CA2001779C - Laser resistant ventilating device with locking ferrule - Google Patents

Laser resistant ventilating device with locking ferrule

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Publication number
CA2001779C
CA2001779C CA002001779A CA2001779A CA2001779C CA 2001779 C CA2001779 C CA 2001779C CA 002001779 A CA002001779 A CA 002001779A CA 2001779 A CA2001779 A CA 2001779A CA 2001779 C CA2001779 C CA 2001779C
Authority
CA
Canada
Prior art keywords
ventilation device
cuff
metal tube
tubing assembly
surgical
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
CA002001779A
Other languages
French (fr)
Other versions
CA2001779A1 (en
Inventor
Philip V. Stoddard
Craig James Bell
Donald R. Schneider
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Mallinckrodt Inc
Original Assignee
Mallinckrodt Medical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US07/009,747 external-priority patent/US4834087A/en
Priority claimed from US07/266,666 external-priority patent/US4953548A/en
Application filed by Mallinckrodt Medical Inc filed Critical Mallinckrodt Medical Inc
Publication of CA2001779A1 publication Critical patent/CA2001779A1/en
Application granted granted Critical
Publication of CA2001779C publication Critical patent/CA2001779C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0402Special features for tracheal tubes not otherwise provided for
    • A61M16/0422Laser-resistant
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0402Special features for tracheal tubes not otherwise provided for
    • A61M16/0425Metal tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0434Cuffs
    • A61M16/0436Special fillings therefor
    • A61M16/0438Liquid-filled
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0434Cuffs
    • A61M16/0443Special cuff-wall materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0434Cuffs
    • A61M16/0454Redundant cuffs
    • A61M16/0459Redundant cuffs one cuff behind another
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0486Multi-lumen tracheal tubes

Landscapes

  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Laser Surgery Devices (AREA)
  • Surgical Instruments (AREA)

Abstract

A liquid-filled sealing cuff of an airtight surgical ventilating device is protected from laser-effected damage during laser surgery by a liquid-containing barrier cuff positioned between an area of the laser surgery and the liquid-filled sealing cuff. The body of the surgical ventilating device is formed of a matte-finished flexible metal tube in the area of the laser surgery to resist damage by laser beam impact and to dispose highly unfocused light when a surgical laser beam is directed against the outer surface of the metal tube.
A locking ferrule prevents disengagement of an atraumatic insertion tip of the device from the flexible metal tube.

Description

20~1779 GGs 590 LASBR RBSISTAN~ VENTI~ATING DBVICB
WIT~ LOC~ING ~ u~-~
Background of the Inventlon F~eld of the In~ention The present invention relates to 8 devlce employed for ventilating a patient during surgical use of a la~er in a patient' 8 airway.
De~crlptlon of the 8ac~ Art Endotracheal tubes for controlling ventilation of a patient during surgery are known in the art. Such devices generally include a tubular body for conveying the ventilation and anesthe~ia gases to and from a patient' 8 lungs. In order to provide a tight ~eal with the trachea for controlled ventilation, a balloon or cuff typically i8 provided near a di~tal end of the endotracheal tube, the cuff being inflatable from out~ide the patient by means of an aux$1iary conduit. In order to minimize the possibility of damaging a respiratory tract into which a ventilation device i9 inserted, ~uch devices usually are constructed of flexible polymeric material.
Laser microlaryngeal surgery is increas$ngly being employed for treatment of localized laryngeal and tracheal lesions. There are several known types of surgical la~ers, including ruby, argon, helium-neon, Nd-YAG and carbon dioxide la~ers. However, the carbon ~p 7~9 dioxide laser appears best for the removal of laryngeal papillomas, polyps, nodules, cysts and the like, since carbon dioxide lasers produce 10.6~ lightwaves which are absorbed by biological ti~sue, de~troying targeted cell membranes and vaporizing cellular contents.
During laser microlaryngeal surgery, an unobstructed, binocular view of a lesion is provided.
This provides advantages over other known types of laryngeal surgery, such as diathermy and cryosurgery, which utilize a probe that may obscure a surgeon's view of the operative field. In addition, laser~ provide a relatively bloodless field, and post-operative edema is usually absent because the area treated by laser i~
sharply defined. Ideally, laser surgery leaves the surrounding tissue totally unaffected, allowing rapid healing with minimal post-operative scarring.
One con~ideration of microlaryngeal surgery is that the operative field is shared by the anesthesiologist and the surgeon. This can be addressed by using an endotracheal tube having an outer diameter sufficiently small to permit the surgery to take place while having an inflatable cuff large enough to ma~e a seal.
Alternatively, the surgery can occur with no tube in the airway with patient ventilation and anesthetic gas delivery given during interruption~ in surgery via a mask.
There are disadvantages to having no tube in the airway. These include: lack of complete airway control, the possibility of apnea or hypoventilation with secondary cardiac arrythmias, laryngospasm from too light a plane of anesthesia, non-immobilized vocal cords, and exhalation of potent anesthetic gases through the open mouth of the patient making scavenging of these gases difficult.

