In some cases, the chamber is connected to at least
one opening in the supporting structure of the implant body.
[0107] Major Axis:
[0108] In some embodiments, a major axis is the longest diameter of
a two dimensional ellipse. In some embodiments, the major axis is
the longest diameter of a cross section of a cylindrical shape,
wherein the cross section is parallel to the base or top of the
cylindrical shape. In some embodiments, the major axis of a
rectangle is the length of the rectangle. In some embodiments, the
major axis of a cuboid is the longest diameter of a cross section
of the cuboid, wherein the cross section is parallel to the base or
top of the cuboid. In some embodiments, the major axis of a
rectangular cuboid is the longest diameter of a cross section of
the rectangular cuboid, wherein the cross section is parallel to
the base or top of the cuboid.
[0109] In some embodiments, the major axis of the main slot and the
major axis of the inner shaft tip are not substantially parallel if
an acute angle of greater than 9 degrees is formed between the
major axis of the main slot and the major axis of the inner shaft
tip. In some embodiments, the major axis of the main slot and the
major axis of the inner shaft tip are not substantially parallel if
an acute angle of greater than 4 degrees is formed between the
major axis of the main slot and the major axis of the inner shaft
tip. In some embodiments, the major axis of the main slot and the
major axis of the inner shaft tip are not substantially parallel if
an acute angle of greater than 7 degrees is formed between the
major axis of the main slot and the major axis of the inner shaft
tip. In some embodiments, the major axis of the main slot and the
major axis of the inner shaft tip are not substantially parallel if
an acute angle of greater than 14 degrees is formed between the
major axis of the main slot and the major axis of the inner shaft
tip.
[0110] In some embodiments, the major axis of the main slot and the
major axis of the inner shaft tip are not substantially parallel if
an angle of about 90 degrees is formed. In some embodiments, the
major axis of the main slot and the major axis of the inner shaft
tip are not substantially parallel if an acute angle of at least 15
degrees is formed in between the two major axes.
[0111] Cross Sections:
[0112] In some embodiments, a cross section is the intersection of
a three dimensional body with a plane. In some embodiments, the
cross section is parallel to the base or top of the three
dimensional body. In some embodiments, a cross section is the
intersection of a three dimensional body with a plane that is
parallel to the base or top of the three dimensional body. In some
embodiments, a cross section of three dimensional body includes a
contour.
[0113] Inner Shaft Tips:
[0114] In some cases, the claimed devices, methods, or kits involve
an inner shaft tip or user of the same. In some embodiments, the
inner shaft tip is attached to the inner shaft body at the
insertion end of an inner shaft. In some embodiments, the inner
shaft tip contacts the implant body. In some embodiments, the inner
shaft tip fits in the main slot of the implant body. In some
embodiments, the inner shaft tip fits in the main slot of the
implant body when a major axis of the inner shaft tip is
substantially parallel to a major axis of the main slot of the
implant body. In some embodiments, substantially parallel includes
an acute intersecting angle of less than 10 degrees. In some cases,
substantially parallel includes an acute intersecting angle of less
than 5 degrees. In some embodiments, substantially parallel
includes an acute intersecting angle of less than 15 degrees.
[0115] In some embodiments, the inner shaft tip rotates in the main
slot of the implant body to lock the implant body to the inner
shaft. In some embodiments, the inner shaft tip is cylindrical. In
some embodiments, the cross section of the inner shaft tip is
elliptical. In some embodiments, the cross section of the inner
shaft tip is rectangular. In some embodiments, the cross section of
the inner shaft tip is rhombus. In some embodiments, a cross
section of the inner shaft tip is a triangle. In some embodiments,
the cross section of the inner shaft tip is a parallelogram.
[0116] In some cases, the inner shaft tip is attached to the inner
shaft body on it bottom-most cross section. In some cases, the
bottom-most cross section of the inner shaft tip is attached to the
top-most cross section of the inner shaft body. In some cases, the
bottom-most cross section is elliptical. In some embodiments, the
mid-point of the major axis of the bottom-most cross section of the
inner shaft tip overlaps with the center of the top-most cross
section of the inner shaft body. In some cases, the inner shaft tip
rotates concentrically when the inner shaft body rates within an
outer shaft.
[0117] In some embodiments, the inner shaft tip is not enclosed in
the outer shaft, when the inner shaft is properly deployed. In some
embodiments, the inner shaft body is substantially enclosed in the
out shaft when the inner shaft is properly deployed. In some
embodiments, substantially enclosed indicates that at least 95% of
the volume of the inner shaft body is enclose. In some embodiments,
substantially enclosed includes at least 98% of the volume of the
inner shaft body is enclosed by the outer shaft. In some
embodiments, substantially enclosed includes at least 99% of the
volume of the inner shaft body is enclosed by the outer shaft. In
some embodiments, substantially enclosed includes at least 92% of
the volume of the inner shaft body is enclosed by the outer
shaft.
[0118] Referring to FIG. 7, in a particular case, mechanism of
locking an implant body to the inner shaft and outer shaft is
shown. In this embodiment, the inner shaft is properly inserted in
the outer shaft 20. The inner shaft tip 31 fit through the outer
shaft opening 215. The knob of the inner shaft 30 is turnable at
the base of the implant insertion device to rotate the inner shaft
tip 31 for about 90 degrees. The outer shaft tips 216 are
symmetrically located by the outer shaft opening and are configured
to attach to the two side slots of an implant body. The inner shaft
tip is substantially cylindrical ellipse. When the elliptical cross
section substantially aligns with the elliptical cross section of
an implant body (top image), the implant body is readily loaded to
the inner shaft tip 31. When the elliptical cross section rotates
about 90 degrees from the elliptical cross section of an implant
body (bottom image), the implant body is locked to the inner shaft
tip 31. The implant body is further attached to the outer shaft via
attachment to the outer shaft tips 22 symmetrically located
proximal to the outer shaft opening 215. In some embodiments, the
insertion stopper 21 is optional. In some embodiments, the
insertion stopper 21 is only present at certain operating angle of
the implant insertion system. In some embodiments, the outer shaft
opening 215 is circular. In some embodiments, the outer shaft
opening 215 is a two dimensional area that big enough to allows
inner shaft tip 31 to pass through from the base toward the
insertion end of the outer shaft.
[0119] Referring to FIG. 8, in particular embodiments, an inner
shaft 30 is shown with a rod-shaped inner shaft body 32 and a
substantially cylindrically elliptical shaped inner shaft tip 31
wider than the part that the tip is immediately adjacent to. In
some cases, the inner shaft tip 31 is cylindrical cuboid. In some
cases, the inner shaft tip is a cube. In some embodiments, the
inner shaft tip is a cylindrical triangle. In some embodiments, the
inner shaft tip is cylindrical parallelogram. In some embodiments,
the inner shaft tip is cylindrical trapezoid. In some embodiments,
the inner shaft tip is an arbitrary three-dimensional shape except
a cylinder or a sphere. In some embodiments, the inner shaft tip 31
is wider than the inner shaft body immediately adjacent thereto in
at least one dimension perpendicular to a plane of rotation of the
inner shaft tip. In some embodiments, the inner shaft body 32 is
flexible so as to fit in a curved or bent outer shaft and rotate
therewithin.
