U.S. patent application number 13/486934 was filed with the patent office on 2012-10-04 for surgery methods using a robotic instrument system.
This patent application is currently assigned to HANSEN MEDICAL, INC.. Invention is credited to Frederic H. Moll.
Application Number | 20120253332 13/486934 |
Document ID | / |
Family ID | 39661452 |
Filed Date | 2012-10-04 |
United States Patent
Application |
20120253332 |
Kind Code |
A1 |
Moll; Frederic H. |
October 4, 2012 |
SURGERY METHODS USING A ROBOTIC INSTRUMENT SYSTEM
Abstract
Various methods for performing various surgical procedures using
a robotic instrument system are disclosed. In one embodiment, the
method comprises advancing a guide instrument into a patient's body
and to the vicinity of a treatment area. The guide instrument may
be a robotically controlled catheter which is controlled by a
robotic catheter system. The guide instrument comprises an elongate
flexible body having a proximal end and a distal end, and an end
effector coupled to the distal end. The end effector may comprise
various devices for assisting and performing the surgical
procedure. For example, the end effector may be a clip applier, a
laser fiber, a cryo fiber, or a needle and grasper. An image
capture device may also be coupled to the distal end to assist in
positioning and operating the guide instrument.
Inventors: |
Moll; Frederic H.; (San
Francisco, CA) |
Assignee: |
HANSEN MEDICAL, INC.
Mountain View
CA
|
Family ID: |
39661452 |
Appl. No.: |
13/486934 |
Filed: |
June 1, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12024760 |
Feb 1, 2008 |
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13486934 |
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60899048 |
Feb 2, 2007 |
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60900584 |
Feb 8, 2007 |
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Current U.S.
Class: |
606/4 ;
606/130 |
Current CPC
Class: |
A61G 13/10 20130101;
A61B 2034/2051 20160201; A61B 90/361 20160201; A61B 2034/2061
20160201; A61B 34/71 20160201; A61B 90/50 20160201; A61B 2017/00261
20130101; A61B 34/30 20160201; A61B 34/20 20160201; A61G 13/101
20130101; A61B 2034/102 20160201; A61G 7/0503 20130101 |
Class at
Publication: |
606/4 ;
606/130 |
International
Class: |
A61F 9/011 20060101
A61F009/011; A61F 9/007 20060101 A61F009/007 |
Claims
1-29. (canceled)
30. A method for repairing a detached retina in a patient's eye,
comprising: providing a robotic medical instrument system
comprising a master input device, an instrument driver, a flexible
sheath, and a guide instrument coaxially coupled within a working
lumen of the flexible sheath; the instrument driver configured to
independently control movement of the guide instrument relative to
the flexible sheath; robotically extending the guide instrument out
of a distal tip of the flexible sheath and into the vitreous body
of the eye, the guide instrument comprising an elongate flexible
body having a proximal end, a distal end, an image capture device,
and an end effector coupled to the distal end; robotically
maneuvering, steering and/or rotating the guide instrument relative
to the flexible sheath while the distal end of the guide instrument
is in the vitreous of the eye; pushing the detached retina toward
the wall of the eye using the guide instrument under robotic
control; robotically positioning the end effector at the area of
the detached retina; and engaging the instrument driver to maneuver
the end effector and repair the detached retina.
31. The method of claim 30, wherein robotically positioning the end
effector comprises the instrument driver maneuvering, steering
and/or rotating the end effector relative to the guide
instrument.
32. The method of claim 31, wherein the end effector comprises a
laser fiber for applying laser energy to repair the detached
retina.
33. The method of claim 32, wherein after inserting the guide
instrument into the vitreous body of the eye through the bulbar
conjunctiva the laser fiber is robotically extended out of the
guide instrument to apply laser photocoagulation to repair the
detached retina.
34. The method of claim 33, guiding the laser fiber using an image
capture device located in the guide instrument, the image capture
device being steered and oriented in the vitreous body by the
instrument driver.
35. The method of claim 34, after applying laser photocoagulation,
using the guide instrument to inject a gas bubble into the vitreous
body to force the detached retina against the eye wall.
