WO2004066829A2 - Endoscopic subxiphoid surgical procedures - Google Patents
Endoscopic subxiphoid surgical procedures Download PDFInfo
- Publication number
- WO2004066829A2 WO2004066829A2 PCT/US2004/000859 US2004000859W WO2004066829A2 WO 2004066829 A2 WO2004066829 A2 WO 2004066829A2 US 2004000859 W US2004000859 W US 2004000859W WO 2004066829 A2 WO2004066829 A2 WO 2004066829A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- epicardial
- tacks
- suture
- probe
- endoscopic
- Prior art date
Links
- 238000001356 surgical procedure Methods 0.000 title abstract description 13
- 210000003516 pericardium Anatomy 0.000 claims description 35
- 210000001519 tissue Anatomy 0.000 claims description 27
- 238000003780 insertion Methods 0.000 claims description 10
- 230000037431 insertion Effects 0.000 claims description 10
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- 230000003247 decreasing effect Effects 0.000 claims 1
- 230000008439 repair process Effects 0.000 abstract description 5
- 230000007423 decrease Effects 0.000 abstract description 4
- 210000004115 mitral valve Anatomy 0.000 abstract description 4
- 239000000523 sample Substances 0.000 description 139
- 238000002679 ablation Methods 0.000 description 67
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
- A61N1/057—Anchoring means; Means for fixing the head inside the heart
- A61N2001/0578—Anchoring means; Means for fixing the head inside the heart having means for removal or extraction
Definitions
- This invention relates to endoscopic surgical procedures and more
- tissue surrounding the first aspect of the present invention tissue surrounding the first aspect of the present invention.
- pulmonary vein ostia is ablated at the site in the intrapericardial space where
- the veins enter into the left atrium as a clinically recognized treatment for
- the probe enters posterior to the superior vena cava, winds
- the tract formed posterior to the superior vena cava enters into the
- one endoscopic cannula is advanced through a thoracotomy
- cannula in the right pleural cavity is used to dissect through the right medial
- endoscopic equipment including endoscope, video camera, light source, video
- intravascular repairs include
- annulus by placing such a preformed structure into the heart's venous system.
- endoscopic camiula is used to enter the pericardium from a subxiphoid
- d contains an attached light emitting diode (LED) that emits light from the tip
- the endoscopic subxiphoid cannula is used to visualize the inferior
- a light emitting clip is attached to the pericardium adjacent the
- an elongated light 'stick' can have
- the subxiphoid can be guided toward the position of the first source of light.
- endoscopic cannula is then removed from the mediastinum and inserted into
- transilluminating light from each clip guides the tissue-dissecting cannula
- Dissection is performed via a combination of blunt dissection with a fransparent tapered tip of the cannula, and dissection with the pericardial entry
- sheath starts in the right pleural cavity, tracks posterior to the superior vena
- An ablation probe is advanced along the dissected path and energy is
- two probes may be advanced along the posterior pericardial surface around
- a reflection i.e., a partition, as used herein,
- An ablation probe is laterally flexible and torsionally rigid to assure proper
- a single endoscopic camiula is used to position an
- a vacuum-assisted cannula is advanced through the
- endoscopic subxiphoid cannula for temporary vacuum-controlled attachment
- the endoscopic cannula is used to enter the pericardium from the subxiphoid
- tacks around the annulus of the mifral valve Specifically, two or more tacks
- the tacks are placed on the epicardial surface near the mitral annulus.
- the tacks are placed on the epicardial surface near the mitral annulus.
- the tacks may be placed immediately inferior to the left
- the tacks may be
- helical or spiral titanium tacks of a type, for example, similar to tacks used to
- Two or more tacks may be inserted into the myocardium, and a suture or wire sfrand may be tlireaded
- the suture or wire contains loops spaced at varying distances for looping onto
- Figure 1 is a pictorial illustration of the interior of the pericardial
- Figures 2a-d are, respectively, partial plan, end and sectional views
- Figure 3 is a pictorial illustration of the path of an ablation cannula
- Figures 4a-c are, respectively, side, bottom and end views of an
- Figure 5 is a plan view of an ablation cannula or probe in
- Figure 6 is a pictorial illusfration of the path of ablation camiulas or
- Figures 7a and 7b comprise a flow chart illustrating one surgical
- Figures 8a, 8b comprise a flow chart illustrating another surgical
- Figure 9 is a pictorial illusfration of an ablation probe and sheath
- Figure 10 is a pictorial illusfration of a configuration ofthe probe
- Figures 11a, l ib comprise a flow chart illustrating a surgical
- Figure 12 is a top anatomical sectional view illustrating a surgical
- Figure 13 is a partial anatomical illusfration of a surgical procedure
- Figure 14 is a plan view of a suction cannula in accordance with
- Figures 15a, 15b are, respectively, bottom and top views of the
- Figure 16 is a plan view of a composite structure including a
- Figure 17 is a pictorial view of a braided sheath that promotes
- Figure 18 is a partial top view of the heart showing the locations of
- Figure 19 is a partial anterior view of the heart showing the
- Figure 20a and 20b are pictorial illustrations of a knotted suture
- Figure 21 is a plan view of Figure 18 for installing the suture of
- Figure 22 is a partial top view of the heart showing the position of
- Figures 23a, 23b comprise a flow chart illustrating an embodiment
- a treatment for chronic atrial fibillation includes ablating cardiac tissue
- This treatment may be accomplished in
- an ablation probe as
- tubular sheath therefor may be initially threaded
- ablation probe may be subsequently advanced into position along the path 13
- an endoscopic camiula enters
- the endoscopic camiula is then also used to visualize the inferior vena cava and an illuminated clip or other detectable
- the jaws of the clip 27 are
- the endocopic cannula can then be
- locations 15, 17 aids in guiding a pericardial entry instrument, and in guiding
- an elongated tubular body 21 which can be rigid or flexible or
- body 21 includes an inner lumen extending therethrough between distal and
- tubular body 21 includes a manual manipulator 25 attached to the
- tubular body 21 as shown in the sectional view of Figure 2b, retains a mating
- One or more of the jaws of clip 27 may include a
- LED light-emitting diode
- controller may be housed in the manual manipulator 25 for convenient control of light made selectively available at the clip 27 that is positioned, for
- the tissue-ablating instrument includes a
- the backbone 33 includes a plurality of
- braided sheath 135, as illustrated in Figure 17, may include non-round cross
- the backbone may provide
- the supporing backbone facilitates the manipulation of the ablating instrument through the anatomy. This assures that the ablating
- instrument can be positioned and retained in continuous orientation toward or
- the distal portions of the ablation probes contain a section
- tissue-ablating energy that emits tissue-ablating energy.
- the supplied energy at various wavelengths
- Radio-frequency energy may be monopolar, that is, the
- a radio-frequency probe may also be bipolar; that is, current
- Microwave energy may be emitted from a
- microwave antenna placed in the distal probe.
- probes incorporate a transducer in the probe that converts electrical signals
- Probes may
- infrared region may also be transmitted tlirough frberoptics to heat cardiac
- a flexible sheath 31 attached to the backbone 33 may house a conduit
- the sheath may be relatively movable with respect to the backbone along a captivating track, as illustrated in Figure 4c,
- the tissue-ablating energy may then be supplied via a distributed electrical
- heater element or a distributed electrode for RF electrical energy, or an
- the sheath 33 containing one or other such tissue-ablating mechanisms may be
- ablating segment need not be longer than approximately the distance along the
- tissue-ablating segment of the instrument may be any tissue-ablating segment of the instrument.
- the tissue-ablating segment of the instrument may be any tissue-ablating segment of the instrument.
- tissue-ablating instrument may be withdrawn from the patient's body.
