Thrombectomy catheter deployment system

• US 20070073233A1
• Filed: 09/28/2005
• Published: 03/29/2007
• Est. Priority Date: 09/28/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Possis Medical, Inc. (Bayer AG)
• Inventors: Bonnette, Michael, Cummings, David, Kneip, Daniel, Thor, Eric, Ball, Douglas, Rogers, Jeffrey, West, David, Hilse, Mark, Teschendorf, John, Scherger, Ernest, Croll, Walter, Karpinski, James, Grant, Chad, Weisel, Stephen, Aasen, Nicole, Abbott, Martyn
• Granted Patent: US 7,935,077 B2
• Time in Patent Office: Days
• US Class Current: 604/151
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 50/10 Furniture specially adapted for surgical or diagnostic appliances or instruments
• CPC Class Codes: A61B 50/13 Trolleys, e.g. carts
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 25/0122 with fluid drive by external fluid in an open fluid circuit
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: A61M 5/36 with means for eliminating or preventing injection or infusion of air into body dialysis systems, blood oxygenators A61M1/14; haemofiltration equipment A61M1/34; automatic tube cut-off A61M39/281

Abstract

A thrombectomy catheter deployment system which greatly simplifies setup procedures and operation of a thrombectomy catheter includes a stand alone drive unit and a disposable pump/catheter assembly which is manually placed into a carriage assembly in the drive unit. The pump/catheter assembly has a plurality of preconnected components including tubular structure and a thrombectomy catheter connected thereto and is transported into or out of the interior of the drive unit for automatic high pressure pump piston head engagement or disengagement with a reciprocating linear actuator and for automatic engagement or disengagement of an effluent waste tube with a roller pump. A barcode reader senses specific operational data pertaining to an individual pump and provides an interface for operation of the reciprocating linear actuator. A bubble trap incorporated for effective debubbling of saline solution is closely coupled to an insert molded pump having an improved valve arrangement. A spiked bag with large tubing is incorporated for bubble-free transfer of saline.

Claims

1. a thrombectomy catheter deployment system:

comprising;

a. a drive unit having a digitally controlled mode; and

,

b. a preconnected pump and thrombectomy catheter assembly, the preconnected pump and thrombectomy catheter assembly being loadable into the drive unit.

2. The thrombectomy catheter deployment system of claim 1, wherein digital control mode information determines the mode of the drive unit.

3. The thrombectomy catheter deployment system of claim 2, wherein the digital control mode information is coordinated with the preconnected pump and thrombectomy catheter assembly.

4. The thrombectomy catheter deployment system of claim 3, wherein the digital control mode information coordinated with the preconnected pump and thrombectomy catheter assembly is carried by the preconnected pump and thrombectomy catheter assembly.

5. The thrombectomy catheter deployment system of claim 4, wherein the digital control mode information coordinated with and carried by the preconnected pump and thrombectomy catheter assembly is communicated from the preconnected pump and thrombectomy catheter assembly to the drive unit, such that the mode is digitally controlled by the preconnected pump and thrombectomy catheter assembly.

6. The thrombectomy catheter deployment system of claim 3, wherein the digital control mode information is in a barcode, and wherein the drive includes a barcode reader, such that the digital control mode information in the barcode determines and controls the mode of the drive unit.

7. The thrombectomy catheter deployment system of claim 3, wherein the digital control mode information is in a radio frequency identification technology code, and wherein the drive includes a radio frequency identification technology code reader, such that the digital control mode information in the radio frequency technology code determines and controls the mode of the drive unit.

8. The thrombectomy catheter deployment system of claim 1, wherein the drive unit includes a capture block and a reciprocating linear actuator, and wherein the preconnected pump and thrombectomy catheter assembly includes a pump piston head, and wherein loading of the preconnected pump and thrombectomy catheter assembly into the capture block results in automatic engagement of the reciprocating linear actuator with the pump piston head.

9. The thrombectomy catheter deployment system of claim 1, wherein the drive unit includes a capture block and an effluent bag support, and wherein the preconnected pump and thrombectomy catheter assembly includes an effluent bag, and wherein loading of the preconnected pump and thrombectomy catheter assembly into the capture block results in automatic positioning of the effluent bag in effluent bag support.

10. The thrombectomy catheter deployment system of claim 1, wherein the drive unit includes a capture block and a roller pump, and wherein the preconnected pump and catheter assembly includes an effluent waste tube engageable by the roller pump, and wherein loading of the preconnected pump and thrombectomy catheter assembly into the capture block results in automatic positioning of the effluent waste tube into the roller pump.

11. The thrombectomy catheter deployment system of claim 1, wherein the pump of the preconnected pump and thrombectomy catheter assembly is an insert molded pump.

12. The thrombectomy catheter deployment system of claim 1, wherein the pump of the preconnected pump and thrombectomy catheter assembly is an insert molded pump with a check valve having a plastic seat and stainless steel check ball.

