US20100168791A1 - Systems and methods for closing a hole in cardiac tissue - Google Patents

Systems and methods for closing a hole in cardiac tissue Download PDF

Info

Publication number
US20100168791A1
US20100168791A1 US12/722,287 US72228710A US2010168791A1 US 20100168791 A1 US20100168791 A1 US 20100168791A1 US 72228710 A US72228710 A US 72228710A US 2010168791 A1 US2010168791 A1 US 2010168791A1
Authority
US
United States
Prior art keywords
lumen
distal end
catheter
heart
wire
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US12/722,287
Inventor
Ghassan S. Kassab
Jose A. Navia, SR.
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CVDevices LLC
Original Assignee
CVDevices LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from PCT/US2008/053061 external-priority patent/WO2008134104A2/en
Application filed by CVDevices LLC filed Critical CVDevices LLC
Priority to US12/722,287 priority Critical patent/US20100168791A1/en
Assigned to CVDEVICES, LLC reassignment CVDEVICES, LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: KASSAB, GHASSAN S., NAVIA, JOSE A., SR.
Publication of US20100168791A1 publication Critical patent/US20100168791A1/en
Priority to US13/035,451 priority patent/US20110224720A1/en
Abandoned legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0587Epicardial electrode systems; Endocardial electrodes piercing the pericardium
    • A61N1/0592Introducing the lead through the pericardium with a needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491Surgical glue applicators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/30Surgical pincettes without pivotal connections
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082Catheter tip comprising a tool
    • A61M25/0084Catheter tip comprising a tool being one or more injection needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M25/04Holding devices, e.g. on the body in the body, e.g. expansible
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0662Guide tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00243Type of minimally invasive operation cardiac
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646Type of implements
    • A61B2017/0065Type of implements the implement being an adhesive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/30Surgical pincettes without pivotal connections
    • A61B2017/306Surgical pincettes without pivotal connections holding by means of suction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M2025/0004Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M2025/0039Multi-lumen catheters with stationary elements characterized by lumina being arranged coaxially
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/12Blood circulatory system
    • A61M2210/125Heart

