US20200046393A1 - Apparatus and methods for performing minimally-invasive surgical procedures - Google Patents

Abstract

Devices, tools and methods for performing minimally invasive surgical procedures. Methods of performing minimally invasive ablation procedures. Methods of performing rapid exchange of tools in a device while the device remains in a reduced-access surgical space.

Description

CROSS-REFERENCE
• This application is a divisional of U.S. application Ser. No. 14/579,870, filed on Dec. 22, 2014, which is a continuation of U.S. application Ser. No. 11/544,897, filed on Oct. 7, 2006 (now U.S. Pat. No. 8,932,208), which is a continuation-in-part application of U.S. application Ser. No. 11/138,950, filed on May 26, 2005 (now abandoned). Each of these applications (U.S. application Ser. No. 14/579,870, U.S. application Ser. No. 11/544,897 and U.S. application Ser. No. 11/138,950) are incorporated herein by reference in their entireties, and we claim priority to each of these applications under 35 USC § 120.
FIELD OF THE INVENTION
• 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.
BACKGROUND OF THE INVENTION
• 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 identify 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 theFlex 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 andFlex 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.
SUMMARY OF THE INVENTION
• Apparatus, devices tools 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.
• Surgical device for performing minimally invasive surgical procedures are provided, including an elongated body having distal and proximal end portions and at least two lumens extending generally along a direction of a longitudinal axis of the elongated body; and a distal tip attachable to the distal end portion of the elongated body, the distal tip including a lens that is viewable therethrough and aligned with one of the at least two lumens that is configured for receiving an endoscope therein.
• In at least one embodiment, a handle is attached to the proximal end portion of the elongated body. In at least one embodiment, a bell is rotatably attached to the handle.
• In at least one embodiment, the elongated body is substantially rigid.
• In at least one embodiment, at least one of the at least two lumens other than the lumen configured for receiving an endoscope therein comprises a service port adapted to receive a tool other than an endoscope. In at least one embodiment, two such service ports are provided.
• In at least one embodiment, each service port provided comprises a tube received within the elongated body of the device.
• In at least one embodiment, each tube extending from a service port comprises a stainless steel hypotube.
• In at least one embodiment, an endoscope is positioned in the lumen that is configured for receiving an endoscope therein.
• In at least one embodiment, the distal tip of the device comprises at least one lumen therethrough, wherein each lumens of the tip is configured and dimensioned to receive one of the tubes therein and provide an exit opening for a service port through the tip.
• In at least one embodiment, a seal is provided between the lens and a portion of the tip proximal to the lens.
• In at least one embodiment, a proximal end portion of each tube is securely held by a handle attached to the proximal end portion of the elongated body.
• In at least one embodiment, the lens is removably mounted to a remainder of the distal tip via mechanical connection.
• In at least one embodiment, the lens is removably mounted to the remainder of the distal tip via at least one of friction fitting and threads.
• In at least one embodiment, the lens is fixed to a remainder of the distal tip via adhesive.
• In at least one embodiment, the distal tip is fixable to a distal end piece that includes at least one lumen, wherein the distal end piece is mountable to the distal end portion of the elongated body, and wherein the at least one lumen of the distal end piece aligns in communication with respective ones of at least one of the at least two lumens of the elongated body, in fluid communication therewith, to function as at least one service port.
• In at least one embodiment, a protrusion extends distally from a distal end of the distal tip.
• In at least one embodiment, a snare device extends through one of the at least two lumens, and the snare device includes a snare on a distal end thereof.
• In at least one embodiment, the snare device further comprises a snare on a proximal end thereof.
• In at least one embodiment, a handle provided on the proximal end portion of the device comprises an open proximal end configured to receive an endoscope therethrough. In at least one embodiment, the handle captures the proximal end portion of the elongated body, thereby preventing axial movement of the elongated body with respect to the handle. In at least one embodiment, the handle allows rotation of the elongated body with respect thereto. In at least one embodiment, the handle prevents rotation of the elongated body with respect thereto.
• In at least one embodiment, a recess is provided in a portion of the handle, wherein the recess is configured and dimensioned to receive a light cable that extends from an endoscope, when the endoscope is received in the elongated body.
• In at least one embodiment, an insert is mounted within the elongated body, wherein the insert and the elongated body cooperate to define the at least two lumens. In at least one embodiment, the insert forms a friction fit with the elongated body within said elongated body.
• In at least one embodiment, a second insert can be provided to be interchanged with the first insert, wherein the second insert and the elongated body cooperate to form lumens having at least one of: a different size, different relative positioning and different number of lumens relative to size, positioning and number of the at least two lumens formed in cooperation between the elongated main body and the first insert.
• In at least one embodiment, a second tip is provided that is interchangeable with the first tip, the second tip comprising at least one of: a different size, different relative positioning and different number of lumens relative to size, positioning and number of the at least one lumen formed in the first tip.
• In at least one embodiment, the distal tip is axially aligned with the lumen that is configured for receiving the endoscope therein, and at least one of the at least two lumens that is not configured for receiving the endoscope therein is positioned radially outwardly from the lumen that is configured to receive the endoscope therein, such that an implement can be delivered though each lumen positioned radially outward, and a distal end portion of the implement is deliverable alongside the tip.
• In at least one embodiment, the distal tip comprises a ball-ended tip.
• In at least one embodiment, the distal tip is bullet shaped.
• In at least one embodiment, the distal tip comprises a notch configured and dimensioned to receive a portion of a snare therein.
• In at least one embodiment, a suction luer is provided in fluid communication with one of the at least two lumens, wherein the suction luer extends from the proximal end portion of the elongated body.
• In at least one embodiment, an introducer tube is provided in fluid communication with one of the at least two lumens, wherein the introduce tube extends from the proximal end portion of the elongated body.
• In at least one embodiment, the elongated body comprises three lumens, and the device further includes an introducer tube in fluid communication with a lumen other than the lumen configured and adapted to receive an endoscope and the lumen in fluid communication with the suction luer, wherein the introducer tube extends from the proximal end portion of the elongated body.
• In at least one embodiment, the tip of the device is releasably attachable to the elongated body. In at least one embodiment, the tip comprises protrusions on a proximal end portion thereof, and the elongated body comprises openings through the walls of the distal end portion thereof, wherein the openings are configured and dimensioned to receive the protrusions.
• In at least one embodiment, a suction tube extends through one of the at least two lumens and provides fluid communication between the distal and proximal end portions of the elongated body.
• In at least one embodiment, a suction tube extends through one of the at least two lumens and provides fluid communication between the distal tip and the proximal end portion of the elongated body.
• In at least one embodiment, the tip of the device includes an inner stop configured to prevent distal advancement of a distal end of the endoscope therepast, to establish an offset between a distal end of the distal tip and the distal end of the endoscope.
• In at least one embodiment, a cage is mounted to the distal tip to extend distally therefrom.
• In at least one embodiment, the lens of the distal tip comprises an outer lens, and the distal tip further includes an inner tapered lens configured to break up reflections when viewing through the endoscope.
• In at least one embodiment, the distal end portion of the elongated body has a first cross-sectional area and the proximal end portion of the elongated body has a second cross-sectional area, wherein the second cross-sectional area is greater than the first cross-sectional area. In at least one embodiment, the distal end portion of the elongated body is teardrop-shaped in cross-section. In at least one embodiment, the proximal end portion of the elongated body is circular in cross-section.
• In at least one embodiment, the lumens are formed by metal tubes within the elongated tubular body.
• In at least one embodiment, the distal tip of the device comprises at least one inflatable member mounted to a proximal end portion thereof.
• In at least one embodiment, a snare capture tool extends through one of the at least two lumens, and has a ball-shaped distal end.
• In at least one embodiment, a retrieval hook tool extends through one of the at least two lumens, and has a hook at a distal end thereof.
• In at least one embodiment, a bolo tool extends through one of the at least two lumens, and has a ball at a distal end thereof. In at least one embodiment, the bolo tool also has a ball at a proximal end thereof.
• In at least one embodiment, a trigger snare tool extends through one of the at least two lumens, the trigger snare tool comprising a snare at a distal end thereof that is extendable distally from the distal end portion of the elongated body, and a trigger configured to actuate the snare, wherein the trigger is located proximally of the proximal end portion of the elongated body.
• In at least one embodiment, the snare of the trigger snare tool is angled relative to a longitudinal axis of the trigger snare tool.
• In at least one embodiment, a perforation tool extends through one of the at least two lumens, and the perforation tool includes a needle or barbed needle at a distal end thereof, wherein the needle or barbed needle is extendable distally of the distal end portion of the elongated body. In at least one embodiment, the perforation tool further includes a cutter blade, wherein the barbed needle is retractable proximally to draw tissue engaged by the barb needle into contact with the cutter blade.
• In at least one embodiment, a perforation tool extends through one of the at least two lumens, wherein the perforation tool comprises graspers adapted to be extended distally to grasp tissue, and a cutter blade, and wherein the graspers are retractable proximally to draw tissue engaged by the graspers into contact with the cutter blade.
• In at least one embodiment, a perforation tool extends through one of the at least two lumens, and the perforation tool includes a cork screw adapted to be extended distally to engage tissue, and a cutter blade, wherein the corkscrew is retractable proximally to draw tissue engaged by the corkscrew into contact with the cutter blade.
• In at least one embodiment, a perforation tool extends through one of the at least two lumens, and the perforation tool comprises a spike configured to pierce through tissue upon an impulsive impact, and a plunger type actuator located on a proximal end portion of the perforation tool.
• In at least one embodiment, a mapping probe tool extends through one of the at least two lumens of the device, and the mapping probe tool includes at least a pair of mapping elements on a distal end portion thereof, wherein the mapping elements are extendable distally of a distal opening of the lumen. In at least one embodiment, the distal end portion of the mapping probe tool is bent at an angle to a longitudinal axis of a remainder of the mapping probe tool when the mapping probe tool is in an unbiased state. In at least one embodiment, the distal end portion of the mapping probe tool is formed in a Y-shape when in an unbiased state, one of the mapping elements being located on one arm of the Y-shape and a second of the mapping elements being located on an arm opposite the one arm.
• In at least one embodiment, a linear ablating probe tool extends through one of the at least two lumens, the linear ablating probe tool comprising a linear ablation element on a distal end portion thereof.
• In at least one embodiment, a point ablation probe tool extends through one of the at least two lumens, the point ablation probe tool comprising an ablation probe point on a distal tip thereof.
• In at least one embodiment, a cautery tool extends through one of the at least two lumens, the cautery tool comprising a cauterizing element on a distal end portion thereof.
• In at least one embodiment, graspers extend through one of the at least two lumens, and the graspers include a tube having sufficient length to simultaneously extend from both distal and proximal openings of the lumen, grasping jaws provided at a distal end portion of the graspers, and an actuator located at a proximal end portion of the graspers, wherein the actuator is linked to the grasping jaws for operation thereof.
• In at least one embodiment, scissors extend through one of the at least two lumens, wherein the scissors include a tube having sufficient length to simultaneously extend from both distal and proximal openings of the lumen, scissor jaws provided at a distal end portion of the scissors, and an actuator located at a proximal end portion of the scissors, and wherein the actuator is linked to the scissor jaws for operation thereof.
• In at least one embodiment, the device further includes an inflatable member that is expandable around a base of the distal tip to achieve a temporary, atraumatic increase in diameter at a distal end portion of the device. In at least one embodiment, a fitting plug is positioned over the elongated body and fixed to the inflatable member for holding the inflatable member in position over the base of the distal tip. In at least one embodiment, a tensioning member interconnects the fitting plug and the inflatable member, and the tensioning member is adjustable to draw the inflatable member into a desired position at the base of the distal tip.
• In at least one embodiment, the lumen of the device that is configured for receiving an endoscope therein comprises a positioning feature for positioning the endoscope at more than one predetermined location. In at least one embodiment, the positioning feature comprises biased sockets configured to receive protrusions on the endoscope therein.
• In at least one embodiment, the distal tip of the device includes at least one window proximal of a distal end of the distal tip, through which viewing by the endoscope is permitted.
• In at least one embodiment, a handle of the device includes proximal and distal stops so that when the endoscope is inserted in the lumen that is configured for receiving an endoscope therein, a light cable of the endoscope abuts the proximal stop for placing the endoscope in one predetermined location relative to the elongated body, and abuts the distal stop for placing the endoscope in a second location relative to the elongated body.
• A surgical device for performing minimally invasive surgical procedures is provided, including: a first elongated body having distal and proximal end portions and at least one lumen extending generally along a direction of a longitudinal axis of the first elongated body and configured and dimensioned for receiving an endoscope therein; a second elongated body aligned substantially parallel with the first elongated body, the second elongated body having distal and proximal end portions and at least one lumen extending generally along a direction of a longitudinal axis of the second elongated body and configured and dimensioned for receiving a tool other than the endoscope therein; and a distal tip attachable to the distal end portion of the first elongated body, wherein the distal tip includes a lens that is viewable therethrough and aligned with the lumen that is configured and dimensioned for receiving an endoscope therein. In at least one embodiment, an endoscope is positioned in the lumen that is configured and dimensioned for receiving an endoscope therein.
• In at least one embodiment, a handle is attached to the proximal end portion of the first elongated body.
• In at least one embodiment, the first and second elongated bodies are substantially rigid.
• In at least one embodiment, the second elongated body is fixed externally to the first elongated body. In at least one embodiment, the second elongated body is welded to the first elongated body.
• In at least one embodiment, a snare device extends through one of the at least one lumen of the second elongated body, wherein the snare device has a snare on a distal end thereof. In at least one embodiment, the snare device further includes a snare on a proximal end thereof.
• In at least one embodiment, the distal tip is attached to the distal end portion of the first elongated body, and a distal end of the endoscope is positioned within the distal tip.
• In at least one embodiment, the distal tip comprises a ball-ended tip.
• In at least one embodiment, the distal tip is bullet shaped.
• In at least one embodiment, the distal tip comprises a notch configured and dimensioned to receive a portion of a snare therein.
• In at least one embodiment, a tool other than an endoscope extends through one of the at least one lumens of the second elongated body. In at least one embodiment, the tool is selected from the group consisting of: suction tool, snare capture tool, retrieval hook tool, bolo tool, trigger snare tool, perforation tool, mapping probe tool, linear ablating probe tool, point ablation probe tool, cautery tool, graspers tool, and scissors tool.
• A surgical device for performing minimally invasive surgical procedures is provided, including: an elongated body having distal and proximal end portions and at least two lumens extending generally along a direction of a longitudinal axis of the elongated body; and an endoscope positioned in one of the at least two lumens that is configured and dimensioned for receiving the endoscope therein; wherein a distal end of the elongated body extends distally past a distal end of the endoscope to shield the distal end of the endoscope during use.
• In at least one embodiment, the distal end of the elongated body is open.
• In at least one embodiment, one of the at least one lumens comprises an irrigation lumen. In at least one embodiment, a nozzle is provided at a distal end of the irrigation lumen. In at least one embodiment, the nozzle is oriented toward the distal end of the endoscope. In at least one embodiment, the nozzle is located out of a field of view of the endoscope.
• In at least one embodiment, the distal end portion of the elongated body is transparent to allow visualization therethrough.
• In at least one embodiment, a snare device extends through one of the at least two lumens of the elongated body, the snare device having a snare on a distal end thereof. In at least one embodiment, the snare device further comprises a snare on a proximal end thereof.
• A surgical device for performing minimally invasive surgical procedures is provided, including: an elongated body comprising a semi-flexible sleeve having distal and proximal end portions and at least one lumen extending generally along a direction of a longitudinal axis of said elongated body; and
• a rigid distal tip attached to a distal end of said elongated body, said distal tip being viewable therethrough.
• In at least one embodiment, the sleeve is sufficiently flexible to navigate around pulmonary veins to at least partially encircle the pulmonary veins and the sleeve is sufficiently rigid so that a proximal portion of the sleeve outside of a patient can be pushed on to advance the distal end portion of the sleeve within the patient.
• In at least one embodiment, an endoscope is inserted in the sleeve, the endoscope having a rigid shaft and being positioned for viewing through the distal tip.
• In at least one embodiment, the distal tip comprises a ball at a distal end thereof.
• In at least one embodiment, the distal tip comprises at least one port in fluid communication with the at least one lumen in the elongated body.
• A surgical device for performing minimally invasive surgical procedures is provided, including: an elongated body comprising a semi-flexible sleeve having distal and proximal end portions; and
• a capturing feature extending distally from a distal end of said elongated body.
• In at least one embodiment, an endoscope is inserted in the sleeve, wherein the endoscope has a distal tip attached thereto that extends distally of the distal end of the elongated body.
• In at least one embodiment, the capturing feature comprises a snare threaded through openings in the distal tip to extend distally therefrom. In at least one embodiment, the elongated body is slidable proximally with respect to the distal tip to cinch down the snare.
• In at least one embodiment, the capturing feature comprises a pad of either a hook or a loop portion of a hook and loop type fastening mechanism.
• In at least one embodiment, the capturing feature comprises a magnet.
• A surgical device for performing minimally invasive surgical procedures is provided, including: an elongated body having distal and proximal end portions and at least two lumens extending generally along a direction of a longitudinal axis of the elongated body, wherein at least one of the lumens comprises a slot opening to an external surface of the elongated body, and the slot is configured and dimensioned to releasably secure a tool therein via friction fit.
• In at least one embodiment, the tool comprises a snare catheter.
• In at least one embodiment, a distal tip attachable to the distal end portion of the elongated body, wherein the distal tip includes a lens that is viewable therethrough and aligned with one of the at least two lumens that is configured for receiving an endoscope therein.
• In at least one embodiment, the slot extends over a majority of a length of the elongated body.
• In at least one embodiment, the slot is formed in an eyelet on the distal end portion of the elongated body.
• In at least one embodiment, the tool includes a distal end portion having a first outside diameter larger than an outside diameter of a portion of the tool immediately proximal of the distal end portion of the tool, wherein the portion immediately proximal is slidable through the slot, and wherein retraction of the tool being positioned through the slot and into the lumen that the slot opens to, secures the distal end portion in the eyelet.
• In at least one embodiment, the slot is formed by a keyed socket on the distal end portion of the elongated member.
• In at least one embodiment, the at least one lumen having a slot is asymmetrical in cross-section and forms a cam surface permitting the tool to be rotated into the at least one lumen having a slot.
• A surgical device for performing minimally invasive surgical procedures is provided, including: an endoscope having an elongated shaft having distal and proximal end portions; a distal tip attachable to the distal end portion of the endoscope, the distal tip including a lens that is viewable therethrough; and a ring provided over the elongated shaft and axially slidable with respect thereto, the ring being configured and dimensioned to releasably fix a distal end portion of a tool thereto.
• In at least one embodiment, the ring comprises a releasable locking mechanism.
• In at least one embodiment, the tool comprises a snare catheter.
• A surgical device for performing minimally invasive surgical procedures is provided, including: a jig having slots configured and dimensioned to receive and releasably fix an endoscope and at least one tool thereto for rapid exchange procedures.
• In at least one embodiment, a pair of such jigs each configured with the slots, is provided.
• In at least one embodiment, an endoscope and a snare catheter are each releasably fixed to the jig.
• A surgical device for performing minimally invasive surgical procedures is provided, including: a jig having at least one opening configured and dimensioned to receive and releasably fix a tool thereto for rapid exchange procedures; and an opening configured and dimensioned to receive an endoscope therethrough, wherein the endoscope is freely slidable with respect to the jig.
• In at least one embodiment, a pair of such jigs are provided.
