DESCRIPTION

Reference to a Related Application

This application is a continuation- in-part of co-pending United States Patent Application Serial No. 144,527, filed January

15, 1988, to issue January 3, 1989 as U.S. Patent No. 4,795,430.

Technical Field

The present invention generally 5 relates to apparatuses utilized in a feeding tube gastrostomy and, in particular, to a device for intubating a gastrostomy or other ostomy formed by a percutaneous endoscopic technique.

10 Background of the Invention

A surgically formed gastrostomy is a preferred method for administering enteral nutrition when oral alimentation is not possible. However the placement and formation

15 of a gastrostomy requires a laparotomy performed under general anesthesia. Such requirements are unacceptable, particularly in patients who present a high general anesthetic risk. Hence a percutaneous endoscopic

20 technique was developed which may be performed under local anesthesia and requires no laparotomy. This technique is disclosed for example in Gauderer & Ponsky, "A Simplified Technique For Constructing A Tube Feeding

25 Gastrostomy*, Surgery, Gynecology &

Obstetrics, vol. 152, 1/81, pp.82-85, the teachings of which are incorporated herein by reference. In addition, a percutaneous endoscopic formation of a gastrostomy may be

performed ^' by a gastroenterologist rather than a surgeon.

Generally, in forming a gastrostomy using a percutaneous endoscopic technique, an 5 illuminating fiberoptic endoscope is inserted into a patient's mouth and advanced into the stomach. The stomach is then inflated with room air and the positioning of the endoscope may be externally visualized by the

10 illuminated tip of the endoscope. The abdominal and gastric walls are then pierced at the positioning of the endoscope and the gastroscope thereby formed.

In order to intubate the

15 gastrostomy, one end of a suture thread is passed externally through the gastrostomy. The one end of the suture is snared by the endoscope and drawn upward through the stomach, esophagus and out of the mouth of the

20 patient. The suture is then tied to the end of a specially prepared catheter. The catheter is typically a 12 to 20 Fr. Pezzer or mushroom-type catheter in which a tapered cannula has been secured to one end of the

25 catheter. The tip of the cannula carries a length of suture to permit the catheter to be tied to the one end of the suture extending from the patient's mouth. A previously removed connecting end of the Pezzer catheter

30 is placed over the catheter and positioned slightly above the mushroom tip of the

catheter to function as one perpendicular bumper for retaining the intubated catheter within the gastrostomy.

The catheter is then intubated by 5 pulling it in a retrograde manner through the mouth, esophagus and into the stomach until the perpendicular bumper above the mushroom tip abuts against inner surfaces of the gastrostomy and the gastric wall. A second

10 perpendicular bumper is placed over the catheter and secured to the abdominal wall to form an anchoring structure of the type disclosed in Fig. 6 of the Gauderer & Ponsky reference cited above.

15 There are many problems with the prior art percutaneous endoscopic catheters. The first perpendicular bumper placed above the mushroom retention tip includes several edges which result in an uncomfortable and

20 difficult intubation of the catheter.

Preferably, the retention tip should be more pliable and have a contoured, edge-free outer configuration to promote a relatively comfortable intubation of the catheter.

25 In addition, the prior art perpendicular bumpers which abut against the gastric and abdominal walls exert concentrated, abrasive contact pressure on specific tissue areas. Such specific contact

30 has been found to create necrosis of the affected tissue. Hence, a need arose for an

anchoring system for the retention tip of the intubated catheter which would evenly diffuse retention pressure on the surrounding affected tissue to avoid tissue necrosis. 5 Further, the inner perpendicular anchoring bumper in some cases would pull free and in most cases was difficult to remove upon conclusion of enteral feeding therapy. Removal is now achieved either by physically

10 pulling the retention tip through the gastrostomy or allowing the tip to pass freely through the gastroenteral tract to become excreted. Either alternative is uncomfortable for the patient and subject to complications.

