U.S. patent application number 17/521434 was filed with the patent office on 2022-03-17 for in-vivo robotic imaging, sensing and deployment devices and methods for medical scaffolds.
The applicant listed for this patent is Miraki Innovation Think Tank, LLC. Invention is credited to Santosh Iyer, Matthew P. Palmer, Adeel Saleem Shafi, Christopher J. Velis.
Application Number | 20220079691 17/521434 |
Document ID | / |
Family ID | 1000005996715 |
Filed Date | 2022-03-17 |
United States Patent
Application |
20220079691 |
Kind Code |
A1 |
Velis; Christopher J. ; et
al. |
March 17, 2022 |
IN-VIVO ROBOTIC IMAGING, SENSING AND DEPLOYMENT DEVICES AND METHODS
FOR MEDICAL SCAFFOLDS
Abstract
A multifunctional robotic system for performing in vivo
procedures includes a control unit comprising a computer processor
and a robotic arm in communication with the control unit for
multi-axis movement of the robotic arm. The robotic arm has a
plurality of passages therein. A printer head is disposed in one of
the passages and is configured to create multi-dimensional objects
in vivo. The robotic system includes a measuring system disposed in
one of the passages.. The computer processor has executable
software configured to receive signals from the measuring system
and is configured to control the printer head and the measuring
system to position the object in an in vivo location based upon the
signals from the measuring system.
Inventors: |
Velis; Christopher J.;
(Lexington, MA) ; Palmer; Matthew P.; (Medford,
MA) ; Shafi; Adeel Saleem; (Cambridge, MA) ;
Iyer; Santosh; (Somerville, MA) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Miraki Innovation Think Tank, LLC |
Cambridge |
MA |
US |
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|
Family ID: |
1000005996715 |
Appl. No.: |
17/521434 |
Filed: |
November 8, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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17212641 |
Mar 25, 2021 |
11173004 |
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17521434 |
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PCT/US19/52999 |
Sep 25, 2019 |
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17212641 |
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62736232 |
Sep 25, 2018 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2090/3762 20160201;
A61B 34/30 20160201; A61B 2017/00296 20130101; A61B 2090/374
20160201; A61B 17/00234 20130101; A61B 90/37 20160201; B29C 64/209
20170801; B29C 64/379 20170801 |
International
Class: |
A61B 34/30 20060101
A61B034/30; A61B 90/00 20060101 A61B090/00; B29C 64/379 20060101
B29C064/379; B29C 64/209 20060101 B29C064/209; A61B 17/00 20060101
A61B017/00 |
Claims
1-40. (canceled)
41. A robotic method for performing medical procedures, the method
comprising: providing a control unit comprising a computer
processor, and a robotic arm in communication with the control
unit, the robotic arm comprising: a casing having a plurality of
passages therein, a printer head disposed in at least one of the
plurality of passages, and an imaging system disposed in at least
one of the plurality of passages, wherein the computer processor is
in communication with the printer head and the imaging system, and
the computer processor comprises executable software; receiving
signals from the imaging system; at least one of: (a) in vivo
measuring, via the imaging system, a cavity for receiving an object
to obtain measurements of the cavity; or (b) in vivo mapping, via
the imaging system, a receiving surface for receiving the object to
obtain a surface map; analyzing, by the executable software, at
least one of the cavity measurements and the surface map, to
generate installation parameters; creating, via the printer head,
the object based upon the installation parameters; and positioning
the object in a predetermined patient specific in vivo location,
based upon the installation parameters.
42. The robotic method of claim 41, further comprising creating the
object at least one of ex vivo and in vivo.
43. The robotic method of claim 41, further comprising: providing a
sensor system disposed in at least one of the plurality of
passages; in vivo ascertaining, via the sensor system, properties
of the receiving surface and areas proximate thereto; and
analyzing, by the executable software, the cavity measurements, the
surface map,. and the properties of the receiving surface, to
generate the installation parameters.
44. The robotic method of claim 43, further comprising
ascertaining, via the sensor system, at least one of density,
hardness, pressure, force, temperature, or chemical composition of
the receiving surface and areas proximate thereto.
45. The robotic method of claim 41, further comprising providing a
biologically engineered substance.
46. The robotic method of claim 45, wherein the biologically
engineered substance is at least one of: (a) applied to the object
in vivo; (b) applied to the object ex vivo; (c) flowable; (d)
injectable; (e) a putty; (f) a paste; (g) a powder; (h) applied to
area proximate to the object; (i) forms at least a portion of the
object; (j) printable via the printer head; or (k) in vivo and ex
vivo curable.
47. The robotic method of claim 45, further comprising: providing a
coating deployment system disposed in at least one of the plurality
of passages; and in vivo applying, by the coating deployment
system, a biologically engineered substance to at least one of the
object or the receiving surface.
48. The robotic method of claim 45, wherein the biologically
engineered substance comprises at least one of: (a) a
vascularization promoting substance; (b) a growth factor substance;
(c) an immune reaction deterrent substance; (d) a bone regeneration
substance; or (e) a tissue regeneration substance; the robotic
method further comprising: disposing the biologically engineered
substance in the coating deployment system; and applying the
biologically engineered substance to at least one of the object and
the receiving surface.
49. The robotic method claim 41, further comprising: providing a
curing device in at least one of the plurality of passages; and in
vivo curing the object, via the curing device.
50. The robotic method of claim 41, further comprising providing at
least one in vivo miniaturized medical device in communication with
the computer processor.
51. The robotic method of claim 41, further comprising providing an
interactive group of in vivo miniaturized medical devices in
communication with the computer processor.
52. The robotic method of claim 41, wherein the robotic method is
performed in a single procedure.
53. The robotic method of claim 41, further comprising: providing
at least one of a post-positioning monitoring system and a
post-positioning alteration system, each being in communication
with the computer processor; monitoring, via the post-positioning
monitoring system, positions of the object relative to the
receiving surface after in vivo placement of the object;
transmitting the positions of the object to the computer processor;
evaluating the positions of the object, via the executable
software; determining, via the executable software, the adequacy of
the positions of the object; generating, by the executable
software, commands to the post-positioning alteration system; and
altering the positions of the object based upon the commands.
54. The robotic method of claim 53, wherein at least one of the
monitoring of the positions, the transmitting of the positions, the
evaluating of the positions, the determining of the adequacy of the
positions, the generating of the commands or the altering of the
positions is accomplished by at least one in vivo miniaturized
medical device.
55. The robotic method of claim 41, further comprising: forming at
least one segment of the object ex-vivo; and transporting the
segment into the cavity via at least one of the passages.
56. The robotic method of claim 41, further comprising forming the
object via a plurality of layers of the material upon one another
to establish a predetermined size of the object based upon the
properties of the receiving surface and the areas proximate
thereto.
57. The robotic method of claim 41, further comprising: providing a
material removal system in at least one of the plurality of
passages; and forming the object oversized relative to the cavity
and removing material from the object via the material removal
system thereby establishing a predetermined size of the object
based upon the properties of the receiving surface and the areas
proximate thereto.
58. The robotic method of claim 41, further comprising: providing
an assembly system in at least one of the passages; in vivo forming
a plurality of segments of the object, each of the segments having
an interlocking system thereon; and in vivo assembling the segments
to one another using the assembly system.
59. The robotic method of claim 41, further comprising at least one
of: (a) wherein the object comprises a medical scaffold positioned
between adjacent vertebral bodies, the cavity is located between
the adjacent vertebral bodies and the receiving surface is on the
adjacent vertebral bodies; (b) wherein the robotic method is
employed for in vivo repairing of damaged hard bone Or cartilage;
(c) wherein the robotic method is employed for in vivo
reconstruction of hard bone comprising in vivo reshaping the hard
bone by in vivo forming and erecting the medical scaffold on a
surface of the hard bone; (d) wherein the robotic method is
employed for in vivo repair of a damaged ligament site, comprising
imaging the damaged site and determining parameters for a medical
scaffold and in vivo forming and erecting the medical scaffold in
the damaged site such that the medical scaffold expands and
contracts with the ligament and to urge a first torn ligament end
towards a second torn ligament end; (e) wherein the robotic method
is employed for in vivo repair of soft tissue; (f) wherein the
robotic method is employed for in vivo nerve repair; (g) wherein
the robotic method is employed for hernia repair; or (h) wherein
the robotic method is employed for bronchial procedures.
60. (canceled)
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a Divisional of, and claims priority to
and the benefit of, U.S. patent application Ser. No. 17/212,641,
filed Mar. 25, 2021, now U.S. Pat. No. ______, which is a
Continuation of, and claims priority to and the benefit of,
International Application No. PCT/US2019/052999, filed Sep. 25,
2019, which, in turn, claims the benefit of and priority to, U.S.
Provisional Application No. 62/736,232, filed on Sep. 25, 2018. The
entire contents of each of the foregoing applications are hereby
incorporated by reference herein.
FIELD OF THE INVENTION
[0002] The present invention relates generally to multi-function
robotic systems for in vivo imaging, sensing and deployment of
medical scaffolds, and more particularly to imaging and sensing
implant sites within the human body to obtain patient specific
implant site parameters, including dimensions, contours, physical
characteristics and chemical properties and in vivo deploying
medical scaffolds corresponding to the patient specific implant
site parameters.
BACKGROUND OF THE INVENTION
[0003] Many orthopedic surgical procedures require the physician to
implant a spacer between two adjacent bones to fill a void, correct
a deformity, or maintain proper spacing. The goal is for these
bones to ultimately fuse together. Traditionally, these spacers are
inserted by first removing diseased or damaged tissue (e.g., the
disc nucleus (soft bone marrow) or removing bone (e.g., spinal
discs include the disc annulus (perimeter made of bone) to correct
a deformity and then implanting the spacer between the adjacent
bones. A plate and/or screws may be used to span the two bones and
provide stability while the bone grows and fuses the two bones
together.
[0004] Many different orthopedic procedures utilize spacers.
Spacers are used in many orthopedic spine surgeries. Anterior
cervical discectomy and fusion (ACDF) is a common cervical spine
procedure where a herniated or degenerative disc is removed, and a
spacer is inserted in its place. The goal of this procedure is for
the two adjacent bones to fuse together, while the overall height
of the spine is maintained (by the spacer). Similar procedures are
performed in lumbar spine and may utilize either a posterior
approach (Posterior Lumbar Interbody Fusion, PLIF) or a
transforaminal approach (Transforaminal Lumbar Interbody Fusion,
TLIF).
[0005] Additionally, spacers may be used for osteotomies of the
medial cuneiform (Cotton Wedge) and for lengthening osteotomies of
the metatarsals (Evans Wedge) and to correct varus or valgus
deformities of the knee (High Tibial Osteotomy Wedges, HTO
Wedge).
