Subcutaneous Infusion Device and Device for Insertion of a Cannula of an Infusion Device and Method

• US 20090264825A1
• Filed: 07/01/2009
• Published: 10/22/2009
• Est. Priority Date: 11/10/2003
• Status: Abandoned Application

• Current Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Original Assignee: Smiths Medical MD Incorporated (ICU Medical Incorporated)
• Inventors: Faust, Mark, Marrs, James, Cote, Steve
• Application Number:
  US12/496,235
• Publication Number:
  US 20090264825A1
• Time in Patent Office: Days
• US Class Current: 604/158
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

An infusion device including a site and a set for delivery of a substance to a patient. The site can include a cannula that is introduced into a subcutaneous layer of skin of the patient. The set can be coupled to the site by placing the set over the site and moving the set from an unlocked to a locked position. The set can be oriented at multiple rotational orientations with respect to the site, and can be coupled and uncoupled with the site multiple times. Also included is a device for inserting a subcutaneous infusion device into a subcutaneous layer of skin of a patient. Some devices automatically retract a needle used to introduce the cannula. Upon full introduction of the needle and associated cannula of the subcutaneous infusion device into a subcutaneous layer of skin of a patient, the device can move the needle into a retracted state.

Claims

1. A container for facilitating placement of a cannula of a medical device through a patient'"'"'s skin, the container comprising:

a housing comprising a cap telescopically slidable over a sleeve, said sleeve defining an axis therethrough and including a resting base configured for placement against said patient'"'"'s skin, said cap being slidable between a first position and a second position along the axis of said sleeve, wherein said cap substantially encases an axial length of said sleeve when said cap is in said second position; and

a retaining member located within said housing, said retaining member having a piercing member secured thereto, said piercing member extending at least partially through said cannula for transcutaneous placement of said cannula;

wherein said piercing member is concealed within said sleeve when said cap is in said first position and exposed from said sleeve when said cap is in said second position;

wherein upon exertion of pressure on said cap, said cap slides axially toward said patient'"'"'s skin along said sleeve so that said piercing member is placed through said patient'"'"'s skin and an end of said cannula is transcutaneously inserted and said medical device is retained on the patient and said piercing member secured to said retaining member is removed.

2. The container of claim 1, wherein a force resulting from an insertion pressure exerted on said cap is transferred to said piercing member.

3. The container of claim 1, further comprising a projecting structure defining said retaining member and extending generally axially from an end portion of said cap within said sleeve.

4. The container of claim 3, wherein said piercing member is attached to said projecting structure.

5. The container of claim 1, wherein said base comprises an adhesive face configured for adhering said base to said patient'"'"'s skin.

6. The container of claim 5, further comprising an adhesive portion attached to said base, said adhesive portion configured for adhering to said patient'"'"'s skin.

7. The container of claim 6, wherein said adhesive portion includes an adhesive layer through which said piercing member passes as said piercing member is advanced towards the patient'"'"'s skin.

8. The container of claim 5, further comprising a protective film for covering said adhesive face prior to adhering said base to said patient'"'"'s skin.

9. The container of claim 1, wherein said sleeve extends distal to a tip of said piercing member prior to insertion of said piercing member.

10. The container of claim 1, wherein said sleeve further comprises a pair of guiding members to guide said cap relative to said sleeve when pressure is exerted on said cap.

11. A container for facilitating placement of a cannula of a medical device through a patient'"'"'s skin, the container comprising:

a housing comprising a cap telescopically slidable over a sleeve said sleeve defining an axis therethrough and including a resting base configured for placement against said patient'"'"'s skin, said cap being slidable between a first position and a second position along the axis of said sleeve, wherein said cap substantially encases an axial length of said sleeve when said cap is in said second position; and

a retaining member located within said housing, said retaining member having a piercing member secured thereto, said piercing member extending at least partially through said cannula for transcutaneous placement of said cannula;

wherein said piercing member is concealed within said sleeve when said cap is in said first position and exposed from said sleeve when said cap is in said second position;

wherein upon exertion of pressure on said cap, said cap slides axially toward said patient'"'"'s skin along said sleeve so that said piercing member is placed through said patient'"'"'s skin and an end of said cannula is transcutaneously inserted and said medical device is retained on the patient and said piercing member is removed together with said housing.

12. A container for facilitating placement of a medical device through a patient'"'"'s skin, the container comprising:

a cylindrical housing in which there are defined a cap and a sleeve, said sleeve including a resting base having a planar surface configured for placement against a patient'"'"'s skin, said cap surrounding at least a portion of said sleeve and being axially slidable relative to said sleeve to substantially encase said sleeve when a sufficient pressure is exerted on said cap;

a retaining member located within said housing, said retaining member having a needle secured thereto;

wherein the container is disposable and upon exertion of said pressure on said cap force resulting from said pressure is transferred to said needle so that said needle is placed through the patient'"'"'s skin by means of said pressure exerted on said cap.