Z~ 79 .

Although performing microlaryngeal surgery with no tube in the airway is undesirable for reasons listed above, problems also arise during laser microlaryngeal surgery when employing an endotracheal tube. These problems typically involve damage caused by the laser of one or both of the endotracheal tube and inflatable cuff.
Laser damage to the ventilation device may result in loss of airway management, burning of respiratory tis~ue, and the production of toxic fumes.
One method which has been proposed to reduce the risk of damaging the endotracheal tube during laser surgery is to wrap the endotracheal tube with metallic tape. However, wrapping a tube in metal tape is time consuming, and rough edges of the tape may abrade and in~ure the mucosa of the pharynx and larynx. In the event of a poor wrapping ~ob, the possibility exists that uncovered areas can be ignited, as does the possibility that loose pieces of tape can be aspirated. Wrapped metal tape increases the possibility of a kink developing in the tube, and inadvertent mucosal damage may occur due to reflection of the laser beam off the type.
Another proposed method for reducing the risk of ignition of an endotracheal tube is to wrap the tube in wet muslin. However, this also i8 time consuming, and the muslin adds additional bulk to the tube.
Additionally, the muslin may dry out and ignite during surgery.
Yet another proposed method for reducing the risk of ignition of an endotracheal tube is to coat the tube with dental acrylic. However, dental acrylic rigidifies the tube and is not completely impenetrable by surgical lasers. The dental acrylic further adds undesired bulk to the tube and is time consuming to apply.
2(~01779 Metal tracheal tubes also have been utilized to avoid ignition of the tube during laser surgery, but problems with the use of metal tracheal tubes have been encountered. These problems include tissue damage brought about by insertion of rigid metal tubes, and inadvertent mucosal damages due to reflection of the laser beam off of the metal tube. Metal tracheal tubes typically have large external diameters which precludes their use with pediatric patients and patients with tracheal stenosis, and generally have no inflatable cuff for creating an air-tight seal. Moreover, the currently available flexible metal tracheal tubes typically are constructed such that the wall of the tube is not air tight.
Venturi ventilation has been employed during laser microlaryngeal surgery, but this may poses problems such as pneumothorax, pneumomediastinum, stomach inflation, aspiration of secretions, complete respiratory obstruction, and dehydration of mucosal surfaces.
The use of metallically filled polymers for tube construction also has been suggested to reduce the risk of ignition of endotracheal tubes. However, proposed metallically filled polymers provide only minimal resistance to penetration by laser beam impact (especially in 0~/N02 enriched atmospheres), and are generally quite expensive.
There remains a need in the art for a surgical ventilation device which is resistant to laser-caused dysfunction during laser surgery.
SummAry of the Inventlon In accordance with the present invention, a ~urgical ventilation device resistant to laser-caused dysfunction during laser surgery defines a continuous gas passageway for passage of ventilation gases during surgery. The ~1779 device includes a beveled di~tal end to facilitate insertion into a patient's airway, the distal end defining a portion of the continuous gas passageway. A
proximal end is also provided for connecting the S continuous gas passageway to a source of gas. The surgical ventilating device of this invention includes an airtight flexible metal tube having an airtight wall portion connecting the distal end and the proximal end of the ventilating device. The metal tube is refiistant to damage by a surgical laser and has a matte outer surface for dispersing unfocused light when a surgical laser beam is directed again~t the outer surface of the device. The metal tube defines a substantial portion of the continuous gas passageway. A lower, liquid-inflatable polymeric sealing cuff and an upper, liquid-inflatable barrier cuff are connected to and longitudinally disposed along a lower polymeric tubing assembly at the distal end of the device, the lower cuff being situated between the upper cuff and the distal end. The lower polymeric tubing assembly, with upper and lower cuffs, is connected to the metal tube by a locking ferrule that compresses the polymeric tubing against the metal tube so as to prevent disengagement. The lower cuff is inflated with liquid to bring the lower cuff into sealing contact with a patient's airway and thereby prevent a gas leakage between the lower cuff and the airway. The upper cuff is inflated with liquid for bringing the upper cuff into contact with airway to thereby shield the lower cuff from damage caused by laser energy directed toward the lower cuff.
Brief DescriPt~on of the Drawings FIG. 1 is an elevation view, partly schematic, of a laser-resistant surgical ventilation device in accordance with the present invention.

