Rigidity-imparting suction system and method

Abstract

Methods and apparatus that can be used to provide access to and support for one or more cardiovascular devices, including suction devices, as well as, in particular, rigidity-granting catheters and associated components. Specifically, this specification describes methods and apparatus for removing agglutinous material from a blood vessel using a rigidity-granting suction sheath catheter adapted for use with the vascular system of a subject.

Claims

1. A rigidity-enhancing suction sheath catheter device, An elongated body including a lumen extending through it, further comprising a rigidity-imparting layer and a bladder layer configured to cause the elongated body to transition between a flexible state and a rigid state by the application of pressure, A device comprising a hemostatic valve region extending proximal to the elongated flexible body, the hemostatic valve region including a housing having a central diameter continuous with the lumen, an annular sealing material within the central diameter, and at least one actuator movably coupled to the housing and configured to open and close the annular sealing material or to seal around a device positioned within the central diameter.

2. Furthermore, the apparatus according to claim 1, wherein at least one actuator is sized and shaped so as to be used by a user with one hand.

3. The apparatus according to claim 1 or 2, further comprising a pressure inlet coupled to the housing configured to receive positive or negative pressure for transitioning the rigidity-imparting layer between the flexible state and the rigid state.

4. The apparatus according to any one of claims 1 to 3, further comprising a mating connector located proximal to the hemostatic valve region and configured to lock-engage with a mating fixture.

5. The apparatus according to any one of claims 1 to 4, further comprising an inwardly wound coil layer adjacent to the rigidity-imparting layer, configured to support the rigidity-imparting layer in the rigid state.

6. The apparatus according to claim 2, wherein the at least one actuator includes a lever.

7. The apparatus according to any one of claims 1 to 6, wherein the hemostatic valve region includes two actuators.

8. The apparatus according to any one of claims 1 to 7, wherein the hemostatic valve region includes a bladder adapter configured to connect a pressure source to the bladder layer in fluid communication in order to control the rigidification of the elongated flexible body.

9. The apparatus according to any one of claims 1 to 8, wherein the surface of the lumen includes a hydrophilic coating.

10. The apparatus according to any one of claims 1 to 9, wherein the outer surface of the elongated flexible body includes a hydrophilic coating.

11. The apparatus according to any one of claims 1 to 10, further comprising a non-traumatic tip.

12. The apparatus according to any one of claims 1 to 11, wherein the elongated flexible body is configured to transition from the flexible state to the rigid state when positive pressure is applied.

13. The apparatus according to any one of claims 1 to 11, wherein the elongated flexible body is configured to transition from the flexible state to the rigid state when negative pressure is applied.

14. The apparatus according to claim 1, further comprising an occlusion configured to pass through the lumen of the elongated body and exit from the distal end of the elongated body, wherein the occlusion has a guidewire lumen extending through the occlusion.

15. A rigidity-enhancing aspiration sheath catheter, An elongated flexible body comprising a plurality of layers including a rigidity-imparting layer and a bladder layer configured to cause the rigidity-imparting layer to transition between a flexible state and a rigid state, and a lumen extending through the elongated flexible body, A hemostatic valve region extending proximal to the elongated flexible body, having a central diameter continuous with the lumen, and including an annular sealing material within the central diameter, and a housing including at least one actuator movably coupled to the housing and configured to open and close the annular sealing material, or to seal around a device positioned within the central diameter, and having a size and shape suitable for use with one hand of the user; A first pressure inlet is configured to be coupled to a pressure source for rigidifying the aforementioned device, A rigidity-enhancing suction sheath catheter comprising a mating connector located proximal to the hemostatic valve region and configured to lock-engage with a mating fixture of a vacuum line to apply suction into the lumen.

16. A system for aspirating clots, An elongated flexible body comprising a plurality of layers including a rigidity-imparting layer and a bladder layer configured to cause the rigidity-imparting layer to transition between a flexible state and a rigid state, and a lumen extending through the elongated flexible body. A hemostatic valve region at the proximal end of the elongated flexible body, having a central diameter continuous with the lumen, and including a first annular sealing material within the central diameter continuous with the lumen, a housing containing the annular sealing material within the central diameter, and a hemostatic valve region including at least one actuator movably coupled to the housing and configured to open and close the annular sealing material, or to seal around a device positioned within the central diameter, and having a size and shape that can be used with one hand by the user, and Including a mating connector located at the proximal end of the hemostatic valve region, A rigidity-enhancing suction sheath catheter, Includes a vacuum line, The aforementioned vacuum line is A mating fixture located at the distal end of a vacuum line, configured to lock-engage with the aforementioned mating connector, A system comprising a vacuum activation valve, which includes a handle and is configured to open or close the vacuum line, is connected in series with the fitting fixture, and is further configured such that the proximal end of the vacuum line is coupled to a vacuum pump and a blood collection chamber.

