Surgical system and procedure for treatment of medically refractory atrial fibrillation

• US 8,535,301 B2
• Filed: 05/14/2012
• Issued: 09/17/2013
• Est. Priority Date: 10/22/1996
• Status: Expired due to Fees

• Current Assignee: St. Jude Medical, Atrial Fibrillation Division, Inc. (Abbott Laboratories)
• Original Assignee: St. Jude Medical, Atrial Fibrillation Division, Inc. (Abbott Laboratories)
• Inventors: Cox, James L., Boyd, Stephen W., Gifford, Hanson S., Vaska, Matthias
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US13/470,886
• Publication Number:
  US 20120226269A1
• Time in Patent Office: 491 Days
• Field of Search: 606 20- 26
• US Class Current: 606/21
• CPC Class Codes: A61B 1/042 characterised by a proximal camera, e.g. a CCD camera
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0057 Implements 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 sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06061 Holders for needles or sutures, e.g. racks, stands hand-held holding instruments A61B17/0483; holders for articles A61B50/20; racks for syringes or for hypodermic or infusion needles A61M5/008
• CPC Class Codes: A61B 17/2909 Handles
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3211 Surgical scalpels, knives; Accessories therefor
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/1447 wherein sliding surfaces cause opening/closing of the end effectors
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00575 : for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00946 : malleable
• CPC Class Codes: A61B 2017/0243 : for immobilizing local areas of the heart, e.g. while it beats
• CPC Class Codes: A61B 2017/047 : having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body
• CPC Class Codes: A61B 2017/0472 : Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 : Knot pushers
• CPC Class Codes: A61B 2017/0475 : using sutures having a slip knot
• CPC Class Codes: A61B 2017/2931 : with releasable head
• CPC Class Codes: A61B 2017/2943 : Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2017/2945 : Curved jaws
• CPC Class Codes: A61B 2017/306 : holding by means of suction
• CPC Class Codes: A61B 2017/3405 : using mechanical guide means
• CPC Class Codes: A61B 2017/3419 : Sealing means between cannula and body
• CPC Class Codes: A61B 2017/3486 : Balloon
• CPC Class Codes: A61B 2017/3492 : against the outside of the body
• CPC Class Codes: A61B 2018/00214 : Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00232 : having an irregular shape
• CPC Class Codes: A61B 2018/00261 : arranged in a line
• CPC Class Codes: A61B 2018/00291 : using suction
• CPC Class Codes: A61B 2018/00363 : Epicardium
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2018/0212 : using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0225 : using an instrument for clamping tissue, e.g. forceps
• CPC Class Codes: A61B 2018/0262 : using a circulating cryogenic fluid
• CPC Class Codes: A61B 2018/1432 : curved
• CPC Class Codes: A61B 2018/145 : wherein the effectors remain parallel during closing and opening
• CPC Class Codes: A61B 2018/1465 : Deformable electrodes
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation
• CPC Class Codes: A61B 90/50 : Supports for surgical instruments, e.g. articulated arms
• CPC Class Codes: A61F 2/2427 : Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61M 2025/028 : having a mainly rigid support structure
• CPC Class Codes: A61M 2039/0252 : for access to the lungs
• CPC Class Codes: A61M 2039/0276 : for introducing or removing fluids into or out of the body
• CPC Class Codes: A61M 2039/0279 : for introducing medical instruments into the body, e.g. endoscope, surgical tools
• CPC Class Codes: A61M 2205/3344 : Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3355 : Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/366 : by liquid heat exchangers
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 39/0247 : Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

The invention provides surgical systems and methods for ablating heart tissue within the interior and/or exterior of the heart. A plurality of probes is provided with each probe configured for introduction into the chest for engaging the heart. Each probe includes an elongated shaft having an elongated ablating surface of a predetermined shape. The elongated shaft and the elongated ablating surface of each probe are configured to ablate a portion of the heart. A sealing device affixed to the heart tissue forms a hemostatic seal between the probe and the penetration in the heart to inhibit blood loss therethrough.

