Septum that decontaminates by interaction with penetrating element

• US 9,931,274 B2
• Filed: 09/15/2016
• Issued: 04/03/2018
• Est. Priority Date: 09/15/2015
• Status: Active Grant

• Current Assignee: Dr Py Institute LLC
• Original Assignee: Dr Py Institute LLC
• Inventors: Py, Daniel
• Primary Examiner(s): NIESZ, JASON KAROL
• Application Number:
  US15/267,131
• Publication Number:
  US 20170071826A1
• Time in Patent Office: 565 Days
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes

Abstract

A septum is penetrable by a needle for decontamination by physical interaction. The septum can include a peripheral portion, an exterior surface], and an interior surface. A penetration portion extends between the exterior and interior surfaces, is spaced inwardly of the peripheral portion, and is penetrable by the needle or other penetrating element. A flex portion is located between the penetration portion and the peripheral portion. A thicker portion extends between the flex portion and the penetration portion, and defines an increased thickness between the exterior and interior surfaces relative to the flex portion. The flex portion is flexible inwardly relative to the peripheral portion during penetration of the penetration portion by a needle or other penetrating element. The penetration portion physically interacts with and decontaminates the needle when it penetrates the septum. The septum may also reduce or prevent retrograde contamination when the needle is withdrawn.

Claims

1. A septum comprising:

a peripheral portion extending about a periphery of the septum, an exterior surface located on an external side of the septum, and an interior surface located on an opposite side of the septum;

a penetration portion penetrable by a needle or other penetrating element extending between the exterior and interior surfaces that is spaced inwardly of the peripheral portion and is penetrable by the needle or other penetrating element;

a flex portion located between the penetration portion and the peripheral portion; and

an increased thickness portion extending between the flex portion and the penetration portion, and defining an increased thickness between the exterior and interior surfaces relative to the flex portion, wherein the flex portion is flexible inwardly relative to the peripheral portion during penetration of the penetration portion by a needle or other penetrating element, and the penetration portion physically interacts with and decontaminates the needle or other penetrating element;

wherein the septum is configured to decontaminate a needle or other penetrating element during penetration of the penetration portion therewith by interaction between the septum and said needle or other penetrating element.

2. A septum as defined in claim 1, wherein the increased thickness portion extends annularly about the penetration portion.

3. A septum as defined in claim 1, wherein the septum defines an axis of symmetry, the flex portion is located on one side of a plane that is substantially normal to the axis of symmetry, and at least a portion of the interior surface defining the increased thickness portion is located on an opposite side of the plane relative to the flex portion.

4. A septum as defined in claim 1, wherein the increased thickness portion is defined by a substantially dome-shaped interior surface.

5. A septum as defined in claim 1, wherein the increased thickness portion is defined by an interior surface that is toroidal, semi-toroidal or partial toroidal in shape.

6. A septum as defined in claim 1, wherein the increased thickness portion is defined by a curvilinear-shaped interior surface.

7. A septum as defined in claim 1, wherein the increased thickness portion is substantially convex-shaped in cross section.

8. A septum as defined in claim 1, wherein the penetration portion defines a reduced thickness between the exterior and interior surfaces as compared to the increased thickness portion.

9. A septum as defined in claim 1, wherein the exterior surface is one or more of substantially dome-shaped and substantially convex-shaped.

10. A septum as defined in claim 1, wherein the penetration portion defines a recess in the exterior surface.

11. A septum as defined in claim 10, wherein the recess of the penetration portion is substantially conically shaped.

12. A septum as defined in claim 10, wherein the recess of the penetration portion is substantially frustoconically shaped.

13. A septum as defined in claim 10, wherein the recess of the penetration portion defines a substantially planar base forming a penetrable exterior surface of the penetration portion.

14. A septum as defined in claim 1, wherein the flex portion includes a recess in the interior surface extending about the increased thickness portion between the increased thickness portion and the peripheral portion.

15. A septum as defined in claim 14, wherein the recess of the flex portion extends annularly about the increased thickness portion and extends radially between the peripheral portion and the increased thickness portion.

16. A septum as defined in claim 14, wherein the recess of the flex portion is substantially v-shaped, substantially u-shaped, or substantially concave-shaped in cross section.

17. A septum as defined in claim 14, wherein the interior surface of the increased thickness portion extends axially from a base of the recess of the flex portion in a direction opposite the exterior surface and thereby defines an increased thickness about the penetration portion.

18. A septum as defined in claim 1, wherein the peripheral portion is co-molded with, over-molded to, or fixedly secured to a mounting surface of a device.

19. A septum as defined in claim 1, wherein the exterior surface is approximately dome-shaped and the interior surface at the increased thickness portion is approximately dome-shaped.

20. A septum as defined in claim 1, wherein the exterior surface is approximately convex-shaped and the interior surface at the increased thickness portion is approximately convex-shaped.

21. A septum as defined in claim 1, wherein the increased thickness portion is configured to one or more of (i) reduce strain on the interior surface of the penetration portion as compared to the exterior surface of the penetration portion during penetration thereof by the needle or other penetrating element;

(ii) apply an annular zone of relatively high radial pressure between an exterior surface of the penetration portion and the needle or other penetrating element as compared to the radial pressure between an interior surface of the penetration portion and the needle or other penetrating element during penetration thereof by the needle or other penetrating element; and

(iii) space the exterior surface at the penetration portion from the interior surface thereof during penetration by the needle or other penetrating element.

