US2021307823A1PendingUtilityA1

Method of surgical perforation via the delivery of energy

Assignee: BAYLIS MEDICAL CO INCPriority: Jan 21, 2003Filed: Jun 17, 2021Published: Oct 7, 2021
Est. expiryJan 21, 2023(expired)· nominal 20-yr term from priority
A61B 2018/00601A61B 18/1206A61B 18/1492A61M 5/007A61B 2090/064A61B 2018/00351A61B 18/24A61B 2090/3966A61B 18/16A61B 2018/00839A61M 29/02A61B 2018/0038
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Claims

Abstract

A method of perforating a tissue of a heart of a patient when an inferior approach to the heart is contraindicated. The method utilizes an electrosurgical apparatus having an energy delivery device which can function as an ECG measuring device at a distal end thereof and a delivery system comprising a dilator. Said method comprises the steps of (a) advancing the dilator through a superior vena cava into the heart of the patient, from a superior approach, until a distal end of the dilator is adjacent the tissue; (b) checking an ECG signal to confirm a position of the energy delivery device; (c) using the electrosurgical apparatus, which is positioned through the dilator, to create a perforation in the tissue by delivering electrical energy to the tissue; (d) advancing the distal end of the electrosurgical apparatus through the perforation; and (e) advancing the dilator over the electrosurgical apparatus.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of perforating a tissue of a heart of a patient, the method utilizing an electrosurgical apparatus having an energy delivery device which can function as an ECG measuring device at a distal end thereof and a delivery system comprising a dilator, said method comprising the following steps in the sequence set forth:
 (a) advancing the dilator through a superior vena cava into the heart of the patient, from a superior approach, until a distal end of the dilator is adjacent the tissue;   (b) checking an ECG signal to confirm a position of the energy delivery device;   (c) using the electrosurgical apparatus, which is positioned through the dilator, to create a perforation in the tissue by delivering electrical energy to the tissue;   (d) advancing the distal end of the electrosurgical apparatus through the perforation; and   (e) advancing the dilator over the electrosurgical apparatus.   
     
     
         2 . The method of  claim 1 , wherein the tissue is an atrial septum. 
     
     
         3 . The method of  claim 1 , wherein step (b) includes, prior to delivering energy, positioning the energy delivery device adjacent the tissue. 
     
     
         4 . The method of  claim 3 , wherein step (b) comprises energy being delivered through the energy delivery device to the tissue. 
     
     
         5 . The method of  claim 1 , further comprising utilizing a splitter for simultaneously connecting the electrosurgical apparatus to both an ECG recorder and an electrical generator, whereby step (c) further comprises simultaneously monitoring and recording ECG while delivering energy to the tissue. 
     
     
         6 . The method of  claim 1 , wherein the dilator is steerable and articulating whereby a shape of the dilator can be adjusted to define a curve. 
     
     
         7 . The method of  claim 6 , wherein the delivery system further comprises a sheath which is steerable and articulating whereby a shape of the sheath can be adjusted to define a curve. 
     
     
         8 . The method of  claim 1 , wherein the delivery system further comprises a sheath which is steerable and articulating whereby a shape of the sheath can be adjusted to define a curve. 
     
     
         9 . The method of  claim 1 , wherein the tissue is an atrial septum of the heart and wherein step (a) further includes positioning the dilator such that a distal end of the dilator is oriented at an angle of about 80 degrees to about 100 degrees relative to a surface of the atrial septum. 
     
     
         10 . The method of  claim 9 , wherein the distal end of the dilator is oriented substantially perpendicularly relative to the surface of the atrial septum. 
     
     
         11 . The method of  claim 9 , wherein step (a) further comprises positioning the dilator such that a distal end of the dilator is oriented at an angle of less than 90 degrees relative to the surface of the atrial septum. 
     
     
         12 . The method of  claim 9 , wherein the electrosurgical apparatus is bent at an angle greater than 90 degrees when it is being positioned. 
     
     
         13 . The method of  claim 9 , wherein the dilator has a distal tip with a curve greater than 90 degrees to facilitate positioning the distal end of the dilator. 
     
     
         14 . The method of  claim 1 , wherein the tissue is an atrial septum of the heart and wherein step (a) further comprises positioning the dilator such that a distal end of the dilator is oriented at an oblique angle relative to a surface of the atrial septum. 
     
     
         15 . The method of  claim 14 , wherein said electrosurgical apparatus further comprises at least one pressure sensor selected from the group consisting of a pressure-transmitting lumen and a pressure transducer and wherein said method comprises measuring pressure. 
     
     
         16 . The method of  claim 14 , wherein step (a) further comprises positioning the dilator such that a distal end of the dilator is oriented at an angle of about 20 degrees to about 70 degrees relative to a surface of the atrial septum. 
     
     
         17 . The method of  claim 16 , wherein the distal end of the dilator is oriented at an angle of about 45 degrees relative to a surface of the atrial septum. 
     
     
         18 . The method of  claim 1 , further comprising a step (f) of implanting a pressure monitor into a left atrium of the patient. 
     
     
         19 . The method of  claim 14 , wherein the delivery system further comprises a sheath and wherein step (a) further comprises using the sheath for positioning the dilator. 
     
     
         20 . The method of  claim 19 , wherein the sheath and the dilator are supported by the superior vena cava.

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