IV membrane attachment systems and methods

• US 10,105,899 B2
• Filed: 03/23/2016
• Issued: 10/23/2018
• Est. Priority Date: 03/26/2015
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Staley, Shaun, Hortin, Justin G., Stoddard, Brent R., Rivkowich, Jason, Trainer, Lawrence J.
• Primary Examiner(s): Sells, James D
• Application Number:
  US15/078,718
• Publication Number:
  US 20160279860A1
• Time in Patent Office: 944 Days
• Field of Search: 156 731
• CPC Class Codes: A61M 2039/205 comprising air venting means
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/1411 Drip chambers A61M5/162, A61M5/1689, A61M5/40 take precedence
• CPC Class Codes: A61M 5/38 using hydrophilic or hydrophobic filters
• CPC Class Codes: B29C 65/08 using ultrasonic vibrations non-plastics element to plastics elements B29C65/645
• CPC Class Codes: B29C 65/1616 Near infrared radiation [NIR], e.g. by YAG lasers
• CPC Class Codes: B29C 65/1635 at least passing through one of the parts to be joined, i.e. laser transmission welding
• CPC Class Codes: B29C 65/1654 scanning at least one of the parts to be joined
• CPC Class Codes: B29C 65/1664 making use of several radiators
• CPC Class Codes: B29C 65/1677 making use of an absorber or impact modifier
• CPC Class Codes: B29C 66/026 Chemical pre-treatments B29C66/028 takes precedence
• CPC Class Codes: B29C 66/112 Single lapped joints
• CPC Class Codes: B29C 66/131 Single flanged joints, i.e. one of the parts to be joined being rigid and flanged in the joint area
• CPC Class Codes: B29C 66/229 Other specific patterns not provided for in B29C66/221 - B29C66/227
• CPC Class Codes: B29C 66/232 said joint lines being multiple and parallel, i.e. the joint being formed by several parallel joint lines
• CPC Class Codes: B29C 66/24221 being circular B29C66/51 takes precedence
• CPC Class Codes: B29C 66/30223 said melt initiators being rib-like
• CPC Class Codes: B29C 66/30326 in the form of porosity
• CPC Class Codes: B29C 66/322 Providing cavities in the joined article to collect the burr
• CPC Class Codes: B29C 66/5344 said single elements being substantially annular, i.e. of finite length, e.g. joining flanges to tube ends B29C66/5346 takes precedence
• CPC Class Codes: B29C 66/5346 : said single elements being substantially flat
• CPC Class Codes: B29C 66/61 : Joining from or joining on the inside for making tubes by bending sheets and joining from the inside B29C53/387
• CPC Class Codes: B29C 66/612 : Making circumferential joints
• CPC Class Codes: B29C 66/652 : moving the welding tool around the fixed article
• CPC Class Codes: B29C 66/71 : characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/712 : the composition of one of the parts to be joined being different from the composition of the other part
• CPC Class Codes: B29C 66/727 : being porous, e.g. foam
• CPC Class Codes: B29C 66/73116 : of different melting point, i.e. the melting point of one of the parts to be joined being different from the melting point of the other part
• CPC Class Codes: B29C 66/73161 : Roughness or rugosity
• CPC Class Codes: B29C 66/73171 : Hydrophilicity
• CPC Class Codes: B29C 66/73921 : characterised by the materials of both parts being thermoplastics
• CPC Class Codes: B29C 66/81431 : comprising a single cavity, e.g. a groove
• CPC Class Codes: B29C 66/8322 : Joining or pressing tools reciprocating along one axis
• CPC Class Codes: B29C 66/9513 : characterised by specific vibration frequency values or ranges
• CPC Class Codes: B29K 2023/00 : Use of polyalkenes or derivatives thereof as moulding material
• CPC Class Codes: B29K 2025/08 : Copolymers of styrene, e.g. AS or SAN, i.e. acrylonitrile styrene B29K2055/02 takes precedence
• CPC Class Codes: B29K 2027/06 : PVC, i.e. polyvinylchloride
• CPC Class Codes: B29K 2081/06 : PSU, i.e. polysulfones; PES, i.e. polyethersulfones or derivatives thereof
• CPC Class Codes: B29L 2023/007 : Medical tubes other than catheters catheters B29L2031/7542
• CPC Class Codes: B29L 2031/753 : Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: B29L 2031/7546 : Surgical equipment

Abstract

An intravenous delivery system may have a liquid source containing a liquid, tubing, and an anti-run-dry membrane positioned such that the liquid, flowing form the liquid source to the tubing, passes through the anti-run-dry membrane. The anti-run-dry membrane may be positioned within an exterior wall of a drip unit, and may have a weld surface secured to a seat of the exterior wall via application of compression to press the weld surface against the seat, and application of coherent light or vibration. In response to application of the coherent light or vibration, localized melting may occur, causing the weld surface to adhere to the seat. The anti-run-dry membrane may be modified to have a melting point close to that of the seat. Ultrasonic or laser welding may be applied in a manner that causes portions of the seat to melt and flow into pores of the weld surface.

