U.S. patent application number 10/843813 was filed with the patent office on 2004-12-30 for bone cement mixing and delivery system.
Invention is credited to Brockman, Christopher S., Coffeen, Jared P., Henniges, Bruce D., Proulx, Marshall K., Tague, Christopher M..
Application Number | 20040267272 10/843813 |
Document ID | / |
Family ID | 34623153 |
Filed Date | 2004-12-30 |
United States Patent
Application |
20040267272 |
Kind Code |
A1 |
Henniges, Bruce D. ; et
al. |
December 30, 2004 |
Bone cement mixing and delivery system
Abstract
A bone cement mixing and delivery system is provided. The system
includes a mixing cartridge for receiving liquid and powder
components of bone cement, a mixing device for mixing the
components, and a delivery gun for discharging the bone cement from
the mixing cartridge. The mixing cartridge comprises a cylinder
having proximal and distal ends with a cylinder wall extending
between the ends. A piston is locked at the distal end by a locking
member that includes a pair of locking tabs protruding into slots
in the cylinder wall. With the piston in the locked position, the
mixing device, e.g., a mixing shaft and blade, mixes the
components. After mixing, the cartridge is placed in the delivery
gun and release buttons on the locking member are engaged by a
release mechanism on the delivery gun to release the piston from
the locked position.
Inventors: |
Henniges, Bruce D.;
(Galesburg, MI) ; Tague, Christopher M.; (Delton,
MI) ; Coffeen, Jared P.; (Paw Paw, MI) ;
Brockman, Christopher S.; (Kalamazoo, MI) ; Proulx,
Marshall K.; (Kalamazoo, MI) |
Correspondence
Address: |
HOWARD & HOWARD ATTORNEYS, P.C.
THE PINEHURST OFFICE CENTER, SUITE #101
39400 WOODWARD AVENUE
BLOOMFIELD HILLS
MI
48304-5151
US
|
Family ID: |
34623153 |
Appl. No.: |
10/843813 |
Filed: |
May 12, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60469651 |
May 12, 2003 |
|
|
|
60520877 |
Nov 18, 2003 |
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Current U.S.
Class: |
606/93 |
Current CPC
Class: |
B01F 15/00506 20130101;
B01F 15/00487 20130101; A61B 2017/8838 20130101; A61B 17/8827
20130101; B01F 15/0279 20130101; B01F 2015/00584 20130101; B01F
15/027 20130101; B01F 15/00941 20130101; B01F 2215/0029 20130101;
A61F 2220/0025 20130101; B01F 13/002 20130101; A61B 17/8822
20130101; A61F 2002/30426 20130101; A61F 2002/4685 20130101; A61F
2002/469 20130101; B01F 11/0054 20130101 |
Class at
Publication: |
606/093 |
International
Class: |
A61F 002/00 |
Claims
What is claimed is:
1. A mixing cartridge for receiving liquid and powder components of
bone cement to be mixed for medical use, said mixing cartridge
comprising: a cylinder having proximal and distal ends and defining
a mixing chamber therebetween for receiving the liquid and powder
components of the bone cement, said cylinder including a cylinder
wall extending between said ends about a longitudinal axis thereof
and said cylinder wall defining at least one female portion at said
distal end; a piston disposed in said cylinder at said distal end;
a locking member coupled to said piston and including at least one
male portion for mating with said at least one female portion in
said cylinder wall to place said piston in a locked position in
said distal end of said cylinder; and said locking member including
a resilient portion for biasing said at least one male portion into
mating engagement with said at least one female portion in said
cylinder wall whereby said piston remains in said locked position
while mixing the liquid and powder components of the bone
cement.
2. A mixing cartridge as set forth in claim 1 wherein said female
portion is further defined as at least one slot and said male
portion is further defined as at least one locking tab protruding
radially outwardly from said longitudinal axis into said at least
one slot in said locked position.
3. A mixing cartridge as set forth in claim 2 wherein said piston
includes a proximal end and a distal end with a cavity defined in
said distal end and said locking member is disposed in said
cavity.
4. A mixing cartridge as set forth in claim 2 wherein said at least
one slot is further defined as a pair of diametrically opposed
slots and said at least one locking tab is further defined as a
pair of diametrically opposed locking tabs protruding radially
outwardly into said slots in said cylinder wall under the bias of
said resilient portion.
5. A mixing cartridge as set forth in claim 4 wherein said
resilient portion extends between said locking tabs to bias said
locking tabs radially outwardly from said longitudinal axis of said
cylinder.
6. A mixing cartridge as set forth in claim 5 wherein said
resilient portion is integral with said locking tabs and extends in
a thin resilient ribbon between said locking tabs.
7. A mixing cartridge as set forth in claim 6 wherein said piston
defines a pair of carrier slots for receiving and axially securing
said locking tabs when said piston is in said locked position and
after said piston is released from said locked position.
8. A mixing cartridge as set forth in claim 7 wherein said piston
includes a step extending partially into each of said carrier slots
and each of said locking tabs defines a channel partially extending
therein for receiving said step when said piston is in said locked
position and after said piston is released from said locked
position.
9. A mixing cartridge as set forth in claim 4 wherein said locking
member includes a pair of release buttons for releasing said piston
from said locked position.
10. A mixing cartridge as set forth claim 9 wherein said release
buttons are integrally formed with said locking tabs and said
release buttons extend distally from said locking tabs to protrude
distally from said piston.
11. A mixing cartridge as set forth in claim 10 wherein each of
said release buttons include a cam surface extending at an acute
angle to said longitudinal axis of said cylinder with said cam
surfaces being engageable to cam said release buttons radially
inwardly toward said longitudinal axis to withdraw said locking
tabs from said slots in said cylinder wall and release said piston
from said locked position.
12. A mixing cartridge as set forth in claim 2 wherein said at
least one slot is further defined as a plurality of slots and said
at least one locking tab is further defined as a plurality of
locking tabs protruding into said slots in said locked
position.
13. A mixing cartridge as set forth in claim 12 wherein said
resilient portion is further defined as a resilient base
resiliently supporting each of said plurality of locking tabs on
said piston with each of said locking tabs being radially biased
outwardly from said piston to engage said slots in said cylinder
wall.
14. A mixing cartridge as set forth in claim 13 wherein said
locking member includes a plurality of release buttons for
releasing said piston from said locked position.
15. A mixing cartridge as set forth in claim 14 wherein said
release buttons are integrally formed with said tabs.
16. A mixing cartridge as set forth in claim 15 wherein said
release buttons are further defined as fingers extending radially
inwardly toward said longitudinal axis of said cylinder with said
fingers being engageable to urge said locking tabs radially
inwardly and withdraw said locking tabs from said slots in said
cylinder wall to release said piston from said locked position.
17. A mixing cartridge as set forth in claim 1 including a cap
sealed to said cylinder at said proximal end.
18. A mixing cartridge for use with a delivery device having a
release mechanism to discharge bone cement from the mixing
cartridge, said mixing cartridge comprising: a cylinder having
proximal and distal ends and defining a mixing chamber therebetween
for receiving liquid and powder components of the bone cement, said
cylinder including a cylinder wall extending between said ends
about a longitudinal axis thereof and said cylinder wall including
one of a male portion or a female portion at said distal end; a
piston disposed in said cylinder at said distal end; a locking
member coupled to said piston and including the other of said male
portion or said female portion for engaging said male portion or
said female portion of said cylinder wall to place said piston in a
locked position in said distal end of said cylinder; and said
locking member including at least one release button for being
engaged by the release mechanism of the delivery device to
disengage said male and female portions and release said piston
from said locked position.
19. A mixing cartridge as set forth in claim 18 wherein said
cylinder wall includes said female portion and said female portion
is further defined as at least one slot and said locking member
includes said male portion with said male portion being further
defined as at least one locking tab protruding radially outwardly
from said longitudinal axis into said at least one slot in said
locked position.
20. A mixing cartridge as set forth in claim 19 wherein said at
least one slot is farther defined as a pair of diametrically
opposed slots and said at least one locking tab is further defined
as a pair of diametrically opposed locking tabs protruding radially
outwardly into said slots in said cylinder wall under the bias of
said resilient portion.
21. A mixing cartridge as set forth in claim 20 wherein said
locking member includes a resilient portion extending between said
locking tabs to bias said locking tabs radially outwardly from said
longitudinal axis.
22. A mixing cartridge as set forth in claim 20 wherein said at
least one release button is further defined as a pair of release
buttons for being engaged by the release mechanism of the delivery
device to release said piston from said locked position.
23. A mixing cartridge as set forth claim 22 wherein said release
buttons are integrally formed with said locking tabs and said
release buttons extend distally from said locking tabs to protrude
distally from said piston.
24. A mixing cartridge as set forth in claim 23 wherein each of
said release buttons include a cam surface extending at an acute
angle to said longitudinal axis of said cylinder with said cam
surfaces being engageable to cam said release buttons radially
inwardly toward said longitudinal axis to withdraw said locking
tabs from said slots in said cylinder wall and release said piston
from said locked position.
