U.S. patent application number 15/461922 was filed with the patent office on 2020-04-02 for devices and methods for anatomic mapping for prosthetic implants.
This patent application is currently assigned to Aortica Corporation. The applicant listed for this patent is Aortica Corporation. Invention is credited to Thomas C. DOUTHITT, Prashanth DUMPURI, Arun Palligaranai TIRUMALAI, Richard VAN BIBBER.
Application Number | 20200100840 15/461922 |
Document ID | / |
Family ID | 56015088 |
Filed Date | 2020-04-02 |
United States Patent
Application |
20200100840 |
Kind Code |
A9 |
VAN BIBBER; Richard ; et
al. |
April 2, 2020 |
DEVICES AND METHODS FOR ANATOMIC MAPPING FOR PROSTHETIC
IMPLANTS
Abstract
A method of generating a patient-specific prosthetic includes
receiving anatomic imaging data representative of a portion of a
patient's anatomy. A first digital representation of the anatomic
imaging data is defined. The first digital representation of the
anatomic imaging data is modified. A second digital representation
of the portion of the patient's anatomy is defined based on the
modifying of the first digital representation of the anatomic
imaging data. A patient-specific prosthetic template of the portion
of the patient's anatomy is generated based at least in part on the
second digital representation of the anatomic imaging data.
Inventors: |
VAN BIBBER; Richard;
(Redmond, WA) ; DOUTHITT; Thomas C.; (Kirkland,
WA) ; TIRUMALAI; Arun Palligaranai; (Sammamish,
WA) ; DUMPURI; Prashanth; (Kirkland, WA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Aortica Corporation |
Bellevue |
WA |
US |
|
|
Assignee: |
Aortica Corporation
Bellevue
WA
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20170333133 A1 |
November 23, 2017 |
|
|
Family ID: |
56015088 |
Appl. No.: |
15/461922 |
Filed: |
March 17, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15163255 |
May 24, 2016 |
9629686 |
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15461922 |
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PCT/US2016/029185 |
Apr 25, 2016 |
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15163255 |
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62151506 |
Apr 23, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2240/005 20130101;
A61F 2/07 20130101; A61B 2034/108 20160201; A61F 2240/002 20130101;
A61B 34/10 20160201; A61F 2/89 20130101; A61F 2002/061
20130101 |
International
Class: |
A61B 34/10 20060101
A61B034/10; A61F 2/07 20130101 A61F002/07 |
Claims
1.-66. (canceled)
67. A method, comprising: receiving a digital representation of a
portion of a patient's blood vessel, the digital representation
including data representative of a first location of an anatomic
feature of the patient's blood vessel; modifying the digital
representation to determine a second location of the anatomic
feature of the patient's blood vessel, the second location
different than the first location; and generating a model of the
portion of the patient's blood vessel, the model including data
representative of the second location of the anatomic feature.
68. The method of claim 67, wherein the digital representation is
based on imaging data associated with the portion of the patient's
blood vessel.
69. The method of claim 67, wherein the model is a patient-specific
template.
70. The method of claim 67, wherein the second location is
calculated from a reference point.
71. The method of claim 67, wherein determining the second location
of the anatomic feature is calculated automatically.
72. The method of claim 71, wherein the automatic calculation of
the second location is based on a user input.
73. The method of claim 72, wherein the user input includes at
least one of an anatomic feature of the patient, a property of a
prosthesis, a delivery device for delivering a prosthesis to the
patient, and an insertion location of a prosthesis.
74. A method, comprising: receiving a digital representation of a
patient's aorta, the digital representation including data
representative of an original branch blood vessel location;
receiving a user input; determining a predicted branch blood vessel
location based on an expected change in position of the patient's
aorta; and generating a model of the patient's aorta, the model
including data representative of the predicted branch blood vessel
location.
75. The method of claim 74, wherein determining the predicted
branch blood vessel location is based at least in part on the user
input.
76. The method of claim 74, wherein determining the predicted
branch blood vessel location is based at least in part on the
expected change in position of the patient's aorta as a result of
the insertion of a prosthesis.
77. The method of claim 74, wherein determining the predicted
branch blood vessel location is based on the expected change in
position of the patient's aorta as a result of the insertion of a
prosthesis and on the user input.
78. The method of claim 74, wherein the user input includes at
least one of an anatomic feature of the patient, a property of a
prosthesis, a delivery device for delivering a prosthesis to the
patient, and an insertion location of a prosthesis.
79. The method of claim 74, wherein the predicted branch blood
vessel location is determined automatically as a result of the user
input.
80. A non-transitory computer readable storage medium encoded with
processor-executable instruction that, when executed by a
processor, performs a method for determining a predicted branch
blood vessel location, the method comprising: receiving, at the
processor, a digital representation of a patient's blood vessel,
the digital representation including data representative of an
original branch blood vessel location; predicting a change in the
patient's blood vessel; automatically determining the predicted
branch blood vessel location based on the predicted change in the
patient's blood vessel; and providing data representative of the
predicted branch blood vessel location.
81. The non-transitory computer readable storage medium of claim
80, wherein the method includes receiving, at the processor, a user
input, the user input including at least one of an anatomic feature
of the patient, a property of a prosthesis, a delivery device for
delivering a prosthesis to the patient, and an insertion location
of the prosthesis.
82. The non-transitory computer readable storage medium of claim
80, wherein the predicted change in the patient's blood vessel is
based on a property of a delivery device for delivering a
prosthesis to the patient.
83. The non-transitory computer readable storage medium of claim
80, wherein the predicted change in the patient's blood vessel is
based on a property of a prosthesis.
84. The non-transitory computer readable storage medium of claim
80, wherein the predicted change in the patient's blood vessel is
based on an insertion location of a prosthesis.
85. The non-transitory computer readable storage medium of claim
80, further comprising: automatically extracting a centerline of
the patient's blood vessel from the digital representation.
86. The non-transitory computer readable storage medium of claim
85, further comprising: automatically predicting a change in the
centerline based on at least one of an anatomic feature of the
patient, a property of a prosthesis, a property of a delivery
device for delivering a prosthesis to the patient, and an insertion
location of a prosthesis.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/163,255, entitled "Devices and Methods for
Anatomic Mapping for Prosthetic Implants," filed May 24, 2016,
which is a continuation of International Patent Application No.
PCT/US2016/029185, entitled "Devices and Methods for Anatomic
Mapping for Prosthetic Implants," filed Apr. 25, 2016, which claims
priority to and the benefit of U.S. Provisional Patent Application
Ser. No. 62/151,506, entitled "Devices and Methods for Anatomic
Mapping for Prosthetic Implants," filed Apr. 23, 2015, the
disclosures of which are hereby incorporated by reference in their
entireties.
BACKGROUND
[0002] The embodiments described herein relate generally to
prosthetic implants and more particularly, to devices and methods
for mapping projected changes in anatomic features resulting from
the placement of a prosthetic implant.
[0003] Prosthetic devices are often implanted into, for example,
diseased portions of a patient to repair, support, stent, and/or
otherwise facilitate the proper function of those diseased
portions. In some instances, prosthetic devices such as stent
grafts can be used to repair diseased portions of a patient's
vascular system. For example, aneurysms within a patient's vascular
system generally involve the abnormal swelling or dilation of a
blood vessel such as an artery, which typically weakens the wall of
the blood vessel making it susceptible to rupture. An abdominal
aortic aneurysm (AAA) is a common type of aneurysm that poses a
serious health threat. A common way to treat AAA and other types of
aneurysms is to place an endovascular stent graft in the affected
blood vessel such that the stent graft spans across (e.g.,
traverses) and extends beyond the proximal and distal ends of the
diseased portion of the vasculature. The stent graft can thus,
reline the diseased vasculature, providing an alternate blood
conduit that isolates the aneurysm from the high-pressure flow of
blood, thereby reducing or eliminating the risk of rupture. In
other instances, a prosthetic device can be an implant and/or
mechanism, which can provide structural or functional support to a
diseased and/or defective portion of the body. In some instances,
however, the arrangement of the anatomy can present challenges when
attempting to place and/or secure a prosthetic device (including
stent grafts or the like). Such challenges can result in
misalignment and/or suboptimal configuration of the prosthetic
device within the anatomy.
[0004] Therefore, a need exists for improved devices and methods
for mapping projected changes in anatomic features resulting from
the placement of a prosthetic implant.
SUMMARY
[0005] Devices and methods for improving the fenestration process
of stent grafts are described herein. In some embodiments, a method
of generating a patient-specific prosthetic includes receiving
anatomic imaging data representative of a portion of a patient's
anatomy. A first digital representation of the anatomic imaging
data is defined. The first digital representation of the anatomic
imaging data is modified. A second digital representation of the
portion of the patient's anatomy is defined based on the modifying
of the first digital representation of the anatomic imaging data. A
patient-specific prosthetic template of the portion of the
patient's anatomy is generated based at least in part on the second
digital representation of the anatomic imaging data.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] FIG. 1 is an illustration of a diseased abdominal aorta
according to an embodiment.
[0007] FIG. 2A is a portion of a stent graft according to an
embodiment and directly after placement within the diseased
abdominal aorta of FIG. 1.
[0008] FIG. 2B is a portion of the stent graft of FIG. 2A and
placed within the diseased abdominal aorta of FIG. 1 and after a
time of indwelling.
[0009] FIG. 3 is an illustration of at least a portion of a
fenestration template according to an embodiment.
[0010] FIG. 4 is an illustration of at least a portion of a
fenestrated stent graft according to an embodiment and formed via
the fenestration template of FIG. 3.
[0011] FIG. 5 is an illustration of the portion of the fenestrated
stent graft of FIG. 4 positioned, for example, within a portion of
a diseased abdominal aorta.
[0012] FIGS. 6 and 7 are illustrations of at least a portion of a
fenestration template according to another embodiment, in a first
configuration and a second configuration, respectively.
[0013] FIG. 8 is a flowchart illustrating a method of forming a
prosthetic, such as a stent graft, according to an embodiment.
DETAILED DESCRIPTION
[0014] Devices and methods for improving the fenestration process
of stent grafts are described herein. In some embodiments, a method
of forming a patient-specific prosthetic includes receiving
anatomic imaging data representative of a portion of a patient's
anatomy. A first digital representation of the anatomic imaging
data is defined. The first digital representation of the anatomic
imaging data is modified. A second digital representation of the
portion of the patient's anatomy is defined based on the modifying
of the first digital representation of the anatomic imaging data. A
patient-specific prosthetic template of the portion of the
patient's anatomy is formed based at least in part on the second
digital representation of the anatomic imaging data.
[0015] As used in this specification, the singular forms "a," "an"
and "the" include plural referents unless the context clearly
dictates otherwise. Thus, for example, the term "a member" is
intended to mean a single member or a combination of members, "a
material" is intended to mean one or more materials, or a
combination thereof.
[0016] As used herein, the words "proximal" and "distal" refer to a
direction closer to and away from, respectively, an operator of,
for example, a medical device. Thus, for example, the end of the
medical device contacting the patient's body would be the distal
end of the medical device, while the end opposite the distal end
would be the proximal end of the medical device. Similarly, when a
device such as an endovascular stent graft is disposed within a
portion of the patient, the end of the device closer to the
patient's heart would be the proximal end, while the end opposite
the proximal end would be the distal end. In other words, the
proximal end of such a device can be upstream of the distal end of
the device.