Claims

1. A method for manufacturing a drip unit for an intravenous delivery system, the method comprising:

providing an exterior wall shaped to at least partially define a drip chamber capable of receiving a liquid from a liquid source, the exterior wall comprising a seat;

providing an anti-run-dry membrane comprising a plurality of pores that are permeable to the liquid, wherein the anti-run-dry membrane is formed of a hydrophilic material configured to resist passage of air through the pores, the anti-run-dry membrane comprising a weld surface;

positioning the anti-run-dry membrane within the drip chamber such that the weld surface is in contact with the seat;

applying compression to press the weld surface against the seat;

applying at least one selection from the group consisting of coherent light and vibration to at least one of the anti-run-dry membrane and the exterior wall to cause localized melting of at least one of the seat and the weld surface; and

in response to the localized melting, causing the weld surface to adhere to the seat.

2. The method of claim 1, wherein providing the anti-run-dry membrane comprises:

providing a hydrophilic material comprising a base material melting point;

performing a melting point reduction procedure on the hydrophilic material; and

forming the anti-run-dry membrane such that, due to performance of the melting point reduction procedure, the anti-run-dry membrane has a membrane melting point significantly lower than the base material melting point;

wherein the membrane melting point is within 20°

C. of a wall melting point of the exterior wall.

3. The method of claim 2, wherein performing the melting point reduction procedure comprises changing a chemical composition of a pre-polymer used to form the hydrophilic material to increase flexibility of a chemical structure of the pre-polymer.

4. The method of claim 2, wherein performing the melting point reduction procedure comprises copolymerizing the hydrophilic material with an additive such that, in combination, the hydrophilic material and the additive have a combined chemical structure more flexible than a base chemical structure of the hydrophilic material.

5. The method of claim 2, wherein performing the melting point reduction procedure comprises adding side branching to an aromatic ring structure of the hydrophilic material, thereby increasing flexibility of the aromatic ring structure.

6. The method of claim 1, wherein the anti-run-dry membrane comprises a membrane melting point at least 20°

C. higher than a wall melting point of the exterior wall, wherein causing the weld surface to adhere to the seat comprises;

causing flowable portions of the seat to enter the pores of the weld surface; and

permitting the flowable portions to solidify within the pores.

7. The method of claim 1, wherein applying the compression comprises using a fixture to apply the compression, wherein applying the selection comprises, during application of the compression, applying the coherent light via a laser.

8. The method of claim 7, wherein the coherent light comprises a wavelength greater than 2,000 nanometers.

9. The method of claim 7, wherein applying the coherent light comprises:

directing the coherent light to a laser impingement area proximate a juncture between the seat and the weld surface; and

moving the laser impingement area along the juncture, in a closed pathway;

wherein causing the weld surface to adhere to the seat comprises causing the weld surface adhere to the seat along the pathway to provide a seal between the seat and the weld surface;

wherein the seal is positioned to cause fluid flowing from an upper part of the drip chamber to a lower part of the drip chamber to flow through the anti-run-dry membrane.

10. The method of claim 7, wherein the exterior wall further comprises an opposing surface aligned with the seat and facing exterior to the exterior wall, wherein applying the coherent light via the laser comprises directing the coherent light at the seat through the opposing surface, along a direction substantially perpendicular to the opposing surface.

11. The method of claim 10, wherein applying the coherent light comprises:

determining an optimal size of a laser impingement area proximate a juncture between the seat and the weld surface; and

determining a surface roughness level of the opposing surface that will cause the laser impingement area to have the optimal size;

wherein providing the exterior wall comprises forming the opposing surface with the surface roughness level;

wherein applying the coherent light comprises directing the coherent light to the laser impingement area, the laser impingement area.