25. A delivery gun for receiving a cartridge containing bone cement
to deliver the bone cement to an anatomical site by discharging the
bone cement from the cartridge, said delivery gun comprising: a
casing; a drive mechanism supported by said casing and advanceable
relative to said casing to discharge the bone cement from the
cartridge; a trigger pivotally supported by said casing and
operatively connected to said drive mechanism to actuate said drive
mechanism upon actuation of said trigger; and a linkage system
operatively interconnecting said trigger with said drive mechanism
to actuate said drive mechanism, said linkage system comprising a
first link pivotally connected to said casing and a second link
pivotally interconnecting said first link and said trigger such
that actuating said trigger moves said second link and said first
link to actuate said drive mechanism and advance said drive
mechanism to discharge the bone cement from the cartridge.
26. A delivery gun as set forth in claim 25 wherein said drive
mechanism includes a drive rod supported by said casing.
27. A delivery gun as set forth in claim 26 wherein said drive
mechanism further includes a first gripper plate responsive to
movement of said linkage system upon actuation of said trigger
wherein said first gripper plate defines an aperture surrounding
said drive rod and said first gripper plate frictionally engages
said drive rod to advance said drive rod when said trigger is
actuated.
28. A delivery gun as set forth in claim 27 including a
speed-changing link pivotally supported by one of said drive
mechanism or said linkage system for pivoting between a high-speed
position and a low-speed position.
29. A delivery gun as set forth in claim 28 wherein said first
gripper plate includes a first coupling device and said
speed-changing link defines a second coupling device for coupling
with said first coupling device in said high-speed position with
said speed-changing link being isolated from said first gripper
plate in said low-speed position.
30. A delivery gun as set forth in claim 29 wherein said first
coupling device is a shoulder and said second coupling device is a
channel for engaging said shoulder in said high-speed position.
31. A delivery gun as set forth in claim 27 including a second
gripper plate aligned with said first gripper plate to increase
frictional contact with said drive rod to advance said drive
rod.
32. A delivery gun as set forth in claim 31 wherein said second
gripper plate includes a peg engaging a notch in said first gripper
plate to align said second gripper plate with said first gripper
plate.
33. A delivery gun as set forth in claim 32 including a spring
positioned over said drive rod between said casing and said gripper
plates to bias said gripper plates into frictional engagement with
said drive rod.
34. A delivery gun as set forth in claim 26 wherein said drive rod
includes a plurality of teeth along a length thereof.
35. A delivery gun as set forth in claim 34 wherein said drive
mechanism includes at least one pawl member for engaging said teeth
to advance said drive rod.
36. A delivery gun as set forth in claim 34 wherein said drive
mechanism includes a pair of pawl members for engaging said teeth
to advance said drive rod.
37. A delivery gun as set forth in claim 36 wherein said pawl
members are further defined as a first pawl member and a second
pawl member with said first pawl member being pivotally supported
by said linkage system and said second pawl member being pivotally
supported by said linkage system for moving between a high-speed
position in which the second pawl member engages said teeth and a
low-speed position in which said second pawl member is isolated
from said teeth.
38. A delivery gun as set forth in claim 37 including biasing
devices for biasing each of said pawl members into engagement with
said teeth on said drive rod.
39. A delivery gun as set forth in claim 38 including a switch
engaging said second pawl member to move said second pawl member
between said high speed and said low speed positions.
40. A delivery gun as set forth in claim 39 wherein said trigger is
pivotally supported by said casing about a pivot axis and said
pivot axis is positioned above said drive rod while said trigger
extends downwardly below said drive rod with said trigger defining
a channel therethrough for receiving said drive rod.
41. A delivery gun as set forth in claim 40 wherein said first and
second links are positioned above said drive rod.
42. A delivery gun as set forth in claim 26 wherein said drive
mechanism includes a ram disk fixed to said drive rod to discharge
the bone cement from the cartridge and said ram disk includes a
release mechanism for releasing a piston of the cartridge from a
locked position.
43. A delivery gun as set forth in claim 42 wherein said release
mechanism includes a bearing surface for engaging release buttons
on the piston to cam the release buttons radially inwardly and
release the piston from the locked position.
44. A delivery gun for receiving a cartridge containing bone cement
to deliver the bone cement to an anatomical site by discharging the
bone cement from the cartridge, said delivery gun comprising: a
casing; a drive rod supported by said casing and advanceable
relative to said casing to discharge the bone cement from the
cartridge; a trigger pivotally supported by said casing; and a
first gripper plate responsive to actuation of said trigger wherein
said first gripper plate surrounds said drive rod and frictionally
engages said drive rod to advance said drive rod when said trigger
is actuated.
45. A delivery gun as set forth in claim 44 including at least one
second gripper plate aligned with said first gripper plate about
said drive rod to increase frictional contact with said drive rod
when advancing said drive rod upon actuation of said trigger.
46. A delivery gun as set forth in claim 45 wherein said at least
one second gripper plate includes a peg and said first gripper
plate defines a notch for receiving said peg to align said at least
one second gripper plate with said first gripper plate.
47. A delivery gun as set forth in claim 44 including a linkage
system operatively interconnecting said trigger with said first
gripper plate, said linkage system comprising a first link
pivotally connected to said casing and a second link
interconnecting said first link and said trigger whereby actuating
said trigger moves said second link and said first link to engage
said first link with said first gripper plate and advance said
drive rod to discharge the bone cement from the cartridge.
48. A delivery gun as set forth in claim 47 wherein said second
link includes a striker extending downwardly therefrom for engaging
said first gripper plate to dislodge said first gripper plate from
said drive rod when said first gripper plate does not return to an
initial position upon release of said trigger.
49. A delivery gun as set forth in claim 44 including a spring
positioned over said drive rod between said casing and first
gripper plate to bias said first gripper plate into frictional
engagement with said drive rod.
50. A delivery gun as set forth in claim 45 including a coating
applied to each of said gripper plates to increase lubricity and
corrosion resistance.
51. A delivery gun as set forth in claim 50 wherein said coating is
electroless-nickel with polytetrafluoroethylene.
52. A bone cement mixing and delivery system for combining liquid
and powder components of bone cement and delivering the bone cement
to an anatomical site of a patient, said system comprising: a
cartridge comprising; a cylinder having proximal and distal ends
and defining a mixing chamber therebetween with said cylinder
including a cylinder wall extending between said ends about a
longitudinal axis thereof, a piston releasably secured in said
cylinder at said distal end, and a locking member for releasably
securing said piston in a locked position at said distal end with
said locking member including at least one release button for
releasing said piston from said locked position, in combination
with a delivery device adapted to hold said cartridge comprising; a
casing, and a drive mechanism supported by said casing and
advanceable relative to said casing to discharge the bone cement
from said cartridge wherein said drive mechanism includes a release
mechanism for engaging said at least one release button to release
said piston from said locked position.
53. A bone cement mixing and delivery system as set forth in claim
52 wherein said cylinder wall defines a plurality of slots at said
distal end and said locking member includes a plurality of locking
tabs radially protruding outwardly into said slots in said locked
position.
54. A bone cement mixing and delivery system as set forth in claim
53 wherein said at least one release button is further defined as a
plurality of release buttons for releasing said piston from said
locked position.
55. A bone cement mixing and delivery system as set forth in claim
54 wherein each of said release buttons include a cam surface
extending at an acute angle to said longitudinal axis of said
cylinder with said cam surfaces being engagable by said release
mechanism to cam said buttons radially inwardly to withdraw said
locking tabs from said slots in said cylinder wall and release said
piston from said locked position.
56. A bone cement mixing and delivery system as set forth in claim
55 wherein said release mechanism includes a bearing surface for
engaging said cam surfaces of said release buttons to cam said
release buttons radially inwardly and release said piston from said
locked position.
57. A bone cement mixing and delivery system as set forth in claim
54 wherein said plurality of release buttons are further defined as
fingers extending radially inwardly toward said longitudinal axis
of said cylinder with said fingers being engagable by said release
mechanism to urge said locking tabs radially inwardly and withdraw
said locking tabs from said slots in said cylinder wall to release
said piston from said locked position.
58. A bone cement loading system for receiving liquid and powder
components of bone cement to be mixed for medical use, comprising:
a cylinder having an open proximal end and a closed distal end and
defining a mixing chamber between said ends; a piston locked in
said cylinder to define said closed distal end; a base defining a
cavity for receiving and securing said closed distal end of said
cylinder to support said cylinder while loading the liquid and
powder components therein; a funnel for coupling to said open
proximal end of said cylinder to channel the powder component of
the bone cement into said mixing chamber, said funnel having a
proximal end and a distal end wherein said distal end has a
circular periphery for snugly fitting into said open proximal end
of said cylinder and said proximal end has an oblong oval-shaped
periphery to facilitate the transfer of the powder component of the
bone cement into said mixing chamber.