• In at least one embodiment, each jig comprises at least two openings for releasably fixing at least two tools.
• In at least one embodiment, an endoscope is slidably received within the jig, and a snare catheter is releasably fixed to the jig.
• In at least one embodiment, an endoscope is slidably received within the jig, a snare catheter is releasably fixed to the jig, and a second tool is releasably fixed to the jig. In at least one embodiment, the second tool comprises a suction tube.
• A surgical device for performing minimally invasive surgical procedures is provided, including: an elongated body having distal and proximal end portions and configured and dimensioned to receive an endoscope therethrough and to apply suction therethrough; and a distal tip attachable to the distal end portion of the elongated body, the distal tip including a lens that is viewable therethrough, the distal tip having a proximal opening having an outside diameter that is greater than an outside diameter of a distal end of the elongated body, such that a gap is formed between the distal tip and the elongated body when the distal tip is attached to the elongated body, facilitating diffuse application of suction.
• In at least one embodiment, struts interconnect the distal tip and the elongated body.
• A routing snare tool configured and dimensioned to be slid through a lumen of a device that also receives an endoscope is provided, including: a flexible outer tube having sufficient column strength to advance the tool through the lumen by pushing on a proximal portion of the outer tube from a location outside of the lumen, to advance the tube without buckling; a snare line having a length greater than a length of the flexible outer tube; and a snare loop fixed to an end of the snare line via heat shrink tubing.
• In at least one embodiment, a second snare loop is fixed to an opposite end of the snare line via heat shrink tubing.
• In at least one embodiment, both ends of the outer tube are chamfered.
• In at least one embodiment, the heat shrink tubing is color coded differently with respect to each snare loop to facilitate ready visual distinction between the two snare loops.
• In at least one embodiment, the snare loop comprises a kink extending distally from a remainder of the snare loop.
• In at least one embodiment, the snare loop is angled, with respect to a longitudinal axis of the snare line, by an angle of less than about thirty degrees.
• In at least one embodiment, a lock is configured to fix a position of the snare line relative to the outer tube to maintain the snare loop in a cinched configuration. In at least one embodiment, the lock comprises an actuator configured to move a clamp into contact with the snare line. In at least one embodiment, the lock comprises a pair of locking clasps that are alternatively lockable and releasable by the same actuating movement by a user.
• A snare capture tool configured and dimensioned to be slid through a lumen of a device that also receives an endoscope is provided, including: an elongated mandrel configured and dimensioned to be slid through the lumen; a handle fixed to a proximal end of the mandrel; and a ball fixed at a distal end of the mandrel.
• In at least one embodiment, a polymeric layer is formed over a majority of the mandrel, wherein a distal end portion of the mandrel extends from a distal end of the polymeric layer and is not covered thereby.
• In at least one embodiment, a compressible spring is provided over the polymeric layer, a proximal end portion of the spring abuts the handle, and the spring has a outside diameter larger than an inside diameter of the lumen, thereby being prevented from insertion into the lumen.
• In at least one embodiment, the snare capture tool is configured and dimensioned, so that when the spring is compressed against a proximal end of the lumen by advancing the handle distally with respect to the lumen, the ball and at least a portion of the distal portion not covered by the polymeric layer extend distally from a distal end of the lumen, and when a driving force is released from the handle, the spring expands, thereby retracting the ball and the at least a portion of the distal portion not covered by the polymeric layer, into the lumen.
• A retrieval hook tool configured and dimensioned to be slid through a lumen of a device that also receives an endoscope is provided, including: an elongated mandrel configured and dimensioned to be slid through the lumen; a handle fixed to a proximal end of the mandrel; and a hook provided at a distal end of the mandrel.
• In at least one embodiment, a polymeric layer is formed over a majority of the mandrel, wherein a distal end portion of the mandrel extends from a distal end of the polymeric layer and is not covered thereby.
• In at least one embodiment, a compressible spring is provided over the mandrel, a proximal end portion of the spring abutting said handle, said spring having a outside diameter larger than an inside diameter of said lumen, thereby being prevented from insertion into said lumen.
• In at least one embodiment, the retrieval hook tool is configured and dimensioned, so that when the spring is compressed against a proximal end of the lumen by advancing the handle distally with respect to the lumen, the hook extends distally from a distal end of the lumen, and when a driving force is released from the handle, the spring expands, thereby retracting the hook into the lumen.
• In at least one embodiment, the mandrel is offset in the polymeric layer, such that longitudinal axes of the mandrel and the polymeric layer do not coincide.
• A bolo tool configured and dimensioned to be slid through a lumen of a device that also receives an endoscope is provided, including: an elongated mandrel configured and dimensioned to be slid through the lumen; a first ball provided at a proximal end of the mandrel; and a second ball provided at a distal end of the mandrel.
• A trigger snare tool and dimensioned to be slid through a lumen of a device that also receives an endoscope is provided, including: an elongated mandrel configured and dimensioned to be slid through the lumen; a snare provided at a distal end of the mandrel; and a snare guide into which the elongated mandrel is slidably received, the snare guide being configured and dimensioned to be slid through the lumen, wherein the snare guide is slidable distally with respect to the mandrel to cinch down the snare.
• In at least one embodiment, a handle is provided at a proximal end of the mandrel; a trigger is slidably positioned over the handle and fixed to a proximal end of the snare guide; and a biasing member is provided that biases the trigger distally from the handle.
• In at least one embodiment, the snare, when uncinched, is oriented at an acute angle with respect to a longitudinal axis of the mandrel.
• A perforation tool configured and dimensioned to be slid through a lumen of a device that also receives an endoscope is provided, including: a perforating member connected to an actuator via an elongated shaft; a sheath configured and dimensioned to be slid through the lumen of the device and to surround the perforating member and the shaft during sliding within the lumen; wherein the actuator is operable to slide the perforating member distally with respect to the sheath to extend the perforating member distally beyond a distal end of the sheath.
• In at least one embodiment, the perforating member comprises a needle.
• In at least one embodiment, the perforating member comprises a spike.
• In at least one embodiment, the perforation tool includes a handle mounted to a proximal portion of the tool, the handle being configured to be mated with a connector of a suction assembly.
• In at least one embodiment, a cutting blade is positioned proximally of the perforating member, and the perforating member is configured to engage tissue, wherein the actuator is actuatable to retract the perforating member, after engaging tissue, to draw the tissue against the cutting blade, thereby cutting an opening through the tissue.
• In at least one embodiment, a second actuator is provided, wherein the second actuator is linked to the cutting blade and is operable to rotate the cutting blade.
• In at least one embodiment, the perforating member comprises a barbed needle.
• In at least one embodiment, the perforating member comprises a corkscrew.
• In at least one embodiment, the perforating member comprises graspers.
• In at least one embodiment, the actuator is further actuatable to open and close the graspers.
• A mapping probe tool configured and dimensioned to be slid through a lumen of a device that also receives an endoscope is provided, including: an elongated member configured and dimensioned to be positioned in the lumen and having a length sufficient to extend a proximal end portion of the elongated member from the proximal end of the lumen while a distal end portion extends distally from a distal end of the lumen; wherein the distal end portion includes at least a pair of probe mapping elements, and the probe mapping elements are electrically connectable to a power source located proximally of the tool via at least one electrical wire connected thereto.
• In at least one embodiment, a handle is fixed to a proximal end portion of the elongated member; and a biasing member is configured to bias the handle away from the lumen, the biasing member being configured and dimensioned to prevent insertion of the biasing member into the lumen.
• In at least one embodiment, the mapping tool is configured and dimensioned, so that when the handle is slid distally with respect to the lumen, thereby biasing the biasing member, the probe mapping elements extend distally from a distal end of the lumen, and when a driving force is released from the handle, the biasing member drives the handle proximally with respect to the lumen, thereby retracting the probe mapping elements into the lumen.
• In at least one embodiment, the distal end portion is Y-shaped in an unbiased configuration, with one of each pair of probes being located on opposite ones of open arms of the Y-shape.
• In at least one embodiment, the distal end portion is angled to a longitudinal axis of a remainder of the elongated member when the elongated member is in an unbiased configuration.
• A linear ablating probe tool configured and dimensioned to be slid through a lumen of a device that also receives an endoscope is provided, including: an elongated member configured and dimensioned to be positioned in the lumen and having a length sufficient to extend a proximal end portion of the elongated member from the proximal end of the lumen while a distal end portion extends distally from a distal end of the lumen; a linear ablation member located at the distal end portion of the elongated member and configured to form a linearly extending lesion in tissue being treated thereby; and at least one ablation conduit connected to the linear ablation member and extending from the linear ablation member to a proximal end portion of the elongated member, a proximal end of each ablation conduit being configured to be connected to a source of ablation energy located proximally of the tool.
• In at least one embodiment, an actuator is located on the proximal end portion of the elongated member, the actuator being operable by a user to deliver ablation energy to the linear ablation member.
• In at least one embodiment, a handle is fixed to a proximal end portion of the elongated member; and a biasing member is configured to bias the handle away from the lumen, the biasing member being configured and dimensioned to prevent insertion of the biasing member into the lumen.
• In at least one embodiment, the linear ablating tool is configured and dimensioned, so that when the handle is slid distally with respect to the lumen, thereby biasing the biasing member, the linear ablation member extends distally from a distal end of the lumen, and when a driving force is released from the handle, the biasing member drives the handle proximally with respect to the lumen, thereby retracting the linear ablation member into the lumen.
• A point ablation probe tool configured and dimensioned to be slid through a lumen of a device that also receives an endoscope is provided, including: an elongated member configured and dimensioned to be positioned in the lumen and having a length sufficient to extend a proximal end portion of the elongated member from the proximal end of the lumen while a distal end portion extends distally from a distal end of the lumen; an ablation probe point provided on a distal end of the elongated member and configured to form a point lesion in tissue being treated thereby; and an ablation conduit connected to the ablation probe point and extending from the ablation probe point to a proximal end portion of the elongated member, a proximal end of the ablation conduit being configured to be connected to a source of ablation energy located proximally of the tool.
• In at least one embodiment, an actuator is located on the proximal end portion of the elongated member, the actuator being operable by a user to deliver ablation energy to the ablation probe point.
• In at least one embodiment, a handle is fixed to a proximal end portion of the elongated member; and a biasing member is configured to bias the handle away from the lumen, the biasing member being configured and dimensioned to prevent insertion of the biasing member into the lumen.
• In at least one embodiment, the point ablation probe tool is configured and dimensioned, so that when the handle is slid distally with respect to the lumen, thereby biasing the biasing member, the ablation probe point extends distally from a distal end of the lumen, and when a driving force is released from the handle, the biasing member drives the handle proximally with respect to the lumen, thereby retracting the ablation probe point into the lumen.
• A cautery tool configured and dimensioned to be slid through a lumen of a device that also receives an endoscope is provided, including: an elongated member configured and dimensioned to be positioned in the lumen and having a length sufficient to extend a proximal end portion of the elongated member from the proximal end of the lumen while a distal end portion extends distally from a distal end of the lumen; a cauterizing element provided on a distal end of the elongated member and configured to cauterize tissue; and an electrical wire connected to the cauterizing element and extending from the cauterizing element to a proximal end portion of the elongated member, a proximal end of the electrical wire being configured to be connected to a power source located proximally of the tool.
• In at least one embodiment, an actuator is located on the proximal end portion of the elongated member, the actuator being operable by a user to deliver energy to the cauterizing element.
• In at least one embodiment, a handle is fixed to a proximal end portion of the elongated member; and a biasing member is configured to bias the handle away from the lumen, the biasing member being configured and dimensioned to prevent insertion of the biasing member into the lumen.
• In at least one embodiment, the cautery tool is configured and dimensioned, so that when the handle is slid distally with respect to the lumen, thereby biasing the biasing member, the cauterizing element extends distally from a distal end of the lumen, and when a driving force is released from the handle, the biasing member drives the handle proximally with respect to the lumen, thereby retracting the cauterizing element into the lumen.
• A graspers tool configured and dimensioned to be slid through a lumen of a device that also receives an endoscope is provided, including: grasping jaws connected to an actuator via an elongated linkage; a sheath configured and dimensioned to be slid through the lumen of the device and to surround the grasping jaws and the linkage during sliding within the lumen; the actuator being operable to slide the grasping jaws distally with respect to the sheath to extend the grasping jaws distally beyond a distal end of the sheath.
• In at least one embodiment, the actuator is further actuatable to open and close the grasping jaws.
• A scissors tool configured and dimensioned to be slid through a lumen of a device that also receives an endoscope is provided, including: scissors jaws connected to an actuator via an elongated linkage; a sheath configured and dimensioned to be slid through the lumen of the device and to surround the scissors jaws and the linkage during sliding within the lumen; the actuator being operable to slide the scissors jaws distally with respect to the sheath to extend the scissors jaws distally beyond a distal end of the sheath.
• In at least one embodiment, the actuator is further actuatable to open and close the scissors jaws.
• A minimally invasive method of routing a flexible tool around an internal structure in a patient's body is provided, including the steps of: inserting a device including an endoscope through a small opening in the patient and advancing the device to position a distal end of the device into a surgical space in which the internal structure resides; inserting the flexible member through a service port in the device and extending a distal end portion of the flexible member distally of a lumen joined by the service port; visually confirming positioning of the distal end portion via the endoscope; removing the device from the patient via the small opening while maintaining the flexible member in the patient, substantially in the current position of the flexible member; inserting the device through a second small opening in the patient and advancing the device to position the distal end of the device into the surgical space in which the internal structure resides, on a side of the internal structure opposite to the side in which the flexible member is placed; connecting the distal end of the device with the distal end portion of the flexible member; and removing the device from the patient via the second small opening, thereby drawing the flexible member around the internal structure.
• In at least one embodiment, the method further includes further comprising advancing the distal end of the flexible member partially around the internal structure after removing the device from the patient via the small opening while maintaining the flexible member in the patient, substantially in the current position of the flexible member.
• In at least one embodiment, the method includes visualizing the distal end of the flexible member through the endoscope to align the device with the flexible member to perform the connecting step.
• In at least one embodiment, the distal end of the flexible member comprises a snare loop and the connecting step comprises cinching the snare loop over a distal end portion of the device.
• In at least one embodiment, the method includes fixing an ablation device to the proximal end of the flexible member and further advancing the flexible member by drawing the flexible member out of the second opening, thereby routing the ablation device around the internal structure.
• In at least one embodiment, the internal structure comprises a plurality of pulmonary veins.
• In at least one embodiment, the method includes ablating tissue along a pathway defined by the ablation device around the internal structure.
• In at least one embodiment, the distal end of the flexible member comprises a ball and the connecting step comprises inserting a retrieval hook tool through a service port of the device, extending a hook of the retrieval hook tool distally of a distal end of a lumen that is in fluid communication with the service port, and hooking the distal end portion of the flexible member with the hook.
• In at least one embodiment, the distal end of the flexible member comprises a snare loop and the connecting step comprises inserting a retrieval hook tool through a service port of the device, extending a hook of the retrieval hook tool distally of a distal end of a lumen that is in fluid communication with the service port, and hooking the snare loop with the hook.
• In at least one embodiment, the distal end of the flexible member comprises a ball and the connecting step comprises inserting a trigger snare tool through a service port of the device, extending a snare of the trigger snare tool distally of a distal end of a lumen that is in fluid communication with the service port, and snaring the distal end portion of the flexible member by cinching down the snare loop after placing the snare loop over the ball.
• In at least one embodiment, after said inserting the through a small opening in the patient and prior to advancing the device to position a distal end of the device into a surgical space in which the internal structure resides, a step of perforating at least one tissue layer to establish a pathway for the advancing step is performed.
• In at least one embodiment, the perforating step comprises inserting a perforating tool through a service port of the device, extending a perforating member distally of a distal end of a lumen that is in fluid communication with the service port and into contact with tissue to be perforated, and perforating the tissue.
• In at least one embodiment, the perforating step comprises inserting a perforating tool through a service port of the device, extending a perforating member distally of a distal end of a lumen that is in fluid communication with the service port and into contact with tissue to be perforated, grasping the tissue and retracting the grasped tissue against a cutting blade, thereby perforating the tissue.
• In at least one embodiment, the method further includes reinserting the device into at least one of the first and second openings, advancing the distal end of the device toward the internal structure, and visually inspecting at least a portion of the lesion formed around the internal structure via the endoscope.
• In at least one embodiment, the method further includes reinserting the device into at least one of the first and second openings, advancing the distal end of the device toward the internal structure, inserting a mapping probe tool through a service port in the device, extending mapping probe elements distally of a distal opening of a lumen in fluid connection with the service port, contacting tissue on opposite sides of a lesion, formed by the ablating step, with at least one mapping probe on each side of the lesion, and measuring sufficiency of the lesion formed with the mapping probe tool.
• A minimally invasive method of routing a flexible tool around an internal structure in a patient's body is provided, including: inserting a device including an endoscope through a small opening in the patient and advancing the device to position a distal end of the device into a surgical space in which the internal structure resides; inserting the flexible member through a service port in the device and extending a distal end portion of the flexible member distally of a lumen joined by the service port; visually confirming the distal end portion via the endoscope; retracting the device to remove the flexible member from a distal end of the lumen, while maintaining the flexible member in the patient, substantially in the current position of the flexible member; distally advancing the device into patient to position the distal end of the device into the surgical space in which the internal structure resides, on a side of the internal structure opposite to the side in which the flexible member is placed; connecting the distal end of the device with the distal end portion of the flexible member; and removing the device from the patient via the small opening, thereby drawing the flexible member around the internal structure.
• In at least one embodiment, the method further includes advancing the distal end of the flexible member partially around the internal structure after removing the flexible member from the device while maintaining the flexible member in the patient, substantially in the current position of the flexible member.
• In at least one embodiment, the method further includes fixing an ablation device to the proximal end of the flexible member and further advancing the flexible member by drawing the flexible member out of the opening, thereby routing the ablation device around the internal structure.
• In at least one embodiment, the method further includes ablating tissue along a pathway defined by the ablation device around the internal structure.
• A minimally invasive method of routing a flexible tool around an internal structure in a patient's body is provided, including the steps of: inserting a device including a semi-flexible sheath slid over an endoscope through a small opening in the patient and advancing the device to position a distal end of the device into a surgical space in which the internal structure resides, the semi-flexible sheath including a rigid, transparent distal end that allows viewing therethrough via the endoscope; visually confirming placement of the distal end of the semi-flexible member via the endoscope; removing the device endoscope from the patient via the small opening while maintaining the semi-flexible member and rigid distal end in the patient, substantially in the current position of the semi-flexible member and rigid distal end; inserting the endoscope through a second small opening in the patient and advancing the endoscope to position the distal end thereof into the surgical space in which the internal structure resides, on a side of the internal structure opposite to the side in which the semi-flexible member is placed; connecting the distal end of the endoscope with the distal end of the semi-flexible member; and removing the endoscope from the patient via the second small opening, thereby drawing the semi-flexible member around the internal structure.
