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

• US 8,702,592 B2
• Filed: 09/30/2010
• Issued: 04/22/2014
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: Mariner Endosurgery Inc.
• Original Assignee: David Allan Langlois, Lawrence Schembri
• Inventors: Langlois, David Allan, Schembri, Lawrence
• Primary Examiner(s): Smith, Philip R
• Assistant Examiner(s): CHOU, WILLIAM B
• Application Number:
  US12/895,149
• Publication Number:
  US 20120083652A1
• Time in Patent Office: 1,300 Days
• Field of Search: 600/104, 600/109, 600/117, 600/118, 600/160, 606/151, 606/174
• US Class Current: 600/117
• 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 surgical system for use on a body of a patient, comprising:

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, and a probe marker on the probe body;

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, and an instrument marker on the instrument body;

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;

a display configured to display the images of the probing portion and of the functional element received by the laparoscope;

a tracking system that includes at least one tracking system sensor positionable to track the probe marker during use of the surgical probe and to track the instrument marker during use of the surgical instrument;

netting that is insertable into the body of the patient and is positionable to restrain at least some of the internal body portions of the patient from obstructing the surgical instrument,

a plurality of safe zone definition sensors positioned on the netting, wherein, for each safe zone definition sensor, the safe zone definition sensor is configured to detect when the probing portion is at a selected proximity to the safe zone definition sensor; and

a controller, wherein for each safe zone definition sensor, the controller is programmed to;

(a) receive an indication from the safe zone definition sensor when the probing portion is at the selected proximity to the safe zone definition sensor;

(b) receive probe marker input from the tracking system corresponding to a position of the probe marker when having received the indication from step (a); and

(c) determine the position of the safe zone definition sensor based on the probe marker input;

and wherein the controller is further programmed to;

(d) determine safe zone defining positions which define a safe zone within which the surgical instrument can operate without causing injury to the patient based at least in part on the plurality of positions determined at step (c);

(e) receive substantially continuous instrument marker input from the tracking system corresponding to a current position of the instrument marker which in turn corresponds to a current position of the functional element;

(f) determine substantially continuously the current position of the functional element based on the instrument marker input;

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

(h) carry 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.

2. A surgical system as claimed in claim 1, wherein, for each safe zone definition sensor, the safe zone definition sensor is configured to detect when the probing portion is in contact with the safe zone definition sensor.

3. A surgical system as claimed in claim 1, wherein the controller is further programmed in step (h) to carry out both actions selected from the group of actions consisting of:

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

disabling the functional element.

4. A surgical system as claimed in claim 1,

wherein the controller is further programmed to:

(i) determine whether the functional element is within a danger zone, wherein the danger zone is a peripheral portion of the safe zone, and

(j) notify the user of the surgical instrument that the functional element is in the danger zone, if the functional element is determined to be in the danger zone in step (i).

5. A surgical system as claimed in claim 1, wherein the controller is programmed to record a history of positions of the functional element determined at step (f) during a surgical procedure.

6. A surgical system as claimed in claim 1, wherein the controller is programmed to record in a computer readable format on a computer readable medium a history of positions of the functional element determined at step (f) during a surgical procedure.

7. A surgical system as claimed in claim 1, wherein the functional element includes at least one sharp edge and at least one sheath, and wherein the action of disabling the functional element includes covering the at least one sharp edge with the at least one sheath.

8. A surgical system as claimed in claim 1, wherein each safe zone definition sensor is configured to sense self-movement in three dimensions and is further configured to indicate to the controller the amount of self-movement that takes place, and wherein, upon receiving an indication of self-movement from at least one of the safe zone definition sensors, the controller is further programmed to update the safe zone defining positions based on the indication.

9. A surgical system as claimed in claim 8, wherein the controller is programmed to record in a computer readable format on a computer readable medium a history of positions of the functional element determined at step (f) during a surgical procedure and a history of the safe zone defining positions during a surgical procedure.

10. A surgical system as claimed in claim 8, wherein each safe zone definition sensor includes an accelerometer.

11. A surgical system as claimed in claim 1, wherein the netting includes a plurality of hold-down elements which are attachable to points outside of the body of the patient to hold the netting in such a way as to restrain at least some of the internal body portions of the patient from obstructing the surgical instrument.

12. A surgical system as claimed in claim 1, wherein the functional element is selected from the group of functional elements consisting of:

a cutting blade and a heated element.

13. A surgical system as claimed in claim 1, wherein the tracking system includes at least one tracking system camera positioned to receive images of the probe marker when the probe is being used on the patient and wherein the controller is programmed to determine the position of the probe based on the images of the probe marker and positioned to receive images of the instrument marker when the instrument is being used on the patient and wherein the controller is programmed to determine the position of the instrument based on the images of the instrument marker.

14. A surgical system as claimed in claim 13, wherein at least one of the probe marker and the instrument marker includes a plurality of LEDs.

