U.S. patent application number 15/068894 was filed with the patent office on 2016-10-13 for patient-specific intraluminal implants.
The applicant listed for this patent is MATERIALISE N.V.. Invention is credited to Toon ROELS, Peter VERSCHUEREN.
Application Number | 20160296321 15/068894 |
Document ID | / |
Family ID | 46970052 |
Filed Date | 2016-10-13 |
United States Patent
Application |
20160296321 |
Kind Code |
A1 |
ROELS; Toon ; et
al. |
October 13, 2016 |
PATIENT-SPECIFIC INTRALUMINAL IMPLANTS
Abstract
A patient-specific intraluminal implant is disclosed. The
implant may comprise a body structure spanning a specific patient's
lumen and an outer surface thereof comprising one or more
patient-specific anatomy engagement surfaces or contact points
corresponding to patient-specific anatomical regions of the lumen
wall. The patient-specific anatomical regions of the lumen wall may
include pre-operatively identified anatomical regions showing
greater stability in time.
Inventors: |
ROELS; Toon; (Oud-Heverlee,
BE) ; VERSCHUEREN; Peter; (Bierbeek, BE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MATERIALISE N.V. |
Leuven |
|
BE |
|
|
Family ID: |
46970052 |
Appl. No.: |
15/068894 |
Filed: |
March 14, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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14032301 |
Sep 20, 2013 |
9283078 |
|
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15068894 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
B33Y 80/00 20141201;
A61F 2/2409 20130101; G06T 2210/41 20130101; A61F 2/2418 20130101;
A61F 2250/0067 20130101; Y10T 29/49 20150115; A61F 2/30942
20130101; A61F 2/07 20130101; A61B 2034/108 20160201; G06T
2219/2021 20130101; A61F 2220/0016 20130101; G06T 19/20 20130101;
A61F 2240/002 20130101; A61F 2250/006 20130101; A61F 2210/0004
20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 21, 2012 |
EP |
12185324.6 |
Claims
1. A patient-specific intraluminal implant comprising: a body
structure spanning a specific patient's lumen and an outer surface
thereof, the outer surface comprising one or more patient-specific
anatomy engagement surfaces or patient-specific contact points
corresponding to patient-specific anatomical regions of the lumen
wall, wherein said patient-specific anatomical regions of the lumen
wall are pre-operatively identified anatomical regions showing
greater stability in time.
2. The patient-specific intraluminal implant of claim 1, wherein
the patient-specific intraluminal implant is an intraluminal
docking structure for a functional element, wherein the
intraluminal docking structure further includes an inner surface
comprising one or more docking features configured to detachably
engage a functional element with the inner surface of the
intraluminal docking structure.
3. The patient-specific intraluminal implant of claim 1, wherein
the patient-specific intraluminal implant is a heart valve or a
heart valve docking structure, and wherein the body structure of
the patient-specific intraluminal implant further comprises: a
distal toroidal attachment structure combined with the one or more
patient-specific anatomy engagement surfaces or contact points
corresponding to anatomical regions on the outflow side of the
patient's heart valve anatomy; and a proximal toroidal attachment
structure combined with the one or more patient-specific anatomy
engagement surfaces or contact points corresponding to anatomical
regions on the inflow side of the patient's heart valve anatomy;
and wherein the pre-operatively identified anatomical regions have
a lower degree of variation in time compared to other anatomical
regions on the inflow or outflow side of the patient's heart valve
anatomy.
4. The patient-specific intraluminal implant of claim 2, wherein
the functional element is one of a stent, graft, stent-graft, vena
cava filter, tubular expandable framework, heart valve or heart
valve frame.
5. The patient-specific intraluminal implant of claim 2, wherein
the functional element a heart valve, and wherein the heart valve
comprises a mitral valve.
6. The patient-specific intraluminal implant of claim 2, wherein
the functional element is a heart valve, and wherein the heart
valve comprises a tricuspid valve.
7. The patient-specific intraluminal implant of claim 1, wherein
the docking station is foldable.
8. The patient-specific intraluminal implant of claim 2, wherein
the docking features comprise anchoring components.
9. The patient-specific intraluminal implant of claim 8, wherein
the anchoring components comprise one or more of a barb, a clip, a
staple, a post, an eyelet, or a hook.
10. The patient-specific intraluminal implant of claim 4, wherein
the intraluminal docking structure and the functional element are
manufactured as a single part through additive manufacturing.
11. The patient-specific intraluminal implant of claim 10, wherein
the intraluminal docking structure is manufactured in
bio-absorbable material.
12. The patient-specific intraluminal implant of claim 2, wherein
the functional element is one or more of a valve, plug, mesh,
sieve, or drug eluting component.
13. The patient-specific intraluminal implant of claim 1, wherein
the outer surface of the intraluminal implant is configured to
comprise patient-specific anatomy engagement surfaces, and wherein
the patient-specific anatomy engagement surfaces are both in
regions at the distal end and at the proximal end of the lumen
wall.
14. The patient-specific intraluminal implant of claim 1, wherein
the at least part of the implant is transitionable from a collapsed
state to an expanded state.
15. The patient-specific intraluminal implant of claim 14, wherein
the implant is configured to retract radially in a collapsed state
and extend radially in an expanded state.
16. The patient-specific intraluminal implant of claim 1, wherein
the body structure comprises a central hollow body.
17. The patient-specific intraluminal implant of claim 16, wherein
the central hollow body connects a distal toroidal attachment
structure and a proximal toroidal attachment structure.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 14/032,301, filed Sep. 20, 2013 (issued as U.S. Pat. No.
9,283,078 on Mar. 15, 2016), which claims priority to European
Patent Application No. 12185324.6, filed Sep. 21, 2012. The
contents each of the above-referenced patent application are hereby
incorporated by reference in their entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] Methods are provided for generating intraluminal implants
which contain structural information that conforms to patient
specific anatomical regions to ensure an optimal fit.
[0004] 2. Description of the Related Technology
[0005] Endoprostheses are a commonly used way of dealing with
diseases in interventional medicine and surgery. Mesh-based
endoprostheses such as stents, stent grafts, heart valve frames,
etc. are of particular importance in cardiovascular applications.
Other fields of medicine also make use of such endoprostheses, e.g.
pulmonary tract stents, esophagus stents, etc.
[0006] Intraluminal endoprostheses such as stents are typically
designed such that they are deployable by catheter or similar stent
delivery system, as it is desirable for stent placement procedures
to be minimally invasive. Some stents are self-expandable, whereas
other stents are inflated via a balloon inside the stent in order
to force the stent to open.