17. The system according to claim 16, further comprising a suction catheter configured to be inserted into the lumen of the rigid-imparting suction sheath catheter through the central bore, wherein the suction catheter includes a second mating connector, and the mating fixture at the distal end of the vacuum line is configured to lock-engage with the second mating connector or the first mating connector.

18. The system according to claim 17, wherein the suction catheter includes a suction lumen extending through it and a suction catheter hemostatic valve region at its proximal end.

19. The system according to claim 16, further comprising a clump-capturing chamber connected in series with a vacuum activation valve, and a visualization chamber mounted above an outlet port, wherein the outlet port is connected to the proximal end region of the vacuum line.

20. The system according to claim 19, wherein the aggregate capture chamber includes a removable tray within the visualization chamber.

21. The system according to claim 20, wherein the removable tray is sized to conform to the inner circumference of the agglutination container.

22. The system according to claim 19, wherein the aggregate capture chamber includes a transparent lid.

23. The system according to claim 22, wherein the transparent lid includes one or more tabs.

24. The system according to claim 16, wherein the plurality of layers include an inner coil layer configured to withstand the application of suction through the lumen.

25. The system according to claim 16, wherein the at least one actuator includes a lever.

26. The system according to claim 16, wherein the hemostatic valve region includes a bladder adapter configured to enable communication between a pressure source and the bladder layer in order to control the rigidification of the elongated flexible body.

27. The system according to claim 16, wherein the surface of the lumen includes a hydrophilic coating.

28. The system according to claim 16, wherein the outer surface of the elongated flexible body includes a hydrophilic coating.

29. The system according to claim 16, wherein the elongated flexible body is configured to transition from the flexible state to the rigid state when positive pressure is applied.

30. The system according to claim 16, wherein the elongated flexible body is configured to transition from the flexible state to the rigid state when negative pressure is applied.

31. The system according to claim 16, further comprising an occlusion configured to pass through the lumen of the elongated body and exit from the distal end of the elongated body, wherein the occlusion has a guidewire lumen extending through the guidewire lumen.

32. A system for aspirating clots, An elongated flexible body comprising a plurality of layers including a rigidity-imparting layer and a bladder layer configured to cause the rigidity-imparting layer to transition between a flexible state and a rigid state, and a lumen extending through the elongated flexible body, and A housing comprising a first annular sealant within the central diameter, located at the proximal end of the elongated flexible body and having a central diameter continuous with the lumen of the elongated flexible body, and configured to seal around a device disposed within the central diameter; and a hemostatic valve region comprising a first actuator, movably coupled to the housing and configured to open and close the annular sealant, having a size and shape suitable for use with one hand by the user, and a first mating connector, A rigidity-enhancing suction sheath catheter, A suction catheter configured to be inserted into the lumen of the rigidity-imparting suction sheath catheter through the central diameter, An elongated suction body including a suction tube lumen extending through it, and, A housing located at the proximal end of the suction catheter and having a suction hemostatic valve central bore continuous with the suction lumen; an annular sealing material located within the suction hemostatic valve central bore configured to seal around a device positioned within the central bore; at least one second actuator, movably coupled to the elongated suction body and configured to open and close the annular sealing material, having a size and shape suitable for use with one hand by the user; and a hemostatic valve region including a second mating connector. A suction catheter and Includes a vacuum line, The aforementioned vacuum line is A mating fixture located at the distal end of a vacuum line, configured to lock-engage with the first mating connector or the second mating connector, A hand-triggered vacuum start valve, which includes a handle and is configured to open or close the vacuum line, and is connected in series with the fitting fixture, Includes a clump-catching chamber, which includes a visualization chamber connected in series with a hand-triggered vacuum activation valve and mounted above the outlet port, the outlet port of which is connected to the proximal end region of the vacuum line, The proximal end of the vacuum line is further configured to be connected to a vacuum pump and a blood collection chamber. system.

