The field of the present invention is apparatus and methods for performing minimally invasive surgery, more particularly to ablation procedures performed with minimally invasive surgical techniques and apparatus.
Various medical conditions, diseases and dysfunctions may be treated by ablation, using various ablation devices and techniques. Ablation is generally carried out to kill or destroy tissue at the site of treatment to bring about an improvement in the medical condition being treated.
In the cardiac field, cardiac arrhythmias, and particularly atrial fibrillation are conditions that have been treated with some success by various procedures using many different types of ablation technologies. Atrial fibrillation continues to be one of the most persistent and common of the cardiac arrhythmias, and may further be associated with other cardiovascular conditions such as stroke, congestive heart failure, cardiac arrest, and/or hypertensive cardiovascular disease, among others. Left untreated, serious consequences may result from atrial fibrillation, whether or not associated with the other conditions mentioned, including reduced cardiac output and other hemodynamic consequences due to a loss of coordination and synchronicity of the beating of the atria and the ventricles, possible irregular ventricular rhythm, atrioventricular valve regurgitation, and increased risk of thromboembolism and stroke.
As mentioned, various procedures and technologies have been applied to the treatment of atrial arrhythmias/fibrillation. Drug treatment is often the first approach to treatment, where it is attempted to maintain normal sinus rhythm and/or decrease ventricular rhythm. However, drug treatment is often not sufficiently effective and further measures must be taken to control the arrhythmia.
Electrical cardioversion and sometimes chemical cardioversion have been used, with less than satisfactory results, particularly with regard to restoring normal cardiac rhythms and the normal hemodynamics associated with such.
A surgical procedure known as the MAZE III (which evolved from the original MAZE procedure) procedure involves electrophysiological mapping of the atria to identifying macroreentrant circuits, and then breaking up the identified circuits (thought to be the drivers of the fibrillation) by surgically cutting or burning a maze pattern in the atrium to prevent the reentrant circuits from being able to conduct therethrough. The prevention of the reentrant circuits allows sinus impulses to activate the atrial myocardium without interference by reentering conduction circuits, thereby preventing fibrillation. This procedure has been shown to be effective, but generally requires the use of cardiopulmonary bypass, and is a highly invasive procedure associated with high morbidity.
Other procedures have been developed to perform transmural ablation of the heart wall or adjacent tissue walls. Transmural ablation may be grouped into two main categories of procedures: endocardial and epicardial. Endocardial procedures are performed from inside the wall (typically the myocardium) that is to be ablated, and is generally carried out by delivering one or more ablation devices into the chambers of the heart by catheter delivery, typically through the arteries and/or veins of the patient. Epicardial procedures are performed from the outside wall (typically the myocardium) of the tissue that is to be ablated, often using devices that are introduced through the chest and between the pericardium and the tissue to be ablated. However, mapping may still be required to determine where to apply an epicardial device, which may be accomplished using one or more instruments endocardially, or epicardial mapping may be performed. Various types of ablation devices are provided for both endocardial and epicardial procedures, including radiofrequency (RF), microwave, ultrasound, heated fluids, cryogenics and laser. Epicardial ablation techniques provide the distinct advantage that they may be performed on the beating heart without the use of cardiopulmonary bypass.
When performing procedures to treat atrial fibrillation, an important aspect of the procedure generally is to isolate the pulmonary veins from the surrounding myocardium. The pulmonary veins connect the lungs to the left atrium of the heart, and join the left atrial wall on the posterior side of the heart. When performing open chest cardiac surgery, such as facilitated by a full sternotomy, for example, epicardial ablation may be readily performed to create the requisite lesions for isolation of the pulmonary veins from the surrounding myocardium. Treatment of atrial ablation by open chest procedures, without performing other cardiac surgeries in tandem, has been limited by the substantial complexity and morbidity of the procedure. However, for less invasive procedures, the location of the pulmonary veins creates significant difficulties, as typically one or more lesions are required to be formed to completely encircle these veins.
One example of a less invasive surgical procedure for atrial fibrillation has been reported by Saltman, “A Completely Endoscopic Approach to Microwave Ablation for Atrial Fibrillation”, The Heart Surgery Forum, #2003-11333 6 (3), 2003, which is incorporated herein in its entirety, by reference thereto. In carrying out this procedure, the patient is placed on double lumen endotracheal anesthesia and the right lung is initially deflated. Three ports (5 mm port in fifth intercostal space, 5 mm port in fourth intercostal space, and a 10 mm port in the sixth intercostal space) are created through the right chest of the patient, and the pericardium is then dissected to enable two catheters to be placed, one into the transverse sinus and one into the oblique sinus. Instruments are removed from the right chest, and the right lung is re-inflated. Next, the left lung is deflated, and a mirror reflection of the port pattern on the right chest is created through the left chest. The pericardium on the left side is dissected to expose the left atrial appendage and the two catheters having been initially inserted from the right side are retrieved and pulled through one of the left side ports. The two catheter ends are then tied and/or sutured together and are reinserted through the same left side port and into the left chest. The leader of a Flex 10 microwave probe (Guidant Corporation, Santa Clara, Calif.) is sutured to the end of the upper catheter on the right hand side of the patient, and the lower catheter is pulled out of a right side port to pull the Flex 10 into the right chest and lead it around the pulmonary veins. Once in proper position, the Flex 10 is incrementally actuated to form a lesion around the pulmonary veins. The remaining catheter and Flex 10 are then pulled out of the chest and follow-up steps are carried out to close the ports in the patient and complete the surgery.
Although advances have been made to reduce the morbidity of atrial ablation procedures, as noted above, there remains a continuing need for devices, techniques, systems and procedures to further reduce the invasiveness of such procedures, thereby reducing morbidity, as well as potentially reducing the amount of time required for a patient to be in surgery, as well as reducing recovery time.
In accordance with the present invention, apparatus and methods for performing endoscopic surgical procedures are provided where only a minimal number of (or even one) openings are required to perform the procedures. Ablation procedures, including epicardial ablation procedures and apparatus for performing such procedures are described. Epicardial atrial ablation may be performed epicardially with access through only one side of a patient's chest required to perform all procedures.
