Novel endotracheal bronchoscope sleeve for ventilation procedures

Abstract

A broncho-sleeve for one-lung or two-lung ventilation procedures includes an elongated body having a distal end and a proximal end, the elongated body defining a lumen therein; and a bronchial cuff attached to the distal end of the elongated body. The bronchial cuff is inflatable to provide a single-lung bronchial blocker allowing one-lung ventilation when the distal end is positioned in a left or a right bronchial lumen, and to provide two-lung ventilation when the distal end is positioned in a trachea. The elongated body has an outer diameter less than 7.5 mm and an inner diameter of at least 2.8 mm.

Description

NOVEL ENDOTRACHEAL BRONCHOSCOPE SLEEVE FOR VENTILATION PROCEDURESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present patent application claims priority benefit to U.S. Provisional Patent Application No. 63 / 547,228, filed on November 3, 2023, the entire content of which is incorporated herein by reference. All references cited anywhere in this specification, including the Background and Detailed Description sections, are incorporated by reference as if each had been individually incorporated.BACKGROUND1. Technical Field

[0002] The currently claimed embodiments of the present invention relate to ventilation devices, and more particularly to a novel broncho-sleeve for one-lung or two-lung ventilation procedures.2. Discussion of Related Art

[0003] The current methodology' for one-lung ventilation procedures involves either insertion of a double-lumen tube (DLT)-which allows the anesthesiologist to regulate ventilation in and out of the isolated lung and the healthy lung-or placement of SLT with a bronchial blocker (BB)- -which uses a balloon to isolate the non- ventilated lung and a single lumen to ventilate the healthy lung. The current DLTs comes in different sizes corresponding to outer diameter of 12 to 15 mm and inner diameter of each lumen in range of 4.3-5.4 mm. The current SLT comes in different sizes corresponding to the outer diameter of 8.5 to 11.5 mm.

[0004] The primary' issues with these devices can be observed at three intervention points:1. Technical difficulty7when placing the double lumen device in the airway leads to damage to the vocal cords (41%), bronchial airway (41%), and tracheal (57%) airway. As a result, achieving correct placement of the device may necessitate extra OR time, which is a hindrance to the OR staffs and surgeons' tight schedules. Furthermore, it is a financial disadvantage to the hospital.2. Frequent dislodgement (12%) during the surgery leads to hypoxemia (5- 10%) if the healthy lung is not adequately ventilated. Dislodgment may also lead to ventilation of the isolated lung which may disrupt the surgical procedure. Additionally, repositioning the device following dislodgement is difficult and requires extra OR time.3. The necessity to exchange the DLT with a single lumen endotracheal tube at the end of the procedure leads to postoperative complications including hypoxemia (lack of oxygen in the blood), pneumothorax (collapsed lung), and mortality7.4. The BB in particular presents issues in effectively isolating the lung and performing suctioning on the isolated lung as well as visualization of the anatomy.

[0005] Therefore, there remains a need for improved devices and methods for ventilation procedures.SUMMARY

[0006] A broncho-sleeve for one-lung or two-lung ventilation procedures according to an embodiment of the current invention includes an elongated body having a distal end and a proximal end, the elongated body defining a lumen therein; and a bronchial cuff attached to the distal end of the elongated body. The bronchial cuff is inflatable to provide a single-lung bronchial blocker allowing one-lung ventilation when the distal end is positioned in a left or a right bronchial lumen, and to provide two-lung ventilation when the distal end is positioned in a trachea. The elongated body has an outer diameter less than 7.5 mm and an inner diameter of at least 2.8 mm.