15. A surgical system as claimed in claim 14, wherein at least one of the probe marker and the instrument marker includes a plurality of LEDs that are configured to emit infrared light.

16. A surgical system as claimed in claim 13, wherein at least one of the probe marker and the instrument marker includes an image of a polygon and a plurality of LEDs.

17. A surgical system as claimed in claim 1, wherein the action of notifying a user of the surgical instrument that the functional element is outside the safe zone comprises an emission of an audible sound.

18. A surgical system as claimed in claim 1, wherein the controller is programmed to emit and alter an audible sound as the functional element approaches a periphery of the safe zone so as to provide to the user of the surgical instrument an indication of the proximity of the functional element to the periphery of the safe zone.

19. A surgical system as claimed in claim 1, wherein the controller is programmed to emit an audible sound made up of a plurality of sound elements emitted at a frequency, wherein, as the functional element approaches a periphery of the safe zone the controller is programmed to alter the frequency of the sound elements emitted so as to provide to the user of the surgical instrument an indication of the proximity of the functional element to the periphery of the safe zone.

20. A surgical system as claimed in claim 1, wherein the tracking system includes at least one tracking system camera positioned to receive images of the probe marker and wherein the controller is programmed to determine the position of the probe based on the images of the probe marker.

21. 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;

(d) providing netting that is insertable into the body of the patient and is positionable to restrain at least some of the internal body portions of the patient from obstructing the surgical instrument;

(e) providing a plurality of safe zone definition sensors positioned on the netting, wherein, for each safe zone definition sensor, the safe zone definition sensor is configured to detect when the probing portion is at a selected proximity to the safe zone definition sensor;

wherein, for each safe zone definition sensor, the method further comprises;

(f) receive an indication from the safe zone definition sensor when the probing portion is at the selected proximity to the safe zone definition sensor;

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(g) determine the position of the probe when an indication is received in step (f);

(h) determine, the position of the safe zone definition sensor based on position of the probe determined in step (g);

wherein the method further comprises;

(i) determine safe zone defining positions which define a safe zone within which the surgical instrument can operate without causing injury to the patient based at least in part on the plurality of positions determined at step (h);

(j) determine substantially continuously whether the functional element is within the safe zone; and

(k) carry out at least one action if the controller determines in step (j) 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.

22. A method as claimed in claim 21, wherein:

the probe includes a probe marker on the probe body;

the instrument includes an instrument marker on the instrument body; and

wherein the method further comprises;

(l) providing a tracking system that includes at least one tracking system sensor positionable to track the probe marker during use of the surgical probe and to track the instrument marker during use of the surgical instrument;

wherein step (g) includes;

(m) receiving, for each indication received in step (f), probe marker input from the tracking system corresponding to a position of the probe marker when having received the indication from step (f), and determining the position of the probe based on the probe marker input;

and wherein step (h) includes;

(n) determining the position of each safe zone definition sensor based on the probe marker input;

and wherein step (j) includes;

(o) receiving substantially continuous instrument marker input from the tracking system corresponding to a current position of the instrument marker which in turn corresponds to a current position of the functional element;

(p) determining substantially continuously the current position of the functional element based on the instrument marker input; and

(q) determining substantially continuously whether the functional element is within the safe zone based on the current position of the functional element determined in step (p).

23. A method as claimed in claim 22, further comprising recording in a computer readable format on a computer readable medium a history of positions of the functional element determined at step (p) during a surgical procedure.

24. A method as claimed in claim 21, wherein, for each safe zone definition sensor, the safe zone definition sensor is configured to detect when the probing portion is in contact with the safe zone definition sensor.

25. A method as claimed in claim 21, further comprising:

(r) determining whether the functional element is within a danger zone, wherein the danger zone is a peripheral portion of the safe zone, and (s) notifying the user of the surgical instrument that the functional element is in the danger zone, if the functional element is determined to be in the danger zone in step (r).

26. A method as claimed in claim 21, wherein each safe zone definition sensor is configured to sense self-movement in three dimensions and is further configured to indicate the amount of self-movement that takes place, and wherein the method further comprises:

updating the safe zone defining positions based on the indication upon receiving an indication of self-movement from at least one of the safe zone definition sensors.

27. A method as claimed in claim 26, further comprising recording in a computer readable format on a computer readable medium a history of positions of the functional element determined at step (p) during a surgical procedure and a history of the safe zone defining positions during a surgical procedure.

28. A method as claimed in claim 26, wherein each safe zone definition sensor includes an accelerometer.

29. A method as claimed in claim 21, wherein the netting includes a plurality of hold-down elements which are attachable to points outside of the body of the patient to hold the netting in such a way as to restrain at least some of the internal body portions of the patient from obstructing the surgical instrument.

30. A method as claimed in claim 21, wherein the functional element is selected from the group of functional elements consisting of:

a cutting blade and a heated element.