Sensing Adjunct for Surgical Staplers

• US 20090234248A1
• Filed: 03/13/2009
• Published: 09/17/2009
• Est. Priority Date: 03/15/2008
• Status: Active Grant

• Current Assignee: Surgisense Corporation
• Original Assignee: Surgisense Corporation
• Inventors: Fischer, Gregory Scott, Zand, Jason Matthew
• Granted Patent: US 8,118,206 B2
• Time in Patent Office: Days
• US Class Current: 600/587
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00221 with wireless transmission of data, e.g. by infrared radiation or radiowaves
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/0086 using infrared radiation
• CPC Class Codes: A61B 5/14556 by fluorescence A61B5/14555 takes precedence
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis

Abstract

A device and method in accordance with the invention for generating a signal indicative of a property of a subject tissue in contact with the working surface of a surgical instrument. The invention describes a sensing adjunct to surgical staplers. The adjunct can take the form of an optionally coupled accessory to a surgical stapler, or a stand-alone substitutive component acting to serve as a replacement for a component of the surgical stapler such as an anvil, housing or cartridge. Embodiments include a sensing anvil serving to act in place of a non-sensing surgical stapler anvil to monitor tissue properties of an anastomosis for the purpose of avoiding anastomotic failure.

Claims

1. An adjunct to a surgical stapler incorporating at least one sensor, wherein the adjunct operates independently of the stapler;

wherein adjunct is optionally coupled to said stapler.

2. The sensing adjunct of claim 1, comprising one of a chemical sensor, a mechanical sensor, an electrical sensor, an optical sensor and an acoustic sensor;

wherein the sensor is for measuring properties of and interactions with a living tissue.

3. The sensing adjunct of claim 2, wherein the adjunct takes the form of a surgical stapler anvil that serves to act in place of a non-sensing surgical stapler anvil.

4. The sensing adjunct of claim 2, wherein the adjunct takes the form of a shell that optionally couples to the anvil or body of a surgical stapler.

5. The sensor of claim 2, wherein the adjunct senses at least one of tissue oxygenation, blood oxygenation, pulse rate, pulse presence, pulse rhythm, tissue perfusion, staple gap, compression force, tissue interaction force, fluorescence, tissue electrical impedance, tissue electrical activity, pH, concentration of cellular respiration metabolites, electromyography, temperature, fluid flow rate, fluid flow volume, tissue pressure, blood pressure, biomarkers, radiotracers, immunologic characteristics, biochemical characteristics, nerve activity, an evoked potential, oxygen delivery, oxygen utilization, tissue characterization, tissue general health, tissue flow dynamics, tissue chemical composition, tissue immunologic activity, tissue pathogen concentration, tissue water content, blood hemoglobin content, tissue chromophore content, tissue neoplastic cell content and tissue dysplastic cell content.

6. The sensing adjunct of claim 2, comprising a plurality of sensors;

wherein the sensors are positioned on either side of, or interleaved between the staples or staple forms.

7. The sensing adjunct of claim 6, comprising a plurality of optical sensors directed to the tissue contacting surface of the surgical stapler;

wherein the optical sensor elements are mechanically coupled to a substrate;

wherein the optical sensor elements are optically coupled to the working surface via optical fiber or other light transmission conduit.

8. The optical sensors of claim 7, wherein the tissue contacting surface of the optical sensors are coated with a fluorescent medium;

wherein the fluorescent properties of the medium change responsive to a property of said tissue.

9. The sensing adjunct of claim 2, comprising one or more sensors that measure at least one of tissue interaction force, tissue compression force and tissue tension.

10. The sensors of claim 9, comprising force or pressure sensing elements mechanically coupled to a rigid substrate;

wherein tissue interaction force at the working surface is mechanically transmitted to the sensor elements by pins or a pressurized cavity.

11. The sensors of claim 9, comprising a pressure sensitive layer consisting essentially of a piezoelectric, resistive, or capacitive film, sheet or coating.

12. The sensing adjunct of claim 1, wherein the adjunct acts independently, or is communicatively coupled via a wireless connection to at least one of another sensing device and a base station.

13. The sensing adjunct of claim 1, wherein the power source is charged without direct electrical contact through an electromagnetic coupling;

wherein the adjunct may be hermetically sealed.

14. The optical sensors of claim 7, wherein the sensor can be modulated to obtain measurements corresponding to multiple tissue depths from the sensor surface by varying at least one of intensity, wavelength and light emitter to receiver spacing.

15. The sensor of claim 14, wherein a sensor placed a single side of an anastomosis is configured to resolve tissue properties for both layers of the apposed tissues.

16. The sensing adjunct of claim 1, wherein the adjunct is configured to quantify staple gap;

wherein the adjunct is a module that optionally mechanically couples to the stapler gap adjustment knob.

17. A stand-alone sensing surgical stapler anvil comprising one of a chemical sensor, a mechanical sensor, an electrical sensor, an optical sensor and an acoustic sensor;

wherein the sensor is for measuring properties of and interactions with a living tissue;

wherein said sensing anvil serves to act in place of a non-sensing surgical stapler anvil.

18. The sensing surgical stapler anvil of claim 17, wherein a sensor is configured to measure at least one of physiologic and mechanical tissue properties of an anastomosis.

19. A method for sensing tissue properties at an anastomosis, wherein a sensor is incorporated into a surgical stapler anvil;

wherein the sensing anvil operates independent of the stapler;

wherein the sensing anvil is optionally coupled to the stapler.

20. The method of claim 19, wherein the sensor is configured to resolve tissue properties for both layers of the apposed tissues by varying at least one of intensity, wavelength and light emitter to receiver spacing.