15 Hence, a need arose for an anchoring and retention tip which could be easily and comfortably removed at the conclusion of enteral feeding therapy through the gastrostomy.

20 Prior to the development of the present invention, a need existed for a catheter specially designed for intubating a gastrostomy or an other ostomy formed by a percutaneous endoscopic technique having (1) 25 an enlarged retention member which is pliable and smoothly contoured for a more comfortable intubation, (2) anchor means which more evenly distributes contact surrounding tissues thereby avoiding tissue necrosis, (3) anchor

30 means which remain abutted against tissue surrounding the ostomy without pulling free

and, (4) an anchor means and retention member which may be compressed or collapsed to facilitate removal of the tube externally through the gastrostomy itself upon completion 5 of enteral feeding therapy. Preferably, unlike the prior art retention tip and bumpers, a most efficient catheter design would combine the anchor means and retention member into a single structure.

10 Summary of the Invention

According to the present invention, a specially designed device has been developed for intubating an ostomy, as for example, a gastrostomy, formed by a percutaneous

15 endoscopic technique. The device of the present inventions meets the foregoing described needs by employing a multi-lumen enteral feeding tube, preferably having at least a fluid delivery lumen and an inflation

20 lumen. The tube includes a port near one end to dispose the inflation lumen to ambient air and an outlet at an other end to convey fluid from within the fluid lumen into the patient. A retention member, preferably an inflatable

25 cuff, is joined near the other end of the tube.

In the preferred embodiment of the present invention, the cuff is substantially filled with a resilient porous material for

30 maintaining the walls of the cuff in a fully

inflated position. The retention cuff is in communication with the inflation lumen and is inflatable and deflatable through the inflation lumen. The walls of the cuff are 5 designed so that in a deflated state, the cuff assumes an edge-free, preferably rounded, outer configuration to facilitate a comfortable intubation of the device into the patient. Likewise, in a fully inflated state,

10 the cuff assumes an outer configuration defining at least one generally flat surface to more diffusely contact and abut against the inner tissue surfaces surrounding the gastrostomy.

15 Joined to the one end of the tube is an elongated tapered sleeve which encloses the one end of the tube. The tapered end of the sleeve carries, preferably, a suture loop for use in intubating the device.

20 In all embodiments of the present invention, means are provided for sealing the inflation lumen. For example, in one embodiment, the sleeve includes a skirt portion which creates a circumferential air-

25 tight seal about the exterior of the tube to selectively seal the ambient air port. The skirt portion of the sleeve is air pressure responsive to permit escape of air from the inflation lumen through the port but

30 preventing the ingress of air into the inflation lumen through the port.

In an alternate embodiment, the ambient air port is sealed by a frangible plug member. The frangible plug member generally includes a stem frangibly connected to an 5 enlarged gripping portion.

The device of the present invention is utilized in intubating a gastrostomy formed by a percutaneous endoscopic technique by the following steps. First, prior to intubation

10 of the device into a patient, the cuff is deflated by compressing it, thereby expelling air out of the inflation lumen through the port. In one embodiment, the skirt portion of the sleeve expands outwardly in response to

15 the greater air pressure within the lumen to permit the escape of air out of the inflation lumen through the port. Upon fully deflating the retention cuff, the air pressure within the inflation lumen decreases relative to

20 ambient air pressure such that the skirt portion contracts inwardly to seal the ambient air port thus preventing ingress of air into the inflation lumen.

In the alternate embodiment, the

25 ambient air port may be sealed by inserting the stem of the frangible plug member into the port. The stem is inserted into the inflation lumen to a point such that when the frangible connection between the stem portion is broken,

30 the stem remains in the port to occlude the inflation lumen.

