Injection site having thermoplastically sealed injection port

• US 4,219,912 A
• Filed: 10/10/1978
• Issued: 09/02/1980
• Est. Priority Date: 10/10/1978
• Status: Expired due to Term

• Current Assignee: Baxter Travenol Laboratories Incorporated
• Original Assignee: Baxter Travenol Laboratories Incorporated
• Inventors: Adams, Elvis E.
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US05/949,881
• Time in Patent Office: 693 Days
• Field of Search: 128/214 R, 128/214 G, 128/214.2, 128/247, 215/232, 215/247, 215/274, 215/355, 156/73.1
• US Class Current: 604/86
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members
• CPC Class Codes: B29C 65/08 using ultrasonic vibrations non-plastics element to plastics elements B29C65/645
• CPC Class Codes: B29C 65/4815 Hot melt adhesives, e.g. thermoplastic adhesives
• CPC Class Codes: B29C 65/5042 covering both elements to be joined
• CPC Class Codes: B29C 65/56 using mechanical means or mechanical connections, e.g. form-fits
• CPC Class Codes: B29C 65/562 using extra joining elements, i.e. which are not integral with the parts to be joined using plastic snap elements B29C65/58; using plastic rivets B29C65/601
• CPC Class Codes: B29C 65/568 using a swaging operation, i.e. totally deforming the edge or the rim of a first part to be joined to clamp a second part to be joined
• CPC Class Codes: B29C 66/1222 comprising at least a lapped joint-segment
• CPC Class Codes: B29C 66/1224 comprising at least a butt joint-segment
• 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 66/135 Single hemmed joints, i.e. one of the parts to be joined being hemmed in the joint area
• 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 66/612 Making circumferential joints
• 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 66/81423 being concave
• CPC Class Codes: B29C 66/81427 comprising a single ridge, e.g. for making a weakening line; comprising a single tooth
• CPC Class Codes: B29C 66/8322 Joining or pressing tools reciprocating along one axis
• CPC Class Codes: B29K 2021/00 Use of unspecified rubbers as moulding material
• CPC Class Codes: B29K 2025/06 PS, i.e. polystyrene
• 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 2033/08 : Polymers of acrylic acid esters, e.g. PMA, i.e. polymethylacrylate
• CPC Class Codes: B29K 2033/12 : Polymers of methacrylic acid esters, e.g. PMMA, i.e. polymethylmethacrylate
• CPC Class Codes: B29K 2067/00 : Use of polyesters or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2069/00 : Use of PC, i.e. polycarbonates or derivatives thereof, as moulding material

Abstract

Injection sites are provided for injecting substances such as medicaments into systems that are feeding parenteral fluid to a patient, which injection sites have injection ports that are thermoplastically sealed into the injection site in a manner that is simpler, faster, less expensive, and more readily automated than other assemblies. The assembly includes a vibratory energy seal of the non-thermoplastic port within a countersunk thermoplastic seat.

Claims

1. An injection site for a parenteral fluid delivery system, comprising:

an injection branch of the injection site having a main bore therethrough, said main bore having an outside end and a fluid outlet;

an elastomeric injection port plug having an outside surface including an outside surface of a wall penetrable by a hypodermic needle, said port plug having an annular outwardly projecting boss, said annular outwardly projecting boss being spaced from said outside surface to form an annular step between said outside surface and said boss of the port plug;

a fluid passageway branch of the injection site, said fluid passageway branch having a passageway that opens into said main bore of the injection branch at a location between said injection port plug and said fluid outlet of the main bore of the injection branch;

a thermoplastic seat at said outside end of said main bore of the injection branch, said seat being generally complementary to the outside surface of said injection port plug and said injection port plug being within said seat; and

said seat having a seal overlying said annular step of the port plug for encapsulation of said injection port plug except for at least part of said outside surface of the plug, said seat seal being formed by a horn for imparting vibratory energy to said outside end of the main bore of the injection branch, said seat seal including substantially the entirety of said outside end of the main bore.

2. The injection site of claim 1, wherein said seat includes a countersink of the outside end of said main bore, said countersink being for receiving said boss of the injection port plug.

3. The injection site of claim 1, wherein said seat seal is a swaged seal overlying said annular outwardly projecting boss of the elastomeric injection port plug.

4. The injection site of claim 1, wherein said seat seal is a swaged seal overlying said annular outwardly projecting boss and a circumferential edge of said outside surface of the elastomeric injection port plug.