[0007] However, in some surgical cases the use of a less invasive
delivery system is hindered by form, size and material of the
intraluminal endoprostheses. When there are no minimally invasive
endoprostheses available, a major surgical intervention is required
and while this can often be conducted for the majority of the
patients, the replacement of such an endoprosthesis after some
years is more difficult due to the aging of the patient. Often
secondary and tertiary major surgical interventions are avoided
when the condition of the patient does not provide for it.
[0008] There have been some further developments in this field and
docking structures have been developed onto which elements such as
heart valves can be attached resulting in a fully functional
endoprosthesis where the part most vulnerable to replacement (e.g.
the heart valve) could be replaced using a minimal invasive surgery
while the docking structure remains in place. These docking
structures have also been made foldable such that these can also be
introduced using minimal invasive surgical methods.
[0009] However, similar to the functional intraluminal
endoprostheses, these types of structures are also prone to
fixation problems as the position of the docking structure is
highly unstable.
[0010] Accordingly, there is a need for improved intraluminal
endoprostheses, docking structures and methods for the production
of these devices.
SUMMARY
[0011] The methods described herein are envisaged to ensure that an
intraluminal implant, such as but not limited to a docking
structure for a functional element, will be positioned in the
optimal location in the patient's lumen. This implies positioning
of the implant in an anatomical location conform to the patient's
anatomy (lumen), but also in an anatomical area or zone that is
stable in terms of its motion in time. To this end, the
intraluminal implants are provided with an outer surface which is
configured to comprise patient-specific anatomy engagement surfaces
or contact points corresponding to specifically selected anatomical
regions of the lumen wall. In this way, the implant can be nested
stably against a specific region of the lumen wall of the patient,
and has an increased chance of being maintained in this
position.
[0012] In particular embodiments, methods are provided for
generating a patient-specific intraluminal implants, comprising the
steps of: identifying for a patient, based on information regarding
the variation in function of time of the anatomy of said lumen in
the anatomical area of interest for placing said intraluminal
implant, the anatomical regions in said anatomical area showing
greater stability in time; identifying and selecting the locations
in the regions so identified which are suitable for use as a base
for the contact surface of a intraluminal implant, and generating a
patient-specific intraluminal implant based on this information,
said implant comprising an outer surface configured to comprise one
or more patient-specific anatomy engagement surfaces or contact
points corresponding to locations of the anatomical regions of the
lumen wall identified corresponding to both criteria.
[0013] In particular embodiments of the methods envisaged herein,
the intraluminal implant is an intraluminal docking station and the
methods comprise the steps of identifying for a patient, based on
information regarding the variation in function of time of the
anatomy of said lumen in the anatomical area of interest for
placing said intraluminal docking structure, the anatomical regions
in said anatomical area showing greater stability in time;
identifying and selecting the locations in the regions
so-identified which are suitable for use as a base for the contact
surface of a intraluminal docking structure, and generating a
patient-specific intraluminal docking structure based on the
information obtained in the previous steps, said docking structure
comprising an outer surface configured to comprise one or more
patient-specific anatomy engagement surfaces or contact points
corresponding to anatomical regions of the lumen wall and an inner
surface comprising one or more docking features for detachably
engaging said inner surface of said intraluminal docking structure
with said functional element.
[0014] More particularly said step of identifying an anatomical
area showing greater stability in time comprises an assessment
based on parameters chosen from one or more of: 2-dimensional
parameters comprising change in planar circumference, area, best
fit ellipse ellipticity, best fit circle diameter and/or maximum
distance across a lumen; 3-dimensional parameters comprising
shortest distance around said lumen, best fit ellipsoid
ellipticity, short or long axis length, best fit cylinder diameter,
and/or best fit sphere diameter; and/or the degree of variation or
displacement of a point or surface.
[0015] In particular embodiments, said the methods envisaged herein
further comprise first step (prior to the steps described above) of
obtaining from said patient information regarding the variation of
the anatomy of said lumen in the anatomical area of interest for
placing said intraluminal implant in function of time.
[0016] More particularly said step of identifying an anatomical
area showing greater stability in time is performed based on three
dimensional (3D) imaging information of the lumen anatomy of said
patient. In particular embodiments step of obtaining from said
patient information regarding the variation of the anatomy of said
lumen comprises obtaining three dimensional (3D) imaging
information of a region of the lumen anatomy of said patient over
time.
[0017] Where the implant is a docking structure, the functional
element for which docking structure are provided can include, but
is not limited to, a valve, plug, mesh, sieve, drug eluting
component.
[0018] In particular embodiments said outer surface of said
intraluminal implant is configured to comprise patient-specific
anatomy engagement surfaces both in regions at the distal end and
at the proximal end of said lumen wall. More particularly said
intraluminal implant comprises one or more attachment structures
for attachment in said lumen and said patient-specific anatomy
engagement surfaces correspond to external surfaces of said
attachment structures.
[0019] In particular embodiments the implant or part thereof is
transitionable from a collapsed state to an expanded state. More
particularly said intraluminal implant or part thereof is adapted
to retract radially in the collapsed state and extend radially in
the expanded state. In further particular embodiments, the
transitionable attachment structures are toroidal attachment
structures.
[0020] In particular embodiments said intraluminal implant
comprises distal and proximal transitionable attachment structures
and said distal and proximal transitionable attachment structure
can be independently expanded to approximately their full
diameters. More particularly said intraluminal implant comprises a
flexible biocompatible contractible fabric or an auxetic material
or structure.
[0021] In particular embodiments, where the intraluminal implant
envisaged is a docking structure, the corresponding docking
features include anchoring components engaging said functional
element by friction, barb, clip, staple, post, eyelet or hook.
[0022] More particularly the methods envisaged herein comprise
generating said intraluminal docking structure and optionally said
functional element as a single part through additive manufacturing.
More particularly said intraluminal docking structure is
manufactured in bio-absorbable material.
[0023] In particular embodiments said patient-specific intraluminal
docking structure is a heart valve docking structure comprising a
body structure which links a distal toroidal attachment structure
and a proximal toroidal attachment structure;
[0024] wherein said method comprises:
[0025] identifying for said patient, the anatomical regions in the
anatomical area of said heart valve showing greater stability in
time;
[0026] identifying and selecting the locations in the regions
identified, which are suitable for use as a base for the contact
surface of a heart valve docking structure, and
[0027] generating a patient-specific heart valve docking structure
based on the information obtained in the above steps, such that
said distal toroidal attachment structure comprises
patient-specific anatomy engagement surfaces or contact points
corresponding to said locations in anatomical regions on the
outflow side of the patient's heart valve anatomy and said proximal
toroidal attachment structure comprises patient-specific anatomy
engagement surfaces or contact points corresponding to said
locations in anatomical regions on the inflow side of the patient's
heart valve anatomy.
