DEVICES AND METHODS FOR MINIMALLY-INVASIVE SURGICAL PROCEDURES
Devices, instruments and tools for minimally invasive surgical procedures. Port devices and methods for hemostatically sealing and providing a port through a tissue wall that interfaces with a fluid containing chamber, by minimally invasive techniques. Assemblies, instruments and methods for minimally invasive access to and through a tissue wall that interfaces with a fluid containing chamber, and for visualizing same. Instruments, assemblies and methods for minimally invasive surgical procedures, including ablation.
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This application claims the benefit of U.S. Provisional Application No. 60/997,985, filed Oct. 5, 2007, which application is incorporated herein, in its entirety, by reference thereto.
FIELD OF THE INVENTIONthe present invention relates to the field of minimally invasive surgery and provides devices, instruments and methods for minimally invasive surgical procedures.
BACKGROUND OF THE INVENTIONA continuing trend in the performance of cardiac surgical procedures, as well as other surgical procedures performed on an internal organ or tissue of an organism is toward minimizing the invasiveness of such procedures. When entering a fluid containing internal organ to provide access for inserting tools therethrough to perform one or more surgical procedures, it would be desirable to provide a hemostatic port that prevents or minimizes introduction of air or other intended fluids or substances into the organ, while at the same time preventing substantial losses of blood or other fluids out of the organ, and while still providing an access port through which instruments can gain access to an intended surgical target site.
It would be further desirable to install such a port device in as atraumatic fashion as possible, by minimally invasive methods.
Examples of cardiac surgical procedures that could benefit from such a device include, but are not limited to: endocardial ablation procedures, valve surgeries, closure of patent foramen ovales, or for any other type of cardiac procedure requiring access into the heart.
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. Surgical 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 by pass.
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 stemotomy, 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 (S 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 let chest. The pericardium on the left side is dissected to expose the left atrial appendage and the two catheters having been initially inserted from the right side are retrieved and pulled through one of the left side ports. The two catheter ends are then tied and/or sutured together and are reinserted through the same left side port and into the left chest. The leader of a Flex 10 microwave probe (Guidant Corporation, Santa Clara, Calif.) is sutured to the end of the upper catheter on the right hand side of the patient, and the lower catheter is pulled out of a right side port to pull the Flex 10 into the right chest and lead it around the pulmonary veins. Once in proper position, the Flex 10 is incrementally actuated to form a lesion around the pulmonary veins. The remaining catheter and Flex 10 are then pulled out of the chest and follow-up steps are carried out to close the ports in the patient and complete the surgery.
Although advances have been made to reduce the morbidity of atrial ablation procedures, as noted above, there remains a continuing need for devices, techniques, systems and procedures to further reduce the invasiveness of such procedures, thereby reducing morbidity, as well as potentially reducing the amount of time required for a patient to be in surgery, as well as reducing recovery time. There remains a continuing need as well for minimizing the invasiveness of other surgical procedures performed within the heart.
There remains a continuing need for minimizing the invasiveness of the procedures for providing access to other internal organs and tissue as well.
SUMMARY OF THE INVENTIONThe present invention provides an assembly usable in performing minimally-invasive ablation procedures is provided that includes: an elongated shaft, a balloon fitted over a distal end of the elongated shaft, the balloon being configured to assumed a deflated configuration, as well as an inflated configuration wherein the balloon has an outside diameter greater than an outside diameter of the balloon in the deflated configuration; and a halo comprising wires configured to be positioned proximal of the balloon in a retracted configuration and movable to a position distal of the balloon in an expanded configuration, wherein, when in the expanded configuration, the halo defines an area larger than a contracted area defined by the halo when in the retracted configuration.
In at least one embodiment, the halo is advanceable over the balloon when the balloon is in the inflated configuration.
In at least one embodiment, the halo comprises superelastic wires that expand a configuration of the halo when moving from the retracted configuration to the expanded configuration.
In at least one embodiment, the superelastic wires slide over the balloon and the balloon deforms somewhat as the halo passes from the retracted configuration to deploy over the balloon to the expanded configuration.
In at least one embodiment, a plurality of push rods are connected to the halo, the push rods being axially slidable relative to the shaft to move the halo from the retracted configuration position and the deployed, expanded configuration position and vice versa.
In at least one embodiment, an actuator is connected to proximal ends of the push rods, the actuator being slidable over the shaft.
In at least one embodiment the actuator comprises an extension extending proximally to a proximal end portion of the shaft.
In at least one embodiment, the halo is electrically connectable to a source of ablation energy proximal of the assembly.
In at least one embodiment, the halo is connectable to a source of ablation energy proximal of the assembly.
In at least one embodiment, a conduit connecting with the balloon extends proximally of a proximal end of the shaft, the conduit being connectable in fluid communication with a source of pressurized fluid.
In at least one embodiment, the shaft comprises a cannula, the cannula being configured and dimensioned to receive an endoscope shaft therein, with a distal tip of the endoscope being positionable within the balloon.
In at least one embodiment, the shaft comprises a shaft of an endoscope.
In at least one embodiment, the halo is formed of two wires and forms a substantially oval shape when in the expanded configuration.
In at least one embodiment, the halo forms an encircling shape when in the expanded configuration.
In at least one embodiment, the halo is formed of four wires and forms a substantially quadrilateral shape when in the expanded configuration.
An instrument usable in performing minimally-invasive ablation procedures is provided that includes: an elongated shaft; a balloon fitted over a distal end of the elongated shaft, the balloon being configured to assume a deflated configuration, as well as an inflated configuration wherein the balloon has an outside diameter greater than an outside diameter of the balloon in the deflated configuration; and a halo comprising wires configured to be positioned proximal of the balloon in a retracted configuration and movable to a position distal of the balloon in an expanded configuration, wherein, when in the expanded configuration, the halo defines an area larger than a contracted area defined by the halo when in the retracted configuration; and an endoscope having a distal tip thereof positioned adjacent to an opening of the balloon or within the balloon.
In at least one embodiment, the shaft comprises a shaft of the endoscope.
In at least one embodiment, the shaft comprises a cannula and wherein a shaft of the endoscope is received in the cannula.
In at least one embodiment, the halo is advanceable over the balloon when the balloon is in the inflated configuration.
In at least one embodiment, the halo comprises superelastic wires that expand a configuration of the halo when moving from the retracted configuration to the expanded configuration.
In at least one embodiment, the superelastic wires slide over the balloon and the balloon deforms somewhat as the halo passes from the retracted configuration to deploy over the balloon to the expanded configuration.
In at least one embodiment, a plurality of push rods are connected to the halo, the push rods being axially slidable relative to the shaft to move the halo from the retracted configuration position and the deployed, expanded configuration position and vice versa.
In at least one embodiment, an actuator is connected to proximal ends of the push rods, the actuator being slidable over the shaft.
