Patent Application
20120277586
1. Technical Field
The present invention relates to a tubular member having a lumen therethrough for transport of fluid material. More particularly, the invention relates to a feeding tube for insertion into the jejunum of a patient, wherein the feeding tube has an echogenically enhanced portion that permits location of the tube under ultrasound imaging.
2. Background Information
Patients for whom normal ingestion of food becomes difficult or impossible may require placement of a feeding tube to assist in providing their nutritional needs. For some individuals, such as comatose patients, stroke victims, or those with a compromised gastrointestinal tract, this may require placement of a tube that is introduced percutaneously into the stomach for delivery of nutritional products directly into the stomach. Such tubes for delivery of nutritional products into the stomach are generally referred to as gastrostomy tubes, or “G”-tubes.
In some situations, feeding a patient through a G-tube can be problematic. Such situations include, among others, the presence of certain congenital abnormalities in the patient, as well as the possibility of severe gastric reflux and/or a high rate of aspiration. In other situations, nutritional targets may not be attained at a satisfactory rate through G-tube feeding. In such patients, feeding may often be accomplished by inserting a feeding tube, sometimes referred to as a jejunostomy tube, or a “J”-tube, directly into the jejunum of the patient. The J-tube bypasses the stomach, thereby avoiding congenital abnormalities, and decreasing the risk of gastric reflux and aspiration. In addition, the J-tube often provides better success in delivering nutrients than a G-tube, and allows the nutrients to be delivered and absorbed more rapidly.
Notwithstanding the foregoing, however, there are some difficulties associated with the use of jejunostomy tubes. For example, due to the generally offset position of the jejunum relative to the stomach, it is often difficult to properly direct the distal end of a J-tube into the jejunum. J-tubes are also typically very flexible, which contributes to the difficulty in directing the tubes to the desired area. In addition, once positioned, J-tubes are subject to dislodgement.
In view of the difficulties encountered in placing such tubes in the jejunum, radiographic imaging techniques, e.g., x-ray, are generally utilized to verify proper placement of such tubes. Since health care workers must transport the patient to the radiology facility to obtain the x-ray, this technique increases the cost and complexity of the feeding tube placement. In addition, the use of radiographic imaging exposes the patient to radiation. If the x-ray indicates that an unsuitable placement was achieved, then the verification process must be repeated following another attempt at placement. This adds still more cost and complexity to the procedure, and further increases the amount of radiation to which the patient is exposed.
Ultrasound visualization is an alternative imaging modality. Ultrasound visualization has favorable characteristics in that it can be performed at the bedside, and eliminates radiation exposure to the patient. However, the use of ultrasound visualization can be problematic if a volume of air/gas is present between the ultrasound transducer head and a structure being visualized. The gastrointestinal tract has a generally “pipe-like” configuration along much of its length. As the feeding tube advances along the GI tract during insertion, it may track the posterior intestinal wall of this tract, leaving an air gap within the intestinal lumen along the anterior wall. Since the transducer head is positioned on the side of the anterior wall, the presence of the air gap inhibits optimal visualization of the feeding tube under ultrasound.
It would be desirable to provide a feeding tube suitable for placement in the jejunum of the patient, wherein the feeding tube is structured in a manner such that proper placement of the feeding tube may be verified by means readily available at the patient's bedside, and by means that do not expose the patient to harmful radiation.
The problems of the prior art are addressed by the feeding tube disclosed herein. In one form, a tube for insertion into a body passageway of a patient is described. An elongated tubular member has a proximal portion, a distal portion, a lumen extending between the proximal and distal portions, and at least one aperture at the distal portion sized and positioned for passage of fluid material therethrough between the lumen and a target area at the body passageway external to the tubular member. An inflatable member is disposed about a length of the elongated tubular member distal portion. The inflatable member is sized and configured such that upon inflation, the inflatable member projects outwardly from the tubular member distal portion so as to be engageable with an interior wall of the body passageway. An echogenic material is disposed along the tubular member distal portion for providing an echogenic capability such that the tubular member length is visible under ultrasound visualization.
