Patent Application
20230033721
The subject matter of the present invention relates generally to a system for securing a nasal tube including a retrieval probe with a flexible distal tip for insertion of a bridle into a nasal passageway of a patient.
The use of nasal tubes is commonly required in a medical setting, and many methods of securing nasal tubes that have been placed are known in the art. Generally, a nasal tube which has been inserted into a nostril may extend into a patient's stomach, intestinal tract, or lungs. Typically, once the nasal tube is in place, it is important to secure the tube. It should be appreciated that failing to properly secure a nasal tube can result in a dangerous situation for a patient, as well as increasing the cost of care, for example, by requiring repositioning of the nasal tube and re-securing the nasal tube.
There are various existing systems and methods for securing a nasal tube. For example, a nasal tube may be secured using a bridle being placed around the vomer bone. A clinician may place the bridle using a long flexible member, such as a tube, including the bridle and a magnet at the distal end, which is held together by the clinician's grasp. The long flexible member is inserted into one nostril, into the naval cavity towards the rear of the vomer bone. A probe with a magnet at the distal end is inserted into the other nostril to allow the magnets to contact each other around the vomer bone. Once the magnets have made contact, the clinician lets go of the bridle to allow the long flexible member to enter the nostril, and the probe is pulled outward, which pulls the long flexible member including the bridle around the vomer bone. With the bridle looped around the vomer bone and extending from both nostrils, the bridle may be secured with a clamp, which may have a channel to accept the nasal tube to secure the nasal tube. For example, the channel can have a smaller inside diameter than the outside diameter of the nasal tube, which provides for a tight fit of the nasal tube in the channel and allows the nasal tube to not fall out of the clamp prior to closing the clamp. The clinician may bring the clamp as close to the nostril as possible and press the tube into the tight channel in the clamp, place the bridle into the clamp, and close the clamp to secure the nasal tube to the bridle.
Existing nasal bridling devices for nasal tube securement typically rely on two catheters inserted into the nares past the vomer bone with magnets at the tip of each catheter to facilitate connection between the catheters behind the vomer bone and pass through of a tether through both nares. These catheters are stiff in nature and connection is made behind the vomer bone at an angle relying on magnetic attraction rather than catheter flexion to make the catheters connect. The catheters must be stiff enough to prevent the catheters from collapsing while entering the nasal passageway and yet flexible enough to curve behind the vomer bone to aid in connection of the catheters. Often, the catheters include a coil wire to increase the stiffness of the catheter, which can result in kinking of the coil wire if the catheter is bent. As a result, the tradeoffs between stiffness and flexibility of the catheters result in increased opportunity for misconnection between the catheters. Moreover, the magnets on these current devices are often limited in magnet exposure. For instance, in some devices the magnet is completely encapsulated in the catheter. Thus, there may be a very small margin for error while connecting the catheters, which more opportunities for misconnection as the connecting surfaces must be near perfect alignment to connect. The increased opportunity for misconnection between the catheters can result in repeated or lengthened procedure time, increasing monetary cost, time, and pain for patients.
Consequently, there is a need for an improved bridle delivery system to allow for controlled insertion into the nasal passageway while providing flexibility to curve around the back of the vomer bone. In particular, an improved bridle delivery system that reduces the probability for misconnections would also be useful.
Objects and advantages of the invention will be set forth in part in the following description, or may be obvious from the description, or may be learned through practice of the invention.
The present invention is directed to a retrieval probe for insertion of a bridle into a nasal passageway of a patient. The retrieval probe includes a proximal end and a distal end; and a catheter between the proximal end and the distal end. The retrieval probe further includes a stiff inner core within a lumen of the catheter, and a magnetic tip disposed at the proximal end. The catheter includes a hollow section disposed between the magnetic tip and a distal end of the stiff inner core.
In one particular embodiment, the catheter can include a first material and the inner core can include a second material. Moreover, the first material and the second material can be dissimilar. Furthermore, the first material can have a first durometer and the second material can have a second durometer, wherein a ratio of the first durometer to the second durometer is in a range from about 1:2 to about 1:4. Moreover, the first material can be a thermoplastic elastomer and the second material can be nylon.
In another embodiment, the inner core can be formed from a solid construction.
In an additional embodiment, the hollow section can be configured to bend at an angle of about 180 degrees without kinking.
In a further embodiment, the hollow section can include a length in a range from about 1.5 cm to about 2.5 cm.
