U.S. patent application number 12/070052 was filed with the patent office on 2008-09-25 for surgical data carrier.
This patent application is currently assigned to AESCULAP AG & Co. KG. Invention is credited to Markus Nesper, Thomas Pleil, Dirk Schauer, Dieter Weisshaupt.
Application Number | 20080230421 12/070052 |
Document ID | / |
Family ID | 39400040 |
Filed Date | 2008-09-25 |
United States Patent
Application |
20080230421 |
Kind Code |
A1 |
Pleil; Thomas ; et
al. |
September 25, 2008 |
Surgical data carrier
Abstract
The invention relates to a surgical data carrier for the
identification of a medical implant, in particular, a surgical
plate for the fixing of bones or bone fragments, comprising a
carrier element and a connecting device which has a receptacle for
the insertion of at least part of the implant. In order to make
such a surgical data carrier available which has an improved
handling capability, it is suggested according to the invention
that the connecting device be designed in such a manner that it can
be transferred from a connecting position, in which the implant is
held in the receptacle, into a release position, in which the data
carrier can be detached from the implant, without any forces acting
on the implant. In addition, the invention relates to a surgical
implantation system as well as an identification system for
identifying and handling a medical implant.
Inventors: |
Pleil; Thomas; (Bad
Duerrheim, DE) ; Nesper; Markus; (Tuttlingen, DE)
; Schauer; Dirk; (Berlin, DE) ; Weisshaupt;
Dieter; (Immendingen, DE) |
Correspondence
Address: |
Lipsitz & McAllister, LLC
755 MAIN STREET
MONROE
CT
06468
US
|
Assignee: |
AESCULAP AG & Co. KG
Tuttlingen
DE
|
Family ID: |
39400040 |
Appl. No.: |
12/070052 |
Filed: |
February 13, 2008 |
Current U.S.
Class: |
206/438 |
Current CPC
Class: |
A61B 17/808 20130101;
A61B 17/28 20130101; A61B 90/94 20160201; A61B 17/80 20130101 |
Class at
Publication: |
206/438 |
International
Class: |
B65D 85/00 20060101
B65D085/00 |
Foreign Application Data
Date |
Code |
Application Number |
Feb 28, 2007 |
DE |
10 2007 011 086 |
Claims
1. Surgical data carrier for the identification of a medical
implant, in particular, a surgical plate for the fixing of bones or
bone fragments, comprising a carrier element and a connecting
device with a receptacle for the insertion of at least part of the
implant, wherein the connecting device is designed in such a manner
that it is transferable from a connecting position, the implant
being held in the receptacle in said connecting position, into a
release position, the data carrier being detachable from the
implant in said release position, without any forces acting on the
implant.
2. Surgical data carrier as defined in claim 1, wherein the
receptacle is enlarged during the transfer of the connecting device
from the connecting position into the release position.
3. Surgical data carrier as defined in claim 1, wherein the
connecting device is designed in such a manner that it is
transferable from the release position into the connecting position
without any forces acting on the implant.
4. Surgical data carrier as defined in claim 1, wherein the
connecting device is designed in such a manner that it takes up the
connecting position automatically proceeding from the release
position.
5. Surgical data carrier as defined in claim 1, wherein the
connecting device comprises at least one connecting element
arranged on the carrier element, said connecting element limiting
the receptacle at least in sections and interacting with the
implant for the connection of the data carrier.
6. Surgical data carrier as defined in claim 5, wherein the at
least one connecting element has a contact surface abutting on the
implant in the connecting position.
7. Surgical data carrier as defined in claim 5, wherein the
connecting device comprises two or more connecting elements
limiting the receptacle in sections.
8. Surgical data carrier as defined in claim 7, wherein the two or
more connecting elements are movable relative to one another.
9. Surgical data carrier as defined in claim 5, wherein the at
least one connecting element is arranged or mounted on the carrier
element so as to be movable.
10. Surgical data carrier as defined in claim 5, wherein the at
least one connecting element is designed to be deformable at least
in sections.
11. Surgical data carrier as defined in claim 5, wherein the at
least one connecting element is designed to project from the
carrier element.
12. Surgical data carrier as defined in claim 1, wherein the
carrier element limits the receptacle at least in sections.
13. Surgical data carrier as defined in claim 5, wherein the at
least one connecting element is designed as a snap-in element.
14. Surgical data carrier as defined in claim 5, wherein the at
least one connecting element is designed as a clamping element.
15. Surgical data carrier as defined in claim 1, wherein the
connecting device has a securing member for securing the implant in
the receptacle in the connecting position.
16. Surgical data carrier as defined in claim 15, wherein the
securing member is adapted to be brought into engagement with a
receptacle comprised by the implant.
17. Surgical data carrier as defined in claim 1, wherein the
carrier element is deformable at least in sections such that the
connecting device is transferable from the connecting position into
the release position.
18. Surgical data carrier as defined in claim 1, wherein the
carrier element comprises a first carrier element section and a
second carrier element section movable relative to one another.
19. Surgical data carrier as defined in claim 18, wherein the
carrier element has a weakened area arranged between the first
carrier element section and the second carrier element section,
said weakened area having a greater deformability than at least one
of the two carrier element sections.
20. Surgical data carrier as defined in claim 18, wherein the
carrier element comprises at least one tool element receptacle for
a handling device for the data carrier on the first carrier element
section and/or on the second carrier element section.
21. Surgical data carrier as defined in claim 20, wherein the at
least one receptacle is designed as a passage of the carrier
element.
22. Surgical data carrier as defined in claim 1, wherein the
carrier element is of a plate-like design.
23. Surgical data carrier as defined in claim 1, wherein the data
carrier comprises a data storage device for storing data able to
identify the implant.
24. Surgical data carrier as defined in claim 23, wherein the data
storage device is adapted to be read in a non-contact manner.
25. Surgical data carrier as defined in claim 23, wherein the data
storage device is arranged at least partially on the carrier
element.
26. Surgical data carrier as defined in claim 1, wherein the data
carrier is produced at least partially from a plastic material.
27. Surgical data carrier as defined in claim 1, wherein the data
carrier is produced at least partially from a shape memory metal
alloy.