[0120] Knobs:
[0121] In some embodiments, the knob is not enclosed in the outer
shaft, when the inner shaft is properly deployed. In some
embodiments, the knob is attached to the base of the inner shaft
body. In some embodiments, the knob is attached to the inner shaft
body on it top-most cross section. In some embodiments, the
top-most cross section of the inner shaft tip is attached to the
bottom-most cross section of the inner shaft body at the base of
the inner shaft body. In some embodiments, the knob of the inner
shaft includes a knob that is attached to the base of the inner
shaft body. In some embodiments, the knob is attached to the
bottom-most cross section of the inner shaft body. In some
embodiments, the knob has a larger cross sectional area than the
cross sectional area of the bottom-most cross section of the inner
shaft body. In some embodiments, the center of the knob and the
center of the bottom-most cross section of the inner shaft body are
aligned along the longest axis of the inner shaft. In some
embodiments, the top-most cross section is substantially square. In
some embodiments, the top-most cross section is substantially
elliptical. In some embodiments, the center of the top-most cross
section of the knob overlaps with the center of the bottom-most
cross section of the inner shaft body. In some embodiments, the
inner shaft body rotates concentrically within an outer shaft when
the knob rotates. In some embodiments, the top cross sectional area
of the knob is substantially the same or bigger than the
bottom-most cross-sectional area of the outer shaft. In some
embodiments, the knob is not inserted into the outer shaft when the
inner shaft is properly deployed. In some embodiments, the knob is
not enclosed by the outer shaft when the inner shaft is properly
deployed.
[0122] Interfaces:
[0123] In some embodiments, the implant insertion device and
implant body includes at least one, two, three, or more than three
interfaces. In some embodiments, the implant insertion device and
implant body includes at least one, two, or three complimentary
interfaces.
[0124] In some embodiments, an interface and a complementary
interface are elements or structures performing complementary
functions to each other. In some embodiments, an interface
comprises an equivalent structure to at least one outer shaft tips
or at least one side slot. In some cases, an interface comprises an
equivalent structure to a cam feature or two different surfaces
that a cam feature can slide thereon. In certain embodiments, the
two different surfaces are displaced by a predetermined distance.
In certain embodiments, the predetermined distance is the maximal
distance that the inner shaft tip can move in one direction with
respect to the outer shaft.
[0125] In some embodiments, a complementary interface is an
equivalent structure to at least one outer shaft tip or at least
one side slot. In some cases, a complementary interface is an
equivalent structure to a cam feature or two different surfaces
that a cam feature can slide thereon. In certain cases, the two
different surfaces are displaced by a predetermined distance. In
certain embodiments, the predetermined distance is the maximal
distance that the inner shaft tip can move in one direction with
respect to the outer shaft when the inner shaft is rotated to lock
the implant body in place.
[0126] In some embodiments, an interface comprises at least one
tip. In some embodiments, an interface comprises at least one slot
to fit a tip. In some embodiments, an interface comprises at least
a cam feature. In some embodiments, an interface comprises two
different surfaces that a cam feature can slide on. In certain
embodiments, the two different surfaces are displaced by a
predetermined distance. In some embodiments, the predetermined
distance is the maximal distance that the inner shaft tip can move
in one direction with respect to the outer shaft.
[0127] In some embodiments, a complimentary interface is at least
one tip. In some embodiments, a complimentary interface is at least
one slot to fit a tip. In some embodiments, a complimentary
interface is at least a cam feature. In some embodiments, a
complimentary interface is two different surfaces that a cam
feature can slide on. In certain embodiments, the two different
surfaces are displaced by a predetermined distance. In some
embodiments, the predetermined distance is the maximal distance
that the inner shaft tip can move in one direction with respect to
the outer shaft.
[0128] In some embodiments, the first or the second interface
comprises a cam feature. In some cases, the first or the second
interface comprises two different surfaces that a cam feature can
slide on. In some cases, the first or the second interface
comprises at least two tips. In some embodiments, the first or the
second interface comprises at least two slots to fit the at least
two tips individually.
[0129] In some embodiments, the first or the second complimentary
interface comprises a cam feature. In some embodiments, the first
or the second complimentary interface comprises two different
surfaces that a cam feature can slide on. In some embodiments, the
first or the second complimentary interface comprises at least two
tips. In some embodiments, the first or the second complimentary
interface comprises at least two slots to fit the at least two tips
individually.
[0130] In certain embodiments, the first interface comprises a cam
feature. In some embodiments, the cam feature is attached to a knob
of an inner shaft. In other embodiments, the cam feature is
attached to an outer shaft. In some embodiments, the first
complimentary interface comprises two different surfaces connected
by a ramp feature that the cam feature can slide on. In some
embodiments, the two different surfaces are at the outer shaft. In
some embodiments, the two different surfaces are at the knob. In
some embodiments, the second interface comprises at least two
spatially separated slots. In some embodiments, the at least two
spatially separated slots are in the implant body. In other
embodiments, the at least two spatially separated slots are in the
outer shaft. In some embodiments, the second complimentary
interface comprises at least two spatially separated tips that fits
in the at least two spatially separated slots. In some embodiments,
the at least two spatially separated tips are on the outer shaft.
In some embodiments, the at least two spatially separated tips are
on the implant body.
[0131] In some embodiments, the first interface is a cam feature or
two different surfaces that a cam feature can slide on. In some
embodiments, the first complementary interface is a cam feature or
two different surfaces that a cam feature can slide on. In some
embodiments, the second interface is a slot or a tip that fits to
the slot. In some embodiments, the second complementary interface
is a slot or a tip that fits to the slot. In some embodiments, the
second interface is a side slot or an outer shaft tip that fits to
the side slot. In some embodiments, the second complementary
interface is a side slot or an outer shaft tip that fits to the
side slot.
[0132] In some embodiments, the first interface, the second
interface, the first complementary interface, and the second
complementary interface are each selected from the list of: a cam
feature, two different surfaces that the cam feature slides on, a
slot, and a tip that fits to the slot.
[0133] In some embodiments, the third interface is a hump. In some
embodiments, the third complementary interface is a hump. In some
embodiments, the third interface is at the knob. In some
embodiments, the third interface is at the inner surface of the
outer shaft. In other embodiments, the third complementary
interface is at the knob. In some embodiments, the third
complementary interface is at the inner surface of the outer
shaft.
[0134] In some embodiments, the third interface unlocks the hump at
the first position and locks the hump at the second position. In
some embodiments, the third interface is a window indented from the
outer surface through the inner surface. In some embodiments, the
third interface further includes a groove at the first position
configured to allow the inner shaft to be pulled out from the base
of the outer shaft. In some embodiments, the groove started from
the base of the outer shaft and goes along the outer shaft until it
connects with the window of the outer shaft.