In yet another embodiment, the magnetic tip can include a magnetic holding tip and a connection member. Moreover, a proximal end of the connection member can be disposed within the magnetic holding tip and a distal end of the connection member can protrude from the magnetic holding tip. Further, the connection member can include an exposed section extending from a distal end of the magnetic holding tip to a distal end of the connection member. Moreover, the exposed section can have a length in a range from about 0.75 mm to about 2 mm. Further, a ratio of a length of the exposed section to a length of the connection member can be in a range from about 1:5 to about 1:2. Moreover, a proximal end of the magnetic holding tip can be disposed within the distal end of the catheter. Further, the connection member can include a permanent magnet and/or a magnetically connective material.
The present invention is further directed to a system for securing a nasal tube. The system includes a bridle, a magnetic connection portion attached to the bridle, and a retrieval probe. The retrieval probe includes a proximal end and a distal end; a catheter between the proximal end and the distal end; an inner core within a lumen of the catheter; and a magnetic tip disposed at the proximal end. The catheter comprises a hollow section disposed between the magnetic tip and a distal end of the inner core. Further, the magnetic connection portion of the bridle and the magnetic tip of the retrieval probe are configured to magnetically couple during a procedure for inserting the bridle in a nasal passageway of a patient.
In one aspect of the system, either the magnetic connection portion of the bridle or the magnetic tip of the retrieval probe can include a permanent magnet. Moreover, the other of the magnetic connection portion of the bridle or the magnetic tip of the retrieval probe can include a magnetically connective material that is not a permanent magnet.
In another aspect of the system, the magnetic connection portion of the bridle and the magnetic tip of the retrieval probe each can include a permanent magnet.
In another aspect of the system, the hollow section of the retrieval probe can be configured to bend up to about 180 degrees to enable coupling of the magnetic connection portion of the bridle and the magnetic tip of the retrieval probe during the procedure for inserting the bridle.
These and other features, aspects, and advantages of the present invention will become better understood with reference to the following description and appended claims. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention.
A full and enabling disclosure of the present invention, including the best mode thereof, directed to one of ordinary skill in the art, is set forth in the specification, which makes reference to the appended figures, in which:
Reference now will be made in detail to embodiments of the invention, one or more examples of which are illustrated in the drawings. Each example is provided by way of explanation of the invention, not limitation of the invention. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the invention. For instance, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. Thus, it is intended that the present invention covers such modifications and variations as come within the scope of the appended claims and their equivalents.
As used herein, the terms “about,” “approximately,” or “generally,” when used to modify a value, indicates that the value can be raised or lowered by 5% and remain within the disclosed embodiment. Further, when a plurality of ranges are provided, any combination of a minimum value and a maximum value described in the plurality of ranges are contemplated by the present invention. For example, if ranges of “from about 20% to about 80%” and “from about 30% to about 70%” are described, a range of “from about 20% to about 70%” or a range of “from about 30% to about 80%” are also contemplated by the present invention.
Generally speaking, the present invention is directed to a retrieval probe for insertion of a bridle into a nasal passageway of a patient and a system for securing a nasal tube. The retrieval probe includes a proximal end and a distal end, and a catheter between the proximal end and the distal end. The retrieval probe also includes an inner core within a lumen of the catheter and a magnetic tip disposed at the proximal end, such that the catheter comprises a hollow section disposed between the magnetic portion and a distal end of the inner core. The magnetic tip includes a connection member formed from a magnetically connective material that is exposed on a distal surface and a lateral surface at the distal end of the retrieval probe. The present inventors have found that providing an inner core within the lumen of the catheter and a hollow section disposed between the magnetic portion and a distal end of the inner core enables the retrieval probe to have significantly improved flexibility at the distal end of the retrieval probe while maintaining increased rigidity control of the length of the retrieval probe proximal to the hollow section while inserting the retrieval probe into a patient's nasal passageway. Moreover, the present inventors have found that the exposure of the magnetically connective connection member at the distal end of the retrieval probe increases the exposure of a magnetic surface to facilitate a stronger connection between the retrieval probe and a coupling member, such as a securement device, without sacrificing patient safety.
The specific features of the retrieval probe and system for securing a nasal tube of the present invention may be better understood with reference to
Referring now to
The retrieval probe 100 includes a handle 108 at the proximal end 102, and a magnetic tip 110 at the distal end 104. The elongated member 106 of the retrieval probe 100 may be approximately 5 inches (about 12.7 cm) long, with the handle 108 being approximately 1 inch (about 2.54 cm) long.