Definitions

  • Ischemic heart disease or coronary heart disease, kills more Americans per year than any other single cause. In 2004, one in every five deaths in the United States resulted from ischemic heart disease. Indeed, the disease has had a profound impact worldwide. If left untreated, ischemic heart disease can lead to chronic heart failure, which can be defined as a significant decrease in the heart's ability to pump blood. Chronic heart failure is often treated with drug therapy.
  • Ischemic heart disease is generally characterized by a diminished flow of blood to the myocardium and is also often treated using drug therapy.
  • many of the available drugs may be administered systemically, local drug delivery (“LDD”) directly to the heart can result in higher local drug concentrations with fewer systemic side effects, thereby leading to improved therapeutic outcomes.
  • LDD local drug delivery
  • Cardiac drugs may be delivered locally via catheter passing through the blood vessels to the inside of the heart.
  • endoluminal drug delivery has several shortcomings, such as: (1) inconsistent delivery, (2) low efficiency of localization, and (3) relatively rapid washout into the circulation.
  • drugs may be delivered directly into the pericardial space, which surrounds the external surface of the heart.
  • the pericardial space is a cavity formed between the heart and the relatively stiff pericardial sac that encases the heart.
  • a catheter may be used to inject a drug into the pericardial space for local administration to the myocardial and coronary tissues.
  • Drug delivery methods that supply the agent to the heart via the pericardial space offer several advantages over endoluminal delivery, including: (1) enhanced consistency and (2) prolonged exposure of the drug to the cardiac tissue.
  • drugs are delivered into the pericardial space either by the percutaneous transventricular method or by the transthoracic approach.
  • the percutaneous transventricular method involves the controlled penetration of a catheter through the ventricular myocardium to the pericardial space.
  • the transthoracic approach involves accessing the pericardial space from outside the heart using a sheathed needle with a suction tip to grasp the pericardium, pulling it away from the myocardium to enlarge the pericardial space, and injecting the drug into the space with the needle.
  • CRT cardiac resynchronization therapy
  • Such patients generally have an abnormality in conduction that causes the right and left ventricles to beat (i.e., begin systole) at slightly different times, which further decreases the heart's already-limited function.
  • CRT helps to correct this problem of dyssynchrony by resynchronizing the ventricles, thereby leading to improved heart function.
  • the therapy involves the use of an implantable device that helps control the pacing of at least one of the ventricles through the placement of electrical leads onto specified areas of the heart. Small electrical signals are then delivered to the heart through the leads, causing the right and left ventricles to beat simultaneously.
  • CRT leads on the heart can be challenging, particularly when the target placement site is the left ventricle.
  • Leads can be placed using a transvenous approach through the coronary sinus, by surgical placement at the epicardium, or by using an endocardial approach. Problems with these methods of lead placement can include placement at an improper location (including inadvertent placement at or near scar tissue, which does not respond to the electrical signals), dissection or perforation of the coronary sinus or cardiac vein during placement, extended fluoroscopic exposure (and the associated radiation risks) during placement, dislodgement of the lead after placement, and long and unpredictable times required for placement (ranging from about 30 minutes to several hours).
  • the only approved non-surgical means for accessing the pericardial space include the subxiphoid and the ultrasound-guided apical and parasternal needle catheter techniques, and each methods involves a transthoracic approach.
  • a sheathed needle with a suction tip is advanced from a subxiphoid position into the mediastinum under fluoroscopic guidance.
  • the catheter is positioned onto the anterior outer surface of the pericardial sac, and the suction tip is used to grasp the pericardium and pull it away from the heart tissue, thereby creating additional clearance between the pericardial sac and the heart.
  • the additional clearance tends to decrease the likelihood that the myocardium will be inadvertently punctured when the pericardial sac is pierced.
  • a system for use with a vacuum source for placing a lead into a tissue of a heart comprising an engagement catheter comprising a proximal end, a distal end, and first and second lumens extending between the proximal end and the distal end; a delivery catheter comprising an elongated tube having a wall and a first lumen, wherein the delivery catheter is configured such that the delivery catheter is capable of at least partial insertion into the second lumen of the engagement catheter; a lead having a tip at a distal end, the lead configured for at least partial insertion into the first lumen of the delivery catheter; and a vacuum port located at the proximal end of the engagement catheter, the vacuum port being operatively connected to the first lumen of the engagement catheter and capable of operative connection to the vacuum source; wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port being configured to removably attach to a targeted tissue on the interior
  • the first lumen of the delivery catheter extends from approximately the proximal end of the tube to or near the distal end of the tube, the first lumen of the delivery catheter having a bend, relative to the tube, at or near the distal end of the tube and an outlet through the wall of the tube at or near the distal end of the tube.
  • the bend of the first lumen of the delivery catheter may form an angle that is approximately 90-degrees.
  • Certain disclosed embodiments of the delivery catheter disclosed herein may further comprise a second lumen extending from approximately the proximal end of the tube to or near the distal end of the tube, the second lumen of the delivery catheter having a bend, relative to the tube, at or near the distal end of the tube and an outlet through the wall of the tube at or near the distal end of the tube.
  • the bend of the second lumen of the delivery catheter may form an angle that is approximately 90-degrees.
  • the lead comprises a pacing lead, and the tip of the pacing lead has a substantially screw-like shape.
  • the delivery catheter may further comprise a steering channel extending from a proximal end of the tube to a distal end of the tube and a steering wire system at least partially located in the steering channel.
  • the steering wire system may comprise a first steering wire, a second steering wire, and a controller, each of the first and second steering wires being attached to the wall of the tube within the steering channel and the controller being attached to a proximal end of each of the first and second steering wires.
  • the controller of the steering wire system may comprise a first handle attached to the proximal end of the first steering wire and a second handle attached to the proximal end of the second steering wire.
  • the controller of the steering wire system comprises a torque system having a first rotatable spool capable of collecting and dispensing the first steering wire and a second rotatable spool capable of collecting and dispensing the second steering wire.
  • the steering wire system further comprises a third steering wire; the first steering wire is attached to the wall of the tube within the steering channel at the distal end of the tube, the attachment between the first steering wire and the wall forming a first attachment point; the second steering wire is attached to the wall of the tube within the steering channel at the distal end of the tube, the attachment between the second steering wire and the wall forming a second attachment point; the third steering wire is attached to the wall of the tube within the steering channel at the distal end of the tube, the attachment between the third steering wire and the wall forming a third attachment point; and the third attachment point is closer to the proximal end of the tube than is the first attachment point or the second attachment point.
  • the delivery catheter further comprises a handle at or near the proximal end of the tube; and the controller of the steering wire system is attached to the handle.
  • a delivery catheter for use in accessing a pericardial space surrounding the external surface of a heart, comprising an elongated tube comprising a wall extending from a proximal end of the tube to a distal end of the tube, a first lumen, and a steering channel extending from a proximal end of the tube to a distal end of the tube, the steering channel forming an orifice at the distal end of the tube; and a steering wire system at least partially located in the steering channel, the steering wire system comprising at least two steering wires attached to the wall of the tube within the steering channel and a controller attached to a proximal end of each of the at least two steering wires; wherein the first lumen extends from approximately the proximal end of the tube to or near the distal end of the tube, the first lumen having a bend, relative to the tube, at or near the distal end of the tube and an outlet through the wall of the tube at or near the distal end of the tube.
  • the steering channel of the tube and the orifice of the tube are sized for insertion over an elongated guide wire such that the elongated guide wire is inserted through the orifice and into the steering channel.
  • Certain embodiments further comprise a pacing lead sized for delivery through the outlet of the first lumen.
  • the at least two steering wires comprise a first steering wire and a second steering wire; and the controller of the steering wire system comprises a first handle attached to the proximal end of the first steering wire and a second handle attached to the proximal end of the second steering wire.
  • the controller of the steering wire system may comprise a torque system having a first rotatable spool capable of collecting and dispensing the first steering wire and a second rotatable spool capable of collecting and dispensing the second steering wire.
  • the first rotatable spool may be attached to a first rotatable dial such that rotation of the first rotatable dial causes rotation of the first rotatable spool; and the second rotatable spool may be attached to a second rotatable dial such that rotation of the second rotatable dial causes rotation of the second rotatable spool.
  • each of the at least two steering wires is attached to the wall of the tube within the steering channel at the distal end of the tube.
  • the at least two steering wires comprise a first steering wire, a second steering wire, and a third steering wire; and the first steering wire is attached to the wall of the tube within the steering channel at the distal end of the tube, the attachment between the first steering wire and the wall forming a first attachment point; the second steering wire is attached to the wall of the tube within the steering channel at the distal end of the tube, the attachment between the second steering wire and the wall forming a second attachment point; the third steering wire is attached to the wall of the tube within the steering channel at the distal end of the tube, the attachment between the third steering wire and the wall forming a third attachment point; and the third attachment point is closer to the proximal end of the tube than is the first attachment point or the second attachment point.
  • Some embodiments further comprise a sensing lead positioned at least partially within the first lumen, and some embodiments further comprise a micro-camera system positioned at least partially within the second lumen. Further, a laser Doppler tip may be positioned at least partially within the second lumen.
  • At least some embodiments disclosed herein include a method of placing a lead in a tissue of a heart, the method comprising: extending into a blood vessel an elongated tube having a proximal end, a distal end, and a first lumen, such that the distal end of the tube is in contact with a targeted tissue on the interior of a wall of the heart; aspirating the targeted tissue such that the wall of the heart is retracted away from a pericardial sac surrounding the heart to enlarge a pericardial space between the pericardial sac and the wall of the heart; accessing the pericardial space through the targeted tissue; inserting at least the distal end of an elongated guide wire into the pericardial space; inserting into the first lumen of the elongated tube and over the elongated guide wire a delivery catheter comprising a first lumen, wherein the first lumen of the delivery catheter has a bend at or near the distal end of the delivery catheter and an outlet at or near the distal
  • the delivery catheter further comprises a steering channel and a steering wire system located at least partially within the steering channel; and the step of directing the delivery catheter such that the outlet of the first lumen of the delivery catheter is adjacent to the tissue of the heart comprises directing the delivery catheter with the steering wire system.
  • Certain embodiments may further comprise the step of extending a laser Doppler tip through a second lumen of the delivery catheter to the pericardial space.
  • the lead is a pacing lead; and the steering wire system further comprises at least two steering wires attached to the delivery catheter inside the steering channel and a controller attached to the proximal ends of the at least two steering wires, the controller being capable of collecting and dispensing at least one of the at least two steering wires.
  • the step of directing the delivery catheter using the steering wire system comprises using the controller to tighten at least one of the at least two steering wires.
  • Certain embodiments may further comprise inserting into the targeted tissue over the guide wire a plug having a first end, a second end, and a hole extending from the first end to the second end.
  • the hole of the plug is self-sealing after removal of the guide wire.
  • FIG. 1 For embodiments disclosed herein include a system for closing a hole in cardiac tissue, the system comprising an engagement catheter comprising a proximal end, a distal end, first and second lumens extending between the proximal end and the distal end, and a vacuum port operatively connected to the first lumen of the engagement catheter at the proximal end of the engagement catheter, the vacuum port being capable of operative connection to a vacuum source, wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to removably attach to a targeted tissue on the interior of a wall of the heart, such that the suction port is capable of forming a reversible seal with the targeted tissue when a vacuum source is operatively attached to the vacuum port; an elongated wire capable of insertion into the second lumen of the engagement catheter; a plug having a first end, a second end, and a hole extending from the first end to the second end, the
  • the elongated wire comprises a lead, while in other embodiments the elongated wire comprises an elongated guide wire.
  • At least some disclosed embodiments include a system for closing a hole in cardiac tissue, the system comprising: an engagement catheter comprising a proximal end, a distal end, first and second lumens extending between the proximal end and the distal end, and a vacuum port operatively connected to the first lumen of the engagement catheter at the proximal end of the engagement catheter, the vacuum port being capable of operative connection to a vacuum source, wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to removably attach to a targeted tissue on the interior of a wall of the heart, such that the suction port is capable of forming a reversible seal with the targeted tissue when a vacuum source is operatively attached to the vacuum port; a delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, the delivery catheter configured such that the hollow tube is capable of
  • the closure member comprises an external cover and an internal cover; the first face of the closure member comprises an outside face of the internal cover; and the second face of the closure member comprises an outside face of the external cover.
  • the external cover is attached to the internal cover.
  • the internal cover further comprises an inside face; the external cover further comprises an inside face; and an adhesive is attached to the inside face of the internal cover and the inside face of the external cover.
  • the closure member may comprise a biodegradable substance.
  • the closure member comprises nitinol.
  • the method further comprises the steps of: reversibly attaching an internal cover to the distal end of the delivery wire, the internal cover being capable of transitioning from a folded configuration within the lumen of the delivery catheter to an expanded configuration outside of the lumen of the delivery catheter; delivering the internal cover to the targeted tissue in the interior of the heart; placing the internal cover onto the targeted tissue from the interior of the heart; releasing the internal cover from the delivery wire; and withdrawing the delivery wire from the interior of the heart.
  • At least some embodiments include a method for closing a hole in a targeted tissue of a heart, the method comprising: providing access to the hole in the targeted tissue by inserting a wire through a lumen of an elongated tube and through the hole in the targeted tissue, the elongated tube having a proximal end and a distal end adjacent to the targeted tissue; inserting into the lumen of the elongated tube and over the wire a plug having a first end, a second end, and a hole extending from the first end to the second end; inserting into the lumen of the elongated tube and over the wire an elongated shaft having a proximal end, a distal end, and a hole extending from the proximal end to the distal end; sliding the elongated shaft toward the distal end of the elongated tube until the plug approaches the hole in the targeted tissue; inserting the plug into the hole in the targeted tissue; and withdrawing the elongated shaft from the elongated tube.
  • the wire comprises a guide wire
  • the hole of the plug closes after the guide wire is withdrawn from the hole of the plug.
  • Certain embodiments include a delivery catheter for use in accessing a pericardial space surrounding the external surface of a heart, comprising: an elongated tube comprising a wall extending from a proximal end of the tube to a distal end of the tube, a first lumen, and a second lumen; wherein the first lumen extends from approximately the proximal end of the tube to or near the distal end of the tube, the first lumen having a bend, relative to the tube, at or near the distal end of the tube and an outlet through the wall of the tube at or near the distal end of the tube; and wherein the second lumen extends from approximately the proximal end of the tube to or near the distal end of the tube, the second lumen having a bend, relative to the tube, at or near the distal end of the tube and an outlet through the wall of the tube at or near the distal end of the tube.
  • the bend of the first lumen may form an angle that is approximately 90-degrees, and the bend of the
  • At least some embodiments further comprise a laser Doppler tip positioned at least partially within the second lumen.
  • a needle may be positioned at least partially within the first lumen.
  • a method of injecting a substance into a cardiac tissue from the pericardial space surrounding the external surface of a heart comprising: extending into a blood vessel an elongated tube having a proximal end, a distal end, and a first lumen, such that the distal end of the tube is in contact with a targeted tissue on the interior of a wall of the heart; aspirating the targeted tissue such that the wall of the heart is retracted away from a pericardial sac surrounding the heart to enlarge a pericardial space between the pericardial sac and the wall of the heart; accessing the pericardial space through the targeted tissue; inserting at least the distal end of an elongated guide wire into the pericardial space; inserting into the first lumen of the elongated tube and over the elongated guide wire a delivery catheter comprising a first lumen, wherein the first lumen of the delivery catheter has a bend at or near the distal end of
  • the substance may comprise gene cells, growth factors, and/or a biodegradable synthetic polymer.
  • the biodegradable synthetic polymer may be selected from the group consisting of polylactides, polyglycolides, polycaprolactones, polyanhydrides, polyamides, and polyurethanes.
  • the substance comprises a tissue inhibitor, such as a metalloproteinase.
  • the substance comprises RGD-liposome biologic glue.
  • the delivery catheter further comprises a second lumen, wherein the second lumen of the delivery catheter has a bend at or near the distal end of the delivery catheter and an outlet at or near the distal end of the delivery catheter.
  • the delivery catheter may further comprise a laser Doppler tip.
  • the method further comprises the step of measuring the thickness of the cardiac tissue using the laser Doppler tip.
  • Certain embodiments include a system for closing a hole in a targeted tissue, comprising: a closure member having a head and a plurality of arms extending from the head, the closure member capable of transitioning between an open position and a closed position; and a delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, the delivery catheter configured such that the closure member is capable of insertion into the hollow tube when the closure member is in the open position.
  • the system further comprises an engagement catheter comprising a proximal end, a distal end, a first lumen extending between the proximal end and the distal end, and a vacuum port operatively connected to the first lumen of the engagement catheter at the proximal end of the engagement catheter, the vacuum port being capable of operative connection to a vacuum source
  • the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to removably attach to a targeted tissue on the interior of a wall of the heart, such that the suction port is capable of forming a reversible seal with the targeted tissue when a vacuum source is operatively attached to the vacuum port; wherein the delivery catheter is configured for inserted into the first lumen of the engagement catheter.
  • the plurality of arms of the closure member may comprise nitinol. In some embodiments, the plurality of arms of the closure member comprise four arms.
  • a method for closing a hole in a targeted tissue of a heart comprises: providing a closure member having a head and a plurality of arms extending from the head, the closure member capable of transitioning between an open position and a closed position; delivering the closure member to the heart through a delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, the delivery catheter configured such that the closure member is capable of insertion into the hollow tube when the closure member is in the open position; deploying the closure member such that the closure member contacts the targeted tissue and transitions to the closed position.
  • the step of delivery the closure member to the heart may comprise advancing the closure member through the delivery catheter by pushing on the head of the closure member using a rod inserted into the hollow tube.
  • FIG. 1A shows an embodiment of an engagement catheter and an embodiment of a delivery catheter as disclosed herein;
  • FIG. 1B shows a percutaneous intravascular pericardial delivery using another embodiment of an engagement catheter and another embodiment of a delivery catheter as disclosed herein;
  • FIG. 2A shows a percutaneous intravascular technique for accessing the pericardial space through a right atrial wall or atrial appendage using the engagement and delivery catheters shown in FIG. 1A ;
  • FIG. 2B shows the embodiment of an engagement catheter shown in FIG. 2A ;
  • FIG. 2C shows another view of the distal end of the engagement catheter embodiment shown in FIGS. 2A and 2B ;
  • FIG. 3A shows removal of an embodiment of a catheter as disclosed herein
  • FIG. 3B shows the resealing of a puncture according to an embodiment as disclosed herein;
  • FIG. 4A to 4C show a closure of a hole in the atrial wall using an embodiment as disclosed herein;
  • FIG. 4D shows another closure of a hole in cardiac tissue using another embodiment as disclosed herein;
  • FIG. 4E shows yet another closure of a hole in cardiac tissue using another embodiment as disclosed herein;
  • FIG. 4F shows still another closure of a hole in cardiac tissue using another embodiment as disclosed herein;
  • FIG. 5A shows an embodiment of an engagement catheter as disclosed herein
  • FIG. 5B shows a cross-sectional view of the proximal end of the engagement catheter shown in FIG. 5A ;
  • FIG. 5C shows a cross-sectional view of the distal end of the engagement catheter shown in FIG. 5A ;
  • FIG. 5D shows the engagement catheter shown in FIG. 5A approaching a heart wall from inside of the heart
  • FIG. 6A shows an embodiment of a delivery catheter as disclosed herein
  • FIG. 6B shows a close-up view of the needle shown in FIG. 6A ;
  • FIG. 6C shows a cross-sectional view of the needle shown in FIGS. 6A and 6B ;
  • FIG. 7 shows an embodiment of a delivery catheter as disclosed herein
  • FIG. 8 shows an embodiment of a steering wire system within a steering channel
  • FIG. 9A shows another embodiment of a steering wire system as disclosed herein, the embodiment being deflected in one location
  • FIG. 9B shows the steering wire system shown in FIG. 9A , wherein the steering wire system is deflected at two locations;
  • FIG. 9C shows the steering wire system shown in FIGS. 9A and 9B in its original position
  • FIG. 10 shows a portion of another embodiment of a steering wire system
  • FIG. 11 shows a cross-sectional view of another embodiment of a delivery catheter as disclosed herein;
  • FIG. 12A shows an embodiment of a system for closing a hole in cardiac tissue, as disclosed herein;
  • FIG. 12B shows another embodiment of a system for closing a hole in cardiac tissue, as disclosed herein;
  • FIG. 12C shows another embodiment of a system for closing a hole in cardiac tissue, as disclosed herein;
  • FIG. 13 shows another embodiment of a system for closing a hole in cardiac tissue, as disclosed herein;
  • FIG. 14 shows another embodiment of a system for closing a hole in cardiac tissue, as disclosed herein;
  • FIG. 15A shows another embodiment of a system for closing a hole in cardiac tissue, as disclosed herein;
  • FIG. 15B shows the embodiment of FIG. 15A approaching cardiac tissue
  • FIG. 15C shows the embodiment of FIGS. 15A-15C deployed on the cardiac tissue.
  • the disclosed embodiments include devices, systems, and methods useful for accessing various tissues of the heart from inside the heart.
  • various embodiments provide for percutaneous, intravascular access into the pericardial space through an atrial wall or the wall of an atrial appendage.
  • the heart wall is aspirated and retracted from the pericardial sac to increase the pericardial space between the heart and the sac and thereby facilitate access into the space.
  • the atrial wall and atrial appendage are rather soft and deformable.
  • suction of the atrial wall or atrial appendage can provide significantly more clearance of the cardiac structure from the pericardium as compared to suction of the pericardium.
  • navigation from the intravascular region (inside of the heart) provides more certainty of position of vital cardiac structures than does intrathoracic access (outside of the heart).
  • Access to the pericardial space may be used for identification of diagnostic markers in the pericardial fluid; for pericardiocentesis; and for administration of therapeutic factors with angiogenic, myogenic, and antiarrhythmic potential.
  • epicardial pacing leads may be delivered via the pericardial space, and an ablation catheter may be used on the epicardial tissue from the pericardial space.
  • catheter system 10 includes an engagement catheter 20 , a delivery catheter 30 , and a needle 40 .
  • engagement catheter 20 has a lumen through which delivery catheter 30 has been inserted
  • delivery catheter 30 has a lumen through which needle 40 has been inserted.
  • Delivery catheter 30 also has a number of openings 50 that can be used to transmit fluid from the lumen of the catheter to the heart tissue in close proximity to the distal end of the catheter.
  • engagement catheter 20 includes a vacuum channel 60 used for suction of a targeted tissue 65 in the heart and an injection channel 70 used for infusion of substances to targeted tissue 65 , including, for example, a biological or non-biological degradable adhesive.
  • injection channel 70 is ring-shaped, which tends to provide relatively even dispersal of the infused substance over the targeted tissue, but other shapes of injection channels may be suitable.
  • a syringe 80 is attached to injection channel 70 for delivery of the appropriate substances to injection channel 70
  • a syringe 90 is attached to vacuum channel 60 through a vacuum port (not shown) at the proximal end of engagement catheter 20 to provide appropriate suction through vacuum channel 60 .
  • a suction port 95 is attached to vacuum channel 60 for contacting targeted tissue 65 , such that suction port 95 surrounds targeted tissue 65 , which is thereby encompassed within the circumference of suction port 95 .
  • syringe 90 is shown in FIG. 2B as the vacuum source providing suction for engagement catheter 20 , other types of vacuum sources may be used, such as a controlled vacuum system providing specific suction pressures.
  • syringe 80 serves as the external fluid source in the embodiment shown in FIG. 2B , but other external fluid sources may be used.
  • a route of entry for use of various embodiments disclosed herein is through the jugular or femoral vein to the superior or inferior vena cavae, respectively, to the right atrial wall or atrial appendage (percutaneously) to the pericardial sac (through puncture).
  • an engagement catheter 100 is placed via standard approach into the jugular or femoral vein.
  • the catheter which may be 4 or 5 Fr., is positioned under fluoroscopic or echocardiographic guidance into the right atrial appendage 110 .
  • Suction is initiated to aspirate a portion of atrial appendage 110 away from the pericardial sac 120 that surrounds the heart.
  • aspiration of the heart tissue is evidenced when no blood can be pulled back through engagement catheter 100 and, if suction pressure is being measured, when the suction pressure gradually increases.
  • a delivery catheter 130 is then inserted through a lumen of engagement catheter 100 .
  • a small perforation can be made in the aspirated atrial appendage 110 with a needle such as needle 40 , as shown in FIGS. 1A and 2A .
  • a guide wire (not shown) can then be advanced through delivery catheter 130 into the pericardial space to secure the point of entry 125 through the atrial appendage and guide further insertion of delivery catheter 130 or another catheter.
  • Flouroscopy or echocardiogram can be used to confirm the position of the catheter in the pericardial space.
  • a pressure tip needle can sense the pressure and measure the pressure change from the atrium (about 10 mmHg) to the pericardial space (about 2 mmHg). This is particularly helpful for transeptal access where puncture of arterial structures (e.g., the aorta) can be diagnosed and sealed with an adhesive, as described in more detail below.
  • CO2 gas can be delivered through a catheter, such as delivery catheter 130 , into the pericardial space to create additional space between the pericardial sac and the heart surface.
  • the catheter system shown in FIG. 1B is retrieved by pull back through the route of entry.
  • the puncture of the targeted tissue in the heart e.g., the right atrial appendage as shown in FIG, 3 A
  • the retrieval of the catheter may be combined with a sealing of the tissue in one of several ways: (1) release of a tissue adhesive or polymer 75 via injection channel 70 to seal off the puncture hole, as shown in FIG.
  • closure may be accomplished by using, for example, a biodegradable adhesive material (e.g., fibrin glue or cyanomethacrylate), a magnetic system, or an umbrella-shaped nitinol stent.
  • a biodegradable adhesive material e.g., fibrin glue or cyanomethacrylate
  • FIG. 3B An example of the closure of a hole in the atrium is shown in FIG. 3B .
  • Engagement catheter 20 is attached to targeted tissue 95 using suction through suction port 60 .
  • Tissue adhesive 75 is injected through injection channel 70 to coat and seal the puncture wound in targeted tissue 95 .
  • Engagement catheter 20 is then withdrawn, leaving a plug of tissue adhesive 75 attached to the atrial wall or atrial appendage.
  • FIGS. 4A-4F Other examples for sealing the puncture wound in the atrial wall or appendage are shown in FIGS. 4A-4F .
  • a sandwich-type closure member having an external cover 610 and an internal cover 620 , is inserted through the lumen of engagement catheter 600 , which is attached to the targeted tissue of an atrial wall 630 .
  • Each of external and internal covers 610 and 620 is similar to an umbrella in that it can be inserted through a catheter in its folded configuration and expanded to an expanded configuration once it is outside of the catheter. As shown in FIG.
  • external cover 610 is deployed (in its expanded configuration) on the outside of the atrial wall to seal a puncture wound in the targeted tissue, having already been delivered through the puncture wound into the pericardial space.
  • Internal cover 620 is delivered through engagement catheter 600 (in its folded configuration), as shown in FIGS, 4 A and 4 B, by an elongated delivery wire 615 , to which internal cover 620 is reversibly attached (for example, by a screw-like mechanism). Once internal cover 620 is in position on the inside of atrial wall 630 at the targeted tissue, internal cover 620 is deployed to help seal the puncture wound in the targeted tissue (see FIG. 4C ).
  • Internal cover 620 and external cover 610 may be made from a number of materials, including a shape-memory alloy such as nitinol. Such embodiments are capable of existing in a catheter in a folded configuration and then expanding to an expanded configuration when deployed into the body. Such a change in configuration can result from a change in temperature, for example.
  • Other embodiments of internal and external covers may be made from other biocompatible materials and deployed mechanically.
  • External cover 610 and internal cover 620 may be held in place using a biocompatible adhesive. Similarly, external cover 610 and internal cover 620 may be held in place using magnetic forces, such as, for example, by the inside face (not shown) of external cover 610 comprising a magnet, by the inside face (not shown) of internal cover 620 comprising a magnet, or both inside faces of external cover 610 or internal cover 620 comprising magnets.
  • closure member 632 comprises external cover 610 and internal cover 620 .
  • the closure member need not have two covers.
  • closure member 632 is made of only one cover 634 .
  • Cover 634 has a first face 636 and a second face 638 , and first face 636 is configured for reversible attachment to distal end 642 of delivery wire 640 .
  • Closure member 632 may be made of any suitable material, including nitinol, which is capable of transitioning from a folded configuration to an expanded configuration.
  • a closure member 1500 comprises an external cover 1510 and an internal cover 1520 within a delivery catheter 1530 .
  • External cover 1510 and internal cover 1520 are attached at a joint 1540 , which may be formed, for example, by a mechanical attachment or by a magnetic attachment.