In at least one embodiment, the actuator comprises an extension extending proximally to a proximal end portion of the endoscope.
In at least one embodiment, the halo is electrically connectable to a source of ablation energy proximal of the instrument.
In at least one embodiment, the halo is connectable to a source of ablation energy proximal of the instrument.
In at least one embodiment, a conduit connecting with the balloon extends proximally of a proximal end portion of the shaft, the conduit being connectable in fluid communication with a source of pressurized fluid.
In at least one embodiment, the halo is formed of two wires and forms a substantially oval shape when in the expanded configuration.
In at least one embodiment, the halo forms an encircling shape when in the expanded configuration.
In at least one embodiment, the halo is formed of four wires and forms a substantially quadrilateral shape when in the expanded configuration.
These and other features of the invention will become apparent to those persons skilled in the art upon reading the details of the devices, assemblies, instruments and methods as more fully described below.
Before the present devices and methods are described, it is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.
Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited.
It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a lumen” includes a plurality of such lumens and reference to “the target” includes reference to one or more targets 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.
DefinitionsThe term “open-chest procedure” refers to a surgical procedure wherein access for performing the procedure is provided by a full stemotomy or thoracotomy, a stemotomy 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 stemotomy 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-stemotomy, 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.
Devices and MethodsWhen inflated, expandable members 14a, 14b expand to expanded configurations which narrow the gap 16 therebetween (or completely eliminate the gap, as illustrated in
The proximal end portion of port device 1I, i.e., the proximal portion of cannula 12 not having the expandable members 14a, 14b thereon may expand only a minimal distance proximally of expandable member 14b, e.g., about 0.5 to about 2 inches. Alternatively, depending upon the use of device 10, this proximal portion may extend a much greater distance. For example, in minimally invasive procedures where port device 1I is installed in an internal organ, the proximal end of device 10 will extend a sufficient length to be able to extend out of the patient when device 10 is installed in the organ as intended. In one example, where device 10 is installed in the left atrial appendage of the heart of a patient the proximal end of conduit 10 extends from about 6 to about 10 inches proximally of the proximal surface of expandable member 14b.
In this embodiment, as well as any of the other embodiments described herein that include cannula 12, a hemostatic valve 15 may be provided within the proximal annular opening of cannula 12, to hemostatically seal the port when no instrument or device is being inserted therethrough. Additionally, valve 15 may at least partially seal against an instrument, tool or device as it is being inserted through cannula 12 so as to prevent or minimize loss of blood or other fluids through cannula 12 during such an insertion.
After inflation of expandable member 14a, the second expandable member 14b can be inflated to expand (either before or after removal of dilator 18, as noted) to, together with expanded expandable member 14b, form a hemostatic seal of the opening through the atrial appendage. This seal is very atraumatic as the expandable members 14a, 14b do not expand radially within and against the opening, but apply axial compression to the tissues surrounding the opening (and to the interface with the opening) to seal it. This is particularly important when the access opening is made in the atrial appendage 4, as the tissue of the atrial appendage 4 tends to be very friable so that if a seal is attempted by expanding something radially within the opening, the tissue tends to tear or otherwise disintegrate or fail. Axial compression of the tissues does not pose such risks, but actually helps maintain the integrity of these tissues and thus forms the seal in a very atraumatic way. This also provides a very stable connection, as once the more distal expandable member 14a is expanded, as shown in
Expandable members are typically formed as inflatable balloons, e.g., comprising a compliant material such as latex, silicone, polyurethane, or the like, or a semi-compliant or non-compliant material such as nylon, polyethylene, polyester, polyamide, polyethylene terepthalate (PET) and urethane, for example, with compliant materials being preferred, since they can be compressed to a smaller cross-sectional area for delivery into the patient and through the opening in the tissue. Alternative forms of expandable members 14a, 14b can be provided, including, but not limited to members comprising closed-cell foam that is compressible and self-expands when a compression force is removed, self expanding stents with attached graft material, etc. When self-expanding, a sheath, additional cannula or other structure for compressing the expandable members 14a. 14b can be used for delivery to the expandable members to the locations on opposite sides of the tissue wall in which the opening to be sealed is formed, and then removal of the sheath, cannula or other compression applying member is removed to allow the expandable members to self-expand, either sequentially (14a first, then 14b) or together.
The assembly in the compact configuration is then driven against the target area (e.g., left atrial appendage) whereby driving the sharp distal tip 24t of introducer needle against the tissue pierces the tissue, thereby forming an opening that is no larger than it has to be to allow passage of the assembly therethrough. Alternatively, an incision can be made with an additional cutting instrument and then the introducer needle and compact configuration can be inserted through the incision. However, by making the opening with the introducer needle tip 24t and expanding it by driving the needle 24 and compact components 14a and 22 therethrough, this ensures that the opening is kept to a minimum size required. Further alternatively, a tool 20 may be used to provide a traction force on the atrial appendage or other tissue to be incised or pierced, to facilitate this step.
Once the needle tip 24t and expandable member 14a have been passed though the opening and positioned interiorly of the opening and the tissue wall of atrium 4, the compression member 25, in this case an additional outer sheath 25 is removed and expandable member 14a is expanded (in this case, inflated) thereby securing it within the atrial appendage 4. Expandable member 14b can be expanded either before or after withdrawal of needle 24 from the site, thereby forming an axially compressive hemostatic seal at and/or around the site of the opening 5. Next, a dilator 18 is inserted through sheath 22 to expand the inner diameter thereof, as well as the inner diameters of the expandable members 14a, 14b and cannula 12, configured with dilator 18 in any of the manners described above, is slid into the sheath 22, following dilator 18. Once cannula 12 has been inserted so that a distal end thereof is flush, or, more typically, extending slightly distally (e.g., ranging from flush up to a distance of about 1 cm) from a distal end surface of expanded expandable member 14a, dilator 18 is removed, thereby completing the installation of port device 10, which is now ready to receive instruments or other devices therethrough to carry out one or more surgical procedures.