13. A container as claimed in claim 12, wherein said base has, on an outer face, an adhesive portion having an adhesive surface and a removable protecting film thereon.

14. A container for facilitating placement of a medical device through a patient'"'"'s skin, the container comprising:

a cylindrical housing in which there are defined a cap and a sleeve, said sleeve including a resting base having a planar surface configured for placement against a patient'"'"'s skin, said cap being axially slidable relative to said sleeve when a sufficient pressure is exerted on said cap;

a retaining member located within said housing, said retaining member having a needle secured thereto;

said retaining member slidable relative to said sleeve when said cap slides relative to said sleeve, thereby allowing placement of said needle under the patient'"'"'s skin and subsequent removal of said container;

wherein the container is disposable and upon exertion of said pressure on said cap force resulting from said pressure is transferred to said needle so that said needle is placed through the patient'"'"'s skin by means of said pressure exerted on said cap.

15. A container for facilitating placement of a medical device through a patient'"'"'s skin, the container comprising:

a cylindrical housing in which there are defined a cap and a sleeve, said sleeve including a resting base having a planar surface configured for placement against a patient'"'"'s skin, said base having, on an outer face, an adhesive portion adhering to said base, said adhesive portion including an adhesive having a removable protecting film thereon, said cap being axially slidable relative to said sleeve when a sufficient pressure is exerted on said cap;

a retaining member located within said housing, said retaining member having a needle secured thereto;

said retainer member slidable relative to said sleeve, thereby allowing placement of said needle under the patient'"'"'s skin and subsequent removal of said container;

wherein the container is disposable and upon exertion of said pressure on said cap force resulting from said pressure is transferred to said needle so that said needle is placed through the patient'"'"'s skin by means of said pressure exerted on said cap; and

wherein said needle is arranged within said housing.

16. A container for facilitating placement of a cannula of a medical device through a patient'"'"'s skin, the container comprising:

a housing comprising a cap telescopically slidable over a sleeve said sleeve defining an axis therethrough and including a resting base configured for placement against said patient'"'"'s skin, said cap being slidable between a first position and a second position along an axis of said sleeve, wherein said cap substantially encases an axial length of said sleeve when said care is in said second position; and

a retaining member located within said housing, said retaining member having a piercing member secured thereto, said piercing member extending at least partially through said cannula for transcutaneous placement of said cannula; and

wherein said piercing member is concealed within said sleeve when said cap is in said first position and exposed from said sleeve when said cap is in said second position; and

wherein upon exertion of pressure on said cap, said cap slides axially toward said patient'"'"'s skin along said sleeve so that said piercing member is placed through said patient'"'"'s skin and an end of said cannula is transcutaneously inserted and said medical device is retained on the patient and said piercing member secured to said retaining member is removed.

17. A device for inserting a cannula of an infusion device into the subcutaneous layer of a patient'"'"'s skin, comprising:

a housing having a closed end slidably coupled and movable longitudinally with respect to a sleeve, said sleeve having an interior through passage and an end portion for placement against the patient'"'"'s skin, said housing being movable between a first position and a second position longitudinally relative to said sleeve, said housing substantially encircling said sleeve when said housing is in said second position; and

a hub mechanism positioned within and coupled to said housing, said hub mechanism having a needle, said needle extending at least partially through said cannula for placement of said cannula into the subcutaneous layer of the patient'"'"'s skin;

wherein said needle is concealed within said sleeve when said housing is in said first position and exposed from said sleeve when said housing is in said second position;

wherein when pressure is applied to the closed end of said housing, said housing is moved toward the patient'"'"'s skin longitudinally with respect to said sleeve to introduce said needle and said cannula into the patient'"'"'s skin, said infusion device with said cannula inserted into the patient being held on the skin of the patient and said needle being removed.

18. The device of claim 17, wherein a force resulting from the pressure applied to the closed end of said housing is transferred to said needle.

19. The device of claim 17, wherein said hub mechanism comprises a cylinder hub that extends longitudinally from the closed end of said housing within said sleeve.

20. The device of claim 19, wherein said needle is held relative to said cylinder hub.

21. The device of claim 17, wherein said end portion includes an adhesive layer to adhesively couple said end portion to the patient'"'"'s skin.