[0017] The embodiments described herein can be formed or
constructed of one or more biocompatible materials. Examples of
suitable biocompatible materials include metals, ceramics, or
polymers. Examples of suitable metals include pharmaceutical grade
stainless steel, gold, titanium, nickel, iron, platinum, tin,
chromium, copper, and/or alloys thereof. Examples of polymers
include nylons, polyesters, polycarbonates, polyacrylates, polymers
of ethylene-vinyl acetates and other acyl substituted cellulose
acetates, non-degradable polyurethanes, polystyrenes, polyvinyl
chloride, polyvinyl fluoride, poly(vinyl imidazole),
chlorosulphonate polyolefins, polyethylene oxide, polyethylene
terephthalate (PET), polytetrafluoroethylene (PTFE), and/or blends
and copolymers thereof
[0018] The embodiments described herein can be used to facilitate
the function and/or the integration of a prosthetic device within a
portion of a patient. For example, in some embodiments, the devices
and/or methods described herein can be used in conjunction with
and/or can otherwise be included endovascular repair using stent
grafts. Although the embodiments are shown and described herein as
being used, for example, to facilitate endovascular repair, in
other embodiments, any of the devices and/or methods described
herein can be used to facilitate treatment of any portion of a
patient. For example, the devices and methods described herein can
facilitate the integration of any suitable implant, prosthetic,
device, mechanism, machine, and/or the like within a portion of the
body of a patient such as the patient's vascular system, nervous
system, muscular-skeletal system, etc. Therefore, while the
embodiments are shown and described herein as being used in the
endovascular repair of an abdominal aortic aneurysm, they are
presented by way of example and are not limited thereto.
[0019] Some of the devices and/or methods described herein can be
used in minimally invasive treatment techniques such as
endovascular repair using stent grafts. Such repair techniques are
generally preferred over traditional open surgical repair and often
result in reduced morbidity or mortality rates. In some instances,
however, the arrangement of the diseased vasculature can result in
a need to alter a portion of the stent graft prior to insertion
into the body. For example, in an endovascular repair of an
abdominal aortic aneurysm, the aneurysm can be situated adjacent to
and/or directly distal to normally functioning vessels branching
from a portion of the aorta. In order to reline the aneurysm with
the stent graft, surgeons often cut openings in the stent graft
fabric to accommodate specific branch vessel origins, a process
known as "fenestration". Specifically, in treating juxtarenal
aneurysms, for instance, the fenestrations or openings of the stent
grafts can correspond to a size, shape, and/or relative position
of, inter alia, the renal arteries.
[0020] Traditionally, the fenestration process involves
measurements based on medical images (such as CT scans) of the
vessel origins. For example, in some instances, longitudinal
distances of branch vessels can be measured and relative angular
locations of the branch vessels can be estimated and/or calculated
from a reference point. Based on these measurements and/or
calculations, a surgeon can mark and cut the stent fabric of a
stent graft to define one or more fenestrations. The fenestrated
stent graft can then be positioned within the diseased vasculature
(e.g., via an endovascular procedure) and oriented to substantially
align the fenestrations with openings of the corresponding branch
vessels.
[0021] In some instances, the devices and/or methods described
herein can be used to generate a template and/or model based on
medical imaging data of a diseased portion of a patient's vascular
system (e.g., an abdominal aortic aneurysm). In some embodiments,
the template can be substantially similar to those described in
U.S. Patent Publication No. 2013/0296998 entitled, "Fenestration
Template for Endovascular Repair of Aortic Aneurysms," filed May 1,
2013 ("the `998 publication"), the disclosure of which is
incorporated herein by reference in its entirety. For example, an
electronic device such as a personal computer, workstation, laptop,
etc. can receive the imaging data and can calculate and/or
otherwise define a digital representation of the imaging data.
Based on the digital representation, the electronic device can
define the template and can send a signal to an output device such
as a 3-D printer or rapid prototyping device, which can then
output, form, and/or 2-D or 3-D print the template. The template,
in turn, can be used to facilitate the fenestration process of a
prosthetic (e.g., a stent graft). Moreover, the devices and/or
methods described herein can be used to determine and/or calculate
a change in the arrangement of a portion of the anatomy resulting
from the insertion and/or indwelling of the prosthetic, and can
form a template representing the portion of the anatomy thereafter,
as described in further detail herein.
[0022] FIGS. 1-2B illustrate a diseased portion of a patient's
abdominal aorta 10. While portions of the abdominal aorta 10 are
described below, the discussion of the abdominal aorta 10 is not
exhaustive; rather, the discussion below provides a reference to
the relevant anatomic structures. The abdominal aorta 10 (also
referred to herein as "aorta") has a proximal end portion 11,
receiving a flow of blood from the descending aorta (not shown),
and a distal end portion 12, supplying a flow of blood to the lower
limbs. As shown in FIG. 1, the aorta 10 at or near the proximal end
portion 11 supplies a flow of blood to the left renal artery 14 and
the right renal artery 13, which in turn, supply blood to the left
and right kidney, respectively. Although not shown in FIG. 1, the
proximal end portion 11 of the aorta 10 also supplies a flow of
blood to the superior mesenteric artery (SMA) and the celiac
artery. The distal end portion 12 of the aorta 10 forms the iliac
bifurcation 20, through which the aorta 10 supplies a flow of blood
to the left common iliac artery 16 and the right common iliac
artery 15, which in turn, supply blood to the left and right lower
limbs, respectively. As shown in FIG. 1, this patient has an
abdominal aortic aneurysm (AAA) 17 positioned distal to the renal
arties 13 and 14 and proximal to the iliac bifurcation 20. More
specifically, the AAA 17 is disposed in a position that precludes
the attachment of a proximal end portion of a stent graft between
the renal arteries 13 and 14 and the AAA 17, and thus, a
fenestrated stent graft 160 (see e.g., FIGS. 2A and 2B) is used for
endovascular repair of the AAA 17.
[0023] In some instances, endovascular repair of the AAA 17
includes scanning and/or otherwise capturing anatomic imaging data
associated with the patient's aorta 10. For example, an imaging
device can be a X-ray device, a computed tomography (CT) device, a
computed axial tomography (CAT) device, a magnetic resonance
imaging device (MM), a magnetic resonance angiograph (MRA) device,
a positron emission tomography (PET) device, a single photon
emission computed tomography (SPECT) device, an ultrasound device,
and/or any other suitable device for imaging a portion of the
patient and/or a combination thereof (e.g., a CT/MRA device, a
PET/CT device, a SPECT/CT device, etc.). The imaging data captured
by the imaging device can thus, be used to determine salient
features of the patient's aorta 10 such as, for example, the branch
vessels in fluid communication with the aorta 10. For example, a
doctor, surgeon, technician, etc. can use the imaging data to
determine and/or calculate a size, shape, position, and/or
orientation of at least the renal arteries 13 and 14. In some
instances, the doctor, surgeon, technician, etc. can form and/or
define one or more fenestrations 165 in the stent graft 160
associated with the determined and/or calculated characteristics of
at least the renal arteries 13 and 14. In other instances, the
imaging data can be used to form and/or define a template or the
like that can define a set of openings and/or otherwise include a
set of indicators associated with at least the renal arteries 13
and 14. The template can then be used to define the fenestrations
165 in the stent graft 160.
[0024] As shown in FIG. 2A, the stent graft 160 can be positioned
within a portion of the patient's abdominal aorta 10 via an
endovascular procedure. For example, the stent graft 160 can be
disposed within a delivery catheter (e.g., in a collapsed,
compressed, restrained, and/or otherwise un-deployed
configuration), which is inserted into, for example, the femoral
artery (not shown). The delivery catheter can be advanced through
the artery and into the abdominal aorta 10. Once advanced to a
desired position within the abdominal aorta 10, the delivery
catheter can be withdrawn relative to the stent graft 160. As the
delivery catheter is retracted and/or withdrawn, the stent graft
160 transitions from the collapsed configuration to an expanded or
deployed configuration, thereby stenting a portion of the abdominal
aorta 10.
[0025] The stent graft 160 includes a proximal end portion 161 and
a distal end portion 162 and defines a lumen therethrough 163. The
stent graft 160 can be any suitable stent graft. For example, the
stent graft 160 can be formed from a resilient, biocompatible
material such as those described above. In some embodiments, the
stent graft 160 can be formed from a polytetrafluoroethylene (PTFE)
or polyethylene terephthalate (PET or Dacron.RTM.). The stent graft
160 also includes a set of stiffening members 164 disposed
circumferentially about the stent graft 160. The stiffening members
164 can be any suitable structure that can, for example, bias the
stent graft 160 in an open configuration, thereby structurally
supporting the stent material (also known as "stent fabric"). In
some embodiments, the stiffening members 164 can be formed from a
metal or a metal alloy such as, for example, those described above.
In some embodiments, such a metal or metal alloy, for example, is
radio-opaque and/or otherwise coated with a radio-opaque material
configured to be visible using, for example, fluoroscopy. The
stiffening members 164 can transition from a restrained or deformed
delivery configuration (e.g., when disposed in a delivery catheter
to an expanded and/or biased indwelling configuration, as shown in
FIG. 2A.
[0026] In this embodiment, the stent graft 160 defines the set of
fenestrations 165, as described above. The fenestrations 165 are
each aligned with its corresponding renal artery 13 or 14 and can
each have a size, shape, and/or configuration that is associated
with its corresponding renal artery 13 or 14. In this manner, the
fenestrations 165 can allow blood to flow from the aorta 10 and
into the left renal artery 14 and the right renal artery 13 via the
fenestrations 165. Although not shown in FIG. 2A, the stent graft
160 can define one or more fenestrations associated with other
branch vessels stemming from the aorta 10 such as, for example, the
superior mesenteric artery (SMA), the celiac artery, and/or the
like.
[0027] As shown in FIG. 2B, the placement and/or indwelling of the
stent graft 160 within the aorta 10 can, for example, alter, shift,
rotate, translate, morph, and/or otherwise reconfigured the
arrangement of the patient's aorta 10. As a result, the openings of
the renal arteries 13 and 14 are shifted relative to the
fenestrations 165 defined by the stent graft 160. In some
instances, the shifting of the aorta 10 relative to the stent graft
160 results in at least a partial blockage of the renal arteries 13
and 14, as shown in FIG. 2B. For example, in some instances, the
openings of the renal arteries 13 and 14 can be about 4 millimeters
(mm) to about 7 mm, and the shifting and/or rearrangement of the
aorta 10 can result in a shifting of the openings of the renal
arteries 13 and 14 relative to the fenestrations 165 by about 1 mm,
about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7
mm, or more. Thus, despite defining the fenestrations 165 in a
position along the stent graft 160 based on the imaging data, the
shifting of the aorta 10 resulting from the placement and/or
indwelling of the stent graft 160 can result in a blockage of the
renal arteries 13 and 14. In some instances, the shifting of the
aorta 10 can result in more than about a 1%, 5%, 10%, 20%, 30%,
40%, 50%, 60%, 70%, 80%, 90%, or 100% blockage of the renal
arteries 13 and 14. Although not shown in FIGS. 2A and 2B, the
shifting of the aorta 10 can result in a similar misalignment of
any branch vessel relative to its corresponding fenestration in the
stent graft 160.
