MXPA01006878A - Gastric balloon catheter with improved balloon orientation - Google Patents

Abstract

A balloon catheter with improved balloon orientation includes a head, a catheter segment extending from the head, and a balloon disposed on the catheter segment opposite the head. Preferably, the balloon is attached to the exterior of the catheter segment at a proximal location and to the interior of the catheter segment at a distal location to thereby form a balloon which extends distally from the distal end of the catheter segment when inflated. The improved orientation of the balloon helps to prevent contact between the distal end of the catheter segment and anatomical structures of the user, thereby reducing irritation.

Description

GASTRIC GLOBE CATHETER WITH IMPROVED GLOBE ORIENTATION BACKGROUND OF THE INVENTION 1. Field of the invention The present invention generally relates to balloon catheters which are used to catheterize a body cavity. More specifically, the present invention relates to a balloon catheter with an improved balloon orientation wherein the balloon is configured to decrease the irritation caused by the catheter while the catheter remains in the body cavity. 2. State of the art There are numerous situations in which a body cavity must be catheterized to achieve some medical objective. More often, catheterization is carried out either for certain substances in or to remove substances from the body. During many of its procedures, it is necessary to keep the catheter in a relatively stable position to carry out the desired insertion or removal. With the use of intravenous delivery catheters (for example, catheters which allow the administration of nutritional solutions directly into the stomach or intestines), for example, it is necessary to ensure that the catheter is not accidentally removed from the stomach or from the intestines. bowels. This is true both during the current administration or removal of fluids, and the periods of time between supplies.

In order to ensure that a catheter is held in the proper position, it is common to use a balloon placed near the distant (patient) end of the catheter shaft. Inflating the balloon causes the balloon to make contact with the anatomical structure (a stomach or duct wall) and thus prevents the catheter from moving out of the proper position. In the case of enteral feeding, a stoma is formed leading to the stomach or intestine. A catheter is placed to extend through the stoma, so as to form a channel in the stomach or intestines through which enteral feeding solutions can be pumped.

Figure 1 shows a side view of a balloon catheter, generally indicated with the number 10, made according to the prior art. The balloon catheter 10 has a head 14 positioned at a near end, the head 14 contains valves which regulate the flow of fluids through the balloon catheter 10. The head 14 also prevents the balloon catheter 10 from fully advancing to through the stoma and into the stomach or intestine of the user.

To prevent the catheter from being pulled out of the wall of the stomach / intestine, a balloon is placed along a segment of catheter 22. Said segment of catheter 22 includes an elongated catheter shaft 26 and a rigid tip 30 which it is attached to the catheter shaft at a distal end opposite the head 14. The catheter shaft 26 is typically made of medical grade silicone. The rigid tip is also typically formed of a medical grade silicone, but is usually configured to be more rigid than the catheter shaft. Rigid tip 30 helps the doctor, etc. to insert the catheter segment 22 through the stoma.

The balloon 18 is typically attached to a proximal end 18A to the catheter shaft 26 by the use of adhesive, thereby forming a near 32. Similarly, the distal end 18b of the balloon 18 is typically adhesively attached to the rigid tip 30, thus forming a distant fist 34.

The balloon 18 is advantageous because it allows the catheter segment 22 to be inserted into the stoma while the balloon is deflated. Once the catheter segment 22 is suitably placed in the stoma, a syringe (not shown) is inserted into a side port 36 of the head 14 and a fluid is injected into the balloon 18 through a lumen (not shown in FIG. Figure 1) of the catheter. The fluid inflates the balloon so that it extends outwardly from the catheter shaft 26 and the rigid tip 30.

Even when balloon 18 remains inflated, catheter segment 22 remains properly positioned in the stoma. If the catheter segment 22 needs to be removed, the balloon 18 can be deflated so that it will not interfere with the removal of the catheter shaft 26 and the rigid tip 30. In such manner, the position of the balloon catheter 10 is maintained. until the removal is desired.