  • each of the external cover and the internal cover may have a ferromagnetic component that is capable of magnetically engaging the other ferromagnetic component.
  • Delivery catheter 1530 is shown after insertion through hole 1555 of atrial wall 1550 .
  • Closure member 1500 may be advanced through delivery catheter 1530 to approach atrial wall 1550 by pushing rod 1560 .
  • Rod 1560 may be reversibly attached to internal cover 1520 so that rod 1560 may be disconnected from internal cover 1520 after closure member 1500 is properly deployed.
  • rod 1560 may engage internal cover 1520 with a screw-like tip such that rod 1560 may be easily unscrewed from closure member 1500 after deployment is complete.
  • rod 1560 may simply engage internal cover 1520 such that internal cover 1520 may be pushed along the inside of delivery catheter 1530 without attachment between internal cover 1520 and rod 1560 .
  • Closure member 1500 is advanced through delivery catheter 1530 until external cover 1510 reaches a portion of delivery catheter 1530 adjacent to atrial wall 1550 ; external cover 1510 is then pushed slowly out of delivery catheter 1530 into the pericardial space. External cover 1510 then expands and is positioned on the outer surface of atrial wall 1550 . When external cover 1510 is properly positioned on atrial wall 1550 , joint 1540 is approximately even with atrial wall 1550 within hole 1555 . Delivery catheter 1530 is then withdrawn slowly, causing hole 1555 to close slightly around joint 1540 . As delivery catheter 1530 continues to be withdrawn, internal cover 1520 deploys from delivery catheter 1530 , thereby opening into its expanded formation. Consequently, atrial wall 1550 is pinched between internal cover 1520 and external cover 1510 , and hole 1555 is closed to prevent leakage of blood from the heart.
  • FIG. 4F shows the occlusion of a hole (not shown) in atrial wall 1600 due to the sandwiching of atrial wall 1600 between an external cover 1610 and an internal cover 1620 .
  • External cover 1610 is shown deployed on the outside surface of atrial wall 1600
  • internal cover 1620 is deployed on the inside surface of atrial wall 1600 .
  • rod 1640 is engaged with internal cover 1620 , and delivery catheter 1630 is in the process of being withdrawn, which allows internal cover 1620 to fully deploy. Rod 1640 is then withdrawn through delivery catheter 1630 .
  • An engagement catheter may surround delivery catheter 1650 , as explained more fully herein.
  • FIGS. 12-15 Other examples for sealing a puncture wound in the cardiac tissue are shown in FIGS. 12-15 .
  • a plug 650 having a first end 652 , a second end 654 , and a hole 656 extending from first end 652 to second end 654 .
  • Plug 650 may be made from any suitable material, including casein, polyurethane, silicone, and polytetrafluoroethylene.
  • Wire 660 has been slidably inserted into hole 656 of plug 650 .
  • Wire 660 may be, for example, a guide wire or a pacing lead, so long as it extends through the hole in the cardiac tissue (not shown). As shown in FIG.
  • first end 652 is covered with a radiopaque material, such as barium sulfate, and is therefore radiopaque.
  • a radiopaque material such as barium sulfate
  • first end 652 of plug 650 has a smaller diameter than second end 654 of plug 650 .
  • plug 680 shown FIG. 12B and plug 684 shown in FIGS. 13 and 14 have first ends that are smaller in diameter than their respective second ends.
  • not all embodiments of plug have a first end that is smaller in diameter than the second end.
  • plug 682 shown in FIG. 12C has a first end with a diameter that is not smaller than the diameter of the second end. Both types of plug can be used to close holes in cardiac tissue.
  • elongated shaft 670 has a proximal end (not shown), a distal end 672 , and a lumen 674 extending from the proximal end to distal end 672 .
  • plug 650 , wire 660 , and shaft 670 are configured for insertion into a lumen of a catheter (see FIG. 14 ), such as an embodiment of an engagement catheter disclosed herein.
  • Plug 650 and shaft 670 are also configured to be inserted over wire 660 and can slide along wire 660 because each of lumen 656 of plug 650 and lumen 674 of shaft 670 is slightly larger in circumference than wire 660 .
  • shaft 672 is used to push plug 684 along wire 674 within elongated tube 676 to and into the hole in the targeted cardiac tissue 678 .
  • Distal end 677 of elongated tube 676 is shown attached to cardiac tissue 678 , but distal end 677 need not be attached to cardiac tissue 678 so long as distal end 677 is adjacent to cardiac tissue 678 .
  • wire 674 may be withdrawn from the hole in plug 684 and the interior of the heart (not shown) and shaft 672 is withdrawn from elongated tube 676 .
  • the plug is self-sealing, meaning that the hole of the plug closes after the wire is withdrawn.
  • the plug may be made from a dehydrated protein matrix, such as casein or ameroid, which swells after soaking up fluid.
  • elongated tube 676 can be withdrawn from the heart.
  • the wire is not withdrawn from the hole of the plug.
  • the wire may be left within the plug so that it operatively connects to the CRT device.
  • plug 680 that is similar to plug 684 .
  • plug 680 comprises external surface 681 having a ridge 683 that surrounds plug 680 in a helical or screw-like shape. Ridge 683 helps to anchor plug 680 into the hole of the targeted tissue (not shown).
  • Other embodiments of plug may include an external surface having a multiplicity of ridges surrounding the plug, for example, in a circular fashion.
  • FIGS. 15A-15C show yet another embodiment of a closure member for closing a hole in a tissue.
  • Spider clip 1700 is shown within catheter 1702 and comprises a head 1705 and a plurality of arms 1710 , 1720 , 1730 , and 1740 . Each of arms 1710 , 1720 , 1730 , and 1740 is attached at its proximal end to head 1705 .
  • spider clip 1700 has four arms, other embodiments of spider clip include fewer than, or more than, four arms. For example, some embodiments of spider clip have three arms, while others have five or more arms.
  • arms 1710 , 1720 , 1730 , and 1740 may be made from any flexible biocompatible metal that can transition between two shapes, such as a shape-memory alloy (e.g., nitinol) or stainless steel.
  • Spider clip 1700 is capable of transitioning between an open position (see FIG. 15A ), in which the distal ends of its arms 1710 , 1720 , 1730 , and 1740 are spaced apart, and a closed position (see FIG. 15C ), in which the distal ends of arms 1710 , 1720 , 1730 , and 1740 are gathered together.
  • the clip can be configured to transition from the open position to the closed position when the metal is warmed to approximately body temperature, such as when the clip is placed into the cardiac tissue.
  • the clip is configured in its closed position, but may be transitioned into an open position when pressure is exerted on the head of the clip. Such pressure causes the arms to bulge outward, thereby causing the distal ends of the arms to separate.
  • spider clip 1700 may be used to seal a wound or hole in a tissue, such as a hole through the atrial wall.
  • FIG. 15B shows spider clip 1700 engaged by rod 1750 within engagement catheter 1760 .
  • engagement catheter 1760 has a bell-shaped suction port 1765 , which, as disclosed herein, has aspirated cardiac tissue 1770 .
  • Cardiac tissue 1770 includes a hole 1775 therethrough, and suction port 1765 fits over hole 1775 so as to expose hole 1775 to spider clip 1700 .
  • Rod 1750 pushes spider clip 1700 through engagement catheter 1760 to advance spider clip 1700 toward cardiac tissue 1770 .
  • Rod 1750 simply engages head 1705 by pushing against it, but in other embodiments, the rod may be reversibly attached to the head using a screw-type system. In such embodiments, the rod may be attached and detached from the head simply by screwing the rod into, or unscrewing the rod out of the head, respectively.
  • the spider clip is held in its open position during advancement through the engagement catheter by the pressure exerted on the head of the clip by the rod. This pressure may be opposed by the biasing of the legs against the engagement catheter during advancement.
  • spider clip 1700 approaches cardiac tissue 1770 and eventually engages cardiac tissue 1770 such that the distal end of each of arms 1710 , 1720 , 1730 , and 1740 contacts cardiac tissue 1770 .
  • Rod 1750 is disengaged from spider clip 1700 , and spider clip 1700 transitions to its closed position, thereby drawing the distal ends of arms 1710 , 1720 , 1730 , and 1740 together.
  • the distal ends grip portions of cardiac tissue 1770 , thereby collapsing the tissue between arms 1710 , 1720 , 1730 , and 1740 such that hole 1775 is effectively closed.
  • Rod 1750 is then withdrawn, and engagement catheter 1760 is disengaged from cardiac tissue 1770 .
  • the constriction of cardiac tissue 1770 holds hole 1775 closed so that blood does not leak through hole 1775 after engagement catheter 1760 is removed.
  • the body's natural healing processes permanently close hole 1775 .
  • Spider clip 1700 may remain in the body indefinitely.
  • Engagement catheter 700 is an elongated tube having a proximal end 710 and a distal end 720 , as well as two lumens 730 , 740 extending between proximal end 710 and distal end 720 .
  • Lumens 730 , 740 are formed by concentric inner wall 750 and outer wall 760 , as particularly shown in FIGS. 5B and 5C .
  • engagement catheter 700 includes a vacuum port 770 , which is attached to lumen 730 so that a vacuum source can be attached to vacuum port 770 to create suction in lumen 730 , thereby forming a suction channel.
  • a suction port 780 is attached to lumen 730 so that suction port 780 can be placed in contact with heart tissue 775 (see FIG. 5D ) for aspirating the tissue, thereby forming a vacuum seal between suction port 780 and tissue 775 when the vacuum source is attached and engaged.
  • the vacuum seal enables suction port 780 to grip, stabilize, and retract tissue 775 .
  • attaching a suction port to an interior atrial wall using a vacuum source enables the suction port to retract the atrial wall from the pericardial sac surrounding the heart, which enlarges the pericardial space between the atrial wall and the pericardial sac.
  • two internal lumen supports 810 , 820 are located within lumen 730 and are attached to inner wall 750 and outer wall 760 to provide support to the walls. These lumen supports divide lumen 730 into two suction channels. Although internal lumen supports 810 , 820 extend from distal end 720 of catheter 700 along a substantial portion of the length of catheter 700 , internal lumen supports 810 , 820 may or may not span the entire length of catheter 700 . Indeed, as shown in FIGS. 5A , 5 B, and 5 C, internal lumen supports 810 , 820 do not extend to proximal end 710 to ensure that the suction from the external vacuum source is distributed relatively evenly around the circumference of catheter 700 . Although the embodiment shown in FIG. 5C includes two internal lumen supports, other embodiments may have just one internal support or even three or more such supports.
  • FIG. 5D shows engagement catheter 700 approaching heart tissue 775 for attachment thereto. It is important for the clinician performing the procedure to know when the suction port has engaged the tissue of the atrial wall or the atrial appendage. For example, in reference to FIG. 5D , it is clear that suction port 780 has not fully engaged tissue 775 such that a seal is formed. However, because suction port 780 is not usually seen during the procedure, the clinician may determine when the proper vacuum seal between the atrial tissue and the suction port has been made by monitoring the amount of blood that is aspirated, by monitoring the suction pressure with a pressure sensor/regulator, or both.
  • the suction can be activated through lumen 730 .
  • a certain level of suction e.g., 10 mmHg
  • a pressure sensor/regulator As long as catheter 700 does not engage the wall, some blood will be aspirated into the catheter and the suction pressure will remain the same. However, when catheter 700 engages or attaches to the wall of the heart (depicted as tissue 775 in FIG. 5D ), minimal blood is aspirated and the suction pressure will start to gradually increase. Each of these signs can alert the clinician (through alarm or other means) as an indication of engagement.
  • the pressure regulator is then able to maintain the suction pressure at a preset value to prevent over-suction of the tissue.
  • An engagement catheter such as engagement catheter 700
  • lumen 740 shown in FIGS. 5A and 5C includes an injection channel 790 at distal end 720 .
  • Injection channel 790 dispenses to the targeted tissue a substance flowing through lumen 740 .
  • injection channel 790 is the distal end of lumen 740 .
  • the injection channel may be ring-shaped (see FIG. 2C ) or have some other suitable configuration.
  • Substances that can be locally administered with an engagement catheter include preparations for gene or cell therapy, drugs, and adhesives that are safe for use in the heart.
  • the proximal end of lumen 740 has a fluid port 800 , which is capable of attachment to an external fluid source for supply of the fluid to be delivered to the targeted tissue.
  • an adhesive may be administered to the targeted tissue by the engagement catheter for sealing the puncture wound left by the needle withdrawn from the targeted tissue.
  • a delivery catheter 850 comprising an elongated hollow tube 880 having a proximal end 860 , a distal end 870 , and a lumen 885 along the length of the catheter. Extending from distal end 870 is a hollow needle 890 in communication with lumen 885 . Needle 890 is attached to distal end 870 in the embodiment of FIGS. 6A , 6 B, and 6 C, but, in other embodiments, the needle may be removably attached to, or otherwise located at, the distal end of the catheter (see FIG, 1 A). In the embodiment shown in FIGS.
  • the junction i.e., site of attachment
  • the clinician when a clinician inserts needle 890 through an atrial wall to gain access to the pericardial space, the clinician will not, under normal conditions, unintentionally perforate the pericardial sac with needle 890 because the larger diameter of hollow tube 880 (as compared to that of needle 890 ) at security notch 910 hinders further needle insertion.
  • security notch 910 is formed by the junction of hollow tube 880 and needle 890 in the embodiment shown in FIGS, 6 A, 6 B, and 6 C
  • other embodiments may have a security notch that is configured differently.
  • a security notch may include a band, ring, or similar device that is attached to the needle a suitable distance from the tip of the needle.
  • other security notch embodiments hinder insertion of the needle past the notch itself by presenting a larger profile than the profile of the needle such that the notch does not easily enter the hole in the tissue caused by entry of the needle.
  • the delivery catheter can be connected to a pressure transducer to measure pressure at the tip of the needle. Because the pressure is lower and much less pulsatile in the pericardial space than in the atrium, the clinician can recognize immediately when the needle passes through the atrial tissue into the pericardial space.
  • needle 890 may be connected to a strain gauge 915 as part of the catheter assembly.
  • tissue not shown
  • needle 890 will be deformed.
  • the deformation will be transmitted to strain gauge 915 and an electrical signal will reflect the deformation (through a classical wheatstone bridge), thereby alerting the clinician.
  • Such confirmation of the puncture of the wall can prevent over-puncture and can provide additional control of the procedure.
  • a delivery catheter such as catheter 850 shown in FIGS. 6A , 6 B, and 6 C
  • an engagement catheter such as catheter 700 shown in FIGS. 5A , 5 B, 5 C, and 5 D
  • engagement catheter 700 may be inserted into the vascular system and advanced such that the distal end of the engagement catheter is within the atrium.
  • the engagement catheter may be attached to the targeted tissue on the interior of a wall of the atrium using a suction port as disclosed herein.
  • a standard guide wire may be inserted through the lumen of the delivery catheter as the delivery catheter is inserted through the inner lumen of the engagement catheter, such as lumen 740 shown in FIGS.
  • Use of the guide wire enables more effective navigation of the delivery catheter 850 and prevents the needle 890 from damaging the inner wall 750 of the engagement catheter 700 .
  • the tip of the delivery catheter with the protruding guide wire reaches the atrium, the wire is pulled back, and the needle is pushed forward to perforate the targeted tissue.
  • the guide wire is then advanced through the perforation into the pericardial space, providing access to the pericardial space through the atrial wall.
  • lumen 885 of delivery catheter 850 may be used for delivering fluid into the pericardial space after needle 890 is inserted through the atrial wall or the atrial appendage.
  • a guide wire (not shown) may be inserted through needle lumen 900 into the pericardial space to maintain access through the atrial wall or appendage. Fluid may then be introduced to the pericardial space in a number of ways. For example, after the needle punctures the atrial wall or appendage, the needle is generally withdrawn. If the needle is permanently attached to the delivery catheter, as in the embodiment shown in FIGS. 6A and 6B , then delivery catheter 850 would be withdrawn and another delivery catheter (without an attached needle) would be introduced over the guide wire into the pericardial space. Fluid may then be introduced into the pericardial space through the lumen of the second delivery catheter,
  • the needle is not attached to the delivery catheter, but instead may be a needle wire (see FIG. 1A ).
  • the needle is withdrawn through the lumen of the delivery catheter, and the delivery catheter may be inserted over the guide wire into the pericardial space. Fluid is then introduced into the pericardial space through the lumen of the delivery catheter.
  • the various embodiments disclosed herein may be used by clinicians, for example: (1) to deliver genes, cells, drugs, etc.; (2) to provide catheter access for epicardial stimulation; (3) to evacuate fluids acutely (e.g., in cases of pericardial tampondae) or chronically (e.g., to alleviate effusion caused by chronic renal disease, cancer, etc.); (4) to perform transeptal puncture and delivery of a catheter through the left atrial appendage for electrophysiological therapy, biopsy, etc.; (5) to deliver a magnetic glue or ring through the right atrial appendage to the aortic root to hold a percutaneous aortic valve in place; (6) to deliver a catheter for tissue ablation, e.g., to the pulmonary veins, or right atrial and epicardial surface of the heart for atrial and ventricular arrythmias; (7) to deliver and place epicardial, right atrial, and right and left ventricle pacing leads (as discussed herein); (8) to occ
  • Delivery catheter 1000 includes an elongated tube 1010 having a wall 1020 extending from a proximal end (not shown) of tube 1010 to a distal end 1025 of tube 1010 .
  • Tube 1010 includes two lumens, but other embodiments of delivery catheters may have fewer than, or more than, two lumens, depending on the intended use of the delivery catheter.
  • Tube 1010 also includes a steering channel 1030 , in which a portion of steering wire system 1040 is located. Steering channel 1030 forms orifice 1044 at distal end 1025 of tube 1010 and is sized to fit over a guide wire 1050 .
  • FIG. 8 shows in more detail steering wire system 1040 within steering channel 1030 (which is shown cut away from the remainder of the delivery catheter).
  • Steering wire system 1040 is partially located in steering channel 1030 and comprises two steering wires 1060 and 1070 and a controller 1080 , which, in the embodiment shown in FIG. 8 , comprises a first handle 1090 and a second handle 1094 .
  • First handle 1090 is attached to proximal end 1064 of steering wire 1060
  • second handle 1094 is attached to proximal end 1074 of steering wire 1070 .
  • Distal end 1066 of steering wire 1060 is attached to the wall of the tube of the delivery catheter within steering channel 1030 at attachment 1100
  • distal end 1076 of steering wire 1070 is attached to the wall of the tube of the delivery catheter within steering channel 1030 at attachment 1110 .
  • attachment 1100 and attachment 1110 are located on opposing sides of steering channel 1030 near distal tip 1120 of delivery catheter 1000 .
  • FIG. 11 shows a cross-sectional view of a delivery catheter 1260 having an elongated tube 1264 comprising a wall 1266 , a steering channel 1290 , a first lumen 1270 , and a second lumen 1280 .
  • Delivery catheter 1260 further includes a steering wire 1292 within a steering wire lumen 1293 , a steering wire 1294 within a steering wire lumen 1295 , and a steering wire 1296 within a steering wire lumen 1297 .
  • Each of steering wire lumens 1293 , 1295 , and 1297 is located within steering channel 1290 and is formed from wall 1266 .
  • Each of steering wires 1292 , 1294 , and 1296 is attached to wall 1266 within steering channel 1290 . As will be explained, the attachment of each steering wire to the wall may be located near the distal tip of the delivery catheter, or may be located closer to the middle of the delivery catheter.
  • steering wire system 1040 can be used to control distal tip 1120 of delivery catheter 1000 .
  • steering wire 1060 pulls distal tip 1120 , which bends delivery catheter 1000 , causing tip deflection in a first direction.
  • steering wire 1070 pulls distal tip 1120 in the opposite direction, which bends delivery catheter 1000 , causing tip deflection in the opposite direction.
  • delivery catheter 1000 can be directed (i.e., steered) through the body using steering wire system 1040 .
  • steering wire system 1040 has only two steering wires, other embodiments of steering wire systems may have more than two steering wires.
  • some embodiments of steering wire systems may have three steering wires (see FIG. 11 ), each of which is attached to the steering channel at a different attachment.
  • Other embodiments of steering wire systems may have four steering wires.
  • more steering wires give the clinician more control for directing the delivery catheter because each additional steering wire enables the user to deflect the tip of the delivery catheter in an additional direction.
  • four steering wires could be used to direct the delivery catheter in four different directions (e.g., up, down, right, and left).
  • a steering wire system includes more than two steering wires
  • the delivery catheter may be deflected at different points in the same direction.
  • a delivery catheter with three steering wires may include two steering wires for deflection in a certain direction and a third steering wire for reverse deflection (i.e., deflection in the opposite direction).
  • the two steering wires for deflection are attached at different locations along the length of the delivery catheter.
  • FIGS. 9A-9C there is shown a steering wire system 1350 within steering channel 1360 (which is shown cut away from the remainder of the delivery catheter) in different states of deflection.
  • Steering wire system 1350 is partially located in steering channel 1360 and comprises three steering wires 1370 , 1380 , and 1390 and a controller 1400 , which, in the embodiment shown in FIGS. 9A-9C , comprises a handle 1405 .
  • Handle 1405 is attached to proximal end 1374 of steering wire 1370 , proximal end 1384 of steering wire 1380 , and proximal end 1394 of steering wire 1390 .
  • Distal end 1376 of steering wire 1370 is attached to the wall of the tube of the delivery catheter within steering channel 1360 at attachment 1378 , which is near the distal tip of the delivery catheter (not shown).
  • Distal end 1386 of steering wire 1380 is attached to the wall of the tube of the delivery catheter within steering channel 1360 at attachment 1388 , which is near the distal tip of the delivery catheter (not shown).
  • Attachment 1378 and attachment 1388 are located on opposing sides of steering channel 1360 such that steering wires 1370 and 1380 , when tightened (as explained below), would tend to deflect the delivery catheter in opposite directions.
  • Distal end 1396 of steering wire 1390 is attached to the wall of the tube of the delivery catheter within steering channel 1360 at attachment 1398 , which is located on the delivery catheter at a point closer to the proximal end of the delivery catheter than attachments 1378 and 1388 .
  • Attachment 1398 is located on the same side of steering channel 1360 as attachment 1388 , such that steering wires 1380 and 1390 , when tightened (as explained below), would tend to deflect the delivery catheter in the same direction. However, because attachment 1398 is closer to the proximal end of the delivery catheter than is attachment 1388 , the tightening of steering wire 1390 tends to deflect the delivery catheter at a point closer to the proximal end of the delivery catheter than does the tightening of steering wire 1380 . Thus, as shown in FIG. 9A , the tightening of steering wire 1390 causes a deflection in the delivery catheter approximately at point 1410 .
  • the tightening of steering wire 1380 at the same time causes a further deflection in the delivery catheter approximately at point 1420 , as shown in FIG. 9B .
  • the tightening of steering wire 1370 therefore, causes a reverse deflection, returning the delivery catheter to its original position (see FIG. 9C ).
  • elongated tube 1010 further includes lumen 1130 and lumen 1140 .
  • Lumen 1130 extends from approximately the proximal end (not shown) of tube 1010 to or near distal end 1025 of tube 1010 .
  • Lumen 1130 has a bend 1134 , relative to tube 1010 , at or near distal end 1025 of tube 1010 and an outlet 1136 through wall 1020 of tube 1010 at or near distal end 1025 of tube 1010 .
  • lumen 1140 has a bend 1144 , relative to tube 1010 , at or near distal end 1025 of tube 1010 and an outlet 1146 through wall 1020 of tube 1010 at or near distal end 1025 of tube 1010 .
  • lumen 1130 is configured as a laser Doppler tip, and lumen 1140 is sized to accept a retractable sensing lead 1150 and a pacing lead 1160 having a tip at the distal end of the lead.
  • the fiberoptic laser Doppler tip detects and measures blood flow (by measuring the change in wavelength of light emitted by the tip), which helps the clinician to identify—and then avoid—blood vessels during lead placement.
  • Sensing lead 1150 is designed to detect electrical signals in the heart tissue so that the clinician can avoid placing a pacing lead into electrically nonresponsive tissue, such as scar tissue.
  • Pacing lead 1160 is a screw-type lead for placement onto the cardiac tissue, and its tip, which is an electrode, has a substantially screw-like shape. Pacing lead 1160 is capable of operative attachment to a CRT device (not shown) for heart pacing.
  • CRT device not shown
  • Each of bend 1134 of lumen 1130 and bend 1144 of lumen 1140 forms an approximately 90-degree angle, which allows respective outlets 1136 and 1146 to face the external surface of the heart as the catheter is maneuvered in the pericardial space.
  • Such angles may range, for example, from about 25-degrees to about 155-degrees.
  • lumen 1130 and lumen 1140 may be configured to allow, for example, the taking of a cardiac biopsy, the delivery of gene cell treatment or pharmacological agents, the delivery of biological glue for ventricular reinforcement, implementation of ventricular epicardial suction in the acute myocardial infarction and border zone area, the removal of fluid in treatment of pericardial effusion or cardiac tamponade, or the ablation of cardiac tissue in treatment of atrial fibrillation.
  • lumen 1130 could be used to deliver a catheter needle for intramyocardial injection of gene cells, stems, biomaterials, growth factors (such as cytokinase, fibroblast growth factor, or vascular endothelial growth factor) and/or biodegradable synthetic polymers, ROD-liposome biologic glue, or any other suitable drug or substance for treatment or diagnosis.
  • suitable biodegradable synthetic polymer may include polylactides, polyglycolides, polycaprolactones, polyanhydrides, polyamides, and polyurethanes.
  • the substance comprises a tissue inhibitor, such as a metalloproteinase (e.g., metalloproteinase 1),
  • the injection of certain substances is useful in the treatment of chronic heart failure to reinforce and strengthen the left ventricular wall.
  • certain substances such as biopolymers and RGD-liposome biologic glue
  • the injection of such substances into the cardiac tissue from the pericardial space alleviates the problems and risks associated with delivery via the transthoracic approach. For instance, once the distal end of the delivery catheter is advanced to the pericardial space, as disclosed herein, a needle is extended through a lumen of the delivery catheter into the cardiac tissue and the substance is injected through the needle into the cardiac tissue.
  • the delivery of substances into the cardiac tissue from the pericardial space can be facilitated using a laser Doppler tip.
  • the laser Doppler tip located in lumen 1140 of the embodiment shown in FIG. 7 can be used to measure the thickness of the left ventricular wall during the procedure (in real time) to determine the appropriate target area for injection.
  • controller 1080 comprises first handle 1090 and second handle 1094
  • other embodiments of the controller may include different configurations.
  • a controller may include any suitable torque system for controlling the steering wires of the steering wire system.
  • FIG. 10 there is shown a portion of a steering wire system 1170 having steering wire 1180 , steering wire 1190 , and controller 1200 .
  • Controller 1200 comprises a torque system 1210 having a first rotatable spool 1220 , which is capable of collecting and dispensing steering wire 1180 upon rotation.
  • Torque system 1210 also has a second rotatable spool 1230 , which is capable of collecting and dispensing steering wire 1190 upon rotation, as described above.
  • Torque system 1210 further includes a first rotatable dial 1240 and a second rotatable dial 1250 .
  • First rotatable dial 1240 is attached to first rotatable spool 1220 such that rotation of first rotatable dial 1240 causes rotation of first rotatable spool 1220 .
  • second rotatable dial 1250 is attached to second rotatable spool 1230 such that rotation of second rotatable dial 1250 causes rotation of second rotatable spool 1230 .
  • torque system 1210 and specifically first and second rotatable dials 1240 and 1250 , may optionally be positioned on a catheter handle (not shown) at the proximal end of tube 1010 .
  • Steering wire system 1170 can be used to direct a delivery catheter through the body in a similar fashion as steering wire system 1140 .
  • first rotatable dial 1240 is rotated in a first direction (e,g., clockwise)
  • steering wire 1180 is tightened and the delivery catheter is deflected in a certain direction.
  • first rotatable dial 1240 is rotated in the other direction (e.g., counterclockwise)
  • steering wire 1180 is loosened and the delivery catheter straightens to its original position.
  • second rotatable dial 1250 is rotated in one direction (e.g., counterclockwise)
  • steering wire 1190 is tightened and the delivery catheter is deflected in a direction opposite of the first deflection.
  • second rotatable dial 1250 is rotated in the other direction (e.g., clockwise)
  • steering wire 1190 is loosened and the delivery catheter is straightened to its original position.
  • steering wire system may comprise other types of torque system, so long as the torque system permits the clinician to reliably tighten and loosen the various steering wires.
  • the magnitude of tightening and loosening of each steering wire should be controllable by the torque system,
  • Delivery catheter 1260 includes tube 1265 , a first lumen 1270 , a second lumen 1280 , and a steering channel 1290 .
  • Steering wires 1292 , 1294 , and 1296 are shown within steering channel 1290 .
  • First lumen 1270 has outlet 1275 , which can be used to deliver a micro-camera system (not shown) or a laser Doppler tip 1278 .
  • Second lumen 1280 is sized to deliver a pacing lead 1300 , as well as a sensing lead (not shown).
  • a pacing lead may be placed on the external surface of the heart using an engagement catheter and a delivery catheter as disclosed herein.
  • an elongated tube of an engagement catheter is extended into a blood vessel so that the distal end of the tube is in contact with a targeted tissue on the interior of a wall of the heart.
  • the targeted tissue may be on the interior of the atrial wall or the atrial appendage.
  • Suction is initiated to aspirate a portion of the targeted tissue to retract the cardiac wall away from the pericardial sac that surrounds the heart, thereby enlarging a pericardial space between the pericardial sac and the cardiac wall.
  • a needle is then inserted through a lumen of the tube and advanced to the heart.
  • the needle is inserted into the targeted tissue, causing a perforation of the targeted tissue.
  • the distal end of a guide wire is inserted through the needle into the pericardial space to secure the point of entry through the cardiac wall.
  • the needle is then withdrawn from the targeted tissue.
  • a delivery catheter as described herein, is inserted into the lumen of the tube of the engagement catheter and over the guide wire.
  • the delivery catheter may be a 14 Fr. radiopaque steering catheter.
  • the distal end of the delivery catheter is advanced over the guide wire through the targeted tissue into the pericardial space.
  • the delivery catheter is directed using a steering wire system as disclosed herein.
  • a micro-camera system may be extended through the lumen of the delivery catheter to assist in the direction of the delivery catheter to the desired location in the pericardial space.
  • Micro-camera systems suitable for use with the delivery catheter are well-known in the art.
  • a laser Doppler system may be extended through the lumen of the delivery catheter to assist in the direction of the delivery catheter.
  • the delivery catheter is positioned such that the outlet of one of the lumens of the delivery catheter is adjacent to the external surface of the heart (e.g., the external surface of an atrium or a ventricle).
  • a pacing lead is extended through the lumen of the delivery catheter onto the external surface of the heart.
  • the pacing lead may be attached to the external surface of the heart, for example, by screwing the lead into the cardiac tissue.
  • the pacing lead may be placed deeper into the cardiac tissue, for example in the subendocardial tissue, by screwing the lead further into the tissue.
  • the disclosed embodiments can be used for subendocardial, as well as epicardial, pacing. While the placement of the leads is epicardial, the leads can be configured to have a long screw-like tip that reaches near the subendocardial wall. The tip of the lead can be made to be conducting and stimulatory to provide the pacing to the subendocardial region. In general, the lead length can be selected to pace transmurally at any site through the thickness of the heart wall. Those of skill in the art can decide whether epicardial, subendocardial, or some transmural location stimulation of the muscle is best for the patient in question.
  • the disclosure may have presented a method and/or process as a particular sequence of steps.
  • the method or process should not be limited to the particular sequence of steps described.
  • Other sequences of steps may be possible. Therefore, the particular order of the steps disclosed herein should not be construed as limitations of the present disclosure.
  • disclosure directed to a method and/or process should not be limited to the performance of their steps in the order written. Such sequences may be varied and still remain within the scope of the present disclosure,

