KR101116542B1 - Catheter with unitary component - Google Patents

Abstract

The present invention relates to a single component having a tip portion integrally formed with the expandable sleeve portion. Another aspect of the invention relates to a catheter comprising a single component. Another aspect of the invention will become apparent upon reading the remainder of the specification.

Balloon Catheter, Head, Shaft, Tip, Expandable Sleeve, Single Component

Description

Catheters with Single Component {CATHETER WITH UNITARY COMPONENT}

The present invention relates to a single component having a tip portion integrally formed with the expandable sleeve portion. The invention also relates to a catheter comprising a single component.

Catheterization of the body cavity is frequently performed in medical procedures for inserting material into or removing material from the body. During many of these procedures, it is necessary to keep the catheter in a relatively stable position to perform the desired insertion or removal. In the use of intestinal feeding catheters (catheters which allow the administration of nutrients directly into the stomach or intestine), for example, it is necessary to ensure that the catheter is not accidentally removed from the stomach or intestine. This is true during the actual administration or removal of the fluid and during the period in between.

In order to ensure that the catheter is held in a proper position, it is common to use a balloon placed near the distal end (patient end) of the catheter shaft. When inflating the balloon, the balloon contacts the anatomical structure (ie, the esophagus or stomach wall), thereby preventing the catheter from moving from its proper location. In the case of intestinal supply, a hole is formed which leads into the stomach or intestine. The catheter is positioned to extend through the orifice, forming a channel into the gastrointestinal or intestine through which the intestinal feed can be injected.

1 shows a side view of a prior art balloon catheter 10 with a head 14 disposed at the base end 15. Head 14 includes a valve (not shown) that regulates the flow of fluid through balloon catheter 10. The head 14 also prevents the balloon catheter 10 from fully advancing through the aperture into the user's stomach or intestine.

To prevent the catheter 10 from being pulled out of the gastrointestinal / intestinal wall, a balloon 18 is disposed along the catheter shaft 26. The catheter 10 is shown having an optional rigid tip 30 attached to the catheter shaft 26 at the distal end 17 opposite the head 14. The catheter shaft 26 is typically made of medical grade silicone. The rigid tip 30, when present, is also often formed of medical grade silicone, but usually consists of rigidity below the catheter shaft 26.

The balloon 18 is advantageous because it allows the catheter shaft 26 to be inserted into a hole (not shown) when the balloon 18 is not inflated. When the catheter shaft 26 is properly positioned in the hole, a syringe (not shown) is inserted into the side port 36 of the head 14 and fluid is introduced into the lumen (not shown in FIG. 1) of the catheter 10. It is injected into the balloon 18 through to inflate the balloon 18.

When the balloon 18 is inflated and maintained, the catheter 10 is properly positioned and stays in the aperture. The position of the balloon catheter 10 is maintained until removal is necessary. If the catheter 10 is to be removed, the balloon 18 may be retracted so as not to interfere with the retraction of the catheter shaft 26 and the rigid tip 30.

The type of balloon 18 shown in FIG. 1 is formed around the periphery of the catheter shaft 26 such that it is reduced or retracted around the shaft 26 when the balloon is retracted but is still certainly larger than the total diameter of the catheter.

Attachment of the balloon 18 to the catheter shaft 26 is often performed by adhering the balloon base end 20 and the balloon distal end 22 to corresponding locations on the outer surface of the catheter shaft 26, respectively, the base cuff 32. ) And end cuff 34. Such cuffs 32, 34 are longitudinal sections of the balloon 18 whose inner diameter corresponds to the outer diameter of the shaft 26 at their respective attachment points to the catheter 10 and are generally not inflated therebetween. Has a distance that is the length of the balloon 18. The cuffs 32, 34 should be of sufficient length to provide a robust and durable seal between the balloon 18 and the catheter shaft 26.

