U.S. patent application number 15/750441 was filed with the patent office on 2018-08-09 for tapping devices, systems and methods for use in bone tissue.
This patent application is currently assigned to Woven Orthopedic Technologies, LLC. The applicant listed for this patent is Woven Orthopedic Technologies, LLC. Invention is credited to Robert LUZZI, Lynn MACDONALD, Francis Patrick MAGEE, Jeffrey P. RADZIUNAS.
Application Number | 20180221059 15/750441 |
Document ID | / |
Family ID | 57944170 |
Filed Date | 2018-08-09 |
United States Patent
Application |
20180221059 |
Kind Code |
A1 |
MAGEE; Francis Patrick ; et
al. |
August 9, 2018 |
TAPPING DEVICES, SYSTEMS AND METHODS FOR USE IN BONE TISSUE
Abstract
A soft tapping device for preparing a bone hole that includes a
substantially cylindrical insert that is sized to enter into a
compressed woven retention device. The substantially cylindrical
insert has protrusions that are adaptable to expand portions of a
compressed woven retention device inside the bone hole. The
substantially cylindrical insert is also configured to exit from
the compressed woven retention device without changing the expanded
portions of the compressed woven retention device.
Inventors: |
MAGEE; Francis Patrick;
(Mackay, ID) ; LUZZI; Robert; (Silverthorne,
CO) ; RADZIUNAS; Jeffrey P.; (Wallingford, CT)
; MACDONALD; Lynn; (Bantam, CT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Woven Orthopedic Technologies, LLC |
Manchester |
CT |
US |
|
|
Assignee: |
Woven Orthopedic Technologies,
LLC
Manchester
CT
|
Family ID: |
57944170 |
Appl. No.: |
15/750441 |
Filed: |
August 5, 2016 |
PCT Filed: |
August 5, 2016 |
PCT NO: |
PCT/US16/45899 |
371 Date: |
February 5, 2018 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
62287756 |
Jan 27, 2016 |
|
|
|
62201273 |
Aug 5, 2015 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61L 2430/02 20130101;
A61B 2017/8655 20130101; A61B 17/686 20130101; A61L 31/028
20130101; A61B 17/8872 20130101; A61B 17/863 20130101; A61B 17/1655
20130101; A61B 17/1617 20130101 |
International
Class: |
A61B 17/68 20060101
A61B017/68; A61L 31/02 20060101 A61L031/02; A61B 17/86 20060101
A61B017/86; A61B 17/88 20060101 A61B017/88 |
Claims
1. A soft tapping device, comprising: a substantially cylindrical
insert sized to enter into a compressed woven retention device, the
substantially cylindrical insert having protrusions that are
adaptable to expand portions of a compressed woven retention device
inside a pilot hole, the substantially cylindrical insert being
configured to exit from the compressed woven retention device
without changing the expanded portions of the compressed woven
retention device.
2. The soft tapping device of claim 1, wherein the protrusions are
a non-cutting thread having a gradually increasing pitch in a
proximal direction along the substantially cylindrical insert.
3. The soft tapping device of claim 1, wherein the protrusions are
expanding balloon members that expand in an outward direction when
the substantially cylindrical insert is compressed in a
longitudinal direction.
4. The soft tapping device of claim 1, wherein the substantially
cylindrical insert includes slots which form tensioned protrusion
slats, wherein the protrusions are the tensioned protrusion slats;
and the protrusions expand in an outward direction when the
substantially cylindrical insert is compressed in a longitudinal
direction.
5. The soft tapping device of claim 1, wherein the expanded
portions of the compressed portions of the compressed woven
retention device allow for a self-tapping screw to insert into the
woven retention device without damaging the woven retention
device.
6. The soft tapping device of claim 1 further comprising a shaft
with a proximal portion and a distal portion, wherein the distal
portion is configured with a non-cutting thread and a rounded
end.
7. The soft tapping device of claim 1 further comprising a shaft
with a proximal portion and a distal portion, wherein distal
portion is configured with a first thread portion and the proximal
portion is configured with a second thread portion with a coarser
pitch than first thread portion of the distal portion, and wherein
the second thread portion is rounder than the first thread
portion.
8. A soft tapping device, comprising: a substantially cylindrical
insert configured and sized to expand portions of a substantially
cylindrical hole, the substantially cylindrical insert being
configured to exit from the hole without changing the expanded
portions of the hole.
9. The soft tapping device of claim 8 further comprising a shaft
with a proximal portion and a distal portion, wherein the distal
portion is configured with a non-cutting thread.
10. The soft tapping device of claim 8, wherein the non-cutting
thread has a radially spiral configuration.
11. The soft tapping device of claim 8, wherein the non-cutting
thread has a base and a radially outward-most peak in between the
proximal portion and a distal end of the distal portion.
12. The soft tapping device of claim 8, wherein the hole is a bone
hole.
13. The soft tapping device of claim 8, wherein the hole is a woven
retention device configured to be disposed in a bone hole.
14. The soft tapping device of claim 8, wherein the hole is a
combination of a bone hole and a woven retention device in the bone
hole.
15. The soft tapping device of claim 8, further comprising a
spring-loaded deburring tool on the shaft.
16. A method of creating a mantle in a bone, comprising: inserting
a compressed woven retention device into a pilot hole of a bone;
inserting a soft tapping device into the compressed woven retention
device, wherein the soft tapping device has ridges that, when
inserted into the compressed woven retention device, expand the
woven retention device with lead in edges; and inserting a
self-tapping screw into the expanded woven retention device.
17. The method of claim 16, further comprising the step of:
expanding the inserted woven retention device with a leading edge
of a ridge on the soft tapping device.