[0007] A device for one-lung ventilation procedures according to an embodiment of the current invention includes an endotracheal tube defining a lumen therein and having a distal endand a proximal end; an inflatable tracheal cuff attached to the distal end of the endotracheal tube; an adaptor at least one of attached to or integral with the proximal end of the endotracheal tube, the adapter comprising a ventilation connector and defining a broncho-sleeve port; and a bronchosleeve having a distal end and a proximal end, the broncho-sleeve configured to be inserted through the broncho-sleeve port for performing a one-lung ventilation procedure. The bronchosleeve comprises a bronchial cuff attached to the distal end thereof, the bronchial cuff being inflatable to provide a single-lung bronchial blocker, and the broncho-sleeve is sufficiently narrow to allow ventilation of a non-target lung alongside the broncho-sleeve through the lumen of the endotracheal tube while the single-lung bronchial blocker is deployed for a target lung.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Embodiments of the present invention, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention.

[0009] FIG. 1 is a schematic illustration of two bronchosleeves according to an embodiment of the current invention being used in conjunction with each other.

[0010] FIG. 2 is a schematic illustration of two bronchosleeves according to an embodiment of the current invention being used in conjunction with each other similar to FIG. 1 but positioned differently.

[0011] FIG. 3 is a schematic illustration of a bronchosleeve according to an embodiment of the current invention in conjunction with a single lumen EET.

[0012] FIG. 4 is a schematic illustration of a bronchosleeve according to an embodiment of the current invention in conjunction with a single lumen EET and a fiberoptic scope.

[0013] FIG. 5 is a schematic illustration that is similar to FIG. 4 showing an example of use.

[0014] FIG. 6 is a schematic illustration of a bronchosleeve according to another embodiment of the current invention.

[0015] FIGS. 7A-7C are a schematic illustrations of bronchosleeves according to additional embodiments of the current invention.

[0016] FIGS. 8A-8B are a schematic illustrations of bronchosleeves according to additional embodiments of the current invention.

[0017] FIG. 9 is a schematic illustration of a bronchosleeve according to another embodiment of the current invention in conjunction with the system being used.

[0018] FIG. 10 is a schematic illustration of a bronchosleeve according to another embodiment of the current invention which is being used in conjunction with a second bronchosleeve according to an embodiment of the current invention.

[0019] FIG. 11 is a schematic illustration to help explain the use of a bronchosleeve according to an embodiment of the current invention.DETAILED DESCRIPTION

[0020] Some embodiments of the current invention are discussed in detail below. In describing embodiments, specific terminology is employed for the sake of clarity. However, the invention is not intended to be limited to the specific terminology so selected. A person skilled in the relevant art will recognize that other equivalent components can be employed, and other methods developed, without departing from the broad concepts of the present invention. All references cited anywhere in this specification are incorporated by reference as if each had been individually incorporated.

[0021] The terms ‘"cuff” and “inflatable cuff" are intended to have broad meanings to include, but are not limited to, inflatable balloons.

[0022] The terms single lumen tube (SLT) and endotracheal tube (ETT) are used interchangeably to refer to the same or equivalent structures.

[0023] Accordingly, an embodiment of the current invention is directed to an accessory device to the single-lumen tube (SLT). In some embodiments, the device has a small diameter tube with an adaptor for bronchoscope insertion and pilot balloon for inflation at the distal end of the device. The distal portion of the tube contains a cuff for inflation inside one bronchus or a trachea.

