IP Library Granted Patent US 11,478,290
Granted Patent B2
US 11,478,290 · App. 16/990,265 · Granted Oct 25, 2022

Method and system for consistent, repeatable, and safe cryospray treatment of airway tissue

Inventors: Wendelin Maners (Hermosa Beach, CA); Ellen Sheets (Boston, MA); Rafael Cordero (Bedford, MA); Marc Davidson (Andover, MA); Wei Li Fan (Boston, MA); David Sherrill (Westford, MA); Brian M. Hanley (Reading, MA); Amy Sarli (Framingham, MA); Stephen Griffin (San Jose, CA); Heather V. Hawkes (Trumbull, CT)
Assignee: CSA Medical, Inc.
A61B18/0218A61B90/98A61B2018/00041A61B2018/00172A61B2018/00541A61B2018/00577A61B2018/00642A61B2018/00714A61B2018/00744A61B2018/00761A61B2018/00791A61B2018/00863A61B2018/00988A61B2018/0212A61B2018/0231
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Quick Facts
Patent No.
US 11,478,290
App. No.
16/990,265
Granted
Oct 25, 2022
Kind
B2
Abstract

A method and system for automated and semi-automated predictable, consistent, safe, effective, and lumen-specific and patient-specific cryospray treatment of airway tissue in which treatment duration is automatically set by the system following entry of patient information and treatment location information into the system by the user, and treatment spray is automatically stopped by the system when the automatically selected treatment duration has been achieved as determined by the system.

Claims (38)

1. A method for treating a condition in an airway of a lung of a patient, comprising:

advancing an energy transfer device to a target region in the airway; and

transferring energy between the energy transfer device and the target region in an amount sufficient to remodel dysfunctional epithelial cells in the target region without either direct or indirect visual confirmation and in an amount configured to elicit a primarily regenerative healing response, such that the condition is improved.

2. The method of claim 1 , wherein the airway comprises the trachea, the bronchus, the bronchiole, or the alveolus, or any combination thereof.

3. The method of claim 1 , wherein the epithelial cells comprise ciliated cells or goblet cells, or both.

4. The method of claim 1 , further comprising inserting a flexible working channel into the lung and wherein advancing the energy transfer device comprises advancing the energy transfer device with or through the working channel.

5. The method of claim 1 , wherein advancing the energy transfer device to the target region comprises navigating through the airway utilizing a 3-D virtual map.

6. The method of claim 1 , wherein advancing the energy transfer device comprises navigating the lung according to a treatment map user interface.

7. The method of claim 1 , wherein the energy comprises ablative energy, thermal energy, or non-thermal energy, or any combination thereof.

8. The method of claim 1 , wherein transferring energy comprises remodeling the dysfunctional epithelial cells.

9. The method of claim 1 , wherein transferring energy comprises preserving an extracellular matrix of the dysfunctional epithelial cells.

10. The method of claim 1 , wherein the amount of the energy transferred, which is sufficient to affect dysfunctional epithelial cells, is calculated.

11. The method of claim 1 , wherein transferring energy is performed on a mucosal layer or epithelial layer of the airway at the target region at a depth of at most 0.5 mm from a surface of the airway.

12. The method of claim 1 , further comprising, during a same procedure or different procedures, re-treating the target region within the airway, treating a different target region within the airway, or treating a different target region within a different airway, or any combination thereof.

13. A method for treating symptoms of COPD in an airway of a lung of a patient, comprising:

advancing an energy transfer device to a target region in the airway; and

transferring energy between the energy transfer device and the target region in an amount sufficient to remodel epithelial cells in the target region without either direct or indirect visual confirmation and substantially without a reparative scarring healing response in the target region, such that one or more of the symptoms are improved.

14. The method of claim 13 , further comprising inserting a flexible working channel into the lung and wherein advancing the energy transfer device comprises advancing the energy transfer device with or through the working channel.

15. The method of claim 13 , wherein the energy comprises ablative energy, thermal energy, or non-thermal energy, or any combination thereof.

16. The method of claim 13 , wherein remodeling the epithelial cells comprises preserving an extracellular matrix of the epithelial cells.

17. The method of claim 13 , wherein the amount of the energy transferred, which is sufficient to remodel epithelial cells, is calculated.

18. The method of claim 13 , wherein the one or more of the symptoms comprise one or more symptoms of chronic bronchitis.

19. A method for reducing mucus production in an airway of a lung of a patient, comprising:

advancing an energy transfer device to a target region in the airway; and

transferring energy between the energy transfer device and the target region in an amount sufficient to remodel epithelial cells in the target region without either direct or indirect visual confirmation and in an amount configured to elicit a primarily regenerative healing response, such that mucus production is reduced.

20. The method of claim 19 , further comprising inserting a flexible working channel into the lung and wherein advancing the energy transfer device comprises advancing the energy transfer device with or through the working channel.

21. The method of claim 19 , wherein the energy comprises ablative energy, thermal energy, or non-thermal energy, or any combination thereof.

22. The method of claim 19 , wherein transferring energy comprises preserving an extracellular matrix of the epithelial cells.

23. The method of claim 19 , wherein the amount of the energy transferred, which is sufficient to reduce epithelial cells, is calculated.

