Methods and Devices for Minimally-Invasive Delivery of Cell-Containing Flowable Compositions

• US 20100185156A1
• Filed: 06/13/2008
• Published: 07/22/2010
• Est. Priority Date: 06/13/2007
• Status: Abandoned Application

• Current Assignee: Shire Regenerative Medicine Incorporated (Shire plc)
• Original Assignee: Pervasis Therapeutics, Inc. (Shire plc)
• Inventors: Choi, Celina, White, Desmond, Nugent, Helen Marie, Ng, Yin Shan, Bollinger, Stephen August, Kanner, Glenn
• Application Number:
  US12/663,297
• Publication Number:
  US 20100185156A1
• Time in Patent Office: Days
• US Class Current: 604/190
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61M 2005/31598 having multiple telescopically sliding coaxial pistons encompassing volumes for components to be mixed
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2202/097 endothelial cells
• CPC Class Codes: A61M 2205/7545 for solid matter, e.g. microaggregates
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 39/223 Multiway valves
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• CPC Class Codes: A61M 5/3145 Filters incorporated in syringes
• CPC Class Codes: A61M 5/31596 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present invention relates to a device for delivering a flowable composition comprising cells, wherein the flowable composition is in an amount effective to treat an injured or diseased site. The device comprises a delivery device adapted for minimally-invasive delivery of the flowable composition through which the flowable composition can be passed while maintaining the effectiveness and viability of the cells of the flowable composition. The present invention further relates to a method for delivering the flowable composition comprising cells. The method comprises the steps of percutaneously inserting a delivery device adapted for minimally-invasive delivery of the flowable composition through which the flowable composition can be passed while maintaining the effectiveness and viability of the cells of the flowable composition and administering the flowable composition at, adjacent to or in the vicinity of the injured or diseased site.

Claims

1. A device for delivering a flowable composition comprising cells, said device comprising:

a delivery device adapted for minimally-invasive delivery of a flowable composition through which the flowable composition can be passed while maintaining the effectiveness and viability of the cells of the flowable composition;

wherein the flowable composition is in an amount effective to treat an injured or diseased site.

2. The device of claim 1 further comprising a penetration device.

3. The device of claim 2 wherein the penetration device comprises an internal diameter of 18 gauge to 24 gauge.

4. The device of claim 2 wherein the penetration device comprises an external diameter of 18 gauge to 25 gauge.

5. The device of claim 3 or 4 wherein the delivery device further comprises the flowable composition;

wherein the flowable composition comprises cells and a biocompatible matrix material; and

wherein the biocompatible matrix material comprises microcarriers.

6. The device of claim 2 wherein the penetration device comprises an internal diameter of 25 gauge to 27 gauge.

7. The device of claim 2 wherein the penetration device comprises an external diameter of 25 gauge to 31 gauge.

8. The device of claim 6 or 7 wherein the delivery device further comprises the flowable composition;

wherein the flowable composition comprises cells and a biocompatible matrix material; and

wherein the biocompatible matrix material comprises particles.

9. The device of claim 1 further comprising a dispensing container wherein the dispensing container is in fluid communication with the delivery device.

10. The device of claim 1 further comprising a control module to control a rate of passage of the flowable composition from the delivery device.

11. The device of claim 1 further comprising a guidance device to locate an injured or diseased site.

12. The device of claim 1 wherein the delivery device further comprises the flowable composition;

wherein the flowable composition comprises a biocompatible matrix and cells; and

wherein the cells are associated via cell to matrix interactions with the biocompatible matrix.

13. The device of claim 12 wherein the cells are endothelial, endothelial-like or non-endothelial cells.

38. The device of claim 1 wherein the flowable composition further comprises a non-cell-associated agent with biologic, pharmaceutical and/or pharmaceutical activity.

14. A device for storing and rinsing a flowable composition, the device comprising:

a first chamber;

a second chamber in fluid communication with the first chamber;

a plunger comprising a screen positioned between the first chamber and the second chamber, wherein the screen permits passage of fluid and denies passage of the flowable composition from the first chamber to the second chamber.