Expandable members 14a, 14b in this case are inflatable balloons, e.g., balloons formed of a thin laver of elastomer, such as silicone, latex, polyurethane etc. The material joining the two expandable members that is position through opening 5 can also be the same as the material for the expandable members, but is typically not inflated, only expanded by dilation. Device 10 also contains one or two lumens extending through cannula 12 and one extending through to join expandable member 14a, for inflating the expandable members 14a. 14b, wherein the one or two lumens are configured in the same manner as in the cannula 12 described, with regard to
Once expandable member/distal end of cannula are abutting or in close proximity to the outer surface of the tissue wall 1 of atrial appendage 4 as illustrated in
One way of providing such expandable members is to mold the expandable members in a substantially hour-glass shape (similar to that shown in
Accordingly, the expandable member 14a is inserted, together with introducer needle distal end portion 24 through the opening formed by tip 24 and into the atrial appendage 4 in a manner as described previously. Once in place, wires/sutures/tethers 28 are actuated to release the compressive forces by the releasable ties that are maintaining the expandable members 14a,14b stretched out in tension over the introducer 24, whereby expandable members retract toward one another, and radially expand to assume the hourglass configuration shown in
Once expandable member 14a is allowed to expand, cloth (e.g., Dacron, woven polymer, or other known biocompatible fabrics acceptable for internal use) or non-compliant, but flexible polymer arms 30 that are attached to expandable member 14a and which extend out of opening 5 can be tensioned/retracted, to pull expandable member 14a against the inner surface of the tissue wall 1 thereby forming an atraumatic hemostatic seal. Flexible arms 30 may have an adhesive 32 coated on all or a portion of the side of each arm facing the external surface of the tissue wall 1, so that once expandable member 14a has been retracted sufficiently to form a hemostatic seal against the inner surface of tissue wall 1, arms 30 can be pressed against the outer surface of tissue wall 1, thereby adhering the arms to the tissue wall 1 and maintaining the hemostatic seal. Additionally or alternatively, arms 30 may be sutured, stapled and/or tacked to the tissue wall.
Device 40 comprises a malleable wire having barbs 42 formed at both ends thereof. Device 40 has a central acute bend 44 and a pair of additional acute bends 46 in an opposite direction. A locking ring 48 that is slidable over the wires of device 40 is initially positioned proximally adjacent this additional pair of bends 46. A pusher rod or wire 50 is attached to the central acute bend 44 and has sufficient column strength to push device 40 distally through cannula 12, and sufficient tensile strength to pull barbs 42 though the tissue wall 1. Bends 44, 46 allow device 40 to be elastically deformed/compressed to be pushed though cannula 12. Once barbed ends 42 clear the distal end of cannula 12, such as by pushing device 40 through cannula 12 by pushing on pusher rod/wire 50 from a location proximal of the proximal end of cannula 12 and outside of the patient's body, the barbed ends 42 spring radially outwardly beyond the outside diameter of cannula 12, Pusher rod/wire 50 can then be retracted proximally until bends 46 approach the distal end of cannula 12, as illustrated in
Barbs 42 can be driven through the tissue wall 1 solely by retracting pusher wire/rod 50 relative to cannula 12, or, alternatively, barbs can be positioned adjacent the external surface of tissue wall 1 through retracting pusher wire/rod 50, and then cannula 12 and pusher wire/rod 50 can be retracted together to drive barbs 42 through the tissue wall 1. In either case, after piercing through the tissue wall 1 with barbs 42, cannula 12 and pusher rod/wire 50 are retracted further together. As cannula 12 begins to exit the opening 5, the acute bends 46 begin to deform an increase in angle through right angle bends (
Spring force provided by linkage 64 may be a predetermined number of pounds sufficient to clamp off the walls of the atrial appendage 4 to prevent blood flow therepast, but not so great as to cause tissue damage or necrosis (e.g., about one to about four pounds force, combined). When scallops 62 are aligned as shown in
Rollers 60 may be independently rotated (such as by using graspers or other endoscopic tool, for example) to align the scallops 62 for opening the port, or to align the cylindrical surfaces to close the port. Alternatively, cylinders 60 may be linked, such as by gears 66 9
As noted earlier, with the minimally invasive installation of any of the port devices 10 described herein, instruments, tools and/or devices can then be inserted through the port device 10 for the performance of one or more minimally invasive surgical procedures.
A halo assembly 102 is installed over shaft 122 (which may be the shaft of an endoscope or a cannula into which an endoscope shaft is inserted). Halo assembly includes an expandable halo 104 formed of electrically conducting superelastic wires, that are capable of being elastically deformed as they are drawn down (by retracting pushrods 106) to the compact configuration shown in
Pushrods 106 are connected proximally to an actuator 110 that is slidable over shaft 122 to either retract halo 104 when actuator is retracted proximally along shaft 122, or to extend and expand halo 104 when actuator is pushed distally with respect to shaft 122. In
When balloon 124 is inflated and pressed up against a structure in an internal cavity, this substantially displaces blood or other fluid that may have been surrounding that structure and enables viewing of the structure via the distal tip of the endoscope residing in the inflated balloon.
As noted, shaft 122 may be provided as a cannula into which the shaft of an endoscope 200 can be inserted to provide a viewing and ablation instrument.
Pushrods 106 interconnect halo 104 and actuator 110 which is slidable over shaft 122. An extension 110e of actuator 110 is provided to allow manipulating from a location proximal of the assembly 100, typically in the vicinity of the proximal end portion of endoscope 200. In at least one embodiment, the wires forming halo 104 have a diameter of about 0.014″ and are formed of Nitinol (nickel-titanium alloy) and pushrods 106 are stainless steel and have a diameter of about 0.037″. Crimps 108 may be coated with white heat shrink tubing 108s and pushrods 106 may be coated with heat shrink tubing 106s (clear, in the example of
Ablation element comprises a metallic tip 302 mounted to a distal surface of balloon 124, preferably centrally mounted on the distal surface, although other locations may be chosen for mounting on the distal surface. Upon insertion of endoscope 200 into assembly 30) and then insertion of this instrument through a minimally invasive opening (such as provided via installation of one of the port devices 10 described herein, for example), balloon 124 can then be inflated, as shown, and then the instrument can be manipulated to slide the distal surface of the inflated balloon 124 along anatomical structures in the space into which the instrument was inserted. For example, in the case where the instrument is inserted through the left atrial appendage, and one or more encircling lesions have been performed around pulmonary vein ostia (such as by using a device of the types described in
A similar procedure can be performed using an instrument comprising an endoscope 200 inserted into an assembly 100 to form one or more encircling lesions around the pulmonary veins. In this procedure, identification and viewing of the location of the pulmonary veins can be conducted with balloon 124 inflated and halo 104 still in the retracted position and configuration. Once the surgeon has familiarized himself/herself with these locations, one or more encircling lesions can be ablated around the pulmonary veins by first deploying the halo to the deployed and expanded configuration on the distal surface of the expanded balloon 124, positioning the balloon against the target tissue so that the halo (as visualized through the balloon 124 and endoscope 2000 encircles the pulmonary ostia to be ablated around, and applying energy to halo 14 to create an encircling lesion, while viewing the ablation procedure, including the halo 104 applying energy to the target tissue, through balloon 124 and endoscope 200. It is further noted, that during sliding movements of the expanded balloon 124 against the tissue surface, balloon 124 can tend to deform somewhat due to the forces of the friction between the balloon and the tissue during sliding movements and the compliant nature of the balloon material. When halo 104 is deployed over the balloon 124 as described above, the structure of the halo 104 helps to rigidify the balloon structure somewhat during these movements, thereby reducing the amount of balloon lag and time that it takes for the balloon to become axially aligned with the cannula 122 after a sliding movement.