• In at least one embodiment, the method further includes advancing the distal end of the semi-flexible member partially around the internal structure after the removal of the endoscope from the patient via the small opening while maintaining the semi-flexible member in the patient, substantially in the current position of the flexible member.
• In at least one embodiment, the method further includes visualizing the distal end of the flexible member through the endoscope to align the device with the flexible member to perform the connecting step.
• In at least one embodiment, the method further includes sliding a sleeve having a distal tip over the endoscope prior to inserting the endoscope through a second small opening.
• In at least one embodiment, the sleeve comprises a snare loop extending from the distal tip, the snare loop being threaded through a distal tip and the distal tip being mounted to the endoscope.
• In at least one embodiment, the connecting step comprises cinching the snare loop around the distal end of the semi-flexible member.
• In at least one embodiment, the cinching is performed by sliding the sleeve proximally with respect to the endoscope.
• In at least one embodiment, the method further includes fixing an ablation device to the proximal end of the semi-flexible member and further advancing the semi-flexible member by drawing the semi-flexible member out of the second opening, thereby routing the ablation device around the internal structure.
• In at least one embodiment, the method further includes ablating tissue along a pathway defined by the ablation device around the internal structure.
• A method of performing rapid exchange of tools in a device while performing a minimally invasive surgical procedure is provided, including the steps of: inserting a device having at least and an endoscope and a first tool received therein, through a small opening in the patient and advancing the device to position a distal end of the device into a reduced-access surgical space; removing the first tool from the device, while maintaining the device and the endoscope in the surgical space; and inserting a second tool into the device, thereby replacing the tool having been removed.
• In at least one embodiment, the removing step comprises removing the first tool through a slot opening to an external surface of the device from a lumen in the device.
• In at least one embodiment, the first tool comprises a snare catheter.
• In at least one embodiment, the removing step comprises removing the first tool from an eyelet on a distal end portion of the device.
• In at least one embodiment, the lumen from which the slot opens is asymmetrical in cross-section and forms a cam surface permitting the second tool to be rotated into the lumen.
• In at least one embodiment, the device comprises a ring provided over an elongated shaft of the endoscope and axially slidable with respect thereto, and wherein the removing step comprises releasing the first tool from the ring.
• In at least one embodiment, the device comprises a jig having slots configured and dimensioned to receive and releasably fix the endoscope and the first tool.
• In at least one embodiment, the device comprises a pair of such jigs.
• In at least one embodiment, the device comprises a jig having an opening configured and dimensioned to receive and releasably fix the first tool thereto for rapid exchange procedures; and an opening configured and dimensioned to receive the endoscope therethrough, wherein the endoscope is freely slidable with respect to the jig.
• A method of relieving side loading by an operating room suction tubing on a device in fluid communication with the operating room suction tubing is provided, including the steps of: providing a length of tubing having a lighter gauge than a gauge of the operating room suction tubing, the length of tubing having proximal and distal ends; connecting the distal end of the length of tubing to a suction assembly of a device to be used to apply suction; and connecting the proximal end of the length of tubing to the operating room suction tubing, thereby putting the suction assembly of the device in fluid communication with the operating room suction tubing.
• In at least one embodiment, the method further comprises clamping the length of tubing to a support.
• In at least one embodiment, the length of tubing comprises a tether extending therefrom, and the clamping step comprises clamping the tether to the support.
• In at least one embodiment, the support is a surgical drape.
• A tool for relieving side loading on a device in fluid communication with an operating room suction tube is provided, including: a length of tubing having a lighter gauge than a gauge of the operating room suction tubing, the length of tubing having proximal and distal ends; a first connector at a distal end of the length of tubing configured and dimensioned to be connected to a suction assembly of the device, to establish fluid communication between the suction assembly and the length of tubing; a second connector at a proximal end of the length of tubing configured and dimensioned to be connected to the operating room suction tube, to establish fluid communication between the operating room suction tube and the length of tubing; and a tether extending from the length of tubing, the tether adapted to be clamped to a support.
• These and other features of the invention will become apparent to those persons skilled in the art upon reading the details of the devices, tools and methods as more fully described below.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1A shows a dissecting instrument that may be used to carry out procedures during the performance of methods described herein.
• FIG. 1B shows an optional tapered or conical transparent tip mounted concentrically with respect to the endoscope andtip20 and withintip20 ofFIG. 1A.
• FIG. 2A shows another example of an instrument useful for performing procedures described herein.
• FIG. 2B is an exploded view of the device shown inFIG. 2A.
• FIG. 2C is a plan view of a device, similar to that shown inFIG. 2A, but having a dissecting tip.
• FIG. 2D is an exploded view of a device that is similar to device shown inFIG. 2A, configured for routing an implement along a navigational course in a reduced access surgical environment.
• FIG. 2E is a plan view of a device, similar to that shown inFIG. 2A, but having a ball tip.
• FIG. 3A shows an assembled view of a device with an endoscope inserted.
• FIG. 3B shows an exploded view of the arrangement shown inFIG. 3A.
• FIGS. 4A and 4B show an end view and longitudinal sectional view of a tip configured as an atraumatic viewing tip that offsets tissue from the endoscope lens by an offset distance.
• FIG. 4C shows one example of a tip having a different offset length than that of the example ofFIG. 4B.
• FIG. 4D shows a tip provided with a cage.
• FIG. 4E shows another modification of a tip in which the distal surface has a parabolic profile or “bullet tip”.
• FIGS. 4F and 4G show tips which differ in configuration by the thickness of the lens at the distal end portion of the tip.
• FIG. 4H shows a tip that is further provided with openings that communicate with lumens in a device to which the tip is connected.
• FIG. 4I is a sectional view of the tip ofFIG. 4H.
• FIG. 4J is a distal end view of the tip ofFIG. 4H.
• FIG. 4K shows a ball ended tip that may be used for routing an implement along a navigational course in a reduced access surgical environment, and/or for retrieving an implement already having been so routed.
• FIG. 4L shows a variation of the tip shown inFIG. 4K, in which a slot, groove, notch or other securement feature is provided at the proximal end portion of the ball.
• FIG. 4M shows a tip similar to that ofFIG. 4K and in which a similar offset has been designed and in which the distal end portion of the lens has varied thickness.
• FIGS. 4N and 40 show sectional and distal end views of a variation of a ball-ended tip that includes openings configured to communicate with lumens in a device to which it is attachable.
• FIGS. 4P-4S show various tips that are adapted to facilitate dissection when connected to a device and inserted into a surgical space.
• FIGS. 5A, 5B and 5C show a viewing tip, ball-ended tip and dissecting tip, respectively.
• FIGS. 6A-6N show alternative arrangements for forming multiple lumens within a tube.
• FIG. 6O is a partial, exploded view of a device showing a proximal end portion of a distal tip configured to function as a bracket to maintain a distal position of an inner tube relative to an outer tube.
• FIG. 6P shows an example where a handle of the device functions as a bracket to maintain proximal end portions of inner in position relative to the outer tube.
• FIG. 7A is a perspective view of a handle employable in at least one device embodiment described herein.
• FIGS. 7B and 7C show opposite handle haves of the handle shown inFIG. 7A.
• FIG. 8A is a perspective view of a variation of a handle employable in at least one device embodiment described herein.
• FIGS. 8B and 8C show opposite handle haves of the handle shown inFIG. 8A.
• FIG. 9A illustrates a tip having threads provided at a proximal end portion thereof.
• FIG. 9B illustrates another tip having threads provided at a proximal end portion thereof.
• FIG. 9C shows an arrangement in which a tip is provided with a quick release mechanism.
• FIG. 10A shows an embodiment of a snare catheter that may be inserted into a tube or lumen for routing to a desired surgical location in a reduced-access surgical site.
• FIG. 10B shows an embodiment of a snare catheter having a preconfigured bend in its distal section when in an unstressed state.
• FIGS. 11A and 11B illustrated a partial view and sectional view of the distal end of another arrangement of an endoscope and tube, in which no tip is used.
• FIG. 12A illustrates a cutaway anterior view of a human heart with an instrument being used to penetrate the pericardial reflection.
• FIG. 12B shows advancement of a snare loop to pass superiorly over the left pulmonary veins, around the left pulmonary veins and into the oblique pericardial sinus.
• FIG. 12C shows an instrument having been inserted into the oblique sinus via a small opening in the patient.
• FIG. 12D shows an ablation device fixed to the proximal end of a member having been routed around the pulmonary veins.
• FIG. 13A illustrates an alternate arrangement of devices that may be used in a procedure like that described with regard toFIGS. 12A-12D, to route an ablation device in order to form an encircling pathway of lesions around the pulmonary veins.
• FIGS. 13B-13C show sliding the flexible device over a catheter for use in a procedure as described above with regard toFIG. 13A.
• FIG. 14 illustrates one example of a lock, wherein an actuator is provided to be slid or rotated by an operator to tighten or loosen a clamp against a snare line.
• FIG. 15 illustrates an alternative locking mechanism that includes a four bar linkage.
• FIG. 16A-16B illustrate a partial perspective view and cross-sectional view of an alternative arrangement for releasing a snare catheter from a device.
• FIGS. 17A-17C illustrate another alternative arrangement for releasing a snare catheter from an instrument/device.
• FIGS. 17D-17E illustrate a modification of the alternative arrangement shown inFIGS. 17A-17C.
• FIGS. 18A, 18B and 18C illustrate a released view, a captured view, and a cross-sectional view of the captured view of another quick release arrangement allows a snare catheter to be rapidly separated from a device.
• FIG. 19 illustrates an arrangement where a ring or sleeve is provided over the shaft of an endoscope so as to be freely slidable with respect thereto, and a snare catheter is releasably fixable to the ring or sleeve.
• FIG. 20A illustrates another arrangement, wherein one or more jigs are provided through which a snare catheter or other tube or tool, and endoscope are passed.
• FIG. 20B is a perspective view of one of the jigs shown inFIG. 20A.
• FIG. 20C shows the assembly ofFIG. 20C without the endoscope.
• FIGS. 21A-21B illustrate a plan view and sectional view of a jig, wherein lumens formed in the jig are provided with slots or gaps that allow a snare catheter and/or other tools, and endoscope to be snapped in and out for rapid exchange.
• FIG. 22 illustrates a modification of a connection of a tip to a device that allows diffuse suction to be applied.
• FIG. 23A shows an exploded view of another example of a device in accordance with an embodiment of the present invention.
• FIG. 23B is a partial, exploded view of the distal end portion of the device shown inFIG. 23A.
• FIG. 23C is a partial, exploded view of the proximal end portion of the device shown inFIG. 23A.
• FIG. 24 shows a suction assembly that is configured and dimensioned to be slid through either of the service ports in the device shown inFIG. 23A.
• FIG. 24A illustrates another example of a snare catheter, which is also referred to as a “routing snare” tool.
• FIG. 24B shows distal and proximal end portions of the snare routing tool shown inFIG. 24A.
• FIG. 25A shows a snare capture tool.
• FIG. 25B is an enlarged view of the proximal end portion of the snare capture tool shown inFIG. 25A.
• FIG. 25C is an enlarged view of the distal end portion of the snare capture tool shown inFIG. 25A.
• FIG. 26A shows an elongated retrieval hook tool configured and dimensioned to be slid though a lumen of a device described herein.
• FIG. 26B illustrates the tool shown inFIG. 26A in use.
• FIG. 26C illustrates a partial view of a hook tool in an alternative configuration.
• FIG. 27A illustrates a bolo tool that may be used in place of a snare assembly for routing an ablation device around the pulmonary veins.
• FIG. 27B shows a retrieval tool that may be used to retrieve the bolo tool shown inFIG. 27A.
• FIG. 27C illustrates a distal end portion of a retrieval tool.
• FIG. 28A illustrates a perforation tool that may be used to perforate the pericardial sac prior to introduction of a device therethrough.
• FIG. 28B shows an alternative arrangement of a perforation tool in which graspers are provided to grasp the pericardial tissue, to draw it back against a cutter blade to form an opening in the pericardial tissue.
• FIG. 28C shows another alternative arrangement of a perforation tool, wherein the grasping implement provided in this example is a cork screw configuration, which can be screwed into the pericardial tissue to grasp or secure it, to draw it back against a cutter blade.
• FIG. 28D shows another alternative arrangement of a perforation tool that may be used to form an opening in the pericardial tissue and/or used for dissection through the pericardial reflections.
• FIG. 28E shows still another alternative arrangement of a perforation tool that may be used to form an opening in the pericardial tissue and/or used for dissection through the pericardial reflections.
• FIG. 29A illustrates a partial view of a mapping probe tool that may be used in a device described herein.
• FIG. 29B shows a variation of the tool ofFIG. 29A.
• FIG. 29C shows another variation of the tool ofFIG. 29A.
• FIG. 30 illustrates a partial view of a linear ablating probe tool that may be used in a device described herein.
• FIG. 31 illustrates a distal end portion of a point/disk ablation probe tool that may be used in a device described herein.
• FIG. 32 illustrates a distal end portion of a monopolar cautery tool that may be used in a device described herein.
• FIG. 33 illustrates graspers that may be used in a device described herein.
• FIG. 34 illustrates scissors that may be used in a device described herein.
• FIG. 35A illustrates an arrangement for minimizing side loading on a suction assembly during use with a device described herein, when the suction assembly is connected to a suction source.
• FIG. 35B illustrates an example of suction tube management wherein an extension tubing is in fluid communication with a suction assembly provided in a device that is configured to be used in surgical site.
• FIG. 35C illustrates a tether that is clamped to a surgical drape to accomplish the suction tube management described with regard toFIG. 35B.
• FIG. 36A shows another alternative arrangement of a device according to an embodiment of the present invention.
• FIG. 36B illustrates the device ofFIG. 36A with inflatable member inflated.
• FIG. 36C shows an end view of the device shown inFIG. 36B.
• FIG. 37A illustrates a device with a positioning feature for positioning an endoscope at more that one predetermined location.
• FIG. 37B illustrates a distal end portion of the device shown inFIG. 37A.
• FIG. 37C illustrates an alternative arrangement that provides for placement of an endoscope in two different locations longitudinally relative to the tip of a device into which the endoscope is inserted.
DETAILED DESCRIPTION OF THE INVENTION
• Before the present devices and methods 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, devices and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods, devices 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”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a lesion” includes a plurality of such lesions and reference to “the location” includes reference to one or more locations 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.
Definitions
• 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. It is further noted that minimally invasive procedures are not limited to closed-chest procedures but may be carried out in other reduced-access, surgical sites, including, but not limited to, the abdominal cavity, for example.
• 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), sometimes referred to as “minimally invasive surgery”. 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 toFIG. 1A, a dissectinginstrument10 is shown that may be used to carry out procedures during the performance of methods described herein. Dissectinginstrument10 includes an endoscope having an elongated tube or shaft16 (e.g., a rigid tube/telescope having a diameter of about 5 to about 7 mm and length of about 25-40 cm). Such endoscopes are available from various companies, including Olympus (Japan), and Stortz and Scholly (Germany) Tube orshaft16 is typically rigid to provide the best maneuverability, onceinstrument10 has been inserted into an area to perform surgical techniques, for dissecting usingtip20. As the dissection can be viewed using the endoscope of thesame instrument10, only one opening, such as a thoracotomy or port, or other small opening, such as a sub-xyphoid opening, to permit the insertion ofinstrument10 is required for performing dissection.
• For purposes of maintaining an established pathway through tissue, such as may be established by dissection as described, a non-collapsing, flexible orrigid tube14 may be placed coaxially over theendoscope shaft16 as shown inFIG. 1A.Tube14 may be made from flexible material such as polyvinyl chloride or polyethylene, incorporated with metal (e.g., stainless steel, NITINOL™ (nickel-titanium alloy) or the like) or plastic (nylon, polyester, or the like) mesh to render it non-collapsing; ortube14 may be constructed of rigid plastic, such as polycarbonate, liquid crystal plastic (LCP), ULTEM® (amorphous thermoplastic polyetherimide), or the like, or from stainless steel or the like.Tube14 is freely slidable overshaft16 and is initially positioned over the proximal portion ofshaft16 as shown inFIG. 1A, thereby leaving a distal portion with a smaller diameter profile for better mobility around the surgical space during dissection. For example,tube14 may be about two thirds the length ofshaft16 for use in non-invasive epicardial ablation techniques as described below, wherein tube is about 27 cm. Of course, the present invention is not limited to this length or to the proportion of the lengths oftube14 toshaft16, as these may vary depending upon the applications that theinstrument10 may be used for, as well as other factors.
• Tip20 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 orprotrusion22 may be provided to extend from the distal end oftip20 to increase friction with thetip20 against tissue to facilitate dissection.Tip20 is transparent to enable direct viewing to the surgical site throughendoscope16 and of the dissection as it is proceeding.Tip20 may be distanced from the lens at thedistal end16dofendoscope shaft16 so that any tissue that contacts tip20 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 oftip20 and the lens at the distal end ofshaft16dpermits a field of view byendoscope10, 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.Tip20 may be removable to allow interchangingtip20 with another tip for carrying out another function, as will be described in more detail below. Optionally, a tapered or conicaltransparent tip24 may be mounted concentrically with respect to the endoscope andtip20 and withintip20, as shown inFIG. 1B. The surface of angled orconical tip24 breaks up the reflected waves from theblunt tip20 and prevents the formation of a ring of reflected light in the visualization throughendoscope16 that might otherwise occur. Further details about such an arrangement are described in co-pending application Ser. No. 11/137,987 filed 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 asharper tip24 within ablunt tip20 may be employed inablation devices10 that use ablunt tip20 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 ofinstrument10 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 theendoscope16. Like some existing endoscopes, theendoscope16 provided withinstrument10 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 endoscope16 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 ofinstrument10 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 ofinstrument10 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 theinstrument10 where it can be connected to an external power source.
• While typically rigid, the distal end portion ofinstrument10 may be formed to be articulating, to provide a greater range of motion during dissecting as well as for directing placement oftube14 in examples wheretube14 is flexible. Further alternatively,endoscope16 may be made flexible or malleable for situations where it would be advantageous for the particular application or technique being practiced.
• FIG. 2A shows another example of aninstrument10 useful for performing procedures for epicardial atrial ablation.Instrument10 includesmain tube17 that is configured to receive an endoscope therethrough, similar to the instrument shown inFIGS. 1A and 1B. Additionally, other lumens may be provided withinmain tube17 to permit greater functionality ofdevice10, as described in more detail below with reference toFIG. 2D. The blunt, generally roundedtip20 may be used in conjunction with an endoscope inserted intodevice10 to provide visualization to facilitate navigation through into the body. In one embodiment, described below, visualization is provided to navigate through the transverse and oblique sinuses in a closed chest cavity.
• FIG. 2B is an exploded view ofdevice10 shown inFIG. 2A.FIG. 2C is a plan view of adevice10 having a dissectingtip22.FIG. 2D is an exploded view of adevice10 that is similar todevice10 as shown inFIG. 2A, configured for routing an implement along a navigational course in a reduced access surgical environment. In one embodiment described below,device10 may be used to route a snare device through the transverse sinus of a chest cavity and leave it there asdevice10 is withdrawn.Device10 may then be inserted into the oblique sinus to capture the snare as the loop of the snare is cinched around theball tip20 ofdevice10. InFIG. 2D, snare30 may be inserted through a lumen intube17 so thatloop36 extends distally of opening178snfor routingsnare30.Snare30 can then be pushed through the lumen intube17 and out of opening178sn, thereby leavingsnare30 in place asdevice10 is withdrawn.
• In all of the embodiments shown inFIGS. 2A-2E,main tube17 is substantially rigid and may be made from stainless steel, or other biocompatible metal, alloy, rigid polymer or composite. The proximal end portion ofmain tube17 is captured byhandle160. The proximal end ofhandle160 is open to receive an endoscope that is guided therethrough and throughmain tube17 viaendoscope lumen162efor viewing throughtip20. Handle160 is typically formed inhalves160a,160bthat may be assembled over the proximal end portion ofmain tube17, thereby capturingtube17 to prevent axial movements with respect to handle160.Tube17 may be mounted to allow rotation with respect to handle160 (as shown inFIG. 2B), or may be mounted to prevent rotation. In order to prevent rotation, for example, proximal disk or washer may be formed with one ormore scallops16k(shown in phantom inFIG. 2B) and handle160 may then be provided with a mating projection or key that mates withscallop16kthereby preventing relative rotation betweenhandle160 andtube17 once handle160 has been assembled ontube17.