15. The device of claim 14 wherein the first chamber is adapted to collect the flowable composition and permit excess fluid to flow into the second chamber.

16. The device of claim 14 wherein the plunger further denies passage of fluid from the second chamber to the first chamber.

17. The device of claim 14 wherein the plunger is adapted to move from the second chamber into the first chamber.

18. The device of claim 17 further comprising a flowable composition wherein movement of the plunger from the second chamber into the first chamber moves the flowable composition out of the first chamber.

19. The device of claim 14 further comprising a third chamber in fluid communication with the first chamber, wherein the third chamber comprises a fluid.

20. The device of claim 19 wherein the fluid comprises saline and, optionally, further comprises at least one of Human Serum Albumin and Lactated Ringer'"'"'s Solution.

21. The device of claim 19 wherein the device is adapted to pass the fluid from the third chamber, through the first chamber, through the screen and into the second chamber.

22. The device of claim 19 further comprising a flowable composition wherein movement of the plunger from the first chamber into the second chamber moves at least a portion of the fluid from the second chamber into the first chamber to facilitate movement of the flowable composition out of the first chamber.

23. The device of claim 19 wherein the fluid is adapted to rinse a flowable composition.

24. The device of claim 23 wherein the first chamber comprises at least one cell and wherein the device is adapted to rinse the at least one cell contained within the first chamber with the fluid from the third chamber and to collect the fluid in the second chamber.

39. The device of claim 14 wherein the flowable composition further comprises a non-cell-associated agent with biologic, pharmaceutical and/or pharmaceutical activity.

25. A device for delivering a flowable composition, the device comprising:

a first chamber;

a second chamber in fluid communication with the first chamber;

a plunger comprising a screen positioned between the first chamber and the second chamber, wherein the screen permits passage of fluid and denies passage of the flowable composition between the first chamber and second chamber.

26. The device of claim 25 wherein the plunger is adapted to move from the second chamber into the first chamber.

27. The device of claim 25 or 26 further comprising a penetration device, wherein the penetration device is in fluid communication with the first chamber.

28. The device of claim 27 further comprising a flowable composition wherein movement of the plunger from the second chamber into the first chamber facilitates movement of the flowable composition from the first chamber to the penetration device.

29. The device of claim 25 wherein the first chamber further comprises cells and wherein the device is adapted to rinse the cells contained within the first chamber with a fluid, to retain the cells within the first chamber, and to collect the fluid in the second chamber.

40. The device of claim 25 wherein the flowable composition further comprises a non-cell-associated agent with biologic, pharmaceutical and/or pharmaceutical activity.

30. A method for delivering a flowable composition, said method comprising:

percutaneously or endoluminally inserting a delivery device adapted for minimally-invasive delivery of a flowable composition through which the flowable composition can be passed while maintaining the effectiveness and viability of the flowable composition; and

administering an amount of the flowable composition effective to treat an injured or diseased site at, into, adjacent to or in the vicinity of the injured or diseased site.

31. The method of claim 30 wherein the flowable composition further comprises a biocompatible matrix and cells and wherein the cells are associated via cell to matrix interactions with the biocompatible matrix.

32. The method of claim 30 wherein the injured or diseased site is an extraluminal site of a tubular body part.

33. The method of claim 30 wherein the injured or diseased site is an exterior or interior surface or volume of a solid organ.

34. The method of claim 30 further comprising the step of providing a guidance device to guide the delivery device to, adjacent to or in the vicinity of the injured or diseased site.

35. The method of claim 30 wherein the guidance device comprises ultrasound.

36. The method of claim 30 wherein the guidance device comprises fluoroscopy.

37. The method of claim 31 wherein the cells are endothelial, endothelial-like or non-endothelial cells.

41. The method of claim 30 wherein the flowable composition further comprises a non-cell-associated agent with biologic, pharmaceutical and/or pharmaceutical activity.