28. Surgical data carrier as defined in claim 1, wherein the data
carrier is produced from a sterilizable material.
29. Surgical data carrier as defined in claim 1, wherein the data
carrier is produced at least partially from a material having a
thermal-coefficient of expansion greater than the thermal
coefficient of expansion of titanium or that of an alloy having
titanium as its main component.
30. Surgical data carrier as defined in claim 1, wherein the data
carrier is produced from a resorbable material.
31. Surgical data carrier as defined in claim 1, wherein the data
carrier is detachable from the implant free from residue.
32. Surgical data carrier as defined in claim 1, wherein the data
carrier is designed in one piece.
33. Surgical implantation system having at least one medical
implant, in particular, a surgical plate for the fixing of bones or
bone fragments as well as a surgical data carrier detachably
connectable to the implant for the identification of the implant,
comprising a carrier element and a connecting device having a
receptacle for the insertion of at least part of the implant,
wherein the connecting device is designed in such a manner that it
is transferable from a connecting position, the implant being held
in the receptacle in said connecting position, into a release
position, the data carrier being detachable from the implant in
said release position, without any forces acting on the
implant.
34. Surgical implantation system as defined in claim 33, wherein
the connecting device is designed in such a manner that it is
transferable from the release position into the connecting position
without any forces acting on the implant.
35. Identification system for identifying and handling a medical
implant, in particular, a surgical plate for the fixing of bones or
bone fragments, said system having a surgical data carrier for the
identification of the implant, said data carrier comprising a
carrier element and a connecting device having a receptacle for the
insertion of at least part of the implant, wherein the connecting
device is designed in such a manner that it is transferable from a
connecting position, the implant being held in the receptacle in
said connecting position, into a release position, the data carrier
being detachable from the implant in said release position, without
any forces acting on the implant, and wherein the identification
system comprises a handling device for transferring the connecting
device from the connecting position into the release position.
36. Identification system as defined in claim 35, wherein the
connecting device is designed in such a manner that it is
transferable from the release position into the connecting position
without any forces acting on the implant.
37. Identification system as defined in claim 35, wherein the
handling device has a first tool element as well as a second tool
element movable relative to it, each tool element being adapted to
be brought into engagement with the carrier element or to abut on
it.
38. Identification system as defined in claim 37, wherein during
use of the handling device the first tool element and the second
tool element are able to engage in tool element receptacles
arranged in the first carrier element section and second carrier
element section, respectively, and designed to correspond to the
first and second tool elements, respectively.
39. Identification system as defined in claim 37, wherein the first
tool element and/or the second tool element each have at least one
carrier element receptacle for engagement of the first carrier
element section and the second carrier element section,
respectively, in sections during use of the handling device.
40. Identification system as defined in claim 37, wherein the first
tool element and/or the second tool element are designed as arms of
forceps.
41. Identification system as defined in claim 37, wherein the first
tool element and/or the second tool element is designed as a
plunger.
42. Identification system as defined in claim 37, wherein the first
tool element and the second tool element are displaceable and/or
pivotable relative to one another.
Description
[0001] The present disclosure relates to the subject matter
disclosed in German application number 10 2007 011 086.5 of Feb.
28, 2007, which is incorporated herein by reference in its entirety
and for all purposes.
BACKGROUND OF THE INVENTION
[0002] The invention relates to a surgical data carrier for the
identification of a medical implant, in particular, a surgical
plate for the fixing of bones or bone fragments, comprising a
carrier element and a connecting device which has a receptacle for
the insertion of at least part of the implant.
[0003] In addition, the invention relates to a surgical
implantation system which has at least one medical implant, in
particular, a surgical plate for the fixing of bones or bone
fragments as well as a surgical data carrier which can be
detachably connected to the implant for the identification of the
implant, comprising a carrier element and a connecting device which
has a receptacle for the insertion of at least part of the
implant.
[0004] Furthermore, the invention relates to an identification
system for identifying and handling a medical implant, in
particular, a surgical plate for the fixing of bones or bone
fragments which has a surgical data carrier for the identification
of the implant, the data carrier comprising a carrier element and a
connecting device which has a receptacle for the insertion of at
least part of the implant.
[0005] In the following, the surgical data carrier will also be
designated simply as "data carrier", the surgical implantation
system simply as "implantation system".
[0006] A surgical data carrier of the type specified at the outset
is known from U.S. Pat. No. 6,929,646 B2. It is part of a surgical
implantation system which comprises, apart from the data carrier, a
surgical plate for the fixing of bones or bone fragments. The data
carrier bears data identifying the implant. For handling the
implant, the data carrier has a carrier element which serves as a
handle for the implant and on which a connecting device is
arranged. The connecting device comprises a receptacle for an
attachment lobe which is arranged on the implant, is to be screwed
to the bone or bone fragment and is held first of all in the
receptacle during use of the implantation system. In order to
separate the implant from the data carrier, a relative movement of
data carrier and implant is required. For this purpose, pulling
forces are exerted both on the implant and on the data carrier.
This has proven to be disadvantageous and complicated, particularly
when the implant is difficult to grasp as a result of its small
size. The pulling force may be applied by way of a counterforce on
the basis of a fixing of the implant to a bone or bone fragment.
This does, however, involve the risk that the fixing of the implant
will be impaired during detachment of the data carrier from the
implant. This can have negative effects on the safekeeping of the
patient.
[0007] Therefore, it would be desirable to have a surgical data
carrier, a surgical implantation system and an identification
system of the type specified at the outset with an improved
handling capability.
SUMMARY OF THE INVENTION
[0008] In accordance with the invention, it is suggested in a
surgical data carrier of the generic type, that the connecting
device is designed in such a manner that it can be transferred from
a connecting position, in which the implant is held in the
receptacle, into a release position, in which the data carrier can
be detached from the implant, without any forces acting on the
implant.
[0009] The data carrier according to the invention can be
transferred from a connecting position into a release position, in
which it can be detached from the implant, without any forces
acting on the implant. Consequently, forces acting on the data
carrier are sufficient for a user to transfer the connecting device
from the connecting position into the release position.