^• Initial deflation of the retention cuff may be accomplished by manually squeezing the cuff. However, in one preferred embodiment, the present invention provides for 5 initial deflation of the cuff through use of a circular deflation strap. The cuff is captivated within the deflation strap and the strap is then tightened thus deflating the cuff and maintaining it in a deflated position

10 until the ambient art port is sealed. The deflation strap is particularly useful in the embodiment of the present invention wherein a frangible plug is utilized for initial sealing of the inflation lumen.

15 Sealing of the ambient air port prevents re-inflation of the cuff. In a deflated state, the retention cuff assumes an edge free generally oval outer configuration. Upon deflating the cuff and sealing

20 the ambient air port, the suture loop carried on the tapered end of the sleeve is tied to the one end of the suture which extends from the patient's mouth. The gastroenterologist then begins pulling on the other end of the

25 suture extending externally from the gastrostomy to lead the device in a retrograde manner through the mouth, esophagus and ultimately into the stomach. The retrograde drawing of the device continues until the

30 deflated cuff abuts against inner tissue surfaces surrounding the gastrostomy. Air is

then externally introduced into the inflation lumen to re-inflate the retention cuff to change the outer configuration of the cuff to create a generally flat anchor surface. 5 In the one method of practicing the present invention, re-inflation of the cuff may be achieved by severing the multi-lumen tube below the sleeve to remove the sleeve from the tube. This exposes the inflation

10 lumen to ambient air resulting in re-inflation of the cuff. In the alternate method wherein a frangible plug has occluded the inflation lumen, the multi-lumen tube may be similarly severed below the plugged area of the

15 inflation lumen.

After re-inflation of the cuff, the inflation lumen should be sealed with a plug, such as another frangible plug member, or other device to prevent deflation of the

20 retention cuff. Then, as is conventional, the severed end of the multi-lumen tube is secured at the exterior of the ostomy by means known in the art such as by tape or suture. This prevents the inflated cuff from dislodging

25 from the tissue wall and to keep the cuff urged against the inner tissue surface surrounding the ostomy.

A luer adaptor or other tube connecting device may be affixed to the

30 severed end of. he tube to place the tube in fluid communication with an enteral

nutritional fluid source.

Other advantages and aspects of the invention will become apparent upon making reference to the specification, claims, ahd 5 drawings to follow.

Brief Description of Drawings

FIG. 1 discloses in perspective view one embodiment of the present invention;

FIG. 2 is a longitudinal section 10 taken along line 2-2 in FIG. 1;

FIG. 2A is a vertical section taken through line 2A-2A of FIG. 2;

FIG. 3 is a fragmented detailed view of a portion of FIG. 2 disclosing outward 15 flexing of the skirt portion of the elongated sleeve permitting an escape of air from within the inflation lumen;

FIG. 3A is the same view of FIG. 3 disclosing an inward contraction of the skirt 20 portion to seal the ambient air port of the inflation lumen;

FIG. 4 illustrates retrograde intubation of one embodiment of the device of the present invention;

25 FIG. 5 illustrates severing a portion of the tube of the present invention to introduce air into the inflation lumen;

FIG. 6 discloses a preferred outer configuration of a fully inflated retention

30 cuff of the present invention;

^• FIG. 7 is a longitudinal section disclosing an alternate embodiment of the present invention;

FIG. 7A is the same view of FIG. 7 5 wherein a plug member having a frangible stem seals the inflation lumen;

FIG. 8 is a side elevational view disclosing an embodiment of a frangible plug member; 10 FIG. 9 is a plan view of an open and extended embodiment of an inflation strap; and,

FIG. 10 is a detailed longitudinal section of a portion of a multi-lumen tube 15 disclosing the frangible plug member of FIG. 8 occluding the inflation lumen.

Detailed Description

While this invention is susceptible of embodiment in many different forms, there 20 is shown in the drawings and will herein be described in detail at least two embodiments of the invention. The present disclosure is to be considered as an exemplification of the principles of the invention and is not

25 intended to limit the broad aspect of the invention to embodiment illustrated.

