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EP-4735079-A1 - SYSTEM AND METHOD FOR BUTTERFLY NEEDLE ASSEMBLY

EP4735079A1EP 4735079 A1EP4735079 A1EP 4735079A1EP-4735079-A1

Abstract

Provided is a butterfly needle assembly (100), including: a flexible member (102) having a central region (104) with a first side member (106) and a second side member (108) collectively providing a generally flat bottom (110), the central region (104) having a middle area (112); an adhesive (114) disposed upon the generally flat bottom (110), the adhesive (114) protected by a removable cover (116); a needle hub (118) disposed within the central region (104), the needle hub (118) receiving a flexible tubing (120) line generally parallel to the generally flat bottom (110) and providing a needle (122) extending generally normal to the generally flat bottom (110) from the middle area (112) of the central region (104), the needle (122) extending for a first length; a removable needle cover (124) initially disposed about the needle (122), the removable needle cover (124) structured and arranged to removably engage with the needle hub (118); and a closing system (134) structured and arranged to close the first side member (106) and the second side member (108) of the flexible member (102) about the needle (122). A method of making a butterfly needle assembly (100) is also provided.

Inventors

  • ALHEIDT, Thomas Alan
  • VANROYEN, Donald Feraser
  • HOFF, Robert Gregory
  • BARONE, Joseph Duane
  • CASE, Brian Christopher

Assignees

  • KORU Medical Systems, Inc.

Dates

Publication Date
20260506
Application Date
20230630

Claims (20)

  1. 1. A butterfly needle assembly, comprising: a flexible member having a central region with a first side member and a second side member collectively providing a generally flat bottom, the central region having a middle area; an adhesive disposed upon the generally flat bottom, the adhesive protected by a removable cover; a needle hub disposed within the central region, the needle hub receiving a flexible tubing line generally parallel to the generally flat bottom and providing a needle extending generally normal to the generally flat bottom from the middle area of the central region, the needle extending for a first length; a removable needle cover initially disposed about the needle, the removable needle cover structured and arranged to removably engage with the needle hub; and a closing system structured and arranged to close the first side member and the second side member of the flexible member about the needle.
  2. 2. The butterfly needle assembly of claim 1, wherein the closing system is provided by a button disposed upon the generally flat bottom proximate to a first distal edge of the first side member and a through-hole disposed proximate to a second distal edge of the second side member.
  3. 3. The butterfly needle assembly of claim 1, wherein the first side member and the second side member have substantially the same second length from the central region, the second length greater than the first length.
  4. 4. The butterfly needle assembly of claim 1, wherein the removable needle cover has a first end disposed through the generally flat bottom into the needle hub, the first end having opposing side tabs structured and arranged to rotatably lock into the needle hub.
  5. 5. The butterfly needle assembly of claim 1, wherein the removable needle cover when engaged to the needle hub hermetically seals the needle.
  6. 6. The butterfly needle assembly of claim 1, wherein the removable needle cover when engaged to the needle hub provides a sealed space about the needle.
  7. 7. The butterfly needle assembly of claim 1, wherein the snap-in needle structure has opposing side ridges structured and arranged to snap under corresponding ridges of the needle hub.
  8. 8. The butterfly needle assembly of claim 1, wherein the needle hub is provided by at least two elements, a needle hub frame united with the flexible member opposite from the adhesive and a snap-in needle structure, the snap-in needle structure provided by a duct member structured and arranged to join with the flexible tubing at a first end and to join with a needle at a second end, the second end generally normal to the first end, the duct member further structured and arranged for snap-in binding with the needle hub frame.
  9. 9. The buterfly needle assembly of claim 8, wherein a first buterfly needle assembly is provided by a first snap-in needle structure providing a first needle with a first gauge, and a second buterfly needle assembly is provided by a second snap-in needle structure providing a second needle with a second gauge, the second gauge different from the first gauge.
  10. 10. The buterfly needle assembly of claim 1, wherein the needle is a straight needle.
  11. 11. The buterfly needle assembly of claim 1, wherein the flexible tubing line is flow control tubing with a luer connector structured and arranged for connection to a liquid source.
  12. 12. The buterfly needle assembly of claim 1 , wherein the flexible member has at plurality of bend grooves evenly disposed on either side of the needle hub and normal to the needle, the bend grooves facilitating the closing of the first side member and the second side member about the needle.
  13. 13. The butterfly needle assembly of claim 1, wherein the butterfly needle assembly is disposed in a sealed package and irradiated to sterilize the buterfly needle assembly.
  14. 14. The buterfly needle assembly of claim 1, wherein the needle hub has an elevated finger gripper.
  15. 15. The butterfly needle assembly of claim 1, wherein the butterfly assembly is structured and arranged to engage with a needle insertion device.
  16. 16. A butterfly needle assembly, comprising: a flexible member having a central region with a first side member and a second side member collectively providing a generally flat bottom; an adhesive disposed upon the generally flat botom, the adhesive protected by a removable cover; a needle hub frame united with the flexible member opposite from the adhesive; a snap-in needle structure provided by a duct member having a first end and a second end, the first end joined with a flexible tubing line and the second end joined with a needle having a first length, the second end generally normal to the first end, the duct member further structured and arranged for snap-in binding with the needle hub frame, the needle extending generally normal to the generally flat bottom from a middle area of the central region, the flexible tubing generally parallel to the generally flat bottom proximate to the first end of the duct member; and a removable needle cover initially disposed about the needle, the removable needle cover structured and arranged to removably engage with the needle hub frame; and a closing system structured and arranged to the first side member and the second side member of the flexible member about the needle.
  17. 17. The butterfly needle assembly of claim 16, wherein the closing system is provided by buton disposed upon the generally flat botom proximate to a first distal edge of the first side member and a through-hole disposed proximate to a second distal edge of the second side member.
  18. 18. The butterfly needle assembly of claim 16, wherein the first side member and the second side member have substantially the same second length from the central region, the second length greater than the first length.
  19. 19. The butterfly needle assembly of claim 16, wherein the removable needle cover has a first end disposed through the generally flat bottom into the needle hub, the first end having opposing side tabs structured and arranged to rotatably lock into the needle hub.
  20. 20. The butterfly needle assembly of claim 16, wherein the removable needle cover when engaged to the needle hub hermetically seals the needle.