20~1779 FIG. 2 is an enlarged elevation view, partly schematic and in partial cross-section, of the laser-resistant double-cuffed distal end of the surgical ventilation device shown in FIG. 1.
FIG. 3 is a cross-sectional view along line 3-3 of FIG. 2.
FIG. 4 i8 a perspective view in partial cross-section and with a portion enlarged of a segment of a metal tube of a surgical ventilating device according to one embodiment of the invention.
FIG. 5 is a partly schematic elevation view with portions broken away of a ventilating device according to the invention showing interconnection of tubing elements according to one embodiment.
FIG. 6 is a cro~s-sectional view of a connected pair of liquid conduits for inflating elastomeric cuffs of the surgical ventilation device shown in FIG. 1.
FIG. 7 is an enlarged, partly schematic, elevation view with portions bro~en away and portions removed, showing interconnection of the lower portions of a ventilating device with a locking ferrule according to a preferred embodiment of the invention.
FIG. 8 is an enlarged, partly schematic, elevation view with portions broken away and portions in cross-section, showing interconnection of the lower portions ofa ventilating device with a locking ferrule according to another embodiment of the invention.
Detailed Description of the Preferred ~mbodiment The endotracheal tube 10 shown in Figs. 1 and 2 is a surgical ventilation device which i~ resistant to laser-caused dysfunction during laser surgery. The device defines a continuous ga~ passageway 12 for passage of ventilation gases (including anesthetic and respiratory ga~es) during surgery.

