U.S. patent application number 13/884188 was filed with the patent office on 2013-12-26 for fuhrungselement und vorrichtung zum einbringen einer knochenbohrung.
This patent application is currently assigned to Jeder GmbH. The applicant listed for this patent is Klaus Eder. Invention is credited to Klaus Eder.
Application Number | 20130344453 13/884188 |
Document ID | / |
Family ID | 44860172 |
Filed Date | 2013-12-26 |
United States Patent
Application |
20130344453 |
Kind Code |
A1 |
Eder; Klaus |
December 26, 2013 |
FUHRUNGSELEMENT UND VORRICHTUNG ZUM EINBRINGEN EINER
KNOCHENBOHRUNG
Abstract
A guide element is constructed for arrangement on a device for
the penetrating extension of a blind hole created in hard tissue,
in particular in the jawbone, wherein the device includes a hollow
body that forms a pressure chamber and that has a distal working
opening and an inlet opening opposite the working opening. The
guide element can be inserted into the inlet opening with a tight
fit and the inlet opening can be closed by the guide element, the
guide element has a through-hole, through which a shaft of a
working tool, for example, of a milling tool, can be guided and
inserted into the hollow body, and the guide element has a
connection for a working medium for applying an internal pressure
in the pressure chamber or in the hollow body.
Inventors: |
Eder; Klaus;
(Perchtoldsdorf, AT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Eder; Klaus |
Perchtoldsdorf |
|
AT |
|
|
Assignee: |
Jeder GmbH
Wien
AT
|
Family ID: |
44860172 |
Appl. No.: |
13/884188 |
Filed: |
September 30, 2011 |
PCT Filed: |
September 30, 2011 |
PCT NO: |
PCT/AT2011/000406 |
371 Date: |
July 18, 2013 |
Current U.S.
Class: |
433/29 ;
433/75 |
Current CPC
Class: |
A61C 1/082 20130101;
A61C 3/03 20130101; A61C 8/0092 20130101; A61C 1/0046 20130101;
A61B 17/176 20130101 |
Class at
Publication: |
433/29 ;
433/75 |
International
Class: |
A61C 8/00 20060101
A61C008/00; A61C 1/00 20060101 A61C001/00 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 9, 2010 |
AT |
A 1839/2010 |
Claims
1.-33. (canceled)
34. A guide element for arrangement on a device for perforating
extension of a blind bore introduced into hard tissue, in
particular into the jaw bone, said device comprising a hollow body
forming a pressure chamber with a distal working opening and an
inlet opening opposite the working opening, said guide element
having a through hole for passage therethrough of a shaft of a
working tool into the hollow body, wherein the guide element is
constructed for form fitting engagement in the inlet opening of the
hollow body of the device, to thereby close the inlet opening, and
wherein the guide element has a connection for a working medium for
establishing an inner pressure in the pressure chamber or in the
hollow body.
35. The guide element of claim 34, wherein the working tool is a
milling tool.
36. The guide element of claim 34, wherein the engagement of the
guide element in the inlet opening is pressure tight and
essentially fluid tight.
37. The guide element of claim 34, wherein the shaft is supported
and guided for movement in the through hole in a pressure tight and
essentially fluid tight manner.
38. The guide element of claim 37, wherein the movement includes a
member selected from the group consisting of a rotating movement, a
circulating movement, a tumbling movement and an axial
movement.
39. The guide element of claim 34, further comprising a sealing
element arranged in the through hole, for further sealing of the
shaft.
40. The guide element of claim 39, wherein the sealing element is
an O-ring.
41. The guide element of claim 34, constructed one-piece or in one
part.
42. The guide element of claim 41, constructed as sterilizable,
disposable component.
43. The guide element of claim 42, wherein the guide element is
made of plastic.
44. The guide element of claim 34, wherein the through hole is
arranged in a disc-shaped head region of the guide element, and
wherein the connection is constructed as a socket for connection to
a tube line and extends radially, outwardly in a plane of the
disc-shaped region.
45. The guide element of claim 44, wherein the through hole is
arranged centrally in the disc shaped head region.
46. The guide element of claim 34, wherein a channel is formed in
the guide element, said channel being closed from all sides, and
connecting the connection with an exit opening leading into the
inlet opening.
47. The guide element of claim 46, wherein the channel extends
separate from the through hole along its entire extent.
48. The guide element of claims 46, wherein the channel has a first
subsection positioned proximate to the connection and extending
perpendicular to a central longitudinal axis of the through hole,
and a second subsection adjoining the first subsection and
extending essentially parallel to the central longitudinal axis of
the through hole.
49. The guide element of claim 34, further comprising a projection
formed on a side of the guide element which faces the inlet opening
during operation.
50. The guide element of claim 49, wherein the projection is
configured cylindrical.
51. The guide element of claim 49, wherein a side surface of the
projection is surrounded by a sealing element.
52. The guide element of claim 51, wherein the sealing element is
constructed as an O-ring.
53. The guide element of claims 34, further comprising a tapered,
downwardly open frustrum-shaped sleeve, said sleeve being formed on
a side of the guide element which faces the inlet opening during
operation, and being centrally traversed by the through hole.
54. The guide element of claims 53, wherein the sleeve directly
adjoins the projection, and wherein a greatest diameter of the
sleeve is smaller than a diameter of the projection.
55. The guide element of claims 34, wherein a side of the guide
element which faces the inlet opening during operation is
configured smooth and planar.
56. The guide element of claims 34, further comprising a latching
element protruding laterally from the guide element, and
constructed for reversible latching engagement into a corresponding
latching recess of the sinus lift device.