At step 604, a hemostatically sealed port is established through the wall of an organ, vessel or tissue having an inner, fluid containing chamber (referred to as the target tissue), inside which a surgical procedure is to be conducted Examples of target tissues (organ, vessel or other tissue) in which a hemostatically sealed port device may be installed through a wall thereof were described above. In one embodiment, a port device is installed through the wall of a left atrial appendage. In another embodiment, a port device 10 is installed though a wall of the heart at or near the apex of the heart to provide access to the left ventricle chamber. The hemostatically sealed is port is installed/established solely by minimally invasive techniques, wherein a port device 10 and any tools used to install the port device 10 are advanced to the target tissue through a minimally invasive opening in the patient. Many of the port devices 10 described herein have a cannula having sufficient length to extend out of the opening through the skin of the patient (and thus outside of the patient) even when the hemostatic seal is made to establish the port through the target organ, vessel or other tissue. Once the hemostatic port 10 has been successfully installed, at least one tool, instrument and or device are passed through the port and into the internal chamber to conduct at least one step of a surgical procedure, see step 606. Many different surgical procedures are possible, including those practiced by current endoscopic methods. In one example, atrial ablation is performed in any of the manners described above. In another example, heart valve surgery is conducted, and/or a heart valve prosthesis having already been implanted is directly visually inspected. After completion of the at least one surgical procedure step, the port is cleared of all tools, instrument and devices and the opening through the wall of the target tissue is closed, step 608. After this, closure of the patient is completed, including closing the opening through the skin, step 610.
The endoscopic trocar assembly 500 includes a rigid trocar sleeve 502 typically having an outside diameter of about 5 mm to about 10 mm and in which a hemostatic valve 504 is provided in the annular space thereof, at a proximal end portion thereof. Optionally, the distal portion may be provided with expandable members 14a and 14b, shown in phantom lines in
Following performance of an endocardial procedure, a seal 508 is introduced to close the tract formed by the endoscopic trocar 502.
The length of inner tube 512 is selected so that when inner tube 512 is fully inserted into outer sleeve 514 (i.e., when stop 512s abuts stop 514 as shown in
The inner tube 512 and suture 510 can be retracted relative to sleeve 514 to pull the seal into sleeve 514, as illustrated in
While holding inner tube 512 stationary relative to the heart 2, trocar 502 and outer sleeve 514 are next retracted proximally back to a position where stop 514s abuts stop 512s as shown in
Alternative to the use of a sheet of prosthetic graft material to form seal 508, seal 508 may be provided as a collagen plug that is installed to close and seal the tract formed by the endoscopic trocar 502. These embodiments of seal 508 can be placed in the same manner as described above with regard to placement of the seal made from a sheet of prosthetic graft material. However, rather than forming a seal over the inside wall surface of the wall in which the opening has been formed and which is being sealed off, these embodiments of seal are pulled at least partially into the opening (in a direction from the inside wall surface toward the outside wall surface) to wedge within the wall (myocardial wall or other wall having been pierced) in order to seal the opening. In the case of a trans-apical procedure on the heart, this provides post procedure hemostasis.
The collagen material from which seal 508 is made in these embodiments induced fibrotic growth into seal 508 and seal 508 also bio-absorbs over time, leaving a permanent tissue seal.
The present invention includes a port device for establishing a hemostatically sealed port through an opening in a tissue wall wherein an inside surface of the tissue wall interfaces with a fluid containing chamber, the device including: a cannula configured to be inserted through the opening in the tissue wall; and a first feature configured to impart an axial force on the tissue wall in a direction away from the fluid containing chamber, wherein axial force on the tissue wall forms a hemostatic seal substantially preventing fluid from escaping through the opening between said cannula and the opening.
In at least one embodiment, a second feature is configured to impart an axial force on the tissue wall in a direction opposing the axial force imparted by the first feature, wherein the tissue wall is axially compressed to form the hemostatic seal.
In at least one embodiment, the first feature comprises an expandable member configured to assume a collapsed configuration with a relatively smaller diameter, and an expanded configuration with a relatively larger diameter, wherein the expandable member expands radially away from the cannula upon expanding.
In at least one embodiment, the first feature comprises a first expandable member configured to assume a collapsed configuration with a relatively smaller diameter, and an expanded configuration with a relatively larger diameter, wherein the expandable member expands radially away from the cannula upon expanding, and wherein the second feature comprises a second expandable member configured to assume a collapsed configuration with a relatively smaller diameter, and an expanded configuration with a relatively larger diameter, wherein the second expandable member expands radially away from the cannula upon expanding; and wherein the first expandable member is located around a distal end portion of the cannula and the second expandable member is located proximally adjacent the first expandable member such that expansion of the first and second expandable members when positioned on opposite sides of the tissue wall axially compresses the tissue wall.
In at least one embodiment, the first and second expandable members comprise first and second balloons.
In at least one embodiment the cannula is rigid.
In at least one embodiment, the first and second balloons are interconnected by a thin, flexible tubular sheath, and the cannula is insertable though central openings formed in the first and second balloons and through the tubular sheath.
In at least one embodiment, the first and second features comprise elastomeric foam, wherein the first and second features are extendable along the cannula in a first configuration having a relatively smaller diameter and wherein the first and second features are configurable to a second, expanded configuration wherein each of the first and second features assume a relatively larger diameter, wherein the first and second features expand radially away from the cannula.
In at least one embodiment, at least one actuator is provided for axially compressing the first and second features to move from the first configuration to the second, expanded configuration.
In at least one embodiment, the first feature is located around a distal end portion of the cannula and the second feature is located proximally adjacent the first feature such that expansion of the first and second features when positioned on opposite sides of the tissue wall axially compresses the tissue wall.
In at least one embodiment, a closure assembly, configured to close the opening after removal of the cannula, is provided.
In at least one embodiment, the closure assembly comprises a double-ended wire having barbs at both ends and configured to be delivered through the cannula, the barbs being drivable though the tissue wall in a direction from the inside surface to the outside surface.
In at least one embodiment, a locking ring is slidable into detents provided on the wire of the closure assembly to maintain the barbs in a configuration holding tissue edges around the opening in a closed, everted orientation.
In at least one embodiment, a pusher element is attachable to the wire and has a length greater than a length of the cannula, and the pusher element is sufficiently rigid to push the wire through the cannula.
In at least one embodiment, a seal member extending over the cannula and surrounds the first feature.
In at least one embodiment, the first feature comprises screw threading on a distal end portion of the cannula, and the second feature comprises an expandable member configured to assume a collapsed configuration with a relatively smaller diameter, and an expanded configuration with a relatively larger diameter, wherein the second expandable member expands radially away from the cannula upon expanding.
