Patent Application
20210220591
The present invention relates to systems, devices, kits, and methods for introducing suction catheters into the airways of patients who are intubated.
Patients who are intubated with an endotracheal (ET) tube are typically intubated to provide acute or chronic treatment with mechanical ventilation, but intubation is also associated with an increase in morbidity. Because ET tubes generally utilize an inflatable balloon or seal between the tube and the walls of the trachea to prevent aspiration or passage of fluids and debris into the trachea, small pools of pathogen-containing secretions may pool in the region above the inflatable balloon, which is typically the subglottic space. If the balloon forms an incomplete seal, small channels may develop between the balloon walls and the walls of the trachea through which debris and subglottic secretions pass into the lower respiratory tract.
In some instances, a suction catheter may be positioned to clear this debris or secretions via suction. Due to limited space in the airway of an intubated patient, these suction catheters tend to be small in diameter and as a result, very flexible. This flexibility may make the suction catheter difficult to manipulate, which may limit the ability of a practitioner to be able to position the suction catheter at a desired location within the airway.
Accordingly, there exists a need for devices and methods which allow for rapid deployment of a suction catheter in a patient and which may also be used in conjunction with conventional ET tubes which are already in wide use. Described here are devices, systems, and methods for providing suction to an airway of a patient. In some variations, the system may comprise a suction catheter and a delivery device. In some variations, the delivery device may comprise an elongate shaft comprising a central shaft region and an atraumatic distal end, an elongate passageway or lumen configured to receive a suction catheter, and a retention element configured to releasably couple to an endotracheal tube. In some variations, the elongate shaft further comprises a grooved piece and a lid piece that are releasably connected to define the elongate passageway. The suction catheter may be at least partially positioned in the elongate passageway and disconnection of the lid piece from the groove piece may release the suction catheter from the elongate passageway. In some variations, the lid piece may be slidably attached to the grooved piece. In some variations, the system may further comprise a stylet positioned in a lumen of the suction catheter. In some variations, the delivery device may further comprise more than one retention element configured to releasably connect the delivery device to an endotracheal tube. Additionally or alternatively, the delivery device may comprise a pair of wings configured to engage an endotracheal tube. In some variations, the delivery device may be curved. In some of these variations, the delivery device may further comprise at least one retention element that may extend away from a center of curvature of the delivery device. In some variations, the delivery device may comprise a skirt member or bulbous structure at an atraumatic distal end of the delivery device.
Also described here are methods of positioning a suction catheter in an airway of a patient intubated with an endotracheal tube. In some variations, the method may comprise advancing a delivery device into the airway, where the delivery device may comprise an elongate shaft, an elongate passageway, and a retention element. The distal outlet of the elongate passageway of the delivery device may be positioned at or near the vocal cords, and a distal portion of the suction catheter may be advanced out of the distal outlet to advance the distal portion of the suction catheter into a trachea. In variations of the method where the elongate shaft comprises a releasably attached grooved piece and lid piece, the lid piece may be disconnected from the grooved piece to release the suction catheter from the elongate passageway. The suction catheter may be used to apply suction to the trachea. In some variations, advancing a distal portion of the suction catheter may comprise advancing the suction catheter with a stylet positioned in the suction catheter.
In some variations, positioning the distal outlet of the elongate passageway of the delivery device at or near the vocal cords may comprise positioning the distal outlet within 2 cm of the vocal cords. In some of these variations, positioning the distal outlet of the elongate passageway of the delivery device at or near the vocal cords may comprise positioning the distal outlet within 1 cm of the vocal cords. Additionally or alternatively, positioning the distal outlet of the elongate passageway of the delivery device at or near the vocal cords may comprise positioning the distal outlet in the trachea distal to the vocal cords. In some variations, the delivery device may comprise a skirt member, and positioning the distal outlet of the elongate passageway of the delivery device at or near the vocal cords may comprise positioning at least a portion of the skirt member in the trachea distal to the vocal cords. In some variations, the lid piece may be slidably connected to the grooved piece, and disconnecting the lid piece from the grooved piece may comprise proximally sliding the lid piece relative to the grooved piece. Additionally or alternatively, the delivery device may comprise a retention element, and the method may further comprise slidably connecting the delivery device to the endotracheal tube with the retention element.
In some variations, the suction catheter may comprise of a shaft and a connector. In some variations, the suction catheter shaft may be reinforcement along the proximal and central regions. In some variations, the suction catheter connector may be removable and/or reattachable.
Also described here are devices, systems, kits, and methods for positioning a suction catheter in the airway of a patient. The kit includes a suction catheter a suction connector configured to attach or releasably attach to the suction catheter, and a delivery device configured to deliver the suction catheter along an endotracheal tube to a suction location. After positioning the tip of the suction catheter at the suction location, the delivery device may be removed and the suction connector may be attached to the catheter.