• Handle160 is rigid and may be made of any of the materials described above for makingtube17. Typically handle17 is molded form a rigid polymer, such as polycarbonate, for example.Pegs160p(e.g., seeFIG. 2B) may be provided to protrude from oneportion160b(such as inFIG. 7C, for example) of handle to mate with sockets or holes160s(FIG. 7B) provided in corresponding locations of theother portion160aofhandle160. Handle160 may be further secured upon assembly by screws, bolts, adhesives, or the like or combinations of the same.FIGS. 7A-7C and 8A-8C show enlarged views of two variations ofhandles160. In both of thesehandles160, arecess161 is provided in at least one of the handle halves160a,160band is configured to receive thelight post13 that extends from the proximal end portion ofendoscope16 to be connected to a light source via fiber optic cable, for example, to thereby capture the endoscope and maintain it integrally with thehandle160,tube17 andtip20,20′.
• Insert166 (FIG. 2B) may be provided as a convenient way to form multiple lumens withinmain tube17.Insert166 has amajor cross-section dimension168 that is slightly less, but nearly equal to the inside diameter17iofmain tube17, so that wheninsert166 is inserted intomain tube17, it forms a friction fit withmain tube17. Alternatively, insert166 may be configured to loosely slide withinmain tube17, and upon insertion to the desired position, may be secured by one or more set screws or other mechanical and/or chemical expedient.Insert166 may be further provided with one or more grooves or “half-lumens”162 that, together with the inside wall ofmain tube17 form full lumens wheninsert166 is positioned withintube17. In the example shown inFIG. 2B, alarge half lumen162eis provided to form a lumen indevice10 through which an endoscope will be passed,half lumen162sis provided to form a lumen to receivesuction tube170, andhalf lumen162snis provided to form a lumen to pass a snare catheter through.
• A further advantage provided byinsert166 is that multiple,interchangeable inserts166 may be provided to change the lumen configuration ofdevice10. Thus, any or all of the size, relative positioning and number of lumens can be altered by use of areplacement insert166 having a different configuration. For example, an additional insert may be provided to form fourlumens162 withtube17. By removing theinsert166 shown inFIG. 2B fromtube17 and inserting the insert with four half lumens (not shown),device10 would then be configured with four lumens.Device10 may also be provided with the capability of interchangingtips20, and therefore a tip having an additional through hole could also be interchanged to accommodate the additional lumen. Of course, inserts166 with less than the number ofhalf lumens162 shown inFIG. 2B may be provided and interchanged to configuredevice10 to have less than three lumens.
• FIGS. 6A-6N show alternative arrangements for forming multiple lumens within atube17. InFIG. 6A insert166 is shown which includes a primary, or relatively large lumen through which an endoscope may be passed, and two secondary, or relativelysmaller lumens162 for any of the uses described above.Insert166 may be extruded from a suitable biocompatible polymer, such as polycarbonate or ABS plastic, for example. InFIG. 6B,lumen162eandlumens162 are each formed as independent tubes and then installed intube17. Alternatively, the independently formed tubes may be joined together with a heat shrink tubing to fromtube17, for example. Thetubes defining lumens162 may be metallic, such as stainless steel or other biocompatible metal known and used in the art, or may be made of substantially rigid polymer. Thetube defining lumen162emay be made from similar materials. The tubes defining the lumens may be installed intube17 as shown in cross-section inFIG. 6B and may be fixed totube17 by adhesives, ultrasonic welding, heat bonding, or in a releasably mechanical fixture, such as by using screws and/or set screws, brackets, clamps, or other mechanical expedient that would be readily apparent to one of ordinary skill in the art.
• FIG. 6C shows a variation in whichlumens162 are not fully circular, but are formed by partial cylinders of material, such as half-pipes, or some other fraction of a full tubular structure. These partial cylinders may be made of any of the same materials described above with regard to thetubes defining lumens162 inFIG. 6B. The spaces162iresulting between the cylinders and partial cylinders may function as additional lumens, and may be used for irrigation, suction or delivery of a wire therethrough, for example. Thetube defining lumen162emay be the same as that described with regard toFIG. 6B. The partial tube may form a more secure fixation to thetube defining lumen162e. Additionally or alternatively, the partial tubes may enable alower profile tube17 to be used, while still providing the number of lumens needed therewithin, with sufficiently large dimensions for each lumen.
• InFIG. 6D, the tubes defining the lumens may be the same as those described with regard toFIG. 6B. In this arrangement,tube17 is form fitted around the configuration of tubes forming the lumens, to form a device have an overall more compact, smaller cross section, as the cross section oftube17 is smaller relative to that shown inFIG. 6B, and is consequently not circular in cross-section, when using the same dimension tubes to form the lumens. In this example, the lumens are formed by three stainless steel tubes, around which a heat shrink wrapping is formed to make theouter enclosure17.
• InFIG. 6E, the main body ofinsert166 may be formed of plastic, such as by extruding, for example, similar to that shown inFIG. 6A. In this arrangement, however, steel tubes are inserted through openings ininsert166 to define thesmaller lumens162. In this case, insert166 may be formed by insert molding, coextrusion, or by forcing the steel tubes into the openings ininsert166.
• FIG. 6F shows another variation of an extruded plastic insert configured to be inserted into atube17. In this arrangement,lumens162eand162 are continuously connected, as thesmaller lumens162 are formed as partial cylinders that open up to, or join lumen162e.
• FIG. 6G shows anotherinsert166 that may be extruded from plastic and that, in addition toprimary lumen162e, has a pair ofsecondary lumens162 of non-circular cross-section. InFIG. 6G,lumens162 are tear drop shaped, butlumens162 may be formed to have any cross-sectional shape that can be extruded. Also, more or fewer than twolumens162 can be formed, as in any of these examples. Further, thelumens162 do not have to be symmetrical or of equal cross-sectional area.
• FIG. 6H illustrates a cross-sectional view ofinsert166 fromFIG. 6F with ashaft16 of an endoscope residing therein as shown in phantom lines. InFIG. 6I,tube17 has a pair ofsmaller tubes18,19 (which may be steel) inserted therein and mounted thereto to formsecondary lumens162.FIG. 6I also illustrates endoscope shaft16 (in phantom) installed intube17. The arrangement shown inFIG. 6H-6J eliminates the need to extrude thelumens162, and requires no further manipulation or machining of tubes, as standard tubes can be assembled to form this arrangement. Furthermore, thetubes forming lumens162 are not glued or welded or attached to each other in any way, but are held in position (mounted) by assemblies or brackets at their distal and proximal ends. For example, the distal end may be held byproximal portion20pof distal tip shown inFIGS. 60 and 23B. Note that only onetube18 is shown inFIG. 6O as an alternative to providing twotubes18,19.FIG. 6P shows an example where handle160 functions as abracket18bto maintain the proximal end portions oftubes18,19 in position relative totube17. Additionally, handle160 may fix aproximal adapter162 of thetubes18,19 viahandle portion162b.
• FIG. 6J shows a perspective view of the distal portion of the arrangement shown inFIG. 6I (without the endoscope shaft16), and shows that thetubes18,19 that definelumens162 may extend distally oftube17 for registration withmating openings178s,178min adistal tip20,20′ to be connected thereto.FIG. 6K shows another configuration of aninsert166 which may be extruded from plastic. In this arrangement,snare lumen162snextends from and is continuous with main or primary (endoscope)lumen162e. A pair oflumens162swhich may be used to apply suction, for example, extend on opposite sides ofsnare lumen162sn. It will be appreciated that many more lumen configurations may be substituted for those shown, whether in an insert, or configured by tubes installed withintube17.
• FIGS. 6L-6N show another arrangement in whichlumens162 and162eare formed by two stainless steel tubes of appropriate diameter that are joined together lengthwise (FIG. 6L), such as by welding, adhesives, or other expedient, seeFIG. 6M. In this arrangement, in order to makedevice10 as compact as possible, particularly at the distal working end of the device, the distal end portion oftube17 is formed to be teardrop shaped, to minimize the cross-sectional area of the tube to substantially what is required bylumens162,162e. The proximal end portion of tube is made circular to form a better seal with the opening made in the patient. Accordingly,tube17 is completed by attached two half shells17a,17b(FIG. 6N, 17bnot shown) around the steel tubes that define thelumens162,162e. The proximal portions of shells17a,17bare semicircular in cross section, and the distal portions combine to make the reduced, teardrop cross-sectional shape.
• Tip20 may be configured to be interchanged, as noted above. In the example shown inFIG. 2B,tip20 hasprongs172 extending proximally therefrom, with pins, pegs or other protrusions176 extending therefrom.Tip20 may further be optionally provided with a gasket orother seal177 to prevent fluid flow intotube17 wheretip20 meetstube17.Main tube17 is provided withopenings174 configured to receive protrusions176, thereby lockingtip20 tomain tube17. Upon inserting,prongs172 are flexed inwardly to allow protrusions176 to pass withintube17. The potential energy stored inprongs172 by such flexing, drives prongs intoopenings174 as the potential energy is converted to kinetic energy, and maintains them there, thereby lockingtip20 with respect totube17. To removetip20 for interchange, protrusions176 are pressed inwardly to clear the walls ofopenings174 and the tip can then be simply pulled out from its attachment withtube17.
• Alternatively,tip20,20′ may be provided with threads20t(e.g., seetip20,FIG. 9A andtip22,FIG. 9B) at a proximal end portion thereof, for connectingtip20,20′ with mating threads on the distal end ofshaft16,17.Tips20,20′ may be injection molded in one piece from polycarbonate plastic, for example or from some other rigid, biocompatible and transparent plastic, glass or composite, or may be machined, for example.
• FIG. 9C shows another arrangement in which any oftips20,20′ described may be provided with a quick release mechanism. InFIG. 9C,tip20 is provided with anannular balloon20bor a plurality of balloons arranged annularly within a proximal end portion oftip20.Tip20, when placed over the distal end ofendoscope shaft16 ormain tube17 is inflated to expandballoon20bagainst the distal end portion ofshaft16 ortube17.Shaft16 ortube17 may be provided with exterior threads, undercuts, an annular channel, a shoulder, knurling or other roughened features16tto increase the friction and or anchor the positioning between theinflated balloon20band shaft/tube16,17.Balloon20bmay be inflated by attaching an irrigation orsuction catheter21 to a valve provided intip20,20′ and inputting compressed gas or saline or other biocompatible fluid under pressure.Catheter21 is then removed and the valve automatically closes to maintainballoon20bin the expanded configuration. To remove the tip, the pressurized gas or fluid is removed fromballoon20b, thereby reducing its size and releasing the friction grip/anchoring of the tip against the shaft/tube.Catheter21 may be reattached to the valve of the tip to release pressure.
• Tip20,20′ may be configured to provide the endoscope with an improved depth of field. Thelens201 of tip20 (FIG. 2B) may be 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 oflens201 and still be able to focus on tissues outside of the tip. Alternatively, the tip of the endoscope may stop at a predetermined distance from the inner surface oflens201, without butting up against the inner surface. As noted, tips may be interchanged to provide specialized functions. For example,device10 inFIG. 2C shows thetip20 ofFIG. 2A having been interchanged withtip20 having aprotrusion22, similar to tips having been described above to facilitate dissection.FIG. 2E showsdevice10 in which tip20 has been replaced byball tip20′.
• FIGS. 4A and 4B show an end view and longitudinal sectional view oftip20 configured as an atraumatic viewing tip that offsets tissue from the endoscope lens by an offsetdistance23, measured from aninner stop20stthat prevents further distal advancement of the distal end of the endoscope inserted withintip20 to the distal end oftip20. A smaller central channel20cmaintains the wall thickness of the tip at a substantially constant thickness to avoid visual distortion. Tips may be provided with varyingoffsets23 to vary the depth of field available to the endoscope.FIG. 4C shows one example oftip20 having a different offsetlength23 than that ofFIG. 4B.
• FIG. 4D shows another alternative arrangement, in whichtip20,20′ may be provided with a cage, such as a metallic or polymeric, substantially rigid,atraumatic wire cage20w. The structural members ofcage20ware spaced sufficiently so as not to substantially obstruct viewing throughtip20 and the endoscope, while offsetting the smooth distal surface oftip20 from tissues, thereby further reducing smearing or obstruction of visualization.Cage20wmay be mounted to tip20 by friction fit (press fit), threading, or other fixing means allowing removability of the cage from the tip, or may be adhered thereto, for example.
• FIG. 4E shows another modification oftip20 in which the distal surface has a parabolic profile or “bullet tip”. Additionally, this or any other tip described herein may be provided with an innertapered lens24, which has been found to break up certain reflections that may otherwise be viewed through the endoscope. The configurations ofFIGS. 4F and 4G differ by the thickness of the lens at the distal end portion oftip20, whereintip20 inFIG. 4G is provided with a thicker distal lens portion to provide greater magnification. The relative thickness of the lens affects the magnification, but this also works in combination with the curvature of the lens (e.g., the degree of concavity or convexity). Thus, variation in the thickness of the lens wall can be provided to vary the degree of magnification and in this way compensate for optical distortions that would otherwise occur. The offset23 of the two configurations shown inFIGS. 4F and 4G is about the same.Lens20 can be configured to offset tissue from the distal end or lens of the endoscope by a distance of about 3 mm to about 20 mm. In one embodiment, the offset23 is about 14 mm (between the distal tip ofendoscope16 and the distal tip of lens20). The diameter oflens20 can range from about 1 mm to about 20 mm. In one embodiment, thelens20 diameter is about 7 mm.
• Tip20,20′ may be further provided withopenings178 that communicate withlumens162 indevice10. For example, whileendoscope lumen162edirects tolens201 oftip20 shown inFIG. 2B, opening178sfluidly communicates withlumen162sso that suction can be delivered outside of tip20 (see also the embodiment shown inFIGS. 4I, 4J and 4H). Additionally, opening178sncommunicates withlumen162sn, permitting a snare catheter to be passed distally ofdevice10 throughlumen162snand opening178sn. In instances where more or fewer lumens are provided indevice10, as described above, more orfewer openings178 may be provided intip20, respectively.
• FIGS. 4K-40 show still further alternative tip configurations that may be provided.FIG. 4K shows a ball endedtip20 that may be used for routing an implement along a navigational course in a reduced access surgical environment, and/or for retrieving an implement already having been so routed, connecting to the implement, and further routing the implement along a further course.Tip20′ is a ball-ending tip that includes a taperedproximal portion20pthat may be conical or some other tapering shape that reduces in cross section in a distal direction. At the distal-most portion ofproximal portion20p, where proximal portion may be smallest in cross-section, a ball-shaped or sphericaldistal portion20dis integral therewith and extends distally therefrom.Spherical portion20dmay be sized on the order of about 2-4 mm in diameter, for example, typically about 3mm Tip20′ may be injection molded in one piece from polycarbonate plastic, for example or from some other rigid, biocompatible and transparent plastic, glass or composite, or may be machined, for example.
• Tip20′ (e.g., seeFIGS. 2E, 4K, 4M, 5B, 9B) is particularly well-suited for engaging a snare catheter. Whenendoscope10 is provided withtip20′ as described above, asendoscope10 is manipulated within a closed surgical space for advancement of ball end20dthroughsuture loop36, this procedure may be completely visualized throughendoscope10, as noted. After the ball end20doftip20′ passes throughsuture loop36,suture loop36 is cinched down on dissectingendoscope10 proximal to ball end20dat and against the proximal portion of theball20das it is tightened and slides distally along taperedportion20pto abut theball20d.
• FIG. 4L shows a variation of thetip20′ shown inFIG. 4K, in which a slot, groove, notch or other securement feature20gis provided at the proximal end portion ofball20d. Upon cinching asnare36 aroundtip20′ in a manner as described above, further insurance that snare36 will not slip from its grasp oftip20′ is provided as a portion ofsnare36 slides intogroove20g.FIG. 4M shows atip20′ similar to that ofFIG. 4K and in which a similar offset23 has been designed and in which the distal end portion of the lens has varied thickness.FIGS. 4N and 40 show a variation of a ball-endedtip20′ that includesopenings178 configured to communicate with lumens in a device to which it is attachable.
• FIGS. 4P-4S show various tips that are adapted to facilitate dissection when connected to a device and inserted into a surgical space. InFIG. 4P, tip20′ is provided with a small (e.g., about 1 mm diameter) nipple orprotrusion22 to extend from the distal end oftip20′. The length25 ofprotrusion22 may vary from about 0.25 to about 1.5 mm, andFIGS. 4P, 4Q and 4R showprotrusions22 of varying lengths. Also, any offset23 provided may be variable, as with previously described embodiments. The configuration ofFIG. 4Q shows a distal end portion of the tip having varied wall thickness. Alternatively,protrusion22 may be formed as a knurled feature as shown inFIG. 4S, or other roughened feature that increases friction betweentip20′ against tissue to facilitate dissection.
• FIGS. 5A, 5B and 5C show aviewing tip20, ball-endedtip20′ and dissectingtip20′, respectively. In each instance, one ormore lumens162 are provided in the shaft ortube16,17 radially from the main lumen provided to receive the endoscope. In this way, suction, irrigation, or other implements can be delivered alongsidetip20,20′.FIGS. 5A and 5B each show a portion of asnare catheter30 extending distally fromlumen162.
• Referring back toFIG. 2B,suction tube170 connects in fluid communication withsuction luer180, which may be made from TYGON® tubing or other vinyl, PVC or nylon surgical tubing.Suction luer180 is further provided at a proximal end thereof withluer connector182 configured to be connected with a source of vacuum, to thereby deliver suction to the distal end ofdevice10 throughsuction tube170 andsuction opening178s. Similarly, an introducer tube184 (FIG. 2C) may be provided to connect withsnare luer162snto guide a snare catheter intodevice10, throughsnare lumen162snand distally out of snare opening178sn. Alternatively,proximal luer connector182 may be connected to a fluid source (e.g., a syringe) to deliver irrigation, or a wash for lens cleaning. This irrigation can also be used in conjunction with an ablation probe (e.g., microwave powered probe, or other known ablation power source) to deliver local fluidic cooling in the vicinity of the ablation probe.
• InFIG. 2D, handle160 is provided as two handlehalves160a,160band is rotatable with respect toshaft17. In this way, the light cable connected to131 can be rotated to be moved out of the operator's way by rotatinghandle160 without the need to rotateshaft17.
• FIG. 3A shows an assembled view andFIG. 3B shows an exploded view of another embodiment of adevice10 with endoscope inserted.Shaft16 of endoscope is inserted through the main lumen ofshaft17 so that the distal tip of the endoscope is positioned withintip20, as described above. Snarecatheter30 is inserted through the lumen formed intube17sso that the distal loop (snare) of the snare catheter can be advanced distally of the distal opening of the lumen throughtube17s.Tube17sis mounted externally oftube17 and runs parallel therewith, so that the lumen intube17sis parallel with the main lumen ofshaft17.
• FIG. 10A shows an embodiment ofsnare catheter30 that may be inserted intotube14 or throughlumen162snintube17 andlumen178 intip20,20′ for routing to a desired surgical location in a reduced-access surgical site. Snarecatheter30 may be constructed of flexible plastic material such as high density polyethylene (HDPE), polytetrafluoroethylene (PTFE, e.g., TEFLON®), polyvinyl chloride, nylon, or the like. Snarecatheter30 may be formed to be substantially straight in an unstressed state (FIG. 10A) or to have a preconfigured bend in its distal section30das shown inFIG. 10B, (e.g., of about the last 10-15 cm of catheter length, which may assist in maneuvering the catheter along a similar curved pathway within the body, such as directing the tip downward after it has been passed throughtube14,17.Catheter30 is sufficiently small to be easily slid throughtube14 orlumen162snand may be on the order of up to about 0.100″ in outside diameter, typically no greater than about 0.087″, for example.Catheter30 may be provided with a rigiddistal tip32 made from a biocompatible metal or rigid polymer.Rigid tip32 allows the snare to hold theball tip20dsecurely, as it does not give as the ball tip is drawn against it, wherein a soft tip may allow the ball tip to slip out when traction is applied to the snare catheter.
• Catheter30 is tubular, to allow suture line orwire34 to pass therethrough.Suture line34 includes asuture loop36 and may be formed with a sliding knot (an Endoloop) in a distal end thereof.Suture loop36 is located distally of the distal end ofcatheter30. 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 wire34 (or tail of the suture loop) extends throughcatheter30 and proximally out of the proximal end ofcatheter30, where it may be attached to apull tab38. Further, alock40 such as a two-way stopcock, clamp, hemostats, or other surgical clamp, tool or locking mechanism may be provided to grasp suture line orwire34 and abut the proximal end ofcatheter30 to prevent backsliding ofcatheter30 with respect to suture line34 (i.e., sliding ofcatheter30 proximally with respect to suture line34) as this device is drawn by ball end20d, or used to draw (route) an ablation device or other element into a desired surgical position, as will be described below.
• FIGS. 11A-11B illustrate another arrangement of an endoscope andtube17, in which notip20,20′ is present at all. Instead,tube17 extends distally past the distal end (opening/lens through which light is received for viewing through the endoscope)16dof the endoscope to shield it from contact with tissues asdevice10 is traversed toward a surgical site along a pathway through and around tissues. The distal end oftube17 is open andendoscope16 views through the open end oftube17. A luer fitting andtubing185, or other input feature for connecting to a source of pressurized saline or other fluid may extend fromhandle160 and fluidly connect with irrigation tube orlumen183. At the distal end of tube orlumen183, anozzle186 may be angled toward or oriented toward thedistal end16dof the endoscope, in a position that is out of the field of view (indicated by the dotted lines16vinFIG. 11B). In this way, thedistal tip16dcan be constantly, intermittently, or at will, irrigated to ensure that the lens of the endoscope does not become smudged or covered with blood or other tissue. Suction may be applied in any of the same manners throughluer connector182 as suction is applied to the distal end oftube17 through one or more lumens to uptake the irrigation fluid. At least the distal end portion oftube17 may be formed to be clear (transparent) to ensure that the field of vision16vis not obstructed. Thus, the distal end portion oftube17 physically shields184 the distal end of the endoscope without inhibiting visibility.