[0028] The application further provides intraluminal implants, such
as but not limited to intraluminal docking structures, and in
particular heart valve docking structures, obtainable using the
methods as disclosed herein.
[0029] More particularly said patient-specific intraluminal
implants comprise a body structure spanning a specific patient's
lumen with an outer surface configured to comprise one or more
patient-specific anatomy engagement surfaces or contact points
corresponding to patient-specific anatomical regions of the lumen
wall, wherein said patient-specific anatomical regions of the lumen
wall are pre-operatively identified anatomical regions showing
greater stability in time.
[0030] In particular embodiments, the application provides
intraluminal docking structures comprising:
[0031] a body structure spanning a specific patient's lumen;
[0032] an outer surface configured to comprise one or more
patient-specific anatomy engagement surfaces or contact points
corresponding to patient-specific anatomical regions of the lumen
wall; and
[0033] an inner surface comprising one or more docking features for
detachably engaging said inner surface of said intraluminal docking
structure with a functional element; wherein said patient-specific
anatomical regions of the lumen wall are pre-operatively identified
anatomical regions showing greater stability in time.
[0034] More particularly said functional element can include, but
is not limited to, a valve, plug, sieve, mesh or drug eluting
component. More particularly said functional element is a standard
functional element. More particularly said docking features include
anchoring components engaging said functional element by friction,
barb, clip, staple, post, eyelet or hook. More particularly said
intraluminal docking structure and optionally said functional
element are manufactured as a single part through additive
manufacturing. More particularly said intraluminal docking
structure is foldable. More particularly said intraluminal docking
structure is manufactured in bio-absorbable material.
[0035] In particular embodiments said intraluminal docking
structure is a heart valve docking structure. More particularly
said heart valve docking structure comprises a body structure
linking:
[0036] a distal toroidal attachment structure and one or more
patient-specific anatomy engagement surfaces or contact points
corresponding to anatomical regions on the outflow side of the
patient's heart valve anatomy; and
[0037] a proximal toroidal attachment structure and one or more
patient-specific anatomy engagement surfaces or contact points
corresponding to anatomical regions on the inflow side of the
patient's heart valve anatomy;
[0038] said body structure comprising one or more coupling features
for linking a functional element to said docking structure, wherein
said patient-specific engagement surfaces or contact points
correspond to anatomical regions with a lower degree of variation
in time compared to other anatomical regions on the inflow or
outflow side of the patient's heart valve anatomy.
BRIEF DESCRIPTION OF THE DRAWINGS
[0039] The following description of the figures of specific
embodiments of the invention is merely exemplary in nature and is
not intended to limit the present teachings, their application or
uses. Throughout the drawings, corresponding reference numerals
indicate like or corresponding parts and features.
[0040] FIG. 1--Illustration of the anatomy of the tricuspid and
mitral valve orifices of the heart.
[0041] FIG. 2--Illustration of a foldable heart valve implant.
[0042] FIG. 3--Illustration of a plane in which measurements of
variations over time could be performed.
[0043] FIG. 4--The cross section as cut with the plane of FIG.
3.
[0044] FIG. 5--Illustration of the measurement of the (A) maximum
distance within the intersection of the orifice; (B) length of
intersection curve; (C) best fitting ellipse, long and short axis
length or ellipticity (long/short axis length); (D) best fitting
circle, smallest fitting or maximum fitting diameter; (E) surface
area.
[0045] FIG. 6--Example of the resulting docking structure (B-D) and
its position in the tricuspid valve (A).
[0046] In the figures, the following numbering is used:
[0047] 1--heart anatomy; 2--Tricuspid valve orifice; 3--right
atrium; 4--right ventricle; 5--Mitral valve orifice; 6--left
atrium; 7--left ventricle; 8--heart valve; 9--atrial side;
10--ventricular side; 11--heart valve zones showing little
movement; 12--intraluminal implant as illustrated by e.g. a heart
valve docking structure; 13--channel structure spanning the
patient's heart valve onto which functional elements can be
attached; 14--cutting plane; 15--cross section of tricuspid valve
orifice; 16--oblique cut through left ventricle; 17--maximum
distance within the intersection of the orifice; 18--length of
intersection curve; 19--best fitting ellipse; 20--best fitting
circle; 21--; surface area; 22 outer surface of the intraluminal
docking structure; 23 inner surface of the intraluminal docking
structure.
DETAILED DESCRIPTION OF CERTAIN INVENTIVE EMBODIMENTS
[0048] The application describes particular embodiments but the
inventive concept described herein is not limited thereto. Any
reference signs in the claims shall not be construed as limiting
the scope thereof.
[0049] As used herein, the singular forms "a", "an", and "the"
include both singular and plural referents unless the context
clearly dictates otherwise.
[0050] The terms "comprising", "comprises" and "comprised of" as
used herein are synonymous with "including", "includes" or
"containing", "contains", and are inclusive or open-ended and do
not exclude additional, non-recited members, elements or method
steps. The terms "comprising", "comprises" and "comprised of" when
referring to recited members, elements or method steps also include
embodiments which "consist of" said recited members, elements or
method steps.
[0051] Furthermore, the terms first, second, third and the like in
the description and in the claims, are used for distinguishing
between similar elements and not necessarily for describing a
sequential or chronological order, unless specified. It is to be
understood that the terms so used are interchangeable under
appropriate circumstances and that the embodiments of the invention
described herein are capable of operation in other sequences than
described or illustrated herein.
[0052] The term "about" as used herein when referring to a
measurable value such as a parameter, an amount, a temporal
duration, and the like, is meant to encompass variations of +/-10%
or less, preferably +/-5% or less, more preferably +/-1% or less,
and still more preferably +/-0.1% or less of and from the specified
value, insofar such variations are appropriate to perform in the
disclosed invention. It is to be understood that the value to which
the modifier "about" refers is itself also specifically, and
preferably, disclosed.
[0053] The recitation of numerical ranges by endpoints includes all
numbers and fractions subsumed within the respective ranges, as
well as the recited endpoints.
[0054] All documents cited in the present specification are hereby
incorporated by reference in their entirety.