Description
RELATED APPLICATION DATA
[0001] The present application claims the benefit under 35 U.S.C.
.sctn.119 to U.S. Provisional Patent Application Ser. Nos.
60/899,048, filed on Feb. 2, 2007, and 60/900,584, filed on Feb. 8,
2007. The foregoing applications are hereby incorporated by
reference into the present application in their entirety.
FIELD OF INVENTION
[0002] The invention relates generally to robotically controlled
systems, such as telerobotic surgical systems, and more
particularly to a using a robotic instrument system for performing
minimally invasive surgical and other therapeutic procedures.
BACKGROUND
[0003] Robotic interventional systems and devices are well suited
for use in performing minimally invasive medical procedures, as
opposed to conventional techniques wherein the patient's body
cavity is open to permit the surgeon's hands access to internal
organs. For example, there is a need for a highly controllable yet
minimally sized system to facilitate imaging, diagnosis, and
treatment of tissues which may lie deep within a patient, and which
may be accessed transcutaneously (e.g., through a surgical port) or
via naturally-occurring pathways such as blood vessels, other
lumens, or combinations thereof.
SUMMARY OF THE INVENTION
[0004] The present invention is directed to methods of performing
various surgical procedures using robotic instrument systems. In
one embodiment, the method comprises performing a medical procedure
for repairing a detached retina in a patient's eye. The method
comprises robotically maneuvering a guide instrument into the
vitreous body of the eye. The guide instrument may be a robotically
controlled catheter which is controlled by a robotic catheter
system. The guide instrument comprises an elongate flexible body
having a proximal end and a distal end, and an end effector coupled
to the distal end. The end effector may comprise various devices
for re-attaching the retina to the sclera of the eye. For example,
the end effector may be a clip applier, a laser fiber, a cryo
fiber, or a needle and grasper. An image capture device may also be
coupled to the distal end to assist in positioning and operating
the guide instrument. The guide instrument is used to push the
detached retina toward the wall of the eye, and then the end
effector is used to re-attach the detached retina to the
sclera.
[0005] In another embodiment, a method for performing a minimally
invasive medical procedure in the thoracic cavity of a patient
and/or on the heart is provided. The method comprises advancing a
first instrument assembly to vicinity of the heart, either through
the thoracic cavity via the ribcage and around the lungs, or via
the patient's trachea to the main bronchi and through the lung into
the mediastinal or pericardial spaces. The first instrument
assembly comprises a guide instrument and a sheath instrument. The
guide instrument comprises an elongate flexible body having a
proximal end and a distal end. The sheath instrument comprises an
elongate flexible body having a working lumen therethrough. To make
up the instrument assembly, the guide instrument is inserted
through the lumen of the sheath instrument. An end effector is
coupled to the distal end of the guide instrument for performing
various functions during a procedure. For example, a needle, a
grasper, an image capture device, a patch, a plurality of needles,
among others, may be coupled to the distal end of the guide
instrument.
[0006] A second instrument assembly may also be advanced to the
same area as the first instrument assembly above, in order to
utilize both instrument assemblies in performing the surgical
procedure. The second instrument assembly may be the same or
similar to the first instrument assembly, although it may be useful
to have different end effectors to enable different of
complementary functions to the end effector of the first instrument
assembly.
[0007] As an example, the first and second instrument assemblies
may be advanced through the inferior vena cava and into the right
atrium in order to treat a patent foramen ovale (PFO), or other
intracardiac procedure.
[0008] In any of the minimally invasive procedures of the present
invention the guide instruments and instrument assemblies may be
performed using a robotic instrument system, such as a robotic
flexible catheter instrument system.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] The drawings illustrate the design and utility of
illustrated embodiments of the invention, in which similar elements
are referred to by common reference numerals. In addition, elements
having the same reference numeral but different letter identifiers
[e.g. a robotic catheter assemblies (28a and 28b)], are the same or
substantially similar elements, and may be described commonly
without the letter identifier [e.g. robotic catheter assembly
(28)].