18. The method of claim 17, further comprising the step of:
removing the soft tapping device without cutting the expanded woven
retention device.
19. The method of claim 18, further comprising the step of:
inserting one of a screw and a self-tapping screw into the pilot
hole after the soft tapping device is removed.
20. The method of claim 19, further comprising the step of:
inputting a slurry into the pilot hole before inserting the
screw.
21. A method of creating a mantle for fixation in a bone hole,
comprising: providing a soft tapping device configured to compress
material in a bone hole; utilizing a soft tapping device to
compress the material in the bone hole; and inserting a woven
retention device.
22. The method of claim 21, wherein the soft tapping device is
configured to provide a surface of the bone hole with soft
edges.
23. The method of claim 22, the compressed woven retention device
being adapted to expand to fill the soft edges of the bone
hole.
24. The method of claim 23, further comprising inserting a screw
into the inserted woven retention device.
25. The method of claim 24, wherein the inserting the screw
comprises inserting a self-tapping screw into the compressed woven
retention device.
26. The method of claim 25, further comprising: adding an additive
to at least one of the expanded woven retention device and bone
hole, wherein the additive is a different material than the woven
retention device.
27. The method of claim 26, wherein the additive is a slurry that
is configured to form a composite material mantle that interfaces
with the self-tapping screw.
28. The method of claim 27, wherein the slurry is a calcium
phosphate cement.
29. The method of claim 28, wherein the material is in one of: 1)
situ bone; 2) bone material and a woven retention device; and 3)
bone material, a woven retention device and a slurry.
Description
RELATED APPLICATIONS
[0001] This application claims priority to U.S. provisional
application No. 62/201,273, filed Aug. 5, 2015, and U.S.
provisional application No. 62/287,756, filed Jan. 27, 2016.
TECHNICAL FIELD
[0002] The present invention relates to devices, systems and
methods for use in fixing fasteners to bone tissue.
BACKGROUND
[0003] In orthopedic surgery it is common to secure a bone screw to
a patient's bone. Bone fracture repair is surgery to fix a broken
bone using plates, nails, screws, or pins. It is common in the
treatment of fractures to attach a plate to the bone utilizing bone
screws. The resulting construct prevents motion of the fractured
bone so that the bone can heal. Alternatively, one or more screws
may be inserted across the break to hold it in place.
[0004] In the treatment of spinal disorders, pedicle screws are
inserted into the patient's vertebrae to serve as anchor points
that can then be connected with a rod. This construct prevents
motion of the vertebral segments that are to be fused.
[0005] In the treatment of detached tendons, screw-like tissue
anchors are inserted into the patient's bone to serve as an anchor
for the reattachment of the tendon.
[0006] One complication with the use of bone screws is the loss of
fixation or grip between the bone screw and the patient's bone.
Another complication with the use of bone screws is the stripping
of the hole in the bone when the bone screw is inserted. This
results in the loss of purchase and holding strength of the bone
screw.
[0007] The presence of osteoporotic bone can increase the
likelihood of complications by reducing the purchase or grip of the
bone screw to the patient's bone, resulting in a loss of holding
strength and loosening of the bone screw or pullout of the bone
screw.
[0008] Current solutions to secure bone screws have not adequately
addressed screw failure and the underlying causes of screw failure.
Also, current solutions have not adequately addressed screw failure
related to bi-cortical intramedullary anchorage.
[0009] One solution contemplates utilizing a woven retention device
above the bone surface to engage with a bone screw. However, this
solution may require precise placement of the woven retention
device to prevent interference with screw engagement.
BRIEF SUMMARY OF THE INVENTION
[0010] There is a need for devices, systems and methods that
enhance the surface of a bone hole to provide enhanced fixation of
a bone anchor to the bone. Additionally, there is a need for
devices, systems and methods for repairing the surface of the bone
hole following damage to the bone hole as in the case of stripping
of the hole in the bone when a bone screw is over-tightened. Also,
there is a need for devices, systems and methods for providing an
enhanced bone hole surface for the reattachment of tendons in, for
example anterior/posterior cruciate ligament repair procedures,
rotator cuff repair procedures, etc. There is a need for a device
that enhances the surface of a bone hole to enhance fixation of a
bone anchor to bone and permits bone ingrowth into its structure.
There is a need for a single device that enhances the surface of a
bone hole to enhance fixation of a bone anchor to bone and
accommodates variations in the diameter and depth of the bone hole.
Further, there is a need for such devices that have enhanced
biocompatibility to aid in tissue and bone healing, regeneration,
and growth.
[0011] According to an embodiment of the present invention, the
level of the material of a woven retention device above the bone
surface can be very important. If the level of the woven retention
device is too deep then the screw may not find the lumen and/or may
push the woven retention device with the screw as the screw
proceeds into the lumen. On the other hand, if the woven retention
device is too proud, there may be difficulty engaging bone, there
may be fiber disruption, or there may be debris formation. Another
challenge lies in the general difficulty in engaging bone with the
interposition of the woven retention device. For example, a
diameter mismatch may occur between the pilot hole and the screw
(2.5 mm vs 3.5 mm).
[0012] A woven retention device can be reduced in diameter and
inserted into a pilot hole that spans a near cortex and a far
cortex. In between the near cortex and the far cortex, there is no
intramedullary bone in one embodiment. A self-tapping screw can
then be inserted into the already inserted woven retention device.
The screw upon entering the woven retention device can dilate a
portion of the woven retention device back to its natural diameter.
