BALLOON IRRIGATION AND CLEANING SYSTEM FOR INTERIOR WALLS OF SINUS CAVITIES

Abstract

A method and apparatus for cleansing the interior surfaces of body cavities employs a balloon catheter adapted to be inserted into a cavity through its ostium with the balloon in collapsed condition. An input flow tube for a cleansing and/or medicating fluid passes through a central passage in the balloon. When the balloon is inflated to establish a narrow passage between the balloon and the cavity walls, a pressurized flow of the fluid is pumped out the distal end of the input flow tube through the passage, parallel to the cavity walls, where it scours the inner wall of the cavity, removing debris as it flows out of the ostium. The fluid flow is urged toward a turbulent condition by attachments to the outer wall of the balloon.

Claims

1. A device for irrigating the interior surface of a sinus cavity accessible through an ostium having an interior wall, the device comprising: an inflatable balloon having a proximal end, a distal end, an interior, and an outer surface; wherein the balloon has a collapsed shape and an inflated shape, and wherein, in the collapsed shape, the balloon is configured for insertion through an ostium and into a sinus cavity, and wherein, in the inflated state, the outer surface of the balloon is spaced apart from the interior wall of the sinus cavity, such that a passage is formed between the outer surface of the balloon and the interior wall of the body cavity; a tubular structure having a distal end coupled to the inflatable balloon, wherein the tubular structure has an outer surface and an inner surface, and wherein the distal end of the tubular structure passes through the interior of the balloon with the outer surface of the tubular structure being sealed at the proximal and distal ends of the balloon; wherein the tubular structure includes a first cannula having one or more apertures into the interior of the balloon for inflating the balloon, and a second cannula having a opening at the distal end of the balloon for delivering irrigation fluid to the passage formed between the outer surface of the balloon and the interior wall of the body cavity; and wherein the irrigation fluid flows around the balloon through the passage in a turbulent or near-turbulent condition, and exits the sinus cavity through the ostium proximate to the proximal end of the balloon.

2. The device of claim 1, wherein the outer surface of the balloon contains a series of projections adapted to contact the interior wall of the cavity when the balloon is inflated, such that the passage is obstructed by the projections, thereby forcing the fluid to flow in transverse directions.

3. The device of claim 2, wherein the projections are irregularly spaced apart protuberances.

4. The device of claim 2, wherein the projections are airfoil-shaped.

5. The device of claim 1, wherein the first cannula is used to inflate and deflate the balloon.

6. The device of claim 1, wherein a positive pressure is applied to the fluid delivered to the second cannula.

7. The device of claim 1, wherein the tubular structure includes a third cannula for receiving the irrigation fluid exiting the passage around the balloon.

8. The device of claim 7, wherein a negative pressure is applied to the fluid removed from the third cannula.

9. The device of claim 1, further including a canopy supported at the distal end of the balloon that extends outwardly causing the fluid flow to move against the inner wall of the cavity.

10. The device of claim 1, further including a deflector supported at the distal end of the balloon having a plurality of holes causing the fluid flow to move against the inner wall of the cavity.

11. The device of claim 1, wherein the balloon in its inflated condition is flaccid and ripples under the force of the inflow fluid to induce the fluid motion toward turbulence.

12. The device of claim 1, wherein the input flow rate is such as to force the flow against the inner wall of the cavity at speeds to induce the fluid motion toward turbulence.

13. The device of claim 1, wherein the outer surface of the balloon defines a spiral track when inflated.

14. The device of claim 1, wherein the balloon is formed with pores or of a porous material such that at least a portion of the the incoming fluid flow is directed to the interior of the balloon so that it passes through the balloon and interacts with the fluid flow between the cavity and balloon walls to induce the fluid motion toward turbulence.

15. The device of claim 1, wherein the turbulent fluid flow is operative to debride the interior wall of the cavity.

16. The device of claim 1, wherein the fluid contains a medication which is applied to the interior wall of the body cavity.

17. The device of claim 1, wherein the balloon has a predetermined shape for conformance with the interior wall of a sinus cavity when inflated.