[0024] According to some embodiments, the Bronchosleeve is a single-lumen device which is inserted through the SLT and slides over the bronchoscope to create a "sleeve," around which ventilation is supplied to the non-target lung. This solution can combine the benefits of a doublelumen tube (DLT) and BB while eliminating the disadvantages of each. The reduced diameter of the Bronchosleeve can allow for easier insertion in comparison to the DLT, whose bulkiness and stiffness prevents flexibility during placement of the device. The device can allow for easier surgical insertion due to its placement within the SLT, whose curvature and radius is better suited for patient airways. Since the Bronchosleeve eliminates the need to switch from a DLT to an SLT post-operatively. it can better integrate into the transition between operative and post-operative patient care. The rates of dislodgement for the bronchosleeve may be lower than those for the DLT since the Bronchosleeve is inserted independently of the SLT and, thus, does not have direct contact with the trachea like the DLT does. While bronchial and EZ blockers limit lung inflation and deflation capabilities due to their miniscule lumen diameter, the Bronchosleeve can permit inflation and both deflation and suction via insertion of a bronchoscope with a suction attachment through its central lumen or a suction catheter. Many surgeons prefer to have the bronchoscope inserted into the lung throughout the procedure to maintain visualization of the lung, for which the Bronchosleeve allows. Overall, the Bronchosleeve allows for lung separation while optimizing key components of surgical functionality required by surgeons and anesthesiologists to efficiently conduct the operation. While performing the same function as the current gold standard, the Bronchosleeve can minimize problems created by current devices and significantly de-risks the one lung ventilation procedure.

[0025] An embodiment of a broncho-sleeve (100, 200) for one-lung or two-lung ventilation procedures is shown schematically in FIG. 1. In that case, two such broncho-sleeves (100, 200) according to some embodiments of the current invention are shown being used for a ventilationprocedure in conjunction. The broncho-sleeves 100, 200 according to an embodiment of the current invention each include an elongated body 102, 202 having a corresponding distal end 104, 204 and a proximal end 106. 206 and a bronchial cuff 108, 208 attached to the distal end 104. 204 of the elongated body, 102, 202, respectively. The elongated body 102, 202 defines a lumen therein. For example, it can be a hollow tube-like structure. The bronchial cuff 108, 208 can be inflatable to provide a single-lung bronchial blocker allowing one-lung ventilation when the distal end is positioned in a left or a right bronchial lumen, and to provide two-lung ventilation when distal end is positioned in a trachea. FIGS. 1 and 2 show a few examples of use of the bronchial cuff which can be used individually if one broncho-sleeve is used, or in combination in different ways in the case that two broncho-sleeves are used. The general concepts of the current invention are not limited only to the examples of bronchial cuffs and broncho-sleeves shown as examples in FIGS. 1 and 2. Further examples will be shown below.

[0026] The elongated body of the broncho-sleeve (102. 202) has an outer diameter less than 7.5 mm and an inner diameter of at least 2.8 mm. In some embodiments, the elongated body (102, 202) of the broncho-sleeve (100, 200) can have an outer diameter within the range of 7.5 mm to 3.0 mm. When it is larger than about 7.5 mm the broncho sleeve becomes too wide to be used in conjunction with a second broncho-sleeve and / or within a single-lumen endotracheal tube. If the outer diameter is less than 3.0 mm. then there isn't sufficient width for the elongated body to have a sufficient wall thickness for the requisite mechanical properties as well as providing a sufficiently wide lumen that can accommodate a bronchoscope and / or provide sufficient ventilation. In some embodiments, the elongated body (102, 202) of the broncho-sleeve may have an outer diameter within the range of 6.5 mm to 4.0 mm, or 6.0 mm to 4.5 mm.

[0027] In an embodiment, the elongated body of the broncho-sleeve (102, 202) may have an outer diameter of about 6.0 mm. In some embodiments, the elongated body (102, 202) of the broncho-sleeve may have a wall thickness of at least 0. 1 mm and less than 0.6 mm. If the wall thickness is less than 0.1 mm, the elongated body may be too flexible and / or too likely to break during use. If the wall thickness is greater than 0.6 mm, the inner diameter of the elongated body (lumen cross sectional width) becomes too narrow to accommodate a bronchoscope and / or provide sufficient ventilation and / or the outer diameter of the elongated body becomes too large and the area between inner diameter of SLT and outer diameter of bronchosleeve (100, 200) becomes too small to ventilate the non-target lung. In some embodiments, the elongated body(102, 202) of the broncho-sleeve (100, 200) may have a wall thickness of at least 0.2 mm and less than 0.6 mm, at least 0.3 mm and less than 0.6 mm, at least 0.4 mm and less than 0.6 mm, or about 0.5 mm.