20Q1~779 Endotracheal tube 10 includes a distal end 14 with a beveled tip to facilitate insertion into a human trachea, and defines a portion of the continuous gas passageway 12.
Endotracheal tube 10 further includes a proximal end 16 for connecting the continuous gas passageway 12 to a source of gas (not shown).
A flexible metal tube 18 having an airtight wall portion is disposed between the distal end 14 and the proximal end 13 of the ventilation device. The flexible metal tube 18 is resistant to damage by a surgical laser, and as can be seen in Fig. 1, metal tube 18 defines a substantial portion of the continuous gas passageway 12.
The proximal end 13 of the ventilation device is connected to the metal tube 18 by an upper polymeric tubing 17 disposed over the proximal end of metal tube 18 to form an airtight fit.
In order to prevent inadvertent and unintended damage to a patient' 8 tissue6 during surgery due to reflection of a laser beam off of the metal tube, metal tube 18 is provided with a matte outer surface for dispersing unfocused light when a surgical laser beam is directed against the outer surface of the metal tube.
The airtight metal tube 18 may be of any suitable construction to permit flexibility, such as a helically convoluted metal hose, a segmented flexible metal hose or corrugated bellows, and is characterized by substantial continuity from one end to another so as not to provide laser-penetrable apertures in the sidewall of the metal tube.
Advantageously, the flexible metal tube 18 i8 constructed of stainless steel for corrosion resistance.
The matte exterior finish of the flexible metal tubing 2~1779 reflects a highly unfocused beam, which minimizes the potential of inadvertently damaging tissue.
One suitable construction for metal tube 18 is shown in Fig. 4. According to this embodiment, metal tube 18 starts out as a thin stainless steel ribbon (i.e., .0035"
thick and .212" wide). This ribbon is fed through a die set to form a helically convoluted hose or tube. The die crimps the ribbon 19 back on to itself as shown in Fig.
4. At the same time ribbon 19 is being formed in the die, a fine metallic filament 21 is fed into an overlapping channel between ad~acent crimped ribbon portions. Metallic filament 21 has a lower melting temperature than the metallic compo~ition of ribbon 19.
The formed strip wound metal hose is heat treated in order to melt the metallic filament 21 and thus hermetically seal the seam.
Referring back to Figs 1-3, approximate the distal end 14 of endotracheal tube 10 is located a lower liquid-inflatable elastomeric sealing cuff 20 with lower proximal cuff shoulder 21 inverted to reduce the required intratracheal length, and an upper liquid-inflatable barrier cuff 22 with upper proximal cuff shoulder 23 inverted to both reduce the re~uired intratracheal length and to minimize the exposure of polymeric materials. The ventilating device is airtight along its length from the proximal end 13 thereof to cuffs 20 and 24.
The lower and upper cuffs 20 and 22, respectively, are mounted on the outer surface of a lower polymeric tubing assembly comprised of a tubular polymeric distal tip member 24 and a tubular polymeric sleeve 24'. As shown in Figs. 1 and 2, the lower cuff 20 is positioned between the upper cuff 22 and the distal end 14 of the endotracheal tube 10.