An endoscopic procedure requiring access through only one side of a patient's chest is provided, including advancing an instrument through an opening in the right chest of the patient; dissecting the patient's pericardium to provide access to a transverse pericardial sinus; advancing a lead through the pericardium and the transverse pericardial sinus and into an oblique pericardial sinus of the patient; dissecting the patient's pericardium to provide access to the oblique pericardial sinus; inserting an instrument into the oblique pericardial sinus; and connecting the lead and the instrument together in the oblique pericardial sinus.
A minimally invasive method of encircling the pulmonary veins of a patient, is provided, wherein entry into only the one side of the patient is required, including the steps of: advancing a lead through an opening in the chest of the patient, through a first opening in the pericardium, and into a transverse pericardial sinus of the patient, across the transverse pericardial sinus and into an oblique pericardial sinus of the patient as the lead tracks downward along a closed border of the pericardium on a side of the heart opposite to the opening in the pericardium; inserting an instrument through a second opening in the pericardium and into the oblique pericardial sinus; and connecting the lead and the instrument together in the oblique pericardial sinus.
Surgical apparatus are provided. In one embodiment, surgical apparatus include an elongated body having distal and proximal end portions and a lumen therethrough; a lens in the lumen; a transparent tip extending distally from the distal end portion; and an elongated tube slidable over the elongated body and adapted to cannulate an opening through tissue formed by the tip.
In another embodiment surgical apparatus are provided including an endoscope having an elongated body and a lumen therethrough, a lens in the lumen, a distal end portion of the endoscope including a distal end portion of the elongated body and a tip extending distally from the elongated body, wherein images are viewable through the tip, lens and lumen; and an elongated lead cinched over the distal end portion of the endoscope and extending proximally therefrom.
In a still further embodiment, surgical apparatus include a dissecting endoscope having an elongated body having distal and proximal end portions and a lumen therethrough; a lens in the lumen, and a transparent tip extending distally from the distal end portion; and a tube having an inside diameter larger than an outside diameter of the elongated body, and slidable over the elongated body, the tube being adapted to be mounted on the elongated body prior to dissecting an opening through tissue by the dissecting endoscope, and to be slid distally with respect to the elongated body and through an opening established by the dissecting endoscope, thereby cannulating the opening, even after removal of the dissecting endoscope therefrom.
In another embodiment, surgical apparatus include an elongated lead having sufficient length to extend from an opening in a right chest of a patient and out of the patient's body at a proximal end of the lead, around four pulmonary veins of the patient and back out of the opening in the right side of the patient at a distal end of the elongated lead, with the elongated lead further comprising a first connector at a distal end thereof; and an elongated instrument having sufficient length to extend through the opening, or a second opening in the right side of the patient to connect with the lead in an oblique pericardial sinus of the patient, the elongated instrument further comprising a second connector, wherein a connection between the elongated instrument and the elongated lead is made via the first and second connectors.
A surgical instrument for performing endoscopic functions is provided, including an elongated body having distal and proximal end portions and a lumen therethrough; a lens in the lumen; and a transparent tip extending distally from the distal end portion, said transparent tip having a distal end portion having a first cross-sectional area larger than a second cross-sectional area of the tip at a location proximal of the distal end portion of the tip, wherein images are viewable through the elongated body, lens and transparent tip.
A surgical device is described, including an elongated tube having sufficient length to extend from an opening in a right chest of a patient and out of the patient's body at a proximal end of the tube, around four pulmonary veins of the patient and back out of the opening in the right side of the patient at a distal end of the tube, the tube further comprising at least one slit between proximal and distal ends of the tube, with the at least one slit being sufficiently long to form an opening to slidably receive an endoscope.
Surgical apparatus are provided including an elongated lead having sufficient length to extend from an opening in a right chest of a patient and out of the patient's body at a proximal end of the lead, around four pulmonary veins of the patient and back out of the opening in the right side of the patient at a distal end of the elongated lead, the elongated lead comprising a first tube and a second tube, a proximal end of the first tube being connectable with a distal end of the second tube; and an elongated instrument having sufficient length to extend through the opening and into a transverse pericardial sinus of the patient, wherein the first tube is configured to be freely slidable over the elongated instrument, and the first tube has a length less than a length of the elongated instrument, so that a distal end of the elongated instrument extends beyond a distal end of the first tube when the first tube is slid over the elongated instrument.
In another embodiment, surgical apparatus include an expandable length tube having an expanded length configuration having sufficient length to extend from an opening in a right chest of a patient through a transverse pericardial sinus of the patient, around left pulmonary veins of the patient and into an oblique pericardial sinus of the patient, and a compressed length configuration having a length shorter than the expandable length configuration, the tube having an opening therethrough configured to pass an ablation probe therethrough.
A surgical device is provided, including an elongated tubular instrument having a main tube with sufficient length to extend through an opening in the chest wall of a patient, through the pericardium of the patient and into the transverse pericardial sinus while a proximal portion of the instrument remains outside the body of the patient; a transparent distal tip mounted to a distal end of the main tube; and a second tube running parallel to the main tube and having an inside diameter sufficient to pass a snare catheter therethrough.
In another embodiment, a surgical device includes an elongated tubular instrument having a main tube with sufficient length to extend through an opening in the chest wall of a patient, through the pericardium of the patient and into the transverse pericardial sinus while a proximal portion of said instrument remains outside the body of the patient; a transparent distal tip mounted to a distal end of said main tube; a lumen extending through said main tube and opening to a proximal end of said device, said lumen configured to receive an endoscope to permit viewing by said endoscope through said transparent distal tip; and a second lumen extending through said main tube and opening at a proximal end portion of said device to receive a snare catheter therethrough.
In still another embodiment, a surgical device includes an elongated ablation probe having a proximal end portion and a distal end portion; and an elongated, flexible tube having a proximal end portion and a distal end portion, wherein the proximal end portion of the tube is releasably connectable to the distal end portion of the probe.
