Aspirating/ventilating apparatus and method

• US 4,569,344 A
• Filed: 07/23/1984
• Issued: 02/11/1986
• Est. Priority Date: 07/23/1984
• Status: Expired due to Term

• Current Assignee: Ballard Medical Products (Kimberly-Clark Corporation)
• Original Assignee: Ballard Medical Products (Kimberly-Clark Corporation)
• Inventors: Palmer, Darrel
• Primary Examiner(s): Recla, Henry J.
• Application Number:
  US06/633,570
• Time in Patent Office: 568 Days
• Field of Search: 128/207.14, 128/207.16, 128/910, 128/205.19, 604/175, 604/171, 604/335, 604/118, 604/119, 604/163, 604/173, 251/95, 251/100, 137/533.17
• US Class Current: 128/207.16
• CPC Class Codes: A61M 1/7413 by changing the cross-section of the line
• CPC Class Codes: A61M 1/86 Connectors between drainage tube and handpiece, e.g. drainage tubes detachable from handpiece
• CPC Class Codes: A61M 16/0463 combined with suction tubes, catheters or the like; Outside connections
• CPC Class Codes: A61M 16/0465 Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
• CPC Class Codes: A61M 25/0111 Aseptic insertion devices
• CPC Class Codes: Y10S 128/91 Anesthesia gas scavenging system
• CPC Class Codes: Y10T 137/7913 Guided head
• CPC Class Codes: Y10T 29/49412 with assembly, disassembly or composite article making
• CPC Class Codes: Y10T 29/4987 Elastic joining of parts
• CPC Class Codes: Y10T 29/49904 Assembling a subassembly, then assembling with a second subassembly

Abstract

A ventilating and aspirating assembly comprising an aspirating catheter tube internally disposed within and coextensive with a surrounding flexible collapsible sterility preserving film envelope, a connector by which ventilating air is involuntarily delivered to and exhausted from the lungs of a medical patient, said connector comprising structure which accommodates the manual insertion of the catheter tube into and manual removal from the trachea/bronchi patient through the connector. This facilitates aspiration of undesired respiratory fluids. The assembly further comprises a detachable connection site for one end of the envelope to the connector and a valve by which aspirating vacuum pressure is selectively communicated to the interior of the catheter tube for evacuation of said respiratory fluids, the valve comprising structure isolating the vacuum pressure from the atmosphere, structure by which the valve is placed in either of a locked and an unlocked condition and structure normally biasing and sealing the valve in a closed position, but accommodating manual displacement counter to the bias into an unsealed open position whereby, with the catheter tube indwelling in the lungs of the patient, the vacuum pressure causes evacuation of fluid from the patient'"'"'s respiratory system through the catheter tube, and a detachable connection site for the other end of the envelope to the valve.

Claims

1. An indwelling ventilating/aspirating apparatus by which a medical patient is subjected to involuntary respiratory therapy and by which fluids from the trachea and/or bronchi are evacuated, the apparatus comprising:

an elongated sterile aspirating catheter tuble comprising relatively small inside and outside diameters, and essentially free distal end for the manual insertion into the trachea/bronchi of the patient, a central portion free from and not subjected to mechanical manipulation, a constrained proximal end, and suction port means disposed at said distal end;

a sterility preserving collapsible envelope essentially surrounding the catheter tube and comprising a elongated sack comprising a thin wall having a transverse dimensional configuration substantially greater than the outside diameter of the catheter tube, the envelope further comprising a distal end and a proximal end, the enevlope maintaining sterility of the catheter tube while accommodating manual manipulation of the catheter tube to and fro by externally collapsing the envelope upon the catheter tube;

first force-fit coupling means comprising central means accommodating manual reciprocation of the catheter tube therethrough, releasable linearly force-fit threadless clamp means comprising means compressively securing and sealing the distal end of the enevelope at the first coupling menas;

second force-fit coupling means comprising means receiving and anchoring the proximal end of the catheter tube against relative displacement, linearly force fit threadless clamp means comprising means at least in part compressively securing and sealing the proximal end of the envelope at the second coupling means;

tracheostomy fitting means comprising first port means comprising means connecting the fitting means with the first force-fit coupling means and means for reciprocably and guidingly receiving the catheter tube, second port means through which ventilating air is introduced from the fitting means into and exhausted from the lungs of the patient and through which the aspirating catheter tube is displaced into and removed from the patient'"'"'s trachea/bronchi, third port means by which oxygenated air passes into the fitting means and forth port means by which air discharged from the lungs is exhausted from the fitting means; and

normally closed normally internal sealed and internally sterile vacuum control mechanism sealed against external entry of contamination, the vacuum control mechanism comprising valve means, valve body means comprising bore means normally closed by the valve means, means by which vacuum suction is communicated to the bore means, means by which the second coupling means are connected to the valve body means, the valve means comprising biased normally closed internal seal means, means by which the valve may be selectively manually locked in a closed position to prohibit inadvertent as well as intentional actuation of the valve means, means by which the valve means may be selectively manually place in an unlocked closed position accommodating subsequent selective manual actuation of the valve means, means by which the valve means are manually displaced from the unlocked closed position to an unlocked open position accommodating aspiration of fluids from the trachea-bronichi of the patient along the catheter tube and across the valve means responsive to communication of said vacuum suction to the distal tip of the catheter tube, as long as the valve means are manually retained in the open position counter to the bias imposed upon the biased seal means, and means which isolate said vacuum suction from atmospheric contamination.