Referring now to the drawings, FIG. 1 discloses one embodiment of device 10 of the present invention comprised of a multi-lumen

30 enteral feeding tube. As disclosed in FIG. 2

and best disclosed in FIG. 2A, feeding tube 12 includes at least an inflation lumen 14 and a fluid delivery lumen 16. Lumens 14 and 16 are separated by a septum 18. As disclosed in 5 FIG. 2, one end 12A of tube 12 has at least one ambient air port 20 which, as will be disclosed later in greater detail, disposes inflation lumen 14 in communication with ambient air. At an other end 12B of tube 12,

10 the fluid outlet 22 (shown in phantom in FIG.

2) conveys fluid from fluid lumen 16 into a patient.

Sealably secured to end 12A of tube 12 is an enclosed sleeve 24, preferably having

15 a tapered elongated conical terminal end 26.

The tapered conical outer configuration of terminal end 26 permits atraumatic parting of esophageal and gastric tissues during the intubation process. As disclosed in FIGS. 1

20 and 2 disposed on the terminal end 26 of sleeve 24 is a suture loop 28 which permits device 10 to be tied to the end of the suture extending from the patient's mouth during the percutaneous endoscopic technique (not shown 25 in the drawings). As disclosed in FIG. 2 , suture loop 28 may preferably fully extend through sleeve 24 through a channel 32 and be secured to end 12A of tube 12 by a fastening knot or other fastening device 34 secured to

30 the septum 18.

FIGS. 1 through 3A disclose one

preferred embodiment of the present invention wherein, joined to sleeve 24, is a skirt portion 36 which circumferentially surrounds end 12A of tube 12 in such a manner to create 5 an airtight seal between skirt portion 36 and outer surfaces of end 12A. Skirt portion 36 is made from a highly pliable plastic or latex rubber so as to be air pressure responsive permitting selective sealing of ambient air

10 port 20. Specifically, skirt portion 36 responds to greater air pressure within inflation lumen 14 to permit the escape of air out of lumen 14 through port 20 However, when ambient air pressure exceeds the air pressure

15 within lumen 14, then skirt portion 36 contracts inwardly to seal port 20 to prevent the further ingress of air into lumen 14.

FIGS. 3 and 3A disclose in greater detail the selective sealing or diaphragmatic

20 action of skirt portion 36. As disclosed in

FIG. 3, when air pressure within inflation lumen 14 increases to exceed ambient air pressure, skirt 36 expands outwardly away from the walls of tube 12 to define a 25 circumferential gap 38 which permits air to exit ambient port 20 and escape from under skirt portion 36. As disclosed in FIG. 3A, when ambient air pressure exceeds the air pressure within inflation lumen 14, skirt

30 portion 36 contracts circumferentially about tube 12 closing gap 38 and thereby forming an

airtight seal about tube 12 and port 20.

The selective sealing of ambient port 20 allows for the controlled inflation and deflation of a retention/anchor member, 5 which preferably is embodied as an annular cuff 40. As best disclosed in FIG. 2, retention cuff 40 is affixed to the other end 12B of tube 12. Retention cuff 40 is sealed and in gas communication with inflation lumen

10 14 through a terminal opening 42 in tube 12.

As shown in phantom in FIGS. 1 and 2, tube 12 passes through cuff 40 so that, as disclosed in FIG. 6, fluid outlet 22 extends below cuff 40. In the preferred embodiment of the

15 present invention, cuff 40 is comprised of a distendable outer wall 40 which defines a cavity preferably substantially filled with a porous resilient foam material 46. As disclosed in FIG. 6, foam material 46 is cut

20 in a configuration so that when cuff 40 is in a fully expanded position, foam material 46 maintains walls 44 in expanded position.