These and other advantages and features of the invention will become apparent to those persons skilled in the art upon reading the details of the methods, apparatus and devices as more fully described below.
Before the present methods and devices are described, it is to be understood that this invention is not limited to particular surgeries, tools, materials, methods or devices described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.
Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited.
It must be noted that as used herein and in the appended claims, the singular forms “a”, “and”, and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “an activation” includes a plurality of such activations and reference to “the lesion” includes reference to one or more lesions and equivalents thereof known to those skilled in the art, and so forth.
The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.
The term “open-chest procedure” refers to a surgical procedure wherein access for performing the procedure is provided by a full sternotomy or thoracotomy, a sternotomy wherein the sternum is incised and the cut sternum is separated using a sternal retractor, or a thoracotomy wherein an incision is performed between a patient's ribs and the incision between the ribs is separated using a retractor to open the chest cavity for access thereto.
The term “closed-chest procedure” or “minimally invasive procedure” refers to a surgical procedure wherein access for performing the procedure is provided by one or more openings which are much smaller than the opening provided by an open-chest procedure, and wherein a traditional sternotomy is not performed. Closed-chest or minimally invasive procedures may include those where access is provided by any of a number of different approaches, including mini-sternotomy, thoracotomy or mini-thoracotomy, or less invasively through a port provided within the chest cavity of the patient, e.g., between the ribs or in a subxyphoid area, with or without the visual assistance of a thoracoscope.
The term “reduced-access surgical site” refers to a surgical site or operating space that has not been opened fully to the environment for access by a surgeon. Thus, for example, closed-chest procedures are carried out in reduced-access surgical sites. Other procedures, including procedures outside of the chest cavity, such as in the abdominal cavity or other locations of the body, may be carried out as reduced access procedures in reduced-access surgical sites. For example, the surgical site may be accessed through one or more ports, cannulae, or other small opening(s). What is often referred to as endoscopic surgery is surgery carried out in a reduced-access surgical site.
Conventional minimally invasive thoracoscopy surgery typically uses three ports on each side of the patient from which access is required. A camera (e.g., an endoscope) is inserted through one port, typically the central port to give the surgeon a “bird's eye” or “god's eye” view of the surgical target. Instruments (e.g., graspers, scissors or other instruments) may then be inserted through the other two ports (e.g., on opposite sides of the camera) and manipulated to perform a surgical procedure, as the working ends of the instruments are viewed via the camera. For example, graspers may be inserted through one of the other two ports and a Kitner sponge stick may be inserted through the other of the two ports. This type of procedure also takes at least two people to perform it: typically an assistant will hold and operate the endoscope through the central port, while a surgeon manipulates the tools through the other two ports. For example, the surgeon may lift up the vena cava with one instrument, and then use the sponge stick to perform the dissection of pericardial layers. As the dissection progresses further inwardly, it can no longer be seen by the endoscope where it is originally positioned. When moving the endoscope in closer to regain a view of the dissection, there is risk of contacting the lens of the scope with the vena cava or other tissue, which blurs the view. Accordingly, the endoscope must then be taken all the way back out of the body through the central port, and wiped off or otherwise cleaned and reinserted. However, the same risk of smudging or blurring the lens persists each time the endoscope needs to be further advanced into the operative site. Accordingly, such a procedure is man-hour intensive, requiring at least two operators, and time consuming, as well as difficult. The present endoscopes use tips that are self-cleaning, and provide a direct view of the surgical procedure that is being performed, while at the same time, being controllable by the surgeon that is also performing the surgical procedure.
With regard to thoracoscopic endocardial atrial ablation procedures, some current surgical techniques may take in the neighborhood of three hours just to accomplish the task of encircling the pulmonary veins in preparation for performing an epicardial ablation.
The present invention provides simple, reliable and safe techniques for minimally invasive procedures, such as closed-chest cardiac procedures that require ports (typically three or less) on only one side of the patient, thereby reducing the invasiveness of procedures that typically require ports on both sides of the patient. Further, the present techniques are much faster, typically requiring only minutes (e.g., about thirty to sixty minutes), as opposed to hours (e.g., about three hours) to encircle the pulmonary veins, for example. Even for procedures that typically are single sided, the present invention may reduce the number of ports that are required on one side of the patient, compared to the three previously required by conventional techniques. Not only are the present techniques less invasive, but devices provided make the procedures easier and safer to carry out.
Referring now to
For purposes of maintaining an established pathway through tissue, such as may be established by dissection as described, a non-collapsing, flexible or rigid tube 14 may be placed coaxially over the endoscope shaft 16 as shown in
Tip 20 is transparent and generally blunt and may be of a generally spherical or other blunt curvature. However, a small (e.g., about 1 mm diameter) nipple or protrusion 22 may be provided to extend from the distal end of tip 20 to increase friction with the tip 20 against tissue to facilitate dissection. Tip 20 is transparent to enable direct viewing to the surgical site through endoscope 16 and of the dissection as it is proceeding. Tip 20 is distanced from the lens at the distal end 16d of endoscope shaft 16 so that any tissue that contacts tip 20 can still be viewed by the endoscope, as the endoscope lens does not become smeared or blurred. Also, the distance between the external distal surface of tip 20 and the lens at the distal end of shaft 16d permits a field of view by endoscope 10, so that the anatomy can be better discerned since all tissue in contact with the length or long axis of the tip is viewed, rather than having a view that is limited to tissue that the endoscope lens contacts, as is the case when using a standard endoscope arrangement. For example, without a tip, an endoscope may bump up against the vena cava, but the view will not permit identification of such, as a constant wall of tissue will be seen in the field of view. Using a tip, however, a length of the vessel will be seen, with some surrounding background in the field of view, so that the vessel can be identified as such. Tip 20 may be removable to allow interchanging tip 20 with another tip for carrying out another function, as will be described in more detail below. Optionally, a tapered or conical transparent tip 24 may be mounted concentrically within with respect to the endoscope and tip 20. The surface of angled or conical tip 24 breaks up the reflected waves from the blunt tip 20 and prevents the formation of a ring of reflected light in the visualization through endoscope 16 that might otherwise occur. Further details about such an arrangement are described in co-pending application Ser. No. (application Ser. No. not yet assigned, Attorney's Docket No. GUID-068) filed concurrently herewith (i.e., May, 26, 2005) and titled “Ablation Instruments and Methods for Performing Ablation”, which is incorporated herein, in its entirety, by reference thereto. This configuration of a sharper tip 20 within a blunt tip 20 may be employed in ablation devices 10 that use a blunt tip 20 as described above, as well as other instruments designed to contact tissues while providing visualization.