[0055] Unless otherwise defined, all terms used in disclosing the
invention, including technical and scientific terms, have the
meaning as commonly understood by one of ordinary skill in the art
to which this invention belongs. By means of further guidance,
definitions for the terms used in the description are included to
better appreciate the teaching of the present invention. The terms
or definitions used herein are provided solely to aid in the
understanding of the invention.
[0056] Reference throughout this specification to "one embodiment"
or "an embodiment" means that a particular feature, structure or
characteristic described in connection with the embodiment is
included in at least one embodiment of the present invention. Thus,
appearances of the phrases "in one embodiment" or "in an
embodiment" in various places throughout this specification are not
necessarily all referring to the same embodiment, but may.
Furthermore, the particular features, structures or characteristics
may be combined in any suitable manner, as would be apparent to a
person skilled in the art from this disclosure, in one or more
embodiments. Furthermore, while some embodiments described herein
include some but not other features included in other embodiments,
combinations of features of different embodiments are meant to be
within the scope of the invention, and form different embodiments,
as would be understood by those in the art. For example, in the
enclosed claims, any of the claimed embodiments can be used in any
combination.
[0057] Provided herein are methods for generating a
patient-specific intraluminal implants or endoprosthesis. The term
"endoprosthesis" or implant refers to a prosthetic device placed
within the body. The term "intraluminal" refers to the fact that
they are made to be placed inside a lumen in the human or animal
body. A "lumen" refers to any cavity or passageway within the body,
and particularly refers to the inside space of a hollow structure.
This can be an existing lumen or a lumen created by surgical
intervention. This includes lumens such as blood vessels, parts of
the gastrointestinal tract, ducts such as bile ducts, parts of the
respiratory system, etc. Different types of implants are envisaged,
such as but not limited to catheters, stents, grafts, stent-grafts,
vena cava filters, tubular expandable frameworks, heart valve
frames, or docking structures. It will be understood to the skilled
person that in the context of intraluminal implants, most often the
implant will ensure/allow a flow of fluid therethrough. However,
embodiments wherein the implant blocks the flow of fluid through
the lumen are also envisaged.
[0058] In particular embodiments, the intraluminal implant
envisaged herein is an intraluminal docking structure, which can be
used to attach or dock particular functional elements to it. The
functional elements envisaged in the context of the docking
structures described herein include but are not limited to elements
or devices such as stents, grafts, stent-grafts, vena cava filters,
tubular expandable frameworks, heart valve frames, etc.
[0059] Typically, the therapeutic objective of these elements or
devices includes restoring or enhancing flow of fluids through the
lumen. However, the objective may alternatively be the prevention
of flow of fluid or other material through a particular lumen. The
functional elements envisaged for use with the docking structures
described herein may be standard devices or patient-specific
devices.
[0060] The methods described herein are envisaged to ensure that
the intraluminal implant will be positioned in the optimal location
in the patient's lumen. Optimal in this context specifically refers
to a location which is known to be stable in motion over time. To
this end, the intraluminal implants are provided which are designed
to be positioned within specifically selected regions of the lumen
wall. In particular embodiments, the implants will be provided with
an outer surface which is configured to comprise patient-specific
anatomy engagement surfaces or contact points corresponding to
these identified anatomical regions of the lumen wall. This ensures
that the implant can be nested and remains nested stably against
the lumen wall of the patient.
[0061] Thus, methods are provided for generating an intraluminal
implant specifically fitting a patient's lumen anatomy. Custom-made
implants reduce the risk of suboptimal intervention results
compared to standard devices. This is specifically applicable to
intraluminal devices, especially when the lumen anatomy has a high
rate of curvature and/or a non-uniform diameter, as is the case
with coronary arteries, cerebral vessels, intestines, etc.
[0062] The methods envisaged herein further involve, prior to the
manufacture of the intraluminal implant, the selection of parts of
the lumen anatomy showing a great stability, such that the
intraluminal implant can be designed to fit specifically in these
areas of the lumen anatomy.
[0063] In particular embodiments, methods are provided for
generating a patient-specific intraluminal implant for placement in
a lumen, comprising the steps of:
[0064] a) identifying for said patient, the anatomical regions in
said anatomical area showing greater stability in time based on
information from said patient regarding the variation of the
anatomy of said lumen in the anatomical area of interest for
placing said intraluminal implant, in function of time;
[0065] b) identifying and selecting the locations in the regions
identified in step (a) which are suitable for use as a base for the
contact surface of an intraluminal implant, and
[0066] c) generating a patient-specific intraluminal implant based
on the information obtained in steps (a) and (b), said implant
comprising an outer surface configured to comprise one or more
patient-specific anatomy engagement surfaces or contact points
corresponding to anatomical regions of the lumen wall identified in
step (b) above The methods envisaged herein may also comprise the
step of obtaining information from the patient regarding the
variation of the anatomy of the lumen in function of time, more
particularly in the anatomical area which is of interest for
placing the intraluminal implant.
[0067] The location of placement of the implant within the lumen
will to some extent be determined by the function of the implant
which is to be placed. However, typically the exact position is not
critical, such that different positions within one area are
possible. Additionally or alternatively, while the structure of the
implant can extend over a larger region of the intraluminal wall,
interaction/complementarity with only a limited region of the
intraluminal wall within this larger region may be sufficient to
ensure a stable fit within the lumen. Thus, the methods described
herein involve determining, within the "region of interest", i.e.
the region which could be used to ensure close interaction of the
implant with the intraluminal wall, those regions which are
optimal. As detailed above, such optimal regions are typically
regions which are characterized by limited movement.
[0068] Typically, this assessment of variation is an assessment of
the variation in function of time. By comparing the movement of
different regions in the one or more areas of interest over time,
the region with the least movement over time can be identified.
[0069] The assessment of movement of a region of the inner wall of
a vessel or other lumen can be ensured in different ways, using
different parameters. Examples of such parameters include:
[0070] 2-dimensional parameters such as but not limited to change
in planar circumference of the lumen, area of the lumen, best fit
ellipse ellipticity of the lumen, best fit circle diameter of the
lumen and/or maximum distance across the lumen;
[0071] 3-dimensional parameters such as shortest distance around
said lumen, best fit ellipsoid ellipticity of the lumen, short or
long axis length of the lumen, best fit cylinder diameter of the
lumen, and/or best fit sphere diameter of the lumen; and/or;
[0072] Additionally or alternatively, the assessment of movement of
a given area can be performed by monitoring the degree of variation
or displacement of a point or a surface of the lumen. In
particular, the degree of variation or displacement of a point or
surface of the lumen can be determined by measurement of the
average relative displacement of a specifying anatomical point of
the lumen in time. When comparing this to the overall average
displacement in time, an anatomical area showing a greater
stability can be regarded as an anatomical area or point which is
less than 50% of the overall average displacement in time.