Claims

1. A method of ablating tissue, comprising:

providing a tissue ablation probe comprising;

a tubular shaft having a proximal end portion and a distal end portion, the distal end portion including a cryogenic ablation surface, and defining a communication passageway;

a cryogen delivery tube extending through the communication passageway from the proximal end portion of the tubular shaft to the distal end portion of the tubular shaft and including at least one aperture proximate the cryogenic ablation surface,

wherein the cryogen delivery tube and the tubular shaft define therebetween a boiler chamber adjacent the cryogenic ablation surface and an exhaust passageway extending through the communication passageway from the boiler chamber to the proximal end portion of the tubular shaft;

shaping the tubular shaft and the cryogen delivery tube via plastic deformation such that the cryogenic ablation surface conforms to a surface of cardiac tissue to be treated;

introducing the tissue ablation probe into a patient'"'"'s body;

manipulating the tissue ablation probe such that the cryogenic ablation surface contacts the surface of cardiac tissue to be treated;

delivering a pressurized cryogen via the cryogen delivery tube such that it exits the at least one aperture and expands in the boiler chamber, thereby cooling the cryogenic ablation surface via the Joule-Thompson effect; and

recovering the expanded cryogen via the exhaust passageway.

2. A method according to claim 1, wherein the step of delivering a pressurized cryogen via the cryogen delivery tube comprises:

delivering a cryogen at a pressure between about 600 psi and about 900 psi; and

permitting the cryogen to expand in the boiler chamber to a pressure between about 50 psi and about 200 psi.

3. A method according to claim 1, further comprising thawing the cryogenic ablation surface prior to removing the cryogenic ablation surface from the surface of cardiac tissue to be treated.

4. A method according to claim 1, wherein the step of introducing the tissue ablation probe into a patient'"'"'s body comprises introducing the tissue ablation device through an intercostal penetration.

5. A method of ablating tissue, comprising:

providing a tissue ablation probe comprising;

an elongate, linear probe body including a proximal end portion, an intermediate portion having a cryogenic ablation surface, and a distal end portion;

wherein the probe body further comprises a malleable section disposed between the proximal end portion and the distal end portion; and

a flexible sheath, wherein the probe body is disposed at least partially within the flexible sheath such that moving the flexible sheath relative to the probe body adjusts an exposed length of the cryogenic ablation surface;

shaping the malleable section of the probe body such that the cryogenic ablation surface will conform to a surface of cardiac tissue to be treated;

placing the cryogenic ablation surface into contact with the surface of cardiac tissue to be treated; and

cooling the cryogenic ablation surface.

6. The method according to claim 5, wherein the probe body is slidably disposed within the flexible sheath.

7. The method according to claim 5, wherein there is overlap between the cryogenic ablation surface and the malleable section.

8. The method according to claim 7, wherein the cryogenic ablation surface and the malleable section are not coextensive.

9. The method according to claim 5, wherein the step of shaping the malleable section of the probe body comprises plastically deforming the malleable section of the probe body.

10. A method of ablating tissue, comprising:

providing a tissue ablation probe having a proximal end portion and a distal end portion, the distal end portion including a cryogenic ablation region and a malleable region;

shaping the malleable region of the tissue ablation probe such that the cryogenic ablation region conforms to a surface of cardiac tissue to be treated;

introducing the tissue ablation probe into a patient'"'"'s body;

manipulating the tissue ablation probe such that the cryogenic ablation region contacts the surface of cardiac tissue to be treated; and

cooling the cryogenic ablation region.

11. The method according to claim 10, wherein there is overlap between the cryogenic ablation region and the malleable region.

12. The method according to claim 11, wherein the cryogenic ablation region and the malleable region are not coextensive.

13. The method according to claim 10, further comprising a sheath surrounding at least a portion of the tissue ablation probe, and wherein the sheath is movable relative to the tissue ablation probe such that an exposed area of the cryogenic ablation region is adjustable.

14. The method according to claim 10, wherein the step of shaping the malleable region of the tissue ablation probe comprises plastically deforming the malleable region of the tissue ablation probe.

15. The method according to claim 10, wherein the step of cooling the cryogenic ablation region comprises delivering a pressurized cryogen and allowing the pressurized cryogen to expand within the cryogenic ablation region, thereby cooling the cryogenic ablation region via the Joule-Thompson effect.

16. The method according to claim 15, wherein the pressurized cryogen is delivered at a pressure of between about 600 psi and about 900 psi and allowed to expand to a pressure of between about 50 psi and about 200 psi.