WO2009124066A2

WO2009124066A2 - Device and method for maintaining unobstructed nasal passageways after nasal surgery

Info

Publication number: WO2009124066A2
Application number: PCT/US2009/038985
Authority: WO
Inventors: Robert Kotler
Original assignee: Robert Kotler
Priority date: 2008-04-01
Filing date: 2009-03-31
Publication date: 2009-10-08
Also published as: US8092478B2; WO2009124066A3; US20090248057A1

Abstract

Methods and devices for maintaining nasal passages open after nasal surgery are provided. In some embodiments, the method of the present invention includes initially cleaning at least some of the bodily fluids from the nasal passages of a patient after the nasal surgery; providing a post-operative device having a first tubular member with a first proximal end and a first distal end, and a second tubular member with a second proximal end and a second distal end, where the first proximal end is connected to the second proximal end with a bridging member, which may include a flexible member to facilitate positioning, and the post-operative device is splintless; inserting the first distal end and the second distal end into the nasal passages of the patient to a location where the first proximal end and the second proximal end each protrude beyond the nostril opening of the patient; and placing a packing material at least partially around each tubular member. In some embodiments of the present invention, a specialized speculum is provided to facilitate placing packing material around the tubular members of the medical device. Medical kits for use following nasal surgery are also provided.

Description

DEVICE AND METHOD FOR MAINTAINING UNOBSTRUCTED NASAL PASSAGEWAYS AFTER NASAL SURGERY

RELATED APPLICATIONS

[0001] The present patent document is a continuation-in-part of Application Serial

No. 12/080,145, filed April 1, 2008, which is hereby incorporated by reference in its entirety.

FIELD OF THE INVENTION

[0002] The present invention relates generally to medical devices and methods, and more particularly, to medical devices and methods for use after nasal surgery.

BACKGROUND OF THE INVENTION

[0003] Nasal surgery may be performed for purposes such as appearance enhancement, reconstruction following an injury, or breathing improvement. Following nasal surgery, it is typically necessary to place packing into the nasal cavity upon the conclusion of the surgery. Such packing may be used to temporarily maintain nasal components in their proper and anatomically correct positions after any manipulation, repositioning, and/or reconstruction that took place during the surgery, while nature begins the healing and repair process.

[0004] Nasal packing may also be used following nasal surgery to reduce the chance of bleeding, by prophylactically tamponading the nasal structures most likely to be the source of bleeding, such as the interior of the nose which contains a plurality of blood vessels. Bleeding after nasal surgery can be fatal or result in the loss of a considerable amount of blood and cause serious complications.

[0005] Post-operative nasal packing may be required for up to five days after nasal surgery. For most patients, any pain following the surgery may be controlled with medication and is secondary to the essentially complete nasal obstruction caused by the packing material. The packing makes mouth breathing obligatory and can cause a dry throat and extreme discomfort for the patient. In addition, the patient's sense of smell, which may be critical to the enjoyment of food, may be compromised. All of this often creates a frightened and anxious patient. [0006] The reported extreme discomfort and the above other significant dissatisfactions caused by the current, requisite full post-operative nasal packing has caused potential patients to forego life-changing nasal surgery that would otherwise have been successful in improving allergy symptoms, improving smell and taste, preventing significant complications such as sinus infections, improving appearance, and/or preventing snoring, for example. Prior attempts to address such problems include the use of a nasal splint with integral, partial breathing passages, such as the splint disclosed in U.S. Patent No. 3,935,859 to Doyle, where the purpose of the splint is to stabilize the repaired nasal septum. Such devices do not contain full breathing tubes, nor do they include breathing tubes that are amenable to easy cleaning by the patient, as the tubes reside entirely within the nasal passages. Experience has shown that such devices quickly become obstructed and, without proper medical attention, the blockage cannot be relieved.

[0007] Prior attempts to maintain open nasal passageways after surgery include embedding an airway within a pre-formed packing material. Such devices are limited to use with only the type, size, and configuration of packing material supplied with the device and cannot be modified based upon the preferences of the physician or the patient. Further, such devices do not allow for easy cleaning of the airway by the patient and therefore, cause patient discomfort as a result of obstruction of the airway.

