US20230233827A1 - Infusion tube system and method for manufacture - Google Patents

Abstract

An infusion tube system and a method for manufacture are provided. An infusion tube system including an infusion tube and a connector attached to the infusion tube at an end of the infusion tube is disclosed. The connector has a proximal end and includes a connector body extending from a distal end to a proximal end along a center axis and defining a cavity. The connector body includes an end wall with an inner surface, and at least one vent opening, and a sidewall extending from the end wall along the center axis with an inner and outer surface. The connector includes a membrane covering the at least one vent opening, the membrane being welded to the inner surface of the end wall along at least one welding seam including a first welding seam such that the membrane covers and seals the at least one vent opening.

Description

RELATED APPLICATIONS
• This application is a continuation application of, and claims the priority benefit of, U.S. application Ser. No. 17/398,535, which was filed on Aug. 10, 2021, and which is a continuation application of U.S. application Ser. No. 15/282,825 entitled “INFUSION TUBE SYSTEM AND METHOD FOR MANUFACTURE,” which was filed on Sep. 30, 2016, and which is a continuation of U.S. application Ser. No. 13/652,722, which was filed on Oct. 16, 2012, and which claims the priority benefit of U.S. Provisional Application Ser. No. 61/548,871 and European Application No. 11185747.0, each of which was filed on Oct. 19, 2011. Those applications are incorporated by reference herein in their entireties.
TECHNICAL FIELD
• The present invention relates to an infusion tube system and a method for manufacture of an infusion tube system, in particular an infusion tube system for coupling to an infusion port of an infusion device.
BACKGROUND
• Present tube systems, in particular tube systems for infusion, comprise a tube and a connector attached to an end of the tube in order to couple the tube to other devices, such as an infusion device or an inserter device.
• Cost-effective manufacture of infusion tube systems for infusion devices requires low or reduced material costs and low or no scrap rate in the production process. Further, it may be desirable to reduce or remove one or more processes in the manufacture cycle.
SUMMARY
• Thus there is a need for devices and methods for reducing material waste in production or manufacture of infusion tube systems. Further, there may be a need for infusion tube systems enabling use of simple infusion devices, e.g. infusion devices with simple coupling systems.
• Accordingly, an infusion tube system is provided, the infusion tube system comprising an infusion tube and a connector attached to the infusion tube at an end of the infusion tube, the connector having a proximal end and comprising a connector body extending from a distal end to a proximal end along a center axis and defining a cavity, the connector body comprising an end wall with an inner surface, and at least one vent opening including a first vent opening, and a sidewall extending from the end wall along the center axis with an inner and outer surface. The connector comprises a membrane covering the at least one vent opening, the membrane being welded to the inner surface of the end wall along at least one welding seam including a first welding seam such that the membrane covers and seals the at least one vent opening.
• It is an important advantage of the present invention that membrane material covering the vent openings has not been subject to substantial heat caused by the welding process, thereby ensuring that the membrane material function as intended leading to more effective manufacture of infusion tube systems due to reduced material waste. Further, the present invention enables a more effective manufacture of tube infusion system due to smaller number of defective tube infusions system and a reduced scrap rate.
• Further disclosed is a method for manufacture of an infusion tube system comprising an infusion tube and a connector, the method comprising providing a connector with a connector body extending from a distal end to a proximal end along a center axis and defining a cavity, the connector body comprising an end wall with an inner surface, and at least one vent opening including a first vent opening, and a sidewall extending from the end wall along the center axis with an inner and outer surface. The method further comprises providing a membrane at the inner surface of the end wall, and welding the membrane to the inner surface of the end wall along at least one welding seam including a first welding seam such that the membrane covers and seals the at least one vent opening.