- tissue-ablating probe in accordance with the present invention in which a
- electrically insulating sheaths 40 may include electrically insulating sheaths 40, for example, to limit exposure
- 35b may be advanced along the posterior pericardial surface within the
- One probe 35a may be advanced along the left lateral
- transverse sinus ends near the
- the probe 35a may frack inferior to
- the second probe 35b is advanced along the right
- pericardium lies along the back of the superior vena cava, and this fold of
- pericardium separates the tips 37 of the two probes 35a, 35b.
- probes 35 a, 35b nearly touch each other, although they are separated by a
- the distal tips 37 of the probes 35a, 35b contain
- probes 35 a, 35b substantially align through the pericardial reflection 41 due to
- the magnetic bands 39 may be
- the probes 35a, 35b may be formed with resilience and a
- the probe 35a may have a preformed
- the probe is
- the probe 35a is positioned
- the probe 35a is advanced
- the probe 35a may
- sheath may also be used in combination with an inner bent stylet. Specifrcally,
- the ablation probe 35a, 35b is flexible. A variety of energy
- sources may achieve ablation of cardiac tissue; e.g. radio frequency,
- microwave, ultrasound, laser radiation, infrared illumination, and the like microwave, ultrasound, laser radiation, infrared illumination, and the like.
- the distal portions of the ablation probes contain a section that emits
- tissue-ablating energy The supplied energy at various wavelengths heats
- Radio-frequency energy may be monopolar, that is, the current
- a radio-frequency probe may also be bipolar; that is, current
- Microwave energy may be emitted from a microwave antenna placed in the distal probe.
- the emitted microwave energy may be emitted from a microwave antenna placed in the distal probe. The emitted microwave energy
- probes incorporate a transducer in the probe that converts electrical signals
- Probes may
- infrared region or from a high-energy laser may also be transmitted through
- the ablation probe is flexible and may have
- a magnetic band 39 is
- 35a, 35b may be moved in this manner to positions aligned with the common
- Helical tacks or barbs can be located at the tips 37 ofthe probes to temporarily anchor the
- the atrial tissue surrounding the four pulmonary veins i.e., the left and right
- An ablation probe may be used to
- ablation rings may be encircled separately in ablation rings.
- ablation probe is placed endoscopically, as illusfrated in the flow chart of
- the anterior pericardium is identified
- the endoscopic cannula is advanced to the lateral border of the
- a second endoscopic camiula is advanced into the right pleural
- the pericardial entry instrument may be used to grasp and enter through the pleural and pericardial layers.
- probe may be advanced from the right pleural cavity tlirough the dissected
- a grasping instrument may be advanced through the subxiphoid
- endoscopic cannula to grasp the probe and pull it into position around the
- the subxiphoid endoscopic cannula is then advanced to the
- pleura cavity is used to dissect a tract posterior to the inferior vena cava, using
- dissection may grasp the distal end of the ablation probe and pull it out through
- the ablation probe remains in the same axial orientation along its
- Torsional deflection of a portion ofthe probe may lead to ablation of
- ablation energy to the esophagus may cause perforation and/or
- an off-round cross-section (e.g., elliptical or substantially
- the flexible ablation probe has a matching cross-section to
- sleeve 135 may be constructed of plastic material (e.g., nylon, polyethylene) to
- the ablation probe uses a
- the energy may be transmitted through the microwave or ultrasonic source
- tubular sleeve into the myocardium of the heart.
- a subxiphoid incision is formed 45, and an endoscopic cannula is
- pericardial entry instrument is inserted through the endoscopic camiula to form an entry 48 tlirough the pericardium.
- the endoscopic cannula is inserted
- endoscopic cannula to clamp to the pericardium near the inferior vena cava.
- the endoscopic cannula is removed 52 from the subxiphoid incision.
- the endoscopic cannula is
- entry instrument is inserted tlirough the endoscopic camiula and used to
- Dissection 56 is conducted posterior to the inferior vena cava to
- the pericardial entry instrument is used
- Dissection 58 is
- the pericardial entry instrument is removed 59 from the endoscopic
- camiula and the ablation probe is inserted 60 tlirough the endoscopic cannula.
- the ablation probe is inserted posterior to the superior vena cava into the
- the cardiac tissue is ablated 61 along a path around the right and left pulmonary veins to form a transmural lesion along the
- the procedure includes forming a subxiphoid incision
- entry instrument is inserted 48 through a subxiphoid endoscopic cannula and
- the pericardium is then penetrated, entered with the subxiphoid
- ablation probe is inserted 63 tlirough the endoscopic cannula and into the
- the probe is advanced lateral
- transverse pericardial sinus is visualized superior to the left superior
- the endoscopic cannula is then removed 64 leaving the probe in the fransverse pericardial sinus.
- the endoscopic camiula is then
- one and other ablation probes are manipulated into close proximity 69 along
- the ablation probes are located at positions along the respective lengths of the
- the ablation probes are then activated 71 to
- a suture loop 85 attached at the distal end of the probe 81 to facilitate
- ablation probe 81 within the intrapericardial space encircling the pulmonary
- Figures 1 1a, 1 lb Initially, the patient is prepared for surgery and selective
- intubation is installed to ventilate the patient's left lung 89.
- tissue-dissecting probe or tip is inserted into the incision to dissect through the
- the ablation probe (or of the sheath therefor) is left in place in the transverse
- the pericardium is penefrated and a grasping instrument is
- the grasper 88 may now orient the tip 85 of the
- ablation probe 81 in proximity to the portion of the probe at its enfrance into
- the grasper 88 may be locked to retain the distal end and the entry position of
- the ablation probe 81 substantially in contact 107 as the sheath 83 of thermally
- insulating material is advanced over the ablation probe 81 toward the grasper
- ablation probe may then be energized, for example, by application thereto of
- epicardium 109 to create a transmural lesion in the endocardium around the
- probe 81 is removed from around the pulmonary veins, and the incisions
- vacuum-assisted suction cannula 111 including an inferior suction chamiel 1 13
- the cannula 1 11 may be flexible, steerable, articulatable, rigid,
- the proximal end of the inferior suction chamiel 113 includes a
- the distal end of the suction channel 113 includes at least one
- a suction cup 121 may be flexibly attached to the
- suction channel 113 for positioning and manipulating at selected angular
- suction cup 121 includes a suction port 123 in fluid communication with
- suction cup 121 may attach via a resilient, press-fit flange 125 onto the distal
- an ablation probe for example, as previously
- the suction cup 121 in a bodily organ such as the heart.
- the suction cup 121 is a suction cup 121
- suction cannula 111 slidably disposed within the instilment channel 133 of
- the resilient suction cup 121 may be
- assisted contact for example, with the pericardium in or about the apex area of
- the suction cup 121 may be re-coiled or re-wrapped about
- FIG. IS there is shown the mifral valve 139 and its annulus
- the present invention can be used to change the size of the mifral valve
- One potential tack placement 143 is located inferior to the left
- placement 145 is located inferior to the coronary sinus in the posterior aspect
- Figure 19 shows an anterior view of the heart, showing
- a conventional tack applier e.g., the TACKER previously available from Origin
- pericardium is performed by the pericardial enty instilment that is inserted 61
- pericardium is penefrated 157, as previously described herein, in the anterior
- suture or wire 147 is prepared 163 for tensioning of the epicardium by
- the tack applier is then removed, and an endoscopic grasper is used to apply
- Two loops are fomied in a sfrand 147 of
- each loop may be tl ⁇ eaded tl ⁇ ough an axially rigid tube 153.