The polymeric portions of the ventilation device, including tubing assembly 24, 24' and upper polymeric tubing 17, may be constructed of any suitable biocompatible material, such as biocompatible polyvinyl chloride, polyurethane, silicone and the like.
Tip member 42, at the distal end 14 of endotracheal tube 10 is an atraumatic insertion tip including a longitudinal ventilation opening lSa, and advantageously includes a transverse ventilation opening lSb in the event that the longitudinal opening lSa i8 blocked during use.
In the embodiment shown in Figs. 1 and 2, the tip member 24 is received within the polymeric sleeve 24' and attached thereto by any suitable mean~, such as an ultraviolet (U.V.) light-cured adhesive, chemical weld or glue. The polymeric slee~e 24' comprises a proximal end section of the lower polyneric assembly, within which is received the distal end of the metal tube 18, thus connecting the distal end 26 of metal tube 19 with the proximal end section of the lower polymeric tubing assembly.
By the present invention, a locking ferrule is provided for preventing disengagement of the lower polymeric tubing assembly from the metal tube 18. At least a portion of the locking ferrule i~ pinched inwardly so as to compress the proximal end section of polymeric sleeve 24' against the metal tube 18. In the embodiment preferred shown in Figs. 2, 5 and 7, the locking ferrule 25 of the invention is an annular metal collar that extends around the proximal end section of polymeric sleeve 24~. An annular crimp 27 is provided by compressing (i.e., crimping) the locking ferrule on its outside diameter, which reduces the outside diameter of the locking ferrule along the crimp and form~ a 2C~01779 mechanical bond between the proximal end section of sleeve 24' and spirals of metal tube 18, thereby preventing disengagement. A glue or other adhesive such as U.V. curable adhesive 29 (shown in Fig. 8) can be used to further connect and seal the distal end of metal tube 18 to sleeve 24'.
Although the annular crimp 27 discussed above with reference to Figs. 2, 5 and 7 is the preferred embodiment, other embodiments that pinch the locking ferrule inwardly may be used. For example, in Fig. 8, a locking ferrule 25' is disclosed which includes a plurality of inwardly pinched depressions 27' that "stake" the locking ferrule 25' to the metal tube 18 while compressing the proximal end section of sleeve 24' against the metal tube 18 to prevent disengagement therefrom. As previously discussed, a glue or other adhesive 29 can be used to further connect and seal the distal end of metal tube 18 to sleeve 24'. An annular crimp as detailed in Fig. 7 is the preferred embodiment over staking, since the annular crimp has been found to form a stronger mechanical bond and provide a better seal than staking.
In the embodiments shown, cuffs 20 and 22 are polymeric, and attached to polymeric tubing 24 by any suitable means such as by heat sealing. Suitable materials for forming the polymeric cuffs include polyvinyl chloride, polyurethane, silicone and the like.
Means are provided for inflating the lower sea~ ng cuff 20 to bring the lower cuff 20 into sealing contact with a patient's trachea and thereby prevent leakage of gas between the lower cuff 20 and the trachea. Although sealing cuff 20 can be inflated with a gaseous fluid, in the preferred embodiment, sealing cuff 20 is inflated with an aqueous liquid. To effect inflation of sealing 20~1779 cuff 20, a first inflation lumen 29 is provided in the lower polymeric tip member 24, lumen 28 being in communication with lower cuff 20 by means of port 30.
See Figs. 2 and 3.
S Inflation lumen 28 is connectable with a fluid source for inflation of lower cuff 20 by means including a first conduit 32.
Conduit 32 i8 disposed within metal tube 18 for protection against laser damage durinq surqery, and connects lower cuff 20 with a first valve 34 for connecting the first conduit 32 with a liquid source ~not ~hown) and for controlling inflation and deflation of lower cuff 20.
Means are provided for inflating the-upper barrier cuff 22 with an aqueous liquid for bringing the upper cuff 22 into contact with a patient's trachea to thereby shield the lower cuff 20 from damage caused by laser energy directed towards the lower cuff. Upper cuff 22 shields the lower cuff from damage by a surgical laser by being positioned between an area of laser surgery (e.g., in an area ad~acent metal tube 18) and the fluid-filled sealing cuff 20.
The upper barrier cuff 22 is inflated by means including a second inflation lumen 36 in the lower polymeric tip member 24,. The second inflation lumen 36 is in communication with the upper cuff 22 through port 38. The second inflation lumen 36 i8 connectable with a second liquid source for inflation of upper cuff 22 by means including a second conduit 40 disposed within metal tube 18 for protection against laser damage. The second conduit 40 connects the second inflation lumen 36 with a second valve 41 in communication with a liquid source (not shown) for controlling inflation and deflation of upper cuff 22.