Although the prior art balloon configuration shown in FIG. 1 serves to keep the balloon catheter 10 in a proper position within the patient, this type of balloon catheter and other known balloon catheter have disadvantages. For example, one drawback of conventional balloon catheter is user inconvenience. For the catheter of FIG. 1, to allow insertion of the catheter 10, the catheter shaft 26 and especially the rigid tip 30 must be relatively rigid or rigid to prevent buckling under insertion pressure. However, this same robustness makes it much easier to stimulate the anatomical structures that the distal tip 30 comes into contact with. This is true in the gastrointestinal and intestinal tract, where the opposing walls of anatomical structures tend to be pressed against each other during physical activity or when the cavity has little food. As the person moves, the rigid tip 30 may repeatedly engage with adjacent anatomical structures (such as the stomach wall), leading to irritation and / or discomfort for the user. Thus, since the presence of an extended rigid catheter tip in this environment is suspected of stimulating opposite surfaces of the body cavity, it would be desirable to be able to protect the patient from exposure to the tip 30.

Thus, in the art, a balloon catheter with a rigid distal tip needs to be isolated from the opposing inner body cavity surface.

Another drawback with prior art balloons of the type described above is that if the balloon is to be secured inside the tip 30, the balloon provides an undesirable restriction of fluid flow therethrough.

Although not done in conventional catheter, if the tip is attached to the inside of the catheter shaft, the flow will be further reduced. Reduction of flow may require prolonged use of the catheter to achieve the desired level of fluid flow. If a catheter with a wide tip or shaft is used to overcome fluid flow problems, the hole into which the catheter should be inserted must be large, thereby creating an increased time for treating the hole and a large opening from which fluid can leak. Will cause other issues such as

Thus, there is a need for a catheter that can provide increased levels of fluid flow (compared to conventional devices) without the need for a large opening.

Another disadvantage of prior art catheter of the type described above is that the catheter is usually first separated into several pieces (eg, catheter, rigid tip, and balloon), and then the tip is attached to one end of the catheter and balloon, Finally, the attachment of the second end of the balloon to the catheter is required. Each method of attachment has been done manually in the past. Naturally, such manual work is slow, expensive and inefficient. Moreover, at each further step of the process, there is a possibility of product error and waste.

Thus, there is a need for catheter, and because of the number of individual pieces or members comprising the catheter and because these pieces are typically assembled at least manually at several assembly stages, in the art, less assembly is required, especially manual assembly There is a need for a catheter that requires less.

For the difficulties and problems described above, a single component has been developed that can be used with the catheter. In particular, one embodiment of the invention relates to a single component having a tip integrally formed with the expandable sleeve portion.

Another embodiment of the invention is directed to a catheter with a single tip. In particular, the catheter includes an elongated shaft and a single component. In particular, the elongated catheter has a distal end, a first lumen suitable for fluid communication, and a second lumen suitable for fluid communication with an exterior and a cavity formed by the exterior and a single component of the shaft. The single component includes a tip region formed integrally with the expandable region.

Another embodiment of the invention is directed to a balloon catheter having a head having at least two openings, a catheter segment extending from the head, and a balloon formed by a sleeve at the first end of the single component, the catheter segment being at least two First and second lumens disposed in communication with the two openings, the first end being attached to the exterior of the catheter segment to form a first cuff, the second end of the single component having a tip portion and at the distal end of the catheter segment Attached.

These and other features and advantages can be seen from the following detailed description and claims in the drawings.

These and other objects, features, and advantages of the present invention will become apparent upon consideration of the following detailed description provided in connection with the accompanying drawings.

1 is a side view of a prior art balloon catheter in an inflated configuration;

2 is a cross-sectional view of one embodiment of a single component made in accordance with the present invention having a tip portion and a balloon or elongated sleeve portion.

3 is a perspective view of one embodiment of a balloon catheter of the present invention having an uninflated balloon.

4 is a perspective view of the balloon catheter of FIG. 3 with the balloon inflated.

4A is an enlarged view of the area enclosed by the circle in FIG.

FIG. 5 is a cross-sectional view of the balloon catheter of FIG. 3.

5A is an enlarged view of the area enclosed by the circle in FIG.

FIG. 6 is a cross-sectional view of the balloon catheter of FIG. 3 except showing another attached single component to the catheter. FIG.

6A is an enlarged view of the area enclosed by the circle in FIG.

FIG. 7 is a cross-sectional view of a balloon catheter similar to that of FIG. 6 except for showing another attachment of the distal end of the tip of a single component.

