Image guided catheters and methods of use
Inventors
Assignees
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Abstract
An interventional medical device that incorporates an imaging system may be minimally invasive and equipped with an anchoring portion at a proximal end for securing the device to a human body. A luer lock may be utilized at the proximal end, for example, for introducing a syringe. The medical device can be in the form of sheaths, catheters, and interventional devices, particularly those suitable for minimally invasive procedures in the pericardium. The imaging system comprises one or more ultrasound transducers and can be used to guide the device to a target area and to perform a procedure and/or provide access to a target area for performing a procedure via a plurality of lumen. In one embodiment, a micro-electro-mechanical system may be utilized to monitor pressure within a human body.
Core Innovation
The invention relates to an interventional medical device for pericardial access configured to perform minimally invasive surgical procedures. The device includes an elongate body having no exterior delivery catheter or sheath and being introduced directly through a chest of a human body to the pericardium after a small stab incision on the skin during use, with a tapered tip at the distal end configured as a conduit from a skin surface of the chest to a target site proximate the pericardium.
The device further includes an insertable needle configured to puncture a pericardial lining proximate the target site during use. A plurality of lumen extend through the elongate body, including one lumen that extends to an end aperture at the distal tip of the tapered tip for needle insertion, and the distal end can include a plurality of apertures corresponding to the lumen.
At least one ultrasound transducer is located at an outer periphery of the tapered tip near the distal end, oriented and configured to provide images for guidance of movement of the elongate body and images of the needle puncture. An anchoring portion near the proximal end maintains proper position during use, and a luer lock near the proximal end permits coupling of the lumen for needle insertion to a syringe during use.
Claims Coverage
The independent claims (clm-00001, clm-00013, and clm-00020) cover six inventive features for pericardial access using an elongate body with a tapered distal tip, distal lumen and needle puncture, ultrasound guidance, proximal anchoring, and luer lock coupling.
Ultrasound transducer at tapered tip for guidance and puncture imaging
At least one ultrasound transducer is located at an outer periphery of the tapered tip of the elongate body and proximally located near the distal end in relation to the end aperture, oriented and configured to provide images for guidance of movement of the elongate body from the chest to the target site proximate the pericardium and images of needle puncture during use.
Direct pericardial conduit via chest stab incision with tapered tip aperture
An elongate body having no exterior delivery catheter or sheath is configured to be introduced directly through a chest to the pericardium after a small stab incision on the skin during use, with proximal and distal ends and a tapered tip at the distal end configured to form a conduit from the skin surface to a target site proximate the pericardium, and the distal tip includes an end aperture.
Needle insertion lumen through distal tip end aperture for puncturing pericardial lining
An insertable needle is configured to puncture a pericardial lining during use, and a plurality of lumen extend through the elongate body including one lumen adapted to receive the insertable needle, with the one lumen extending to the end aperture at the distal tip for needle extension during use.
Proximal anchoring portion for maintaining proper position
An anchoring portion near the proximal end of the elongate body maintains a proper position during use of the device.
Luer lock coupling for syringe to lumen for needle insertion
A luer lock near the proximal end of the elongate body permits coupling of the one lumen for needle insertion to a syringe during use of the device.
Catheter with multiple distal apertures and needle removal after puncture
A catheter for pericardial access includes a plurality of apertures at the distal end corresponding to the plurality of lumen, and the catheter is configured for advancement to the pericardial lining while the insertable needle is removed after pericardial lining puncture during use of the device.
Across the independent claims, the inventive features combine a tapered distal-tip conduit introduced directly through a chest stab incision for pericardial access, an insertable needle delivered via a distal end-aperture lumen to puncture the pericardial lining, ultrasound transducers positioned near the distal tip to provide guidance and puncture imaging, and proximal anchoring with luer lock coupling.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Minimally invasive surgical procedures via pericardial access in the human body, including biopsy procedures and drainage of effusions including pericardial effusion, ascites, chest effusion, and abscess.
Intracardiac and cardiac procedures via pericardial access, including epicardial mapping, endocardial/epicardial mapping, ablation, and lead placement.
Intracardiac treatment via pericardial access without entry of the device through a blood vessel.
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