In another form, a method for positioning a feeding tube in the jejunum of a patient is described. A distal end of a feeding tube is inserted into an oral cavity of a patient. The feeding tube comprises a generally elongated tubular member having a proximal portion, a distal portion, a lumen extending between the proximal portion and the distal portion. At least one aperture is provided at the distal portion for passage of fluid material from the lumen to the jejunum. The feeding tube comprises an inflatable member disposed about a length of the tubular member distal portion. The feeding tube further comprises an echogenic material disposed at the tubular member distal portion. The feeding tube distal end is advanced such that the distal portion of the generally elongated tubular member extends into the small intestine of the patient. An inflation medium comprising water or saline is passed into the inflatable member to inflate the member to substantially span a diameter of the small intestine. An ultrasound transducer head is arranged along an anterior body wall of the patient, and a placement of the feeding tube distal end is viewed via ultrasound visualization of the echogenic material.
In still another form, a tube for insertion into a body passageway of a patient is described. The tube comprises an elongated tubular member having a proximal portion, a distal portion, a lumen extending between the proximal and distal portions, and at least one aperture at said distal portion sized and positioned for passage of fluid material therethrough between the lumen and a target area at the body passageway external to the tubular member. An inflatable member is disposed about a length of the elongated tubular member distal portion. The inflatable member is sized and configured such that upon inflation the inflatable member projects outwardly from the tubular member distal portion so as to be engageable with an interior wall of the body passageway. The inflatable member includes an echogenic material engaged therewith in a manner such that the inflatable member is visible under ultrasound visualization.
For purposes of promoting an understanding of the present invention, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It should nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates.
In the following discussion, the terms “proximal” and “distal” will be used to describe the opposing axial ends of the inventive feeding tube, as well as the axial ends of various component features. The term “proximal” is used in its conventional sense to refer to the end of the feeding tube (or component thereof) that is closest to the operator during use. The term “distal” is used in its conventional sense to refer to the end of the feeding tube (or component thereof) that is initially inserted into the patient, or that is closest to the patient during use.
Although referred to herein generally as “liquid” or “fluid” products, those skilled in the art will appreciate that the materials transported through the tube may be of various consistencies and viscosity. Therefore, it is to be understood that the “liquid” or “fluid” products referred to herein may also include some solid and/or semi-solid portions, as well known in the art.
Feeding tube 10 comprises an elongated tubular member 12 having a proximal portion 14 (
As shown in
Although the feeding tube in the preferred embodiments described herein includes two lumens, the tube can be fashioned to have more, or fewer, lumens. For example, although the inflation lumen 26 in
A luer fitting 38 or other suitable connector is provided for connection to a source (not shown) for the inflation fluid. An extension tube 37 extends from luer fitting 38 to establish communication by any conventional means with small diameter lumen 26 for transmission of the inflation fluid. A conventional valve or clamp 39, or a stop-cock, may be provided for controlling flow of the inflation fluid through extension tube 37 in well known fashion.
Proximal tube portion 14 and adapter 32 as shown and described are conventional, and further discussion of them is not germane to an understanding of the features of the present invention. Those skilled in the art will appreciate that other conventional proximal fittings, connectors, etc., used for establishing communication with the various lumens of a multi-lumen catheter may be substituted for the arrangement illustrated in
As shown in
Preferably, the distal tip 17 of tube 10 is closed. When the distal tip is closed, the fluid material passes through apertures 40. In addition, with a closed distal end, a conventional guiding or tracking member (e.g., stiff wire guide, mandrel, stylet) may be used to aid initial insertion of the tube if desired. In some instances, however, it may be preferred to maintain an open distal end to permit passage of liquid product therethrough. When the feeding tube has an open distal end, the presence of apertures 40 is optional.