- one loop may be placed on an inserted
- vascular clips 155 are placed (step 167 of Figure 23b) at the base of
- Figure 22 shows the anterior tack 143 and a posterior tack 145 in
- a suture loop extends around the posterior tack 145 and the loop is
- Vascular clips 155 are placed on the suture tails adjacent the respective
- slipknots 149, 151 and the suture tails are then trimmed short to complete the
- a band or belt may
- tacks 143, 145 to facilitate segmented tensioning of sutures or bands or belts
- cl ⁇ onic afrial fibrillation is greatly facilitated by a tissue-ablating probe, or
- probes, of the present invention inserted along a tissue-dissected path and
- oriented instilments facilitate temporary attachment of an elongated body
- subxiphoid access to the intrapericardial space facilitates placing epicardial
Abstract
Endoscopic subxiphoid surgical procedures provide intrapericardial access for placement of epicardial tacks about the annulus of the mitral valve for supporting a tensioned suture or band that decreases the size of the mitral annulus to repair a regurgitative mitral valve.
Description
ENDOSCOPIC SUBXIPHOID SURGICAL PROCEDURES
Field of the Invention:
[0001] This invention relates to endoscopic surgical procedures and more
particularly to epicardial ablation of atrial tissue to treat chronic atrial
fibrillation, and to surgical instruments and access procedures for surrounding
the pulmonary veins at their sites of entry into the left atrium as targeted for
tissue ablation, or for installing epicardial tacks and tensioning the epicardium
between tacks to correct mitral valve regurgitation due to annular dilation.
Background of the Invention:
[0002] In one aspect ofthe present invention, tissue surrounding the
pulmonary vein ostia is ablated at the site in the intrapericardial space where
the veins enter into the left atrium as a clinically recognized treatment for
chronic atrial fibrillation. Cardiac surgeons have been entering the chest
through a standard sternotomy, dissecting a tract under the superior vena cava
and the inferior vena cava, and threading an ablation probe around the four
pulmonary veins. The probe enters posterior to the superior vena cava, winds
through the transverse sinus of the pericardium, loops around the four
pulmonary veins, and exits the tract that was dissected posterior to the inferior
vena cava. The tract formed posterior to the superior vena cava enters into the
transverse sinus of the pericardium. The tract fomied posterior to the inferior
vena cava completes the path of the ablation probe around the pulmonary
veins.
[0003] In order to perform the above described probe placement
endoscopically, one endoscopic cannula is advanced through a thoracotomy
incision, or other entry incision, into the intrapericardial space adjacent the
superior vena cava, and a second endoscopic cannula is inserted into the right
pleural cavity via another thoracotomy incision. This latter endoscopic
cannula in the right pleural cavity is used to dissect through the right medial
pleura and the pericardium posterior to the superior vena cava, guided by
transillumination light emitted by the other endoscopic cannula.
[0004] This technique uses two endoscopes, and two full sets of
endoscopic equipment, including endoscope, video camera, light source, video
monitor and light cable. The physical space occupied by two sets of
endoscopic equipment is cumbersome in the operating room, and the expense
is prohibitive to hospitals. Therefore, it is desirable to perform the procedure
using one set of endoscopic equipment and one endoscopic cannula.
[0005] In other types of surgical procedures, various operative techniques
have been suggested for repairing regurgitant mih-al valves, including surgical
placement of a closed or open ring at the mitral annulus to correct a dilated
annulus causing regurgitation through the valve. A "bowtie" stitch placed
across the mitral orifice may reform a large orifice into two smaller openings
and decrease mitral regurgitation. Alternatively, intravascular repairs include
insertion of a stent or spring into the coronary sinus to reshape the mitral
annulus by placing such a preformed structure into the heart's venous system.
Summary of the Invention:
[0006] In accordance with one embodiment of the present invention an
endoscopic camiula is used to enter the pericardium from a subxiphoid
approach, visualize the superior vena cava, and place an illuminated clip on the
pericardium adjacent the superior vena cava. The clip, as shown in Figures 2a-
d, contains an attached light emitting diode (LED) that emits light from the tip
of the clip. The endoscopic subxiphoid cannula is used to visualize the inferior
vena cava, and a light emitting clip is attached to the pericardium adjacent the
inferior vena cava. In another embodiment, an elongated light 'stick' can have
a distal end positioned adjacent the inferior vena cava, and a second endoscope
can be guided toward the position of the first source of light. The subxiphoid
endoscopic cannula is then removed from the mediastinum and inserted into
the right pleural cavity through a small thoracotomy incision. The
transilluminating light from each clip guides the tissue-dissecting cannula
during dissection under the superior and inferior vena cava, respectively.
Dissection is performed via a combination of blunt dissection with a
fransparent tapered tip of the cannula, and dissection with the pericardial entry
instalment.
[0007] Following dissection posterior to the inferior vena cava and
dissection posterior to the superior vena cava, a flexible elongated probe or a
flexible tubular sheath is used to encircle the pulmonary veins. The probe or
sheath starts in the right pleural cavity, tracks posterior to the superior vena
cava, then tracks along the transverse sinus superior to the right and left
superior pulmonary veins, then inferior to the left and right inferior pulmonary
veins, and posterior to the inferior vena cava, back out into the right pleural
cavity. An ablation probe is advanced along the dissected path and energy is
applied to ablate atrial tissue surrounding the pulmonary veins.
[0008] In accordance with another embodiment of the present invention,
two probes may be advanced along the posterior pericardial surface around
different courses to substantially encircle the four pulmonary veins, with the
tips of the probes separated by a reflection (i.e., a partition, as used herein,
fomied of dense tissue) of the pericardium along the back ofthe superior vena
cava, and by a pericardial reflection between the right inferior pulmonary vein
and the inferior vena cava. The two probes nearly touch each other, separated
by the pericardial reflections, in substantial encirclement of the pulmonary
veins, and magnetic tips and bands are disposed on the probes to aid in
aligning the probes on the opposite sides of the pericardial reflections. An
ablation probe is laterally flexible and torsionally rigid to assure proper
orientation of applied tissue-ablatmg energy relative to cardiac tissue along the
encircling path around the pulmonary veins. In another procedure according
to the present invention, a single endoscopic camiula is used to position an
ablation probe around the right and left pulmonary veins via right inter-costal
thoracotomy and subxiphoid incisions. In still another procedure according to
the present invention, a vacuum-assisted cannula is advanced through the
endoscopic subxiphoid cannula for temporary vacuum-controlled attachment
to the epicardial surface of the heart.
[0009] In accordance with another embodiment of the present invention,
the endoscopic cannula is used to enter the pericardium from the subxiphoid
approach to attach epicardial tacks and to tension the epicardium between
tacks around the annulus of the mifral valve. Specifically, two or more tacks
are placed on the epicardial surface near the mitral annulus. The tacks are
connected by a suture or wire that may be tensioned to alter the shape and size
of the annulus. The tacks may be placed immediately inferior to the left
circumflex arteiy, in the area corresponding to the anterior aspect of the mifral
annulus, and immediately inferior to the coronary sinus, in the area
corresponding to the posterior aspect ofthe mifral annulus. The tacks may be
helical or spiral titanium tacks of a type, for example, similar to tacks used to
fixate prosthetic mesh in laparoscopic hernia repair. Two or more tacks may
be inserted into the myocardium, and a suture or wire sfrand may be tlireaded
through the portion of the tacks that is not embedded into the myocardium.
The suture or wire contains loops spaced at varying distances for looping onto
the tacks to adjust the amount of tension between the tacks. Tensioning the
epicardium in this manner decreases the size of the mifral annulus and corrects
the regurgitation due to annular dilation.