18. The device of claim 1, wherein the balloon has a predetermined shape for conformance with the interior wall of a maxillary sinus cavity when inflated.

19. The device of claim 1, wherein the balloon has a predetermined shape for conformance with the interior wall of a surgically created ethmoid cavity when inflated.

20. The device of claim 19, wherein the balloon further includes a non-irrigating extension adapted to engage with a middle turninate to maintain the position of the balloon within the ethmoid cavity.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Other objects, advantages, and applications of the present invention will be made apparent by the following detailed description of preferred embodiments of the invention. The description makes reference to the accompany drawings in which:

[0020] FIG. 1 is a cross-sectional view through the upper forward portion of a human skull illustrating a device formed in accordance with the present invention for irrigating a paranasal sinus of the person;

[0021] FIG. 2 is an enlarged cross section of a body cavity having its inner wall being irrigated by a first embodiment of a device formed in accordance with the present invention;

[0022] FIG. 3 is a cross section through the device and cavity of FIG. 3 taken along lines 4-4 of FIG. 3;

[0023] FIG. 4 is a cross-sectional view like FIG. 2, illustrating an alternative embodiment of the invention which includes a deflector disposed at the output end of an inflow tube in order to direct the flow through the passage between the exterior of the balloon and the interior wall of the cavity;

[0024] FIG. 5 is a cross section through a body cavity employing an alternative embodiment of the invention which comprises an extending canopy for aiding and directing the fluid flow against the interior walls of the cavity;

[0025] FIG. 6 is a similar cross-sectional view through an alternative embodiment of the invention having a spiral canopy supported on its exterior surface to accelerate the fluid flow and drive it against the interior walls of the cavity;

[0026] FIG. 7 is an enlarged cross section of one form of a protuberance formed on the balloon exterior;

[0027] FIG. 8 is a simplified diagram in partial cross section that illustrates these sinus structures;

[0028] FIG. 9 illustrates a specialized irrigation balloon for greater conformance with the maximillary sinus to achieve turbulent irrigation of maxillary sinus walls;

[0029] FIG. 10 shows an ethmoid cavity balloon including an elongated irrigating portion and a non-irrigating balloon extension that engages with a middle turbinate to maintain the irrigating portion of the balloon in position; and

[0030] FIG. 11 illustrates a ring used to better seal the ostium to a sinus cavity for controlled washing.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] While the present description of the invention deals with the paranasal sinuses as the body cavities to be treated, it should be understood that the method and apparatus of the present invention have application to other body cavities and passages such as arteries, naso-lachrymal ducts, eustachian tubes, or the like and the present description should not be viewed as limited to the paranasal sinuses.

[0032] The paranasal sinuses are prime examples of the type of body cavities that may be treated using the methods and apparatus of the present invention because they are lined with mucus-producing tissue which normally drains out of each sinus under gravity forces but in certain cases this drainage does not operate properly and the openings between the sinuses and the connecting nasal passages may become blocked, leading to congestion of the sinuses and potential microbial growth which can produce a sinus infection. The mucosal linings of the cavity become contaminated with both live and dead bacteria and other debris. Removing this debris may be a first step in curing the infection.

[0033] Referring to FIG. 1, the method and apparatus of the present invention is directed toward irrigating, for the purpose of debriding and cleaning the interior surface of a body cavity such as a paranasal sinus 10, Essentially, the invention comprises a fluid inflow tube 12 which carries a balloon 18 which may be inserted into the cavity 10 through its ostium while the balloon is in a deflated condition, and then air and/or fluid flow through the tube 12 inflates the balloon 18 to create a narrow passage between the exterior of the balloon and the interior wall of the cavity. A fluid inflow through the tube 12 then exits the balloon as will be subsequently detailing and moves forcefully against the interior wall of the cavity to perform the cleaning and debriding operation.

[0034] Referring to FIG. 2, which constitutes a cross section through the paranasal cavity 10, an instrument which practices the method of the present invention comprises an inflow or irrigation tube 12 which is adapted to pass through the ostium 14 of the cavity 10 so that a first end of the irrigation tube is outside of the cavity and a second end. terminates in an open end 16 of the tube which may be positioned near the distal end of the cavity 10 with respect to the ostium.