Inflatable balloon 20 is positioned along tube distal end 16. In the non-limiting embodiment of
The degree of compliance of a balloon refers to the ability of the balloon diameter to increase with increasing pressure. Generally, compliant balloons are capable of greater increase in diameter upon inflation than semi-compliant balloons, which in turn are capable of greater increase in diameter than non-compliant balloons. When a compliant balloon is utilized, a particular balloon 20 can be readily used with patients of various sizes, and having anatomic features of a variety of sizes and shapes.
Compliant balloons are preferred for use herein, as such balloons are readily capable of expansion until the outer surface of the balloon contacts the interior jejunum wall. Typically, such balloons are made from materials such as silicone, urethane, latex, or a silicone/polyurethane copolymer. Non-compliant and semi-compliant balloons, on the other hand, are typically made from materials such as polyethylene terephthalate (PET), polyamides (nylons), or a polyether block amide, such as PEBAX®. These balloons remain substantially at a pre-selected diameter as the internal balloon pressure increases beyond that required to fully inflate the balloon. The use of compliant, semi-compliant, and non-compliant balloons is now well known in the medical arts, and those skilled in the art can readily select an appropriate balloon composition for a particular application.
The respective proximal 21 and distal 22 ends of the balloon are secured to the tubular member 12 by conventional techniques, such as via heat bonding. From the standpoint of ease of bonding, it is often preferred to utilize a balloon formed of the same or a similar material as the elongated tubular member. However, when the balloon and the tubular member are formed of different materials, secure connections can nonetheless be achieved by use of suitable adhesives known for such use in the medical field, such as cyanoacrylates. Those skilled in the art are well aware of suitable techniques for securing a balloon to a tubular member for medical applications, and other well-known techniques may be substituted for those described.
Distal portion 16 of elongated tubular member 12 includes at least one inflation port 18 sized and positioned for transmission of the inflation medium via inflation lumen 26 to the interior space of balloon 20. Preferably, balloon 20 is positioned proximal of apertures 40 along the length of elongated tubular member 12 as shown, to prevent interference with the flow of the nutritional products or other fluid from large diameter lumen 24 through the apertures.
Those skilled in the art will appreciate that the feeding tube may include additional features well known in the art. For example, the outer surface of the elongated tubular member may be provided with a series of projections, such as fins or fin-like elements, along the distal portion thereof to enhance the advancement of the feeding tube into the jejunum via peristalsis. Feeding tubes having features that promote self-advancement by peristalsis are further described in, for example, U.S. Pat. Nos. 6,589,213 and 6,767,339, both incorporated by reference herein. Additionally, the feeding tube may be provided with a series of markings displayed at discrete locations along the length of the tubular member to enable the health care worker to monitor the advancement of the tube into the jejunum.
As stated above, the elongated tubular member can be provided with one or more additional lumens that extend through at least a portion of the length of the tubular member. Such additional lumens could be used, e.g., to provide an additional fluid source, such as providing a liquid medication in addition to the liquid nutritional products, and/or to provide a conduit through which various pressures or functions within the patient's body may be monitored. An increase in the number of lumens may necessitate minor alteration in the features of the inventive tube as described herein, such as the location of the apertures at the distal end of the tubular member; however those skilled in the art can readily make such alterations when following the teachings of the present invention.
It is sometimes difficult to direct the distal tip of a tube to a target site within the anatomy of a patient that is off-set, or has an otherwise non-direct path, relative to an entry site. A feeding tube that is intended to be directed into the jejunum of a patient is an example of such a tube. Due to the difficulty in inserting tubes to such sited, it is generally desirable to verify the proper placement of the tube following insertion. When verifying the placement of a feeding tube in the jejunum, the normal procedure is to transport the patient to the radiology facility to obtain an x-ray. However, this procedure increases the cost and complexity of the feeding tube placement. In addition, the procedure exposes the patient to radiation.