[0135] In some embodiments, the hump is inserted into the outer
shaft when it is locked at the second position. In some
embodiments, the hump is visible through the window of the outer
shaft at least at the locked position. In other embodiments, the
hump is visible through the window of the outer shaft at the locked
and the unlocked position. The hump is at least 5 mms and no
greater than 5 cm away from the base of the outer shaft toward the
insertion end of the insertion device.
[0136] In some embodiments, the outer shaft and the inner shaft
interact via an interface and a complementary interface to lock or
unlock to each other. In some cases, the interface or the
complementary interface comprises a camp or two displaced surfaces
that the cam is configured to access so as to generate a linear
displacement between the outer shaft and the inner shaft. In some
cases, the two displaced surfaces are connected by a ramp. In some
cases, the two displaced surfaces are connected by a step. In some
embodiments, the two displaced surfaces are connected by a curve, a
groove, a notch, a dent, or a hump. In some embodiments, the two
displaced surfaces are connected by at least one stair. In some
embodiments, switching between the two displaced surfaces are
configurable with the assistance of actuation elements including
one or more of: a gear, a gear set, a latch, a bolt, a threaded
fitting, a clip, a magnetic element, a clamp, a hook, a spring, or
a switch.
[0137] In some embodiments, the inner shaft and the implant body
interacts via an interface and a complementary interface to lock or
unlock one to the other. In some embodiments, the interface or the
complementary interface comprises a slot and a tip that can fit
through the slot and rotate in order to lock or unlock one to each
other. In some embodiments, the interface or the complementary
interface comprises threaded and fitted elements. In some
embodiments, the interface or the complementary interface comprises
a latching and a latchable element. In some embodiments, the
interface or the interface comprises threaded and fitted elements.
In some embodiments, the interface or the complementary interface
comprises a clipping and a clipable element. In some embodiments,
the interface or the complementary interface comprises gearing
elements. In some embodiments, the interface or the complementary
interface comprises magnetic elements.
[0138] Referring to FIG. 9, in a particular embodiment, the outer
shaft 20 includes a groove 211 at the inner surface of the outer
shaft that a hump of the knob can slide along. The outer shaft also
has a window 210 indented from the outer surface to the inner
surface of the outer shaft. The edge of the window connects with
the groove so that the hump can slide along the groove 211 into the
window 210. At the first position, the hump is aligned with the
groove 211 and the window 210 edge connecting to the groove 211.
When the inner shaft rotates about 90 degrees to the second
position, the hump is at the opposite edge of the window 210. In
some embodiments, the window 210 and the hump that can be locked or
unlocked to the window 210 is replaceable by an interface and a
complementary interface that are functionally equivalent.
[0139] Referring to FIG. 10, in a particular embodiment, the outer
shaft 20 comprises a window 210 indented from the outer surface to
the inner surface of the outer shaft. A hump 37 on the knob of the
inner shaft 30 slides from an edge of the window at the first
position (left image) to an opposite edge of the window at the
second position (right image), when the inner shaft rotates about
90 degrees. The outer shaft also includes windows 210 to facilitate
molding of the hollow cavity to hold inner shaft therewithin. In
some embodiments, the window 210 and the hump 37 that interacts
with the window in order to lock or unlock the inner shaft to the
outer shaft is replaceable by an interface and a complementary
interface that are functionally equivalent to them. In some
embodiments, the interface and the complementary interface comprise
threaded fittings. In some embodiments, the interface and the
complementary interface comprise a spring. In some embodiments, the
interface and the complementary interface comprise a clamp. In some
embodiments, the interface and the complementary interface comprise
a latching element and a latchable element. In some embodiments,
the interface and the complementary interface comprise a magnetic
element. In some embodiments, the interface and the complementary
interface comprise a deformable element. In some embodiments, the
hump 37 is a usable operable element, for example, the hump 37 is
supported by a spring force so that it can be pushed in to unlock
from the window 210. In some embodiments, the hump 37 is a flexible
element so that it deforms to lock or unlock to the outer shaft. In
some embodiments, the inner shaft is injection moldable.
[0140] Humps:
[0141] In some embodiments, the knob includes at least one hump. In
some cases, a second hump is configured to indicate the unlocking
of the inner shaft from the outer shaft. In some cases, a second
hump is guided into part of the groove when the inner shaft or the
knob is at the first position. The first hump is at the edge of the
window and the groove, slidable to pull the inner shaft out. The
first and the second hump are aligned in a direction perpendicular
to the rotation plane of the knob. The first and second hump are
spatially offset by at least 5 mms and no greater than 5 cm.
[0142] In some embodiments, the width of the window is configured
to allow the first hump to sit at one window edge at a first
position and sit at a second window edge at a second position.
[0143] In some embodiments, the first position is the unlocked
position of the inner shaft to the outer shaft. The first position
is the locked position of the implant body to the inner shaft while
the second position is the unlock position of the implant body to
the inner shaft. The second position is the locked position of the
inner shaft to the outer shaft.
[0144] In some embodiments, the inner shaft body includes at least
one hump. In some embodiments, the outer shaft body includes at
least an interface, i.e., a protrusion to interact with the hump.
In some embodiments, the hump and the interface interacts to
prevent the inner shaft from accidentally backing out after being
inserted in the outer shaft.
[0145] Referring to FIG. 11, in a particular embodiment, an inner
shaft 30 is properly inserted into an outer shaft 20. In some
embodiments, the inner shaft includes at least two symmetrically
located humps 33 to ensure concentric rotation of the inner shaft
within the outer shaft. In some embodiments, the inner shaft tip 31
is not enclosed by the outer shaft 20. The insertion stopper 21 is
located close to the insertion end of the outer shaft 20. The inner
shaft body includes a hump 34 that interacts with an interface 212,
i.e. a ramped protrusion to lock the inner shaft body 30 within the
outer shaft 20.
[0146] Positions:
[0147] In some embodiments, the implant insertion devices are
configurable in at least a first position and a second position. In
some embodiments, the implant insertion devices are configurable in
at least two different positions, i.e., an unlocked position and a
locked position. In some embodiments, at the first position, the
inner shaft is unlocked to the outer shaft. In some embodiments,
when the implant body is properly loaded, the implant body is
locked to the inner shaft at the first position. Further, the
implant body is also attached to the outer shaft via an interface
and a complementary interface. In some embodiments, the implant is
properly locked, and the insertion device is ready for implant
insertion. In some embodiments, at least one hump of the knob is at
the edge of the corresponding window on the outer shaft, and the
hump is ready to slide out a groove on the inner surface of the
outer shaft so as to unlock the inner shaft from the outer
shaft.