[0010] FIG. 1A illustrates one embodiment of a robotic catheter
system;
[0011] FIG. 1B illustrates another embodiment of a robotic catheter
system;
[0012] FIGS. 2A-6B illustrate various embodiments of medical
procedures for retinal detachment repair;
[0013] FIGS. 7A-7B illustrate alternative methods for minimally
invasively accessing the thoracic cavity with one or more
robotically controlled, flexible guide instruments;
[0014] FIGS. 8A-8C illustrate additional minimally invasive
techniques for accessing the thoracic cavity, and in particular the
mediastinal or pericardial spaces;
[0015] FIGS. 9A-9C illustrate one embodiment of a method for patent
foramen ovale (PFO) closure procedure using a balloon
apparatus;
[0016] FIGS. 10A-10F illustrate one embodiment of a method for PFO
closure with a plurality of needles;
[0017] FIGS. 11A-11F illustrate another embodiment of a method for
PFO closure using a balloon apparatus;
[0018] FIG. 12A-12C illustrates one embodiment of another method
for a PFO closure procedure using a patch; and
[0019] FIGS. 13A-13F illustrate one embodiment of a method for PFO
closure with a suture.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0020] The present invention is directed to robotic catheter
systems and methods of performing various surgical procedures using
such robotic catheter systems. For example, FIGS. 1A and 1B
illustrate example of embodiments of robotic catheter systems (32)
suitable for use in performing the surgical procedures described
herein.
[0021] Referring first to FIG. 1A, one embodiment of a robotic
catheter system (32), includes an operator control station (2)
located remotely from an operating table (22), and a robotic
catheter assembly (1002). The robotic catheter assembly (1002) is
coupled to the operating table (22) by an instrument driver
mounting brace (20). The robotic catheter assembly (1002) comprises
a robotic instrument driver (16) and an instrument (18), such as a
guide instrument (18) (also referred to herein as an instrument
guide catheter, guide catheter, robotic guide instrument, robotic
guide catheter, or the like). A communication link (14) transfers
signals between the operator control station (2) and instrument
driver (16). The instrument driver mounting brace (20) of the
depicted embodiment is a relatively simple, arcuate-shaped
structural member configured to position the instrument driver (16)
above a patient (not shown) lying on the table (22).
[0022] In FIG. 1B, another embodiment of a robotic catheter system
(32) is depicted, wherein the arcuate-shaped member (20) is
replaced by a movable support assembly (26). The support assembly
(26) is configured to movably support the instrument driver (16)
above the operating table (22) in order to position the instrument
driver (16) for convenient access into desired locations relative
to a patient (not shown). The support assembly (26) in FIG. 1B is
also configured to lock the instrument driver (16) into position
once it is positioned.
[0023] The instrument (18) is typically an elongate, flexible
device configured to be inserted into a patient's body. As
non-limiting examples, an instrument (18) may comprise an
intravascular catheter, an endoscopic surgical instrument or other
medical instrument. The instrument (18) may also comprise an
instrument assembly (28) comprising a robotic guide instrument
(18), or a coaxially coupled and independently controllable robotic
sheath instrument (30) (see FIG. 44A) and a robotic guide
instrument (18), as described in the U.S. patent applications
incorporated by reference below. The instrument (18) or instrument
assembly (28) is configured to be operable via the instrument
driver (16) such that the instrument driver (16) can operate to
steer the instrument (18) or instrument assembly (28) and also to
operate tools and devices which may be provided on the instrument
assembly (18) or instrument assembly (28) (e.g. an imaging device
or cutting tool disposed on the distal end of the instrument (18)
or instrument assembly (28)). The guide instrument (18) may be
movably positioned within the working lumen of the sheath
instrument (30) to enable relative insertion of the two instruments
(30, 18), relative rotation, or "roll" of the two instruments (30,
18), and relative steering or bending of the two instruments
(30,18) relative to each other, particularly when a distal portion
of the guide instrument (18) is inserted beyond the distal tip of
the sheath instrument (30).
