Anti-extravasation catheter

• US 10,456,510 B2
• Filed: 02/11/2014
• Issued: 10/29/2019
• Est. Priority Date: 10/24/2006
• Status: Active Grant

• Current Assignee: Cannuflow Inc.
• Original Assignee: Cannuflow Inc.
• Inventors: Kucklick, Theodore R.
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Lee, Weng
• Application Number:
  US14/178,094
• Publication Number:
  US 20140163459A1
• Time in Patent Office: 2,086 Days
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02152 specially adapted for venous pressure
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile

Abstract

The disclosed devices and methods provide for the minimization of fluid extravasation during use of infusion catheters such as peripherally inserted central catheters and central venous catheters. The anti-extravasation catheter allows a surgeon to drain fluids from soft tissue surrounding an infusion site while also providing fluid inflow to a patient.

Claims

1. An anti-extravasation system comprising:

a catheter having a length and outer diameter suitable for extending from a peripheral vein insertion point on a patient to a treatment site, said catheter characterized by an elongated venous section located distal to an interstitial section and comprising;

an inflow lumen;

at least one drainage lumen;

a dissolvable plug disposed within the at least one drainage lumen; and

a plurality of apertures disposed only in the interstitial section of the catheter, said plurality of apertures in fluid communication with the at least one drainage lumen and adapted to drain fluid from tissue surrounding the insertion point when the catheter is operably disposed within the patient;

wherein the venous section of the catheter comprises a uniform outer surface and is structured to prevent fluid communication between the outer surface of the venous section and the at least one drainage lumen; and

a hub proximal to the interstitial section and placed in fluid communication with the inflow lumen and the at least one drainage lumen.

2. The system of claim 1 wherein the catheter is sized and dimensioned such that the interstitial section resides in body tissue overlying the insertion point in a peripheral vein and the venous section of the catheter resides in the central venous system of the patient when disposed within the patient.

3. The system of claim 1 wherein the catheter is sized and dimensioned such that the interstitial section resides in body tissue overlying the insertion point in a peripheral vein and the venous section of the catheter resides in the peripheral vein.

4. The system of claim 1 wherein the plurality of apertures comprise longitudinal channels.

5. The system of claim 1 wherein the plurality of apertures comprise fenestrations.

6. The system of claim 1 further comprising an extravasation sensor operably coupled to the catheter, said sensor selected from the group consisting of a temperature sensor, a pressure sensor, a conductivity sensor, an optical sensor and a Ph sensor.

7. The system of claim 6 further comprising a control system operably coupled to the catheter, said control system adapted to detect the occurrence of extravasation and alert a user when extravasation occurs.

8. The system of claim 1 wherein the dissolvable plug comprises a material selected from the group consisting of starches, gelatins, lactose, sucrose, sugars and cellulose.

9. The system of claim 1 further comprising an over-pressure valve in fluid communication with the drainage lumen.

10. The system of claim 1 further comprising an outer sleeve disposed over the outer diameter of the catheter.

11. The system of claim 1 further comprising an anti-extravasation agent source placed in fluid communication with the drainage lumen.

12. A method for performing chemotherapy comprising:

providing a chemotherapy therapeutic fluid source;

providing an anti-extravasation catheter, said catheter having a length and outer diameter suitable for extending from a peripheral vein insertion point on a patient to a treatment site, said catheter characterized by an elongated venous section located distal to an interstitial section and comprising;

an inflow lumen;

at least one drainage lumen; and

a plurality of apertures disposed only in the interstitial section of the catheter, said plurality of apertures in fluid communication with the at least one drainage lumen and adapted to drain fluid from tissue surrounding the insertion point when the catheter is operably disposed within the patient;

a dissolvable plug disposed within the at least one drainage lumen and in fluid communication with the plurality of apertures;

wherein the venous section of the catheter comprises a uniform outer surface and is structured to prevent fluid communication between the outer surface of the venous section and the at least one drainage lumen;

disposing the anti-extravasation catheter inside a patient;

placing the plurality of apertures in fluid communication with tissue surrounding the insertion point;

infusing the chemotherapy therapeutic fluid into the patient through the catheter; and

draining interstitial fluid from tissue surrounding the catheter insertion point during a chemotherapeutic session through the plurality of apertures.

13. The method of claim 12 wherein the dissolvable plug comprises a material selected from the group consisting of starches, gelatins, lactose, sucrose, sugars and cellulose.

14. The method of claim 12 further comprising the steps of:

providing an antidote source; and

infusing the antidote into the tissue.

15. The method of claim 14 further comprising the step of cycling between infusing the antidote to the tissue and aspirating the interstitial fluid from the tissue surrounding through the catheter.

16. The method of claim 12 further comprising the step of detecting the occurrence of extravasation with an extravasation sensor operably coupled to the catheter, said sensor selected from the group consisting of a temperature sensor, a pressure sensor, a conductivity sensor and a Ph sensor.

17. The method of claim 16 further comprising the steps of:

providing a control system operably connected to the catheter, said control system adapted to detect the occurrence of extravasation; and

alerting a user of the occurrence of extravasation using the control system.