13. The thrombectomy catheter deployment system of claim 1, wherein the preconnected pump and thrombectomy catheter assembly is disposable.

14. The thrombectomy catheter deployment system of claim 1, wherein the preconnected pump and thrombectomy catheter assembly is one of a plurality of preconnected pump and thrombectomy catheter assemblies.

15. The thrombectomy catheter deployment system of claim 14, wherein each preconnected pump and thrombectomy catheter assembly of the plurality of preconnected pump and thrombectomy catheter assemblies is identified by digital mode control information coordinated with the preconnected pump and thrombectomy catheter assembly.

16. The thrombectomy catheter deployment system of claim 1, wherein the preconnected pump and thrombectomy catheter assembly loaded in the drive unit causes isovolumetric flow during thrombectomy.

17. The thrombectomy catheter deployment system of claim 5, wherein absence of coordinated digital control mode information carried by the preconnected pump and catheter assembly precludes loading of the preconnected pump and thrombectomy catheter assembly in the drive unit.

18. The thrombectomy catheter deployment system of claim 8, wherein the drive unit awaits operator intervention to load a preconnected pump and thrombectomy catheter assembly from the capture block.

19. The thrombectomy catheter deployment system of claim 18, wherein the operator intervention is supplying power to the drive unit.

20. The thrombectomy catheter deployment system of claim 1, wherein the drive unit includes a carriage assembly, a reciprocating linear actuator, a roller pump, a capture block and means for reading encrypted digital control mode information from the preconnected pump and thrombectomy catheter assembly, and wherein the preconnected pump and thrombectomy catheter assembly includes an insert molded pump with a plastic check ball seat and a stainless steel check ball, an effluent waste tube, a bubble trap, a thrombectomy catheter and encrypted digital control mode information, and wherein loading of the preconnected pump and thrombectomy catheter assembly into the capture block results in thrombectomy catheter deployment without operator intervention except spiking a reservoir of fluid.

21. A thrombectomy catheter deployment system comprising:

a. a reusable drive unit having a digitally controlled mode; and

,

b. a plurality of disposable preconnected pump and thrombectomy catheter assemblies, each of the disposable assemblies carrying encrypted digital control instructions, the encrypted digital control instructions enabling automatic loading by the reusable drive unit and, subsequent to deployment, controlling the mode of isovolumetric flow by the resulting deployed thrombectomy catheter.

22. The thrombectomy catheter deployment system of claim 21, wherein the encrypted digital control instructions of each assembly are coordinated with the properties of the each disposable assembly and the reusable drive unit.

23. The thrombectomy catheter deployment system of claim 22, wherein the plurality of disposable preconnected pump and thrombectomy catheter assemblies includes at least one disposable assembly carrying encrypted digital control instructions distinct from instructions of another assembly of the plurality.

24. The thrombectomy catheter deployment system of claim 23, wherein the at least one disposable assembly carrying encrypted digital control instructions distinct from instructions of another assembly represents a difference in manufacturing tolerances.

25. The thrombectomy catheter deployment system of claim 23, wherein the at least one disposable assembly carrying encrypted digital control instructions distinct from instructions of another assembly represents an intended difference dimensions and not a difference in manufacturing tolerances.

26. The thrombectomy catheter deployment system of claim 25, wherein the at least one disposable assembly carrying encrypted digital control instructions distinct from instructions of another assembly and represents an intended difference in dimensions is further includes operator readable indicia to facilitate selection of a disposable assembly enabling a desired distinct mode when deployed.

27. A method of thrombectomy, the method comprising the steps of:

a. providing a thrombectomy catheter deployment system characterized by a drive unit, the drive unit having a digital mode, and a preconnected pump and catheter assembly loadable in the drive unit, the assembly providing digital instruction to the drive unit; and

,

b. loading the preconnected pump and catheter assembly into the drive unit, thereby deploying the thrombectomy catheter.

28. The method of claim 27, wherein the drive unit is reusable and the preconnected pump and catheter assembly is disposable.

29. The method of claim 28, wherein the preconnected pump and catheter assembly includes a pump and the pump is an insert molded pump.

30. The method of claim 28, wherein the preconnected pump and catheter assembly includes a pump and the pump has a plastic check valve seat.

31. A method of deploying a thrombectomy catheter, the method comprising the steps of:

a. providing a thrombectomy catheter deployment system characterized by a drive unit, the drive unit having a digital mode, and a preconnected pump and catheter assembly loadable in the drive unit, the assembly providing digital instruction to the drive unit; and

,

b. loading the preconnected pump and catheter assembly into the drive unit, thereby deploying the thrombectomy catheter.

32. The method of claim 31, wherein the drive unit is reusable and the preconnected pump and catheter assembly is disposable.