As the screw continues to proceed to the end of the woven retention
device, the woven retention device continues to dilate to fit. As
the screw approaches a far or near cortex or inner cortex bone, an
area of a woven retention device that becomes susceptible to
breakage or damage as the screw and the bone can pinch or put
pressure on a portion of the woven retention device.
To ameliorate this, a soft tapping device is contemplated in
accordance with the principles of the invention. The soft tapping
device is shown and described herein in various embodiments. The
soft tapping device can, any of, contact, engage, compact,
compress, expand and/or dilate bone, with respect to the bone
inside a bone hole alone, and/or, in combination with a fixation
device, for example, a woven retention device.
[0013] In one aspect of the invention, a soft tapping device
comprises a substantially cylindrical insert sized to enter into a
compressed woven retention device, the substantially cylindrical
insert having protrusions that are adaptable to expand portions of
a compressed woven retention device inside a pilot hole, the
substantially cylindrical insert being configured to exit from the
compressed woven retention device without changing the expanded
portions of the compressed woven retention device. In another
aspect of the invention the protrusions are a non-cutting thread
having a gradually increasing pitch in a proximal direction along
the substantially cylindrical insert. In another aspect of the
invention, the protrusions are expanding balloon members that
expand in an outward direction when the substantially cylindrical
insert is compressed in a longitudinal direction. In another aspect
of the invention, the substantially cylindrical insert includes
slots which form tensioned slats, wherein the protrusions are the
tensioned slats; and the protrusions expand in an outward direction
when the substantially cylindrical insert is compressed in a
longitudinal direction. In another aspect of the invention, the
expanded portions of the compressed portions of the compressed
woven retention device allow for a self-tapping screw to insert
into the woven retention device without damaging the woven
retention device. In another aspect of the invention, the soft
tapping device further comprises a shaft with a proximal portion
and a distal portion, wherein the distal portion is configured with
a non-cutting thread and a rounded end. In another aspect of the
invention, the soft tapping device further comprises a shaft with a
proximal portion and a distal portion, wherein distal portion is
configured with a first thread portion and the proximal portion is
configured with a second thread portion with a coarser pitch than
first thread portion of the distal portion, and wherein the second
thread portion is rounder than the first thread portion.
[0014] In another aspect of the invention, a soft tapping device
comprises a substantially cylindrical insert configured and sized
to expand portions of a substantially cylindrical hole, the
substantially cylindrical insert being configured to exit from the
hole without changing the expanded portions of the hole. In another
aspect of the invention, the soft tapping device further comprises
a shaft with a proximal portion and a distal portion, wherein the
distal portion is configured with a non-cutting thread. In another
aspect of the invention, the non-cutting thread has a radially
spiral configuration. In another aspect of the invention, the
non-cutting thread has a base and a radially outward-most peak in
between the proximal portion and a distal end of the distal
portion. In another aspect of the invention, the hole is a bone
hole. In another aspect of the invention, the hole is a woven
sleeve configured to be disposed in a bone hole. In another aspect
of the invention, the hole is a combination of a bone hole and a
woven sleeve in the bone hole. In another aspect of the invention,
the soft tapping device further comprises a spring-loaded deburring
tool on the shaft.
[0015] In another aspect of the invention, a method of creating a
mantle in a bone comprises inserting a compressed woven retention
device into a pilot hole of a bone; inserting a soft tapping device
into the compressed woven retention device, wherein the soft
tapping device has ridges that, when inserted into the compressed
woven retention device, expand the woven retention device with lead
in edges; and inserting a self-tapping screw into the expanded
woven retention device. In another aspect of the invention, the
method further comprises the step of: expanding the inserted woven
retention device with a leading edge of a ridge on the soft tapping
device. In another aspect of the invention, the method further
comprises the step of: removing the soft tapping device without
cutting the expanded woven retention device. In another aspect of
the invention, the method further comprises the step of: inserting
one of a screw and a self-tapping screw into the pilot hole after
the soft tapping device is removed. In another aspect of the
invention, the method further comprises the step of: inputting a
slurry into the pilot hole before inserting the screw.
[0016] In another aspect of the invention, a method of creating a
mantle for fixation in bone comprises providing a soft tapping
device configured to compress material in a bone hole; utilizing a
soft tapping device to compress the material in the bone hole; and
inserting a woven retention device. In another aspect of the
invention, the soft tapping device is configured to provide a
surface of the bone hole with soft edges. In another aspect of the
invention, the method further comprises inserting a compressed
woven retention device into the bone hole, the compressed woven
retention device being adapted to expand to fill the soft edges of
the bone hole. In another aspect of the invention, the method
further comprises inserting a screw into the inserted woven
retention device. In another aspect of the invention, inserting the
screw comprises inserting a self-tapping screw into the compressed
woven retention device. In another aspect of the invention, the
method further comprises adding an additive to at least one of the
expanded woven retention device and bone hole, wherein the additive
is a different material than the woven retention device. In another
aspect of the invention, the additive is a slurry that is
configured to form a composite material mantle that interfaces with
the self-tapping screw. In another aspect of the invention, the
slurry is a calcium phosphate cement. In another aspect of the
invention, the material is in one of: 1) situ bone; 2) bone
material and a woven retention device; and 3) bone material, a
woven retention device and a slurry.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1A shows a side view of a woven retention device in
relation to a bone hole.
[0018] FIG. 1B shows a side view of a woven retention device placed
in a bone hole.
[0019] FIG. 2A shows a side view of one embodiment of the invention
placed in a long bone, illustrating features that mate with the
promixal and distal cortex of the bone.
[0020] FIG. 2B shows a top view of one embodiment of the
invention.
[0021] FIG. 2C shows a side view of a bone screw placed within a
woven retention device placed in a bone hole.