57. A device for penetrating extension of a blind bore introduced
into hard tissue, in particular the jaw bone, comprising: a working
tool having a shaft; a hollow body forming a pressure chamber, said
hollow body being constructed for sealing insertion into the blind
bore and having a distal working opening proximate to the bone
during operation, and an inlet opening opposite the working
opening; and a guide element closing the inlet opening and having a
through hole constructed for guiding therethrough the shaft of the
working tool into the hollow body, and a connection for connection
to a tube line for a working medium for establishing a pressure in
the pressure chamber.
58. The device of claim 57, wherein the working tool is constructed
as a milling tool.
59. The device of claim 57, wherein the pressure chamber is
configured cylindrical.
60. The device of claim 57, wherein the guide element closes the
inlet opening and with this the pressure chamber pressure tight and
essentially fluid tight, and wherein a pressure of 1.5 bar is
achievable inside the pressure chamber.
61. The device of claim 60, wherein the pressure is at least 2.5
bar
62. The device of claim 57, wherein the shaft is supported and
guided for movement in the through hole in a pressure tight and
essentially fluid tight manner and preferably, a pressure is
achievable inside the pressure chamber of at least 1.5 bar,
preferably at least 2.5 bar.
63. The device of claim 62, wherein the movement includes a member
selected from the group consisting of a rotating movement, a
circulating movement, a tumbling movement and an axial
movement.
64. The device of claims 57, wherein the guide element is
constructed for reversible and non-destructive attachment on, and
removal from the hollow body.
65. The device of clam 57, further comprising a handle element
arranged on the hollow body.
66. The device of claim 57, wherein the guide element is arranged
in a recess formed at a distal end of the handle element.
67. The device of claim 66, wherein the handle element is provided
with a groove and wherein the tube line extends in the groove.
68. The device of claim 67, wherein the groove is provided with
fixing elements.
69. The device of claims 57, further comprising a latching recess,
wherein the guide element is fixable in position by reversible,
latching engagement in the latching recess through a pivoting
motion.
70. The device of claims 69, wherein the latching recess is formed
in a border surface of the recessed region.
71. The device of claims 69, wherein the guide element is engagable
in the latching recess by pivoting about the through hole as
rotation axis by 30.degree. to 50.degree..
72. The device of claim 57, wherein the guide element is insertable
with the projection into the inlet opening in a fluid tight manner,
in particular up to a projecting stop.
73. The device of claim 57, wherein a portion of the inlet opening
is configured in the form of a hollow funnel shaped region that
conically narrows from a broader starting region.
74. The device of claim 57, wherein the outer walling of the sleeve
is spaced apart from the funnel shaped inner walling of the entry
opening.
75. The device of claim 57, further comprising a flange on an
outside of the hollow body, said flange being adjustable along the
hollow body and detachably fastenable to the hollow body and having
a sealing portion, said sealing portion reaching between the hollow
body and a walling of the blind bore.
76. The device of claim 75, wherein the sealing portion is
configured conical.
77. The device of claim 57, further comprising an elastic bellow
arranged between the guide element and the working tool.
78. The device of claim 57, wherein the working tool comprises a
rotating shaft.
79. The device of claim 78, wherein the working tool is constructed
as a milling tool, or a rotation free working tool.
80. The device of claim 79, wherein the rotation-free working tool
is constructed as an ultrasound-Osteotome or a laser cutting
tool.
81. The device of claim 57, further comprising a manual or
automatic pressure control unit, connected with the device via the
connection.
82. The device of claim 57, wherein the device further comprises a
device for generating or transmitting mechanical or electromagnetic
vibrations to the working medium in the pressure chamber.
83. The device of claim 57, wherein a diameter of the shaft
decreases stepwise toward a drill head of the working tool, wherein
the shaft has a first subsection located in the pressure chamber
and a second subsection lying sealingly in a region of the through
hole, and wherein the first subsection has a smaller diameter than
the second subsection.
84. The device of claim 57, wherein the milling tool has a drill
head, said drill head having a tip with a small surface and a
strong curve, to ensure a punctiform and small-surfaced penetration
through the bone plate.
85. A set, comprising: the guide element of claim 34; at least one
tube line; and a syringe, wherein the guide element, the tube line
and the syringe are sterilized and packaged aseptically in a closed
container, preferably a plastic bag.
Description
[0001] The invention relates to a guide element according to the
preamble of claim 1 and a device for penetrating extension of a
blind hole introduced into hard tissue, in particular into the jaw
bone, according to claim 15.
[0002] Such an extension of a bone bore is for example required in
the filed of dental surgery when performing a procedure referred to
as sinus lift. Sinus lift means an operation in which the mucosa of
the maxillary sinus or sinus membrane or Schneider's membrane is
partially detached and lifted to create a space between the bone
and the mucosa of the maxillary sinus. Into the created hollow
space, an autologous bone, for example from the tuber maxillae, the
linea obliqua, the chin region or from the hip crest (bone
replacement materials, bone graft) or a synthetic bone replacement
material, for example bone replacement material of the brand
Bio-Oss.RTM. from the company Geistlich AG, often mixed with
autologous bone, is then introduced. This material is intended to
convert into bone within 6 months, to ensure a solid base for an
implant.
[0003] The conventional approach for a sinus lift is to prepare a
mucoperiostal flap, buccally in the region of the molars, and to
mill an oval window into the thus exposed bone, without damaging
the underlying mucosa of the maxillary sinus. The oval bone disc
which his attached to the mucosa of the maxillary sinus is then
carefully pushed in the direction of the maxillary sinus, wherein
the mucosa of the maxillary sinus is carefully detached from the
bone around the window using special instruments. Because the
mucosa of the maxillary sinus is very fragile, comparable to the
chorion of an egg, this procedure has to be performed very
carefully because of the risk of damaging the mucosa of the
maxillary sinus. The space which is thus created in the maxillary
sinus is then filled with the bone replacement material and the
buccal window is covered with a film. Generally, the film is made
of an absorbable material such as a membrane of the brand
Bio-Gide.RTM. of the company Geistlich AG. After this, the
mucoperiostal flap is densely sutured up. This method is relatively
invasive and causes stress to the patient due to strong swelling
and discoloration up to 10 days, and may also involve pain. This
surgical procedure is often also referred to as "open" or
"classical" sinus lift. In case a sufficient residual bone height
remains, e.g. a height of 5 mm, the implants can be inserted at the
same time of the sinus lift (one time sinus lift). The implants can
be exposed to full load only after solidification of the bone
replacement material. When the residual bone height is too thin,
the insertion of the implants is performed in a second procedure
about 6-8 months after the sinus lift (second sinus lift).
