Patent Application
20200397976
This invention relates to a method and apparatus useful to clean, scrub, debride or irrigate, the interior surfaces of body cavities and more particularly to such a method and apparatus employing a balloon-like inflatable catheter.
Balloon catheters have been employed to provide treatment to relatively inaccessible body cavities such as occluded blood vessels, nasal cavities, wounds, or paranasal sinuses and the like. In some cases, these balloons are used to introduce fluids onto the linings of various body cavities to carry medications such as antibiotics and the like into intimate contact with the interior surfaces of the cavities. Attempts to clean a cavity with a forceful jet into the cavity that is filled with fluid is defeated as its force is absorbed by the fluid. A device that reduces the volume of the cavity to a thin rim over the entire surface can force the flow directly onto the walls and in a direction that parallels the walls but without dissipation of the force and covering the entire surface. In essence this is the basic concept of this invention.
Certain of these balloons have been formed with walls of porous materials so that the fluids from the interior of the balloons will flow outwardly against the body cavity interior surfaces to provide medicated fluids or the like to those surfaces. U.S. Patent Publication 2007/0129751 assigned to Acclarent, Inc. discloses a device for balloon sinusplasty which may employ a balloon with porous walls to deliver fluids to the interior walls of sinus cavities. The fluid flows from the interior of the balloon are thus generally directed perpendicularly to the interior surfaces of the body cavity and are sometimes pressurized so that any medication contained in the fluid will forcefully impact the interior walls of the cavity. These fluid streams can only clean areas similar to the cross-sections of the streams and schemes for moving the streams over the side walls invariably leave some areas untouched or under cleaned. Increasing the force of the streams impacting the walls may do harm to the walls.
In many medical situations it is desirable to remove dead cells and the like which may have accumulated on the interior wall of a body cavity. For example, in a healthy nose mucus produced by the lining of the paranasal sinuses drains out of the sinus through the ostium, an opening connecting the interior of the sinus cavity to the nasal passages, carrying cellular and bacterial debris with it. In conditions such as sinusitis the mucus may be prevented from freely exiting the ostium and tends to accumulate the debris on the interior walls of the sinus cavities interfering with the normal functions and healing of the cavities. This mucosal congestion may result in microbial growth on the surface which must be removed to restore the sinuses to their normal function.
The present invention is accordingly directed toward methods and apparatus to irrigate, with or without medication, to scrub, clean, and/or debride the interior surfaces of infected body cavities or body cavities suffering from accumulations of dead cells, mucous, bacteria accumulations or the like to restore them to a healthy condition. This is preferably done by a fluid flow in a direction generally parallel to the cavity wall to scrub the wall without imposing forces that may harm the wall.
Very broadly the method and apparatus comprises a balloon which may be inserted in deflated condition through the ostium of the cavity to be treated and then inflated to produce restricted passages between the complementary walls of the balloon and body cavity. A pressurized fluid flow is then introduced into the area between one end of the balloon, preferably the distal end, considering the ostium end to be the proximal end. This fluid flow passes over the outer sides of the balloon through the restricted passage. At the other end of the balloon, preferably near the ostium, an outflow tube, which may be negatively pressurized, sucks out the fluid, as well as any debris picked up by the fluid flow over the interior walls of the cavity, such as cellular debris and the like. In other embodiments the fluid flow out of the cavity may be under the force of gravity and/or the pressure of the inflowing fluid. This fluid flow along the interior walls of the cavity has many advantages over devices that direct the fluid flow perpendicularly against the walls. First, pointing a forceful stream at the inner wall of the cavity is inefficient. First, the stream pointed more or less perpendicular to the wall cleans only an area more or less the cross sectional area of stream. Repeated movement of the stream, crisscrossing the inner surface area over and over again is problematic that the walls can be completely scrubbed clean. Also in some cases the force of the stream impacting the wall may be increased to a point that the wall itself is injured. A flow of cleaning fluid that runs parallel to the wall is a far more thorough and efficient means of scrubbing the interior wall of a cavity with a greater freedom to increase pressures without destroying the interior wall.
Second, soon after liquid is forced into a cavity the cavity will fill and the effect of the stream is dissipated by the inertia of the liquid in the cavity. To push a relatively thin stream into a filled cavity, no matter how large the outflow, produces a languid flow across/parallel to the cavity inner surface.
In one embodiment of the invention, which will be subsequently disclosed in detail, the inflow tube passes through the center of the balloon and the central passage through the balloon is sealed against the outer wall of the inflow tube, in the manner of a Foley Catheter. In this embodiment, when the balloon is in a collapsed condition, it may be inserted through the ostium, into the cavity, by passing the inflow tube into the cavity. The output end of the inflow tube projects beyond one end of the balloon. This arrangement resembles a Foley Catheter.