In one embodiment, a method of providing suction to an airway of a patient may be provided, comprising placing a suction guide device along an endotracheal tube inserted into an airway of a patient, wherein the endotracheal tube comprises a distal end and a proximal end, advancing the suction guide along the endotracheal tube towards the distal end of the endotracheal tube, positioning a catheter shaft at a location using the suction guide, withdrawing the suction guide from the airway while maintaining the catheter shaft at the location, and attaching a suction connector to the catheter shaft after withdrawing the delivery device from the airway. The suction connector may be pre-attached to the catheter shaft and the method further may comprises removing the suction connector from the catheter shaft before withdrawing the suction guide from the airway. The method may further comprise securing the catheter shaft to the endotracheal tube to resist displacement of the catheter shaft from the location after withdrawing the suction guide from the airway. Securing the catheter shaft may comprise coupling the suction catheter and endotracheal tube using a coupling member. The coupling member may be a clip, clamp or adhesive tape. The suction connector may be pre-attached to the catheter shaft at a first end of the suction connector. Attaching the suction connector to the catheter shaft may be performed using a second end of the suction connector. Inserting the suction catheter may be performed before advancing the delivery device along the endotracheal tube, or may be performed after advancing the delivery device along the endotracheal tube. The suction catheter may be pre-inserted into the lumen of the delivery device at the point of manufacture.
In another embodiment, a system comprises a suction guide configured to slidably couple to an endotracheal tube, a catheter shaft configured to couple to the suction guide, and a suction connector comprising a first end, a second end and a lumen therebetween, wherein the suction connector may be configured to attach to the catheter shaft, wherein the suction guide, catheter shaft and suction connector are located in a sealed packaging. The system may further comprise one or more coupling members. The one or more coupling members may be a clip, clamp, or adhesive tape. The suction connector may be configured to releasably attach to the catheter shaft. The suction connector may be pre-attached to the catheter shaft in the packaging. The catheter shaft may be pre-inserted into the suction guide in the packaging.
In still another embodiment, a system comprises a catheter shaft comprising a proximal end, a distal end, and a longitudinal lumen therebetween, and a suction connector comprising a first end, a second end and a lumen therebetween, wherein the suction connector may be configured to be attachable to the catheter shaft at the first end and the second end of the suction connector. The first end of the suction connector may have a different configuration than the second end of the suction connector. The second end may comprise a metal and the first end does not comprise a metal. The catheter shaft may comprise one or more interference openings spaced apart from a proximal end of the catheter shaft configured to attach to the suction connector. A proximal end of the catheter shaft may comprise a helically threaded interface. The second end of the suction connector may comprise a helically threaded interface complementary to the helically threaded interface of the catheter shaft. The first end of the suction connector comprises may be sized to form a friction fit with the proximal end of the catheter shaft. The second end of the suction connector comprises a radially inward protrusion within the lumen and in the second end of the suction connector. The radially inward protrusion may comprise a height orthogonal to the lumen, a leading surface and a trailing surface, where the leading surface may be closer to a second opening of the second end than the trailing surface. The leading surface may be angled away from the second opening. The leading surface may comprise a first open angle that may be greater than a second open angle of the trailing surface. The radially inward protrusion comprises a truncated shape, comprising a tip surface between the leading and trailing surfaces, wherein the tip surface comprises an angular orientation that may be different from the leading surface and the trailing surface. The height of the radially inward protrusion may be in a range of about 0.020 inches to about 0.035 inches. The first open angle may be in the range of about 135 degrees to about 165 degrees. The second open angle may be in the range of about 50 degrees to about 90 degrees. The suction catheter may further comprise a suction control opening in communication with the lumen. The suction catheter may further comprise a closure structure configured to reversibly close communication through the suction control opening and into the lumen. The closure structure may comprise a tethered cap. The system may further comprising a suction guide comprising a lumen and configured to slidably couple to an endotracheal tube, wherein the lumen may be configured to removably receive the catheter shaft. The suction guide, catheter shaft, and suction connector may be provided in sealed packaging. The catheter shaft may further comprise a tongue reinforcement member, the tongue reinforcement member comprising a proximal end, a distal end and a elongate body therebetween. The proximal end of the catheter shaft may comprise a threaded metal annular body, and the proximal end of the tongue reinforcement member may be attached to threaded metal annular body. The distal end of the tongue reinforcement member may be located in the longitudinal lumen of the catheter shaft and may be unattached to the catheter shaft. The distal end of the tongue reinforcement member may be located 2 cm to 10 cm proximal to the distal end of the catheter shaft. The system may further comprise a suction guide configured to releasably and slidably couple to an endotracheal tube, and comprising an elongate lumen configured to receive the catheter shaft. The tongue reinforcement member may be a metal wire.