[0006] Spacers used in orthopedic procedures need to be made of
biocompatible materials and be strong enough to support the loads
applied to them. Often, they are manufactured from polymers, metal
alloys, or biological tissue. Suitable polymers are typically in
the polyaryl-ether-ketone (PAEK) family, with
polyether-ether-ketone (PEEK) being the most commonly used polymer
for spacers. Polymer materials have the advantage of being
radiolucent so as not to be visible on x-ray while also having a
Young's modulus more similar to bone so as to avoid stress
shielding. Spacers are also commonly manufactured from titanium
(CP-Ti) and titanium alloys (i.e., titanium 6-aluminum 4-vanadium
(Ti-6-4)). Spacers may be manufactured from synthetic or allograft
bone. Spacers may be made of solid (bulk) material or may be
porous. Porous implants are advantageous as they allow for bone to
grow into the implant and also reduce the Young's modulus of
stiffer materials to be closer to that of bone.
[0007] While these implants do fulfill their biologic requirement
of filling a gap between two bones, they are limited to fixed
pre-manufactured sizes. While three-dimensional (3D) printing
technology has advanced to allow for custom manufactured wedges,
physicians remain limited by surgical site access, can only implant
wedges that fit through and around the anatomy of the region, and
need adequate lead time to allow for the wedge to be manufactured.
Thus, improvements are desirable in this field of technology.
[0008] Problems with spinal implants include, but are not limited
to when putting a cage in spinal disc space the clinician doesn't
know if the cage is placed on center (soft marrow) or edges (hard
cortical bone). Typical processes for implantation rely on x-ray
alone to attempt to locate the implant. Spinal discs include a disc
annulus (perimeter made of bone) and a disc nucleus (soft bone
marrow). Often, the interface between bone and the implant is poor,
which can result in weak or poor bone growth.
[0009] Conventional implants, medical scaffolds and spacers
positioned between two bones, e.g., vertebral bones, often
demonstrate movement and shifting once positioned between the
bones. The movement and shifting can occur due to patient movement,
incorrect placement, and/or use of standard size implants or
spacers that do not comport with the dimensions and configuration
of the cavity between the vertebra and contours of the surface of
the vertebra. The vertebra are formed by a central trabecular bone
(i.e., soft bone) surrounded by cortical bone (i.e., dense or hard
bone). The trabecular bone is exposed on axial ends of the vertebra
and the cortical bone extends circumferential therearound. The
implants, medical scaffolds and spacers must be supported in the
cavity by the cortical bone and be maintained spaced apart from the
trabecular bone. However, the movement and shifting of the
implants, medical scaffolds and spacers can cause the implants,
medical scaffolds and spacers to displace into the trabecular bone.
Such shifting results in improper spacing of the vertebra and
causes the patient to suffer pain. Thus, improvements are desirable
in this technology to maintain the positioning of the spacer or
implant.
SUMMARY
[0010] There is disclosed herein a multifunctional robotic system
for performing in vivo procedures. The robotic system includes a
control unit that has a computer processor. The multifunctional
robotic system includes a robotic arm that is in communication with
the control unit for multi-axis movement of the robotic arm. The
robotic arm includes a casing having a plurality of passages
therein. A printer head is disposed in and is operable from one or
more of the plurality of passages. The printer head is configured
to create one or more multi-dimensional objects. The
multifunctional system includes a measuring system that is disposed
in and is operable from one or more of the plurality of passages.
The computer processor is in communication with the printer head
and the measuring system. The computer processor has executable
software configured to receive signals from the measuring system.
The executable software is configured to control the printer head
and the measuring system to position the object in an in vivo
location based upon the signals from the measuring system.
[0011] In one embodiment, the measuring system includes an imaging
system configured to in vivo measure a cavity for receiving the
object and mapping a receiving surface in the cavity.
[0012] In one embodiment, the measuring system includes a sensor
system disposed in and operable from at least one of the plurality
of passages. The sensor system is configured to ascertain
properties of the receiving surface and areas proximate thereto. In
one embodiment, the sensor system is configured to ascertain at
least one of density, hardness, and chemical composition.
[0013] In one embodiment, the positioning of the object comprises
forming the object in vivo.
[0014] In one embodiment, the positioning of the object comprises
forming the object ex vivo.
[0015] In one embodiment, one or more segments of the object are
formed ex vivo and one or more of the passages has a conveyor
system for transporting the segment to the cavity.
[0016] In one embodiment, the casing is configured to fit in a
lumen of a body.
[0017] In one embodiment, the imaging system is a magnetic
resonance imaging system, a computed topography system or
combinations thereof.
[0018] In one embodiment, a coating deployment system disposed in
and is operable from one or more of the plurality of passages. The
coating deployment system is configured to in vivo apply a
biologically engineered substance to the object and/or the
receiving surface.
[0019] In one embodiment, the multifunctional robotic system
employs a biologically engineered substance. For example, the
biologically engineered substance is: (a) applied to the object in
vivo; (b) applied to the object ex vivo; (c) flowable; (d)
injectable; (e) a putty; (f) a paste; (g) a powder; (h) applied to
area proximate to the object; (i) forms at least a portion of the
object; (j) printable via the printer head; (k) in vivo and ex vivo
curable; and (l) combinations thereof. Thee biologically engineered
substance is: (a) a vascularization promoting substance; (b) a
growth factor substance; (c) an immune reaction deterrent
substance; (d) a bone regeneration substance; (e) a tissue
regeneration substance; and 9e) combinations thereof. In one
embodiment, the biologically engineered substance is disposed in
and applied from the coating deployment system. In one embodiment,
the biologically engineered material is a self-assembling
arginine-rich peptide that has nanophase characteristics and
biomimetic nature and is employed in tissue healing, for example
used in an uncured plug form and cured in vivo.
[0020] In one embodiment, the printer head includes a material
discharge port for in vivo discharging material for in vivo
building of the object.
[0021] In one embodiment, the object is composed of a plurality of
layers of the material formed additively upon one another to
establish a predetermined size of the object based upon the
properties of the receiving surface and the areas proximate
thereto.
[0022] In one embodiment, a material removal system is disposed in
one or more of the plurality of passages. The object is formed in
an oversized state relative to the cavity. The material removal
system is configured to establish a predetermined size of the
object based upon the properties of the receiving surface and the
areas proximate thereto.
[0023] In one embodiment, one or more of the passages includes an
assembly system and the object has a plurality of segments, each
having an interlocking system thereon. The assembly system is
configured to in vivo assemble the segments to one another and to
lock the interlocking systems of adjacent segments to one
another.
[0024] In one embodiment, an optical device disposed in and is
operable from one or more of the plurality of passages. The optical
device is in communication with the computer processor to transmit
in vivo images to the computer processor.
[0025] In one embodiment, a curing device is disposed in and is
operable from one or more of the plurality of passages. The, the
curing device is configured to in vivo cure material deposited in a
body cavity.
[0026] In one embodiment, the curing device is a laser, a heat
source, a chemical reactant or combinations thereof.
[0027] In one embodiment, a multi-axis positioner is disposed in
and is operable from one or more of the plurality of passages. The
multi-axis positioner is in communication with the printer head and
the computer processor to control dynamic positioning of the
printer head in vivo.
[0028] In one embodiment, a heat sink, a material evacuation
system, a coolant deployment system, an insulation system or
combinations thereof is disposed in one or more of the plurality of
passages.
[0029] In one embodiment, the robotic arm has a sterile interface
for mitigating infection caused by in vivo deployment of the
object.
[0030] In one embodiment, one or more in vivo miniaturized medical
devices are in communication with the computer processor.
[0031] In one embodiment, an interactive group of in vivo
miniaturized medical devices is in communication with the computer
processor.
[0032] In one embodiment, a post-positioning monitoring system
and/or a post-positioning alteration system are in communication
with the computer processor. The post-positioning monitoring system
is configured to monitor the position of the object relative to the
receiving surface and the post-positioning alteration system is
configured to reposition and alter the object.
[0033] In one embodiment, the measuring system, the sensor system,
the post-positioning monitoring system and the post-positioning
alteration system is located in the object.
[0034] In one embodiment, the printer head, the measuring system,
the sensor system, the post-positioning monitoring system and the
post-positioning alteration system is located in at least one
miniaturized medical device in an in vivo configuration.
[0035] There is further disclosed herein, an implant for in vivo
deployment. The implant includes a structural member configured for
in vivo deployment in a body. The structural member includes a
communication system disposed therein. The communications system is
configured for communications between the structural member and
locations external to the structural member. The implant includes
one or more of: (a) an imaging system; (b) a sensor system; and (c)
an alteration system, each disposed in the structural member. The
imaging system is configured to in vivo measure a cavity for
receiving the implant and mapping a receiving surface for the
implant and is in communication with the communications system. The
sensor system is configured to recognize or ascertain
characteristics of the structural member and is in communication
with the communication system. The alteration system is configured
to alter the characteristics of the structural members and is in
communication with the communication system.
[0036] In one embodiment, the sensor system includes: (a) a strain
sensor configured to measure dimensional changes in the structural
member as a function of time; (b) a force sensor configured to
measure stresses in the structural member as a function of time;
(c) a pressure sensor configured to measure pressure applied to the
structural member; (d) an imaging sensor to detect environmental
conditions external to the imaging sensor; and (e) combinations
thereof.
[0037] In one embodiment, the communication system includes a
wireless system configured to transmit communication external to
the structural member.
[0038] In one embodiment, the communication system is in
communication with one or more in vivo miniaturized medical devices
or is contained in one or more of the in vivo miniaturized medical
devices.
[0039] In one embodiment, the alteration system includes: (a) a
deformation device configured to change dimensions of the
structural member to selectively compensate for fit-up anomalies
between the structural member and mating surfaces; (b) a tension
adjustment device configured to selectively increase and decrease
tension in response to external forces applied to the structural
member; (c) a density adjustment device configured to selectively
adjust density of the structural member; (d) a reactor system
configured to selectively dissolve portions of the structural
member; (e) one or more in vivo miniaturized medical device in
communication with the structural member; and (f) combinations
thereof.
[0040] In one embodiment, the structural member has outside
diameter of a magnitude sufficient to prevent portions of the
implant from intruding into trabecular bone of a vertebral body
when the structural member is disposed between adjacent vertebral
bodies.
[0041] In one embodiment, the structural member is made up of a
plurality of subsections or segments interlocked with adjacent
subsections or segments.
[0042] In one embodiment, the structural member is inflatable and
deflatable.
[0043] In one embodiment, the implant employs a biologically
engineered substance. In one embodiment, the biologically
engineered substance is: (a) applied to the object in vivo; (b)
applied to the object ex vivo; (c) flowable; (d) injectable; (e) a
putty; (f) a paste; (g) a powder; (h) applied to area proximate to
the object; (i) forms at least a portion of the object; (j)
printable via the printer head; (k) in vivo and ex vivo curable;
and (l) combinations thereof.
[0044] In embodiment, a portion of or the entire structural member
is coated with the biologically engineered substance.