59. A bone cement loading system as set forth in claim 58 wherein
said base is oblong in shape and said cavity is circular in
shape.
60. A bone cement loading system as set forth in claim 59 wherein
one of said base and said cylinder includes a plurality of detents
and the other of said base and said cylinder defines a groove in a
surface thereof for releasably receiving said detents to facilitate
a snug fit between said base and said cylinder.
61. A bone cement mixing system for mixing liquid and powder
components of bone cement for medical use, comprising: a cartridge
including a cylinder having proximal and distal ends and defining a
mixing chamber between said ends; a mixing shaft rotatably
supported by said cartridge for rotation about an axis and
including a portion extending outside of said mixing chamber; and a
blade operatively connected to said portion and disposed in said
mixing chamber for rotating with said mixing shaft about said axis
to mix the liquid and powder components of the bone cement, said
blade including a center hub coupled to said mixing shaft and an
outer ring extending from said center hub wherein said outer ring
forms an acute angle with said axis and said acute angle is between
twenty and seventy degrees to ensure adequate mixing of the bone
cement.
62. A bone cement mixing system as set forth in claim 61 wherein
said blade is adapted to remain in said mixing chamber after mixing
is complete and said portion of said mixing shaft extending outside
of said mixing chamber is adapted to be removed from said operative
connection with said blade after mixing.
63. A bone cement mixing system as set forth in claim 61 wherein
said blade has an effective height that is greater than one quarter
inch to further ensure adequate mixing of the bone cement.
64. A bone cement mixing system as set forth in claim 63 wherein
said blade is flexible and adapted to flatten in said mixing
chamber such that said effective height of said blade is reduced
and said acute angle is increased to approximately ninety degrees
to minimize axial space occupied by said blade in said mixing
chamber.
65. A bone cement mixing system as set forth in claim 61 wherein
said blade has an effective height that is approximately one half
inch and said acute angle is approximately sixty degrees to ensure
adequate mixing of the bone cement.
66. A bone cement mixing system as set forth in claim 61 including
a plurality of radially inwardly protruding fingers attached to
said outer ring wherein one of said plurality of fingers protrudes
radially inwardly in a first plane and another of said plurality of
fingers protrudes radially inwardly in a second plane spaced from
and parallel to said first plane.
67. A bone cement mixing system as set forth in claim 61 including
a protruding node attached to said outer ring and protruding
radially outwardly to control spacing between said blade and an
inner periphery of said cylinder by scraping along said inner
periphery of said cylinder.
68. A method of mixing liquid and powder components of bone cement
in a mixing chamber of a mixing cartridge using a rotary power tool
with a portion of a mixing shaft extending outside of the mixing
chamber to connect to the rotary power tool and a blade being
operatively connected to the portion and disposed within the mixing
chamber to mix the liquid and powder components of the bone cement,
said method comprising the steps of: connecting the rotary power
tool to the portion of the mixing shaft extending outside of the
mixing chamber; actuating the rotary power tool once connected to
the portion of the mixing shaft to rotate the blade and mix the
liquid and powder components of the bone cement; displacing the
rotary power tool during actuation relative to the mixing cartridge
to completely mix the liquid and powder components of the bone
cement; and removing the operative connection between the blade and
the portion of the mixing shaft extending outside of the mixing
chamber once mixing is complete.
69. A method as set forth in claim 68 wherein removing the
operative connection between the blade and the portion of the
mixing shaft extending outside of the mixing chamber is further
defined as releasing the blade from the mixing shaft.
70. A method as set forth in claim 69 wherein axially displacing
the rotary power tool during actuation includes moving the rotary
power tool both proximally and distally during actuation to
completely mix the liquid and powder components of the bone
cement.
71. A method as set forth in claim 68 wherein removing the
operative connection between the blade and the portion of the
mixing shaft extending outside of the mixing chamber is further
defined as severing the portion of the mixing shaft extending
outside of the mixing chamber.
72. A method as set forth in claim 68 wherein displacing the rotary
power tool during actuation relative to the mixing cartridge is
further defined as axially displacing the rotary power tool during
actuation relative to the mixing cartridge.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. provisional
patent application Ser. No. 60/469,651, filed May 12, 2003 and U.S.
provisional patent application Ser. No. 60/520,877, filed Nov. 18,
2003, the advantages and disclosures of which are herein
incorporated by reference.
FIELD OF THE INVENTION
[0002] The present invention generally relates to a bone cement
mixing and delivery system. More specifically, the present
invention relates to a mixing cartridge for receiving liquid and
powder components of bone cement to be mixed, a mixing device for
mixing the components, and a delivery gun for discharging the bone
cement from the mixing cartridge into an anatomical site of a
patient.
BACKGROUND OF THE INVENTION
[0003] Bone cement mixing and delivery systems are well known for
mixing liquid and powder components of bone cement and delivering
the prepared bone cement to an anatomical site during various
surgical procedures. Bone cement is particularly useful in
orthopedic procedures in which a prosthetic device is fixed to a
bone or joint structure to improve the strength, rigidity, and
movement of the structure. In a total hip arthroplasty (THA)
procedure, in which a hip joint is replaced with a prosthetic
device, bone cement is used to fix the prosthetic device in place
in a medullary canal of a femur.
[0004] Typically, the bone cement is prepared in a mixing
cartridge. The mixing cartridge includes a cylinder having proximal
and distal ends with a mixing chamber defined between the ends. The
mixing cartridge further includes a cap covering the proximal end
of the cylinder and a piston disposed in the distal end of the
cylinder such that the mixing chamber is further defined between
the cap and the piston. The piston may be releasably secured in a
locked position in the cylinder by a cotter pin. The cap supports a
mixing device, i.e., a mixing shaft and blade, for mixing the
liquid and powder components of the bone cement in the mixing
chamber.
[0005] Once the bone cement is mixed, the mixing cartridge is
prepared for inserting into a delivery gun to discharge the bone
cement. This may include disengaging the mixing shaft and coupling
a nozzle to the cap to provide a discharge point for the bone
cement. At the same time, the piston is released from the locked
position in the distal end of the cylinder by pulling the cotter
pin. This allows the piston to be driven by the delivery gun
through the mixing chamber to discharge the bone cement from the
nozzle. An alternative solution for securing and releasing the
piston is shown in U.S. Pat. No. 5,328,262 to Lidgren et al.
[0006] In Lidgren et al., the piston is releasably secured in the
locked position in the distal end of the cylinder by a gripping
portion in the form of a flange, which extends along only a portion
of an inner periphery of the cylinder. The piston in Lidgren et al.
has a corresponding gripping portion in the form of an outwardly
directed lip that protrudes behind the flange. The lip defines a
groove with an outer surface of the piston to receive the flange.
To release the piston from the locked position, the flange is
rotated through the groove until the flange has been rotated past
the lip. Lidgren et al. discloses a base that is used to secure the
piston from rotation while a user rotates the cylinder relative to
the piston to release the piston from the locked position. This
method of releasing the piston from the locked position, much like
pulling the cotter pin, requires additional manipulation by a
user.
[0007] Once the piston is released from the locked position, the
mixing cartridge is inserted into the delivery gun. A typical
delivery gun includes a ram disk that engages the piston and drives
the piston through the mixing chamber to discharge the bone cement
from the nozzle. The delivery gun includes a cradle for supporting
the mixing cartridge and a casing for supporting a drive rod that
engages the ram disk and advances the ram disk to drive the piston.
The drive rod includes a plurality of teeth and a pawl member
engages the teeth to advance the drive rod. A trigger supports the
pawl member and the casing rotatably supports the trigger.
Actuation of the trigger relative to the casing urges the pawl
member against the teeth to advance the drive rod.
[0008] An example of such a delivery gun is illustrated in U.S.
Pat. No. 5,431,654 to Nic. In the '654 patent to Nic, two pawl
members are used to independently advance the drive rod and the ram
disk. The pawl members provide high speed/low force and low
speed/high force advancement of the drive rod. A switch is used to
select between the speeds. When high speed is selected, both pawl
members engage the drive rod, while only the high-speed pawl member
actually advances the drive rod. When low speed is selected, the
high-speed pawl member is isolated from the teeth such that only
the low speed pawl member engages the teeth to advance the drive
rod. However, in Nic, the trigger directly supports each of the
pawl members which results in a low mechanical advantage to advance
the drive rod and ram disk.
BRIEF SUMMARY OF THE INVENTION
[0009] A mixing cartridge for receiving liquid and powder
components of bone cement to be mixed for medical use. The mixing
cartridge comprises a cylinder having proximal and distal ends with
a mixing chamber defined therebetween. The cylinder includes a
cylinder wall extending between the ends about a longitudinal axis
of the cylinder. A piston is disposed in the cylinder at the distal
end such that the mixing chamber is further defined between the
proximal end and the piston. A locking member is coupled to the
piston to lock the piston in the distal end. The locking member
includes a male portion engaging a female portion in the cylinder
wall to place the piston in a locked position at the distal end of
the cylinder. The locking member includes a resilient portion for
biasing the male portion into mating engagement with the female
portion. The piston remains in the locked position at the distal
end of the cylinder while mixing the liquid and powder
components.