8 is a cross-sectional view of a balloon catheter similar to that of FIG. 6 except that the proximal end of the single component is attached upside down to the catheter shaft.

One embodiment of the invention is directed to a single component having a tip portion integrally formed with an expandable sleeve portion. In some embodiments, the tip portion of a single component may be rigid or rigid.

Another embodiment of the invention is directed to a single component having a catheter with an elongated shaft and a tip region integrally formed with the expandable region. The elongated shaft should have a distal end, a first lumen suitable for fluid communication, and a second lumen suitable for fluid communication with the outside and the cavity formed by the outer and single components of the shaft. It will be appreciated that the size and shape of the cavities formed between them by the expandable region of the outside of the shaft and the single catheter are variable.

As used herein, the term "end" refers to the direction of the patient and "donation" refers to the direction of the therapist.

Another embodiment of the invention is directed to a balloon catheter having a head having at least two openings through which fluid passes, a catheter shaft or segment extending from the head, and a balloon formed by a sleeve at the first end of the single component , The catheter shaft has first and second lumens, each lumen is arranged to communicate with at least one of the at least two openings, the first end of the single component being attached to the outside of the catheter shaft to form a first cuff The second end of the single component has a tip portion and is attached to the distal end of the catheter shaft. The sleeve is usually intended to be compressed around the catheter shaft when not inflated.

While an expandable sleeve portion is referenced in the claims and at the beginning of the specification, the term expandable sleeve portion also refers to a balloon, sleeve, elongated sleeve, expandable sleeve, expandable region or portion, inflatable member, any suitable for expansion. Means other means, but are not limited thereto. However, the term expandable sleeve portion will be referred to hereinafter as a balloon, to facilitate reading and understanding of this specification and not by way of limitation. Further, reference will be made to balloon inflation throughout the specification, but it will be understood that the invention is not limited to inflation only. That is, although expansion is used herein to facilitate reading and understanding of the specification, the term expansion also means or includes, but is not limited to, expansion, enlargement, swelling, and the like.

While the tip portion is referenced in the claims and at the beginning of the specification, the term tip portion refers to or includes, but is not limited to, all shapes and sizes of tips, tip members, tips, tip areas, portions of a single component including the tips, and the like. It will be understood that it is not considered. However, the term tip portion will be referred to as a tip so as to facilitate reading and understanding of the present specification and not be limited thereby.

Reference will now be made to the drawings wherein the various elements of the invention have been given reference numerals and the invention has been described to enable those skilled in the art to make and use the invention. It is to be understood that each example is provided by way of explanation of the invention and not as a limitation of the invention. For example, features shown or described with respect to one embodiment may be used in another embodiment to create another embodiment. These and other variations and modifications are within the scope and spirit of the present invention.

Referring now to FIG. 2, a single component 117 is shown having a tip 119 and a balloon 118. Tip 119 of component 117 may be rigid or rigid when present, or at least as rigid as balloon 118 and / or catheter shaft 114 (FIG. 3), as described below. It can be more rigid.

The single component 117 of Figure 2 is typically used in connection with a catheter, such as the balloon catheter 110 of Figures 3-8. Catheter 110 includes a base head 112, a shaft 114, and a single component 117. Referring now to FIGS. 5 and 6, the head 112 is a base opening into the supply lumen 122 within the shaft 114 to bolus inject or supply other nutrients, agents, and the like to a patient (not shown). Have 120. Although not required, a non-return valve 124, which is typically included to prevent backflow of the nutritional formulation, is shown disposed between the opening 120 and the supply lumen 122. An expansion port 126 is disposed in the head 112 and in communication with the expansion lumen 128 extending longitudinally through the shaft 114. Expansion lumen 128 is connected to shaft 114 at port 134 into cavity 135 created by balloon 118 and shaft 114 of single component 117, as described in more detail below. End on the side. One-way valve 130 may be disposed between expansion port 126 and expansion lumen 128. Application of fluid positive pressure, such as air or physiological saline, into and / or into the inflation lumen 128 by the inflation port 126 may inflate the balloon 118 of the single component 117. The valve 130 helps to prevent accidental contraction of the balloon 118. Also shown in connection with the head 112 is a plug 131 for the base opening 120 and a string 136 for holding the plug 131 in the ready position. Plug 131 may be inserted through opening 120 to reduce or eliminate contamination when opening 120 is not used. Feed lumen 122 extends longitudinally through shaft 114 and terminates at distal end 140 of shaft 114.

