WO2008024261A2 - Image-guided therapy of the fossa ovalis and septal defects - Google Patents

Image-guided therapy of the fossa ovalis and septal defects Download PDF

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Publication number
WO2008024261A2
WO2008024261A2 PCT/US2007/018143 US2007018143W WO2008024261A2 WO 2008024261 A2 WO2008024261 A2 WO 2008024261A2 US 2007018143 W US2007018143 W US 2007018143W WO 2008024261 A2 WO2008024261 A2 WO 2008024261A2
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Prior art keywords
fossa ovalis
pfo
catheter
sheath
defect
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PCT/US2007/018143
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French (fr)
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WO2008024261A3 (en
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David C. Amundson
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Cardio-Optics, Inc
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Publication of WO2008024261A3 publication Critical patent/WO2008024261A3/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
    • A61B5/0086—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters using infrared radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy

Definitions

  • the fossa ovalis In the heart there exists a structure called the fossa ovalis on the septal wall of the atrium, which, in the pre-natal state, permits transfer of blood between the left and right hearts. At birth, the fossa ovalis is usually closed and the heart functions in a normal manner with the right heart pumping blood into the lungs and returned to the left heart. In about 10-15% of the patients, however, the fossa ovalis remains partly open, creating a condition known as preforamen ovale, or PFO. In this situation, blood flows between the right and left atria of the heart.
  • PFO patients have a much higher incidence of stroke since thrombi from the leg veins, instead of being filtered by the lungs, can transfer directly from the right to left atria where it can travel to the brain causing a stroke. This condition has also been associated with the presence of migraine headaches.
  • ASD's or VSD's also need to be repaired with patches or umbrella systems either surgically or percutaneously using a catheter containing an expandable patch or umbrella system.
  • PFO's if a catheter is used for device employment, the effectiveness of the closure is assessed by observing bubbles crossing the ASD or VSD on ICE.
  • the fossa ovalis is also involved in another procedure, called transeptal puncture, in which it is punctured to gain access to the left atrium for various procedures such as catheter ablation, such as the pulmonary vein procedure.
  • transeptal puncture in which it is punctured to gain access to the left atrium for various procedures such as catheter ablation, such as the pulmonary vein procedure.
  • the principle means of puncturing the fossa ovalis is using a Brockenbrough needle assembly. In this approach, a usually metallic sheath is inserted, and guided by fluoroscopy or ICE, the sheath is placed against the fossa ovalis.
  • an ICE catheter is also inserted in the right atrium and positioned so that the ultrasonic energy is in the direction of the fossa ovalis.
  • a so-called "tenting" effect is observed on the ultrasonic image. Since the fossa ovalis is thinner then the septum and shaped as a roughly two-centimeter oval, correct apposition of the sheath against the fossa ovalis is imaged ultrasonically as an increased indentation over about two centimeters. It is so named because it is similar to the appearance of the top of a circular tent.
  • a stylet with a sharp distal end is inserted through the metallic sheath to puncture the fossa ovalis and gain access to the left atrium.
  • Other methods of fossa ovalis puncture include applying radiofrequency energy to an electrode on the distal end or screwing through the fossa ovalis using a stylet with a screw at the distal end.
  • Fluoroscopy only provides a silhouette of the sheath without imaging the fossa ovalis.
  • ICE imaging only infers the fossa ovalis or septal defect from its different elastic characteristics as compared to the septal wall while applying pressure on the sheath.
  • an infrared wavelength in low-absorptive wavelength regions provides direct images of structures, through flowing blood to about two centimeters in an 80 deg field of view, much like an endoscope. It permits the fossa ovalis or septal defect to be seen directly at distances ranging ' from
  • the characteristic fossa ovalis oval-shape can be imaged and the endoscope can be advanced/retracted to provide a close up or far. away view of the fossa ovalis or septal defect.
  • a main teaching of this patent is means and methods of combining the therapeutic tools to close defects in the fossa ovalis or septal defect or to puncture the fossa ovalis with an infrared endoscope.
  • an infrared endoscope contains a channel for the PFO or septal defect closure device.
  • This can be either a two-lumen sheath with channels for an infrared endoscope and the PFO septal defect closure device, or a sheath incorporating the infrared endoscope with a channel for the PFO septal defect closure device.
  • Either implementation is referred to as a sheath with the infrared endoscope (SIE) 1
  • SIE infrared endoscope
  • the SIE is routed from a vein in the groin to the right atrium, until the fossa ovalis is clearly imaged.