• An example of using devices described herein in a method according to the present invention will now be described, initially with reference toFIG. 12A.FIG. 12A illustrates a cutaway anterior view of a human heart1 withinstrument10 being used to penetrate thepericardial reflection2. The right side of the pericardium has been previously incised, using endoscopic shears (not shown). At least one port or opening11 is formed in the right chest of the patient (e.g., a port11 though the second or third intercostal space of the right chest) to provide access to the heart byinstrument10.Instrument10 is next inserted through opening11 andtip20,22 is used to dissect throughpericardium2 until superior vena cava3 can be visualized throughendoscope16. Dissection may be performed by carefully scrapingtip20/protrusion22 against the pericardial tissue to separate it with a side-to-side or up-and-down motion oftip20, for example. Dissection through the pericardial membrane (pericardial reflection) is made posterior to the superior vena cava thereby providing an entrance to the transverse pericardial sinus4. Upon achieving access to the transverse pericardial sinus4 withinstrument10,snare catheter30 may be inserted into the lumen intube17sand then distally advanced to extend snare loop distally from the lumen intube17s, as shown inFIG. 12A, to place it into the transverse pericardial sinus. Although the anatomical structures described herein are well-known and would be readily understood by those of ordinary skill in the art reading the present disclosure and referring to the Figs. herein, additional views may be found in United States Application Publication No. US2004/0111101 A1, (e.g., seeFIG. 1 and description thereof), which published on Jun. 10, 2004 and which is hereby incorporated herein, in its entirety, by reference thereto.Snare loop36 may continue to be advanced until it passes superiorly over the left pulmonary veins, around the left pulmonary veins5 and into the obliquepericardial sinus7, as shown inFIG. 12B.
• InFIG. 12A, assnare catheter30 is being distally advanced, the distal end of catheter30 (i.e., snare loop36) contacts against thepericardium2 on the left side of the heart, and upon further distal advancement ofcatheter30, the distal end ofcatheter30 andsuture loop36 are deflected downwardly and are further advanced, into the obliquepericardial sinus7, which is a majority of the region shown just beneath the left5 and right6 pulmonary veins on the posterior aspect of the heart inFIG. 12B. As can be seen inFIG. 12B,catheter30 at this stage has begun to encircle the pulmonary veins5,6. At this stage,instrument10 may be removed, while leavingsnare catheter30 in place.
• Next, withcatheter30 remaining in place as shown inFIG. 12B,instrument10 may be reinserted throughopening13 and used to dissect the pericardium at a location posterior to the inferior vena cava to form an opening to the oblique pericardial sinus. Alternatively,instrument10 may be reinserted through opening11 to perform this dissection in a similar manner. This is described in more detail in application Ser. No. 11/138,950. In either case, after thedissection instrument10 may then be inserted into the obliquepericardial sinus7.FIG. 12C showsinstrument10 having been inserted into the oblique sinus viaopening13. Insertion may be performed while viewing through theendoscope16 to aligntip20 withsuture loop36. Upon successfully passingtip20 throughsuture loop36 as shown inFIG. 12C, the operator next applies traction tosuture line34, while holdingcatheter30 stationary with respect to movement of thesuture line34. This causessuture loop36 to cinch down assuture line34 is pulled through the sliding knot of thesuture loop36. If theloop36 is formed of NITINOL®, or other nickel-titanium alloy, no sliding knot is present, rather the loop diameter decreases by virtue of the loop being pulled into the catheter. This action is continued untilsuture loop36 is in tight contact withdevice10 proximal oftip20, thereby effectively “lassoing”instrument10. Note that sinceinstrument10 necks down just proximal oftip20 as shown inFIGS. 1A and 1B, that suture loop is capable of maintaining a grip ondevice10, even under tension. A lock (not shown) may be fixed to suture line orwire34 in a position abutting the proximal end ofcatheter30 to preventcatheter30 from backsliding, as noted above, and particularly to preventsuture loop36 from expanding.
• Onceinstrument10 has been captured bysuture loop36, as described,instrument10 is then withdrawn back out of the opening into which it was inserted, drawingsuture loop36 and the distal end portion ofsnare catheter30 with it, out of the body. Anablation device50 is fixed to the proximal end of suture line34 (FIG. 12D), after removing the lock (if used). As one method,suture line34 may be tied to a distal leader52 ofablation device50. A suitable ablation device that may be used asablation device50 is theFlex 10 microwave probe (Guidant Corporation, Santa Clara, Calif.), although the present invention is not limited to use of this product only. Other ablation devices configured to form a long linear lesion and which are sufficiently flexible to surround the pulmonary veins as described herein may be substituted. Further, the energy type for performing the ablation need not be microwave energy, but may alternatively be any of the other types of energy that have been used to form lesions (e.g., Rf, electrical, heat, chemical, ultrasonic, etc.).
• Continued pulling on the distal end portion ofcatheter30 drawscatheter30 further out of the opening which, as a consequence, drawsablation device50 in through opening11 and leadsablation device50 around the pulmonary veins into the position previously occupied bycatheter30. At this stage, lesions can be formed by applying ablation energy through theablation device50 to ablate a pathway about three-quarters of the way around the pulmonary veins. Graspers or other instrument for use in an endoscopic environment can then be inserted through opening11 and used to grasp the distal end ofablation device50, and draw it superiorly so that it overlaps with the proximal end portion of theablation device50, thereby closing the loop around the pulmonary veins. The last quarter of the pathway can then be ablated to complete the formation of lesions all the way around the pulmonary veins. Alternatively, the overlapping procedure can be performed with the graspers prior to forming any lesions, and then lesions can be formed all the way around the pulmonary veins.
• Prior to commencing ablation, adequate positioning/location of theablation device50 can be confirmed by maneuvering and viewing throughdevice10 at locations along theablation device50, relative to the tissues that the device is located along. After formation of the lesions and removal of theablation device10 can again be inserted through opening11 and/oropening13 to inspect the lesions to determine whether they have been adequately formed. If, upon inspection, it is determined that further ablation needs to be performed (such as when a continuous lesion has not been formed all the way around the pulmonary veins, or a portion of the pathway formed by the lesions has been inadequately formed, for example), then the ablation device may be reinstalled in at least the position where the further ablation is required, using the techniques described above, and additional ablation energy can be applied to the target location where it has been determined that further ablation is necessary. Re-inspection can be performed after this, usinginstrument10 as described. This process can be iterated, if desired, until the surgeon is satisfied that the lesions have been adequately formed.
• When using theFlex 10 or similar product,ablation device50 may be actuated to incrementally form the lesion around the pulmonary veins, a segment at a time. For example, when using theFlex 10, a segment of tissue about one inch in length is ablated with each incremental ablation step. While the ablation device remains stationary, an antenna slides inside of it to change the location of tissue affected by energy emission from the antenna. The superior port11 may be approximately 10 to 15 mm in diameter, and theinferior port13 may be approximately 5 to 12 mm in diameter, but is typically about 5 mm in diameter.
• FIG. 13A illustrates an alternate arrangement of devices that may be used in a procedure like that described above with regard toFIGS. 12A-12D, to route anablation device50 in order to form an encircling pathway of lesions around the pulmonary veins. In this example,catheter30′ is provided as a semi-flexible sleeve.Rigid tip32′ is provided with a ball-shapedend33 that is configured to be engaged by a snare in a manner as described above.Rigid tip32′ and ball-shaped end are preferably made of a transparent plastic material to allow light to pass therethrough, and function as a lens forendoscope16 ascatheter30′ is installed as described below. One ormore ports35 may be provided indistal tip32′ which may be placed in fluid communication with a source of suction or irrigation via one or more lumens formed in the interior offlexible sleeve30′.
• Catheter30′ is installed through opening11 usinginstrument10.Catheter30′ is configured and dimensioned to be slid overinstrument10 as illustrated inFIGS. 13B-13C. Once arranged as inFIG. 13C,catheter30′ is inserted through opening11 and advanced to position ball-shapedend33 superiorly of the left pulmonary veins anddevice10 can then be withdrawn, leavingcatheter30′ in position.Catheter30′, while being flexible enough to bend as it traverses around the pulmonary veins, has sufficient rigidity so thattip32′ can be distally advanced by pushing on a proximal portion ofsleeve30′ from a location outside of the patient. Astip32 is distally advanced, it (e.g., ball tip33) contacts against thepericardium2 on the left side of the heart, and upon further distal advancement ofcatheter30′, the distal end ofcatheter30′ (i.e.,tip32′ and ball tip33) are deflected downwardly and are further advanced, into the obliquepericardial sinus7.
• Next,device10, havingtip20 installed thereon withsleeve17 slid over theendoscope16, as shown inFIG. 13A is inserted through an opening (13 or11) and advanced into the oblique pericardial sinus to captureball tip33. This is illustrated inFIG. 13A. Upon successfully lassoingtip32′ withsuture loop36,suture loop36 is retracted (slid proximally with respect to endoscope16). As the proximal end loop ofsnare line34 is fixed tosleeve17 andsnare line34 is threaded through openings formed intip20 as shown inFIG. 13A, this action draws snare line into the distal opening oftip20, thereby reducing the size ofsnare36 and cinching thesnare36 aroundtip32′ in abutment against the proximal side ofball33.
• Oncetip32′ has been captured bysuture loop36, as described,instrument10 is then withdrawn back out of the opening into which it was inserted, drawingsuture loop36 and the distal end portion ofcatheter30′ with it, out of the body. The remainder of the procedure is the same as described above with regard toFIGS. 12C-12D. Alternative mechanisms may be provided for connectinginstrument10/instrument tip20 withcatheter30/sleeve catheter30′ to perform the procedure described. For example, tip32′ may be provided with a pad of either the hook or loop portion of a hook and loop type fastening mechanism andtip20 ofinstrument10 may be provided with the opposite one of these. As another example,tip20 and snare36 may be provided with magnets on at least distal portions thereof that attract to one another when these component are brought near to one another.
• As noted above with regard toFIG. 12C, a lock provided to fix suture line orwire34 in a position to maintain thesnare loop36 cinched around the distal end portion of thecatheter30/sleeve catheter30′ to ensure that it maintains the connection as thecatheter30,30′ is pulled out of the body.FIG. 14 illustrates one example of such a lock, wherein an actuator (e.g., thumb wheel)40 is provided to be slid or rotated by the operator to tighten or loosen a clamp againstsnare line34, thereby allowingsnare line34 to be slid relative to handle160 when in the unlocked configuration, and locking thesnare line34 relative to thehandle160 when in the locked configuration.
• FIG. 15 illustrates analternative locking mechanism40 that includes a four bar linkage mounted to a proximal end portion offsnare catheter30. Pairs ofbars41 are connected bypivot joints42, with the twoproximal-most bars41 being joined by a third pivot joint43. The proximal end ofsnare line34 is also connected to this proximal joint43. The distal-most bars41 are pivotally mounted to a proximal end portion ofsnare catheter30.Bars41 are substantially rigid so that they do not bend significantly and thereby hold the intended position of thesnare line34.Lock40 has an unlocked configuration as shown inFIG. 15 and a locked configuration. To lock the mechanism, the operator holdscatheter30 and pulls on pivot joint43. This causes pivot joints42 to move toward one another until locking clasps44 push past one another. The extending arms of locking clasps deflect as they make contact with one another, allowing them to push past each other. Upon cessation of pulling on joint43 and thus release of the pressure on pivot points42, the extending arms of the locking clasps contact one another, thereby locking the locking mechanism in the locked configuration. In the locked configuration, bars41 are more nearly aligned with the longitudinal axis ofcatheter30. This extends the length ofsnare line34 between the proximal end ofcatheter30 and pivot joint43, causing a withdrawal ofsnare line34 and a portion ofsnare36 into the distal end ofcatheter30, thereby cinching down the size ofsnare36. To unlock the mechanism, joint43 is again pulled causing thejoints42 to again push towards one another, and then joint43 is quickly released. When joint43 is pulled, the locking clasps44 are pushed beyond contact with each other thereby releasing their engagement. Thesegments41 are biased toward the open position, such as by forming them from leaf springs biased to the open configuration, for example. The momentum generated by quickly releasing the pivot joints43 allowsclasps44 to deflect and push past one another allowing thebars41 to spring open to the open position shown inFIG. 15, asbars41 are spring biased toward the open configuration. In one alternative configuration, the pair of bars on each side ofsnare line34 may be replaced by a single spring steel band that is biased to the open configuration. This would also eliminate the pivot joints42.
• FIGS. 16A-16B illustrate an alternative arrangement for releasingsnare catheter30 frominstrument10 once snare has been placed into the transverse pericardial sinus as described above. In this arrangement,lumen162 formed to receivesnare catheter30 is formed as a slot or groove that is configured to form a friction fit withsnare catheter30 upon receivingsnare catheter30 therein.FIG. 16B shows a cross sectional view oftube17. At least the portion oftube surrounding groove162 is formed of an elastomer, so that the opening that runs longitudinally oftube17 can expand to receive or releasesnare catheter30. Once installed,slot162 maintainssnare catheter30 therein firmly. To release thesnare catheter30, snare catheter may be “peeled out” or “unzipped” fromslot162 starting from the proximal end portion, where the operator pulls the proximal end ofsnare catheter30 out ofslot162 and this motion propagates to the distal end ofsnare catheter30, thereby releasingsnare catheter30 fromtube17.
• FIGS. 17A-17C illustrate another alternative arrangement for releasingsnare catheter30 frominstrument10. In this arrangement,lumen162 is formed by a retainingeyelet162rthat extends radially fromtube17 and forms lumen162 with a slot configuration (see the cross-sectional views ofFIGS. 17B and 17C). Eyelet162rmay be formed of an elastomer, or from a more rigid polymer, or even metal, as it functions differently from the slot described above with regard toFIG. 16A. In this arrangement, snarecatheter30 includes adistal end portion30rthat has a larger outside diameter than the outside diameter of the remainder of thecatheter30. The outside diameter ofend portion30ris configured to form a friction fit with the inside diameter oflumen162 formed byeyelet162r. Thegap162gforming the slot inlumen162 is wider than the outside diameter of the portion ofsnare catheter30 that is proximal of the enlargeddistal portion30r. The outside diameter ofsnare catheter30 is ramped or tapered30sto transition the outside diameter from the main portion ofcatheter30 to the enlargeddistal portion30rand to facilitate the loading and release functions of this arrangement.
• To load or installcatheter30 ontube17 so that it is fixed totube17, catheter30 (the smaller diameter portion) is passed throughgap162g, as illustrated in the cross-sectional view ofFIG. 17C.Catheter30 is then retracted relative to tube17 (e.g., by pulling on the proximal end portion ofcatheter30 while holdingtube17 relatively fixed) to slide enlarged portion into a frictional fit withlumen162, as illustrated in the cross-sectional view ofFIG. 17B. In this arrangement, snare36 andcatheter30 can be delivered to the transverse pericardial sinus, in a manner as described above. To releasecatheter30 from the device, the operator can push on the proximal end portion ofcatheter30 while holding the device (including tube17) relatively motionless. This pushes enlargeddistal portion30rout of contact withlumen162 and aligns a smaller outside diameter portion ofcatheter30 withgap162gas illustrated inFIG. 17C. At this time,catheter30 can be lifted out throughgap162g, thereby releasingcatheter30 fromtube17 ofdevice10.
• FIGS. 17D-17E illustrate a modification of the arrangement shown inFIGS. 17A-17C. In this arrangement, akeyed socket162ris provided at a distal end portion oftube17. A matchingkey30ris provided to extend radially from a distal end portion ofcatheter30.Key30ris configured to form a friction fit withsocket162rwhen drawn intosocket162rby proximally pulling key30rintosocket162rfrom a position distal of the opening of162r. To releasecatheter30,catheter30 is pushed in the distal direction to drive key30rout of contact withsocket162r.
• FIGS. 18A-18C illustrate another quick release mechanism that allowssnare catheter30 to be rapidly separated fromtube17 ofdevice10. In this arrangement, thelumen162 configured to receivesnare catheter30 is slotted, as bygap162gthat has a sufficient width to allowsnare catheter30 to be rotated intolumen162 in the direction of rotation indicated by the arrows inFIG. 18A. Both thelumen162 and snarecatheter30 are asymmetrical in cross section, so as to define a cam surface circumferentially. These surfaces are matching so that the surface ofcatheter30 follows the surface oflumen162 assnare catheter30 is rotated into place. Removal ofcatheter30 fromtube17 occurs in the same manner, only by rotatingcatheter30 in the opposite direction.FIG. 18B illustratessnare catheter30 installed intube17 andFIG. 18C shows a cross sectional illustration of this taken along line18-18.
• FIG. 19 illustrates an arrangement wheretube17 is done away with altogether. In this arrangement, a ring orsleeve45 is provided over the shaft ofendoscope16 so as to be freely slidable with respect thereto. Snarecatheter30 is fixed to ring45, such as by a releasable locking mechanism, e.g., a mechanism like that inFIG. 18A, or alternative.Endoscope16 can be first inserted to perform the dissections, etc, and placed into the transverse pericardial sinus. Then asnare catheter30 andring45 can be advanced distally overendoscope16 to positionsnare36 as desired.Catheter30 can then be released fromring45, such as by rotating it for example. Optionally, a rigid wire release mechanism46 may be provided to run within or alongside ofcatheter30 to the attachment to ring45, which can be torqued to aid in the release function, and then withdrawn.
• FIGS. 20A-20C illustrate another arrangement that does not requiretube17. In this arrangement, one or more (typically two, although more or fewer may be used) jigs17 are provided through whichsnare catheter30 another tube31 (which may function to deliver suction, irrigation, or delivery of other tools), andendoscope16 are passed.Catheter30 andtube31 may form a friction fit with thelumens162 though which they are passed, butendoscope shaft16 is freely slidable withinlumen162e. In this way, oncesnare36 has been placed in a desired location (e.g., transverse pericardial sinus),endoscope16 can be withdrawn fromlumens162eand from the patient, leavingcatheter30 andtube31 in place, held in their relative positions by jig(s)17j, seeFIG. 20C.
• FIGS. 21A-21B show another jig arrangement17jwherein thelumen162 formed in jig17jare provided with slots orgaps162gthat allow thesnare catheter30 andendoscope16 to be snapped in and out for rapid exchange. Note that although jig17jis shown as a single elongated jig, that a pair or more of similar, shorter jigs may be provided and snapped into place, in relative locations along thecatheter30 andendoscope16 like that shown inFIG. 20A. Also, neither this jig17jnor the jig17jofFIG. 20A is limited to two lumens, as one or moreadditional lumens162 may be provided for a suction line or other tube or instrument, for example.
• FIG. 22 illustrates a modification of a connection oftip20 todevice10 that allows diffuse suction to be applied. In this arrangement, the inside diameter of the proximal opening oftip20 is greater than the outside diameter oftube17.Tip20 may be mounted totube17 by a series of circumferentially spaced struts that extend radially from the distal end portion oftube17, thereby maintaining a gap between the proximal end oftip20 and the distal end oftube17. Thus, when suction is applied throughtube17, fluid drawn through the gaps betweentip20 andtube17 as indicated by the arrows inFIG. 22.
• FIG. 23A shows an exploded view of another example of adevice10 in accordance with the present invention.Device10 includes abell165 and handle160 that attaches totube17 to receiveendoscope16 therein.Tube17 thus functions as a cannula and is typically rigid, e.g., stainless steel or other metal tube or rigid polymer. Twoservice ports162 are provided bytubes18,19 received withintube17, such as stainless steel hypotubes, for example (see the partial exploded view inFIG. 23B). Alternatively, only one such service port, or more than two service ports may be provided in the same manner. An example of anendoscope16 that may be received indevice10 is theGuidant 7 mm Extended Length Endoscope, model FGVH-1111 (Guidant Corporation, Santa Clara, Calif.). A camera attachment13cis provided at the proximal end ofendoscope16 for connecting a camera thereto, and alight source attachment131 extends out from a proximal end portion ofendoscope16 for attachment to a light source via fiber optic cable.Bell165 has the capacity to rotate about 300 degrees relative to handle160 andtube17, thus allowing a secure grip of theendoscope16 at the endoscope'slight source port131.Service ports162 are typically about 1 mm to about 6 mm in inside diameter, more typically about 1.5 to 3 mm inside diameter. In at least one embodiment, service ports are about 2 mm inside diameter and allow for passage of surgical tools (e.g., suction assembly, snare catheter (also referred to as routing snare), snare retrieval tool, graspers, etc.) therethrough to deliver the working ends of such tools out to the distal end of thedevice10 throughopenings178sand178sn, respectively.Tube17 is typically about 28-40 cm in length, more typically about 32-35 cm, but may be made to be longer or shorter as desired. Typically,tube17 has an inner diameter in the range of about 9-12 mm, more typically about 10.3-10.9 mm. It should be noted thattube17 is fixed byhandle160, thereby preventing it from rotating with respect to handle160. For example, pins inside the handle halves ofhandle160 may be provided to engage holes (not shown) through the wall oftube17 thereby fixingtube17 with respect to handle160. This type of engagement is the same as that described with fixingtip20 to the distal end of tube17 (e.g., seeFIG. 2B).
• Distal tip20 in this case includeslens201 that is fixable todistal end piece20pthat includes the distal ends178s,178snof the service ports that are in fluid communication withlumens162 whentip20 is installed ontubes17,18,19.Distal end piece20pmay be molded of rigid plastic or made of metal. Upon installation, the distal ends oftubes18,19 are received inlumens178s,178snanddistal end piece20pmay be connected totube17 in a manner described above with regard toFIG. 2B or by friction fit, or adhesives, or other fixation expedient.Lens201 may be threaded todistal piece20por friction fit or otherwise mechanically connected for removability, but in the example shown, is fixed todistal end piece20pvia adhesive. Aseal177 may be provided to form an airtight seal betweenlens201 anddistal piece20pin the same manner that seal177 forms a seal betweendistal piece20pandtube17. Alternatively, only oneseal177 may be provided betweencomponents201 and20p, with no seal provided betweencomponents20pand17.
• Lens201 is optimized to provide visualization in the presence of an air space as well as in a fluid environment and in direct contact with tissue. The air chamber insidelens201 is sealed viaseal177 to avoid fluid ingress and minimize fogging.
• FIG. 23C shows a proximal portion of thedevice10 shown inFIG. 23A, withhandle160 in an exploded view, andtube17 disassembled for a better view oftubes18,19. The proximal ends oflumens162 are shown at the proximal ends oftube18,19, which are securely held in the recesses provided inhandle halves160a,160b. These are the locations at which tools are inserted for delivery of the working ends of such tools out ofopenings178s,178sn.
• The boundaries of all components ofdevice10 that are to be inserted into the patient have been designed to be atraumatic and there are no sharp edges or abrupt transitions in these components in the assembled state. All components ofdevice10 ofFIGS. 23A-23C may be mechanically connected, except thattip201 is adhered todistal end20p, as noted.