Brief Description of the Drawings:
[0010] Figure 1 is a pictorial illustration of the interior of the pericardial
sac (anterior view, heart removed);
[0011] Figures 2a-d are, respectively, partial plan, end and sectional views
of an endoscopic probe in accordance with one embodiment of the present
invention;
[0012] Figure 3 is a pictorial illustration of the path of an ablation cannula
or probe within the intrapericardial space in the illustration of Figure 1 ;
[0013] Figures 4a-c are, respectively, side, bottom and end views of an
ablation probe in accordance with one embodiment of the present invention;
[0014] Figure 5 is a plan view of an ablation cannula or probe in
accordance with another embodiment of the present invention;
[0015] Figure 6 is a pictorial illusfration of the path of ablation camiulas or
probes within the intrapericardial space in the illusfration of Figure 1 achieved
with probes of the embodiment illustrated in Figure 5;
[0016] Figures 7a and 7b comprise a flow chart illustrating one surgical
procedure according to the present invention;
[0017] Figures 8a, 8b comprise a flow chart illustrating another surgical
procedure according to the present invention;
[0018] Figure 9 is a pictorial illusfration of an ablation probe and sheath
according to one embodiment of the present invention;
[0019] Figure 10 is a pictorial illusfration of a configuration ofthe probe
according to Figure 9 following a surgical procedure according to the present
invention;
[0020] Figures 11a, l ib comprise a flow chart illustrating a surgical
procedure according to one embodiment ofthe present invention;
[0021] Figure 12 is a top anatomical sectional view illustrating a surgical
procedure according to the present invention;
[0022] Figure 13 is a partial anatomical illusfration of a surgical procedure
according to the present invention;
[0023] Figure 14 is a plan view of a suction cannula in accordance with
one embodiment of the present invention;
[0024] Figures 15a, 15b are, respectively, bottom and top views of the
suction pod of Figure 14;
[0025] Figure 16 is a plan view of a composite structure including a
vacuum-assisted cannula slidably disposed within the endoscopic cannula;
[0026] Figure 17 is a pictorial view of a braided sheath that promotes
torsional rigidity for properly orienting an ablation probe;
[0027] Figure 18 is a partial top view of the heart showing the locations of
epicardial tacks placed according to one embodiment of the surgical
procedures of the present invention;
[0028] Figure 19 is a partial anterior view of the heart showing the
placement in the epicardium of the anterior tack in accordance with the present
invention;
[0029] Figure 20a and 20b are pictorial illustrations of a knotted suture and
apparatus for positioning and tensioiiing the suture between epicardial tacks in
accordance with the present invention;
[0030] Figure 21 is a plan view of Figure 18 for installing the suture of
Figures 20a, 20b between epicardial tacks;
[0031] Figure 22 is a partial top view of the heart showing the position of
the suture loop between epicardial tacks; and
[0032] Figures 23a, 23b comprise a flow chart illustrating an embodiment
of the surgical procedure in accordance with the present invention.
Detailed Description of the Invention:
[0033] Referring now to Figure 1 , there is shown an anterior view of the
interior of the pericardial sac (with the heart removed) that indicates the spatial
orientations of various vessels including the right and left pulmonary veins 9,
1 1. A treatment for chronic atrial fibillation includes ablating cardiac tissue
encircling the pulmonary veins 9, 11. This treatment may be accomplished in
accordance with the present invention using an endoscopic camiula or probe
via subxiphoid and thoracotomy access. Specifically, an ablation probe, as
later described herein, or a tubular sheath therefor may be initially threaded
around the pulmonary veins along a path 13 as indicated in Figure 3, and the
ablation probe may be subsequently advanced into position along the path 13
through the tubular sheath. In one embodiment, an endoscopic camiula enters
the pericardium from a subxiphoid incision along a dissected channel in order
to visualize the superior vena cava and place an illuminating clip, as later
described herein, at a location 15 on the pericardium adjacent the superior
vena cava. Of course, other detectable energy sources or elements may also be
positioned in an end effector such as a scissor-like structure including blades
or jaws or other effector elements, or in a distal-end illuminator in place of an
illuminated chip, using detectable sources such as infrared, ultrasound,
fluoroscopy, and the like. The endoscopic camiula is then also used to
visualize the inferior vena cava and an illuminated clip or other detectable
energy source is then also attached to the pericardium at a location 17 adjacent
the inferior vena cava. Once in a desired position, the jaws of the clip 27 are
closed on pericardial tissue, for example, by sliding the shaft 23 and manual
manipulator 25 backward relative to the tubular body 21. The dimensions of
the illuminated clip 27, including the tubular body 21 and the manipulator 25,
are smaller than the cross sectional dimensions of the instrument channel of
the subxiphoid endoscopic cannula, which can therefore be removed from the
body while leaving the illuminated clip in place. Similarly, if a fiber optic
cable is attached to the clip, the smaller dimensions of the fiber optic cable and
clip allow removal of subxiphoid endoscopic cannula while leaving the clip in
place to be illuminated by subsequent attachment of a light source to the
proximal end of the fiber optic cable. The endocopic cannula can then be
removed from the mediastinum following attachment of the clip for insertion
of the endoscopic camiula (or insertion by another endoscopic cannula) into
the right pleural cavity through a small thoracotomy incision. The light from
each clip, or other detectable energy source, as discussed above, at the
locations 15, 17 aids in guiding a pericardial entry instrument, and in guiding
an endoscopic cannula with a transparent tapered tip during blunt tissue
dissection under the superior and inferior vena cava along the path 13, 19
within the intrapericardial space, as shown in Figure 3.
[0034] Referring now to the views in Figures 2a-d of an illuminated clip,
there is shown an elongated tubular body 21 which can be rigid or flexible or
malleable or otherwise adjustable, articulateable or steerable. The tubular
body 21 includes an inner lumen extending therethrough between distal and
proximal ends thereof. An inner shaft 23, which can have the physical
characteristics described above for body 21 , is slidable within the lumen in the
tubular body 21 , and includes a manual manipulator 25 attached to the
proximal end and a clip 27 with resilient jaws or other suitable attachment
mechanism such as barbs disposed in attached or detachable configuration to
the distal end of the shaft 23. A square, or other non-rotational shape of the
tubular body 21 , as shown in the sectional view of Figure 2b, retains a mating
shape of clip 27 in proper alignments with slots 29 that are oriented to
facilitate expansion of the jaws of clip 27 toward an open configuration. As
the shaft 23 and manual manipulator 25 and clip 27 slide forward relative to
tubular body 21, the jaws of the clip resiliently extend into the open
configuration, as shown. One or more of the jaws of clip 27 may include a
light-emitting diode (LED) 26 as a light source for fransluminating the surgical
site through the pericardium to which the jaws may attach. Of course, other
light sources such as point-to-point cabling of optical fibers from a remote
light source to the jaws of clip 27 may also be used, and a switch 24 or other
controller may be housed in the manual manipulator 25 for convenient control
of light made selectively available at the clip 27 that is positioned, for
example, in the manner as previously described.