[0148] In some embodiments, at the second position, the inner shaft
is locked to the outer shaft. In some embodiments, the implant body
is unlocked to the inner shaft at the second position, thus
releasable from the insertion device. In some embodiments, the
implant body is still attached to the outer shaft via an interface
and a complementary interface. In other embodiment, the implant
body slightly detached from the outer shaft via an interface and a
complementary interface. In some embodiments, the implant body is
ready to be released from the implant insertion device at the
second position. In some embodiments, at least one hump of the knob
is at the opposite edge of the corresponding window on the outer
shaft, and the hump locks the inner shaft to the outer shaft. In
some embodiments, the second position is the loading position to
load an implant body on the implant insertion device in order to
properly lock the implant body to the inner shaft at the first
position. In other embodiments, the implant body is loadable at the
first position if switching to the second position enters the
properly loading procedure afterwards. In some cases, the implant
body is held tightly or locked to the insertion device when the
inner shaft is configured at a first position such that the camp
feature rests on the `distal most` or `higher` of the two different
surfaces of the base. In some cases, the implant body is released
or not held tight against the implant insertion device when the
inner shaft is configured at a second position such that the cam
rests at a "proximal most" or "lower" of the two different
surfaces.
[0149] Outer Shaft Tips:
[0150] In some embodiments, the outer shaft includes two outer
shaft tips proximal to the outer shaft opening at the insertion end
of the outer shaft. In some embodiments, each of the two outer
shaft tips holds one side slot of the two side slots of the implant
body when the implant body is locked to the outer shaft. In some
embodiments,
[0151] In some embodiments, the outer shaft tips are symmetrically
adjacent to the outer shaft opening. In some embodiments, two outer
shaft tips are each of a semi-cylindrical shape. In some
embodiments, a cross section of each of the two outer shaft tips is
a semi-ellipse. In some embodiments, a cross section of each of the
two outer shaft tips is a rectangle. In some embodiments, a cross
section of each of the two outer shaft tips is a semi-rectangle. In
some embodiments, a cross section of each of the two outer shaft
tips is a triangle. In some embodiments, a cross section of each of
the two outer shaft tips is a circle sector. In some embodiments, a
cross section of each of the two outer shaft tips is a circle. In
some embodiments, a cross section of each of the two outer shaft
tips is a trapezoid. In some embodiments, a cross section of each
of the two outer shaft tips is a pentagon or a rhombus. In some
embodiments, the cross section of each of the two outer shaft tips
is a parallelogram. In some embodiments, a cross section of each of
the outer shaft tips is an arbitrary two dimensional shape.
[0152] In some embodiments, the outer shaft tips are on the outer
surface of the outer shaft. In some embodiments, the outer shaft
tips are attached on the outer surface of the outer shaft. In some
embodiments, the outer shaft tips are protrusions extending from
the outer surface of the countershaft. In some embodiments, the
outer shaft tips are protrusions extending from the outer surface
of the countershaft toward the implant insertion direction. In some
embodiments, the outer shaft tips extend along the longest axis of
the outer shaft from the insertion end of the outer shaft.
[0153] Outer Shaft Openings:
[0154] In some embodiments, the outer shaft includes an opening
that allows passage of the inner shaft tip from the insertion the
outer shaft to the exertion of the outer shaft. In some
embodiments, the outer shaft opening has a cross section that is
substantially identical to the cross section of the inner shaft
tip. In some embodiments, the outer shaft opening has a longest
axis that is substantially identical to the longest axis of the
cross section of the inner shaft tip. In some embodiments, the axis
is a straight line connecting two points on the closing contour of
a two dimensional shape. In some embodiments, the longest axis is
the longest straight line connecting two points on the closing
contour of a two dimensional shape.
[0155] In some embodiments, the outer shaft opening is cylindrical.
In some embodiments, the cross section of the outer shaft opening
is an ellipse. In some embodiments, the cross section of the outer
shaft opening is a rectangular. In some embodiments, the cross
section of the outer shaft opening is a rhombus. In some
embodiments, a cross section of the outer shaft opening is a
triangle. In some embodiments, the cross section of the outer shaft
opening is a parallelogram. In some embodiments, preferred by a
molding process, the outer shaft opening is circular.
[0156] Outer Shaft Bodies:
[0157] In some embodiments, the outer shaft body is hollow so as to
accommodate an inner shaft body therewithin. In some embodiments,
the outer shaft body has a straight rod-shape. In other
embodiments, the outer shaft body is curved.
[0158] In some embodiments, the outer shaft body includes a
plurality of windows. In some embodiments, the windows are indented
into the outer shaft body from the outer surface and connect with a
hollow cavity therewithin. In some embodiments, the windows are
configured to facilitate injection molding of the hollow cavity
within the outer shaft. In some embodiments, the windows from two
opposite sides of the outer surface are formed by mold parts
comprising interleaved protrusions such that the internal cavity of
the outer shaft is formed by the continuous points of contact among
the interleaved protrusions. In some cases, the windows are
artefactual remnants of the use of the intercalated protrusions in
the molding process. In some embodiments, the windows are
interleaved such that the overlapping areas are relatively small
comparing to the length of the outer shaft body. Such small areas
of overlap facilitate the support and endurance of force and
pressure of the outer shaft during an insertion. In certain
embodiment, the overlapping area of two adjacent windows from two
opposite sides of the outer shaft forms a through hole between the
two opposite sides of the outer shaft. Therefore, the through hole
reduces support and endurance of force and pressure the outer
shaft. In some embodiments, a curved outer shaft accommodates a
flexible inner shaft therewithin. In some embodiments, a curved
outer shaft is configured to facilitate implant insertion at a
narrow angle determined by the patient's anatomy or medical
conditions.
[0159] In some cases, use of intercalating protrusions to create an
internal cavity in the outer shaft allows casing of a bent or
curved outer shaft, which is difficult to achieve with an injection
mold part that would need to be removed after casting.
[0160] In some embodiments, the outer shaft body has an outer face.
In some embodiments, the window is not extended to the outer face
of the outer shaft. In some embodiments, the outer face has a close
contour. In some embodiments, each window has its width along the
base-to-tip direction of the outer shaft. In some embodiments, each
window has its width greater than its length, the length being in a
direction perpendicular to the base-to-tip direction. In some
embodiments, the base-to-tip direction is a curved line. In other
embodiments, the base-to-tip direction is a spline fitted to the
curved central line of the outer shaft body from the base to the
tip.
[0161] Referring to FIG. 12, in some embodiments, the outer shaft
body is curved. The outer shaft 1220 includes a window 210 that
locks or unlocks to the hump of the knob. The outer shaft has a
curved outer face 214. The outer shaft has interleaved windows 213
from opposite sides of the outer surface overlapping so as to
generate a continuous hollow cavity to fit inner shaft
therewithin.
[0162] Referring to FIG. 13, in a particular embodiment, molds for
creating the inner surface of the outer shaft body is shown. In
some embodiments, the outer shaft body 20 has an inner surface
generated by interleaved molds from two opposite sides of the outer
surface. An intercalated mold includes a protruding volume that is
substantially cylindrical 218 to create an internal space to hold a
substantially cylindrical inner shaft body therewithin. The
interleaved mold also includes an additional volume 217 that
connects with the cylindrical volume 218 to create a window 213
which is indented from the outer surface of the outer shaft 20. The
intercalating nature of the mold features that produce the indented
windows 213 intercalate to generate a continuous internal space to
allow an inner shaft body to fit therewithin.