[0035] The tube 12 passes through a central cavity in a balloon 18 which is shown in inflated condition. The wall of the central cavity is secured to the outer wall of the tube 12 as in a Foley Catheter. The distal end 16 of the tube 12 extends beyond the balloon 18 and the proximal end of the tube 12 extends through the ostium 14 to the exterior of the cavity

[0036] An inflation tube 20 which is formed about the outer wall of the tube 12 extends through the ostium and carries air from a pump 22 into the balloon 18, through side ports 24, in order to inflate the balloon after it has been inserted into the cavity through the ostium. A second pump 26 is connected to the inlet or irrigation tube 12 at the proximal end. It acts to pump fluid from any appropriate source (not shown) through the tube 12 and out the open distal end 16 at the far end of the cavity 10. The output end 16 of the input tube 12 may be fitted with an appropriate nozzle, spray head, or the like (not shown) or it may simply be left open in certain embodiments.

[0037] The flow from the output 16 of the tube 12 passes through the relatively narrow passage 30 defined by the inner wall of the body cavity 10 and the outer wall of the balloon 18. The flow extends downwardly in the drawing of FIG. 2 until it reaches the area of the ostium which it may pass through by gravity and the force of the input flow, or alternatively exit the cavity 10 through a suction passage 32 which is evacuated by a pump 34.

[0038] Depending upon the inflow rate through the tube 16, the viscosity of the fluid being pumped through the tube, and physical dimensions of the apparatus, the fluid flow may achieve turbulence at various points during its passage. The turbulence aids in scouring any debris from the inner wall of the body cavity 10. A nonturbulent or laminar flow will also act to debride material from the inner wall of the cavity. The balloon 18 may be inflated to a condition wherein its outer surface is somewhat flaccid and deforms under the fluid flow forces, which will assist in the creation of a turbulent flow in certain geometries.

[0039] A plurality of protuberances 34 spaced over the exterior of the balloon may contact the inner walls of the cavity 10 to assist in spacing the outer surface of the balloon with respect to the inner wall of the cavity or, in alternative embodiments, the outer ends of the projections 34 may be spaced from the inner wall of the cavity when the balloon is in its inflated condition.

[0040] The protuberances are spaced along the outer surface so that there is no clear path for the fluid to flow through the channel 30, but rather the protuberances deflect the flow laterally, increase the speed of the flow, and in certain situations may bring the flow to a turbulent state. The cross sections of the protuberances 34 may be airfoil shaped or the like, as shown in FIG. 7, to increase the speed of a flow over their surfaces and promote turbulence at their trailing edges.

[0041] At the far end of the flow path, adjacent to the ostium 14, the output flow may be pressurized by the suction pump 36 or, in some embodiments, it may simply flow out of the ostium under gravity forces and/or the pressure of the incoming flow.

[0042] In use, the balloon 18 is initially deflated so that it lies closely along the exterior of the inflow tube 12 and may be inserted into the body cavity 10 through the ostium 14, with the tube. The balloon may then be inflated by air or other gas through the pump 22 and the tube 20. The gas will flow outwardly into the interior of the balloon through the ports 24. The balloon 18 may be inflated until the extending edges of the projections 34 contact the inner wall of the cavity 10 or, to a lesser degree, allowing a larger free channel 30 for fluid flow. Fluid is then forced through the inflow tube 12 by the pump 26 and exits into the channel 30 through the top 16 of the inflow tube 12. The fluid is forced through the channel 30 which surrounds the balloon and scours the inner walls of the cavity 10 to remove any loose material such as dead cells, accumulated. mucus, and the like. This material is then carried out the ostium through the fluid forces and gravity or alternatively through the channel 32 based on the vacuum created by the pump 36. After the irrigation is completed, the balloon may be deflated by reversing the pump 22 and then the inflow tube 12, with the collapsed balloon draped over its surface, may be withdrawn through the ostium 14.

[0043] FIG. 3 is a cross-sectional view through the embodiment of FIG. 2, taken along line 4-4 of FIG. 2. The arrows illustrate the transverse pattern of the fluid flow as a result of interference between the otherwise downward flow toward the ostium, wherein the lateral movement is forced by the interference between the flow and the projections 34.