  • the SIE is then advanced toward the fossa ovalis to inspect its rim.
  • PFO' s septal defects appear as flaps on the oval border.
  • the site of the opening will appear on the infrared image as flaps (likely for PFO 's) or a clear hole.
  • the PFO septal defect closure device With the SEE positioned into the hole, the PFO septal defect closure device can be advanced and the outer umbrella deployed.
  • the SDS is then retracted to image the hole in the fossa ovalis or septal defect and the inner umbrella.
  • the SIE is retracted to image the entire PFO septal defect closure device to assure complete PFO or septal defect closure.
  • PFO or septal defect closure devices besides the dual-umbrella "clamshell" approach may also be inserted through the therapeutic channel of the SIE. Since the fossa ovalis is imaged directly, a number of more advanced PFO closure devices are possible but require direct imaging of the fossa ovalis hole or flaps as provided by the SEE. Moreover, imaging the fossa ovalis or septal defect permits stabilizing tools such as an extendable flat plate or grasper to stabilize the fossa ovalis during the PFO closure procedure which permits more precise techniques, such as suturing or stapling.
  • infrared imaging permits direct closure techniques using suture, staples, electricity, applied heat or chemical/biological materials. Since infrared imaging allows the hole or defect to be imaged in relation to therapeutic tools, device-less, direct closure becomes possible.
  • a third lumen in the sheath could introduce a stabilizing element in the form of a flat plate or grasper device. A stabilizer would permit the defect edges to be apposed for a long enough time to execute the defect closing therapy, such as percutaneous suturing.
  • Direct closure means include:
  • Suture A percutaneous suture device, which sutures tissue together to close the PFO or septal defect. Suturing is highly advantageous for PFO 's which frequently consists of two flaps in close apposition which open and close.
  • Stapler A percutaneous stapling device, which staples tissue together to close the PFO or septal defect. Stapling is highly advantageous for PFO 's, which frequently consists of two flaps in close apposition, which open and close.
  • Adhesive Bonding A catheter, which applies tissue-adhering adhesive to close the PFO or septal defect. "Gluing" is highly advantageous for PFO 's, which frequently consists of two flaps in close apposition, which open and close.
  • a catheter which applies biological material, which grows over the fossa ovalis or septal defect opening to close the PFO or septal defect.
  • Stem cells seeded onto the fossa ovalis or septal defect which produces hole-covering tissue, such as collagen
  • a catheter which applies electrical (such as bipolar radiofrequency energy), to close the PFO or septal defect
  • the sheath is either a two-lumen sheath with channels for an infrared endoscope and the transeptal puncture device, or a sheath incorporating the infrared endoscope, with a channel for the transeptal puncture device. Either implementation is referred to as a sheath with the infrared endoscope (SIE).
  • SIE infrared endoscope
  • the SIE is routed from a vein in the groin to the right atrium, until the fossa ovalis is clearly imaged.
  • the transeptal puncture device is then advanced toward the fossa ovalis, guided by infrared imaging.
  • a transeptal puncture is performed.
  • the SIE is advanced over the transeptal puncture device and into the left atrium to assist in left-heart procedures, such as pulmonary vein isolation.
  • the transeptal puncture device can be any transeptal device including a Brockenbrough needle puncture assembly, a radiofrequency puncture device or other devices employing heating and a transeptal crossing device employing a screw, which is rotated through the septum. Infrared imaging permits conclusive identification of the fossa ovalis. It also permits the real-time observation of the transeptal crossing.
  • a further advantage of an infrared-guided transeptal device is that about 10-15% of patients have a defect If this defect is imaged, the sheath can be advanced towards the opening. Since the sheath contains the infrared endoscope, the sheath can be manipulated into the defect under infrared-imaging guidance. This permits navigation of the sheath through the defect and into the left atrium. Navigating through the fossa ovalis opening, without transeptal puncture, would reduce procedure time and complications for this minority group of patients.
  • Figures 1 A drawing of a bi-lumen catheter where the infrared catheter in inserted into one port and the PFO-septal defect closure device in the second port.
  • a tri-lumen catheter with channels for the infrared endoscope, suture/stapling device and tissue-stabilizing device is provided.
  • Figure 1 shows a two-lumen sheath (1) out of which are two ports (2,3). Out of one port (2), the infrared endoscope (4) can be advanced/retracted. Out of the other (3) port a device (5) similar to the CardioSEAL NMT is advanced/retracted and is shown with the two umbrella elements (6) deployed.