Although the configuration shown in Figure 1 works well to keep the balloon catheter 10 in the proper position, the balloon catheter has disadvantages. A primary disadvantage is discomfort for the user. In order to allow the insertion of the catheter segment 22, the catheter shaft 26 especially the rigid tip 30 must be relatively firm to prevent bending under insertion pressures. This same firmness, however, makes the distant tip 26 much more prone to irritate the anatomical structures which come into contact with the rigid tip 30. This is especially true in the stomach and in the intestines and where the opposite walls of the anatomical structures have to be applied on each other during the physical insertion or when the cavity has very little or no food. As the person moves, the rigid tip 30 repeatedly makes contact with the adjacent anatomical structure (such as the stomach wall) and can lead to considerable irritation and discomfort for the user.

While it would be advantageous to prevent the rigid tip 30 from contacting any of the adjacent anatomical structures, the balloon 18 provides certain inherent limitations. The balloon 18 should have the cuffs close and distant, 32 and 34, to seal from the balloon when the fluid is injected into the lumen in communication with the balloon. Additionally, the cuffs 32 and 34 should be of sufficient length to provide a tight and durable seal between the balloon 18 and the catheter shaft 22 which will withstand bending and bending caused by the movements of the user. Therefore, several millimeters from the distal tip 26 (and potentially the distal end of the cuff) are left exposed-leaving a significant potential for irritation.

Another disadvantage with the configuration shown in Figure 1 is that the distal cuff 34 forms a seal 34a at its distal end. The seal 34a provides an abrupt edge which has a tendency to trap the tissue defining the stoma through which the catheter segment 22 is placed, thereby forming the frustrating insertion of the balloon catheter 10. By catching the seal 34a in the tissue, this can cause the catheter segment to buckle and can also cause irritation; therefore there is a need for a balloon catheter having a balloon orientation which isolates the firm distal tip from the surfaces of the internal body cavity. There is also a need for an improved balloon catheter which lacks a gasket or abrupt edge along the segment of the catheter that can interfere with the placement of the catheter through the stoma.

SYNTHESIS OF THE INVENTION It is therefore an object of the present invention to provide a balloon catheter having an improved balloon orientation which decreases or eliminates contact between the rigid tip at the distal end of the catheter segment and the anatomical structures during use.

It is another object of the present invention to provide such a catheter which is relatively inexpensive to manufacture and relatively easy to use.

In still another object of the present invention is to provide such a balloon catheter which does not obstruct the flow of the solution through the catheter segment.

It is yet another object of the present invention to provide such a balloon catheter, wherein the balloon catheter does not interfere with the catheter tip with the insert.

In still another object of the present invention is to provide such a balloon catheter which provides a reduced profile which lacks joints along the outside of the catheter segment from the proximal end to thereby facilitate insertion of the catheter segment and of the balloon through the stoma.

The above-mentioned objects and others of the invention not expressly numbered are embodied in an illustrative embodiment of the balloon catheter with an improved orientation including an elongated catheter shaft and a rigid tip to aid insertion through a stoma or other opening the body cavity Positioned at the distal end of the catheter shaft and at the rigid tip is a balloon placed in a coaxial relationship with the catheter shaft and the rigid tip. The balloon is configured to inflate in such a way that the balloon covers the distant rigid tip and therefore isolates it from the adjacent anatomical structures when the balloon catheter is being used.

In accordance with one aspect of the present invention, the balloon has a proximal cuff wherein said proximal end of the balloon is attached to the catheter shaft in a sealing contact. Typically this was achieved by the use of a glue. The distal end of the balloon extends over the rigid tip of the catheter to thereby avoid contact between the catheter tip and the anatomical structures. In a preferred embodiment, the distal end of the balloon extends around the rigid tip and then extends closely within an opening in the rigid tip to form a grip in the rigid tip. In such a configuration, the balloon is configured to extend outward and slightly distally from the rigid tip with inflation, thus avoiding contact between the rigid tip and adjacent anatomical structures during use. Additionally, with the balloon stretched over the rigid tip of the catheter, an elastic cushion is provided between the rigid tip and the stoma during insertion of the catheter.

According to another aspect of the invention, the balloon is formed of an elastomeric sleeve which has an inner diameter which is essentially the same as the outer diameter of the catheter segment. Therefore, when the balloon is not inflated, the elastomeric material of the catheter embraces the outside of the catheter segment, thereby minimizing the size of the stoma necessary to comfortably insert the device.