[0163] Locking and Unlock Mechanisms:
[0164] In some embodiments, the implant body is properly locked to
the outer shaft, when each of the two side slots fits to one of the
two outer shaft tips. In some embodiments, the fitting of each of
the two side slots to one of the two outer shaft tips, when the
implant body the implant body is properly locked to the outer
shaft, is configured to hold the implant body fixed to the implant
insertion device. In some embodiments, the implant body is properly
locked to the implant insertion device when each of the two side
slots of the outer shaft fits to one of the two outer shaft tips,
and the inner shaft is locked to the implant body. In some
embodiments, the implant body is first locked to the inner shaft
and then locked to the outer shaft. In other embodiments, the
implant body is first locked to the outer shaft with an inner shaft
properly inserted therewithin then locked to the inner shaft. In
some embodiments, the implant body is locked to the inner shaft and
the outer shaft substantially simultaneously when the inner shaft
is properly inserted within the outer shaft. In some embodiments,
the implant is properly locked to the insertion device by a
rotation of the knob. In some embodiments, the rotation of the knob
should be timely controlled so that there is some engagement
between inner shaft tip and the implant body. In some embodiments,
the timely controlled rotation is configured to position the ramp
with respect to the matching notch so that the motion does not pull
inner shaft away from the implant before the inner shaft tip can
pull implant toward the outer shaft.
[0165] In some embodiments, the proper locking of the implant body
to the outer shaft is configured to facilitate reduction of
pressure on the implant body during insertion. In some embodiments,
the proper locking of the implant body to the outer shaft is
configured to eliminate rotation of the implant body with respect
to the implant insertion device during insertion. In some
embodiments, the proper locking of the implant body to the outer
shaft is configured to eliminate rotation of the implant body. In
some embodiments, the proper locking of the implant body to the
outer shaft is configured to reduce unwanted implant release from
the implant insertion device during insertion. In some embodiments,
the proper locking of the implant body to the outer shaft increases
the area of interaction between the implant body and the implant
insertion device. In some embodiments, the proper locking of the
implant body to the outer shaft increases the area of interaction
with the implant body so that the force on the implant body is
partly transferred to the implant insertion device. In some
embodiments, the proper locking of the implant body to the outer
shaft is configured to reduce the pressure on the implant body. In
some embodiments, the proper locking of the implant body to the
outer shaft is configured to decrease the risk of implant breakage.
In some embodiments, the proper locking of the implant body to the
outer shaft is configured to decrease the risk of unwanted implant
detachment from the implant insertion device.
[0166] In some embodiments, the implant body is properly unlocked
from the outer shaft when each of the two side slots disassociate
from one of the two outer shaft tips. In some embodiments, the
implant body is properly unlocked from the implant insertion device
when the implant body is properly unlocked from the inner shaft
tip. In some embodiments, the implant body is properly unlocked to
the implant insertion device when each of the two side slots of the
outer shaft disassociates from previously fitted outer shaft tip,
and the inner shaft is unlocked to the implant body. In some
embodiments, the implant body is first unlocked from the inner
shaft and then unlocked from the outer shaft. In other embodiments,
the implant body is first unlocked from the outer shaft with an
inner shaft properly inserted therewithin then unlocked to the
inner shaft. In some embodiments, the implant body is unlocked from
the inner shaft and the outer shaft substantially simultaneously
when the inner shaft is properly inserted within the outer shaft.
In some embodiments, the implant is properly unlocked to the
insertion device by a rotation of the knob. In some embodiments,
the rotation of the knob should be timely controlled so that there
is some disassociation between inner shaft tip and the implant
body. In some embodiments, the timely controlled rotation is
configured to position the ramp with respect to the matching notch
so that the motion pull outer shaft away from the implant before
the inner shaft tip can unlock the implant body.
[0167] In some embodiments, the implant body is only properly
lockable to the implant insertion device when it is first loaded
onto the inner shaft when the inner shaft is locked to the outer
shaft. In some embodiments, the outer face of the outer shaft is
shaped so as to enable proper locking of the implant body only when
the inner shaft is locked to the outer shaft. In some embodiments,
the implant body is properly lockable to the implant insertion
device when it is first loaded onto the inner shaft when the inner
shaft is locked or unlocked to the outer shaft.
[0168] Kits:
[0169] In certain embodiments, kits comprising at least one
insertion device and or at least one implant body as disclosed
herein, sealed in a sterile container, are disclosed herein. In
some embodiments, a first kit cover is a sealed cover enclosing at
least one implant insertion device and at least one implant body.
In some embodiments, a first kit cover is a sealed cover enclosing
at least one implant insertion device and at least two implant
bodies. In some embodiments, the enclosed implant bodies are
configured to be properly locked or unlocked to the enclosed
implant insertion device within the kit. In some embodiments, the
contents held in the first kit cover are sterile. In some
embodiments, a first kit cover is peelably sealed. In some
embodiments, the first kit cover is hermetic but peelably sealed.
In some embodiments, a second kit cover is a sealed cover enclosed
in the first kit cover. In some embodiments, the contents held
within the second kit cover are sterile. In some embodiments, the
second cover is peelably sealed. In some embodiments, the second
kit cover is hermetic but peelably sealed. In some embodiments,
properly opening the first kit cover does not affect the sealing of
the second kit cover.
[0170] In some embodiments, the kit includes a device tray, a
device holder, or use of the same. In some embodiments, the device
tray or holder has at least one compartment. In some embodiments,
the at least one compartment is configured to securely hold an
implant insertion device, an implant, or both. In some embodiments,
the device tray is configured to securely protect the implant
insertion device and/or implant from damages. In some embodiments,
the kit has compartments to hold the implant insertion device
and/or implant individually or together in a locked configuration.
In some embodiments, the kit encloses at least one implant body
therewithin. In some embodiments, the kit encloses at least one
implant insertion device therewithin.
[0171] In some embodiments, the device tray and the kit cover is
for single-use only. In some embodiments, the device tray and the
kit cover are not for reuses after the inner most kit cover has
been opened. In some embodiments, the inner most kit cover is the
first or the second kit cover.
[0172] Disclosed herein are sterile kits enclosing the implant
insertion devices and/or implant bodies as disclosed herein, for
example, a kit with two different kit covers, at least the
inner-most kit cover encloses contents that are sterile. These
contents include at least an implant insertion device, each implant
insertion device having an outer shaft and an inner shaft that can
be inserted and locked to the outer shaft, and/or at least an
implant body, having at least two interfaces to lock to the inner
shaft and/or the outer shaft independently. Some kit comprises an
individual kit cover for each individual implant body, for example,
as the inner-most kit cover, each implant body having at least two
interfaces to lock to the inner shaft and/or the outer shaft
independently, the kits enclosing individual sterile implant bodies
are then packed in an outer layer of kit cover.