A light emitter (not shown) may be provided in the distal end portion of instrument 10 to direct light out of the distal end so that the operator may visualize the position of the distal end in the surgical site by viewing through the endoscope 16. Like some existing endoscopes, the endoscope 16 provided with instrument 10 contains a visualization portion (e.g., rod lenses) and a fiber optic light-carrying portion (e.g., optical transmission fibers). A light cable connects to endoscope 16 and supplies light to the light-carrying portion, from an external light source (e.g., Xenon light source, which may be in the vicinity of 300 Watts power). Thus, a surgeon or operator may directly view the positioning and movements of the distal end of instrument 10 from outside the patient, without the need to resort to any indirect visualization or sensing techniques for positioning, and this greatly increases the accuracy and precision of placement of instrument 10 for performing dissection. The fact that the procedure can be viewed through the same instrument that is carrying out the dissection also removes the requirement for placing an additional opening through the patient to insert a separate endoscope, as is done with traditional endoscopic surgeries. A power supply line (not shown) may be connected to the light source to extend proximally out of the instrument 10 to be connected to an external power source.
While typically rigid, the distal end portion of instrument 10 may be formed to be articulating, to provide a greater range of motion during dissecting as well as for directing placement of tube 14 in examples where tube 14 is flexible. Further alternatively, endoscope 16 may be made flexible or malleable for situations where it would be advantageous for the particular application or technique being practiced.
An example of using instrument 10 in a method according to the present invention will now be described, initially with reference to
A snare catheter 30 may next be inserted into tube 14 and manipulated around the pulmonary veins as described below. Snare catheter 30 may be constructed of flexible plastic material such as polyethylene, polytetrafluoroethylene (PTFE, e.g., TEFLON®), polyvinyl chloride, nylon, or the like. Snare catheter 30 may be formed to be substantially straight in an unstressed state (
Catheter 30 is tubular, to allow suture line or wire 34 to pass therethrough. Suture line 34 includes a suture loop 36 formed with a sliding knot (an Endoloop) in a distal end thereof. Suture loop 36 is located distally of the distal end of catheter 30. Suture loop may be formed from a conventional suture material or braided stainless steel wire cable, for example. Alternatively, the entire suture line may be made of NITINOL®, or other nickel-titanium alloy without the need to use a sliding knot. The proximal end of suture line or wire 34 (or tail of the suture loop) extends through catheter 30 and proximally out of the proximal end of catheter 30, where it may be attached to a pull tab 38. Further, a lock 40 such as a two-way stopcock, clamp, hemostats, or other surgical clamp, tool or locking mechanism may be provided to grasp suture line or wire 34 and abut the proximal end of catheter 30 to prevent backsliding of catheter 30 with respect to suture line 34 (i.e., sliding of catheter 30 proximally with respect to suture line 34) as this device is used to draw an ablation device into position, as will be described below.
As catheter 30 is inserted through tube 14, once the distal end of catheter is pushed out the distal end of tube 14 and against the pericardium 2 on the left side of the heart, the distal end of catheter 30 and suture loop 36 are deflected downwardly and are further advanced, into the oblique pericardial sinus 7, which is a majority of the region shown just beneath the left 5 and right 6 pulmonary veins on the posterior aspect of the heart in
Next, with catheter 30 remaining in place as shown in
Once instrument 10 has been captured by suture loop 36, as described, an ablation device 50 is fixed to the proximal end of suture line 34 (
By pulling instrument 10 through the opening 11, this begins to draw catheter 30 out of the opening 11 along with instrument 10 as long as suture loop maintains the capture of tip 20. Movement of catheter 30, in turn, draws ablation device 50 in through opening 11 and leads ablation device 50 around the pulmonary veins into the position previously occupied by catheter 30. By drawing catheter 30 through the same opening 11 that ablation device 50 was drawn into, this maneuvers ablation device 50 to surround the pulmonary veins, as shown in
Alternative to the single port method described above, a similar method may be carried out through the use of two ports. While this alternative procedure requires some additional manipulation, it is a viable alternative and may be used, for example, if the surgeon wants to use additional tools for carrying out any of the procedures of the method. For example, the surgeon may want to use additional tools to assist in initially opening the pericardium. Additionally, some surgeons will be more comfortable or accustomed to using multiple ports to provide additional instruments (e.g., graspers) to the surgical site to retract tissue and thereby increase exposure of the anatomy, for example. For example, port 11 may be placed in the second intercostal space, in the anterior to mid-axillary line, and the second port 13 may be placed in the third or fourth intercostal space, in the anterior to mid-axillary line. The superior port 11 may be approximately 10 to 15 mm in diameter, and the inferior port 13 may be approximately 5 to 12 mm in diameter, but is typically about 5 mm in diameter.