33. A method for removing agglomerated material, A step of advancing a rigid-imparting suction sheath catheter within a blood vessel, such that the distal end of the rigid-imparting suction sheath catheter is near the agglutinous material within the blood vessel, while the rigid-imparting suction sheath catheter is in a flexible state, wherein the proximal end of the rigid-imparting suction sheath catheter includes a hemostatic valve portion. The steps include transitioning the rigidity-improving suction sheath catheter from the flexible state to a more rigid state, A method comprising the step of removing the agglomerated material by aspirating it through the rigidity-imparting aspiration sheath catheter in a more rigid state than described above.

34. The steps include inserting the suction catheter through the rigidity-granting suction sheath catheter, When the rigidity-imparting suction sheath catheter is in a more rigid state than described above, the steps include extending the suction catheter distally from the rigidity-imparting suction sheath catheter so that it approaches the aggregated material, The step of aspirating through the aforementioned aspiration catheter and The method according to claim 33, further comprising:

35. The method according to claim 33, wherein the step of transitioning the rigidity-imparting suction sheath catheter from the flexible state to the more rigid state includes the step of applying pressure to one or more layers of the rigidity-imparting suction sheath catheter.

36. The method according to claim 33, further comprising the step of applying suction through the rigid-imparting suction sheath while suction is being applied through the suction catheter.

37. The method according to claim 33, further comprising the step of observing the lumpy material aspirated into the window of a lumpy capture chamber connected in series with the rigidity-imparting suction sheath catheter.

38. The method according to claim 33, further comprising the step of connecting a vacuum line to the proximal end of the rigidity-imparting suction sheath catheter.

39. The method according to claim 33, wherein the step of aspirating through the rigidity-imparting suction sheath catheter includes the step of activating a hand-triggered activation valve in series with a vacuum line coupled to the rigidity-imparting suction sheath catheter.

40. The method according to claim 34, wherein the step of extending the suction catheter distally from the rigidity-granting suction sheath catheter includes the step of advancing the suction catheter distally without the use of a guidewire.

41. The method according to claim 33, wherein the step of extending the suction catheter distally from the rigidity-imparting suction sheath catheter includes the step of advancing the suction catheter, and includes the step of steering the distal end of the suction catheter when the rigidity-imparting suction sheath catheter is in the more rigid state.

42. The method according to claim 33, further comprising the step of converting the rigidity-imparting suction sheath catheter to the flexible state, moving the rigidity-imparting suction sheath catheter within the blood vessel, and repositioning the rigidity-imparting suction sheath catheter within the blood vessel by rigidifying the rigidity-imparting suction sheath catheter.

43. The method according to claim 42, wherein the step of moving the rigidity-imparting suction sheath catheter includes the step of moving the suction sheath catheter within the blood vessel while there is an obstruction in the lumen of the rigidity-imparting suction sheath catheter.

44. The method according to claim 33, wherein the step of advancing the rigidity-imparting suction sheath catheter to the treatment site includes the step of advancing the distal end of the rigidity-imparting catheter to the patient's pulmonary artery.

45. A method for removing agglomerated material, Steps include advancing the guidewire through the blood vessel, The steps include advancing the rigid-enhancing suction sheath catheter via the guidewire so that its distal end is near the treatment site within the blood vessel, The steps include applying or removing pressure within the wall of the rigidity-improving suction sheath catheter to transition the rigidity-improving suction sheath catheter from a flexible state to a more rigid state, A method comprising the step of applying suction through the rigid-imparting suction sheath catheter to remove a clot from the blood vessel, wherein the rigid-imparting sheath catheter is held in a fixed position within the blood vessel while suction is being applied.

46. A method for removing agglomerated material, Steps include advancing the guidewire through the blood vessel, The steps include advancing the rigid-enhancing suction sheath catheter via the guidewire so that its distal end is near the treatment site within the blood vessel, The steps include: applying or removing pressure within the wall of the rigidity-improving suction sheath catheter to transition the rigidity-improving suction sheath catheter from a flexible state to a more rigid state; When the rigidity-enhancing suction sheath catheter is in a more rigid state than described above, the step of extending the suction catheter distally from the rigidity-enhancing suction sheath catheter through the rigidity-enhancing suction sheath catheter, A method comprising the step of removing a clot of material from a blood vessel by aspirating through the suction catheter.

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