[0008] Other attempts have been made to develop devices for insertion into the nasal passages, where the devices are designed to prevent snoring. Such devices are not designed for post-operative use. For example, several of these devices exert pressure against the inner walls of the nasal passages, which may be damaging to the delicate nasal architecture after surgery. In addition, because such devices are not designed for use after surgery, they do not address the problem of obstruction caused by accumulating blood and other bodily fluids following nasal surgery.

[0009] Therefore, what is needed are devices and methods that allow the advantages of complete nasal packing following surgery without totally obstructing the nasal passages of a patient and compromising the patient's ability to breathe normally, and without causing damage to the delicate nasal architecture following nasal surgery. SUMMARY OF THE INVENTION

[0010] In some embodiments of the present invention, a method for maintaining nasal passages open after nasal surgery is provided. The method may include: initially cleaning at least some of the bodily fluids from the nasal passages after nasal surgery; providing a post-operative device having a first tubular member with a first proximal end and a first distal end, and a second tubular member with a second proximal end and a second distal end, where the first proximal end is connected to the second proximal end with a bridging member, which may include a flexible member to facilitate adjustment of the tubular member within the nostril and/or nasal passages of the patient, and the post-operative device is splintless; inserting the first distal end and the second distal end into the nasal passages of the patient to a location where the first proximal end and the second proximal end each protrude beyond the nostril opening of the patient, where the location may be identified by the presence of a ring member surrounding each tubular member; and at least partially surrounding each tubular member with packing material. In some embodiments, prior to the placement of the packing material, the bridging member is secured to the columella of the patient using sutures, for example, to prevent displacement. In other embodiments, the postoperative device includes one or more fins through which a suture may be passed to secure the device to the internal partition and the septum of the patient. The first proximal end may be connected to the second proximal end either before or after the first distal end and the second distal end are inserted into the nasal passages. In other embodiments, a single-unit medical device is used, and no connection is necessary.

[0011] In certain embodiments, the method of the present invention includes cleaning each tubular member with a fluid-containing syringe. Although not necessary, an adapter may be used to removably connect the syringe to each tubular member, if desired. In some embodiments, the method includes measuring the length of the nasal floor of a patient and trimming the first distal end and the second distal end, based on the result of the measuring, prior to securing the post-operative device.

[0012] In some embodiments of the present invention, a specialized speculum is provided to facilitate placing packing material at least partially around the tubular members of a post-operative medical device. The speculum may include two leg members, where one leg member includes an engagement member configured to coincide with the tubular member and permit the medical professional to exert pressure against the tubular member to thereby increase the space between the tubular member and the inner portion of the nostril and facilitate insertion of packing material into the nasal cavity using forceps or another suitable medical instrument.

[0013] In other embodiments of the present invention, a medical kit for use following nasal surgery is provided. The medical kit may include a post-operative medical device having a first tubular member with a first proximal end and a first distal end, and a second tubular member with a second proximal end and a second distal end, where the first proximal end is connected to the second proximal end with a bridging member, and the post-operative device is splintless; an insertion speculum adapted to at least partially surround and mate with'the post-operative medical device; and a syringe for cleaning the tubular members of the medical device. The medical kit may also include a packing material and/or a measuring device configured to measure the length of the nasal floor of a patient. In some embodiments, the kit also includes a suction catheter, such as a 1OF flexible plastic suction catheter or other suitable catheter, which may be used to assure patency of the tubular system after insertion and fixation and to allow the anesthesiology specialist unobstructed access to the throat to suction blood, mucous and other fluids from the throat prior to termination of the anesthetic and awakening of the patient.

[0014] Other features and advantages of the present invention will be apparent from the following detailed description of exemplary embodiments, taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 is a perspective view of one embodiment of a post-operative medical device of the present invention;

[0016] Figure 2 is a top view of the post-operative medical device of Figure 1 ;

[0017] Figure 3 is a front view of the post-operative medical device of Figure 1;

[0018] Figure 4 is a perspective view of the post-operative medical device of Figure 1 inserted into the nasal passages of a patient; [0019] Figure 5 is a magnified perspective view of one embodiment of the postoperative medical device of the present invention inserted into the nasal passages of a patient;

[0020] Figure 5A is a perspective view of one embodiment of the post-operative medical device of the present invention after the insertion of packing material around the tubular members of the medical device;