[0045] In one embodiment, the biologically engineered substance is
one or more of: (a) a vascularization promoting substance; (b) a
growth factor substance; (c) an immune reaction deterrent
substance; (d) a bone regeneration substance; (e) a tissue
regeneration substance; and (f) combinations thereof.
[0046] There is also disclosed herein a robotic method for
performing in vivo procedures. The method includes providing a
control unit that has a computer processor. A robotic arm is in
communication with the control unit. The robotic arm has a casing
with a plurality of passages therein. A printer head is disposed in
one or more of the plurality of passages. An imaging system is
disposed in one or more of the plurality of passages. The computer
processor is in communication with the printer head and the imaging
system. The computer processor has executable software that
receives signals from the imaging system. The method includes: (a)
in vivo measuring, via the imaging system, a cavity for receiving
an object to obtain measurements of the cavity; and/or (b) in vivo
mapping, via the imaging system, a receiving surface for receiving
the object to obtain a surface map. The executable software
analyzes the cavity measurements and/or the surface map, to
generate installation parameters. The printer head creates (e.g.,
in vivo or Ex vivo or combinations thereof) the object based upon
the installation parameters. The object is positioned in a
predetermined patient specific in vivo location, based upon the
installation parameters.
[0047] In one embodiment, the method includes providing a sensor
system disposed in one or more of the plurality of passages; in
vivo ascertaining, via the sensor system, properties of the
receiving surface and areas proximate thereto; and the executable
software analyzing the cavity measurements, the surface map and the
properties of the receiving surface, to generate the installation
parameters.
[0048] In one embodiment, the method includes ascertaining, via the
sensor system, density, hardness and/or chemical composition of the
receiving surface and areas proximate thereto.
[0049] In one embodiment, the method includes providing a
biologically engineered substance. The biologically engineered
substance is: (a) applied to the object in vivo; (b) applied to the
object ex vivo; (c) flowable; (d) injectable; (e) a putty; (f) a
paste; (g) a powder; (h) applied to area proximate to the object;
(i) forms a portion of or the entire the object; (j) printable via
the printer head; (k) in vivo and ex vivo curable; and (l)
combinations thereof.
[0050] In one embodiment, the method includes providing a coating
deployment system disposed in one or more of the plurality of
passages; and the coating deployment system in vivo applies a
biologically engineered substance to the object and/or the
receiving surface.
[0051] In one embodiment, the biologically engineered substance is:
(a) a vascularization promoting substance; (b) a growth factor
substance; (c) an immune reaction deterrent substance; (d) a bone
regeneration substance; (e) a tissue regeneration substance; and
(f) combinations thereof. In one embodiment, the biologically
engineered substance is disposed in the coating deployment system;
and the biologically engineered substance is applied to the object
and/or the receiving surface.
[0052] In one embodiment, the method includes providing a curing
device in one or more of the plurality of passages; and the object
is cured in vivo, via the curing device.
[0053] In one embodiment, the method includes providing one or more
in vivo miniaturized medical devices in communication with the
computer processor.
[0054] In one embodiment, the method includes providing an
interactive group of in vivo miniaturized medical devices in
communication with the computer processor.
[0055] In one embodiment, the method includes providing a
post-positioning monitoring system and/or a post-positioning
alteration system, each being in communication with the computer
processor. The method includes: monitoring, via the
post-positioning monitoring system, positions of the object
relative to the receiving surface after in vivo placement of the
object; transmitting the positions of the object to the computer
processor; evaluating the positions of the object, via the
executable software; and determining, via the executable software,
the adequacy of the positions of the object. The executable
software generates commands to the post-positioning alteration
system; and alters the positions of the object based upon the
commands.
[0056] In one embodiment, the monitoring of the positions, the
transmitting of the positions, the evaluating of the positions, the
determining of the adequacy of the positions, the generating of the
commands and the altering of the positions is accomplished by one
or more in vivo miniaturized medical devices.
[0057] In one embodiment, the method includes forming one or more
segments of the object ex-vivo and transporting the segment into
the cavity via one or more of the passages.
[0058] In one embodiment, the method includes forming the object
via a plurality of layers of the material upon one another to
establish a predetermined size of the object based upon the
properties of the receiving surface and the areas proximate
thereto.
[0059] In one embodiment, the method includes providing a material
removal system in one or more of the plurality of passages; and
forming the object oversized relative to the cavity. The method
also includes removing material from the object via the material
removal system thereby establishing a predetermined size of the
object based upon the properties of the receiving surface and the
areas proximate thereto.
[0060] In one embodiment, the method includes providing an assembly
system in one or more of the passages; and in vivo forming a
plurality of segments of the object, each of the segments having an
interlocking system thereon. The method includes in vivo assembling
the segments to one another using the assembly system.
[0061] In one embodiment, the method is employed in one or more of:
(a) a medical scaffold positioned between adjacent vertebral
bodies, the cavity is located between the adjacent vertebral bodies
and the receiving surface is on the adjacent vertebral bodies; (b)
in vivo repairing of damaged hard bone or cartilage; (c) in vivo
reconstruction of hard bone comprising in vivo reshaping the hard
bone by in vivo forming and erecting the medical scaffold on a
surface of the hard bone; (d) in vivo repair of a damaged ligament
site, comprising imaging the damaged site and determining
parameters for a medical scaffold and in vivo forming and erecting
the medical scaffold in the damaged site such that the medical
scaffold expands and contracts with the ligament and to urge a
first torn ligament end towards a second torn ligament end; (e) in
vivo repair of soft tissue; and (f) in vivo nerve repair
procedures.
[0062] In one embodiment, (a) the object is a medical scaffold
positioned between adjacent vertebral bodies, the cavity is located
between the adjacent vertebral bodies and the receiving surface is
on the adjacent vertebral bodies; (b) wherein the method is
employed for in vivo repairing of damaged hard bone or cartilage;
(c) wherein the method is employed for in vivo reconstruction of
hard bone comprising in vivo reshaping the hard bone by in vivo
forming and erecting the medical scaffold on a surface of the hard
bone; (d) wherein the method is employed for in vivo repair of a
damaged ligament site, comprising imaging the damaged site and
determining parameters for a medical scaffold and in vivo forming
and erecting the medical scaffold in the damaged site such that the
medical scaffold expands and contracts with the ligament and to
urge a first torn ligament end towards a second torn ligament end;
(e) wherein the method is employed for in vivo repair of soft
tissue; and/or (f) wherein the method is employed for in vivo nerve
repair.
[0063] There is disclosed herein a device for in-vivo
three-dimensional printing. The device includes a multi-axial
robotic arm, a three-dimensional printer head secured to a distal
end of the robotic arm; and a control unit in communication with
the robotic arm and the three-dimensional printer head. The
three-dimensional printer head is configured to coordinate with the
control unit to control motion of the robotic arm and operation of
the three-dimensional printer head for depositing of material via
three-dimensional printing, in-vivo.
[0064] In one embodiment, the three-dimensional printer head is
configured to print a spacer used in an orthopedic procedure.
[0065] In one embodiment, the three-dimensional printer head is
configured to print a spacer between two adjacent vertebrae.
[0066] In one embodiment, the three-dimensional printer head is
configured to print a structure out of polyether-ether-ketone.
[0067] In one embodiment, the three-dimensional printer head is
configured to print a structure out of titanium alloy.
[0068] In one embodiment, the three-dimensional printer head is
configured to print a porous object.
[0069] In one embodiment, the control unit is in communication with
at least one of a magnetic resonance imaging system and a computed
tomography system and the control unit is configured to receive a
model to be printed that is specific to a patient and is generated
by a pre-operative scan performed by at least one of the magnetic
resonance imaging system and computed tomography system.
[0070] There is also disclosed herein, a method of providing
therapy to a patient that includes providing a device for in-vivo
three-dimensional printing. The device includes a multi-axial
robotic arm, a three-dimensional printer head secured to a distal
end of the robotic arm and a control unit in communication with the
robotic arm and the three-dimensional printer head. The method
includes controlling motion of the robotic arm and the
three-dimensional printer head and in-vivo depositing material by
the three-dimensional printer head.
[0071] In one embodiment, the method includes in-vivo printing a
spacer in an orthopedic procedure.
[0072] In one embodiment, the method includes in-vivo printing of a
spacer between two adjacent vertebrae.
[0073] In one embodiment, the method includes in-vivo printing a
structure from a polyether-ether-ketone material.
[0074] In one embodiment, the method includes in-vivo printing a
structure from a titanium alloy.
[0075] In one embodiment, the method includes in-vivo printing a
porous object.
[0076] In one embodiment, the method includes establishing
communication between the control unit and at least one of a
magnetic resonance imaging system and a computed tomography system,
generating a pre-operative scan performed by at least one of the
magnetic resonance imaging system and computed tomography system;
receiving by the control unit a model to be printed that is
specific to a patient.
DESCRIPTION OF THE DRAWINGS
[0077] The drawings show embodiments of the disclosed subject
matter for the purpose of illustrating the invention. However, it
should be understood that the present application is not limited to
the precise arrangements and instrumentalities shown in the
drawings, wherein:
[0078] FIG. 1A illustrates a representative anterior cervical
spacer formed in accordance with the present invention;
[0079] FIG. 1B illustrates a representative posterior lumbar
interbody spacer formed in accordance with the present
invention;
[0080] FIG. 1C illustrates a representative transforaminal lumbar
interbody spacer formed in accordance with the present
invention;
[0081] FIG. 2A illustrates a representative Cotton wedge spacer
formed in accordance with the present invention;
[0082] FIG. 2B illustrates a representative Evans wedge spacer
formed in accordance with the present invention;
[0083] FIG. 3A illustrates a representative Anterior Cervical
Discectomy and Fusion implant configuration;
[0084] FIG. 3B illustrates a representative Posterior Lateral
Interbody Fusion implant configuration;
[0085] FIG. 3C illustrates a representative Transforaminal
Interbody Fusion implant configuration;
[0086] FIG. 4A illustrates a representative robotic arm formed in
accordance with the present invention;
[0087] FIG. 4B illustrates a representative robotic arm formed in
accordance with the present invention;
[0088] FIG. 5 illustrates a representative 3D printer head formed
in accordance with the present invention;
[0089] FIG. 6 illustrates a representative workflow for an in-vivo
robotic 3D printer formed in accordance with the present
invention;
[0090] FIG. 7 illustrates a representative in-vivo robotic 3D
printer printing a spacer between two adjacent vertebrae;
[0091] FIG. 8 illustrates a representative keying mechanism to
secure a spacer to bone;
[0092] FIG. 9 is a schematic diagram of the multifunction robotic
system of the present invention;
[0093] FIG. 10A is an enlarged partial cut away view of detail 10A
of FIG. 9;
[0094] FIG. 10B is a front view of the printer head of FIG.