Alternatively, an anatomical area showing a greater stability can
be regarded as an anatomical area or point which shows an average
displacement in time of 2 mm or less.
[0073] The methods described above allow the identification of the
regions, within the anatomical regions of interest, which have the
greater stability over time. However, other factors may play a role
in the selection of the region of the luminal wall to place the
intraluminal implant so as to ensure a stable fit. More
particularly, the presence in the vessel wall of anatomical
features which allow a closer interaction between the intraluminal
implant and the vessel wall may be of interest. These features are
typically irregularities in the vessel wall (formed by connective
or muscle tissue).
[0074] The methods envisaged herein may thus further comprise the
step of identifying, within the regions identified to be more
stable, those locations which are most suitable for use as a base
for the contact surface of an intraluminal implant.
[0075] The methods described herein further comprise generating an
implant having specific features based on this information.
[0076] In particular embodiments, the intraluminal implant
envisaged is an intraluminal docking structures, in these
embodiments, the methods will comprise generating a device which
comprises, in addition to the outer surface described above, an
inner surface comprising one or more docking features for
detachably engaging said inner surface of said intraluminal docking
structure with said functional element.
[0077] The general structure of the intraluminal docking structure
may be standard, but is typically also based on patient information
regarding the anatomy of the patient's lumen and the functional
element to be introduced into the lumen.
[0078] The intraluminal docking structures envisaged in the context
of the present application may thus have different shapes and
sizes. The general features of such docking structures are known in
the art. In some embodiments they are to some extent hollow to
allow introduction of a functional element therein. In particular
embodiments, the intraluminal docking structures are envisaged to
comprise a body forming a channel structure spanning part the
patient's lumen. Thus, intraluminal docking structures are
typically characterized by an outer surface, at least part of which
is envisaged to contact the luminal wall and an inner surface, at
least part of which will contact the functional element.
[0079] Generally, the intraluminal implant is defined by its
envisaged function, its envisaged position in the lumen and the
natural flow of blood or other fluids through the device. More
particularly, the distal end of the implant is the end at which the
blood flow exits the intraluminal implant and the proximal end is
the end at which the blood flow enters the intraluminal implant.
This is of particular interest where the intraluminal implant
comprises a body extending in the direction of the lumen and
different contact areas with the lumen wall are envisaged.
[0080] In particular embodiments the intraluminal implant is
envisaged to comprise one or more toroidal attachment structures
for positioning/attachment in the lumen. More particularly,
intraluminal implants are envisaged which comprise two toroidal
attachment structures connected by a central body. The term
"toroidal" as used herein typically refers to a torus or ring
shaped structure.
[0081] As detailed above, the methods disclosed herein generally
rely on information relating to the patient's lumen anatomy. This
type of information is typically obtained through known medical
imaging techniques. The term "medical imaging" as used herein
refers to techniques and processes used to create images of the
human or animal body (or parts and function thereof), typically for
clinical purposes (medical procedures seeking to reveal, diagnose
or examine disease) or medical science (including the study of
normal anatomy and physiology).
[0082] The information relating to the variation of the lumen
anatomy in function of time for use in the methods described herein
is obtained from a patient by three dimensional (3D) imaging of the
lumen in function of time. The imaging information can be obtained
using any type of imaging apparatus or imaging technique which
allows imaging or scanning the patient's lumen in function of time
in an accurate manner. These may include equipment such as cameras
and scanners for industrial, household or medical use. In
particular embodiments the imaging techniques and appliances used
are typical medical imaging tools such as, but not limited to
computer tomography (CT) scans including for instance multi-slice
CT (MSCT) scans, magnetic resonance imaging (MRI) scans,
ultrasound, 3D ultrasound, Positron emission tomography (PET)
scans, Single-photon emission computed tomography (SPECT) scans or
other imaging modalities. A summary of medical imaging has been
described in "Fundamentals of Medical imaging", by P. Suetens,
Cambridge University Press, 2002.
[0083] The methods described herein comprise the step of generating
a patient-specific intraluminal implant, which is characterized by
specific features which will determine the position of the
intraluminal implant in the patient and which are based on the
selection of the regions in the intraluminal wall suitable for the
placement or anchoring of the implant. More particularly, the outer
surface of the intraluminal implant, i.e. the surface contacting
the intraluminal wall, is provided with one or more
patient-specific anatomy engagement surfaces or patient-specific
contact points.
[0084] More particularly, as used herein the terms
"patient-specific anatomy engagement surfaces" or "patient-specific
contact points" relate to surfaces which are designed based on an
individual patient's lumen anatomy, thereby including features
which have a custom fit on a specific location in a specific
patient's lumen anatomy. The use of the patient-specific surface in
the structures as disclosed herein allows to ensure an improved or
optimized accuracy of the positioning of the implant. Where the
implant is an intraluminal docking station, this further increases
accuracy of the positioning of the functional element.
[0085] In particular embodiments the implant structures as
disclosed herein comprise at least two discrete patient-specific
elements or surfaces which ensure a patient-specific fit on the
anatomy of a patient. In particular embodiments, the
patient-specific surface conforms to or is complementary with at
least part of the patient's anatomy. More particularly, as regions
are selected which comprise anatomical features of interest, the
patient-specific surfaces are designed to ensure a close fit with
the anatomical features of interest.
[0086] As a result, the devices envisaged herein can be made to
have a rigid structure (or expand/deploy into a rigid structure)
while ensuring a perfect fit in the lumen of the patient. Indeed,
the structure need not adjust to the patient's anatomy upon
placement, as it is designed to securely fit the patient's anatomy.
Moreover, as the devices envisaged herein are configured by way of
the patient-specific surface(s) to ensure a perfect with in one
specific position within the patient, they do not require
identifying the optimal fit during placement.
[0087] The patient-specific surfaces are provided on the outer
surface of the intraluminal implant, more particularly, those parts
of the outer surface envisaged to be in direct contact with the
luminal surface. In particular embodiments, where the implant
comprises one or more toroidal attachment structures, the
patient-specific surfaces are provided on the outer surface of the
one or more toroidal attachment structures.