[0010] One advantage of the mixing cartridge is the conveniently
positioned locking member used to lock the piston in the distal
end. By using the resilient portion to bias the male portion into
mating engagement with the female portion, a user can easily
release the piston from the locked position by either manually or
mechanically acting against the bias of the resilient portion to
disengage the male and female portions.
[0011] A delivery gun is also provided for discharging the bone
cement from the cartridge once the bone cement is prepared. The
delivery gun comprises a casing for supporting the cartridge. A
drive mechanism is supported by the casing and advanceable relative
to the casing to force the bone cement from the cartridge. The
casing pivotally supports a trigger operatively connected to the
drive mechanism to advance the drive mechanism upon actuation of
the trigger to force the bone cement from the cartridge. A linkage
system works in conjunction with the trigger to advance the drive
mechanism. The linkage system comprises a first link pivotally
connected to the casing and a second link interconnecting the first
link and the trigger such that actuating the trigger moves the
second link and the first link to advance the drive mechanism.
[0012] An advantage of the delivery gun is the use of the linkage
system to increase the mechanical advantage needed to successfully
advance the drive mechanism and force the bone cement from the
cartridge while minimizing fatigue to a user of the delivery
gun.
[0013] In one aspect of the delivery gun, the drive mechanism
includes a drive rod and gripper plates to advance the drive rod.
The gripper plates frictionally engage the drive rod to advance the
drive rod when the trigger is actuated. In one embodiment, the
gripper plates include mating pegs and notches to align adjacent
gripper plates. In another embodiment, the gripper plates are
coated to increase lubricity and corrosion resistance thereof.
[0014] In another aspect of the delivery gun, the drive mechanism
includes a drive rod and first and second pawl members to advance
the drive rod. In one embodiment, the second pawl member is movable
into engagement with teeth on the drive rod for high-speed
advancement of the drive rod and out from engagement with the teeth
for low-speed advancement. During low-speed advancement, only the
first pawl member engages the teeth to advance the drive rod.
During high-speed advancement, both pawl members engage the teeth,
but only the second pawl member works to advance the drive rod.
[0015] A bone cement mixing and delivery system is also provided.
The mixing and delivery system includes the cartridge and the
delivery gun. In this aspect of the invention, the locking member
includes a release button to release the piston from the locked
position. At the same time, the delivery gun includes a release
mechanism integrated into the drive mechanism to engage the release
button. When the cartridge is placed into the cradle of the
delivery gun, the drive mechanism is advanced and the release
mechanism engages the release button to release the piston from the
locked position. This configuration reduces the number of steps
typically associated with releasing the piston. By incorporating
the release mechanism into the drive mechanism, when the drive
mechanism is advanced, the piston is automatically released.
[0016] A bone cement loading system for receiving the liquid and
powder components of the bone cement is also provided. The loading
system includes the cylinder with the piston locked in the distal
end. A base defining a cavity is provided for receiving and
securing the distal end of the cylinder. A funnel is provided for
coupling to the proximal end of the cylinder to channel the powder
component of the bone cement into the mixing chamber. The funnel
has a proximal end with an oblong oval-shaped periphery to
facilitate loading of the powder component of the bone cement into
the mixing chamber and a distal end with a circular periphery for
snugly fitting into the proximal end of the cylinder. One
particular advantage to this loading system is the use of the
oblong oval-shaped funnel. The shape of the funnel reduces any mess
typically associated with filling the mixing chamber with
powder.
[0017] A bone cement mixing system comprising the mixing cartridge
and a mixing shaft and blade is also provided. The blade is coupled
to the mixing shaft and disposed in the mixing chamber for rotating
with the mixing shaft about the longitudinal axis to mix the liquid
and powder components of the bone cement. The blade includes a
center hub coupled to the mixing shaft and an outer ring extending
from the center hub. The outer ring forms an acute angle with the
longitudinal axis of between twenty and seventy degrees to ensure
adequate mixing of the bone cement in the mixing chamber.
[0018] A method of mixing the liquid and powder components of the
bone cement in the mixing chamber is also provided. The method
includes using a rotary power tool connected to a portion of the
mixing shaft extending outside of the mixing chamber to mix the
liquid and powder components of the bone cement. The blade is
disposed in the mixing chamber while being operatively connected to
the portion of the mixing shaft extending outside of the mixing
chamber. In the method, the rotary power tool is first connected to
the portion of the mixing shaft extending outside of the mixing
chamber. Then the rotary power tool is actuated to rotate the blade
and mix the liquid and powder components of the bone cement. At the
same time, the rotary power tool is axially displaced relative to
the mixing cartridge to completely mix the liquid and powder
components of the bone cement. Once mixing is complete, the
operative connection between the blade and the portion of the
mixing shaft extending outside of the mixing chamber is
removed.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0019] Advantages of the present invention will be readily
appreciated as the same becomes better understood by reference to
the following detailed description when considered in connection
with the accompanying drawings wherein:
[0020] FIG. 1 is an exploded perspective view of a mixing cartridge
of the present invention in combination with a mixing shaft and
blade;
[0021] FIG. 2 is an assembled perspective view of the mixing
cartridge with the mixing shaft and blade supported therein;
[0022] FIG. 3 is an exploded perspective view of a cap of the
mixing cartridge;
[0023] FIG. 4 is a cross-sectional view of the cap of FIG. 3 and a
partial cross-sectional view of a cylinder of the mixing cartridge
to illustrate fitting of the cap to the cylinder;
[0024] FIG. 5 is an exploded perspective view of the cap and the
mixing shaft and blade;
[0025] FIG. 6 is an assembled perspective view of the cap with the
mixing shaft and blade supported therein;
[0026] FIG. 7 is a perspective view of the blade;
[0027] FIG. 7A is a side elevational view of the blade of FIG.
7;
[0028] FIGS. 8-8A and 9 are perspective views of alternative
blades;
[0029] FIG. 10 is a an exploded perspective view of the mixing
shaft and a latch rod;
[0030] FIG. 11 is an elevational end view of the mixing shaft and
latch rod of FIG. 10;
[0031] FIG. 12 is a cross-sectional view of the mixing shaft and
latch rod of FIGS. 10 and 11;
[0032] FIG. 13 is an exploded perspective view of a release latch
coupling the mixing shaft and latch rod;
[0033] FIGS. 14A-14C illustrate the release of the blade from the
mixing shaft;
[0034] FIG. 15 is an exploded perspective view of a piston of the
mixing cartridge;
[0035] FIG. 16 is a cross-sectional view of the piston of FIG.
15;
[0036] FIG. 17 is a perspective view of an alternative piston of
the mixing cartridge;
[0037] FIG. 18 is a top view of the alternative piston of FIG.
17;
[0038] FIG. 19 is an exploded perspective view of the cap and a
nozzle;
[0039] FIG. 20 is an assembled perspective view of the cap and
nozzle;
[0040] FIG. 21 is a blown-up view of a locking mechanism of the cap
and nozzle;
[0041] FIGS. 22-23 are perspective views of the nozzle;
[0042] FIG. 24 is a perspective view of a delivery gun of the
present invention illustrating a linkage system of the delivery
gun;
[0043] FIGS. 24A-24B illustrate alternative linkage systems of the
present invention;
[0044] FIG. 25 is an elevational view illustrating release of a
locking member securing the piston;
[0045] FIG. 26 is a partial perspective view of an alternative
linkage system and drive mechanism of the delivery gun;
[0046] FIG. 27 is a partial perspective view of the alternative
linkage system and drive mechanism of FIG. 26 employing a striker
to prevent freeze-up of the drive mechanism;
[0047] FIGS. 28 is an elevational view of a second alternative
embodiment of the linkage system and drive mechanism of the
delivery gun in a low-speed position;
[0048] FIG. 29 is a perspective view of the second alternative
embodiment of the linkage system and drive mechanism in the
low-speed position;
[0049] FIG. 30 is an elevational view of the second alternative
embodiment of the linkage system and drive mechanism in a
high-speed position;
[0050] FIG. 31 is a perspective view of the second alternative
embodiment of the linkage system and drive mechanism in the
high-speed position;
[0051] FIG. 32 is an exploded view of a cylinder of the mixing
cartridge and a base and funnel used to fill the cylinder with
components of bone cement; and
[0052] FIGS. 33-42 illustrate various steps associated with the
present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0053] Referring to the Figures, wherein like numerals indicate
like or corresponding parts throughout the several views, a bone
cement mixing and delivery system is generally shown. The bone
cement mixing and delivery system comprises a mixing cartridge 100
for receiving liquid monomer and powdered copolymer components of
bone cement to be mixed, a mixing device (mixing shaft 150 and
blade 152) for mixing the components, and a delivery device, e.g.,
a delivery gun 500, for discharging the bone cement from the mixing
cartridge 100 into an anatomical site (not shown). An exemplary use
for the bone cement is to secure a prosthetic device used to
replace a joint structure such as in a total hip arthroplasty (THA)
procedure.