10A;
[0095] FIG. 10C is an enlarged partial cut away view of the
multi-function head of FIG. 10B illustrating a multi-axis
positioner;
[0096] FIG. 11 is a schematic view of the multifunction head of
FIG. 10B illustrating a sterile interface;
[0097] FIG. 12A is a schematic view of a miniaturized robotic
medical device;
[0098] FIG. 12B is a schematic view of the miniaturized robotic
medical device of FIG. 12A shown in a lumen of a body;
[0099] FIG. 13 is a schematic view of an interactive group of the
miniaturized robotic medical devices of FIG. 12A;
[0100] FIG. 14A is a schematic view of a medical scaffold of the
present invention illustrated with strain gauges and force
sensors;
[0101] FIG. 14B is a schematic view of a medical scaffold of the
present invention illustrated with pressure sensors;
[0102] FIG. 14C is a schematic view of a medical scaffold of the
present invention illustrated with imaging sensors;
[0103] FIG. 14D is a schematic view of a medical scaffold of the
present invention illustrated with a wireless communications
system;
[0104] FIG. 14E is a schematic view of a medical scaffold of the
present invention illustrated with a device for selectively
deforming the medical scaffold;
[0105] FIG. 14F is a schematic view of a medical scaffold of the
present invention illustrated with a device for selectively
changing the hardness, composition and/or density of the medical
scaffold;
[0106] FIG. 14G is a schematic view of a medical scaffold of the
present invention illustrated with module configured to selectively
dissolve portions of or the entire medical scaffold;
[0107] FIG. 14H is a schematic view of a medical scaffold of the
present invention illustrated with layers of different
densities;
[0108] FIG. 15A is a schematic coronal view of the precursor state
of the medical scaffold of the present invention shown positioned
between two vertebra before sizing;
[0109] FIG. 15B is a schematic coronal view of the medical scaffold
of the present invention shown positioned between two vertebra
after sizing;
[0110] FIG. 15C is a schematic view of a medical scaffold having a
plurality of layers, in accordance with aspects of the present
disclosure;
[0111] FIG. 16A is a schematic view of an embodiment of the medical
scaffold of the present invention shown in a deflated state;
[0112] FIG. 16B is a schematic view of the medical scaffold of FIG.
16A shown in an inflated state;
[0113] FIG. 17A is an exploded axial view of a segmented medical
scaffold of the present invention;
[0114] FIG. 17B is a perspective view of one of the segments of the
medical device of FIG. 17A showing interlocking features employed
therewith;
[0115] FIG. 18 is a coronal view of the medical scaffold of the
present invention shown with solid non-vascularized zone and a
vascularized zone;
[0116] FIG. 19A is an axial view of a ligament with a partial tear
therein;
[0117] FIG. 19B is an axial view of the ligament of FIG. 19A with a
medical scaffold of the present invention disposed in the tear;
[0118] FIG. 19C is a coronal view of the medical scaffold shown
disposed in a torn ligament site;
[0119] FIG. 20 is a schematic view of a fractured bone have medical
scaffolds deployed thereon; and
[0120] FIG. 21 is a schematic view of a torn nerve with a tubular
medical scaffold therearound.
DETAILED DESCRIPTION
[0121] FIGS. 1A-FIG. 1C illustrate exemplary spine spacers 5 used
to assist fusion of adjacent vertebrae. FIG. 1A illustrates a
cervical spine spacer 10 used to assist in the fusion of adjacent
vertebrae. This spacer is used as part of an Anterior Cervical
Discectomy Fusion procedure. FIG. 1B illustrates a spacer 20 used
for Posterior Lumbar Interbody Fusion. FIG. 1C illustrates a spacer
25 used for Transforaminal Lumbar Interbody Fusion. Spacers 10, 20,
and 25 may have a hollow interior region 15 to allow for bone
growth. Hollow region 15 may be packed with bone grafting material
or other materials known in the art to stimulate bone growth.
Spacers 10, 20, and 25 are shown manufactured from PEEK polymers;
however, it should be appreciated that these implants may be
manufactured from other suitable biocompatible materials including,
but not limited to, titanium alloys.
[0122] FIGS. 2A and FIG. 2B illustrate exemplary spacers used for
orthopedic extremity surgery. FIG. 2A illustrates a spacer 30
referred to as a Cotton wedge that is used for osteotomies of the
medial cuneiform. FIG. 2B illustrates a spacer 35 referred to as an
Evans wedge that is used for lengthening osteotomies of the
metatarsals. Spacers 30 and 35 may have a hollow interior region 15
to allow for bone growth. Hollow region 15 may be packed with bone
grafting material or other materials known in the art to stimulate
bone growth. Spacers 30 and 35 are shown manufactured from a porous
titanium alloy; however, it should be appreciated that these
implants may be manufactured from other suitable biocompatible
materials.
[0123] FIG. 3A illustrates a representative anterior cervical
discectomy and fusion implant configuration. Two spacers 10 are
used to maintain vertebral spacing and assist with the fusion of
adjacent vertebrae 36 of the cervical spine. A plate 37A may be
used to secure the vertebrae in place and create a ridged construct
to allow for bone fusion to occur. Plate 37A is fixed to vertebrae
36 using screws 37B. FIG. 3B illustrates a representative posterior
lumbar interbody fusion procedure. Two spacers 20 are used to
maintain vertebral spacing and assist with the fusion of the
adjacent vertebrae 38 of the lumbar spine. Pedicle screws 39A and
rods 39B are used to stiffen the construct. FIG. 3C illustrates a
representative transforaminal lumbar interbody fusion procedure. A
spacer 25 is used to maintain vertebral spacing and assist with the
fusion of the adjacent vertebrae 38 of the lumbar spine. Pedicle
screws 39A and rods 39B are used to stiffen the construct. Screws
and rods shown can be 3D printed or supplement a 3D printed
scaffold using off-the-shelf screws and rods.
[0124] FIG. 4A illustrates an exemplary robotic arm 40 that can be
used to control a 3D printer head. This robotic arm 40 can be
configured to be deployed via an endoscope. Unlike a traditional 3D
printer which is limited in motion to the three-basic x, y, and z
axes, robotic arm 40 may have many axes to allow the robot to have
sufficient degrees of freedom to access the regions needed to print
an object such as a spacer, scaffold or implant.
[0125] Robotic arm 40 may be a 6-axis robotic arm. S-axis 45 also
known as the Fanuc J1 axis is located at the robot base 80 and
allows the robot arm to rotate from the left to the right. This
motion extends the work area to include the area on either side and
behind the arm, thus allowing the arm to be positioned in many
positions around the patient. This axis may allow the robot to spin
up to a full revolution upon its center point. The L-axis allows
the lower arm 85 of the robot to extend forward and backward. It is
the axis powering the movement of the entire lower arm. This axis
is also known as the Fanuc J2 axis. The U-axis 55 extends the
robot's vertical reach. It allows the upper arm 90 to reach behind
the body, further expanding the work envelope. This axis gives the
upper arm 90 better access to regions of the anatomy and is also
referred to as the Fanuc J3 axis. The R-axis 60 works in
conjunction with the B-axis 65 to aid in the positioning of the end
effector (in this example a 3D printer head). This axis, known as
the wrist roll, rotates the upper arm 90 in a circular motion. This
axis is also known as the Fanuc J4 axis. The B-axis 65 allows the
wrist 70 to tilt up and down. This axis is responsible for pitch
and yaw motion. This axis is also known as the Fanuc J5 axis. The
T-axis 70 is the wrist of the robot arm. It is responsible for a
twisting motion, allowing the robot to rotate freely in a circular
motion. It is also known as the Fanuc J6. Attached to T-axis 70 is
a mounting plate 75 for attaching a 3D printer head 95 (FIG.
5).
[0126] Alternatively, FIG. 4B illustrates an exemplary flexible
robotic arm 85. Flexible robotic arm 85 is made up of many
individual joints 90 that each allow for multiple degrees of
freedom. Robotic arm 85 may be attached to a base 80 and has a
mount 75 at the end for attachment of a 3D printer head 95 (FIG.
5). A control unit (e.g., the control unit 210 of FIG. 9) is in
communication with the robotic arm 85 and the 3d printer head 95 to
enable accurate positioning and functionality thereof.
[0127] FIG. 5 illustrates an exemplary printer head 95. Printer
head 95 has an orifice 100 for extruding material for printing.
Material feed line 105 transports raw material to the printer head
for use in printing. There may be additional lines 110 for
controlling the printer head and providing cooling to the printed
part.
[0128] Printer head 95 may be compatible with any of the following
3D printing technologies: stereolithography (SLA), digital light
processing (DLP), fused deposition modeling (FDM), selective laser
sintering (SLS), selective laser melting (SLM), electronic beam
melting (EBM), laminated objected manufacturing (LOM). In summary
these technologies print material in layers by fusing multiple thin
layers atop each other to build structures. The 3D printed object
can be fully solid, fully porous, or may have regions of both solid
and porous construction.
[0129] Many different polymers, metal alloys, ceramics, and
composites can be 3D printed using these printing technologies.
Suitable polymers include: polyaryl-ether-ketone (PAEK),
polyether-ether-ketone (PEEK), poly(glycolic acid) (PGA), and
Poly(lactic acid) (PLA). Additionally, many different metal alloys
can be 3D printed using these technologies. Suitable metal alloys
include: titanium 6-aluminum 4-vanadium (Ti-6-4), commercially pure
Titanium (CP-Ti), Cobalt-Chrome-Molybdenum (CoCrMo), and 316
Stainless Steel (316SS). Suitable ceramics include aluminum oxide
materials, and calcium phosphate materials (including tricalcium
phosphate, calcium hydroxyapatite, etc.). Suitable composites
include carbon fiber materials. It should be appreciated that these
represent exemplarily biocompatible materials and are not meant to
be an exhaustive list of all compatible materials. Depending on the
material being printed, the extrusion nozzle may heat the material
sufficiently to make it printable. This may be accomplished with
thermal resistive heating or ultrasonic energy. For metal alloys
(and a subset of polymers) a laser may be used to heat and fuse the
material together. Additionally, light curing polymers may be
utilized for 3D printing. When utilizing a light curing polymer,
the printer head has both a light source of sufficient wavelength
and power to cure the polymer, and an orifice for extruding the
light curing polymer.
[0130] FIG. 6 illustrates a representative workflow for in-vivo
robotic 3D printing. Prior to surgery, the patient may undergo a
pre-operative CT/MRI scan 115 to produce a computer model of the
anatomy including the diseased or damaged tissue. This computer
model can be run through a computer 120 which accounts for the
patient's age, height, weight, adjacent anatomy, and other
physiology to produce a surgery plan and 3D computer model of the
object that will be printed. This model is then sent to the robotic
3D printer 125 for printing.
[0131] FIG. 7 illustrates robotic in-vivo 3D printing for a
cervical spacer for use in an anterior cervical discectomy fusion.
