Intranasal Occlusion Device And Methods Of Using The Same

Abstract

An intranasal occlusion device having an inflatable balloon within a sponge that is used to prevent drainage of fluid, such as blood and other fluids into the airway during sinus and nasal minor procedures or surgeries, and methods of using the device to occlude an intranasal cavity of a patient. The device provides for suction to remove the fluid and may facilitate office-based minor procedures or surgeries.

Claims

1. An intranasal expandable occlusion device comprising: an expandable body further comprising a flexible inflatable balloon that is surrounded by at least one flexible expandable sponge having an exterior surface, and a flexible expandable cover that is impermeable to liquids and overlies a portion of the exterior surface of the at least one sponge but that provides access to the at least one sponge proximate an anterior end of the at least one sponge; an inflation catheter connected to the balloon; and a suction catheter connected to the sponge.

2. The intranasal expandable occlusion device of claim 1, wherein the at least one sponge further comprises two sponges that surround the balloon.

3. The intranasal expandable occlusion device of claim 1, wherein the at least one sponge further comprises at least one poly-vinyl alcohol sponge.

4. The intranasal expandable occlusion device of claim 1, wherein the at least one sponge is expandable by applying fluid to moisten the sponge.

5. The intranasal expandable occlusion device of claim 1, wherein the at least one sponge is expandable by inflating the balloon.

6. The intranasal expandable occlusion device of claim 1, wherein the body is generally cube-shaped when expanded.

7. The intranasal expandable occlusion device of claim 1, wherein the body is dimensioned to have an expanded size that is approximately 20 mm high, 27 mm wide and 26 mm long.

8. The intranasal expandable occlusion device of claim 1, wherein the cover further comprises an outer surface having a line that corresponds to a preselected desired positioning of the body when in use.

9. The intranasal expandable occlusion device of claim 1, wherein the cover further comprises an elastomeric material.

10. The intranasal expandable occlusion device of claim 1, wherein the suction catheter includes a plurality of openings that are located within the at least one sponge.

11. A method of providing intranasal occlusion for a patient comprising the steps of: locating near a patient an intranasal expandable occlusion device comprising: an expandable body further comprising a flexible inflatable balloon that is surrounded by at least one flexible expandable sponge having an exterior surface, and a flexible expandable cover that is impermeable to liquids and overlies a portion of the exterior surface of the at least one sponge but that includes access to the at least one sponge proximate an anterior end of the at least one sponge; an inflation catheter connected to the balloon; and a suction catheter connected to the sponge; inserting the body of the intranasal expandable occlusion device into the nose of the patient in an unexpanded condition; positioning the body of the intranasal expandable occlusion device in the choanae and nasopharnyx; and expanding the body of the intranasal expandable occlusion device so as to seal the choanae and nasopharynx.

12. The method of claim 11, wherein the step of inserting the body of the intranasal expandable occlusion device further comprises inserting the body via anterior nares of the patient under endoscopic guidance.

13. The method of claim 11, wherein the cover further comprises an outer surface having a line that corresponds to a preselected desired positioning of the body when in use and the line is used for preferred placement when positioning the body of the intranasal expandable occlusion device in the choanae.

14. The method of claim 11, wherein the at least one sponge further comprises at least one poly-vinyl alcohol sponge.

15. The method of claim 11, wherein the step of expanding the body further comprises moistening the at least one sponge.

16. The method of claim 11, wherein the step of expanding the body further comprises inflating the balloon via the inflation catheter.

17. The method of claim 11, wherein the step of positioning the body of the intranasal expandable occlusion device in the choanae and nasopharynx includes adjusting the position for patient comfort.

18. The method of claim 11, further comprising using the suction catheter to remove fluid from within the at least one sponge.

19. The method of claim 11, wherein upon completion of a procedure, the body may be removed with the balloon in a deflated condition by pulling the body anteriorly through the nose.