An operating endoscope 60 (e.g., a 12 mm, 0-degree operating endoscope) with endoscopic graspers 62 advanced through the working channel, may be inserted through opening 11 and used to grasp the right pleura and pericardium 2 anterior to the phrenic nerve 64, for example, as shown in
Dissecting endoscope 10 may then be inserted through opening 11, as shown in
Dissection scope 10 is then inserted through inferior port 13 and is used to dissect through the reflection of the pericardium posterior to the inferior vena cava, inferior to the right inferior pulmonary vein. As a result, tip 20 of dissection endoscope 10 lies in the oblique pericardial sinus 7. Catheter 30 and suture loop 36 are also in the oblique pericardial sinus 7. Distal tip 20 and suture loop 36 are visible via dissecting endoscope 10 and thus may be viewed from outside of the patient during this phase of the procedure. Dissection endoscope 10 is maneuvered to insert tip 20 through suture loop 36, as visually guided by the operator viewing the procedure via endoscope 10. Once tip 20 has been inserted through suture loop 36, as shown in
Dissecting endoscope 10 is then pulled out of inferior port 13, bringing the suture loop 36 and the distal end of catheter 30 out of the patient's body, as well, as schematically represented in
Operating endoscope 60 may next be inserted into opening 11 and endoscopic graspers 62 may then be used to grasp catheter 30 and pull it out of opening 11. Alternatively, dissecting endoscope may be inserted into opening 11 and maneuvered to again pass tip 20 through suture loop 36, after which suture loop 36 can again be cinched down in the same manner as described earlier. Once so connected, catheter 30 can then be drawn out of opening 11 by pulling endoscope 10 back out of the opening, after which endoscope may again be disconnected from catheter 30 in the same way as discussed previously. Either technique results in both ends of catheter 30 protruding out of opening 11.
Next, ablation probe 50 is connected to the proximal end of catheter 30 in a manner as described previously, after stop 40 has been removed, such as by cutting for example. The distal end of catheter 30 is then pulled out of the patient's body, through opening 11, to pull ablation probe 50 into place around the pulmonary veins, into the configuration shown in
Variations of the previously described methods and devices may be employed to form a lesion surrounding the pulmonary veins by epicardial ablation. In one variation, endoscope 10 is provided with a replaceable tip 20. That is tip 20 may be removed from the distal end of endoscope and replaced with a different shape tip, such as tip 20′ shown in
Tip 20 may be provided so as to be removable from device 10, such as by providing mating threads between tip 20 and shaft 16, for example, with appropriate sealing to prevent fluids from passing through the connection. Additionally or alternatively, tip 20 may be fixed to shaft 16 by one or more of the following: bayonet fitting, threaded stem attached to tip 20 that runs the full length of the tube 16 and is secured at the proximal end of tube 16 with a nut that mates with the threads, mating projections and holes or sockets, etc. Similarly, any tip to be interchanged with tip 20 may be provided with the same threads or other connection expedient that may be used for removably securing tip 20 to device 10 with a fluid tight seal.
Tip 20′ is provided with threads 20t at a proximal end portion thereof, for connecting tip 20′ with mating threads on the distal end of shaft 16, as shown in
In carrying out any of the previously described methods, tip 20 may be used to carry out procedures up until the time that suture loop 36 is positioned in the oblique pericardial sinus, and dissection of the pericardium at a location posterior to the inferior vena cava to form an opening to the oblique pericardial sinus has been completed. At this time, dissecting endoscope 10 is removed from the body (if it was used to perform the dissection of the pericardium at a location posterior to the inferior vena cava, otherwise dissecting endoscope may already be out of the body) and tip 20 is removed and replaced by tip 20′.
Endoscope 10 is then reinserted into the body and manipulated (under direct visualization through endoscope 10) to direct tip 20′ though suture or wire loop 36. Suture loop 36 is then cinched around tip 20′ in a manner as described above, with the difference being that suture loop 36 is cinched down over tapered region 20p and to abut against the proximal portion of ball 20d as shown in
Further alternatively, all functions of dissecting endoscope may be carried out with tip 20′ in place. In this case, dissecting endoscope may also be alternatively provided with a fixed, non-removable tip in the configuration of tip 20′. In either of these situations, tip 20′ may be further provided with a small (e.g., about 1 mm diameter) nipple or protrusion 22 to extend from the distal end of tip 20′, as shown in
As loop 21 is distal to the end of the endoscope shaft 16, both loops 21,36′ are visible through the endoscope (dissecting endoscope 10) at all times during locking together of the loops as well as during pulling the endoscope 10 and catheter 30 out of the body. While tip 20″ is shown to have a conical taper, it is not limited to this shape but may be essentially any other blunt shape, e.g., shaped like tip 20 or some other blunt shape. Tip 20″ may be permanently fixed to dissecting endoscope 10 or may be removable for replacement by a different tip.
Snare catheter 30 may be about 6 French in diameter, as noted previously, and may be about 60 to about 70 cm in length. The distal tip of catheter 30 may have a rounded end or may be connectable with a separately attachable tip 31, see
Alternatively, suture or wire loop 36 may be glued or otherwise fixed inside a small plastic tube that forms the elongated body/suture line 34 that runs through catheter and extends proximally therefrom. In any case, the body of suture loop 36, as well as suture line/elongated body 34 have sufficient column strength to allow an operator to push on suture line 34 from the portion that extends proximally from the proximal end of catheter 30, to enlarge the size of loop 36.
Catheter 30 may be provided with one or more transverse holes 39 (see
Another alternative procedure includes substituting a long tube 70 in place of the tube 14 and catheter 30 used as described in the previous procedures.
Additionally, suture loop 36 is positioned to extend from the distal end of tube 70 during use, as shown in
When using tube 70, the preliminary steps of forming the opening 11 in the patient's right chest wall, and dissecting, including dissecting pericardium to open an entrance to the transverse pericardial sinus 4, can be carried out by any of the techniques and devices/various combination of devices discussed above. However, instead of having tube 14 mounted over dissecting endoscope 10 during the dissection procedures, dissecting endoscope 10 is inserted through a portion of tube 70 prior to initiating the dissection procedures. Note also, that dissection endoscope 10 could be withdrawn back out of the patient after forming the opening to the transverse pericardial sinus, if preferred, to then insert the dissecting endoscope 10 through a portion of tube 70 and then reinsert dissection endoscope 10 along with tube 70 into the patient. However, this requires an extra step and accordingly, dissection is typically performed with tube 70 already in place over dissecting endoscope 10.