Subsequently, a relative movement of the implant and the data
carrier can be brought about for detaching the data carrier. It is
not, therefore, necessary to exert any pulling or holding force on
the implant. This gives the data carrier an improved handling
capability. In addition, potential negative consequences, which may
be the result of detachment of the data carrier from a fixed
implant, may be avoided to a great extent with the use of the
surgical data carrier according to the invention.
[0010] In the connecting position, the implant can be held in the
receptacle, for example, in a force-locking, form-locking and/or
frictional manner. It is, for example, possible for a section of
the implant to be partially enclosed in an annular manner by the
connecting device. This can form a recess for this purpose and/or
engage around or behind the implant in sections. It is also
conceivable for part of the implant to be held in the receptacle by
way of clamping.
[0011] It is favorable when the receptacle is enlarged during the
transfer of the connecting device from the connecting position into
the release position. As a result of the enlargement of the
receptacle during the transfer of the connecting device into the
release position, any force locking, form locking and/or frictional
locking between data carrier and implant can, for example, be
overcome in order to detach the data carrier from the implant. The
receptacle favorably comprises an insertion opening for the implant
which is likewise enlarged when the connecting device is
transferred from the connecting position into the release position.
The insertion opening can preferably be enlarged to such an extent
that the part of the implant held in the receptacle can pass
through the insertion opening during the detachment of the data
carrier from the implant without having to touch the sections
bordering on the insertion opening.
[0012] It is of advantage when the connecting device is designed in
such a manner that it can be transferred from the release position
into the connecting position without any forces acting on the
implant. This allows the data carrier to be connected to the
implant without any force needing to the exerted on the implant for
this purpose. On the contrary, only a force acting on the data
carrier is sufficient. As a result, the data carrier has an even
better handling capability.
[0013] The connecting device is preferably designed in such a
manner that it takes up the connecting position automatically
proceeding from the release position. The connecting position can
define, for example, a rest position of the connecting device. As a
result, it can be ensured that the data carrier can be detached
from the implant only by a user consciously initiating the release
procedure. In addition, the connecting of the data carrier to the
implant can be made easier with such an embodiment. After the
insertion of at least part of the implant into the receptacle, the
connecting device transfers automatically from the release position
into the connecting position without any effort on the part of the
user. This makes the data carrier user friendly.
[0014] The connecting device advantageously comprises at least one
connecting element which is arranged on the carrier element, limits
the receptacle at least in sections and interacts with the implant
for the connection of the data carrier. This favors a simple
construction of the data carrier. The connecting element
interacting with the implant defines a limitation of the receptacle
in sections and is, in addition, arranged directly on the carrier
element.
[0015] It is favorable when the at least one connecting element has
a contact surface which abuts on the implant in the connecting
position. A form-locking, force-locking or frictional connection
can be provided between the connecting device and the implant in
the connecting position via the contact surface. It can be ensured
by a form-locking, force-locking and/or frictional connection that
the implant is held securely in the receptacle in the connecting
position.
[0016] In order to make a simple construction of the data carrier
possible, the connecting device preferably comprises two or more
connecting elements which limit the receptacle in sections. The
receptacle can, in particular, be defined between them. Each
connecting element therefore limits the receptacle at least in
sections.
[0017] It is of advantage when the two or more connecting elements
are movable relative to one another. As a result of a relative
movement of the two or more connecting elements, it is possible in
a simple manner for the receptacle and/or its insertion opening to
be enlarged so that the detachment of the data carrier from the
implant is made possible. The transferability of the connecting
device from the connecting position into the release position
and/or vice versa is advantageously based on the relative movement
of the two or more connecting elements. It may be provided for all
or only some of the connecting elements to be movable relative to
one another when more than two connecting elements are present.
[0018] The at least one connecting element is preferably arranged
or mounted on the carrier element so as to be movable. As a result,
the at least one connecting element may be designed to be movable
in a technically simple way. A movable mounting of the at least one
connecting element may be brought about in accordance with the
methods known to the person skilled in the art. A movable
arrangement of the at least one connecting element on the carrier
element may be achieved, for example, by way of a materially
elastic section of the at least one connecting element or a
materially elastic intermediate member between the carrier element
and the at least one connecting element.
[0019] It is favorable when the at least one connecting element is
designed to be deformable at least in sections, preferably even
elastically deformable. As a result of deformation of the at least
one connecting element which can be based on a material elasticity
thereof, it is possible, for example, for the at least one
connecting element to be movable at least in sections. In
accordance with the above explanations, the transferability of the
connecting device from the connecting position into the release
position and/or vice versa can be based on such a deformability of
the at least one connecting element. It may be provided for the at
least one connecting element to be designed to project from the
carrier element.
[0020] It is of advantage when the carrier element limits the
receptacle at least in sections. This offers the possibility of
giving the data carrier a simple construction. In particular, it
may be provided for the at least one connecting element and the
carrier element to limit the receptacle completely or essentially
completely.
[0021] The at least one connecting element is preferably designed
as a snap-in element. As a result, a form-locking connection can,
for example, be provided between the at least one connecting
element and the implant, by way of, for example, engagement around
or behind the implant. This allows the implant to be held
particularly securely in the receptacle in the connecting position.
The implant can also have a suitable, in particular, corresponding
snap-in receptacle for the snap-in element.
[0022] It has proven to be favorable when the at least one
connecting element is designed as a clamping element. This offers
the possibility of providing a force-locking or frictional
connection between the at least one connecting element and the
implant in the connecting position so that, as a result, the
implant is held securely in the receptacle in the connecting
position.
[0023] It is of advantage when the connecting device has a securing
member which secures the implant in the receptacle in the
connecting position. It can be ensured as a result of the securing
member that the implant is held particularly securely in the
receptacle in the connecting position. A projection arranged on the
at least one connecting element may be provided, for example, as
securing member which forms a recess for the implant in the
connecting position and/or engages around or behind it.
[0024] The securing member can preferably be brought into
engagement with a receptacle comprised by the implant since, as a
result, it is possible for the implant to be held even more
reliably in the receptacle in the connecting position. A design of
the securing member as a snap-in nose is, for example, conceivable.
This can interact, for example, with a preferably corresponding
snap-in receptacle arranged in the implant.