[0028] In some embodiments the elongated body (102, 202) of the broncho-sleeve(100, 200) may have an inner diameter (lumen cross sectional width) of at least 2.8 mm and less than 6.5 mm, at least 3.5 mm and less than 6.0 mm, at least 4.0 mm and less than 5.5 mm, or about 5.0 mm. In some embodiments, the elongated body (102, 202) of the broncho-sleeve (100, 200) has an outer diameter of about 6.0 mm, an inner diameter of about 5.0 mm and a wall thickness of about 0.5 mm. The term “about'’ means to within the tolerance ranges for similar devices sold in the field of use.

[0029] In some embodiments the elongated body (102, 202) of the broncho-sleeve (100, 200) may have an inner area (lumen cross sectional area) of at least 6 mm2(for the inner diameter of 2.8mm) and less than 45 mm2(for the inner diameter of 7.5). In some embodiments, the elongated body (102, 202) of the broncho-sleeve (100, 200) has an outer diameter of about 6.0 mm corresponding to the area of 28 mm2, an inner diameter of about 5.0 mm corresponding to the area of 20 mm2and a wall thickness of about 0.5 mm. When such a bronchosleeve (6.0 mm outer diameter) is placed via 8.0mm SLT with inner area of 50 mm2then the area to ventilate the nondependent lung is 22 mm2(50 mm2-28 mm2) which is roughly the same as an area to ventilate dependent lung via bronchosleeve (20 mm2). Combining SLT and bronchosleeve of different sizes will allow flexibility to have higher area for ventilation of either dependent or non-dependent lung depending on clinical needs.

[0030] In some embodiments, the broncho-sleeve (100. 200) can be inserted into the trachea as a standalone airway device. In some embodiments, one or two broncho-sleeves can be inserted in the airway via oral or nasal routes. (See, e g., FIGS. 1 and 2.) In some embodiments, when two broncho-sleeves are inserted, each is positioned into the left or right bronchus or main bronchus. One broncho-sleeve can be positioned in the trachea and the other advanced into the left or right main bronchus. This allows a combination of two broncho-sleeves to function as ■‘Left or Right DLT” without the need of single lumen ETT. In some embodiments, the bronchosleeve inserted into the airway can be used as a guide to facilitate insertion of single lumen ETT over the broncho-sleeve. (See, e.g., FIG. 3-6 and 9.) In FIG. 3, broncho-sleeve 300 is insertedthrough the lumen of ETT 320. To place ETT 320 over broncho-sleeve 300 the connector 322 on the broncho-sleeve to the ventilator is removable to allow passage inside ETT 320.

[0031] In a situation when a single lumen ETT is already placed in the airway, the bronchosleeve according to an embodiment of the current invention can be inserted and advanced into the trachea or bronchus through the lumen of the single lumen ETT. In this case, a combination of the single lumen ETT and broncho-sleeve can be used to separate lung ventilation.

[0032] In a situation when a single lumen ETT is already in place but needs to be changed, the broncho-sleeve according to an embodiment of the current invention can be inserted into the ETT to be used as an ETT tube exchanger.

[0033] In some embodiments, the broncho-sleeve 400 is designed explicitly for challenging narrow, intricate and difficult airways. It can be inserted into the airway either via oral or nasal passage. With its slender outer diameter, the broncho-sleeve can be precisely positioned with the intricate airway using a fiberoptic scope 432 where a larger single lumen endotracheal tube cannot be placed correctly. (See, for example, FIG. 4.) The broncho-sleeve according to an embodiment of the current invention not only provides efficient ventilation to both lungs, but it also sets a steadfast guiding track. This path then allows for seamless insertion of a larger size single lumen endotracheal tube, which can now smoothly "zip line’" over the broncho-sleeve along an established route for optimal placement.