[0044] FIG. 4 illustrates an alternative form of the invention which includes a foldable deflector 44 supported on the output end 16 of the inflow tube 12. In this embodiment the same numbers are applied to the components to the extent they are identical to the components of the embodiment of FIG. 2.

[0045] The deflector is a thin, concave shell which extends to a form parallel to the inner wall 10 of the cavity, at the end of the cavity opposite to the ostium. It may be formed of a flexible material. The deflector 44 is supported on the end 16 of the input tube by means of ribs 46 which preferably have one end pivotably attached to the end 16 of the inflow tube and their other ends pivotably attached to the shell 44 at spaced points. The deflector 44 may be moved to a collapsed form wherein it lies along the sides of the distal end of the tube 12 for insertion and removal of the tube through the ostium. It preferably has a plurality of holes 48 in its surface to allow the flow from the output of the tube 12 to move against the inner wall of the cavity 10 on the convex side of the deflector. The deflector forces the flow from the output end 16 of the tube 12 along the sides of the balloon through the channel 30.

[0046] In the embodiment of FIG. 4 there are no projections 34 extending from the surface of the balloon, but the input flow rate is such as to force the flow against the inner wall 10 of the cavity at speeds which may achieve turbulence to aid the scouring action. Since there are no projections from the outside of the balloon, the balloon may be inflated into closer proximity to the wall 10 of the cavity than the embodiment of FIG. 2.

[0047] The deflector 44 may normally assume its collapsed condition about the exterior of the tube 12 through use of biasing means such as a spring (not shown). It may then be forced open by the flow out of the end 16 of the tube 12. Alternatively, it may normally be biased toward an extended position and cables or the like (not shown) may be passed through the tube 12 from the exterior of the cavity 10 to the deflector 44 to force it into a folded condition.

[0048] FIG. 5 illustrates another embodiment of the invention, much like the embodiment of FIG. 3, but further including a canopy 50 which has one end 52 attached to the exterior of the balloon and the other end free of the balloon. The canopy 50 may be normally biased so as to lie over the surface of the balloon 18 for insertion and removal of the apparatus through the ostium 14. Once in the cavity, and after the balloon is inflated through the tube 20, the lower end 54 of the canopy 50 may be shaped to extend outwardly toward the side walls of the cavity and force the fluid flow against the side walls 10 of the cavity. By narrowing the resulting passage between the exterior of the balloon and the interior of the cavity, the flow is accelerated and may attain turbulence at certain points of its path.

[0049] FIG. 6 discloses another embodiment of the invention, similar to the embodiment of FIG. 5, with the exception that instead of having a single canopy 50 encircling the balloon, as illustrated in FIG. 5, a spiral canopy 60 extends along the entire height of the balloon 18. The output flow from the deflector 44 is directed against the top section of the spiral canopy 60 and the edges of the canopy 60 extend close to the inner walls of the cavity 10. The flow is forced to follow the spiral path created by the canopy 60 and the fluid flow forces the flow to attain a high speed along the spiral path, heightening the ability to achieve turbulence in the flow.

[0050] Alternatively, the canopy 60 could take the form of separate closed rings extending around the perimeter of the balloon 18, rather than a closed spiral track 60. These rings would create a corrugated pattern that would force the flow through the channel 12 to move back and forth laterally while still moving from the outlet 16 to the ostium, increasing the scouring action.

[0051] The protuberances 34 illustrated in the embodiments of FIG. 2 and FIG. 4 may be used in any of the embodiments and may be arranged in the shape of an airfoil, as illustrated in FIG. 7 at 80 to enhance the turbulence of the fluid.

[0052] The balloons disclosed herein may be axially symmetrical, as would be the case with spherical or axially symmetric oblong shapes. However, in alternative embodiments, irregular including asymmetrical shapes may be used, particularly for improved conformance with specific body cavities or passages. Balloons with predetermined shapes may be particularly effective in scrubbing nasal cavities, which present irregular spaces and ostia of different sizes and shapes.