Described here are delivery devices, systems, and methods for positioning a suction catheter in a patient's airway. Specifically, a distal end of the suction catheter may be positioned in the subglottic space of a patient, such that the suction catheter may be used to remove debris or secretions from the trachea. For example, a patient may be intubated with an endotracheal (“ET”) tube, and the devices described here may advance a suction catheter along the ET tube to position the suction catheter in the patient's airway proximal to a balloon of the ET tube. Continuous or intermittent suctioning with the suction catheter may help prevent microaspiration or aspiration of material and/or bacteria past the balloon of the ET tube and into the patient's lungs.
The systems described here generally comprise a suction catheter and a delivery device. The delivery device may be configured to engage the suction catheter such that advancement of the delivery device into the airway of a patient also advances the suction catheter. The delivery device may facilitate placement of a distal end of the suction catheter in the space between the ET balloon and the vocal cords of the patient. Once the suction catheter is so positioned, some variations of the delivery device may be configured to disengage the suction catheter to allow for removal of the delivery device while leaving the suction catheter in the airway. Alternatively, the delivery device may be configured such that removal of the delivery device also removes the suction catheter, and the delivery device may remain in place while suctioning occurs.
For the purposes of illustration,
When the suction catheter (314) is positioned in the lumen of the delivery device, such as shown in
The delivery device may be configured to constrain the suction catheter within an elongate passageway or lumen, which may reduce or otherwise limit the bending or buckling of the suction catheter while positioned in the lumen. This may increase column strength or the pushability of the suction catheter, which may facilitate advancement of the suction catheter along the delivery device. Additionally, the suction catheter may conform to the shape of the delivery device when positioned in the lumen, which may facilitate advancement of the suction catheter along an ET tube, as discussed in more detail herein. The lumen of the delivery device may be configured to accommodate a predetermined size (e.g., 10 Fr) or sizes of suction catheters. In some variations, the delivery device may have more than one lumen, which may, for example, facilitate the use of more than one catheter (e.g., a suction catheter and an infusion catheter for irrigation).
In variations of the delivery device that comprise an elongate shaft without a lid, a lumen of the delivery device may be a lumen of the elongate shaft. The shapes of the elongate shaft and lumen transverse cross-sections may be any suitable shape (e.g., circle, oval, rectangle). These shapes may be the same or different the elongate shaft and lumen, and these shapes may be uniform throughout the length of the elongate shaft, but need not be. In some variations, it may be advantageous for the elongate shaft to have rounded edges in order to reduce the risk of trauma to a patient's tissue. The sides of the elongate shaft may comprise openings or perforations, as is seen in
In some variations, as shown in
For example,
The lid piece (304) and grooved piece (302) may be releasably connected in any suitable manner. In some variations, the delivery device may comprise a peel-away lid piece or structure, and the lid piece (304) and grooved piece (302) may be held in a fixed relationship via one or more frangible connections. The one or more frangible connections may be broken or otherwise severed to release the lid piece (304) from the grooved piece (302). In some variations, the grooved piece (302) and lid piece (304) may be formed as a single member, where thinned or perforated regions may separate the grooved piece (302) and the lid piece (304). In these variations, the connecting regions may be frangible upon application of a force to the lid piece (304) and/or grooved piece (302). In other variations, the grooved piece (302) and lid piece (304) may be formed separately, and may be connected (e.g., via adhesive, ultrasonic bonding, welding, or the like), where the connections between the grooved piece (302) and lid piece (304) are frangible.
In other variations, the grooved piece (302) and lid piece (304) may be slidably connected. In these variations, the delivery device (300) may be configured such that the lid piece (304) may be slid relative to the grooved piece (302) to expose the side opening (322) of the grooved piece, as shown in
An atraumatic distal end or distal tip of a delivery device may be advanced into a patient's airway in order to deliver a suction catheter to the subglottic space (distal to the vocal cords and proximal to an ET balloon). When the distal tip of the delivery device has been positioned at a desired location in the airway (e.g., in proximity of the vocal cords), the suction catheter may be advanced relative to the delivery device, such that the distal end of the suction catheter is advanced distal to the distal tip of the delivery device. The distal tip of the delivery device may be advanced distal to the vocal cords and into the subglottic space, but need not be. For example, the distal tip of the delivery device may be advanced to a position proximal to the vocal cords, and the distal end of the suction catheter may then be advanced relative to the delivery device such that only the suction catheter moves past the vocal cords and into the subglottic space.
In some variations, it may be advantageous for the distal tip of the delivery device to have a shape and/or materials that reduce the risk of trauma to the vocal cords or other tissue that the distal tip may engage. For example, distal tip may comprise a distal edge and/or lateral protrusions that may be configured to be atraumatic if one or more of these surfaces contacts tissue. The distal edge may be the most distal portion of the distal tip, and may be the portion of the delivery device most likely to contact tissue that is in the longitudinal path of the delivery device as the delivery device is advanced along an ET tube. The distal edge may comprise one or more different shapes, including a blunted shape or a more spherical, bulbous shape. Lateral protrusions may extend in a transverse plane relative to the direction of advancement of the delivery device along an ET tube. These protrusions may be defined as portions of the distal tip that extend in the transverse plane from the delivery device midline a distance greater than twice the diameter of the elongate passageway. Lateral protrusions may comprise one or more sizes and shapes, including a blunted shape and a more spherical, bulbous shape. The way in which the distal tip may contact tissue may relate to the relationship between the distal tip and a retention element. For example, in some variations, the distal tip comprises a retention element that is the most distal portion of the delivery device. In some variations, a retention element is proximal and adjacent to the distal tip.