Abstract

Systems and methods for closing a hold in cardiac tissue. In at least one embodiment of a system for closing a hole in cardiac tissue, the system comprises an engagement catheter having a first and second lumen extending therethrough, an elongated wire capable of insertion into the second lumen of the engagement catheter, a plug capable of insertion into the second lumen of the engagement catheter; an elongated shaft capable of insertion into the second lumen of the engagement catheter, wherein the elongated wire is sized for slidable insertion through the lumen of the shaft and the hole of the plug.

Description

    PRIORITY
  • This U.S. continuation patent application is related to, and claims the priority benefit of, U.S. Nonprovisional patent application Ser. No. 12/596,964, filed Oct. 21, 2009, which is related to, claims the priority benefit of, and is a U.S. national stage application of, International Patent Application No. PCT/US2008/053061, filed on Feb. 5, 2008, which (i) claims priority to U.S. Provisional Patent Application Ser. No. 60/914,452, filed Apr. 27, 2007, and (ii) is related to, claims the priority benefit of and in at least some designated countries should be considered a continuation-in-part application of, International Patent Application No. PCT/US2007/015207, filed Jun. 29, 2007, which is related to, and claims the priority benefit of, U.S. Provisional Patent Application Ser. No. 60/914,452, filed Apr. 27, 2007, and U.S. Provisional Patent Application Ser. No. 60/817,421, filed Jun. 30, 2006. The contents of each of these applications are hereby incorporated by reference in their entirety into this disclosure.
  • BACKGROUND
  • Ischemic heart disease, or coronary heart disease, kills more Americans per year than any other single cause. In 2004, one in every five deaths in the United States resulted from ischemic heart disease. Indeed, the disease has had a profound impact worldwide. If left untreated, ischemic heart disease can lead to chronic heart failure, which can be defined as a significant decrease in the heart's ability to pump blood. Chronic heart failure is often treated with drug therapy.
  • Ischemic heart disease is generally characterized by a diminished flow of blood to the myocardium and is also often treated using drug therapy. Although many of the available drugs may be administered systemically, local drug delivery (“LDD”) directly to the heart can result in higher local drug concentrations with fewer systemic side effects, thereby leading to improved therapeutic outcomes.
  • Cardiac drugs may be delivered locally via catheter passing through the blood vessels to the inside of the heart. However, endoluminal drug delivery has several shortcomings, such as: (1) inconsistent delivery, (2) low efficiency of localization, and (3) relatively rapid washout into the circulation.
  • To overcome such shortcomings, drugs may be delivered directly into the pericardial space, which surrounds the external surface of the heart. The pericardial space is a cavity formed between the heart and the relatively stiff pericardial sac that encases the heart. Although the pericardial space is usually quite small because the pericardial sac and the heart are in such close contact, a catheter may be used to inject a drug into the pericardial space for local administration to the myocardial and coronary tissues. Drug delivery methods that supply the agent to the heart via the pericardial space offer several advantages over endoluminal delivery, including: (1) enhanced consistency and (2) prolonged exposure of the drug to the cardiac tissue.
  • In current practice, drugs are delivered into the pericardial space either by the percutaneous transventricular method or by the transthoracic approach. The percutaneous transventricular method involves the controlled penetration of a catheter through the ventricular myocardium to the pericardial space. The transthoracic approach involves accessing the pericardial space from outside the heart using a sheathed needle with a suction tip to grasp the pericardium, pulling it away from the myocardium to enlarge the pericardial space, and injecting the drug into the space with the needle.
  • For some patients with chronic heart failure, cardiac resynchronization therapy (“CRT”) can be used in addition to drug therapy to improve heart function. Such patients generally have an abnormality in conduction that causes the right and left ventricles to beat (i.e., begin systole) at slightly different times, which further decreases the heart's already-limited function. CRT helps to correct this problem of dyssynchrony by resynchronizing the ventricles, thereby leading to improved heart function. The therapy involves the use of an implantable device that helps control the pacing of at least one of the ventricles through the placement of electrical leads onto specified areas of the heart. Small electrical signals are then delivered to the heart through the leads, causing the right and left ventricles to beat simultaneously.
  • Like the local delivery of drugs to the heart, the placement of CRT leads on the heart can be challenging, particularly when the target placement site is the left ventricle. Leads can be placed using a transvenous approach through the coronary sinus, by surgical placement at the epicardium, or by using an endocardial approach. Problems with these methods of lead placement can include placement at an improper location (including inadvertent placement at or near scar tissue, which does not respond to the electrical signals), dissection or perforation of the coronary sinus or cardiac vein during placement, extended fluoroscopic exposure (and the associated radiation risks) during placement, dislodgement of the lead after placement, and long and unpredictable times required for placement (ranging from about 30 minutes to several hours).
  • Clinically, the only approved non-surgical means for accessing the pericardial space include the subxiphoid and the ultrasound-guided apical and parasternal needle catheter techniques, and each methods involves a transthoracic approach. In the subxiphoid method, a sheathed needle with a suction tip is advanced from a subxiphoid position into the mediastinum under fluoroscopic guidance. The catheter is positioned onto the anterior outer surface of the pericardial sac, and the suction tip is used to grasp the pericardium and pull it away from the heart tissue, thereby creating additional clearance between the pericardial sac and the heart. The additional clearance tends to decrease the likelihood that the myocardium will be inadvertently punctured when the pericardial sac is pierced.
  • Although this technique works well in the normal heart, there are major limitations in diseased or dilated hearts—the very hearts for which drug delivery and CRT lead placement are most needed. When the heart is enlarged, the pericardial space is significantly smaller and the risk of puncturing the right ventricle or other cardiac structures is increased. Additionally, because the pericardium is a very stiff membrane, the suction on the pericardium provides little deformation of the pericardium and, therefore, very little clearance of the pericardium from the heart.
  • Thus, there is need for an efficient, easy to use, and relatively inexpensive technique that can be used to access the heart for local delivery of therapeutic and diagnostic substances, as well as of CRT leads and other types of leads.
  • BRIEF SUMMARY
  • Disclosed herein are devices, systems, and methods for accessing the internal and external tissues of the heart. At least some of the disclosed embodiments provide access to the external surface of the heart through the pericardial space for localized delivery of leads to the heart tissue. In addition, various disclosed embodiments provide devices, systems, and methods for closing a hole or wound in cardiac tissue.
  • For example, disclosed herein is a system for use with a vacuum source for placing a lead into a tissue of a heart, comprising an engagement catheter comprising a proximal end, a distal end, and first and second lumens extending between the proximal end and the distal end; a delivery catheter comprising an elongated tube having a wall and a first lumen, wherein the delivery catheter is configured such that the delivery catheter is capable of at least partial insertion into the second lumen of the engagement catheter; a lead having a tip at a distal end, the lead configured for at least partial insertion into the first lumen of the delivery catheter; and a vacuum port located at the proximal end of the engagement catheter, the vacuum port being operatively connected to the first lumen of the engagement catheter and capable of operative connection to the vacuum source; wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port being configured to removably attach to a targeted tissue on the interior of a wall of the heart, such that the suction port is capable of forming a reversible seal with the targeted tissue when the vacuum source is operatively attached to the vacuum port, and wherein the system is capable of enlarging a pericardial space between the targeted tissue and a pericardial sac that surrounds the heart by retracting the targeted tissue away from the pericardial sac. In at least some embodiments, the first lumen of the delivery catheter extends from approximately the proximal end of the tube to or near the distal end of the tube, the first lumen of the delivery catheter having a bend, relative to the tube, at or near the distal end of the tube and an outlet through the wall of the tube at or near the distal end of the tube. In addition, the bend of the first lumen of the delivery catheter may form an angle that is approximately 90-degrees.
  • Certain disclosed embodiments of the delivery catheter disclosed herein may further comprise a second lumen extending from approximately the proximal end of the tube to or near the distal end of the tube, the second lumen of the delivery catheter having a bend, relative to the tube, at or near the distal end of the tube and an outlet through the wall of the tube at or near the distal end of the tube. The bend of the second lumen of the delivery catheter may form an angle that is approximately 90-degrees.
  • In certain embodiments, the lead comprises a pacing lead, and the tip of the pacing lead has a substantially screw-like shape.
  • The delivery catheter may further comprise a steering channel extending from a proximal end of the tube to a distal end of the tube and a steering wire system at least partially located in the steering channel. The steering wire system may comprise a first steering wire, a second steering wire, and a controller, each of the first and second steering wires being attached to the wall of the tube within the steering channel and the controller being attached to a proximal end of each of the first and second steering wires. The controller of the steering wire system may comprise a first handle attached to the proximal end of the first steering wire and a second handle attached to the proximal end of the second steering wire.
  • In at least some embodiments, the controller of the steering wire system comprises a torque system having a first rotatable spool capable of collecting and dispensing the first steering wire and a second rotatable spool capable of collecting and dispensing the second steering wire.
  • In some embodiments, the steering wire system further comprises a third steering wire; the first steering wire is attached to the wall of the tube within the steering channel at the distal end of the tube, the attachment between the first steering wire and the wall forming a first attachment point; the second steering wire is attached to the wall of the tube within the steering channel at the distal end of the tube, the attachment between the second steering wire and the wall forming a second attachment point; the third steering wire is attached to the wall of the tube within the steering channel at the distal end of the tube, the attachment between the third steering wire and the wall forming a third attachment point; and the third attachment point is closer to the proximal end of the tube than is the first attachment point or the second attachment point.
  • In some embodiments, the delivery catheter further comprises a handle at or near the proximal end of the tube; and the controller of the steering wire system is attached to the handle.
  • Also disclosed herein is a delivery catheter for use in accessing a pericardial space surrounding the external surface of a heart, comprising an elongated tube comprising a wall extending from a proximal end of the tube to a distal end of the tube, a first lumen, and a steering channel extending from a proximal end of the tube to a distal end of the tube, the steering channel forming an orifice at the distal end of the tube; and a steering wire system at least partially located in the steering channel, the steering wire system comprising at least two steering wires attached to the wall of the tube within the steering channel and a controller attached to a proximal end of each of the at least two steering wires; wherein the first lumen extends from approximately the proximal end of the tube to or near the distal end of the tube, the first lumen having a bend, relative to the tube, at or near the distal end of the tube and an outlet through the wall of the tube at or near the distal end of the tube. In at least some embodiments, the steering channel of the tube and the orifice of the tube are sized for insertion over an elongated guide wire such that the elongated guide wire is inserted through the orifice and into the steering channel. Certain embodiments further comprise a pacing lead sized for delivery through the outlet of the first lumen.
  • In certain embodiments, the at least two steering wires comprise a first steering wire and a second steering wire; and the controller of the steering wire system comprises a first handle attached to the proximal end of the first steering wire and a second handle attached to the proximal end of the second steering wire. The controller of the steering wire system may comprise a torque system having a first rotatable spool capable of collecting and dispensing the first steering wire and a second rotatable spool capable of collecting and dispensing the second steering wire. The first rotatable spool may be attached to a first rotatable dial such that rotation of the first rotatable dial causes rotation of the first rotatable spool; and the second rotatable spool may be attached to a second rotatable dial such that rotation of the second rotatable dial causes rotation of the second rotatable spool. In some embodiments, each of the at least two steering wires is attached to the wall of the tube within the steering channel at the distal end of the tube.
  • In certain embodiments, the at least two steering wires comprise a first steering wire, a second steering wire, and a third steering wire; and the first steering wire is attached to the wall of the tube within the steering channel at the distal end of the tube, the attachment between the first steering wire and the wall forming a first attachment point; the second steering wire is attached to the wall of the tube within the steering channel at the distal end of the tube, the attachment between the second steering wire and the wall forming a second attachment point; the third steering wire is attached to the wall of the tube within the steering channel at the distal end of the tube, the attachment between the third steering wire and the wall forming a third attachment point; and the third attachment point is closer to the proximal end of the tube than is the first attachment point or the second attachment point.
  • Some embodiments further comprise a sensing lead positioned at least partially within the first lumen, and some embodiments further comprise a micro-camera system positioned at least partially within the second lumen. Further, a laser Doppler tip may be positioned at least partially within the second lumen.
  • At least some embodiments disclosed herein include a method of placing a lead in a tissue of a heart, the method comprising: extending into a blood vessel an elongated tube having a proximal end, a distal end, and a first lumen, such that the distal end of the tube is in contact with a targeted tissue on the interior of a wall of the heart; aspirating the targeted tissue such that the wall of the heart is retracted away from a pericardial sac surrounding the heart to enlarge a pericardial space between the pericardial sac and the wall of the heart; accessing the pericardial space through the targeted tissue; inserting at least the distal end of an elongated guide wire into the pericardial space; inserting into the first lumen of the elongated tube and over the elongated guide wire a delivery catheter comprising a first lumen, wherein the first lumen of the delivery catheter has a bend at or near the distal end of the delivery catheter and an outlet at or near the distal end of the delivery catheter; advancing at least the distal end of the delivery catheter through the targeted tissue into the pericardial space; directing the delivery catheter such that the outlet of the first lumen of the delivery catheter is adjacent to the tissue of the heart; extending a lead through the first lumen of the delivery catheter into the tissue of the heart; withdrawing the delivery catheter from the pericardial space; and withdrawing the guide wire from the pericardial space. In some embodiments, the delivery catheter further comprises a steering channel and a steering wire system located at least partially within the steering channel; and the step of directing the delivery catheter such that the outlet of the first lumen of the delivery catheter is adjacent to the tissue of the heart comprises directing the delivery catheter with the steering wire system. Certain embodiments may further comprise the step of extending a laser Doppler tip through a second lumen of the delivery catheter to the pericardial space.
  • In some embodiments, the lead is a pacing lead; and the steering wire system further comprises at least two steering wires attached to the delivery catheter inside the steering channel and a controller attached to the proximal ends of the at least two steering wires, the controller being capable of collecting and dispensing at least one of the at least two steering wires.
  • In certain embodiments, the step of directing the delivery catheter using the steering wire system comprises using the controller to tighten at least one of the at least two steering wires.
  • Certain embodiments may further comprise inserting into the targeted tissue over the guide wire a plug having a first end, a second end, and a hole extending from the first end to the second end. In some embodiments, the hole of the plug is self-sealing after removal of the guide wire.
  • Other embodiments disclosed herein include a system for closing a hole in cardiac tissue, the system comprising an engagement catheter comprising a proximal end, a distal end, first and second lumens extending between the proximal end and the distal end, and a vacuum port operatively connected to the first lumen of the engagement catheter at the proximal end of the engagement catheter, the vacuum port being capable of operative connection to a vacuum source, wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to removably attach to a targeted tissue on the interior of a wall of the heart, such that the suction port is capable of forming a reversible seal with the targeted tissue when a vacuum source is operatively attached to the vacuum port; an elongated wire capable of insertion into the second lumen of the engagement catheter; a plug having a first end, a second end, and a hole extending from the first end to the second end, the plug being capable of insertion into the second lumen of the engagement catheter; and an elongated shaft having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, the elongated shaft being capable of insertion into the second lumen of the engagement catheter; wherein the elongated wire is sized for slidable insertion through the lumen of the shaft and the hole of the plug. The first end of the plug may be radiopaque. In some embodiments, the first end of the plug has a smaller diameter than the second end of the plug. Certain embodiments may include a plug having an external surface that has a screw-shaped ridge.
  • In some embodiments, the elongated wire comprises a lead, while in other embodiments the elongated wire comprises an elongated guide wire.
  • At least some disclosed embodiments include a system for closing a hole in cardiac tissue, the system comprising: an engagement catheter comprising a proximal end, a distal end, first and second lumens extending between the proximal end and the distal end, and a vacuum port operatively connected to the first lumen of the engagement catheter at the proximal end of the engagement catheter, the vacuum port being capable of operative connection to a vacuum source, wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to removably attach to a targeted tissue on the interior of a wall of the heart, such that the suction port is capable of forming a reversible seal with the targeted tissue when a vacuum source is operatively attached to the vacuum port; a delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, the delivery catheter configured such that the hollow tube is capable of insertion into the second lumen of the engagement catheter; an elongated delivery wire having a proximal end and a distal end, the distal end of the delivery wire being capable of insertion through the hollow tube of the delivery catheter; and a closure member having a first face and a second face, the closure member being capable of transitioning from a folded configuration within the hollow tube of the delivery catheter to an expanded configuration outside of the hollow tube of the delivery catheter; wherein the first face of the closure member is configured for reversible attachment to the distal end of the delivery wire. In at least some embodiments, the closure member comprises an external cover and an internal cover; the first face of the closure member comprises an outside face of the internal cover; and the second face of the closure member comprises an outside face of the external cover. Further, the internal cover may further comprise an inside face; the external cover may further comprise an inside face; and at least one of the inside face of the internal cover and the inside face of the external cover may comprise a magnet.
  • In at least some embodiments, the external cover is attached to the internal cover. In some embodiments, the internal cover further comprises an inside face; the external cover further comprises an inside face; and an adhesive is attached to the inside face of the internal cover and the inside face of the external cover.
  • The closure member may comprise a biodegradable substance. In some embodiments, the closure member comprises nitinol.
  • Also disclosed herein are embodiments including a method for closing a hole in a targeted tissue of a heart, the method comprising: contacting the targeted tissue in the interior of the heart with a distal end of an elongated tube, the elongated tube having a first lumen and a second lumen; aspirating the targeted tissue such that the targeted tissue is retracted away from a pericardial sac surrounding the heart and a pericardial space between the pericardial sac and the targeted tissue is enlarged; inserting through the first lumen of the elongated tube a delivery catheter having a lumen; inserting an elongated delivery wire through the lumen of the delivery catheter, the elongated delivery wire having an external cover that is capable of transitioning from a folded configuration within the lumen of the delivery catheter to an expanded configuration outside of the lumen of the delivery catheter, the external cover being reversibly attached to a distal end of the delivery wire; delivering the external cover through the hole in the targeted tissue into the pericardial space; placing the external cover onto the targeted tissue from the pericardial space; releasing the external cover from the delivery wire; and withdrawing the delivery wire from the targeted tissue. In some embodiments, the method further comprises the steps of: reversibly attaching an internal cover to the distal end of the delivery wire, the internal cover being capable of transitioning from a folded configuration within the lumen of the delivery catheter to an expanded configuration outside of the lumen of the delivery catheter; delivering the internal cover to the targeted tissue in the interior of the heart; placing the internal cover onto the targeted tissue from the interior of the heart; releasing the internal cover from the delivery wire; and withdrawing the delivery wire from the interior of the heart.
  • At least some embodiments include a method for closing a hole in a targeted tissue of a heart, the method comprising: providing access to the hole in the targeted tissue by inserting a wire through a lumen of an elongated tube and through the hole in the targeted tissue, the elongated tube having a proximal end and a distal end adjacent to the targeted tissue; inserting into the lumen of the elongated tube and over the wire a plug having a first end, a second end, and a hole extending from the first end to the second end; inserting into the lumen of the elongated tube and over the wire an elongated shaft having a proximal end, a distal end, and a hole extending from the proximal end to the distal end; sliding the elongated shaft toward the distal end of the elongated tube until the plug approaches the hole in the targeted tissue; inserting the plug into the hole in the targeted tissue; and withdrawing the elongated shaft from the elongated tube. In some embodiments, the first end of the plug has a diameter that is smaller than the diameter of the second end of the plug, and the first end of the plug may be radiopaque. The embodiment may further comprise the step of confirming the location of the plug using radiographic imaging.
  • In at least some embodiments, the wire comprises a guide wire, and the hole of the plug closes after the guide wire is withdrawn from the hole of the plug.
  • Certain embodiments include a delivery catheter for use in accessing a pericardial space surrounding the external surface of a heart, comprising: an elongated tube comprising a wall extending from a proximal end of the tube to a distal end of the tube, a first lumen, and a second lumen; wherein the first lumen extends from approximately the proximal end of the tube to or near the distal end of the tube, the first lumen having a bend, relative to the tube, at or near the distal end of the tube and an outlet through the wall of the tube at or near the distal end of the tube; and wherein the second lumen extends from approximately the proximal end of the tube to or near the distal end of the tube, the second lumen having a bend, relative to the tube, at or near the distal end of the tube and an outlet through the wall of the tube at or near the distal end of the tube. The bend of the first lumen may form an angle that is approximately 90-degrees, and the bend of the second lumen may form an angle that is approximately 90-degrees.
  • At least some embodiments further comprise a laser Doppler tip positioned at least partially within the second lumen. A needle may be positioned at least partially within the first lumen.
  • Disclosed herein are embodiments including a method of injecting a substance into a cardiac tissue from the pericardial space surrounding the external surface of a heart, the method comprising: extending into a blood vessel an elongated tube having a proximal end, a distal end, and a first lumen, such that the distal end of the tube is in contact with a targeted tissue on the interior of a wall of the heart; aspirating the targeted tissue such that the wall of the heart is retracted away from a pericardial sac surrounding the heart to enlarge a pericardial space between the pericardial sac and the wall of the heart; accessing the pericardial space through the targeted tissue; inserting at least the distal end of an elongated guide wire into the pericardial space; inserting into the first lumen of the elongated tube and over the elongated guide wire a delivery catheter comprising a first lumen, wherein the first lumen of the delivery catheter has a bend at or near the distal end of the delivery catheter and an outlet at or near the distal end of the delivery catheter; advancing at least the distal end of the delivery catheter through the targeted tissue into the pericardial space; directing the delivery catheter such that the outlet of the first lumen of the delivery catheter is adjacent to the external surface of the heart; extending a needle through the first lumen of the delivery catheter into the cardiac tissue; injecting the substance into the cardiac tissue; and withdrawing the delivery catheter from the pericardial space. The substance may comprise gene cells, growth factors, and/or a biodegradable synthetic polymer. The biodegradable synthetic polymer may be selected from the group consisting of polylactides, polyglycolides, polycaprolactones, polyanhydrides, polyamides, and polyurethanes. In certain embodiments, the substance comprises a tissue inhibitor, such as a metalloproteinase. In at least certain embodiments, the substance comprises RGD-liposome biologic glue.
  • In at least some embodiments, the delivery catheter further comprises a second lumen, wherein the second lumen of the delivery catheter has a bend at or near the distal end of the delivery catheter and an outlet at or near the distal end of the delivery catheter. The delivery catheter may further comprise a laser Doppler tip. In some embodiments, the method further comprises the step of measuring the thickness of the cardiac tissue using the laser Doppler tip.
  • Certain embodiments include a system for closing a hole in a targeted tissue, comprising: a closure member having a head and a plurality of arms extending from the head, the closure member capable of transitioning between an open position and a closed position; and a delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, the delivery catheter configured such that the closure member is capable of insertion into the hollow tube when the closure member is in the open position. In at least some embodiments, the system further comprises an engagement catheter comprising a proximal end, a distal end, a first lumen extending between the proximal end and the distal end, and a vacuum port operatively connected to the first lumen of the engagement catheter at the proximal end of the engagement catheter, the vacuum port being capable of operative connection to a vacuum source, wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to removably attach to a targeted tissue on the interior of a wall of the heart, such that the suction port is capable of forming a reversible seal with the targeted tissue when a vacuum source is operatively attached to the vacuum port; wherein the delivery catheter is configured for inserted into the first lumen of the engagement catheter.
  • The plurality of arms of the closure member may comprise nitinol. In some embodiments, the plurality of arms of the closure member comprise four arms.
  • In at least certain embodiments, a method for closing a hole in a targeted tissue of a heart, the method comprises: providing a closure member having a head and a plurality of arms extending from the head, the closure member capable of transitioning between an open position and a closed position; delivering the closure member to the heart through a delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, the delivery catheter configured such that the closure member is capable of insertion into the hollow tube when the closure member is in the open position; deploying the closure member such that the closure member contacts the targeted tissue and transitions to the closed position. The step of delivery the closure member to the heart may comprise advancing the closure member through the delivery catheter by pushing on the head of the closure member using a rod inserted into the hollow tube.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1A shows an embodiment of an engagement catheter and an embodiment of a delivery catheter as disclosed herein;
  • FIG. 1B shows a percutaneous intravascular pericardial delivery using another embodiment of an engagement catheter and another embodiment of a delivery catheter as disclosed herein;
  • FIG. 2A shows a percutaneous intravascular technique for accessing the pericardial space through a right atrial wall or atrial appendage using the engagement and delivery catheters shown in FIG. 1A;
  • FIG. 2B shows the embodiment of an engagement catheter shown in FIG. 2A;
  • FIG. 2C shows another view of the distal end of the engagement catheter embodiment shown in FIGS. 2A and 2B;
  • FIG. 3A shows removal of an embodiment of a catheter as disclosed herein;
  • FIG. 3B shows the resealing of a puncture according to an embodiment as disclosed herein;
  • FIG. 4A to 4C show a closure of a hole in the atrial wall using an embodiment as disclosed herein;
  • FIG. 4D shows another closure of a hole in cardiac tissue using another embodiment as disclosed herein;
  • FIG. 4E shows yet another closure of a hole in cardiac tissue using another embodiment as disclosed herein;
  • FIG. 4F shows still another closure of a hole in cardiac tissue using another embodiment as disclosed herein;
  • FIG. 5A shows an embodiment of an engagement catheter as disclosed herein;
  • FIG. 5B shows a cross-sectional view of the proximal end of the engagement catheter shown in FIG. 5A;
  • FIG. 5C shows a cross-sectional view of the distal end of the engagement catheter shown in FIG. 5A;
  • FIG. 5D shows the engagement catheter shown in FIG. 5A approaching a heart wall from inside of the heart;
  • FIG. 6A shows an embodiment of a delivery catheter as disclosed herein;
  • FIG. 6B shows a close-up view of the needle shown in FIG. 6A;
  • FIG. 6C shows a cross-sectional view of the needle shown in FIGS. 6A and 6B;
  • FIG. 7 shows an embodiment of a delivery catheter as disclosed herein;
  • FIG. 8 shows an embodiment of a steering wire system within a steering channel;
  • FIG. 9A shows another embodiment of a steering wire system as disclosed herein, the embodiment being deflected in one location;
  • FIG. 9B shows the steering wire system shown in FIG. 9A, wherein the steering wire system is deflected at two locations;
  • FIG. 9C shows the steering wire system shown in FIGS. 9A and 9B in its original position;
  • FIG. 10 shows a portion of another embodiment of a steering wire system;
  • FIG. 11 shows a cross-sectional view of another embodiment of a delivery catheter as disclosed herein;
  • FIG. 12A shows an embodiment of a system for closing a hole in cardiac tissue, as disclosed herein;
  • FIG. 12B shows another embodiment of a system for closing a hole in cardiac tissue, as disclosed herein;
  • FIG. 12C shows another embodiment of a system for closing a hole in cardiac tissue, as disclosed herein;
  • FIG. 13 shows another embodiment of a system for closing a hole in cardiac tissue, as disclosed herein;
  • FIG. 14 shows another embodiment of a system for closing a hole in cardiac tissue, as disclosed herein;
  • FIG. 15A shows another embodiment of a system for closing a hole in cardiac tissue, as disclosed herein;
  • FIG. 15B shows the embodiment of FIG. 15A approaching cardiac tissue; and
  • FIG. 15C shows the embodiment of FIGS. 15A-15C deployed on the cardiac tissue.
  • DETAILED DESCRIPTION
  • For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of this disclosure is thereby intended.
  • The disclosed embodiments include devices, systems, and methods useful for accessing various tissues of the heart from inside the heart. For example, various embodiments provide for percutaneous, intravascular access into the pericardial space through an atrial wall or the wall of an atrial appendage. In at least some embodiments, the heart wall is aspirated and retracted from the pericardial sac to increase the pericardial space between the heart and the sac and thereby facilitate access into the space.
  • Unlike the relatively stiff pericardial sac, the atrial wall and atrial appendage are rather soft and deformable. Hence, suction of the atrial wall or atrial appendage can provide significantly more clearance of the cardiac structure from the pericardium as compared to suction of the pericardium. Furthermore, navigation from the intravascular region (inside of the heart) provides more certainty of position of vital cardiac structures than does intrathoracic access (outside of the heart).
  • Access to the pericardial space may be used for identification of diagnostic markers in the pericardial fluid; for pericardiocentesis; and for administration of therapeutic factors with angiogenic, myogenic, and antiarrhythmic potential. In addition, as explained in more detail below, epicardial pacing leads may be delivered via the pericardial space, and an ablation catheter may be used on the epicardial tissue from the pericardial space.
  • In the embodiment of the catheter system shown in FIG. 1A, catheter system 10 includes an engagement catheter 20, a delivery catheter 30, and a needle 40. Although each of engagement catheter 20, delivery catheter 30, and needle 40 has a proximal end and a distal end, FIG. 1A shows only the distal end. Engagement catheter 20 has a lumen through which delivery catheter 30 has been inserted, and delivery catheter 30 has a lumen through which needle 40 has been inserted. Delivery catheter 30 also has a number of openings 50 that can be used to transmit fluid from the lumen of the catheter to the heart tissue in close proximity to the distal end of the catheter.
  • As shown in more detail in FIGS. 2A, 2B, 2C, engagement catheter 20 includes a vacuum channel 60 used for suction of a targeted tissue 65 in the heart and an injection channel 70 used for infusion of substances to targeted tissue 65, including, for example, a biological or non-biological degradable adhesive. As is shown in FIGS. 2B and 2C, injection channel 70 is ring-shaped, which tends to provide relatively even dispersal of the infused substance over the targeted tissue, but other shapes of injection channels may be suitable. A syringe 80 is attached to injection channel 70 for delivery of the appropriate substances to injection channel 70, and a syringe 90 is attached to vacuum channel 60 through a vacuum port (not shown) at the proximal end of engagement catheter 20 to provide appropriate suction through vacuum channel 60. At the distal end of engagement catheter 20, a suction port 95 is attached to vacuum channel 60 for contacting targeted tissue 65, such that suction port 95 surrounds targeted tissue 65, which is thereby encompassed within the circumference of suction port 95. Although syringe 90 is shown in FIG. 2B as the vacuum source providing suction for engagement catheter 20, other types of vacuum sources may be used, such as a controlled vacuum system providing specific suction pressures. Similarly, syringe 80 serves as the external fluid source in the embodiment shown in FIG. 2B, but other external fluid sources may be used.
  • A route of entry for use of various embodiments disclosed herein is through the jugular or femoral vein to the superior or inferior vena cavae, respectively, to the right atrial wall or atrial appendage (percutaneously) to the pericardial sac (through puncture).
  • Referring now to FIG. 1B, an engagement catheter 100 is placed via standard approach into the jugular or femoral vein. The catheter, which may be 4 or 5 Fr., is positioned under fluoroscopic or echocardiographic guidance into the right atrial appendage 110. Suction is initiated to aspirate a portion of atrial appendage 110 away from the pericardial sac 120 that surrounds the heart. As explained herein, aspiration of the heart tissue is evidenced when no blood can be pulled back through engagement catheter 100 and, if suction pressure is being measured, when the suction pressure gradually increases. A delivery catheter 130 is then inserted through a lumen of engagement catheter 100. A small perforation can be made in the aspirated atrial appendage 110 with a needle such as needle 40, as shown in FIGS. 1A and 2A. A guide wire (not shown) can then be advanced through delivery catheter 130 into the pericardial space to secure the point of entry 125 through the atrial appendage and guide further insertion of delivery catheter 130 or another catheter. Flouroscopy or echocardiogram can be used to confirm the position of the catheter in the pericardial space. Alternatively, a pressure tip needle can sense the pressure and measure the pressure change from the atrium (about 10 mmHg) to the pericardial space (about 2 mmHg). This is particularly helpful for transeptal access where puncture of arterial structures (e.g., the aorta) can be diagnosed and sealed with an adhesive, as described in more detail below.
  • Although aspiration of the atrial wall or the atrial appendage retracts the wall or appendage from the pericardial sac to create additional pericardial space, CO2 gas can be delivered through a catheter, such as delivery catheter 130, into the pericardial space to create additional space between the pericardial sac and the heart surface.
  • Referring now to FIG. 3A, the catheter system shown in FIG. 1B is retrieved by pull back through the route of entry. However, the puncture of the targeted tissue in the heart (e.g., the right atrial appendage as shown in FIG, 3A) may be sealed upon withdrawal of the catheter, which prevents bleeding into the pericardial space. The retrieval of the catheter may be combined with a sealing of the tissue in one of several ways: (1) release of a tissue adhesive or polymer 75 via injection channel 70 to seal off the puncture hole, as shown in FIG. 3B; (2) release of an inner clip or mechanical stitch to close off the hole from the inside of the cavity or the heart, as discussed herein; or (3) mechanical closure of the heart with a sandwich type mechanical device that approaches the hole from both sides of the wall (see FIGS. 4A, 4B, and 4C). In other words, closure may be accomplished by using, for example, a biodegradable adhesive material (e.g., fibrin glue or cyanomethacrylate), a magnetic system, or an umbrella-shaped nitinol stent. An example of the closure of a hole in the atrium is shown in FIG. 3B. Engagement catheter 20 is attached to targeted tissue 95 using suction through suction port 60. Tissue adhesive 75 is injected through injection channel 70 to coat and seal the puncture wound in targeted tissue 95. Engagement catheter 20 is then withdrawn, leaving a plug of tissue adhesive 75 attached to the atrial wall or atrial appendage.
  • Other examples for sealing the puncture wound in the atrial wall or appendage are shown in FIGS. 4A-4F. Referring now to FIGS. 4A-4C, a sandwich-type closure member, having an external cover 610 and an internal cover 620, is inserted through the lumen of engagement catheter 600, which is attached to the targeted tissue of an atrial wall 630. Each of external and internal covers 610 and 620 is similar to an umbrella in that it can be inserted through a catheter in its folded configuration and expanded to an expanded configuration once it is outside of the catheter. As shown in FIG. 4A, external cover 610 is deployed (in its expanded configuration) on the outside of the atrial wall to seal a puncture wound in the targeted tissue, having already been delivered through the puncture wound into the pericardial space. Internal cover 620 is delivered through engagement catheter 600 (in its folded configuration), as shown in FIGS, 4A and 4B, by an elongated delivery wire 615, to which internal cover 620 is reversibly attached (for example, by a screw-like mechanism). Once internal cover 620 is in position on the inside of atrial wall 630 at the targeted tissue, internal cover 620 is deployed to help seal the puncture wound in the targeted tissue (see FIG. 4C).
