U.S. patent application number 13/994705 was filed with the patent office on 2013-12-05 for apparatus comprising an aligning device, set and method.
This patent application is currently assigned to Transcatheter Technologies GMBH. The applicant listed for this patent is Wolfgang Goetz, Hou-Sen Lim. Invention is credited to Wolfgang Goetz, Hou-Sen Lim.
Application Number | 20130325101 13/994705 |
Document ID | / |
Family ID | 45478261 |
Filed Date | 2013-12-05 |
United States Patent
Application |
20130325101 |
Kind Code |
A1 |
Goetz; Wolfgang ; et
al. |
December 5, 2013 |
Apparatus Comprising an Aligning Device, Set and Method
Abstract
An apparatus for use during implanting at least one medical
implant at an implantation site within a patient's body may include
an aligning device for aligning the apparatus at the implantation
site. The aligning device is capable of being transferred from a
non-aligning position into an aligning position.
Inventors: |
Goetz; Wolfgang;
(Regensburg, DE) ; Lim; Hou-Sen; (Singapore,
SG) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Goetz; Wolfgang
Lim; Hou-Sen |
Regensburg
Singapore |
|
DE
SG |
|
|
Assignee: |
Transcatheter Technologies
GMBH
Regensburg
DE
|
Family ID: |
45478261 |
Appl. No.: |
13/994705 |
Filed: |
December 12, 2011 |
PCT Filed: |
December 12, 2011 |
PCT NO: |
PCT/EP11/06253 |
371 Date: |
August 27, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61422669 |
Dec 14, 2010 |
|
|
|
Current U.S.
Class: |
623/1.11 ;
623/2.11 |
Current CPC
Class: |
A61F 2/2439 20130101;
A61F 2/95 20130101; A61F 2250/0096 20130101; A61F 2/2427 20130101;
A61F 2/2418 20130101 |
Class at
Publication: |
623/1.11 ;
623/2.11 |
International
Class: |
A61F 2/24 20060101
A61F002/24; A61F 2/95 20060101 A61F002/95 |
Claims
1. An apparatus for use during implanting at least one medical
implant at an implantation site within a patient's body, wherein
the apparatus comprises: an aligning device for aligning the
apparatus at the implantation site, wherein the aligning device is
capable of being transferred from a non-aligning position into an
aligning position.
2. The apparatus according to claim 1, wherein the aligning device
is further capable of being transferred from the aligning position
into the non-aligning position.
3. The apparatus according to claim 1, wherein the aligning device
for aligning the apparatus comprises of at least one wire or
several wires.
4. The apparatus according to claim 1, wherein the aligning device
comprises of two or more aligning sections for aligning the
apparatus by means of contact with the tissue of the implantation
site or of the implantation organ, wherein the aligning sections
are designed or embodied such that they are in contact with the
tissue or the organ independently from each other and/or are
designed or embodied such that they are capable of being
transferred from the non-aligning position into the aligning
position independently from each other.
5. The apparatus according to claim 1, wherein the aligning device
comprises consists of a memory shape material.
6. The apparatus according to claim 1, wherein at least one section
of the aligning device comprises a through opening.
7. The apparatus according to claim 1, wherein at least one section
of the aligning device comprises an open or closed wound
section.
8. The apparatus according to claim 1, further comprising: a shaft
comprising a reception area for receiving the implant.
9. The apparatus according to claim 1, wherein the aligning device
comprises a means for releasing a fluid for medical imaging.
10. The apparatus according to claim 1, wherein the implant is a
stent or a cardiac valve arrangement.
11. A set comprising at least one apparatus according to claim 1;
and at least one implant.
12. A method comprising the step of: using a set according to claim
11.
13. The method according to claim 12, comprising the step of:
transferring the aligning device for aligning the apparatus after
having inserted the apparatus at the implantation site from the
non-aligning position into the aligning position and/or vice
versa.
14. The method according to claim 12, comprising the step of:
directing a fluid for medical imaging through a lumen of the
aligning device.
15. A method comprising the step of: using an apparatus according
to claim 1.
16. The method according to claim 15, comprising the step of:
transferring the aligning device for aligning the apparatus after
having inserted the apparatus at the implantation site from the
non-aligning position into the aligning position and/or vice
versa.
17. The method according to claim 15, comprising the step of:
directing a fluid for medical imaging through a lumen of the
aligning device.
18. The apparatus according to claim 1, wherein the aligning device
for aligning the apparatus consists of at least one wire or several
wires.