The elongated member 106 can include a flexible catheter 107 formed from a catheter wall 112 surrounding a lumen 114. The catheter 107 has a length 128 extending from a proximal end 130 of the catheter 107 to a distal end 132 of the catheter 107. The length 128 can be in a range from about 4 inches (about 10 cm) to about 6 inches (about 15 cm), such as from about 4.5 inches (about 11.4 cm) to about 5.5 inches (about 14 cm), such as about 5 inches (about 12.7 cm).
The catheter wall 112 has an outer surface 116 and an inner surface 120. Optionally, as shown in
The catheter 107 can have an outer diameter 124 defined by the outer surface 116 and an inner diameter 126, i.e., a diameter of the lumen 114, defined by the inner surface 120 of the catheter wall 112. The outer diameter 124 can be in a range from about 0.05 inches (about 1.3 mm) to about 0.17 inches (about 4.3 mm), such as from about 0.08 inches (about 2 mm) to about 0.15 inches (about 3.8 mm), such as from about 0.10 inches (about 2.6 mm) to about 0.13 inches (about 3.3 mm). To define the outer diameter 124 in other terms, the catheter 107 can be in a size from 4 French to 13 French. The inner diameter 126 of the catheter 107 can be in a range from about 0.04 inches (about 1 mm) to about 0.1 inches (about 2.5 mm), such as from about 0.06 inches (about 1.6 mm) to about 0.09 inches (about 2.3 mm), for instance about 0.08 inches (about 2 mm). The catheter wall 112 has thickness 122 in the radial direction from the outer surface 116 to the inner surface 120. The thickness 122 can be in a range from about 0.01 inches (about 0.25 mm) to about 0.03 inches (about 0.75 mm).
The catheter 107 can be formed from a soft, pliable material. For instance, the wall 112 of the catheter 107 can be formed from a variety of materials, giving due consideration to the goals of flexibility, lightweight, strength, smoothness, and biocompatibility or non-reactivity to anatomical systems, i.e., safety. Suitable materials for the catheter 107 include thermoplastic elastomers such as polyolefins, including polyethylene and polypropylene, polyamides, polyimides, teflon (polytetrafluoroethylene), polyesters, polyurethanes, any copolymers thereof, and other materials known in the art. In some particular embodiments, the catheter 107 can be formed from polyether block amide (PEBA), which may be sold under the trade name PEBAX®. The material of the catheter 107 can have a durometer in a range from about 15 to about 35, such as from about 20 to about 30, such as a durometer of about 25.
An inner core 134 can be provided to the catheter 107. For instance, as shown in
The inner core 134 can be formed from a material having a higher degree of stiffness or rigidity and low flexibility compared to the catheter 107. For instance, the inner core 134 can be formed from nylon or any other suitable material. The material of the inner core 134 can be dissimilar from the material of the catheter 107. In some aspects of the invention, the inner core 134 is formed from a solid piece of material (“solid construction”), e.g., extruded in a generally cylindrical shape. The inner core 134 can have a diameter 192 small enough to be disposed within the lumen 114 of the catheter 107 while still providing sufficient stiffness and support to the flexible catheter 107. The material of the inner core 134 can have a durometer of in a range from about 60 to about 90, such as from about 70 to about 80, such as a durometer of about 75 shore D. In this regard, a ratio of the durometer of the catheter 107 material to the durometer of the inner core 134 can be in a range from about 1:2 to about 1:4, such as about 1:3. The ratio of the durometer of the catheter 107 material to the durometer of the inner core 134, along with the wall thickness 122 as described above, can be selected to optimize the flexibility and control of the elongated member 106. For instance, the durometer of the inner core 134 can be reduced to increase the flexibility of the elongated member 106.
As shown in
As shown in
The catheter connection section 156 can have a constant diameter portion 180 having a diameter 178 adjacent to the shoulder 160, and a tapered portion 182 extending between a proximal end of the magnetic holding tip body 152 and the constant diameter portion 180. The catheter connection section 156 can have an interference fit with the inner surface 120 of the catheter wall 112. For instance, the diameter 178 can be in a range from about 0.085 inches (about 2.2 mm) to about 0.115 inches (about 2.9 mm), such as from about 0.095 inches (about 2.4 mm) to about 0.11 inches (about 2.8 mm), such as from about 0.099 inches (about 2.5 mm) to about 0.105 inches (about 2.7 mm). The catheter connection section 156 can have a total length in a range from about 0.15 inches (about 3.8 mm) to about 0.2 inches (about 5.1 mm), such as from about 0.16 inches (about 4 mm) to about 0.18 inches (about 4.6 mm).
