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EP-3681411-B1 - SURGICAL COATED NEEDLES

EP3681411B1EP 3681411 B1EP3681411 B1EP 3681411B1EP-3681411-B1

Inventors

  • OU, DUAN LI
  • CICHOCKI, JR., FRANK RICHARD
  • NGUYEN, THIEN

Dates

Publication Date
20260506
Application Date
20180911

Claims (14)

  1. A system (800) for coating a surgical needle (100), the system comprising: a first coating system (810) that is configured to apply a primer coat and a base coat to a first portion (104) of a surgical needle blank; a laser drilling system (830) that is configured to create a suture attachment end (110) within a second portion (106) of the surgical needle blank, thereby forming the surgical needle (100); and a second coating system (840) that is configured to apply a top coat to the surgical needle (100), the second coating system (840) including a basket (300) configured to house the surgical needle (100) during application of the top coat, the basket (300) having a base portion (302), a top portion (304), and a first and a second pair of opposing sidewalls (306a&b, 308a&b) each extending from the base portion (302) to the top portion (304), thereby defining a total surface area of the basket (300), the basket (300) having a drainage area that is from 50 % to about 95 % of the total surface area.
  2. The system (800) of claim 1, further comprising a first drying system (850) that is configured to remove at least a portion of excess top coat from the surgical needle (100), and the drying system (850) includes a vacuum drying chamber (700).
  3. The system (800) of claim 1, further comprising a second drying system (860) that is configured to remove at a least a portion of solvent from the top coat.
  4. The system (800) of claim 1, further comprising a curing system (820) that is configured to at least partially cure at least one of the primer coat and the base coat.
  5. The system (800) of claim 1, wherein the first coating system (810) is a spray coating system.
  6. The system (800) of claim 1, wherein the base portion (302) includes a porous substrate (316) that is configured to retain the surgical needle (100) within the basket (300) and allow at least a portion of excess top coat to pass therethrough.
  7. The system (800) of claim 6, wherein the top portion (304) includes a porous substrate (318) that is configured to allow air to pass therethrough.
  8. The system (800) of claim 7, wherein each sidewall (306a&b, 308a&b) has an inner surface (310) and an outer surface (312) with one or more drainage holes (314) extending therebetween, the one or more drainage holes (314) being configured to allow at least a portion of excess top coat to pass therethrough, and wherein the one or more drainage holes (314) remain open when the top portion (304) is in contact with the inner surfaces (310).
  9. A method for coating a surgical needle (100), the method comprising: spray coating a primer coat onto a first portion (104) of a surface of a surgical needle blank formed from a tungsten-rhenium alloy, the first portion (104) of the surgical needle blank having a tissue-penetrating end (108); spray coating a base coat that differs from the primer coat onto the primed surface of the surgical needle blank; laser-drilling the surgical needle blank within a second portion (106) of the surgical needle blank to create a suture attachment end (110) opposite the tissue-penetrating end (108), thereby forming the surgical needle (100); and dip coating a top coat that differs from the base coat onto the base coat and onto the suture attachment end (110).
  10. The method of claim 9, wherein the top coat is formed from a composition comprising a silicone at a concentration from about 1 % to 3 % by weight of the composition.
  11. The method of claim 9, further comprising vacuum drying the top coat.
  12. The method of claim 11, further comprising, after vacuum drying, removing at least a portion of solvent from the top coat at a temperature from about 90 °C to 130 °C.
  13. The method of claim 9, wherein dip coating the top coat comprises placing the surgical needle (100) in a basket (300) and placing the basket (300) into a top coating solution, the basket (300) having a drainage area that is from 50 % to about 95 % of a total surface area of the basket (300).
  14. The method of claim 13, wherein the basket (300) has a base portion (302), a top portion (304), and a first and a second pair of opposing sidewalls (306a&b, 308a&b) each extending from the base portion (302) to the top portion (304), and wherein the base and top portions (302, 304) each include a porous substrate (316, 318) and the sidewalls (306a&b, 308a&b) each include one or more drainage holes (314).

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application 62/559,267, entitled "Surgical Coated Needles," filed on September 15, 2017. BACKGROUND OF THE INVENTION Medical devices which repeatedly come into contact with bodily tissue, such as surgical needles, are required to be lubricious, yet durable enough to withstand multiple contacts with tissue. Suitable lubricity is often imparted to the medical devices by applying one or more coating compositions to the medical devices. For example, silicone based compositions. Typically, surgical needles have a distal piercing point (tissue-penetrating tip) and a proximal suture mounting section (suture attachment end). The proximal suture mounting sections are typically a channel formed in the proximal end or a bore hole laser drilled into the proximal end. The lubricious coatings are applied to the surgical needles prior to being laser drilled. However, due to the energy required for laser drilling, the coatings can char during laser drilling. Charring can lead to gumming/fouling of the cutoff dies. Additionally, this charring can lead to visual defects and/or reduction in lubricity of the surgical needles. US2011/0112565 A1 relates to medical devices including surgical needles which are capable of being repeatedly passed through the tissue using minimal force, and which can be manufactured with one or more coatings. Accordingly, there remains a need for improved surgical needles, systems, and methods that address current issues with laser drilling surgical needles. BRIEF SUMMARY OF THE INVENTION Systems and methods for coating surgical needles are provided herein. According to the invention, a system includes a first coating system, a laser drilling system, and a second coating system. The first coating system is configured to apply a primer coat and a base coat to a first portion of a surgical needle blank. The laser drilling system is configured to create a suture attachment end within a second portion of the surgical needle blank, thereby forming the surgical needle. The second coating system is configured to apply a top coat to the surgical needle. The second coating system includes a basket that is configured to house the surgical needle during application of the top coat. The basket has a base portion, a top portion, and a first and a second pair of opposing sidewalls each extending from the base portion to the top portion, thereby defining a total surface area of the basket. The basket has a drainage area that is from about 50 % to 95 % of the total surface area. In one aspect, the first coating system can be a spray coating system. In some aspects, the system can include a first drying system that can be configured to remove at least a portion of excess top coat from the surgical needle. In one aspect, the drying system can include a vacuum drying chamber. In other aspects, the system can include a second drying system that can be configured to remove at least a portion of solvent from the top coat. In some aspects, the system can include a curing system that can be configured to at least partially cure at least one of the primer coat and the base coat. The basket can have a variety of configurations. For example, in some aspects, the base portion can include a porous substrate that can be configured to retain the surgical needle within the basket and allow at least a portion of excess top coat to pass therethrough. In such aspects, the top portion can include a porous substrate that is configured to allow air to pass therethrough. In such aspects, each sidewall can have an inner surface and an outer surface with one or more drainage holes extending therebetween, the one or more drainage holes can be configured to allow at least a portion of excess top coat to pass therethrough, and the one or more drainage holes can remain open when the top portion is in contact with the inner surfaces. Methods for coating a surgical needle are also provided. According to the invention, the method includes spray coating a primer coat onto a first portion of a surface of a surgical needle blank formed from a tungsten-rhenium alloy, the first portion of the surgical needle blank having a tissue-penetrating end, spray coating a base coat that differs from the primer coat onto the primed surface of the surgical needle blank, laser-drilling the surgical needle blank within a second portion of the surgical needle blank to create a suture attachment end opposite the tissue-penetrating end, thereby forming the surgical needle, and dip coating a top coat that differs from the base coat onto the base coat and the suture attachment end. In one aspect, the top coat can be formed from a composition comprising a silicone at a concentration from about 1 % to 3 % by weight of the composition. In some aspects, the method can include vacuum drying the top coat. In one aspect, the method can include, after vacuum drying, removing at