The feeding tube described herein includes an echogenic capability that enables the health care worker to observe in real time the location of the end of a tube in a body passageway, such as the jejunum. The presence of the echogenic capability enables tip confirmation to be carried out under ultrasound visualization at the patient's bedside. As a result, there is no need to transport the patient to another location for further verification, and the patient need not be exposed to harmful radiation.
In the embodiment shown in
In order to apply sheath 50 to the tubular member 12, the tubular member 12 may be stretched in longitudinal fashion to a smaller diameter, and the sheath may be inserted thereover. When the stretching is relaxed, tubular member 12 returns to its original diameter, and sheath 50 is snugly engaged therewith. Alternatively, a sheath 50 may be placed within the lumen of the tubular member, and the sheath is locked in place as the tubular member distal end 17 is closed in a conventional heated tip-forming device. As another alternative, an adhesive can be applied to the tubular member, and the sheath can be affixed to the tubular member via the adhesive. It is known to fashion echogenic bands over tubular members, such as catheters, and a skilled artisan can readily fashion a suitable technique herein. Tubular members having echogenic bands or sheaths applied thereto are known in the art for other purposes. Examples of catheters include the ECHOTIP® ureteral catheter, and the ECHOTIP® Soft-Pass Embryo Transfer catheter, both available from Cook Medical, of Bloomington, Ind.
In the embodiment shown, the echogenic surface comprises a series of irregularities, such as deformations 52, distributed along the exterior surface of sheath 50. Deformations 52 are imperfections that are formed along the surface of the sheath in a manner that enhances the ability of the sheath to scatter and/or reflect the ultrasound energy. The deformations may be formed along the length of the sheath by well-known processes, such as media blasting, physical deformation, machining (e.g., knurling on a lathe), micro-dimpling, etc. Those skilled in the art will appreciate that there are many other ways of forming deformations in a substrate of a type that will result in the scatter and/or reflectance of ultrasound signals, and that may be substituted for the techniques described above. Deformations 52 should be formed in a manner such that they do not adversely affect the mechanical properties of the sheath in any material fashion.
The presence of the imperfections, such as deformations 52, causes ultrasound waves that contact the deformations to travel in multiple directions and in generally random fashion. The increase in scatter and/or reflection of the ultrasound waves enhances the temporal visualization of the tip of the feeding tube during ultrasound examination. By viewing the ultrasound signals created thereby, the health care worker may confirm proper tip location. Alternatively, if it is determined that the desired tip location has not been achieved, the location of the tube may be adjusted on-site.
Although the echogenic surface has been described hereinabove as a sheath that is positioned over the portion of the tubular member, other means for enhancing echogenic signals may be substituted. For example, rather than providing a sheath 50 as described, in an alternative embodiment, one or more echogenic cannulae 60, 62, 64 may be provided, as shown in
Another embodiment illustrating echogenic enhancement of a tubular member is shown in
Echogenic ribbon 80 may be fitted over distal portion 16 of tubular member 12 by any convenient mechanism, such as wrapping it around the distal portion, or by stretching the distal end of tubular member, and applying the ribbon to the stretched end. If desired, an adhesive can be utilized to provide a more secure attachment. As another alternative, ribbon 80 can be embedded into the wall of the tubular member, and a plastic can be extruded or otherwise applied over the ribbon. Utilizing a coiled ribbon 80 as described herein provides added flexibility to the distal end of the tube when compared to the use of the elongated sheath, which may facilitate passage into the jejunum.
Although ribbon 80 is shown in
Another variation is shown in
As yet another alternative, instead of utilizing a separate echogenic sheath, ribbon, etc., the tubular member may be formed to have an echogenic material incorporated into all or any designated portion of its matrix. One example of this is to incorporate a known echogenic material, such as glass spheres, echogenic metal or alloys (e.g., tungsten), etc., into the extrusion composition for the tubular member. Glass spheres, as well as various metals and alloys, are known to enhance echogenicity, and in this case, these materials may be readily incorporated into the polymer matrix for the feeding tube. Preferably, however, the materials (e.g., the glass spheres) will only be incorporated into the distal portion of the tubular member. In this event, the distal portion of the tubular member having the echogenic enhancement can be affixed (e.g., via heat bonding, adhesion, etc.) to the proximal portion. Once this tubular member is formed, there would be no further need to add other materials to enhance echogenicity, as sufficient echogenicity for visualization under ultrasound is provided by the matrix materials. The balloon would then be affixed to the tube in the same manner as before.