[0022] FIG. 3A shows a side view of an embodiment of the
invention.
[0023] FIG. 3B shows a close-up side view of a distal end of an
embodiment of the invention.
[0024] FIG. 3C shows a close-up side view of a distal end of an
embodiment of the invention.
[0025] FIG. 3D shows a close-up side view of a distal end of an
embodiment of the invention.
[0026] FIG. 3E shows a close-up side view of a central portion of
an embodiment of the invention.
[0027] FIG. 4A shows a side view of another embodiment of the
invention.
[0028] FIG. 4B shows a close-up side view of a distal end of an
embodiment of the invention.
[0029] FIG. 4C shows a close-up side view of a distal end of an
embodiment of the invention.
[0030] FIG. 5A shows a side view of another embodiment of the
invention.
[0031] FIG. 5B shows a close-up side view of a distal end of an
embodiment of the invention.
[0032] FIG. 5C shows a close-up side view of a distal end of an
embodiment of the invention.
[0033] FIG. 5D shows a cross-section view of an embodiment of the
invention.
[0034] FIG. 5E shows a close-up side view of a distal end of an
embodiment of the invention.
[0035] FIG. 6 shows a side view of another embodiment of the
invention.
[0036] FIG. 7 shows a side view of another embodiment of the
invention.
[0037] FIG. 8A shows a side view of another embodiment of the
invention.
[0038] FIG. 8B shows a side view of another embodiment of the
invention.
[0039] FIG. 9A shows a side view of another embodiment of the
invention.
[0040] FIG. 9B shows a side view of another embodiment of the
invention.
[0041] FIG. 9C shows a cross-section of another embodiment of the
invention.
[0042] FIG. 10A shows a side view of another embodiment of the
invention.
[0043] FIG. 10B shows a side view of another embodiment of the
invention.
[0044] FIG. 10C shows a side view of another embodiment of the
invention.
[0045] FIG. 10D shows a side view of another embodiment of the
invention.
[0046] FIG. 10E shows a side view of another embodiment of the
invention.
[0047] FIG. 10F shows a side view of another embodiment of the
invention.
[0048] FIG. 10G shows a side view of another embodiment of the
invention.
[0049] FIG. 10H shows a side view of another embodiment of the
invention.
[0050] FIG. 10I shows a side view of another embodiment of the
invention.
[0051] FIG. 11A shows a schematic of the threading in an embodiment
of the invention.
[0052] FIG. 11B shows a schematic of the threading in an embodiment
of the invention.
[0053] FIG. 12 shows a side view of a bone hole in an embodiment of
the invention.
[0054] FIG. 13A shows a schematic of the threading in an embodiment
of the invention.
[0055] FIG. 13B shows a cross-section of the shaft in an embodiment
of the invention.
[0056] FIG. 14A shows a side view of another embodiment of the
invention.
[0057] FIG. 14B shows a close-up view of the bone hole in an
embodiment of the invention.
[0058] FIG. 15A shows a perspective view of the relaxed state of
another embodiment of the invention.
[0059] FIG. 15B shows a perspective view of the activated state of
an embodiment of the invention.
[0060] FIG. 16A shows a perspective view of the relaxed state of
another embodiment of the invention.
[0061] FIG. 16B shows a perspective view of the activated state of
an embodiment of the invention.
[0062] FIG. 16C shows a close-up perspective view of the activated
state of an embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0063] As shown in FIG. 1A, a woven retention device 1 may be
placed in a bone hole 3 located within a bone 2. The bone hole 3
may be substantially cylindrical. The woven retention device 1 may
initially be in a compressed state, as shown in FIG. 1A. The woven
retention device 1 may distribute pressure from the bone screw to
multiple points of contact on the exterior surface of the woven
retention device 1. The woven retention device 1 may be the woven
retention device disclosed in U.S. Pat. No. 8,992,537, which is
incorporated by reference herein.
[0064] As shown in FIG. 1B, a soft tapping device 100 having soft
edges can be designed to run inside the woven retention device 1
after the compressed woven retention device has been placed in the
pilot hole. The soft tapping device 100 is a substantially
cylindrical insert and can expand the woven retention device 1, as
shown in FIG. 1B, and then exit the bone hole 3 so that a
self-tapping screw can then enter the expanded woven retention
device 1 without damage to the woven retention device 1 because of
the soft edges. This allows for the woven retention device 1 to be
properly placed within the bone hole 3 in a desired location, with
desired dilation. In an embodiment, the soft tapping device 100 may
also be designed to be inserted in the bone hole before a woven
retention device has been placed in the hole.
[0065] As shown in FIG. 2A, the soft tapping device 100 may be
inserted into the bone hole 3, such that it passes through the
proximal cortex 2a of the bone, and is inserted into the distal
cortex 2b of the bone. As shown in FIG. 2B, the soft tapping device
100 includes a head 110, which includes a tool attachment surface
111 that allows for a driving tool to drive the soft tapping device
100 into the bone 2. In an embodiment, the tool attachment surface
111 may be a hex head, for example a Torx hex head. The proximal
end of the shaft 101 near the head 110 is not threaded to avoid
engagement with the bone and thus reduce friction and back-out
resistance. The soft tapping device 100 includes a shaft portion
101, distal end 102, and a distal tip portion 103. The soft tapping
device 100 further includes a thread 120 on an outer surface of the
soft tapping device 100. The thread 120 may have a radially spiral
configuration.