In accordance with yet another aspect of the invention, the rigid tip is formed with an annular groove or recess adjacent its distal end. The annular recess is preferably and slightly deeper than the thickness of the material forming the balloon. The distal end of the balloon is then adhesively attached to the rigid tip in the annular recess so that the cuff formed by the holder forms a channel which is approximately the same cross sectional size as the channel through the remainder of the rigid tip . Preferably, the channel defined by the cuff will be equal to or greater in internal diameter than that which runs through the remainder of the rigid tip. By providing a cuff which has a channel of essentially the same internal diameter as the remains of the rigid tip, the cuff does not serve as a restriction to the flow of fluid through the balloon catheter.

BRIEF DESCRIPTION OF THE DRAWINGS The objects mentioned above and others, the features and advantages of the invention will be apparent from a consideration of the following detailed description presented in connection with the accompanying drawings in which: Figure 1 shows a side view of a balloon catheter made in accordance with the teachings of the prior art. The balloon catheter being in a configuration employed; Figure 2 shows a side view of a balloon catheter made in accordance with the teachings of the present invention, the balloon catheter balloon being positioned around the exterior of the catheter segment in an uninflated configuration; Figure 3 shows a cross-sectional view of the balloon catheter of Figure 2, taken along the longitudinal median line A-A with the balloon not inflated resting on the outside of the catheter segment.

Figure 4 shows the side view of the balloon catheter of Figure 2 with the balloon in an inflated configuration; Y Figure 5 shows a cross-sectional view of the balloon catheter of Figure 4 taken along the longitudinal medial line B-B.

DETAILED DESCRIPTION Reference will now be made to the drawings in which various elements of the present invention will be given numerical designations and in which the invention will be discussed as to enable one skilled in the art to make and use the invention. It should be understood that the following description is by way of example only of the principles of the present invention and should not be seen as narrowing the pending claims.

Referring to Figure 2, there is shown a lateral figure of a balloon catheter, generally indicated with the number 110, made in accordance with the teachings of the present invention. The balloon catheter 110 is similar to the privo art in the sense that it includes a head 114. an elastomeric sleeve forming a balloon 118, and a catheter segment 122. The catheter segment 122 includes a catheter shaft 126 and a rigid tip (not visible due to balloon 118) which is attached to a distal end of the catheter shaft. catheter. A first central opening 140 in the head 114 allows injection of the enteral supply solution, etc., through the catheter segment 122 and into the user. A plug 142 is positioned on a lanyard 144 which extends from the head 114. The plug 142 can be placed in the first central opening 140 to prevent contamination of the catheter 110 when the opening is not being used to deliver the fluids through of the balloon catheter 110.

A second side opening 148 serves as a port through which the fluid can be injected in or can be removed from the balloon 118 through a lumen in the catheter segment 122. Thus, the second side opening 148 allows the user or to a doctor, etc. , selectively controlling the inflation and deflation of the balloon 118. The specific details of both the first central opening 140 and the second lateral opening 148 are discussed in further detail in the description in relation to the cross-sectional view shown in Figure 3.

As the prior art balloon catheter 10 shown in Figure 1, the balloon 118 includes a close fist 132 which extends longitudinally along the catheter shaft 126 so as to be coaxial therewith. Balloon catheter 110 also includes a distal cuff (not shown in FIG. 2) which secures the distal end of balloon 118. However, unlike the prior art balloon catheter 10 of FIG. 1, the distant cuff does not it is positioned along the outside of the rigid tip, several millimeters close to the distal end of the rigid tip. Rather, the distal cuff of balloon 118 is positioned in such a manner that the balloon covers the distal end of the rigid tip, thereby avoiding contact between the rigid tip and the anatomical structures underlying it. In such a configuration, the balloon 118 minimizes the irritation associated with the gastric balloon catheters of the prior art.

Turning now to Figure 3, there is shown a cross-sectional view of the balloon catheter 110 of Figure 2, taken along the longitudinal median line A-A. The balloon catheter 110 includes the head 114, the balloon 118 and the catheter segment 122. As mentioned previously, the head 114 includes a first central opening 140 and a second lateral opening 148. The first central opening 140 includes a valve anti-reflux 152 which is configured to allow nutrient solutions, etc., to pass inside the user but to prevent fluid flow out of the user unless properly attached by a syringe or other sampling device that has a nipple which corresponds to the anti-reflux valve. The antireflection valve 152 is placed in communication with a conduit in the shape of a lumen and delivery 156 which extends through the catheter shaft 126, and a duct or channel 160 through the grid tip 130 attached to the distal end 126a of the catheter shaft. When the fluid is injected into the first central opening 140, it flows through the anti-reflux valve 152, the supply lumen 156 and the channel 160 and into the balloon catheter user 110.