[0034] In some embodiments, the elongated body of the broncho-sleeve has at least a distal portion that is formed into a coil structure 110 having a restoring force upon being stretched or compressed by one of a bronchoscope or a stylet. (See FIGS. 1. 2, 6, 8B. 9 and 10 for some examples.)

[0035] In some embodiments, the lumen defined by the elongated body is configured to receive a bronchoscope therein. (See FIGS. 4, 5, and 9-11 for some examples.)

[0036] In some embodiments, the elongated body 702C, 802A further includes a shapememory material 750, 850 at least one of attached to or embedded therein, the shape-memory material 750, 850 being responsive to a change of temperature. For example, a nitinol wire is suitable in some embodiments. (See FIGS. 7C, 8A for an example.)

[0037] In some embodiments, the lumen defined by said elongated body 702B is wider at the distal end 704 thereof. (See FIGS. 7B and 9 for a couple of examples.)

[0038] In some embodiments, the wide distal end has a width that substantially matches a width of the lumen of the endotracheal tube to be able to perform a cleaning function during use while the elongated body is drawn towards a proximal end of the endotracheal tube. (See FIGS. 7B and 9 for a couple of examples.)

[0039] In some embodiments, the bronchial cuff has a width that substantially matches a width of the lumen of the endotracheal tube to be able to perform a cleaning function during use while the elongated body is drawn towards a proximal end of the endotracheal tube. (See FIGS. 7B and 9 for a couple of examples.)

[0040] In some embodiments, the broncho-sleeve further includes a ventilator port at the proximal end of the elongated body of the broncho-sleeve configured to attach to a ventilator to effect at least one of ventilation, suctioning, or deflation of the target lung and removal of fluids therefrom. (See FIGS. 1-4, and 6-11 for some examples.)

[0041] In some embodiments, the bronchial cuff is configured to be inflatable to substantially a tracheal width to be able to secure a second broncho-sleeve used in conjunction therewith by opposing the coil structure of second broncho-sleeve. (See FIGS. 1 and 10 for a couple of examples.)

[0042] FIG. 10 shows examples of embodiments in which a basket or a hook 1060 can be included at the distal end 1004 of the elongated body 1002 of the broncho-sleeve 1000 to prevent obstruction of the distal end 1004 when the bronchosleeve 1000 touches the bronchial wall.

[0043] FIGS. 7C and 8A show examples of embodiments in which the inflatable cuff is a balloon that inflates asymmetrically to one side allowing for occlusion of the segmental bronchus.

[0044] Additional embodiments of the current invention include an endotracheal tube defining a lumen therein and having a distal end and a proximal end, an inflatable tracheal cuff attached to the distal end of the endotracheal tube, an adaptor at least one of attached to or integral with the proximal end of the endotracheal tube (the adapter including a ventilation connector and defininga broncho-sleeve port), and a broncho-sleeve according to an embodiment of the current invention.(See FIGS. 3-6, 9 and 11 for some examples.)

[0045] Some test of devices according to some embodiments lead to the following results.

[0046] Test #1 : The Bronchosleeve initially exceeded the bronchoscope length, limiting compatibility. Solution: Trimmed the device to match bronchoscope length and adjusted the lumen for cuff inflation, achieving precise alignment.

[0047] Test #2: Initial rigidity of the Bronchosleeve restricted essential bronchoscope maneuverability7within the trachea and bronchial tree. Solution: Shortened the device by 2 cm, allowing full, unimpeded movement of the bronchoscope tip for precise positioning.

[0048] Test #3: Contact with the bronchial wall led to lumen occlusion as the Bronchosleeve folded. Solution: Adj usted placement and evaluated reinforcement with a nitinol wire to maintain flexibility while preventing collapse.

[0049] Test #4: The deflated cuff was initially too wide, obstructing insertion through standard 9.0 ETT adapters. Solution: Temporarily removed the ETT adapter during testing; the final iteration incorporates an external adapter design for seamless insertion.