Using a spirally slit tube 70 offers the advantage that dissecting endoscope can be inserted through any of the various slits, thereby allowing the surgeon to tailor the length of the portion of tube 70 that will reside over the shaft of dissecting endoscope 10. However, a tube 70 with a single slit may be used in the same manner as described herein, with the difference being that the length of the portion of tubing 70 residing on the shaft of dissecting endoscope 10 will be predetermined. As another alternative, a tube having several slits 74 may be provided to give the surgeon some choice in the length of the portion of tubing 70 that will be slid over the shaft of dissecting endoscope 10. Whatever variation of tube 70 is used, suture loop 36 extends distally from the distal end of tube 70 after mounting on dissecting endoscope 10, as shown in
Upon entering transverse pericardial sinus 4 with the distal end of dissecting endoscope 10, tube 70 is advanced distally so that the distal end portion of tube 70 enters transverse pericardial sinus 4 and dissecting endoscope 10 is then removed from within tube 70 and removed from the body of the patient through opening 11. The slit 72,74 in tube 70 through which dissecting endoscope had been inserted closes upon removal of dissecting endoscope 10 and tube 70 assumes the shape of a continuous tube. Tube 70 is advanced inferiorly along the left border of the pericardium and into oblique pericardial sinus 7 (along the pathway described in the previously described methods) by pushing and manipulating tube 70 from its proximal end portion outside the body.
Any of the techniques or combinations of the same, for dissecting and creating an opening to the transverse pericardial sinus may then be used to provide the opening to the oblique pericardial sinus. Dissecting endoscope 10 may then be used to identify the distal end of tube 70 and suture loop 36,36′. Tip 20,20′,20″ may then be passed through loop 36,36′ respectively to join tube 70 to dissecting endoscope 10 in any of the ways described previously. The distal end of tube 70 is then manipulated to pull it out of opening 11 (either using single opening 11 procedures or dual-opening 11,13 procedures, both of which are described in detail above).
Next, ablation probe 50 may be inserted through the opening at the proximal end of tube 70 and advanced until it exits the distal end of tube 70, with tube 70 acting as a low friction guide for placement of ablation probe 50. Tube 70 is then removed from the patient's body by pulling on one end of the tube (typically the distal end) while holding the proximal end of ablation device 50 to make sure that it is not displaced from its proper orientation around the pulmonary veins. Endoscopic graspers may next be used to grasp the distal portion of ablation probe 50 to insert it back into the mediastinum. Epicardial ablation probe 50 is positioned to completely encircle the four pulmonary veins, and may be held in position using graspers 62 while energy is being delivered to accomplish the epicardial ablation. After completing the ablation, ablation device 50 is then pulled out of the chest and follow-up steps are carried out to close the opening in the patient and complete the surgery.
Further alternatively, tube 70 may be used in procedures using two openings 11,13, similar to those procedures described above that use two openings, only with the use of tube 70 instead of a snare catheter 30 and tube 14. Ablation probe 50 may be advanced manually through tube 70.
Further alternatively, when using operating endoscope 60 with endoscopic graspers 62, tube 70 need not have a suture loop, as graspers 62 may be used to grasp tube 70 and pull it out of opening 11. Alternatively, dissecting endoscope may be inserted into opening 11 and maneuvered to again pass tip 20 through suture loop 36, 36′, after which suture loop 36,36′ can again be cinched down/clasped in the same manner as described earlier. Once so connected, tube 70 can then be drawn out of opening 11 by pulling endoscope 10 back out of opening, after which endoscope may again be disconnected from tube 70 in the same way as discussed previously. Either technique results in both ends of tube 70 protruding out of opening 11.
Further alternatively, two separate lengths of tubing 80 and 90 may be used to position an ablation probe into a desired position for performing an ablation. For example, tube 80 may be similar in length and material to tube 14 discussed above. Additionally, the ends of tube 80 include connectors 82 and 84, respectively, that are configured to connect with connectors on other components as described hereafter. Initially, tube 80 is mounted over dissecting endoscope 10 in the same manner as described with regard to tube 14 above. Tube 80 may be about two-thirds the length of shaft 16 for example. After endoscope 10 has completed dissecting posterior to the superior vena cava and tip 20 lies in the transverse pericardial sinus, tube 80 is advanced distally into the transverse sinus. Endoscope 10 is then removed from inside tube 80 and the patient's body, and tube 90 is next connected to tube 80. Tube 90 includes a connector 92 at its distal end that is configured to mate and forms a connection with connector 82 at the proximal end of tube 80. In the example shown in
The resulting long, connected tube formed from tubes 80 and 90 is then distally advanced by pushing on/manipulating tube 90 to advance the distal end of tube 80 to track downward along the left border of the pericardium, lateral to the left pulmonary veins 5, and into the oblique pericardial sinus 7. Next, or in the meantime, tip 20,20′ will have been removed from the distal end of dissecting endoscope 10 and replaced with dissecting connector tip 20t (
In any case, connector tip 22t is configured to mate with and form a connection with connector 84 at the distal end of tube 80. In the example shown in
Next, ablation probe 50 is advanced through tube 90,80, by manually pushing probe 50 through tube 90,80, to position it in the desired orientation around the pulmonary veins. Tube 80,90 is then removed by pulling the distal end of tube through the opening 11, while ensuring that ablation probe 50 is not advanced with the advancement of tube 80, 90, by holding onto the probe 50 with one hand, for example, until tube 80,90 is completely removed from the body, leaving ablation probe 50 in place for performing the epicardial ablation.
Endoscopic graspers may next be used to grasp the distal portion of ablation probe 50 to insert it back into the mediastinum. Epicardial ablation probe 50 is positioned to completely encircle the four pulmonary veins, and may be held in position using graspers 62 while energy is being delivered to accomplish the epicardial ablation. After completing the ablation, ablation device 50 is then pulled out of the chest and follow-up steps are carried out to close the opening in the patient and complete the surgery.