  • FIG. 2 shows a sheath (7) which contains an indwelling infrared endoscope (9) and a working channel (8) out of which a Closing a PFO or septal defect is a device (5) similar to the CardioSEAL NMT is advanced/retracted and is shown with the two umbrella elements (6) deployed. Either configuration can be used for infrared endoscopic guidance of PFO/septal defect closure.
  • a PFO is closed.
  • PFO 's consist of flaps at the fossa ovalis rim which open and close in synchrony with the heart beat.
  • the sheath containing the infrared endoscope and PFO/septal defect closure device are positioned so that the PFO/septal defect closure device is in its minimized position with the umbrellas collapsed and positioned inside the working channel lumen.
  • the bi-lumen sheath (Fig 1, 1) is inserted in a vein in the groin and routed to the mid right atrium.
  • the fossa ovalis is then imaged and the opening in the fossa ovalis localized.
  • the PFO closure device is then advanced towards the defect in the PFO under infrared imaging guidance.
  • the PFO closure device is then advanced through the opening in the fossa ovalis and the first balloon is activated and placed on the left atrial septal wall and blocking the fossa ovalis flap/hole.
  • the PFO closure device is then retracted so that the second umbrella can be applied on the right atrial septal wall of the PFO and positioned to block the fossa ovalis flap/hole.
  • FIG 3 shows a tri-lumen sheath (10) where a port is now available for a stabilizer (11).
  • the stabilizer element is a device, which can be inserted/placed on the PFO opening to stabilize the defect from heart beat motion. It could take the form of a flat plate, like the stabilizers used in minimum invasive surgery (MIS) or the stabilizer could be a device, which grips the tissue to keep it stationary. Such a stabilizer could be used in dual-umbrella closure techniques as shown in Figure 2.
  • MIS minimum invasive surgery
  • FIG. 3 shows instead of a dual-umbrella system a suturing catheter (12).
  • the suturing catheter permits the flap-defect in the fossa ovalis to be sutured together. In suturing or stapling, it is important to isolate the flap-defect from heart motion to be able to execute the suturing procedure.
  • the suturing system consists of long sutures running to the proximal end of the catheter, where the physician controls the suturing procedure from actions on the proximal end of the catheter.
  • the stabilizer (11) catheter is advanced into the flap-defect in the fossa ovalis, where it "pinches" the flaps together.
  • the suturing catheter is then advanced to the flap-defect and sutures the flap s together while being held together by the pincher stabilizer:
  • the result is PFO closure without the need for implanting a medical device.
  • the PFO could be stapled together to achieve the same result.
  • a catheter which applies biological material, which grows over the fossa ovalis or septal defect opening to close the PFO or septal defect.
  • Biological material such as collagen or other membraneous material is placed on the flaps or defect, where it gradually grows over the PFO.
  • stem cell seeding of cells near the opening which develop into a surface-covering like collagen
  • Photochemical Bonding A catheter, which applies a photochemical and then irradiates it with visible light to activate the photochemical to close the PFO or. septal defect.
  • the photochemical is first applied on the flap surfaces, following by irradiation at a visible or infrared wavelength by the infrared endoscope to activate the photochemical resulting in bonding of the flaps.
  • a grasping stabilization tool would be used for defect boundary apposition.
  • Ultrasonic Bonding A catheter, which applies ultrasonic energy to close the PFO or septal defect through heat generation caused by rapid movement of the ultrasonic transducer.
  • a grasping stabilization tool would be used for defect boundary apposition.
  • a bi-lumen or tri-lumen catheter if stabilization is needed or a sheath with integral infrared imaging is employed.
  • tri-lumen sheath Figure 3
  • the suturing catheter (12) is replaced by a catheter incorporating one of the bonding techniques mentioned above. •
  • the flaps are pinchd together by the stabilizing element (i 1) and the catheter incorporating the bonding method is advanced and applied to the pinched tissue.
  • septal defect repair can use the same methodology described above for PFO closure.
  • Septal defects are different from PFO's in that a hole is usually present rather then opening flaps. If the hole can be positioned by the stabilizer element, so that the hole boundaries can be joined, all of the methodologies above can be employed. If this is not possible, a patch can be used which can be sutured/stapled onto the septal defect to effect closure and create a greater surface area coveragfe of the septal defect.
  • a Dacron patch could be positioned to cover the septal defect under infrared imaging guidance and a suturing mechanism is employed to stitch the periphery of the patch.
  • the infrared imaging is useful in assessing procedure success.
  • the infrared catheter examines the repaired portion of the fossa/septal defect and looks for gaps in the bonded section. If some are found, they are "touched up" with a second application of the bonding catheter.