An assembly for establishing a hemostatically sealed port through an opening in a tissue wall is provided, wherein an inside surface of the tissue wall interfaces with a fluid containing chamber, and the assembly comprises: a port device including a cannula having a biocompatible material on a distal end portion thereof that fuses or adheres to the tissue wall at the perimeter of the opening when heated, and a trocar having a sharp distal tip heatable to a temperature to at least partially melt tissue of the tissue wall as it is advanced therethrough, wherein the trocar is slidable through the cannula.
An assembly for establishing a hemostatically sealed port through an opening in a tissue wall is provided, wherein an inside surface of the tissue wall interfaces with a fluid containing chamber, and the assembly comprises: a port device including a cannula configured to be inserted through the opening in the tissue wall and a first feature configured to impart an axial force on the tissue wall in a direction away from the fluid containing chamber, wherein axial force on the tissue wall forms a hemostatic seal substantially preventing fluid from escaping through the opening between the cannula and the opening; and a dilator insertable through the cannula and having a sharp distal tip, wherein the sharp tip of the dilator is adapted to form the opening through the tissue and wherein the dilator dilates the opening formed by the sharp tip and the cannula is advanced through the dilated opening together with the dilator.
In at least one embodiment, the dilator is removably attachable within the cannula.
In at least one embodiment, the port device further comprises a second feature configured to impart an axial force on the tissue wall in a direction opposing the axial force imparted by the first feature, wherein the tissue wall is axially compressed to form the hemostatic seal.
In at least one embodiment, the first feature comprises a first expandable member configured to assume a collapsed configuration with a relatively smaller diameter, and an expanded configuration with a relatively larger diameter, wherein the expandable member expands radially away from the cannula upon expanding; wherein the second feature comprises a second expandable member configured to assume a collapsed configuration with a relatively smaller diameter, and an expanded configuration with a relatively larger diameter, wherein the second expandable member expands radially away from the cannula upon expanding; and wherein the first expandable member is located around a distal end portion of the cannula and the second expandable member is located proximally adjacent the first expandable member such that expansion of the first and second expandable members when positioned on opposite sides of the tissue wall axially compresses the tissue wall.
In at least one embodiment, the first and second expandable members comprise first and second balloons.
An assembly for establishing a hemostatically sealed port through an opening in a tissue wall is provided, wherein an inside surface of the tissue wall interfaces with a fluid containing chamber, and the assembly comprises: a port device including first and second annularly shaped balloons interconnected by a thin, flexible tubular sheath; and an inserter having a sharp distal up for creating the opening through the tissue wall; wherein the first and second balloons and the tubular sheath are wrappable around the introducer to provide a first compact configuration having a reduced cross-sectional area, and wherein, upon creating the opening with the distal tip and inserting a distal end portion of the introducer and the first balloon through the tissue wall, the first and second balloons are inflatable to expand to a second, expanded configuration that unwraps the first and second balloons and the sheath, and wherein the first and second balloons axially compress the tissue wall.
In at least one embodiment, a cannula is insertable through the second balloon, the tubular sheath and the first balloon in the second, expanded configuration.
In at least one embodiment the cannula is rigid.
An assembly for establishing a hemostatically sealed port through an opening in a tissue wall is provided, wherein an inside surface of the tissue wall interfaces with a fluid containing chamber, and the assembly comprises: a port device including a first expandable portion and a second expandable portion; a rigid cannula; and an introducer having a sharp distal tip for creating the opening through the tissue wall; wherein the first expandable portion is placed in a compact configuration over a distal end portion of the introducer and the second expandable portion is placed in a compact configuration over a distal end portion of the cannula; and wherein, upon creating the opening with the distal tip and inserting the distal end portion of the introducer and the first expandable portion through the tissue wall, the first and second expandable portions are expanded to a second, radially expanded configuration wherein the first and second expandable portions axially compress the tissue wall.
In at least one embodiment, the introducer is removed after the expansion of the expandable portions, leaving the port device forming a hemostatically sealed port through the tissue wall.
A port device for establishing a hemostatically sealed port through an opening in a tissue wall is provided, wherein an inside surface of the tissue wall interfaces with a fluid containing chamber, and the device comprises: a first feature configured to impart an axial force on the tissue wall in a direction away from the fluid containing chamber; and a second feature configured to impart an axial force on the tissue wall in a direction opposing the axial force imparted by the first feature, wherein the tissue wall is axially compressed to form the hemostatic seal.
In at least one embodiment, the first feature comprises a resilient, self-expanding ring.
In at least one embodiment, the ring comprises a superelastic material.
In at least one embodiment, the second feature comprises a plurality of flexible arms attached to the first feature and adapted to extend through the opening.
In at least one embodiment, the flexible arms each comprise an attachment feature adapted to attach the flexible arms, respectively to an outer surface of the tissue wall.
In at least one embodiment, the attachment features comprise adhesive.
In at least one embodiment, a thin film extends across the ring and forms a seal therewith.
In at least one embodiment, the film comprises a slit therethrough.
A closure device for closing an opening in a tissue wall is provided, wherein an inside surface of the tissue wall interfaces with a fluid containing chamber, and the device is deliverable through a cannula and closure is performed as a minimally invasive procedure. The device includes a double-ended wire having barbs at both ends and configured to be delivered through the cannula, the barbs being drivable though the tissue wall in a direction from the inside surface to the outside surface; and a locking ring slidable into detents provided on the wire to maintain the barbs in a configuration holding tissue edges around the opening in a closed, everted orientation.
In at least one embodiment, a pusher element is attachable to the wire and has a length greater than a length of the cannula and the pusher element is sufficiently rigid to push the wire through the cannula.
A port device for establishing a hemostatically sealed port through an opening in a tissue wall is provided, wherein an inside surface of the tissue wall interfaces with a fluid containing chamber, and the device comprises: first and second rollers extending substantially parallel to one another and mechanically linked to allow separation thereof to increase a space therebetween and movement together to reduce the space; and at least one scallop provided in each roller, wherein the rollers are rotatable to align the scallops to form an opening aligned with the opening in the tissue wall, and wherein the rollers are further rotatable to align cylindrical surfaces thereof with each other to close the opening in the tissue wall and form a hemostatic seal.
In at least one embodiment, the rollers are resiliently biased toward one another.
A port device for establishing a hemostatically sealed port through an opening in a tissue wall is provided, wherein an inside surface of the tissue wall interfaces with a fluid containing chamber, and the device comprises: a cannula having a closable distal end portion, the distal end portion comprising a plurality of spring-biased clamshell doors openable to allow an instrument to be passed therethrough, the clamshell doors being spring-biased to a closed configuration.
In at least one embodiment, the distal end portion is bullet-shaped when the clamshell doors are in the closed configuration.
A port device for establishing a hemostatically sealed port through an opening in a tissue wall is provided, wherein an inside surface of the tissue wall interfaces with a fluid containing chamber, and the device comprises, a plug having a central annulus extending therethrough along a longitudinal axis of the plug; a channel formed circumferentially in and around an external portion of the plug and compression members configured to compress the plug to expand the channel into contact with wall edges of an opening through a tissue wall.