Another variation involves the use of expanding length tube 100 as illustrated in
Suture loop 36 extends from the distal end of expandable tube 100 and from catheter 30 as described above, as suture line 34 runs through the inner smaller diameter lumen or through catheter 30, depending upon the particular variation used, and may be connected at a distal end to pull tab 38. Further, a lock 40 may be provided, as described in earlier embodiments. In a relaxed or uncompressed state, elongatable/expanding length tube 100 may be about twice the length of shaft 16 and tip 20 combined. When fully compressed, tube 100 may be about two-thirds the length of shaft 16, as shown in
After performing the dissection into the transverse pericardial sinus 4, such as by using dissecting endoscope 10 in a manner as described above, endoscope 10 and tube 110 are held steady, such as by preventing flange 114 from rotating, for example, and tube 100 is rotated to unscrew connector 104 from connector 112, thereby freeing tube 100 to expand back toward the relaxed, uncompressed configuration. As it is released, the operator may rotate tube 100, which may help to maneuver tube 100 through the transverse sinus, as it expands. Once expandable tube 100 has expanded over the distal end of dissecting endoscope 10, dissecting endoscope 10 may be removed from the body, and then tube 100 is further manipulated to advance it through the desired pathway, tracking down along the left border of the pericardium and into the oblique pericardial sinus. Even in its relaxed, uncompressed state, tube 100 has sufficient column strength to allow it to be pushed from a proximal portion thereof to advance the distal end of tube 100, in spite of the presence of some friction along the tissue surfaces against tube 100. This arrangement allows a long tube 100 to be compressed and loaded on dissecting endoscope 10 while exposing the distal third of endoscope 10 and thereby providing a small profile endoscope for dissection posterior to the vena cavae.
Once expanded and manipulated into the oblique pericardial sinus, the procedure may be further carried out in any of the manners discussed above with regard to elongated tube 80,90. A connection between tube 100 and dissecting catheter 10, to pull tube 100 from the oblique pericardial sinus out of the body, may be made using suture loop 36 for a snare-type connection, in any of the manners previously described, or using connector tip 20t to mate with connector 104, for example.
In either case, dissecting endoscope may then be reinserted through opening 11, or inserted through opening 13, depending upon whether a single opening or dual opening procedure is being performed, to approach suture loop 36 to be snared thereby in a manner as described above. The remainder of these procedures may be carried out in the same manner as described in previous examples that used a snare catheter 30 to draw ablation probe 50 into place.
Another approach to reducing the number of steps required to place ablation probe 50 around the pulmonary veins 5,6 is exemplified in
In addition to guiding ablation probe along the desired pathway around the pulmonary veins, torque tube 130, by its torsional rigidity property, is configured to also facilitate the torsional control of the ablation probe 50. Ablation probe 50 has a particular side that is designed to be placed against the tissue to be ablated, to optimally space the ablation element (antennae) at the desired distance from the tissue for delivery of energy thereto to perform the ablation (in the case of a microwave probe; alternatively, the intended side for contact with the tissue may place an ablation element into direct contact with the tissue, e.g., as in the case of use of an Rf ablation element). If such particular side is not in contact with the cardiac tissue when ablation probe 50 has been pulled into position to surround the pulmonary veins, then torque tube 130 can be rotated about its longitudinal axis to deliver torque to ablation probe 50 so as to rotate the probe 50, until the appropriate side of the probe is in contact with the tissue.
At the proximal end of torque tube 130, an opening or entry hole 132 may be provided, to allow another instrument to be inserted into the torque tube 130. Torque tube 130 is annular and therefore open space is provided between opening 132 and a distal opening 134 in torque tube, as shown more clearly in the sectional view of
In using the arrangement shown in
In order to direct the distal end of torque tube 130 downwardly, a slightly curved stylet 150 may be inserted into torque tube 130 as shown in
Once the distal end of torque tube 130 is directed toward the oblique pericardial sinus 7, and stylet 150 has been removed from torque tube 130, further advancement of torque tube 130, by pushing from a location outside of the body, drives the distal end toward the oblique pericardial sinus 7, as the pericardial sac on the left hand side guides torque tube 130 toward the desired location. Once the distal end of torque tube 130 has been delivered to a desired location in the oblique pericardial sinus, snare catheter 30 may then be inserted through entry hole 132 and advanced through torque tube 130 until suture loop 136 extends distally from opening 134. At this stage, any of the procedures for inserting dissecting endoscope 10 into oblique pericardial sinus 7 and snaring a tip of the endoscope 10 with suture loop 136 may be carried out to connect torque tube 130 to dissecting endoscope 10. Note that the proximal portion line that extends proximally out of opening 132 needs to be locked, such as by using lock 40, for example, to prevent additional suture line 34 from advancing into catheter 30 as torque tube is being pulled out of the body by pulling on dissecting endoscope.
Additionally, snare catheter 30 needs to be locked with respect to torque tube 130, so that is does not advance further into torque tube 130 as torque tube 130 is being pulled by dissecting endoscope 10. Still further, snare catheter 30 should be sufficiently long so that the locked proximal portions of catheter 30 and suture line 34 still extend from opening 11 even when the distal end of torque tube 130 is pulled out of the patient. This makes it easier to unlock the locks, and increase the size of loop 36 to release the dissection catheter. After such release, snare catheter may be pulled out of torque tube 130 and the body by pulling from the proximal portion of snare catheter that extends out of the body.
The connection between torque tube 130 and ablation probe 50 makes it unnecessary to tie leads 52 through openings, thereby eliminating that step required when using alternative procedures. In fact the leads 52 can be eliminated altogether. Torque tube 130 may be disconnected in some situations before the distal end of ablation probe 50 is placed back into the mediastinum, to make it easier to manipulate and encircle the pulmonary veins. However, such is not necessary. As in earlier described procedures, the snare catheter is pulled out of the body using the endoscope tip 20,22, bringing the ablation probe 50/torque tube 130 with it. The snare catheter is removed and torque tube 130 may be removed before ablation probe is returned to the mediastinum, as already noted. An endoscopic grasper may be used to position probe 50 around the pulmonary veins to perform ablation.