BRIEF DESCRIPTION OF THE DRAWINGS
• The above and other features and advantages of the present invention will become readily apparent to those skilled in the art by the following detailed description of exemplary embodiments thereof with reference to the attached drawings, in which:
• FIG.1 is a first perspective view of an exemplary infusion tube system;
• FIG.2 is a second perspective view of the infusion tube system inFIG.1;
• FIG.3 is an end view of the infusion tube system inFIG.1 seen from the distal end of the connector perpendicular to the center axis;
• FIG.4 is a cross section U-U of the infusion tube system inFIG.1 as indicated inFIG.5;
• FIG.5 shows an infusion tube system perpendicular to the center axis;
• FIG.6 is a detailed view of a part of the infusion tube system as indicated by the circle inFIG.4;
• FIG.7 is a side view of infusion tube systems;
• FIG.8 is a cross section A-A of infusion tube systems as indicated inFIG.7;
• FIG.9 is a first perspective view of an exemplary infusion tube system;
• FIG.10 is a second perspective view of the infusion tube system inFIG.9;
• FIG.11 is an end view of the infusion tube system inFIG.9 seen from the distal end of the connector perpendicular to the center axis;
• FIG.12 is a side view of the infusion tube system ofFIG.9;
• FIG.13 is a cross section O-O of the infusion tube system ofFIG.9 as indicated inFIG.12;
• FIG.14 is a detailed view of a part of the infusion tube system as indicated by the circle inFIG.13;
• FIG.15 is a perspective view of an exemplary weld horn used for manufacture of the infusion tube system ofFIG.1-6;
• FIG.16 schematically illustrates steps of the method according to the present invention; and
• FIG.17 is a cross section U-U of an exemplary infusion tube system as indicated inFIG.5.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
• The figures are schematic and simplified for clarity, and they merely show details which are essential to the understanding of the invention, while other details have been left out. Throughout, the same reference numerals are used for identical or corresponding parts.
• The infusion tube system comprises an infusion tube and a connector at an end, e.g. a first end, of the infusion tube. The connector may be adapted for coupling to an inlet or outlet port of an infusion device having a housing accommodating a pump device and a reservoir with medicine, e.g. insulin, or other infusion liquid.
• The connector has a distal end, a proximal end and a connector body extending from a distal end to a proximal end of the connector body along a center axis and defining a cavity.
• The connector body comprises an end wall with an inner surface, and at least one sidewall extending from the end wall along the center axis and having an inner and outer surface. The inner surface of the end wall and the sidewall define or at least partly define the cavity. The cavity may be cylindrical or at least partly cylindrical with a cross section of suitable size and shape, i.e. the inner surface of the sidewall may have a cross section perpendicular to the center axis, the cross section being substantially constant along at least a part of the center axis. In one or more embodiments, cross section areas of the cavity may increase towards the distal end of the connector. The cavity may be cylindrical with a circular or non-circular (oval, polygonal or elliptical) inner surface cross-section perpendicular to the center axis.
• The end wall comprises at least one vent opening including a first vent opening. The at least one vent opening connects or communicates the cavity with the surroundings through the end wall and a membrane covering the at least one vent opening. The at least one vent opening may include a plurality of vent openings including the first vent opening and a second vent opening formed in the end wall. Further, a third and/or fourth vent opening may be formed in the end wall. A vent opening may have any suitable size and shape. In one or more embodiments, one or more vent openings are circular, elliptical, kidney-shaped or oval, e.g. with a diameter or maximum extension less than 8 mm, such as in the range from 0.5 mm to 5 mm. In one or more embodiments, one or more vent openings may have an area in the range from 0.3 mm²to 20 mm². The area of the respective vent openings depends e.g. on the number of vent openings in the end wall and the available inner surface area of the end wall. In one or more embodiments with three to six vent openings, the area of each vent opening may be in the range from 0.3 mm²to 2 mm². In one or more embodiments, with one or two vent openings, the area of the vent openings may be in the range from 1.0 mm²to 10 mm².
