Sensing adjunct for surgical staplers

• US 8,118,206 B2
• Filed: 03/13/2009
• Issued: 02/21/2012
• Est. Priority Date: 03/15/2008
• Status: Active Grant

• Current Assignee: Surgisense Corporation
• Original Assignee: Surgisense Corporation
• Inventors: Zand, Jason Matthew, Fischer, Gregory Scott
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US12/404,276
• Publication Number:
  US 20090234248A1
• Time in Patent Office: 1,075 Days
• Field of Search: 600/300, 600/587, 600/593, 2271751-1821
• US Class Current: 227/175.1
• 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. A self contained adjunct sensing system configured to be detachably coupled to a surgical stapler, the adjunct sensing system comprising:

an adjunct housing configured to be detachably coupled to the surgical stapler;

wherein the adjunct housing maintains

at least one sensor configured to sense at least one property of tissue and an interaction with tissue;

a processor configured to receive and process signals from said at least one sensor; and

a communications interface configured to transfer information at least one of to and from the processor.

2. The adjunct sensing system of claim 1, wherein said at least one sensor comprises at least one of a chemical sensor, a mechanical sensor, an electrical sensor, an optical sensor, and an acoustic sensor;

wherein the sensor is configured to measure at least one of a property of tissue and an interaction with a living tissue.

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

4. The adjunct sensing system of claim 2, wherein the adjunct sensing system takes the form of a member that is detachably coupleable to the anvil or body of a surgical stapler.

5. The adjunct sensing system of claim 2, wherein the adjunct sensing system 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 adjunct sensing system of claim 4, where said member comprises one of a sleeve, clip, cap, and shell.

7. The adjunct sensing system of claim 2, wherein said at least one sensor comprises a plurality of sensors;

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

8. The adjunct sensing system of claim 7, wherein said plurality of sensors includes a plurality of optical sensors directed to the tissue contacting surface of the surgical stapler;

wherein optical sensor elements of said optical sensors 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.

9. The adjunct sensing system of claim 8, 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.

10. The adjunct sensing system of claim 2, wherein said at least one sensor is configured to measure at least one of tissue interaction force, tissue compression force, and tension acting on tissue.

11. The adjunct sensing system of claim 10, wherein said at least one sensor comprises 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.

12. The adjunct sensing system of claim 10, wherein said at least one sensor comprises a pressure sensitive layer comprising at least one of a piezoelectric, resistive, and capacitive film, sheet, or coating.

13. The adjunct sensing system of claim 2, wherein the at least one optical 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.

14. The adjunct sensing system of claim 13, wherein a sensor placed a single side of an anastomosis is configured to resolve tissue properties for both layers of the apposed tissues.

15. The adjunct sensing system of claim 1, wherein the adjunct sensing system is configured to act independently, or is communicatively coupled via a wireless connection to at least one of an indicator, another sensing device, and a base station.

16. The adjunct sensing system of claim 1, further comprising a power source, wherein the power source is charged without direct electrical contact through an electromagnetic coupling;

wherein the adjunct sensing system is hermetically sealed.

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

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

18. The adjunct sensing system of claim 1, further comprising a memory configured to store information from at least one of the sensor and the processor.

19. The adjunct sensing system of claim 1, further comprising an indicator.

20. An adjunct configured to be detachably coupled with a surgical stapler, the adjunct comprising:

an adjunct housing configured to be detachably coupled to the surgical stapler;

a self contained sensing system, the sensing system including

at least one sensor;

a processor configured to receive and process signals from said at least one sensor; and

a communications interface configured to transfer information at least one of to and from the processor; and

wherein the self contained sensing system is maintained by the adjunct housing.

21. The adjunct of claim 20, wherein the adjunct housing forms an anvil including a staple form member.

22. The adjunct of claim 21, wherein the staple form member has a substantially circular or semi-circular configuration.

23. The adjunct of claim 21, wherein the staple form member has a substantially linear configuration.

24. The adjunct of claim 20, wherein the adjunct housing is configured to be detachably coupled with an anvil portion of a surgical stapler.

25. The adjunct of claim 20, wherein the adjunct housing is in the form of one of a sleeve, a shell, a cap, or a clip.

26. The adjunct of claim 20, further comprising a memory configured to store information from at least one of the sensor and the processor.

27. The adjunct of claim 20, further comprising an indicator communicatively coupled with said sensing system.

28. The adjunct claim 20, wherein said sensing system is communicatively coupled with at least one reference sensor, which provides a baseline measurement of at least one of a physiologic property of tissue and a mechanical property of tissue.

29. The adjunct of claim 20, further comprising an actuator configured to vary staple gap or height.

30. The adjunct of claim 29, wherein the actuator comprises a motorized actuator.

31. The adjunct of claim 29, wherein the actuator is configured to control an adjustment knob of the surgical stapler.

32. The adjunct of claim 20, further comprising an actuator configured to assist with firing of the surgical stapler.

33. The adjunct of claim 32, wherein the actuator comprises a motorized actuator.

34. The adjunct of claim 20, wherein readings of said at least one sensor are configured to provide information utilized to maintain consistency by one of tissue interaction force, tissue compression force, and tension acting on tissue.

35. The adjunct of claim 20, wherein the sensing system is configured to provide guidance regarding a surgical procedure.

36. The adjunct of claim 35, wherein the guidance predicts success of a surgical procedure.

37. The adjunct of claim 36, wherein the guidance avoids or detects failure of a surgical procedure.

38. The adjunct of claim 20, wherein the adjunct is configured to deliver a therapy to tissue.

39. The adjunct of claim 38, wherein said therapy comprises at least one of photodynamic, pharmaceutical, bio-adhesive, brachy-, and nano-therapies.

40. A surgical assembly comprising:

a device for creating an anastomosis; and

an adjunct maintained by an adjunct housing, the adjunct housing configured to be removably coupled with the device, the adjunct comprising a self contained sensing system configured to sense at least one of a physiologic property of tissue and a mechanical property of tissue using a sensor, process signals related to said sensed tissue properties using a processor, and transfer information related to at least one of said sensed tissue properties and said processed signals using a communications interface.

41. The surgical assembly of claim 40, wherein said device is a surgical stapler.

42. The surgical assembly of claim 40, wherein said device is a surgical compression anastomosis ring.