20. The method of claim 11, further comprising a step of delivering intranasal medication or intranasal irrigation.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] In describing the preferred embodiments, reference is made to the accompanying drawing figures wherein like parts have like reference numerals, and wherein:

[0013] FIG. 1 is a schematic view that illustrates the relevant anatomy of the posterior nasal cavity and nasopharynx of a patient;

[0014] FIG. 2 is a schematic view that illustrates an example intranasal expandable occlusion device of the present disclosure positioned in the posterior nose;

[0015] FIG. 3 is a schematic cross-section view that illustrates the components of the device shown in FIG. 2;

[0016] FIG. 4 is a schematic anterior perspective view that illustrates the device shown in FIG. 2 in an unexpanded condition;

[0017] FIG. 5 is a schematic anterior perspective view that illustrates the device shown in FIG. 2 in an expanded condition;

[0018] FIG. 6 is a schematic upper perspective view that illustrates the device shown in FIG. 2 in the expanded condition shown in FIG. 5; and

[0019] FIG. 7 is a perspective view of the device shown in FIG. 2 and further connected to a source for inflation of the balloon.

[0020] It should be understood that the drawings are not to scale. While some mechanical details of example intranasal expandable occlusion devices, including other plan and section views of the example shown, and of examples that may have alternative configurations, have not been included, such details are considered within the comprehension of those of skill in the art in light of the present disclosure. It also should be understood that the present invention is not limited to the example embodiments illustrated.

BRIEF DESCRIPTION OF THE PREFERRED EMBODIMENT

[0021] The general relevant anatomy of the posterior nasal cavity and nasopharynx of a patient are shown in FIG. 1. Thus, the nostrils present anterior nares and a nasal cavity includes the inferior turbinate, the middle turbinate and the superior turbinate, which are above the palate and anterior to the choanae and nasopharynx. This sets the stage for the area within which nasal and sinus surgeries and other procedures often are performed. Unfortunately, this also is a crowded space within which a surgeon must operate and which has a tendency to generate bleeding that can obscure the field or site of the surgical procedure.

[0022] FIGS. 2-7 provide an example intranasal expandable occlusion device 10, which is shown in FIG. 2 in a preferred location for use within the relevant anatomy of the posterior nasal cavity and nasopharynx, so as to seal off the rest of the upper airway and prevent aspiration. As may be seen in FIG. 3, the device 10 includes an expandable body 12. The body 12 further includes a flexible inflatable balloon 14 that is surrounded by at least one flexible expandable sponge 16 having an exterior surface 18, and a flexible expandable cover 20 that is impermeable to liquids and overlies a portion of the exterior surface 18 of the at least one sponge 16 but that includes access to the at least one sponge 16 proximate an anterior end 24 of the at least one sponge 16. In this example, the cover 20 extends over the posterior end and along the sides of the at least one sponge 16, and access to the at least one sponge 16 is provided by an opening 22 toward an anterior end of the at least one sponge 16. The opening 22 will allow fluid, such as blood and other fluids to reach and be collected by the at least one sponge 16. The device 10 also includes an inflation catheter 26 connected to the balloon 14, and a suction catheter 28 connected to the sponge 16.

[0023] The at least one sponge 16 of the intranasal expandable occlusion device 10 may be of unitary construction, while being shaped for advantageous bilateral placement, or alternatively may include two or more sponges that surround the balloon 14. In a preferred embodiment, the at least one sponge 16 may be constructed as at least one poly-vinyl alcohol sponge. It will be appreciated that when the sponge 16 is constructed as a poly-vinyl alcohol sponge, or of other suitable materials, it may be expanded by applying fluid, such as by applying approximately 1 cc or more of saline to moisten the sponge. This provides a safe, effective, low pressure and cost efficient means of employing a first expansion capability of the body 12. In some instances, this may provide sufficient expansion to seal the choanae and nasopharynx. However, the intranasal expandable occlusion device 10 may be expanded to a further extent by inflating the balloon 14 that is surrounded by the sponge 16. A sealing fit within the choanae and nasopharynx may be achieved with the body 12 being of several configurations, but a particularly suitable configuration may be a construction wherein the body 12 is generally cube-shaped when expanded. Thus, for example, for an average adult patient, it may be suitable to have the body 12 dimensioned so as to have an unexpanded size that is approximately 11 mm high, 5 mm wide and 22 mm long, and an expanded size that is approximately 20 mm high, 27 mm wide and 26 mm long. It will be appreciated, however, that other dimensions may be suitable, depending on the anatomy of the patient.