[0025] The carrier element is advantageously deformable at least in
sections such that the connecting device can be transferred from
the connecting position into the release position. As a result, the
transfer of the connecting device from the connecting position into
the release position may be brought about, in particular, by a
force acting only on the carrier element. This can be of advantage,
particularly in the case of implants which have small dimensions,
such as, for example, surgical plates for the fixing of bones or
bone fragments, such as those used in the field of oral, dental or
facial surgery. Normally, connecting devices with receptacles for
implants of this type likewise have small dimensions. A direct
handling of such connecting devices is, therefore, difficult or
even impossible for a user. This is the case, for example, with the
implantation system described in U.S. Pat. No. 6,929,646 B2
specified at the outset. In comparison, the handling of the data
carrier is improved for a user as a result of the embodiment now
described. The carrier element can be configured to be sufficiently
large to make simple gripping by the user possible.
[0026] It may also be provided for the carrier element to be
deformable at least in sections such that the connecting device can
be transferred from the release position into the connecting
position.
[0027] The carrier element preferably comprises a first carrier
element section and a second carrier element section which can be
moved relative to one another. As a result, the data carrier can be
designed in a simple manner in accordance with the embodiment last
described. It may be provided, for example, for a connecting
element of the connecting device to be arranged not only on the
first but also on the second carrier element section and for these
connecting elements to be movable relative to one another as a
result of a relative movement of the carrier element sections. As a
result of the relative movement of the connecting elements, a
receptacle defined between the connecting elements can, for
example, be enlarged. An implant held in the receptacle can,
therefore, be released and so the data carrier can be detached from
the implant.
[0028] The carrier element advantageously has a weakened area which
is arranged between the first carrier element section and the
second carrier element section and has a greater deformability than
at least one of the two carrier element sections. The formation of
a weakened area between the carrier element sections allows the
carrier element sections to be designed in a technically simple
manner so as to be movable relative to one another. The increased
deformability of the weakened area can be based, for example, on
the fact that the carrier element has a reduced material thickness
at the weakened area in comparison with at least one of the carrier
element sections. The weakened area can, in particular, form a film
hinge between the carrier element sections.
[0029] The carrier element favorably comprises at least one tool
element receptacle for a handling device for the data carrier on
the first carrier element section and/or on the second carrier
element section. This allows a tool element of the handling device
which corresponds to the at least one tool element receptacle to be
able to engage in the at least one tool element receptacle. If the
tool element is in secure engagement with the tool element
receptacle, the data carrier and, with it, an implant held in the
tool element receptacle of the connecting device can be moved,
transported, held or the like. This has proven to be useful during
the insertion of the implant, which can be placed at its
predetermined location together with the data carrier by means of
the handling device, into the body of the patient. In addition, it
may be provided for a force to be exerted on the first and/or the
second carrier element section by means of the tool element of the
handling device in order to move the two carrier element sections
relative to one another and, as a result, to transfer the
connecting device from the connecting position into the release
position and/or vice versa.
[0030] The at least one receptacle is preferably designed as a
passage of the carrier element.
[0031] A constructionally simple embodiment of the data carrier may
be achieved in that the carrier element is of a plate-like design.
In this respect, the first carrier element section and the second
carrier element section are favorably designed as oppositely
located sides of the plate-like carrier element, between which a
weakened area can be arranged.
[0032] The data carrier advantageously comprises a data storage
device for storing data which can identify the implant. The data
suitable for identifying the implant can, for example, include the
name of the producer, type and size of the implant, article number,
serial number, batch number or the like. As a result, it can be
determined, for example, what type of implant is involved.
[0033] When a serial number is present, a precise identification of
the implant can even be carried out. This of great importance for
documentation purposes for medical procedures and can serve the
purpose of tracing the implant after its insertion.
[0034] It may be provided for the data carrier to be designed such
that the data are stored in a physical form. It is possible, for
example, to apply the data by way of embossing on the data carrier
or by spraying onto the data carrier. A utilization of the data
storage device, with which the storing of data can be carried out
by way of writing on the data carrier, application of labels, tags
or the like, is also understood in the present case as a suitable
way of storing data in a physical form.
[0035] Furthermore, the data storage device can be designed such
that the data suitable for identifying the implant are stored in an
electronic form. In this respect, it may be provided for the data
stored in such a manner to be modifiable and, in particular,
modifiable one time.
[0036] It is favorable when the data storage device can be read in
a non-contact manner. For example, it may be read inductively with
the use of a transponder, in particular, an RFID chip. This is of
significance, especially in the case of data stored
electronically.
[0037] Furthermore, the data carrier can be read in a non-contact
manner as a result of the use of optical means. This is understood
in the present case as the reading of the data stored by the data
storage device with the aid of an optical imaging device, such as,
in a particularly advantageous manner, the human eye. Optical
scanners and/or bar code readers, by means of which the data stored
in the data storage device can be read, are also conceivable.
[0038] It is favorable for a simplified and fast reading of the
data when the data storage device can be read mechanically, i.e.,
with the aid of a technical device.
[0039] The data storage device is advantageously arranged, at least
partially, on the carrier element since, as a result, it is
possible to give the data carrier a compact constructional
form.
[0040] It has proven to be favorable when the data carrier is
produced at least partially from a plastic material. This allows a
technically simple and inexpensive production of the data carrier.
Polymer materials, such as polyether ether ketone (PEEK), polyether
ketone ketone (PEKK), polyoxymethylene (POM),
polytetrafluoroethylene (PTFE, Teflon) or the like, are, for
example, conceivable.
[0041] It is of advantage when the data carrier is produced at
least partially from a shape memory metal alloy. In this respect,
the movable parts of the data carrier are preferably manufactured
from a shape memory metal alloy. Such an embodiment is useful, in
particular, when the data carrier is reused. It can then be ensured
that the data carrier can again take up a defined original shape
even after several movement cycles.
[0042] It has proven to be favorable when the data carrier is
produced from a sterilizable material since this allows it to be
sterilized. The data carrier can advantageously be sterilized as
often as required. The sterilization is preferably brought about in
a single procedure with the implant held in the receptacle. As a
result of the sterilization of the data carrier, a risk of
infection for a patient, for whom the implant is intended, can be
reduced even when the data carrier is intended to remain in the
body of the patient.