Retention cuff 40 is placed in a deflated state by compressing, preferably by

25 squeezing, cuff 40 so that the air trapped within walls 44 and foam material 46 is expelled upwardly into the inflation lumen and out of port 20. Discontinuing such squeezing of cuff 40 results in a decrease in air

30 pressure within inflation lumen 14 so that ambient air pressure acts upon skirt 36 to

seal port 20 in the manner described above. Such sealing of port 20 prevents re-inflation of retention cuff 40 and maintains cuff 40 in a deflated position. Re-inflation of cuff 40 5 is achieved by introducing ambient air into inflation lumen 14 by methods to be described below in greater detail.

Cuff 40 combines in a single structure both the retention and anchoring

10 functions achieved by prior art catheter mushroom-type tips and perpendicular rubber bumpers. However, unlike the prior art mushroom tip/bumper combination, cuff 40 in a deflated state, assumes an essentially edge-

15 free, rounded configuration which facilitates intubation of device 10. Cuff 40, in a deflated state, preferably assumes a oval or pill-shape as disclosed in FIGS. 1 and 2. In a fully inflated state, cuff 40 assumes a

20 different configuration. The walls 44 of cuff

40 are molded or pre-formed so that the outer configuration of cuff 40 changes from a deflated state to a fully inflated state. For example, cuff 40 includes a fold or crease

25 line 48 which changes the outer configuration of cuff 40 from deflation to full inflation. As disclosed in FIG. 6, upon full inflation of cuff 40, fold line 48 defines a peripheral edge of a generally flat retention and anchor

30 surface 50. Surface 50 is of a sufficient surface area to evenly distribute contact

pressures on the tissue surrounding the gastrostomy to avoid the necrosis of tissue commonly encountered by use of prior art retention bumpers. Hence, a novel aspect of 5 the present invention is that the retention cuff, in a deflated position, has an edge-free contour to facilitate a comfortable intubation, whereas, in a fully inflated state, retention cuff 40 assumes a different

10 configuration to define an edged, flattened surface for anchoring tube 12 within the gastrostomy.

FIGS. 4 through 6 disclose the general method of using device 10 in

15 intubating an ostomy formed by a percutaneous endoscopic technique. As disclosed in FIG. 4, after the length of suture has been drawn out of a patient's mouth such that the free ends of the suture extend from both the patient's

20 mouth and the gastrostomy, the suture is tied to loop 28 of the device of the present invention. The device of the present invention is then drawn downward through the mouth, esophagus and into the stomach in a 25 retrograde manner. The pulling of the suture through the gastrostomy continues until the deflated retention cuff 40 abuts against the inner tissue surfaces of the gastrostomy as disclosed in FIG. 5. To retain and anchor the

30 fluid outlet end 12B of tube 12 within the gastrostomy, retention cuff 40 is re-inflated

by introducing air into the inflation lumen 14 and then the inflation lumen 14 is sealed as disclosed below to prevent inadvertent deflation. As is conventional, the exposed 5 portion of tube 12 is then secured near the external tissue surface of the ostomy to maintain the position of the retention cuff 40 against the inner tissue surrounding the ostomy, as disclosed in FIG. 6. The exposed

10 portion may be secured by conventional means such as by tape or suture 51 the tube 12 to the external tissue.

In one preferred method of using the present invention, re-inflation of the

15 retention cuff 40 may be accomplished by severing, as disclosed in FIG. 5, completely through a portion of tube 12 external to the gastrostomy. Upon severing completely through tube 12, inflation lumen 14 is exposed to

20 ambient air thereby raising the air pressure within lumen 14 to automatically inflate cuff 40. In some instances it may be necessary to assist the inflation operation by injecting air into inflation lumen 14 through the

25 insertion of the tip of an air-filled syringe into inflation lumen 14. Upon full inflation of retention cuff 40, inflation lumen 14 is sealed with a plug or other device to prevent deflation of cuff 40, such as frangible plug

30 60 of FIG. 8 which will be disclosed in more detail below.

With retention and anchoring of device 10 complete, a luer adaptor or other tube connection means may be affixed to the severed end of tube 12 to join tube 12 to ^' a 5 source of enteral nutritional fluid. It should be noted that such adaptor or tube connection means may also function to seal inflation lumen 14.