22. A septum as defined in claim 1, wherein the interior surface of the septum is sterile.

23. A septum as defined in claim 1, wherein the penetration portion, increased thickness portion, and flex portion are each made of an elastic material, and the exterior surface is one or more of curvilinear, substantially convex or substantially dome-shaped, and a resulting penetration hole from the needle or other penetrating element is self-resealing.

24. A septum as defined in claim 1, wherein the penetration portion is configured such that an aperture formed in the septum by the needle or other penetrating element closes or seals progressively in a direction from the interior surface of the septum toward the exterior surface of the septum as the needle or other penetrating element is withdrawn from the septum.

25. A septum as defined in claim 1, wherein the septum is configured to prevent liquid or contaminants exterior to the needle or other penetrating element from passing or flowing from to the interior surface of the septum as the needle or other penetrating element is withdrawn from the septum.

26. A septum as defined in claim 1, wherein the septum is configured to move liquid or contaminants from one or more of (i) an exterior surface of the needle or other penetrating element or (ii) the penetration portion and toward the exterior surface of the septum during withdrawal of the needle or other penetrating element from the septum.

27. A septum as defined in claim 1, wherein the septum is configured to apply a pressure to the needle or other penetrating element of at least 0.4 MPa.

28. A septum comprising:

first means extending about a periphery of the septum for engaging the septum to a device;

second means extending between exterior and interior surfaces of the septum that is spaced inwardly of the first means for penetration by the needle or other penetrating element and physically interacting with and decontaminating the needle or other penetrating element;

third means located between the first means and the second means for flexing inwardly relative to the first means during penetration of the second means by a needle or other penetrating element; and

fourth means extending between the second means and the third means for one or more of (i) reducing strain on the interior surface of the second means as compared to the exterior surface of the second means during penetration by the needle or other penetrating element, (2) applying an annular zone of relatively high pressure between an exterior portion of the second means and the needle or other penetrating element as compared to an interior portion of the second means, and (3) spacing the exterior surface at the second means from the interior surface thereof during penetration by the needle or other penetrating element to thereby provide a zone or ring of safety between the exterior and interior surfaces where the needle or other penetrating element penetrates the second means,

wherein the septum is configured to decontaminate the needle or other penetrating element during penetration of the second means therewith by interaction between the septum and said needle or other penetrating element.

29. A septum as defined in claim 28, wherein the first means is a peripheral portion of the septum, the second means a penetration portion of the septum, the third means is a flex portion of the septum, and the fourth means is an increased thickness portion of the septum.

31. A method as defined in claim 29, further comprising one or more of reducing the strain or incurring a lower strain on the interior surface of the penetration portion, as compared to the exterior surface of the penetration portion during penetration thereof by the needle or other penetrating element.

30. A method comprising:

penetrating a penetration portion of the septum defining an exterior surface and an interior surface with a needle or other penetrating element;

during said penetrating step, applying a zone of relatively high, approximately radial pressure onto the needle or other penetrating element at or near the exterior surface of the penetration portion, and applying a zone of relatively lower, approximately radial pressure onto the needle or other penetrating element at or nearer to the interior surface of the penetration portion; and

progressively wiping an exterior surface of the needle or other penetrating element at at least the zone of relatively high, approximately radial pressure as the needle or other penetrating element penetrates through the septum, and thereby decontaminating portions of the needle or other penetrating element that has penetrated the septum.

32. A method as defined in claim 30, further comprising, during the penetrating step, preventing the exterior surface of the penetration portion from invaginating, curling or rolling inwardly about the needle or other penetrating element.

33. A method as defined in claim 30, further comprising preventing germs, bacteria or other contaminants on the exterior surface of the penetration portion from being placed into communication with, and contaminating the interior surface of the penetration portion, or an environment of an interior surface of the septum.

34. A method as defined in claim 30, further comprising spacing the exterior surface of the penetration portion from the interior surface thereof during the penetrating step, and providing a ring of safety between the exterior and interior surfaces of the penetration portion at an interface of the needle or other penetrating element and the septum that prevents germs, bacteria or other contaminants on the exterior surface of the penetration portion from being placed into communication with, and contaminating the interior of the penetration portion, or an environment of an interior surface of the septum.

35. A method as defined in claim 30, wherein the relatively high, approximately radial pressure applied during the applying step in the zone of relatively high, radial pressure is at least 0.4 MPa.

36. A method as defined in claim 30, further comprising:

withdrawing the needle or other penetrating element from the septum;

during said withdrawing step, applying a zone of relatively high, approximately radial pressure onto the needle or other penetrating element at or near the exterior surface of the penetration portion, and applying a zone of relatively lower, approximately radial pressure onto the needle or other penetrating element at or near the internal surface of the penetration portion; and

progressively wiping the needle or other penetrating element during the withdrawing step and thereby preventing liquid or contaminants from passing or flowing from the exterior surface of the penetration portion or an exterior surface of the needle or other penetrating element to the interior surface of the penetration portion.

37. A method as defined in claim 36, wherein the wiping step includes wiping the needle or other penetrating element in a direction from an interior surface of the septum toward an exterior surface of the septum.

38. A method as defined in claim 36, further comprising, during the withdrawing step, progressively closing or sealing an aperture formed in the septum by the needle or other penetrating element in a direction from the interior surface of the penetration portion toward the exterior surface of the penetration portion.

39. A method as defined in claim 30, further comprising moving liquid or contaminants from one or more of (i) a surface of the needle or other penetrating element or (ii) the penetration portion toward the exterior surface of the penetration portion during withdrawal of the needle or other penetrating element from the septum.