Kink-Resistant Tubing
Tubing for use in gastrointestinal applications includes a hollow tube and a spring positioned inside the tube. The spring is corrosion resistant and helps to prevent kinking of the tubing when the tubing is bent. An encapsulant may be positioned over the spring. The spring may be co-extruded with the tubing.
Latest Applied Medical Technology, Inc. Patents:
- Magnet-assisted suture graspers
- Magnet-assisted suture grasper comprising a suture retrieval needle, a retriever body, a grasper wire, a grasper arm, and a grasper magnet
- Magnet-assisted suture graspers
- Magnetic suture
- Gastric jejunal feeding tube devices for gastric jejunal feeding of an infant or child
This application claims priority to U.S. Provisional Application No. 61/745,640, filed on Dec. 23, 2012, the disclosure of which is incorporated herein by reference in its entirety.
FIELDThe examples described herein concern kink-resistant tubing. One application for the example kink-resistant tubing is in gastrointestinal applications.
BACKGROUNDLow profile gastrojejunostomy (“G-J”)feeding tubes have been developed for use in smaller patients, such as pediatric patients, in small sizes such as 14 French. As the G-J feeding tubes are placed in younger and younger patients, the intestinal anatomy that the device is used in also becomes smaller. The jejunal portion of the small intestine in infants is very tight, compact and tortuous. The entire gastrointestinal tract fits in an abdominal cavity roughly the size of a softball. Each twist and turn of the jejunum must be navigated by the distal portion of the G-J device tube.
As the jejunal path becomes more tortuous, the probability of kinking of the G-J tube increases. If the tubing kinks, the device is rendered ineffective and must be replaced with a new device. Most patients that depend upon direct jejunal feedings for nutrition cannot tolerate a kinked tube for very long. Since most G-J device placements are performed by interventional radiology, the occurrence (or reoccurrence) of this expensive procedure, which is typically scheduled in advance, is something that hospitals and insurance companies would like to limit. Parents of pediatric patients would also like to reduce the time spent at the hospital, as well as the amount of radiation exposure to their children during fluoroscopy placements. Examples of kinked G-J tubing are shown in
A kink resistant tubing is disclosed and described herein.
The examples described herein are directed toward tubing that utilizes a king-resistant feature. This kink-resistant feature can be incorporated into G-J tubing, including single lumen or multi-lumen tubing or any other type of tubing. The kink-resistant tubing helps to maintain tubing patency and flow as the tube bends, twists and turns its way through the folds of the small intestine. While the tubing described herein is described in the context of G-J feeding tubes, it should be readily recognized that the examples described herein can be utilized in any type of system or application that requires non-kinking of tubing.
In one example, shown in
The spring 14 may be positioned in the tubing and may be inserted into a round or somewhat round interior of tubing. The spring may be formed to fit within the interior shape of the tubing. Transitional tubing may not have an entirely round interior, but the spring 14 may still be used with transitional tubing. The spring is inserted into the interior of the tubing through the end of the tubing. Different size springs may be selected based upon the size (e.g., French size) and length of the tubing 10. The spring may traverse part of the length of the tubing, or all of the length of the tubing.
The spring 14 may be made of a biocompatible metal or of a flexible polymer. An example of a biocompatible metal is 316L stainless steel. Other metal and plastic materials may be used.
In the case of a post-extrusion secondary process for installing the spring 14 in the tubing 10, a support structure may be utilized for securedly adhering the spring 14 to the inner diameter of the silicone tubing 10. The inside of the tubing 10 may serve as the support structure. Alternatively, a separate piece of tubing (not shown) may serve as the support structure. The separate piece of tubing that is used for the support structure should be sized so that it fits inside the inner diameter of the tubing 10. The support structure should allow the spring to be maintained on the interior of the tubing for at least 6-12 months. When the inner wall of the tubing is used as the support structure for the spring, the spring may be encapsulated against the support structure by an encapsulant. Because the tubing 10 is used in a lipid-rich environment, the spring 14, support structure, and encapsulant, if any, must be able to withstand the environment without corroding while maintaining tube flexibility. The tubing 10 should also be MRI-compatible, if desired. The spring 14, support structure, and encapsulant, if any, should produce a low profile within the tubing's inner diameter.
An example of kink-resistant tubing is depicted in
The following advantages are associated with the kink-resistant tubing:
-
- 1) Increased G-J Button longevity;
- 2) More reliable feedings for patients that already have difficulty receiving enough nutrition;
- 3) Reduces the number of G-J replacements by interventional radiology;
- 4) Reduces the number of hospital visits;
- 5) Reduces the patient's exposure to radiation;
- 6) Increases the possibility of developing even smaller G-J buttons than those used today, such as a 12 French button;
- 7) Provides peace-of-mind for parents, patients, and doctors;
- 8) Increases the possibility of preventing retrograde movement of the distal portion of the tubing 10 and preventing the tubing from coiling back into the stomach;
- 9) Improves the ability to use a medical-grade spring stainless steel, such as 316L stainless, that would show up very well during placement under fluoroscopy; and
- 10) Improves ability to maintain flow through the device even if the device begins to coil within the stomach.