The variation of distal tip shown in
One or more portions of the distal tip may comprise one or more materials that may be compliant (e.g., elastomer, foam), which may decrease the risk of trauma to the vocal cords if these portion or portions of the distal tip engage the vocal cords or other tissue. In some variations, it may be advantageous for the distal tip to comprise more than one material that may have different material properties. For example, a stiff material may increase the likelihood that the distal tip may be easily advanced past the epiglottis and a more compliant material may decrease the risk of trauma to tissues that the distal tip may engage (e.g., the vocal cords).
The variation of distal tip in
Of note, the area between the two vocal cords (the rima glottidis), has a smaller cross sectional area than the cross sectional area of the airway just proximal to the vocal cords. In some variations, the shape and/or materials of the distal tip may reduce the likelihood that the distal tip may be advanced distal to the vocal cords, which may reduce the risk of trauma to the vocal cords. For example, the distal tip may have a cross sectional area larger than the area between the vocal cords (the rima glottidis). This may result in a user feeling resistance to advancement if the distal tip engages the vocal cords and may reduce the risk of further advancement past the vocal cords.
In some variations, the structure and/or materials of the distal tip may reduce the risk of trauma to tissue if the distal tip is advanced past the vocal cords. For example, the distal tips in
The distal tip of the delivery device may be integrally formed with the elongate shaft (e.g. by overmolding) or may be formed separately and connected in any suitable manner (e.g., via adhesive, ultrasonic bonding, welding, or the like).
The delivery device may comprise one or more handles that may have one or more functions (e.g., manipulate the delivery device, secure the catheter, remove a lid). For example, one or more handles may be held by user in order to maneuver the delivery device. The longitudinal length of a handle for manipulating a delivery device may be at least one inch and may comprise ridges, projections, or indentations to facilitate gripping. As shown in
During advancement of a delivery device into an airway, a handle may serve as a stop to indicate that the delivery device has been inserted a desired distance, as will be discussed in more detail herein. The handle's transverse cross-sectional area may be larger than the transverse cross-sectional area of the elongate shaft and large enough to increase the likelihood that the handle will engage a patient's tissue (e.g., the teeth). Other structural and/or material features of the handle may increase the likelihood that the handle engages a patient's tissue (e.g., ridges, protrusions). During advancement, a handle on a proximal end of the delivery device may engage a patient's teeth which may reduce the risk of further advancement. Halting advancement of the delivery device after a desired length of the delivery device has been inserted into the airway may reduce the risk of advancing the distal tip of the delivery device distal to a desired location in the airway (e.g., in proximity to the vocal cords).
In some variations, the delivery device may comprise more than one handle that may have one or more of the same or different functions. For example, in
The delivery device may comprise one or more retention elements or engagement cuffs that may connect or otherwise align with an ET tube, which may allow the one or more retention elements to guide the delivery device along the ET tube. In some variations, such as shown in
While shown in
When the delivery device is curved, as is described in more detail herein, the one or more retention elements may extend away or toward a center of curvature of the delivery device. In variations where the one or more retention elements (208, 209) extend away from a center of curvature of the delivery device (200), such as shown in
In some variations, the one or more retention elements may be sized and configured to reduce the risk of advancement of the retention elements past the vocal cords or other tissue structures of the airway. In these variations, the one or more retention elements may limit the forward advancement of the delivery device into the airway. In some of these variations, the delivery device may be configured such that the distal tip of the delivery device is positioned proximally of the vocal cord when the one or more retention elements engage the vocal cords or other tissues of the airway. In other variations, the distal tip of the delivery device may be advanced distally of the vocal cords when the one or more retention elements engage the vocal cords or other tissues of the airway. The one or more retention elements may be configured to minimize the distance between the delivery device and the ET tube while the delivery device is advanced along the ET tube. It may be advantageous for the delivery device to track closely to the ET tube in order to minimize the risk of the delivery device contacting and/or traumatizing airway tissue. For example, in some variations of the delivery device, it may be advantageous for a retention element to be positioned close to the distal tip in order to reduce the risk of the distal tip deflecting away from the ET tube. In some of these variations, the distance between the distal tip of the delivery device and a most distal retention element may be less than 2 cm.