24. The method of claim 19 , wherein the epithelial cells comprise ciliated cells or goblet cells, or both.

25. A method for treating a condition in an airway of a lung of a patient, comprising:

advancing an energy transfer device to a target region in the airway; and

transferring energy between the energy transfer device and the target region in an amount sufficient to remodel epithelial cells in the target region without necessitating either direct or indirect visual confirmation and substantially without a reparative scarring healing response in the target region, such that the condition is improved.

26. The method of claim 25 , wherein the energy comprises ablative energy, thermal energy, or non-ablative energy, or any combination thereof.

27. The method of claim 25 , wherein transferring energy comprises preserving an extracellular matrix of epithelial cells.

28. The method of claim 25 , wherein transferring energy is performed to a predetermined depth of at most 0.5 mm from the surface of the airway from a surface of the airway at the target region within a mucosal layer or an epithelial layer, or both layers.

29. The method of claim 25 , wherein the amount of the energy transferred, which is sufficient to alter epithelial cells, is calculated.

30. The method of claim 25 , wherein the epithelial cells comprise ciliated cells or goblet cells, or both.

Assignments (3)
SECURITY INTEREST Recorded Apr 28, 2023
From: CSA MEDICAL, INC.
To: CHV III, L.P.; SV LIFE SCIENCES FUND V, L.P.; SV LIFE SCIENCES FUND V, STRATEGIC PARTNERS, L.P.; INTERSOUTH PARTNERS VII, L.P.; MATHERS ASSOCIATES; BHCM CSA MEDICAL, LLC; ALFRED M. RANKIN, JR. TRUST; BENMIKE INVESTMENT CO. LLC; CHARLES G. BROWN, INC.; CLAIBORNE R. RANKIN REVOCABLE TRUST U/A/D 6/22/71; BROWN, DAVID P.; INKLEY, E. DALE; COWELL, ENSIGN; EVERGREEN VENTURES LTD; KRONEBERGER, G. BRIAN, JR.; LINCOLN, G. RUSSELL; G. RUSSELL LINCOLN REVOCABLE TRUST DTD 10/31/2007; GUIDE MEDICAL VENTURES, LLC; H&B INVESTMENT PARTNERSHIP; MAHONEY, JAMES J.; DAVIDSON, MARC S.; DYER, MARK V.; MEDTECH INVESTMENTS, LLC; ELLIS, MICHAEL A.; MWK TRUST, MIRIAM WINDER-KELLY TTE; SMITH, NATANIEL T.; HERMANN, TIM VON; SCHWARZ, RICHARD T.; PECK, STEVEN E.; SCHAEFER, STEVEN E.; SYCAMORE FUND 1, LLC; SYMARK LLC; WEGLICKI, TIMOTHY T.; MELITA, TOM; VICTOIRE G. RANKIN TRUST; WILLIAM E. CONWAY UTA DATED 12/12/80 AS AMENDED
Reel/Frame 063474/0974 →
SECURITY INTEREST Recorded Dec 16, 2022
From: CSA MEDICAL, INC.
To: CHV III, L.P.; SV LIFE SCIENCES FUND V, L.P.; SV LIFE SCIENCES FUND V, STRATEGIC PARTNERS, L.P.; INTERSOUTH PARTNERS VII, L.P.; MATHERS ASSOCIATES; DISRUPTIVE INNOVATION FUND, LP; BHCM CSA MEDICAL, LLC; ALFRED M. RANKIN, JR. TRUST; BENMIKE INVESTMENT CO. LLC; CHARLES G. BROWN, INC.; CLAIBORNE R. RANKIN REVOCABLE TRUST U/A/D 6/22/71; BROWN, DAVID P; INKLEY, E. DALE; COWELL, ENSIGN; EVERGREEN VENTURES LTD; KRONEBERGER, G. BRIAN, JR.; LINCOLN, G. RUSSELL; G. RUSSELL LINCOLN REVOCABLE TRUST DTD 10/31/2007; GUIDE MEDICAL VENTURES, LLC; H&B INVESTMENT PARTNERSHIP; MAHONEY, JAMES J, JR.; DAVIDSON, MARC S; DYER, MARK V.; MEDTECH INVESTMENTS, LLC; ELLIS, MICHAEL A; MWK TRUST, MIRIAM WINDER-KELLY TTE; SMITH, NATHANIEL; NATIONAL FINANCIAL SERVICES/ FIDELITY INVESTMENTS CUSTODIAN FBO STEVEN E. SCHAEFER IRA; HERMANN, TIM VON; SCHWARZ, RICHARD T; PECK, STEVEN E.; SCHAEFER, STEVEN E.; SYCAMORE FUND 1, LLC; SYMARK LLC; WEGLICKI, TIMOTHY T.; MELITA, TOM; VICTOIRE G. RANKIN TRUST; WILLIAM E. CONWAY UTA DATED 12/12/80 AS AMENDED
Reel/Frame 062132/0359 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 24, 2020
From: MANERS, WENDELIN; SHEETS, ELLEN; CORDERO, RAFAEL; DAVIDSON, MARC; FAN, WEI LI; SHERRILL, DAVID; HANLEY, BRIAN M.; SARLI, AMY; GRIFFIN, STEPHEN; HAWKES, HEATHER V.
To: CSA MEDICAL, INC.
Reel/Frame 054457/0541 →