5. The injection site of claim 1, wherein said seat seal includes a ring partially overlying said annular outwardly projecting boss of the elastomeric injection port plug, said seat includes a countersink of the outside end of said main bore, said countersink being for receiving said boss of the injection port plug, said coountersink includes a second countersink therein for receiving said ring, and said seat seal is a vibratory energy butt and shear bond of the ring to said second countersink.

6. In an improved parenteral fluid delivery system including a parenteral fluid storage container;

a needle;

an injection site having an parenteral fluid inlet, an injection branch having a main bore therethrough for passing a supplementary fluid into the injection site, and a fluid outlet opening into both the parenteral fluid inlet and the branch; and

tubing communicating the storage container with the parenteral fluid inlet and communicating the fluid outlet with the needle;

the improvement comprising;

an elastomeric injection port plug having an outside surface including an outside surface of a wall penetrable by a hypodermic needle, said port plug having an annular outwardly projecting boss, said annular outwardly projecting boss being spaced from said outside surface to form an annular step between said outside surface and said boss of the port plug;

a thermoplastic seat at the outside end of said main bore of the injection branch, said seat being generally complementary to the outside surface of said injection port plug and said injection port plug being within said seat; and

said seat having a seal overlying said annular step of the port plug for encapsulation of said injection port plug except for at least part of said outside surface of the plug, said seat seal being formed by a horn for imparting vibratory energy to said outside end of the main bore of the injection branch, said seat seal including substantially the entirety of said outside end of the main bore.

7. The parenteral fluid delivery system of claim 6, wherein said seat includes a countersink of the outside end of said main bore, said countersink being for receiving said boss of the injection port plug.

8. The parenteral fluid delivery system of claim 6, wherein said seat seal is a swaged seal overlying said annular outwardly projecting boss of the elastomeric injection port plug.

9. The parenteral fluid delivery system of claim 6, wherein said seat seal is a swaged seal overlying said annular outwardly projecting boss and a circumferential edge of said outside surface of the elastomeric injection port plug.

10. The parenteral fluid delivery system of claim 6, wherein said seat seal includes a ring partially overlying said annular outwardly projecting boss of the elastomeric injection port plug, said seat includes a countersink of the outside end of said main bore, said countersink being for receiving said boss of the injection port plug, said countersink includes a second countersink therein for receiving said ring, and said seat seal is a vibratory energy butt and shear bond of the ring to said second countersink.

11. A method of constructing injection sites for patenteral fluid delivery systems, comprising:

providing an elastomer injection port plug member with an outside surface of a wall penetrable by a hypodermic needle and with an outwardly extending annular boss spaced from said outside surface to form an annular step between said outside surface and said boss;

forming a thermoplastic seat within an injection branch of an injection site having a main bore with an outside end and a fluid outlet therethrough and having a fluid passageway branch opening into said main bore at a location between said injection port plug member and said fluid outlet, said seat being generally complementary to the outside surface of the injection port plug member;

inserting the injection port plug member into the thermoplastic seat; and

encapsulating the injection port plug member except for at least part of the outside surface of the plug member, said encapsulating step including imparting vibratory energy to the outside end of the main bore of the injection branch until said outside end overlies the annular step of the port plug and until said seat seal includes substantially tne entirety of said outside end of the main bore.

12. The method of claim 11, wherein said step of forming a thermoplastic seat includes countersinking the outside end of the main bore to a circumference equal to or less than the circumference of the boss of the injection port plug member.

13. The method of claim 11, wherein said encapsulating step includes swaging the outside end of the thermoplastic seat over the boss of the injection port plug member.

14. The method of claim 11, wherein said encapsulating step includes swaging the outside end of the thermoplastic seat over the boss and over a circumferential edge of the outside surface of the injection port plug member.

15. The method of claim 11, wherein said step of forming a thermoplastic seat includes first countersinking the outside end of the main bore to a circumference equal to or less than the circumference of the boss of the plug member and further countersinking the outside end of the first countersink to a circumference greater than the first countersink, wherein said inserting step includes locating a ring to partially overlie the boss, and wherein said encapsulating step includes butt bonding and shear bonding the ring to the further countersink.

16. The method of claim 11, wherein said encapsulating step includes compressing the boss of the elastomeric plug member to enhance sealing between the seat and the plug member.

17. The method of claim 11, further comprising solvent bonding the injection site to tubing for parenteral fluid delivery systems.