[0035] Referring now to Figures 4a-c, there is shown an embodiment of a
tissue-ablating instrument or probe according to one embodiment of the
present invention that can be inserted in the dissected channel through tissue
(or in the insertion tube therefor) along the path 13, 19 within the
intrapericardial space. Specifically, the tissue-ablating instrument includes a
flexible or steerable or articulatable guide or sheath 31 and an articulated
backbone 33 attached to the sheath 31 along a selected length of the
instrument. In one embodiment, the backbone 33 includes a plurality of
successive segments 33 that are each pimied 32 or hinged together in iterative
tongue 34 and groove 30 array, as illusfrated in Figures 4a, 4b, 4c, to provide
lateral flexibility with torsional and longitudinal rigidity. Alternatively, a
braided sheath 135, as illustrated in Figure 17, may include non-round cross
section to facilitate retaining an ablation probe of similar non-round mating
shape in proper axially angular orientation during slidable positioning along
the length of the sheath. In other embodiments, the backbone may provide
telescoping confrol of length and/or torsional control in conventional manner
to facilitate twisting all or part of the length thereof into confomial orientation
against cardiac tissue. Also, these forms of control over the mechanical
characteristics ofthe supporing backbone facilitate the manipulation of the
ablating instrument through the anatomy. This assures that the ablating
instrument can be positioned and retained in continuous orientation toward or
against cardiac tissue along the path 13, 19 anterior to the posterior
pericardium for proper application of tissue-ablating energy only to the cardiac
tissue. For example, the distal portions of the ablation probes contain a section
that emits tissue-ablating energy. The supplied energy at various wavelengths
heats cardiac tissue. Radio-frequency energy may be monopolar, that is, the
current supplied via the probe travels tlirough the patient's body to a cutaneous
grounding pad. A radio-frequency probe may also be bipolar; that is, current
travels between two spaced conductor bands on the probe. There may be
multiple spaced bands disposed on the probe to promote current conduction
between adjacent bands. Microwave energy may be emitted from a
microwave antenna placed in the distal probe. The emitted microwave energy
may heat tissue in proximity to the antenna, in contrast to radio frequency
probes which must make contact with tissue to cause heating. Ultrasound
probes incorporate a transducer in the probe that converts electrical signals
into ultrasonic energy that vibrates cells in tissue to generate heat. Probes may
contain fiberoptic cables to cany laser light to tissue for heating. Light in the
infrared region may also be transmitted tlirough frberoptics to heat cardiac
tissue. A flexible sheath 31 attached to the backbone 33 may house a conduit
for tissue ablating-energy, and the sheath may be relatively movable with
respect to the backbone along a captivating track, as illustrated in Figure 4c,
for enhanced ability to manipulate the ablating instrument into proper position.
The tissue-ablating energy may then be supplied via a distributed electrical
heater element, or a distributed electrode for RF electrical energy, or an
infrared conduit, or a microwave instrument in conventional manner (see, for
example, U.S. Patent No. 6,383,182).
[0036] In the configuration of the instrument, as illusfrated in Figures 4a-c,
the sheath 33 containing one or other such tissue-ablating mechanisms may be
positioned as previously described and oriented toward cardiac tissue within
the intrapericardial space along the entire path 13, 19. The active, tissue-
ablating segment need not be longer than approximately the distance along the
portion of the path 13, 19 of insertion around the set of four pulmonary veins.
Alternatively, the tissue-ablating segment of the instrument may be
substantially shorter than the path 13, 19 around the pulmonary veins and may
be applied serially along the path 13, 19 to ablate tissue along the entire path.
Following application of tissue-ablating energy along the path 13, 19, the
tissue-ablating instrument may be withdrawn from the patient's body.
[0037] Referring now to Figure 5, there is shown another embodiment of a
tissue-ablating probe in accordance with the present invention in which a
flexible elongated body 35, for example, as illustrated and described above
with reference to Figures 4a-c, also includes magnetic components 37, 39 at
the distal end and at a location proximal the distal end for selectively
positioning a pair of such tissue-ablating probes along paths, as shown in
Figure 6. Portions of the ablation probes 35 proximal the magnetic bands 39
may include electrically insulating sheaths 40, for example, to limit exposure
of cardiac tissue to RF energy only along the portions of the probes 35
intermediate the tips 37 and bands 39. It is desirable to conduct the tissue-
ablating procedure from the subxiphoid access site to avoid multiple incisions
in a patient's chest, either as thoracotomy incisions or thoracoscopic incisions.
[0038] Therefore, to encircle the pulmonary veins within the
intrapericardial space, as shown in Figure 6, two tissue-ablating probes 35a,
35b may be advanced along the posterior pericardial surface within the
intrapericardial space. One probe 35a may be advanced along the left lateral
aspect of the pericardium, frack superior to the left superior pulmonary vein,
and enter the transverse pericardial sinus. The transverse sinus ends near the
right superior pulmonary vein. Inferiorly, the probe 35a may frack inferior to
the left inferior pulmonary vein, transversely across the oblique pericardial
sinus toward the right inferior pulmonary vein, where the probe encounters a
pericardial reflection 41 extending between the right inferior pulmonary vein
and the inferior vena cava. The second probe 35b is advanced along the right
lateral aspect of the pericardium, tracking lateral to the inferior vena cava,
right inferior pulmonary vein, and right superior pulmonary vein. The probe
35b fracks superior to the right superior pulmonary vein, until its tip rests close
to the tip of the probe 35a in the transverse sinus. A reflection 43 of the
pericardium lies along the back of the superior vena cava, and this fold of
pericardium separates the tips 37 of the two probes 35a, 35b.
[0039] In order to form a substantially continuous ring of ablated tissue
surrounding the pulmonary veins, it is desirable to have the tips 37 of the
probes 35 a, 35b nearly touch each other, although they are separated by a
pericardial reflection 43. The distal tips 37 of the probes 35a, 35b contain
magnets of opposite polarity to cause the probes to align themselves via
magnetic attraction on opposite sides of the pericardial reflection 43 that
separates the tips 37. Additionally, the magnetic bands 39 on the ablating
probes 35 a, 35b substantially align through the pericardial reflection 41 due to
the attractive magnetic forces involved. The magnetic bands 39 may be
adjusted along the lengths ofthe probes 35a, 35b to accommodate the patient's
anatomy in positioning the magnets properly in close proximity.
[0040] The probes 35a, 35b may be formed with resilience and a
predetermined bend, and be retained in sfraightened-out configuration by a
rigid outer sheath that facilitates positioning the probe around comers and into
the transverse sinus. For example, the probe 35a may have a preformed
ninety-degree bend several centimeters proximal to its distal tip. The probe is
inserted tlirough a straight, rigid cannula, and advanced through the operating
channel of the endoscopic subxiphoid cannula. The probe 35a is positioned
superior to the left superior pulmonary vein, and the camiula refracted to allow
the probe to bend and enter the transverse sinus. The probe 35a is advanced
further and frilly into the transverse sinus. Alternatively, the probe 35a may
have an inner lumen that accepts a bent stylet which is inserted into the probe
whenever a bend in the probe is desired. A relatively rigid, straight outer
sheath may also be used in combination with an inner bent stylet. Specifrcally,
as the bent stylet, which is initially retracted out of the probe 35 a, is advanced
distally into the probe 35a, the portion of the probe 35a that lies distal to the
rigid, straight outer sheath will take the shape of the bent stylet.
[0041] The ablation probe 35a, 35b is flexible. A variety of energy
sources may achieve ablation of cardiac tissue; e.g. radio frequency,
microwave, ultrasound, laser radiation, infrared illumination, and the like. For
example, the distal portions of the ablation probes contain a section that emits
tissue-ablating energy. The supplied energy at various wavelengths heats
cardiac tissue. Radio-frequency energy may be monopolar, that is, the current
supplied via the probe travels through the patient's body to a cutaneous
grounding pad. A radio-frequency probe may also be bipolar; that is, current
fravels between two spaced apart conductor bands on the probe. There may be
multiple spaced bands disposed on the probe to promote current conduction
between adjacent bands. Microwave energy may be emitted from a
microwave antenna placed in the distal probe. The emitted microwave energy
may heat tissue in proximity to the antenna, in contrast to radio frequency
probes which must make contact with tissue to cause heating. Ultrasound
probes incorporate a transducer in the probe that converts electrical signals
into ultrasonic energy that vibrates cells in tissue to generate heat. Probes may
contain fiberoptic cables to carry laser light to tissue for heating. Light in the
infrared region or from a high-energy laser may also be transmitted through
frberoptics to heat cardiac tissue. The ablation probe is flexible and may have
various controllable mechanical characteristics, for example, as previously
described herein with reference to Figures 4a-c. In another embodiment, as
illustrated and later described herein with reference to Figure 17, a braided
structure forms the length of the probe body 35. A magnetic band 39 is
selectively located at axial positions along the probe as desired, for example,
by using a pair of endoscopic graspers inserted tlirough an instrument channel
in the subxiphoid endoscopic cannula to slide the band 39 along the probe to a
selected position, as shown in Figure 5. The magnetic band 39 on each probe
35a, 35b may be moved in this manner to positions aligned with the common
site directly under the right inferior pulmonary vein to magnetically draw the
probes together across the pericardial reflection between the right inferior
pulmonary vein and the inferior vena cava, as shown in Figure 6. Helical tacks
or barbs can be located at the tips 37 ofthe probes to temporarily anchor the
probes at the location 43 adjacent the pericardial reflection.