In this procedure an incision is first created to expose the
intervertebral disc space. The degenerative disc material is
removed, and a burr is used to prepare the endplates of the
vertebrae for the spacer. It should be appreciated that the process
of exposing the intervertebral disc space and removing the
degenerative disc material can be accomplished using the robotic
arm and appropriate accessory devices (i.e., scalpel, high speed
burr). With the degenerative disc removed, and the endplates
prepared, the robotic 3D printer can print the patient specific
spacer 5 directly between the two vertebrae.
[0132] As shown in FIG. 7, the system for creating orthopedic
implants in-vivo during a surgical procedure includes a heat
dissipation system 150 and byproduct and waste removal system 151
that are in communication with the head 95, the orifice 100 and/or
the object such as spacer 5. The heat dissipation system 150 and
the byproduct and waste removal system 151 are in communication
with one or more heat exchangers 154, 154' and storage systems 155,
155' located in the head 95 or outside of the body for controlling
the temperature of the spacer 5 and surrounding bone and tissue and
discharging or adding heat as required. The byproduct and waste
removal system 151 is configured to discharge waste generated
during the printing process and can be used to supply materials to
the print area. The system for creating orthopedic implants in-vivo
during a surgical procedure further includes imaging system 152 for
measuring the size, hardness, shape of the implants (e.g., spacer
5) in real time as they are being formed and after they cure, as
well recording images of the implants and transmitting such images
and measurements, in some cases, in real-time to a computer
processor 153, 153' located in the head 95 and/or outside of the
body.
[0133] It should be appreciated that while the endplates of the
vertebrae are being prepared, groves, holes, or other mechanisms
for keying the spacer between the vertebrae can be produced. FIG. 8
illustrates a representative keying mechanism for securing spacer 5
to adjacent vertebrae 36, 38. Prior to commencing 3D printing a
negative keying mechanism 130 can be cut into the end plates 135.
When the spacer 5 is printed, a positive key 140 is printed to fill
the negative keying mechanism 130. Thus, when the spacer is
printed, it is securely engaged within both vertebrae.
[0134] As shown in FIG. 9, a multifunctional robotic system for
performing in vivo procedures is generally designated by the
numeral 200. The system 200 can be configured to be deployed via an
endoscope. The multi-function head 295 is configured to survey a
target site and prepare the site accordingly. For example, the
multi-function head 295 includes a material evacuation system that
is configured to remove material such as damaged or diseased
tissue. The multifunctional robotic system 200 employs direct
visualization and instant feedback for entire procedure. The
clinician cleans disc nucleus space and removes soft bone marrow
with a flexible instrument using the direct visualization and
feedback. For example, the clinician uses a laser scanner to
visualize a cavity to determine cleanliness thereof, to obtain
images of the cavity and to determine where the bone is to place
deploy the medical scaffold 205, as described herein. Sensors or
other tools are used to determine the density of the bone to
distinguish which is bone and which is soft bone marrow.
[0135] The robotic system 200 includes a control unit 210 that has
a computer processor 212 therein. The computer processor 212 is
configured with executable software 214, as described herein. The
robotic system 200 includes a robotic arm 240 pivotally mounted to
a base 280. The base 280 includes a control module 281 that is in
communication with the control unit 210 via signal conductors 210A.
The robotic arm 240 is configured for multi-axis movement as
described herein with respect to FIGS. 4A and 4B. While the
multifunctional robotic system 200 is described as being used for
in vivo procedures, the present invention is not limited in this
regard as the multifunctional robotic system 200 may be employed
for ex vivo procedures, a combination of in vivo and ex vivo
procedures and in cooperation with one or more miniaturized medical
devices 505 as described herein with reference to FIGS. 12A and
12B.
[0136] As shown in FIG. 10A, the robotic arm 240 has a casing 240C
that has a plurality of passages 240P therein. The casing 240C is
configured to fit in a lumen or tissue, muscle or fat of a body of
a living organism, such as a human. As an example, the casing can
have a diameter of about 25mm or less or a diameter such that arm
240 can be deployed to a treatment site via an endoscope.
[0137] The passages 240P may be tubular and house electrical
conduits, signal cables and sub-tube assemblies. A multi-function
head 295 is secured to a distal end of the robotic arm 240. As
shown in FIG. 9, the passages 240P are in communication with the
control module 281 and the multi-function head 295.
[0138] As shown in FIGS. 10A and 10B, the multi-function head 295
has seven openings 241A, 241B, 241C, 241D, 241E, 241F and 241G that
are in communication with a respective one of the plurality of
passages 240P. The openings 241A, 241B, 241C, 241D, 241E, 241F and
241G are illustrated as being on an axial face 295F of the
multi-function head 295. However, the openings 241A, 241B, 241C,
241D, 241E, 241F and 241G may be located on other surfaces of the
multi-function head 295 such as a circumferential surface 295C of
the multi-function head 295 and include more or less than seven
openings. While the multi-function head 295 is illustrated as being
cylindrical, the present invention is not limited in this regard as
other suitable shapes may be employed such as a spherical
shape.
[0139] As shown in FIGS. 10A and 10B, a printer head 242E is
disposed in and is operable from opening 241E of one of the
plurality of passages 240P. The printer head 242E is configured to
create one or more multi-dimensional objects 205 (e.g., a medical
scaffold, an implant, and spacers 5, 10, 20, 25, 30, 35, as
described herein with reference to FIGS. 1A, 1B, 1C, 2A and 2B) in
vivo, as described herein with reference to the printer head 95 of
FIG. 5. The printer head 242E includes a material discharge port
242EP for in vivo discharging a material (e.g., a polymer) for in
vivo building of the object 205 (e.g., a medical scaffold).
[0140] As shown in FIGS. 10A and 10B, the multifunctional robotic
system 200 includes a measuring system that includes an imaging
system 242A and/or a sensor system 242B. As shown in FIGS. 10A and
10B, the imaging system 242A is disposed in and is operable from
the opening 241A of one of the plurality of passages 240P. The
imaging system 242A can be configured to in vivo measure a cavity
250C for receiving the object 205 and mapping a receiving surface
260F of body part 220A, 220B, 220C (e.g., vertebrae), as shown in
FIG. 9. For example, the contour and dimensions of the receiving
surface 260F including the location of soft and hard tissue, is
obtained via the imaging system 242A and is transmitted to the
computer processor 212 for analysis by the executable software 214.
Images and numerical values of the contour and dimensions are
displayed and stored by the computer processor 212. In one
embodiment, the imaging system 242A is an optical visualization
system. The computer processor 212 includes a display configured to
display three-dimensional images of the cavity 250C and the
receiving surface 260F and to overlay images of the object 205 to
verify proper sizing of the object 205. While the imaging system
242A is described as being an optical visualization system, the
present invention is not limited in this regard as a computed
topography system, X-ray optics, ultrasonic systems, sonar systems,
spectral based imaging systems, and/or magnetic resonance imaging
can also be employed.
[0141] As shown in FIGS. 10A and 10B, a sensor system 242B is
disposed in and is operable from the opening 241B of one of the
plurality of passages 240P. The sensor system 242B can be
configured to in vivo ascertain properties including density,
hardness, anatomy, vibration, force, pressure, temperature and/or,
chemical composition of the object and the receiving surface 260F
of body part 220A, 220B, 220C and areas proximate thereto.
[0142] The computer processor 212 is in communication with the
robotic arm, the control module 281, the multi-function head 295,
the printer head 242E, the imaging system 242A and the sensor
system 242B. The executable software 214 is configured to receive
signals from the measuring system, the executable software being
configured to control the printer head and the measuring system to
position the object in an in vivo location based upon the signals
from the measuring system.
[0143] As shown in FIGS. 10A and 10B, a coating deployment system
242C is disposed in and is operable from the opening 241C of one of
the plurality of passages 140P. The coating deployment system 242C
can be configured to store and apply a biologically engineered
substance to the object 205 and/or the receiving surface 260F. The
biologically engineered substance can be applied to the object 205
in vivo via the coating deployment system 242C (which is either in
the opening 241C or in a medical device 505 as described in more
detail below). Alternatively, the biologically engineered substance
can be applied to the object 205 ex vivo via the coating deployment
system 242C or another suitable coating system. In one embodiment,
the biologically engineered substance is disposed in and applied to
the object 205 from the coating deployment system 242C and it is
contemplated that the biologically engineered substance can coat
the object 205 or be injected in or around the object 205, e.g., an
area proximate to the object. In another embodiment, the object 205
is made from a biologically engineered substance, e.g., is made ex
vivo and then implanted in a patient, or 3D printed via the printer
head 242E in vivo in a patient.
[0144] The biologically engineered substances include, but are not
limited to: (a) a vascularization promoting substance; (b) a growth
factor substance; (c) an immune reaction deterrent substance; (d) a
bone regeneration substance; and (e) a tissue regeneration
substance. In some embodiments, the substance comprises a
nanomaterial. The biologically engineered substance(s) can be in
any form, such as, for example, a putty, a paste, a powder, or a
liquid. The biologically engineered substance(s) can be flowable
and/or injectable.
[0145] Bone regeneration and tissue regeneration substances
include, but are not limited to, a composition having
polypeptide-functionalized nanotubes capable of encouraging growth
and adhesion of certain cells to the object 205. The composition
can be flowable or moldable such that it can be placed or
positioned in a site or area of choice and then cure into a
hardened state. The nanotubes in the composition range in lengths
between about 1 nm and about 999 microns, and it is envisioned that
the functionality of the nanotubes can vary within the composition,
such that different functionalities encourage different cells to
grow and adhere to the object 205. Such compositions and nanotubes
are described in U.S. Pat. No. 8,795,691, which is incorporated by
reference in its entirety herein. It is contemplated that the bone
regeneration and tissue regeneration substance can coat an object
205 and/or be injected in or around the object 205 or be the object
itself. When the object 205 is made from the bone regeneration and
tissue regeneration substance, the substance is capable of being
injected or 3D printed and cured in vivo. Alternatively, when the
object 205 is made from the bone regeneration and tissue
regeneration substance, the object can be formed ex vivo, cured and
then implanted in the patient or formed and implanted in vivo.
[0146] As shown in FIGS. 10A and 10B, an optical device 242D is
disposed in and is operable from the opening 241D of one of the
plurality of passages 240P. The optical device 242D is in
communication with the computer processor 212 to transmit in vivo
images to the computer processor 212. The optical device is
configured to have the ability to switch between optical and
spectral i.e. Raman spectroscopy to differentiate between different
tissues in close proximity to the robotic arm 240.
[0147] As shown in FIGS. 10A and 10B, a curing device 242F is
disposed in and is operable from the opening 241F of one of the
plurality of passages 240P. The curing device 242F is configured to
in vivo cure and un-cure material deposited in a body cavity 205.
The curing device 242F includes a laser, a heat source and/or a
chemical reactant.