[0028] In some embodiments, an electronic device can be configured
to determine and/or calculate the shift in the anatomy that would
result from the insertion and/or indwelling of prosthetic (e.g., a
stent graft) and can define one or more digital representations of
the anatomy. For example, the electronic device can be a personal
computer (PC), a laptop, a workstation, and/or the like disposed in
a central location or distributed in multiple locations. The
electronic device can include at least a processor and a memory. In
some embodiments, the electronic device can also include a display
and/or the like. The memory can be, for example, a random access
memory (RAM), a memory buffer, a hard drive, a database, an
erasable programmable read-only memory (EPROM), an electrically
erasable read-only memory (EEPROM), a read-only memory (ROM), a
solid-state drive (SSD), and/or the like. The processor can be any
suitable processor configured to run and/or execute a set of
instructions, for example, stored in the memory. For example, the
processor can be a general-purpose processor, a Field Programmable
Gate Array (FPGA), an Application Specific Integrated Circuit
(ASIC), a Digital Signal Processor (DSP), a central processing unit
(CPU), an accelerated processing unit (APU), a front-end processor,
a graphics-processing unit (GPU), and/or the like. In some
embodiments, the memory can store instructions and/or code to cause
the processor to execute modules, processes and/or functions
associated with determining the shift in the anatomy, defining a
digital representation of the shifted anatomy, and/or forming a
fenestration template, as described in further detail herein. In
addition, the memory can be configured to store data (e.g., in a
database) such as imaging data, patient data, data associated with
the digital representation of the anatomy, data associated with the
fenestration template, etc.
[0029] As described above, the electronic device can be used to
receive imaging data of a portion of a patient's anatomy and can
determine and/or calculate a change in the portion of the patient's
anatomy that can result from the implantation of a prosthetic. In
addition, the electronic device can be configured to define a
digital representation of the portion of the patient's anatomy
before and/or after the change in the portion of the anatomy. Based
on the digital representation of the portion of the patient's
anatomy, the electronic device can define a fenestration template,
which in turn, can be used to form and/or define fenestrations in
the stent fabric of a stent graft. For example, an imaging device
can be configured to capture and/or scan imaging data associated
with a patient's anatomy, as described above. The electronic device
is configured to receive the imaging data and can store it, for
example, in the memory. For example, the electronic device can be
in communication with the imaging device via a network, or the
like. In other embodiments, a user can cause the imaging data to be
saved to the memory and/or the like.
[0030] Once the electronic device receives the imaging data, the
electronic device can perform any number of processes and/or
functions associated with analyzing the imaging data to define the
digital representation (also referred to herein as "model") of the
imaging data. In some embodiments, the electronic device can be
configured to present the model of the imaging data on a display
and/or the like. In this manner, the electronic device can, for
example, graphically represent an accurate anatomic model of the
portion of the patient (e.g., the abdominal aorta). In some
instances, the electronic device can, for example, determine
salient anatomic features and can identify them in the model. The
electronic device can then define a digital representation that
includes only those salient anatomic features, thereby reduces
processing load and/or file size. The electronic device can also
store any suitable digital representation in the memory and can,
for example, associate the digital representations with the patient
(e.g., in a database).
[0031] In some instances, based on the model of the imaging data, a
portion of the model of the imaging data, the model of the salient
anatomic features, and/or a combination thereof, the electronic
device can define, for example, a prosthesis template.
Specifically, as described herein, the electronic device can define
a fenestration template configured to facilitate the fenestration
process of a stent graft according to the patient's anatomy. Such a
fenestration template can include openings (fenestrations),
protrusions, markers, indicators, frangible portions, and/or any
other suitable feature corresponding to, for example, the openings
of the aorta leading to the branch vasculature, as described in
further detail herein. In some embodiments, the template can be
substantially similar to any of those described in the `998
publication, incorporated by reference above.
[0032] In some instances, the electronic device can also perform
one or more processes to adjust, modify, change, update, augment,
morph, and/or otherwise alter the data associated with the model to
define an updated model based on a set of characteristics
associated with at least one of the patient, the prosthesis (e.g.,
the stent graft), and/or a manner in which the prosthesis will be
delivered. For example, as described above, the electronic device
can be configured to define an updated model based on the effects
of the placement of the prosthesis and its indwelling within, for
example, the aorta. Said another way, because the anatomy of at
least the abdominal aorta changes when a stent graft is disposed
therein and/or while it is being positioned therein, the electronic
device is configured to adjust the data associated with the model
to account for such changes based on characteristics associated
with the patient, the stent graft, and/or the delivery method.
[0033] For example, in addition to a mapping (e.g., location
information or topography) of the patient's anatomy, the imaging
data can also include information related to any other discernable
characteristic identified by the imaging technique. Specifically,
the imaging data can include, inter alia, a degree of aortic
angulation at the juxtarenal neck or other segment of the aorta; a
degree, pattern, and location of atherosclerotic disease including
plaque, calcification, and/or thrombus; morphometric
characteristics of the vascular structure that influence size,
position, angulation, or tortuosity such as vessel diameter (i.e.,
vascular lumen diameter); and/or vessel wall thickness, vessel
length, location and number of branch arteries, and/or the like. In
some embodiments, the electronic device can extract data associated
with these characteristics and can store the extracted data in the
memory. Moreover, the extracted data can be stored with and/or
otherwise associated with other stored patient data and/or stored
prosthetic data. For example, the electronic device can store
anthropomorphic data of the patient such as body composition, body
temperature, height, weight, body-mass index (BMI), abdominal
circumference (absolute or normalized), age, and/or the like;
pre-existing vascular or extravascular prostheses or foreign
bodies; impact of specific delivery methods such as use of guide
wires, catheters, and/or the like; degree of oversizing of the
prostheses required to achieve stability; mechanical properties of
the prosthesis such as, for example, body material or fabric type,
stent or support strut geometry and/or thickness, type of metals or
other support materials, stiffness and diameter of the prosthesis
and/or devices used to deliver the prosthesis; and/or the like.
[0034] In some instances, the electronic device can determine,
evaluate, and/or otherwise calculate a weight, value, score,
percentage, scale value, influence measure, impact measure,
importance measure, and/or any other suitable quantifiable
evaluation of the data associated with the aforementioned
characteristics. Specifically, the electronic device can perform
one or more processes, calculations, evaluations, etc. to determine
a quality or measure of impact of the identified characteristics.
For example, in some instances, a first amount of angulation of a
juxtarenal neck can be greater than a second amount of angulation
of a juxtarenal neck. Thus, when a greater angulation of the
juxtarenal neck is indicative of and/or otherwise corresponds to a
shifting and/or changing of the aortic arrangement resulting from
the placement of a stent graft, the first amount of angulation can
be associated with a greater value, score, weight, measure, etc.,
than the second amount of angulation.
[0035] Expanding further, in at least one embodiment, the
electronic device can perform such an analysis based on, for
example, a weighted analysis in which characteristics and/or
factors resulting in a greater amount of shifting of the aortic
anatomy are associated with a greater weighting than those that
affect a lesser amount of shifting. For example, the weighting of
the characteristics can be associated with a value (e.g., a
multiplier or the like) such as, for example, a percentage
represented in decimal format between zero and one (e.g., 10%
represented as 0.1, 25% represented as 0.25, 50% represented as
0.5, etc.). In other instances, the percentages used in a weighted
analysis can be 100% or greater represented in decimal format
(e.g., 125% represented as 1.25, 175% represented as 1.75, 200%
represented as 2.0, etc.). In still other instances, the weighted
analysis can be based on any suitable scoring system or scale such
as, for example, 1-10, 1-100, 1-1000, etc. including whole numbers
or fractions thereof.
[0036] In some instances, a first set of characteristics can have a
greater weight than a second set of characteristics. For example,
in some embodiments, the characteristics extracted from the imaging
data can, as a group, have a higher weight than the set of
characteristics associated with, for example, method of placing the
stent graft, as a group. In this manner, the electronic device can
perform any suitable evaluation, calculation, determination, etc.
of the set of characteristics associated with the prosthesis (e.g.,
the stent graft), the patient, and/or the delivery method of the
prosthesis. Moreover, while specific examples of a weighting system
are described, in other embodiments, the electronic device can
perform any suitable weighting and/or evaluating technique. In some
embodiments, the characteristics are generally associated with a
numerical measure (e.g., a stiffness of the prosthesis is a
calculable value based on the properties of the material); thus,
the electronic device can be configured to use the "intrinsic" or
predetermined values in a predefined equation or the like. Thus, by
quantifying such characteristics, the electronic device can adjust
and/or update the data associated with the model to define an
updated model based on an anticipated, predicted, predetermined,
calculated, and/or otherwise probable shift in the arrangement
resulting from the insertion and indwelling of the endovascular
stent graft. Said another way, the model can be based on a
predetermined data set, and the predetermined data set can be
updated based on data associated with an anticipated, predicted,
predetermined, calculated, and/or otherwise probable shift in the
arrangement resulting from the insertion and indwelling of the
endovascular stent graft. In some instances, the electronic device
can present the updated model on a display or the like.
[0037] In some instances, based on the updated model of the imaging
data, a portion of the updated model of the imaging data, the model
of the salient anatomic features and/or a an updated model of the
salient anatomic features, and/or combination thereof, the
electronic device can define, for example, a prosthesis template.
Specifically, as described herein, the electronic device can define
a fenestration template configured to facilitate the fenestration
process of a stent graft according to the patient's anatomy. Such a
fenestration template can include openings (fenestrations),
protrusions, markers, indicators, frangible portions, and/or any
other suitable feature corresponding to, for example, the
projected, anticipated, adjusted, and/or otherwise calculated
location of the openings of the aorta leading to the branch
vasculature, as described in further detail herein.
[0038] In some instances, the electronic device can include and/or
can be in communication with an output device configured to form
the template. For example, the output device can be a printer, a
rapid prototype machine, a computer numerical controlled (CNC)
machine, and/or the like. For example, in some embodiments, the
output device is a three-dimensional (3-D) printer configured as
and/or otherwise implementing stereolithography (SLA), ink jet
systems (e.g., PolyJet, MultiJet, and/or the like), fused
deposition modeling (FDM), selective laser sintering (SLS), and/or
the like. In such embodiments, the output device can receive a
signal from the electronic device indicative of an instruction to
produce a 3-D printed output. Specifically, the electronic device
can send instructions to cause the output device to 3-D print a
fenestrated template used when forming the fenestrated stent
graft.