In some variations, the delivery device may be configured to be curved during advancement of the delivery device, which may allow the delivery device to follow the anatomy of the trachea. When the delivery device is coupled to or aligned with an ET tube, the curvature of the delivery device may match a curvature of the ET tube. The delivery device may be pre-formed straight and be flexible in order to conform to the shape of an airway or ET tube. Alternatively, the delivery device may be pre-formed with a curve and be flexible or rigid. For example, in some variations, the delivery device may have a pre-formed curve with a radius of curvature between 3.9 inches and 12 inches. In some of these variations, the radius of curvature may be approximately 8 inches. The delivery device may be flexible and may be capable of bending to a bend radius of approximately 2 inches. The initial radius of curvature and allowable bend radius may facilitate the use of the delivery device in a range of airways (e.g., straight, curved, narrow) and/or may indicate to a user where on an ET tube the delivery device should be aligned (e.g., on the underside). The deflection force needed to achieve a 2 inch bend radius may be sufficiently low to allow the delivery device to conform to the shape of an ET tube without changing the shape of the ET tube curve. In some variations, the delivery device may require a deflection force less than 1 lbf to bend from an initial 8 inch radius of curvature to a 2 inch radius of curvature. In some of these variations, the deflection force required may be less than 0.25 lbf.
One or more portions of the delivery device may have a permanent curvature (e.g., may be pre-formed with a curve) and/or be flexible. For example, in some variations, the elongate shaft may be pre-formed with a curve. In some variations of the delivery device that comprise a lid piece, the lid piece may be pre-formed with a curve. In others of these variations, the lid piece may be flexible, and the lid piece may conform to the curvature of the grooved piece when the lid piece is releasably connected to the grooved piece. In other variations, the lid piece may be pre-formed with a curve and the grooved piece may be flexible. In these variations, the grooved piece may conform to curvature of the lid piece when the lid piece and grooved piece are releasably connected. In still other variations, both the lid piece and the grooved piece may be flexible, such that the delivery device may take on a specific curvature or otherwise conform to the patient's anatomy or an ET tube. It should also be appreciated that in some variations a straightened or curved stylet may be inserted into a portion of the delivery device (e.g., the lumen in the elongate shaft) to alter the curvature of the delivery device.
It may be advantageous for some variations of the delivery device to comprise an indicator of a maximum insertion distance. The maximum insertion distance may be defined as the distance a delivery device may be inserted into a patient's airway that should not be exceeded. Advancing a delivery device farther than this maximum insertion distance may increase the risk of trauma to a patient's tissue (e.g., a patient's vocal cords). The distance may be defined in relation to a portion of the patient, such as the patient's teeth. If resistance to advancement of the delivery device is felt by a user, the user may stop advancing the delivery device as the resistance may be an indicator that a portion of the delivery device may be engaging a patient's tissue. However, in some cases, the distal end of the delivery device may be advanced to a desired location (e.g., in proximity to a patient's vocal cords) before resistance is felt by a user. In these situations, a proximal alignment region on the delivery device may indicate that the maximum insertion distance has been reached and may reduce the risk of further advancement, which may reduce the risk of engaging and/or traumatizing a patient's tissue. For example, in some variations, a maximum insertion distance may be determined to be 10 cm from a patient's teeth. When a delivery device is inserted this maximum insertion distance, as measured from the most distal portion of the delivery device to the patient's teeth, the most distal portion of the delivery device will have reached or passed the vocal cords in less than 5% of individuals.
The maximum insertion distance may be indicated to a user in any suitable way. For example, the delivery device may comprise a proximal alignment region, which may be a marking (e.g., on the elongate shaft, on the handle) that is located the maximum insertion distance from the most distal portion of the delivery device (e.g., the distal end of the distal tip). The marking may be aligned with a portion of a patient (e.g., a patient's teeth) if resistance to advancement has not been felt by a user prior to this alignment. The delivery device may comprise one or markings that may be used for patients with one or more different characteristics (e.g., gender, height, age) that may be correlated with different sized airways. In other variations, the delivery device may comprise one or more features that engage a portion of a patient (e.g., a patient's teeth) to indicate that the delivery device has been inserted the maximum insertion distance. For example, a handle may contact a patient's teeth during advancement and may indicate that the delivery device has been inserted the maximum insertion distance.
In the variation shown in
As mentioned, the systems described here may comprise a delivery device and a suction catheter. In some variations, the suction catheter may be preloaded into a lumen of the delivery device. In some variations where a stylet is positioned in the suction catheter, the stylet may also be preloaded into the suction catheter. In some variations, the delivery device may not be preloaded with a suction catheter. The suction catheter may be any suitable suction catheter, and may include any configuration of elements. In some variations, the suction catheter may comprise a single suction outlet or may comprise a plurality of suction outlets. In some variations, the suction catheter may comprise an atraumatic distal tip to reduce the risk of trauma to airway tissue (e.g. vocal cords). In some variations, the atraumatic distal tip may comprise one or more compliant materials (e.g., foam) and/or structures (e.g., rounded edges) that reduce the risk of tissue trauma. In some variations, the atraumatic distal tip may comprise a distal sponge member, and in these variations suction may be applied through the sponge member. In some variations, at least a distal portion of the suction catheter may be flexible, which may allow the suction catheter to bend when contacting tissue and minimize the risk of the suction catheter tip puncturing or otherwise damaging tissue.