[0148] As shown in FIG. 10C a multi-axis positioner 259P is
disposed in the multi-function head 295 and is in communication
with imaging system 242A, the sensor system 242B, coating
deployment system 242C, the optical device 242D, printer head 242E,
the curing device 242F and the computer processor 212 to control
and position the imaging system 242A, the sensor system 242B, the
coating deployment system 242C, the optical device 242D, printer
head 242E (e.g., the dynamic positioning of the print head in vivo)
and the curing device 242F, in vivo.
[0149] As shown in FIGS. 10A and 10B, the opening 241G includes one
or more of a heat sink, a material removal/evacuation system 242M,
a coolant deployment system and an insulation system, all of which
are in communication with the multi-axis positioner 259P, for
control and positioning thereof.
[0150] As shown in FIG. 11, a sterile interface 261 is provided
between the robotic arm 240 and the multifunction head 295 for each
of the passages 240P, for mitigating infection caused by in vivo
deployment of the object 205.
[0151] In one embodiment, and as shown in FIG. 9, a plurality of in
vivo miniaturized medical devices 505 are deployed in a lumen of a
patient and are used in conjunction with or independent of the
multifunctional robotic system 200. In some embodiments, the
medical devices 505 can be deployed to perform various functions
and subsequently removed via system 200. In some embodiments, the
medical devices 505 can remain at the treatment site permanently or
semi-permanently, for example, upon reabsorption by the body. In
these embodiments, one or more medical devices 505 can be the
scaffold itself. Such medical devices 505 are discussed in related
PCT Application No. PCT/US2019/24247, incorporated by reference
herein. As shown in FIGS. 12A and 12B, an exemplary intra-body
controllable medical device (hereinafter "the medical device") 505
is illustrated. In one embodiment, medical device 505 is capsule
shaped. Medical device 505 has a distal end 510, a proximal end
515, and body 520 connecting the distal end 510 and proximal end
515. In one embodiment, a control unit, a power supply system, an
intra-device storage system, an imaging system, a therapy system, a
sample and data gathering system, and a material dispensing system
may be located within body 520 of the medical device 505, as
described herein. In one embodiment, the medical device 505 works
in concert with portions of the multifunctional robotic system 200
by undertaking tasks and functions previously described with
respect to the multi-function head 295. For example, in one
embodiment the medical device 505 includes in its body 520 one or
more of the imaging system 242A, the sensor system 242B, the
coating deployment system 242C, the optical device 242D, the
printer head 242E, and the curing device 242F. The functions (i.e.,
measuring, sensing, etc.) not included in the medical device 505
are maintained in the multi-function head 295. In addition to the
aforementioned functions, it is further contemplated that the
medical device 505 can also perform other functions such as
material dispensing or delivery, and sample gathering. The material
dispensing or delivery and/or sample gathering can be done in
addition to the aforementioned function such that the medical
device 505 is multi-functional, or can be done independently of the
aforementioned functions, e.g., the multi-function head 295
includes measuring, sensing, etc., while the medical device
delivers a pharmaceutical, bone growth material, hardware for
installation of an object, etc.
[0152] While not illustrated herein, it is contemplated that when a
plurality of medical devices 505 are deployed in a patient, the
plurality of medical devices includes a combination of two or more
of the following: a first medical device having the imaging system
242A, a second medical device having the sensor system 242B, a
third medical device having the coating deployment system 242C, a
fourth medical device having the optical device 242D, a fifth
medical device having the printer head 242E, and a sixth medical
device having the curing device 242F. The functions (i.e.,
measuring, sensing, etc.) not included in the medical device 505
are maintained in the multi-function head 295.
[0153] In addition to the aforementioned functions, it is further
contemplated that each of the medical devices 505 in the plurality
of medical devices can also perform other functions such as
material dispensing or delivery and sample gathering. The material
dispensing or delivery and sample gathering can be done in addition
to the aforementioned functions such that the medical device 505 is
multi-functional, or can be done independently of the
aforementioned functions, e.g., the multi-function head 295 or one
or more other medical devices 505 include measuring, for example,
imaging and/or sensing various aspects of the treatment site. In
one embodiment, the medical device 505 delivers the biologically
engineered substance disclosed herein, a pharmaceutical, bone
growth material, hardware for installation of an object, gathers a
sample. In one embodiment, the medical device 505 is deployed in
vivo by the multifunctional robotic system 200 via the
multi-function head 295.
[0154] The intra-body controllable medical device 505 is sized
according to the anatomy that it will need to navigate, and the
method used to deliver it. For example, overall dimensions for
medical device operating within the gastrointestinal track may have
a diameter of about 25 mm and a length of about 75 mm.
[0155] As shown in FIG. 12B, the medical device 505 includes the
body 520 having interior area 520A. A first propulsion system 530A
and a second propulsion system 530B (e.g., a sprocket and track
system) are linked to the host structure 320. While the first
propulsion system 530A and a second propulsion system 530B are
shown and described, the present invention is not limited in this
regard as only one propulsion system or more than two propulsion
systems may be employed without departing from the broader aspects
of the present invention. The first propulsion system 530A and the
second propulsion system 530B are configurable into a peripheral
boundary 523 (e.g., a skin or exterior surface) of a miniaturized
size and are adapted to fit in a lumen 500 (or tissue, muscle or
fat) of a living organism, such as a human. In one embodiment, the
medical device 505 is configured to navigate in bone marrow within
a bone. In one embodiment, a retractable, removable or pivotable
member 524 (e.g., a door, window or flap) selectively covers the
opening 522. Propulsion systems 530A and 530B may be used to move
device 505 within lumen 500. Additionally, propulsion systems 530A
and 530B may be used to as orientation control device 531A and
531B. The propulsion systems can generate smaller and or finer
movements to maintain the position of the device within the lumen
500 and can be used to change the orientation of the device within
the lumen 500, tissue, muscle or fat. Controlling the orientation
of the medical device 505 within the lumen 500, tissue, muscle or
fat allows the intra-device storage system, imaging system, therapy
system, sample and data gathering system, and/or a material
dispensing system to be adjacent to a region of interest within the
lumen, tissue, muscle, bone marrow or fat.
[0156] As shown in FIG. 12B, a first power supply 540A and a second
power supply 540B are in communication (e.g., via power supply
conductors or transmission lines or channels generally designated
by the dashed lines marked 511P) with the first propulsion system
530A and the second propulsion system 530B. While the first power
supply 540A and the second power supply 540B are shown and
described as being in communication with the first propulsion
system 530A and the second propulsion system 530B, the present
invention is not limited in this regard as only one power supply or
more than two power supplies may be employed and any of the power
supplies (e.g., 530A or 530B) may be in communication with one or
more propulsion systems (e.g., 540A or 540B).
[0157] As shown in FIG. 12B, a control unit 550 is in communication
(e.g., via signal transmitting lines, wires or wireless channels,
generally designated by dashed lines marked 511S) with the first
propulsion system 530A, the second propulsion system 530B, the
first power supply 540A and the second power supply 540B. The
control unit 550 includes a computer process controller 555 that is
configured to control the first propulsion system 530A, the second
propulsion system 530B to move the host structure 520, the first
propulsion system 530A and the second propulsion system 530B in the
lumen 500 so that the host structure 520, the first propulsion
system 530A, the second propulsion system 530B and the control unit
550 are self-maneuverable within the lumen 500.
[0158] As shown in FIG. 12B, a tracking device 551, a signal
transmitter 552 and a signal receiver 553 are in communication with
the control unit 550 via signal lines 5115 for tracking and guiding
the medical device 505 within the lumen 500.
[0159] As shown in FIG. 13, in one embodiment, an interactive group
of medical devices 505 in communication with the computer processor
212.
[0160] As shown in FIG. 13, the interactive group of devices
includes two or more devices 505 that are in communication with one
another and/or an external computer-based control system. The two
or more medical devices 505 are configured to cooperate with one
another to distribute components such as power supplies, medical
devices, storage compartments and auxiliary devices among the
medical devices so that the medical devices operate together as a
group to accomplish the intended functional operations and to
enable the use of smaller sized individual medical devices 505 than
those that would otherwise not fit into the lumen. The interactive
group of medical devices 505 can be configured to operate
collectively as a swarm of a plurality of medical devices 505 to
provide additional functionality. The interactive group of medical
devices 505 includes tethering 570 or towing devices (e.g.,
winches) between medical devices to assist in propulsion of the
medical devices 505 through the lumens. Additionally, the medical
devices 505 may communicate wirelessly 565 between devices. Medical
devices 505 may communicate with a receiver or controller 580
located outside the body 290. Medical device 505 may operate like a
drone, communicating and being controlled by an operator in the
same room or in a different location from the patient. Furthermore,
when contemplating a swarm of devices, two or more controllable
medical devices 505 may be deployed. A first medical device 505 may
leave the swarm group and navigate to a region of interest. This
device 505 may perform a first task and communicate back to the
other devices in the swarm and direct a second device 505 to
navigate to the first device 505. Second device 505 may be selected
from a number of devices in the swarm because of its particular
capabilities (e.g., second device 505 may have an additional
battery, an imaging system, a therapy system, a sample and data
gathering system, and/or a material dispensing system). Second
device 505 may transfer capabilities to first device 505 or second
device 505 may perform a task related to its specific capabilities.
This serial communication and deployment of devices from the swarm
may continue until the desired procedure is completed.
[0161] As shown in FIG. 9, a post-positioning monitoring system
277A and a post-positioning alteration system 277B are each in
communication with the computer processor 212. In one embodiment,
the post-positioning monitoring system 277A is located in vivo
(e.g., inside the body 290) and another post-positioning monitoring
system 277A is located outside the body 290. It is contemplated
that in vivo post-positioning monitoring system 277A and/or the in
vivo post-positioning alteration system 227B can be placed in one
or more medical devices 505. The post-positioning monitoring
systems 277A is configured to monitor the position of the object
205 relative to the receiving surface 260F. The post-positioning
alteration system 277B is located in vivo (e.g., inside the body
290) and is configured to reposition and alter the object 205,
based upon commands received from the executable software 214.
[0162] As shown in the exemplary embodiments illustrated in FIGS.
14A-14G, the imaging system, the sensor system, the
post-positioning monitoring system and/or the post-positioning
alteration system is located in the object 205, as described
herein.
[0163] As shown in FIG. 14A, the object 205 (e.g., the medical
scaffold, implant) has a network 288A of strain gauges and force
sensors secured thereto, for measuring the fit and changes in fit
of the object 205 as a function of time. The network 288A is in
communication with the computer processor 212, for transmitting
signals and data collected by the network 288A to the computer
processor 212. It is contemplated that the network 288A of strain
gauges and force sensors is in communication with one or more of
the medical devices 505.
[0164] As shown in FIG. 14B, the object 205 (e.g., the medical
scaffold, implant) has a network 288B of pressure sensors disposed
in (e.g., embedded in) the object 205 for monitoring changes in the
external environment surrounding the object 205, such as pressures
applied to the object 205 by vertebra 205 (see FIG. 9). The network
288B is in communication with the computer processor 212, for
transmitting signals and data collected by the network 288B to the
computer processor 212. It is contemplated that the network 288B of
pressure sensors can be in communication with one or more of the
medical devices 505.