[0039] FIG. 3 illustrates an example of a fenestration template 250
according to an embodiment. In some instances, the fenestration
template 250 can be formed, for example, via the process described
above and used to generate and/or locate fenestrations on a stent
graft. More specifically, in some embodiments, the output device
can be a 3-D printer and/or other suitable rapid prototype machine
configured to print the fenestration template 250. The fenestration
template 250 can be formed from any suitable biocompatible material
such as those described herein. The fenestration template 250
includes a proximal end portion 251 and a distal end portion 252,
and defines a lumen 253 and a set of fenestrations 255. Generally,
the shape, diameter, length, etc. of the fenestration template 250
corresponds to the calculated arrangement of the lumen of the aorta
segment represented by the updated model. In other words, the
fenestration template 250 corresponds to the updated model defined
by the electronic device, which in turn, corresponds to a
calculated, projected, and/or modified arrangement of the aorta in
response to the insertion and indwelling of, for example, the
endovascular stent graft. Hence, a fenestration template 250
generally has a tubular or cylindrical shape. In some embodiments,
such as illustrated in FIG. 3, the fenestration template 250 can
define the lumen 253 that substantially corresponds to a calculated
arrangement of the lumen of the aorta. In some instances, the
diameter of the lumen 253 is at least partially based on a diameter
of the stent graft to be positioned within the patient. Although
the fenestration template 250 is shown and described above as
defining the lumen 253 (e.g., is hollow and/or substantially
annular), in other embodiments, the fenestration template 250 can
be substantially solid and the fenestrations 255 can be, for
example, semi-blind, as shown and described in detail in the '998
publication.
[0040] The fenestrations 255 are defined along the fenestration
template 250 such that each fenestration 255 corresponds to a
calculated position of the corresponding branch vasculature such
as, for example, the renal arteries. In addition, the fenestration
template 250 defines and/or can optionally define one or more
fenestrations 255 corresponding to one of the SMA, the celiac
artery, and/or any other branch vasculature. In addition, the
diameters of the fenestrations 255 defined by the fenestration
template can substantially correspond to the actual or calculated
diameters of the openings of the branch vessels in fluid
communication with a patient's aorta (see e.g., FIGS. 1-2B). In
other embodiments, the fenestrations 255 can have a predefined
diameter, for example, between about 2 mm and about 10 mm. While
the fenestration template 250 is shown as having four fenestrations
255, the position and/or number of the fenestrations 255 can be
arranged in any suitable manner corresponding to the calculated
position and/or number, respectively, of the branch openings
defined by the patient's aorta. Thus, the fenestration template 250
can provide a model and/or template used to locate a corresponding
set of fenestrations in a stent graft or the like, as described in
further detail herein.
[0041] While the fenestration template 250 is shown and described
as defining the set of fenestrations 255, in other embodiments, a
fenestration template can include a set of markers, indicators,
protrusions, spikes, recesses, bumps, and/or any other suitable
discontinuity configured to indicate a desired location (e.g., a
calculated location) of a fenestration along a stent graft. In some
embodiments, the fenestration template 250 can be formed from
multiple materials. For example, one or more portions of the
fenestration template 250 that correspond with the fenestrations
255 can be formed from a material substantially different from the
remaining portions of the fenestration template 250. Such a
material can have substantially different mechanical properties
than the mechanical properties of a material forming the other
portions of the fenestration template 250. For example, such
materials can form a frangible portion or an otherwise deformable
portion corresponding to the fenestrations 255.
[0042] As described above, the fenestration template 250 can be
used, for example, as a guide to form a set of fenestrations in a
stent graft used for endovascular repair of an abdominal aortic
aneurysm (see e.g., FIGS. 1-2B). By way of example, FIG. 4
illustrates at least a portion of a fenestrated stent graft 260
according to an embodiment. As described above, a stent graft can
define one or more fenestrations configured to accommodate one or
more branch vessels when the stent graft is deployed in an aorta.
Specifically, in this embodiment, the fenestrated stent graft 260
includes a proximal end portion 261 and a distal end portion 262,
and defines a lumen 263. The fenestrated stent graft 260 can be any
suitable stent graft and/or prosthetic. For example, in some
embodiments, the fenestrated stent graft 260 can be an
off-the-shelf stent graft. In other embodiments, the fenestrated
stent graft 260 can be a patient-specific stent graft with a size,
shape, and/or configuration corresponding to the patient's
anatomy.
[0043] The fenestrated stent graft 260 can have any suitable shape,
size, and/or configuration. For example, in some embodiments, the
stent graft 260 can have a size that is associated with a size of
the lumen defined by the aorta. In other embodiments, the
fenestrated stent graft 260 can have a size that is associated with
an adjusted or calculated size of the lumen defined by the aorta
resulting from the endovascular placement of the fenestrated stent
graft 260. Moreover, the fenestrated stent graft 260 can have any
suitable mechanical properties such as, for example, strength,
stiffness, etc. As shown in FIG. 4, in some embodiments, the
fenestrated stent graft 260 can include a set of stiffening members
264 disposed about the fenestrated stent graft 260, which can, for
example, increase a stiffness fenestrated stent graft 260.
[0044] As described above, the fenestrated stent graft 260 can be
positioned relative to the fenestration template 250 such that the
fenestration template 250 can mark, guide, indicate, and/or
otherwise provide a template for making a set of fenestrations 265
in the fenestrated stent graft 260. For example, in some
embodiments, the fenestrated stent graft 260 can be inserted into
the lumen 253 defined by the fenestration template 250 and
positioned in a desired position relative thereto. In some
embodiments, adjustment may be made to the relative positions of
the fenestrated stent graft 260 and/or the fenestration template
250 to optimize the fenestration process. For example, the
fenestrated stent graft 260 and/or fenestration template 250 may be
moved along a longitudinal axis and/or rotated relative to each
other about the longitudinal axis to avoid placement of
fenestrations 255 defined by the fenestration template 250 over the
stiffening members 264. In some embodiments, the fenestrations 265
can be made with the fenestration template 250 still engaged with
and/or coupled to the fenestrated stent graft 260. For example, the
fenestrations 255 defined by the fenestration template 250 can
provide a guide or outline along the fenestrated stent graft 260,
which in turn, can be cut (e.g., with a blade, a laser, a water
jet, etc.), punched, drilled, and/or the like. In other
embodiments, the locations of the fenestrations 265 can be marked,
for example, with a sterile pen or other marking devices on the
fenestrated stent graft 260 (e.g., through the fenestrations 255
defined by the fenestration template 250) and the actual
fenestrations 265 can be defined at the marked locations after the
fenestration template 250 is decoupled and/or removed from the
fenestrated stent graft 260.
[0045] While the fenestrated stent graft 260 is described above as
being inserted into the lumen 253 of the fenestration template 250,
in other embodiments, the fenestrated stent graft 260 can be slid
over the fenestration template 250. That is to say, the
fenestration template 250 can be inserted into the lumen 263
defined by the fenestrated stent graft 260. In some embodiments,
the fenestrations 255 defined by the fenestration template 250 can
be visible through the fenestrated stent graft 260. In other
embodiments, the fenestration template 250 can provide a marking or
indicator associated with the locations of the fenestrations 255.
Thus, the fenestrations 265 can be defined along the fenestrated
stent graft 260, as described above.
[0046] Although not shown in FIGS. 3 and 4, in some embodiments, a
coating material can be applied and/or otherwise disposed on a
surface of the fenestration template 250 configured to contact the
fenestrated stent graft 260, and/or vice versa. Such a coating can,
for example, allow for smooth rotation or movement of the
fenestrated stent graft 265 relative to the fenestration template
250. In some embodiments, such coating material can, for example,
smooth relatively small-scale roughness due to the layer-by-layer
deposition of the modeling material during 3-D printing.
[0047] As shown in FIG. 4, the fenestrations 265 can be disposed
along the fenestrated stent graft 260 in any suitable manner.
Similarly, the fenestrations 265 can have any suitable size,
diameter, and/or shapes. For example, the fenestrations 265 can
have substantially the same size and/or shape as the fenestrations
255 defined by the fenestration template 250, which in turn, can
correspond to the size and/or shape of the branch vessel openings
and/or the adjusted or calculated branch vessel openings in the
patient's aorta, as described above. For example, the fenestrations
265 can be substantially circular if the corresponding adjusted
and/or calculated branch vessel is substantially circular and would
otherwise be covered by the graft material when the fenestrated
stent graft 260 is positioned in the patient's aorta. Similarly,
the fenestrations 265 defined by the fenestrated stent graft 260
can be disposed at any suitable position along a length of the
fenestrated stent graft 260. For example, in some embodiments, the
fenestrations 265 can be located at and/or near the proximal end
portion 261 or the distal end portion 262 of the fenestrated stent
graft 260. In this embodiment, the fenestrations 265 are disposed
at or near the proximal end portion 261 of the fenestrated stent
graft 260. In some embodiments, the peripheral edges of the
fenestrated stent graft 260 that define the fenestrations 265 can
be at least partially reinforced to provide stability, for example,
for anchoring of fenestrated stent graft 260 to the branch vessels
extending from the aorta. In some embodiments, the peripheral edge
defining a fenestration 265 can be stitched or sutured using wires
and/or can be coupled (e.g., via stitches) to a ring or a similar
support frame.
[0048] As shown in FIG. 5, when the fenestrations 265 are defined
along the fenestrated stent graft 260, the fenestrated stent graft
260 can be positioned within a portion of the patient's body using
any suitable endovascular procedure. In this embodiment, the
fenestrated stent graft 260 is positioned within the patient's
aorta 10. As shown, the fenestrated stent graft 260 can include,
for example, a first set of fenestrations 265A, which are
associated with and/or otherwise correspond to the left renal
artery 14 and the right renal artery 13. Specifically, the
fenestrations 265A are each aligned with its corresponding renal
artery 13 or 14 and can each have a size, shape, and/or
configuration that is associated with its corresponding renal
artery 13 or 14. In some embodiments, the size, shape, and/or
position of the fenestrations 265A is associated with and/or
substantially corresponds to the adjusted and/or calculated size,
shape, and/or position of its corresponding renal artery 13 and 14.
For example, placing the fenestrated stent graft 260 within the
aorta 10 can, for example, alter, shift, rotate, translate, morph,
and/or otherwise reconfigured the arrangement of the patient's
aorta 10. Thus, by basing the fenestration template 250 off of the
updated model the size, shape, and/or position of the fenestrations
265 defined by the fenestrated stent graft 260 can correspond to
the desired branch vasculature (e.g., the left renal artery 14
and/or the right renal artery 13). Moreover, in addition to
positioning the fenestrated stent graft 260 within a portion of the
patient's aorta 10, the renal arteries 13 and/or 14 can also be
stented, for example, through the fenestrations 265A (not shown in
FIG. 5). As such, the fenestrated stent graft 260 and the stents
within the renal arteries 13 and/or 14 can limit and/or
substantially prevent migration of the fenestrated stent graft 260
relative to the patient's aorta 10.
[0049] As shown in FIGS. 4 and 5, in some embodiments, the
fenestrated stent graft 260 can include a second set of
fenestrations 265B, which are associated with and/or otherwise
correspond to other branch vessels that otherwise, might be blocked
by an un-fenestrated portion of the fenestrated stent graft 260.
For example, the fenestrations 265B can be associated with and/or
otherwise correspond to the superior mesenteric artery (SMA) 18 and
the celiac artery 19, respectively. In other embodiments, the
fenestrated stent graft 260 can define fenestrations to accommodate
more or fewer branch vessels than illustrated here. For example, in
some embodiments, the fenestrated stent graft 260 can define
fenestrations to accommodate the inferior mesenteric artery (IMA),
internal iliac arteries, and/or the like. Thus, the fenestrations
265 defined by the fenestrated stent graft 260 can allow blood to
flow from the aorta 10 to the branch vasculature, which would
otherwise be obstructed by the fenestrated stent graft 260
material.