[0042] In the treatment of chronic atrial fibrillation, it is desirable to ablate
the atrial tissue surrounding the four pulmonary veins (i.e., the left and right
superior and inferior pulmonary veins). An ablation probe may be used to
ablate the atrial tissue surrounding all four pulmonary veins in a single circle.
Alternatively, the two left pulmonary veins and the two right pulmonary veins
may be encircled separately in ablation rings.
[0043] In accordance with one embodiment of the present invention, an
ablation probe is placed endoscopically, as illusfrated in the flow chart of
Figures 7a and 7b. Specifrcally, using an endoscopic cardiac access camiula,
inserted tlirough a subxiphoid incision, the anterior pericardium is identified
and entered. The endoscopic cannula is advanced to the lateral border of the
superior vena cava within the pericardium. A small, 2 cm incision is made in
the right chest, at approximately the 5th intercostal space and the anterior
axillary line. A second endoscopic camiula is advanced into the right pleural
cavity to dissect the tracts posterior to the superior and inferior vena cavae. A
light source supplying the endoscopic camiula in the right pleural cavity may
be dimmed or extinguished to allow light from the subxiphoid endoscopic
cannula to fransilluminate through the pericardial and pleural layers to mark
the correct spot for vena caval dissection. The pericardial entry instrument
may be used to grasp and enter through the pleural and pericardial layers.
Following dissection of a tract posterior to the superior vena cava, the ablation
probe may be advanced from the right pleural cavity tlirough the dissected
tract into the transverse pericardial sinus and lateral to the left pulmonary
veins. A grasping instrument may be advanced through the subxiphoid
endoscopic cannula to grasp the probe and pull it into position around the
pulmonary veins. The subxiphoid endoscopic cannula is then advanced to the
lateral border of the inferior vena cava, and the endoscopic cannula in the right
pleura cavity is used to dissect a tract posterior to the inferior vena cava, using
the frarisilluminated light from the subxiphoid endoscopic cannula to pinpoint
the location of the dissection tract. Following dissection of the tract posterior
to the inferior vena cava, the pericardial entry instrument used for the
dissection may grasp the distal end of the ablation probe and pull it out through
the dissected tract to complete enrichment of all four pulmonary veins.
[0044] The ablation probe remains in the same axial orientation along its
length. Torsional deflection of a portion ofthe probe may lead to ablation of
unintended tissue adjacent the left atrium; for example the esophagus.
Application of ablation energy to the esophagus may cause perforation and/or
necrosis of the esophagus, with subsequent leakage, scaning and stricture. If a
flexible ablation probe is used for the procedure, prior insertion of a rion-
torsional sleeve posterior to the vena cavae and around the pulmonary veins
may prevent twisting of the ablation lead. A tubular sleeve 135, as illusfrated
in Figure 17, may contain a braided support in its wall that maintains axial
alignment of the sleeve along its flexible length. The tubular sleeve 135
contains an off-round cross-section, (e.g., elliptical or substantially
rectangular) and the flexible ablation probe has a matching cross-section to
prevent the probe from twisting out of axial alignment as it is advanced
through the length of the non-torsional tubular sleeve 135. Manipulation with
the endoscopic instruments of the separate sleeve 135 through the dissected
tracts and around the pulmonary veins is desirable to prevent injury to the
ablation probe from the pulling and grasping movements exerted during
encirclement of the pulmonary veins. The braided support in the tubular
sleeve 135 may be constructed of plastic material (e.g., nylon, polyethylene) to
allow transmission of ablation energy through the wall of the tubular sleeve
without significant absorption ofthe energy. If the ablation probe uses a
microwave or ultrasonic source, the energy may be transmitted through the
tubular sleeve into the myocardium of the heart.
[0045] More specifrcally, the flow chart of Figures 7a and 7b illustrates a
surgical procedure in accordance with one embodiment of the present
invention. A subxiphoid incision is formed 45, and an endoscopic cannula is
advanced 47 through the incision and mediastinum toward the pericardium. A
pericardial entry instrument is inserted through the endoscopic camiula to form
an entry 48 tlirough the pericardium. The endoscopic cannula is inserted
tlπough the entry in the pericardium 49. An illumination source is inserted
tlirough the endoscopic cannula to attach 50 to the pericardium near the
superior vena cava. A second illumination is inserted 51 tlirough the
endoscopic cannula to clamp to the pericardium near the inferior vena cava.
The endoscopic cannula is removed 52 from the subxiphoid incision. An
intercostal incision is made 53 in the right chest. The endoscopic cannula is
advanced 54 through the incision into the right chest cavity. The pericardial
entry instrument is inserted tlirough the endoscopic camiula and used to
penetrate the right pleura 55 near the illumination source adjacent the inferior
vena cava. Dissection 56 is conducted posterior to the inferior vena cava to
reach the intrapericardial space. The pericardial entry instrument is used
through the endoscopic camiula to penetrate the right pleura 57 near the
illumination source adjacent the superior vena cava. Dissection 58 is
conducted posterior to the superior vena cava to reach the tranverse pericardial
sinus. The pericardial entry instrument is removed 59 from the endoscopic
camiula and the ablation probe is inserted 60 tlirough the endoscopic cannula.
The ablation probe is inserted posterior to the superior vena cava into the
intrapericardial space in the transverse pericardial sinus, along a path
encircling the right and left pulmonary veins, and posterior to the inferior vena
cava out into the right chest. The cardiac tissue is ablated 61 along a path
around the right and left pulmonary veins to form a transmural lesion along the
path.
[0046] Refening now to Figures 8a, 8b, there is shown a flow chart
illustrating another surgical procedure in accordance with an embodiment of
the present invention. The procedure includes forming a subxiphoid incision
45 and advancing a subxiphoid endoscopic cannula through the incision
toward the pericardium 47, in a mariner as previously described. A pericardial
entry instrument is inserted 48 through a subxiphoid endoscopic cannula and
advanced into contact with the pericardium at a location near its anterior apical
region. The pericardium is then penetrated, entered with the subxiphoid
endoscopic cannula, and the entry instilment is removed from the body. An
ablation probe is inserted 63 tlirough the endoscopic cannula and into the
intrapericardial space along one path around the left pulmonary veins and
laterally along the fransverse pericardial sinus. The probe is advanced lateral
to the left inferior and left superior pulmonary veins. The opening to the
transverse pericardial sinus is visualized superior to the left superior
pulmonary vein, through the endoscopic cannula. The probe is advanced into
the opening to the transverse pericardial sinus, and is pushed frirther to the end
of the sinus. The tip of this ablation probe extends to the pericardial reflection
adjacent the superior vena cava, corresponding to the end of the fransverse
pericardial sinus. The endoscopic cannula is then removed 64 leaving the
probe in the fransverse pericardial sinus. The endoscopic camiula is then
reinserted through the same subxiphoid incision and same pericardial opening
for insertion therethrough of another ablation probe 65 along another path
lateral to the inferior vena cava.