[0165] As shown in FIG. 14C, the object 205 (e.g., the medical
scaffold, implant) has a network 288C of imaging sensors (e.g., of
X-ray radiography, magnetic resonance imaging, medical
ultrasonography or ultrasound, confocal microscopy, elastography,
optical-coherence tomography, tactile imaging, thermography,
spectral imaging, and medical digital photography) disposed in
(e.g., embedded in) the object 205 for monitoring changes in the
external environment surrounding the object 205. The network 288C
is in communication with the computer processor 212, for
transmitting signals and data collected by the network 288C to the
computer processor 212. It is contemplated that the network 288C of
imaging sensors can be in communication with one or more of the
medical devices 505.
[0166] As shown in FIG. 14D, the object 205 (e.g., the medical
scaffold, implant) has a network 288D comprising wireless
communications systems (e.g., Bluetooth.RTM., 2G, 3G, 4G, 5G/wife,
or any known wireless communication system) disposed in (e.g.,
embedded in) the object 205 for communication with the computer
processor 212 and for transmitting signals and data collected by
the network 288C to the computer processor 212. It is contemplated
that the network of 288D of imaging sensors can be in communication
with one or more of the medical devices 505.
[0167] As shown in FIG. 14E, the object 205 (e.g., the medical
scaffold, implant) has a device 288E for selectively deforming the
object (e.g., expanding in the direction of the arrow D1 or
contracting in the direction of the arrow D2) disposed in (e.g.,
embedded in) the object 205 for adjusting the fit of the object 205
in the cavity 250C (see FIG. 9). The device 288E is in
communication with the computer processor 212, for transmitting
signals to the device 288E for selective deformation of the object
205. It is contemplated that the device 288E can be in
communication with one or more of the medical devices 505.
[0168] As shown in FIG. 14F, the object 205 (e.g., the medical
scaffold, implant) has a device 288F for selectively change the
hardness, composition and/or density of the object (e.g., tension
or loosen) disposed in (e.g., embedded in) the object 205 for
adjusting the fit of the object 205 in the cavity 250C (see FIG.
9). The device 288F is in communication with the computer processor
212, for transmitting signals to the device 288F for selective
changing the hardness, composition and/or density of the object
205. It is contemplated that the device 288F can be in
communication with one or more of the medical devices 505.
[0169] As shown in FIG. 14G, the object 205 (e.g., the medical
scaffold, implant) includes a module 288G configured to selectively
dissolve portions of or the entire object 205 disposed in (e.g.,
embedded in) the object 205 for adjusting the fit of the object 205
in the cavity 250C (see FIG. 9). The device 288G is in
communication with the computer processor 212, for transmitting
signals to the device 288G for the selective deformation of the
object. It is contemplated that the module 288G can be in
communication with one or more of the medical devices 505.
[0170] As shown in FIG. 14H, the object 205 includes layers D3 and
D4 that have different densities.
[0171] As discussed above, in one embodiment the printer head 242E,
the imaging system 242A, the sensor system 242B, the
post-positioning monitoring system 277A and/or the post-positioning
alteration system 277B is or are located in one or more
miniaturized medical devices 505 in an in vivo configuration, for
example as illustrated in FIGS. 12A, 12B and 13. The
post-positioning monitoring systems 277A are deployed after the
initial installation of the object 205 in the body 290 to obtain
condition parameters indicative of the fit of the object 205
relative to the receiving surfaces 260F and to transmit the
condition parameters to the computer processor 212. The executable
software analyzes the condition parameters and generates signals to
the post-positioning alternation system 277B to implement
alterations to the object 205.
[0172] As shown in FIG. 15A, in one embodiment, the medical
scaffold 205 is formed using negative techniques. For example, the
medical scaffold 205' is in vivo formed in an oversized condition
(e.g., oversized relative to the cavity 250C) in the cavity 250N
and/or in an area proximate to the cavity 250C using the printer
head 242E to inject material into the cavity 250C or the area
proximate thereto . As shown in FIG. 9, the multi-function head 295
includes a material removal system 242M (e.g., a machining system,
a scraper, a vacuum, and/or a dissolving system) disposed in one or
more openings 241A, 241B, 241C, 241D, 241E, 241F and 241G and/or in
one or more of the passages 240P. The material removal system 242M
is employed in vivo to remove material from the oversized medical
scaffold 205' to create a predetermined and properly sized medical
scaffold 205 based upon the properties of the receiving surface
260F and the areas proximate thereto, as shown in FIG. 15B. The
material removed from the oversized medical scaffold 205' is
disposed of via a suction system and/or dissolved in vivo. The
properly sized medical scaffold 205 (e.g., implant) is sized to
seat on the hard bone HB of the vertebra 220A and be spaced apart
from the soft tissue ST of the vertebra 220A, as shown in FIG. 15B.
In some embodiments, the medical scaffold 205 can be formed to a
size relative to the cavity and subsequently, the material removal
system 242M can remove one or more portions of the scaffold 205 to
create a pores or voids in scaffold 205. In some embodiments, one
or more substances can be injected into the pores or voids, for
example, a substance to promote cell adhesion and growth
surrounding the scaffold 205.
[0173] As shown in FIG. 15C, the medical scaffold 205 has a
plurality of layers 206A, 206B, 206C, 206D, 206E, 206F, 206G and
206H that are formed additively by successively applying the layers
206A, 206B, 206C, 206D, 206E, 206F, 206G and 206H to one another by
the printer head 242E in vivo or ex vivo. The layers 206A, 206B,
206C, 206D, 206E, 206F, 206G and 206H are formed axially radially,
circumferentially and combinations thereof. The number and size of
the layers 206A, 206B, 206C, 206D, 206E, 206F, 206G and 206H are
determined by the executable software 214 to create a properly
sized medical scaffold 205. The layers 206A, 206B, 206C, 206D,
206E, 206F, 206G and 206H of the material formed additively upon
one another establish a predetermined size of the medical scaffold
205 based upon the properties of the receiving surface 260F and the
areas proximate thereto.
[0174] While the medical scaffold 205 is shown and described as
being positioned between the two vertebra 220A and 220B, the
present invention is not limited in this regard as the medical
scaffold 205 may be positioned in other parts of a body, internally
or externally, including but not limited to bone, soft tissue and
ligaments.
[0175] As shown in FIGS. 16A and 16B, the object 205 is selectively
inflatable and deflatable by injecting or withdrawing a fluid
(e.g., gas, liquid or gel), respectively. A deflated object 205' is
illustrated in FIG. 16A and inflated object 205 is shown in FIG.
16B. In the inflated state, the object 205 is properly sized to fit
in a predetermined cavity, such as between two adjacent
vertebra.
[0176] As shown in FIGS. 17A and 17B the object 205 includes a
plurality of subsections or segments 205L, 205M, 205N, 205P, 205Q
and 205R that are interlocked with adjacent subsections or
segments, via an interlocking system such as latch 206 and slot 207
arrangement. One or more of the passages 240P has an assembly
system 242N therein. The assembly system 242N is configured to in
vivo assemble the segments 205L, 205M, 205N, 205P, 205Q and 205R to
one another and to lock the interlocking systems of adjacent
segments 205L, 205M, 205N, 205P, 205Q and 205R to one another. The
assembly system 242N is in communication with and receives commands
from the executable software 214 to control the assembly process.
The segments 205L, 205M, 205N, 205P, 205Q and 205R are formed in
vivo via the printer head 242E. In some embodiments, one or more of
the segments 205L, 205M, 205N, 205P, 205Q and 205R are formed ex
vivo. In some embodiments, one or more of the passages 240P has a
conveyor system 243C (see FIG. 9) arranged therein for transporting
the segments 205L, 205M, 205N, 205P, 205Q and 205R to the cavity
250C. In one embodiment, the conveyor system 243C includes a fluid
pressurization and depressurization source 243D that is in
communication with the passage 240P to transport the segments 205L,
205M, 205N, 205P, 205Q and 205R in the passage 240P to the cavity
250C, via a fluid such as a liquid or gas. Mechanical conveyor
systems (e.g., lanyards, tracks or magnetic devices) may also be
employed to transport the segments 205L, 205M, 205N, 205P, 205Q and
205R in the passage 240P to the cavity 250C.
[0177] As shown in FIG. 18 in a meniscus or other cartilage
application, the medical scaffold 205 includes a solid portion 205H
and a vascularized portion 205V that has a plurality of vascular
passages 205Q selectively formed therein.
[0178] As shown in FIG. 19A a cartilage 292 with a partial tear
292T (e.g., meniscus tear) is shown in an axial view. A medical
scaffold 205 is shown disposed in the tear 292T. As shown in FIG.
19B, the medical scaffold is shown positioned in a damaged
cartilage site. The medical scaffold 205 can be in vivo formed and
erected in the damaged site based upon prior imaging and mapping of
the damaged site. A biologically engineered substance may be
employed to promote vascularization and growth of the cartilage
292.
[0179] Referring to FIG. 19C, a ligament 297 is shown with a tear
(e.g., torn anterior cruciate ligament (ACL) or torn medial
patellofemoral ligament (MPFL)) therethrough. The medical scaffold
205 is secured to a first end 297A' of a portion of the torn
ligament and is also secured to a second end 297B' of another
portion 297B of the torn ligament 297. The medical scaffold 205
includes a tensioner 205T which urges the first torn ligament end
297A' towards a second torn ligament end 297B' to promote curing
and healing of the torn ligament. Thus, the medical scaffold 205
deforms, flexes, expands and contracts with the ligament 297. The
torn ligament 297 is cross linked with one or more adjacent health
ligaments 297 and tissue via one or more of the medical scaffolds
205. A biologically engineered substance may be employed to promote
vascularization and growth of the ligament 297.
[0180] As shown in FIG. 20, a bone 299 is shown with a fracture
299F and focal bone lesion 299L. An internal medical scaffold 2051
is in vivo deployed in the medullary cavity of the bone 299 and an
external medical scaffold 205E is deployed by surrounding the
exterior of the bone 299 and the fracture 299F. In some
embodiments, the medical scaffold 205 is employed to fuse, join or
weld the fractures 299F to one another. Another medical scaffold
205L is in vivo deployed in and around the focal bone lesion 299L.
The bone 299 is shown with bone wear surface 299W thereon. A
surface mounted medical scaffold 205W is deployed in vivo on the
wear surface 299W of the bone 299 to confirm with mapping and
imaging of the bone wear surface 299W, mating surfaces and areas
proximate thereto. The biologically engineered substance, as
described herein, is employed to promote vascularization, bone
grown and tissue growth in cooperation with the internal medical
scaffold 205I, the external medical scaffold 205E and the surface
mounted medical scaffold 205W.