  • Internal cover 620 and external cover 610 may be made from a number of materials, including a shape-memory alloy such as nitinol. Such embodiments are capable of existing in a catheter in a folded configuration and then expanding to an expanded configuration when deployed into the body. Such a change in configuration can result from a change in temperature, for example. Other embodiments of internal and external covers may be made from other biocompatible materials and deployed mechanically.
  • After internal cover 620 is deployed, engagement catheter 600 releases its grip on the targeted tissue and is withdrawn, leaving the sandwich-type closure to seal the puncture wound, as shown in FIG. 4C. External cover 610 and internal cover 620 may be held in place using a biocompatible adhesive. Similarly, external cover 610 and internal cover 620 may be held in place using magnetic forces, such as, for example, by the inside face (not shown) of external cover 610 comprising a magnet, by the inside face (not shown) of internal cover 620 comprising a magnet, or both inside faces of external cover 610 or internal cover 620 comprising magnets.
  • In the embodiment shown in FIGS. 4A, 4B, and 4C, the closure member comprises external cover 610 and internal cover 620. However, in at least certain other embodiments, the closure member need not have two covers. For example, as shown in FIG. 4D, closure member 632 is made of only one cover 634. Cover 634 has a first face 636 and a second face 638, and first face 636 is configured for reversible attachment to distal end 642 of delivery wire 640. Closure member 632 may be made of any suitable material, including nitinol, which is capable of transitioning from a folded configuration to an expanded configuration.
  • In the embodiment shown in FIG. 4E, a closure member 1500 comprises an external cover 1510 and an internal cover 1520 within a delivery catheter 1530. External cover 1510 and internal cover 1520 are attached at a joint 1540, which may be formed, for example, by a mechanical attachment or by a magnetic attachment. In embodiments having a magnetic attachment, each of the external cover and the internal cover may have a ferromagnetic component that is capable of magnetically engaging the other ferromagnetic component.
  • Delivery catheter 1530 is shown after insertion through hole 1555 of atrial wall 1550. Closure member 1500 may be advanced through delivery catheter 1530 to approach atrial wall 1550 by pushing rod 1560. Rod 1560 may be reversibly attached to internal cover 1520 so that rod 1560 may be disconnected from internal cover 1520 after closure member 1500 is properly deployed. For example, rod 1560 may engage internal cover 1520 with a screw-like tip such that rod 1560 may be easily unscrewed from closure member 1500 after deployment is complete. Alternatively, rod 1560 may simply engage internal cover 1520 such that internal cover 1520 may be pushed along the inside of delivery catheter 1530 without attachment between internal cover 1520 and rod 1560.
  • Closure member 1500 is advanced through delivery catheter 1530 until external cover 1510 reaches a portion of delivery catheter 1530 adjacent to atrial wall 1550; external cover 1510 is then pushed slowly out of delivery catheter 1530 into the pericardial space. External cover 1510 then expands and is positioned on the outer surface of atrial wall 1550. When external cover 1510 is properly positioned on atrial wall 1550, joint 1540 is approximately even with atrial wall 1550 within hole 1555. Delivery catheter 1530 is then withdrawn slowly, causing hole 1555 to close slightly around joint 1540. As delivery catheter 1530 continues to be withdrawn, internal cover 1520 deploys from delivery catheter 1530, thereby opening into its expanded formation. Consequently, atrial wall 1550 is pinched between internal cover 1520 and external cover 1510, and hole 1555 is closed to prevent leakage of blood from the heart.
  • FIG. 4F shows the occlusion of a hole (not shown) in atrial wall 1600 due to the sandwiching of atrial wall 1600 between an external cover 1610 and an internal cover 1620. External cover 1610 is shown deployed on the outside surface of atrial wall 1600, while internal cover 1620 is deployed on the inside surface of atrial wall 1600. As shown, rod 1640 is engaged with internal cover 1620, and delivery catheter 1630 is in the process of being withdrawn, which allows internal cover 1620 to fully deploy. Rod 1640 is then withdrawn through delivery catheter 1630. An engagement catheter (not shown) may surround delivery catheter 1650, as explained more fully herein.
  • Other examples for sealing a puncture wound in the cardiac tissue are shown in FIGS. 12-15. Referring now to FIG. 12A, there is shown a plug 650 having a first end 652, a second end 654, and a hole 656 extending from first end 652 to second end 654. Plug 650 may be made from any suitable material, including casein, polyurethane, silicone, and polytetrafluoroethylene. Wire 660 has been slidably inserted into hole 656 of plug 650. Wire 660 may be, for example, a guide wire or a pacing lead, so long as it extends through the hole in the cardiac tissue (not shown). As shown in FIG. 12A, first end 652 is covered with a radiopaque material, such as barium sulfate, and is therefore radiopaque. This enables the clinician to view the placement of the plug in the body using radiographic imaging. For example, the clinician can confirm the location of the plug during the procedure, enabling a safer and more effective procedure for the patient.
  • As shown in FIG. 12A, first end 652 of plug 650 has a smaller diameter than second end 654 of plug 650. Indeed, plug 680 shown FIG. 12B and plug 684 shown in FIGS. 13 and 14 have first ends that are smaller in diameter than their respective second ends. However, not all embodiments of plug have a first end that is smaller in diameter than the second end. For example, plug 682 shown in FIG. 12C has a first end with a diameter that is not smaller than the diameter of the second end. Both types of plug can be used to close holes in cardiac tissue.
  • Referring again to FIG. 12A, elongated shaft 670 has a proximal end (not shown), a distal end 672, and a lumen 674 extending from the proximal end to distal end 672. Although no catheter is shown in FIG. 12A, plug 650, wire 660, and shaft 670 are configured for insertion into a lumen of a catheter (see FIG. 14), such as an embodiment of an engagement catheter disclosed herein. Plug 650 and shaft 670 are also configured to be inserted over wire 660 and can slide along wire 660 because each of lumen 656 of plug 650 and lumen 674 of shaft 670 is slightly larger in circumference than wire 660.
  • As shown in FIGS. 13 and 14, shaft 672 is used to push plug 684 along wire 674 within elongated tube 676 to and into the hole in the targeted cardiac tissue 678. Distal end 677 of elongated tube 676 is shown attached to cardiac tissue 678, but distal end 677 need not be attached to cardiac tissue 678 so long as distal end 677 is adjacent to cardiac tissue 678. Once plug 684 is inserted into the hole, wire 674 may be withdrawn from the hole in plug 684 and the interior of the heart (not shown) and shaft 672 is withdrawn from elongated tube 676. In some embodiments, the plug is self-sealing, meaning that the hole of the plug closes after the wire is withdrawn. For example, the plug may be made from a dehydrated protein matrix, such as casein or ameroid, which swells after soaking up fluid. After shaft 672 is withdrawn, elongated tube 676 can be withdrawn from the heart.
  • It should be noted that, in some embodiments, the wire is not withdrawn from the hole of the plug. For example, where the wire is a pacing lead, the wire may be left within the plug so that it operatively connects to the CRT device.
  • Referring now to FIG. 12B, there is shown a plug 680 that is similar to plug 684. However, plug 680 comprises external surface 681 having a ridge 683 that surrounds plug 680 in a helical or screw-like shape. Ridge 683 helps to anchor plug 680 into the hole of the targeted tissue (not shown). Other embodiments of plug may include an external surface having a multiplicity of ridges surrounding the plug, for example, in a circular fashion.
  • FIGS. 15A-15C show yet another embodiment of a closure member for closing a hole in a tissue. Spider clip 1700 is shown within catheter 1702 and comprises a head 1705 and a plurality of arms 1710, 1720, 1730, and 1740. Each of arms 1710, 1720, 1730, and 1740 is attached at its proximal end to head 1705. Although spider clip 1700 has four arms, other embodiments of spider clip include fewer than, or more than, four arms. For example, some embodiments of spider clip have three arms, while others have five or more arms.
  • Referring again to FIGS. 15A-15C, arms 1710, 1720, 1730, and 1740 may be made from any flexible biocompatible metal that can transition between two shapes, such as a shape-memory alloy (e.g., nitinol) or stainless steel. Spider clip 1700 is capable of transitioning between an open position (see FIG. 15A), in which the distal ends of its arms 1710, 1720, 1730, and 1740 are spaced apart, and a closed position (see FIG. 15C), in which the distal ends of arms 1710, 1720, 1730, and 1740 are gathered together. For embodiments made from a shape-memory alloy, the clip can be configured to transition from the open position to the closed position when the metal is warmed to approximately body temperature, such as when the clip is placed into the cardiac tissue. For embodiments made from other types of metal, such as stainless steel, the clip is configured in its closed position, but may be transitioned into an open position when pressure is exerted on the head of the clip. Such pressure causes the arms to bulge outward, thereby causing the distal ends of the arms to separate.
  • In this way, spider clip 1700 may be used to seal a wound or hole in a tissue, such as a hole through the atrial wall. For example, FIG. 15B shows spider clip 1700 engaged by rod 1750 within engagement catheter 1760. As shown, engagement catheter 1760 has a bell-shaped suction port 1765, which, as disclosed herein, has aspirated cardiac tissue 1770. Cardiac tissue 1770 includes a hole 1775 therethrough, and suction port 1765 fits over hole 1775 so as to expose hole 1775 to spider clip 1700.
  • Rod 1750 pushes spider clip 1700 through engagement catheter 1760 to advance spider clip 1700 toward cardiac tissue 1770. Rod 1750 simply engages head 1705 by pushing against it, but in other embodiments, the rod may be reversibly attached to the head using a screw-type system. In such embodiments, the rod may be attached and detached from the head simply by screwing the rod into, or unscrewing the rod out of the head, respectively.
  • In at least some embodiments, the spider clip is held in its open position during advancement through the engagement catheter by the pressure exerted on the head of the clip by the rod. This pressure may be opposed by the biasing of the legs against the engagement catheter during advancement.
  • Referring to FIG, 15C, spider clip 1700 approaches cardiac tissue 1770 and eventually engages cardiac tissue 1770 such that the distal end of each of arms 1710, 1720, 1730, and 1740 contacts cardiac tissue 1770. Rod 1750 is disengaged from spider clip 1700, and spider clip 1700 transitions to its closed position, thereby drawing the distal ends of arms 1710, 1720, 1730, and 1740 together. As the distal ends of the arms are drawn together, the distal ends grip portions of cardiac tissue 1770, thereby collapsing the tissue between arms 1710, 1720, 1730, and 1740 such that hole 1775 is effectively closed.
  • Rod 1750 is then withdrawn, and engagement catheter 1760 is disengaged from cardiac tissue 1770. The constriction of cardiac tissue 1770 holds hole 1775 closed so that blood does not leak through hole 1775 after engagement catheter 1760 is removed. After a relatively short time, the body's natural healing processes permanently close hole 1775. Spider clip 1700 may remain in the body indefinitely.
  • Referring now to FIGS. 5A, 5B, 5C, and 5D, there is shown another embodiment of an engagement catheter as disclosed herein. Engagement catheter 700 is an elongated tube having a proximal end 710 and a distal end 720, as well as two lumens 730, 740 extending between proximal end 710 and distal end 720. Lumens 730, 740 are formed by concentric inner wall 750 and outer wall 760, as particularly shown in FIGS. 5B and 5C. At proximal end 710, engagement catheter 700 includes a vacuum port 770, which is attached to lumen 730 so that a vacuum source can be attached to vacuum port 770 to create suction in lumen 730, thereby forming a suction channel. At distal end 720 of catheter 700, a suction port 780 is attached to lumen 730 so that suction port 780 can be placed in contact with heart tissue 775 (see FIG. 5D) for aspirating the tissue, thereby forming a vacuum seal between suction port 780 and tissue 775 when the vacuum source is attached and engaged. The vacuum seal enables suction port 780 to grip, stabilize, and retract tissue 775. For example, attaching a suction port to an interior atrial wall using a vacuum source enables the suction port to retract the atrial wall from the pericardial sac surrounding the heart, which enlarges the pericardial space between the atrial wall and the pericardial sac.
  • As shown in FIG. 5C, two internal lumen supports 810, 820 are located within lumen 730 and are attached to inner wall 750 and outer wall 760 to provide support to the walls. These lumen supports divide lumen 730 into two suction channels. Although internal lumen supports 810, 820 extend from distal end 720 of catheter 700 along a substantial portion of the length of catheter 700, internal lumen supports 810, 820 may or may not span the entire length of catheter 700. Indeed, as shown in FIGS. 5A, 5B, and 5C, internal lumen supports 810, 820 do not extend to proximal end 710 to ensure that the suction from the external vacuum source is distributed relatively evenly around the circumference of catheter 700. Although the embodiment shown in FIG. 5C includes two internal lumen supports, other embodiments may have just one internal support or even three or more such supports.
  • FIG. 5D shows engagement catheter 700 approaching heart tissue 775 for attachment thereto. It is important for the clinician performing the procedure to know when the suction port has engaged the tissue of the atrial wall or the atrial appendage. For example, in reference to FIG. 5D, it is clear that suction port 780 has not fully engaged tissue 775 such that a seal is formed. However, because suction port 780 is not usually seen during the procedure, the clinician may determine when the proper vacuum seal between the atrial tissue and the suction port has been made by monitoring the amount of blood that is aspirated, by monitoring the suction pressure with a pressure sensor/regulator, or both. For example, as engagement catheter 700 approaches the atrial wall tissue (such as tissue 775) and is approximately in position, the suction can be activated through lumen 730. A certain level of suction (e.g., 10 mmHg) can be imposed and measured with a pressure sensor/regulator. As long as catheter 700 does not engage the wall, some blood will be aspirated into the catheter and the suction pressure will remain the same. However, when catheter 700 engages or attaches to the wall of the heart (depicted as tissue 775 in FIG. 5D), minimal blood is aspirated and the suction pressure will start to gradually increase. Each of these signs can alert the clinician (through alarm or other means) as an indication of engagement. The pressure regulator is then able to maintain the suction pressure at a preset value to prevent over-suction of the tissue.
  • An engagement catheter, such as engagement catheter 700, may be configured to deliver a fluid or other substance to tissue on the inside of a wall of the heart, including an atrial wall or a ventricle wall. For example, lumen 740 shown in FIGS. 5A and 5C includes an injection channel 790 at distal end 720. Injection channel 790 dispenses to the targeted tissue a substance flowing through lumen 740. As shown in FIG. 5D, injection channel 790 is the distal end of lumen 740. However, in other embodiments, the injection channel may be ring-shaped (see FIG. 2C) or have some other suitable configuration.
  • Substances that can be locally administered with an engagement catheter include preparations for gene or cell therapy, drugs, and adhesives that are safe for use in the heart. The proximal end of lumen 740 has a fluid port 800, which is capable of attachment to an external fluid source for supply of the fluid to be delivered to the targeted tissue. Indeed, after withdrawal of a needle from the targeted tissue, as discussed herein, an adhesive may be administered to the targeted tissue by the engagement catheter for sealing the puncture wound left by the needle withdrawn from the targeted tissue.
  • Referring now to FIGS. 6A, 6B, and 6C, there is shown a delivery catheter 850 comprising an elongated hollow tube 880 having a proximal end 860, a distal end 870, and a lumen 885 along the length of the catheter. Extending from distal end 870 is a hollow needle 890 in communication with lumen 885. Needle 890 is attached to distal end 870 in the embodiment of FIGS. 6A, 6B, and 6C, but, in other embodiments, the needle may be removably attached to, or otherwise located at, the distal end of the catheter (see FIG, 1A). In the embodiment shown in FIGS. 6A, 6B, and 6C, as in certain other embodiments having an attached needle, the junction (i.e., site of attachment) between hollow tube 880 and needle 890 forms a security notch 910 circumferentially around needle 890 to prevent needle 890 from over-perforation. Thus, when a clinician inserts needle 890 through an atrial wall to gain access to the pericardial space, the clinician will not, under normal conditions, unintentionally perforate the pericardial sac with needle 890 because the larger diameter of hollow tube 880 (as compared to that of needle 890) at security notch 910 hinders further needle insertion. Although security notch 910 is formed by the junction of hollow tube 880 and needle 890 in the embodiment shown in FIGS, 6A, 6B, and 6C, other embodiments may have a security notch that is configured differently. For example, a security notch may include a band, ring, or similar device that is attached to the needle a suitable distance from the tip of the needle. Like security notch 910, other security notch embodiments hinder insertion of the needle past the notch itself by presenting a larger profile than the profile of the needle such that the notch does not easily enter the hole in the tissue caused by entry of the needle.
  • It is useful for the clinician performing the procedure to know when the needle has punctured the atrial tissue. This can be done in several ways. For example, the delivery catheter can be connected to a pressure transducer to measure pressure at the tip of the needle. Because the pressure is lower and much less pulsatile in the pericardial space than in the atrium, the clinician can recognize immediately when the needle passes through the atrial tissue into the pericardial space.
  • Alternatively, as shown in FIG. 6B, needle 890 may be connected to a strain gauge 915 as part of the catheter assembly. When needle 890 contacts tissue (not shown), needle 890 will be deformed. The deformation will be transmitted to strain gauge 915 and an electrical signal will reflect the deformation (through a classical wheatstone bridge), thereby alerting the clinician. Such confirmation of the puncture of the wall can prevent over-puncture and can provide additional control of the procedure.
  • In some embodiments, a delivery catheter, such as catheter 850 shown in FIGS. 6A, 6B, and 6C, is used with an engagement catheter, such as catheter 700 shown in FIGS. 5A, 5B, 5C, and 5D, to gain access to the pericardial space between the heart wall and the pericardial sac. For example, engagement catheter 700 may be inserted into the vascular system and advanced such that the distal end of the engagement catheter is within the atrium. The engagement catheter may be attached to the targeted tissue on the interior of a wall of the atrium using a suction port as disclosed herein. A standard guide wire may be inserted through the lumen of the delivery catheter as the delivery catheter is inserted through the inner lumen of the engagement catheter, such as lumen 740 shown in FIGS. 5B and 5C. Use of the guide wire enables more effective navigation of the delivery catheter 850 and prevents the needle 890 from damaging the inner wall 750 of the engagement catheter 700. When the tip of the delivery catheter with the protruding guide wire reaches the atrium, the wire is pulled back, and the needle is pushed forward to perforate the targeted tissue. The guide wire is then advanced through the perforation into the pericardial space, providing access to the pericardial space through the atrial wall.
  • Referring again to FIGS, 6A, 6B, and 6C, lumen 885 of delivery catheter 850 may be used for delivering fluid into the pericardial space after needle 890 is inserted through the atrial wall or the atrial appendage. After puncture of the wall or appendage, a guide wire (not shown) may be inserted through needle lumen 900 into the pericardial space to maintain access through the atrial wall or appendage. Fluid may then be introduced to the pericardial space in a number of ways. For example, after the needle punctures the atrial wall or appendage, the needle is generally withdrawn. If the needle is permanently attached to the delivery catheter, as in the embodiment shown in FIGS. 6A and 6B, then delivery catheter 850 would be withdrawn and another delivery catheter (without an attached needle) would be introduced over the guide wire into the pericardial space. Fluid may then be introduced into the pericardial space through the lumen of the second delivery catheter,
  • In some embodiments, however, only a single delivery catheter is used. In such embodiments, the needle is not attached to the delivery catheter, but instead may be a needle wire (see FIG. 1A). In such embodiments, the needle is withdrawn through the lumen of the delivery catheter, and the delivery catheter may be inserted over the guide wire into the pericardial space. Fluid is then introduced into the pericardial space through the lumen of the delivery catheter.
  • The various embodiments disclosed herein may be used by clinicians, for example: (1) to deliver genes, cells, drugs, etc.; (2) to provide catheter access for epicardial stimulation; (3) to evacuate fluids acutely (e.g., in cases of pericardial tampondae) or chronically (e.g., to alleviate effusion caused by chronic renal disease, cancer, etc.); (4) to perform transeptal puncture and delivery of a catheter through the left atrial appendage for electrophysiological therapy, biopsy, etc.; (5) to deliver a magnetic glue or ring through the right atrial appendage to the aortic root to hold a percutaneous aortic valve in place; (6) to deliver a catheter for tissue ablation, e.g., to the pulmonary veins, or right atrial and epicardial surface of the heart for atrial and ventricular arrythmias; (7) to deliver and place epicardial, right atrial, and right and left ventricle pacing leads (as discussed herein); (8) to occlude the left atrial appendage through percutaneous approach; and (9) to visualize the pericardial space with endo-camera or scope to navigate the epicardial surface of the heart for therapeutic delivery, diagnosis, lead placement, mapping, etc. Many other applications, not explicitly listed here, are also possible and within the scope of the present disclosure.
  • Referring now to FIG. 7, there is shown a delivery catheter 1000. Delivery catheter 1000 includes an elongated tube 1010 having a wall 1020 extending from a proximal end (not shown) of tube 1010 to a distal end 1025 of tube 1010. Tube 1010 includes two lumens, but other embodiments of delivery catheters may have fewer than, or more than, two lumens, depending on the intended use of the delivery catheter. Tube 1010 also includes a steering channel 1030, in which a portion of steering wire system 1040 is located. Steering channel 1030 forms orifice 1044 at distal end 1025 of tube 1010 and is sized to fit over a guide wire 1050.
  • FIG. 8 shows in more detail steering wire system 1040 within steering channel 1030 (which is shown cut away from the remainder of the delivery catheter). Steering wire system 1040 is partially located in steering channel 1030 and comprises two steering wires 1060 and 1070 and a controller 1080, which, in the embodiment shown in FIG. 8, comprises a first handle 1090 and a second handle 1094. First handle 1090 is attached to proximal end 1064 of steering wire 1060, and second handle 1094 is attached to proximal end 1074 of steering wire 1070. Distal end 1066 of steering wire 1060 is attached to the wall of the tube of the delivery catheter within steering channel 1030 at attachment 1100, and distal end 1076 of steering wire 1070 is attached to the wall of the tube of the delivery catheter within steering channel 1030 at attachment 1110. As shown in FIG. 7, attachment 1100 and attachment 1110 are located on opposing sides of steering channel 1030 near distal tip 1120 of delivery catheter 1000.
  • In the embodiment of FIG. 8, steering wires 1060 and 1070 are threaded as a group through steering channel 1030. However, the steering wire systems of other embodiments may include steering wires that are individually threaded through smaller lumens within the steering channel. For example, FIG. 11 shows a cross-sectional view of a delivery catheter 1260 having an elongated tube 1264 comprising a wall 1266, a steering channel 1290, a first lumen 1270, and a second lumen 1280. Delivery catheter 1260 further includes a steering wire 1292 within a steering wire lumen 1293, a steering wire 1294 within a steering wire lumen 1295, and a steering wire 1296 within a steering wire lumen 1297. Each of steering wire lumens 1293, 1295, and 1297 is located within steering channel 1290 and is formed from wall 1266. Each of steering wires 1292, 1294, and 1296 is attached to wall 1266 within steering channel 1290. As will be explained, the attachment of each steering wire to the wall may be located near the distal tip of the delivery catheter, or may be located closer to the middle of the delivery catheter.
  • Referring now to FIGS. 7 and 8, steering wire system 1040 can be used to control distal tip 1120 of delivery catheter 1000. For example, when first handle 1090 is pulled, steering wire 1060 pulls distal tip 1120, which bends delivery catheter 1000, causing tip deflection in a first direction. Similarly, when second handle 1094 is pulled, steering wire 1070 pulls distal tip 1120 in the opposite direction, which bends delivery catheter 1000, causing tip deflection in the opposite direction. Thus, delivery catheter 1000 can be directed (i.e., steered) through the body using steering wire system 1040.
  • Although steering wire system 1040 has only two steering wires, other embodiments of steering wire systems may have more than two steering wires. For example, some embodiments of steering wire systems may have three steering wires (see FIG. 11), each of which is attached to the steering channel at a different attachment. Other embodiments of steering wire systems may have four steering wires. Generally, more steering wires give the clinician more control for directing the delivery catheter because each additional steering wire enables the user to deflect the tip of the delivery catheter in an additional direction. For example, four steering wires could be used to direct the delivery catheter in four different directions (e.g., up, down, right, and left).
  • If a steering wire system includes more than two steering wires, the delivery catheter may be deflected at different points in the same direction. For instance, a delivery catheter with three steering wires may include two steering wires for deflection in a certain direction and a third steering wire for reverse deflection (i.e., deflection in the opposite direction). In such an embodiment, the two steering wires for deflection are attached at different locations along the length of the delivery catheter. Referring now to FIGS. 9A-9C, there is shown a steering wire system 1350 within steering channel 1360 (which is shown cut away from the remainder of the delivery catheter) in different states of deflection. Steering wire system 1350 is partially located in steering channel 1360 and comprises three steering wires 1370, 1380, and 1390 and a controller 1400, which, in the embodiment shown in FIGS. 9A-9C, comprises a handle 1405. Handle 1405 is attached to proximal end 1374 of steering wire 1370, proximal end 1384 of steering wire 1380, and proximal end 1394 of steering wire 1390. Distal end 1376 of steering wire 1370 is attached to the wall of the tube of the delivery catheter within steering channel 1360 at attachment 1378, which is near the distal tip of the delivery catheter (not shown). Distal end 1386 of steering wire 1380 is attached to the wall of the tube of the delivery catheter within steering channel 1360 at attachment 1388, which is near the distal tip of the delivery catheter (not shown). Attachment 1378 and attachment 1388 are located on opposing sides of steering channel 1360 such that steering wires 1370 and 1380, when tightened (as explained below), would tend to deflect the delivery catheter in opposite directions. Distal end 1396 of steering wire 1390 is attached to the wall of the tube of the delivery catheter within steering channel 1360 at attachment 1398, which is located on the delivery catheter at a point closer to the proximal end of the delivery catheter than attachments 1378 and 1388. Attachment 1398 is located on the same side of steering channel 1360 as attachment 1388, such that steering wires 1380 and 1390, when tightened (as explained below), would tend to deflect the delivery catheter in the same direction. However, because attachment 1398 is closer to the proximal end of the delivery catheter than is attachment 1388, the tightening of steering wire 1390 tends to deflect the delivery catheter at a point closer to the proximal end of the delivery catheter than does the tightening of steering wire 1380. Thus, as shown in FIG. 9A, the tightening of steering wire 1390 causes a deflection in the delivery catheter approximately at point 1410. The tightening of steering wire 1380 at the same time causes a further deflection in the delivery catheter approximately at point 1420, as shown in FIG. 9B. The tightening of steering wire 1370, therefore, causes a reverse deflection, returning the delivery catheter to its original position (see FIG. 9C).
  • Referring again to FIG. 7, elongated tube 1010 further includes lumen 1130 and lumen 1140. Lumen 1130 extends from approximately the proximal end (not shown) of tube 1010 to or near distal end 1025 of tube 1010. Lumen 1130 has a bend 1134, relative to tube 1010, at or near distal end 1025 of tube 1010 and an outlet 1136 through wall 1020 of tube 1010 at or near distal end 1025 of tube 1010. Similarly, lumen 1140 has a bend 1144, relative to tube 1010, at or near distal end 1025 of tube 1010 and an outlet 1146 through wall 1020 of tube 1010 at or near distal end 1025 of tube 1010. In the embodiment shown in FIG. 7, lumen 1130 is configured as a laser Doppler tip, and lumen 1140 is sized to accept a retractable sensing lead 1150 and a pacing lead 1160 having a tip at the distal end of the lead. The fiberoptic laser Doppler tip detects and measures blood flow (by measuring the change in wavelength of light emitted by the tip), which helps the clinician to identify—and then avoid—blood vessels during lead placement. Sensing lead 1150 is designed to detect electrical signals in the heart tissue so that the clinician can avoid placing a pacing lead into electrically nonresponsive tissue, such as scar tissue. Pacing lead 1160 is a screw-type lead for placement onto the cardiac tissue, and its tip, which is an electrode, has a substantially screw-like shape. Pacing lead 1160 is capable of operative attachment to a CRT device (not shown) for heart pacing. Although lead 1160 is used for cardiac pacing, any suitable types of leads may be used with the delivery catheters described herein, including sensing leads.
  • Each of bend 1134 of lumen 1130 and bend 1144 of lumen 1140 forms an approximately 90-degree angle, which allows respective outlets 1136 and 1146 to face the external surface of the heart as the catheter is maneuvered in the pericardial space. However, other embodiments may have bends forming other angles, smaller or larger than 90-degrees, so long as the lumen provides proper access to the external surface of the heart from the pericardial space. Such angles may range, for example, from about 25-degrees to about 155-degrees. In addition to delivering leads and Doppler tips, lumen 1130 and lumen 1140 may be configured to allow, for example, the taking of a cardiac biopsy, the delivery of gene cell treatment or pharmacological agents, the delivery of biological glue for ventricular reinforcement, implementation of ventricular epicardial suction in the acute myocardial infarction and border zone area, the removal of fluid in treatment of pericardial effusion or cardiac tamponade, or the ablation of cardiac tissue in treatment of atrial fibrillation.
  • For example, lumen 1130 could be used to deliver a catheter needle for intramyocardial injection of gene cells, stems, biomaterials, growth factors (such as cytokinase, fibroblast growth factor, or vascular endothelial growth factor) and/or biodegradable synthetic polymers, ROD-liposome biologic glue, or any other suitable drug or substance for treatment or diagnosis. For example, suitable biodegradable synthetic polymer may include polylactides, polyglycolides, polycaprolactones, polyanhydrides, polyamides, and polyurethanes. In certain embodiments, the substance comprises a tissue inhibitor, such as a metalloproteinase (e.g., metalloproteinase 1),
  • The injection of certain substances (such as biopolymers and RGD-liposome biologic glue) is useful in the treatment of chronic heart failure to reinforce and strengthen the left ventricular wall. Thus, using the embodiments disclosed herein, the injection of such substances into the cardiac tissue from the pericardial space alleviates the problems and risks associated with delivery via the transthoracic approach. For instance, once the distal end of the delivery catheter is advanced to the pericardial space, as disclosed herein, a needle is extended through a lumen of the delivery catheter into the cardiac tissue and the substance is injected through the needle into the cardiac tissue.
  • The delivery of substances into the cardiac tissue from the pericardial space can be facilitated using a laser Doppler tip. For example, when treating ventricular wall thinning, the laser Doppler tip located in lumen 1140 of the embodiment shown in FIG. 7 can be used to measure the thickness of the left ventricular wall during the procedure (in real time) to determine the appropriate target area for injection.
  • Referring again to FIG. 8, although controller 1080 comprises first handle 1090 and second handle 1094, other embodiments of the controller may include different configurations. For example, instead of using handles, a controller may include any suitable torque system for controlling the steering wires of the steering wire system. Referring now to FIG. 10, there is shown a portion of a steering wire system 1170 having steering wire 1180, steering wire 1190, and controller 1200. Controller 1200 comprises a torque system 1210 having a first rotatable spool 1220, which is capable of collecting and dispensing steering wire 1180 upon rotation. For example, when first rotatable spool 1220 rotates in a certain direction, steering wire 1180 is collected onto spool 1220, thereby tightening steering wire 1180. When spool 1220 rotates in the opposite direction, steering wire 1180 is dispensed from spool 1220, thereby loosening steering wire 1180. Torque system 1210 also has a second rotatable spool 1230, which is capable of collecting and dispensing steering wire 1190 upon rotation, as described above.
  • Torque system 1210 further includes a first rotatable dial 1240 and a second rotatable dial 1250. First rotatable dial 1240 is attached to first rotatable spool 1220 such that rotation of first rotatable dial 1240 causes rotation of first rotatable spool 1220. Similarly, second rotatable dial 1250 is attached to second rotatable spool 1230 such that rotation of second rotatable dial 1250 causes rotation of second rotatable spool 1230. For ease of manipulation of the catheter, torque system 1210, and specifically first and second rotatable dials 1240 and 1250, may optionally be positioned on a catheter handle (not shown) at the proximal end of tube 1010.
  • Steering wire system 1170 can be used to direct a delivery catheter through the body in a similar fashion as steering wire system 1140. Thus, for example, when first rotatable dial 1240 is rotated in a first direction (e,g., clockwise), steering wire 1180 is tightened and the delivery catheter is deflected in a certain direction. When first rotatable dial 1240 is rotated in the other direction (e.g., counterclockwise), steering wire 1180 is loosened and the delivery catheter straightens to its original position. When second rotatable dial 1250 is rotated in one direction (e.g., counterclockwise), steering wire 1190 is tightened and the delivery catheter is deflected in a direction opposite of the first deflection. When second rotatable dial 1250 is rotated in the other direction (e.g., clockwise), steering wire 1190 is loosened and the delivery catheter is straightened to its original position.
  • Certain other embodiments of steering wire system may comprise other types of torque system, so long as the torque system permits the clinician to reliably tighten and loosen the various steering wires. The magnitude of tightening and loosening of each steering wire should be controllable by the torque system,
  • Referring again to FIG. 11, there is shown a cross-sectional view of delivery catheter 1260. Delivery catheter 1260 includes tube 1265, a first lumen 1270, a second lumen 1280, and a steering channel 1290. Steering wires 1292, 1294, and 1296 are shown within steering channel 1290. First lumen 1270 has outlet 1275, which can be used to deliver a micro-camera system (not shown) or a laser Doppler tip 1278. Second lumen 1280 is sized to deliver a pacing lead 1300, as well as a sensing lead (not shown).
  • A pacing lead may be placed on the external surface of the heart using an engagement catheter and a delivery catheter as disclosed herein. For example, an elongated tube of an engagement catheter is extended into a blood vessel so that the distal end of the tube is in contact with a targeted tissue on the interior of a wall of the heart. As explained above, the targeted tissue may be on the interior of the atrial wall or the atrial appendage. Suction is initiated to aspirate a portion of the targeted tissue to retract the cardiac wall away from the pericardial sac that surrounds the heart, thereby enlarging a pericardial space between the pericardial sac and the cardiac wall. A needle is then inserted through a lumen of the tube and advanced to the heart. The needle is inserted into the targeted tissue, causing a perforation of the targeted tissue. The distal end of a guide wire is inserted through the needle into the pericardial space to secure the point of entry through the cardiac wall. The needle is then withdrawn from the targeted tissue.
  • A delivery catheter, as described herein, is inserted into the lumen of the tube of the engagement catheter and over the guide wire. The delivery catheter may be a 14 Fr. radiopaque steering catheter. The distal end of the delivery catheter is advanced over the guide wire through the targeted tissue into the pericardial space. Once in the pericardial space, the delivery catheter is directed using a steering wire system as disclosed herein. In addition, a micro-camera system may be extended through the lumen of the delivery catheter to assist in the direction of the delivery catheter to the desired location in the pericardial space. Micro-camera systems suitable for use with the delivery catheter are well-known in the art. Further, a laser Doppler system may be extended through the lumen of the delivery catheter to assist in the direction of the delivery catheter. The delivery catheter is positioned such that the outlet of one of the lumens of the delivery catheter is adjacent to the external surface of the heart (e.g., the external surface of an atrium or a ventricle). A pacing lead is extended through the lumen of the delivery catheter onto the external surface of the heart. The pacing lead may be attached to the external surface of the heart, for example, by screwing the lead into the cardiac tissue. In addition, the pacing lead may be placed deeper into the cardiac tissue, for example in the subendocardial tissue, by screwing the lead further into the tissue. After the lead is placed in the proper position, the delivery catheter is withdrawn from the pericardial space and the body. The guide wire is withdrawn from the pericardial space and the body, and the engagement catheter is withdrawn from the body.
  • The disclosed embodiments can be used for subendocardial, as well as epicardial, pacing. While the placement of the leads is epicardial, the leads can be configured to have a long screw-like tip that reaches near the subendocardial wall. The tip of the lead can be made to be conducting and stimulatory to provide the pacing to the subendocardial region. In general, the lead length can be selected to pace transmurally at any site through the thickness of the heart wall. Those of skill in the art can decide whether epicardial, subendocardial, or some transmural location stimulation of the muscle is best for the patient in question.
  • While various embodiments of systems and methods for closing a hole in cardiac tissue have been described in considerable detail herein, the embodiments are merely offered by way of non-limiting examples of the disclosure described herein. It will therefore be understood that various changes and modifications may be made, and equivalents may be substituted for elements thereof, without departing from the scope of the disclosure. Indeed, this disclosure is not intended to be exhaustive or to limit the scope of the disclosure.
  • Further, in describing representative embodiments, the disclosure may have presented a method and/or process as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth herein, the method or process should not be limited to the particular sequence of steps described. Other sequences of steps may be possible. Therefore, the particular order of the steps disclosed herein should not be construed as limitations of the present disclosure. In addition, disclosure directed to a method and/or process should not be limited to the performance of their steps in the order written. Such sequences may be varied and still remain within the scope of the present disclosure,