• The connector comprises a membrane covering the at least one vent opening including the first vent opening and other vent openings if present. The membrane is welded to an inner surface defining the cavity. The membrane may be welded to the inner surface of the end wall such that the membrane covers and seals the at least one vent opening including the first vent opening and other vent openings if present. Thus air or other gasses must pass the membrane in order to flow from the cavity to the surroundings through the at least one vent opening, e.g. in order to equalize pressure between the cavity and the surroundings. The membrane enables pressure equalization of a cavity within an infusion device through the vent opening and at the same time providing a substantially liquid tight infusion device when the infusion tube system is connected to the infusion port of the infusion device.
• The membrane is welded to the inner surface of the end wall along at least one welding seam including a first welding seam and optionally a second welding seam. The first welding seam and/or the second welding seam may form a dosed curve. The first welding seam may surround at least the first vent opening. In one or more embodiments, the first welding seam surrounds all the vent openings in the end wall. In one or more embodiments, the second welding seam may if present form a closed curve surrounding a fluid path opening or a connector needle in the end wall.
• The second welding seam may form a dosed curve surrounding one or more vent openings including a second vent opening in the end wall.
• The first welding seam may form a dosed outer welding seam and the second welding seam may form a dosed inner welding seam surrounded by the outer welding seam, wherein the membrane area between the inner welding seam and the outer welding seam covers at least one vent opening, e.g. the first vent opening. In one or more embodiments, the membrane area between an inner welding seam and an outer welding seam covers all vent openings in the end wall. Welding seams may cross each other.
• In one or more embodiments welding seam(s), e.g. the first welding seam and/or a second welding seam, forms a dosed curve surrounding one or more vent openings and wherein the connector needle or a fluid path opening in the end wall is arranged outside the dosed curve of the welding seam.
• A welding seam may have a suitable length which at least for an outer welding seam may depend on the number and configuration of vent openings to be surrounded. In one or more embodiments, the first welding seam may have a length in the range from 4 mm to about 100 mm, such as in the range from 10 mm to 50 mm, such as about 30 mm. The welding seam must be sufficiently wide to ensure sealing of the membrane to the inner surface of the cavity. On the other hand, the width of a welding seam is limited, e.g. in order to maximize the non-welded area of the membrane. Accordingly, a welding seam, e.g. the first welding seam and/or the second welding seam may have a width in the range from 0.1 mm to 3.0 mm, such as from 0.3 mm to 2.0 mm. In one or more embodiments, a welding seam width of 0.5 mm to 1 mm may be advantageous.
• The total welding area being the sum of welding areas for respective welding seams may be less than 95% of the common area between the membrane and the inner surface of the end wall. In one or more embodiments, the total welding area is less than 90% of the common, i.e. overlapping, area between the membrane and the inner surface of the end wall.
• The total welding area being the sum of welding areas for respective welding seams may be less than 90% of the area of the inner surface of the end wall. In one or more embodiments, the total welding area being the sum of welding areas for respective welding seams may be less than 70%, such as less than 50% of the area of the inner surface of the end wall.
• The membrane is made of a suitable material in order to allow air or other gasses to flow through the membrane while substantially preventing liquid, e.g. water from the surroundings, to pass the membrane. The membrane may be air-permeable and may be made of or comprise a thermoplastic polymer, such as Polytetrafluoroethylene (PTFE). The membrane may be a hydrophobic membrane.
• The membrane may be attached to the inner surface of the cavity by various welding methods, preferably by ultrasonic welding.
• The connector may comprise a hollow connector needle with a distal end attached to the connector body and extending from the inner surface of the end wall into the cavity forming a fluid path between the infusion tube and the cavity. A fluid path opening may be formed in the inner surface of the end wall forming a fluid path between the infusion tube and the cavity.