  • Figure 4 shows a bi-lumen sheath with (1) with one port (2) containing a Brockenbrough transeptal puncture device (14) whose needle (15) Has been pushed against.the fossa ovalis (16).
  • the other port (2) contains an infrared imaging catheter (4).
  • the fossa ovalis is imaged by the infrared endoscope.
  • the Brockenbrough transeptal puncture device is advanced until the needle is clearly imaged touching the fossa ovalis near the center.
  • the needle is advanced to puncture the fossa ovalis.
  • the Brockeribrough needle and sheath is first advanced to the left atrium, followed by the bi-lumen sheath.
  • SIE infrared image guided transeptal puncture using the sheath with an infrared endoscope
  • direct imaging of the fossa ovalis and septal defects permits a number of therapeutic approaches for either the opening or closing of the fossa ovalis and for the closing of septal defects.
  • the therapeutic procedure is imaged under direct, real-time infrared imaging. Imaging in other directions other than straight ahead is also possible with the use of a prism or mirror. For example, imaging out the side of the catheter is created with a 90 deg prism/mirror. This is useful in transeptal puncture where the catheter could be directed and anchored into the ventricle or IVC and the side-viewing window in the direction of the fossa ovalis.
  • Guidewires might also be deployed for the purpose of anchoring the sheath in a cardiac vein/artery/valve.
  • the sheath may also be manipulated by robotic control such as the magnetic system manufactured by Stereotaxis or the pulley system manufactured by Hansen Medical or other robotic control systems.

Abstract

The invention relates to direct imaging of the fossa ovalis and septal defects for the purpose of providing therapeutic approaches for either the opening or the closing of the fossa ovalis and for the closing of septal defects. In all cases, the therapeutic procedure is imaged under direct, real-time infrared imaging.

Description

Image-Guided Therapy of the Fossa Ovalis and Septal Defects Background
In the heart there exists a structure called the fossa ovalis on the septal wall of the atrium, which, in the pre-natal state, permits transfer of blood between the left and right hearts. At birth, the fossa ovalis is usually closed and the heart functions in a normal manner with the right heart pumping blood into the lungs and returned to the left heart. In about 10-15% of the patients, however, the fossa ovalis remains partly open, creating a condition known as preforamen ovale, or PFO. In this situation, blood flows between the right and left atria of the heart. PFO patients have a much higher incidence of stroke since thrombi from the leg veins, instead of being filtered by the lungs, can transfer directly from the right to left atria where it can travel to the brain causing a stroke. This condition has also been associated with the presence of migraine headaches.
Because of these conditions, physicians have developed procedures to close off the PFO using a dual umbrella system such as the CardioSEAL NMT or the Amplatzer PFO Closure Device. The umbrella system is collapsed inside of a percutaneous catheter and then opened once in the right atrium. The catheter is first manipulated through the hole and the outer umbrella deployed. The catheter is then retracted and the inner umbrella deployed to form a "clamshell" around the PFO.
Currently, the procedure is guided by fluoroscopy and intracardiac ultrasound (ICE), which provide useful but limited information concerning the PFO coverage by the umbrella system. Occasionally, the umbrella system provides insufficient coverage of the PFO, a condition often missed by the combination of fluoroscopy and ICE. Moreover, PFO devices can unseat from the PFO requiring an additional procedure to retrieve them and reseat them effectively in the PFO. Correct placement of the PFO closure device is assessed by ICE as bubbles are injected in the vicinity of the PFO and observed on the ICE monitor to see if they cross over to the left atrium. A similar condition occurs with septal defects, in which a hole between atria (ASD) or ventricles (VSD) occurs in the heart development. ASD's or VSD's also need to be repaired with patches or umbrella systems either surgically or percutaneously using a catheter containing an expandable patch or umbrella system. As with PFO's, if a catheter is used for device employment, the effectiveness of the closure is assessed by observing bubbles crossing the ASD or VSD on ICE.
The fossa ovalis is also involved in another procedure, called transeptal puncture, in which it is punctured to gain access to the left atrium for various procedures such as catheter ablation, such as the pulmonary vein procedure. The principle means of puncturing the fossa ovalis is using a Brockenbrough needle assembly. In this approach, a usually metallic sheath is inserted, and guided by fluoroscopy or ICE, the sheath is placed against the fossa ovalis.