In the embodiment shown in Fig. 1, the first and second conduits 32 and 40 exit metal tube 18 through a standard 15 mm connector 16 for connecting to a source of gas. The connector 16 can be constructed of rigid or semi-rigid biocompatible polymeric materials such as PVC
and ABS. The connector 16 is attached to metal tube 18 by any suitable means, such as glue or other adhesive.
If desired connector 16 can be attached to metal tube 18 in the same manner as lower polymeric sleeve 24'.
Conduits 32 and 40 are adhered together a~ shown in Fig. 6 by means of a solvent or by extruding them as one.
This, along with the orientation of lumens 36 and 28, allow easy passage of suctions and stylets through gas passageway 12. Conduits 32 and 40 exit through a port in connector 16. They are anchored in this port by means such as glue.
In the embodiment shown in Fig. 5, the ends 18a and 18b of metal tube 18 are partially deconvoluted. The increase in distance between convolutions of metal tube 18 at the ends provides a means for an adhesive to mechanically hold onto the stainless steel tubing. The proximal end 18a of the tube 18 has adhesive applied to it 360 around the outer diameter thereof and tXe upper polymeric tubing 17, such as a standard l5mm connector, is slid over the metal tube. The distal end 18b of tube 18 has adhesive applied to it 360 around the outer diameter thereof and lower polymeric sleeve 24' expanded and placed on the metal tube. A plastic atraumatic tip including ventilation openings l5a and 15b (as shown in Fig. 2) can be solvent bonded to the internal diameter of the lower polymeric sleeve 24~ such that it butts up against the end of the metal tube. Locking ferrule 25 is 20Ct1779 crimped (and/or staked, if desired) about the proximal end section of sleeve 24~ to prevent disengagement from metal tube 18.
After tracheal tube 10 is intubated (i.e., inserted S into a patient~s trachea), the cuffs 20 and 22 are fluid filled with sterile isotonic saline solution. The lower sealing cuff 20 is pressurized to maintain a tracheal seal, and the upper bearing cuff 22 is filled, but advantageously not to the point of creating any substantial pres~ure (e.g., filled to near atmospheric pressure). When fluid in the upper barrier cuff i~ at or near atmospheric pressure, a single perforation of the barrier cuff 22 by a surgical laser does not result in substantial fluid drainage from barrier cuff 22.
The probability of hitting a cuff during a single laser laryngeal surgery procedure can be determined from Pried, M.P., "A Survey of the Complications of Laser Surgeryn, Arch. OtolarYnqoloq~, 110:31-34 (1984). The probabilities have been calculated as follows:
P (hitting cuff 1 time) = .06173 P (hitting cuff 2 times) = .00381 P (hitting cuff 3 times) = .00024 P (hitting cuff 4 times) = .00001 Since a single laser perforation of the barrier cuff 22 does not result in a substantial amount of fluid drainage due to about atmospheric pressure in ~arrier cuff 22, it can be seen that barrier cuff 22 provides a substantial amount of protection for sealing cuff 20 and distal end 14 of tubing 24. Further, water is an excellent absorber of the 10.6~ wavelength of a carbon dioxide laser such that surface molecules of the water are boiled off and the laser energy dissipated providing further protection for sealing cuff 20. The water in the barrier cuff 22 also eliminates virtually any threat of ignition and burning of the polymeric cuffs.
According to one embodiment, the barrier cuff may be filled with a colored aqueous solution which will leak S out if the cuff i8 perforated and thereby visually indicate that the cuff has been perforated. An example of a suitable dye for coloring the aqueous ~olution i8 methylene blue. Other types of dyes may also be used.
It can be seen that the present invention provides a stable surgical ventilation system which is highly resistant to laser-caused dysfunction during laser surgery. The matte-finished flexible metal tube i8 ~mpenetrable by a surgical laser and reflects a highly out-of-focus beam to preclude inadvertent damage to tissue. The locking ferrule preventY disengagement of the metal tube from the lower polymeric tubing carrying the double-cuff system. The liquid-filled barrier cuff provides protection to the tracheal sealing cuff against damage by a laser beam impact. The double-cuff system allows the user at least one cuff hit that will not cause loss of protection by the barrier cuff and lead to tracheal tube dysfunction. This, along with the very low probability that the cuff will be hit again and the stability of the system resulting from the locking ferrule, provides for safe and effective airway control during laser surgery.
Since many modifications, variations and changes in detail may be made to the described embodiments, it is intended that all matter in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense.

Claims (22)