FIGS. 7 through 10 disclose another

10 preferred embodiment of the present invention.

As best disclosed in FIGS. 7 and 7A a multi- lumen enteral feeding tube 10 as previously disclosed is provided wherein skirt 36 is omitted or rendered non-functional. However,

15 in this embodiment, tapered end 26 is nonetheless utilized to facilitate intubation. In this embodiment, ambient-air port 20 is exposed rather than being concealed underneath skirt 36. In this embodiment, initial sealing

20 of the inflation lumen 14 is accomplished by occluding the lumen with a plug member of the type disclosed in FIG. 8 which is inserted into the lumen through ambient-air port 20. As disclosed in FIG. 8, frangible

25 plug 60 generally comprises a solid cylindrical stem 62 and an enlarged gripping portion 64 on one end of stem 62. A portion of stem 62 is crimped or narrowed to define a frangible region 66. The diameter of stem 62

30 is dimensioned to permit an interference fit with the inner diameter of inflation lumen 14.

Frangible region 66 is adapted to allow gripping portion 64 to be twisted or bent to break-off stem 62 allowing the gripping portion to be removed. 5 As disclosed in FIGS. 7 and 7A, prior to intubation, retention cuff 40 is compressed. In this embodiment, however, inflation lumen 14 is occluded by inserting plug 60 into the inflation lumen while the

10 cuff 40 is still compressed thus preventing premature re-inflation of the retention cuff.

FIG. 10 best discloses that the frangible plug 60 is inserted through ambient port 20 to a position where frangible portion

15 66 is inside inflation lumen 14 so that when stem 62 is broken from gripping portion 64, stem 62 is totally enclosed with lumen 14 thus not presenting any protrusion which would cause damage during intubation.

20 In this embodiment, retention cuff

40 may be compressed by squeezing the cuff in the palm off one hand while holding tube 12 between the thumb and forefinger of the same hand leaving the other hand of the user free

25 to grip the frangible plug for insertion while the cuff remains compressed.

After intubation, air may be introduced into the retention cuff 40 in a manner similar to that disclosed above by

30 cutting the multi-lumen tube 12 below the occluded area. As disclosed above the

retention cuff may be maintained in the re- inflated position by the insertion of another frangible plug member into the exposed open end of the inflation lumen 14. 5 Cuff 40 may also be compressed and maintained in a compressed state by an adjustable strap 70 such as disclosed in FIG. 9. Strap 70 is a generally flat flexible member including a widened body portion 72, an

10 integral narrowed tongue portion 74 on one end of the body portion which has a plurality of barbs 78 on the its edges and a slot 76 at an opposite end of the body portion. Body portion 72 is dimensioned to engage on a

15 substantial portion of the outer surface of retention cuff 40. Tongue portion 74 is cooperatively dimensioned with slot 76 so that the tongue may be inserted into the slot and pulled therethrough with barbs 78 engaging the

20 edges of the slot to prevent retrograde movement of the tongue.

Thus, as disclosed in FIGS. 7 and 7A, prior to intubation retention cuff 40 is captured within strap 70 and then the tongue 25 74 is pulled through slot 76 to compress the cuff and maintain the cuff in the compressed state until the user can insert frangible plug member 60 into port 20 to seal the inflation lumen 14. Once the plug member is inserted,

30 strap 70 can be removed by pulling or cutting the strap.

Utilization of the compression strap allows the user to more easily accomplish retaining the cuff in a compressed state until the lumen can be plugged. In certain 5 instances, use of the compression strap may also provide a more aseptic means for compressing the retention cuff by avoiding contact of the cuff with the hands.

While the specific embodiments have

10 been illustrated and described, numerous modifications come to mind without significantly departing from the spirit of the invention and the scope of protection is only limited by the scope of the accompanying

15 Claims.