In the case of fluoroscopy, the silhouette of the metallic or radioopaque sheath is imaged in relation to the low-contrast heart silhouette. This can result in sheath misplacement because fluoroscopy only presents a two-dimensional image of the sheath in relation to the septal wall. Since the fossa ovalis is invisible in fluoroscopy, improper positioning of the sheath against the fossa ovalis occurs, sometimes with disastrous results. A feared complication is puncture of the nearby aorta, often requiring emergency cardiac surgery to repair the puncture.
With the advent of ICE, another means of assessing sheath-fossa ovalis now exists. In this approach, an ICE catheter is also inserted in the right atrium and positioned so that the ultrasonic energy is in the direction of the fossa ovalis. When the physician presses the sheath against the surface of the fossa ovalis, a so-called "tenting" effect is observed on the ultrasonic image. Since the fossa ovalis is thinner then the septum and shaped as a roughly two-centimeter oval, correct apposition of the sheath against the fossa ovalis is imaged ultrasonically as an increased indentation over about two centimeters. It is so named because it is similar to the appearance of the top of a circular tent. While the ICE method has gained acceptance from the electrophysiology community, it is only an inferred means of imaging the fossa ovalis. However, it is not confirmative. It relies on physician judgment of the degree of indentation required to identify the fossa ovalis. Fossa ovali and septal wall thicknesses vary individually. Though more accurate than fluoroscopy, it is still subject to error with the same complications as fluoroscopy-guided transeptal puncture.
Once the sheath is identified in good apposition to the fossa ovalis, a stylet with a sharp distal end is inserted through the metallic sheath to puncture the fossa ovalis and gain access to the left atrium. Other methods of fossa ovalis puncture include applying radiofrequency energy to an electrode on the distal end or screwing through the fossa ovalis using a stylet with a screw at the distal end.
Invention Summary
Repair or puncture of the fossa ovalis or closing septal defects is currently guided by indirect means, such as fluoroscopy or ICE. Fluoroscopy only provides a silhouette of the sheath without imaging the fossa ovalis. ICE imaging only infers the fossa ovalis or septal defect from its different elastic characteristics as compared to the septal wall while applying pressure on the sheath.
Direct imaging of the fossa ovalis in which the oval-shaped fossa ovalis is seen in three dimensions (as in an endoscope) make the above procedures more precise and permits the possibility of more complicated procedures. This patent teaches means and methods of performing fossa ovalis and septal defect closing and puncture using direct infrared imaging as taught in United States Patent 6,178,346.
In infrared imaging, an infrared wavelength in low-absorptive wavelength regions provides direct images of structures, through flowing blood to about two centimeters in an 80 deg field of view, much like an endoscope. It permits the fossa ovalis or septal defect to be seen directly at distances ranging ' from
0.2 — 2 cm. For example the characteristic fossa ovalis oval-shape can be imaged and the endoscope can be advanced/retracted to provide a close up or far. away view of the fossa ovalis or septal defect. A main teaching of this patent is means and methods of combining the therapeutic tools to close defects in the fossa ovalis or septal defect or to puncture the fossa ovalis with an infrared endoscope.
A. PFO and Septal Defect Closure Guidance with Infrared Endoscopy In PFO closure guidance with infrared endoscopy, an infrared endoscope contains a channel for the PFO or septal defect closure device. This can be either a two-lumen sheath with channels for an infrared endoscope and the PFO septal defect closure device, or a sheath incorporating the infrared endoscope with a channel for the PFO septal defect closure device. Either implementation is referred to as a sheath with the infrared endoscope (SIE)1 The steps are as follows:
1. The SIE is routed from a vein in the groin to the right atrium, until the fossa ovalis is clearly imaged.
2. The SIE is then advanced toward the fossa ovalis to inspect its rim. Generally, PFO' s septal defects appear as flaps on the oval border. The site of the opening will appear on the infrared image as flaps (likely for PFO 's) or a clear hole.
3. Gauging the size of the hole in relation to the two-centimeter fossa ovalis allows the proper sized PFO septal defect closure device to be selected.
4. With the SEE positioned into the hole, the PFO septal defect closure device can be advanced and the outer umbrella deployed.
5. The SDS is then retracted to image the hole in the fossa ovalis or septal defect and the inner umbrella. 6. The SIE is retracted to image the entire PFO septal defect closure device to assure complete PFO or septal defect closure.
Other PFO or septal defect closure devices besides the dual-umbrella "clamshell" approach may also be inserted through the therapeutic channel of the SIE. Since the fossa ovalis is imaged directly, a number of more advanced PFO closure devices are possible but require direct imaging of the fossa ovalis hole or flaps as provided by the SEE. Moreover, imaging the fossa ovalis or septal defect permits stabilizing tools such as an extendable flat plate or grasper to stabilize the fossa ovalis during the PFO closure procedure which permits more precise techniques, such as suturing or stapling.
