Systems and methods for management of thrombosis

• US 9,433,427 B2
• Filed: 04/06/2015
• Issued: 09/06/2016
• 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:
  US14/680,017
• Publication Number:
  US 20150282821A1
• Time in Patent Office: 519 Days
• US Class Current: 1/1
• 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

In one embodiment an aspiration system includes an elongate tubular member having a lumen; an aspiration catheter configured to be inserted through the lumen of the elongate tubular member, and including a tubular aspiration member having a proximal end, a distal end, and a lumen, and configured to at least partially extend out of the lumen of the elongate tubular member at the distal end of the elongate tubular member; an elongate support member coupled to the tubular aspiration member and extending between a proximal end of the aspiration catheter and the proximal end of the tubular aspiration member; and an annular sealing member coupled to the tubular aspiration member and configured to create a seal against an inner surface of the elongate tubular member, when a vacuum sufficient to cause aspiration is actively applied to the lumen of the elongate tubular member.

Claims

1. An aspiration system comprising:

an elongate tubular member for insertion into the vasculature of a patient, the elongate tubular member having a proximal end, a distal end, a lumen extending from the proximal end to the distal end, and an inner surface defined by the lumen;

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 a lumen, and 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 patient;

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

an annular seal comprising at least one annular sealing member coupled to the tubular aspiration member;

a vacuum source configured for coupling to the proximal end of the elongate tubular member; and

wherein the at least one annular sealing member is configured to create a seal against the inner surface of the elongate tubular member, substantially preventing liquid having a viscosity of about 0.0025 Pascal-seconds 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 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.

2. The aspiration system of claim 1, wherein the aspiration catheter is freely translatable longitudinally in relation to the elongate tubular member when no vacuum is applied to the lumen of the elongate tubular member.

3. The aspiration system 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.

4. The aspiration system of claim 3, further comprising an annular concavity at the second end of the at least one annular sealing member.

5. The aspiration system of claim 1, wherein the inner surface of the elongate tubular member has a first inner diameter at a location adjacent the distal end of the elongate tubular member.

6. The aspiration system of claim 5, 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 which is greater than the first inner diameter of the inner surface of the elongate tubular member.

7. The aspiration system of claim 5, wherein the at least one annular sealing member comprises a hydrogel disposed on at least a cylindrical outer surface portion of the tubular aspiration member and having a non-hydrated state having a non-hydrated diameter and an unconstrained state having an unconstrained hydrated diameter, the non-hydrated diameter less than the first inner diameter of the inner surface of the elongate tubular member and the unconstrained hydrated diameter greater than the first inner diameter of the inner surface of the elongate tubular member, such that the at least one annular sealing member is configured to seal against the first inner diameter of the inner surface of the elongate tubular member when the hydrogel is in its hydrated state.

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

9. The aspiration system of claim 1, wherein the proximal end of the aspiration catheter is configured to extend proximally from the proximal end of the elongate tubular member when the distal end of the tubular aspiration member extends into the vasculature of the patient.

10. The aspiration system of claim 1, wherein the tubular aspiration member has an outer diameter and an inner diameter, and wherein the elongate support member includes a distal end comprising a partial cylinder having an outer radius and an inner radius, at least one of the outer radius and inner radius configured to substantially match either the outer diameter of the tubular aspiration member or the inner diameter of the tubular aspiration member.

11. The aspiration system of claim 1, further comprising;

a vacuum source;

a housing having a first port adapted for coupling to the vacuum source and a second port adapted for coupling to the proximal end of the elongate tubular member;

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 when a deviation in fluid pressure measured by the measurement device exceeds a pre-set threshold.

12. The aspiration system of claim 11, wherein the communication device is configured to generate a first type of alert in response to a deviation measured by the measurement device comprising a plurality of increases and decreases of vacuum pressure.

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

14. The aspiration system of claim 11, further comprising a memory module, wherein the measurement device is configured to compare measured deviations in pressure with information contained in the memory module.

15. The aspiration system of claim 1, further comprising:

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 inner lumen of the tubular aspiration member.

16. The aspiration system of claim 15, wherein the high pressure injection lumen is carried along the length of the elongate support member.

17. The aspiration system of claim 16, wherein the elongate support member comprises a hypo tube having the high pressure injection lumen as its lumen.

18. The aspiration system of claim 15, 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.

19. The aspiration system of claim 15, wherein the inner surface of the elongate tubular member has a first inner diameter at a location adjacent the distal end of the elongate tubular member, and 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 annular sealing members having an outer diameter which is greater than the first inner diameter of the inner surface of the elongate tubular member.

20. The aspiration system of claim 15, wherein the at least one annular sealing member comprises a hydrogel disposed on at least a cylindrical outer surface portion of the tubular aspiration member.

21. The aspiration system of claim 1, wherein the at least one annular sealing member is configured to create a seal against the inner surface of the elongate tubular member, substantially preventing liquid having a viscosity of about 0.0025 Pascal-seconds 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 pressure of between about −

82,737 pascal and about −

95,526 pascal is actively applied to the lumen of the elongate tubular member at the proximal end of the elongate tubular member.

22. The aspiration system of claim 1, wherein the at least one annular sealing member is configured to create a seal against the inner surface of the elongate tubular member, substantially preventing liquid having a viscosity of about 0.0025 Pascal-seconds 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 pressure of about −

46,662 pascal is actively applied to the lumen of the elongate tubular member at the proximal end of the elongate tubular member.

23. The aspiration system of claim 22, wherein the at least one annular sealing member is configured to allow liquid having a viscosity of about 0.0025 Pascal-seconds from passing through an annular space between the elongate tubular member and the tubular aspiration member in a proximal to distal direction from the lumen of the elongate tubular member to a location distal to the at least one annular sealing member when a pressure of about 46,662 pascal is actively applied to the lumen of the elongate tubular member at the proximal end of the elongate tubular member.