Those skilled in the art will appreciate that other known ways of imparting echogenicity to a material may be substituted for those described herein, including, e.g., the techniques disclosed in U.S. Patent Application Publ. 2008/0097213, incorporated by reference herein.
The following example describes one preferred use of the inventive tube, namely as a naso-jejunal feeding tube for transmitting nutritional products from the nasal cavity to the jejunum. Those skilled in the art will appreciate that with minor modification, the tube may be inserted other than through the nose, and may be advanced to destinations other than the jejunum.
Initially, the distal end of the tube is inserted through the oral cavity, and is advanced into the stomach with the balloon in an uninflated condition. A conventional guiding or tracking member (e.g., stiff wire guide, mandrel, stylet) can be used if desired to assist in advancing the tube into the stomach. If the guiding or tracking member is used, it is removed once advancement into the stomach is achieved. Insufflation and auscultation may be used to confirm that the distal tip of the feeding tube is in the stomach.
The feeding tube is then advanced through the stomach of the patient such that the distal portion of the generally elongated tubular member extends into the small intestine of the patient. Preferably, the distal end portion 16 of the tubular member is advanced into the small intestine via peristaltic activity along the GI tract. In cases of weak peristaltic activity, pharmacological agents may be used to increase this activity pursuant to well-known techniques. Reliance on peristaltic activity is optional, however, and other known means of directing a feeding tube to the jejunum may be employed, either in conjunction with peristalsis, or as an alternative to peristaltic activity.
Once the distal end of the feeding tube is believed to have reached the jejunum, the next step is to confirm placement of the tip in the jejunum. In many cases, the feeding tube advances along the posterior wall of the small intestine upon insertion. An example of this arrangement is shown in
As shown in
As stated above, the medium selected for use herein as the inflation medium is of a type that allows suitable penetration by ultrasound signals. Air and/or gases having a density similar to that of air, will not typically be suitable inflation media, as they do not have sufficient density to adequately transmit ultrasound signals. On the other hand, media having a greater density than air, such as water, saline, and other fluids having a density similar to, or greater than, that of water and/or soft body tissue are particularly suitable. Those skilled in the art are capable of selecting an appropriate inflation fluid based upon the discussion provided herein.
Upon inflation of the balloon as shown in
If suitable placement is confirmed by the ultrasound image, the balloon may be deflated by once again releasing clamp 39, and withdrawing the medium (e.g., via a syringe), or otherwise allowing the medium to drain from the interior of the balloon. Following deflation of the balloon, the clamp is re-set, and the feeding tube may be secured to the patient in any conventional fashion. The adapter 32 at the proximal end of the feeding tube is then engaged by conventional means to the fluid reservoir, and the nutritional products are transmitted through the feeding tube into the jejunum of the patient.
Upon transmission of an inflation medium as discussed above, balloon 120 is inflated to a suitable configuration, such as that shown in
Although balloon 120 shown in
Although the tube has been primarily described herein as a feeding tube, the tube is not limited to this use. With minor modification, the tube may be used in other operations in which it is desired to confirm a location of a portion of a tubular or similar member in a body passageway. Other possible uses include esophageal balloons, tracheostomy tube cuffs, balloons utilized with endotracheal tubes, as well as angioplasty balloons.
While these features have been disclosed in connection with the illustrated preferred embodiments, other embodiments of the invention will be apparent to those skilled in the art that come within the spirit of the invention as defined in the following claims.