[0050] As shown in FIGS. 4 and 5, in some embodiments, the
arrangement of the fenestrated stent graft 260 and/or the patient's
aorta can be such that a fenestration 265 is partially defined by
the fenestrated stent graft 260. For example, as shown, the
proximal most fenestration 265B is disposed at the proximal end of
the fenestrated stent graft 260 and corresponds to the celiac
artery 19 that is partially covered by the graft material during
deployment. As such, the fenestration 265B for the celiac artery 19
is partially circular or U-shaped to accommodate the portion of the
celiac artery 19 otherwise blocked by the graft material. In other
embodiments, any of the fenestrations 265 can have non-circular
and/or irregular shapes.
[0051] In some embodiments, the fenestrations 265 can be marked to
facilitate location of the fenestrations 265 during deployment of
the fenestrated stent graft 260. For example, the peripheral edges
of the fenestrated stent graft 260 that define the fenestrations
265 may be sutured using gold wires and/or wires of other
radio-opaque materials. Similarly, the location of the fenestration
265 can be marked by one or more radio-opaque markers 212. Such
radio-opaque wires or markers can facilitate fluoroscopic
visualization of the fenestrations 265 during an endovascular
repair procedure and allow a physician to locate the fenestration
265 with respect to the corresponding branch vessel. In other
embodiments, the fenestrations can be sutured and/or otherwise
marked using any suitable material that can increase visibility,
for example, when using any suitable imaging device (e.g., MRI
scan, CAT scan, PET scan, X-Ray scan, ultrasound, etc.).
[0052] As described above, the fenestrated stent graft 260 can have
an arrangement that substantially corresponds with the fenestrated
template 250. Moreover, the fenestrated template 250 can be, for
example, 3-D printed and/or otherwise output by the output device
210 based on an adjusted, updated, calculated, and/or otherwise
modified model of the patient's aorta 10. When the fenestrated
stent graft 260 is inserted into the patient's aorta 20, the
arrangement of the aorta 10 shifts and/or otherwise moves in
response thereto. Thus, with the fenestrated stent graft 260 being
based on the fenestrated template 250, which in turn, is based on
the updated model representing the shifted and/or moved arrangement
of the patient's aorta 10, the fenestrations 265 each can be
accurately sized, shaped, and/or positioned to correspond with its
associated branch vasculature, as described in detail above.
[0053] While the fenestration template 250 is shown and described
above as being 3-D printed and/or otherwise produced by a rapid
prototyping machine to have a substantially cylindrical shape, in
other embodiments, a fenestration template can be, for example,
substantially flat and configured to be rearranged to form desired
fenestration template. For example, FIGS. 6 and 7 illustrate a
fenestration template 350 according to another embodiment, in a
first configuration and a second configuration, respectively. As
shown in FIG. 6, in this embodiment, the fenestration template 350
is a substantially flat sheet with fenestrations 355 corresponding
to the openings of branch vessels of the aorta (e.g., the aorta 10
in FIG. 1). As described above with reference to the fenestration
template 250, the fenestration template 350 can be manufactured
using any suitable process such as three-dimensional (3-D) printing
or additive prototyping/manufacturing, subtractive manufacturing,
3-D printing, and/or the like or a combination thereof. As such,
the fenestration template 350 can be configured to substantially
correspond to an updated and/or adjusted model of the patient's
aorta, as described in detail above.
[0054] In some embodiments, the fenestration template 350 can be
made of any elastic material such as thermoplastic, plaster, metal
alloy, titanium alloy, paper, metal foil, plastic film,
photopolymer, a biocompatible graft material, and/or any other
suitable material. In this manner, the fenestration template 350,
for example, can be manipulated from its first configuration, in
which the fenestration template 350 is a substantially flat sheet,
to its second configuration, in which the fenestration template 350
at least partially forms a tubular and/or cylindrical shape, as
indicated by the arrows AA in FIG. 7. For example, in some
embodiments, the fenestration template 350 can be manipulated to
form a partial tubular or cylindrical structure. In such
embodiments, the fenestration template 350 can be formed from a
substantially resilient material that can, for example, maintain
its shape until a sufficient force is exerted to reconfigure the
fenestration template 350. In this manner, the fenestration member
350 can be positioned relative to a stent graft or the like (e.g.,
the fenestrated stent graft 160 in FIGS. 4 and 5) and reconfigured
to be placed in contact with an inner surface or an outer surface
of the stent graft.
[0055] In other embodiments, the fenestration template 350 can be
reconfigured to form a substantially complete tubular or
cylindrical structure. For example, a first end portion 357 of the
fenestration template 350 can be configured to overlap and couple
to a second end portion 358 of the fenestration template 350. In
some embodiments, the first end portion 357 and the second end
portion 358 can include a coating, an adhesive, and/or the like
configured to couple the first end portion 357 to the second end
portion 358. In some embodiments, the first end portion 357 and/or
the second end portion 358 can include indicia and/or other
indicator configured to indicate, for example, a diameter of the
fenestration template 350 when placed in the second configuration.
Thus, the fenestration template 350 can be sized to fit a given
stent graft and/or lumen of the aorta.
[0056] As described in detail above, the fenestration template 350
defines a set of fenestrations 355 that can be disposed along the
fenestration template 350 at a position associated with an opening
to a corresponding branch vasculature of the aorta. The size,
shape, and/or configuration of the fenestrations 355 similarly can
be associated with the openings of the branch vasculature. More
specifically, the arrangement of the fenestrations 355 can
substantially correspond to an adjusted, calculated, updated,
and/or otherwise modified arrangement of the patient's aorta in
response to the placement of an endovascular stent graft. In this
manner, the fenestration template 350 can be transitioned to its
second configuration and placed in engagement with an endovascular
stent graft to facilitate, mark, locate, and/or otherwise at least
partially define a set of fenestrations in the endovascular stent
graft that substantially correspond to the modified arrangement of
the patient's aorta. As described in detail above, with the desired
fenestrations defined by the stent graft, the stent graft can be
positioned within the patient's aorta (see e.g., FIG. 5) during any
suitable endovascular procedure.
[0057] While the fenestration templates 250 and 350 are shown and
described above as defining the fenestrations 255 and 355,
respectively, in other embodiments, a fenestration template can
include one or more bumps and/or protruding structures instead of
or in addition to fenestrations or markings to designate the
locations of the fenestrations on the stent graft. The protruding
structure may be used to mark and/or cut the graft material to
define the fenestrations therein. In some embodiments, such a
fenestration template can include one or more protruding structures
on the outer surface or on the inner surface of the fenestration
template according to what surface is configured to contact the
stent graft. The protruding structures can be of any suitable
dimension and/or shapes. For example, the protruding structure can
have a semi-spherical shape or a conical shape, and/or can have or
form a pointed tip. As such, the protruding structures can be
configured to mark locations of the fenestrations on the stent
graft material upon contact using, for example, a thermal,
mechanical, chemical device and/or reaction. For example, the
protruding structures may be heated (e.g., electrically) to act as
thermal cautery tools for generating fenestrations in the graft
material. In other embodiments, the protruding structures may have
sharp tips used to puncture the graft material to form the
fenestrations therein.
[0058] Referring now to FIG. 8, a flowchart is presented
illustrating a method 1000 of forming a patient-specific prosthetic
(e.g., an aortic stent graft) according to an embodiment. The
method 1000 includes receiving anatomic imaging data of a portion
of a patient's anatomy (e.g., including a blood vessel, such as an
abdominal aorta, and/or associated branch blood vessels), at 1001.
In some embodiments, an electronic device such as a PC or
workstation receives the anatomic imaging data. The electronic
device can include a graphic user interface-driven application. The
imaging data is from an imaging device in communication with the
host device such as, for example, an X-ray device, a computed
tomography (CT) device, computed axial tomography (CAT) device) a
magnetic resonance imaging device (MM), a magnetic resonance
angiograph (MRA) device, a positron emission tomography (PET)
device, a single photon emission computed tomography (SPECT)
device, an ultrasound device, and/or any other suitable device for
imaging a portion of a patient and/or a combination thereof (e.g.,
CT/MRA device, PET/CT device, SPECT/CT device, etc.). In some
embodiments, the imaging device can scan and/or otherwise capture
imaging data of the patient's abdominal aorta and/or a portion
thereof.
[0059] More specifically, the anatomic imaging data of the portion
of the patient's anatomy can be loaded as an input. For example, a
user can select and load a DICOM contrast CT series of the patient
abdomen. In some embodiments, a variety of images can be loaded,
including, for example, computed tomography (CT) images, magnetic
resonance (MR) images, and ultrasound (US) images. In some
embodiments, two or more images of the same image type or of
different image types can be fused to improve image quality,
simplify segmentation, and improve measurement accuracy. For
example, in some embodiments, different image types (e.g., MR and
CT) can be geometrically registered to improve segmentation.
Additionally, some features of the portion of the patient's anatomy
may be more clearly visible in one image type than another, so
fusion of the information from two or more images can improve the
clarity and accuracy of the images and/or data.
[0060] In some embodiments, data can be resampled for improved
image resolution. Data interpolation can be used to improve
measurement accuracy. For example, if images are sampled 2 mm apart
along the Z-axis, then the point-to-point distance between two
images can only be measured in steps of 2 mm. By interpolating
between the images (i.e., creating intermediate images between the
two), measurement accuracy can be improved. As another example, an
additional CT image can be created from two CT images spaced 2 mm
apart, such that the additional CT image is placed between the
original two CT images and spaced only 1 mm from each of the first
two CT images. Data interpolation can improve the accuracy of
measurements to, for example, sub-pixel accuracy.
[0061] A first digital representation of the anatomic imaging data
is defined, at 1002. For example, the electronic device can define
the first digital representation or the like associated with and/or
corresponding to the patient's anatomy. The first digital
representation can be, for example, an anatomic model of the
patient's abdominal aorta. In some instances, the first digital
representation can be an anatomic model of the patient's abdominal
aorta, a first branch blood vessel, and a second branch blood
vessel based on the anatomic imaging data. Moreover, in some
instances, a user can manipulate the electronic device to cause the
anatomic model to be graphically presented on a screen using, for
example, a solid modeling program and/or any other computer-aided
design (CAD) program.
[0062] The images associated with the anatomic imaging data can be
displayed such that the user can better visualize the patient's
anatomy. The images can be displayed in a standard layout for 3-D
medical images. For example, the images can be displayed in a
2.times.2 layout as axial, sagittal, and coronal slices. The images
can also be displayed in a 3-D cube view. In some embodiments, the
user can manipulate the images for improved visualization of the
anatomy. For example, the user can step through the slices, change
contrast settings, and change the zoom settings (i.e., adjust the
magnification).