[0004] A newer method is the so called crestal sinus lift which
does not require folding open of the bone plate. Access to the
maxillary sinus is enabled from the jaw crest. At the toothless
portion of the jaw crest, the oral mucosa is punched through up to
the bone by means of a specially provided punch (Jesch's punch) and
a blind hole is milled into the bone up to just below the mucosa of
the maxillary sinus with a cylindrical milling machine. The punch
used for this, automatically lifts the mucosal disc from the bone
and creates a central through hole for the further bore or milling.
The bore is milled below the bony sinus floor generally antral
i.e., starting from the crest by means of a cylindrical milling
tool for example with a diameter of 3.5 to about 1 mm, wherein the
bone thickness is previously measured by means of X-ray. Because
the mucosa of the maxillary sinus must not be damaged by the
milling tool, the jaw bone must not be fully drilled through with
the milling tool, so that at the bottom of the blind hole a thin
bone plate remains, against the backside of which the mucosa of the
maxillary sinus rests. Conventionally, this thin bone plate is then
carefully pushed in the direction of the maxillary sinus with a
cylindrical instrument, so that it is pushed in the direction of
the maxillary sinus along with the mucosa of the maxillary sinus
which is attached above the bone disc to the top of the bone disc.
This "puncturing" of the bone disc is a critical point for the
procedure because an excessive pushing-in of the bone disc leads to
the mucosa of the maxillary sinus being lifted tent-shape and being
tensioned, which may lead to damage to the mucosa of the maxillary
sinus. The mucosa of the maxillary sinus is then carefully lifted,
and the bone replacement material is then introduced into the newly
created free space via the bore. The implant is then anchored
mostly directly in the bore.
[0005] Even though very advanced methods have been developed to
detach the mucosa of the maxillary sinus as carefully as possible
and sufficiently far away from the jaw bone through the small bore,
which mostly has a diameter of only about 4 mm, the moment at which
the jaw bone is perforated remains a critical moment which requires
great experience and particular skill of the doctor, wherein even
when taking all precautions, there is still a residual risk of
causing damage to the mucosa of the maxillary sinus when
perforating the bone plate. In order to make the sinus
lift-procedure safer, means are desired which facilitate this
penetrating extension of the jaw bone bore, and at the same time
lower the risk of damage to the fragile sinus membrane behind the
jaw bone.
[0006] Such an advantageous means is known from WO 2010/048648 A1,
where a device is described which has a tubular body with a distal
working opening and an entry opposite the working opening, which
entry is closed by a sealing element which is traversed by a shaft
of a working tool, e.g. of a milling tool. On the tubular body, a
connection for applying an internal pressure is arranged. The
tubular body is sealingly inserted into a blind hole which was
previously introduced into the jaw bone, wherein the distal working
opening rests against the end of the blind hole thereby mostly
sealing the inner space. The working medium inside the tubular
body, preferably NaCl solution, can now be pressurized via the
connection, for example by means of a syringe connected to the
connection. With the working tool, which can be controlled from
outside, the bone disc which remains between the blind hole and the
maxillary sinus is milled off in the region of the working opening.
At the moment when the head of the working tool penetrates the bone
and enters into the region below the sinus membrane, the
overpressure in the interior of the tubular body, causes the
working medium to enter through the free opening and to push the
sinus membrane located there behind away from the bone and with
this out of the working area of the working tool and out the zone
of danger. The discharge of the working medium causes the pressure
to decrease which indicates the perforation of the bone and also
prevents an excessive bloating of the sinus membrane.
[0007] Such a device is safe to operate, and excellent surgical
result with minimal risk to the mucosa of the maxillary sinus can
be achieved with such a device. However, a certain disadvantage is
that cleaning of the device is relatively costly and difficult. In
particular, it is very difficult to clean the thin connection
channel via which the pressure medium is supplied into the tubular
body or the pressure chamber, thoroughly enough so that no
contaminations remain. Generally, each reuse of medical equipment
or products in the field of surgery bears certain infection risks
for the patient and any contamination can lead to health problems,
disease or even death of the patient. Although thorough
re-sterilization of the device allows killing a predominant portion
of the germs, such a re-sterilization is time consuming, exposes
the material to stress and is cost intensive and still does not
exclude a certain residual risk of a microbial contamination.
[0008] It is thus an object of the present invention to further
refine the aforementioned device while still retaining its
advantageous functionality, in that its contamination safety is
increased and the risk of infection for the patient is lowered.
[0009] This object is solved by creating a guide element which is
especially configured according to the characterizing features of
claim 1.
[0010] This guide element according to the invention can be
arranged as cost saving exchangeable component on the surgical
device and can be used as expendable single use item.
[0011] The guide element is particularly suited, shaped and
configured to be arranged on a device for penetrating extension of
a blind hole introduced into hard tissue, in particular the jaw
bone. Such a device includes a hollow body which forms an internal
pressure chamber and has a distal working opening and an inlet
opening opposite the working opening. This device essentially also
corresponds to the device known from WO 2010/048648 A1.