33. The method of claim 31, wherein the preconnected pump and catheter assembly includes a pump and the pump is an insert molded pump.

34. A method of performing sequential thrombectomies, the method comprising the steps of:

a. providing a thrombectomy catheter deployment system characterized by a reusable drive unit, the reusable drive unit having a digital mode control, and a plurality of disposable preconnected pump and catheter assemblies, each assembly of the plurality loadable in the drive unit and each assembly of the plurality providing digital instruction to the drive unit;

b. loading a preconnected pump and catheter assembly of the plurality into the drive unit and proving digital instruction thereto, thereby deploying a thrombectomy catheter for use in a first thrombectomy of the sequential thrombectomies;

c. unloading the loaded preconnected pump and catheter assembly; and

,

d. loading another preconnected pump and catheter assembly of the plurality into the drive unit, thereby deploying a thrombectomy catheter for use in another thrombectomy of the sequential thrombectomies.

35. The method of claim 34, wherein the preconnected pump and catheter assembly includes a pump and the pump is an insert molded pump.

36. The method of claim 34, further comprising the step of:

a. reprogramming the drive unit to coordinate with the another preconnected pump and catheter assembly.

37. A drive unit for thrombectomy comprising:

a. transporting components selected from the group consisting of;

wheels, brakes, handles, and combinations thereof;

b. a frame having a lower and an upper region, the frame carried at the lower region by the transporting components and having at least one support devices thereon and defining an interior and an exterior of the drive unit;

c. paired centrally located automatically opening doors carried on the frame;

d. a carriage assembly associated with the paired doors and accommodating inwardly and outwardly movement to and from the interior of the drive unit;

e. means on the carriage assembly for accommodating a manually placed preconnected pump and catheter assembly, such that the preconnected pump and carriage assembly is transported into or out of the interior of the drive unit for automatic engagement with a reciprocating linear actuator located within the interior of the drive unit;

f. a user interface is incorporated at the upper region of the frame;

g. a roller pump assembly carried by the frame, such that an effluent waste tube of a preconnected pump and catheter assembly may be automatically engaged by the roller pump assembly when the reciprocating linear actuator automatically engages the preconnected pump and catheter assembly; and

,

h. a programmable computer control, carried on the frame, wherein the reciprocating linear actuator and roller pump assembly together are digitally controlled to provide a mode and isovolumetric flow coordinated with the preconnected pump and catheter assembly.

38. A preconnected pump and catheter assembly for autoloading in a drive unit comprising:

a. a pump for engagement by a linear actuator;

b. a thrombectomy catheter in communication with the pump, the thrombectomy catheter having a distal and proximal end with high pressure fluid from the pump passing distally and lower pressure effluent passing proximally through the catheter;

c. a bubble trap in communication with the pump;

d. a connection manifold assembly adjacent the bubble trap;

e. an effluent waste tube for engagement by a roller pump assembly;

f. an effluent collection bag receiving effluent from the effluent waste tube;

g. a saline supply tube supplying the pump;

h. a bag spike for connecting the saline supply tube to a reservoir of fluid;

i. a coaxial high pressure saline supply tube and effluent return tube connected to the proximal end of the thrombectomy catheter; and

,

j. digital information for controlling a linear actuator for the pump and a roller pump assembly for the effluent waste tube, in combination, such that an isovolumetric flow at a digitally controlled mode is available for thrombectomy.

39. A method of making a pump for use with a linear actuator to supply a thrombectomy catheter, the method comprising the steps of:

a. providing a steel tube; and

,

b. molding a continuous plastic about the steel tube to encompass the steel tube and thereby form a plastic lined cylinder of the pump.

40. The method of claim 39, further comprising the step of:

a. molding a plastic check valve seat within the steel tubing.

41. The method of claim 39, further comprising the step of:

a. molding a data plate exterior to the cylinder to carry digital information concerning operational parameters of the pump.

42. The method of claim 39, further comprising the steps of:

a. providing a piston;

b. partially inserting the piston in the cylinder; and

,

c. providing a flexible boot connecting the piston and cylinder.

43. The method of claim 39, wherein the steel is stainless steel.

44. The method of claim 39, wherein the plastic is a glass-filled nylon.

45. The method of claim 44, wherein the glass-filled nylon is Zytel®

.

46. The method of claim 40, further comprising the step of:

a. placing a check ball adjacent the plastic seat.

47. The method of claim 46, wherein the check ball is stainless steel.

48. The method of claim 47, wherein the check ball is captured adjacent the plastic seat, such that the check ball blocks flow on a pressurization strokes of the pump and allows fluid passage on intake strokes of the pump.

49. The method of claim 48, wherein the discharge outlet of the thrombectomy pump is situated adjacent the check valve seat with the stainless steel check ball captured therebetween.

50. The method of claim 39, wherein the piston is sealed to the cylinder by a UHMWPE or HDPE seal.