12. The method of claim 7, wherein the anti-run-dry membrane comprises a membrane component and a welding component having a substantially rigid construction, wherein the membrane component comprises the pores and the welding component comprises the weld surface.

13. The method of claim 1, wherein applying the compression comprises using an ultrasonic welding horn to apply the compression, wherein applying the selection comprises, during application of the compression, applying the vibration via the ultrasonic welding horn.

14. The method of claim 13, wherein the anti-run-dry membrane comprises a weld surface pore size of the pores proximate the weld surface, and a displaced pore size of the pores displaced from the weld surface, wherein the weld surface pore size is significantly larger than the displaced pore size.

15. The method of claim 13, wherein providing the exterior wall comprises forming a first energy director on the seat, wherein the first energy director is shaped to protrude toward a location at which the anti-run-dry membrane will reside, relative to the exterior wall;

wherein positioning the anti-run-dry membrane within the drip chamber comprises positioning the weld surface in contact with the first energy director.

16. The method of claim 15, wherein providing the exterior wall further comprises forming a second energy director on the seat, displaced from the first energy director such that the seat comprises a seat channel positioned between the first energy director and the second energy director, wherein the second energy director is shaped to protrude toward the location;

wherein positioning the anti-run-dry membrane within the drip chamber comprises positioning the weld surface in contact with the second energy director;

wherein the ultrasonic welding horn comprises a horn channel;

wherein using the ultrasonic welding horn to apply the compression comprises;

aligning the horn channel with the seat channel; and

urging the ultrasonic welding horn against the weld surface and the seat;

wherein causing the weld surface to adhere to the seat comprises causing a flowable portion of the weld surface to flow into the seat channel.

17. The method of claim 13, wherein providing the exterior wall comprises providing the seat with a tapered shape comprising a leading edge, wherein using the ultrasonic welding horn to apply the compression comprises urging the ultrasonic welding horn against the leading edge;

wherein, during application of the vibration, the leading edge acts as an energy director by facilitating initiation of melt flow of the seat at the leading edge.

18. A method for manufacturing a drip unit for an intravenous delivery system, the method comprising:

providing an exterior wall shaped to at least partially define a drip chamber capable of receiving a liquid from a liquid source, the exterior wall comprising a seat;

providing an anti-run-dry membrane comprising a plurality of pores that are permeable to the liquid, wherein the anti-run-dry membrane is formed of a hydrophilic material configured to resist passage of air through the pores, the anti-run-dry membrane comprising a weld surface;

positioning the anti-run-dry membrane within the drip chamber such that the weld surface is in contact with the seat;

with a laser, directing coherent light to a laser impingement area proximate a juncture between the seat and the weld surface;

moving the laser impingement area along the juncture, in a closed pathway such that the weld surface adheres to the seat along the pathway; and

in response to motion of the laser impingement area along the juncture, causing the weld surface to adhere to the seat along the pathway to provide a seal between the seat and the weld surface, wherein the seal is positioned to cause fluid flowing from an upper part of the drip chamber to a lower part of the drip chamber to flow through the anti-run-dry membrane.

19. A method for manufacturing a drip unit for an intravenous delivery system, the method comprising:

providing an exterior wall shaped to at least partially define a drip chamber capable of receiving a liquid from a liquid source, the exterior wall comprising a seat;

providing an anti-run-dry membrane comprising a plurality of pores that are permeable to the liquid, wherein the anti-run-dry membrane is formed of a hydrophilic material configured to resist passage of air through the pores, the anti-run-dry membrane comprising a weld surface;

positioning the anti-run-dry membrane within the drip chamber such that the weld surface is in contact with the seat;

moving an ultrasonic welding horn into contact with at least one of the anti-run-dry membrane and the exterior wall; and

with the ultrasonic welding horn, applying vibration to at least one of the seat and the weld surface;

in response to application of the vibration, causing the weld surface to adhere to the seat.

20. The method of claim 19, wherein the anti-run-dry membrane is formed of a hydrophilic material;

wherein the anti-run-dry membrane comprises a membrane melting point that is within 20°

C. of a wall melting point of the exterior wall;

wherein providing the exterior wall comprises providing the seat with a tapered shape comprising a leading edge, wherein moving the ultrasonic welding horn into contact with at least one of the anti-run-dry membrane and the exterior wall comprises urging the ultrasonic welding horn against the leading edge;

wherein, during application of the vibration, the leading edge acts as an energy director by facilitating initiation of melt flow of the seat at the leading edge.