Claims (26)

1. A system for closing a hole in cardiac tissue, the system comprising:
an engagement catheter comprising a proximal end, a distal end, first and second lumens extending between the proximal end and the distal end, and a vacuum port operatively connected to the first lumen of the engagement catheter at the proximal end of the engagement catheter, the vacuum port being capable of operative connection to a vacuum source, wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to removably attach to a targeted tissue on the interior of a wall of the heart, such that the suction port is capable of forming a reversible seal with the targeted tissue when a vacuum source is operatively attached to the vacuum port;
an elongated wire capable of insertion into the second lumen of the engagement catheter;
a plug having a first end, a second end, and a hole extending from the first end to the second end, the plug being capable of insertion into the second lumen of the engagement catheter; and
an elongated shaft having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, the elongated shaft being capable of insertion into the second lumen of the engagement catheter;
wherein the elongated wire is sized for slidable insertion through the lumen of the shaft and the hole of the plug.
2. The system of claim 1, wherein:
the first end of the plug is radiopaque.
3. The system of claim 2, wherein:
the first end of the plug has a smaller diameter than the second end of the plug.
4. The system of claim 3, wherein:
the plug comprises an external surface that has a screw-shaped ridge.
5. The system of claim 1, wherein:
the elongated wire comprises an elongated guide wire; and
the hole in the plug is self-sealing,
6. A system for closing a hole in cardiac tissue, the system comprising:
an engagement catheter comprising a proximal end, a distal end, first and second lumens extending between the proximal end and the distal end, and a vacuum port operatively connected to the first lumen of the engagement catheter at the proximal end of the engagement catheter, the vacuum port being capable of operative connection to a vacuum source, wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to removably attach to a targeted tissue on the interior of a wall of the heart, such that the suction port is capable of forming a reversible seal with the targeted tissue when a vacuum source is operatively attached to the vacuum port;
a delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, the delivery catheter configured such that the hollow tube is capable of insertion into the second lumen of the engagement catheter;
an elongated delivery wire having a proximal end and a distal end, the distal end of the delivery wire being, capable of insertion through the hollow tube of the delivery catheter; and
a closure member having a first face and a second face, the closure member being capable of transitioning from a folded configuration within the hollow tube of the delivery catheter to an expanded configuration outside of the hollow tube of the delivery catheter;
wherein the first face of the closure member is configured for reversible attachment to the distal end of the delivery wire.
7. The system of claim 6, wherein:
the closure member comprises an external cover and an internal cover;
the first face of the closure member comprises an outside face of the internal cover; and
the second face of the closure member comprises an outside face of the external cover.
8. The system of claim 7, wherein:
the internal cover further comprises a first inside face;
the external cover further comprises a second inside face; and
at least one of the first inside face and the second inside face of the external cover comprises a magnet.
9. The system of claim 7, wherein:
the internal cover further comprises a first inside face;
the external cover further comprises a second inside face; and
an adhesive is attached to the first inside face and the second inside face.
10. The system of claim 9, wherein:
the closure member comprises a biodegradable substance.
11. The system of claim 7, wherein:
the external cover is attached to the internal cover.
12. The system of claim 11, wherein:
the closure member comprises nitinol.
13. A method for closing a hole in a targeted tissue of a heart, the method comprising the steps of:
contacting a targeted tissue in the interior of a heart with a distal end of an elongated tube, the elongated tube having a first lumen and a second lumen;
aspirating the targeted tissue such that the targeted tissue is retracted away from a pericardial sac surrounding the heart and a pericardial space between the pericardial sac and the targeted tissue is enlarged;
inserting through the first lumen of the elongated tube a delivery catheter having a lumen;
inserting an elongated delivery wire through the lumen of the delivery catheter, the elongated delivery wire having an external cover that is capable of transitioning from a folded configuration within the lumen of the delivery catheter to an expanded configuration outside of the lumen of the delivery catheter, the external cover being reversibly attached to a distal end of the delivery wire;
delivering the external cover through the hole in the targeted tissue into the pericardial space;
placing the external cover onto the targeted tissue from the pericardial space;
releasing the external cover from the delivery wire; and
withdrawing the delivery wire from the targeted tissue.
14. The method of claim 13, further comprising the steps of:
reversibly attaching an internal cover to the distal end of the delivery wire, the internal cover being capable of transitioning from a folded configuration within the lumen of the delivery catheter to an expanded configuration outside of the lumen of the delivery catheter;
delivering the internal cover to the targeted tissue in the interior of the heart;
placing the internal cover onto the targeted tissue from the interior of the heart;
releasing the internal cover from the delivery wire; and
withdrawing the delivery wire from the interior of the heart.
15. A method for closing a hole in a targeted tissue of a heart, the method comprising the steps of:
inserting a wire through a lumen of an elongated tube and through a hole in a targeted tissue, the elongated tube having a proximal end and a distal end adjacent to the targeted tissue;
inserting into the lumen of the elongated tube and over the wire a plug having a first end, a second end, and a hole extending from the first end to the second end;
inserting into the lumen of the elongated tube and over the wire an elongated shaft having a proximal end, a distal end, and a hole extending from the proximal end to the distal end;
sliding the elongated shaft toward the distal end of the elongated tube until the plug approaches the hole in the targeted tissue;
inserting the plug into the hole in the targeted tissue; and
withdrawing the elongated shaft from the elongated tube,
16. The method of claim 15, wherein:
the first end of the plug has a diameter that is smaller than the diameter of the second end of the plug.
17. The method of claim 16, wherein:
at least a portion of the first end of the plug is radiopaque,
18. The method of claim 17, further comprising the step of:
confirming the location of the plug using radiographic imaging.
19. The method of claim 15, wherein:
the wire comprises a guide wire; and
the hole of the plug closes after the guide wire is withdrawn from the hole of the plug.
20. A system for closing a hole in a targeted tissue, comprising:
a closure member having a head and a plurality of arms extending from the head, the closure member capable of transitioning between an open position and a closed position; and
a delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, the delivery catheter configured such that the closure member is capable of insertion into the hollow tube when the closure member is in the open position.
21. The system of claim 20, further comprising:
an engagement catheter comprising a proximal end, a distal end, a first lumen extending between the proximal end and the distal end, and a vacuum port operatively connected to the first lumen of the engagement catheter at the proximal end of the engagement catheter, the vacuum port being capable of operative connection to a vacuum source, wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to removably attach to a targeted tissue on the interior of a wall of the heart, such that the suction port is capable of forming a reversible seal with the targeted tissue when a vacuum source is operatively attached to the vacuum port;
wherein the delivery catheter is configured for inserted into the first lumen of the engagement catheter.
22. The system of claim 21, wherein:
the plurality of arms of the closure member comprise nitinol.
23. The system of claim 22, wherein:
the plurality of arms of the closure member comprise four arms,
24. A method for closing a hole in a targeted tissue of a heart, the method comprising the steps of:
providing a closure member having a head and a plurality of arms extending from the head, the closure member capable of transitioning between an open position and a closed position;
delivering the closure member to a heart through a delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, the delivery catheter configured such that the closure member is capable of insertion into the hollow tube when the closure member is in the open position;
deploying the closure member such that the closure member contacts a targeted tissue of the heart and transitions to the closed position.
25. The method of claim 24, wherein:
the plurality of arms comprise four arms.
26. The method of claim 25, wherein:
the step of delivery the closure member to the heart comprises advancing the closure member through the delivery catheter by pushing on the head of the closure member using a rod inserted into the hollow tube.
US12/722,287 2006-06-30 2010-03-11 Systems and methods for closing a hole in cardiac tissue Abandoned US20100168791A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US12/722,287 US20100168791A1 (en) 2006-06-30 2010-03-11 Systems and methods for closing a hole in cardiac tissue
US13/035,451 US20110224720A1 (en) 2010-03-11 2011-02-25 Devices, systems, and methods for closing a hole in cardiac tissue

