TISSUE SAMPLING DEVICES, SYSTEMS AND METHODS

• US 20100312141A1
• Filed: 05/10/2010
• Published: 12/09/2010
• Est. Priority Date: 05/08/2009
• Status: Active Grant

• Current Assignee: Broncus Medical Incorporated
• Original Assignee: Broncus Technologies, Inc
• Inventors: GWERDER, Eric J., WEISS, Aaron M., SCHWARDT, Jeffrey, ROSCHAK, Edmund J., KEAST, Thomas M.
• Granted Patent: US 8,517,955 B2
• Time in Patent Office: Days
• US Class Current: 600/567
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/2676 Bronchoscopes
• CPC Class Codes: A61B 10/025 for taking bone, bone marrow or cartilage samples
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 10/06 Biopsy forceps , e.g. with cup-shaped jaws
• CPC Class Codes: A61B 18/042 using additional gas becoming plasma
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2010/0216 Sampling brushes
• CPC Class Codes: A61B 2010/0258 Marrow samples
• CPC Class Codes: A61B 2010/045 Needles pointed biopsy devices with vacuum aspiration A61B10/0283
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00595 Cauterization
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/141 Snare
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61B 2090/0811 : for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2090/3987 : Applicators for implanting markers
• CPC Class Codes: A61B 5/01 : Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61M 1/81 : Piston pumps, e.g. syringes
• CPC Class Codes: A61M 1/84 : Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 25/0102 : Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61N 2005/1024 : Seeds
• CPC Class Codes: A61N 5/1007 : Arrangements or means for the introduction of sources into the body

Abstract

Methods, devices, and systems are described herein that allow for improved sampling of tissue from remote sites in the body. A tissue sampling device comprises a handle allowing single hand operation. In one variation the tissue sampling device includes a blood vessel scanning means and tissue coring means to excise a histology sample from a target site free of blood vessels. The sampling device also includes an adjustable stop to control the depth of a needle penetration. The sampling device may be used through a working channel of a bronchoscope.

Claims

1. A tissue sampling device, configured to have multiple set penetration depths, the device comprising:

a sheath being flexible to advance through tortuous anatomy;

a shaft extending in the sheath, where the shaft and sheath are moveable relative to each other;

a coring tip located at a distal end of the shaft, the coring tip having a tissue penetrating distal end and a cavity to excise a tissue sample;

a handle assembly comprising a sheath hub and a coring hub moveably coupled thereto, the sheath hub located on the sheath and the coring hub located on the shaft, where the sheath hub and coring hub each include a grip surface located on the respective hubs to allow for a single handed movement of the coring hub relative to the sheath hub for moving the shaft relative to the sheath, where a length of the shaft and coring hub relative to a length of the sheath and the sheath hub is selected such that when the sheath hub is spaced a maximum distance from the coring hub, the coring tip is located within the sheath and when the sheath hub is spaced a minimum distance from the coring hub, the coring tip advances from the sheath; and

the coring hub further comprising at least a plurality of recesses each configured to removably nest a stop member, the plurality of recesses being located along a length of the coring hub, such that when the stop member is in one of the recesses, the stop member limits an advancement distance that the coring tip advances from the sheath.

2. The tissue sampling device of claim 1, further comprising at least one distance indicator associated with at least one recess, where the indicator provides visual confirmation of the penetration depth of the device.

3. The tissue sampling device of claim 1, where the sheath includes a reinforcing coil in at least a portion of the sheath.

4. The tissue sampling device of claim 1, where the shaft comprises a coil extending along at least a portion of the shaft.

5. The tissue sampling device of claim 1, further comprising an ultrasound catheter extending through a lumen of the shaft.

6. The tissue sampling device of claim 5, where the ultrasound catheter is configured to transmit and receive an ultrasound signal in a direction parallel to an axis of a distal portion of the ultrasound catheter.

7. The tissue sampling device of claim 6 wherein the ultrasound catheter is a Doppler catheter.

8. The tissue sampling device of claim 6 wherein the ultrasound catheter is an EBUS catheter.

9. The tissue sampling device of claim 1, further comprising a fitting on a proximal end of the coring hub, where the fitting is adapted to form a fluid seal with a syringe.

42. The tissue sampling device of claim 1, where the coring device comprises a lumen that extends from the coring tip through a rear surface of the coring hub.