Currently, in PFO and septal defect repair, a device is inserted into the opening and expanded, usually two opposed umbrella-like structures covered with a metallic or Dacron mesh. While the complication rate for these procedures is very low (~1%), it is generally due to misplaced devices not completely covering the defect or device migration into a heart chamber. A device-less PFO repair technique is desirable since it would not have chronic device complications such as migration or infection.
The added precision afforded by infrared imaging permits direct closure techniques using suture, staples, electricity, applied heat or chemical/biological materials. Since infrared imaging allows the hole or defect to be imaged in relation to therapeutic tools, device-less, direct closure becomes possible. In any of these methods a third lumen in the sheath could introduce a stabilizing element in the form of a flat plate or grasper device. A stabilizer would permit the defect edges to be apposed for a long enough time to execute the defect closing therapy, such as percutaneous suturing. Direct closure means include:
1. Suture. A percutaneous suture device, which sutures tissue together to close the PFO or septal defect. Suturing is highly advantageous for PFO 's which frequently consists of two flaps in close apposition which open and close. 2. Stapler. A percutaneous stapling device, which staples tissue together to close the PFO or septal defect. Stapling is highly advantageous for PFO 's, which frequently consists of two flaps in close apposition, which open and close.
3. Adhesive Bonding. A catheter, which applies tissue-adhering adhesive to close the PFO or septal defect. "Gluing" is highly advantageous for PFO 's, which frequently consists of two flaps in close apposition, which open and close.
4. Biological Material Bonding A catheter, which applies biological material, which grows over the fossa ovalis or septal defect opening to close the PFO or septal defect. Stem cells seeded onto the fossa ovalis or septal defect which produces hole-covering tissue, such as collagen
5. Electrical Bonding. A catheter, which applies electrical (such as bipolar radiofrequency energy), to close the PFO or septal defect
6. Thermal Bonding. A catheter, which applies thermal energy to close the. PFO or septal defect.
7. Photochemical Bonding. A catheter, which applies a photochemical and then irradiates it with visible light to activate the photochemical to close the PFO or septal defect.
8. Ultrasonic Bonding. A catheter, which applies ultrasonic energy to close the PFO or septal defect.
B. Transeptal Puncture Guidance with Infrared Endoscopy Since fluoroscopy and ICE are indirect images, it occurs that punctures are made outside the fossa ovalis. A feared complication of misplacing the puncture is puncturing the nearby aorta, which often requires emergency cardiac surgery to close the aortic puncture wound. Ih contrast, the fossa ovalis is positively identifiable from the infrared image. The infrared image provides a three dimensional, direct view of the characteristic fossa ovalis oval shape and shows the puncture device location on the fossa ovalis wall. The catheter can be advanced/retracted for closer/farther views of the fossa ovalis. The sheath is either a two-lumen sheath with channels for an infrared endoscope and the transeptal puncture device, or a sheath incorporating the infrared endoscope, with a channel for the transeptal puncture device. Either implementation is referred to as a sheath with the infrared endoscope (SIE).
1. The SIE is routed from a vein in the groin to the right atrium, until the fossa ovalis is clearly imaged.
2. The transeptal puncture device is then advanced toward the fossa ovalis, guided by infrared imaging.
3. Upon verification that the transeptal puncture device is in contact with the fossa ovalis, a transeptal puncture is performed.
4. The SIE is advanced over the transeptal puncture device and into the left atrium to assist in left-heart procedures, such as pulmonary vein isolation.
The transeptal puncture device can be any transeptal device including a Brockenbrough needle puncture assembly, a radiofrequency puncture device or other devices employing heating and a transeptal crossing device employing a screw, which is rotated through the septum. Infrared imaging permits conclusive identification of the fossa ovalis. It also permits the real-time observation of the transeptal crossing.
A further advantage of an infrared-guided transeptal device is that about 10-15% of patients have a defect If this defect is imaged, the sheath can be advanced towards the opening. Since the sheath contains the infrared endoscope, the sheath can be manipulated into the defect under infrared-imaging guidance. This permits navigation of the sheath through the defect and into the left atrium. Navigating through the fossa ovalis opening, without transeptal puncture, would reduce procedure time and complications for this minority group of patients.
Figures 1. A drawing of a bi-lumen catheter where the infrared catheter in inserted into one port and the PFO-septal defect closure device in the second port.