In another embodiment the balloon will have irregular projections extending from its outer surface which will contact the interior walls of the cavity and create interrupted passages between the outer wall of the balloon and the interior wall of the cavity. Fluid, which may be medicated, is then introduced through an inflow tube which extends through the center of the balloon and terminates at the distal end of the cavity. Pressurized fluid flow is then passed through the inflow tube and directed by a nozzle at the end of the tube against a deflecting structure, preferably supported on the distal end of the balloon, which directs the flow from the tube into the passage between the balloon exterior and the interior wall of the cavity.
The irregularities on the balloon prevent direct flow out of these passages and continually deflect the fluid stream laterally, parallel to the cavity wall in such a way as to achieve turbulent or near turbulent conditions in the fluid. The flow will debride contaminating elements on the interior wall of the cavity and carry them to the proximal end of the balloon and of the cavity where they are drawn through outflow tubes, preferably with an active suction pressure exerted on the tubes.
The balloon may have radically extending corrugations on its outer surface to aid in creating turbulence or near turbulence in the fluid flow.
In certain embodiments of the invention which will be subsequently disclosed in detail the cross sectional shape of the protuberances that project from the sides of the balloon will be such as to induce turbulence or near turbulence in the fluid flow. Turbulence is also a function of the dimensions of the device and the viscosity and flow rate of the fluid. Turbulence will greatly aid the debriding action. The surface of the balloon may have dimples or indentations to affect flow towards a turbulent nature.
In other embodiments of the invention the outer surface of the balloon will carry a resilient deflecting cowling which will lie flat over the exterior of the balloon when it is collapsed over the inflow tube and when the balloon is inflated one end of the cowling will project outwardly toward the interior of the cavity at an angle toward the ostium to aid the deflection of the flow through the cavity.
In one embodiment of the invention the exterior side of the balloon supports a planar raceway which spirals toward the ostium end of the cavity when the balloon is inflated. This raceway forces the input fluid to traverse a longer path than it would if it could flow directly toward the ostium end of the passage between the exterior of the balloon and the interior wall of the cavity. This increases the flow rate of the fluid after it exits the input tube and improves the ablating force against the cavity interior, as well as elongate the flow path to increase the cleaning action.
In some embodiments of the invention a concave deflector is supported above the output end of the input flow tube so as to deflect the flow around the sides of the balloon. This deflector may be supported on the flow tube by umbrella-like ribs which allow the deflector to fold along the sides of the outflow tube during insertion of the tube and the deflated balloon through the ostium of the body cavity. Once in the cavity, the deflector may be opened up either by a spring mechanism or the force of the outflow from the tube. Alternatively, the deflector may be moved between its folded and unfolded position by the manipulation of cords or the like which may be controlled from the exterior of the cavity. The deflector may have a number of holes in its surface to allow the fluid flow to irrigate the area of the cavity wall covered by the deflector.
In still another embodiment of the invention the walls of the balloon may be formed with pores or of a porous material. In this embodiment the incoming fluid flow, or at least a portion of it, is directed to the interior of the balloon so that it passes through the pores under the inflow pressure and irrigates the walls of the cavity and may additionally interact with the fluid flow between the cavity and balloon walls to assist in the creation of turbulence in that fluid flow.
The fluid flow is preferably arranged so that it achieves turbulence, or near turbulence which acts to scrub the interior walls of the body cavity as the fluid flows through the channels between the opposed walls of the balloon and the cavity. In the embodiments with protuberances extending from the balloon toward the wall of the cavity, the shape and position of these protuberances, as well as indentations of the balloon wall, may be such as to influence the flow toward turbulence.
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:
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.
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.
Referring to
Referring to
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
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.
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
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.
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.
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
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.
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.
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.
In the embodiment of
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.
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.
The protuberances 34 illustrated in the embodiments of
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.
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 sinus—the entrance to sinus—is a relatively long track between neighboring sinuses to approach ostium. Neighboring sinuses must be dealt to reach the ostium.
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.
In the embodiment of
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.
In certain procedures, a ring may be used to close the sinus for controlled washing. Making reference to
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.
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.
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.
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.
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.
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.
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.
This application is a continuation-in-part of U.S. patent application Ser. No. 14/172,393, filed Feb. 4, 2014, now U.S. Pat. No. 10,758,667, which claims the benefit of U.S. Provisional Application 61/760,468 filed on Feb. 4, 2013, the entire content of all related applications being incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 61760468 | Feb 2013 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14172393 | Feb 2014 | US |
| Child | 17007153 | US |
