Aspiration monitoring system and method

• US 10,226,263 B2
• Filed: 12/22/2016
• Issued: 03/12/2019
• Est. Priority Date: 12/23/2015
• Status: Active Grant

• Current Assignee: Incuvate, LLC
• Original Assignee: Incuvate, LLC
• Inventors: Look, David M., Culbert, Bradley S.
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US15/388,716
• Publication Number:
  US 20170181760A1
• Time in Patent Office: 810 Days
• 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 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/81 Piston pumps, e.g. syringes
• CPC Class Codes: A61M 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2210/12 Blood circulatory system

Abstract

A system for removal of blood or thrombus includes an aspiration catheter having an elongate shaft including an aspiration lumen having proximal end configured to couple to a vacuum source, and a distal end having an orifice, an elongate member configured for placement through the aspiration lumen and having a distal portion including a disruption element configured to disrupt thrombus within the aspiration lumen, and a monitoring device configured for removable connection in between the aspiration catheter and the vacuum source, and including a housing, a pressure sensor in fluid communication with an interior of the housing, a measurement device coupled to the pressure sensor and configured for measuring deviations in fluid pressure, and a communication device coupled to the measurement device and configured to generate an alert signal when a deviation in fluid pressure measured by the measurement device exceeds a pre-set threshold.

Claims

1. A system for removal of blood or thrombus comprising:

a vacuum source;

an aspiration catheter having an elongate shaft including an aspiration lumen having a proximal end and a distal end, the proximal end configured to couple to the vacuum source, the distal end having an orifice;

an elongate member configured for placement through the aspiration lumen, the elongate member having a proximal portion configured to extend from the proximal end of the aspiration lumen;

a rotating device configured to couple to the proximal portion of the elongate member, the rotating device comprising a body and a rotation element, the body configured to be gripped by a user and the rotational element configured to rotate the elongate member when the rotating device is coupled to the elongate member; and

a self-contained monitoring device for real time monitoring of catheter aspiration, configured for removable connection in between the aspiration catheter and the vacuum source, comprising;

a housing having a first port adapted for detachable connection to the vacuum source and a second port adapted for detachable connection with the aspiration catheter;

a pressure sensor in fluid communication with an interior of the housing;

a measurement device coupled to the pressure sensor and configured for measuring deviations in fluid pressure; and

a communication device coupled to the measurement device and configured to generate an alert signal when a deviation in fluid pressure measured by the measurement device exceeds a pre-set threshold.

2. The system of claim 1, wherein the elongate member is configured to macerate thrombus such that it can be aspirated through the aspiration lumen.

3. The system of claim 1, wherein the elongate member is straight or substantially straight.

4. The system of claim 1, wherein the elongate member has a wavy or undulating form.

5. The system of claim 1, wherein the elongate member has a helical or spiral form.

6. The system of claim 5, wherein the elongate member comprises a coil having a central axis.

7. The system of claim 6, wherein the elongate member comprises a substantially straight shaft having a longitudinal axis and a distal end coupled to a proximal end of the coil, and wherein the central axis of the coil and the longitudinal axis of the substantially straight shaft are not co-linear.

8. The system of claim 7, wherein the coil has an outer diameter, and wherein the longitudinal axis of the substantially straight shaft extends along a line closer to a circular projection of the outer diameter of the coil than the central axis of the coil.

9. The system of claim 8, wherein the longitudinal axis of the substantially straight shaft extends along a line within the circular projection of the outer diameter of the coil.

10. The system of claim 1, wherein the communication device is configured to generate a first type of alert in response to a deviation measured by the measurement device comprising one or more increases and decreases of vacuum pressure.

11. The system of claim 10, wherein the first type of alert comprises at least one of an audible alert, a visible alert, and a tactile alert.

12. The system of claim 10, wherein the communication device is configured to generate a second type of alert in response to the deviation comprising one or more increases and decreases of vacuum pressure no longer being measured by the measurement device.

13. The system of claim 1, further comprising a memory module, wherein the measurement device is configured to compare measured deviations in pressure with information contained in the memory module.

14. The system of claim 1, wherein the measurement device comprises a microprocessor.

15. The system of claim 1, wherein the alert signal is configured to indicate a clogged condition.

16. The system of claim 1, wherein the alert signal is configured to indicate a system leak.

17. The system of claim 1, wherein the alert signal is configured to indicate thrombus being aspirated.

18. The system of claim 1, wherein the alert signal is configured to indicate thrombus no longer being aspirated.

19. The system of claim 1, wherein the alert signal is configured to indicate at least two of the states selected from the group consisting of a clogged condition, a system leak, thrombus being aspirated, and thrombus no longer being aspirated.

20. The system of claim 1, wherein the elongate member is configured to guide a catheter through a portion of the vascular system of a subject.

21. The system of claim 20, where the elongate member is configured to guide the aspiration catheter through the portion of the vascular system of the subject.

22. The system of claim 1, wherein the elongate member is a guidewire.