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US81742106P 2006-06-30 2006-06-30
US91445207P 2007-04-27 2007-04-27
PCT/US2007/015207 WO2008010905A2 (en) 2006-06-30 2007-06-29 Percutaneous intravascular access to cardiac tissue
PCT/US2008/053061 WO2008134104A2 (en) 2007-04-27 2008-02-05 Devices, systems, and methods for accessing the epicardial surface of the heart
US59696409A 2009-10-21 2009-10-21
US12/722,287 US20100168791A1 (en) 2006-06-30 2010-03-11 Systems and methods for closing a hole in cardiac tissue

Related Parent Applications (2)

Application Number Title Priority Date Filing Date
PCT/US2008/053061 Continuation WO2008134104A2 (en) 2006-06-30 2008-02-05 Devices, systems, and methods for accessing the epicardial surface of the heart
US12/596,964 Continuation US8211084B2 (en) 2006-06-30 2008-02-05 Devices, systems, and methods for accessing the epicardial surface of the heart

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US13/035,451 Continuation-In-Part US20110224720A1 (en) 2010-03-11 2011-02-25 Devices, systems, and methods for closing a hole in cardiac tissue

Publications (1)

Publication Number Publication Date
US20100168791A1 true US20100168791A1 (en) 2010-07-01

Family

ID=38957265

Family Applications (11)

Application Number Title Priority Date Filing Date
US12/305,864 Abandoned US20100069849A1 (en) 2006-06-30 2007-06-29 Percutaneous intravascular access to cardiac tissue
US12/722,287 Abandoned US20100168791A1 (en) 2006-06-30 2010-03-11 Systems and methods for closing a hole in cardiac tissue
US12/723,278 Active 2028-01-25 US8303481B2 (en) 2006-06-30 2010-03-12 Devices and methods for assisting heart function
US12/722,913 Active US8128593B2 (en) 2006-06-30 2010-03-12 Removing fluid from a bodily tissue via a catheter with circumferential concave grooves
US12/816,655 Active 2027-10-20 US8894606B2 (en) 2006-06-30 2010-06-16 Devices, systems, and methods for accessing cardiac tissue
US13/323,174 Active 2027-08-29 US8876776B2 (en) 2006-06-30 2011-12-12 Engagement catheter systems and devices and methods of using the same
US13/539,574 Active US8777904B2 (en) 2006-06-30 2012-07-02 Systems and methods for engaging heart tissue
US14/332,064 Abandoned US20170080218A9 (en) 2006-06-30 2014-07-15 Engagement and delivery catheter systems
US14/552,708 Active 2028-06-03 US9907954B2 (en) 2006-06-30 2014-11-25 Devices and systems for accessing cardiac tissue
US15/913,446 Active 2029-03-05 US11191955B2 (en) 2006-06-30 2018-03-06 Devices and systems for accessing cardiac tissue
US17/544,731 Pending US20220088377A1 (en) 2006-06-30 2021-12-07 Devices and systems for accessing cardiac tissue

Family Applications Before (1)

Application Number Title Priority Date Filing Date
US12/305,864 Abandoned US20100069849A1 (en) 2006-06-30 2007-06-29 Percutaneous intravascular access to cardiac tissue

Family Applications After (9)

Application Number Title Priority Date Filing Date
US12/723,278 Active 2028-01-25 US8303481B2 (en) 2006-06-30 2010-03-12 Devices and methods for assisting heart function
US12/722,913 Active US8128593B2 (en) 2006-06-30 2010-03-12 Removing fluid from a bodily tissue via a catheter with circumferential concave grooves
US12/816,655 Active 2027-10-20 US8894606B2 (en) 2006-06-30 2010-06-16 Devices, systems, and methods for accessing cardiac tissue
US13/323,174 Active 2027-08-29 US8876776B2 (en) 2006-06-30 2011-12-12 Engagement catheter systems and devices and methods of using the same
US13/539,574 Active US8777904B2 (en) 2006-06-30 2012-07-02 Systems and methods for engaging heart tissue
US14/332,064 Abandoned US20170080218A9 (en) 2006-06-30 2014-07-15 Engagement and delivery catheter systems
US14/552,708 Active 2028-06-03 US9907954B2 (en) 2006-06-30 2014-11-25 Devices and systems for accessing cardiac tissue
US15/913,446 Active 2029-03-05 US11191955B2 (en) 2006-06-30 2018-03-06 Devices and systems for accessing cardiac tissue
US17/544,731 Pending US20220088377A1 (en) 2006-06-30 2021-12-07 Devices and systems for accessing cardiac tissue

Country Status (7)

Country Link
US (11) US20100069849A1 (en)
EP (1) EP2035074A4 (en)
JP (1) JP2009542338A (en)
AU (1) AU2007275844B2 (en)
CA (1) CA2656341C (en)
NZ (2) NZ573919A (en)
WO (1) WO2008010905A2 (en)

Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110184510A1 (en) * 2010-01-22 2011-07-28 4Tech, Sarl Tricuspid valve repair using tension
US20140222064A1 (en) * 2013-02-01 2014-08-07 St. Jude Medical Puerto Rico Llc Dual lumen carrier tube with retractable sleeve and methods
US8961596B2 (en) 2010-01-22 2015-02-24 4Tech Inc. Method and apparatus for tricuspid valve repair using tension
US8961594B2 (en) 2012-05-31 2015-02-24 4Tech Inc. Heart valve repair system
US9241702B2 (en) 2010-01-22 2016-01-26 4Tech Inc. Method and apparatus for tricuspid valve repair using tension
US9307980B2 (en) 2010-01-22 2016-04-12 4Tech Inc. Tricuspid valve repair using tension
US9375218B2 (en) 2006-05-03 2016-06-28 Datascope Corp. Systems and methods of tissue closure
US9693865B2 (en) 2013-01-09 2017-07-04 4 Tech Inc. Soft tissue depth-finding tool
US9801720B2 (en) 2014-06-19 2017-10-31 4Tech Inc. Cardiac tissue cinching
US9907681B2 (en) 2013-03-14 2018-03-06 4Tech Inc. Stent with tether interface
US9907547B2 (en) 2014-12-02 2018-03-06 4Tech Inc. Off-center tissue anchors
US10022114B2 (en) 2013-10-30 2018-07-17 4Tech Inc. Percutaneous tether locking
US10039643B2 (en) 2013-10-30 2018-08-07 4Tech Inc. Multiple anchoring-point tension system
US10052095B2 (en) 2013-10-30 2018-08-21 4Tech Inc. Multiple anchoring-point tension system
US10058323B2 (en) 2010-01-22 2018-08-28 4 Tech Inc. Tricuspid valve repair using tension
US10220134B2 (en) 2010-04-23 2019-03-05 Mark D. Wieczorek Transseptal access device and method of use
US10307569B2 (en) 2010-04-23 2019-06-04 Mark D. Wieczorek Transseptal access device and method of use
US10485545B2 (en) 2013-11-19 2019-11-26 Datascope Corp. Fastener applicator with interlock
US10806579B2 (en) 2017-10-20 2020-10-20 Boston Scientific Scimed, Inc. Heart valve repair implant for treating tricuspid regurgitation
US11653928B2 (en) 2018-03-28 2023-05-23 Datascope Corp. Device for atrial appendage exclusion
US11857417B2 (en) 2020-08-16 2024-01-02 Trilio Medical Ltd. Leaflet support

Families Citing this family (80)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008091557A2 (en) 2007-01-23 2008-07-31 Cvdevices, Llc Devices, systems, and methods to evaluate cardiovascular function
US8366707B2 (en) 2007-01-23 2013-02-05 Cvdevices Llc Systems and methods for epicardial navigation
WO2008112870A2 (en) * 2007-03-13 2008-09-18 University Of Virginia Patent Foundation Epicardial ablation catheter and method of use
US9211405B2 (en) 2007-03-22 2015-12-15 University Of Virginia Patent Foundation Electrode catheter for ablation purposes and related method thereof
DK2142107T3 (en) 2007-03-30 2013-04-15 Sentreheart Inc Devices and systems for closing the left ventricular pendant
US9050064B2 (en) * 2007-04-27 2015-06-09 Cvdevices, Llc Systems for engaging a bodily tissue and methods of using the same
WO2009062061A1 (en) * 2007-11-09 2009-05-14 University Of Virginia Patent Foundation Steerable epicardial pacing catheter system placed via the subxiphoid process
WO2010115030A1 (en) 2009-04-01 2010-10-07 Sentreheart, Inc. Tissue ligation devices and controls therefor
US9642534B2 (en) 2009-09-11 2017-05-09 University Of Virginia Patent Foundation Systems and methods for determining location of an access needle in a subject
JP2013521016A (en) 2010-02-26 2013-06-10 ボード オブ トラスティーズ オブ ザ レランド スタンフォード ジュニア ユニバーシティ System and method for intraluminal valve generation
JP5735097B2 (en) * 2010-04-13 2015-06-17 センターハート・インコーポレイテッドSentreHEART, Inc. Methods and devices for pericardial access
US11419632B2 (en) 2010-04-23 2022-08-23 Mark D. Wieczorek, P.C. Transseptal access device and method of use
EP2613821B1 (en) 2010-09-07 2023-02-15 Paul A. Spence Cannula systems
WO2012048005A2 (en) * 2010-10-05 2012-04-12 Emory University Devices, systems, and methods for improving access to cardiac and vascular chambers
EP3777727B1 (en) 2011-04-20 2024-01-24 The Board of Trustees of the Leland Stanford Junior University Systems for endoluminal valve creation
EP4101399A1 (en) 2011-08-05 2022-12-14 Route 92 Medical, Inc. System for treatment of acute ischemic stroke
US10314594B2 (en) 2012-12-14 2019-06-11 Corquest Medical, Inc. Assembly and method for left atrial appendage occlusion
US10813630B2 (en) 2011-08-09 2020-10-27 Corquest Medical, Inc. Closure system for atrial wall
US10307167B2 (en) 2012-12-14 2019-06-04 Corquest Medical, Inc. Assembly and method for left atrial appendage occlusion
JP6189847B2 (en) 2011-10-14 2017-08-30 アシスト・メディカル・システムズ,インコーポレイテッド Apparatus for measuring and processing anatomical structures
JP5984372B2 (en) * 2011-12-09 2016-09-06 オリンパス株式会社 Pericardial fluid volume control system
EP3628247B1 (en) 2012-02-07 2022-08-10 Intervene, Inc. System for endoluminal valve creation
US9549679B2 (en) 2012-05-14 2017-01-24 Acist Medical Systems, Inc. Multiple transducer delivery device and method
US9244196B2 (en) 2012-05-25 2016-01-26 Johnson & Johnson Vision Care, Inc. Polymers and nanogel materials and methods for making and using the same
WO2014062827A1 (en) * 2012-10-16 2014-04-24 Spence Paul A Devices, systems, and methods for facilitating flow from the heart to a blood pump
US20140142689A1 (en) 2012-11-21 2014-05-22 Didier De Canniere Device and method of treating heart valve malfunction
US9955990B2 (en) 2013-01-10 2018-05-01 Intervene, Inc. Systems and methods for endoluminal valve creation
US9814816B2 (en) 2013-06-21 2017-11-14 Corvivo, Inc. Artificial ventricles
US9320841B2 (en) * 2013-06-21 2016-04-26 Corvivo, Inc. Ventricular assist device
US10231613B2 (en) 2013-09-27 2019-03-19 Intervene, Inc. Visualization devices, systems, and methods for informing intravascular procedures on blood vessel valves
US9566443B2 (en) 2013-11-26 2017-02-14 Corquest Medical, Inc. System for treating heart valve malfunction including mitral regurgitation
US9265512B2 (en) 2013-12-23 2016-02-23 Silk Road Medical, Inc. Transcarotid neurovascular catheter
JP6993085B2 (en) 2014-01-10 2022-01-13 バイエル・ヘルスケア・エルエルシー Single-use disposable set connector
US9962519B2 (en) * 2014-01-14 2018-05-08 The Charles Stark Draper Laboratory, Inc. Seeping flow anti-clotting blood catheter
US10959752B2 (en) 2014-02-28 2021-03-30 Sentreheart Llc Pericardial access devices and methods
US9511219B1 (en) * 2014-03-24 2016-12-06 Subhajit Datta Dual vacuum device for medical fixture placement including for thoracoscopic left ventricular lead placement
EP3122266B1 (en) 2014-03-24 2018-06-06 Intervene, Inc. Devices and systems for controlled hydrodissection of vessel walls
CN107223062B (en) 2014-10-01 2019-12-17 心脏器械股份有限公司 Standby controller system with updates
JP5945586B2 (en) * 2014-12-08 2016-07-05 オリンパス株式会社 Medical device guide system
US10842626B2 (en) 2014-12-09 2020-11-24 Didier De Canniere Intracardiac device to correct mitral regurgitation
US10603018B2 (en) 2014-12-16 2020-03-31 Intervene, Inc. Intravascular devices, systems, and methods for the controlled dissection of body lumens
CA3207200A1 (en) 2015-01-09 2016-07-14 Bayer Healthcare Llc Multiple fluid delivery system with multi-use disposable set and features thereof
WO2016117238A1 (en) * 2015-01-23 2016-07-28 テルモ株式会社 Guide wire
ES2770321T3 (en) 2015-02-04 2020-07-01 Route 92 Medical Inc Rapid Aspiration Thrombectomy System
US11065019B1 (en) 2015-02-04 2021-07-20 Route 92 Medical, Inc. Aspiration catheter systems and methods of use
CN107810028B (en) 2015-05-15 2021-06-25 美国政府(由卫生和人类服务部的部长所代表) Three-dimensional right auricle bending catheter
WO2017019563A1 (en) 2015-07-24 2017-02-02 Route 92 Medical, Inc. Anchoring delivery system and methods
US10646247B2 (en) 2016-04-01 2020-05-12 Intervene, Inc. Intraluminal tissue modifying systems and associated devices and methods
TWI651107B (en) 2016-06-15 2019-02-21 拜耳保健公司 Multi-use disposable system and syringe therefor
CN106215261B (en) * 2016-08-29 2018-10-02 安徽通灵仿生科技有限公司 A kind of ventricle subsidiary conduit pump
EP3831281A1 (en) 2016-08-30 2021-06-09 The Regents of The University of California Methods for biomedical targeting and delivery and devices and systems for practicing the same
US11224435B2 (en) 2016-09-23 2022-01-18 Sentreheart Llc Devices and Methods for left atrial appendage closure
US11266810B2 (en) 2016-10-10 2022-03-08 Clph, Llc Isolation and attachment catheters and methods for using them
CN110799236A (en) 2016-10-25 2020-02-14 玛芬股份有限公司 Vascular anchoring introducer sheath
EP3568186B1 (en) 2017-01-10 2022-09-14 Route 92 Medical, Inc. Aspiration catheter systems
AU2018210353B2 (en) 2017-01-20 2023-09-28 Route 92 Medical, Inc. Single operator intracranial medical device delivery systems and methods of use
US11497576B2 (en) 2017-07-17 2022-11-15 Voyager Therapeutics, Inc. Trajectory array guide system
EP3459469A1 (en) 2017-09-23 2019-03-27 Universität Zürich Medical occluder device
US11191547B2 (en) 2018-01-26 2021-12-07 Syntheon 2.0, LLC Left atrial appendage clipping device and methods for clipping the LAA
EP3749233A1 (en) * 2018-02-06 2020-12-16 Septulus Ab Negative pressure-based gripping system and method
WO2019161327A1 (en) * 2018-02-19 2019-08-22 Bayer Healthcare Llc Syringe rolling apparatus and method
JP2021518208A (en) 2018-03-23 2021-08-02 メドトロニック,インコーポレイテッド AV Synchronized VfA Cardiac Treatment
CN111936046A (en) 2018-03-23 2020-11-13 美敦力公司 VFA cardiac therapy for tachycardia
EP3768377B1 (en) 2018-03-23 2023-11-22 Medtronic, Inc. Vfa cardiac resynchronization therapy
JP2021519143A (en) 2018-03-27 2021-08-10 センターハート・インコーポレイテッドSentreHEART, Inc. Devices and methods for left atrial appendage closure
AU2019269606A1 (en) 2018-05-17 2020-12-03 Route 92 Medical, Inc. Aspiration catheter systems and methods of use
CN112770807A (en) 2018-09-26 2021-05-07 美敦力公司 Capture in atrial-to-ventricular cardiac therapy
US11679265B2 (en) 2019-02-14 2023-06-20 Medtronic, Inc. Lead-in-lead systems and methods for cardiac therapy
US11697025B2 (en) 2019-03-29 2023-07-11 Medtronic, Inc. Cardiac conduction system capture
US11213676B2 (en) * 2019-04-01 2022-01-04 Medtronic, Inc. Delivery systems for VfA cardiac therapy
US10925615B2 (en) 2019-05-03 2021-02-23 Syntheon 2.0, LLC Recapturable left atrial appendage clipping device and methods for recapturing a left atrial appendage clip
US11712188B2 (en) 2019-05-07 2023-08-01 Medtronic, Inc. Posterior left bundle branch engagement
US11305127B2 (en) 2019-08-26 2022-04-19 Medtronic Inc. VfA delivery and implant region detection
US20210138239A1 (en) 2019-09-25 2021-05-13 Swift Sync, Llc Transvenous Intracardiac Pacing Catheter
US11497431B2 (en) 2019-10-09 2022-11-15 Medtronic, Inc. Systems and methods for configuring cardiac therapy
US11642533B2 (en) 2019-11-04 2023-05-09 Medtronic, Inc. Systems and methods for evaluating cardiac therapy
US11813466B2 (en) 2020-01-27 2023-11-14 Medtronic, Inc. Atrioventricular nodal stimulation
JP2023525206A (en) * 2020-03-20 2023-06-15 バード・ペリフェラル・バスキュラー・インコーポレーテッド Sealant injection needle assembly and sealant delivery device for use in lung access procedures
US11813464B2 (en) 2020-07-31 2023-11-14 Medtronic, Inc. Cardiac conduction system evaluation
WO2022140784A1 (en) * 2020-12-22 2022-06-30 Nxt Biomedical, Llc Surgical drain methods and articles