[0012] The guide element according to the invention is insertable
into the inlet opening of the device with a form fit, whereby the
device can be sealingly closed by inserting the guide element. The
guide element also has a through hole through which a shaft of a
working tool, for example a milling tool can be passed and inserted
into the hollow body of the device there underneath. In addition, a
connection for supply of a working medium is provided in the guide
element for establishing the required internal pressure in the
chamber. This pressure serves for pushing away the sinus membrane
after perforating the bone.
[0013] With this, the guide element according to the invention
ensures that when applied correctly, a pressure chamber can be
formed in the first place or a sufficient pressure can be built up.
In addition, the pressure medium is also supplied exclusively via
or through the guide element, in contrast to the device of WO
2010/048648, in which the pressure medium is supplied via a fixed,
lateral connection socket which directly enters into the pressure
chamber and is difficult to clean. Beside these two functions, the
guide element also ensures that the shaft of the working tool is
sealingly inserted into the blind hole and at the same time can be
moved to remove the remaining floor plate.
[0014] A significant advantage is that the guide element can be
exchanged, and after the intended use can be detached and
discharged, which increases the safety of the surgical procedure
and strongly decreases the risk of infection for the patient.
[0015] The guide element can thus be manufactured, distributed and
stored as separate, aseptically packaged component similar to a
syringe or syringe needle and is removed from the packaging just
prior to the surgery and connected to the surgical instruments, and
disposed after use. Such a disposal of the device of WO 2010/048648
would not be advisable, because this is an expensive precision
component made of stainless steel. In this way, it is also ensured
that a possible expiration date is observed or not exceeded and the
operational safety is ensured.
[0016] Further advantageous embodiments of the guide element
according to the invention are described in the dependent
claims.
[0017] It is particularly advantageous when the guide element
causes a pressure tight and essentially fluid tight closure of the
inlet opening. Even though certain minor leakiness and/or leakage
of pressure medium is tolerable, the required buildup of pressure
and the maintenance of this pressure can be significantly better
achieved when the guide element closes the inlet opening as tight
as possible. A decrease in pressure which occurs when perforating
the bone can also be detected better, faster and more reliably, and
the milling tool can be stopped in time.
[0018] It is also very advantageous when the through hole of the
guide element causes a pressure tight and essentially fluid tight
support and guiding of the shaft, also in order to achieve the
internal pressure in the pressure chamber of usually about 2 to 2.5
Bar in the first place and then maintain this pressure. At the same
time, the through hole has to be configured so that at least one
advance movement, drive and/or control movement of the shaft is
ensured for example a rotation, a circular movement and/or an axial
forward movement of the shaft when removing the floor plate of the
blind hole, without significantly negatively affecting the sealing
properties.
[0019] In this context, it is particularly advantageous when a
sealing element, for example an O-sealing is arranged inside the
through hole for further sealing the shaft. This ensures additional
tightness of the system. In embodiments in which a conventional
rotatingly driven milling tool is used, the sealing element
functions as shaft sealing and has to seal the rotating shaft
without excessively limiting its freedom of movement. This requires
a relatively high quality of the sealing element and leads to a
fast wear of the sealing element.
[0020] Configuring the sealing element one-piece or in one part, in
particular as sterilisable, disposable plastic injection-molded
part, has the advantage that it can be manufactured easily and cost
effectively and ensures a contamination free working.
[0021] In a further advantageous constructive configuration of the
guide element, the through hole is arranged in a disc-shaped head
region of the guide element, preferably centered, and the
connection is configured as socket for connecting a tube line and
preferably extends radially outwardly.
[0022] In order to achieve a reliable supply of the working- or
pressure medium, an inner channel which is closed from all sides
can be formed in the guide element, which channel connects the
connection with an outlet opening which leads into the inlet
opening.
[0023] In this context, it is advantageously provided that the
channel extends separate from the through hole over its entire
extent.
[0024] It is particularly advantageous when a first subsection of
the channel which is proximate to the connection, extends
perpendicular to the central longitudinal axis of the through hole,
and a second adjoining subsection of the channel is essentially
parallel to the central longitudinal axis of the through hole. In
this way, the channel can be worked into the guide element very
easily for example also by subsequent borings.
[0025] In order to ensure a tight but nevertheless rotatable
insertion of the guide element into the inlet opening, according to
a further advantageous embodiment, a preferably cylindrical
projection is formed on the side of the guide element which faces
the inlet opening, and is preferably surrounded by a sealing
element, for example an O-ring.
[0026] In a further advantageous embodiment, a tapered,
frustrum-shaped sleeve which is open at its bottom is formed on the
side of the guide element which faces toward the inlet opening,
which sleeve is traversed centrally by the through hole. This
extends the through hole and enhances the sealing effect, and the
guiding of the shaft.
[0027] According to a particularly advantageous embodiment, the
sleeve rests slightly closer and more sealingly against the shaft
than the reaming portion of the through hole. The sleeve, in
particular its front most distal section, thus contributes the most
to the sealing and embraces the shaft particularly closely and
tightly. The other sections of the through hole also seal well over
their entire length but a certain play remains between the shaft
and the inner surface of the through hole. This allows the shaft to
slightly move radially, advantageously supported by flexible
material properties of the guide element which allow for a certain
distortion. Due to its small material thickness the sleeve is
slightly more flexible anyway and permits tumbling movements of the
shaft. With this, the sleeve improves the tightness as well as the
movability of the milling tool.
[0028] Constructively, it is advantageous when the sleeve is formed
on the cylindrical projection and the greater diameter of the
sleeve is preferably smaller than the diameter of the
projection.
[0029] Because according to an advantageous embodiment, the guide
element is inserted into the surgical instrument with a rotating
and pivoting movement, it is advantageous when the bottom side of
the guide element which faces the inlet opening is smooth and
planar, which enables an easy pivoting of the guide element.