19. The apparatus according to claim 1, wherein the aligning device
consists of two or more aligning sections for aligning the
apparatus by means of contact with the tissue of the implantation
site or of the implantation organ, wherein the aligning sections
are designed or embodied such that they are in contact with the
tissue or the organ independently from each other and/or are
designed or embodied such that they are capable of being
transferred from the non-aligning position into the aligning
position independently from each other.
20. The apparatus according to claim 1, wherein the aligning device
consists of a memory shape material.
Description
[0001] The present invention relates to an apparatus according to
claim 1 for inserting an implant and a set according to claim 11.
It further relates to a method according to claim 12.
[0002] From practice, implants for replacing or supporting body
functions (such as, e.g., stents) are known that are inserted into
the patient's body by means of an apparatus in case of complex or
difficult, respectively, conditions of orientation such as an
insufficient direct sight onto the implantation site.
[0003] One object of the present invention is to suggest an
apparatus for orienting during implanting or for aligning an
implant or an apparatus for implanting the implant. Furthermore, an
appropriate set comprising such an apparatus and a method are
proposed.
[0004] This object is solved by an apparatus having the features of
claim 1.
[0005] Thus, according to the invention, an apparatus for use
during implanting at least one medical implant at an implantation
site in a patient's body is proposed, wherein the apparatus
comprises an aligning device for aligning the apparatus at the
implantation site, wherein the aligning device is capable of being
transferred from a non-aligning position into an aligning
position.
[0006] The object according to the invention is further solved by a
set comprising at least one apparatus according to the invention
and at least one implant.
[0007] The object according to the invention is further solved by a
method comprising using an apparatus according to the invention
and/or a set according to the invention.
[0008] Advantageous embodiments of the apparatus according to the
invention are each subject-matter of the dependent claims.
[0009] In certain embodiments, aligning the apparatus according to
the invention is alternatively or additionally understood as
aligning the medical implant.
[0010] In some embodiments according to the invention, aligning is
alternatively or additionally understood as orienting the apparatus
or the medical implant such that a user of the apparatus according
to the invention is aware of the position of the apparatus and/or
the implant relative to a body tissue or a body structure or an
anatomic condition of the implantation site, respectively, after
aligning or that the user is given a corresponding hint by means of
the alignment.
[0011] In certain embodiments according to the invention, aligning
is understood as aligning the apparatus and/or the medical
implant.
[0012] In certain embodiments according to the invention, the
aligning device is capable of being transferred from the aligning
position into the non-aligning position as well.
[0013] In one embodiment of the apparatus according to the
invention, the aligning device is or comprises a wire or a
filament, respectively.
[0014] In the following, the term "wire" or "filament",
respectively, may also define a plurality of wires or filaments,
respectively, whenever a person skilled in the art recognizes the
exchangeability of the terms.
[0015] In some embodiments according to the invention, the aligning
device comprises a through opening or passage opening,
respectively, in at least one section thereof.
[0016] In certain embodiments according to the invention, the
through opening extends along the aligning device or a section
thereof. The through opening may be present in an interior of the
aligning device. It can be intended or provided and/or serve for
transporting or guiding or directing a fluid from one end of the
aligning device or of the section thereof to another end portion of
the aligning device or of the section.
[0017] In one embodiment of the apparatus according to the
invention, the through opening is penetrable or permeable,
respectively, for fluids in its longitudinal direction. The term
"penetrable" or "permeable", respectively, hereby refers to the
ability of the aligning device to be flown through by fluids and/or
to guide the said.
[0018] In certain embodiments according to the invention, the
aligning device is movable--namely either as a whole or in sections
thereof--relative to the apparatus according to the invention.
[0019] According to the invention, "movable" may also be understood
as "slidable". A corresponding support may be provided, but does
not have to be provided. A corresponding material combination may
be provided, but does not have to be provided.
[0020] In one embodiment according to the invention, the apparatus
is tubular (i.e., having a hollow interior), such as, e.g., a
hollow cylinder having a through opening in or along its interior.
The apparatus may be designed symmetrically or asymmetrically, both
relative to its through direction and also in another direction, in
particular in a direction or plane perpendicular to the through
direction.
[0021] In one embodiment according to the invention, a shaft of the
apparatus is penetrable or permeable, respectively, in its interior
in at least sections of its longitudinal direction. The shaft
comprises a wall. The shaft comprises at least one shaft opening or
shaft aperture, respectively. The at least one shaft aperture is
preferably not arranged at the front side but at or on a lateral or
envelop surface of the shaft. The shaft aperture is preferably a
through opening establishing a connection between the interior and
an exterior of the shaft of the apparatus. In certain embodiments
according to the invention, the aligning device can be delivered or
passed or transferred from the non-aligning position into the
aligning position through the shaft aperture.