[0181] As shown in FIG. 21, a nerve 291 is shown with fractured
ends 291F that define a damaged nerve site. A tubular medical
scaffold 205 is deployed around the damaged nerve site so that
portions of the nerve 291 and the fractured ends 291F are contained
within an interior area of the tubular medical scaffold 205. The
imaging system 242A and the sensor system 242B are employed to in
vivo image, measure and map the damaged nerve site and to determine
parameters for the tubular medical scaffold 205. The tubular
medical scaffold is in vivo formed around the damaged nerve site.
The biologically engineered substance, disclosed herein, is
employed, for example, by applying the biologically engineered
substance to an interior surface of the tubular medical scaffold
205 to cause the nerve to grow into the tubular medical scaffold
205 and rejoining of the fractured nerve ends 291F.
[0182] A method for performing in vivo procedures includes:
accessing the target site, for example, endoscopically, visualize
the density of materials in target site; viewing images on a
computer display; and assessing where medical scaffold can be
optimally placed. Additionally, the method includes, for example,
3D printing an object , e.g., medical scaffold, at a tissue defect,
for example, in the case of a spinal procedure, between two
vertebrae (in some embodiments, without need for additional
materials such as plates, screws and rods), where the scaffold is
customized to the patient. The procedure can use material such as
the biologically engineered substance, as disclosed herein, deploy
(e.g., flow, inject, paste) the biologically engineered substance
in and/or around medical scaffold. Optionally, the method can
further include creating voids in adjacent tissue, for example, in
the case of a spine, in the adjacent vertebra, and applying a
substance to the voids to provide additional stability. In some
embodiments, the scaffold can be created ex vivo and subsequently
implanted. In some embodiments, the method can be performed in a
single procedure.
[0183] There is disclosed herein a method for performing in vivo
procedures. The method includes providing a control unit 210 having
a computer processor 212 and a robotic arm 240 in communication
with the control unit 212. The robotic arm 240 has a casing that
has a plurality of passages 240P therein. A printer head 242E is
disposed in the opening 242E of one of the plurality of passages
240P. A imaging system 242A is disposed in the opening 214A one of
the plurality of passages 240P. A sensor system 242B is disposed in
the opening 241B of one of the plurality of passages 240P. The
computer processor 212 is in communication with the printer head
242E, the imaging system 242A and the sensor system 242B. The
computer processor 212 has executable software 214 therein which is
configured for receiving signals from the imaging system 242A and
the sensor system 242B.
[0184] The method includes in vivo measuring, via the imaging
system 242A, a cavity 250C for receiving an object 205 and to
obtain measurements of the cavity 250C. The method includes in vivo
mapping, via the imaging system 242A, a receiving surface 260F for
receiving the object 205 to obtain a surface map. The method also
includes in vivo ascertaining, via the sensor system 242B,
properties of the receiving surface 260F and areas proximate
thereto. The method includes ascertaining, via the sensor system
242B, at density, hardness and/or chemical composition of the
receiving surface 260F and areas proximate thereto. The executable
software 214 correlates the cavity measurements, the surface map
and the properties of the receiving surface 260F and areas
proximate thereto, to generate installation parameters. The method
further includes creating, via the printer head 242E, the object
205 in vivo based upon the installation parameters. The object 205
is positioned in a predetermined patient specific in vivo location,
based upon the installation parameters.
[0185] In some embodiments, the method includes providing a coating
deployment system 242C disposed in the opening 241C of one of the
plurality of passages 240P. The method includes having the coating
deployment system in vivo apply a biologically engineered substance
to object 205 and/or the receiving surface 260F. The biologically
engineered substance can include one or more of the following: (a)
a vascularization promoting substance; (b) a growth factor
substance; (c) an immune reaction deterrent substance; (d) a bone
regeneration substance; and/or a tissue regeneration substance. The
method can include disposing the biologically engineered substance
in the coating deployment system 242C; and applying the
biologically engineered substance to the object 205 and the
receiving surface 260F.
[0186] The method includes providing a curing device 242D in the
opening 241D of one of the plurality of passages 240P; and in vivo
curing and/or un-curing the object 205, via the curing device 242D,
for example using ultraviolet systems and/or laser systems.
[0187] In some embodiments, the method includes providing a
post-positioning monitoring system 277A and a post-positioning
alteration system 277B, each being in communication with the
computer processor 212. The method includes monitoring, via the
post-positioning monitoring system, 277A positions of the object
205 relative to the receiving surface 260F after in vivo placement
of the object 205. The method further includes transmitting the
positions of the object 205 to the computer processor 212;
evaluating the positions of the object 205, via the executable
software 214; and determining, via the executable software 214, the
adequacy of the positions of the object 205. The executable
software 214 generates commands to the post-positioning alteration
system 277B; and the positions of the object 205 is altered based
upon the commands.
[0188] As an example, the method can be employed for forming object
205 positioned between adjacent vertebral bodies 220A in the cavity
250C, located between the adjacent vertebral bodies 220A. In one
embodiment, the receiving surface 260F is on the adjacent vertebral
bodies 220A. In one embodiment, the method is employed for in vivo
repairing of damaged hard bone or cartilage. In one embodiment, the
method is employed for in vivo reconstruction of hard bone
comprising in vivo reshaping the hard bone by in vivo forming and
erecting the medical scaffold on a surface of the hard bone. In one
embodiment, the method is employed for in vivo repair of a damaged
ligament site, comprising imaging the damaged site and determining
parameters for a medical scaffold and in vivo forming and erecting
the medical scaffold in the damaged site such that the medical
scaffold expands and contracts with the ligament and to urge a
first torn ligament end towards a second torn ligament end. In one
embodiment, the method is employed for in vivo repair of soft
tissue. In one embodiment, the method is employed for in vivo nerve
repair.
[0189] While the systems and methods herein have been described
primarily for spinal applications, these can be applied to various
hard and soft tissue applications. Objects in hard tissue
applications can include a hard, bone-like object with an added
material to recruit bone growth, such as a biologically engineered
substance, the ability to selectively vascularize some or all of
the scaffold (for example, in meniscus applications) and the
ability to adjust the scaffold, for example via curing/uncuring at
time subsequent to deployment. Exemplary applications include: (1)
cartilage repair such as repairing a torn meniscus including
deploying a medical scaffold 205 that has cartilage-like properties
and selectively creating a vascularized portion 205V of the medical
scaffold 205 that has a plurality of vascular passages 205Q
selectively formed therein as discussed herein with reference to
FIGS. 19A and 19B; (2) bone 299 fracture 299F and/or focal bone
lesion 299L repair including the in vivo deployment of an internal
medical scaffold 2051 in the medullary cavity of the bone 299
and/or an external medical scaffold 205E surrounding the exterior
of the bone 299 and the fracture 299F and in vivo deploy another
medical scaffold 205L in and around the focal bone lesion 299L, as
shown in FIG. 20 and employing a biologically engineered substance
to promote vascularization, bone grown and tissue growth, as
described herein; (3) bone wear surface 299W reshaping (e.g., hip
or knee bone reshaping, facial bone reconstruction, nose bone
reshaping, cheek and chin bone reshaping and jaw reshaping)
including the in vivo deployment of a surface mounted medical
scaffold 205W on the surface of the bone 299 to confirm with
mapping and imaging of the bone wear surface 299W, mating surfaces
and areas proximate thereto, as shown in FIG. 20 and employing a
biologically engineered substance to promote vascularization, bone
grown and tissue growth, as described herein; (4) forming of post
sites in bone such as via drilling holes in bone for placement of
posts to be secured with a bone compatible adhesive; (5) fusing
vertebra to one another; and (6) eliminating micro-motion after
deployment of the scaffold.
[0190] Objects in soft tissue applications can be soft, for example
a structurally stable yet deformable scaffold that moves with the
adjacent anatomy, the ability to selectively vascularize some or
all of the scaffold, for example via a coating, the ability to
adjust the scaffold, for example via curing/uncuring at times
subsequent to deployment. Examples of these types of scaffolds are
shown in FIGS. 14A-14G. Exemplary applications include: (1)
ligament repair 297 of a torn ligament (e.g., torn anterior
cruciate ligament (ACL) or torn medial patellofemoral ligament
(MPFL)) wherein a medical scaffold 205 with a tensioner 205T is
secured between two ends 297A' and 297B' of the torn ligament 297
to urge the two ends 297A' and 297B' to one another to promote
healing and curing of the torn ligament, as described herein with
respect to FIG. 19C and a biologically engineered substance is
employed to promote vascularization and tissue growth to promote
rejoining of the two ends 297A' and 297B' to one another, as
described herein; (2) dermal repair including treatment of burns
and deceased skin and use of collagen based scaffolds to retain
skin elasticity and provide structural support relative to tissue
and muscle; (3) adipose repair (e.g., breast reconstruction, fat
loss reconstruction, and cancer caused tissue loss) to mitigate
tissue and bone volume loss by mapping and imaging a target area
and in vivo forming the medical scaffold 205 in a predetermined
location based upon the mapping and imaging; (4) peripheral nerve
surgery including providing an in vivo imaging system and an in
vivo printer head; imaging a damaged site of a nerve using the in
vivo imaging system to determine parameters for a tubular medical
scaffold; in vivo forming and erecting the tubular medical scaffold
around the damaged site; and employing a biologically engineered
substance, for example applying the biologically engineered
substance to an interior surface of the tubular medical scaffold to
cause the nerve to grow into the tubular medical scaffold, as
described herein with reference to FIG. 21; (5) abdominal or
scrotal hernia repair using the multifunctional robotic system 200
to form, either ex vivo or in vivo, a mesh and deploying the mesh
in the body; (6) bronchial repair procedures wherein the medical
scaffold is customized in fit and size based upon in vivo imaging
and sensing consistent with patient specific bronchial anatomy and
wherein the medical scaffold is flexible and is configured to
expand in response to a patient's coughing; and (7) real time
tracking of surgical procedures, including the use of
electromagnetic systems to track in vivo movement of the medical
scaffold and body parts connected thereto.
[0191] While the system and methods herein have been described to
printing the object in vivo, the object can also be printed ex vivo
and subsequently implanted.
[0192] Although this invention has been shown and described with
respect to the detailed embodiments thereof, it will be understood
by those of skill in the art that various changes may be made and
equivalents may be substituted for elements thereof without
departing from the scope of the invention. In addition,
modifications may be made to adapt a particular situation or
material to the teachings of the invention without departing from
the essential scope thereof. Furthermore, the embodiments disclosed
herein may be combined with one another in any combination or stand
alone. Therefore, it is intended that the invention not be limited
to the particular embodiments disclosed in the above detailed
description, but that the invention will include all embodiments
falling within the scope of the appended claims.
[0193] Although the present invention has been disclosed and
described with reference to certain embodiments thereof, it should
be noted that other variations and modifications may be made, and
it is intended that the following claims cover the variations and
modifications within the true scope of the invention.
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