1. A surgical ventilation device defining a continuous gas passageway for passage of ventilation gases during surgery, which is resistant to laser-caused dysfunction, the ventilation device comprising:
a. a lower polymeric tubing assembly including a distal end which comprises a distal end of the ventilation device, which defines a portion of the continuous gas passageway and which is adapted for insertion into a patient's airway, the lower polymeric tubing assembly further including a proximal end section;
b. a proximal end having means for connecting the ventilation device to a source of gas;
c. a flexible airtight metal tube defining a substantial portion of the continuous gas passageway and connecting the lower polymeric tubing assembly and the proximal end of the ventilation device, the metal tube being resistant to damage by a surgical laser and having a matte outer surface for dispersing unfocused light when a surgical laser beam is directed against the outer surface, wherein a distal end of the metal tube is received within the proximal end section of the lower polymeric tubing assembly;
d. an upper liquid-inflatable cuff connected to and disposed along the lower polymeric tubing assembly near the distal end of the ventilation device;
e. a lower liquid-inflatable cuff connected to and disposed along the lower polymeric tubing assembly near the distal end of the ventilation device, the lower cuff being located between the distal end of the ventilation device and the upper cuff;
f. a locking ferrule that extends around the proximal end section of the lower polymeric tubing assembly, wherein at least a portion of the locking ferrule is pinched inward to compress the proximal end section of the lower polymeric tubing assembly against the metal tube and thereby prevent separation of the lower polymeric tubing assembly and the metal tube;
g. means for inflating the lower cuff with liquid for bringing the lower cuff into sealing contact with the patient's airway to prevent leakage of gas between the lower cuff and the airway, the means for inflating the lower cuff including a first conduit disposed within the metal tube to thereby protect the first conduit from laser damage, the first conduit being in contact with the lower cuff and being connectable with a source of liquid for inflating the lower cuff; and h. means for inflating the upper cuff with liquid for bringing the upper cuff into contact with the patient's airway the thereby shield the lower cuff from damage caused by laser energy directed toward the lower cuff, the means for inflating the upper cuff including a second conduit disposed within the metal tube to thereby protect the second conduit from laser damage, the second conduit being in contact with the upper cuff and being connectable with a source of liquid for inflating the upper cuff.
2. The surgical ventilation device according to claim 1, wherein the ventilation device is airtight from the proximal end of the ventilation device to the upper and lower cuffs.
3. The surgical ventilation device according to claim 1, wherein the locking ferrule is metal.
4. The surgical ventilation device according to claim 3, wherein the locking ferrule is crimped into place about the metal tube with the proximal end section of the lower polymeric tubing assembly compressed therebetween.
5. The surgical ventilation device according to claim 3, wherein the locking ferrule is staked into place about the metal tube with the proximal end section of the lower polymeric tubing assembly compressed therebetween.
6. The surgical ventilation device according to claim 1, further including an adhesive between the metal tube and the proximal end section of the lower polymeric tubing assembly.
7. The surgical ventilation device according to claim 1, wherein the lower polymeric tubing assembly is comprised of a tubular polymeric distal tip member and a tubular polymeric sleeve that connects the tip member to the metal tube, the sleeve including the proximal end section of the lower polymeric tubing assembly.
8. The surgical ventilation device according to claim 1, wherein the metal tube is formed from a material selected from the group consisting of helically convoluted metal hose, segmented flexible metal hose and corrugated bellows.
9. The surgical ventilation device according to claim 1, further including an upper polymeric tubing assembly connecting the proximal end of the ventilation device to the metal tube.
10. The surgical ventilation device according to claim 1, wherein liquid for filling the upper and lower cuffs is an aqueous liquid.
11. The surgical ventilation device according to claim 1, wherein the patient's airway is a patient's trachea.
12. A surgical ventilation device defining a continuous gas passageway for passage of ventilation gases during surgery, which is resistant to laser-caused dysfunction, the ventilation device comprising:
a. a lower polymeric tubing assembly including a distal end which comprises a distal end of the ventilation device, which defines a portion of the continuous gas passageway and which is adapted for insertion into a patient's airway, the lower polymeric tubing assembly further including a proximal end section;
b. a proximal end having means for connecting the ventilation device to a source of gas;