[0066] As shown in FIG. 2C, after the soft tapping device 100 is
removed from the bone 2 and/or the woven retention device 1, the
woven retention device 1 is properly placed within the proximal
cortex 2a and distal cortex 2b of the bone 2, and dilated to a
particular diameter to accommodate a particular bone screw 4. It is
understood that the soft tapping device 100 is shaped to dilate and
place the woven retention device 1 without damaging the woven
retention device 1.
[0067] The thread 120 may be of the type that compresses the bone
2, woven retention device 1, and/or composition in a bone hole 3 as
described herein. For example, the thread 120 can make up the soft
edges of the soft tapping device, as detailed above. In an
embodiment, the soft tapping device 200 does not cut into the bone
2, woven retention device 1 and/or composition. The term "cut" is
intended to be used broadly to include the separation of at least a
portion of a physical object, into two or more portions, through
the application of an acutely directed force. The soft tapping
device 100 does not have a cutting thread like a traditional screw
or tap. The soft tapping device 100 can have a non-cutting thread
provided on the soft tapping device. The application of a tap (as
defined broadly as a helical threaded feature) permits a localized
dilating of the bone to reduce the radial force needed to compact
the bone. As shown in FIG. 2A, the soft tapping device can have a
helical thread at the distal portion of the device. The term
"non-cutting thread" is intended to be used broadly to include
threads that are of the type that preferably do not cut the bone
and/or woven device, and that can be non-cutting at the crest of
the thread, for example, they can be rounded at the crest of the
thread, so as to not cut what it comes into contact with, for
example, so as to not cut the bone and/or woven retention device.
Non-cutting threads can include threads with no cutting flutes or
features such as a longitudinal scallop that is intended to engage
bone on its sharp edge to bite into bone. As shown in FIG. 13A,
non-cutting thread can also include threads that have blunt,
truncated or soft edges at the crest of the thread, whereas cutting
threads 126 have triangular or sharp edges at the crest of the
thread. These non-cutting threads can include rounded threads 121
and square threads 122 that do not have a sharp peak that can cut
into bone. The threads of the soft tapping device can also mimic
the thread geometry of the screw that is intended to be inserted
into the woven retention device, so the screw follows the thread
path created by the soft tapping device. In this way, the bone is
dilated in a pattern that is in the shape of the screw pitch. FIG.
13B shows a cross-section of the soft tapping device 100, where
threads 120 extend from the core surface of the shaft 101 and have
soft edges at the radially outward-most peak or crest 124 of the
thread 120.
[0068] As shown in FIGS. 3A-C, in a first embodiment, a soft
tapping device 200 can be configured, as discussed above, with a
shaft portion 101, distal end 102, distal tip portion 103, and
thread 120. The edges of the soft tapping device 200 can be in the
shape of a center bulging ridged insert where the soft tapping
device gradually increases in diameter. In this embodiment, the
distal tip 103 includes thread 120 wherein the thread pitch is
tight enough to grab the surface, but the thread is somewhat
rounded to avoid aggressive cutting. In an embodiment, a soft
tapping device 200 with a 2.5 mm shaft diameter may include thread
120 that may have a 1 mm pitch at the distal tip, which increases
to an 8 mm pitch at the proximal end of the distal tip. The thread
may have a maximum outer diameter of 3.5 mm, and the distal tip may
have a 12.degree. taper angle. Further, the thread 120 on the shaft
101 may be coarser with a greater pitch, where the thread pitch may
also increase in the proximal direction, and a thread geometry that
is even rounder than at the distal tip 103. For example, as shown
in FIG. 3D, the thread 120 may be rounded beginning with a radius
of 0.2 mm, and height of 0.5 mm at the distal tip 103 and have a
60.degree. thread angle. Contrastingly, as shown in FIG. 3E, the
thread 120 at the shaft 101 may be more rounded with a radius of
0.32 mm, and a height of 0.55 mm, and have a 29.degree. thread
angle. The thread 120 may have a base 125 and a radially
outward-most peak or crest 124. In this embodiment, the distal end
102 may be rounded with a near cortex chamfer leading edge 104 that
meets the distal tip 103. This shape of the distal end 102 allows
for the soft tapping device 200 to press against the bone 2 without
cutting it before the first thread engages.
[0069] The soft edges of the soft tapping device 100 can expand the
woven retention device and provide a "lead in" at the diameter
mismatch areas. Thus, the soft edges of the soft tapping device
100, i.e. the thread 120, can act as a lead in edge that expands
the woven retention device. Alternatively, or additionally, soft
edges can expand, dilate and/or compress the bone material in the
bone hole and provide a "lead in" at the diameter mismatch areas.
As shown in FIG. 2A, the distal cortex 2b is compounded by the fact
that the woven retention device 1 upon reaching the distal cortex
2b is now constrained.
[0070] As shown in FIGS. 4A-C, in an embodiment, the distal tip 103
of a soft tapping device 201 may be tapered directly into the
distal end 102, and have a greater taper than the soft tapping
device 200 of FIG. 3A. In an embodiment, the thread 120 on the soft
tapping device 201 may have the same shape and size on the distal
tip 103 and the shaft 101. In an embodiment, the thread 120 on the
shaft 101 may have an increasing pitch in the proximal direction.
The thread 120 may have a finer pitch at distal tip 103 than the
soft tapping device 200 of FIG. 3A. This promotes engagement with
the bone 2. In an embodiment, the distal end 102 may have a
narrower end that also includes a chamfer 104 between the distal
end 102 and the distal tip 103. This rounded shape of the distal
end 102 allows for the soft tapping device 201 to slightly pierce
bone 2 and allow a smaller diameter thread to engage with the bone
before tapering to a larger diameter.