An assembly usable in performing minimally-invasive ablation procedures is provided that includes: an elongated shaft, a balloon fitted over a distal end of the elongated shall, the balloon being configured to assumed a deflated configuration, as well as an inflated configuration wherein the balloon has an outside diameter greater than an outside diameter of the balloon in the deflated configuration; and a halo comprising wires configured to be positioned proximal of the balloon in a retracted configuration and movable to a position distal of the balloon in an expanded configuration, wherein, when in the expanded configuration, the halo defines an area larger than a contracted area defined by the halo when in the retracted configuration.
In at least one embodiment, the halo is advanceable over the balloon when the balloon is in the inflated configuration.
In at least one embodiment, the halo comprises superelastic wires that expand a configuration of the halo when moving from the retracted configuration to the expanded configuration.
In at least one embodiment, the superelastic wires slide over the balloon and the balloon deforms somewhat as the halo passes from the retracted configuration to deploy over the balloon to the expanded configuration.
In at least one embodiment, a plurality of push rods are connected to the halo, the push rods being axially slidable relative to the shaft to move the halo from the retracted configuration position and the deployed, expanded configuration position and vice versa.
In at least one embodiment, an actuator is connected to proximal ends of the push rods, the actuator being slidable over the shaft.
In at least one embodiment the actuator comprises an extension extending proximally to a proximal end portion of the shaft.
In at least one embodiment, the halo is electrically connectable to a source of ablation energy proximal of the assembly.
In at least one embodiment, the halo is connectable to a source of ablation energy proximal of the assembly.
In at least one embodiment, a conduit connecting with the balloon extends proximally of a proximal end of the shaft, the conduit being connectable in fluid communication with a source of pressurized fluid.
In at least one embodiment, the shaft comprises a cannula, the cannula being configured and dimensioned to receive an endoscope shaft therein, with a distal tip of the endoscope being positionable within the balloon.
In at least one embodiment, the shaft comprises a shaft of an endoscope.
In at least one embodiment, the halo is formed of two wires and forms a substantially oval shape when in the expanded configuration.
In at least one embodiment, the halo forms an encircling shape when in the expanded configuration.
In at least one embodiment, the halo is formed of four wires and forms a substantially quadrilateral shape when in the expanded configuration.
An instrument usable in performing minimally-invasive ablation procedures is provided that includes: an elongated shaft; a balloon fitted over a distal end of the elongated shaft, the balloon being configured to assume a deflated configuration, as well as an inflated configuration wherein the balloon has an outside diameter greater than an outside diameter of the balloon in the deflated configuration; and a halo comprising wires configured to be positioned proximal of the balloon in a retracted configuration and movable to a position distal of the balloon in an expanded configuration, wherein, when in the expanded configuration, the halo defines an area larger than a contracted area defined by the halo when in the retracted configuration; and an endoscope having a distal tip thereof positioned adjacent to an opening of the balloon or within the balloon.
In at least one embodiment, the shaft comprises a shaft of the endoscope.
In at least one embodiment, the shaft comprises a cannula and wherein a shaft of the endoscope is received in the cannula.
In at least one embodiment, the halo is advanceable over the balloon when the balloon is in the inflated configuration.
In at least one embodiment, the halo comprises superelastic wires that expand a configuration of the halo when moving from the retracted configuration to the expanded configuration.
In at least one embodiment, the superelastic wires slide over the balloon and the balloon deforms somewhat as the halo passes from the retracted configuration to deploy over the balloon to the expanded configuration.
In at least one embodiment, a plurality of push rods are connected to the halo, the push rods being axially slidable relative to the shaft to move the halo from the retracted configuration position and the deployed, expanded configuration position and vice versa.
In at least one embodiment, an actuator is connected to proximal ends of the push rods, the actuator being slidable over the shaft.
In at least one embodiment, the actuator comprises an extension extending proximally to a proximal end portion of the endoscope.
In at least one embodiment, the halo is electrically connectable to a source of ablation energy proximal of the instrument.
In at least one embodiment, the halo is connectable to a source of ablation energy proximal of the instrument.
In at least one embodiment, a conduit connecting with the balloon extends proximally of a proximal end portion of the shaft, the conduit being connectable in fluid communication with a source of pressurized fluid.
In at least one embodiment, the halo is formed of two wires and forms a substantially oval shape when in the expanded configuration.
In at least one embodiment, the halo forms an encircling shape when in the expanded configuration.
In at least one embodiment, the halo is formed of four wires and forms a substantially quadrilateral shape when in the expanded configuration.
An instrument facilitating the making of an opening, by endoscopic techniques, through a tissue wall is provided, wherein an inside surface of the tissue wall interfaces with a fluid containing chamber, while directly visualizing the making of the opening, the instrument comprising: a rigid trocar sleeve; and an endoscope slidable within the trocar sleeve and fitted with a transparent, sharp tip over a distal end of the endoscope, wherein the transparent, sharp tip is also slidable within the trocar.
In at least one embodiment, a stop is provided on a shaft of the endoscope, wherein, when the endoscope is inserted into the trocar sleeve to an extent where the stop abuts a proximal end of the trocar sleeve, the distal end of the endoscope and the transparent sharp tip are positioned distally adjacent a distal end of the trocar sleeve.
A sealing assembly for closing an opening, by endoscopic techniques, through a tissue wall is provided, wherein an inside surface of the tissue wall interfaces with a fluid containing chamber, and the assembly comprises: a seal an inner tube, a suture attached to the seal and extending through the inner tube, the suture have sufficient length to extend proximally of the inner tube when the seal is positioned distally of a distal end of the inner tube; and an outer sleeve configured to allow the inner tube to be advanced therethrough.
In at least one embodiment, the inner tube is rigid.
In at least one embodiment, the seal comprises woven polyester or Dacron.
In at least one embodiment, the seal has a surface area larger than an area of the opening to be closed.
In at least one embodiment, the suture comprises at least one of nylon and polypropylene.
In at least one embodiment, a trocar sleeve is provided, wherein the outer sleeve has an outside diameter sized to form a slip fit inside the trocar sleeve.
In at least one embodiment, the outer sleeve has a length greater than a length of the trocar sleeve.
In at least one embodiment the trocar sleeve is rigid.
In at least one embodiment, the inner tube has a length greater than a length of the outer sleeve.
In at least one embodiment, the inner tube comprises a stop on a proximal end portion thereof, wherein when the inner tube is inserted into the outer sleeve to an extent where the stop abuts a proximal end of the outer sleeve, a distal end of the inner tube extends distally of a distal end of the outer sleeve by a predetermined distance that is greater than a thickness of the tissue wall.
In at least one embodiment, the predetermined distance is about 6 cm.