[0030] It is advantages when a laterally projecting latching
element is provided which can be reversibly latched into a
corresponding latching through hole of the device, which ensures a
safe operating position, but also easy removal.
[0031] In a further aspect, the invention relates to a device or a
surgical instrument for penetrating extension of a blind hole
introduced into hard tissue, in particular into the jaw bone. This
device includes a working tool for example a milling tool, the
guide element according to the invention and a hollow body which
forms a pressure chamber. This hollow body has a preferably
cylindrical inner hollow space with a distal working opening and an
inlet opening opposite the working opening. The inlet opening is
closed with the guide element, further, a shaft of the working tool
is passed through or can be passed through the through hole and can
be inserted into the hollow space of the hollow body. In addition,
a tube line for introducing a fluid working medium for generating
an internal pressure in the pressure chamber can be connected to
the connection of the guide element.
[0032] With such a device, the above mentioned advantages are
achieved and a safe and timely removal of the sinus membrane from
the zone of danger i.e., the working area of the working tool is
ensured. At the same time, the risk of contamination is
significantly reduced, because the guide element can be
exchanged.
[0033] According to a particularly advantageous embodiment, the
drill head of the milling tool is significantly smaller than the
blind hole and has a small-surfaced tip which may be strongly
curved. This ensures a punctiform peroration of the bone plate
which reduces the risk for the sinus membrane. In this way, the
fluid can already flow through the small initial opening before the
drill head breaks through with its entire diameter and would come
into contact with the sinus membrane. A large-surface initial
perforation of the bone plate, as would be the case with flat drill
heads, is not advantageous.
[0034] Advantageous embodiments of this device provide for example
that the guide element closes the inlet opening, and with this the
pressure chamber, pressure tight and essentially fluid tight and a
preferably constant pressure of at least 2 bar can be achieved
inside the pressure chamber.
[0035] It is further advantageous that the shaft is supported and
guided in the through hole in a pressure tight and essentially
fluid tight manner and a preferably constant pressure of at least 2
bar can be reached inside the pressure chamber, however, at the
same time at least an advance movement, drive movement, and/or
control movement of the shaft for example a rotation, a circulating
motion and/or an axial advance movement of the shaft is ensured. As
mentioned before, this allows reaching and maintaining the pressure
required for pushing away the sinus membrane, at simultaneous
retention of the movability of the working tool.
[0036] In order to ensure an easy removability of the guide element
and to prevent that the guide element is reused as a result of
negligence, it is advantageous when the guide element can be
attached reversibly and destruction free on the hollow body and is
easily and simply removable from the same.
[0037] A very easy handling can be achieved in that a handle
element is arranged on the hollow body. With this, the surgeon or
dentist can securely place the hollow body in the blind hole and
remove the hollow body again.
[0038] A constructively advantageous and easy to use embodiment is
achieved in that the guide element is arranged in a recessed region
on the distal end of the handle element.
[0039] When the tube line extends in a, as the case may be with
fixing elements provided in the handle element formed groove, it is
ensured that the tube line is supported securely and space
effectively and a bending or unintended tearing off from the
connection is not possible.
[0040] In order to achieve a stable operating position, according
to an advantageous refinement, a latching through hole can be
formed preferably in the border surface of the recessed region,
into which latching through hole the corresponding latching element
of the guide element can be clicked and the guide element can be
fixed in this position, wherein the engagement occurs in particular
by a rotating and pivoting of the guide element by about 30.degree.
to 50.degree. with the through hole as rotation axis.
[0041] In this context, it is advantageous in particular in order
to achieve an easy rotatablitiy, when the guide element is
insertable into the inlet opening with the cylindrical projection
in a fluid tight manner, in particular up to a stop.
[0042] In order to make it possible to supply the pressure medium
and simultaneously pass the shaft through the through hole through
the guide element, it is advantageous when the outer walling of the
sleeve is spaced apart from the funnel-shaped inner walling of the
inlet opening.
[0043] For sealing insertion into the jaw bore, the uppermost
portion of the hollow body which is to be inserted into the blind
hole, can be configured conical. The conical region can be pressed
into the blind hole by applying manual force. This is advantageous
in particular when a handle extension is provided which impedes a
rotation of the instrument which has been inserted into the bore in
the mouth region. The rotation of the instrument can serve for
screwing the instrument into the bore. For this purpose, in a
further embodiment, a self cutting thread can be provided on the
hollow body in the region which is to be introduced into the blind
hole. This ensures a secure fit of the hollow body in the bore and
improves the sealing against to the inner walling of the bore.
[0044] In order to further improve the sealing, a flange which can
be provided on the outside of the hollow body and can be adjusted
along the hollow body and detachably fixed to the hollow body, has
a conical sealing attachment which reaches between the hollow body
and the walling of the blind hole. This flange is pressed against
the oral mucosa with the cone and then fixed for example by means
of an Allen screw, thereby also closing this end of the pressure
chamber pressure tight.
[0045] In order to achieve a slow forward feed of the milling head
and to avoid an abrupt advance as far as possible, an elastic
bellow can be arranged between the guide element and the working
tool.
[0046] According to a further advantageous embodiment, the working
tool is a rotatingly driven working tool for example a milling
tool, or a rotation-free working tool, for example an ultrasound
osteotome or a laser cutting device. Such working tools are
described in detail in WO 2010/048648 A1 and are hereby
incorporated by reference into the present application. In the
context of this invention, rotation-free means that the working
tool and the sealing element contact one another essentially
without the occurrence of relative velocities, because the working
tool does not rotate about its main axis. As a result, a rotating
shaft does not have to be sealed by means of a rotation shaft
sealing, which lowers the stress on the sealing element.