[0054] Referring to FIGS. 1 and 2, the bone cement mixing system
comprises the mixing cartridge 100 in combination with the mixing
shaft 150 and blade 152 used to mix the components of the bone
cement in the mixing cartridge 100. The mixing cartridge 100
includes a cylinder 102 having proximal 104 and distal 106 ends. A
mixing chamber 108 is defined between the ends 104, 106. The
cylinder 102 includes a cylinder wall 110 extending between the
ends 104, 106, about a longitudinal axis L. A cap 112 is coupled to
the cylinder 102 at the proximal end 104 and a piston 114 is
disposed in the cylinder 102 at the distal end 106 such that the
mixing chamber 108 is further defined between the cap 112 and the
piston 114. The components of the bone cement are placed in the
mixing chamber 108 and mixed by the mixing shaft 150 and blade 152,
as will be described further below.
[0055] In the preferred embodiment, the cylinder 102 has locking
strips 116 disposed on the cylinder wall 110 at the proximal end
104 to insert into locking slots 118 on the cap 112. Each of the
locking strips 116 include a straight portion lying perpendicular
relative to the longitudinal axis L and an angled portion lying at
an angle relative to the straight portion. As should be
appreciated, the locking strips 116 and locking slots 118 could be
reversed, i.e., the locking strips 116 positioned on the cap 112
and the locking slots 118 defined in the cylinder wall 110. The
locking strips 116 and locking slots 118 are configured to provide
quick locking of the cap 112 onto the cylinder 102 with a
one-quarter turn of the cap 112. Those of ordinary skill in the art
will appreciate that numerous methods are available for connecting
the cap 112 to the cylinder 102, such as mating threads, snap-fit
connections, etc. A groove 120 is formed in the cylinder 102 at the
proximal end 104 to seat an o-ring seal 122. The o-ring seal 122
assists in sealing the cap 112 to the cylinder 102.
[0056] Referring to FIGS. 3-4, the cap 112 includes radially
inwardly protruding ramps 124 that lead into the locking slots 118
to facilitate the fit with the locking strips 116 on the cylinder
wall 110. When first placing the cap 112 on the cylinder 102, the
locking strips 116 are positioned between the ramps 124. As the cap
112 is rotated, the ramps 124 cam the locking strips 116 proximally
to urge the proximal end 104 of the cylinder 102 into a sealed
relationship with the cap 112, as shown in FIG. 4 (only a portion
of the cylinder wall 110 with two locking strips 116 is shown in
FIG. 4 for illustrative purposes). In the preferred embodiment,
there are four locking strips 116 and four locking slots 118 to
facilitate the sealed relationship between the cap 112 and the
cylinder 102.
[0057] Referring specifically to FIG. 4, an o-ring seal 126 and
dynamic seal 128 operate together within an orifice 130 in the cap
112 to movably support and seal to the mixing shaft 150. The mixing
shaft 150 slides through the orifice 130 and the dynamic seal 128
and is movably supported therein. The dynamic seal 128 allows
nearly frictionless rotational, as well as axial movement of the
mixing shaft 150 within the mixing chamber 108 to mix the liquid
and powder components of the bone cement, while maintaining a snug
fit within the orifice 130. A filter 132 and liner 134 are
positioned on an interior of the cap 112 to allow a vacuum to be
drawn in the mixing chamber 108 by way of a vacuum port 136. The
vacuum port 136 is isolated from the mixing chamber 108 by the
filter 132 and liner 134 to prevent fouling of a vacuum pump (not
shown). Referring to FIGS. 5-6, a vacuum tube 138 is shown attached
to the vacuum port 136 to draw the vacuum in the mixing chamber 108
during mixing.
[0058] Referring to FIG. 7, the preferred blade 152 used to mix the
bone cement is shown. The blade 152 is integrally formed from
plastic in one piece and has an outer ring 154 connected to a
center hub 156 by vanes 158. Ears 160 protrude radially inwardly
from the center hub 156 to facilitate a releasable connection to
the mixing shaft 150. The releasable connection is described
further below. Referring to FIG. 7A, the outer ring 154 forms an
acute angle a with the longitudinal axis L of the cylinder 102
(which is also a rotational mixing axis of the blade 152). The
acute angle a is important for efficient mixing of the bone cement.
The acute angle a is preferably between twenty and seventy degrees,
and more preferably sixty degrees. The blade 152 has an effective
height H that is greater than one quarter inch to ensure adequate
mixing. Preferably, the effective height H of the blade 152 is
approximately one half inch.
[0059] Referring back to FIG. 7, two radially inwardly protruding
fingers 157 are attached to the outer ring 154. One of the fingers
157 protrudes radially inwardly in a first plane and the other
finger 157 protrudes radially inwardly in a second plane spaced
from and parallel to the first plane. The center hub 156 is
positioned between the planes. The fingers 157 are used to scrape
proximal and distal regions of the mixing chamber 108 to ensure
complete mixing. A protruding node 159 is also attached to the
outer ring 154. The node 159 protrudes radially outwardly to
control spacing between the blade 152 and an inner periphery of the
cylinder wall 110 by scraping along the inner periphery of the
cylinder wall 110 in the mixing chamber 108.
[0060] FIGS. 8 and 8A illustrate alternative blades 252, 352 that
could also be used to mix the bone cement. Each of the blades 152,
252, 352 is designed to flatten at the proximal end 104 of the
cylinder 102 adjacent to the cap 112 after the blade 152, 252, 352
is released from the mixing shaft 150 in the mixing chamber 108.
This ensures that the maximum possible amount of bone cement can be
discharged from the mixing cartridge 100. In the case of the
preferred blade 152, the blade 152 is flexible and the outer wall
154 flattens into a plane perpendicular to the longitudinal axis L
and occupied by the center hub 156, as illustrated by hidden lines
in FIG. 7A. Thus, the effective height H is reduced and the acute
angle a becomes close to ninety degrees. This is accomplished by
twisting at the vanes 158. Spaces 155, 255, 355 formed in the
center hub 156, 256, 356 ensure that once the blade 152, 252, 352
is flattened, the bone cement can pass through the blade 152, 252,
352 when discharged from the mixing cartridge 100. To further
facilitate the discharge of the bone cement past the blades 152,
252, 352, each of the center hubs 156, 256, 356 are sized to
partially fit within the aperture 130 defined in the cap 112.
[0061] Another alternative blade 452 is shown in FIG. 9. This blade
452 is a relatively thick disk 452 with chamfered ends 453 forming
an acute chamfer angle with a sidewall 457. The chamfer angle is
preferably sixty degrees. In the preferred embodiment, the disk is
about one half inch thick and about one eighth inch less in
diameter than the inner periphery of the cylinder wall 110. In one
embodiment, the inner periphery of the cylinder wall 110 is about
two and one quarter inches in diameter. As should be appreciated,
the slight distance between the side wall 457 of the disk 452 and
the inner periphery of the cylinder wall 110 creates a shear force
on the bone cement as the disk 452 is rotated and moved axially in
the mixing chamber 108. The shear force is the force applied to the
bone cement to mix the bone cement. This blade 452 also includes a
space 455 formed in a center of the disk 452 and ears 460 for
releasably attaching to the mixing shaft 150.
[0062] Referring to FIGS. 10-13 the mixing shaft 150 has a release
latch 162 for releasing the blade 152 from the mixing shaft 150
once mixing of the bone cement is complete. The release latch 162
moves between a holding position and a releasing position. In the
holding position, the blade 152 is secured to the mixing shaft 150
to mix the bone cement in the mixing chamber 108. In the releasing
position, the blade 152 is released from the mixing shaft 150 to
remain in the mixing chamber 108 while the mixing shaft 150 is
removed from the cap 112 to make way for a nozzle 204, as will be
described further below. The release latch 162 is operatively
connected to a latch rod 164, which latches the blade 152 to the
mixing shaft 150 in the holding position. The latch rod 164 defines
a split cavity 166 for receiving split legs 168 of the release
latch 162 in a snap-fit manner. The latch rod 164 is rotatably
supported within the mixing shaft 150.