In other words, the catheter connection section 156 can extend a distance approximately equal to the length into the lumen 114 of the catheter 107 at the distal end 132 of the catheter. As a result, the hollow section 142 of the catheter 107 can be formed between the inner core 134 and the magnetic holding tip body 152. Thus, the total length 144 of the hollow section 142 can be in a range from about 0.3 inches (about 0.75 cm) to about 1.85 inches (about 4.7 cm), such as from about 0.55 inches (about 1.4 cm) to about 1.35 inches (about .4 cm), such as from about 0.6 inches (about 1.5 cm) to about 1 inch (about 2.5 cm). As described above, the hollow section 142 may be sufficiently flexible, including having a sufficient length 144 as set forth in the preceding sentence, to bend or flex up to about 180 degrees of motion in any direction.
The protruding section 158 can have a diameter 168 approximately equal to or slightly larger than the outer diameter 124 of the catheter 107. For instance, the diameter 168 can be in a range from about 0.115 inches (about 2.9 mm) to about 0.13 inches (about 3.3 mm), such as from about 0.12 inches (about 3 mm) to about 0.13 inches (about 3.3 mm), for instance about 0.125 inches (about 3.175 mm). In this regard, the protruding section 158 can have a minimally obstructive transition from the catheter 107 to the magnetic tip 110 to reduce opportunity for trauma to a patient's tissue during an insertion procedure. Additionally, the protruding section 158 can have a length 164 from the shoulder 160 to a distal end of the magnetic holding tip body 152 in a range from about 0.15 inches (about 4 mm) to about 0.25 inches (about 6.4 mm), such as from about 0.17 inches (about 4.3 mm) to about 0.2 inches (about 5 mm), for instance from about 0.18 inches (about 4.6 mm) to about 0.19 inches (about 4.8 mm).
The magnetic tip 110 can also include a connection member 154, e.g., a magnet or a magnetically connective material. For instance, the connection member 154 can be formed from a permanent magnet, a rare earth magnet, or any suitable material to provide for magnetic coupling with a cooperating magnetic coupling. The connection member 154 can be held within the magnetic holding tip 152. For instance, the connection member 154 can be disposed within the protruding section 158 of the magnetic holding tip body 152. In some aspects of the present invention, the magnetic holding tip body 152 can be overmolded over the connection member 154 to permanently couple the magnetic holding tip body 152 and the connection member 154; however, any suitable method of attaching the connection member 154 can be used. The connection member 154 is configured to extend or protrude from the magnetic holding tip body 152 as shown in
As shown in
Turning now to
At the proximal catheter transition section 184, the inner core 134 can be disposed within the catheter 107. For instance, a length 188 of the inner core 134 can extend within the handle 108. As shown in
The present invention is further directed to a system for securing a nasal tube that can include the retrieval probe 100 and a securement device, such as the securement device 200 illustrated in
In use, the securement device 200 can be inserted into a first nostril, e.g., by inserting the securement device within a delivery probe (not shown) and inserting the delivery probe into the first nostril. The magnetic connection portion 204 of the securement device 200 can be inserted towards the rear of the vomer bone of a patient through the first nostril. Then, the retrieval probe 100 can be inserted into a second nostril, with the connection member 154 exposed at the distal end 104 of the retrieval probe 100 and inserted towards the rear of the vomer bone of the patient within the second nostril. The magnetic connection portion 204 of the securement device 200 and the connection member 154 of the retrieval probe 100 can be magnetically coupled behind the patient's vomer bone. For instance, the hollow section 142 of the retrieval probe 100 can bend or flex behind the vomer bone as the magnetic attraction between the connection member 154 and the magnetic connection portion 204 increases to bring the connection member 154 and the magnetic connection portion 204 together. After the magnetic connection portion 204 and the connection member 154 are coupled, the retrieval probe 100 is removed from the second nostril, such that the bridle 202 extends into the first nostril and out from the second nostril. If applicable, the delivery probe is then removed from the first nostril. For example, when the retrieval probe 100 is removed from the second nostril, the bridle 202 is left hanging out of both nostrils. Then, the bridle 202 can be secured using any suitable means. Moreover, a nasal tube can be inserted and/or secured to the bridle using any suitable means to secure the nasal tube within the patient's nose and deter or discourage the patient from pulling on the nasal tube.
This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they include structural elements that do not differ from the literal language of the claims or if they include equivalent structural elements with insubstantial differences from the literal language of the claims.