[0063] Image processing algorithms can be used to segment the
portion of the patient's anatomy (e.g., the aorta) to focus on the
volume of interest. After segmentation, the image data can be
cropped to speed up image processing. In some embodiments, the
volume of interest can be manually entered by a user via a
user-selected file or through interactive user input. In other
embodiments, the volume of interest can be determined automatically
using image analysis techniques. For example, the aorta can be
identified in contrast CT images. Image analysis techniques can
then be used to automatically detect a particular portion of the
aorta, such as the space ranging from the celiac artery to the
renal artery to the ileac arteries.
[0064] In some embodiments, the image processing methods (i.e.,
image analysis techniques) can determine a sub-volume of interest
for further processing. For example, brightness and/or edge
detection can be used to determine the location of a particular
portion of a patient's anatomy, such as the location of the
abdominal aorta and branch vessels (e.g., the renal artery). The
location data of the sub-volume of interest can be used to define
the sub-volume of interest such that it contains only the data
associated with the sub-volume of interest (e.g., a sub-volume of
interest including only the aorta and branch vessels).
[0065] In some embodiments, atlas-based methods can be used to
model the anatomy to avoid noisy or incomplete data. Such methods
begin with the expected layout of the patient's anatomy, such as
the relative locations of anatomical features and expected ranges
of dimensions. For example, for a typical patient, the celiac
artery is expected to be positioned above the renal arties.
Additionally, the diameters of the renal arteries are expected to
range from about 4 mm to about 10 mm.
[0066] In some embodiments, the method can include modifying the
initial anatomical model (i.e., the first digital representation)
created from the anatomic imaging data using additional data
collected through any method described herein. Because the initial
anatomical model is used as a starting point and the initial
anatomical model is then adjusted with collected data, this method
avoids holes in the model that can result from incomplete data.
Additionally, noise can be avoided because a user or image
processing algorithm can recognize if collected data is within an
expected range of the initial anatomical model. If collected data
is outside of an expected range, the data can be discarded or
flagged for review.
[0067] In some embodiments, a combination of user input and
automatic detection is used to define the volume of interest. For
example, after an initial automatic detection using the methods
described herein, user input can be used to refine the boundaries
of the volume of interest.
[0068] Particular portions of the patient's anatomy, such as the
branch vessels of the aorta, can be automatically segmented. In
some embodiments, segmentation can be through "region growing." For
"region growing" segmentation, initial seed points can be
user-specified or automatically detected. Next, additional nearby
data points with similar characteristics to the initial seed points
can be identified. Similar characteristics can include, for
example, intensity values. For example, CT images can be quantified
using Hounsfield units. An expected range of Hounsfield units for
blood vessels in contrast CT images can be identified. The expected
range can be used to identify data points in the CT images that are
likely to be associated with blood vessels. The initial seed points
and nearby data points with similar characteristics can be combined
to create a model of the particular portion of the patient's
anatomy, such as the branch vessels. In other embodiments, the
particular portion of the patient's anatomy can be automatically
segmented using deformable models. For example, the boundary of a
vessel can be detected in a first image. The boundary can be, for
example, circular or elliptical. The boundary in the first image
can be "grown" through the volume of interest (i.e., the boundary
shape in the first image can be stacked through the volume).
Constraints can be imposed on the overall shape of the "grown"
boundary such as, for example, smoothness or orientation. In other
embodiments, an atlas-based model can be used to segment the
vessel. An initial "atlas" model can be constructed from training
data and expert knowledge. Additional data, which may be collected
from the patient, can be used to map the initial "atlas" model to
the patient's anatomy.
[0069] Following segmentation, portions of the patient's anatomy
can be extracted from the segmented images. For example, the aortic
trunk and the branch vessels can be segmented and extracted.
Morphological filters can be used to separately extract the aortic
trunk and branch vessels. Alternatively or additionally, in some
embodiments, elliptical contours can be fitted to the segmented
surface points. Outlier detection methods can then be used to
exclude branch vessel points and only fit points that belong to the
main trunk.
[0070] In some embodiments, each vessel can be identified using a
user's knowledge of anatomy and patient orientation (e.g., right
versus left). For example, the user can distinguish between the
left and right renal arteries and between the celiac artery and the
superior mesenteric artery (SMA). Another example is that the user
may know the relative locations of vessels in a typical anatomy
(e.g., the celiac is above the renal arteries) and the user can use
this information in identifying each vessel. A third example is
that the user may intend to identify a portion of the aorta with a
specific shape (e.g., a long tube with four to six branch vessels).
Each of the dimensions of the specific shape can have an expected
range of values (e.g., the aorta diameter will be between 15 mm and
30 mm). Thus, knowledge of the anatomy can assist with segmentation
and locating, for example, an aneurysm. Additionally, relevant
information from the patient's medical record (e.g., a missing
renal artery) can be used.
[0071] In some embodiments, centerlines of portions of a patient's
anatomy can be extracted from the segmented portions. For example,
the centerlines of the aortic trunk and branch vessels (i.e. the
lines passing through the central axes of the aortic trunk and
branch vessels and following the geometry of the main trunk and
branch vessels) can be extracted from the segmented portions of the
aortic trunk and branch vessels. In some embodiments, the
centerlines can be extracted automatically. In some embodiments, a
curved planar reformation (CPR) image can be optionally generated
and displayed. In some embodiments, a distance transform can be
applied to a segmented image and can connect points with maximum
distances using a fast marching method. The distance transform
allows for distances from each point in the segmented image to the
closest neighbor of each point in the background to be computed.
For example, if the distance transform is applied to a circular
contour the distances will be maximum at the center and decrease
radially. A fast marching method can then be applied to connect
points with maximum distances. In other embodiments, contours
(e.g., elliptical, spline, etc.) can be fit to the segmented image
and centroids or weighted centroids of the contours can be computed
to define the centerline. In other embodiments, vessel specific
properties can be computed and used to compute centerlines. For
example, vesselness, a measure of how similar a structure is to
tube used in some methods of image segmentation, can be computed
and used to compute centerlines.
[0072] The first digital representation of the anatomic imaging
data is modified, at 1003. For example, as described above, the
patient's anatomy can shift, rearrange, and/or otherwise adjust
when a prosthetic such as an endovascular stent graft is disposed
therein. When the portion of the patient's anatomy is a portion of
the abdominal aorta, this shifting can result in a corresponding
shifting or movement of the openings to the branch vasculature in
fluid communication with the aorta, which in turn, can result in a
reduction in accuracy of the first digital representation of the
anatomic imaging data relative to the shifted anatomy. Accordingly,
in some embodiments, the electronic device can adjust and/or update
data associated with the first digital representation. For example,
the data can be adjusted and/or updated based on patient data such
as a degree of aortic angulation at the juxtarenal neck or other
segment of the aorta; a degree, pattern, and location of
atherosclerotic disease including plaque, calcification, and/or
thrombus; morphometric characteristics of the vascular structure
that influence size, position, angulation, or tortuosity such as
vessel diameter (i.e., vascular lumen diameter); and/or vessel wall
thickness, vessel length, location and number of branch arteries,
and/or the like; anthropomorphic data of the patient such as body
composition, body temperature, height, weight, BMI, abdominal
circumference (absolute or normalized), age, and/or the like;
pre-existing vascular or extravascular prostheses or foreign
bodies, and/or the like. In some instances, the data can be
adjusted and/or updated based on data associated with mechanical
properties of the prosthesis such as, for example, body material or
fabric type, stent or support strut geometry and/or thickness, type
of metals or other support materials, stiffness and diameter of the
prosthesis, an amount of oversizing of the prosthesis, and/or the
like. In addition, the data can be adjusted and/or updated based on
data associated with a delivery method of the prosthesis such as,
for example, an impact of specific delivery methods such as use of
guide wires, catheters, and/or the like. A second digital
representation of the portion of the patient's anatomy is defined
based on the modifying of the first digital representation of the
anatomic imaging data, at 1004. In other words, the first digital
representation of anatomic imaging data can be associated with a
portion of the patient's anatomy in a first configuration and a
second digital representation of the anatomic imaging data can be
associated with the portion of the patient's anatomy in a second
configuration. The portion of the patient's anatomy can transition
from the first configuration to the second configuration in
response to insertion of a prosthetic (e.g. a patient-specific
prosthetic).
[0073] In some embodiments, the first digital representation of
anatomic imaging data can be modified based on a predetermined data
set, and the predetermined data set can be based on data associated
with the second digital representation. By quantifying
characteristics of, for example, a patient-specific prosthetic, a
patient, and/or a manner of introducing the patient-specific
prosthetic to a portion of a patient's anatomy, the data associated
with the first digital representation can be adjusted and/or
updated to define the second digital representation based on an
anticipated, predicted, predetermined, calculated, and/or otherwise
probable shift in the arrangement resulting from the insertion and
indwelling of a prosthetic (e.g., an endovascular stent graft).
Said another way, the first digital representation can be based on
a predetermined data set, and the predetermined data set can be
updated based on data associated with an anticipated, predicted,
predetermined, calculated, and/or otherwise probable shift in the
arrangement resulting from the insertion and indwelling of the
prosthetic.
[0074] In some embodiments, the anatomic imaging data can be a
first anatomic imaging data set. The modifying of the first digital
representation of the first anatomic imaging data set can be based
on data associated with the patient-specific prosthetic, a patient,
and/or a manner of introducing the patient-specific prosthetic to a
portion of a patient's anatomy. The data associated with the
patient-specific prosthetic, a patient, and/or a manner of
introducing the patient-specific prosthetic to a portion of a
patient's anatomy can be updated with data associated with a second
anatomic imaging data set, the second anatomic imaging data set
being representative of the patient-specific prosthetic disposed
within the portion of the patient's anatomy.
[0075] Specifically, in some embodiments, the modification of the
first digital representation to define a second digital
representation of the portion of the patient's anatomy (i.e. the
predicted changes in the patient's anatomy) can be based on
predicted changes to the centerline of a portion of the patient's
anatomy. For example, the modification can be based on predicted
changes to the extracted centerline of the aortic trunk. The
extracted centerline (as described above) is typically a sequence
of points in 3-D space (e.g., having x-, y-, and z-coordinates). A
low order polynomial function can be fitted to the points using a
least squares fitting technique to produce a modified centerline
(i.e., an adjusted centerline) that is a prediction of the shape of
the portion of the patient's anatomy after insertion of a
graft.
[0076] In some embodiments, the modification of the first digital
representation to define a second digital representation of the
portion of the patient's anatomy (i.e. the predicted changes in the
patient's anatomy) can be based on the expected deformation of the
patient's anatomy as a result of inserting a device (e.g., a graft)
into the anatomy. For example, mathematical models of the segmented
volumes and/or surfaces, such as finite element method (FEM) or
parametric representations, can be created based on expected
deformation of the segmented volumes and/or surfaces. Models
reflecting the expected deformation can be built from training data
consisting of pre-procedure, intra-procedure, and post-procedure
images. The anatomy of interest can be segmented and the resulting
changes can be modeled using machine learning approaches. In other
words, data can be collected from a deformed portion of one or more
patients` anatomy (e.g., a deformed aorta) and the data can be used
to create a training data set. The training data set can be used to
model the predicted deformation of a portion of a patient's anatomy
in future procedures.