• FIG. 24 shows asuction assembly170 that is configured and dimensioned to be slid through either of theservice ports162 indevice10.Suction assembly170 may be provided with unlimited ability to slide through alumen162, or, alternatively, may be limited to a predefined range of motion by anchoringsuction assembly170 to handle160 with a tether (not shown). A luer connector182 (in this example, a female luer connector, although a male luer connector or other type of connector may be used) is provided at the proximal end ofsuction assembly170 for connection of the assembly to a source of vacuum. A luer connector provides compatibility with most typical operating room vacuum sources. The main body of thesuction assembly170 may be provided with varying degrees of rigidity along its length. For example, theproximal end portion170pmay be rigid, such as a metal hypotube, for example, to facilitate the attachment of theconnector182 and to make it easier for an operator to grip the tube. Themiddle portion170mof the tubing may be a plastic tubing that is flexible enough to easily traverse the shallow curvature of thehypotubes18,19 of theservice ports162, but rigid enough to permit the tool to be advanced and retracted by pushing and pulling on the proximal end portion oftube170 without elastic response. Thedistal portion170doftube170 is still more flexible to provide atraumatic interaction with the tissues of the patient, yet stiff enough to maintain an open passage for vacuumed fluids. In this regard, distal portion is relatively short to prevent it from collapsing upon itself under strong vacuum. For example, the length ofdistal portion170dmay be from about 0.05″ to about 0.75″, typically about 0.30″. Optionally, the tube structure ofdistal portion170dmay be provided with small side holes (not shown) extending through the wall of the tube to further assist in preventing the distal portion from collapsing upon itself when under strong vacuum.Distal portion170dmay also be colored with a color that provides great contrast relative to the patient's tissue so that it can be easily viewed and located in the view through the endoscope.
• FIG. 24A illustrates another example of a snare catheter, which is also referred to as a “routing snare” tool. This example is configured and dimensioned to be slide through either of thelumens162 indevice10 ofFIG. 23A. The outer tubing, catheter orouter sleeve30 is also referred to as thesnare guide30 and is made of a flexible plastic, e.g., high density polyethylene, or other flexible plastics that have been mentioned above. Snareguide30 may have a length on the order of 28 to 60 inches, typically about 30 to 40 inches, but may be made longer if desired. The outside diameter ofsnare guide30 may be in the range of about 0.070 to about 0.100 inches, typically about 0.076 to about 0.090 inches. The inside diameter ofsnare guide30 may be in the range of about 0.040 to about 0.70 inches, typically about 0.048 to about 0.058 inches. Both ends ofsnare guide30 may be chamfered to make them less traumatic to the anatomy during insertion of either end into a patient, and easier to advance through a cannula, such aslumen162, for example, as well as easier to navigate in the surgical site. The average wall thickness of snare guide is in the range of about 0.010 to about 0.020 inches, typically about 0.015 inches to provide for a strong wall that can receive the snare assembly without failure. This thickness of the wall also provides sufficient column strength to allow it to be advanced throughlumen162 and the anatomy by pushing on a proximal portion of snare guide30 that is outside of these structures, without buckling of thesnare guide30. Snareguide30 may also be colored with a color (e.g., bright orange) that provides great contrast relative to the patient's tissue so that it can be easily viewed and located in the view through the endoscope.
• The snare assembly is made up of thesnare line34, e.g., a core mandrel of nickel-titanium alloy, which may have a diameter of about 0.020 to about 0.025 inches, in one embodiment, about 0.023±0.004 inches. The mandrel ends may be ground down to a smaller diameter (e.g., in one embodiment, to about 0.018±0.003 inches) over a length of about four to ten inches at each end to increase maneuverability, both by the smaller diameter and by the increased flexibility that results from the smaller diameter. Snareloops36 are provided at both ends of the snare line and may be formed of braided nickel-titanium wire formed by standard nickel-titanium shape memory metal processing. Upon braiding and shaping the material into the form ofsnare loops36, at the ends of eachloop36, a long straight portion of the loop material is left extending from the braided loop. These two long straight portions are paced in contact with the core mandrel of thesnare line34 for connection therewith. Snareloops36 are maintained in connection withsnare line34 by Fluorinated Ethylene-Propylene (FEP) heat shrink tubing37 (outer heat shrink tubing) that is shrunk over the extensions from theloops36 that are in contact with the mandrel when the heat shrink tubing is applied, seeFIG. 24B. The strength of the bond betweensnare36 andmandrel34 allows for tension loads to exceed six to nine pounds prior to failure, typically about nineteen to twenty-four or more pounds force. Heat shrinktubing37 may have a shrink factor of about 1.5 to 1.7:1. In one embodiment the shrink factor is about 1.6:1. Heat shrinktubing37 may extend about six to fourteen inches from the ends of the mandrel toward the middle, typically about nine to eleven inches. The wire that forms thesnare loops36 extends about 1−/2 to two inches, typically about one inch, beyond the end of themandrel34 and heat shrinktubing37 before bending to form the loop. An inner heat shrinktubing37amay be provided over the parallel wires that form both ends of theloop36. Inner heat shrink tubing may have a shrink factor of about 1.2 to 1.4:1, typically about 1.3:1. The transition between outer37 and inner37aheat shrink tubes is made atraumatic by fusing the tubes together. The inner heat shrinktubing37amay be color coded so that a user can easily and immediately differentiate between the proximal anddistal snares36, especially in the case where both snares36 (i.e., both ends of the snare assembly) are fed through a common port or incision in the patient (e.g., opening11). For example, inFIG. 24B, the heat shrinktubing37 adjacent thedistal snare36 is clear and the heat shrinktubing37 adjacent theproximal snare36 is black. Of course, other colors may be substituted. For example, white and black may be used to provide maximum contrast. Black and green, or some other color combination may alternatively be used. Typically, the color combination chosen will provide sufficient contrast or color distinction to accomplish the intended function.
• The wire from which snares36 are made may be a braided wire.Mandrel34 is typically formed as a single rod or wire. In one embodiment, the wire is a seven strand braid of Nitinol® (nickel-titanium alloy) and is about 0.012±0.003 inches in diameter, with each strand being approximately 0.0035 inches in diameter. In one embodiment,snare loop36 defines an angle relative to mandrel34 of about 29±14 degrees. At this transition, a large radius of curvature of about ½ to 1.5 inches is defined. The profile ofsnare loop36 can be substantially round or oval. The diameter or length may be about 0.4 to 1.2 inches, typically between about 0.6 and 0.9 inches. All curves on the snares (loops)36 are gentle and composed of large radius curvature. Thesnares36 may be provided with a kink or nipple36nthat may facilitate capturing a ball tip or other object to be lassoed. Kink or nipple36nhelps reduce local stresses at the tip. The kink is not provided with a sharp tip to avoid stress concentration and potential failure of such a sharp tip. Nipple or kink26ndistributes the loads and bend angles of the shape memory material in theloop36, so that there is no location in the loop that is bent beyond its plastic deformation limit. Kink or nipple36nmay comprise substantiallyparallel legs361 that are about 0.06±0.05 inches apart, typically about 0.06±0.02 inches apart, and about 0.06±0.05 inches long, typically about 0.06±0.02 inches long, and join at the distal end of nipple36nalong a tangent radius to the loop.
• The materials of thesnare guide30 and snare assembly allow it to be sterilized under gamma ray irradiation, ethylene oxide sterilization, or other known methods of sterilization.
• FIGS. 25A-25C show asnare capture tool100 that is configured and dimensioned to be deployed through either oflumens162 indevice10 ofFIG. 23A. Snare capture tool may be deployed intoservice port162 at the proximal end of eithertube18 or19 and delivered through eitheropening178sor178snand placed for capture bysnare loop36 similar to the way that tip20,20′,22 was described as being captured above. Thus,device10 ofFIG. 23A does not require the use of a ball-ended tip, as a bullet-shaped tip or other shape optimized for viewing can be used assnare capture tool100 is used to capturesnare loop36.
• At the proximal end of snare capture tool100 a grip or handle102 may be provided to facilitate handling and operation of thetool100 by a user. An elongated metal wire mandrel104 (e.g., stainless steel, nickel-titanium alloy or other biocompatible metal, typically stainless steel) extends fromgrip102 at the proximal end oftool100 toball106 at the distal end oftool100, which it typically welded tomandrel104.Ball106 may be made from the same material asmandrel104 and is typically stainless steel. Apolymeric layer108 is formed over the majority ofmandrel104 which increases the diameter of the main body, but is still a small enough diameter to pass freely throughlumen162.Layer108 may be made from high density polyethylene, or other flexible plastics that have been mentioned above. The thickness oflayer108 maintains the mandrel centered insidelumen162 and provides added stability toball106 andbare mandrel104 at the distal end portion oftool100 during use.
• Aspring110 is provided overlayer108 and abuts a portion ofgrip102 at a proximal end thereof.Spring110 has a diameter that prevents it from enteringlumen162. Thus, whentool100 is inserted intoservice port162 it can be advanced until the distal end ofspring110 abuts theservice port162 at the proximal end of eithertube18 ortube19. In this position,ball106 is positioned just inside oflumen178sor178sn, and the bare portion ofmandrel104 is retained withinlumen162. Upon pushinggrip102 to compressspring110,ball106 and the bare portion of themandrel104 are extended out of opening178sor178sn(as well as past the distal end oftip20, so as to be in a working configuration.Layer108 may be color coded to visually differentiate it from the color of the snare guide. Upon release of thegrip102,spring110 expands, drawing the distal end oftool100 back intolumen162, into a stowed configuration.
• In the working configuration,ball106 can be maneuvered into position to be lassoed bysnare loop136 orball106 can be maneuvered to “spear” through the opening insnare loop136, after whichsnare loop136 can be cinched down to perform the capture. The “bare” portion of themandrel104 that exists betweenball106 and the distal end oflayer108 provides a reduced diameter (less than that ofball106 and less than that of layer108) that provides a contact area on whichsnare loop36 may be cinched down against. After cinching, the cinched snare is prevented from sliding off the distal end oftool100 by the larger diameter ofball106 and is prevented from sliding proximally alongtool100 by the shoulder formed by the distal end oflayer108 which has a larger diameter.
• In one use ofdevice10 and associated tools described above with regard toFIGS. 23A-25C,device10, withsuction assembly170 inserted through one of the service ports/lumens162 is placed under direct visualization through opening11 on the ride hand side of the patient's chest.Tip20/device10 is then advanced over the collapsed right lung and through an opening (e.g., incision) formed in the pericardial sac and into the transverse pericardial sinus. Suction may be applied continuously, intermittently, or on an as needed basis during these procedures viasuction assembly170 that is connected to a source of suction. After the inside surface of the pericardial sac at the left side of the patient's heart is visualized through endoscope16 (and tip20), routing snare30 (snare guide and snare assembly) are inserted into theavailable service port162.Snare30 is advanced beyond thedistal end20 ofdevice10 under visualization viaendoscope16 andtip20. Snaremandrel34 flexes assnare36 contacts the internal surface of the pericardial sac and advances toward the apex of the heart, around the left pulmonary veins, as thesnare catheter assembly30 is further distally advanced.Device10 is then removed out of opening11 while maintaining the snare guide and snareassembly30 in position.
• Device10 is then reintroduced into the surgical area by passing it in throughopening13. Note that, in an alternative procedure,device10 may be reinserted through opening11 to perform this part of the procedure. Note further, that for embodiments where snare catheter is provided for rapid exchange/release fromtube17, thatdevice10 does not even need to be completely removed from opening11 prior to continuing with this part of the procedure. In this case,device10 is inserted throughopening13 andtip20 is advanced into the pericardial sac and traversed to theoblique sinus7.Device10 androuting snare30 are manipulated until the distal end of routingsnare30/snare36 are visible viaendoscope16. At this time,snare capture tool100 is introduced into theavailable service port162 and advanced throughlumen162. By compressingspring110,ball106 andbare mandrel portion104 extend pastdistal tip20 andball106 is inserted through the opening insnare36. Snaremandrel34 is then retracted proximally while holdingsnare guide30 in place to reduce the diameter of the loop ofsnare36 thereby cinchingsnare36 against thebare mandrel portion104. The cinched snare may be locked in position using any of the locking mechanisms described above. Alternatively, a surgeon may simply clamp thesnare mandrel24 where it extends proximally from the proximal end of snare guide, using a hemostat or other common surgical clamp to preventmandrel34 from sliding distally with respect to snareguide30. Next,device10 is withdrawn from the opening, thereby bringingsnare capture tool100 and snareassembly30 with it, and routing the snare assembly/routing snare30 further around the pulmonary veins.
• Once the distal end of therouting snare30/snare loop36 is outside of the patient's body, snare36 is released (such as by unlocking the locking mechanism and pulling proximally on the snare guide) and removed from contact with thesnare capture tool100. The ablation device is next connected to the proximal end of thesnare assembly30.Device10 can optionally be reintroduced into the patient to confirm, under direct visualization thoughdevice10, adequate placement of therouting snare30 prior to placing theablation tool50 usingrouting snare30. In one embodiment, sutures extending from theablation device50 are tied to theproximal snare loop36 of thesnare assembly30. The color coding of the shrink layers37amay be used to ascertain that the connection is being made to theproximal snare36. Once the sutures are tied,snare36 is cinched down on the tied sutures to further secure the connection. The distal end portion of thesnare routing assembly30 is then pulled out of the patient, thereby routing the ablation device around the pulmonary veins. After the distal end ofablation device50 is pulled out of the patient, therouting snare assembly30 is disconnected from the ablation device, such as by reversing the connection procedures, or by cutting the connecting sutures.Device10 can then be reinserted through opening11 and oropening13 to visually inspect the placement of theablation device50 prior to applying ablation energy. The rest of the procedure is the same as that described above with regard toFIGS. 12A-12D. After forming lesions,device10 can again be reinserted to inspect the lesions formed to see if the ablation has been adequately performed to complete the electrical isolation of the pulmonary veins.
• FIGS. 26A-26C illustrate anothertool120 that may be used withdevice10.Tool120 is a slender, elongated retrieval hook tool configured and dimensioned to be slid thoughlumen162. The distal end ofhook tool120 comprises ahook122 that can be used to capturesnare36. Thus,hook tool120 may be used as an alternative to snarecapture tool100 to capturesnare36 in the performance of a procedure, such as the procedure described above for example.Retrieval hook tool120 is configured and dimensioned to be deployed through either oflumens162 indevice10 ofFIG. 23A.Retrieval hook tool120 may be deployed intoservice port162 at the proximal end of eithertube18 or19 and delivered through eitheropening178sor178snand used to hooksnare36.
• At the proximal end ofhook tool120 an actuator or handle124 may be provided to facilitate handling and operation of thetool120 by a user. An elongated metal wire mandrel126 (e.g., stainless steel, nickel-titanium alloy or other biocompatible metal, typically stainless steel) extends fromactuator124 at the proximal end oftool120 to hook122 formed at the distal end oftool120.Hook122 may be made from the same material asmandrel126 and is typically bent or shaped from the same, such as a stainless steel wire, either round or flat, for example. Apolymeric layer128 may optionally be formed over the majority ofmandrel104 which increases the diameter of the main body, but is still a small enough diameter to pass freely throughlumen162.Layer128 may be made from high density polyethylene, or other flexible plastics that have been mentioned above. The thickness oflayer128 maintains the mandrel centered insidelumen162 in the configuration shown inFIG. 26A and provides added stability to hook122 at the distal end portion oftool120 during use.
• Aspring110 is provided over mandrel126 (and overlayer128 when used) and abuts a portion ofactuator124 at a proximal end thereof.Spring110 has a diameter that prevents it from enteringlumen162. Thus, whentool120 is inserted intoservice port162 it can be advanced until the distal end ofspring110 abuts theservice port162 at the proximal end of eithertube18 ortube19. In this position,hook122 is positioned just inside oflumen178sor178sn, and the bare portion ofmandrel126, just proximal ofhook122 is retained withinlumen162. Upon pushingactuator124 to compressspring110,hook122 and the bare portion of themandrel126 just proximal ofhook122 are extended out of opening178sor178sn(as well as past the distal end oftip20, so as to be in a working configuration. Upon release of theactuator124,spring110 expands, drawing the distal end oftool120 back intolumen162, into a stowed configuration.
• In the working configuration,hook122 can be maneuvered into position to hooksnare36 to perform the capture, as illustrated inFIG. 26B. The “bare” portion of themandrel126 that exists betweenhook122 and the distal end oflayer128 provides a reduced diameter and facilitates guiding the wire ofsnare36 between the arms ofhook122 during the hooking procedure.
• FIG. 26C illustrates a partial view ofhook tool122 in an alternative configuration. In this configuration,mandrel126 is offset withinlayer128 to minimize the likelihood of the free end122fofhook122 from catching on the wall of thedistal end portion20p(or other tube through which thehook tool120 is inserted) upon retraction of thehook122. By offsettingmandrel126, the free end122fis offset by a distance δ from the wall oflumen162.
• FIG. 27A illustrates abolo tool130 that may be used in place ofsnare assembly30 for routing an ablation device around the pulmonary veins.Bolo tool130 is configured and dimensioned to be slid through either of thelumens162 indevice10 ofFIG. 23A.Tool130 is typically made to have a length of about 28 to 60 inches, typically about 34 to 40 inches, but may be made longer or shorter if desired. The extended,slender body134 ofbolo tool130 may be made as a core mandrel of solid or braided wire, e.g., from stainless steel or nickel-titanium alloy, or other biocompatible metal. Aball136 is provided at each end of thebolo tool130 may be formed of the same material from which mandrel134 is formed. The materials of thebolo tool130 allow it to be sterilized under gamma ray irradiation, ethylene oxide sterilization, or other known methods of sterilization.
• In use,bolo tool130 may be placed in the same manner that snareassembly30 is placed, as described above. Once thedistal ball136 has been placed in theoblique sinus7,device10 is inserted to advance thedistal tip20 into the oblique sinus. A trigger snare tool (retrieval tool)140 (seeFIG. 27B) is provided to be placed to retrieve thebolo tool130. Note that, alternatively,snare assembly30 may be used to retrievebolo tool130.Trigger snare tool140 includes asnare36 at its distal end connected to a proximally located handle144 viamandrel34. The majority ofmandrel34 may be surrounded by asnare guide30. Thesnare36,mandrel34 and snare guide may be made the same as that described above with regard to the snare assembly. Intool140,trigger142 is slidably positioned overhandle144. A spring (not shown) biases trigger142 distally fromhandle144 to cause snare guide30 to translate distally with respect tomandrel34, thereby cinching down the size ofsnare loop36. InFIG. 27B,tool140 is shown in the uncinched or open configuration, which is achieved by theoperator squeezing trigger142 back proximally against thehandle144. Upon release of thetrigger142, the spring drives trigger142 and snareguide30 distally with respect to handle144 andmandrel34.
• Snare36 may be formed (such as by shape memory setting, or mechanical deformation) so that whentrigger140 is retracted to the open configuration, snare36 deploys at a predetermined acute angle with respect to the longitudinal axis ofmandrel34, as shown inFIG. 27C, e.g., less than about 30 degrees, typically about 15 to 25 degrees. This angulation places snare36 more directly in the field of view of theendoscope16 throughtip20.
• FIG. 28A illustrates aperforation tool150 that may be used to perforate the pericardial sac prior to introduction ofdevice10 therethrough, for example.Perforation tool150 is configured and dimensioned to be slid through either of thelumens162 indevice10 ofFIG. 23A for use therewith. Aprotective sheath152 is provided to surround the working components oftool150 as it is traversed through alumen162.Sheath152 has a limited amount of flexibility to manage the curvature of thelumens18,19, and may be made of plastic, e.g., HDPE. A needle (or barbed needle, as shown)154 is provided at a distal end portion oftool150 and is connected to actuator156 vianeedle shaft155.Actuator156 is slidable with regard tosheath152 so that sliding ofactuator156 distally relative tosheath152 drives needle154 distally of the distal end ofsheath152. In the case of a needle, this action can be used to perforate the pericardium. In the case of abarbed needle154, this action pierces the pericardium. Upon retraction of actuator156 (i.e., sliding it proximally with respect to sheath152) the barb(s) ofbarbed needle154 retains the pericardium and draws it againstcutter blade158 mounted withintool150, to cut a larger hole in the pericardium. Optionally,cutter blade158 may be connected to asecond actuator153 at the proximal end portion oftool150 that may be rotated or oscillated to increase the cutting action ofblade158 against the pericardial tissue.Tool150 may also be used for dissecting through the pericardial reflections.
• FIG. 28B shows an alternative arrangement of aperforation tool150 in which graspers154 are provided to grasp the pericardial tissue, to draw it back againstcutter blade158 to form the opening in the pericardial tissue.Perforation tool150 is configured and dimensioned to be slid through either of thelumens162 indevice10 ofFIG. 23A for use therewith.Graspers154 are mechanically linked toactuator156 which is slidable with respect tosheath152 to advance the graspers distally out ofsheath152 and to retractgraspers158 back intosheath152 to pull the tissue againstcutter158.Actuator156 also rocks with respect to sheath152 (see rotational arrows) to operate the opening and closing of the jaws ofgrasper154.Tool150 may also be used for dissecting through the pericardial reflections.
• FIG. 28C shows another alternative arrangement of aperforation tool150 in which the grasping implement154 provided in this example is a cork screw configuration, which can be screwed into the pericardial tissue to grasp or secure it, to draw it back againstcutter blade158 to form the opening in the pericardial tissue.Perforation tool150 is configured and dimensioned to be slid through either of thelumens162 indevice10 ofFIG. 23A for use therewith.Cork screw tip154 is mechanically linked toactuator156 viarod155.Actuator156 is slidable with respect tosheath152 to advance thecork screw tip154 distally out ofsheath152 and against the tissue to be grasped, and to retractcork screw154 back intosheath152 to pull the tissue againstcutter158.Actuator156 is also rotatable to drive the screwing of the cork screw into the tissue to be perforated. Actuator may b slid distally with respect tosheath152 at the same time that it is rotated to help drive thecork screw tip154 into the tissue.Tool150 may also be used for dissecting through the pericardial reflections.