The second side opening 148 forms an inflation port in which a releasable one-way valve 164 is positioned. The one-way releasable valve 164 is placed in communication with the inflation lumen 168 which runs through the catheter shaft 126 essentially parallel to the delivery lumen 156. The distal end 168a of the inflation lumen 168 is connected in a side opening 172 provided, so that the inflation lumen communicates with the elastomeric sleeve between the cuffs 132 and 134, thereby forming the balloon 118. The application of fluid pressure (e.g., air injection or saline solution) through the injection lumen 168 causes the fluid to fill the cavity between the elastomeric sleeve of the balloon 118 and the catheter segment 122, thereby causing the balloon to inflate.

Unlike the balloon catheter 10 shown in FIG. 1, the distal cuff 134 of balloon 118 is not fastened several millimeters away from the distal end 130 and along the outside of rigid tip 130. Rather, the distal end 118a of the balloon 118 is wrapped on the distal end 130a of the rigid tip 130 and secured to an inner wall of the catheter segment 122 which forms the conduit through the catheter segment. Preferably, this was achieved by holding the distal end 118a of the balloon 118 inside the rigid tip 130. In such a manner, the distal end 118a of the balloon 118 always covers the distal end 130a of the rigid tip 130. In other words, the distal end 118a of the balloon 118 prevents the rigid tip 130 from sticking directly into the anatomical structures positioned on one side thereof.

An additional advantage of the configuration shown in Figures 2 to 5 is that the elastomeric sleeve which forms the balloon 118 is attached in such a way that no joint (such as the seal 34a in Figure 1) is formed at the end proximal of the balloon. As discussed in the background section, seal 34a (FIG. 1) of the distal end of balloon 18 in the prior art configurations provides a border over which tissue around the stoma can trap, thus interfering with the insertion of the catheter. 10. In addition, the abrupt edge also provides another shore which is likely to cause irritation to the anatomical structures with which it is repeatedly hooked.

In contrast, the elastomeric sleeve which forms the balloon 118 in the present invention lacks any proximal joint which could interfere with the insertion of the catheter or which could cause irritation by contact with the anatomical structures. In contrast, the near end of the elastomeric sleeve which forms the balloon 118 embraces the exterior of the catheter segment 122 and wraps around the distal end 130 of the rigid tip 130 rather than forming a seal. Thus, the elastomeric sleeve provides a smooth outer surface from the near cuff 132 to the distal end 130a, thereby facilitating the insertion of the catheter segment 122 through a stoma.

In a preferred embodiment, an annular recess 180 is formed in the rigid tip 130 on one side of the distal end 130a thereof. The annular recess 180 is slightly and preferably greater in depth than the thickness of the distal end 118a of the balloon 118. The distal end 118a of the balloon 118 nests in the annular recess 180 and is preferably attached to it by an adhesive. Because the annular recess is slightly deeper than the thickness of the distal end 118a of the balloon 118, the distal end of the balloon forms a channel 160a which is approximately the same size in diameter as the channel 160 placed close thereto through the stiff tip 130. In other words, the cuff 134 formed by the junction of the distal end 118a of the balloon 118 inside the annular recess 180 of the rigid tip 130 does not extend radially inwardly as to potentially restrict fluid flow through the channel 160 and inside the patient.

Turning now to Figure 4, there is shown a side view of the balloon catheter of Figure 2, with the balloon in an inflated configuration. The head 114, the balloon 118, the catheter segment 122 and the related structures are shown and marked according to Figure 2. Figure 4 was provided to demonstrate the orientation of the balloon 118 when it is inflated. Unlike the prior art configuration shown in Figure 1, balloon 118 extends distally beyond the distal end! 130a (FIG. 2) of the rigid tip 130 (FIG. 2). This, in turn, prevents the rigid tip 130 from directly contacting the anatomical structures, such as the opposite mucosa.