[0071] While in some embodiments the soft tapping devices disclosed
can be used to prepare the woven retention device for a
self-tapping screw to enter the woven retention device, in another
embodiment the soft tapping device can be a self-tapping screw. In
an embodiment, the soft tapping device 202 may be configured where
the distal end 102 and distal tip 103 is not tapered but configured
with threads like a cutting tap, where the threads transition to a
coarser pitch for the soft tap feature mid-shaft, and there are no
threads at the proximal end. As shown in FIG. 5A-D, the distal end
102 and distal tip 103 of the soft tapping device 202 may have a
thread 120 that is different than the proximal end and shaft 101.
The distal tip 103 has threads that may be sharper (e.g. triangle
thread versus square or rounded, as discussed with respect to FIG.
13A) and a smaller pitch to engage the proximal surface of the
proximal cortex on starting and the proximal end of the distal
cortex surface. This allows the screw tip to self-center and the
woven retention device to displace laterally and allows the screw
to engage. The proximal end has even softer thread geometry, such
as rounded threads and a coarser pitch as discussed above with
respect to FIGS. 3A-E. Thus, the soft edges can provide enough
expansion to allow a self-tapping screw to be used. As shown in
detail in FIGS. 5D-E, in an embodiment the distal tip 103 of soft
tapping device 202 may have cortical thread 120 that is scalloped
or saw-toothed, to further engage and cut into the bone 2. This
allows for the soft tap thread 120 to engage the bone 2 quickly. In
an embodiment, as shown in FIG. 5D, the thread 120 has an outer
diameter of 2.45 mm at the distal tip 103, and an outer diameter of
2.6 mm at the shaft 101. The distal tip 103 may be 2.8 mm long, and
the distal end 102 may have a radius of 0.85 mm. As shown in FIG.
5E, the cortical thread 120 may have a height of 0.375 mm, a
35.degree. angle at the distal face, a 3.degree. angle at the
proximal face, and a radius of 0.05 mm at the surface.
[0072] As shown in FIG. 6, in an embodiment the distal tip 103 of
the soft tapping device 203 may have more rounded thread 120.
[0073] As shown in FIG. 7, in an embodiment, the soft tapping
device 204 may include a distal tip 103 with a similar pitch and
taper as soft tapping device 201 as shown in FIG. 4A. In an
embodiment, the shaft 101 of the soft tapping device 204 is smooth,
with no threading. This prevents engagement of the soft tapping
device 200 with both cortices 2a, 2b at the same time.
[0074] Additionally, as shown in FIGS. 8A-B, the soft tap may have
longitudinal cleanout grooves 105 along part or all of the length
that runs along a longitudinal axis of the soft tapping device 205,
206. This allows for the removal of debris as the soft tapping
device 205, 206 moves through the bone so that any bone fragments
or various other debris can exit the bone lumen. For example, FIG.
8A shows the embodiment of FIG. 7, but further including
longitudinal cleanout grooves 105 along the distal tip 103 of the
soft tapping device 205. Similarly, FIG. 8B shows the embodiment of
FIG. 4A, but further including longitudinal cleanout grooves 105
along the distal tip 103 of the soft tapping device 206.
[0075] As shown in FIG. 9A, an embodiment of the soft tapping
device 207 may have thread 120 of consistent shape and size, with
an invariable very fine pitch. As shown in FIG. 9B, an embodiment
of the soft tapping device 208 may have a rounded thread 120 of
consistent shape and size, with a variable pitch. As shown in FIG.
9C, the soft tapping device 100 may also have a shaft 101 that
tapers throughout the cylindrical body, before reaching the distal
end 102. This may allow for more gentle introduction into the woven
retention device 1, while providing a relatively small distal end
102.
[0076] As shown in FIGS. 10A-H, embodiments of the soft tapping
devices 100 may have an increased ratio of thread height to shaft
101 core, in order to increase engagement with bone 2. In an
embodiment, a shaft 101 core diameter may be 1.5 mm. In these
embodiments, the soft tapping devices 100 may include a tip as
shown in FIG. 5C, using a cortical thread 120 profile. In these
embodiments, the taper on the tip may be very low, to allow gradual
engagement of these sharper cortical threads. In these embodiments,
the shaft portion 101 may have thread 120 with increased pitch with
soft rounded threads, to allow for a more aggressive engagement. In
an embodiment, a cortical profile thread on the tip may have a
pitch of 1 mm and a tip thread outer diameter of either 2.45 or 2.5
mm. It is understood that these various embodiments may be selected
by a user to fit an appropriate bone hole or pilot hole.