Description

SYSTEM AND METHOD FOR BUTTERFLY NEEDLE ASSEMBLY FIELD OF THE INVENTION [0001] The present invention relates generally to systems and methods for subcutaneous infusion systems and equipment, and more particularly needle assemblies which provide a flexible member for stabilizing and protecting the needle when disposed into the tissues of a patient, and systems to reduce the opportunity for accidental needle stick before and after use, the assembly also providing ease of assembly for a variety of different needle gauges with a common flexible member element as well as sterilization prior to use. BACKGROUND [0002] Infusion systems for the delivery of liquid pharmaceuticals are widely used and relied upon by patients and care givers alike. [0003] With a typical injection, commonly referred to as a “shot” a patient is quickly injected with a medicant provided by a handheld syringe directly connected to a needle. The caregiver punctures the patient’s skin with the needle to reach desired tissues or structures, depresses the plunger of the syringe to inject the medicant, and then withdraws the needle. This process is typically performed in less than one minute. [0004] With an infusion, typically the medicant is delivered over a period of time. The needle is inserted to reach the desired tissues or structures and then remains in contact with those tissues or structures for the duration of the treatment which is typically measurable in many minutes or hours. [0005] One form of infusion therapy is Immuno Globulin (Ig) therapy, and it is frequently used to improve the quality of life for patients with conditions such as Primary Immune Deficiency (PID), Secondary Immune Deficiency (SID), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIPD), and Severe Combined Immunodeficiency (SCID). Historically, Ig therapy has been administered intravenously (IVIg) every 3-4 weeks, which can result in inconsistent serum levels and burdensome infusion experiences for patients. [0006] Subcutaneous Ig therapy (SCIg) is a more convenient option that allows for consistent serum levels and can be done at home. However, SCIg has its own challenges, such as the need for patients to prepare and administer the infusions themselves and potential site leakage during infusions. This device will administer therapy subcutaneously through single or multiple injection sites depending on the drug volumes prescribed. [0007] While important in any medical setting, for home use, it is quite important that the infusion needle system assembly in particular be as simple and straightforward to use as possible. [0008] To assist with ensuring that the needle reaches the desired tissues or structures, infusion needles are often provided in specific lengths. In addition, to help anchor the needle during the infusion procedure, these needles often have an anchor of sorts, from which the needle extends, and which is taped in place upon a patient once the needle element has been disposed into their tissues. [0009] To further minimize the possibility of disturbing the needle, in many cases a needle bent to a 90° is used, so that medicant supply tubing is essentially parallel to the patient’s skin, and capable of being taped in place while the delivery end of the needle is perpendicular to the skin and at the desired pre-determined depth. Fabrication of 90° is more involved than fabrication of straight needles, so desirable as such a configuration may be for an infusion butterfly needle, additional cost is typically necessary. [0010] Two other issues are also common - maintaining sterility of the needle before use and avoidance of accidental needle stick before and after use. There have been various efforts to address at least the needle stick issue. US Patent 6,911,020 to Raines teaches a Huber Needle With Folding Safety Wings. A 90° Huber needle is mounted with the horizontal portion of the needle disposed within a hub such that the perpendicular portion of the needle extends away from the hub and is mostly between a pair of folding wings. Although the entire Raines assembly may be provided in a hermetically sealed bag, once opened, all elements of the Rains assembly are exposed to the elements including the needle. In addition, as the hub is formed about the horizontal portion of the needle, to provide different needle gauges requires an entirely different casting and assembly process. [0011] US Patent 5,951,522 to Rosato et al., entitled Hypodermic Needle Safety Enclosure teaches a similar device. Here again, a 90° Huber needle is partially enclosed by a wing structure. When disposed upon a patient at an insertion site, the wing elements fold up and apart to allow the needle to be exposed and disposed into the patient. The wings then also provide a generally flat surface over which tape may be affixed to secure the needle assembly during infusion. When removed, the wing elements unfold about the needle once again. So while attentive to before and af