[0022] In one embodiment according to the invention, the shaft of
the apparatus comprises a plurality of shaft apertures that are
evenly or unevenly spaced around or across a periphery or a lateral
surface of the shaft. Additionally or alternatively, the shaft
apertures may be dispersed along a longitudinal direction of the
shaft.
[0023] Sections of the aligning device may enter and/or exit
through the shaft apertures.
[0024] In some embodiments according to the invention, the aligning
device comprises two or more aligning sections that may be actuated
independently from each other such that they can contact the tissue
of the implantation site or of the implantation organ or of the
organ independently from each other, respectively.
[0025] For this purpose, the aligning sections are in some
embodiments capable of being transferred from the non-aligning
position into the aligning position independently from each
other.
[0026] In some embodiments according to the invention, the aligning
device comprises or consists of a memory shape material.
[0027] In certain embodiments according to the invention, the
aligning device of the apparatus comprises at least one open or
closed loopy or wound section. The latter can have the form of a
loop or sling.
[0028] The open or closed wound section may have the form of a pig
tail, a spiral, a helix, or the like.
[0029] In some embodiments according to the invention, the
apparatus comprises a reception area for receiving the implant.
[0030] In some embodiments according to the invention, the
reception area is a shaft or has the form of a shaft.
[0031] The reception area can receive the implant releasably such
that the implant can be delivered to the implantation site by means
of the apparatus. After having reached the final implantation site,
the implant may be released from the reception area optionally by
using appropriate means or devices, respectively. Then, the implant
stays at the implantation site while the reception area may be
removed from the implantation site together with the other sections
of the apparatus.
[0032] In certain embodiments according to the invention, the
aligning device of the apparatus is connected or intended or
provided and suited for a connection with a means or device,
respectively, for releasing a fluid for medical imaging.
[0033] In some embodiments according to the invention, the implant
is a stent and/or a cardiac valve arrangement.
[0034] In one embodiment according to the invention, the aligning
device is designed or embodied as a spring, in particular as a
spiral or coil spring, and/or is formed from an
appropriate--preferably an elastic or flexible--material such as,
e.g., a plastic material or gum.
[0035] In one embodiment of the apparatus according to the
invention, the apparatus comprises at least two or at least three
different passages or apertures, respectively.
[0036] When according to the invention at least two or three
different passages or apertures, respectively, are mentioned, this
can, in one embodiment according to the invention, refer to a
respective different geometrical shape of the passages or
apertures, respectively. In other words, the passages or apertures,
respectively, may differ in their design.
[0037] In one embodiment according to the invention, the "three
different passages or apertures, respectively" may differ in their
area size.
[0038] In one embodiment according to the invention, a passage or
aperture, respectively, is the open passage between an exterior of
the apparatus or of the shaft of the apparatus and an interior of
the apparatus or of the shaft of the apparatus.
[0039] In one embodiment according to the invention, the passages
or apertures, respectively, may each comprise a range of
geometrical designs. Thus, the passages or apertures, respectively,
do not have to have an unchangeable design or size as long as the
respective function (and optionally only this function) is possible
within the respective range of the geometrical design. Within the
limits predetermined by means of the range, the respective passages
or apertures, respectively, may therefore--to all intents and
purposes--be variable.
[0040] In one embodiment according to the invention, the apparatus
is designed or embodied for folding and/or unfolding an implant
that is, for example, a stent or a cardiac valve arrangement.
[0041] In one embodiment of the set according to the invention, the
implant is a foldable and/or unfoldable implant.
[0042] In one embodiment of the method according to the invention,
the method comprises transferring the aligning device from the
non-aligning position into the aligning position and/or vice versa,
after having inserted the apparatus at the implantation site.
[0043] In one embodiment of the method according to the invention,
the method comprises directing a fluid for medical imaging through
a lumen of the aligning device.
[0044] The advantages achievable by means of the apparatus
according to the invention may also be obtained by means of the set
according to the invention and the method according to the
invention. Some or all of the following advantages may be achieved
in some or in all of the embodiments according to the
invention.
[0045] Among the advantages achievable according to the invention
is that the mechanical stress or impairment of the tissue of the
implantation site in general is in certain embodiments according to
the invention at best only little.