[0173] Anatomical Planes:
[0174] In some embodiments, the longitudinal plane is formed by the
left-to-right axis and the anterior-to-posterior axis of a subject.
In some embodiments, the longitudinal axis of is the head to toe
axis of a subject. In some embodiments, the coronal plane is a
plane formed by the left to right and the head-to-toe axis of a
subject. In some embodiments, the sagittal plane is the plane
formed by the anterior to posterior axis and the head-to-toe axis
of a subject.
[0175] In some embodiments, the left-to-right axis is an anatomical
axis defined by a subject's left to the subject's right. In some
embodiments, the head-to-toe axis is an anatomical axis defined by
a subject's head to the subject's feet. In some embodiments, the
anterior-to-posterior axis is an anatomical axis defined by a
subject's belly to the subject's back.
[0176] In some embodiments, a height of an object is the along the
head-to-toe axis, when the object is properly deployed in a
subject. In some embodiments, a width of an object is the along the
left-to right-axis, when the object is properly deployed in a
subject. In some embodiments, a length of an object is the along
the anterior-to-posterior axis, when the object is properly
deployed in a subject.
[0177] In some embodiments, the implant body has a non-uniform
height to accommodate the lordosis or kyphosis angle of the spinal
cord. In some cases, the longitudinal plane is a plane formed
substantially by the left-to-right axis and the
anterior-to-posterior axis of a subject.
[0178] Implant Insertion Directions:
[0179] In some embodiments, the implant is inserted from the
anterior to the posterior direction of the patient. In other
embodiments, the implant is inserted from the posterior to the
anterior direction of the patient. In some embodiments, the implant
is inserted from the left to the right direction of the patient. In
some embodiments, the implant is inserted from the right to the
left direction of the patient. In some embodiments, the implant is
inserted from a direction determined by the operational angle of
the patient and then rotated into its proper location.
[0180] Cam Features:
[0181] In some embodiments, the insertion device includes a cam
feature that translates a rotation of the inner shaft into a linear
movement of the inner shaft with respect to the outer shaft. In
some cases, a cam feature is attached to the top-most cross-section
of the knob. In some cases, the cam feature faces the bottom-most
cross section of the outer shaft. In some cases, the cam feature
faces the base of the outer shaft. In some cases the outer shaft
includes at least one cam feature that is attached to the
bottom-most cross section of the outer shaft. In some cases, the
knob includes at least one cam feature that is attached to the
top-most cross section of the knob that does not go into the outer
shaft. In some cases, the cam feature faces the top-most
cross-section of the outer shaft. In some cases, the cam feature
faces the top of the knob.
[0182] In some embodiments, the cam feature includes at least a
step feature. In some cases, the cam feature includes at least a
step, wherein the step starts at the top-most cross section of the
knob and rises toward the insertion end of the inner shaft. In some
cases, the cam feature includes an upward ramp feature and a
downward ramp feature, wherein the upward and downward ramp is
substantially vertical to the top-most cross section of the knob.
In some cases, the cam feature includes an upward ramp feature and
a downward ramp feature, wherein each plane of the upward ramp and
downward ramp have an acute angle with the top-most cross section
of the knob. In some cases, the upward ramp extends from a cross
sectional that is closer to the bottom-most cross section toward
the insertion end of the inner shaft. In some cases, the downward
ramp extends from a cross sectional that is closer to the top-most
cross section toward the bottom-most cross section of the inner
shaft. In some cases, the cam feature has a step feature with a
uniform height extending from the top-most cross section of the
knob toward the insertion end of the inner shaft. In some cases,
the cam feature is a dent feature with a uniform depth extending
from the top-most cross section of the knob toward the bottom
most-cross section of the knob. In some cases, the cam feature is a
three dimensional shape including a plane with an upward ramp. In
some cases, the cam feature is a three dimensional shape including
a plane with a downward ramp. In some cases, the cam feature is a
three dimensional shape including a plane with an upward and a
downward ramp. In some cases, the cam feature is cylindrical. In
some cases, the cam feature is cylindrical with a cross section of
a circle sector. In some cases, the cam feature is cylindrical with
a cross section of a portion of a circle sector. In some cases, the
cam feature is cylindrical with a cross section of a triangle. In
some cases, the cam feature is cylindrical with a cross section of
a rhombus. In some cases, the cam feature is cylindrical with a
cross section of a trapezoid. In some cases, the cam feature is
cylindrical with a cross section of a pentagon. In some cases, the
cam feature is cylindrical with a cross section of a parallelogram.
In some cases, the cam feature is an arbitrary three dimensional
shape that attaches to the bottom-most cross section of the outer
shaft. In other cases, the cam feature is an arbitrary three
dimensional shape that attaches to the top-most cross section of
the knob.
[0183] In some embodiments, the outer shaft includes at least two
different surfaces at the bottom of the outer shaft facing the cam
feature. In some cases, the knob includes at least two different
surfaces at the top-most cross section of the knob that does not go
into the outer shaft facing the cam feature. In some cases, the two
different surfaces allow a cam feature to slide on. In some cases,
one of the two different surfaces includes a first position or an
unlocked position of the inner shaft to the outer shaft. In some
cases, the other of the two different surfaces includes a second
position or a locked position of the inner shaft to the outer
shaft. In some cases, one of the two different surfaces which
includes a first position or an unlocked position of the inner
shaft to the outer shaft is closer to the base of the insertion
device. In some cases, the other of the two different surfaces
which includes a second position or a locked position of the inner
shaft to the outer shaft is closer to the tip of the insertion
device. The offset of the two different surfaces determines the
linear displacement that an inner shaft tip moves with respect to
the outer shaft.
[0184] In some embodiments, the two different surfaces are
connected by a ramp feature. In some cases, one of the two
different surfaces connects to the edge of the ramp that is closer
to the base of the knob. In yet certain cases, the other of the two
different surfaces connects to the edge of the ramp that is closer
to the insertion end of the device.
[0185] In some embodiments, the height of the ramp determines the
linear displacement of the inner shaft tip with respect to the
outer shaft. In other cases, the length and the acute tilted angle
of the ramp from the two different surfaces determines the linear
displacement of the inner shaft tip with respect to the outer
shaft. In some cases, the displacement of the inner shaft is along
the direction from the base toward the tip of the insertion
device.
[0186] Referring to FIG. 9, in some embodiments the base of the
outer shaft includes at least two different surfaces at the bottom
of the outer shaft facing the top of the knob. In some cases, the
outer shaft 20 includes a first surface 22, or 26 and a second
surface 24 or 28 that a cam feature of the knob slides on. A ramp
element, 23 or 27, connects the first and second surfaces. The
outer shaft also has a stopper 25 or 29 that stops the sliding of
the cam feature from the first position to the second position, or
from the second position to the first position. The outer shaft
also includes a groove 211 at the inner surface of the outer shaft
that a hump of the knob can slide along. The outer shaft also has a
window 210 indented from the outer surface to the inner surface of
the outer shaft. The edge of the window connects with the groove so
that the hump can slide along the groove 211 into the window 210.