43. The tissue sampling device of claim 1, where the coring tip comprises a cannula having a sharpened distal end.

44. The tissue sampling device claim 1 wherein the sheath comprises a side port for receiving tissue to excised with said coring tip and shaft.

10. A tissue sampling system, configured to have at least one set penetration depth, the device comprising:

a sheath being flexible to navigate tortuous anatomy;

a shaft extending in the sheath, where the shaft and sheath are moveable relative to each other, where the shaft has a sufficient flexibility to navigate tortuous anatomy;

a coring tip located at a distal end of the shaft, the coring tip having a sharp tip to excise a tissue sample and a cavity to temporarily retain the tissue sample;

a device handle comprising a sheath handle and a shaft handle moveably coupled thereto, the sheath handle affixed to a proximal end of the sheath and the shaft handle affixed to a proximal end of the shaft, where the sheath handle and shaft handle each include a grip surface situated to allow for single handed movement of the shaft handle relative to the sheath handle to move the shaft relative to the sheath, where when the sheath handle is spaced a maximum distance from the coring hub, the coring tip is located within the sheath and when the sheath handle is spaced a minimum distance from the shaft handle, the coring tip advances from the sheath to define the at least one penetration depth; and

an Ultrasound catheter having an Ultrasound sensor located at a distal end of a catheter shaft, the Ultrasound catheter slidably located in the shaft.

11. The tissue sampling system of claim 10, where the coring handle comprises at least a plurality of recesses each configured to removably nest a stop member, the plurality of recesses being located along a length of the coring hub, such that when the stop member is in one of the recesses, the stop member limits an advancement distance that the coring tip advances from the sheath.

12. The tissue sampling system of claim 11, further comprising at least one distance indicator associated with at least one recess, where the indicator provides visual confirmation of the penetration depth of the device.

13. The tissue sampling system of claim 10, where the sheath includes a reinforcing coil in at least a portion of the sheath.

14. The tissue sampling system of claim 10, where the shaft comprises a coil extending along at least a portion of the shaft.

15. The tissue sampling system of claim 10, where the Ultrasound sensor of the Ultrasound catheter is configured to transmit and receive an Ultrasound signal in a direction parallel to an axis of a distal portion of the Ultrasound catheter.

16. The tissue sampling system of claim 10, further comprising a fitting on a proximal end of the coring hub, where the fitting is adapted to form a fluid seal with a syringe.

17. The tissue sampling system of claim 10, where the coring device comprises a lumen that extends from the coring tip through a rear surface of the coring hub.

18. The tissue sampling system of claim 10, where the coring tip comprises a cannula having a sharpened distal end.

38. The system of claim 10, further comprising a stylet, said stylet comprising a stylet tip, and said stylet adapted to be locked in a position within said shaft such that the stylet tip is in the vicinity of said sharp tip and proximal to the sharp tip.

39. The system of claim 38 wherein said stylet comprises a polymer tube, and a metal shaft wherein said polymer tube is concentrically disposed about the exterior of the metal shaft.

40. The system of claim 10 wherein the sheath comprises a sheath flat and the shaft comprises a shaft collar such that the shaft collar contacts the sheath flat when the shaft is advanced relative to the sheath beyond a predetermined distance.

41. The system of claim 38 wherein said stylet further comprises a stylet collar and said shaft comprises shaft flat such that the stylet collar contacts the shaft flat when the stylet is advanced relative to the shaft beyond a predetermined distance.

19. A method of obtaining a tissue sample from a lung, the method comprising:

advancing a tissue sampling catheter into an airway of the lung, where the tissue sampling catheter comprises a sheath having a shaft extending therethrough, the shaft having a coring tip comprising a tissue penetrating distal end to penetrate tissue and a cavity to excise the tissue sample, where the coring tip is retracted within the sheath when the tissue sampling catheter enters the airway of the lung;

positioning a distal end of the sheath adjacent to a site in the airway;

advancing an Ultrasound catheter through the tissue sampling catheter such that a tip of the Ultrasound catheter exits through the coring tip;

scanning the site for determining a presence or absence of a blood vessel using the Ultrasound catheter;

retracting the Ultrasound catheter from the coring tip; and

advancing the coring tip from the sheath thereby penetrating tissue with the coring tip such that the sample of tissue is located within the cavity of the coring tip.

20. The method of claim 19, where advancing the coring tip from the sheath comprises advancing the coring tip from the sheath by a pre-determined distance.