The view of Figure 5 provides a better view of the significant advance obtained by the present invention by providing a cross-sectional view of the balloon catheter of Figure 4 taken along the longitudinal medial line B-B. The view of the balloon catheter 110 is essentially the same as that of FIG. 2 (other than the balloon inflation 118), and is therefore numbered accordingly.

The focus on the balloon 118 and the rigid tip 130 will be apparent to those skilled in the art that the configuration described above provides a significant improvement in inflating the rigid tip of the patient's anatomical structures. Specifically, the formation of the distant fist 134 (Figures 3 and 5) on the inside of the rigid tip 130 provides a direct barrier (the material forming the balloon) between the rigid tip and the adjacent anatomical structures.

Additionally, when the balloon 118 is inflated, the balloon extends for a distance glue distally from the near ar towards the nearby fist 132, thereby forming something of a donut shape avoiding the forced contact between the rigid tip 130 and any adjacent anatomical structures . Of course, the distance at which the balloon 118 extends distally from the rigid tip 130 will depend on the number of factors such as the flexibility of the material used in the balloon, the amount of material and whether any of the bends or other structural supports are provided throughout the globe. When the balloon is deflated, the balloon 118 still prevents any direct contact between the rigid tip 130 and the adjacent anatomical structures.

Any advantage of the present invention is that it allows a more secure distal seal without increasing the potential for irritation. Because the catheter segment of the prior art is not protected at the distal end of the inflated balloon, it is desirable to minimize the discomfort to reduce the length of the cuff at the distal end of the catheter segment. If the fist is very long, a considerable amount of the catheter segment will extend beyond the balloon. In contrast, by having the distal end 118a of the balloon 118 atta to the interior of the rigid tip 130, the distal end 130a of the rigid tip 130 is covered, and those constituting the balloon catheter 110 can form a larger cuff for increase sealing without increasing irritation. The larger cuff provides an improved seal and therefore provides superior prevention of filtrates from the balloon. Although shown in Figure 3 and Figure 5, being adjacent to the distal aperture of the rigid tip 130, the distal cuff 134 may also be located closely within the catheter segment 122. Thus, a balloon catheter is described. with an improved balloon orientation. Those skilled in the art will appreciate that numerous modifications can be made without departing from the scope and spirit of the present invention. For example, even though the catheter shaft and the rigid tip are shown as two different elements which have to be clamped, it would be possible to form a catheter segment which uses a single piece of tubed catheter to carry out the functions of the shaft. catheter and rigid tip. The appended claims are intended to cover such modifications.

Claims (25)

R E I V I N D I C A C I O N S

1. A balloon catheter comprising an elongated catheter segment having a proximal end and a distal end; Y an inflatable balloon attached to the elongated catheter tube on one side of the distal end, to form a proximal cuff at the near end of the balloon and a distal cuff, the nearby cuff being attached to the outside of the catheter segment and the distal cuff being attached to the inside the catheter segment so that the balloon embraces the outside of the catheter segment when it is not inflated, thereby facilitating the insertion of the balloon catheter through a stoma.

2. The balloon catheter as claimed in clause 1 characterized by the balloon having a distal end, wherein the catheter segment comprises a catheter shaft and a rigid tip attached to the catheter shaft, the rigid tip has an interior that define a conduit; and wherein the near end of the balloon is attached to the catheter shaft and the balloon end is attached to the inside of the rigid tip.

3. The balloon catheter as claimed in clause 2 characterized in that the rigid tip has an annular recess and wherein the distal end of the balloon nests in the recess.

4. The balloon catheter as claimed in clause 3 characterized in that the rigid tip has a distal end and wherein the annular recess is formed inside the rigid tip immediately to one side of the distal end of the rigid tip.

5. The balloon catheter as claimed in clause 4, characterized in that the balloon is formed of an elastomeric sleeve having a thickness wherein the annular recess is deeper than the thickness of the elastomeric sleeve.

6. The balloon catheter as claimed in clause 2 characterized by the rigid tip having a channel extending therethrough, and wherein clamping the distal end of the balloon to the rigid tip does not decrease the diameter in cross section of the channel through the rigid tip.

7. The balloon catheter as claimed in clause 2 characterized in that the balloon extends distally from the distal cuff, around the distal end of the rigid tip, and then close to the nearby cuff.