• The connector may comprise at least one annular protrusion including a first annular protrusion on the inner surface of the end wall, the first annular protrusion surrounding at least the first opening, wherein the membrane is welded to the inner surface of the end wall along the first annular protrusion.
• The connector may comprise a support structure extending from the end wall in a proximal direction along the center axis. The support structure may define a support cavity accommodating at least a part of the infusion tube. Typically, a part of the outer surface of the infusion tube is attached to an inner surface of the support structure defining the support cavity.
• FIG.1-6 show different views of an infusion tube system according to the present invention. Theinfusion tube system1 comprises aninfusion tube2 and aconnector4 attached to theinfusion tube2 at an end of theinfusion tube2. Theconnector4 has a proximal end6 and comprises a connector body8 extending from adistal end10 to aproximal end12 along a center axis X and defining acavity14. The connector body8 comprises anend wall16 with aninner surface18 and anouter surface20. At least one vent opening including a first vent opening22 is formed in theend wall16. Theconnector4 illustrated inFIGS.1 and2 has a second vent opening24, and optionally a third vent opening26 and/or a fourth vent opening28 in theend wall16. The connector body8 comprises asidewall30 extending from theend wall16 along the center axis X with aninner surface32 and anouter surface34. Further, theconnector4 comprises amembrane36 covering thevent openings22,24,26,28. Themembrane36 is welded to theinner surface18 of theend wall16 along afirst welding seam38 and asecond welding seam40 such that themembrane36 covers and seals the fourvent openings22,24,26,28. Thevent openings22,24,26,28 have a circular cross-section perpendicular to the center axis X with a diameter D₁, D₂, D₃, D₄, respectfully, of about 1 mm. Thecavity14 defined by theinner surfaces18,32 is cylindrical with a circular cross-section having a diameter of about 12 mm and a length of about 10 mm. Theconnector4 optionally comprises ahollow connector needle42 attached to the connector body8 and extending from theinner surface18 of theend wall16 into thecavity14. Theconnector needle42 forms a fluid path from the flow channel in theinfusion tube2 to the distal end44 of thehollow connector needle42. In the absence of a connector needle, a fluid path opening in theend wall16 may connect the flow channel of the infusion tube with thecavity14.
• Thefirst welding seam38 forms a closed curve in the form of a circle having a diameter in the range from 8 to 10 mm surrounding the first, second, third and fourth vent opening, and thesecond welding seam40 forming a closed curve, e.g. a circle with a diameter e.g. of about 3.5 mm to 4.5 mm, surrounding theconnector needle42 and positioned on the inside of the vent openings as seen e.g. in the end view inFIG.3 and in the detailed view inFIG.6. Thefirst welding seam38 forms a closed outer welding seam and thesecond welding seam40 forms a closed inner welding seam surrounded by theouter welding seam38, wherein themembrane area46 between the inner welding seam and the outer welding seam covers the vent openings in the end wall, i.e. the fourvent openings22,24,26,28 in this configuration. The first and second welding seams each have a width about 1 mm.
• Themembrane36 is circular with a diameter about the diameter of the inner surface of the end wall (e.g. ±15%). An opening may be formed in the membrane to allow the connector needle to pass therethrough.
• Theconnector4 comprises asupport structure48 extending from theend wall16 in a proximal direction along the center axis. Thesupport structure48 defines a cavity accommodating at least a part of the infusion tube, the infusion tube being attached to the inner surface defining the cavity, e.g. by gluing. The outer surface of thesupport structure48 is adapted for facilitating manual handling of the infusion tube system, e.g. when the connector is to be connected to a device, such as an infusion port of an infusion device.