[0024] Alternatively, manually steerable and operable instruments
or instrument assemblies may also be utilized. Thus, all of the
technologies described herein may be utilized with manually or
robotically steerable instruments, such as those described in the
below-referenced patent application, U.S. patent application Ser.
No. 11/481,433.
[0025] Exemplary embodiments of an operator control station (2), an
instrument driver (16), an instrument (18) and instrument assembly
(28), a robotic sheath instrument (30), a robotic guide instrument
(18), and various instruments (50), are described in detail in the
following U.S. patent applications, and are incorporated herein by
reference in their entirety:
[0026] U.S. patent application Ser. Nos. 10/923,660, filed Aug. 20,
2004; 10/949,032, filed Sep. 24, 2005; 11/073,363, filed Mar. 4,
2005; 11/173,812, filed Jul. 1, 2005; 11/176,954, filed Jul. 6,
2005; 11/179,007, filed Jul. 6, 2005; 11/202,925, filed Aug. 12,
2005; 11/331,576, filed Jan. 13, 2006; U.S. Provisional Patent
Application Nos. 60/785,001, filed Mar. 22, 2006; 60/788,176, filed
Mar. 31, 2006; U.S. patent application Ser. Nos. 11/418,398, filed
May 3, 2006; 11/481,433, filed Jul. 3, 2006; 11/637,951, filed Dec.
11, 2006; 11/640,099, filed Dec. 14, 2006; and U.S. Provisional
Patent Applications Nos. 60/833,624, filed Jul. 26, 2006, and
60/835,592, filed Aug. 3, 2006.
[0027] For clarity, the sheath and guide catheter instruments
described in the exemplary embodiments below may be described as
having a single lumen/tool/end-effector, etc. However, it is
contemplated that alternative embodiment of catheter instruments
may have a plurality of lumens/tools/end-effectors/ports, etc.
Furthermore, it is contemplated that in some embodiments, multiple
catheter instruments may be delivered to a surgical site via a
single multi-lumen sheath, each of which is robotically driven and
controlled by via an instrument driver. Some of the catheter
instruments described herein are noted as flexible. It is
contemplated that different embodiments of flexible catheters may
be designed to have varying degrees of flexibility and control. For
example, one catheter embodiment may have controlled flexibility
throughout its entire length whereas another embodiment may have
little or no flexibility in a first portion and controlled
flexibility in a second portion. Similarly, different embodiments
of these catheters may be implemented with varying degrees of
freedom.
[0028] Turning now to FIGS. 2A-6B, various embodiments of medical
procedures for retinal detachment repair are illustrated. Retinal
detachment is a disorder of the eye in which the retina peels away
from its underlying layer of support tissue. The thin retina is
stuck to the inside wall of the eye by a single-cell layer of
pigment cells, called the retinal pigment epithelium (RPE). The
cavity inside the more or less spherical retina is filled with a
clear jelly, called the vitreous body. The vitreous body adheres to
the retina. A detached retina occurs when the retina is no longer
in contact with the RPE. This often occurs when the vitreous body
shrinks somewhat and pulls the retina off the RPE. When the
shrinkage of the vitreous body is uneven, traction on the retina
becomes greater in one area. This may cause a tear or rip in the
retina. Initial detachment may be localized, but without rapid
treatment the entire retina may detach, leading to vision loss and
blindness. The retinal tear opens an area of contact between the
water expressed out of the shrinking vitreous body, and the RPE.
This water tends to unglue the retina off the RPE, thus producing a
retinal detachment. The detachment of the retina deprives it from
nourishment. To restore vision, it is necessary to reattach the
retina. Retinal detachment surgical procedures include, but are not
limited to, pneumatic retinopexy, scleral buckling,
photocoagulation, cryotherapy, and vitrectomy, any of which may be
performed with the use of robotically controlled flexible sheath
(30) and/or guide instruments (18), as described herein.
