Systems and methods for controlling reperfusion in a vessel

• US 10,376,678 B2
• Filed: 12/30/2016
• Issued: 08/13/2019
• Est. Priority Date: 01/08/2016
• Status: Active Grant

• Current Assignee: Makaha Medical, LLC
• Original Assignee: Makaha Medical, LLC
• Inventors: Levine, Marc-Alan
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Darb, Hamza A
• Application Number:
  US15/395,010
• Publication Number:
  US 20170197064A1
• Time in Patent Office: 956 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 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/00035 pH
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2562/221 Arrangements of sensors with cables or leads, e.g. cable harnesses
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/14553 specially adapted for cerebral tissue
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6851 Guide wires
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61F 2007/0056 for cooling
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 1/3613 : Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 2025/0042 : Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2205/3375 : Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3606 : cooled
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/208 : pH-value
• CPC Class Codes: A61M 25/0021 : characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: A61M 39/06 : Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 39/10 : Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014

Abstract

A system for controlling reperfusion in a blood vessel of a patient including a flexible elongated member configured and dimensioned for insertion in the vessel of the patient, the elongated member having a proximal portion and a distal portion, the elongated member configured for insertion so the distal portion extends distal of a clot in the blood vessel. A sensor is positioned at the distal portion of the elongated member for positioning distal of the blood clot, the sensor measuring a parameter of blood downstream of the clot. An indicator communicates with the sensor, the indicator indicating a measured parameter for insertion of an instrument for controlling blood flow.

Claims

1. A system for controlling reperfusion in a blood vessel of a patient comprising:

a flexible elongated member configured and dimensioned for insertion in the vessel of the patient, the elongated member having a proximal portion and a distal portion, the elongated member configured for insertion so the distal portion extends distal of a blood clot in the blood vessel;

a sensor positioned at the distal portion of the elongated member for positioning distal of the blood clot, the sensor measuring a parameter of blood downstream of the blood clot;

an indicator communicating with the sensor, the indicator indicating a measured parameter of the blood to determine a) a blood clot treatment and b) whether restoration of normal blood flow as a result of clot removal is acceptable or needs to be controlled by a blood flow regulating catheter inserted over the flexible elongated member; and

the blood flow regulating catheter positionable over the flexible elongated member, the catheter having a mechanical thrombectomy device for mechanically removing the blood clot and a balloon distal of the mechanical thrombectomy device, the balloon inflatable to reduce blood flow in the vessel until the parameter of blood rises to an acceptable level, the balloon being partially deflatable to gradually restore blood flow around an outer wall of the balloon and downstream of the balloon and through the vessel as the blood clot is removed.

2. The system of claim 1, further comprising a connector connecting the elongated member to the indicator.

3. The system of claim 1, wherein the flexible elongated member comprises a guidewire.

4. The system of claim 1, wherein the sensor is embedded in a wall of the elongated member.

5. The system of claim 1, wherein the sensor is positioned on an outer surface of the elongated member.

6. The system of claim 1, wherein the parameter is a pH level of blood, and the sensor is a pH sensor measuring the pH level of the blood downstream of the blood clot to determine the condition of the vessel.

7. The system of claim 6, wherein if the pH level is below a predetermined level, blood flow rate is reduced after blood clot removal.

8. The system of claim 1, wherein the parameter is an oxygen level of blood, and the sensor is an oxygen sensor measuring the oxygen level of the blood downstream of the blood clot to determine the condition of the vessel.

9. The system of claim 8, wherein if the oxygen level is below a predetermined level, blood flow rate is reduced after blood clot removal.

10. A system for controlling reperfusion in a blood vessel of a patient comprising:

a flexible elongated member configured and dimensioned for insertion in the vessel of the patient, the elongated member having a proximal portion and a distal portion, the elongated member configured for insertion so the distal portion extends distal of a blood clot in the blood vessel;

a sensor positioned at the distal portion of the elongated member for positioning distal of the blood clot, the sensor measuring a parameter of blood downstream of the blood clot;

an indicator communicating with the sensor, the indicator indicating a measured parameter of the blood to determine a) a blood clot treatment and b) whether restoration of normal blood flow as a result of clot removal is acceptable or needs to be controlled by a blood flow regulating catheter inserted over the flexible elongated member; and

the blood flow regulating catheter positionable over the flexible elongated member, the catheter having a lumen to transport cryogenic fluid into the blood vessel distal of the blood clot to reduce blood flow in the vessel, the cryogenic fluid flowing out of a distal opening of the catheter into the blood vessel.

11. The method of claim 10, wherein the parameter is one of a pH level of blood or an oxygen level of blood.

12. A method for determining the rate for reperfusion in a vessel of a patient comprising the steps of:

a) providing an elongated flexible member;

b) inserting the flexible member through vasculature of the patient and past a blood clot in the vessel to a position downstream of the clot in the vessel;

c) measuring a parameter of the blood downstream of the blood clot;

d) indicating to a user the parameter of the blood to enable the user to determine a condition of the vasculature and determine an effect blood flow will have on the vessel downstream once the blood clot is removed and blood flow restored to determine a rate of reperfusion; and

e) during removal of the blood clot, controlling the rate of perfusion of blood through the vessel by slowing the rate of perfusion until the parameter of blood rises to an acceptable level.

13. The method of claim 12, further comprising a pH sensor on a distal portion of the flexible member for measuring a pH level, the pH sensor measuring the pH level as the blood clot is removed.

14. The method of claim 12, further comprising the steps of inserting a blood flow regulating catheter over the flexible member and controllably deflating a balloon of the catheter prior to removal of the blood clot to slow reperfusion if a determination is made that slow perfusion is warranted, wherein the balloon is controllably deflated until the parameter of the blood rises to the acceptable level as indicated by an indicator in response to measurement by a sensor in communication with the blood in the vessel.

15. The method of claim 14, wherein a step of inflating the balloon is performed if the indicator indicates the pH level is below 7.

16. The method of claim 15, further comprising the step of slowing perfusion after removal of the blood clot by injecting a cryogenic fluid through the catheter and into the blood vessel.

17. The method of claim 12, further comprising the steps of inserting a blood flow regulating catheter over the flexible member and delivering a cryogenic fluid into the blood vessel prior to removal of the blood clot to slow reperfusion if a determination is made that slow perfusion post clot removal is warranted until the parameter of blood rises to the acceptable level as indicated by a sensor in communication with the blood in the vessel, the cryogenic fluid injected into the blood vessel through a distal opening in the catheter.

18. The method of claim 12, wherein the flexible member is a guidewire, and further comprising the step of inserting a catheter over the guidewire, the catheter enabling slow perfusion of blood after removal of the blood clot.

19. The method of claim 12, further comprising the step of slowing perfusion after removal of the blood clot by adjusting inflation of an inflatable balloon carried by a catheter, the catheter insertable over the flexible member and the balloon controlling perfusion during removal of the clot and after removal of the clot by a mechanical device, the balloon axially spaced from the mechanical device.