[0021] Figure 6 is a sectional view of the nasal architecture of a patient illustrating the placement of a tubular member of one embodiment of a post-operative medical device of the present invention in a nasal passage of the patient;

[0022] Figure 7 is a perspective view illustrating the use of a device for cleansing a tubular member of one embodiment of a post-operative medical device of the present invention;

[0023] Figure 8 is a perspective view of one embodiment of the specialized speculum of the present invention;

[0024] Figure 8A is an illustration of one embodiment of the specialized speculum of the present invention inserted into a nostril opening of a patient;

[0025] Figure 9 is an illustration of the placement of packing material into the nasal cavity of a patient using one embodiment of a specialized speculum of the present invention;

[0026] Figure 10 is a side view of another embodiment of a post-operative medical device of the present invention, illustrating a suturing fin, a ring member, and a curved bridging member containing a flexible member therein; and

[0027] Figure 11 is a perspective view of one embodiment of the post-operative medical device of the present invention after the insertion of packing material around the tubular members of the medical device, where the medical device also includes suturing fins, ring members, and a curved bridging member.

[0028] Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. DETAILED DESCRIPTION

[0029] Referring now to Figures 1 to 3, one embodiment of a post-operative medical device 10 of the present invention is shown. In this embodiment, the medical device 10 is splintless. That is, the medical device is devoid of splints, where a splint is generally a device that is used to stabilize a repaired nasal septum. Although this embodiment of the medical device of the present invention is splintless and need not be used in conjunction with a splint to achieve its intended purpose, the medical device may, nonetheless, be used in conjunction with a splint, if the medical professional so chooses.

[0030] The embodiment of the medical device 10 shown in Figures 1 to 3 includes two tubular members 20, where each tubular member 20 has a plurality of graduations 22 and a slight curvature along its length. Each tubular member 20 has a proximal end 30, a distal end 32, and a lumen 24 that extends from the proximal end 30 to the distal end 32. The proximal end 30 of one tubular member 20 is connected to the proximal end 30 of the other tubular member 20 with a bridging member 26. Any suitable bridging member may be used to prevent extrusion of the tubular members from the nasal passages. For example, the bridging member may be a suture or a piece of plastic having any suitable shape.

[0031] As shown in the embodiment of Figure 10, the bridging member 26 may be configured to arc away from the columella of a patient and may include a flexible member 80 to facilitate the adjustment and proper positioning of the medical device within the nasal passages of a patient. The flexible member 80 may be attached to or embedded within the bridging member 26 at any suitable position and may extend a distance into the tubular members 20, if desired. The flexible member 80 may be made of any suitable material and may have any suitable dimension and shape that results in the manipulability of the bridging member 26 and tubular members 20 to a desired position within the potentially unique anatomy of a patient. For example, in one embodiment, the flexible member 80 is made of 0.02 inch diameter stainless steel wire. Such a flexible member 80 also may allow customization of the medical device to accommodate differing distances between the tubular members for individual patients having a wide or narrow separation between the nostrils, for example. [0032] Although in the embodiments shown in Figures 1 to 3 the tubular members 20 have a generally symmetrical, slightly curved, cylindrical configuration with a generally circular proximal tip 34, numerous other configurations are possible. For example, in some embodiments of the present invention, the tubular members of the medical device have a generally straight configuration with oblong proximal ends. Any tubular member configuration that fits comfortably within the nasal passages of a patient and permits sufficient airflow through the nasal passages may be used.

[0033] As shown in Figures 1 and 2, the bridging member 26 may be placed a distance d from the tip 34 of the proximal end 30. In other embodiments, such as the embodiment shown in Figure 10, the bridging member 26 may extend outwardly from the tubular members 20 to which it is attached, and proper placement of the device may be assured by the inclusion of a ring member 90 on the tubular member(s) 20.

[0034] In the embodiment of Figures 1 and 2, the bridging member 26 contains a plurality of apertures 28 through which a suture may be passed to attach the bridging member 26 to a columella of a patient. In other embodiments, the bridging member may contain no apertures, and a suture may be passed through the material of the bridging member, or the bridging member may contain a recessed trough that may serve as a resting location for a suture. In still other embodiments, such as the embodiment shown in Figure 10, a suture may be passed through or otherwise secured using fins 82 attached to the tubular members 20, rather than using the bridging member 26 to secure the device. In certain embodiments, the bridging member is connected to a single tubular member adapted for insertion into one nasal passage.