[0029] Referring to FIGS. 2A-2B, a flexible guide instrument (18)
is inserted into the vitreous body of an eye through the bulbar
conjunctiva. The guide instrument (18) is maneuvered towards the
retinal detachment (999) and is used to push the retina back
towards the wall of the eye. In this embodiment, a clip applier
(804) for dispensing one or more clips (804) is disposed on the
distal tip of the guide catheter (18). Clips (805) are fired from
the clip applier (804) to fasten the retina to the sclera. In one
embodiment, the clips (805) are fabricated from resorbable material
such as polyglycolide so that the clips (805) will be metabolized
by the body over time.
[0030] Referring to FIGS. 3A-3B, a similar approach for repairing a
retinal detachment (999) is disclosed. In this embodiment, a
flexible guide instrument (18) is equipped with an image capture
device (853), an arcuate needle (5), and a grasper (802). The
flexible guide instrument (19) is inserted into the vitreous body
of an eye. The guide instrument (18) is robotically controlled to
push the area of retinal detachment (999) back against the eye
wall. Then the arcuate needle (5) and grasper (802) are used to
suture the retina to the sclera using sutures (855). The sutures
(855) of this embodiment are also fabricated from a resorbable
polyglycolide material such as Ethicon Vicryl, Spenco Polysorb, or
Syneture Dexon sutures.
[0031] Cryotherapy (freezing) and laser photocoagulation are
treatments used to create a scar/adhesion around the retinal hole
to prevent fluid from entering the hole and accumulating behind the
retina and exacerbating the retinal detachment. Cryopexy and
photocoagulation are generally interchangeable. However, cryopexy
is generally used in instances where there is a lot of fluid behind
the hole and laser retinopexy will not take. Laser photocoagulation
uses heat, in the form of laser light, and cryotherapy uses extreme
cold to seal the retina. Referring to FIGS. 4A-4B, a flexible guide
instrument (18) having an image capture device (853) and a laser
fiber (761) is inserted into the vitreous body of an eye through
the bulbar conjunctiva to perform a laser photocoagulation. The
guide instrument's (18) capability of robotic steerability allows
the surgeon to precisely orient and position the laser (761) at the
treatment location without causing undue trauma to the patient's
eye. The image capture device (853) may be used to assist in
positioning the guide instrument (18) and the laser fiber (761).
Once the laser (761) is positioned at the desired location and
orientation, the laser (761) is operated to apply laser
photocoagulation to repair the retinal hole or tear in the
retina.
[0032] Referring to FIGS. 5A-5B, a flexible guide instrument (18)
having an image capture device (853) and a cryo fiber (997) is
inserted into the vitreous body of an eye through the bulbar
conjunctiva. Again, the image capture device (853) may be used to
assist in advancing and positioning the guide instrument (18) and
the cryo fiber (997). Once the cryo fiber (997) is properly
positioned proximate the retinal detachment or tear, the cryo fiber
(997) is operated to perform a cryotherapy on a retinal hole or
tear in the retina.
[0033] Pneumatic retinopexy is a treatment method wherein a gas
bubble is injected into the vitreous cavity inside of the eye,
which forces the retina back into position. The retina usually
reattaches within several days provided that the bubble is kept in
position against the retinal detachment. The surgeon may help seal
the retina back into place against the wall of the eye with laser
photocoagulation or cryotherapy. A vitrectomy procedure involving
removal of the vitreous humor may be required for more complicated
retinal detachments. This procedure removes the vitreous jelly as
well as any scar tissue, and replaces it with a gas bubble. This
gas bubble sometimes helps push the retina back against the eye
wall.
[0034] Referring to FIGS. 6A-6B, a flexible guide instrument (18)
is inserted into the vitreous body of an eye through the bulbar
conjunctiva. In this embodiment, the flexible guide instrument (18)
is equipped with an image capture device (853) and an irrigation
port (861). The irrigation port may be used to inject a gas or
fluid into the vitreous cavity. FIG. 6B illustrates a gas bubble
(998) which has been injected by the irrigation port (861) at the
location of a retinal detachment (999) thereby holding the retina
in place against the eye wall.