[0050] Test #5: Excess wall thickness in the Bronchosleeve prototype increased the outer diameter, complicating insertion. Solution: Reduced wall thickness for the modified design, optimizing the outer diameter for smoother insertion and improved fit.

[0051] Test #6: Incompatibility with existing adapters limited the capacity7for lung ventilation testing. Solution: Designed a custom adapter, modeled on bronchial blocker adapters but tailored to fit the Bronchosleeve, ensuring ventilation functionality7.

[0052] While various embodiments of the present invention have been described above, they have been presented by way of example only, and not limitation. Thus, the breadth and scope of the present invention should not be limited by any of the above-described illustrative embodiments but should instead be defined only in accordance with the following claims and their equivalents.

[0053] The embodiments illustrated and discussed in this specification are intended only to teach those skilled in the art how to make and use the invention. In describing embodiments of the disclosure, specific terminology is employed for the sake of clarity. However, the disclosure is not intended to be limited to the specific terminology so selected. The above-described embodiments of the disclosure may be modified or varied, without departing from the invention, as appreciated by those skilled in the art considering the above insights. It is therefore to be understood that, within the scope of the claims and their equivalents, the invention may be practiced otherwise than as specifically described. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

WE CLAIM:

1. A broncho-sleeve for one-lung or two-lung ventilation procedures, comprising: an elongated body having a distal end and a proximal end, said elongated body defining a lumen therein; and a bronchial cuff attached to said distal end of said elongated body, said bronchial cuff being inflatable to provide a single-lung bronchial blocker allowing one-lung ventilation when said distal end is positioned in a left or a right bronchial lumen, and to provide two-lung ventilation when distal end is positioned in a trachea, wherein said elongated body has an outer diameter less than 7.5 mm and an inner diameter of at least 2.8 mm.

2. The broncho-sleeve according to claim 1, wherein said elongated body has an outer diameter less than 7.5 mm and greater than 3.0 mm and an inner diameter of at least 2.8 mm and less than 6.5 mm.

3. The broncho-sleeve according to claim 2, wherein said elongated body has a wall thickness of at least 0. 1 mm and less than 0.6 mm.

4. The broncho-sleeve according to claim 3, wherein said elongated body has an outer diameter of about 6.0 mm, an inner diameter of at about 5.0 mm, and a wall thickness of about 0.5 mm.

5. The broncho-sleeve according to claim 1, wherein said elongated body has at least a distal portion that is formed into a coil structure having a restoring force upon being stretched or compressed by one of a bronchoscope or a stylet.

6. The broncho-sleeve according to any one of claims 1-5. wherein said elongated body has at least a proximal portion that is formed into a coil structure having a restoring force upon being stretched or compressed.

7. The broncho-sleeve according to any one of claims 1-6, wherein at least a portion of said elongated body of said broncho-sleeve and said bronchial cuff are configured to be inserted into a lumen defined by an endotracheal tube of said device for one-lung ventilation procedures, and wherein said at least said portion of said elongated body of said broncho-sleeve is sufficiently narrow to allow ventilation of a non-target lung there alongside through said lumen of said endotracheal tube while said single-lung bronchial blocker is deployed for a target lung.

8. The broncho-sleeve according to any one of claims 1-7. wherein said lumen defined by said elongated body is configured to receive a bronchoscope therein.

9. The broncho-sleeve according to any one of claims 1-8, wherein said elongated body further comprises a shape-memory material at least one of attached to or embedded therein, said shape-memory material being responsive to a change of temperature.

10. The broncho-sleeve according to any one of claims 1-9, wherein said lumen defined by said elongated body is wider at said distal end thereof.

11. The broncho-sleeve according to claim 7, wherein said bronchial cuff has a width that substantially matches a width of said lumen of said endotracheal tube to be able to perform a cleaning function during use while said elongated body is drawn towards a proximal end of said endotracheal tube.