[0043] It is of advantage when the data carrier is produced at
least partially from a material which has a thermal coefficient of
expansion which is greater than the thermal coefficient of
expansion of titanium or that of an alloy, the main component of
which is titanium. Medical implants for the fixing of bones or bone
fragments are often produced from titanium or a titanium alloy, the
main component of which is titanium. It is possible by means of
this embodiment for the sections of the data carrier limiting the
receptacle to expand to a greater extent than the implant during
common sterilization of the data carrier and an implant held in the
receptacle. In the case where the implant is seated in the
receptacle in a form-locking manner at a normal temperature, spaces
may be formed between the implant and the specified sections due to
heating up during the sterilization procedure. Hot steam can
penetrate the spaces during the sterilization procedure, cover the
areas of the implant arranged in the receptacle and likewise
sterilize them.
[0044] The data carrier is preferably produced from a resorbable
material. Normally, the data carrier is to be detached from the
implant as determined after the insertion of the implant into the
body of the patient. If this does not occur intentionally or also
unintentionally, the risk of an infection for the patient as a
result of the data carrier remaining in the body can be reduced in
this way.
[0045] It is of advantage when the data carrier can be detached
from the implant free from residue since, as a result, it can be
ensured that no residues of the data carrier, which represent a
potential risk of infection for the patient, remain during the
insertion of the implant into the body of the patient and
detachment of the data carrier from the implant.
[0046] It is favorable for the inexpensive production of the data
carrier when the data carrier is designed in one piece. Preferably,
it is produced, in particular, in one piece from a plastic
material.
[0047] As already mentioned, the invention also relates to a
surgical implantation system.
[0048] Moreover, in accordance with the invention, it is suggested
in a generic surgical implantation system, that the connecting
device is designed in such a manner that it can be transferred from
a connecting position, in which the implant is held in the
receptacle, into a release position, in which the data carrier can
be detached from the implant, without any forces acting on the
implant.
[0049] The data carrier has the advantages already explained and so
the surgical implantation system has an improved handling
capability.
[0050] It is of advantage, in particular, when the data carrier is
designed as one of the data carriers described above. The
implantation system then has the additional advantages mentioned in
the explanations concerning these data carriers.
[0051] As already mentioned, the invention relates, in addition, to
an identification system for identifying and handling a medical
implant.
[0052] Furthermore, in accordance with the invention, it is
suggested in a generic identification system, that the connecting
device is designed in such a manner that it can be transferred from
a connecting position, in which the implant is held in the
receptacle, into a release position, in which the data carrier can
be detached from the implant, without any forces acting on the
implant and that the identification system comprises a handling
device for transferring the connecting device from the connecting
position into the release position.
[0053] The identification system has the advantages already
specified in conjunction with the explanations concerning the data
carrier. The connecting device may be transferred from the
connecting position into the release position by means of the
handling device in order to detach the data carrier from the
implant.
[0054] The data carrier is, in particular, advantageously designed
as one of the data carriers described above. The identification
system then has the additional advantages mentioned in the
explanations concerning these data carriers.
[0055] It is favorable when the handling device has a first tool
element as well as a second tool element moveable relative to it,
these tool elements each being able to be brought into engagement
with the carrier element or to abut on it. If the carrier element
has, for example, two carrier element sections which can be moved
relative to one another, a relative movement of the carrier element
sections can be initiated by bringing the first tool element into
engagement with the first carrier element section and the second
tool element into engagement with the second carrier element
section. If the carrier element sections interact with connecting
elements defining the connecting device, a relative movement of the
connecting elements can also be brought about as a result. A
receptacle defined between the connecting elements can be enlarged
so that the data carrier can be detached from the implant.
[0056] In a preferred embodiment of the identification system, the
first tool element and the second tool element can engage in tool
element receptacles which are arranged on the first carrier element
section and section carrier element section, respectively, and are
designed to correspond to the first and second tool elements,
respectively, during use of the handling device.
[0057] In a further, preferred embodiment of the identification
system, the first tool element and/or the second tool element each
have at least one carrier element receptacle for engaging with the
first carrier element section and the second carrier element
section, respectively, in sections during use of the handling
device.
[0058] In the last two embodiments mentioned, a relative movement
of the carrier element sections of the carrier element can be
brought about, as explained above, as a result of a relative
movement of the two tool elements in order to initiate the
detachment of the data carrier from the implant. When the first
and/or the second tool element is in engagement with the carrier
element, it is, in addition, possible to move, transport, hold the
data carrier or the like, preferably with an implant held in the
receptacle. For example, the data carrier can be transported by
means of the handling device to the predetermined location, i.e.,
for example, the bone or the bone fragment with an implant held in
the receptacle during the insertion of the implant into the body of
a patient. Subsequently, the implant can be fixed to the bone or
bone fragment and then the data carrier detached from the implant
by means of the handling device.
[0059] It is favorable when the first tool element and/or the
second tool element are designed as arms of forceps. Forceps are
part of the standard equipment for an operative set of instruments
and can be used as a handling device. As a result, it is not
necessary to make a handling device available which is specially
configured for the data carrier and so such an identification
system can be offered inexpensively.
[0060] The first tool element and/or the second tool element is
preferably designed as a plunger. This can abut on the carrier
element in order to act on it with a force in order to bring about
relative movement of the carrier element sections.
[0061] It is of advantage when the first tool element and the
second tool element can be displaced and/or pivoted relative to one
another. As explained, a relative movement of the carrier element
sections for the detachment of the data carrier can be initiated as
a result of the relative movement of the tool elements.