[0035] Referring to FIGS. 7A-7B, alternative methods of minimally
invasively accessing the thoracic cavity with one or more
robotically controlled, flexible catheter instrument assemblies
(28) are disclosed. In FIG. 7A, a flexible catheter assembly (28)
comprising a steerable sheath (30) and guide instrument (18) are
introduced into the thoracic cavity through an intercostal
penetration. By traversing past the ribcage and around the lungs,
the catheters (18/30) may be maneuvered under the Xiphoid process
to the mediastinal or pericardial spaces, thus obtaining access to
the heart (8) or other tissue structure of interest, such as tumors
which may lie in the mediastinal space. Alternatively, a slightly
more direct access route may be utilized wherein one or more
instruments are maneuvered into the mediastinal or pericardial
space through a puncture directly adjacent the Xiphoid process.
Such techniques may be particularly useful for minimally invasive
cardiac procedures such as repair or replacement of aortic, mitral,
or other heart valves, repair of septal defects, pulmonary
thrombectomy, electrophysiological mapping and ablation, coronary
artery bypass grafting, angioplasty, atherectomy, treating
aneurysms, and resecting, biopsying, or ablating tissue structures
of interest, such as tumors which may lie in the mediastinal space.
Referring to FIG. 7B, a second flexible catheter assembly (28b)
comprising a second steerable sheath (30b) and a second guide
instrument (18b) are introduced on the left side of the patient's
thoracic cavity. The two sets of catheters (28a/28b) may be
controlled to operate together on the heart (8), lungs, or upper
gastrointestinal tract. It is further contemplated that additional
catheters may be introduced into the thoracic cavity at alternative
intercostal spaces. In alternative embodiments, catheters may be
robotically steered to the diaphragm and possibly into the
abdominal cavity.
[0036] FIGS. 8A-8C disclose additional minimally invasive
techniques for accessing the thoracic cavity, and in particular the
mediastinal or pericardial spaces. Referring to FIG. 8A, a flexible
sheath (30) is inserted down a patient's trachea to the main
bronchi. In this embodiment, the sheath (30) enters into the right
lung via the right main bronchi. By using a tissue-crossing tool
configuration, such as a needle and/or dilator, a puncture is made
through the right lung to gain access to the mediastinal or
pericardial spaces under the sternum. In this illustration, the
sheath (30) is held at about the puncture and a flexible guide
instrument (18) is inserted into the pericardial space. As shown in
FIG. 8A, the guide instrument (18) carries an ablation catheter (6)
and may be used to ablate the heart (8) or other tissue structures
of interest, such as tumors which may lie within the mediastinal or
pericardial spaces.
[0037] Referring to FIG. 8B, the example of FIG. 8A is expanded
upon and a second flexible instrument assembly (28b) comprising a
flexible steerable sheath (30b) and guide instrument (18b) is
inserted down the trachea, through the left main bronchi, and into
the left lung. As described above, a puncture is made in the left
lung to access the mediastinal or pericardial space. The second
sheath instrument (30b) is parked in the left lung as the second
guide instrument (18b) is introduced into the mediastinal or
pericardial space. In this embodiment, the first guide catheter
(18a) is equipped with an ablation catheter (6) and the second
guide catheter (18b) carries an image capture device (853) in its
central lumen. By robotically steering the two catheters (28a/28b)
about the mediastinal or pericardial spaces, various important
tissue structures, such as tumors which may lie in the mediastinal
space, or external regions of the heart (8), are accessible and a
surgeon may perform ablation, or other procedures using a variety
of end effectors, such as RF ablation end effectors, high intensity
focused ultrasound end effectors, cryo-ablation end effectors,
grasper end effectors, needle biopsy end effectors, snare or loop
biopsy end effectors, and the like, while viewing the region of
interest on a display. The embodiments described herein in
reference to FIGS. 7B and 8B, wherein two flexible instrument
platforms are advanced to the same operating environment, present
the operator with the advantage of having a surgical
"triangulation" type of spatial configuration, wherein compressive
loads, tensile loads, dissection and distraction techniques, and
the like may be performed in a similar manner as they are utilized
in conventional "two-handed" surgery.