• FIGS.7 and8 is a sideview ofinfusion tube systems1,100 and a cross-section A-A as indicated. Theinfusion tube systems1,100 are shown withoutmembrane36. A sealingelement50 is formed as an annular protrusion on theouter surface34 and perpendicular to the center axis X. The sealingelement50 may be formed as an integrated part of and in the same material as the connector body8. In one or more embodiments, the sealing element may be molded to the connector body in a two-step molding process, e.g. in a resilient material to facilitate coupling and sealing of theconnector4 at an infusion port. In one or more embodiments, the sealing element may be an a-ring at least partly accommodated in an annular recess at theouter surface34 of thesidewall30.
• FIGS.9-14 show different views of an infusion tube system according to the present invention. Theinfusion tube system100 only has a first vent opening22 in theend wall16. Afirst welding seam38 forms a closed oval curve surrounding the first vent opening22, thereby sealing the first vent opening with themembrane36. Theconnector needle42 is arranged outside the closed curve of thefirst welding seam38.
• The first vent opening22 in theinfusion tube system100 is oval and having an area of about 1.5 mm²(W=1 mm and length L=2 mm) A single or limited number of vent openings may allow for a smaller membrane leading to material cost savings. Themembrane36 ofinfusion tube system100 is about half the size of the membrane area ininfusion tube system1 as shown inFIG.1-6.
• FIG.15 shows a weld horn used for manufacture of theinfusion tube system1. Theweld horn300 comprises abody301 with a firstannular protrusion302 and secondannular protrusion304 for forming thefirst welding seam38 and thesecond welding seam40, respectively ofinfusion tube system1.
• FIG.16 is a flow chart illustrating a method according to the invention namely a method for manufacture of an infusion tube system comprising an infusion tube and a connector. Themethod400 comprises providing402 a connector with a connector body extending from a distal end to a proximal end along a center axis and defining a cavity, the connector body comprising an end wall with an inner surface, and at least one vent opening including a first vent opening, and a sidewall extending from the end wall along the center axis with an inner and outer surface. Further, the method comprises providing404 amembrane36 at the inner surface of the end wall, and welding406 by ultrasonic welding a membrane to the inner surface of the end wall along at least one welding seam including afirst welding seam38 such that the membrane covers and seals the at least one vent opening. Welding406 comprises pressing the membrane between the connector body8 and aweld horn300 comprising at least one annular weld protrusion forming at least one welding seam.
• FIG.17 shows a cross-section of an exemplaryinfusion tube system102. For illustrative purposes, the membrane is not shown inFIG.17. Theconnector4 comprises at least one protrusion extending from theinner surface18 of the end wall in the distal direction, i.e. towards thedistal end10. The at least one protrusion comprises afirst protrusion52 forming a circular or annular protrusion, e.g. surrounding thevent openings22,24,26,28. Further, asecond protrusion54 forms a circular or annular protrusion by the first protrusion, wherein thevent openings22,24,26,28 are positioned between thefirst protrusion52 and thesecond protrusion54 radially from the center axis. Theprotrusions52,54 may have a height, of at least 0.5 mm. In an embodiment similar to theinfusion tube system100, a first protrusion forming a dosed curve may surround one or more vent openings while the connector needle or a fluid path opening is positioned on the outside of the dosed curve formed by the first protrusion.
• Thesupport structure48 and the connector body8 may form an integrated unit, i.e. molded in a single process as illustrated in the figures.
• It should be noted that in addition to the exemplary embodiments of the invention shown in the accompanying drawings, the invention may be embodied in different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the concept of the invention to those skilled in the art.
LIST OF REFERENCES
• 1,100,102 infusion tube system
• 2 infusion tube
• 4 connector
• 6 proximal end of connector
• 8 connector body
• 10 distal end of connector body
• 12 proximal end of connector body
• 14 cavity
• 16 end wall
• 18 inner surface of end wall
• 20 outer surface of end wall
• 22 first vent opening
• 24 second vent opening
• 26 third vent opening
• 28 fourth vent opening
• 30 sidewall
• 32 inner surface of side wall
• 34 outer surface of side wall
• 36 membrane
• 38 first welding seam
• 40 second welding seam
• 42 connector needle
• 44 distal end of connector needle
• 46 sealing membrane area
• 48 support structure
• 50 sealing element
• 52 first protrusion
• 54 second protrusion
• 200 detail view
• 300 weld horn
• 301 body
• 302 first annular protrusion
• 304 second annular protrusion
• X center axis X

