DEVICE FOR MONITORING PHYSIOLOGICAL PARAMETERS IN VIVO

• US 20120273548A1
• Filed: 04/03/2012
• Published: 11/01/2012
• Est. Priority Date: 04/27/2011
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Ma, Yong, Scarborough, Nelson, Power, James, Viola, Frank, Campbell, Shannon, Godek, Marisha, Shah, Rohan, Mukherjee, Nilay, Mckenna, Edward
• Granted Patent: US 9,649,113 B2
• Time in Patent Office: Days
• US Class Current: 227/176.1
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00115 with audible or visual output with imaging means A61B90/37, A61B34/20
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00221 with wireless transmission of data, e.g. by infrared radiation or radiowaves
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/6847 mounted on an invasive device
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence

Abstract

A monitoring system is disclosed for in vivo monitoring of preselected physiological parameters associated with acute and/or chronic tissue compromise or failure in one or multiple tissue/organ sites in real time. In one method, a body portion of a surgical stapling device is positioned adjacent a first tissue section, an anvil assembly adapted to engage the body portion is positioned adjacent a second tissue section, and a monitoring device is positioned adjacent the first and/or second tissue sections. The monitoring device includes a sensor adapted to measure a preselected physiological parameter and a transmitter for transmitting signal to an extracorporeal receiving unit. The surgical stapling device is fired to mechanically secure the first and second tissue sections with at least one staple and the preselected physiological parameter is monitored via the information transmitted from the monitoring device to the receiving unit.

Claims

1. A method of real time monitoring of an anastomosis, the method comprising the steps of:

positioning a body portion of a surgical stapling device including a staple cartridge adjacent a first tissue section;

positioning an anvil assembly including a shaft adapted to engage the body portion of the surgical stapling device adjacent a second tissue section;

positioning a monitoring device adjacent the first or second tissue section, the monitoring device comprising a sensor adapted to measure a preselected physiological parameter and a transmitter for transmitting signal to an extracorporeal receiving unit;

firing the surgical stapling device to mechanically secure the first and second tissue sections with at least one staple from the staple cartridge along a staple line; and

monitoring the preselected physiological parameter via information transmitted from the monitoring device to the receiving unit.

2. The method of claim 1, wherein the step of positioning a monitoring device further comprises the step of placing the monitoring device on a portion of the first and/or section tissue section external of the staple line.

3. The method of claim 2, wherein the step of placing the monitoring device further comprises the step of affixing the monitoring device to the tissue with a biocompatible adhesive.

4. The method of claim 2, wherein the step of placing the monitoring device further comprises the step of affixing the monitoring device to the tissue section with a surgical fastener.

5. The method of claim 1, wherein the step of positioning a monitoring device further comprises the step of placing a buttress incorporating the monitoring device on the shaft of the anvil assembly.

6. The method of claim 1, wherein at least one monitoring device is affixed using a staple from the staple cartridge of the surgical stapling device.

7. The method of claim 6, wherein the staples have at least one monitoring device on a crown of the staple and at least one monitoring device on a leg of the staple.

8. The method of claim 7 and wherein the step of firing the surgical stapling device further comprises the step of positioning the first and second tissue sections between the monitoring devices of the staple.

9. The method of claim 1, wherein the step of positioning a monitoring device further comprises the step of placing an anastomosis ring including the monitoring device and having first and second separable members onto the body portion and shaft of the surgical stapling device.

10. The method of claim 1, wherein the step of monitoring the preselected physiological parameter includes sending a signal indicating a measurement of the parameter to he receiving unit.

11. The method of claim 1, further comprising the step of wearing the receiving unit on a body of a patient.

12. The method of claim 1, wherein the step of monitoring the preselected physiological parameter further includes the step of introducing an exogenous marker into the first and second tissue sections.

13. A method of monitoring tissue in real time, the method comprising the steps of:

positioning a surgical fastener including a monitoring device comprising a sensor adapted to measure a preselected physiological parameter and a transmitter for transmitting signal from the sensor about tissue in a body of a patient; and

positioning an extracorporeal receiving unit for collecting data from the monitoring device in proximity to the body of the patient, the receiving unit including an indicator to alert the patient when a predetermined test criterion of the preselected physiological parameter is met.

14. The method of claim 13, wherein the step of positioning the extracorporeal receiving unit further comprises the step of placing the receiving unit on the body of patient.