[0038] Referring to FIG. 8C, the ablation catheter (6) of the first
guide instrument (18a) has been replaced with a first grasper (802)
and a second grasper (802) is provided adjacent the image capture
device (853) at the distal tip of the second guide instrument
(18b). Also visible in FIG. 8C are the left and right coronary
arteries. The graspers (802) may be operated together to perform a
minimally invasive coronary artery bypass surgery. Other types of
surgeries may also be performed once the thoracic cavity is
accessed via this method. Although these examples have been
illustrated with the delivery of a limited set of tools and
instruments through a catheter instrument, it is contemplated that
a plurality of other tools such as a needle, clip applier,
irrigation port, contrast agent port, illumination port, lasso
catheter, balloon, etc. may be delivered to the mediastinal or
pericardial space via a catheter instrument traversing down the
trachea and through the lungs.
[0039] As the catheter instruments (28) are retracted from the
thoracic cavity at the end of these procedures, the punctures may
be closed with a resorbable material such as a fibrin sealant or
polyglycolide sutures available from on commercially as Vicryl,
Polysorb, or Dexon sutures. Alternatively, nonabsorbable sutures or
clips may also be used in some instances.
[0040] FIGS. 9A-9C illustrate one embodiment of a method for a
patent foramen ovale (PFO) closure procedure using a balloon
apparatus. A guide instrument catheter (18) with a balloon
structure (102) is advanced up the inferior vena cava (50) to the
right atrium (9). The balloon (102) is deployed out the distal tip
of the catheter (18) and inflated in the right atrium (9). The
balloon (102) is then placed against the septal wall (64)
separating the right atrium (9) and the left atrium (10). A needle
(816) is extended through a lumen in the balloon (102) to pierce
both sides of the PFO (66) and bring them together. In one
procedure, the needle (816) is used to irritate the tissue around
the PFO (66) to encourage closure. In another instance, the needle
(816) is used to suture close the PFO (66). In yet another
embodiment, the needle (816) may be used to inject medicine into
the tissue. The needle (816) of one embodiment may be a self
closing needle that locks into place when it is ejected from the
balloon apparatus (102), thus hooking together the PFO (66).
[0041] FIGS. 10A-10F illustrate one embodiment of a method for PFO
closure with a plurality of "one shot" Nitinol needles (7). A
sheath catheter (30) travels up the inferior vena cava and passes a
guide catheter (18) into the right atrium (9). Disposed at that
distal tip of the guide catheter (18) are a plurality of harpoon
looking needles (7). In one embodiment, the needles (7) are
circumferentially arranged about the distal surface of the guide
catheter (18). When each of these needles (7) are in a ready
position on the distal surface, they are open in a linear
configuration as shown in FIG. 10C, and when released, the needles
(7) spring into a closed position as shown in FIG. 10D. The guide
catheter (18) is maneuvered up against the PFO (66) such that the
barbed ends of the needles (7) pierce through the septal wall (64)
and into the left atrium (10) at FIG. 10E. The needles (7) are
released from the distal surface of the guide catheter (18) at FIG.
10F and the guide catheter (18) back away from the PFO. Upon
release, each of the needles (7) spring into a closed position such
as that shown in FIG. 10F, thus latching together the PFO (66). In
one embodiment, each of the needles (7) are separately deployable
from the others. In another embodiment, the plurality of needles
(7) may be grouped together with a mounting ring and deployed as a
single unit.
[0042] FIGS. 11A-11F illustrate another embodiment of a method for
PFO closure using a balloon apparatus. A guide catheter (18) is
inserted into the right atrium (9) via the inferior vena cava (50).
A balloon (102) is deployed out the distal tip of the guide
catheter (18). In this embodiment, the top surface of the balloon
(102) is comprised of a detachable fibrin or polyglactin patch
(104) having a plurality of tiny barbs or hooks as shown in the
enlarged view of FIG. 11C. As the balloon (102) is inflated, the
patch (104) opens up and spreads out, as shown in the enlarged
views of FIGS. 11C and 11D. The guide catheter (18) is robotically
controlled to press the balloon (102) and the patch (104) against
the PFO (66). The barbs on the patch (104) latch onto the septal
wall (64) and cover the PFO (66) area. As the guide catheter (18)
is retracted away from the septal wall (64), the patch (104) clings
to the septal wall (64) and is detached from the balloon (102). As
a result, the balloon (102) is deflated and the patch (104) is left
in place over the PFO (66). Although a resorbable patch is
described in this example, it is also contemplated that a
nonabsorbable patch may also be used for PFO closure.