At the first position, the hump is aligned with the groove 211 and
the window 210 edge connecting to the groove 211. The camp is on
top of surfaces 22 and 26. When the inner shaft rotates about 90
degrees to the second position, the hump is at the opposite edge of
the window 210. The hump feature and the window 210 prevent the
inner shaft from being removed from the outer shaft while inner
shaft is in unlocked with respect to an implant body. The inner
shaft cam is on top of surfaces 28 and 24 at the second
position.
[0187] Referring to FIG. 14, in a particular embodiment, the base
of the outer shaft includes at least two different surfaces at the
bottom of the outer shaft facing the top of the knob. In some
embodiments, the outer shaft 20 (right image) includes a first
surface 22 and a second surface 24 that a cam feature of the knob
slides thereon. A ramp element, 23 connects the first surface, 22
and the second surface, 24. The outer shaft also has a stopper 25
that stops the sliding of the cam feature from the first position
to the second position, or from the second position to the first
position. In some cases, the knob of the inner shaft 30 includes a
cam feature 35 that slides on the first and the second surfaces and
the ramp features of the outer shaft to transform rotation of the
inner shaft into linear displacement of the inner shaft tip. The
inner shaft body 32 is connected to the top of the knob 36. The
groove 219 is configured to providing tactile feedback in the
locking or unlocking of the inner shaft to the outer shaft. The
groove 219 is optional in some embodiments.
[0188] FIG. 15 shows the inner shaft body 30 in an exemplary
embodiment. The inner shaft body comprises a knob 36 at the base of
the inner shaft 30, and the inner shaft body 32 connects to the top
of the knob 36. The knob 36 comprises a hump 37 for interacting
with the complementary window on the outer shaft so at to lock or
unlock the inner shaft to the outer shaft. The knob also comprises
at least one cam 35 that slides on the base of the outer shaft
while the inner shaft rotates within the cavity of the outer shaft.
Optionally, the knob comprises a hump 38 for providing tactile
feedback in the locking or unlocking of the inner shaft to the
outer shaft. The hump 38 interacts with a groove on the inner
surface of the outer shaft so as to provide slight resistance and a
snap tactile feel to the user during locking or unlocking of the
inner shaft to the outer shaft. In some cases, the hump 37
supported by a spring force so that it can be pushed in to unlock
from the window on an outer shaft. In some cases, the hump 37 is a
flexible element so that it deforms to lock or unlock to the outer
shaft. In some cases, the inner shaft is injection moldable.
[0189] FIG. 16 shows an exemplary embodiment of a cam feature in
locking an implant body to the inner shaft. A cam feature located
on the knob of the inner shaft 30 on the top surface of the knob
facing the base of the outer shaft 20. Rotation of the knob 30
allows a cam feature to slide on a ramp feature of the outer shaft
so as to transform the rotation into a linear movement of the inner
shaft tip 31. At a second position (top image), the inner shaft tip
31 extends further away from the outer shaft 20, the implant is not
locked to the inner shaft tip 31. At a first position (bottom
image) the inner shaft tip 31 is rotated 90 degrees and also pulled
closer to the outer shaft 20 and to the insertion stopper 21, thus
the implant body is locked between the outer shaft 20 and the inner
shaft tip 31.
[0190] Detectable Tags:
[0191] In some embodiments, detectable tags are compounds or
compositions that are detectable to one or more medical imaging or
detection modalities. Non-limiting examples of medical imaging or
detection modalities are one or more selected from: MRI, MRI-PET,
CT, x-ray, ultrasound, OCT, fluorescence, bioluminescence, PET,
SPECT, microPET, and microSPECT. In some cases radio-opaque
material such as barium sulfate is added to resin before the
injection molding process as to provide radio-opacity to the
instruments. A range of 1% to 40% of barium sulfate, or equivalent,
concentration (weight/weight) may be used.
[0192] Methods:
[0193] Also disclosed herein are methods related to use of
individual components or entities of the implant insertion devices
and/or the implant bodies disclosed herein, for example, for the
delivery of a graft tissue to the intervertebral space of a
patient. Some methods related securing an implant body to an
implant insertion device, for example, by rotating an inner shaft
such that at least one cam at the base of the inner shaft moves
from a first position to a second position displaced by a distance
sufficient to pull an implant body thereby locking it in place
against an outer surface of an insertion device. Simultaneously, by
rotating the inner shaft, the inner shaft tip rotates in the
chamber of the implant body so that it locks the implant body to
the inner shaft at the second position. Some method related to
reversely unlock an implant body from an insertion device after the
implant body is properly delivered, for example by reversely
rotating an inner shaft such that the implant body is unlocked from
the inner shaft and is readily removable from the insertion
device.
[0194] "About":
[0195] In some embodiments, "about" is used to indicate a -10% to a
10% range about a central number. For example, "about 100" means a
range of at least 90 to no more than 110.
EXAMPLES
[0196] The following illustrative examples are representative of
embodiments of the devices and methods described herein and are not
meant to be limiting in any way.
Example 1
[0197] A sterilely-packed single-use only implant delivery system
as disclosed herein is used to deliver an implant and a graft
tissue to an intervertebral space of a patient. The implant
delivery system includes an implant insertion device and an implant
body. These implant insertion devices are injection molded. The
device is discarded after a single use. This medical procedure is
repeated in multiple hospitals on 100 patients in need of a spinal
implant using the injection moldable single-use devices. Each
procedure is performed with a new, single sterilely packed
injection moldable device which is discarded after a one-time
usage. A machine crafted, reusable implant delivery device is used
to insert an implant to the intervertebral space of a patient. The
reusable device is cleaned and sterilized on-site and/or off-site
between usages. The medical procedure is repeated in hospitals on
100 patients using the reusable devices. The post-procedure
infection is monitored in all 200 patients. A substantially higher
device-related infection is found in patients operated by reusable
devices than those by single-use devices.
Example 2
[0198] A sterilely-packed single-use only implant delivery system
as disclosed herein is used to deliver an implant and a tissue to
an intervertebral space of a patient. The implant delivery system
includes an implant insertion device and an implant body. These
implant insertion device is injection molded and discarded after a
single use. This medical procedure is repeated in multiple
hospitals on 80 patients in need of a spinal implant using the
injection moldable single-use devices. Each procedure is performed
with a new, single sterilely packed injection moldable device which
is discarded after a one-time usage. In comparison, a machine
crafted, reusable implant delivery device is used to insert an
implant to the intervertebral space of a patient. The reusable
device is cleaned and sterilized between usages. The medical
procedure is repeated in hospitals on 80 patients using the
reusable devices. The post-procedure infection is monitored in all
160 patients. A significantly higher cost per usage is found with
the reusable device when compared to the single-use injection
moldable device. The cost of reusable device includes the cost of
cleaning, sterilization, transportation to offsite professional
cleaning facilities, packing after cleaning, transportation after
cleaning back to hospitals, and additional treatment costs to
device-related infections.