[0035] The medical device 10 may be placed within a patient after nasal surgery, as shown in Figure 4. As shown, each tubular member 20 is placed into the nostril openings 38 of the patient and through the nasal passages, as shown in more detail in Figure 5. The bridging member 26 lies beneath the columella 42 of the patient and may be attached to the columella 42 with a suture 40 that passes through one or more apertures 28 in the bridging member 26, and the suture may be tied on the external side of the bridging member 26.

[0036] In some embodiments, such as the embodiment of Figure 10, the tubular members 20 include a fin(s) 82 having one or more apertures 84 therein to facilitate the suturing or fixation of the tubular members within the nasal passages of the patient. For example, a medical professional may pass a suture from one fin 82, through the internal partition and the septum, to a fin on the other tubular member, and then back again to properly secure the tubular members within the nasal passages of the patient. In certain embodiments, the fins 82 do not include any apertures, and the needle is passed through the fin material. In addition, an external nasal protector 36 may be applied to the top of a patient's nose following surgery, as shown in Figure 4.

[0037] Referring now to Figure 5A, one embodiment of the post-operative medical device of the present invention is shown with packing material 58 placed within the nasal cavity of a patient near the tubular members 20 of the medical device. Referring to Figure 11 , another embodiment of the post-operative medical device of the present invention is shown with packing material 58 placed within the nasal cavity of a patient near the tubular members 20 of the medical device. In this embodiment, a fin 82 is attached to each tubular member 20 of the medical device and may facilitate fixation of the medical device to the patient by allowing a suture 40 to be passed through the fins 82, as described above. This embodiment also includes ring members 90 positioned near the nostril opening, a curved bridging member 26, and a flexible member 80 associated with the bridging member 26 and extending into the tubular members 20.

[0038] The internal positioning of one embodiment of a tubular member 20 of a medical device of the present invention is shown in Figure 6. As shown, the tubular member 20 protrudes from the nostril opening 38 and extends into the nasal cavity 44, lying near the floor 46 of the nasal cavity 44. The distal end 32 of the tubular member 20 extends to a position near the upper portion of the throat 48 and the back portion of the nasal cavity 50, beyond the area of the nasal cavity that ultimately will be filled with packing material. Air flows from the proximal end 30 of the tubular member 20 to the distal end 32 of the tubular member 20 and, via the throat, into the lungs of the patient.

[0039] The embodiments of the medical device of the present invention may have any suitable dimensions, so long as each tubular member of the medical device fits comfortably within the nasal passage of a patient without exerting excessive pressure on the inner walls of the nasal cavity. In some embodiments, each tubular member has an inner diameter of about 2 millimeters to about 6 millimeters and an outer diameter of about 4 millimeters to about 8 millimeters. In other embodiments, each tubular member has an inner diameter of about 3 millimeters to about 5 millimeters and an outer diameter of about 5 millimeters to about 7 millimeters. In still other embodiments, each tubular member has an inner diameter of about 4 millimeters and an outer diameter of about 6 millimeters. In certain embodiments in which a fin is attached to the tubular member(s), such as the embodiment of Figure 10, the fin may extend any suitable distance from the outer surface of the tubular member, such as from about 0.5 to about 4 millimeters, from about 1 to about 3 millimeters, or about 1.5 millimeters, for example. In some embodiments, the fin includes two apertures that are spaced apart by a distance of about 1 to about 7 millimeters, from about 3 to about 5 millimeters, or about 4 millimeters. The fin may be attached to the tubular member at any suitable location, such as about 4 to about 12 millimeters, about 5 to about 9 millimeters, or about 8 millimeters from the proximal end 30 of the tubular member 20 to the center of the nearest aperture 84 within the fin 82.

[0040] Each tubular member of the medical device of the embodiments ^• of the present invention may have any suitable length for positioning within a nasal passage of a patient. In certain embodiments, each tubular member has a length such that the tubular member protrudes slightly beyond the nostril opening of a patient, as shown in Figures 4 and 5, and extends rearwardly to a location near the back of the nasal cavity, as shown in Figure 6. In some embodiments, each tubular member is adapted to be trimmed to the appropriate length. The appropriate length may be determined by the use of a suitable measuring device, including graduated markings on the medical device itself.