[0062] The following description of preferred embodiments serves to
explain the invention in greater detail in conjunction with the
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0063] FIG. 1: shows a perspective view of a first embodiment of a
surgical implantation system according to the invention;
[0064] FIG. 2: shows a sectional view along line 2-2 in FIG. 1;
[0065] FIG. 3: shows a view similar to FIG. 2 during a
sterilization procedure of the surgical implantation system in the
heated state;
[0066] FIG. 4: shows a second, preferred embodiment of a surgical
implantation system according to the invention in a perspective
view;
[0067] FIG. 5: shows a third, preferred embodiment of a surgical
implantation system according to the invention in a perspective
view;
[0068] FIG. 6: shows a fourth, preferred embodiment of a surgical
implantation system according to the invention in a perspective
view;
[0069] FIG. 7: shows a fifth, preferred embodiment of the surgical
implantation system according to the invention in a perspective
view;
[0070] FIG. 8: shows a partial illustration of a first, preferred
embodiment of an identification system according to the invention
with an implant in a sectional view similar to FIG. 2;
[0071] FIG. 9: shows a view similar to FIG. 8 during the detachment
of the surgical data carrier from the implant;
[0072] FIG. 10: shows a perspective, partial illustration of a
second, preferred embodiment of an identification system according
to the invention with an implant during the fixing to a bone
fragment;
[0073] FIG. 11: shows a sectional view along line 11-11 in FIG. 10
and
[0074] FIG. 12: shows a view similar to FIG. 11 during the
detachment of the surgical data carrier from the implant.
DETAILED DESCRIPTION OF THE INVENTION
[0075] A first, preferred embodiment of a surgical implantation
system according to the invention is shown in FIG. 1 and given,
altogether, the reference numeral 10. The implantation system 10
comprises an implant 12 as well as a first, preferred embodiment of
a surgical data carrier 14 likewise according to the invention.
[0076] The implant 12 is designed as a surgical two-hole plate 16
produced from titanium for connecting two bones and/or bone
fragments. It comprises a first attachment lobe 18 to be connected
to a first bone and/or bone fragment as well as a second attachment
lobe 20 spaced therefore and to be connected to a second bone
and/or bone fragment. The first attachment lobe 18 and the second
attachment lobe 20 have screw holes 22 and 24, respectively, which
can be penetrated by fixing means, such as, for example, bone
screws which are not shown in FIG. 1, in order to connect the
two-hole plate 16 to the bone and/or bone fragment. Such a bone
screw passing through a screw hole is shown in FIG. 10 described
later on.
[0077] The first attachment lobe 18 and the second attachment lobe
20 are connected to one another via a web 26. This is of a flat
design, like the first attachment lobe 18 and the second attachment
lobe 20, so that the two-hole plate 16 is, altogether, of a flat
design and approximately defines a plate plane.
[0078] The data carrier 14, which forms the implantation system 10
together with the implant 12, is arranged on the web 26. It is
produced in one piece from a material which can be sterilized as
often as required in saturated steam. This can, for example, be a
polymer material, such as, for example, polyether ether ketone
(PEEK), polyether ketone ketone (PEKK), polyoxymethylene (POM),
polytetrafluoroethylene (PTFE, Teflon) or the like.
[0079] A carrier element 28 of the data carrier 14 is designed as a
carrier plate 30 with a square cross section in a plan view of the
data carrier. The carrier plate 30 has an upper side 32 pointing
away from the two-hole plate 16 and an underside 34 pointing
towards the two-hole plate 16 and, in particular, the web 26 (FIGS.
2 and 3). The carrier plate 30 abuts on the web 26 via the
underside 34.
[0080] The underside 34 is not flat because the carrier plate 30
has areas with different material thicknesses. It comprises a first
carrier plate section 36 as well as a second carrier plate section
38 with identical material thicknesses which are formed on
oppositely located sides of the carrier plate 30. The first carrier
plate section 36 and the second carrier plate section 38 therefore
represent carrier element sections of the carrier element 28.
Between the first carrier plate section 36 and the second carrier
plate section 38, the carrier plate 30 has a weakened area 40 with
a reduced material thickness in comparison with the first carrier
plate section 36 and the second carrier plate section 38. The
weakened area 40 will be explained in greater detail further
on.
[0081] The data carrier 14 is, altogether, of a symmetric design
with respect to at least two planes of symmetry, the first of which
extends at right angles to the plane defined by the carrier plate
30 and along the weakened area 40 and the second of which extends
at right angles to the plane defined by the carrier plate 30 and at
right angles to the direction of the weakened area 40 through the
center thereof.
[0082] The data carrier 14 is connected to the two-hole plate 16
via a connecting device 42 formed on the underside 34 of the
carrier plate 30. It comprises a first connecting element 44 which
projects at right angles from the underside 34 at an edge area 46
of the first carrier plate section 36 as well as a second
connecting element 48 which projects at right angles from the
underside 34 at an edge area 50 of the second carrier plate section
38. The edge areas 46 and 50 point towards the center of the
carrier plate 30.
[0083] The first connecting element 44 and the second connecting
element 48 are designed as bars 52 and 54 extending parallel to the
weakened area 40 and limit between them, in sections, a receptacle
56 for the implant 12 which is also limited in sections by the
underside 34 of the carrier plate 30.
[0084] The implant 12 is held within the receptacle 56 by the web
26. The bars 52 and 54 abut on the web 26 with side surfaces 58 and
60, respectively, which limit the receptacle 56 to the side along
the web 26. Furthermore, the carrier plate 30 abuts partially on
the web 26 with the underside 34. The weakened area 40 corresponds
to that area of the carrier plate 30, with which the carrier plate
30 abuts on the web 26. The web 26 is in this way held in the
receptacle 56 more or less in a form-locking manner. The carrier
plate sections 36 and 38 are arranged on oppositely located sides
of the web 26.
[0085] A position of the connecting device 42, in which the implant
12 is held at least partially in the receptacle 56, is designated
as connecting position of the connecting device 42.
[0086] Securing members in the form of projections 62 and 64,
respectively, are arranged at the ends of the bars 52 and 54 facing
away from the carrier plate 30, these projections forming a recess
for the web 26. They engage around the web 26 in the connecting
position and secure it in the receptacle 56 in this way.
[0087] Between the projections 62 and 64, the receptacle 56
comprises an insertion opening 66, through which the web 26 can be
introduced into the receptacle 56. The insertion opening 66 is, at
the same time, a removal opening, through which the web 26 can be
withdrawn from the receptacle 56. The detachment of the data
carrier 14 from the implant 12 will be explained further on.
[0088] In further, preferred embodiments of a data carrier
according to the invention, at least one connecting element of the
connecting device can be designed, for example, as a snap-in
element. In addition, at least one connecting element can be
designed as a clamping element, whereby it is made possible for the
implant to be clamped securely in the receptacle. Accordingly, the
implant can be held in the receptacle in the connecting position
preferably in a form-locking, force-locking or frictional
manner.