[0077] In some embodiments, the modification of the first digital
representation to define a second digital representation of the
portion of the patient's anatomy can take into account
characteristics of a particular device (e.g., a patient-specific
prosthetic) to be delivered to the anatomy. For example, the
modification can take into account the wire stiffness of a graft
and account for variations in wire stiffness between manufacturers.
In some embodiments, for example, a lower order polynomial fit can
be used to model the predicted change in centerline if a stiffer
device is inserted into the anatomy (e.g. a stiffer graft).
Additionally, training data can be used to model changes as a
result of the characteristics of particular devices.
[0078] In some embodiments, the modification of the first digital
representation to define a second digital representation can take
into account anatomic-specific information (e.g., characteristics
associated with a specific patient or set of patients). For
example, if the particular patient's anatomy is unusually
angulated, the anatomical shift of the anatomy as a result of a
device being inserted (e.g., a graft) is likely to favor one side
of the anatomy (e.g. the aorta vessel wall). Additionally, the
insertion location (e.g., left versus right femoral artery) can
cause the device to favor one side of the anatomy (e.g. aorta
vessel wall). Training data can also be used to model changes as a
result of a particular patient's anatomy. Additionally, in some
embodiments, the modification of the first digital representation
to define a second digital representation can take into account
procedure-specific details (i.e., characteristics associated with a
method of introducing a patient-specific prosthetic to the
anatomy). For example, the modification can account for insertion
location (e.g., left side versus right side), patient breathing,
and/or physician preferences.
[0079] In some embodiments, the user (e.g., clinician or surgeon)
can manually account for patient-specific details (i.e.,
characteristics associated with a patient). For example, a user can
use a different method to locate (for digitally representation) the
distal or proximal end of a vessel depending on the presence of a
calcium deposit. In other embodiments, the modification of the
first digital representation can take into account patient-specific
details using algorithms. For example, the modification can account
for calcium deposits or plaque, the presence of artifacts
obstructing blood flow through the aorta, and/or the angle of
curvature of the aorta and branch vessels.
[0080] In some embodiments, intra-procedure data can be
incorporated to refine algorithms used to modify the first digital
representation. The intra-procedure data can include imaging data
such as fluoroscopy, CT, or any other suitable imaging data.
Additionally, in some embodiments, machine learning can be used to
refine the algorithms. In some embodiments, intra-procedural data
can be used to validate measurements and refine the algorithms. A
model (e.g., a modified digital representation) can first be used
to predict changes in the anatomy or how the graft would line up
along the centerlines of the anatomy. The intra-procedure data can
then be analyzed to observe the actual changes. The deviations from
the predicted changes to the actual changes (obtained from
intra-procedure data) can in turn be used to refine future models
(e.g., future digital representations).
[0081] For example, patient breathing can deform organs in a
non-rigid manner. To account for non-rigid movements, a non-rigid
deformation can be applied to pre-operative models (e.g., a first
digital representation). The amount and shape of deformation
resulting from a force on a graft caused by patient breathing.
Intra-procedure images of a patient can be analyzed and compared to
the patient's pre-operative images to determine the appropriate
non-rigid deformation for future digital representations.
[0082] As another example, intra-procedure images can be used to
modify the first representation (i.e. to build a predictive model)
based on where the device (e.g. a graft) is expected to eventually
be located in the patient based on the side of insertion. For
example, grafts that are inserted from the right side of a patient
may typically shift to a positon next to the left side of the aorta
wall. The expected location can be quantified through
intra-operative measurements and a predictive model can be
created.
[0083] Calcium deposits along the arterial wall of a vessel can
affect the stiffness of the vessel. Additionally, other calcium
deposits and/or diseased portions of the vessel can increase or
decrease the stiffness of the arterial wall. Stiffness of the
vessel wall is inversely related to the amount of flexibility of
the vessel wall. In some embodiments, calcium deposits and/or
diseased portions can be accounted for during the modification of
the first digital representation pre-operatively by modeling the
stiffness as a material property. For example, finite element
models can be used that model the stiffness as a material
property.
[0084] When calcium deposits are located near branch vessels,
identification of the location of the branch vessels can be more
difficult. In some embodiments, expert clinician knowledge
regarding the location of calcium deposits and/or branch vessels
can be incorporated into the modification of the first digital
representation to define a second digital representation. Clinician
inputs can be collected and used to modify the first digital
representation (i.e., built into a predictive model) that can be
applied to future patients and/or procedures. As the number of
patients in a training set increases, the accuracy of the
predictive model can increase. Additionally, as more data is
collected via the training set, outlier patient data can be
discarded.
[0085] In some embodiments, portions of the first digital
representation can be modified to define the second digital
representation using a centerline modified for the second digital
representation as described above (i.e. an adjusted centerline).
For example, the branch vessel locations (i.e., expected locations
of the branch vessels during the procedure) can be predicted using
the adjusted centerline of an aorta. As described above, the
adjusted centerline can be used to predict the path that the graft
will take within a patient's anatomy. The adjusted branch vessel
locations can then be predicted by projecting the vessel endpoints
(i.e., the points where the vessels join the aorta which can be
obtained from imaging data) on to the adjusted centerline of the
aorta. Identification of the branch vessel endpoints (proximal and
distal ends) can be performed automatically or manually. To
identify the branch vessel endpoints automatically, a segmented
vessel surface and a segmented aorta surface can be produced using
the segmentation steps described above. The intersection points of
the segmented vessel surface and the segmented aorta surface can
then be used to locate and define the branch vessel endpoints
(i.e., where the branch vessel connects to the aorta).
[0086] In other embodiments, vessel locations can be predicted by
projecting a central point of the vessel along the adjusted
centerline of the aorta. The identification of the central point of
the branch vessels can be performed automatically or manually. To
identify the central point of the branch vessel automatically, the
centerlines for the branch vessels, the main centerline of the
aorta, and the segmented aorta produced by the segmentation steps
above can be used to determine the junction point (also referred to
as the "branch vessel junction") where a branch vessel centerline
and an outer surface or wall of the segmented aorta intersect (i.e.
the central point of the vessel along the outer surface of the
aorta based on the adjusted centerline of the aorta). The vessel
radius can then be estimated and the vessel location can be defined
as .+-.the radius from the projected branch vessel junction (i.e.
the vessel central point on the outer surface of the segmented
aorta).
[0087] In some embodiments, pre-operative images can be deformed
(i.e. the first digital representation can be modified to define
the second digital representation) using a deformation field. The
deformation field can be created using the output from the finite
element models described above for deforming the aorta and
associated branch vessels. The output from the finite element
models is a deformation field with x, y, and z displacement values
for every voxel in the 3-D image. The deformation field can then be
applied to pre-operative images to deform them the images will
reflect the predicted change in shape of the patient's anatomy as a
result of device insertion. Thus, a user (e.g. a clinician or a
surgeon) can use the deformed images in accounting for deformations
during pre-procedure planning. Additionally, the deformed images
can be used as a training tool for surgical residents to aid in
learning about intra-operative changes to the shape of the aorta,
centerline adjustment, and the like.
[0088] In some embodiments, centerlines (e.g., centerlines of the
aortic trunk and branch vessels) can be extracted automatically
from mathematical models. Said another way, centerlines can be
extracted (using methods described herein) from deformed images. In
such embodiments, centerlines can be extracted from intra-procedure
or post-procedure image data reflecting anatomy deformed by device
insertion. Branch vessel locations can then be predicted based on
the extracted centerlines. Similarly as described above, these
centerlines can be used for pre-procedure planning (e.g.
modification of the first digital representation to define a second
digital representation) and for training/teaching aids.
[0089] A patient-specific prosthetic template of the portion of the
patient's anatomy is formed based, at least in part, on the second
digital representation of the anatomic imaging data, at 1005. For
example, as described above, the electronic device can include
and/or can send a signal to an output device such as a 3-D printer
or a rapid prototyping machine. As such, the output device can be
caused to output the patient-specific prosthetic template
associated with the updated, adjusted, calculated, and/or otherwise
modified data, which in turn, is associated with a projected (i.e.,
predicted), anticipated, and/or calculated arrangement of the
patient's abdominal aorta. The patient-specific prosthetic template
can include openings (fenestrations), protrusions, markers,
indicators, frangible portions, and/or any other suitable feature
corresponding to, for example, the openings of the aorta leading to
the branch vasculature, as described above with reference to, for
example, the fenestration template 250 and the fenestrated stent
graft 260. For example, the patient-specific prosthetic template
(also referred to as a "patient-specific fenestration template")
can include a first indicator or marker corresponding to the
location of a first branch blood vessel extending from a patient's
aorta in the second digital representation and a second indicator
or marker corresponding to the location of a second branch blood
vessel extending from a patient's aorta in the second digital
representation. The first marker and the second marker can be a
first opening and a second opening in the patient-specific
prosthetic template.
[0090] For example, in some embodiments, the relative locations of
the vessels can be automatically quantified in a 3-D or 4-D
coordinate system. Additionally, relevant dimensions such as, for
example, diameters and volume of flow, can be automatically
quantified. This information can be used to modify the first
digital representation to define the second digital representation
of the portion of the patient's anatomy. The second digital
representation can then be used to create a fenestration template
(also referred to as a "patient-specific prosthetic template"). The
fenestration template can be used to modify a graft. For example,
the fenestration template can be used to create fenestrations in a
graft at the predicted location of the vessels such that
fenestrations are at the appropriate location and of an appropriate
size and shape to allow pass-through of the vessels. In some
embodiments, for example, the fenestration template can be a flat
sheet configured to be wrapped around a portion of an aortic graft
to allow a used to identify fenestration locations in the aortic
graft. In embodiments in which the fenestration template includes a
first marker and a second marker, a first fenestration location in
the aortic graft can correspond to the first marker and a second
fenestration location in the aortic graft can correspond to the
second marker. In some embodiments, the fenestration template can
include a tubular body defining a lumen configured to be at least
partially disposed over and aortic graft. In other embodiments, the
fenestration template can include a tubular body configured to be
at least partially disposed in a lumen of an aortic graft.
Alternatively, in some embodiments, the digital representation data
can directly feed into the graft manufacturing process to produce a
fenestrated graft.
[0091] For example, in some embodiments, to form a fenestration
template of a portion of a patient's aorta, the average diameter of
the aorta at user-specified end points at the celiac and SMA branch
vessels can be computed. Next, the locations of the branch vessels
can be translated to cylindrical coordinates on the surface of a
cylinder. The cylinder can have a diameter equal to the average
diameter of the aorta (e.g., the average of the diameter at the
celiac and the SMA branch vessels). Each branch vessel location can
be defined by its central point and radius on the surface of this
cylinder as described above.
[0092] In some embodiments, clinical knowledge can be incorporated
into the process of quantifying the relative location of vessels.
Clinical knowledge can be incorporated automatically or manually.
For example, information regarding when to block an accessory
vessel, when to create a larger fenestration for multiple vessels,
how to account for stenosis, visible calcium buildup, and the like,
can be used to modify the template based on the second digital
representation. In some embodiments, for example, an option can be
provided to allow the user to either create a fenestration in the
template for an accessory renal artery or to block off the
accessory renal artery and not provide access through the graft in
that location.