2. A drawing of a sheath incorporating the infrared endoscope with a port available for the PFO-septal defect closure device.
3. A tri-lumen catheter with channels for the infrared endoscope, suture/stapling device and tissue-stabilizing device.
4. A drawing of a bi-lumen catheter where the infrared catheter in inserted into one port and the transeptal puncture device in the second port touching the fossa ovalis. Detailed Embodiments <-
A. PFO and Septal Defect Closure under Infrarέ iging Guidance..
Figure 1 shows a two-lumen sheath (1) out of which are two ports (2,3). Out of one port (2), the infrared endoscope (4) can be advanced/retracted. Out of the other (3) port a device (5) similar to the CardioSEAL NMT is advanced/retracted and is shown with the two umbrella elements (6) deployed.
Figure 2 shows a sheath (7) which contains an indwelling infrared endoscope (9) and a working channel (8) out of which a Closing a PFO or septal defect is a device (5) similar to the CardioSEAL NMT is advanced/retracted and is shown with the two umbrella elements (6) deployed. Either configuration can be used for infrared endoscopic guidance of PFO/septal defect closure.
In the first embodiment, a PFO is closed. Generally PFO 's consist of flaps at the fossa ovalis rim which open and close in synchrony with the heart beat. First of all, the sheath containing the infrared endoscope and PFO/septal defect closure device are positioned so that the PFO/septal defect closure device is in its minimized position with the umbrellas collapsed and positioned inside the working channel lumen. The bi-lumen sheath (Fig 1, 1) is inserted in a vein in the groin and routed to the mid right atrium. The fossa ovalis is then imaged and the opening in the fossa ovalis localized. The PFO closure device is then advanced towards the defect in the PFO under infrared imaging guidance. The PFO closure device is then advanced through the opening in the fossa ovalis and the first balloon is activated and placed on the left atrial septal wall and blocking the fossa ovalis flap/hole. The PFO closure device is then retracted so that the second umbrella can be applied on the right atrial septal wall of the PFO and positioned to block the fossa ovalis flap/hole.
Figure 3 shows a tri-lumen sheath (10) where a port is now available for a stabilizer (11). The stabilizer element is a device, which can be inserted/placed on the PFO opening to stabilize the defect from heart beat motion. It could take the form of a flat plate, like the stabilizers used in minimum invasive surgery (MIS) or the stabilizer could be a device, which grips the tissue to keep it stationary. Such a stabilizer could be used in dual-umbrella closure techniques as shown in Figure 2.
Figure 3 shows instead of a dual-umbrella system a suturing catheter (12). The suturing catheter permits the flap-defect in the fossa ovalis to be sutured together. In suturing or stapling, it is important to isolate the flap-defect from heart motion to be able to execute the suturing procedure. The suturing system consists of long sutures running to the proximal end of the catheter, where the physician controls the suturing procedure from actions on the proximal end of the catheter.
When using a stabilizer, after the flap opening of the PFO has been imaged with the infrared endoscope (4), the stabilizer (11) catheter is advanced into the flap-defect in the fossa ovalis, where it "pinches" the flaps together. The suturing catheter is then advanced to the flap-defect and sutures the flap s together while being held together by the pincher stabilizer: The result is PFO closure without the need for implanting a medical device. In a similar manner, the PFO could be stapled together to achieve the same result. There are many other means of closing a PFO or septal defect which are not currently useful since the defect cannot be imaged during the procedure. These include:
J. Adhesive Bonding. A catheter, which applies tissue-adhering adhesive to close the PFO or septal defect. "Gluing" is highly advantageous for PFO's, which frequently consists of two flaps in close apposition, which open and close. Poly methyl methacrylate (Superglue) would be a suitable gluing candidate. A grasping stabilization tool would be used for defect boundary appostion.
2. Biological Material Bonding A catheter, which applies biological material, which grows over the fossa ovalis or septal defect opening to close the PFO or septal defect. Biological material such as collagen or other membraneous material is placed on the flaps or defect, where it gradually grows over the PFO. Alternatively, stem cell seeding of cells near the opening which develop into a surface-covering like collagen
3. Electrical Bonding. A catheter, which applies electrical (such as bipolar radiofrequency energy), to close the PFO or septal defect. Tissue welding has long been in use using radiofrequency energy. A grasping stabilization tool would be used for defect boundary apposition.
4. Thermal Bonding. A catheter, which applies thermal energy to close the PFO or septal defect. A laser coupled to a diffuser has been used in other medical applications to join tissue. A grasping stabilization tool would be used for defect boundary apposition.