In another variation, the suction catheter 2800 comprises a separate suction connector (2802), as shown in
Referring to
The interface between the connector interface (2810) and shaft interface (2812) may be configured in a variety of ways to provide a sealed connection therebetween. In some variations, the interface may be configured to provide reversible attachment, such that the suction connector (2802) may be attached and re-attached to catheter shaft (2804), while in other embodiments, the hub may be configured to attach to the catheter shaft (2804) once, while resisting detachment. In some variations, the interfaces may comprise a threaded interface, a friction fit interface, a barbed interface, a snapfit, a Luer lock interface, a bayonet mount interface, a quick connect interface (e.g. John Guest fitting), and the like. In some variations, the suction connector and/or the shaft interface may comprise a releasable latch to facilitate detachment of the suction connector, while in other embodiments, the suction connector and catheter interface may comprise a ramped surface with a flange or recess which permits sliding up and over the ramped surface while resisting movement in the opposite direction.
The catheter shaft (2804) may be a single lumen or multi-lumen body and may comprise one or more distal openings (2818) and/or side openings (2820) for each lumen. Likewise, the suction connector (2802) may be configured with a corresponding number of lumens and proximal openings corresponding to the lumen(s) of the tubular body (2804). The suction connector (2802) may optionally comprise a flow control (2822), such as stopcock or valve to open and close the lumen, and/or switch connections between a lumen and a proximal opening of the suction connector, for example. In some further variations, the flow control (2822) may comprise a control lumen which is in communication with the internal lumen of the suction connector (2802) and to the atmosphere, which may be selectively closed or occluded using a cap (2824) which may or may not be attached to the connector (2802) or catheter shaft (2804) by a tether (2826). In use, the cap (2824) may be placed over the control lumen to maintain occlusion of the control lumen so that any suction or vacuum source coupled to the proximal end (2816) of the suction connector (2802) is in isolated fluid communication with distal end (2808) of the catheter shaft (2804) to facilitate removal of secretions. When the cap (2824) is removed so that the control lumen is open to the atmosphere, the suction or vacuum source is no longer in isolated fluid communication with the distal end (2808) of the catheter shaft (2804) and primarily draws air from the atmosphere through the flow control (2822). However, by occluding the control lumen of the flow control (2822) with his or her finger, the user may easily and selectively reestablish or break isolated fluid communication with the distal end (2808) of the catheter shaft (2804) to apply suction or to stop suction, so that any body tissue or or material that may be occluding the distal end (2808) of the shaft may be separated, which may facilitate removal of secretions. The flow control (2822) may optionally comprise a seat or flange (2830) surrounding the control lumen, to facilitate positioning of the user's finger to occlude the flow control (2822).
The catheter shaft may comprise any of a variety of catheter materials, including silicone, nylon, polyethylene, polypropylene, polytetrafluoroethylene, polyvinyl chloride and the like. The catheter shaft may comprise one or more materials to make it radiopaque and therefore visible on a radiographic image. The connector interface, and suction connector may be constructed from one or more materials, such as metal, ceramic, or plastic. Some suitable plastics that may be used include polypropylene, polyethylene, polyvinyl chloride, nylon, acrylonitrile butadiene styrene or the like. The lumen of the suction connector may comprise a circular cross-sectional shape, or any other suitable shape that allows fluid and debris from the suction catheter to travel through it. The catheter shaft may have a length in the range of about 4 cm to about 40 cm or more, and may have an external diameter size from about 3 F to about 14 F or more. The lumen of the suction connector may be sized to provide a complementary interfit with the external diameter of the catheter shaft.
In some variations, the suction catheter shaft may be reinforced along a portion of the shaft length, comprising an atraumatic distal end and distal region, a proximal region, and a central shaft region. In some variations the proximal and/or central shaft region may be reinforced, compared to the atraumatic tip or distal region, which may prevent or reduce the risk of suction catheter displacement after initial placement in the patient's airway. It is hypothesized that certain patients may dislodge the suction catheter with their tongue if the proximal and/or central regions of the catheter shaft are too flexible. The reinforcement or stiffness may be characterized by a three-point bend test, wherein the maximum deflection force in a three-point bend is <0.1 lbf for the atraumatic tip and 0.20 lbf to 1.0 lbf for the central shaft region. In other variations, the maximum deflection force is in the range of about 0.30 lbf to about 0.40 lbf, or about 0.40 lbf to about 0.45 lbf for the central region.