[0063] Referring to FIGS. 14A-14C, the transition of the release
latch 162 between the holding position and the releasing position
is illustrated. Referring first to FIG. 14C, the exposed end 170 of
the latch rod 164 is generally "T" shaped. The corresponding end
172 of the mixing shaft 150 has opposed notches 174 that are
adapted to receive the ears 160 on the center hub 156 of the blade
152. Initially, the ears 160 are positioned in the notches 174 and
the exposed end 170 is positioned over the ears 160 to hold the
blade 152 to the mixing shaft 150. See FIG. 14A. To release the
blade 152, the release latch 162 is depressed and rotated. Rotating
the release latch 162 rotates the latch rod 164 with respect to the
mixing shaft 150 thus rotating the exposed end 170 away from the
ears 160 to release the blade 152. See FIG. 14B. With the blade 152
released, the mixing shaft 150 is withdrawn from the cap 112 while
the blade 152 remains in the mixing chamber 108.
[0064] A proximal end 176 of the mixing shaft 150, which represents
a portion of the mixing shaft 150 extending outside of the mixing
chamber 108 during mixing, is adapted to engage a rotary power tool
177 (see FIG. 37), such as a reamer drill, used to rotate the
mixing shaft 150 and blade 152 and mix the bone cement. The
proximal end 176 of the mixing shaft 150 is operatively connected
to the blade 152 to transfer the rotation of the rotary power tool
177 to the blade 152. When the blade 152 is released from the
mixing shaft 150, the operative connection is removed. The
operative connection is also removed if the portion of the mixing
shaft 150 extending outside of the mixing chamber 108 is severed
from the rest of the mixing shaft 150 in the mixing chamber 108, as
in alternative embodiments. A manually operated mixing handle (not
shown) could engage the mixing shaft 150 at the proximal end 176 to
mix the bone cement in other embodiments.
[0065] Referring to FIGS. 15-16, the piston 114 is positioned
within the distal end 106 of the cylinder 102 to further seal the
mixing chamber 108. The piston 114 has a skirt 178 extending about
the inner periphery of the cylinder wall 110. The piston 114 also
includes a proximal end 180 and a distal end 182 defining a cavity
184.
[0066] Referring specifically to FIG. 16, the piston 114 is
releasably secured in a locked position in the distal end 106 of
the cylinder 102 by a locking member 186. The locking member 186 is
disposed in the cavity 184 and includes diametrically opposed
locking tabs 188 protruding into diametrically opposed slots 190
defined in the cylinder wall 110 to secure the piston 114 to the
cylinder 102. It should be appreciated that the slots 190 could be
in the form of any suitable female portion, e.g., slot, groove,
channel, etc., used for interlocking with a corresponding male
portion such as the locking tabs 188. Furthermore, while the
embodiment of FIG. 16 illustrates two-way locking, i.e., the piston
114 being locked from moving proximally and distally, the locking
member 186 could also be used for one-way locking, i.e., for
preventing only proximal movement of the piston 114.
[0067] The locking member 186 is integrally formed from plastic and
a resilient portion 192 of the locking member 186 biases the
locking tabs 188 radially outwardly from the longitudinal axis L
into the slots 190. The resilient portion 192 is in the form of a
thin resilient ribbon 192 acting like a spring and extending is a
winding shape between the locking tabs 188. The locking tabs 188
couple the locking member 186 to the piston 114 by protruding
through carrier slots 194 formed in the skirt 178. In the preferred
embodiment, a step 196 protrudes into each of the carrier slots 194
to define a guide for sliding engagement within a channel 198
partially defined in each of the locking tabs 188. In the locked
position, the carrier slots 194 are axially and radially aligned
with the slots 190 formed in the cylinder wall 110.
[0068] The piston 114 is locked at the distal end 106 of the
cylinder 102 while the liquid and powder components are added and
mixed in the mixing cartridge 100. The piston 114 is released from
the locked position after mixing of the bone cement is complete.
Release buttons 200, integrally formed with the locking tabs 188,
are used to release the piston 114 from the locked position. The
release buttons 200 are disposed on the locking tabs 188 and
protrude distally therefrom. Each of the release buttons 200
includes a cam surface 202 forming an acute angle with the
longitudinal axis L. The piston 114 is released from the locked
position by squeezing the release buttons 200 radially inwardly
against the bias of the resilient portion 192 to withdraw the
locking tabs 188 from the slots 190. This action can be performed
either manually or mechanically, as will be described further
below. After release from the slots 190, the locking tabs 188
remain coupled to the piston 114 in the carrier slots 194.
[0069] Referring to FIGS. 17-18, an alternative locking member 386
is shown. The alternative locking member 386 includes locking tabs
388 that are biased radially outwardly from the longitudinal axis L
of the cylinder 302 to engage the slots 390 in the cylinder wall
310. In this embodiment, four slots 390 are defined in the cylinder
wall 310 to receive the locking tabs 388. The resilient portion 392
is further defined as a resilient base 392 resiliently supporting
each of the locking tabs 388 on the piston 314 with each of the
locking tabs 388 being radially biased outwardly from the skirt 378
of the piston 314 to engage the slots 390 in the cylinder wall 310.
The release buttons 400 are further defined as fingers 400
extending radially inwardly toward the longitudinal axis L of the
cylinder 302 with the fingers 400 being engageable to urge the
locking tabs 388 radially inwardly and withdraw the locking tabs
388 from the slots 390 in the cylinder wall 310 to release the
piston 314 from the locked position.
[0070] Referring to FIGS. 19-23, once the bone cement is mixed, and
the mixing shaft 150 is withdrawn from the cap 112, the nozzle 204
is positioned on the cap 112. In the disclosed embodiment, the
nozzle 204 is set in place by pushing a hollow shaft 205 of the
nozzle 204 down into the orifice 130 of the cap 112 and then
twisting the nozzle 204 slightly, about one-quarter turn. The
nozzle 204 is attached to the cap 112 to prepare the mixing
cartridge 100 for placement into the delivery gun 500.
[0071] The cap 112 has a nipple 206 protruding from an outer
surface 208 thereof. The nipple 206 has tabs 210, which engage
detent members 212 in the nozzle 204. After the nozzle 204 is fully
rotated into position, the tabs 210 fully engage the detent members
212 while being positioned proximal to the detent members 212 to
secure the nozzle 204 in place. A stop 214 on the cap 112, best
shown in FIG. 19, prevents the nozzle 204 from rotating freely in
the clockwise direction after the tabs 210 have engaged the detent
members 212. The stop 214 extends downwardly from one of the tabs
210 to abut a side surface 216 of one of the detent members 212 to
prevent further clockwise rotation.
[0072] The nozzle 204 and cap 112 have first 218 and second 220
locking protrusions. The first locking protrusion 218 acts as a
detent and slides over the second locking protrusion 220 to a
locked position as illustrated in FIG. 21. In this position, rear
flat surfaces 222, 224 of the locking protrusions 218, 220, abut
one another to prevent the nozzle 204 from being turned in the
opposite direction, thereby preventing removal of the nozzle 204
from the cap 112. The nozzle 204 can be removed by deflecting an
outer skirt 226 of the nozzle 204 and rotating the nozzle 204
counterclockwise thereby disengaging the locking protrusions 218,
220. Both the nozzle 204 and cap 112 are formed from plastic, which
facilitates the detent-like locking and unlocking of the nozzle 204
to the cap 112.
[0073] With the nozzle 204 in place, the mixing cartridge 100 is
ready to be placed within the delivery gun 500. Referring to FIG.
24, the delivery gun 500 of the present invention includes a cradle
502 for supporting the mixing cartridge 100 and a casing 504 fixed
to the cradle 502 for supporting a drive mechanism 506, a linkage
system 508, and corresponding components. The cradle 502 includes
an endplate 510, which has an opening 512 for receipt of the nozzle
204. The endplate 510 holds the mixing cartridge 100 in position in
the cradle 502. In the preferred embodiment, the casing 504 and the
endplate 510 are connected by two connecting bars 514 (one on each
side of the mixing cartridge 100) to reduce the weight of the
delivery gun 500. A handle 516 is integrally formed with the casing
504 to maneuver the delivery gun 500 during use.
[0074] To dispense the bone cement from the mixing cartridge 100,
the piston 114 must first be released from the locked position.
Referring to FIG. 25, this is accomplished using a release
mechanism 518 integrated into the delivery gun 500. Once the mixing
cartridge 100 is in place in the cradle 502, a ram disk 520
protrudes into the cavity 184 in the distal end 182 of the piston
114. The release mechanism 518 is integrated into the ram disk 520.
The release mechanism 518 includes a bearing surface 522 forming an
acute angle with the longitudinal axis L for catching the release
buttons 200 to cam the release buttons 200 radially inwardly. More
specifically, the cam surfaces 202 of the release buttons 200 slide
along the bearing surface 522, while being cammed radially
inwardly. This action pulls the locking tabs 188 radially inwardly
to withdraw the locking tabs 188 from the slots 190 in the cylinder
wall 110 and release the piston 114 from the locked position (when
the alternative piston 314 is used, the ram disk has a flat bearing
surface that axially presses the fingers 400 proximally to bend
each resilient base 392 inwardly and urge the locking tabs 388
radially inward). A centering pin 800 can be used to center the ram
disk 520 in a centering cavity 802 of the piston 114 to facilitate
the release of the piston 114 from the locked position.