The various components of balloon catheter 110 may be made of any suitable material, and may preferably be formed from a biocompatible material such as medical grade silicone or the like. As above, the valves 124 and 130 may be formed of any suitable material, but are preferably made of a suitable polymer, such as polycarbonate.

Typically, from a conventional manufacturing standpoint, the catheter and tip of the conventional device were made separately and subsequently assembled. The reason for past discrete manufacturing is that in one or more cases the tip 30 (FIG. 1) is made of a different material than that used to construct the catheter 10 (FIG. 1), or is made of the same material for the tip 30 ( Examples include, but are not limited to, those that exhibit different physical properties than the catheter 10 as a result of other processing conditions or steps. In each case (ie when manufactured as a single piece or as a multiple piece (with a catheter)), the tip 119 (Figs. 5-8) and the shaft 114 of the present invention are preferably fastened or buckled. It must be able to withstand insertion pressure without

The single component 117 of the present invention may be configured in a variety of suitable ways, including but not limited to injection molding, transfer molding, or dipping. Moreover, the single component 117 may be attached to the catheter 10 by a variety of means including but not limited to adhesion or attachment in one of the aforementioned injection molding, transfer molding, or dipping processes. Single component 117 may also be attached to catheter 10 by chemical bonding, such as solvent bonding. As shown in FIGS. 5 and 5A, the single component 117 may be attached to the catheter 110 in a manner that overlaps the distal end 140 of the catheter 110. The overlap may be on the exterior of the catheter shaft 114 (FIGS. 5 and 5A) or on the interior of the shaft 114 (FIGS. 6 and 6A). Optionally, as shown in FIG. 7, the single component 117 has little or no overlap, for example, and the confinement of the supply lumen 122 prevents the distal end 121 of the single component 117 from the catheter 110. It may be attached to the end 140 of the catheter shaft 114 such that little or no occurrence occurs at the point of attachment between the distal ends 140.

Any manner of attachment of the single component 117 to the catheter shaft 114 described above also avoids the undesirable restraint of flow associated with the tip of the prior art having a balloon attached to the inside of the tip (and thereby fluid communication To reduce the size of the passage through the available tip). Thus, the use of a single component 117 (FIGS. 2-8) allows the user to achieve a desired level of fluid flow in a shorter time under the same use conditions as compared to a conventional device with a balloon attached to the inside of the tip. May make it possible to use a tip 119 (FIGS. 5-8) with a smaller cross-sectional area and / or smaller sized catheter shaft 114. It will be appreciated that there are several advantages or advantages associated with the ability to use a catheter with a smaller shaft, and that there is no adverse effect as a result of using a catheter with a smaller shaft diameter.

As shown in FIGS. 3-8, the single component 117 has at least a portion of the balloon 118 of the single component 117 overturned around or around all or a portion of the tip 119 of the single component 117. Is designed to be.

As described above, since the configuration and / or physical characteristics of the catheter 110 and tip 119 may vary, the configuration and / or physical characteristics of one or more portions or regions of the single component 117 may also vary. That is, for example, the single component 117 will have a thickness, but the thickness and weight, shape, or density of one or more portions of the single component may vary. In particular, the portion of the single component 117 comprising the tip 119, for example, may have different characteristics than the portion of the component 117 comprising the balloon 118 (eg, hardness, thickness, elasticity, density). And the like).

In addition, within each region or portion of the single component 117, the properties and / or characteristics of the components may vary. For example, the tip 119 may be tapered and / or a portion of the single component 117 with the balloon 118 may be more expandable or elastic in some areas than others. Although areas or portions of a single component 117 are mentioned separately in some cases herein, it will be understood that they are in fact one component, part of a single component 117. It is also to be understood that while regions may be commonly referred to as separate regions, there is in fact no clear distinction about where one region or portion begins and the other region or portion ends. Thus, it can be found within the single component 117 that a portion or a portion of the region may be referred to as a transition zone, which may exhibit the characteristics and / or characteristics of both regions. The transition zone can also be found within a portion of the single component 117. For example, within a portion of a single component 117 that includes balloons 118 having different levels of elasticity, there will be a transition zone between regions that exhibit different levels of elasticity.