12. The broncho-sleeve according to any one of claims 1 -11 , further comprising a ventilator port at said proximal end of said elongated body of said broncho-sleeve configured to attach to a ventilator to effect at least one of ventilation, suctioning, or deflation of said target lung and removal of fluids therefrom.

13. The broncho-sleeve according to any one of claims 1-12, wherein said bronchial cuff is configured to be inflatable to substantially a tracheal width to be able to secure a second broncho-sleeve used in conjunction therewith.

14. A device for one-lung ventilation procedures, comprising: an endotracheal tube defining a lumen therein and having a distal end and a proximal end; an inflatable tracheal cuff attached to said distal end of said endotracheal tube; an adaptor at least one of attached to or integral with said proximal end of said endotracheal tube, said adapter comprising a ventilation connector and defining a bronchosleeve port; and a broncho-sleeve having a distal end and a proximal end, said broncho-sleeve configured to be inserted through said broncho-sleeve port for performing a one-lung ventilation procedure, wherein said broncho-sleeve comprises a bronchial cuff attached to said distal end thereof, said bronchial cuff being inflatable to provide a single-lung bronchial blocker, andwherein said broncho-sleeve is sufficiently narrow to allow ventilation of a non-target lung alongside said broncho-sleeve through said lumen of said endotracheal tube while said single-lung bronchial blocker is deployed for a target lung.

15. The device according to claim 14, wherein said elongated body has an outer diameter less than 7.5 mm and greater than 3.0 mm and an inner diameter of at least 2.8 mm and less than 6.5 mm.

16. The device according to claim 15, wherein said elongated body has a wall thickness of at least 0. 1 mm and less than 0.6 mm.

17. The device according to claim 16, wherein said elongated body has an outer diameter of about 6.0 mm, an inner diameter of at about 5.0 mm, and a wall thickness of about 0.5 mm.

18. The device according to claim 14, wherein said elongated body has at least a distal portion that is formed into a coil structure having a restoring force upon being stretched or compressed by one of a bronchoscope or a stylet.

19. The device according to any one of claims 14-18, wherein said elongated body has at least a proximal portion that is formed into a coil structure having a restoring force upon being stretched or compressed.

20. The device according to any one of claims 14-19. wherein at least a portion of said elongated body of said broncho-sleeve and said bronchial cuff are configured to be inserted into a lumen defined by an endotracheal tube of said device for one-lung ventilation procedures, andwherein said at least said portion of said elongated body of said broncho-sleeve is sufficiently narrow to allow ventilation of a non-target lung there alongside through said lumen of said endotracheal tube while said single-lung bronchial blocker is deployed for a target lung.

21. The device according to any one of claims 14-20, wherein said lumen defined by said elongated body is configured to receive a bronchoscope therein.

22. The device according to any one of claims 14-21, wherein said elongated body further comprises a shape-memory material at least one of attached to or embedded therein, said shapememory material being responsive to a change of temperature.

23. The device according to any one of claims 14-22, wherein said lumen defined by said elongated body is wider at said distal end thereof.

24. The device according to claim 20, wherein said bronchial cuff has a width that substantially matches a width of said lumen of said endotracheal tube to be able to perform a cleaning function during use while said elongated body is drawn towards a proximal end of said endotracheal tube.

25. The device according to any one of claims 14-24, further comprising a ventilator port at said proximal end of said elongated body of said broncho-sleeve configured to attach to a ventilator to effect at least one of ventilation, suctioning, or deflation of said target lung and removal of fluids therefrom.

26. The device according to any one of claims 14-25, wherein said bronchial cuff is configured to be inflatable to substantially a tracheal width to be able to secure a second broncho-sleeve used in conjunction therewith.

27. The device according to any one of claims 14-26 wherein said adaptor further comprises a bronchoscope port to permit a bronchoscope to be inserted into said lumen of said endotracheal tube alongside said broncho-sleeve.

Images