5. Photochemical Bonding. A catheter, which applies a photochemical and then irradiates it with visible light to activate the photochemical to close the PFO or. septal defect. The photochemical is first applied on the flap surfaces, following by irradiation at a visible or infrared wavelength by the infrared endoscope to activate the photochemical resulting in bonding of the flaps. A grasping stabilization tool would be used for defect boundary apposition.
6. Ultrasonic Bonding. A catheter, which applies ultrasonic energy to close the PFO or septal defect through heat generation caused by rapid movement of the ultrasonic transducer. A grasping stabilization tool would be used for defect boundary apposition. In each of these cases, a bi-lumen or tri-lumen catheter (if stabilization is needed) or a sheath with integral infrared imaging is employed. In the case of tri-lumen sheath (Figure 3), the suturing catheter (12) is replaced by a catheter incorporating one of the bonding techniques mentioned above. • As in the suturing embodiment, the flaps are pinchd together by the stabilizing element (i 1) and the catheter incorporating the bonding method is advanced and applied to the pinched tissue.
In the same manner as for PFO's, septal defect repair can use the same methodology described above for PFO closure. Septal defects are different from PFO's in that a hole is usually present rather then opening flaps. If the hole can be positioned by the stabilizer element, so that the hole boundaries can be joined, all of the methodologies above can be employed. If this is not possible, a patch can be used which can be sutured/stapled onto the septal defect to effect closure and create a greater surface area coveragfe of the septal defect. For example, a Dacron patch could be positioned to cover the septal defect under infrared imaging guidance and a suturing mechanism is employed to stitch the periphery of the patch.
In all of these procedures, the infrared imaging is useful in assessing procedure success. The infrared catheter examines the repaired portion of the fossa/septal defect and looks for gaps in the bonded section. If some are found, they are "touched up" with a second application of the bonding catheter.
JB. Transeptal Puncture under Infrared imaging Guidance.
Figure 4 shows a bi-lumen sheath with (1) with one port (2) containing a Brockenbrough transeptal puncture device (14) whose needle (15) Has been pushed against.the fossa ovalis (16). The other port (2) contains an infrared imaging catheter (4).
In this procedure, the fossa ovalis is imaged by the infrared endoscope. After imaging, the Brockenbrough transeptal puncture device is advanced until the needle is clearly imaged touching the fossa ovalis near the center. Following verification of needle appostion to the fossa ovalis, the needle is advanced to puncture the fossa ovalis. The Brockeribrough needle and sheath is first advanced to the left atrium, followed by the bi-lumen sheath.
Besides traditional transeptal puncture technique, other means of trranseptal crossing may also be employed. These include:
1. Screwing through the fossa ovalis. In this method a screw is advanced to the fossa ovalis and rotated to screw the fossa ovalis.
2. Burning through the fossa ovalis. In this method an RF or laser catheter is advanced to the fossa ovalis and a hole burned through the fossa ovalis either with radiofrequency energy or from a heated laser diffuser.
3. Examining the fossa ovalis to find a PFO. Since about 15-20 % of patients have an opening in their fossa ovali, the opening could be localized in these patients and the entire sheath passed into the left atrium under direct infrared imaging without any modification to the fossa ovalis.
The key elements of infrared image guided transeptal puncture using the sheath with an infrared endoscope (SIE) are the following:
1. Navigating the SIE to view the fossa ovalis and confirm its identity by the size and shape and position relative to other structures.
2. Observing the transeptal crossing device contacting a point within the fossa ovalis.
3. Observing the transeptal crossing.
In summary, direct imaging of the fossa ovalis and septal defects permits a number of therapeutic approaches for either the opening or closing of the fossa ovalis and for the closing of septal defects. In all cases, the therapeutic procedure is imaged under direct, real-time infrared imaging. Imaging in other directions other than straight ahead is also possible with the use of a prism or mirror. For example, imaging out the side of the catheter is created with a 90 deg prism/mirror. This is useful in transeptal puncture where the catheter could be directed and anchored into the ventricle or IVC and the side-viewing window in the direction of the fossa ovalis. Guidewires might also be deployed for the purpose of anchoring the sheath in a cardiac vein/artery/valve. The sheath may also be manipulated by robotic control such as the magnetic system manufactured by Stereotaxis or the pulley system manufactured by Hansen Medical or other robotic control systems.

Claims

Claims
1. A medical catheter comprising means for direct, real-time infrared imaging of the fossa ovalis and means for either opening or closing the fossa ovalis.
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