[0075] Referring back to FIG. 24, once the piston 114 is released,
the piston 114 can be driven through the mixing chamber 108 by the
drive mechanism 506 to force the bone cement from the nozzle 204.
The drive mechanism 506 includes a drive rod 524 movably supported
by bushings 526 in the casing 504. The ram disk 520 is fixed to the
drive rod 524. The drive mechanism 506 further includes a first
gripper plate 528 responsive to movement of the linkage system 508
upon actuation of a trigger 530. The first gripper plate 528
defines an aperture surrounding the drive rod 524. The first
gripper plate 528 frictionally engages the drive rod 524 to advance
the drive rod 524. The first gripper plate 528 is urged forward
while in frictional contact with the drive rod 524 by the linkage
system 508 when the trigger 530 is actuated. The first gripper
plate 528 thereby advances the drive rod 524 and ram disk 520
relative to the casing 504 to drive the piston 114 and force the
bone cement from the mixing cartridge 100. The trigger 530 is
pivotally supported by the casing 504 and operatively connected to
the drive mechanism 506 to advance the drive mechanism 506 upon
actuation of the trigger 530.
[0076] The linkage system 508 includes a first link 532, which is
pivotally mounted to the casing 504 about a pivot axis A adjacent
to the first gripper plate 528. The first link 532 is adapted to
engage the first gripper plate 528 when the first link 532 pivots
about the pivot axis A. A second link 536 pivotally interconnects
the trigger 530 to the first link 532 via support pins 538, 540.
The links 532, 536 and trigger 530 are interconnected to move in
unison upon rotation of the trigger 530 about a second pivot axis
B. When the trigger 530 is pulled, the second link 536 rotates the
first link 532 about the pivot axis A, which engages the first
gripper plate 528 and urges the first gripper plate 528 forward
while the first gripper plate 528 is in frictional engagement with
the drive rod 524 thereby advancing the drive rod 524. A return
spring 542 returns the links 532, 536 and the trigger 530 to an
initial position upon release of the trigger 530. At the same time,
a first spring 534 momentarily disengages the first gripper plate
528 from the drive rod 524 to slide the first gripper plate 528
back to an initial position to await the next pull of the trigger
530. The casing 504 pivotally supports the first link 532 and the
trigger 530 about the pivot axes A and B via support pins 544,
546.
[0077] A speed-changing link 548 is pivotally connected to the
second link 536 about a support pin 549. The speed-changing link
548 selectively pivots into and out from engagement with the first
gripper plate 528 by way of a switch 550. The speed-changing link
548 pivots between a high-speed position and a low-speed position
about the support pin 549 (the low-speed position is shown in FIG.
24). The high-speed position corresponds to faster advancement of
the drive rod 524 at a lower force. This allows the user to quickly
advance the drive rod 524 to drive the piston 114 and dispense high
volumes of bone cement at low pressure. The low-speed position
corresponds to slower advancement of the drive rod 524 at a higher
force, which exerts more force on the piston 114 to pressurize the
bone cement.
[0078] The first gripper plate 528 and the speed-changing link 548
have complementary first and second coupling devices 552, 554 used
to couple the first gripper plate 528 with the speed-changing link
548 in the high-speed position. More specifically, in the
embodiment of FIG. 24, the first gripper plate 528 has a shoulder
552 that is received within a channel 554 on the speed-changing
link 548. The speed-changing link 548 engages the shoulder 552 in
the high-speed position. In the high-speed position, a user's
gripping force is transmitted through the trigger 530 to the second
link 536 and the speed-changing link 548 to engage the first
gripper plate 528 and advance the drive rod 524. The speed-changing
link 548 is isolated from the first gripper plate 528 in the
low-speed position. The low-speed position corresponds to the
speed-changing link 548 being switched or disconnected from the
shoulder 552. In the low-speed position, the user's gripping force
is transmitted through the trigger 530 to both the first 532 and
second 536 links to engage the first gripper plate 528 and advance
the drive rod 524. This results in slower advancement of the drive
rod 524, but at a much higher mechanical advantage than the
high-speed position. As a result, the user can better pressurize
the bone cement during injection.
[0079] The pivot axes A and B and the links 532, 536, 548 are
positioned above the drive rod 524, while the trigger 530 extends
below the drive rod 524. A channel 556 defined in the trigger 530
facilitates this configuration. There are several advantages to
this configuration. Moving the second pivot axis B away from a
user's hand results in better usage of the stronger index and ring
fingers by allowing those fingers more travel distance as the
trigger 530 is actuated. This configuration also allows the handle
516 to be closer to the drive rod 524, which is believed to reduce
wrist strain when the user pushes the delivery gun 500 forward
during cement pressurization. Another benefit is that it allows for
a more streamlined casing design and better weight
distribution.
[0080] In one embodiment, shown in FIG. 24, a secondary gripper
plate 562 is mounted about the drive rod 524 adjacent to the first
gripper plate 528. The addition of one or more secondary gripper
plates 562 to the first gripper plate 528 adds strength to the
delivery gun 500 while still permitting proper operation. By using
two or more gripper plates 528, 562, increased frictional contact
with the drive rod 524 is obtained without adversely affecting
performance.
[0081] A release pin 558 disengages the gripper plates 528, 562 to
allow a user to freely move the drive rod 524 by hand. The release
pin 558 is connected to a retainer plate 560 and is adapted to
engage the first gripper plate 528. When the retainer plate 560 is
pushed by the user, the release pin 558 engages the first gripper
plate 528 which forces the first gripper plate 528 to tilt back
against the bias of the first spring 534 thus releasing the drive
rod 524. Any secondary gripper plates 562 follow. As should be
appreciated, pushing the retainer plate 560 also pivots the
retainer plate 560 releasing its engagement with the drive rod 524.
With both the retainer plate 560 and the gripper plates 528, 562
released, the drive rod 524 is free to move. This allows the user
to manually move the drive rod 524 with respect to the casing
504.
[0082] The delivery gun 500 is unique among bone cement guns with a
friction-plate mechanism in the way that it handles wear and
deformation of the gripper plates 528, 562. In the disclosed
embodiments, the gripper plates 528, 562 are tilted by the first
spring 534 into frictional contact with the drive rod 524.
Regardless of the amount of wear or deformation of the gripper
plates 528, 562 or the drive rod 524, the gripper plates 528, 562
require no further tilting to engage the drive rod 524 upon
actuation of the trigger 530. Thus, advancement of the drive rod
524 is produced over the entire actuation of the trigger 530 and
efficiency is maintained throughout the life of the delivery gun
500.
[0083] Referring to FIGS. 24A and 24B, alternatives of the linkage
system 508' and 508" are shown. These alternatives are represented
with similar numerals to the embodiment of FIG. 24 to indicate like
parts. FIG. 24A illustrates a configuration of the linkage system
508' in which the linkage system 508' lies beneath the drive rod
524'. Furthermore, the speed-changing link 548' in this embodiment
is pivotally connected to the first gripper plate 528' and includes
a hook-shaped end to engage the support pin 538' in the high-speed
position and disengage the support pin 538' in the low-speed
position. FIG. 24B illustrates a configuration of the linkage
system 508" in which the first gripper plate 528" is pushed by the
linkage system 508", as opposed to being pulled by the linkage
system 508 and 508' in FIGS. 24 and 24A. Here, the speed-changing
link 548" is pivotally connected to the first gripper plate 528" to
pivot into engagement with a notch 555" defined in the trigger 530"
in the high-speed position and out from engagement with the notch
555" in the low-speed position. These alternatives of the linkage
system 508' and 508" illustrate the flexibility of design, e.g.,
the selection of mechanical advantage, provided by the linkage
system of the present invention.
[0084] Referring to FIGS. 26-27, an alternative embodiment of the
drive mechanism 606 and linkage system 608 is shown (only a portion
of the drive mechanism 606 and linkage system 608 is shown for
illustrative purposes). In this embodiment, the linkage system 608
comprises the same components as previously described with an
improved first link 632 and gripper plates 628, 662. In this
embodiment, a plurality of secondary gripper plates 662 are aligned
along the drive rod 624 next to the first gripper plate 628. The
first link 632 defines a female recess 664 and the first gripper
plate 628 includes a male member 668 for mating engagement with the
female recess 664. The secondary gripper plates 662 are aligned
relative to the first gripper plate 628 via mating notches 670 and
pegs 672 formed therein. The notches 670 and pegs 672 assume the
same shape to mate with one another and maintain alignment. This
arrangement minimizes alignment changes that may cause slipping or
uneven wear. The arrangement also reduces contact between the
gripper plates 628, 662 and an interior wall of the casing 504. The
gripper plates 628, 662 are shown spaced in FIG. 26 for
illustration only. In practice, the gripper plates 628, 662 abut
one another, as shown in FIG. 27.