21. The method of claim 19, where advancing the coring tip from the sheath comprises actuating a handle to drive the coring tip into tissue, where the handle comprises a sheath hub and a coring hub moveably coupled thereto, where the sheath hub and coring hub each include a digit grip surface located on the respective hubs to allow for single handed movement of the shaft hub relative to the coring hub by the pre-determined distance for moving the shaft relative to the sheath.

22. The method of claim 19, adjusting a removable stop located on the coring hub, where the removable stop limits the pre-determined distance that the coring tip advances from the sheath.

23. The method of claim 19, further comprising advancing a scope into the body and advancing the tissue sampling device through a working channel of the scope.

24. The method of claim 19, further comprising coupling a vacuum source to the coring device.

25. The method of claim 24, further comprising creating a vacuum in the vacuum source and fluidly isolating the vacuum source from the coring device using a valve.

26. The method of claim 24, further comprising aspirating the coring device using the vacuum source.

27. The method of claim 19, further comprising positioning a adjustable stop on a coring handle, where the coring handle is affixed to a shaft having the coring tip at a distal end thereof, where positioning the adjustable stop sets a penetration depth of the coring tip.

36. The method of claim 19, wherein said sample is located behind an airway wall, said method further comprising, subsequent to retracting said Ultrasound catheter, advancing a stylet tip through said tissue sampling catheter until the stylet tip is positioned at said coring tip, and thrusting said coring tip together with said stylet tip through said airway wall thereby creating an opening in said airway wall.

37. The method of claim 36, further comprising removing said stylet prior to the step of advancing the coring tip.

28. A method of obtaining a tissue sample from an airway in a lung by pre-selecting a maximum depth of the sample in tissue, the method comprising:

advancing a tissue sampling catheter into an airway of the lung, where the tissue sampling catheter comprises a sheath having a shaft extending therethrough, the shaft having a coring tip comprising a tissue penetrating distal end to penetrate tissue and a cavity to excise the tissue sample, where the coring tip is retracted within the sheath when the tissue sampling catheter enters the airway of the lung;

positioning a distal end of the sheath adjacent to a site in the airway;

setting an adjustable stop on a handle of the tissue sampling catheter, where a location of the adjustable stop on the handle determines a pre-determined distance that the coring tip extends from the sheath, where the pre-determined distance corresponds to the maximum depth;

actuating the handle to extend the coring tip from the sheath by the pre-determined distance thereby penetrating tissue with the coring tip such that the sample of tissue is located within the cavity of the coring tip.

29. The method of claim 28, where penetrating tissue with the coring tip comprises actuating the handle to drive the coring tip to penetrate tissue, where the handle comprises a sheath hub and a coring hub moveably coupled thereto, where the sheath hub and coring hub each include a digit grip surface located on the respective hubs to allow for single handed movement of the coring hub relative to the sheath hub by the pre-determined distance for moving the sheath relative to the shaft.

30. The method of claim 28, further comprising advancing a scope into the body and advancing the tissue sampling catheter through a working channel of the scope.

31. The method of claim 28, further comprising coupling a vacuum source to the tissue sampling catheter.

32. The method of claim 31, further comprising creating a vacuum in the vacuum source and fluidly isolating the vacuum source from the tissue sampling catheter using a valve.

33. The method of claim 31, further comprising aspirating the tissue sampling catheter using the vacuum source.

34. The method of claim 28, wherein said shaft further comprises a contiguous lumen to hold multiple samples of tissue, and further comprising obtaining multiple samples of tissue from multiple penetration sites.

35. The method of claim 28, further comprising inserting an accessory device through a contiguous lumen in said shaft wherein said accessory device is selected from the group consisting of a delivery catheter, an rf ablation probe, ultrasound probe, fiber scopes, guidewires, forceps, a temperature measuring device, an optical fiber, an aspiration catheter, cautery probes, argon plasma probes, cryotherapy catheters, cytology brushes, snares, wires for placing electrical leads, stylets, trocars, seed delivery catheters, and fiducial delivery catheters.

45. The method of claim 28, further comprising inserting an accessory device through a contiguous lumen in said shaft wherein said accessory device is selected from the group consisting of a brachytherapy seed delivery catheter comprising a seed, and a fiducial delivery catheter comprising a fiducial.

46. The method of claim 45, wherein the accessory device is a fiducial delivery catheter, and said method further comprises delivering the fiducial.