[0046] This advantage can even be increased in that the aligning
device or the aligning sections thereof are in some embodiments
according to the invention wires or filaments, respectively, e.g.,
made from or comprising Nitinol, however, in any case, sections
having a certain flexibility. This can also favor a gentle handling
with the tissue of the implantation site as the mechanical stress
applied on the tissue is low. Bleedings, wounds, irritations, and
the like can be prevented.
[0047] One of the advantages achievable according to the invention
is further that both implanting as well as imaging the implantation
site is possible at the same time by using the apparatus in one
embodiment according to the invention. In these embodiments, there
is no further device or means required for this purpose in addition
to the apparatus according to the invention for fulfilling both
functions. This can both facilitate the handling of the required
instruments as well as require an only smaller access or fewer
accesses than the solutions known.
[0048] Another advantage is that, in some embodiments according to
the invention, a proper alignment--or more proper as compared to
the state of the art--to the morphology of the implantation site is
possible. According to the invention, it is thus, e.g., possible to
achieve an appropriate alignment even for two-part cardiac valves
or the connection sites thereof with the heart muscle,
respectively, as, due to the multiple separation of the aligning
device, another number of aligning sections is used than is, e.g.,
provided or required for cardiac valves comprising three valves.
Thus, in some embodiments according to the invention, if needed,
e.g., not three but only two aligning sections may be used or
transferred into the aligning position. Moreover, the two aligning
sections used can exit the apparatus appropriately at positions
being suitably spread across the periphery of the apparatus or the
shaft thereof. This allows a further advantageous flexibility
during use of the apparatus according to the invention in some of
its embodiments. Thus, the latter can be used for, e.g., aligning
any arbitrary one of the cardiac valve prostheses known during the
implantation thereof.
[0049] A still further advantage of the present invention which can
be achieved in certain embodiments is the simple match of the
aligning device or the aligning sections thereof. This can, for
example, be achieved by means of a memory shape (or shape memory,
respectively,) material. Thus, the aligning device or sections
hereof may consist of Nitinol wires or filaments, respectively,
that can be brought into an appropriate form easily, which they are
able to reassume after omitting external limitations.
[0050] In the following, the present invention will be exemplarily
described with reference to the accompanying drawing. In the
drawing, identical reference numerals denote same or identical
elements or components, respectively. In the drawing:
[0051] FIG. 1 shows a set according to the invention comprising an
apparatus according to the invention in a first embodiment
comprising a medical implant and an aligning device;
[0052] FIG. 2 shows an apparatus according to the invention in a
second embodiment comprising a medical implant and an aligning
device;
[0053] FIG. 3 shows an aligning section of an apparatus according
to the invention in a further embodiment; and
[0054] FIG. 4 shows an aligning section of an apparatus according
to the invention in a still further embodiment.
[0055] FIG. 1 shows a set 1 according to the invention comprising
an apparatus 3 according to the invention of a first embodiment.
The apparatus 3 having an end portion and a tip 31 comprises a
medical implant 6 and an aligning device 9.
[0056] The implant 6 comprises two ring structures 61 that can be
expanded or folded by means of threads 7. The threads 7 are guided
through an interior of the apparatus 3 and can be actuated at a
further end portion of the apparatus 3 as a continuation 71. The
ring structures 61 are distanced from each other by means of struts
63 that are arranged between the ring structures 61. As can be
recognized by a person skilled in the art, the implant 6 shown in
FIG. 1 is just an arbitrary example of an implant selected for
illustrative purposes. For details of the implant shown in FIG. 1
it is referred to WO 2009/109348 A1.
[0057] In the example of FIG. 1, the aligning device 9 comprises
two aligning sections 91 and 93; however, according to the
invention, more or fewer than two aligning sections could also be
provided or intended.
[0058] The aligning sections 91, 93 of the representation of FIG. 1
are designed or embodied as wires or filaments, respectively, and
in form of loops or slings, respectively, i.e., in form of closed
structures. However, according to the invention, a closed structure
is not required.
[0059] Each of the aligning sections 91, 93 is supported by the
tissue G at a section 911 or 931 and thereby contacts tissue G. As
the aligning sections 91, 93 show a stiffness resulting from their
material and/or shape, they show a resistance during pulling back
or retrieving, respectively, the apparatus 3 guided from the bottom
through the tissue aperture A in FIG. 1. They hereby align the
apparatus 3 relative to the tissue G or the tissue aperture A
thereof by requiring an increased force for retrieving the
apparatus 3 out of the tissue aperture A (i.e., in a downward
direction in FIG. 1) or by even preventing such a retrieval.