[0024] The flexible expandable cover 20 is impermeable to fluids and may be constructed of a thin flexible elastomeric material, such as a sheet or film of elastomeric plastic, rubber or other suitable elastomeric material that accommodates expansion of the sponge 16 and/or balloon 14. The device 10 is shown in an unexpanded condition in FIG. 4, and in an expanded condition in FIGS. 5 and 6. The cover 20 has an outer surface 30. As best seen in FIGS. 2 and 4-6, the outer surface 30 of the cover may feature a line 32 that corresponds to a preselected desired positioning of the body 10 when in use in a patient, and the cover 20 permits fluid to be collected in the sponge 16 without passing through the least one sponge 16 to the upper airway.

[0025] As best seen in FIG. 3, the suction catheter 28 of the intranasal expandable occlusion device 10 includes a plurality of openings 34 that are located within the at least one sponge 16. In addition, the inflation catheter 26 that is connected to the balloon 14 may be connected at its proximal end to a suitable inflation source 38, which is shown in FIG. 7 as a syringe. The inflation catheter 26 preferably includes a one way valve 36 or other suitable configuration at its proximal end, to ensure that the balloon will not inadvertently collapse during a procedure. Depending on the characteristics of the balloon 14, the inflation source 38 may provide fluid for inflation of the balloon 14 that could range from a gas to a liquid, and may be other than a syringe.

[0026] The present disclosure also provides a method of providing intranasal occlusion for a patient comprising multiple steps. The steps include locating an intranasal expandable occlusion device 10 that includes an expandable body 12 further having a flexible inflatable balloon 14 that is surrounded by at least one flexible expandable sponge 16 having an exterior surface 18, and a flexible expandable cover 20 that is impermeable to fluids and overlies a portion of the exterior surface 18 of the at least one sponge 16 but that includes access to the at least one sponge 16 proximate an anterior end 24 of the at least one sponge 16. The access in this example is provided by an opening 22 near the anterior end of the at least one sponge 16. The device 10 also includes an inflation catheter 26 connected to the balloon 14 and a suction catheter 28 connected to the sponge 16. The method further includes the steps of inserting the body 12 of the intranasal expandable occlusion device 10 into the nose of the patient in an unexpanded condition, such as the condition shown in FIG. 4, and positioning the body 12 of the intranasal expandable occlusion device in the choanae and nasopharynx. The method additionally includes the step of expanding the body 12 of the device 10 so as to seal the choanae and nasopharynx, as may be seen in FIG. 2.

[0027] The step of inserting the body 12 of the intranasal expandable occlusion device may further include inserting the body 12 via anterior nares of the patient under endoscopic guidance. As noted above, the cover 20 may further include an outer surface 30 having a line 32 that corresponds to a preselected desired positioning of the body when in use, and the method may include using the line 32 for preferred placement when positioning the body 12 of the device 10 in the choanae.

[0028] The method also may include wherein the at least one sponge 16 further includes two or more sponges that surround the balloon 14 and/or the at least one sponge 16 further includes at least one poly-vinyl alcohol sponge, or at least one sponge constructed of other suitable materials. It will be appreciated that the step of expanding the body 12 may include moistening the at least one sponge 16, and further may include inflating the balloon 14 via the inflation catheter 26. The body 12 also may be further expanded simply by including a step of inflating the balloon 14.

[0029] After inserting the intranasal expandable occlusion device 10, the step of positioning the body 12 of the device 10 in the choanae and nasopharynx may include adjusting the position for patient comfort. Ideally, the device 10 may be used without need for general anesthesia, and therefore, without need to be within a full hospital operating room.

[0030] The method of providing intranasal occlusion for a patient also may include using the suction catheter 28 to remove fluids that have been collected within the at least one sponge 16. The method also may include steps associated with additional equipment, such as additional air inflation or suction systems or medication delivery systems to perform other procedures, such as delivery of intranasal medications or intranasal irrigation. It further will be appreciated that upon completion of a procedure wherein the device 10 is used, the body 12 may be removed with the balloon 14 in a deflated condition by pulling the body 12 anteriorly through the nose of the patient.

[0031] The disclosed intranasal expandable occlusion device provides a novel and highly advantageous option for use with patients that may undergo surgery or other procedures within a physician's office or another cost effective setting. The device provides for appropriate space for surgery or other procedures, while sealing off the rest of the upper airway, to prevent aspiration. While the disclosed device is susceptible of embodiment in many different forms, there is shown in the drawings an example embodiment with the understanding that the present disclosure can be considered as an exemplification of the principals of the invention and is not intended to limit the invention to the example embodiment illustrated, and is only limited by the appended claims and legal equivalents thereof.