22. A device for inserting a cannula of an infusion device into the subcutaneous layer of a patient'"'"'s skin, comprising:

a housing having a closed end slidably coupled to and movable longitudinally with respect to a sleeve, said sleeve having an interior through passage and an end portion for placement against the patient'"'"'s skin, said housing being movable between a first position and a second position longitudinally relative to said sleeve, said housing substantially encircling said sleeve when said housing is in said second position; and

a hub mechanism positioned within and coupled to said housing, said hub mechanism having a needle, said needle extending at least partially through said cannula;

wherein said needle is concealed within said sleeve when said housing is in said first position and exposed from said sleeve when said housing is in said second position;

wherein when pressure is applied to the closed end of said housing, said housing is moved toward the patient'"'"'s skin longitudinally with respect to said sleeve to introduce said needle and said cannula into the patient'"'"'s skin, said infusion device with said cannula inserted into the patient being held on the skin of the patient and said needle being removed together with said housing.

23. A container for facilitating placement of a medical device through a patient'"'"'s skin, the container comprising:

a cylindrical housing in which there are defined a cap and a sleeve, said sleeve including a resting base having a planar surface configured for placement against a patient'"'"'s skin, said cap being axially slidable relative to said sleeve when a sufficient pressure is exerted on said cap;

a retaining member located within said housing, said retaining member having a needle secured thereto;

a releasing member releasing said needle from said retaining member and allowing placement of said needle under the patient'"'"'s skin and subsequent removal of said container when said cap is moved longitudinally relative to said sleeve;

wherein the container is disposable and upon exertion of said pressure on said cap a force resulting from said pressure on said cap is imparted to said needle so that said needle is placed through the patient'"'"'s skin by means of said pressure exerted on said cap.

24. A container for facilitating placement of a medical device through a patient'"'"'s skin, the container comprising:

a cylindrical housing in which there are defined a cap and a sleeve, said sleeve including a resting base having a planar surface configured for placement against a patient'"'"'s skin, said cap being axially slidable relative to said sleeve when a sufficient pressure is exerted on said cap;

a retaining member located within said housing, said retaining member having a needle secured thereto;

a releasing member for releasing said needle from said retaining member and allowing placement of said needle under the patient'"'"'s skin and subsequent removal of said container when said cap is moved longitudinally relative to said sleeve;

said retainer member slidable relative to said sleeve, thereby allowing placement of said needle under the patient'"'"'s skin and subsequent removal of said container;

wherein the container is disposable and upon exertion of said pressure on said cap a force resulting from said pressure on said cap is imparted to said needle so that said needle is placed through the patient'"'"'s skin; and

wherein said needle is arranged within said housing.

25. A container for facilitating placement of a cannula of a medical device through a patient'"'"'s skin, the container comprising:

a housing comprising a cap slidable relative to a sleeve, said sleeve defining an axis therethrough and including a resting base configured for placement against said patient'"'"'s skin, said cap being slidable between a first position and a second position along the axis of said sleeve; and

a retaining member located within said housing, said retaining member having a piercing member secured thereto, said piercing member extending at least partially through said cannula for transcutaneous placement of said cannula; and

a releasing member for releasing said piercing member from said retainer member;

wherein said piercing member is concealed within said sleeve when said cap is in said first position and exposed from said sleeve when said cap is in said second position; and

wherein upon exertion of pressure on said cap, said cap slides axially toward said patient'"'"'s skin relative to said sleeve so that said piercing member is placed through said patient'"'"'s skin and an end of said cannula is transcutaneously inserted and said medical device is retained on the patient and said piercing member secured to said retaining member is removed.

26. A container for facilitating placement of a medical device through a patient'"'"'s skin, the container comprising:

a cylindrical housing in which there are defined a cap and a sleeve, said sleeve including a resting base having a planar surface configured for placement against a patient'"'"'s skin, said cap being axially slidable relative to said sleeve when a sufficient pressure is exerted on said cap;

a retaining member located within said housing, said retaining member having a needle secured thereto;

a releasing member for releasing said needle from said retaining member when said cap slides relative to said sleeve, thereby allowing placement of said needle under the patient'"'"'s skin and subsequent removal of said container;

wherein the container is disposable and upon exertion of said pressure on said cap force resulting from said pressure is transferred to said needle so that said needle is placed through the patient'"'"'s skin.

27. A device for inserting a subcutaneous infusion device into skin of a patient, comprising:

a housing;

a hub coupled to the housing and defining an interior passage;

a needle hub including a needle, the needle hub being positioned in the interior passage of the hub so that the needle hub is held in a fixed position relative to the hub and the housing;

a sleeve; and

a spring engaging the needle hub;

wherein the housing, the hub, and the needle hub are movable relative to the sleeve to introduce the needle of the needle hub and an associated cannula of an infusion device into a subcutaneous layer of skin, and wherein, upon the needle and associated infusion device being fully inserted into the subcutaneous layer of skin, the needle hub is slideable relative to the hub, and the needle hub including the needle are moveable by the spring through the passage of the hub to a retracted state, leaving the infusion device positioned on the skin of the patient.