[0047] The tips of these ablation probes substantially align 67 on opposite
sides of the pericardial reflection adjacent the superior vena cava as a result of
magnetic attraction between oppositely-poled magnetic tips. In addition, the
one and other ablation probes are manipulated into close proximity 69 along
their lengths on opposite sides of the pericardial reflection between the right
inferior pulmonary vein and the inferior vena cava. Magnetic bands on each of
the ablation probes are located at positions along the respective lengths of the
ablation probes to magnetically attract into substantial alignment 70 on
opposite sides of the pericardial reflection between the right pulmonary vein
and the inferior vena cava. With the associated tips and bands of the ablation
probes aligned in close proximity, the ablation probes are then activated 71 to
apply tissue-ablating energy to cardiac tissue along the substantially
continuous encircling path thus formed by the two ablation probes.
[0048] Referring now to Figure 9, there is shown an ablation probe 81 that
is slidable within an insertion sheath 83, and that is laterally flexible at least in
one direction but that is torsionally and longitudinally rigid, for example,
attributable to a backing structure of tongue and groove segments that are
successively pimied or hinged together, as illusfrated and described herein with
reference to Figures 4a, 4b. In this embodiment, the ablation probe 81
includes a suture loop 85 attached at the distal end of the probe 81 to facilitate
gripping and pulling of the probe for placement along a path 87 substantially
encircling the pulmonary vein ostia, as illusfrated in Figure 10. To position the
ablation probe 81 within the intrapericardial space encircling the pulmonary
vein ostia, a surgical procedure is performed as illusfrated in the flow chart of
Figures 1 1a, 1 lb. Initially, the patient is prepared for surgery and selective
intubation is installed to ventilate the patient's left lung 89. The patient's right
lung is deflated and a small right thoracotomy incision is performed 91 on the
fourth intercostal space approximately mid-clavicular to the anterior axillary
line, as shown on Figures 12 and 13. An endoscopic cannula equipped with a
tissue-dissecting probe or tip is inserted into the incision to dissect through the
pleura 93 bordering the right mediastinum and posterior to the superior vena
cava in preparation for entering the transverse pericardial sinus. The ablation
probe (or a sheath therefor) is inserted 95 tlirough a working channel in the
endoscopic cannula and into the transverse pericardial sinus. A distal end of
the ablation probe (or of the sheath therefor) is left in place in the transverse
pericardial sinus as the endoscopic camiula is removed 97 back through the
dissected channel, leaving the ablation probe (or sheath therefor) in place.
[0049] Then, a small incision is fomied in the subxiphoid area and tissue is
bluntly dissected to expose the linea alba. An incision is made in the linea alba
in order to advance 99 the endoscopic camiula posterior to the sternum toward
the pericardium. The pericardium is penefrated and a grasping instrument is
inserted tlirough the working channel in the endoscopic cannula and into the
infra-pericardial space to grasp the loop 85 on the distal tip of the ablation
probe 81 and pull the probe laterally around the left pulmonary veins 101 to a
level below the left inferior pulmonary vein.
[0050] The loop 85 on the tip ofthe ablation probe 81 is then grasped and
pulled across the oblique pericardial sinus toward the right border of the
pericardium, anterior to the inferior vena cava, and then upwardly lateral to the
right pulmonary veins toward the ablation probe at its enfrance into the
transverse pericardial sinus. The grasper 88 may now orient the tip 85 of the
ablation probe 81 in proximity to the portion of the probe at its enfrance into
the fransverse pericardial sinus in a configuration, as illusfrated in Figure 10.
The grasper 88 may be locked to retain the distal end and the entry position of
the ablation probe 81 substantially in contact 107 as the sheath 83 of thermally
insulating material is advanced over the ablation probe 81 toward the grasper
to thermally shield the portion of the ablation probe 81 that extends from the
grasper 88 toward the intercostal incision 91. With the ablation probe 81
encircling the left and right pulmonary veins substantially as shown in Figure
10 and oriented toward cardiac tissue within the infrapericardial space, the
ablation probe may then be energized, for example, by application thereto of
RF or microwave electrical signal or other tissue-ablating energy, to ablate the
epicardium 109 to create a transmural lesion in the endocardium around the
pulmonary veins. Thereafter, the grasper 88 is unlocked and the ablation
probe 81 is removed from around the pulmonary veins, and the incisions
performed during the surgical procedure are sutured.
[0051] Refening now to Figure 14, there is shown a plan view of a
vacuum-assisted suction cannula 111 including an inferior suction chamiel 1 13
and a superior instrument channel 1 15 aligned therewith substantially over the
entire length ofthe inferior suction channel 113 between distal and proximal
ends thereof. The cannula 1 11 may be flexible, steerable, articulatable, rigid,
twistable or have other desirable mechanical characteristics that facilitate
manipulation of an ablation probe, as previously described herein.
Specifically, the proximal end of the inferior suction chamiel 113 includes a
hose connection 117 for attachment to a vacuum supply, and a manually-
confrollable suction valve 119 for selectively altering the pressure differential
relative to ambient pressure within the suction chamiel 113.
[0052] The distal end of the suction channel 113 includes at least one
flexible, resilient suction cup 121 disposed with a central axis thereof
substantially orthogonal to the elongated axis of the suction channel 113. In an
alternative embodiment, a suction cup 121 may be flexibly attached to the
suction channel 113 for positioning and manipulating at selected angular
orientations relative to an elongated axis of the cannula 111.
[0053] As illusfrated in the bottom view of Figure 15a, the interior recess
of the suction cup 121 includes a suction port 123 in fluid communication with
the suction channel 113. Also, as shown in the top view of Figure 15b, the
suction cup 121 may attach via a resilient, press-fit flange 125 onto the distal
end of the inferior suction chamiel 113. The superior instilment channel 115
is illustrated in Figure 15b as overlaying the flange 125, for example, to
slidably support therein an ablation probe, for example, as previously
described herein or an elongated, flexible needle 127 capable of delivering
medications, injecting undifferentiated cells, installing electrical conductors, or
the like, in a bodily organ such as the heart. Alternatively, the suction cup 121
may be attached via flexible coupling to the suction channel 113 and in fluid
communication therewith to facilitate temporary suction attachment ofthe
instilment to an organ such as the heart at any convenient angle of approach.
[0054] Refening now to Figure 16, there is shown a plan view ofthe
assembled endoscopic cannula 131 and suction cannula 1 11 of Figure 14, with
the suction cannula 111 slidably disposed within the instilment channel 133 of
the endoscopic cannula. Specifically, the resilient suction cup 121 may be
curled or wrapped about the axis of the inferior suction chamiel 113 for
slidable passage tlirough the instilment channel 133. The resilient suction cup
121, once extended distally outside the instilment channel, resiliently expands
to the undeformed cup shape to provide a large contact area of vacuum-
assisted contact, for example, with the pericardium in or about the apex area of
a patient's heart. The suction cup 121 may be re-coiled or re-wrapped about
the axis of the inferior suction channel 113 for return to the instilment chamiel
133 ofthe subxiphoid endoscopic cannula in response to withdrawal or
retraction of the inferior and superior channels 113, 1 15 back through the
instilment chamiel 133, and in response to the peripheral edges of the suction
cup 121 coming into contact with the angled distal edge of the instilment
channel 133.