Examples showing an example spring reinforcement positioned in the jejunal lumen at the transitional area of a G-J tubing 10 is shown in
Another example of a kink-resistant tubing embodiment is described. In this example, the spring 14 is positioned in an outer wall of the multi-lumen portion and the diameter of the multi-lumen portion remains substantially the same along the entire length of the feeding tube. As with prior examples, the G-J button 24 may be overmolded over the proximal end of the feeding tube. Stripes 12, 22 may be positioned on an exterior surface of the feeding tube. The spring 14 is embedded into the outer wall of the feeding tube. When the feeding tube transitions from tri-lumen to bi-lumen, the outer diameter of the tube remains the same. This example allows for a thin outer wall of the feeding tube because the spring 14 provides reinforcement of the wall of the feeding tube. Thus, with this embodiment, it is possible to have a smaller diameter feeding tube because greater area inside the feeding tube can be used to provide the lumens. In this example, the tri-lumen portion of the tubing may have a length L3 of about 4 inches, the bi-lumen portion may have a length L4 of about 19 inches, and the total length L5 for the feeding tube may be about 23 inches. Other lengths may alternatively be used.
As previously discussed, the spring may be inserted into the tubing during the tubing extrusion process as an alternative to a post-extrusion insertion process. The tubing may be silicone, polyurethane, or other types of materials.
The use of a polymeric spring instead of a metal spring allows for the device to be considered MRI “safe”. Polymeric coils may be more easily cut by a physician to a specific length. This would also make it less likely for there to be a sharp end at the place where the tubing is cut since no metal is utilized.
In one example, tubing for use in gastrointestinal applications includes a hollow tube and a spring coupled to the tube. The spring is corrosion resistant and helps to prevent kinking of the tubing when the tubing is bent. The spring may be positioned against an inner diameter of the hollow tube and may also include an encapsulant positioned over the tubing. The spring may be made of a stainless steel or a polymeric material. The tubing may be made of a silicone material, a polyurethane material, or a polymeric material. The tubing may have a substantially round inner diameter, or the tubing may not have a substantially round interior surface. The spring may be positioned in the hollow tube during a tube extrusion manufacturing process such that the spring is embedded in a wall of the tubing, or the spring may be positioned in the hollow tube during a post-extrusion process. The hollow tube may include multiple lumens in a single tube, and the spring may be associated with one or more of the lumens. A G-J button may be coupled to the hollow tube at one end thereof. The multiple lumens may include a first gastric lumen, a second jejunal lumen, and a third lumen.
In another example, a kink-resistant tubing includes a tubing wall and a spring positioned one of inside the tubing wall or adjacent an interior surface of the tubing wall. The spring helps to deter the tubing from kinking when bent. When the spring is positioned inside the tubing wall, the spring is incorporated into the tubing wall during an extrusion manufacturing process of the tubing. When the spring is positioned adjacent the tubing wall, the spring is added to the tubing after the extrusion process has been completed.
In another example, a multi-lumen feeding tube that is coupled to a G-J button includes a multi-lumen and a spring positioned along at least part of the length of the multi-lumen tube. The multi-lumen tube has at least two lumens at a proximal end thereof and at least one lumen at a distal end thereof, with the lumens comprising at least a gastric lumen and a jejunal lumen. The spring is provided in order to provide a kink-resistant feature to the feeding tube.
The gastric and jejunal lumens are about the same length as one another and the multi-lumen feeding tubing also includes a jejunal tube inserted into the jejunal lumen, with the jejunal tube having a length that is greater than the length of the gastric and jejunal lumens. The spring is positioned along at least part of the length of the jejunal tube. The jejunal tube may have a cone-shaped portion at a proximal end thereof and the cone-shaped portion may be formed integrally with or formed in a post-processing step. The cone-shaped portion may be made of a higher durometer material than the material of the tube. The tube may be inserted into an opening in the G-J button into the jejunal lumen such that the cone-shaped portion seats in the G-J button to couple the jejunal tube to the jejunal lumen and G-J button.
The spring may be coupled to the jejunal lumen of the multi-lumen tube and the jejunal lumen may have a length that is greater than the gastric lumen, with the spring extending along at least part of the length of the jejunal lumen or along substantially all of the length of the jejunal lumen. The spring may be coextruded with the jejunal lumen such that the spring is embedded in the wall of the jejunal lumen.
The spring may be coupled to the outer wall of the multi-lumen tube such that the spring is co-extruded with the outer wall of the multi-lumen tube. The multi-lumen tube may have a substantially constant outer diameter along its length, and the multi-lumen tube may have at least a gastric lumen and a jejunal lumen, with the gastric lumen having a length that is less than a length of the jejunal lumen, and the spring extends along part or all of the length of the jejunal lumen.