In some embodiments, the catheter shaft may comprise one or more metal or semi-rigid plastic reinforcement structures or members which are partially located along the proximal and/or central region of the catheter shaft. The tongue reinforcement structure may be attached to the outer surface or lumenal surface of the catheter shaft, or may be embedded within the wall of the catheter shaft. In one particular embodiment, the catheter shaft may comprise an elongate reinforcement member located within the lumen of the catheter shaft, wherein the proximal end of the reinforcement member is welded or otherwise attached to the catheter shaft or suction connector, while the distal end of the reinforcement structure may be attached or may be free-floating or otherwise unattached within the lumen. In other variations, the reinforcement structure may comprise a helical or woven structure, and may be welded, adhered, and/or embedded partially or fully along the length of the catheter shaft. In some further variations, the reinforcement structure may have a variable stiffness along its length, e.g. the cross-section shape of the reinforcement structure may decrease from a proximal location to a distal location.
In other variations, the reinforcement structure may comprise a coating or thin-walled film, and may be bonded, adhered, and/or embedded partially or fully along the length of the catheter shaft. In some variations, the catheter shaft has a length of about 25 cm to about 40 cm, an external diameter in the range of about 10 Fr to about 14Fr. The elongate reinforcement structure has a length of about 25 cm to about 40 cm, or about 30 to about 35 cm. In some variations, the elongate reinforcement structure has a shorter length than the catheter shaft. In some further variations, the distal end of the elongate reinforcement structure is located about 2 to about 10 cm proximal, to the distal tip of the catheter shaft, and in other embodiments, may be located about 2 cm to about 5 cm proximal to the distal tip of the catheter shaft.
The second end (3004) of the connector (3000) may comprise a constant or variable diameter or cross-sectional size. In the particular example depicted in
As depicted in
The suction connector (3000) may also further comprise a flow control (3034) comprising a control opening (3036) with a control lumen (3038) in fluid communication the connector lumen (3006). As noted previously, the control lumen of the flow control (3034) may be selectively occluded with the user's finger, so that the user may easily and selectively reestablish or break isolated fluid communication with the catheter shaft. This particular embodiment does not include a cap or plug to occlude the control lumen (3038), but may be provided separately and may be coupled by a looped tether to the suction connector (3000).
In some variations, a kit may comprise the devices and/or systems described here. For example, in the variation shown in
Described here are methods of a delivery of a suction catheter to the airway of a patient. For example, the delivery devices described above with respect to
When the delivery device is advanced along the ET tube, the delivery device may be advanced to position a distal outlet of a lumen of the delivery device at or near the vocal cords. In some variations, the delivery device may be advanced until the delivery device (e.g., the distal tip or retention element of the delivery device) engages airway tissue in proximity to the vocal cords, such as the ventricular folds, corniculate cartilage, or cuneiform cartilage. A user may feel resistance to further advancement when the delivery device engages airway tissue and may stop advancing the delivery device at that point, which may reduce the risk of tissue trauma. In other variations, it may be advantageous to advance the delivery device such that the likelihood of engaging airway tissue with the distal tip of the delivery device is minimized, which may reduce the risk of tissue trauma. The distance between a patient's vocal cords and other portions of the patient (e.g., the teeth of the patient) may be variable, but advancing a delivery device a predetermined, maximum insertion distance into an airway (e.g., 10-11 cm from the distal tip of the delivery device to a patient's teeth) may reduce the risk of engaging airway tissue in most patients. In some variations, advancement of the delivery device until there is an alignment of a proximal alignment region of the delivery device with a portion of the ET tube or the patient may indicate that the delivery device has been advanced the maximum insertion distance. For example, the delivery device may comprise a marking that is the maximum insertion distance from the distal end of the delivery device (e.g., a marking that is 10-11 cm from the distal tip of the delivery device). The delivery device may be advanced until the marking of the delivery device aligns with a portion of the patient (e.g., the teeth of the patient) or the ET tube (e.g., a proximal end of the ET tube, a marker on the ET tube, or the like).
In some variations of the delivery device, the portion of the delivery device that may be indicate that the delivery device has been advanced a maximum insertion distance into an airway may be a handle. For example, the delivery device may be advanced along an ET tube into an airway until the handle engages a portion of the patient (e.g., the teeth of the patient) or a portion of the ET tube (e.g., the proximal end of the ET tube). This may indicate that the delivery device has been advanced into the airway the maximum insertion distance. In variations of the delivery device that comprise a clip, as shown in
In some variations, one or more portions of the delivery device may be advanced distally of the vocal cords and into the trachea. For example, in variations where the delivery device comprises a skirt member, at least a portion of the skirt member may be advanced distal to the vocal cords. Additionally or alternatively, when a portion of the delivery device is advanced distally of the vocal cords and into the trachea, the distal outlet may be positioned past the vocal cords. In other variations, the distal outlet may be positioned proximally of the vocal cords. In some of these variations, the distal outlet may be positioned within 2 cm of the vocal cords. In some of these variations, the distal outlet may be positioned within 1 cm of the vocal cords.