[0043] FIGS. 12A-12C illustrate one embodiment of another method
for a PFO closure procedure using a patch. A first guide catheter
(18a) with a grasper (802) and an image capture device (853) is
advanced up the inferior vena cava (50) to the right atrium (9). A
second guide catheter (18b) with another grasper (802) and an
irrigation port (861) is also advanced up the inferior vena cava
(50) to the right atrium (9). One of the graspers (802) deploys a
patch (105) fabricated from polyglycolide or fibrin. Together, the
two graspers (802) are used to position the patch (105) against the
PFO (66) and mount it into place with a clip or suture (which can
be applied using the graspers (802) or other device), or fibrin
sealant (which can be dispensed through the irrigation port
(861)).
[0044] FIGS. 13A-13F illustrate one embodiment of another method
for PFO closure using one or more sutures. In FIG. 13A, a sheath
instrument (30) and a guide instrument (18) are advanced into the
right atrium (9) to a position proximate to the septal wall (64). A
needle (5) is used to pierce the septal wall (64) at a location
above the PFO (66) in this illustration and the guide instrument
(18) is passed transseptally to the left atrium (10), as shown in
FIG. 12B. The guide instrument (18) is robotically steered into a
U-turn to face the septal wall (64) in the left atrium (10), as
shown in FIG. 12C. The septal wall (64) is pierced at a location
below the PFO (66) with a needle (5), as shown in FIG. 12C. At FIG.
12D, the guide instrument (18) is advanced back through the septal
wall (64) where the wall (64) was just pierced, such that the guide
instrument reenters the right atrium (9). Still referring to FIG.
12D, a hook, needle, or suture capture device (37) is deployed from
the lumen of the guide instrument (18). The hook (37) is maneuvered
to a suture lumen opening (39) located in the external sidewall of
the sheath instrument (30). In this implementation, a suture lumen
(33) located in the sidewall of the sheath (30) provides a conduit
through which the suture (35) may be inserted from the proximal end
of the sheath (30) and dispensed through the suture lumen opening
(39) at the distal end of the sheath (30). In another embodiment,
the suture lumen opening (39) may be located at the distal tip of
the sheath (30) or inside the sheath instrument (30). In yet
another embodiment, the suture may be deployed from a catheter
separate from the sheath (30) and the guide (18). The hook (37)
snares the suture (35). The guide instrument (18) is then retracted
back along its path back through the septal wall (64) into the left
atrium (10) and then back through the septal wall (64) again and
into the right atrium (9). As the guide instrument (18) is
retracted, the suture (35) is pulled along by the hook (37) until
the end of the suture (35) is also in the right atrium (9), as
shown in FIG. 12E. The suture (35) is pulled taut such that the PFO
(66) is closed and the suture is tied together into a knot to hold
the PFO (66) closed. In one embodiment a knot pusher may be used to
push forth a knot from the distal end of the catheter (18) to hold
the suture (35) in place. In this example, a cutter (803) is used
to cut the suture (35) and then the catheters (18/30) may be
withdrawn.
[0045] While multiple embodiments and variations of the many
aspects of the invention have been disclosed and described herein,
such disclosure is provided for purposes of illustration only. Many
combinations and permutations of the disclosed system are useful in
minimally invasive surgery, and the system is configured to be
flexible. Many combinations and permutations of the disclosed
system are useful in minimally invasive surgery, and the system is
configured to be flexible, and it should be understood that the
invention generally, as well as the specific embodiments described
herein, are not limited to the particular forms or methods
disclosed, but also cover all modifications, equivalents and
alternatives falling within the scope of the appended claims.
* * * * *