8. The balloon catheter as claimed in clause 1 characterized in that the catheter segment has a distal end with a recess formed therein, and wherein the distal end of the balloon nests in the recess.

9. The balloon catheter as claimed in clause 1 characterized in that the balloon comprises an elastomeric sleeve having a near end and a distal end, and wherein the close fist is formed at the near end of the elastomeric sleeve, and wherein the distal cuff is formed at the distal end of the elastomeric sleeve.

10. A balloon catheter comprising: a head having at least two openings through which the solution may be in fluid communication with an internal organ of a patient; a catheter segment extending from the head, the catheter segment has a first and a second lumen placed in communication with at least two openings; Y a balloon formed by a sleeve with a first end attached to the outside of the catheter segment so as to form a first cuff and a second end attached to the inside of the catheter segment so as to form a second cuff, the balloon is folded into the catheter segment When it is not inflated to facilitate therefore the insertion through the stoma.

11. The balloon catheter as claimed in clause 10, characterized in that the first cuff is placed close to the second cuff.

12. The balloon catheter as claimed in clause 11 characterized by the sleeve having a proximal end attached to the exterior of the catheter segment and a distal end attached to the interior of the catheter segment.

13. The balloon catheter as claimed in clause 12 characterized in that the catheter segment comprises a catheter shaft having a distal end and a rigid tip attached to the distal end of the catheter shaft.

14. The balloon catheter as claimed in clause 13 characterized in that the near end of the sleeve is attached to the outside of the catheter shaft, and wherein the distal end of the sleeve is attached to the inside of the rigid tip.

15. The balloon catheter as claimed in clause 10 characterized in that the head has a plurality of valves configured to selectively control the flow of fluid through the balloon catheter.

16. The balloon catheter as claimed in clause 10 characterized in that the head has a cross-sectional diameter larger than the catheter segment.

17. The balloon catheter as claimed in clause 10 characterized in that the catheter segment has a distal tip where the balloon covers said distal tip.

18. The balloon catheter as claimed in clause 10 characterized in that the catheter segment has a distal tip and wherein the balloon extends distally of the distal tip when inflated.

19. The balloon catheter configured for placement through a stoma in a body cavity so that the balloon catheter is maintained in the stoma, the balloon catheter comprises: a head having at least one opening through which a fluid can be injected; «« A catheter segment extending from the head part to a distal tip, the catheter segment has an exterior and a wall defining a passage through the interior; and an elongated sleeve attached to the exterior of the catheter segment and the inside the catheter segment around the conduit, to form an inflatable balloon which covers the distal tip of the catheter segment, the sleeve 10 being in a collapsed state when it is not inflated wherein the sleeve closely surrounds the catheter segment and wherein the sleeve extends radially outwardly from the catheter segment when inflated.

20. The balloon catheter as claimed in clause 19 characterized by the attachment of the elongate sleeve to the exterior of the catheter segment forming a close fist of the balloon, and wherein the elongated sleeve is secured to the interior of the catheter segment. forms a distal fist 20 balloon.

21. The balloon catheter as claimed in clause 20 characterized by the distal cuff defining a part of the conduit through the catheter segment.

22. The balloon catheter as claimed in clause 19, characterized in that the catheter segment comprises a catheter shaft and a rigid tip attached to a distal end of the catheter shaft opposite the head.

23. The balloon catheter as claimed in clause 22 characterized in that the sleeve is attached to the outside of the catheter shaft and the inside of the rigid tip.

24. The balloon catheter as claimed in clause 23 characterized in that the rigid tip comprises an annular recess and wherein the sleeve is placed in the annular recess.

25. The balloon catheter as claimed in clause 19, characterized in that the clamping of the sleeve to the outside of the catheter segment is close to the clamping of the sleeve to the interior of the catheter segment. SUMMARY A balloon catheter with a balloon orientation is improved and includes a head, a catheter segment extending from the head, and a balloon placed on the catheter segment opposite the head. Preferably, the head is attached to the exterior of the catheter segment at a location close to and within the catheter segment at a distant location to thereby form a balloon which extends distally from the distal end of the catheter segment when inflated. The improved orientation of the balloon helps to avoid contact between the distal end of the catheter segment and the anatomical structures of the user thus reducing irritation.