[0077] More specifically, in FIG. 10A, in an embodiment, soft
tapping device 209 includes a thread pitch at the shaft portion 101
of 2 mm, with a maximum outer diameter of 2.6 mm. The soft tapping
device 209 may have a 38.5 mm working length, measured from the
base of the head 110 to the first thread 120. In FIG. 10B, soft
tapping device 210 includes a thread pitch at the shaft portion 101
of 2 mm, with a maximum outer diameter of 3.2 mm. The soft tapping
device 210 may have a 54.4 mm working length, measured from the
base of the head 110 to the first thread 120. In FIG. 10C, soft
tapping device 211 includes a thread pitch at the shaft portion 101
of 2 mm, with a maximum outer diameter of 3.5 mm. The soft tapping
device 211 may have a 54.4 mm working length, measured from the
base of the head 110 to the first thread 120. In FIG. 10D, soft
tapping device 212 includes a thread pitch at the shaft portion 101
of 4 mm, with a maximum outer diameter of 2.9 mm. The soft tapping
device 212 may have a 58.4 mm working length, measured from the
base of the head 110 to the first thread 120. In FIG. 10E, soft
tapping device 213 includes a thread pitch at the shaft portion 101
of 4 mm, with a maximum outer diameter of 3.2 mm. The soft tapping
device 213 may have a 58.4 mm working length, measured from the
base of the head 110 to the first thread 120. In FIG. 10F, soft
tapping device 214 includes a thread pitch at the shaft portion 101
of 4 mm, with a maximum outer diameter of 3.5 mm. The soft tapping
device 214 may have a 58.4 mm working length, measured from the
base of the head 110 to the first thread 120. In FIG. 10G, soft
tapping device 215 includes a thread pitch at the shaft portion 101
of 6 mm, with a maximum outer diameter of 2.9 mm. The soft tapping
device 215 may have a 67.4 mm working length, measured from the
base of the head 110 to the first thread 120. In FIG. 10H, soft
tapping device 216 includes a thread pitch at the shaft portion 101
of 6 mm, with a maximum outer diameter of 3.2 mm. The soft tapping
device 216 may have a 67.4 mm working length, measured from the
base of the head 110 to the first thread 120. In FIG. 10I, soft
tapping device 217 includes a thread pitch at the shaft portion 101
of 6 mm, with a maximum outer diameter of 3.5 mm. The soft tapping
device 217 may have a 67.4 mm working length, measured from the
base of the head 110 to the first thread 120.
[0078] As shown in FIGS. 11A-B, in an embodiment the thread 120 may
have a path 123 along the soft tapping device 100. As shown in FIG.
11A, at the distal tip 103, the pitch may be 1 mm, where the taper
expands from 0.56 mm to 2.4 mm. The thread 120 may have 7
revolutions around the distal tip 103, with an overall length of 7
mm. As shown in FIG. 11B, at the shaft, the pitch may be 1 mm, with
a consistent shaft diameter of 2.4 mm. The thread 120 may have 12
revolutions around the shaft 101, with an overall length of 36 mm.
In addition, or alternatively, the soft tapping device 100 can be
inserted into a bone or pilot hole 3 to compact, compress, expand
and/or dilate the bone or pilot hole 3 before insertion of the
woven retention device into the bone hole. This soft tapping device
100 can create a bone bed or mantle 5 in the bone material of the
bone or pilot hole 3, as shown in FIG. 12, so that when the woven
retention device and/or screw is introduced into the bone or pilot
hole 3, the bone 2, woven retention device 1 and screw 4 engage
reliably. Indeed, a self-tapping screw can be utilized with the
woven retention device without damage to the woven retention
device.
[0079] The soft tapping device 100 can have soft edges that create
a complementary impression in the surface of the bone tissue of the
bone hole 3. Thus, the complementary impression can provide
recesses to the soft edges of the soft tapping device 100 that
provide ridges. The soft tapping device 100 can have threads 120
that are the same or different from a screw that could create a
track for screw threads to follow or not to follow. In this manner,
an interface for screws to cut through for better fixation can be
created.
[0080] The soft tapping device 100 can be used to push out and/or
compress bone in a radial direction of the bone or pilot hole 3.
Additionally, or alternatively, the soft tapping device 100 can be
used to push out and/or dilate the woven retention device outward,
which when the woven retention device 1 is inside the bone hole 3
can similarly push out and/or compress bone out in a direction of
the bone or pilot hole 3. This pushed-out bone surface with or
without the expanded woven retention device 1 inside the bone hole
can be referred to as a layer or mantle, as shown in FIG. 12. The
term "mantle" is intended to be interpreted broadly to encompass
the bone material in the bone hole 3 that will engage and/or
interface with a fastener either directly or indirectly. In one
embodiment, the mantle, layer, or composite 5 can be created solely
by arranging and/or configuring the existing bone material inside
the bone hole 3 utilizing the soft tapping device 100. The process
of soft tapping through radially expanding and/or compressing bone
material radially outwardly can be repeated one or more times. The
bone 2 can be prepared with the bone's own material alone before
insertion of a woven retention device 1, the bone's own material
and a woven retention device 1 together, e.g., after the woven
retention device 1 is inserted in the bone hole 3, and/or with the
bone's own material and a third element, feature or substance that
can be added, e.g., added to the bone hole and/or the woven
retention device. The third item can be a substance as described
herein and can be different from the bone tissue and the woven
retention device 1.
[0081] In an embodiment, a third substance, or an additive
different from the woven retention device, can be added to the bone
or pilot hole 3 before or after the woven retention device 1 has
been inserted into the bone or pilot hole 3. The third substance or
additive can facilitate the formation of a mantle 5 of a composite
material into which a fastener can then be introduced. The third
substance can be bone material, such as autograft or allograft, or
bone substitute materials, such as bone cement. The third substance
or additive can be a slurry. The slurry can be any of a number of
slurries known in the art including calcium phosphate cement
slurries. The third substance can be in situ bone, bone material
and a woven retention device 1, or bone material, a woven retention
device 1, and a slurry. In this manner, an insert, layer or mantle
can be created from the inside of the bone or pilot hole 3. This
layer or mantle 5 can provide for improved screw fixation and/or
for use with various screw types including both self-tapping and
non-self-tapping screws.
[0082] A bone hole 3 in accordance with the principles of the
invention can be formed or created in various non-limiting ways.