[0047] The working tool can be a piezoelectric surgical instrument,
preferably an ultrasound ostetome which operates in a range between
20 and 200 micrometers. As an alternative, the working tool can be
a laser cutting tool which has preferably a pulsed CO2-Laser or a
solid-state laser, wherein the wavelength of the laser is
preferably adjusted to the absorption characteristics of the bone
tissue and can be coupled with an endoscope.
[0048] In a further advantageous embodiment of the invention, the
milling tool can be connected with a manual or automatic control
unit via the connection. This enables an exact regulation and
control of the internal pressure, wherein the perforation of the
bone can be immediately recognized by way of the decrease in
pressure and the milling tool can be switched off if necessary.
[0049] When the apparatus has a device for generating or
transmitting mechanical or electromagnetic vibrations, additional
vibrations, preferably pressure-free ultrasound vibrations can be
introduced into the system or the working medium in order to
accelerate detachment of the sinus membrane.
[0050] In a further advantageous embodiment, the diameter of the
shaft decreases toward the drill head with at least one step. The
partial section of the shaft which lies in the region of the
pressure chamber has a smaller diameter than the partial section of
the shaft which lies sealingly in the region of the through hole.
In this way, the shaft is sealingly supported in the through hole,
however, a pressure chamber of sufficient size remains and the
shaft has sufficient mobility to allow removal of the remaining
bone plate as completely as possible.
[0051] The invention also relates to a set including the guide
element according to the invention and a tube line for connection
to the guide element and optionally a syringe for generating the
required internal pressure, wherein the guide element and the tube
line as well as the syringe are sterilized and aseptically packaged
in a closed container, preferably a plastic bag. This facilitates
storage and handling and ensures contamination free working.
[0052] Further advantages and embodiments of the invention become
apparent from the description and the included drawings.
[0053] The invention is now schematically shown by way of a
particularly advantageous exemplary embodiment in the drawings,
which is not to be understood as limiting, and is exemplary
described with reference to the drawings:
[0054] FIG. 1 shows the guide element according to the invention in
a perspective view obliquely from above.
[0055] FIG. 2 shows the guide element according to FIG. 1 in a view
oblique from below.
[0056] FIG. 3 shows the entire device with the guide element
according to the invention, the hollow body and a working tool.
[0057] FIG. 4 to 7 show stepwise the preparation and assembly of
the device.
[0058] FIG. 4 shows the insertion of the guide element into the
hollow body.
[0059] FIG. 5 shows the pivoting of the inserted guide element.
[0060] FIG. 6 shows the device after the latching engagement with
of the guide element.
[0061] FIG. 7 shows a cross section through the device with
inserted shaft of the working tool at the time point of perforation
of the working tool through the bone plate.
[0062] FIG. 1 shows a particularly preferred exemplary embodiment
of the guide element 100 according to the invention in an oblique
view from above. The here shown guide element 100 is formed by a
sterilizable polymer, as it is known in the field of medical
technology. The guide element is configured one-piece or as one
part and is produced by means of injection molding. However,
sealings and bores can be performed subsequently.
[0063] In a disc-shaped head region 110 of the guide element 100, a
cylindrical through hole 101 is formed centrally, which completely
traverses the guide element 100. During operation, the shaft 5 of a
working tool 6, for example a milling tool is passed through this
through hole 101. The diameter of the through hole 101 is slightly
greater than the diameter of the shaft 5 of the working tool 6, so
that the milling tool 5, 6 remains movable in the hollow body 1,
and working medium can flow around the milling tool 5, 6.
[0064] Adjoining this head region 110 is a connection 108 in the
form of a socket for fastening a tube line 111 which is not shown
in this Figure. The tube line 11 is inserted into this socket. The
connection 108 extends radially and outwardly from the center of
the through hole 101, and the central longitudinal axis lies in the
plane of the disc-shaped head region 110 which plane is oriented
parallel to the surface.
[0065] Adjacent to the connection 108, a projecting nose 109 is
formed, which extends tangentially from the head region 110
parallel to the connection 108 and protrudes height wise as well as
longitudinally over the connection 108. The nose 109 serves on one
hand for securing the connection of the tube line 111 and for
better grip during pivoting.
[0066] Between the head region 110 and the connection 108, a
slightly downwardly offset, projecting latching element 107 is
molded with which the guide element 100 can be reversibly fastened
to the device.
[0067] As can be seen in FIGS. 3 to 7, a cylindrical elevation
which is arranged around the through hole 101 can be formed on the
topside of the guide element 100, in particular for improving the
guiding and the tightness.
[0068] FIG. 2 shows the guide element 100 from the opposite side
obliquely from below. The bottom surface 106 of the guide element
100, which bottom surface 106 faces the bone 24 during operation,
is smooth and planar, which ensures a good slideability and
rotatablility and pivotability. A cylindrical projection 104 is
formed in the head region 110, and is surrounded by a sealing
element 4 in the form of an O-ring which is retracted in a groove.
With this, the guide element 100 is form fittingly inserted into
the device, as described in the following Figures.
[0069] An upwardly tapered frustrum-shaped sleeve 105, is molded on
the projection 104. The greatest diameter on the base of the sleeve
105 is about 30 to 40% smaller than the diameter of the cylindrical
projection 104.
[0070] Like the head region 110, the cylindrical projection 104 and
the sleeve 105 are arranged concentrically around the central
longitudinal axis of the through hole 101 and are traversed in
their center by the through hole 101.
[0071] A channel 102, which is closed from all sides and is located
completely inside the guide element 101, extends from the
connection 108 and connects the connection with the outlet opening
103. The outlet opening 103 leads out at the bottom surface of the
cylindrical projection 104 adjacent the sleeve 105 and ensures
introduction of the fluid working- or pressure medium, in most
cases physiological saline solution, into the inlet opening 3 of
the device. The channel 102 is separated from the through hole 101
along its entire extent. The channel 102 has a first subsection
which is near the connection 108 and has an initial greater
diameter, and is oriented perpendicular and radially relative to
the longitudinal axis of the through hole 101. The diameter of the
channel 102 then decreases and the channel turns at a right angle.
