System and method for inhibiting injury to a patient during laparoscopic surgery

• US 9,492,070 B2
• Filed: 03/14/2014
• Issued: 11/15/2016
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: Mariner Endosurgery Inc.
• Original Assignee: Mariner Endosurgery Inc.
• Inventors: Langlois, David Allan, Schembri, Lawrence
• Primary Examiner(s): Nguyen, Anhtuan T
• Assistant Examiner(s): CHOU, WILLIAM B
• Application Number:
  US14/212,952
• Publication Number:
  US 20150025318A1
• Time in Patent Office: 977 Days
• Field of Search: 600/104, 600/109, 600/117, 600/118, 600/160, 606/151, 606/174
• US Class Current: 1/1
• CPC Class Codes: A61B 1/00055 for alerting the user
• CPC Class Codes: A61B 1/3132 for laparoscopy
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• 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 2017/00283 with a device releasably connected to an inner wall of the abdomen during surgery, e.g. an illumination source
• CPC Class Codes: A61B 2017/0225 flexible, e.g. fabrics, meshes, or membranes
• CPC Class Codes: A61B 2034/2048 using an accelerometer or inertia sensor
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 2090/3991 having specific anchoring means to fixate the marker to the tissue, e.g. hooks
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/064 using markers A61B5/062 takes precedence
• CPC Class Codes: A61B 90/03 Automatic limiting or abutting means, e.g. for safety
• CPC Class Codes: A61B 90/18 Retaining sheets, e.g. immobilising masks made from a thermoplastic material

Abstract

This group of inventions provides means and methods for preventing the damaging portions of surgical tools, such as laparoscopic devices, from adversely contacting tissues and organs that are not in the desired field of surgery. As such, the present disclosure pertains to any form of a warning or positioning device or methods, including those that are facilitated via software that are adapted and arranged for use in tracking portions of surgical instruments during laparoscopic surgery or other medical procedures. Such systems include those that are adapted and arranged to provide a warning to the surgeon or other medical personnel regarding the positional status of an instrument, and those that are adapted and arranged for disabling or attenuating the portions of those instruments that might be dangerous to a patient when a dangerous portion of the instrument is near or outside the desired, or denominated, field of surgery. Data relating to the position and orientation of the instrument and of the position of a safe zone within which the instrument can be kept safely is optionally (preferably) stored throughout a medical procedure for later playback for training purposes or for ensuring that a patient was not injured during a medical procedure.

Claims

1. A method of using a surgical system on a body of a patient, comprising:

(a) providing a probe including an interior portion that is configured to be at least partially inserted into the body of the patient during use, a probe body to which the interior portion of the probe is connected, wherein the probe body is configured to be outside the body of the patient during use, wherein the interior portion of the probe includes a probing portion;

(b) providing a surgical instrument including an interior portion that is configured to be at least partially inserted into the body of the patient during use, an instrument body to which the interior portion of the surgical instrument is connected, wherein the instrument body is configured to be outside the body of the patient during use, wherein the interior portion of the surgical instrument includes a functional element;

(c) providing a laparoscope including an interior portion that is configured to be at least partially inserted into the body of the patient during use, a laparoscope body to which the interior portion of the laparoscope is connected, wherein the laparoscope body is configured to be outside the body of the patient during use, wherein the interior portion of the laparoscope includes an image receiving element, wherein, during use, the image receiving element is positionable in a surgical field in the body of the patient to receive images of the probing portion when the probing portion is in the surgical field and to receive images of the functional element when the functional element is in the surgical field; and

,

(d) providing the patient in a stationary position in a surgical theatre;

(e) pre-defining a three-dimensional safe zone in a target region within the body of the patient while the patient remains in the stationary position by using the probe to define a denominated surgical field in the target region; and

(f) while keeping the patient in the stationary position after step (e), inserting the interior portion of the surgical instrument into the patient and performing a surgery therewith in the surgical theatre.

2. A method as claimed in claim 1, wherein the safe zone is saved for continuous comparison to position information from the surgical instrument, laparoscope or both the surgical instrument and laparoscope during the surgery to determine if the surgical instrument and/or laparoscope are in the safe zone.

3. A method as claimed in claim 1, wherein the probe determines positions of a plurality of points on internal body portions surrounding the surgical field to pre-define the safe zone.

4. A method of using a surgical system on a body of a patient, comprising:

(a) providing a probe including an interior portion that is configured to be at least partially inserted into the body of the patient during use, a probe body to which the interior portion of the probe is connected, wherein the probe body is configured to be outside the body to be operated on during use, wherein the interior portion of the probe includes a probing portion, and a probe marker on the probe body;

(b) providing a surgical instrument including an interior portion that is configured to be at least partially inserted into the body of the patient during use, an instrument body to which the interior portion of the surgical instrument is connected, wherein the instrument body is configured to be outside the body to be operated on during use, wherein the interior portion of the surgical instrument includes a functional element, and an instrument marker on the instrument body;

(c) providing a laparoscope including an interior portion that is configured to be at least partially inserted into the body of the patient during use, a laparoscope body to which the interior portion of the laparoscope is connected, wherein the laparoscope body is configured to be outside the body to be operated on during use, wherein the interior portion of the laparoscope includes an image receiving element, wherein, during use, the image receiving element is positionable in a surgical field the body of the patient to receive images of the probing portion when the probing portion is in the surgical field and to receive images of the functional element when the functional element is in the surgical field;

(d) providing the patient in a stationary position in a surgical theatre;

(e) pre-defining a three-dimensional safe zone in a target region within the body of the patient while the patient remains in the stationary position by using the probe to define a denominated surgical field in the target region;

(f) while keeping the patient in the stationary position after step (e), using the functional element of the surgical instrument to perform a function in the surgical field and determining substantially continuously the current position of the functional element based on the instrument marker;

(g) determining substantially continuously whether the functional element is within the safe zone based on the current position of the functional element determined in step (f);

(h) carrying out at least one action if the controller determines in step (g) that the functional element is outside of the safe zone, wherein the at least one action is selected from the group of actions consisting of;

notifying a user of the surgical instrument that the functional element is outside the safe zone; and

disabling the functional element, and

(i) recording positions of the functional element determined at step (f) over a selected period of time.