[0088] Where the intraluminal implant is a docking structure, the
methods envisaged herein further comprise providing the
intraluminal docking structure with one or more docking features
for detachably engaging a functional element. Typically, the
docking features are provided on the internal surface of the
intraluminal docking structure. The nature of the docking features
will be determined by the nature of the functional element for
which the docking structure is intended. In a particular embodiment
according to the method disclosed herein, said docking features
include anchoring components engaging said functional element by
friction, barb, clip, staple, post, eyelet or hook. In particular,
the docking features anchor to the functional element through
friction. This friction can be increased by making the edges rough
in nature (texturing) or in a more rigid material. In particular
embodiments the docking features of the intraluminal docking
structure comprise roughened surfaces while no roughened surfaces
for docking purposes are present on the functional element. More
particularly, where the functional element is a standard element
such as a standard TAVI device, the functional element is not
roughened. However, other embodiments are also envisaged. In
particular embodiments the functional element comprises roughened
surfaces while no roughened surfaces for docking purposes are
present on the docking features of the intraluminal docking
structure. In particular embodiments both the docking features of
the intraluminal docking structure and the functional element
comprise roughened surfaces.
[0089] In particular embodiments, the intraluminal docking
structure disclosed herein is envisaged for use with a functional
element which is selected from a valve, plug, mesh or a component
for eluting a drug. Indeed, docking stations are of particular
interest to allow the replacement of a functional element while
maintaining the docking in the lumen. In particular embodiments,
the intraluminal docking structure is a temporary structure used
for placement of an endoprosthesis or a drug eluting component.
More commonly however, the intraluminal docking structure in
combination with a functional element such as a valve or stent
forms an endoprosthesis envisaged to be maintained within the
body.
[0090] As detailed above, the general structure of the implant will
be determined by the nature of the function (or functional element)
for which it is intended and the anatomy of the lumen where it is
to be placed. The length and diameter of the intraluminal implant
thus, in part, depends on the anatomy of the lumen into which it is
to be deployed and its intended function. For example, coronary
stents typically have a length between 10 and 30 mm and a diameter
(when deployed) between 2 and 5 mm, whereas a thoracic
endoprosthesis typically has a length between 10 and 20 cm and a
diameter between 25 and 40 mm.
[0091] In particular embodiments the intraluminal implants
envisaged are at least partially covered by a graft material such
as but not limited to an engineered, animal, human or tissue. In
further particular embodiments, the endoprosthesis is a heart valve
and comprises an engineered heart valve (i.e. of human or animal
material) integrated into the structure. In particular embodiments,
the implant is a docking structure which itself is envisaged to be
at least partially covered by graft material or which is envisaged
for use with a functional element which is at least partially
covered by graft material.
[0092] In certain embodiments, the intraluminal implant as
disclosed herein is an endovascular implant. In further particular
embodiments the intraluminal implant is a heart valve. In further
embodiments, the intraluminal implant is a docking structure, such
as a heart valve docking structure. This latter embodiment will be
described more in detail below.
[0093] In a particular embodiment the intraluminal implant can be
used to deliver drugs or medicine, either directly or by way of a
functional element. Upon introduction, the intraluminal implant
and/or where applicable the functional element are prone to
calcification. To prevent or minimize the calcification several
treatments have been employed before the tissue is fixed. Some
strategies include treating the implanted structures with ethanol,
metallic salts, detergents, biophosphonates, coimplants of
polymeric controlled release drug delivery systems, and covalent
attachment of ant calcifying agents. In the particular embodiment
the implanted structure is treated in 40% to 80% ethanol for 20 to
200 hours before fixation in a buffered glutaraldehyde solution.
The ethanol pretreatment prevents calcification in of the structure
after implantation and serves to remove cholesterol and
phospholipids from the tissue before fixation.
[0094] In particular embodiments, the methods as disclosed herein
further provide that the implant or part thereof is transitionable
from a collapsed state to an expanded state. The intraluminal
implant as envisaged herein may be self-expanding or balloon
expandable. A self-expanding structure has the ability to revert
readily from a reduced profile configuration to a larger profile
configuration in the absence of a restraint upon the device that
maintains the device in the reduced profile configuration. Balloon
expandable refers to a device that comprises a reduced profile
configuration and an expanded profile configuration, and undergoes
a transition from the reduced configuration to the expanded
configuration via the outward radial force of a balloon expanded by
any suitable inflation medium. The implant is particularly capable
of collapsing to a diameter small enough to pass through the
desired introducer size.
[0095] More particularly, the intraluminal implant is
transitionable from a collapsed state to an expanded state where
the equilibrium shape of the structure can be the expanded state,
the collapsed state or a state in between. More particularly, the
intraluminal implant comprises two equilibrium stages. The
transition from one state to another may be triggered through an
activation mechanism bringing the structure from one state to the
other and/or blocking the implant in a specific state. Accordingly,
these structures are transported in a collapsed state towards the
anatomical position where it is eventually deployed. These types of
expandable structures require the use of shape memory alloys such
as Nitinol. If the location or performance of the intraluminal
implant is not acceptable, the support structure may be caused to
contract by changing its temperature, causing it to return to its
preset "remembered" shape, which in this case is a smaller,
radially collapsed shape. The temperature controlling media could
be a fluid such as saline, and could be delivered while a catheter
is inserted through the support structure. This would cause the
intraluminal implant to collapse down on the catheter allowing
removal or possibly redeployment. Other shape memory materials are
available, and may have more desirable mechanical properties for
use as expandable intraluminal implant.
[0096] In another particular embodiment, the intraluminal implant
is transitionable from a collapsed state to an expanded state
through an activation mechanism bringing the structure into the
expanded state. The activation mechanism may be a mechanical switch
or a blocking element. Preferably, this type of intraluminal
implant is a balloon expandable intraluminal implant where
typically biocompatible alloys, such as stainless steel,
cobalt-chromium, or other materials known in the art are used. The
balloon expandable intraluminal implant is deployed in any way
desired, using the typically known methods available in the prior
art. If the location or performance of the intraluminal implant is
not acceptable, the support structure may be caused to contract by
deflating the balloon causing it to return to its collapsed state,
allowing removal or possible redeployment.
[0097] In a particular embodiment, the intraluminal implant is a
docking structure and a combination of the intraluminal docking
station and functional element is provided as a self-expanding
endoprosthesis. In more particular embodiments, the implant such as
the docking structure is a recapturable self-expanding device.
Typically, such recapturable devices are braided from a
super-elastic or high strength alloy and have relatively low radial
strength. As they are pulled back into a sheath they collapse on
their diameter and lengthen facilitating recapturability. Not all
braided self-expanding structures are recapturable.