This adjoining second subsection extends essentially parallel to
the central longitudinal axis of the through hole 101. In this way,
the channel 102 can be formed constructively simple in the
one-piece guide element, for example by two subsequent bores.
[0072] FIG. 3 shows the device according to the invention in a
perspective view. This exemplary and not limiting device for
penetrating extension of a blind hole in the jaw bone 24 includes a
working tool 6 in the form of a milling tool 6, and the guide
element 100 described above which is fixedly connected with a
hollow body 1.
[0073] The hollow body 1 is arranged on a handle element 112 which
has the shape of a flat small rod. The guide element 100 is
arranged in a recessed region 113 on the front end of the handle
element 112. The hollow body 1 has an essentially cylindrical inner
space 12, a distal working opening 2, and an inlet opening 3
opposite the working opening 2. Through this inlet opening 3 the
pressure medium as well as the shaft 5 of the working tool 6 is
inserted into the hollow space 12 of the hollow body 1. The hollow
body 1 is essentially constructed as the tubular body described in
WO 2010/048648.
[0074] In order to be able to form a pressure chamber 7 inside the
hollow body 1, it is necessary to seal the hollow space 12 of the
hollow body 1 and the shaft 5 of the milling tool 6 in the region
of the inlet opening 3. This pressure chamber 7 and the pressure
generated therein, ensure that the sinus membrane 26 is timely
pushed away of out of the zone of danger when perforating the bone
plate.
[0075] The formed pressure chamber 7 can either be located
completely inside the hollow body 1, when the working opening 2 is
sealingly flush with the bottom of the blind hole. However, the
pressure chamber 7 can also extend up to a region outside the
actual hollow body 1, which is delimited by the walling of the
blind hole and the conical sealing unit or the flange 11. During
operation, both these features have a sealing effect and complement
each other in order to maintain the system as pressure tight and
fluid tight as possible.
[0076] The inlet opening 3 on the other end of the pressure chamber
7 is closed in a pressure tight and fluid tight manner by the
tightly and form fittingly inserted guide element 100. In addition,
the shaft 5 is already inserted and traverses the through hole 101,
however, it does not yet exit through the working opening 2, and is
thus not yet operational. In the connection 108, the tube line 111
is already connected, thus enabling supply of pressure medium into
the inside of the hollow body 1. The tube line 11 extends in a
recessed groove 114 which is configured as handle element 112. This
groove is bent meander-shaped at two points in order to fasten the
tube on these fixing elements 117. The tube line 111 can lead to a
syringe or to a manual or automatic pressure control unit, with
which the pressure can be introduced and controlled.
[0077] FIGS. 4 to 7 show the stepwise preparation of the device for
the procedure:
[0078] In FIG. 4, the guide element 100 is already connected with
the tube line 111 however, not yet attached to the hollow body 1.
In the front portion of the handle element 112, the recessed region
113 can be recognized in which the guide element 100 is arranged.
In the front-most distal region of the recessed region 113, the
inlet opening 3 is arranged, which defines the access to the inner
hollow space 12 of the hollow body 1. The inlet opening 3 is
initially very wide and configured cylindrical in a first section
up to a stop or a circumferential stop surface 119 which has a
decreased diameter relative to the through hole 101. In this
cylindrical region, of the inlet opening 3 the cylindrical
projection 104 of the guide element 100 is inserted form fittingly,
wherein the bottom surface of the cylindrical projection 104 then
rests on the stop 119. This ensures a secure rotatability or
pivotability and simultaneous guiding and tightness, wherein the
central longitudinal through hole 101 forms the rotation axis.
[0079] The inlet opening 3 is tapered downwardly conically and
forms a funnel shaped hollow region. Inside the hollow body 1
extends the essentially cylindrical hollow space 12 up to the
working opening 2.
[0080] In FIG. 5, the guide element 100 is already form fittingly
and sealingly inserted into the inlet opening 2 with the projection
104. The guide element 100 is then rotated or pivoted by about
30.degree. to 40.degree. in the direction of the arrow, until the
connection 108 essentially points toward the start of the groove
114. Practically, the pivoting is carried out by gripping and
applying pressure on the nose 109. The latching element 107 can be
latchingly engaged in a form fitting and force fitting manner into
the corresponding latching recess 115 in the handle element 112,
more specifically into the vertical border surface of the recessed
region 113, thereby fixing the guide element 100 in position.
[0081] In FIG. 6, this engagement has already occurred and the tube
line 111 is also already inserted and fixed in the rove 114. The
device is now prepared and in practice the hollow body 1 is now
sealingly inserted into the pre-drilled blind hole in the jaw bone
24 of the patient.
[0082] FIG. 7 shows a cross section through the device with
inserted shaft 5 of the working tool 6 during a sinus lift at the
time point when the working tool 6 perforates the bone plate of the
haw bone 24 of the upper jaw. FIG. 7 shows the device in its
spatially correct positioning in practice relative to the
patient.
[0083] As in the conventional crestal sinus lift, a blind hole is
introduced into the jaw bone 24 in a prior procedure starting from
the jaw crest, wherein an approximately 1 mm deep bone plate
remains between the end of the blind hole and the maxillary sinus
25. This is necessary in order to prevent damage to the mucosa of
the maxillary sinus 26 which rests against the jaw bone 24 in the
maxillary sinus 25.
[0084] Then, the hollow body 1 is sealingly inserted into the
prepared blind hole, until the working opening 2 abuts the bone
plate. The hollow body 1 stands still during the procedure, is
fixed in position and can even be screwed in.