• FIG. 28D shows another alternative arrangement of aperforation tool150 that may be used to form an opening in the pericardial tissue and/or used for dissection through the pericardial reflections.Perforation tool150 is configured and dimensioned to be slid through either of thelumens162 indevice10 of FIG.23A for use therewith. Advantageously,tool150 is also adapted to be delivered throughsuction assembly170, or other catheter, for example. Thus handle157 is configured to be mounted to a connector of a suction assembly (for example, by being fitted with the mating counterpart of luer connector182). Aspike154, sharpened end ofwire155 or other sharpened feature configured to pierce through tissue upon an impulsive impact is provided at the distal end ofshaft155 which is connected proximally toactuator156. In this example,actuator156 is a plunger type actuator. Thus, upon pressing on actuator (e.g. with a thumb) while holding handle relatively stationary (such as by holding the finger grips with the fingers),tip154 is impulsively driven into the pericardium or other tissue against which thetube170 has been contacted to drive an opening through the tissue. Upon release of theactuator156,spring110 retractstip154 out of the tissue and back intotubing170.
• FIG. 28E shows another alternative arrangement of aperforation tool150 that may be used to form an opening in the pericardial tissue and/or used for dissection through the pericardial reflections.Perforation tool150 is configured and dimensioned to be slid through either of thelumens162 indevice10 ofFIG. 23A for use therewith. Advantageously,tool150 is also adapted to be delivered throughsuction assembly170, or other catheter, for example. Thus handle157 is configured to be mounted to a connector of a suction assembly (for example, by being fitted with themating counterpart159 of luer connector182). A sharpened end ofshaft155 is provided in this embodiment for piercing tissue. Alternatively, a spike, or other sharpened configuration may be provided.Shaft155 is connected proximally toactuator156. In this example,actuator156 is a plunger type actuator. Thus, upon pressing on actuator (e.g. with a thumb) while holdinghandle157 relatively stationary (such as by holding the finger grips with the fingers),tip154 is impulsively driven into the pericardium or other tissue against which thetube170 has been contacted to drive an opening through the tissue. Upon release of theactuator156, spring110 (in this example, a leaf spring) retractstip154 out of the tissue and back intotubing170.
• FIG. 29A illustrates a partial view of amapping probe tool210 that may be used to gauges the effectiveness of a lesion formed during an ablation procedure as described herein.Mapping probe tool210 is configured and dimensioned to be slid through either of thelumens162 indevice10 ofFIG. 23A for use therewith. Optionally,tool210 may also be adapted to be delivered throughsuction assembly170, or other catheter, for example.
• In the example shown,tool210 is provided with a longslender tube211 having sufficient length to simultaneously extend from both distal and proximal openings oflumen162 ofdevice10. Optionally,tool210 as shown inFIG. 29A, as well as any variations or other embodiments of mapping probe tool, may be provided with a handle at a proximal end thereof, such as a handle of the type described with regard toFIG. 25B, for example. Further optionally, a biasing member, such as a spring, may be provided to function in the manner described above with regard to spring110 (FIG. 25B). That is, when biasing member is biased by driving the proximal portion oftool210 distally, the probe mapping elements are extended distally from the distal end of lumen162 (or suction tube or other catheter), and when this biasing is released, the biasing member draws the probe mapping elements back into concealment within the distal end portion of the vessel (lumen162, suction tube or other catheter) through which the tool has been inserted.
• Tube211 is provided with at least a pair ofprobe mapping elements212 on a distal end portion thereof. Probe mappingelements212 may be provided as electrodes, for example, which are configured to emit an electrical signal as well as receive an electrical signal.Elements212 are separated by a distance along thetube210 that is configured to place theelements212 on opposite sides of a lesion that has been formed by ablation. Typically, this distance is in the range of about 1 mm to about 20 mm. In one example, this distance is about 6 mm. Anelectrical wire212 is connected to eachmapping element214, andwires212 extend proximally throughtube210 and extend proximally out of tube to be connected to a power source and metering equipment so that the results of mapping can be measured. Alternatively, a solid rod may be substituted fortube211, in which case,wires214 can be run externally of the rod, and optionally fixed to the external wall of the rod, at one or a plurality of points along the length of the rod, or continuously over the length of the rod.
• To perform a mapping procedure, after insertion oftool210 throughdevice10 as described and positioned distally so thatelectrodes212 are exposed,electrodes212 are placed on opposite sides of a lesion in contact with tissues that have not been ablated. Then a signal is emitted through one ofelectrodes212, while the opposite electrode is configured to receive the emitted signal. Depending upon the strength of the signal received, and potentially also a time delay from emission to reception, known electronic measurement equipment can indicate whether the lesion has been sufficiently formed. When a fully encircling lesion has been completed, there should be substantially no reception of a signal emitted from inside the circle, when attempting to receive it outside the circle, or vice versa. It is noted thatelectrodes212 may be configured, so that the functions of the emitter and receiver electrodes may be readily switched, so that mapping can be conducted in either direction between the electrodes.
• FIG. 29B shows a variation of thetool210 ofFIG. 29A. In this example, the distal end portion of tube orrod210 is biased in the bent configuration shown.Bend213 is configured to orient the distal end portion oftool210 with respect to the remainder of the tool at an acute angle.Bend213 is flexible, such as a living joint, or hinged and biased with a biasing member, so that the distal end portion oftool210 may be substantially axially aligned with the remainder of the tool when it is inserted intolumen162 or other catheter. When the distal end portion is passed distally out of the distal end of thelumen162 or other catheter, the distal end portion oftool210 then resumes its bent configuration. This bent configuration can facilitate the placement of themapping elements212 on opposite sides of a lesion, as the distal end portion oftool210 is oriented more transverse to a lesion by the preconfigured bend.
• FIG. 29C shows another variation of thetool210 ofFIG. 29A. In this example, the distal end portion of tube orrod210 is preconfigured into a Y-shaped configuration, thereby separatingelements212 by a distance established between the open arms of the Y-shape, as shown. The open Y-shape configuration is the unbiased configuration, and is deformable (such as by biasing forces) to substantially align the open arms of the Y-shaped end so that they can be inserted into alumen162 or other catheter. In this regard, the Y-shaped end may be resilient and elastically deformable. Alternatively, the Y-shaped end may be hinged and biased to the open configuration, similar to the manner described with regard to bend213 above. In the bent configuration shown. In the closed configuration, Y-shapedend215 has the arms substantially in a parallel configuration so that it can be passed throughlumen162 or other catheter. When thedistal end portion215 is passed distally out of the distal end of thelumen162 or other catheter, thedistal end portion215 oftool210 then resumes its open Y-shaped configuration as shown inFIG. 29C. This can facilitate the placement of themapping elements212 on opposite sides of a lesion, as the arms215aseparate theelements212 upon the expansion to the open configuration.
• FIG. 30 illustrates a partial view of a linearablating probe tool220 that may be used withdevice10 to form a linear lesion. Linearablating probe tool220 is configured and dimensioned to be slid through either of thelumens162 indevice10 ofFIG. 23A for use therewith. Optionally,tool220 may also be adapted to be delivered through another catheter, for example.
• In the example shown,tool220 is provided with a longslender tube221 having sufficient length to simultaneously extend from both distal and proximal openings oflumen162 ofdevice10. Optionally,tool220 as shown inFIG. 30, as well as any variations or other embodiments of mapping probe tool, may be provided with a handle at a proximal end thereof, such as a handle of the type described with regard toFIG. 25B, for example. Further optionally, a biasing member, such as a spring, may be provided to function in the manner described above with regard tospring110. In any case, an actuator226, such as a triggering mechanism, button or other actuating mechanism may be provided to allow an operator to commence delivery of ablation energy tolinear ablation element222. When a biasing member such asspring110 is employed, it can be biased by driving the proximal portion/handle oftool220 distally. As a result theablation element222 extends distally from the distal end of lumen162 (or suction tube or other catheter), and when this biasing is released, the biasing member draws theablation element222 back into concealment within the distal end portion of the vessel (lumen162, suction tube or other catheter) through which the tool has been inserted. If such a biasing arrangement is not used, the positions of theablation element222 can be controlled by manually sliding thetool220 distally and proximally, respectively, with respect to the vessel that it is inserted through.
• Tube221 is provided with at oneablation conduit224 to deliver ablation energy toablation element222 from a location outside of the patient and proximal oftool220. In the case where ablation element ablates via Rf energy, heat, ultrasonic or microwave energy,conduit221 may comprise at least one electrical wire, for example. For chemical ablation, conduit may comprise a tube for delivery of a chemical. For laser ablation, conduit may comprise at least one light guide, such as one or more optical fibers, for example. Linear ablation element may be on the order of about 0.5″ to about 2.0″, typically about 1″ in length. Alternatively, a solid rod may be substituted fortube221, in which case,conduit224 can be run externally of the rod, and optionally fixed to the external wall of the rod, at one or a plurality of points along the length of the rod, or continuously over the length of the rod.
• To perform a linear ablation procedure, after insertion oftool220 throughdevice10 as described and positioned distally so thatlinear ablation element222 is exposed,ablation element222 is contacted to tissue in the target location to be ablated. Then ablation energy is provided tolinear ablation element222, either by user actuation of actuator226, or by actuation of an ablation energy source connected toconduit224 and located proximally oftool220. Ablation energy is applied, either continuously, or intermittently, until a sufficient lesion is believed to have been formed, which may be based on visual observation throughdevice10. Thereafter, the sufficiency of the lesion may be checked usingtool210 in a manner as described above. Reapplication of ablation energy may be performed, if necessary, as many times a necessary, in the manner described above, until a satisfactory lesion has been formed.
• FIG. 31 illustrates a distal end portion of a point/diskablation probe tool230 that may be used withdevice10 to form a point lesion.Tool230 may be useful for connecting previously formed linear lesions, where a small gap of non-ablated tissue remains therebetween, for example, or to ablate an ectopic focus identified by mapping, for example. Point/diskablation probe tool230 is configured and dimensioned to be slid through either of thelumens162 indevice10 ofFIG. 23A for use therewith. Optionally,tool230 may also be adapted to be delivered through another catheter, for example.Tool230 may be constructed in any of the ways and to have any of the features described above with regard totool220, with the difference being at the distal end portion oftool230. Thus, only the distal end portion oftool230 is described here and illustrated inFIG. 31. Also,tool230 may perform ablation using any of the different types of ablation energy described above with regard totool220.
• Anablation probe point232 is provided on the distal tip of the distal end portion oftube231 and is connected via anablation conduit231 to the proximal end oftool230 in a manner as described above with regard toconduit221.Ablation probe point232 is dimensioned to be about the same or less than the outside diameter oftube221, although alternative embodiments can be formed as a disk that is slightly larger in diameter than the outside diameter oftube221. In effect,point232 is actuated to form a small lesion that is not extended substantially linearly. As such,point232, although typically disk shaped or semi-spherical, need not be, but could be any other shape that does not have an elongated dimension.
• To perform a point ablation procedure, after insertion oftool230 throughdevice10 andpositioning tool230 distally so thatablation probe point232 is exposed,ablation probe point232 is contacted to tissue in the target location to be ablated. Then ablation energy is provided toablation probe point232, in any of the manners described above with regard to providing ablation energy tolinear ablation element222. Ablation energy may be applied, either continuously, or intermittently, until a sufficient point lesion is believed to have been formed, which may be based on visual observation throughdevice10. Thereafter, the sufficiency of the lesion may be checked usingtool210 in a manner as described above. Reapplication of ablation energy may be performed, if necessary, as many times a necessary, in the manner described above, until a satisfactory lesion has been formed.
• FIG. 32 illustrates a distal end portion of amonopolar cautery tool240 that may be used withdevice10 to cauterize tissue.Tool240 may be useful for creating openings, such as through the pericardium for example, and/or to cut through unwanted adhesions, or other tissue needing to be cleared to perform a procedure.Monopolar cautery tool240 is configured and dimensioned to be slid through either of thelumens162 indevice10 ofFIG. 23A for use therewith. Optionally,tool240 may also be adapted to be delivered through another catheter, for example.Tool240 may be constructed in any of the ways and to have any of the features described above with regard totool220, with the differences being at the distal end portion oftool240. Also, rather than an ablation conduit,tool240 is provided with anelectrical wire244 to deliver electrical energy to the distal end of the tool. Thus, only the distal end portion oftool240 is described here and illustrated inFIG. 32.
• A monopolar cauterizing element (such as an electrode, for example)242 is provided on the distal tip of the distal end portion oftube241 and is connected viaelectrical wire241 to proximal end oftool240, wherewire241 extends proximally to be connected to a power source that supplies the cauterizing energy. Alternatively,tool240 may be modified to provide a bi-polar cauterizing system, as would be readily apparent to those of ordinary skill in the art.
• To perform cauterization, after insertion oftool240 throughdevice10 andpositioning tool240 distally so that cauterizingelement242 is exposed, cauterizingelement242 is contacted, or brought into close approximation with, tissue to be cauterized. Then cauterization energy is provided tocauterizing element242, from an external power source, viaelectrical line244. Cauterization energy may be applied, either continuously, or intermittently, until cauterization has been considered to have been successfully performed. Such consideration may be based on visual observation throughdevice10. Reapplication of cauterization energy may be performed, if necessary, as many times as necessary, in the manner described above, until a satisfactory cauterization has been achieved.
• FIG. 33 illustratesgraspers250 that may be used withdevice10 to grasp tissue in a reduced access surgical site.Graspers250 are configured and dimensioned to be slid through either of thelumens162 indevice10 ofFIG. 23A for use therewith. Optionally,tool250 may also be adapted to be delivered through a suction assembly or another catheter, for example.
• In the example shown,tool250 is provided with a longslender tube251 having sufficient length to simultaneously extend from both distal and proximal openings oflumen162 ofdevice10. Graspingjaws252 are provided at a distal end portion oftool250 and are connected to an actuator256 located at a proximal end portion oftool250, vialinkage254. Whenjaws252 are in the retracted position, such as shown inFIG. 33,jaws252 are concealed within the distal end portion oftube251. This position is useful astool250 is advanced throughlumen162 or other catheter, to preventjaws252 from getting caught or jammed during translation oftool250. Actuator256 is slidably advanceable with respect totube251. Thus, by advancing actuator256 distally with respect totube251, this extends graspingjaws252 distally beyond the distal end of252. This action is performed once the distal end oftube252 has been placed near the target surgical area, such as by extending it beyond the distal end oflumen162 in one example. Actuator256 also rocks with respect totube251 to operate the opening and closing ofjaws252 vialinkage254.
• FIG. 34 illustratesscissors260 that may be used withdevice10 to cut tissue in a reduced access surgical site.Scissors260 are configured and dimensioned to be slid through either of thelumens162 indevice10 ofFIG. 23A for use therewith. Optionally,scissors260 may also be adapted to be delivered through a suction assembly or another catheter, for example.
• In the example shown,tool260 is configured similarly to graspers250 described above with regard toFIG. 33. As such, only the differences at the distal end portion of thetool260 and actuation thereof are described here.Scissor jaws262 are provided at a distal end portion oftool260 and are connected to anactuator266 located at a proximal end portion oftool260, vialinkage264. Whenscissor jaws262 are in the retracted position, they are concealed within the distal end portion oftube261. As shown inFIG. 34,scissor jaws262 have been advanced distally beyond the distal end oftube261, by slidingactuator266 distally with respect totube261, so thatscissor jaws262 can be operated. Opening and closing of the scissor jaws in this example is controlled by rockingactuator166. InFIG. 34,scissor jaws262 have been opened by rocking actuator in the distal rotational direction.
• The suction tubing provided in a typical operating room setting for the suction provided in the operating room is typically a fairly heavy gauge tubing relative to the tubing provided forsuction assembly170. Accordingly, side loading may be placed uponsuction assembly170 during use withdevice10 whenassembly170 is connected to a suction source, due to the weight of the tubing connected to the suction source. One way of minimizing exposure to such loads is illustrated inFIG. 35A, where a length oftubing270 that is lighter in gauge than the operating room suction tubing is provided as an extension tubing betweensuction assembly170 and the operatingroom suction line272. For example,tubing270 may have an inside diameter of about 3/32 to 9/32 inches and an outside diameter of about 0.125 to about 0.375 inches, and may have a length of about two to five feet, typically about forty-two inches. A mating luer connector274 is provided for connection withconnector182 ofsuction assembly170 to provide fluid communication betweentube270 andtube170. Abarbed end connector276 is provided at the proximal end to connectluer connector278 at the proximal end oftube270 with thesuction line272 for fluid communication therewith. This connection may then be fixed to a fixed structure on the operating table, such as a surgical drape for example, using aclamp279, such as a towel clamp for example, while ensuring the slack is maintained intube270, so that any forces applied bytubing272 toconnection276/278 are not transmitted tosuction assembly170.
• FIG. 35B illustrates an example of suction tube management whereinextension tubing270 is in fluid communication withsuction assembly170 provided indevice10 that is configured to be used insurgical site271. In this arrangement, atether273 is provided at the proximal end of tubing270 (which may be fixed to connector278) andtether273 is clamped tosurgical drape277 to accomplish the suction tube management, see the enlarged illustration ofFIG. 35C.
• FIG. 36A shows another alternative arrangement of adevice10 according to the present invention. Although not all are shown inFIG. 36A,device10 may include all of the features described above with regard toFIG. 23A. Additionally,device10 is provided with aninflatable member280, such as a toroidal balloon, or other shape, that is expandable around the base of the outside surface oftip20 to achieve a temporary, atraumatic increase in the diameter at the distal end portion ofdevice10. This function can be used to support, reorient and help place theablation device50 in the surgical site. That is, the soft, atraumatic surface of theinflated member280 can be pushed or pulled against the ablation device to reposition or reorient it, without significant risk of damaging tissues. Service portdistal openings278s,278sn, if service ports are present, extend distally ofinflatable member280. Alternatively,inflatable member280 can be expanded to facilitate the placement of other tools, such assnare assembly30 orsnare retrieval tool100 or other tools described.
• FIG. 36B illustratesdevice10 withinflatable member280 inflated, andFIG. 36C shows an end view ofdevice10 ofFIG. 36B. Afitting plug282 is placed overshaft17 ofdevice10 and is fixed toinflatable member280 for holdinginflatable member280 in position over the proximal portion oftip20. Aninflation lumen284 extends throughfitting plug282 and is in fluid communication withinflatable member280. Fluid (isotonic saline, air or other fluid) is inputted throughinflation port285 under pressure to inflateinflatable member285. Atensioning rod286 interconnects the distal end portion282doffitting plug282 to aproximal base portion282p.Proximal base portion282pis fixed with respect totube17 while distal end portion282dcan slide with respect thereto. Atensioning nut288 is threaded over the proximal end portion ofrod286. Whennut288 is torqued to increase tension inrod286, the distal portion282dis drawn towardproximal portion282p, drawinginflatable member280 into position and maintaining it at the base oftip20 as inflatable member expands.
• FIG. 37A illustrates a positioning feature for positioningendoscope16 at more that one predetermined location. This feature may be employed with any of thedevices10 described herein. In this arrangement the proximal end portion of thelumen162einto which the shaft ofendoscope16 is received may be provided with a wire form or other deflectable or spring loadedportion290 includingsockets292 into which nubs, bumps orother protrusions294 on theendoscope shaft16 fits into when they are aligned with the sockets. In the example shown, endoscope can be placed into two predetermined locations longitudinally relative totube17 whereprotrusions294 will snap intosockets292. Note that this feature is not limited to two predetermined placement locations, as more can be added. Only two are shown for simplifying the drawing and explanation. In the position shown, protrusions are engaged in the more distal set ofsockets292 which positions the distal end of endoscope atposition296 for a close or more detailed field of view. Upon retractingendoscope16 so that protrusions engage with the more proximal set ofsockets292, the distal end ofendoscope16 is positioned atlocation298 to provide a wider field of view of the target.
• In addition to the ability to change the field of view of the endoscope with the above feature, an additional advantage may be provided when atip20 having one or more windows oropenings20wiis provided, as illustrated inFIG. 37B. In this instance, whentip20 is in aliquid environment position296 may be assumed, as little to no distortion occurs when viewing through the lens oftip20. In a location where the environment of the tip is air, however, more distortion may be experienced. In this case,endoscope16 can be retracted so that the distal tip of the endoscope assumesposition298, where viewing through the one ormore openings20wican be performed to eliminate distortion.
• FIG. 37C illustrates an alternative arrangement that provides for placement of endoscope in two different locations longitudinally relative to tip20, whereinhandle160 is formed to include proximal anddistal stops160pr,160d. Whenendoscope16 is positioned so that thelight cable connector131 abuts againstproximal stop160pr, as shown inFIG. 37C, then the distal end ofendoscope16 is placed atposition298, whereas whenendoscope16 is slid distally from this position to abutlight cable connector131 against distal stop13d, then the distal end ofendoscope16 is placed atposition296.
• 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.