c. a flexible airtight metal tube defining a substantial portion of the continuous gas passageway and connecting the lower polymeric tubing assembly and the proximal end of the ventilation device, the metal tube being resistant to damage by a surgical laser and having a matte outer surface for dispersing unfocused light when a surgical laser beam is directed against the outer surface, wherein a distal end of the metal tube is received within the proximal end section of the lower polymeric tubing assembly;
d. an upper liquid-inflatable cuff connected to and disposed along the lower polymeric tubing assembly near the distal end of the ventilation device;
e. a lower liquid-inflatable cuff connected to and disposed along the lower polymeric tubing assembly near the distal end of the ventilation device, the lower cuff being located between the distal end of the ventilation device and the upper cuff;
f. a locking ferrule that extends around the proximal end section of the lower polymeric tubing assembly, wherein at least a portion of the locking ferrule is pinched inward to compress the proximal end section of the lower polymeric tubing assembly against the metal tube and thereby prevent separation of the lower polymeric tubing assembly and the metal tube;
g. means for inflating the lower cuff with liquid for bringing the lower cuff into sealing contact with the patient's airway to prevent leakage of gas between the lower cuff and the airway, the means for inflating the lower cuff including; a first inflation lumen disposed within the lower polymeric tubing assembly and communicating with the lower cuff, a first conduit in communication with the first inflation lumen and disposed within the metal tube to thereby protect the first conduit from laser damage, and a first valve in communication with the first conduit and connecting the first conduit with a liquid source, the first valve for controlling inflation of the lower cuff; and h. means for inflating the upper cuff with liquid for bringing the upper cuff into contact with the patient's airway to thereby shield the lower cuff from damage caused by laser energy directed toward the lower cuff, the means for inflating the upper cuff including; a second inflation lumen disposed within the lower polymeric tubing assembly and communicating with the upper cuff, a second conduit in communication with the second inflation lumen and being disposed within the metal tube to thereby protect the second conduit from laser damage, a second valve in communication with the second conduit and connecting the second conduit with a liquid source, the second valve for controlling the inflation of the upper cuff.
13. The surgical ventilation device according to claim 12, wherein the ventilation device is airtight from the proximal end of the ventilation device to the upper and lower cuffs.
14. The surgical ventilation device according to claim 12, wherein the locking ferrule is metal.
15. The surgical ventilation device according to claim 14, wherein the locking ferrule is crimped into place about the metal tube with the proximal end section of the lower polymeric tubing assembly compressed therebetween.
16. The surgical ventilation device according to claim 14, wherein the locking ferrule is staked into place about the metal tube with the proximal end section of the lower polymeric tubing assembly compressed therebetween.
17. The surgical ventilation device according to claim 12, further including an adhesive between the metal tube and the proximal end section of the lower polymeric tubing assembly.
18. The surgical ventilation device according to claim 12, wherein the lower polymeric tubing assembly is comprised of a tubular polymeric distal tip member and a tubular polymeric sleeve that connects the tip member to the metal tube, the sleeve including the proximal end section of the lower polymeric tubing assembly.
19. The surgical ventilation device according to claim 12, wherein the metal tube is formed from a material selected from the group consisting of helically convoluted metal hose, segmented flexible metal hose and corrugated bellows.
20. The surgical ventilation device according to claim 12, further including an upper polymeric tubing assembly connecting the proximal end of the ventilation device to the metal tube.
21. The surgical ventilation device according to claim 12, wherein liquid for filling the upper and lower cuffs is an aqueous liquid.
22. The surgical ventilation device according to claim 12, wherein the patient's airway is a patient's trachea.
CA002001779A 1987-02-02 1989-10-30 Laser resistant ventilating device with locking ferrule Expired - Lifetime CA2001779C (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US07/009,747 US4834087A (en) 1987-02-02 1987-02-02 Laser resistant ventilating device
US009,747 1987-02-02
US266,666 1988-11-03
US07/266,666 US4953548A (en) 1987-02-02 1988-11-03 Laser resistant ventilating device with locking ferrule

Publications (2)

Publication Number Publication Date
CA2001779A1 CA2001779A1 (en) 1990-05-03
CA2001779C true CA2001779C (en) 1994-08-30

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CA002001779A Expired - Lifetime CA2001779C (en) 1987-02-02 1989-10-30 Laser resistant ventilating device with locking ferrule

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CA2001779A1 (en) 1990-05-03

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