[0093] In some embodiments, a template representation (a
patient-specific prosthetic template) of the vessels can be
created. The template representation can be used, for example, with
a 3-D printer or fed into a graft manufacturing process such as,
for example, an STL model or other CAD models. In some embodiments,
the template representation can be an STL model of a cylindrical
shell having a wall thickness of 2 mm with fenestrations (i.e.,
holes) corresponding to the branch vessels. Additionally, in some
embodiments, an internal serial number can be placed at the bottom
of the STL model. Graft manufacturer data, such as CAD models and
strut patterns, can be incorporated into the template
representation. For example, manufacturer strut pattern information
can be used to define fenestrations in locations on a graft without
struts. In some embodiments, the graft manufacturing process can be
modified such that the strut patterns are customized to not overlap
with fenestration locations.
[0094] In some instances, the patient-specific prosthetic template
can be used to form the patient-specific prosthetic. For example,
in some embodiments, the patient-specific prosthetic can be, for
example, a stent graft. In such embodiments, the stent graft and
the patient-specific template can be placed in contact and/or
otherwise made to engage each other. As such, the patient-specific
template can be used to form at least a portion of the stent graft
(i.e., the patient-specific prosthetic). More specifically, the
patient-specific template can define a set of fenestrations (i.e.,
lumens) in a wall of the patient-specific template associated with
the openings of the branch vessels of the aorta. In this manner,
the patient-specific template can be used to guide the placement of
and/or otherwise locate a corresponding set of fenestrations in the
stent graft, each of which corresponds to an opening of a different
branch vessel. In some embodiments, the patient-specific template
can direct a means of defining the fenestrations (e.g., a blade, a
laser, a water jet, a punch, a drill, and/or the like). In other
embodiments, the patient-specific template can be configured to at
least partially form the fenestrations of the stent graft (e.g.,
the patient-specific template can include a protrusion or the like
configured to puncture and/or otherwise define an opening in the
stent graft. Thus, the patient-specific template can facilitate the
formation of the fenestrations defined by the stent graft, which
are each disposed along the stent graft in a position corresponding
to a modified and/or shifted position of a branch vessel of the
aorta, which results from the placement of the stent graft, as
described in detail above with reference to the fenestration
patient-specific template 250 and the fenestrated stent graft
260.
[0095] Some of the embodiments described herein are configured to
define a first digital representation of anatomic imaging data of a
portion of a patient's anatomy and to modify the first digital
representation to define a second digital representation of the
portion of the patient's anatomy based on a set of characteristics
associated with the patient, a prosthetic, and/or a manner of
delivering the prosthetic. In other embodiments, the second digital
representation of the portion of the patient's anatomy can be from
a plurality of digital representations of the portion of patient's
anatomy. That is to say, in some embodiments, the modifying of the
first digital representation of the portion of the patient's
anatomy can result in a plurality of modified digital
representations of the portion of the patient's anatomy (including
the second digital representation). In such instances, each
modified digital representation of the portion of the patient's
anatomy (simply referred to herein as "modified representation")
can be based on a different set of characteristics or a different
combination of the characteristics associated with the patient, the
prosthetic, and/or the manner of delivering the prosthetic.
[0096] For example, a first digital representation of a portion of
a patient's anatomy can be modified to define a second digital
representation of the portion of the patient's anatomy based on
patient data, prosthetic data, and/or a first method of delivering
the prosthetic. Similarly, the first digital representation of the
portion of the patient's anatomy can be modified to define a third
digital representation of the portion of the patient's anatomy
based on the patient data, the prosthetic data, and/or a second
method of delivering the prosthetic. In this manner, a
patient-specific prosthetic template such as the fenestration
templates 150, 250, and/or 350 based on the second digital
representation can also be specific to the first method of
delivering the prosthetic, while a patient-specific prosthetic
template based on the third digital representation can also be
specific to the second method of delivering the prosthetic. In a
similar manner, a digital representation can also be based on the
size, shape, and/or configuration of the prosthetic. As such, a
user can input a selection or the like of a digital representation
of a specific prosthetic template from a plurality of specific
prosthetic templates. Moreover, in some instances, a score,
confidence value, rating, and/or any other indicator can be
associated with the digital representation of each prosthetic
template and can be indicative of an accuracy of the digital
representation of each prosthetic template and the associated
modified representation of the patient's anatomy. Said another way,
a digital representation of a plurality of patient-specific
prosthetic templates and a plurality of confidence values can be
defined. Each confidence value from the plurality of confidence
values can be associated with the digital representation of a
different patient-specific prosthetic template from the plurality
of patient-specific prosthetic templates and can represent a degree
of accuracy between the digital representation of that
patient-specific prosthetic template and the second digital
representation of the anatomic imaging data. Thus, in some
instances, a user can select a digital representation of the
prosthetic template with the highest score suitable for a
patient.
[0097] Any of the embodiments described herein can be configured to
define a modified representation of a portion of a patient's
anatomy based on data associated with any suitable set of
characteristics associated with the patient, a prosthetic, a manner
of delivery, and/or the like. In some embodiments, the data
associated with the set of characteristics can be updated based on,
for example, empirical data and/or the like. For example, in some
embodiments, a value, weight, score, factor, and/or the like can be
associated with each characteristic in the set of characteristics.
In some instances, anatomic imaging data can be taken of the
portion of the patient's anatomy after the delivery of a prosthetic
and based on data included in the post-delivery anatomic imaging
data the value, weight, score, factor, and/or the like associated
with the set of characteristics can be updated. In this manner, the
accuracy of a projected change in the portion of the anatomy as a
result of the delivery and/or indwelling of a prosthetic can be
increased based on adjusting and/or "tuning" the weight and/or
influence of one or more characteristics associated with the
patient, the prosthetic, and/or the delivery method.
[0098] Some embodiments described herein relate to a computer
storage product with a non-transitory computer-readable medium
(also can be referred to as a non-transitory processor-readable
medium) having instructions or computer code thereon for performing
various computer-implemented operations. The computer-readable
medium (or processor-readable medium) is non-transitory in the
sense that it does not include transitory propagating signals per
se (e.g., a propagating electromagnetic wave carrying information
on a transmission medium such as space or a cable). The media and
computer code (also can be referred to as code) may be those
designed and constructed for the specific purpose or purposes.
Examples of non-transitory computer-readable media include, but are
not limited to, magnetic storage media such as hard disks, floppy
disks, and magnetic tape; optical storage media such as Compact
Disc/Digital Video Discs (CD/DVDs), Compact Disc-Read Only Memories
(CD-ROMs), and holographic devices; magneto-optical storage media
such as optical disks; carrier wave signal processing modules; and
hardware devices that are specially configured to store and execute
program code, such as Application-Specific Integrated Circuits
(ASICs), Programmable Logic Devices (PLDs), Read-Only Memory (ROM)
and Random-Access Memory (RAM) devices. Other embodiments described
herein relate to a computer program product, which can include, for
example, the instructions and/or computer code discussed
herein.
[0099] Some embodiments and/or methods described herein can be
performed by software (executed on hardware), hardware, or a
combination thereof. Hardware modules may include, for example, a
general-purpose processor, a field programmable gate array (FPGA),
and/or an application specific integrated circuit (ASIC). Software
modules (executed on hardware) can be expressed in a variety of
software languages (e.g., computer code), including C, C++,
Java.TM. Ruby, Visual Basic.TM., and/or other object-oriented,
procedural, or other programming language and development tools.
Examples of computer code include, but are not limited to,
micro-code or micro-instructions, machine instructions, such as
produced by a compiler, code used to produce a web service, and
files containing higher-level instructions that are executed by a
computer using an interpreter. For example, embodiments may be
implemented using imperative programming languages (e.g., C,
FORTRAN, etc.), functional programming languages (Haskell, Erlang,
etc.), logical programming languages (e.g., Prolog),
object-oriented programming languages (e.g., Java, C++, etc.) or
other suitable programming languages and/or development tools.
Additional examples of computer code include, but are not limited
to, control signals, encrypted code, and compressed code.
[0100] Some embodiments and/or methods described herein can be
performed by software (executed on hardware), hardware, or a
combination thereof and configured to process and/or execute one or
more programs and/or instructions stored, for example, in memory.
Specifically, some of the embodiments described such as the host
device 120 can be configured to process and/or execute one or more
programs associated with 3-D solid modeling, computer aided design
(CAD), volume or surface reconstruction, image analysis and/or
segmentation, and/or the like. Such programs can include but are
not limited to, for example, MATLAB, TeraRecon, FreeCAD,
SolidWorks, AutoCAD, Creo, and/or the like. Such programs can be
used, for example, to identify features of interest, which can be
traced with spline curves fit to user-specified points. In
addition, indicators or markers can be placed at specific 3-D
locations to indicate the origins of the branch vessels. In an
embodiment, the outlines are converted to 3-D contours that define
the feature locations in the 3-D space. The 3-D contours can be
converted to a mesh to define a 3-D surface model. In some
embodiments, segmentation software can be configured to obtain
different types of imaging data such as CT imaging data, ultrasound
data, and/or the like. In some embodiments, the size of the
generated 3-D surface model can be modified to optimize the graft
fenestration process. For example, the surface model may be
radially expanded to add a predefined wall thickness to allow
generation of a solid fenestration template.
[0101] In some embodiments such programs, can produce 3-D and
multi-planar views of CT image sets. In some embodiments, such a
visualization tool can perform automatic vessel boundary detection,
which can be imported into segmentation software that generates the
3-D surfaces to expedite the model generation and hence the
fenestration generation process. In some embodiments, such
visualization tools can automatically generate 3-D surface data for
a digital model and/or a fenestration template. Once the vessel
boundaries are identified, corresponding openings in the 3-D
digital model can be created and/or defined. In some embodiments, a
subtraction between the solid part model and a cylinder with the
desired fenestration diameter can define the openings in the 3-D
digital model. In another embodiment, holes representing the
origins of branch vessels may be added using a CAD program such as
those listed above. In some embodiments, a 3-D digital model is
converted to a solid object model format such as stereolithography
(STL) or Virtual Reality Modeling Language (VRML) that is supported
by a 3-D printer or similar template generation device.
Advantageously, the availability of automatic aorta boundary
detection makes the creation of the present fenestration template a
practical option for routine use in endovascular aortic aneurysm
repair. Raw imaging data or the segmented aorta boundaries and
fenestration locations may be sent to an outside processing
facility, and the fenestration template shipped back to the surgery
site. Therefore, individual clinical sites not employ individuals
with expertise in image segmentation, CAD software, and/or 3-D
output devices.
[0102] While various embodiments have been described above, it
should be understood that they have been presented by way of
example only, and not limitation. Where schematics and/or
embodiments described above indicate certain components arranged in
certain orientations or positions, the arrangement of components
may be modified. While the embodiments have been particularly shown
and described, it will be understood that various changes in form
and details may be made. Although various embodiments have been
described as having particular features and/or combinations of
components, other embodiments are possible having a combination of
any features and/or components from any of embodiments as discussed
above.
[0103] Where methods and/or events described above indicate certain
events and/or procedures occurring in certain order, the ordering
of certain events and/or procedures may be modified. Additionally,
certain events and/or procedures may be performed concurrently in a
parallel process when possible, as well as performed sequentially
as described above.
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