[0098] In a further particular embodiment, it is provided that said
intraluminal implant or part thereof is adapted to retract radially
in the collapsed state and extend radially in the expanded
state.
[0099] In particular embodiments of the method disclosed herein
said intraluminal implants, such as but not limited to intraluminal
docking structures and optionally the functional element envisaged
for use therewith are manufactured by additive manufacturing. In
more particular embodiments, said implant, such as a docking
structure and/or the functional element for use therewith, is
manufactured as a single part.
[0100] Additive Manufacturing can be defined as a group of
techniques used to fabricate a tangible object typically using 3D
computer aided design (CAD) data. Currently, a multitude of
Additive Manufacturing techniques is available, including Selective
Laser Sintering, stereolithography, Fused Deposition Modeling,
foil-based techniques, etc. Selective laser sintering (SLS) and
selective laser melting use a high power laser or another focused
heat source to sinter or weld small particles of plastic, metal, or
ceramic powders into a mass representing the 3D object to be
formed. Fused deposition modeling and related techniques make use
of a temporary transition from a solid material to a liquid state,
usually due to heating. The material is driven through an extrusion
nozzle in a controlled way and deposited in the required place as
described among others in U.S. Pat. No. 5,141,680. Foil-based
techniques fix coats to one another by means of gluing or photo
polymerization or other techniques and cut the object from these
coats or polymerize the object. Such a technique is described in
U.S. Pat. No. 5,192,539.
[0101] Typically, AM techniques start from a digital representation
of the 3D object to be formed. Generally, the digital
representation is sliced into a series of cross-sectional layers
which can be overlaid to form the object as a whole. The AM
apparatus uses this data for building the object on a
layer-by-layer basis. The cross-sectional data representing the
layer data of the 3D object may be generated using a computer
system and computer aided design and manufacturing (CAD/CAM)
software.
[0102] The material used to manufacture the disclosed structures
may depend on the (additive) manufacturing method used and the
specifications of the endoprosthesis to be manufactured. In
particular embodiments, the intraluminal implant is made of a
material which is biocompatible as well as compatible with additive
manufacturing, including shape memory alloy, super elastic alloy,
polymer, stainless steel or any other material which is used in
endovascular prostheses. Preferably said material is a shape memory
and/or super elastic material, including metals, metal alloys and
polymers. In particular embodiments, the wires used for making the
endoprosthesis comprise nitinol, stainless steel, titanium,
platinum, pyrolitic carbon, polyglycolic acid, expanded
polytetrafluoroethylene, polyethylene terephtalate, polylactic acid
or any other (biocompatible) metal, ceramic or polymer known in the
art.
[0103] In particular embodiments, the intraluminal implant may
further be coated. In further embodiments, the coating is an
(inert) coating selected from the group consisting of polysulfone,
silicone rubber, polyurethane, synthetic glycocalix, amorphous
silicon carbide, diamond-like carbon, magnesium phosphate,
magnesium oxide, or mixtures thereof.
[0104] In particular embodiments, the intraluminal implants
envisaged herein comprise a flexible biocompatible contractible
fabric or an auxetic material. The contractible aspect of the
intraluminal implant is the result of the structure and/or material
of the intraluminal implant. When the structure is provided with
mechanical hinges that allow folding of the structure the ratio of
the amount of material versus free space should be low to allow the
contraction. Alternatively, elastic materials may also be used to
provide the collapsible characteristics, whereby regions in the
structure having a higher elasticity act as bending points. Typical
flexible biocompatible materials include, but are not limited to,
polymers, such as epoxies, acrylates, polycarbonate, polyolefins,
polyamide, PEEK, polyurethanes, Poly(Acrylonitrile, Butadiene,
Styrene) (ABS), sulphones and/or Polyethylenimine; metals, such as
stainless steel, aluminum, cobalt, chrome, gold, platinum, nickel
or alloys thereof; and/or ceramics, such as aluminae, Zr oxide
and/or Si carbide.
[0105] In a particular embodiment said intraluminal implant is made
of a bio-absorbable material.
[0106] The patient envisaged in which the intraluminal implants
described herein can be used may be a human or animal patient.
Particularly, said intraluminal implant can be an intraluminal
docking structure such as a heart valve docking structure.
[0107] More particularly, methods are provided wherein said
patient-specific intraluminal implant is a heart valve comprising a
distal toroidal attachment structure a proximal toroidal attachment
structure; and a body structure linking the distal toroidal
attachment structure to the proximal toroidal attachment structure,
thereby spanning the patient's heart valve. In particular
embodiments, these methods comprise identifying for said patient,
the anatomical regions in the anatomical area of said heart valve
showing greater stability in time; identifying and selecting the
locations in the regions identified, which are suitable for use as
a base for the contact surface of a heart valve, and generating a
patient-specific heart valve based on the information obtained in
the previous identification steps such that said distal toroidal
attachment structure comprises patient-specific anatomy engagement
surfaces or contact points corresponding to anatomical regions on
the outflow side of the patient's heart valve anatomy and said
proximal toroidal attachment structure comprises patient-specific
anatomy engagement surfaces or contact points corresponding to
anatomical regions on the inflow side of the patient's heart valve
anatomy. In particular embodiments, the patient-specific
intraluminal implant can be a heart valve docking structure and the
heart valve docking structure comprises a distal toroidal
attachment structure, a proximal toroidal attachment structure, and
a body structure linking the distal toroidal attachment structure
to the proximal toroidal attachment structure, thereby spanning the
patient's heart valve such as described above.
[0108] The application further provides intraluminal implants such
as those obtainable by the methods described herein. More
particularly, the application provides intraluminal implants which
comprise a body structure spanning a specific patient's lumen with
an outer surface configured to comprise one or more
patient-specific anatomy engagement surfaces or contact points
corresponding to patient-specific anatomical regions of the lumen
wall, wherein said patient-specific anatomical regions of the lumen
wall are pre-operatively identified anatomical regions showing
greater stability in time.