Claims (22)

1-87. (canceled)

88. A surgical device for performing minimally invasive surgical procedures, said device comprising:

an elongated body having distal and proximal end portions and at least two lumens extending generally along a direction of a longitudinal axis of said elongated body; and

an endoscope positioned in one of said at least two lumens that is configured and dimensioned for receiving said endoscope therein; wherein a distal end of said elongated body extends distally past a distal end of said endoscope to shield said distal end of said endoscope during use.

89. The device ofclaim 88, wherein said distal end of said elongated body is open.

90. The device ofclaim 88, wherein one of said at least one lumens comprises an irrigation lumen.

91. The device ofclaim 90, further comprising a nozzle at a distal end of said irrigation lumen.

92. The device ofclaim 91, wherein said nozzle is oriented toward said distal end of said endoscope.

93. The device ofclaim 91, wherein said nozzle is located out of a field of view of said endoscope.

94. The device ofclaim 88, wherein said distal end portion of said elongated body is transparent to allow visualization therethrough.

95. The device ofclaim 88, further comprising a snare device extending through one of said at least two lumens of said elongated body, said snare device having a snare on a distal end thereof.

96. The device ofclaim 95, wherein said snare device further comprises a snare on a proximal end thereof.

97. The device ofclaim 90, further comprising a snare device extending through one of said at least two lumens of said elongated body, said snare device having a snare on a distal end thereof.

98-119. (canceled)

120. A surgical device for performing minimally invasive surgical procedures, said device comprising a jig having slots configured and dimensioned to receive and releasably fix an endoscope and at least one tool thereto for rapid exchange procedures.

121. The surgical device ofclaim 120, wherein a pair of said jigs configured with said slots is provided.

122. The surgical device ofclaim 120, wherein an endoscope and a snare catheter are each releasably fixed to the jig.

123. A surgical device for performing minimally invasive surgical procedures, said device comprising:

a jig having at least one opening configured and dimensioned to receive and releasably fix a tool thereto for rapid exchange procedures; and

an opening configured and dimensioned to receive an endoscope therethrough, wherein said endoscope is freely slidable with respect to said jig.

124. The device ofclaim 123, comprising a pair of said jigs each configured with said openings.

125. The device ofclaim 123, wherein each said jig comprises at least two of said openings for releasably fixing at least two tools.

126. The device ofclaim 125, further comprising an endoscope slidably received within said jig, and a snare catheter releasably fixed to said jig.

127. The device ofclaim 125, further comprising an endoscope slidably received within said jig, a snare catheter releasably fixed to said jig, and a second tool releasably fixed to said jig.

128. The device ofclaim 127, wherein said second tool comprises a suction tube.

129-225. (canceled)

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