Example 3
[0199] A sterilely-packed single-use only implant delivery system
as disclosed herein is used to deliver an implant and a tissue to
an intervertebral lumbar space of a patient. The implant delivery
system includes an implant insertion device and an implant body.
These implant insertion devices are injection molded. The device is
discarded after a single use. This medical procedure is repeated in
multiple hospitals on 80 patients in need of a spinal implant using
the injection moldable single-use devices. Each procedure is
performed with a new, single sterilely packed injection moldable
device which is discarded after a one-time usage. A machine
crafted, reusable implant delivery device is used to insert an
implant to the intervertebral space of a patient. The reusable
device is cleaned sterilized on-site and/or off-site between
usages. The medical procedure is repeated in hospitals on 80
patients using the reusable devices. The post-procedure infection
is monitored in all 160 patients. A significantly higher cost per
usage is found with the reusable device when compared to the
single-use injection moldable device. In particular, 80 implant
delivery devices of the present invention are injection molded
along with implant bodies with 10 different dimensions that fits in
various locations of the spinal cord. 80 traditional reusable
implant insertion devices with implant bodies of different
dimensions are machined. The cost of injection molding and
machining of a same number of implant delivery devices and implant
bodies are compared. The cost of materials is also compared for two
different manufacturing processes. The cost of injection molding is
significantly lower than machine-crafting an implant delivery
device or an implant with the identical dimensions. The packing and
sterilization cost for each implant delivery device is also greatly
lower than that of each traditional reusable implant insertion.
Example 4
[0200] A sterilely-packed single-use only implant delivery system
as disclosed herein is used to deliver an implant and tissue to an
intervertebral space of a patient. The implant delivery system
includes an implant insertion device and an implant body. These
implant insertion devices are injection molded. The device is
discarded after a single use. Radio frequency (RF) tags are loaded
on the implant to guide the procedure with real-time imaging. The
implant body is securely locked to the inner shaft body by a
rotation of the inner shaft in the chamber of the implant body.
Further, the implant body is also locked to the outer shaft by
fitting an interface of the implant body securely to the
complementary interface at the insertion end of the outer shaft.
The implant is securely fastened to the implant delivery device so
that it protects the implant from undesired rotation or breakage
during the procedure of implant insertion. The procedure is
repeated for 10 times. A different implant delivery device not
disclosed herein with no proper secure locking of the implant body
to inner shaft or the outer shaft of the implant delivery device is
also used for spinal insertion in a patient. The procedure is
performed for 10 patients with not securely locked insertion
device. The insertions of implants are successful as indicated by
the radio frequency tags of the implant in all 10 patients with
securely locked implant. For the other 10 patients, the implant
body wobbles and rotates on the delivery device in some of those
procedures, as indicated by the RF tags, when the implant body
experiences uneven friction from the tissue. In addition, the
undesirable breakage of implant bodies at the unlocked interface is
significantly higher than that of the securely locked implant
bodies possibly due to extreme pushing forces exerted only on the
small connecting surface of the unlocked interface.
Example 5
[0201] A sterilely-packed single-use only implant delivery system
as disclosed herein is used to deliver an implant and a tissue to
an intervertebral space of a patient. The implant delivery system
includes an implant insertion device and an implant body. These
implant insertion devices are injection molded. The device is
discarded after a single use. This medical procedure is repeated in
multiple hospitals on 100 patients in need of a spinal implant
using the injection moldable single-use devices. Each procedure is
performed with a new, single sterilely packed injection moldable
device which is discarded after a one-time usage. A machine
crafted, reusable implant delivery device is used to insert an
implant to the intervertebral space of a patient. The reusable
device is cleaned sterilized on-site and/or off-site between
usages. The medical procedure is repeated in hospitals on 100
patients using the reusable devices. The implant delivery devices
and implant bodies are packed in a kit with two pealably sealed kit
covers. The first kit cover is not sterile. Within the first kit
cover, individual sterile covers are contained to securely an
implant delivery device and an implant body in each sterile kit
cover. Each second kit contains implant insertion device implant
body of different sizes for procedures of different surgical needs.
Optionally, the implant is securely locked to the implant delivery
device so that it reduces the device handling in a procedure. Upon
arrival in the operation suite, the first kit cover is removed
before or upon arrival at the operation suites. Right before
operation, a sterile kit with the right implant shape and size is
selected to be opened to keep the device and implant body
therewithin sterile. A biocompatible material is injected before or
after the implant insertion into the internal space of the implant
for spinal fusion. After implant insertion, the implant delivery
device is disposed.
Example 6
[0202] A sterilely-packed single-use only implant delivery system
as disclosed herein is used to deliver an implant and a tissue to
an intervertebral space of a patient. The implant delivery system
includes an implant insertion device and an implant body. These
implant insertion devices are injection molded. The device is
discarded after a single use. Each implant delivery system is
injection molded in separated pieces, these pieces includes an
inner shaft, an outer shaft, and an implant body. The implant
bodies and the implant delivery devices are molded in different
dimensions and sizes so that the implant body fits in the various
intervertebral spaces between any two adjacent vertebral of the
spinal cord.
Example 7
[0203] A sterilely-packed single-use implant delivery system as
disclosed herein is used to deliver an implant and tissue to an
intervertebral space of a patient. The implant delivery system
includes an implant insertion device and an implant body. These
implant insertion devices are injection molded. The device is
discarded after a single use. Each implant delivery system is
injection molded in separated pieces including an inner shaft, an
outer shaft, and an implant body. The inner shaft is molded in two
separated pieces including a knob and an inner shaft body together
with the inner shaft tip. The inner shaft body and inner shaft tip
are molded together using durable, medical imaging compatible
metals to increase the durability of the inner shaft body and
tip.
Example 8
[0204] A sterilely-packed single-use only implant delivery system
as disclosed herein is used to deliver an implant and a tissue to
an intervertebral space of a patient. The implant delivery system
includes an implant insertion device and an implant body. These
implant insertion devices are injection molded. The device is
discarded after a single use. Radio frequency (RF) tags are loaded
on the implant to guide the procedure with real-time imaging. The
implant delivery system is used in a Magnetic Resonance Imaging
(MRI) guided implant insertion procedure. Traditional machinable
implant insertion devices made of magnetic metal are not compatible
with MRI and causes detrimental accidents. Traditional
machine-crafted implant device made of magnetic metal cannot be
used in any MRI guided implant insertion. An injection moldable
implant delivery device of the present invention made of
non-magnetic MRI-compatible materials is safe to use for MRI guided
implant insertion procedure. Radio frequency tags are attached to
edges of the implant body before the procedure so that the
real-time position of the implant body is MRI visible to ensure
proper and accurate implant insertion.
[0205] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention.
* * * * *