In at least one embodiment, the suture and the inner tube are retractable, relative to the outer sleeve, to draw the seal into a distal end portion of the outer sleeve.
In at least one embodiment, the seal is deformed when it is drawn into the distal end portion of the outer sleeve.
A method of establishing a hemostatically sealed port through an opening in a tissue wall is provided, wherein an inside surface of the tissue wall interfaces with a fluid containing chamber, the method including the steps of: providing a minimally invasive opening through the skin of a patient; advancing a sharp instrument, through the minimally invasive opening to the tissue wall; establishing an opening through the tissue wall, by manipulating the instrument from outside of the patient; and installing a port device though the opening in the tissue wall and forming a hemostatic seal between the port device and the opening, by manipulations performed by an operator outside of the patient.
In at least one embodiment, the installing comprises inserting a distal end portion of the port device including a distal end portion of a cannula and a first expandable member through the opening through the tissue wall to position the first expandable member inside of an inside surface of the tissue wall, and expanding the first expandable member.
In at least one embodiment, a second expandable member is expanded at a location outside of an outside surface of the tissue wall, wherein the first and second expandable members axially compress the tissue wall.
In at least one embodiment, the first expandable member is an inflatable balloon.
In at least one embodiment, the first expandable member comprises polymer foam.
In at least one embodiment, the first expandable member comprises an expandable stent.
In at least one embodiment, the second expandable member is an inflatable balloon.
In at least one embodiment, the second expandable member comprises polymer foam.
In at least one embodiment, the second expandable member comprises an expandable stent.
In at least one embodiment, at least one surgical procedure is performed through the tissue wall by inserting at least one tool, instrument or device through the port device and manipulating the at least one tool, instrument or device from a location outside of the patient.
In at least one embodiment, the tissue wall is a tissue wall of an atrial appendage.
In at least one embodiment, the atrial appendage is the left atrial appendage.
In at least one embodiment, the tissue wall is a myocardial wall of the heart of the patient.
In at least one embodiment, the opening is made in the myocardial wall at or near the apex of the heart, providing access to the left ventricle.
In at least one embodiment, a proximal end portion of the cannula extends out of the patient, through the minimally invasive opening through the skin, after the step of installing the device to form the hemostatic seal.
In at least one embodiment, the step of establishing an opening through the tissue wall comprises piercing the tissue wall and dilating the tissue wall with a dilator, and wherein a portion of the port device, following the dilator is inserted through the opening through the tissue wall, after which the dilator is removed.
In at least one embodiment, the step of establishing an opening through the tissue wall comprises piercing the tissue wall with a sharp tip of an inserter, and wherein first and second expandable members are compressed and wrapped around the inserter, wherein the installing the port device comprises inserting the first expandable member through the opening through the tissue wall, expanding the first expandable member inside of the tissue wall, expanding the second expandable member outside of the tissue wall, and withdrawing the inserter.
In at least one embodiment, a rigid cannula is inserted through annular openings in the first and second expanded expandable members.
In at least one embodiment, the step of establishing an opening through the tissue wall comprises piercing the tissue wall with a sharp tip of an inserter, and wherein a first expandable members is placed, in a non-expanded configuration over a distal end portion of the inserter, and a second expandable member is placed, in a non-expanded configuration over a distal end of a cannula, and wherein the installing the port device comprises inserting the distal end portion of the inserter and first expandable member through the opening through the tissue wall, expanding the first expandable member inside of the tissue wall, expanding the second expandable member outside of the tissue wall, and withdrawing the inserter.
In at least one embodiment, the step of establishing an opening through the tissue wall comprises piercing the tissue wall with a sharp tip of an inserter, and wherein an expandable member is placed, in a non-expanded configuration over a distal end portion of the inserter, and wherein the installing the port device comprises inserting the distal end portion of the inserter and a first expandable portion of the expandable member through the opening through the tissue wall, expanding the first expandable portion inside of the tissue wall, expanding a second expandable portion of the expandable member outside of the tissue wall, and withdrawing the inserter.
In at least one embodiment, a rigid cannula is inserted through annular openings in the first and second expanded expandable portions.
In at least one embodiment, the step of installing comprises inserting a resilient ring portion of the port device, while in a reduced size configuration through the opening through the tissue wall; allowing the resilient ring to expand to an expanded configuration; drawing the ring against an inner surface of the tissue wall, and fixing a plurality of arms attached to the ring and extending through the opening in the tissue wall to an outer surface of the tissue wall.
In at least one embodiment, the step of installing comprises placing a pair of rollers on the tissue wall, against an outer surface thereof on opposite sides of the opening through the tissue wall; and compressing a double thickness of the tissue wall together by relative movement of the rollers toward one another.
In at least one embodiment, the rollers are rotated to align scallops provided in both rollers, thereby allowing access through the opening via an opening between the rollers provided by the scallops.
In at least one embodiment, the step of installing comprises placing a pair of rollers on the tissue wall, against an outer surface thereof on opposite sides of a target location where the opening through the tissue wall is to be formed, compressing a double thickness of the tissue wall together by relative movement of the rollers toward one another rotating the rollers to align scallops provided in both rollers, thereby allowing access to the tissue wall by the sharp instrument to form the opening through the tissue wall.
In at least one embodiment, a sealing member is sealed on an outer surface of the tissue wall, to establish a sealed working space prior to at least one of the establishing an opening through the tissue wall and the installing a port device though the opening.
In at least one embodiment, the step of installing comprises inserting a closable, bullet-shaped distal end of a cannula through the opening through the tissue wall, wherein the bullet-shaped distal end is pushable open by inserting a tool, instrument or device through the cannula, and is spring biased to automatically close when no tool, instrument or device is positioned between portions of the openable distal end, thereby hemostatically sealing the distal end.
In at least one embodiment, an ablation procedure is performed on an endocardial surface of the left atrium.
In at least one embodiment, at least one instrument is inserted into the left ventricle.
A method of performing ablation by minimally invasive methods while directly visualizing the ablation procedure is provided, including the steps of advancing an instrument through a minimally invasive opening through the skin of a patient and through an opening through a tissue wall to enter a fluid containing chamber against an inner surface of which ablation is to be performed; expanding a balloon at a distal end of the instrument; contacting the expanded balloon against an inner surface of a wall of the chamber, visualizing the inner surface of the wall of the chamber in a location contacted; identifying a target location to ablate by the contacting and visualizing steps, while intermittently moving the balloon to contact different locations, if necessary until the target location is identified; advancing a halo over the balloon to position the halo around an identified location and against the target location to be ablated, between the target location and a distal surface of the balloon; and applying ablation energy though the halo while visualizing the halo and target location through the balloon.
In at least one embodiment, the chamber is the left atrium, the identified location is at least one pulmonary vein ostium, and the target location is an inside surface of the atrial wall surrounding the at least one pulmonary vein ostium.
