Pleural manometry catheter

• US 10,646,629 B2
• Filed: 09/22/2014
• Issued: 05/12/2020
• Est. Priority Date: 10/11/2013
• Status: Active Grant

• Current Assignee: Rocket Medical PLC
• Original Assignee: Rocket Medical PLC
• Inventors: Roe, Edwin Richard, Varey, Richard Martin
• Primary Examiner(s): Marcetich, Adam
• Application Number:
  US15/028,691
• Publication Number:
  US 20160263296A1
• Time in Patent Office: 2,059 Days
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61M 1/73 comprising sensors or indicators for physical values
• 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 2025/0003 having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2210/101 Pleural cavity
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405

Abstract

A pleural manometry catheter comprises two tubes and a pressure transducer. The first tube provides a first flow path from the pleural cavity to the pressure transducer. The second tube provides a second flow path from the pleural cavity such that fluid can be drained from the pleural cavity. The pressure transducer comprises a processor for processing, continuously, the real-time fluctuations in the pressure of the second flow path and therefore the pleural cavity as fluid is aspirated from it via the first tube.

Claims

1. A double-skinned pleural manometry catheter comprising:

a first catheter tube and a second catheter tube sealed from the first catheter tube,

the first catheter tube having a first end, a second end and a bore extending therebetween to define a first tube interior, said first end adapted for insertion into a pleural cavity of a patient, the first catheter tube having a first aperture formed near the first end of the first catheter tube so as to communicate the interior of the first catheter tube with a pleural fluid within the pleural cavity of a patient, said second end of the first catheter tube remote from the first end and in communication with the first aperture by a first pleural fluid flow path, the second end of the first catheter tube configured to be external to the pleural cavity of the patient when in use, means connected to the second end of the first catheter tube for draining pleural fluid from the pleural cavity of the patient through said first pleural fluid flow path;

the second catheter tube having a first end, a second end and a bore extending therebetween to define a second tube interior, said first end of said second catheter tube adapted for insertion into the pleural cavity of the patient, the second catheter tube having a second aperture formed near the first end of the second catheter tube so as to communicate the interior of the second catheter tube with the pleural fluid with the pleural cavity of the patient, said second end of the second catheter tube remote from the first end and in communication with the second aperture by a second pleural fluid flow path, the second end of the second catheter tube configured to be external to the pleural cavity of the patient when in use, the second end of the second catheter tube for draining pleural fluid from the pleural cavity of the patient through said second pleural fluid flow path;

wherein pleural fluid may be drained through the first and second pleural fluid flow paths in parallel simultaneously; and

a pressure transducer connected to the second end of the second catheter tube and adapted to continuously detect real-time fluctuations in the pressure of the pleural fluid being drained from the pleural cavity of the patient through the second pleural fluid flow path, the real-time fluctuations in the fluid pressure at in the second pleural flow path corresponding to real-time fluctuations of the pressure within the pleural cavity of the patient, and

a processor for receiving and interpreting the real-time fluctuations detected by the pressure transducer,

wherein the processor includes an alarm to alert a user to a change in the pleural cavity pressure dose to a predetermined negative pleural cavity pressure, and

wherein the processor emits an audible alarm signal, the alarm signal increasingly changing in volume and/or regularity and/or periodicity in proportion to the detected pressure within the pleural cavity approaching said predetermined negative cavity pressure;

wherein the first catheter tube is of a lesser diameter than the catheter second tube and wherein the first catheter tube is an inner tube and the second catheter tube is an outer tube, the first catheter tube running along the internal bore of the second, outer catheter tube, such that there is a space between the outer diameter of the inner catheter tube and the inner diameter of the outer catheter tube, and wherein at least a part of the second pleural flow path between the second aperture of the second catheter tube and the second end of the second catheter tube comprises the space between the inner and outer catheter tubes; and

wherein the second catheter tube has an internal bore, the internal bore of the second catheter tube at the first end of the second catheter tube comprising a tapered portion and wherein the internal bore tapers so as to form a touching fit and is joined to the first and inner catheter tube.

2. The double-skinned pleural manometry catheter according to claim 1, wherein the inner catheter tube comprises a first, substantially straight portion and a second, curved portion.

3. The double-skinned pleural manometry catheter according to claim 2, wherein the second portion of the inner catheter tube is resiliently deformable.

4. The double-skinned pleural manometry catheter according to claim 2, wherein the first aperture is one of a plurality of first apertures, the second, curved portion having an inner diameter, the first apertures of the inner catheter tube being disposed along the inner diameter of the second, curved portion.

5. The double-skinned pleural manometry catheter according to claim 1, further comprising a valve attached to the second end of the first catheter tube and being in fluid communication with the first catheter tube, and wherein the valve is biased shut.

6. The double-skinned pleural manometry catheter according to claim 5, wherein the valve can only be opened by the projection of a solid object in a direction pointed toward the first aperture of the first catheter tube.

7. The double-skinned pleural manometry catheter according to claim 6, wherein the solid object is a needle of an integrated syringe or a non-integrated syringe.

8. The double-skinned pleural manometry catheter according to claim 1, wherein the second catheter tube comprises first and second portions, wherein the second portion is substantially perpendicularly disposed to the first portion.

9. The double-skinned pleural manometry catheter according to claim 1, wherein the first aperture is one of a plurality of first apertures, the first apertures of the inner catheter tube being oval in shape.

10. The double-skinned pleural manometry catheter according to claim 1, wherein the catheter further comprises a plate affixed to the first and second catheter tubes at a location between the first ends of the first and second catheter tubes and the second ends of the first and second catheter tubes, the plate laterally surrounding and extending radially from the first and second catheter tubes, the plate defining distal portions of the first and second catheter tubes that respectively include the first ends of the first and second catheter tubes, such that only the distal portions of the first and second catheter tubes may be inserted into the pleural cavity of the patient.

11. The double-skinned pleural manometry catheter according to claim 10 wherein the second catheter tube has a first portion including the first end of the second catheter tube and a second portion including the second end of the second catheter tube, a surface of the plate occupying a plane substantially perpendicular to the first portion of the second catheter tube.

12. The double-skinned pleural manometry catheter according to claim 1, further comprising a stabiliser for keeping the catheter firmly retained in place after insertion within said pleural cavity.