[0060] After aligning the apparatus 3 as described above and thus
the accompanying alignment of the implant 6 relative to the tissue
G or the tissue aperture A, the implant 6 can be expanded by means
of the threads 7 or the continuations 71 thereof, respectively.
Subsequently--as well as at any other point of time--, the aligning
sections 91 and 93 may be pulled into an interior of the apparatus
3 by pulling a continuation 95 of the aligning sections 91 and 93.
The loops or slings, respectively, of the aligning device 9, i.e.,
the aligning sections 91 and 93, shown in FIG. 1 are thus not
present outside the apparatus 3 anymore. Therewith, the alignment
is cancelled or offset. The apparatus 3 can be pulled downwards out
of the tissue aperture A (after having released the implant 6 from
the apparatus 3).
[0061] FIG. 2 shows an apparatus 3 according to the invention of a
second embodiment comprising an end portion 31 and an interior 11.
The apparatus 3 comprises an aligning device 9 comprising two
aligning sections 91 and 93. The aligning sections 91 and 93 are
continued within the interior 11 of the apparatus 3 in form of
continuations 95 and can be pulled into, e.g., the interior 11 by
means of the latter.
[0062] As compared to the apparatus 3 of FIG. 1, the apparatus 3
shown in FIG. 2 comprises a flexible or stiff sheath 13. The latter
is movable relative to the shaft of the apparatus 3 by, e.g., being
retrieved in the direction of the arrow (to the left border of FIG.
2).
[0063] When the sheath 13 is in a non-retrieved state, the aligning
sections 91 and 93 are kept from lifting off the apparatus 3 or an
outer surface thereof, respectively, which they would do otherwise
due to their shape memory characteristics. By retrieving the sheath
13 in the direction of the arrow, the limitation on the moving or
unfolding capability of the aligning sections 91 and 93 relative to
the apparatus 3 is offset.
[0064] In FIG. 2 a state is shown in which the aligning section 91
could already be released from the apparatus 3 and transferred into
its memory shape state after the sheath 13 having been retrieved.
In the shape memory state predetermined by the manufacturing
process, one end of the aligning section 91 lifts off the apparatus
3 and winds up in a C shape manner. According to the invention, any
other shape into which the aligning section could wind up instead
of a C shape is contemplated as well.
[0065] In the state shown in FIG. 2, the sheath 13 is not retrieved
to a sufficient extent for also releasing the other aligning
section 93. The latter still unchangedly contacts the apparatus 3
or an outer surface thereof, respectively. Only after the sheath
has been pulled back a little bit further--not shown in FIG. 2--,
also the aligning section 93 will deform in an intended manner and
be released from the outer surface of the apparatus 3.
[0066] FIG. 3 shows an aligning section 91 of an apparatus
according to the invention in a further embodiment. The aligning
section 91 has a still further shape. The said may be referred to
as spirally.
[0067] FIG. 4 shows an aligning section 93 of an apparatus
according to the invention in a still further embodiment.
[0068] The aligning section 93 has a still further geometrical
outer shape.
[0069] The aligning section 93 further comprises a continuous lumen
933 within its interior. The latter extends along the whole length
of the aligning section 93. According to the invention, in other
embodiments, the lumen can, however, also only extend across a
(part) portion of the aligning section 93.
[0070] In some embodiments, the lumen 933 is provided or intended
to administer a fluid therethrough. The fluid can be a drug, a
contrast agent, e.g., for imaging methods, or the like. The fluid
can be introduced in and discharged out of the lumen along the
directions of the arrows of FIG. 4. By means of the lumen, it is
advantageously possible to use the aligning device both for
aligning and for administering at the same time. In this way,
introducing or inserting, respectively, an additional instrument
for aligning or administering may advantageously be omitted.
[0071] As the aligning device is inserted together with the
apparatus which is also used for inserting the implant into the
body, inserting one or more further instruments for an alignment or
an administration of an agent in addition to the apparatus may
advantageously be omitted.
TABLE-US-00001 Reference numeral list reference numeral description
1 set 11 interior 13 sheath 3 apparatus 31 tip 6 medical implant 61
ring structures 63 struts 7 threads 71 continuation of the threads
9 aligning device 91, 93 aligning sections 911, 931 sections 933
lumen 95 continuation of the aligning sections A tissue aperture G
tissue
* * * * *