Mitral Valve Treatment
[0055] Refening now to the partial or cut-away top view of a human heart
illustrated in Figure IS, there is shown the mifral valve 139 and its annulus
141. The present invention can be used to change the size of the mifral valve
annulus by placing tacks and tightening bands endoscopically on the exterior
of the heart. One potential tack placement 143 is located inferior to the left
circumflex artery in the anterior aspect of the mitral annulus, and another tack
placement 145 is located inferior to the coronary sinus in the posterior aspect
of the mifral annulus. Figure 19 shows an anterior view of the heart, showing
the tack 143 located inferior to the left circumflex coronary artery. A
conventional tack applier (e.g., the TACKER previously available from Origin
Medsystems, Inc., or the PROTACK available from U.S. Surgical) may be
infroduced tlirough the endoscopic subxiphoid camiula, as previously
described herein, for example, with reference to steps 45, 47 and 61 of Figure
8a as illustrated in the flow chart of Figures 23a, 23b, entry through the
pericardium is performed by the pericardial enty instilment that is inserted 61
via the operating channel of the endoscopic subxiphoid cannula and the
pericardium is penefrated 157, as previously described herein, in the anterior
pericardial surface near the apex of the heart. Following pericardial enty, the
pericardial enty instrument is removed, and the tack applier shaft is advanced
159 tlπough the operating channel ofthe endoscopic subxiphoid cannula to
apply tacks 161 at the locations 143, 145 shown in Figures 23a, 23b. A looped
suture or wire 147 is prepared 163 for tensioning of the epicardium by
placement 165 onto the tacks, and by applying the desired amount of tension.
The tack applier is then removed, and an endoscopic grasper is used to apply
the looped suture or wire sfrand 147 to the epicardial tacks 143, 145.
[0056] Refening also to Figures 20a and 20b, there is shown an
embodiment of a tension suture. Two loops are fomied in a sfrand 147 of
suture, with a slipknot 149, 151 formed at the base of each loop. The free end
of each loop may be tlπeaded tlπough an axially rigid tube 153. The tube 153
functions as a knot pusher to close down on each loop, thereby shortening the
distance between the two loops. In use, one loop may be placed on an inserted
tack 143 and tightened down. The second loop is placed on the second tack
145 and the tail on the second loop is pulled through the tube 153 to shorten
the loop and apply tension between the two tacks. At the desired amount of
tension, vascular clips 155 are placed (step 167 of Figure 23b) at the base of
each suture tail to prevent the slipknots 149, 151 from slipping, thereby
preserving the tension between the tacks 143, 145.
[0057] Figure 22 shows the anterior tack 143 and a posterior tack 145 in
place with a length of suture 147 looped and tightened down on the anterior-
tack 143. A suture loop extends around the posterior tack 145 and the loop is
tightened down and drawn toward the anterior tack 143 to the desired tension.
Vascular clips 155 are placed on the suture tails adjacent the respective
slipknots 149, 151 and the suture tails are then trimmed short to complete the
mifral valvular repair.
[0058] In other embodiments ofthe present invention, a band or belt may
be tensioned between anterior and posterior tacks 143, 145 to avoid cutting
into the epicardium. Also, additional tacks may be installed in the epicardium
at locations about the mitral annulus intermediate the anterior and posterior-
tacks 143, 145 to facilitate segmented tensioning of sutures or bands or belts
from tack to tack about the mifral annulus. Thereafter, the instilments are
removed from the body and the subxiphoid incision is closed 171 to complete
the procedure.
[0059] Therefore, ablation of cardiac tissue within the intrapericardial
space substantially surrounding the four pulmonary veins as a treatment for
clπonic afrial fibrillation is greatly facilitated by a tissue-ablating probe, or
probes, of the present invention inserted along a tissue-dissected path and
manipulated through an endoscopic cannula that is infroduced along a
dissected working chamiel from a subxiphoid or intercostal incision. Suction-
oriented instilments facilitate temporary attachment of an elongated body
having a working channel therethrough to implement surgical procedures on
the suction-attached organ at precise locations thereon, hi addition, the
subxiphoid access to the intrapericardial space facilitates placing epicardial
tacks about the annulus of the mifral valve for tensioning the epicardium
between tacks to decrease the size of the mitral valve amiulus as a repair of a
regurgitant valve.
Claims
1. Surgical apparatus for installing a tension element on epicardial
tissue exposed through an aperture in a patient's pericardium, the apparatis
comprising:
a tacking instilment configured for insertion through an endoscopic
cannula and through the aperture in the pericardium for installing a plural
number of epicardial tacks at selected locations in the epicardial tissue to
support the element in tension between at least a pair of the plural number of
tacks.
2. The surgical apparatus according to claim 1 in which the tacking
instilment is configured to install one epicardial tack at a region of the mifral
amiulus below the circumflex coronaiy arteiy, and another epicardial tack at a
region of the mitral amiulus below the coronary sinus.
3. The surgical apparatis according to claim 1 in which the element
includes a sfrand attached to each of the installed epicardial tacks in tension
therebetween.
4. The surgical apparatus according to claim 3 in which the sfrand is a
suture.
5. The surgical apparatus according to claim 3 in which the sfrand is a
band or belt.
6. The surgical apparatis according to claim 1 in which the tension
element includes a suture with a pair of loops fomied with slip knots having
trailing suture ends at spaced locations along the length of the suture, with one
of the pair of loops of the suture positioned about one ofthe plural number of
installed epicardial tacks, and with another of the pair of loops of the suture
positioned about another of the plural number of installed epicardial tacks, the
trailing sutire ends being manipulable to tension the suture between the pair of
loops disposed about the installed epicardial tacks.
7. The surgical apparatus according to claim 6 including an elongated
hollow tube disposed along a frailing sutire end from a slip knot for
engagement thereof with a distal end ofthe tube to facilitate pulling on the
trailing sutire end relative to the tibe for selectively decreasing a suture loop
about an installed epicardial tack.
8. The surgical apparatus according to claim 2 in which the tacking
instilment is configured to install an additional number of epicardial tacks
intermediate said one and another tacks to support elements in tension between
at least pairs of the number of installed epicardial tacks.
9. The surgical apparatus according to claim 6 including clips attached to
the frailing suture ends to inhibit slip thereof through the knots.
10. The surgical apparatis according to claim 9 including a clip-applying
instilment configured for insertion through the endoscopic camiula to attach a
clip to a trailing suture end adjacent the corresponding slipknot.
11. The surgical apparatus according to claim 10 including an instilment
configured to trim the frailing sutire end remote from the clip attached thereto.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/346,663 US7264587B2 (en) | 1999-08-10 | 2003-01-17 | Endoscopic subxiphoid surgical procedures |
US10/346,663 | 2003-01-17 | ||
US10/369,980 US7288096B2 (en) | 2003-01-17 | 2003-02-18 | Apparatus for placement of cardiac defibrillator and pacer |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2004066829A2 true WO2004066829A2 (en) | 2004-08-12 |
WO2004066829A3 WO2004066829A3 (en) | 2005-08-18 |
Family
ID=34840889
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2004/000859 WO2004066829A2 (en) | 2003-01-17 | 2004-01-13 | Endoscopic subxiphoid surgical procedures |
Country Status (2)
Country | Link |
---|---|
US (2) | US7288096B2 (en) |
WO (1) | WO2004066829A2 (en) |
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US7972265B1 (en) | 1998-06-22 | 2011-07-05 | Maquet Cardiovascular, Llc | Device and method for remote vessel ligation |
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US8986335B2 (en) | 1998-08-12 | 2015-03-24 | Maquet Cardiovascular Llc | Tissue dissector apparatus and method |
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US9775930B2 (en) | 2006-11-17 | 2017-10-03 | Abbott Cardiovascular Systems Inc. | Composition for modifying myocardial infarction expansion |
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US10888689B2 (en) | 2008-10-01 | 2021-01-12 | Covidien Lp | Endoscopic ultrasound-guided biliary access system |
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Also Published As
Publication number | Publication date |
---|---|
WO2004066829A3 (en) | 2005-08-18 |
US20040143284A1 (en) | 2004-07-22 |
US20060116746A1 (en) | 2006-06-01 |
US7288096B2 (en) | 2007-10-30 |
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