For example, the bone hole can be formed in a bone either by
creating a pilot hole by such means as drilling, tapping, use of an
awl or other instruments, or in the form of a screw stripping a
pilot hole. Thus, a pilot hole as used herein can refer to a bone
hole freshly drilled or stripped by a screw or formed in a bone in
other ways. A soft tapping device 100 can compress and/or expand
the pilot hole and provide soft edges to the pilot hole based on
the exterior surface of the soft tapping device, before or after a
woven retention device has been inserted into the pilot hole. A
slurry can be added into the pilot hole either with the woven
retention device or before insertion of the woven retention device
into the pilot hole. The slurry may be a different material from
the woven retention device. A fastener, such as a bone screw, can
then be inserted to interface with the soft-tap created mantle 5
inside the pilot hole.
[0083] The above embodiments envision the woven retention device 1
being inserted into the bone hole 3 and then the soft tapping
device 100 is inserted inside the woven retention device 1 to
further dilate the hole as well as embed the woven device into the
bone, forming a bone-woven device-composite mantel. However, the
soft tapping device 100 can be inserted into the bone hole 3 before
the woven retention device 1, thus preparing and conditioning the
hole. Then the woven device is inserted. This sequence reduces
insertion force for the woven device, as well as ensuring the woven
device is uniformly radially expanded in the hole. All of the soft
tap embodiments disclosed above can be applied in this sequence. In
addition, the alternative combination of insertion the soft tapping
device, then inserting the woven retention device and then
re-inserting the soft tapping device into the woven retention
device may provide additional benefit, depending on the condition
of the bone, the bone hole size and shape, etc.
[0084] Preparing the bone hole for the woven retention device as
described above can be accomplished with other configurations of
the soft tapping device. The soft tapping device geometry can
target a specific location within the bone hole. For example, in
FIG. 14A, the soft tapping device can have features that condition
the proximal end of the distal cortex only. Shown in the FIG. 14A
is a spring-loaded surface 130 that deburrs and/or chamfers the
proximal side of the distal cortex bone surface creating a lead-in
feature. As shown in FIG. 14B, the spring-loaded deburring tool may
create a chamfered hole 6 at the surface of the bone 2, which can
create a larger area for the woven retention device 1 or a bone
fastener to enter the bone hole 3. This feature can be incorporated
with any of the above embodiments of the soft tapping device
100.
[0085] Similar to the deburring function described above, in the
scenario of inserting the soft tapping device prior to insertion of
the woven retention device, the soft tapping device can have more
aggressive cutting features or an even separate "hard tap" device
can be inserted into the bone hole to core or cut some or all of
the bone hole edges to prepare the hole for the woven retention
device, as discussed with respect to FIGS. 5A-B, above. This is
counterintuitive to the surgeon who works to not remove bone
assuming that even a small amount of bone will improve screw
retention.
[0086] As shown in FIGS. 15A-B and 16A-C, embedding the woven
retention device and/or compacting the bone hole surface can be
accomplished with other expandable configurations. For example, a
soft tapping device 301, 302 may be formed such that the relaxed
tap may be inserted into the hole, and activated by compressing the
proximal end of the soft tapping device 301, 302. Activating the
soft tapping device increases its diameter in total or in a
localized way. For example, as shown in FIGS. 15A-B, the "threads"
as described above can be protrusions 310 that are expanded
radially from the shaft of the soft tapping device, such as a
balloon-type device that forms balloon members. FIG. 15A shows a
relaxed soft tapping device 301, which is tensioned or deflated
such that the shaft surface is smooth and of a uniform diameter.
FIG. 15B shows an activated soft tapping device 301, where the soft
tapping device 301 is either compressed in a longitudinal direction
or inflated, such that the protrusions 310 expand in an outward
direction from the shaft of the soft tapping device 301. In this
case, the expanded feature is not intended to remove bone but to
push/compact bone away from the shaft radially.
[0087] Alternatively, other mechanical means can be employed to
expand these bone compacting features. For example, there can be
singular or multiple expandable features of FIG. 16A-C that are
located at various positions along the longitudinal axis, creating
radially expanded features along the length. For example, FIG. 16A
shows a relaxed soft tapping device 302, which is tensioned such
that the shaft surface is smooth and of a uniform diameter. FIG.
16B shows an activated soft tapping device 302, where the soft
tapping device 302 is compressed in a longitudinal direction, such
that the protrusions 320 expand in an outward direction from the
shaft of the soft tapping device 301 to create expanded portions.
FIG. 16C shows the activated soft tapping device 302 in more
detail, where the surface of the soft tapping device 301 includes
slots 321, that form tensioned protrusion slats 322 that can expand
in an outward direction from the shaft of soft tapping device 302
to create expanded portions. In this case, the expanded feature is
not intended to remove bone but to push/compact bone away from the
shaft radially. Other mechanical means besides the two-end
constrained leaf spring-like mechanism as shown in FIGS. 15A-B and
16A-C can be used to expand a portion or multiple of portions of
the device.
[0088] The various embodiments and inventions contemplated here are
preferably utilized in with a woven device, for example, a woven
retention device. An exemplary woven retention device contemplated
for use in accordance with the principles of the invention are
described and shown in, for example, U.S. Pat. No. 8,956,394, filed
Aug. 5, 2014 and U.S. Pat. No. 8,992,537, filed Sep. 16, 2014, the
contents of which are hereby incorporated by reference herein in
their entireties.
[0089] The embodiments illustrated and discussed in this
specification are intended only to teach those skilled in the art
how to make and use the invention. In describing embodiments of the
invention, specific terminology is employed for the sake of
clarity. However, the invention is not intended to be limited to
the specific terminology so selected. The above-described
embodiments of the invention may be modified or varied, without
departing from the invention, as appreciated by those skilled in
the art in light of the above teachings. It is therefore to be
understood that, within the scope of the claims and their
equivalents, the invention may be practiced otherwise than as
specifically described.
* * * * *