Another alternative procedure involves the use of dissecting endoscope 10 to dissect the pericardial reflection underneath the superior vena cava, using tip 20. Next dissecting endoscope 10 is pulled back out of opening 11 and tip 20 is removed and replaced by tip 20′. Loop 36 is cinched down over tip 20′ to connect snare catheter 30 to dissecting endoscope 10 and together, dissecting endoscope 10 and snare catheter 30 are inserted into the transverse pericardial sinus and the distal end of snare catheter may be advanced by dissecting endoscope 10 over to reach the pericardium 2 on the left side of the heart, where loop may then be loosened and dissecting catheter 10 may be removed for further manipulation of catheter 10 to deflect the distal end downwardly for advancement into the oblique pericardial sinus. All further steps and techniques for this procedure have been previously described above with regard to alternative procedures using snare catheter 30.
Alternative to advancing the distal end of snare catheter 30 over to pericardium 2 on the left side of the heart, dissecting endoscope may be released and removed after initially positioning the distal end of catheter 30 through the opening in the pericardium and into transverse pericardial sinus 4, after which, catheter 30 can be advanced to find its own pathway over to the pericardium 2 on the left side of the heart. Further alternatively, a tip 20′ with nub 22 may be used to perform the dissection of the pericardial reflection under the superior vena cava while suture loop 36 has already been cinched down to connect snare catheter 30 thereto. In this case, dissecting endoscope 10 does not need to be pulled out of the body after performing the initial dissection, but can instead be inserted directly into the transverse pericardial sinus with the snare catheter 30 already attached.
Handle 160 is rigid and may be made of any of the materials described above for making tube 16. Typically handle 16 is molded form a rigid polymer, such as polycarbonate, for example. Pegs 160p protrude from one portion 160a of handle and are provided to mate with sockets 160s provided in corresponding locations of the other portion 160b of handle 160. Handle 160 may be further secured upon assembly by screws, bolts, adhesives, or the like or combinations of the same.
Insert 166 is provided as a convenient way to form multiple lumens within main tube 16. Insert 166 has a major cross-section dimension 168 that is slightly less, but nearly equal to the inside diameter 16i of main tube 16, so that when insert 166 is inserted into main tube 16, it forms a friction fit with main tube 16. Alternatively, insert 166 may be configured to loosely slide within main tube 16, and upon insertion to the desired position, may be secured by one or more set screws or other mechanical and/or chemical expedient. Insert 166 is further provided with one or more grooves or “half-lumens” 162 that, together with the inside wall of main tube 16 form full lumens when insert 166 is positioned within tube 16. In the example shown, a large half lumen 162e is provided to form a lumen in device 10 through which an endoscope will be passed, half lumen 162s is provided to form a lumen to receive suction tube 170, and half lumen 162sn is provided to form a lumen to pass a snare catheter through. A further advantage provided by insert 166 is that multiple, interchangeable inserts 166 may be provided to change the lumen configuration of device 10. For example, an additional insert may be provided to form four lumens 162 with tube 16. By removing the insert 166 shown in
Tip 20 may be configured to also be interchanged, as noted above. In the example shown, tip 20 has prongs 172 extending proximally therefrom, with pins, pegs or other protrusions 176 extending therefrom. Tip 20 may further be optionally provided with a gasket or other seal 177 to prevent fluid flow into tube 16 where tip 20 meets tube 16. Main tube 16 is provided with openings 174 configured to receive protrusions 176, thereby locking tip 20 to main tube 16. Upon inserting, prongs 172 are flexed inwardly to allow protrusions 176 to pass within tube 16. The potential energy stored in prongs 172 by such flexing, drives prongs into openings 174 as the potential energy is converted to kinetic energy, and maintains them there, thereby locking tip 20 with respect to tube 16. To remove tip 20 for interchange, protrusions 176 are pressed inwardly to clear the walls of openings 174 and the tip can then be simply pulled out from its attachment with tube 16.
In the example shown, tip 20 is configured to provide the endoscope with an improved depth of field. The lens 201 of tip 20 is provided with a constant wall thickness throughout (and may be formed of clear polycarbonate, for example), and with a radius of curvature that allows the distal end of an endoscope to butt up against the inner surface of lens 201 and still be able to focus on tissues outside of the tip. As noted, tips may be interchanged to provide specialized functions. For example, device 10 in
Tip 20,20′ may be further provided with openings 178 that communicate with lumens 162 in device 10. For example, while endoscope lumen 162e directs to lens 201 of tip 20 shown in
Suction tube 170 fluidly connects with suction luer 180, which may be made from TYGON® tubing or other vinyl, PAC or nylon surgical tubing. Suction luer 180 is further provided at a proximal end thereof with luer connector 182 configured to be connected with a source of vacuum, to thereby deliver suction to the distal end of device 10 through suction tube 170 and suction opening 178s. Similarly, an introducer tube 184 may be provided to connect with snare luer 162sn to guide a snare catheter into device 10, through snare luer 162sn and distally out of snare opening 178sn.
Turning now to FIGS. 14A-C, a discussion of an improved light delivery configuration for prevention of reflections from the lens of tip 20 to an endoscope viewing therethrough is discussed.
As light is directed from the fiber optic 6 in the configuration of
In order to eliminate such reflections tip 20 may be designed with a lens 201 that interfaces with endoscope 8 such that fiber optic 6 is aligned with a proximal end surface 20e of lens 201. With this arrangement, light emitted from fiber optic 6 is made incident on the proximal surface 20e of lens 201 and directed between the walls 20i, 20o, and then exits outer wall 20o as it is directed onto the object to be viewed. With this arrangement there can be no light reflected from the inner surface of the lens 201 and this eliminates the problem discussed above. Since the proximal surface 20e is substantially parallel with the emission end of fiber optic 6, there is essentially no reflection of incident light back from surface 20e, but even if there is a slight reflection, the reflection is at so small an angle that it does not detrimentally effect the light viewed through lenses 4 since the angle is not great enough to direct such reflected light into lenses 4.
While the present invention has been described with reference to the specific embodiments thereof, it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process step or steps, to the objective, spirit and scope of the present invention. All such modifications are intended to be within the scope of the claims appended hereto.