Citations (41)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3583404A (en) * 1969-06-23 1971-06-08 Kendall & Co Nonblocking catheter
US3630207A (en) * 1969-08-08 1971-12-28 Cutter Lab Pericardial catheter
US4946457A (en) * 1987-12-03 1990-08-07 Dimed, Incorporated Defibrillator system with cardiac leads and method for transvenous implantation
US5195968A (en) * 1990-02-02 1993-03-23 Ingemar Lundquist Catheter steering mechanism
US5292332A (en) * 1992-07-27 1994-03-08 Lee Benjamin I Methods and device for percutanceous sealing of arterial puncture sites
US5715817A (en) * 1993-06-29 1998-02-10 C.R. Bard, Inc. Bidirectional steering catheter
US6113611A (en) * 1998-05-28 2000-09-05 Advanced Vascular Technologies, Llc Surgical fastener and delivery system
US6200303B1 (en) * 1997-04-30 2001-03-13 Beth Israel Deaconess Medical Center, Inc. Method and kit for transvenously accessing the pericardial space via the right atrium
US6338345B1 (en) * 1999-04-07 2002-01-15 Endonetics, Inc. Submucosal prosthesis delivery device
US20020072768A1 (en) * 2000-12-07 2002-06-13 Ginn Richard S. Apparatus and methods for providing tactile feedback while delivering a closure device
US20020091354A1 (en) * 1997-09-23 2002-07-11 Navia Jose Antonio Intraluminal catheter with expandable tubular open-walled element
US20020165561A1 (en) * 2001-05-01 2002-11-07 Stephen Ainsworth Self-closing surgical clip for tissue
US20020168317A1 (en) * 2000-03-03 2002-11-14 Intramedical Imaging, Llc Methods and devices to expand applications of intraoperative radiation probes
US6500167B1 (en) * 1997-09-05 2002-12-31 Biosense Webster, Inc. Omni-directional steerable catheter
US20030009145A1 (en) * 2001-03-23 2003-01-09 Struijker-Boudier Harry A.J. Delivery of drugs from sustained release devices implanted in myocardial tissue or in the pericardial space
US20030109852A1 (en) * 2001-12-11 2003-06-12 Cardiac Pacemakers, Inc. Deflectable telescoping guide catheter
US6595982B2 (en) * 1996-06-03 2003-07-22 Terumo Kabushiki Kaisha Tubular medical device
US6613062B1 (en) * 1999-10-29 2003-09-02 Medtronic, Inc. Method and apparatus for providing intra-pericardial access
US6626930B1 (en) * 1999-10-21 2003-09-30 Edwards Lifesciences Corporation Minimally invasive mitral valve repair method and apparatus
US20030225420A1 (en) * 2002-03-11 2003-12-04 Wardle John L. Surgical coils and methods of deploying
US6663633B1 (en) * 2000-10-25 2003-12-16 Pierson, Iii Raymond H. Helical orthopedic fixation and reduction device, insertion system, and associated methods
US20040010216A1 (en) * 2000-02-24 2004-01-15 Zhu Yong Hua Device for closing tissue openings
US20040018228A1 (en) * 2000-11-06 2004-01-29 Afmedica, Inc. Compositions and methods for reducing scar tissue formation
US6692458B2 (en) * 2000-12-19 2004-02-17 Edwards Lifesciences Corporation Intra-pericardial drug delivery device with multiple balloons and method for angiogenesis
US6776784B2 (en) * 2001-09-06 2004-08-17 Core Medical, Inc. Clip apparatus for closing septal defects and methods of use
US20040230131A1 (en) * 2003-02-21 2004-11-18 Kassab Ghassan S. System and method for measuring cross-sectional areas and pressure gradients in luminal organs
US6837893B2 (en) * 2000-09-01 2005-01-04 Onux Medical, Inc. Multi-fastener surgical apparatus and method
US20050113760A1 (en) * 2003-11-24 2005-05-26 Chachques Juan C. Diagnostic and injection catheter, in particular for an application in cardiology
US6918890B2 (en) * 1997-09-19 2005-07-19 Cecil C. Schmidt Direct pericardial access device and method
US20050256450A1 (en) * 1997-11-04 2005-11-17 Boston Scientific Scimed, Inc. Catheter for the delivery of therapeutic agents to tissues
US20050261673A1 (en) * 2003-01-15 2005-11-24 Medtronic, Inc. Methods and apparatus for accessing and stabilizing an area of the heart
US6991616B2 (en) * 1998-10-02 2006-01-31 Boston Scientific Scimed, Inc. Steerable device for introducing diagnostic and therapeutic apparatus into the body
US7029468B2 (en) * 2002-06-25 2006-04-18 Enpath Medical, Inc. Catheter assembly with side wall exit lumen and method therefor
US20060106442A1 (en) * 2004-05-19 2006-05-18 The Board Of Trustees Of The Leland Stanford Junior University Devices and methods for treating cardiac pathologies
US7081125B2 (en) * 1997-03-12 2006-07-25 Neomend, Inc. Universal introducer
US20060207612A1 (en) * 2005-02-08 2006-09-21 Jasper Jackson Tissue anchoring system for percutaneous glossoplasty
US20060217764A1 (en) * 2001-09-06 2006-09-28 Ryan Abbott Systems and Methods for Treating Septal Defects
US20060240113A1 (en) * 1993-07-19 2006-10-26 Angiotech Pharmaceuticals, Inc. Anti-angiogenic compositions and methods of use
US20070010708A1 (en) * 2004-02-12 2007-01-11 Ness Gregory O Instruments and methods for accessing an anatomic space
US7326231B2 (en) * 2000-02-09 2008-02-05 Anson Medical Limited Device for the repair of arteries
US7942897B2 (en) * 2003-07-10 2011-05-17 Boston Scientific Scimed, Inc. System for closing an opening in a body cavity

Family Cites Families (45)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2922420A (en) * 1957-11-29 1960-01-26 Sierra Eng Co Epidural needle
US4556059A (en) * 1982-09-03 1985-12-03 Adamson Jr Howard Spring operated tracheotome
CA1221596A (en) * 1984-03-09 1987-05-12 David Evans Surgical needle
US4552554A (en) * 1984-06-25 1985-11-12 Medi-Tech Incorporated Introducing catheter
US5041109A (en) * 1986-10-27 1991-08-20 University Of Florida Laser apparatus for the recanalization of vessels and the treatment of other cardiac conditions
US4991578A (en) * 1989-04-04 1991-02-12 Siemens-Pacesetter, Inc. Method and system for implanting self-anchoring epicardial defibrillation electrodes
US5114401A (en) * 1990-02-23 1992-05-19 New England Deaconess Hospital Corporation Method for central venous catheterization
US5558644A (en) * 1991-07-16 1996-09-24 Heartport, Inc. Retrograde delivery catheter and method for inducing cardioplegic arrest
US6572529B2 (en) * 1993-06-17 2003-06-03 Wilk Patent Development Corporation Intrapericardial assist method
US5360416A (en) * 1993-09-30 1994-11-01 Sherwood Medical Company Thin-walled anesthesia needles
US5827216A (en) * 1995-06-07 1998-10-27 Cormedics Corp. Method and apparatus for accessing the pericardial space
US6447539B1 (en) * 1996-09-16 2002-09-10 Transvascular, Inc. Method and apparatus for treating ischemic heart disease by providing transvenous myocardial perfusion
US6042581A (en) * 1996-11-08 2000-03-28 Thomas J. Fogarty Transvascular TMR device and method
US5968010A (en) * 1997-04-30 1999-10-19 Beth Israel Deaconess Medical Center, Inc. Method for transvenously accessing the pericardial space via the right atrium
US5972013A (en) * 1997-09-19 1999-10-26 Comedicus Incorporated Direct pericardial access device with deflecting mechanism and method
US6511412B1 (en) 1998-09-30 2003-01-28 L. Vad Technology, Inc. Cardivascular support control system
US6432039B1 (en) 1998-12-21 2002-08-13 Corset, Inc. Methods and apparatus for reinforcement of the heart ventricles
US6333345B1 (en) * 1999-05-14 2001-12-25 Sepracor, Inc. Methods of using and compositions comprising N-desmethylzolpidem
DE60027720T2 (en) * 1999-06-08 2007-04-26 Altea Therapeutics Corp. APPARATUS FOR MICROPORING A BIOLOGICAL TISSUE THROUGH A FILM TISSUE INTERFACE DEVICE AND METHOD
US6241706B1 (en) 1999-07-16 2001-06-05 Datascope Investment Corporation Fast response intra-aortic balloon pump
US20030187461A1 (en) * 1999-08-10 2003-10-02 Chin Albert K. Releasable guide and method for endoscopic cardiac lead placement
US7526342B2 (en) * 1999-08-10 2009-04-28 Maquet Cardiovascular Llc Apparatus for endoscopic cardiac mapping and lead placement
US7060200B1 (en) 1999-09-03 2006-06-13 Merck Patent Gmbh Multireactive polymerizable mesogenic compounds
JP4674975B2 (en) * 2000-05-26 2011-04-20 オリンパス株式会社 Endoscope hood
US6837848B2 (en) * 2003-01-15 2005-01-04 Medtronic, Inc. Methods and apparatus for accessing and stabilizing an area of the heart
US6890295B2 (en) * 2002-10-31 2005-05-10 Medtronic, Inc. Anatomical space access tools and methods
US7740623B2 (en) * 2001-01-13 2010-06-22 Medtronic, Inc. Devices and methods for interstitial injection of biologic agents into tissue
MXPA03007665A (en) * 2001-02-26 2004-03-16 Univ Duke Novel dendritic polymers and their biomedical uses.
US6626821B1 (en) * 2001-05-22 2003-09-30 Abiomed, Inc. Flow-balanced cardiac wrap
US6907298B2 (en) 2002-01-09 2005-06-14 Medtronic, Inc. Method and apparatus for imparting curves in implantable elongated medical instruments
EP2317639A1 (en) 2002-03-18 2011-05-04 SRI International Electroactive polymer devices for moving fluid
US7903742B2 (en) * 2002-07-15 2011-03-08 Thomson Licensing Adaptive weighting of reference pictures in video decoding
US7681572B2 (en) 2002-08-20 2010-03-23 Aga Ab Method and devices for administration of therapeutic gases
US20050054994A1 (en) 2002-09-25 2005-03-10 Iulian Cioanta Catheters with suction capability and related methods and systems for obtaining biosamples in vivo
US7165552B2 (en) * 2003-03-27 2007-01-23 Cierra, Inc. Methods and apparatus for treatment of patent foramen ovale
US7273446B2 (en) * 2003-10-31 2007-09-25 Spence Paul A Methods, devices and systems for counterpulsation of blood flow to and from the circulatory system
US7517321B2 (en) * 2005-01-31 2009-04-14 C. R. Bard, Inc. Quick cycle biopsy system
US20070010793A1 (en) 2005-06-23 2007-01-11 Cardiac Pacemakers, Inc. Method and system for accessing a pericardial space
US8019404B2 (en) 2006-10-06 2011-09-13 The Cleveland Clinic Foundation Apparatus and method for targeting a body tissue
US20080269876A1 (en) * 2007-04-24 2008-10-30 Medtronic Vascular, Inc. Repair of Incompetent Heart Valves by Papillary Muscle Bulking
JP5174891B2 (en) * 2007-04-27 2013-04-03 シーヴィ デヴァイシズ,エルエルシー Devices, systems, and methods for accessing the epicardial surface of the heart
EP2144569A4 (en) * 2007-04-27 2014-03-26 Cvdevices Llc Devices, systems, and methods for accessing the epicardial surface of the heart
WO2010042869A1 (en) 2008-10-10 2010-04-15 Intervalve, Inc. Valvuloplasty catheter and methods
US8628552B2 (en) * 2011-03-16 2014-01-14 Pacesetter, Inc. Apparatus and method for accessing an intrapericardial space
EP2908745A4 (en) * 2012-10-22 2016-06-15 Sentreheart Inc Pericardial access devices and methods

Patent Citations (44)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3583404A (en) * 1969-06-23 1971-06-08 Kendall & Co Nonblocking catheter
US3630207A (en) * 1969-08-08 1971-12-28 Cutter Lab Pericardial catheter
US4946457A (en) * 1987-12-03 1990-08-07 Dimed, Incorporated Defibrillator system with cardiac leads and method for transvenous implantation
US5195968A (en) * 1990-02-02 1993-03-23 Ingemar Lundquist Catheter steering mechanism
US5292332A (en) * 1992-07-27 1994-03-08 Lee Benjamin I Methods and device for percutanceous sealing of arterial puncture sites
US5715817A (en) * 1993-06-29 1998-02-10 C.R. Bard, Inc. Bidirectional steering catheter
US20060240113A1 (en) * 1993-07-19 2006-10-26 Angiotech Pharmaceuticals, Inc. Anti-angiogenic compositions and methods of use
US6595982B2 (en) * 1996-06-03 2003-07-22 Terumo Kabushiki Kaisha Tubular medical device
US7081125B2 (en) * 1997-03-12 2006-07-25 Neomend, Inc. Universal introducer
US6200303B1 (en) * 1997-04-30 2001-03-13 Beth Israel Deaconess Medical Center, Inc. Method and kit for transvenously accessing the pericardial space via the right atrium
US6500167B1 (en) * 1997-09-05 2002-12-31 Biosense Webster, Inc. Omni-directional steerable catheter
US6918890B2 (en) * 1997-09-19 2005-07-19 Cecil C. Schmidt Direct pericardial access device and method
US20020091354A1 (en) * 1997-09-23 2002-07-11 Navia Jose Antonio Intraluminal catheter with expandable tubular open-walled element
US20050256450A1 (en) * 1997-11-04 2005-11-17 Boston Scientific Scimed, Inc. Catheter for the delivery of therapeutic agents to tissues
US6113611A (en) * 1998-05-28 2000-09-05 Advanced Vascular Technologies, Llc Surgical fastener and delivery system
US6991616B2 (en) * 1998-10-02 2006-01-31 Boston Scientific Scimed, Inc. Steerable device for introducing diagnostic and therapeutic apparatus into the body
US6338345B1 (en) * 1999-04-07 2002-01-15 Endonetics, Inc. Submucosal prosthesis delivery device
US6626930B1 (en) * 1999-10-21 2003-09-30 Edwards Lifesciences Corporation Minimally invasive mitral valve repair method and apparatus
US6613062B1 (en) * 1999-10-29 2003-09-02 Medtronic, Inc. Method and apparatus for providing intra-pericardial access
US20040087938A1 (en) * 1999-10-29 2004-05-06 Medtronic, Inc. Method and apparatus for providing intra-pericardial access
US7326231B2 (en) * 2000-02-09 2008-02-05 Anson Medical Limited Device for the repair of arteries
US20040010216A1 (en) * 2000-02-24 2004-01-15 Zhu Yong Hua Device for closing tissue openings
US7931628B2 (en) * 2000-02-24 2011-04-26 Loma Linda University Medical Center Device for closing tissue openings
US20020168317A1 (en) * 2000-03-03 2002-11-14 Intramedical Imaging, Llc Methods and devices to expand applications of intraoperative radiation probes
US6837893B2 (en) * 2000-09-01 2005-01-04 Onux Medical, Inc. Multi-fastener surgical apparatus and method
US6663633B1 (en) * 2000-10-25 2003-12-16 Pierson, Iii Raymond H. Helical orthopedic fixation and reduction device, insertion system, and associated methods
US20040018228A1 (en) * 2000-11-06 2004-01-29 Afmedica, Inc. Compositions and methods for reducing scar tissue formation
US7842068B2 (en) * 2000-12-07 2010-11-30 Integrated Vascular Systems, Inc. Apparatus and methods for providing tactile feedback while delivering a closure device
US20020072768A1 (en) * 2000-12-07 2002-06-13 Ginn Richard S. Apparatus and methods for providing tactile feedback while delivering a closure device
US6692458B2 (en) * 2000-12-19 2004-02-17 Edwards Lifesciences Corporation Intra-pericardial drug delivery device with multiple balloons and method for angiogenesis
US20030009145A1 (en) * 2001-03-23 2003-01-09 Struijker-Boudier Harry A.J. Delivery of drugs from sustained release devices implanted in myocardial tissue or in the pericardial space
US20020165561A1 (en) * 2001-05-01 2002-11-07 Stephen Ainsworth Self-closing surgical clip for tissue
US20060217764A1 (en) * 2001-09-06 2006-09-28 Ryan Abbott Systems and Methods for Treating Septal Defects
US6776784B2 (en) * 2001-09-06 2004-08-17 Core Medical, Inc. Clip apparatus for closing septal defects and methods of use
US20030109852A1 (en) * 2001-12-11 2003-06-12 Cardiac Pacemakers, Inc. Deflectable telescoping guide catheter
US20030225420A1 (en) * 2002-03-11 2003-12-04 Wardle John L. Surgical coils and methods of deploying
US7029468B2 (en) * 2002-06-25 2006-04-18 Enpath Medical, Inc. Catheter assembly with side wall exit lumen and method therefor
US20050261673A1 (en) * 2003-01-15 2005-11-24 Medtronic, Inc. Methods and apparatus for accessing and stabilizing an area of the heart
US20040230131A1 (en) * 2003-02-21 2004-11-18 Kassab Ghassan S. System and method for measuring cross-sectional areas and pressure gradients in luminal organs
US7942897B2 (en) * 2003-07-10 2011-05-17 Boston Scientific Scimed, Inc. System for closing an opening in a body cavity
US20050113760A1 (en) * 2003-11-24 2005-05-26 Chachques Juan C. Diagnostic and injection catheter, in particular for an application in cardiology
US20070010708A1 (en) * 2004-02-12 2007-01-11 Ness Gregory O Instruments and methods for accessing an anatomic space
US20060106442A1 (en) * 2004-05-19 2006-05-18 The Board Of Trustees Of The Leland Stanford Junior University Devices and methods for treating cardiac pathologies
US20060207612A1 (en) * 2005-02-08 2006-09-21 Jasper Jackson Tissue anchoring system for percutaneous glossoplasty

Cited By (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11369374B2 (en) 2006-05-03 2022-06-28 Datascope Corp. Systems and methods of tissue closure
US10595861B2 (en) 2006-05-03 2020-03-24 Datascope Corp. Systems and methods of tissue closure
US9375218B2 (en) 2006-05-03 2016-06-28 Datascope Corp. Systems and methods of tissue closure
US10058323B2 (en) 2010-01-22 2018-08-28 4 Tech Inc. Tricuspid valve repair using tension
US8475525B2 (en) 2010-01-22 2013-07-02 4Tech Inc. Tricuspid valve repair using tension
US8961596B2 (en) 2010-01-22 2015-02-24 4Tech Inc. Method and apparatus for tricuspid valve repair using tension
US10238491B2 (en) 2010-01-22 2019-03-26 4Tech Inc. Tricuspid valve repair using tension
US9241702B2 (en) 2010-01-22 2016-01-26 4Tech Inc. Method and apparatus for tricuspid valve repair using tension
US9307980B2 (en) 2010-01-22 2016-04-12 4Tech Inc. Tricuspid valve repair using tension
US20110184510A1 (en) * 2010-01-22 2011-07-28 4Tech, Sarl Tricuspid valve repair using tension
US10433963B2 (en) 2010-01-22 2019-10-08 4Tech Inc. Tissue anchor and delivery tool
US10405978B2 (en) 2010-01-22 2019-09-10 4Tech Inc. Tricuspid valve repair using tension
US10307569B2 (en) 2010-04-23 2019-06-04 Mark D. Wieczorek Transseptal access device and method of use
US10220134B2 (en) 2010-04-23 2019-03-05 Mark D. Wieczorek Transseptal access device and method of use
US8961594B2 (en) 2012-05-31 2015-02-24 4Tech Inc. Heart valve repair system
US10206673B2 (en) 2012-05-31 2019-02-19 4Tech, Inc. Suture-securing for cardiac valve repair
US10449050B2 (en) 2013-01-09 2019-10-22 4 Tech Inc. Soft tissue depth-finding tool
US9788948B2 (en) 2013-01-09 2017-10-17 4 Tech Inc. Soft tissue anchors and implantation techniques
US9693865B2 (en) 2013-01-09 2017-07-04 4 Tech Inc. Soft tissue depth-finding tool
US20140222064A1 (en) * 2013-02-01 2014-08-07 St. Jude Medical Puerto Rico Llc Dual lumen carrier tube with retractable sleeve and methods
US9131932B2 (en) * 2013-02-01 2015-09-15 St. Jude Medical Puerto Rico Llc Dual lumen carrier tube with retractable sleeve and methods
US9907681B2 (en) 2013-03-14 2018-03-06 4Tech Inc. Stent with tether interface
US10052095B2 (en) 2013-10-30 2018-08-21 4Tech Inc. Multiple anchoring-point tension system
US10039643B2 (en) 2013-10-30 2018-08-07 4Tech Inc. Multiple anchoring-point tension system
US10022114B2 (en) 2013-10-30 2018-07-17 4Tech Inc. Percutaneous tether locking
US10485545B2 (en) 2013-11-19 2019-11-26 Datascope Corp. Fastener applicator with interlock
US11564689B2 (en) 2013-11-19 2023-01-31 Datascope Corp. Fastener applicator with interlock
US9801720B2 (en) 2014-06-19 2017-10-31 4Tech Inc. Cardiac tissue cinching
US9907547B2 (en) 2014-12-02 2018-03-06 4Tech Inc. Off-center tissue anchors
US11389152B2 (en) 2014-12-02 2022-07-19 4Tech Inc. Off-center tissue anchors with tension members
US10806579B2 (en) 2017-10-20 2020-10-20 Boston Scientific Scimed, Inc. Heart valve repair implant for treating tricuspid regurgitation
US11653928B2 (en) 2018-03-28 2023-05-23 Datascope Corp. Device for atrial appendage exclusion
US11857417B2 (en) 2020-08-16 2024-01-02 Trilio Medical Ltd. Leaflet support

Also Published As

Publication number Publication date
US11191955B2 (en) 2021-12-07
AU2007275844A1 (en) 2008-01-24
US20140330211A1 (en) 2014-11-06
CA2656341C (en) 2015-12-29
US20160339210A9 (en) 2016-11-24
US20100069849A1 (en) 2010-03-18
WO2008010905A2 (en) 2008-01-24
US8128593B2 (en) 2012-03-06
US20150080805A1 (en) 2015-03-19
US20100185044A1 (en) 2010-07-22
AU2007275844B2 (en) 2013-05-23
US20120277725A1 (en) 2012-11-01
US8876776B2 (en) 2014-11-04
US20100168655A1 (en) 2010-07-01
US8894606B2 (en) 2014-11-25
US20170080218A9 (en) 2017-03-23
EP2035074A4 (en) 2012-11-07
US9907954B2 (en) 2018-03-06
JP2009542338A (en) 2009-12-03
US20100256599A1 (en) 2010-10-07
US20220088377A1 (en) 2022-03-24
NZ573919A (en) 2012-08-31
CA2656341A1 (en) 2008-01-24
US20180193635A1 (en) 2018-07-12
US20120116317A1 (en) 2012-05-10
US8777904B2 (en) 2014-07-15
WO2008010905A3 (en) 2008-11-13
NZ599528A (en) 2013-11-29
EP2035074A2 (en) 2009-03-18
US8303481B2 (en) 2012-11-06

Similar Documents

Publication Publication Date Title
US8777904B2 (en) Systems and methods for engaging heart tissue
US8211084B2 (en) Devices, systems, and methods for accessing the epicardial surface of the heart
US11013892B2 (en) Steering engagement catheter devices, systems, and methods
US9393383B2 (en) Intravascular catheters, systems, and methods
US9050064B2 (en) Systems for engaging a bodily tissue and methods of using the same
US9955999B2 (en) Systems, devices, and methods for transeptal atrial puncture using an engagement catheter platform
US9901710B2 (en) Steering engagement catheter devices, systems, and methods
US20110224720A1 (en) Devices, systems, and methods for closing a hole in cardiac tissue
AU2008246012A1 (en) Devices, systems, and methods for pericardial access

Legal Events

Date Code Title Description
AS Assignment

Owner name: CVDEVICES, LLC,INDIANA

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:KASSAB, GHASSAN S.;NAVIA, JOSE A., SR.;REEL/FRAME:024509/0687

Effective date: 20070322

Owner name: CVDEVICES, LLC, INDIANA

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:KASSAB, GHASSAN S.;NAVIA, JOSE A., SR.;REEL/FRAME:024509/0687

Effective date: 20070322

STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION