Self-sealing injection sites and plugs

• US 5,725,507 A
• Filed: 10/30/1996
• Issued: 03/10/1998
• Est. Priority Date: 03/04/1994
• Status: Expired due to Term

• Current Assignee: Coloplast A/S
• Original Assignee: Mentor Corporation (Johnson & Johnson)
• Inventors: Petrick, Timothy B.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/739,617
• Time in Patent Office: 496 Days
• Field of Search: 604/86, 604/87, 604/88, 604/167, 604/244, 604/246, 604/256, 604/891.1, 604/200, 604/201, 428/213, 428/217, 428/218, 215/247-250
• US Class Current: 604/201
• CPC Class Codes: A61M 2039/0072 Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
• CPC Class Codes: A61M 2205/195 by the needle tip shape
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members
• CPC Class Codes: A61M 5/152 pressurised by contraction of elastic reservoirs containers for dispensing contents by contraction of an elastic bag provided therein, in general B65D83/0061
• CPC Class Codes: B29C 55/00 Shaping by stretching, e.g. drawing through a die; Apparatus therefor B29C61/08 takes precedence
• CPC Class Codes: B29C 63/10 around tubular articles
• CPC Class Codes: B29K 2995/0046 Elastic
• CPC Class Codes: Y10T 428/24992 Density or compression of components

Abstract

Small compression type injection site in the form of a self-sealing septum-like member that is self-sealing for hypodermic needle punctures and the like and a method of manufacture. Compressive stresses are introduced into a stretched elastomeric rod, whereby the decreased diameter cross section is maintained by placing a wrapping around and about the stretched rod and adhesively sealing it thereto. Sliced cross-sectional pieces of the rod then provide injection sites to be incorporated into the wall of an implantable prosthesis as by bonding or the like.

Claims

1. A self-sealing body for use as an injection site with a syringe needle, said self-sealing body comprising:

an elastomeric core member defining a circumferential outer surface and a longitudinal axis, a first side, and a second side, said elastomeric core member being initially tensioned along said longitudinal axis so as to deform said elastomeric core member radially inwardly; and

a filament wrapping member wound spirally so as to circumferentially surround at least a portion of said circumferential outer surface of said elastomeric core member and generally uniformly compress said elastomeric core member inwardly in said radial direction such that the syringe needle may be inserted entirely through said elastomeric core member to create an insertion passage from said first side to said second side without piercing said filament wrapping member, and further such that the syringe needle may be completely withdrawn from said elastomertic core member with the radial compression of said filament wrapping member on said elastomeric core member sealing the insertion passage created by the syringe needle, said elastometric core member initially being generally deformed from an undeformed configuration prior to said filament wrapping member being wrapped spirally thereabout, said filament wrapping member preventing said elastomeric core member from returning to said undeformed configuration and thereby generally uniformly compressing said elastomeric core member.

2. A self-sealing injection site for use with a syringe needle, said self-sealing injection site comprising:

an elastometric core member having a longitudinal axis and defining a pair of opposing surfaces and a circumferential outer surface interconnecting said pair of opposing surfaces, said elastomeric core member being initially tensioned along said longitudinal axis so as to deform said elastometric core member radially inwardly toward said longitudinal axis and increase the density of said elastomeric core member in a radial direction; and

a filament wrapping member wrapped spirally around and circumferemtially surrounding at least a portion of said elastomeric core member and generally uniformly compressing said elastomeric core member inwardly in a radial direction such that the syringe needle may be inserted entirely through the elastomeric core member to create an insertion passage extending between said pair of opposing surfaces without piercing said filament wrapping member, and further such that the syringe needle may be completely withdrawn from said elastomeric core member with the radial compression of said filament wrapping member on said elastomeric core member sealing the insertion passage created by the syringe needle, said elastomeric core member initially being generally uniformly deformed from an undeformed configuration prior to said filament wrapping member being spirally wrapped thereabout, said filament wrapping member preventing said elastomeric core member from returning to said undeformed configuration and the thereby generally uniformly compressing said elastomeric core member.

3. The self-sealing injection site of claim 2 including adhesive associated with the filament wrapping member to adhere the filament wrapping member to the elastomeric core member.

4. The self-sealing injection site of claim 2 wherein the filament wrapping member is metal.

5. The self-sealing rejection site of claim 2 wherein the filament wrapping member is a synthetic material.

6. The self-sealing rejection site of claim 2 wherein the self-sealing injection site is at least partially inserted within a housing, and further wherein the filament wrapping member has an outer surface adapted for sealing contact with the housing.

7. The self-sealing injection site of claim 2 including a colorant with the to provide a distinctive color to the elastomeric core for the purpose of visualization.

8. The self-sealing injection site of claim 2 including a radiopaque material within the elastomeric core to provide visualization under fluoroscopy.

9. The self-scaling injection site of claim 2 including a colorant associated with the filament wrapping member to provide a distinctive color for purposes of visualization.

10. The self-sealing injection site of claim 2 including a radciopaque material associated with the filament wrapping member to provide visualization under fluoroscopy.

11. The self-sealing injection site of claim 2 wherein the elastomeric core member is in the form of a slug.

12. The self-sealing injection site of claim 11 wherein the slug is silicone.

13. The self-sealing injection site of claim 12 wherein the filament wrapping member is fiberglass.

14. The self-sealing injection site of claim 13 wherein the filament wrapping member is a generally continuous thin strand of synthetic material.

15. The self-sealing injection site of claim 2 wherein the filament wrapping member comprises a generally continuous thin strand of material.

16. The self-sealing injection site of claim 15 wherein the filament wrapping member is fiberglass.

17. The self-sealing injection site of claim 15 wherein the filament wrapping member is polyethylene terephthalate.

18. The self-sealing injection site of claim 15 wherein the filament wrapping member is a synthetic material.

19. The self-sealing injection site of claim 15 wherein the filament wrapping member is of natural fibers.

20. The self-sealing rejection site of claim 15 wherein the filament wrapping member is bifilar.

21. The self-sealing rejection site of claim 15 wherein the filament wrapping member is metallic.

22. The self-sealing injection site of claim 15 wherein the filament wrapping member is a monofilament.

23. The self-sealing injection side of claim 15 including adhesive associated with the filament wrapping member for bonding the filament wrapping member and the elastomeric core together.

24. The self-sealing injection site of claim 23 wherein the filament wrapping member is impregnated with the adhesive.

25. In combination, a device including an opening therein and a sealing body closing said opening, said sealing body having an elastomeric core defining a circumferential surface and a filament wrapping member wound spirally around at least a portion of and disposed on said circumferential surface, said elastomeric core being initially deformed prior to said filament wrapping member being disposed thereon, said filament wrapping member compressing said elastomertric core radially and generally uniformly such that an insertion passage may be created through said elastromeric core without piercing said filament wrapping member, and further such that said insertion passage will automatically seal due to the radial compression of said filament wrapping member on said elastomeric core, said elastomeric core initially being deformed from an undeformed configuration, said filament wrapping member preventing said elastomeric core from returning to said undeformed configuration and thereby maintaining the generally uniform compression of said elastomeric core.

26. The combination of claim 25 wherein the device is a medical device.

27. The combination of claim 26 wherein the device is implantable.

28. The combination of claim 25 wherein the sealing body is an injection site.

30. The combination of claim 25 wherein the filament wrapping member is a generally continuous thin strand of material.

31. The combination of claim 30 including an adhesive associated with the filament wrapping member to adhere the filament wrapping member to the elastomeric core.

29. The combination of clam 25 wherein the sealing body is bonded at least partially within the opening.

32. As an injection site for use with a syringe needle, the injection site comprising:

an elastomeric body; and

a filament wrapping member wound spirally around at least a portion of said elastomeric body so as to generally uniformly compress said elastomeric body and provide stored energy of compression in said elastomeric body such that the syringe needle may be inserted through said elastomeric body to create an injection passage without piercing said filament wrapping member, and subsequently sealing after the syringe needle is withdrawn from said elastomeric body, such that the self-sealing property of said elastomeric body is improved by said stored energy of comprression, said elastomeric body initially being generally deformed radially inward from an undeformed configuration prior to the filament wrapping member being mounted thereon, said filament wrapping member preventing said elastomeric body from returning to said underformed configuration and thereby generally maintaining said compression of said elastomeric body compressed.