[0085] In this embodiment, each of the gripper plates 628, 662 also
defines a pair of semi-spherical grooves 674. In FIG. 26, only the
first of the pair of grooves 674 are shown in each of the gripper
plates 628, 662. The other of the pair of grooves 674 is located in
a rear surface of each of the gripper plates 628, 662,
cater-cornered from the first of the pair of grooves 674. These
grooves 674 increase the frictional contact with the drive rod 624.
When the gripper plates 628, 662 are urged forward while in
frictional engagement with the drive rod 624 by the first link 632,
a substantial portion of a rim 676 defined by each of the grooves
674 frictionally contacts the drive rod 624.
[0086] Referring to FIG. 27, autoclave sterilization of the
delivery gun 500 can create a tendency for the gripper plates 628,
662 to adhere to the drive rod 624 beyond their initial positions
when the trigger 630 is released. In this situation the first
spring 634 cannot produce enough force to disengage the gripper
plates 628, 662 from the drive rod 624, and the gripper plates 628,
662 do not return to their initial positions. FIG. 27 shows a way
to prevent this condition. A striker 678, in the form of a
downwardly protruding portion of the second link 636, closely
follows one of the gripper plates 628, 662 during actuation of the
trigger 630. In the event that any of the gripper plates 628, 662
do not properly disengage the drive rod 624 upon release of the
trigger 630, the striker 678 will contact the notch 670 in the
closest gripper plate 628, 662 and dislodge the gripper plate 628,
662 from the drive rod 624. The first spring 634 can then properly
return the gripper plates 628, 662 to their initial positions.
[0087] A coating has been added to an exterior of each of the
gripper plates 528, 562, 628, 662 in FIGS. 24 and 26-27. The
coating increases lubricity and corrosion resistance. This
facilitates sliding between the gripper plates 528, 562, 628, 662
as they engage the drive rod 524, 624. The coating also reduces
corrosion due to autoclave sterilization that may cause the gripper
plates 528, 562, 628, 662 to adhere to one another and prevent
proper engagement with the drive rod 524, 624. The coating used may
be Electroless-Nickel with polytetrafluoroethylene (PTFE) or other
like coatings possessing the same or similar properties.
[0088] Referring to FIGS. 28-31, another alternative embodiment of
the drive mechanism 706 and linkage system 708 is shown. This
embodiment also provides selective high-speed and low-speed
advancement of the drive rod 724. This alternative drive mechanism
706 eliminates the gripper plate by providing teeth 780 on the
drive rod 724. A cross-section of the drive rod 724 shows the teeth
780 on a flat upper surface 782, while a lower surface 784 is
smooth and round. The first link 732, which in previous embodiments
urged the first gripper plate 528, 628 forward with the drive rod
524, 624, now pivotally supports a first pawl member 786. The first
pawl member 786 is spring-biased into engagement with the teeth
780.
[0089] A second pawl member 788 is pivotally supported by the
second link 736. The second pawl member 788 is pivotable between a
high-speed position in which the second pawl member 788 is
spring-biased into engagement with the teeth 780 to advance the
drive rod 724, and a low-speed position in which the second pawl
member 788 is disengaged and isolated from the teeth 780. In the
low-speed position, the first pawl member 786 advances the drive
rod 724. The low-speed position is illustrated in FIGS. 28-29. In
the high-speed position, with the second pawl member 788 engaging
the teeth 780, the first pawl member 786 remains in engagement with
the teeth 780, but only ratchets along the teeth 780 as the second
pawl member 788 advances the drive rod 724. The high-speed position
is illustrated in FIGS. 30-31. The principle of increasing
mechanical advantage in the low-speed position relative to the
high-speed position also applies in this embodiment.
[0090] The switch 750 is used to pivot the second pawl member 788
out from engagement with the teeth 780 of the drive rod 724 in the
low-speed position (see FIGS. 28-29) and into engagement with the
teeth 780 in the high-speed position (see FIGS. 30-31). A switch
similar to that shown in U.S. Pat. No. 5,431,654 to Nic, herein
incorporated by reference, can be used for this purpose. The switch
750 extends through the casing 704 and terminates in a button that
is manipulated by a user to move the second pawl member 788 between
the high-speed and low-speed positions (see briefly FIGS. 41-42).
This also applies to the switch 550 used to move the speed-changing
link 548 in previous embodiments.
[0091] In this embodiment, the retainer plate 560 can be removed.
In its place, a spring-biased non-return pawl member 790 retains
the drive rod 724 in position upon advancement. The drive rod 724
can be freely moved in the casing 704 by rotating the drive rod 724
one hundred and eighty degrees such that the pawl members 786, 788,
790 are out of engagement with the teeth 780. Upon such rotation,
the pawl members 786, 788, 790 ride on the smooth lower surface 784
of the drive rod 724 allowing the user to freely pull the drive rod
724 relative to the casing 704. This is generally disclosed in the
'654 patent to Nic.
[0092] Each of the pawl members 786, 788, 790 are pivotally
supported by pins. Springs, such as those shown in the '654 patent
to Nic, bias the pawl members into engagement with the teeth 780 on
the drive rod 724 (except when the switch 750 acts against the bias
of the spring in the low-speed position to disengage the second
pawl member 788 from the teeth 780).
[0093] Mixing and delivery of the bone cement will now be described
with reference to FIGS. 32-42. Referring first to FIG. 32, a bone
cement loading system is shown. The bone cement loading system
comprises a base 900 supporting the cylinder 102 while loading the
liquid and powder components of the bone cement into the mixing
chamber 108. The base includes a cavity for receiving the distal
end 106 of the cylinder 102. Detents 903 are formed in the cavity.
A groove 905 is defined in an outer surface of the cylinder 102 to
receive the detents 903 and facilitate a snug fit between the base
900 and the cylinder 102. It should be appreciated that the detents
903 could be formed on the cylinder 102 with the groove 905 defined
in the base 900. The distal end 106 of the cylinder 102 may also be
press fit into the base 900. The base 900 is oblong and oval in
shape to fully support the cylinder 102 on a work surface, while
the cavity is circular in shape to fit the circular shaped cylinder
102. A funnel 902 couples to the cylinder 102 to channel the powder
into the cylinder 102 during loading. The funnel 902 includes a
proximal end 911 having an oblong oval-shaped periphery to
facilitate the loading of the powder into the mixing chamber 108
and a distal end 909 having a circular periphery to snugly fit
inside the proximal end 104 of the cylinder 102.
[0094] FIGS. 33-42 illustrate ten steps for preparing and injecting
the bone cement. The mixing cartridge 100, delivery gun 500, and
other components are generically shown in each step for
illustrative purposes only.
[0095] In STEP 1, shown in FIG. 33, the funnel 902 is coupled to
the cylinder 102 and the powder is poured into the mixing chamber
108.
[0096] In STEP 2, shown in FIG. 34, after the powder is poured into
the mixing chamber 108, the funnel 902 is removed, and the liquid
component, e.g., liquid monomer, of the bone cement is added. In
this manner, the present invention avoids wetting of the funnel 902
and the associated clean-up.
[0097] In STEP 3, shown in FIG. 35, the cap 112 with the mixing
shaft 150 and blade 152 supported therein is attached to the
cylinder 102.
[0098] In STEP 4, shown in FIG. 36, the vacuum line 138 is attached
to the vacuum port 136 and a vacuum is drawn in the mixing chamber
108 with the liquid and powder components therein.
[0099] In STEP 5, shown in FIG. 37, with the vacuum drawn, the
power tool (reamer) is then connected to the mixing shaft 150.
[0100] In STEP 6, shown in FIG. 38, with the vacuum still drawn,
the mixing shaft 150 is moved axially with respect to the mixing
cartridge 100 and rotated by the power tool. The blade 152 (not
shown in FIG. 38) is moved axially the entire extent of the mixing
cartridge 100 while rotating to ensure that the liquid and powder
components are fully mixed.
[0101] In STEP 7, shown in FIG. 39, once mixed, the release latch
162 is moved to release the blade 152 (not shown in FIG. 39). The
blade 152 remains in the mixing chamber 108 once released. The
mixing shaft 150 is then removed from the mixing cartridge 100.
Mixing is now complete.
[0102] In STEP 8, shown in FIG. 40, the nozzle 204 is pushed down
on the cap 112 and rotated into place.
[0103] In STEP 9, shown in FIG. 41, the mixing cartridge 100 is
positioned in the cradle 502.
[0104] In STEP, shown in FIG. 42, the piston 114 is released from
the distal end 106 of the cylinder 102 and the delivery gun 500 is
primed and ready to discharge the bone cement from the mixing
cartridge 100.
[0105] It will be appreciated that the above description relates to
the disclosed embodiments by way of example only. Many apparent
variations of the disclosed invention will be known to those of
skill in this area and are considered to be within the scope of
this invention and are considered to be within the scope of the
following claims. Obviously, many modifications and variations of
the present invention are possible in light of the above
teachings.
* * * * *