The term “substantially,” if used herein, is a term of estimation.
While various features are presented above, it should be understood that the features may be used singly or in any combination thereof. Further, it should be understood that variations and modifications may occur to those skilled in the art to which the claimed examples pertain. The examples described herein are exemplary. The disclosure may enable those skilled in the art to make and use alternative designs having alternative elements that likewise correspond to the elements recited in the claims. The intended scope may thus include other examples that do not differ or that insubstantially differ from the literal language of the claims. The scope of the disclosure is accordingly defined as set forth in the appended claims.
Claims
1. Tubing for use in gastrointestinal applications comprising:
- a hollow tube; and
- a spring coupled to the tube;
- wherein the spring is corrosion resistant and helps to prevent kinking of the tubing when the tubing is bent.
2. The tubing of claim 1, wherein the spring is positioned against an inner diameter of the hollow tube and further comprising an encapsulant positioned over the tubing.
3. The tubing of claim 1, wherein the spring is made of a stainless steel or a polymeric material.
4. The tubing of claim 1, wherein the tubing is a made of a silicone material, a polyurethane material, or a polymeric material.
5. The tubing of claim 1, wherein the tubing has a substantially round inner diameter, or the tubing does not have a substantially round interior surface.
6. The tubing of claim 1, wherein the spring is positioned in the hollow tube during a tube extrusion manufacturing process such that the spring is embedded in a wall of the tubing, or the spring is positioned in the hollow tube during a post-extrusion process.
7. The tubing of claim 1, wherein the hollow tube includes multiple lumens in a single tube, and the spring is associated with one or more of the lumens.
8. The tubing of claim 1, further comprising a G-J button coupled to the hollow tube at one end thereof.
9. The tubing of claim 7, wherein the multiple lumens include a first gastric lumen, a second jejunal lumen, and a third lumen.
10. A kink-resistant tubing comprising:
- a tubing wall; and
- a spring positioned one of inside the tubing wall or adjacent an interior surface of the tubing wall,
- wherein the spring helps to deter the tubing from kinking when bent.
11. The tubing of claim 10, wherein when the spring is positioned inside the tubing wall, the spring is incorporated into the tubing wall during an extrusion manufacturing process of the tubing, or
- when the spring is positioned adjacent the tubing wall, the spring is added to the tubing after the extrusion process has been completed.
12. A multi-lumen feeding tube that is coupled to a G-J button comprising:
- a multi-lumen tube having at least two lumens at a proximal end thereof and at least one lumen at a distal end thereof, with the lumens comprising at least a gastric lumen and a jejunal lumen; and
- a spring positioned along at least part of the length of the multi-lumen tube in order to provide a kink-resistant feature to the feeding tube.
13. The feeding tube of claim 12, wherein the gastric and jejunal lumens are about the same length and further comprising a jejunal tube inserted into the jejunal lumen, with the jejunal tube having a length that is greater than the length of the gastric and jejunal lumens and the spring being positioned along at least part of the length of the jejunal tube.
14. The feeding tube of claim 13, wherein the jejunal tube has a cone-shaped portion at a proximal end thereof and the cone-shaped portion is formed integrally with or in a post-processing step.
15. The feeding tube of claim 14, wherein the cone-shaped portion is made of a higher durometer material than the material of the tube and the tube is inserted into an opening in the G-J button into the jejunal lumen such that the cone-shaped portion seats in the G-J button to couple the jejunal tube to the jejunal lumen and G-J button.
16. The feeding tube of claim 12, wherein the spring is coupled to the jejunal lumen of the multi-lumen tube and the jejunal lumen has a length that is greater than the gastric lumen, with the spring extending along at least part of the length of the jejunal lumen or along substantially all of the length of the jejunal lumen.
17. The feeding tube of claim 16, wherein the spring is coextruded with the jejunal lumen such that the spring is embedded in the wall of the jejunal lumen.
18. The feeding tube of claim 12, wherein the spring is coupled to the outer wall of the multi-lumen tube such that the spring is co-extruded with the outer wall of the multi-lumen tube.
19. The feeding tube of claim 18, wherein the multi-lumen tube has a substantially constant outer diameter along its length, and the multi-lumen tube has at least a gastric lumen and a jejunal lumen, with the gastric lumen having a length that is less than a length of the jejunal lumen, and the spring extends along part or all of the length of the jejunal lumen.
Type: Application
Filed: Dec 23, 2013
Publication Date: Jul 10, 2014
Applicant: Applied Medical Technology, Inc. (Brecksville, OH)
Inventors: Grant W. Phillips (Richfield, OH), Derek M. Williams (Cuyahoga Falls, OH), George J. Picha (Brecksville, OH)
Application Number: 14/138,780
International Classification: A61J 15/00 (20060101);