[0053] FIG. 8 is a simplified diagram in partial cross section that illustrates these sinus structures. The nasal cavities are shown at 802. The inferior turbinates are shown at 804, the middle turbinates at 806, and the superior turbinates at 808. The ethmoid cavities are shown at 810, the maxillary sinus at 812, and the lacral ducts at 814.

[0054] The types of ostia associated with sinus cavities may include virgin, sphenoid, frontal, and post-surgical ethmoid openings. Virgin or natural maxillary ostia are typically very small and an important factor in maxillary sinus disease. On the other hand, accessory sinus ostia are often quite large. Sphenoid sinus ostia also have small openings. These include the frontal and ethmoid sinuses. The frontal sinusthe entrance to sinusis a relatively long track between neighboring sinuses to approach ostium. Neighboring sinuses must be dealt to reach the ostium.

[0055] The ethmoid sinuses are very small, and the openings are not negotiable without surgical intervention to establish post-ethmoid surgical openings. That is, ethmoid sinuses produce a large open space without a distinct opening. The walls of the ethmoid sinuses are compromised as a purposeful result of the sinus surgery, however, leaving a very large opening to the nasal cavity from anterior to posterior and a relatively shallow cavity. Thus, after balloon sinuplasty, all ethmoid sinuses should accommodate the turbulent balloon irrigation described herein.

[0056] FIGS. 9, 10 relate to the specialized balloons to achieve irrigation for problem sinuses. In both examples, the flow of irrigation fluid also expands the balloon. Though irregular in shape, the balloons may use any of the structures or methods disclosed herein to promote turbulent flow. The use of dedicated shapes for particular applications is particularly important for maxillary sinus and ethmoid irrigation. FIG. 9 illustrates a specialized irrigation balloon for greater conformance with the maximillary sinus to achieve turbulent irrigation of maxillary sinus walk. The device enters through the opening to the maxillary sinus (maxillary osmium) that may or may not need to be widened surgically (balloon sinuplasty). The balloon 902 is made to generally fit the pyramid shaped interior of the maxillary sinus.

[0057] In the embodiment of FIGS. 9, 10, the flow from the inflow tube may be used to inflate the balloon and exits the distal aspect of the balloon at 904, and forced to flow between the sinus wall and the balloon. Irregular features 906 on the outer surface of the balloon assure a turbulent flow. The inflow tube 912 is preferably narrower than the maxillary osmium and allows for surrounding outflow 910. Additional features may include small holes 914 in the balloon to leak fluid and prevent excessive pressure of then balloon that would impede the desired flow. A further option may include a relatively firm outflow at the ostium to guide the outflow of fluid.

[0058] Balloons associated with the frontal sinus may be saccular. A post-operative ethmoid space is relatively shallow, with the entire sinus complex being open to the nasal cavity. A balloon for post-operative ethmoid spaces may assume an elongated sausage shape to fit from anterior to posterior, with dedicated holes to direct irrigation onto the ethmoid surface. A challenge with ethmoid irrigation is the lack of means to hold the balloon in the cavity. In contrast to other shapes disclosed herein, where the distal portion of the balloon is wider than the proximal portion, with elongated tubular shapes back-out is possible under fluid pressure. Thus, to maintain stability, an ethmoid balloon may include an extension that inflates around then middle turbinate and holds the irrigation balloon within the ethmoid sinus during the irrigation.

[0059] FIG. 10 shows an ethmoid cavity balloon which actually includes two inflatable portions: an elongated irrigating portion 920, and a non-irrigating balloon extension 922 that locks onto a middle turbinate to maintain the irrigating portion 920 balloon in a surgically created ethmoid cavity. As with other embodiments disclosed herein, the inflow tube is bendable but preferably relatively stiff, and the out-flow 930 of irrigation fluid may travel outside of the tubular structure 922 used to deliver in-flow irrigation fluid 924.

