Thrombectomy catheter deployment system

• US 7,935,077 B2
• Filed: 09/28/2005
• Issued: 05/03/2011
• Est. Priority Date: 09/28/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Hilse, Mark Alfred, Kneip, Daniel Joseph, Weisel, Stephen Earl, Scherger, Ernest Ralph III, Grant, Chad Nicholas, Ball, Douglas James, Teschendorf, John Lloyd, Aasen, Nicole Jaye, Abbott, Martyn Stuart, Rogers, Jeffrey William, Thor, Eric Joel, Karpinski, James Fredrick, Cummings, David Charles, Croll, Walter Charles, Bonnette, Michael John, West, David Woodruff
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Eisenberg; Rebecca E
• Application Number:
  US11/237,558
• Publication Number:
  US 20070073233A1
• Time in Patent Office: 2,043 Days
• Field of Search: 604/14, 604/19, 604 65- 67, 604319-320
• US Class Current: 604/67
• 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;

a carriage assembly having capture tabs; and

a pump connector having a dome-shaped receptor cavity and a retractable pin; and

,

b. a thrombectomy catheter assembly comprising a combination of a pump and catheter, said combination being rigidly coupled to each other such that the combination is loaded into the drive unit as a single unitary item;

said pump having a base with an upper portion and a lower portion, the upper portion also comprising an annular surface that mates with the capture tabs of the carriage assembly;

said pump further comprising a piston head having a generally hemispherical top portion with at least two arcuate ribs forming a space therebetween, said top portion adapted to mate with said dome-shaped receptor cavity;

wherein said pin is capable of deploying into the space.

2. The thrombectomy catheter deployment system of claim 1, wherein operating information from the thrombectomy catheter assembly determines the digitally controlled mode of the drive unit.

3. The thrombectomy catheter deployment system of claim 2, wherein the operating information is in a barcode, and wherein the drive unit includes a barcode reader, such that the operating information in the barcode determines and controls the digitally controlled mode of the drive unit.

4. The thrombectomy catheter deployment system of claim 2, wherein the operating information is in a radio frequency identification technology code, and wherein the drive unit includes a radio frequency identification technology code reader, such that the operating information in the radio frequency technology code determines and controls the digitally controlled mode of the drive unit.

5. The thrombectomy catheter deployment system of claim 2, wherein the thrombectomy catheter assembly cannot be operatively loaded in the drive unit without the information carried by the thrombectomy catheter assembly.

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

7. The thrombectomy catheter deployment system of claim 6, wherein the drive unit awaits operator intervention to load the thrombectomy catheter assembly from the capture block.

8. The thrombectomy catheter deployment system of claim 7, wherein the operator intervention is supplying power to the drive unit.

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 thrombectomy catheter assembly includes an effluent bag, and wherein loading of the thrombectomy catheter assembly into the capture block results in automatic positioning of the effluent bag in the 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 thrombectomy catheter assembly includes an effluent waste tube engageable by the roller pump, and wherein loading of the 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 thrombectomy catheter assembly is an insert molded pump.

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

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

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

16. A thrombectomy catheter deployment system comprising:

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

a carriage assembly having capture tabs; and

a pump connector having a dome-shaped receptor cavity and a retractable pin; and

,

b. a plurality of disposable catheter assemblies, each of the disposable catheter assemblies comprising at least a pump and a thrombectomy catheter that are preconnected and carrying encrypted digital control instructions, said pump having a base with an upper portion and a lower portion, the upper portion also comprising an annular surface that mates with the capture tabs of the carriage assembly;

said pump further comprising a piston head having a generally hemispherical top portion with at least two arcuate ribs forming a space therebetween, said top portion adapted to mate with said dome-shaped receptor cavity;

wherein said pin is capable of deploying into the space, 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.

17. The thrombectomy catheter deployment system of claim 16, wherein the encrypted digital control instructions of each disposable catheter assembly include properties of each disposable assembly and are coordinated with the reusable drive unit.

18. The thrombectomy catheter deployment system of claim 17, wherein the plurality of disposable catheter assemblies includes at least one disposable catheter assembly carrying encrypted digital control instructions distinct from the encrypted digital control instructions of another disposable catheter assembly of the plurality.

19. The thrombectomy catheter deployment system of claim 18, wherein the at least one disposable catheter assembly carrying encrypted digital control instructions distinct from the encrypted digital control instructions of another disposable catheter assembly represents a difference in manufacturing tolerances.

20. The thrombectomy catheter deployment system of claim 18, wherein the at least one disposable catheter assembly carrying encrypted digital control instructions distinct from the encrypted digital control instructions of another disposable catheter assembly represents an intended difference in dimensions and not a difference in manufacturing tolerances.

21. The thrombectomy catheter deployment system of claim 20, wherein the at least one disposable catheter assembly carrying encrypted digital control instructions distinct from the encrypted digital control instructions of another disposable catheter assembly representing an intended difference in dimensions further includes operator readable indicia to facilitate selection of the disposable catheter assembly enabling a desired distinct mode on the drive unit when the thrombectomy catheter is deployed.