Systems and methods for management of thrombosis

• US 9,913,936 B2
• Filed: 07/14/2016
• Issued: 03/13/2018
• Est. Priority Date: 04/08/2014
• 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:
  US15/209,989
• Publication Number:
  US 20160317726A1
• Time in Patent Office: 607 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 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00991 Telescopic means
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61M 1/90 Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
• CPC Class Codes: G06Q 30/02 Marketing; Price estimation or determination; Fundraising
• CPC Class Codes: G06Q 30/0207 Discounts or incentives, e.g. coupons or rebates
• CPC Class Codes: G06Q 30/0601 Electronic shopping [e-shopping]

Abstract

A method for aspirating material from a patient includes providing an elongate tubular member having a lumen having a first diameter adjacent its distal end, providing an aspiration catheter including a tubular aspiration member having an aspiration lumen and configured to at least partially extend out of the lumen of the elongate tubular member, an elongate support member coupled to the tubular aspiration member, and at least one annular sealing member coupled to the tubular aspiration member and configured to seal against the first diameter, placing the distal end of the elongate tubular member into vasculature, inserting the aspiration catheter into the lumen of the elongate tubular member, extending the distal end of the tubular aspiration member out of the distal end of the elongate tubular member such that the at least one annular sealing member is aligned with the first diameter of the lumen of the elongate tubular member, and applying a vacuum to the lumen of the elongate tubular member at the such that material is aspirated through the tubular aspiration member and into the lumen of the elongate tubular member.

Claims

1. A method for aspirating material from a patient comprising:

providing an elongate tubular member having a distal end configured to be inserted into the vasculature of a subject, a proximal end configured to extend externally from the subject, and a lumen extending from the proximal end to the distal end, the lumen having a first diameter adjacent the distal end;

providing an aspiration catheter having a proximal end and a distal end and configured to be inserted through the lumen of the elongate tubular member, the aspiration catheter comprising;

a tubular aspiration member having a proximal end, a distal end, and an aspiration lumen extending between the proximal end and the distal end of the tubular aspiration member, the tubular aspiration member configured to at least partially extend out of the lumen of the elongate tubular member at the distal end of the elongate tubular member and into the vasculature of the subject;

an elongate support member coupled to the tubular aspiration member and extending between the proximal end of the aspiration catheter and the proximal end of the tubular aspiration member; and

at least one annular sealing member coupled to the tubular aspiration member and configured to seal against the first diameter of the lumen of the elongate tubular member;

placing the distal end of the elongate tubular member into the vasculature of the subject;

inserting the aspiration catheter into the lumen of the elongate tubular member;

extending the distal end of the tubular aspiration member out of the distal end of the elongate tubular member such that the distal end of the tubular aspiration member is adjacent a target area within the vasculature of the subject and the at least one annular sealing member is aligned with the first diameter of the lumen of the elongate tubular member; and

applying a vacuum from a vacuum source to the lumen of the elongate tubular member at the proximal end of the elongate tubular member such that material adjacent the target area is aspirated through the tubular aspiration member from its distal end to its proximal end and into the lumen of the elongate tubular member.

2. The method of claim 1, wherein the material comprises blood or thrombus.

3. The method of claim 1, wherein the material is caused to exit a proximal end of the lumen of the elongate tubular member.

4. The method of claim 1, wherein the at least one annular sealing member is configured to create a seal against the first diameter of the elongate tubular member such that a liquid having a viscosity of about 0.0025 Pascal-seconds is prevented from passing through an annular space between the elongate tubular member and the tubular aspiration member in a distal to proximal direction and into the lumen of the elongate tubular member proximal to the at least one annular sealing member when a vacuum sufficient to cause aspiration of the liquid through the aspiration lumen of the tubular aspiration member and the lumen of the elongate tubular member from the distal end of the tubular aspiration member to the proximal end of the elongate tubular member is actively applied to the lumen of the elongate tubular member at the proximal end of the elongate tubular member.

5. The method of claim 1, wherein the at least one annular sealing member has a first end, a second end, and a wall, the first end coupled to the tubular aspiration member and having a first outer diameter and the second end having a second outer diameter, greater than the first outer diameter, the second end located distally from the first end.