[0041] Any suitable materials may be used for the medical device of the present invention. In some embodiments, a soft and pliable medical grade silicon is used for the tubular members, the bridging member, and the fins, if present. In other embodiments, a more rigid material is used. If desired, any or all portions of the medical device also may include a suitable coating.

[0042] In some embodiments of the present invention, the post-operative medical device includes three separate components: a first tubular member, a second tubular member, and a bridging member, where the components are connected to one another by one or more suitable connecting mechanisms. In other embodiments, the medical device is a single, integrally molded device. Such an embodiment eliminates the possibility of separation of the components during insertion or removal of the device or during the duration of residence of the device within the nasal passages of a patient. As shown in Figure 10, in some embodiments, the device includes one or more fins 82, and the tubular member 20 includes multiple portions, such as a sleeve portion 86, a body portion 88, and a ring member 90 that surrounds the sleeve portion 86. These portions may be separate pieces, a single integrally molded piece, or any combination thereof.

[0043] In one embodiment of the present invention, a method^' for maintaining nasal passages open after nasal surgery, where the nasal passages are prone to obstruction by bodily fluids, is provided. In this embodiment, at least some of the bodily fluids are initially cleaned from the nasal passages after the nasal surgery. A post-operative medical device having a first tubular member and a second tubular member is provided, where the medical device is devoid of splints. The first tubular member has a first proximal end and a first distal end, and the second tubular member has a second proximal end and a second distal end. The first proximal end is connected to the second proximal end with a bridging member. The first distal end is inserted into a first nasal passage of a patient, and the second distal end is inserted into a second nasal passage of the patient. In this embodiment, the tubular members are simultaneously inserted into the nasal passages of the patient. In other embodiments, the tubular members are sequentially inserted into the nasal passages before the first and second proximal ends of the tubular members are connected with a bridging member. Packing may then be placed at least partially around each tubular member within the first and second nasal passages. In some embodiments, a suture is passed through the bridging member to stitch the bridging member to the columella of the patient. In other embodiments, a suture is passed through one or more fins attached to the tubular members to secure the device to the internal partition and the septum of the patient.

[0044] In certain embodiments of the method of the present invention, the insertion of a tubular member into a nasal passage comprises inserting the tubular member into the nasal passage until the distal end of the tubular member contacts the upper portion of the throat, and then pulling the tubular member out of the nasal passage a small distance, such as a distance of about 1 to about 5 millimeters. Alternatively, a measuring device may be used to determine the length of the nasal floor before the tubular member is inserted into the nasal passage. The tubular member may then be trimmed at the distal end to the proper length, if necessary, and inserted into the nasal passage the proper distance. Graduations on the tubular member may facilitate this purpose. In certain embodiments, the tubular member protrudes from the nasal opening a small distance, such as about 1 to about 7 millimeters, about 2 to about 6 millimeters, or about 3 to about 5 millimeters. Such protrusion facilitates the cleaning of the tubular member by the patient.

[0045] In some embodiments, the proper placement of the medical device is ensured by the inclusion of a ring member 90 at a desired distance from the proximal end 30 of the tubular member 20, as shown in Figure 10. In some embodiments, the distance from the proximal end 30 of the tubular member 20 to the center of the ring member 90 is about 1 to about 6 millimeters, about 2 to about 5 millimeters, or about 4 millimeters. The ring member 90, which may have any suitable dimensions (for example, a width of about 1 to 5 millimeters or about 3 millimeters, and a protrusion distance of about 0.5 to about 3 millimeters or of about 1 millimeter from the surface of the tubular member to the outermost portion of the ring member), may be positioned at a location on the tubular member(s) 20 such that resting the ring member 90 at the nostril level confirms the proper location of the tubular member(s) 20 before the tubular members 20 are secured within the nasal passages. The tubular members would then be assured to be readily accessible for cleaning by the patient or caregiver during their residency within the nasal passages.