[0109] In particular embodiments, the outer surface of the
intraluminal implants envisaged herein comprise an outer surface
comprising both patient-specific anatomy engagement surfaces or
contact points and non-patient-specific surfaces, wherein the
non-patient specific surfaces correspond to anatomical regions of
the lumen wall are pre-operatively identified anatomical regions
showing lesser stability in time. Thus, in particular embodiments
the patient-specific anatomy engagement surfaces or contact points
do not extend over the entire outer surface of the implant, but
represent one or more discrete areas on the outer surface of the
implant. In particular embodiments, the patient-specific anatomy
engagement surfaces or contact points are characterized by an
irregular free-form surface, while the non-patient-specific surface
parts are characterized by a regular and/or smooth surface. In
particular embodiments, the outer surface of the implant comprises
a combination of patient-specific surface areas and toroidal
attachment structures. In particular embodiments, a toroidal
attachment structure can be positioned within a patient-specific
surface area. In further embodiments, the patient-specific anatomy
engagement surface is present on the one or more toroidal
attachment structures.
[0110] Thus in particular embodiments, intraluminal implants are
provided which comprise a structure characterized by a central
hollow body which connects:
[0111] a distal toroidal attachment structure combined with one or
more patient-specific anatomy engagement surfaces or contact points
corresponding to anatomical regions on the outflow side of the
patient's heart valve anatomy; and
[0112] a proximal toroidal attachment structure combined with one
or more patient-specific anatomy engagement surfaces or contact
points corresponding to anatomical regions on the inflow side of
the patient's heart valve anatomy.
[0113] In particular embodiments, the application provides
intraluminal docking structures comprising a body structure
spanning a specific patient's lumen, an outer surface configured to
comprise one or more patient-specific anatomy engagement surfaces
or contact points corresponding to patient-specific anatomical
regions of the lumen wall; and an inner surface comprising one or
more docking features for detachably engaging said inner surface of
said intraluminal docking structure with a functional element;
wherein said patient-specific anatomical regions of the lumen wall
are pre-operatively identified anatomical regions showing greater
stability in time.
[0114] In particular embodiments, heart valve docking structures
are provided which comprise a structure characterized by a central
hollow body which connects:
[0115] a distal toroidal attachment structure comprising
patient-specific anatomy engagement surfaces or contact points
corresponding to anatomical regions on the outflow side of the
patient's heart valve anatomy; and
[0116] a proximal toroidal attachment structure comprising
patient-specific anatomy engagement surfaces or contact points
corresponding to anatomical regions on the inflow side of the
patient's heart valve anatomy.
[0117] More particularly, the heart valve docking structures are
characterized in that the patient-specific engagement surfaces or
contact points correspond to anatomical regions of the intraluminal
wall neighboring said valve characterized by greatest stability in
time.
[0118] More particularly, the distal and proximal toroidal
attachment structures of the heart valve docking station are
constructed and configured to be positioned, when in use, against
an annulus defined by tissue surrounding the patient's tricuspid,
mitral, aortic or pulmonary valve, and in particular the patient's
tricuspid or mitral valve. More particularly, the heart valve
docking structure is particularly suitable for use onto the
patient's tricuspid or mitral valve. As these heart valves are
difficult to reach using the currently available minimally invasive
valve devices, the heart valve docking structure as disclosed
herein would be particularly suitable for the tricuspid or mitral
heart valves. The application further provides combinations of
intraluminal docking structures as described herein and functional
elements for use therewith.
[0119] The application further provides methods for introducing a
functional element into the lumen of a patient, using the
intraluminal docking structures described herein. More particularly
these methods involve positioning the intraluminal docking
structure specifically and correctly into the patient's anatomy.
The intraluminal docking structures as disclosed herein are
introduced into the patient using a guide wire.
[0120] This will be exemplified herein for the positioning of a
heart valve docking structure. While the traditional way to repair
or replace a heart valve is to perform a sternotomy, the
intraluminal docking structures disclosed herein can be deployed
without requiring invasive surgery. In particular embodiments, the
methods for introducing the docking structures involve the
following steps:
[0121] creating an incision in such location as traditionally
required for a transcatheter heart valve access, for instance
including but not limited to: femoral veins or arteries,
transapical, transaortic or subclavian access, transjugular,
transcarotid;
[0122] introduction of a sheath and guide wire;
[0123] optionally, performing of a balloon valvuloplasty (breaking
open of the diseased valve by inflating a balloon in it);
[0124] collapsing of the docking and provision onto the catheter.
It will be brought over the guide wire to the location of
deployment.
[0125] Deployment of the docking structure. The deployment can be
as a self-expanding device by pushing it out of the catheter and by
the device restoring to its original state because of elasticity.
Alternatively, a mechanical deformation mechanism (balloon,
pulling, pushing, . . . ) and a locking mechanism can be used that
allows for opening and locking the deployment degree of freedom.
Once in place, the functional element is released from its delivery
system and onto the docking station. The functional element can be
deployed using a transcatheter approach.
[0126] The present invention will be illustrated by the following
non-limiting embodiments.
EXAMPLES
Identification of Suitable Locations for Use in the Development of
a Patient-Specific Intraluminal Implant
[0127] The present example provides a particular embodiment which
may be used to identifying and selecting the locations in a
patient's anatomy that are suitable for use as a base for the
patient-specific contact surfaces of an intraluminal implant, such
as but not limited to, an intraluminal docking structure.
[0128] In first instance the patient's anatomy onto which the
intraluminal docking structure needs to be deployed is identified
(e.g. the tricuspid valve a shown in FIG. 1). Using medical imaging
equipment, the variation of the anatomy of tricuspid valve is
monitored in function of time. For this purpose, a plane is
identified in which the measurements are performed (FIG. 3),
thereby providing cross section images (FIG. 4) of the plane cut in
function of time. From these images specific parameters are
measured such as for instance the maximum distance within the
intersection of the tricuspid valve orifice (FIG. 5, Item A); the
length of intersection curve (FIG. 5, Item B); the best fitting
ellipse (FIG. 5, Item C); the best fitting circle (FIG. 5, Item D);
and/or the surface area (FIG. 5, Item E). These data serve as a
basis for identifying for said patient, the anatomical regions in
said anatomical area showing greater stability in time and
identifying and selecting the locations which are suitable for use
as a base for the contact surface of an intraluminal implant. On
the basis of this information a patient-specific intraluminal
implant is generated (FIG. 6). The positioning of an exemplary
implant in a lumen is illustrated in FIG. 2. The implant (12) is
characterized by an outer surface (22) comprising one or more
patient-specific anatomy engagement surfaces or contact points
corresponding to locations of the anatomical regions of the lumen
wall which have been selected according to the methods described
herein.
[0129] In further embodiments, where the intraluminal implant is a
docking structure, it may further comprise an inner surface (23)
comprising one or more docking features for detachably engaging the
inner surface of with a functional element.
* * * * *