6. The method of claim 5, wherein the at least one annular sealing member has an annular concavity at its second end.

7. The method of claim 1, wherein the at least one annular sealing member comprises a plurality of annular sealing members arrayed along a proximal portion of the tubular aspiration member, each of the plurality of annular sealing members having an outer diameter.

8. The method of claim 1, wherein the at least one annular sealing member comprises a hydrogel disposed on at least an outer surface portion of the tubular aspiration member.

9. The method of claim 1, further comprising:

tracking the aspiration catheter over a guidewire with the guidewire within the aspiration lumen of the tubular aspiration member.

10. The method of claim 9, wherein the tracking step is performed when no vacuum is applied to the lumen of the elongate tubular member.

11. The method of claim 1, further comprising:

providing a self-contained monitoring device for real time monitoring of catheter aspiration 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; and

coupling the self-contained monitoring device between the aspiration catheter and the vacuum source.

12. The method of claim 11, further comprising:

stopping aspiration when the communication device of the self-contained monitoring device generates a first alert signal.

13. The method of claim 1, wherein the aspiration catheter further comprises:

a high pressure injection lumen having a proximal end and a distal end and extending from the proximal end of the aspiration catheter to a location adjacent the distal end of the tubular aspiration member; and

at least one orifice at the distal end of the high pressure injection lumen configured to allow high pressure liquid injected through the high pressure injection lumen to be released into the aspiration lumen of the tubular aspiration member.

14. A method for aspirating thrombus from a patient comprising:

providing an elongate tubular member having a distal end configured to be inserted into the vasculature of a subject, a proximal end configured to extend externally from the subject, and a lumen extending from the proximal end to the distal end, the lumen having a first diameter adjacent the distal end;

providing an aspiration catheter having a proximal end and a distal end and configured to be inserted through the lumen of the elongate tubular member, the aspiration catheter comprising;

a tubular aspiration member having a proximal end, a distal end, and an aspiration lumen extending between the proximal end and the distal end of the tubular aspiration member, the tubular aspiration member configured to at least partially extend out of the lumen of the elongate tubular member at the distal end of the elongate tubular member and into the vasculature of the subject;

an elongate support member coupled to the tubular aspiration member and extending between the proximal end of the aspiration catheter and the proximal end of the tubular aspiration member; and

at least one annular sealing member coupled to the tubular aspiration member and configured to seal against the first diameter of the lumen of the elongate tubular member;

placing the distal end of the elongate tubular member into the vasculature of the subject;

inserting the aspiration catheter into the lumen of the elongate tubular member;

extending the distal end of the tubular aspiration member out of the distal end of the elongate tubular member such that the distal end of the tubular aspiration member is adjacent thrombus within the vasculature of the subject and the at least one annular sealing member is aligned with the first diameter of the lumen of the elongate tubular member; and

applying a vacuum from a vacuum source to the lumen of the elongate tubular member at the proximal end of the elongate tubular member such that the thrombus is aspirated through the tubular aspiration member from its distal end to its proximal end and into the lumen of the elongate tubular member.

15. The method of claim 14, wherein the extending step is performed when no vacuum is applied to the lumen of the elongate tubular member.

16. The method of claim 14, wherein the aspiration catheter further comprises:

a high pressure injection lumen having a proximal end and a distal end and extending from the proximal end of the aspiration catheter to a location adjacent the distal end of the tubular aspiration member; and

at least one orifice at the distal end of the high pressure injection lumen configured to allow high pressure liquid injected through the high pressure injection lumen to be released into the aspiration lumen of the tubular aspiration member.

17. The method of claim 14, wherein the at least one annular sealing member has a first end, a second end, and a wall, the first end coupled to the tubular aspiration member and having a first outer diameter and the second end having a second outer diameter, greater than the first outer diameter, the second end located distally from the first end.

18. The method of claim 17, wherein the at least one annular sealing member has an annular concavity at its second end.

19. The method of claim 14, wherein the at least one annular sealing member comprises a plurality of annular sealing members arrayed along a proximal portion of the tubular aspiration member, each of the plurality of annular sealing members having an outer diameter.

20. The method of claim 14, wherein the at least one annular sealing member comprises a hydrogel disposed on at least an outer surface portion of the tubular aspiration member.