[0089] On its upper side 32, the data carrier 14 has a data storage
device 68 with a storage area 70 which comprises part of the upper
side 32 (FIG. 1). Data 72 for identifying and characterizing the
implant 12 are deposited at the storage area 70. They can include,
for example, the name of the producer, batch number, article
number, serial number, type and size of the implant and the like.
The data 72 are cast directly onto the data carrier 14 during its
production and protrude from the carrier plate 30 as relief-like
writings 74a, 74b, 74c.
[0090] The data 72 can be read optically, i.e., with the aid of an
optical imaging device, in particular, the human eye. They can,
therefore, be recognized by a user, such as, for example, a
surgeon.
[0091] The data carrier 14 serves the purpose of describing,
marking and identifying the implant 12 by means of the data 72.
After the implant 12 has been inserted into the body of a patient,
the data carrier 14 can be detached from the implant 12 as
explained below and remain in the patient's file, for example, for
documentation purposes so that it is possible to trace the implant
12 back.
[0092] The storage area 70 is arranged completely on the carrier
element 28. However, it may also be provided for the storage area
70 to be arranged only partially on the carrier element, wherein it
can, for example, also be partially arranged on the first
connecting element 44 and/or on the second connecting element
48.
[0093] Additional, preferred embodiments of a data carrier
according to the invention comprise data storage devices, with
which the data can be deposited, in contrast to the reliefs, in a
different type of physical form, such as, for example, by way of
embossing, attachment of an adhesive label or tag, lettering or
printing on the surface or the like.
[0094] Optical readability of the data can also be achieved by
means of a mechanically operated, optical imaging device. The use
of a bar code reader is mentioned as an example, with which bar
codes can be read which are advantageously arranged on an adhesive
label secured to the carrier plate 30.
[0095] In the case of the data carrier 14, the data storage device
68 can also be of an electronic nature so that the data can be
stored in an electronic manner and/or computed in the storage. In
particular, it may be provided for the electronic data storage
device to be read inductively and, therefore, without contact,
possibly with the use of a transponder and particularly an RFID
chip. An electronic RFID chip could preferably be arranged, for
example, in the carrier plate 30.
[0096] As already mentioned, the data carrier 14 is produced from a
sterilizable plastic material. This has a thermal coefficient of
expansion which is greater than the thermal coefficient of
expansion of titanium, from which the implant 12 is produced.
During the sterilization of the implantation system 10, a gap 76 is
formed during heating between the web 26 and the sections limiting
the receptacle 56 (FIG. 3), i.e., the side surfaces 58 and 60, the
projections 62 and 64 and the underside 34, on account of the
increased thermal coefficient of expansion. Consequently, it is
possible to also sterilize the areas of the web 26 adjacent to
these specified sections without it being necessary to separate the
data carrier 14 from the implant 12 beforehand. This gives the
implantation system 10 a great user-friendly capability.
[0097] Additional, preferred embodiments of an implantation system
according to the invention are shown in FIGS. 4 to 7 and given the
reference numerals 80, 85, 90 and 95, respectively.
[0098] The implantation system 80 comprises a square four-hole
plate 81 and a data carrier 82 according to the invention which is
of the same constructional design as the data carrier 14 and
differs from it only as a result of the data identifying the
four-hole plate 81. Four attachment lobes 83a, 83b, 83c and 83d
form the "corners" of the four-hole plate 81.
[0099] In a similar way, the implantation system 85 comprises a
T-shaped three-hole plate 86 as well as a data carrier 87 according
to the invention which is of the same constructional design as the
data carrier 14 and differs from the data carrier 14 as a result of
the data identifying the three-hole plate 86. An attachment lobe
88a is arranged at one end of the "long stroke" of the T and two
attachment lobes 88b and 88c are located at the ends of the "cross
stroke" of the T.
[0100] The implantation system 90 comprises a cover plate 91 for a
bore hole as well as a data carrier 92 according to the invention
which is of the same constructional design as the data carrier 14
and differs from the data carrier 14 as a result of the data
identifying the cover plate 91 for the bore hole. The cover plate
91 for the bore hole is of a star-shaped design and has six
attachment lobes 93a, 93b, 93c, 93d, 93e and 93f as well as a
central bore 94.
[0101] The implantation system 95 comprises a two-hole plate 96
which is of an identical design to the two-hole plate 16 as well as
a data carrier 97 according to the invention. The data carrier 97
is essentially of the same constructional design as the data
carrier 14. Its carrier plate 98 does, however, have a plate
section 102 covering a first attachment lobe 100 of the two-hole
plate 96. In addition, the data carrier 97 differs from the data
carrier 14 as a result of the data identifying the two-hole plate
96.
[0102] As already mentioned, the data carrier 14 can be detached
from the implant 12. This is brought about in that the connecting
device 42 is transferred from the connecting position, in which the
implant 12 is held in the receptacle 56, into a release position,
in which the data carrier 14 can be detached from the implant. The
transfer of the connecting device 42 from the connecting position
into the release position can be brought about as follows:
[0103] As a result of forces acting on the carrier plate 30, in
particular, on the first carrier plate section 36 and on the second
carrier plate section 38, it is possible to move the first carrier
plate section 36 and the second carrier plate section 38 relative
one another.
[0104] The carrier plate 30 can, in particular, be curved because
it has a reduced material thickness at the weakened area 40 in
comparison with the first carrier plate section 36 and the second
carrier plate section 38. Consequently, the weakened area 40
defines a section of the carrier element 28 with a greater
deformability than the first carrier plate section 36 and the
second carrier plate section 38. The weakened area 40 forms, in
particular, a film hinge, at which the first carrier element
section 36 and the second carrier element section 38 can be pivoted
relative to one another about a pivot axis 105 which extends along
the weakened area 40. As a result, the first connecting element 44
and the second connecting element 48 can be moved relative to one
another and, in particular, in respective directions pointing away
from the web 26. In this way, the insertion opening 66 of the
receptacle 56 defined between the projections 62 and 64 and the
receptacle 56 can be enlarged.