[0060] In certain procedures, a ring may be used to close the sinus for controlled washing. Making reference to FIG. 11, such a ring 950 would be attached to the inflow cannula, and contain the ports or a short cannula that facilitate outflow. The ring 950 would encircle the inflow cannula, such that pressing, or pressure, on this ring will seal the opening for irrigation. For ethmoid sinuses, a larger, thin-walled soft ring can accommodate the irregularities of the edges of the ethmoid sinuses, sealing them for irrigation/washing. FIG. 11 also depicts the following: [0061] 952: inflatable balloon filled with solution (i.e., sterile saline solution with/without medications, antibiotics, etc.) [0062] 953: Balloon outer wall [0063] 954: Inflow channel [0064] 955: Irrigation space between balloon outer wall and interior surface of cavity [0065] 956: inflow solution [0066] 958: Small ports in inflow tube for balloon inflation [0067] 960: Perforated distal shield [0068] 962: Fluid flow around outersurface of balloon [0069] 964: Balloon surface features to establish turbulent flow [0070] 966: Turbulent fluid flow [0071] 970: Exit channel maintained in an open condition by ring 950 [0072] 972: Sinus ostium [0073] 974: Outflow solution

[0074] In summary, this invention provides systems, devices and methods for turbulent washing of a body cavity. Washing may be taken to include any form of improved irrigation, cleansing, rinsing, debriding, scrubbing, scraping, and the like, with the goal being to produce turbulent flow along the surface of a body cavity to strip from it debris including dead and dying cellular material, mucous and bacterial or fungal material. Fluid flow through a balloon cannula device establishes a turbulent flow close to cavity surfaces to be cleaned. In preferred embodiments, the balloon is inflated within a cavity, but only enough to partially fill that cavity, leaving a space between balloon and cavity surface.

[0075] The balloon may be placed through a sinus opening (i.e., ostium). The balloon is coupled to a cannula that traverses from proximal to distal to carry the irrigation fluid. Small apertures may be placed in the cannula in addition to a central distal outlet. The balloon outer surface may be modified to include randomly placed, irregularly projections to cause the turbulence, and/or including a fast current, to clean the surface. Embodiments of the invention establish a pressure gradient by introducing irrigation at the distal aspect of the cavity with relief proximately. Accessory exit ports may be created to assure that there is a pressure gradient from distal to proximal, thereby producing an effective flow. The balloon may be inflated through small apertures in the cannula that traverses from the proximal entrance to distal exit.

[0076] The balloon is preferably made of a thin polymeric material, flexible enough to keep shifting to produce a randomly moving surface. The balloon is constructed so as produce an optimally narrow space between the outer balloon surface and inner surface of the cavity or passage to be cleaned. The balloon may be shaped to enhance conformance within different sinuses or other body structures.

[0077] Different approaches may be used to establish, encourage or maintain turbulent flow. The outer surface of the balloon may be structured to disturb laminar flow, instead supporting a continuous turbulent, randomly shifting flow. In preferred embodiments the structure includes projections that extend from the outer surface of the balloon. Such projections may be affixed to the outer balloon surface with any number of waterproof adhesives, including polymer adhesives, epoxy, etc.

[0078] Alternatively, areas of the balloon may include a random pattern of weakened regions during the creation of the balloon, such that pressure from within cause bulges on the outer surface. It is anticipated that controlled, thin areas of the balloon that will cause small bulges. Random, minute apertures may be provided to leak solution from within the balloon to further support turbulent flow.

[0079] The transversing cannula to which the inflatable balloon is coupled may be constructed of a flexible, semi-rigid or rigid material, depending upon the target cavity or passage to be cleaned. The cannula may be glued or otherwise attached to entrance to the balloon and/or exit of the balloon. The internal diameter of the cannula is such that the total inflow diameter at the entrance to the balloon is equal to the total outflow cannula diameter(s), thus not causing the balloon to swell and close off flow. Alternative embodiments may provide a shortened cannula at the entrance to the balloon, with a shorter outflow cannula with the inflow pressure expanding the balloon.

[0080] In terms of the assembly at the exit orifice of the balloon, the transversing cannula may be joined to the balloon with epoxy or other adhesives, heat sealed, or the like. As described, a shield may extend from the exit port redirect flow, and may be perforated to allow cleaning function just beyond distal orifice. The shield should help to protect tissue injury from direct flow.