The suction catheter may be loaded into the lumen of the delivery device before or after advancement of the delivery device into the airway. In some instances, the suction catheter may be pre-loaded into the delivery device, such that the suction catheter is advanced with the delivery device. The suction catheter may be pre-loaded into the delivery device in any suitable manner. In variations of the delivery device comprising a lid piece, the suction catheter may be pre-loaded before or after the lid piece has been attached to the grooved piece. In variations where the suction catheter is pre-loaded before the lid piece has been attached, the suction catheter may be positioned in a channel of the grooved piece, and the lid piece may be connected to the grooved piece to enclose the suction catheter in the lumen of the delivery device. In variations where the suction catheter is pre-loaded after the lid piece has been attached to the grooved piece to form a lumen, the suction catheter may be advanced into a proximal inlet of the lumen. In variations of the delivery device that do not comprise a lid piece, the suction catheter may similarly be preloaded by advancing the suction catheter into a proximal inlet of the delivery device lumen. In these variations, a stylet may aid in advancement of the suction catheter into the lumen. In some variations, the suction catheter is advanced until the distal end of suction catheter is at or near the distal outlet of the delivery device lumen. In variations of the delivery device that comprise a lock, the suction catheter may be secured in the lock after the catheter has been preloaded. This may increase the likelihood that the suction catheter is advanced into the airway with the delivery device.
In variations, where the suction catheter is loaded into the lumen of the delivery device after advancement of the delivery device into the airway, the suction catheter may be advanced into the proximal inlet of the delivery device lumen. In some variations, a stylet may aid in advancement of the suction catheter into the lumen.
With the distal outlet of the lumen of the delivery device positioned at or near the vocal cords, the distal end of a suction catheter may be advanced out of the distal outlet of the lumen to advance the distal end of the suction catheter into the area between the ET balloon and the vocal cords. In some of these variations, the distal end of the suction catheter may be advanced until it engages a balloon of the ET tube, as indicated by a user feeling resistance to further advancement of the suction catheter. In variations where a stylet is positioned within the suction catheter, the stylet may aid in advancement of the suction catheter.
In variations of the delivery device that do not comprise a lid piece or otherwise disengage from the suction catheter while it is in an airway, the suction port of the suction catheter may be connected to suction source after the suction catheter is positioned between the ET balloon and the vocal cords. When suctioning is complete, the delivery device and the suction catheter may be proximally withdrawn from the airway together. In order the reduce the risk of dislodging the ET tube during withdrawal of the delivery device, the ET tube may be secured or otherwise held in place while the delivery device and suction catheter are withdrawn.
A suction connector may be attached, removed, or reattached to the proximal end of a suction catheter in any of the method variations described above. For example, in some variations, a suction connector may be attached to a suction catheter prior to inserting the suction catheter into a delivery device. In other variations, a suction connector may be attached to a suction catheter prior to withdrawing a delivery device from a patient's airway. A suction connector may also be removed from a suction catheter prior to withdrawing a delivery device and reattached to the suction catheter after withdrawing the delivery device. In other variations, a suction connector may be attached to a suction catheter after withdrawing a suction guide. In still other variations, a suction connector may remain attached to a suction catheter while a suction guide is being withdrawn from a patient's airway and after the suction catheter has been removed from the delivery device.
As noted previously in
Once the suction guide is positioned at the desired location, the suction catheter may be unlocked from the suction guide and then advanced distally while the suction guide is maintained at its current position. When the cuff (3404) of the ET tube (3400) or other resistance it felt, suction catheter advancement is stopped, as illustrated in
In some variations, the suction catheter and suction guide may be removed immediately after the suction procedure. In other variations, the suction catheter may be left in place so that continuous, intermittent, periodic or as-needed suction may be applied to the patient without having to reinsert the suction guide and suction catheter. In these embodiments, an example of which is depicted in
After removal of the suction connector as depicted in
A suction catheter may be secured at any time after it is positioned in a patient's airway to resist its displacement from where it is positioned, and it may be secured using one or more coupling members, such as a clip, clamp, or adhesive tape. A suction connector may also be attached to a suction catheter before or after the suction catheter is secured. For example, in some variations, a suction catheter may be coupled to an endotracheal tube using one or more coupling members after a delivery device has been withdrawn from a patient's airway. In other variations, a suction catheter may be coupled to an endotracheal tube using one or more coupling members after the suction catheter is positioned in a patient's airway but prior to the withdrawal of a delivery device from the patient's airway.
This application claims the benefit of priority to U.S. Provisional Patent Application Ser. No. 62/327,059, entitled “Suction Catheter with Detachable Connector and Methods Thereof”, filed on Apr. 25, 2016, which is hereby incorporated by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2017/029303 | 4/25/2017 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62327059 | Apr 2016 | US |