2. An apparatus according to claim 1 wherein the catheter tube and the envelope are, respectively, formed of light-transmitting material.

4. An apparatus according to claim 1 wherein the envelope is formed of a synthetic resinous film.

5. An apparatus according to claim 1 wherein the suction port means of the catheter tube comprise axially and transversely disposed ports at the distal end of the catheter tube.

6. An apparatus according to claim 1 wherein the central means of the first force-fit coupling means comprise means closely surrounding the reciprocable catheter tube to form a seal therewith which resists passage thereacross of ventilating air under pressure.

7. An apparatus according to claim 1 wherein the means compressively securing the distal end of the envelope comprise means which are linearly displaced without twisting in an axial direction along said distal end and which form at least one common compressive annular line seal and annular securing site in respect to both the inside and the outside surfaces of the envelope.

8. An apparatus according to claim 1 wherein the linearly force-fit threadless clamp means of the second force-fit coupling means comprise means which are linearly displace without threading or twisting along the proximal end of the envelope and which cause to be formed at least one common compressive annular seal and annual fastening site at both the inside and outside surfaces of the proximal end of the envelope.

9. An apparatus according to claim 1 wherein the linearly force-fit threadless clamp means of the first force-fit coupling means comprise separate male and female members which comprise mating male and female annular fastening means sized and shaped to form without threading or twisting at least one compressive annular seal and annular fastening site with the inside and outside surfaces of the distal end of the envelope.

10. An apparatus according to claim 1 wherein the linearly force-fit threadless clamp means of the second force-fit coupling means comprise separate male and female members which comprise mating male and female annular fastening means sized and shaped to form without threading or twisting at least one compressive annular seal and annular fastening site with the inside and outside surfaces of the proximal end of the envelope.

11. An apparatus according to claim 1 wherein the first force-fit coupling means and fitting means comprise selectively mating male/female means by which said first coupling means and said fitting means are releasably connected one to the other so as to resist inadvertent separation but accommodate intentional separation.

12. An apparatus according to claim 1 wherein the proximal end of the catheter tube is permanently connected to the second force-fit coupling means.

14. An apparatus according to claim 1 wherein the means by which the valve means may be selectively manually locked comprise stop means.

15. An apparatus according to claim 14 wherein the stop means comprise opposed abutment means when in the locked condition and unopposed when in the unlocked condition.

16. An apparatus according to claim 1 wherein said means by which the valve means may be selectively manually locked comprise an exposed biased manual actuator.

17. An apparatus according to claim 1 wherein the valve means comprise manually responsive biased plunger means.

18. An apparatus according to claim 17 wherein said plunger means is reciprocally associated with guide means in the valve body means which cause the plunger means to reciprocate essentially linearly.

19. An apparatus according to claim 1 further comprising external readable indicia visually informing a medical attendant when the valve means are in the locked condition and when the valve means are in the unlocked condition.

20. An apparatus according to claim 1 further comprising seal means disposed in mating relation with the first coupling means and comprising means by which a static and dynamic seal is created with the outside surface of the catheter tube in respect to ventilating pressure whereby the outside surface of the catheter tube is wiped as it is displaced.

21. An apparatus according to claim 20 wherein the seal means are cup-shaped and further comprise second means by which a seal is formed with the first coupling means and third means by which a seal is formed with the tracheostomy fitting means.

3. An apparatus according to c1aim 1 wherein the catheter tube is formed of synthetic resinous material.

13. An apparatus according to laim 1 wherein the means for reciprocably and guidingly receiving the catheter tube comprise seal site means which closely surround the reciprocable catheter tube to form a seal therewith which resists passage thereacross of ventilating air under pressure and which provides a guide which gives direction to the catheter tube as it is manually displaced to and fro.