As shown in FIGS. 2-4, the single component 117 has one end 121 (FIG. 2) adjacent the portion of the single component 117 with the tip 119 and the single component with the balloon 118. It has a second end 123 adjacent to the portion of 117. The end 123 of the balloon 118, which can be flipped around at least a portion of the tip 119, can be attached to the catheter shaft 114 (FIGS. 3, 3A, 4, and 4A) in various suitable ways.

For example, the end 123 may be attached to the exterior of the shaft 114 as shown in FIGS. 3, 3A, 4, and 4A. In embodiments where the end 123 is attached to the exterior of the catheter 110, the end 123 may be attached to form a cuff 132 (FIGS. 3, 3A, 4, 4A), or As shown in FIG. 8 and filed in the name of Letson et al. On November 30, 2002, which is incorporated herein by reference in its entirety, is commonly assigned and commonly referred to as "catheter with upside down balloon member attached." It may be attached in an inverted manner as described in pending US patent application Ser. No. 10 / 307,057.

The size of the catheter 110 and the length (expanded and unexpanded) of the balloon 118 are the size and shape of the body cavity (not shown) in which the catheter 110 should be used, and the size of the catheter 110 that must be moved through the catheter 110. It will be appreciated that it may vary depending on the nature of the material. That is, in some cases, it may be desirable to use a catheter 110 with a larger and / or wider shaft 114 than other embodiments. Also, as described in more detail below, the balloon 118 of the catheter 110 may be designed to have a constant size and / or shape in one or both of its expanded or unexpanded configurations.

It will also be appreciated that the length of the balloon 118 and the point along the shaft 114 to which the end 123 of the balloon 118 is attached may affect the shape of the resulting balloon. As a result, other suitable ways of controlling the shape of the inflated balloon 118 include annular rings, such as those shown in 160, 160 ', and 160 "in Figure 2. Other ways of controlling the shape of the uninflated balloon Include, but are not limited to, rotational dipping, which is commonly done to produce uniform films in the condom industry.Another suitable way of controlling the shape of the resulting balloon is U.S., Willis et al., Which is incorporated herein by reference in its entirety. Including but not limited to those described in patent 6,264,631 B1.

Although the present invention has been described in detail with respect to specific embodiments thereof, those skilled in the art can readily understand variations, modifications, and equivalents to the described embodiments when understanding the present invention. It is intended that the present invention cover such modifications and variations as come within the scope of the appended claims and their equivalents.

Claims (15)

delete delete delete delete delete delete Catheter 110, An elongated shaft 114 comprising a distal end 140, a first lumen 122 for fluid communication, an exterior, a second lumen 128 for fluid communication, Expandable region 118, A tip region 119 attached to the distal end 140 of the shaft 114, The tip region 119 is integrally formed with the expandable region 118 to form a single component 117, The second lumen 128 for fluid communication is in fluid communication with a cavity formed by the single component and outside of the shaft, The expandable region 118 of the single component 117 extends from the tip region 119 of the single component 117 to the base attachment of the catheter 110 at the base at the distal end, The expandable region 118 is attached to the outside of the shaft 114 to form a balloon, Catheter 110. delete delete delete delete The method of claim 7, wherein The size and shape of the cavity defined by the exterior of the shaft and the expandable area of the single component is variable, Catheter. The method according to claim 7 or 12, wherein The tip region is more rigid than the expandable region of the single component, Catheter. The method according to claim 7 or 12, wherein At least a portion of the tip area is tapered, Catheter. A head having at least two openings, The catheter of claim 7 or 12 extending from the head, The expandable area of the single component is a sleeve, The first end 123 of the single component is attached to the outside of the catheter to form a first cuff, The second end 121 of the single component has a tip portion attached to the distal end of the catheter, The balloon catheter is compressed around the catheter when the balloon is not inflated.

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