[0046] Additionally, in some embodiments, the medical device may be used as a conduit for the insertion of a suction catheter or other medical instrument into the patient. For example, a suction catheter may be inserted through a tubular member of the medical device, rather than through the mouth of the patient, and used to prevent blood, mucous, or other fluids from entering the lungs of the patient and to prevent aspiration upon awakening of the patient. Insertion of a medical instrument through the tubular members also may be conducted to confirm the absence of any kinks in the tubular members and assure patency after insertion.

[0047] The medical device may remain within the nasal passages of a patient for any suitable period of time. The device may remain within the nasal passages until the nasal architecture is sufficiently healed to permit removal of the packing material, as determined by the patient's physician. For example, the device may remain within the nasal passages of a patient for a period of about one to about five days. In some embodiments of the method of the present invention, the device is removed after about two days, three days, four days, or five days. The device may be removed in any suitable manner, including without limitation, by hand or by using an appropriate medical instrument.

[0048] In certain embodiments of the method of the present invention, such as the embodiment illustrated in Figure 7, a syringe 52 is used to clean each tubular member 20 by using water or another suitable fluid 54 to flush any obstructing material through the tubular member 20. The cleaning may be performed by either the patient or the physician by simply placing the syringe at least partially into the tubular member and squeezing the syringe 52 to release the fluid 54 and flush the obstructing material from the tubular member 20. Any suitable type of syringe or other cleaning device may be used. For example, a suction device, an elongated and flexible rod-like device adapted to be inserted into the tubular member, or a syringe 52 with a flexible bulb portion 56 (such as a 1.5 ounce bulb syringe, for example) may be used. The cleaning device may include an adapter to removably connect the cleaning device to each tubular member.

[0049] Any type of suitable packing material may used in this embodiment of the method of the present invention. Examples of suitable packing materials include, but are not limited to, polyvinyl alcohol expandable foam packing; petrolatum- impregnated gauze; absorbable, oxidized, regenerated cellulose knitted fabric; absorbable, oxidized, regenerated cellulose pledgets; cotton wadding; and nonadherent pads. In embodiments where non-adherent pads are used, the pad may be folded along the longitudinal axis of the pad before insertion of the pad into the nasal passage. Multiple pads may be used in this manner. [0050] To assist with the placement of packing material into the nasal cavity of a patient to at least partially surround the tubular member of the medical device, a specialized speculum may be used. One embodiment of such a speculum 60 is illustrated in Figure 8. In this embodiment, the speculum has a handle 68, a first leg member 64, and a second leg member 62. The first leg member may have any shape suitable for insertion into the nasal passage of a patient and for application of pressure against the inner wall of the nasal cavity to temporarily expand the nostril opening 38, as shown in Figure 8A, and increase the medical professional's visual and spatial access to the area surrounding a tubular member of a medical device, with minimal discomfort to the patient. In one embodiment, the first leg member 64 has a slightly curved or arc shape that generally conforms to the curvature of the nostril of the patient, and the second leg member 62 includes a tube engaging member 66 adapted to partially surround and/or mate with a tubular member 20 of a post-operative medical device. The tube engaging member 66 may be integral with the second leg member 62 of the specialized speculum 60 or it may be added as a retrofit to a typical speculum to create a specialized speculum.

[0051] In operation, as shown in Figure 9, after insertion of a tubular member 20 into the nasal passage of a patient following surgery, the specialized speculum 60 may be inserted into the nasal passage in a first position. The speculum may then be moved to a second position that results in the tube engaging member 66 partially surrounding and mating with the external curvature of the tubular member 20 of the post-operative medical device, thereby stabilizing the tubular member 20 and exerting sufficient pressure against the tubular member 20 to permit easy placement of packing material 58 between the tubular member 20 and the inner wall of the nasal cavity 44 of the patient. The packing material 58 may be inserted using forceps 70, as shown in Figure 9, or any other suitable instrument.

[0052] The specialized speculum 60 may be made from any suitable material for insertion into the nasal passage of a patient. For example, the specialized speculum 60 may be made from a suitable metal such as a sterilizable stainless steel. Alternatively, the specialized speculum may be made from a less costly, single-use material such as a suitable plastic. [0053] In some embodiments of the present invention, a kit is provided, where the kit includes a post-operative medical device and a specialized speculum, such as the speculum described above. In certain embodiments, the specialized speculum is a single-use speculum. In some embodiments, the kit also may include other components useful following nasal surgery, such as a suitable packing material.