22. An indwelling ventilating/aspirating apparatus by which a medical patient is subjected to involuntary respiratory therapy and by which fluids from the trachea and/of bronchi are evacuated, the apparatus comprising:

an elongated sterile aspirating catheter tube comprising relatively small inside and and outside diameters, an essentially free distal end for manual insertion into the trachea/bronchi of the patient, a free central portion not subjected to mechanical manipulation, a constrained proximal end, and suction port means disposed at said distal end;

a sterility preserving collspsible envelope essentially surrounding the catheter tube and comprising an elongated sack comprising a thin wall having a transverse dimension configuration substantially greater than the outside diamater of the catheter tube, the envelope further comprising a distal end and a proximal end, the envelope maintaining sterility of the catheter tube while accomodating manual manipulation of the catheter tube to and fro by externally collapsing the envelope upon the catheter tube;

first force-fit coupling means comprising central means accommodating manual reciprocation of the catheter tube therethrough, releasable clamp means comprising means compressively securing and sealing the distal end of the envelope at the first coupling means;

second force-fit coupling means comprising means receiving and anchoring the proximal end of the catheter tube against relative displacement, clamp means comprising means at least in part compressively securing and sealing the proximal end of the envelope at the second coupling means;

tracheostomy fitting means comprising first port means comprising means connecting the fitting means with the first force-fit coupling means and means for reciprocably and guidingly receiving the catheter tube, second port means through which ventilating air is introduced from the fitting means into and exhausted from the lungs of the patient and through which the aspirating catheter tube is displaced into and removed from the patient'"'"'s trachea/bronchi, third port means by which oxygenated air passes into the fitting means and forth port means by which air discharged from the lungs is exhausted from the fitting means; and

vacuum control means comprising valve means, means by which vacuum suction is communicated to the valve means, means by which the second coupling means are connected to the valve means, biased internal seal means associated with the valve means, means by which the valve means may be selectively manually locked in a closed position to prohibit inadvertent as well as intentional actuation of the valve means, means by which the valve means may be selectively manually placed in an unlocked position accommodating subsequent selective manual actuation of the valve means, means by which the valve means are manually displaced from the unlocked closed position to an unlocked open position accommodating aspiration of fluids from the trachea-bronchi of the patient along the catheter tube and across the valve means responsive to communication of said vacuum suction to the distal tip of the catheter tube, and means which isolate said vacuum suction from access to the atmosphere;

the valve means comprising manually responsive plunger means and the seal means comprising elastic means having memory which elastic means are in stretch fit relation with the plunger means whereby the seal means functions to both bias itself and the plunger toward the closed position and to seal the vacuum suction away from the catheter tube when biased into the closed position.

23. An apparatus according to claim 22 wherein the seal means comprise a sock-shaped configuration, a toe portion of which surrounds one end of the plunger and a leg portion of which is folded upon itself and connected in tensile stretch fit relation to a stationary portion of the valve means.

24. An apparatus according to claim 23 wherein the plunger means are centrally hollow to allow passage of air from the toe portion of the seal means during assembly.

25. A ventilating and aspirating assembly comprising:

an aspirating catheter tube internally disposed within said coextensive with a surrounding flexible collapsible sterility preserving envelope;

connector means by which ventilating air is involuntarily delivered to and exhausted from the lungs of a medical patient, said connector means comprising means accommodating the manual insertion of one end of the catheter tube into and manual removal from the trachea/bronchi of the patient through the connector means to facilitate aspiration of undesired respiratory fluids, and means detachably connecting one end of the envelope to the connector means; and

normally closed valve structure by which aspirating vacuum pressure is selectively communicated to the interior of the catheter tube for evacuation of said fluids, the valve structure comprising valve means, valve body means in which the valve means may be manually displaced, the valve body means comprising bore means connected to the other end of said catheter tube and which at all times isolate the valve means vacuum pressure from the atmosphere, actuator means by which the valve means are place in either of a locked or an unlocked condition and means normally simultaneously biasing and sealing the valve means in a closed position, but accommodating on-going manual displacement counter to the bias into an unsealed open position and manual retention of the valve means in the open position counter to the bias whereby, with the catheter tube indwelling, the vacuum pressure causes evacuation of fluid from the patient'"'"'s respiratory system through the catheter tube and the bore means of the valve body means;

means detachably connecting a second end of the envelope to the valve body means.

26. A method of using a ventilating/aspirating assembly comprising the step of:

linearly force-fit connecting, without twisting or threading, the distal and proximal ends of a sterility preserving flexible manually collapsible envelope respectively between a ventilating/aspirating fitting and a manual normally closed aspirating sealed and internally sterile control valve, stationarily connecting the proximal end of aspirating catheter tube to the control valve, which catheter tube is coextensively disposed within the envelope, and slidably associating the distal end of the catheter tube with the ventilating/aspirating fitting, selectively manually advancing the distal end of the catheter tube through the fitting by manipulation of the catheter tube from outside the envelope a desired distance into the respiratory system of a patient while a vacuum suction is isolated from both the atmosphere and the catheter tube, manually actuating and manually maintaining the actuation of the control valve, when the distal end of the catheter tube is properly placed within said respiratory sytsem, to displace and unseat an internal sterile seal within the valve counter to the normally closed seal bias for a time sufficient to evacuate said fluids from the respiratory system, manually releasing the valve to oppositely displace and seat the seal responsive to said bias thereby once more isolating the vacuum suction from the atmosphere and from the catheter tube to thereby terminate said evacuation, continuously isolating said vacuum suction and catheter tube from the atmosphere during both seating and unseating of the seal within the valve, and manually retracting the catheter tube from the respiratory system by manipulation through the envelope.