[0105] When the insertion opening 66 is sufficiently large, the
connecting device 42 is in a release position, in which the data
carrier 14 can be detached from the implant 12 and moved away from
it. In this respect, the transfer of the connecting device 42 from
the connecting position into the release position is possible
without any forces acting on the implant 12. "Without any acting
forces" need not require, in the present case, a complete lack of
contact between the data carrier 14 and the implant 12. However, no
contrary holding force acting on the implant 12 is required for the
transfer of the connecting device 42. As a result, the data carrier
14 offers a particularly good handling capability for a user, for
example, a surgeon.
[0106] The data carrier 14 can, in particular, be detached from the
implant 12 without any residue.
[0107] Vice versa, the connecting device 42 can be transferred from
the release position into the connecting position without any
forces acting on the implant 12. The data carrier 14 is designed
such that the connecting device 42 automatically takes up the
connecting position proceeding from the release position. The
connecting position therefore defines a rest position of the
connecting device 42. As a result, it can be ensured that the
detachment of the data carrier 14 from the implant 12 must be
carried out intentionally by the user and so any unintentional
separation of data carrier 14 and implant 12 can be avoided to a
great extent.
[0108] The transfer of the connecting device 42 from the connecting
position into the release position and vice versa can take place
manually by a user acting on the carrier element 28. It may,
however, also be provided for this to take place with the aid of a
tool. For this purpose, reference is made in the following to FIGS.
8 and 9.
[0109] The data carrier 14 according to the invention and a
handling device 108 form a preferred embodiment of an
identification system according to the invention for identifying
and handling a medical implant, here the implant 12, this
embodiment being shown in FIGS. 8 and 9 and given the reference
numeral 110. The implant 12 and the data carrier 14 form the
described implantation system 10 according to the invention.
[0110] The handling device 108 comprises a first tool element 112
with a first gripping arm 114 and a second gripping arm 116 which
can be brought into engagement with the carrier element 28. They
are in engagement with the carrier plate 30, accessing the carrier
plate 30 from the side thereof facing away from the web 26. The
first gripping arm 114 and the second gripping arm 116, which are
illustrated as being arranged symmetrically to one another with
respect to the first plane of symmetry, have at their ends for this
purpose concave carrier element receptacles 118 and 120,
respectively, in which the first carrier plate section 36 and the
second carrier plate section 38, respectively, engage in sections.
The data carrier 14 and, with it, also the implant 12 held in the
receptacle 56 can, therefore, be moved, transported, held or the
like by means of the handling device 108 and, in particular, the
implant 12 can be placed at its predetermined location.
[0111] A second tool element 122 of the handling device 108 is
designed as a plunger 124 which is arranged between the first
gripping arm 114 and the second gripping arm 116 and is
displaceable relative to them in the first plane of symmetry and at
right angles to the carrier plate 30. If its plunger head 126 is
brought into contact with the carrier element 28 as a result of
abutment on the weakened area 40 and the plunger 124 is displaced
relative to the first gripping arm 114 and the second gripping arm
116, the carrier plate 30 can be caused to curve as a result. In
this respect, the first carrier plate section 36 and the second
carrier plate section 38 pivot relative to one another about the
pivot axis 105 which extends along the weakened area 40.
[0112] Consequently, the first connecting element 44 and the second
connecting element 48 are moved relative to one another in order to
enlarge the insertion opening 66 and the receptacle 56 so that the
data carrier 14 can be detached from the implant 12 (FIG. 9). This
means that the connecting device 42 can be transferred from the
connecting position into the release position by means of the
handling device 108. Vice versa, the connecting device 42 can also
be transferred from the release position into the connecting
position by means of the handling device 108. In both cases, this
can take place without any forces acting on the implant.
[0113] A further, preferred embodiment of an identification system
according to the invention comprises a handling device 128 as well
as a preferred embodiment of a surgical data carrier 14' according
to the invention and is given the reference numeral 130 in FIGS. 10
to 12.
[0114] The data carrier 14' is essentially of the same
constructional design as the data carrier 14 described above. In
order to designate the features of the data carrier 14', the
reference numerals of the identical and/or functionally similar
features of the data carrier 14 are, therefore, used with a prime
sign added. The data carrier 14' differs from the data carrier 14
only due to the configuration of its carrier element 28'. This has,
in a plan view, the shape of an irregular hexagon. The data carrier
14' forms, together with the implant 12 which is likewise
illustrated in FIGS. 10 to 12, a preferred embodiment of a surgical
implantation system 10' according to the invention.
[0115] The screw hole 24 of the second attachment lobe 20 of the
implant 12 has a bone screw 132 passing through it which is screwed
by means of a surgical screw instrument 134 to a bone fragment not
illustrated in the drawings in order to secure the two-hole plate
16 to it.
[0116] The handling device 128 has a first tool element 136 and a
second tool element 138 which form arms 140 and 142, respectively,
of forceps 144, as which the handling device 128 is configured. The
arms 140 and 142 are illustrated as being arranged symmetrically to
one another with respect to the first plane of symmetry of the data
carrier 14' and can be moved relative to one another, in
particular, spread relative to one another.
[0117] The first arm 140 and the second arm 142 can be brought into
engagement with the carrier element 28' in that their ends pass
through tool element receptacles 146 and 148 in the form of
passages 150 and 152, respectively, of the first carrier plate
section 36' and the second carrier plate section 38', respectively.
The first arm 140 and the second arm 142 can be wedged in the
passages 150 and 152, respectively, merely as a result of slight
spreading of the arms relative to one another and so the data
carrier 14' and, with it, the implant 12 can be moved, transported
or the like.
[0118] As a result of considerable spreading of the first arm 140
and the second arm 142 relative to one another, the carrier plate
30' can be curved at its weakened area 40', wherein the first
carrier plate section 36' and the second carrier plate section 38'
are pivoted relative to one another about the pivot axis 105' which
extends along the weakened area 40. This enables the first
connecting element 44' and the second connecting element 48' to be
moved relative to one another (FIG. 12). As a result, the insertion
opening 66' and the receptacle 56' can be enlarged as explained
above and the connecting device 42' be transferred from the
connecting position, in which the implant 12 is held in the
receptacle 56', into a release position, in which the data carrier
14' can be detached from the implant 12, without any forces acting
on the implant 12.
* * * * *