Claims (20)

What is claimed is:

1. A method of making a connector for an infusion tube system, the method comprising:

forming a first vent opening that extends through an end wall of a connector body of the connector;

forming a first protrusion that extends away from an inner surface of the end wall toward a distal end of the connector body, wherein forming the first protrusion comprises defining, only by the first protrusion, a curve that completely surrounds the first vent opening;

establishing a fluid path to permit fluid communication between an infusion tube of the infusion tube system and a cavity at least partially surrounded by the connector body, wherein establishing the fluid path comprises arranging the fluid path outside of the curve and defining the fluid path by a needle that lies on a center axis of the connector;

covering the first vent opening at the inner surface by a membrane such that the membrane extends outside of the curve to the needle; and

welding the membrane to the inner surface along a first welding seam at the first protrusion.

2. The method ofclaim 1, wherein the first vent opening is the only vent opening formed in the connector body.

3. The method ofclaim 1, wherein forming the first protrusion comprises defining, only by the first protrusion, the curve such that the curve extends only partway around the center axis.

4. The method ofclaim 1, wherein the inner surface has an annular portion that encircles the fluid path and defines a radially-outermost periphery of the inner surface relative to the center axis of the connector, and wherein forming the first protrusion comprises locating the first protrusion radially inward of the annular portion relative to the center axis such that the first protrusion does not define the radially-outermost periphery of the inner surface.

5. The method ofclaim 4, wherein the annular portion of the inner surface is flat along the radially-outermost periphery of the inner surface all the way around the center axis of the connector.

6. The method ofclaim 5, wherein the first vent opening is the only vent opening formed in the connector body.

7. The method ofclaim 1, wherein welding the membrane to the inner surface comprises sealing the first vent opening at the first welding seam.

8. The method ofclaim 7, wherein welding the membrane to the inner surface comprises forming a closed curve at the first welding seam surrounding at least the first vent opening.

9. The method ofclaim 1, further comprising forming a support structure that extends in a proximal direction from the end wall and is sized to accommodate at least a part of an infusion tube of the infusion tube system.

10. A method of making a connector for an infusion tube system, the method comprising:

forming a first vent opening through an end wall of the connector;

forming a first protrusion that extends away from an inner surface of the end wall, wherein forming the first protrusion comprises defining, only by the first protrusion, a curve that completely surrounds the first vent opening;

defining a fluid path between an infusion tube of the infusion tube system and a cavity at least partially surrounded by the connector using a needle that lies on a center axis of the connector and is arranged outside of the curve;

covering the first vent opening at the inner surface by a membrane; and

welding the membrane to the inner surface along a first welding seam at the first protrusion.

11. The method ofclaim 10, wherein the first vent opening is the only vent opening formed in the connector.

12. The method ofclaim 10, wherein forming the first protrusion comprises defining, only by the first protrusion, the curve such that the curve extends only partway around the center axis.

13. The method ofclaim 12, wherein the curve extends all the way around a curve axis that is spaced from the center axis in a radial direction.

14. The method ofclaim 13, wherein the curve defines an oval shape.

15. The method ofclaim 10, wherein welding the membrane to the inner surface comprises sealing the first vent opening at the first welding seam.

16. The method ofclaim 15, wherein welding the membrane to the inner surface comprises forming a closed curve at the first welding seam surrounding at least the first vent opening.

17. The method ofclaim 10, wherein welding the membrane to the inner surface comprises welding the membrane to the inner surface along the first welding seam at the first protrusion such that the membrane extends outside of the curve to the needle.

18. The method ofclaim 10, wherein the inner surface has an annular portion that encircles the fluid path and defines a radially-outermost periphery of the inner surface relative to the center axis of the connector, and wherein forming the first protrusion comprises locating the first protrusion radially inward of the annular portion relative to the center axis such that the first protrusion does not define the radially-outermost periphery of the inner surface.

19. The method ofclaim 18, wherein the annular portion of the inner surface is flat along the radially-outermost periphery of the inner surface all the way around the center axis of the connector.

20. The method ofclaim 19, wherein the first vent opening is the only vent opening formed in the connector.

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