[0085] For improving the sealing effect, the flange 10 is shifted
on the tube body 1 towards the jaw bone 24, so that the conical
sealing portion 11 which is arranged on the flange 10 is strongly
pushed against the oral mucosa 27 at the outer border of the blind
hole, and the blind hole is sealed. Optionally, a cofferdam can
also be used. Inside the pressure chamber 7, a hydrostatic pressure
of about 0.5 to 3 bar can then be established.
[0086] The working medium in the pressure chamber 7 serves
simultaneously for dissipating heat generated by the milling and as
lubricant for the rotating shaft 5. Small amounts of working medium
which can leak along the rotating shaft 5 do not pose a problem for
the functionality of the device, because the pressure of the
working medium can be maintained in the pressure chamber 7 via the
connection 108. Good sealing properties are nevertheless very
advantageous because the pressure decrease at the moment of
perforation of the bone plate can be more readily recognized when
the pressure chamber is sealed tight.
[0087] After this, the shaft 5 of the working tool 6 is inserted
through the through hole 101 and the inlet opening 3 into the
inside of the hollow body 1. The diameter of the shaft 5 is
configured to decrease toward the tip. Thus, the diameter of the
shaft 5 decreases in the region of the entry point of the inlet
opening 3 by about one quarter. As a result, sufficient space
remains between the shaft 5 and the inner surface of the hollow
space 12 to form the pressure chamber 7 and to provide sufficient
freedom of movement for the milling tool to perform tumbling
movements. In the end side region of the drill head of the milling
tool 6, the diameter decreases again by one quarter. In addition,
the outermost tip or the drill head of the milling tool 6 or the
shaft 5 is relatively strongly curved or essentially configured
puncitform in order to ensure as much as possible a puncitform,
small-surface perforation through the bone plate.
[0088] The shaft 5 traverses the through hole 101, the inlet
opening 3 and the inner hollow space 21 of the hollow body 1
completely and exits through the working opening 2, so that the
remaining bone plate can be worked on. The distal region of the
shaft 5 with smaller diameter can be guided through the through
hole 101 relatively easily, the rear region with greater diameter
then comes to sit form fittingly in the through hole 101.
[0089] The shaft 5 thus sealingly rests against the inner surface
of the through hole 101 in this region or is additionally also
sealed, guided and supported in the region of the cylindrical
projection 104 and the sleeve 105. Inside the through hole 101, an
additional sealing for example an O-ring can also be provided
however, this is not the case in the present exemplary
embodiment.
[0090] Nevertheless, the shaft 5 is movable axially, i.e., upwards
and downwards according to the arrow, which is required especially
in the case of rotating milling tools 6 in order to achieve the
necessary forward advance for milling through the bone plate in the
jaw bone 24. In addition, it is further possible, for example due
to the flexibility of the material of the guide element 100, to
move the shaft 5 in a rotating or tumbling movement, to remove the
bony floor plate as expansively and completely as possible.
[0091] This rotating movement is also possible when using a working
tool with a shaft 5 which rotates about its own axis. The shaft 5
is nevertheless supported fluid tight and pressure tight especially
in the region of the sleeve 105, and a sufficient pressure can be
built up in the pressure chamber 7 when the hollow body 1 is
sealingly inserted into the blind hole.
[0092] Via the connection 108, the working medium, for example a
physiological saline solution, can now be introduced into the inlet
opening 3. Because the outer walling of the sleeve 105 is spaced
apart from the inner walling of the funnel-shaped inlet opening 3,
the rinsing medium flows outside along the sleeve 105 and along the
shaft 5 into the inner space 12 or the pressure chamber 7.
[0093] The milling tool 6 in FIG. 7 is then progressively moved
further downward, so that the milling head exits at the lower end
through the working opening 2 and touches the floor plate, wherein
the advance of the shaft 5 or the milling tool 6 is very slow, for
example about 1 mm/min.
[0094] As soon as the floor plate is perforated minimally at one
point, which is facilitated by the punctiform drill- or milling
head, the pressurized working medium immediately exits through this
minimal opening and the sinus membrane 26 is immediately pushed out
of the zone of danger away from the drill head and slightly
detached from the jaw bone 24, before the drill head can fully
traverse the opening. This corresponds to the situation shown in
FIG. 7.
[0095] The milling tool is then turned off and the sinus membrane
26 is further detached as known from WO 2010/048648 in order to
increase the space for the bone replacement material, for example
by additional supply of pressure medium and as the case may be, by
introducing vibrations.
[0096] The shaft 5 can remain in the through hole 101 as sealing
element for the time being. As an alternative, the shaft 5 can also
be removed and the through hole 101 can be sealingly closed by
inserting a stopper. This allows to further exert pressure or to
maintain the pressure constant.
[0097] As the case may be, vibrations, for example ultrasound
vibrations, can be introduced into the medium to facilitate a
further detachment of the sinus membrane 26.
[0098] For exchanging or removing the guide element 100 after the
procedure, the guide element 100 is gripped at the nose 109 and
pivotally rotated in the opposite direction indicated by the arrow
in FIG. 5. In the front most region of the handle element 112, a
continuously increasing outer border 116 is formed, which interacts
with the bottom surface 106, forces the guide element 100 upwards
during the pivoting and eventually lifts the guide element 100 out
of the inlet opening 3.
[0099] According to the invention, it is further provided that the
guide element 100 is distributed as sterilized and aseptically
packaged disposable item or medical product either by itself or
combined with the tube line 111. Just prior to starting the
procedure, the surgeon or dentist can tear open the packaging and
remove the guaranteed contamination-free guide element 100 and the
tube unit 111, fasten the same to the hollow body 1 and arrange the
working tool correspondingly.
[0100] For the functionality of the device and in particular the
application on the patient reference is made to the discussion in
WO 2010/048648 A1.
* * * * *