In at least one embodiment, the step of applying ablation energy forms an encircling lesion in the tissue at the target location.
In at least one embodiment, the opening through the tissue wall includes a port device installed therethrough forming a hemostatic seal between the port device and the opening, and wherein the instrument is inserted through the port device.
In at least one embodiment, the instrument is removed from the patient, and the method further includes: advancing a second instrument through the minimally invasive opening through the skin of the patient and through the opening through the tissue wall to enter the chamber; expanding a balloon at a distal end of the second instrument; contacting the expanded balloon against an inner surface of a wall of the chamber to locate a lesion formed by the applying ablation energy; visualizing the lesion through the balloon contacting the lesion; aligning an ablation element on a distal surface of the balloon to contact the lesion; applying ablation energy though the ablation element, while dragging the ablation element along tissue to form a linear lesion; and visualizing movement of the ablation element and formation of the linear lesion as the ablation element is dragged and ablation energy is applied.
A method of performing ablation by minimally invasive methods while directly visualizing the ablation procedure is provided, including the steps of advancing an instrument through a minimally invasive opening through the skin of a patient and through an opening through a tissue wall to enter a fluid containing chamber against an inner surface of which ablation is to be performed; expanding a balloon at a distal end of the instrument; contacting the expanded balloon against an inner surface of a wall of the chamber; visualizing the inner surface of the wall of the chamber in a location contacted; identifying a target location to ablate by the contacting and visualizing steps, while intermittently moving the balloon to contact different locations, if necessary until the target location is identified, aligning an ablation element on a distal surface of the balloon to contact the target location; applying ablation energy though the ablation element, while dragging the ablation element along tissue to form a linear lesion; and visualizing movement of the ablation element and formation of the linear lesion as the ablation element is dragged and ablation energy is applied.
A method of establishing, by endoscopic techniques, an opening through a tissue wall wherein an inside surface of the tissue wall interfaces with a fluid containing chamber, while visualizing the establishment of the opening, is provided, including the steps of: providing a minimally invasive opening through the skin of a patient, advancing an instrument including an endoscope having a sharp, transparent tip mounted on a distal end thereof, and a trocar, wherein the endoscope is slidably received in the trocar and the tip extends distally from a distal end of the trocar, through the minimally invasive opening to the tissue wall, and driving the sharp, transparent tip through the tissue wall while visualizing the passage of the sharp, distal tip into the tissue wall and through the wall, where the fluid is visualized, visualization being performed through the endoscope.
In at least one embodiment, the endoscope and sharp tip are withdrawn from the patient, leaving the trocar installed through the tissue wall to function as a port.
In at least one embodiment, a proximal end portion of the trocar extends out of the patient, through the minimally invasive opening through the skin when a distal end portion of the trocar is inserted through the tissue wall.
In at least one embodiment, at least one surgical procedural step is carried out that includes advancing at least one of a tool, instrument or device through the trocar and into the fluid containing chamber.
In at least one embodiment, the tissue wall is a myocardial wall of the heart.
In at least one embodiment, the tip is driven though the tissue wall at a location at or near the apex of the heart, and the chamber is the left ventricle.
In at least one embodiment, trocar is removed, the method further including hemostatically closing a tract left by insertion of the trocar through the opening through the tissue wall.
In at least one embodiment, the closing comprises, introducing a seal through the tract and into the chamber; retracting the seal against the tract opening and an inner surface of the tissue wall surrounding the tract opening, by retracting a suture attached to the seal and extending through the tract, through the opening through the skin and out of the patient; and advancing a clip over the suture and against an outer surface of the tissue wall to maintain tension on the suture, thereby maintaining the seal compressed against the inner surface.
In at least one embodiment, the closing comprises: introducing a seal through the tract and into the chamber; retracting the seal against the tract opening and an inner surface of the tissue wall surrounding the tract opening, by retracting a suture attached to the seal and extending through the tract, through the opening through the skin and out of the patient; and advancing a suture loop over the suture and against an outer surface of the tissue wall, and cinching the suture loop against the outer surface of the tissue wall to maintain tension on the suture, thereby maintaining the seal compressed against the inner surface.
A method of hemostatically closing is provided, by minimally invasive procedures, a tract formed by insertion of a trocar through a tissue wall wherein an inside surface of the tissue wall interfaces with a fluid containing chamber, the method including the steps of: inserting a seal through the trocar and into the chamber, the trocar having been inserted through a minimally invasive opening through the skin of a patient and through an opening in the tissue wall; retracting the trocar to remove it from the opening through the tissue wall; retracting the seal against the tract opening and an inner surface of the tissue wall surrounding the tract opening, by retracting a suture attached to the seal and extending through the tract, through the opening through the skin and out of the patient; and advancing a clip or suture loop over the suture and securing the clip or suture loop against an outer surface of the tissue wall to maintain tension on the suture, thereby maintaining the seal compressed against the inner surface.
Further provided is a method of hemostatically closing, by minimally invasive procedures, an opening where a cannula is placed through a tissue wall wherein an inside surface of the tissue wall interfaces with a fluid containing chamber, the method including the steps of: delivering a closure assembly through the cannula and into the chamber; retracting the closure assembly to drive barbs of the closure assembly through the tissue wall in a direction from the inside surface to the outside surface; partially withdrawing the cannula to begin everting tissue edges defining the opening; completely withdrawing the cannula and sliding a locking ring on the closure assembly into a locked position to maintain the tissue edges everted and hemostatically sealing the opening.
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
1-29. (canceled)
30. A hemostatic port device, comprising:
- a cannula;
- a needle located within the cannula, wherein a distal end portion of the needle is distal to a distal end portion of the cannula;
- a first expandable member mounted over the distal end portion of the cannula; and
- a second expandable member mounted over the distal end portion of the needle so there is a gap located between the first expandable member and the second expandable member, wherein the second expandable member and the first expandable member are annular, and wherein when the first expandable member and the second expandable member are expanded, the first expandable member and the second expandable member expand to capture tissue therebetween so as to form a hemostatic seal with the tissue.
31. The hemostatic port device of claim 30, further comprising:
- a pressurized fluid source disposed to deliver pressurized fluid to each of the first expandable member and the second expandable member so as to inflate the first expandable member and the second expandable member.
32. The hemostatic port device of claim 30, wherein the first expandable member is an inflatable balloon stretched over the distal end portion of the cannula, and the second expandable member is an inflatable balloon stretched over the distal end portion of the needle.
Type: Application
Filed: Mar 23, 2021
Publication Date: Jul 8, 2021
Applicant: MAQUET CARDIOVASCULAR LLC (Wayne, NJ)
Inventors: Evan R. ANDERSON (Woodside, CA), Alfredo R. CANTU (Pleasanton, CA), Albert K. CHIN (Palo Alto, CA), Amar KENDALE (Sunnyvale, CA)
Application Number: 17/210,198