[0054] The embodiments of the present invention may be useful for at least the surgical specialties relating to head and neck (ear, nose, and throat) surgery and plastic surgery. Additionally, individuals practicing oral surgery, a dental specialty whose sphere includes some nasal surgery, may avail themselves of the advantages of the present invention, as may other medical professionals.

[0055] While the invention has been described with reference to particular embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims.

Claims

CLAIMSWhat is claimed is:

1. A method for maintaining nasal passages open after nasal surgery, wherein the nasal passages are prone to obstruction by bodily fluids, the method comprising:

(a) initially cleaning at least some of the bodily fluids from the nasal passages after the nasal surgery;

(b) providing a post-operative device comprising a first tubular member comprising a first proximal end and a first distal end, and a second tubular member comprising a second proximal end and a second distal end, wherein the first proximal end is connected to the second proximal end with a bridging member, and the post-operative device is splintless;

(c) inserting the first distal end and the second distal end into the nasal passages to a location where the first proximal end and the second proximal end each protrude beyond a nostril opening of a patient; and

(d) at least partially surrounding each tubular member with a packing material.

2. The method of claim 1 further comprising securing the bridging member to a columella or a septum of a patient.

3. The method of claim 2 wherein the bridging member is secured by suturing the bridging member to the columella or the septum.

4. The method of any of claims 2 to 3 wherein the bridging member comprises an aperture.

5. The method of any of claims 1 to 4 wherein the method further comprises cleaning each tubular member with a syringe comprising a fluid.

6. The method of any of claims 1 to 5 wherein each tubular member has an inner diameter of about 4 millimeters and an outer diameter of about 6 millimeters.

7. The method of any of claims 1 to 6 further comprising removing the postoperative device from the nasal passages at least two days after insertion.

8. The method of any of claims 1 to 7 further comprising trimming the first distal end and the second distal end prior to securing the post-operative device.

9. The method of any of claims 1 to 8 further comprising using a speculum to facilitate at least partially surrounding each tubular member with packing material.

10. A post-operative medical device comprising:

(a) a first tubular member comprising a first proximal end and a first distal end, wherein the first proximal end is configured to protrude from a first nostril opening of a patient;

(b) a second tubular member comprising a second proximal end and a second distal end, wherein the second proximal end is configured to protrude from a second nostril opening of a patient; and

(c) a bridging member connecting the first proximal end to the second proximal end; wherein the post-operative medical device is splintless.

11. The post-operative medical device of claim 10 wherein the device comprises an integral unit.

12. The post-operative medical device of any of claims 10 to 11 wherein the bridging member is positioned a first distance from the first proximal end and a second distance from the second proximal end, where the first distance is the same as the second distance.

13. The post-operative medical device of any of claims 10 to 12 wherein the bridging member comprises a flexible member configured to facilitate positioning of the device within the nostril openings of the patient.

14. The post-operative medical device of any of claims 10 to 13 further comprising a first fin attached to the first tubular member and a second fin attached to the second tubular member.

15. The post-operative medical device of any of claims 10 to 14 further comprising a first ring member surrounding the first tubular member and a second ring member surrounding the second tubular member, each ring member configured to facilitate positioning of the device within the nostril openings of the patient.

16. A medical kit for use following nasal surgery, the medical kit comprising: (a) a post-operative medical device comprising a first tubular member comprising a first proximal end and a first distal end, and a second tubular member comprising a second proximal end and a second distal end, wherein the first proximal end is connected to the second proximal end with a bridging member, and the post-operative device is splintless;

(b) an insertion speculum adapted to at least partially surround the postoperative medical device; and

(c) a syringe.

17. The medical kit of claim 16 wherein the insertion speculum comprises a first leg member, a second leg member, and an engagement member associated with the second leg member and configured to coincide with the first tubular member and the second tubular member.

18. The medical kit of any of claims 16 to 17 further comprising a packing material.

19. The medical kit of any of claims 16 to 18 further comprising a medical device comprising a plurality of graduations.

20. The medical kit of any of claims 16 to 19 further comprising a suction catheter.