US11541172B2

US11541172B2 - Infusion set with safety device

Info

Publication number: US11541172B2
Application number: US17/035,561
Authority: US
Inventors: Charles Hwang
Original assignee: Becton Dickinson and Co
Current assignee: Becton Dickinson and Co
Priority date: 2012-10-05
Filing date: 2020-09-28
Publication date: 2023-01-03
Anticipated expiration: 2032-10-05
Also published as: US10821226B2; CN203874209U; JP6560395B2; US20180001020A1; CA2828832A1; CA3111543C; JP6621974B2; CA3198239A1; US20210008278A1; CA2828832C; JP2014076362A; JP2018126587A; US20140100544A1; EP2716314A1; US9789250B2; CA3111543A1; ES2727902T3; EP2716314B1

Abstract

An infusion base for attachment to a user of an infusion set comprises an adapter having a lower portion, an inner wall portion, and a gap between the lower portion and the inner wall portion. At least one of the lower portion and the inner wall portion is configured to receive an attachment.

Description

This application is a continuation of U.S. patent application Ser. No. 15/708,710, filed Sep. 19, 2017, which is a division of U.S. patent application Ser. No. 13/646,582, filed Oct. 5, 2012 and issued as U.S. Pat. No. 9,789,250 on Oct. 17, 2017, the entire disclosures of these applications being incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to infusion sets that use a rigid infusion cannula or introducer having a sharp or piercing end that penetrates the skin of a patient. More particularly, the present invention relates to protecting the rigid infusion cannula or introducer attached to an infusion set before the cannula pierces the skin of a user, and/or after the rigid infusion cannula or introducer has been removed from the patient.

BACKGROUND OF THE INVENTION

Diabetes patients use some form of daily insulin therapy to maintain close control of their glucose levels. Infusion pump therapy is one preferred method. Infusion pump therapy occurs via an infusion cannula (i.e., an infusion needle or a flexible catheter) and requires an infusion pump. Infusion pump therapy offers the advantages of continuous infusion of insulin, precision dosing, and programmable delivery schedules.

The use of an infusion pump requires the use of a disposable component, typically referred to as an infusion set, tubing set, which administers insulin from a reservoir that is pumped into the skin of the user. An infusion set typically consists of a pump connector, a length of tubing, and a hub or base from which an infusion cannula extends. The base has an adhesive that attaches the base on the skin surface during use. The base, with the infusion cannula attached thereon, may be applied to the skin manually or with the aid of a manual or automatic insertion device.

There are many available types of infusion sets incorporating various types of infusion cannulas, including steel needle infusion sets and soft catheter sets. Soft catheter sets can be inserted into a patient with the aid of a steel introducer needle, which is later removed from the patient, leaving the soft catheter in place. The steel cannula infusion set utilizes a steel needle or cannula that is secured to the base.

An advantage of the steel cannula infusion sets is that the steel cannulas, due to their rigidity are less susceptible to kinking. Kinking occurs when the infusion cannula, be it rigid or soft, is unable to resist mechanical forces that may bend or twist the infusion cannula, resulting in a restricted flow of infusate exiting the catheter. Another advantage of a steel cannula infusion set is that the steel cannula pierces the patient's skin without the need for a separate introducer needle, as in soft catheter sets.

A steel cannula typically is protected by a disposable protective tube (typically made of plastic) that is attached to the base, surrounding the steel cannula, prior to use, and such attachment generally is not very secure. The user removes the disposable tube before the steel cannula is inserted into the user's skin. The protective tube is generally disposed of.

A steel cannula infusion set is illustrated in FIGS. 1-5

FIG. 1 illustrates a steel cannula infusion set 1 having a plastic fluid connector or hub 22 that is detachably attached to a plastic base 10, a fluid tubing set 28, and a plastic connector 26 which is attachable to a pump (not shown). The connector 26 includes an outer wall 262. The line set 20 includes the hub 22 and the fluid tubing set 28. The line set 20 is attached to or detached from the base 10, as illustrated in FIGS. 2 and 3 .

FIG. 2 is a top view of the infusion set 1, illustrated with the hub 22 attached to the base 10. An adhesive pad 19 is attached to the base 10 and is configured to be attachable to the skin of the user. FIG. 3 illustrates a view of the infusion set 1, wherein the line set 20 is detached from the base 10. The base 10 includes an infusion adapter 14, to which the steel cannula 13 is attached.

FIG. 4 is a cross-sectional view of the infusion set 1, taken along lines 4-4 of FIG. 1 , that more clearly illustrates how the infusate (insulin) is pumped into the steel cannula 13. The hub 22 of the line set 20 includes a hub port 25 that receives the fluid tubing set 28. The hub 22 includes a flow cannula 24. The base 10 includes a main base portion 12 and the adapter 14 includes a cylindrical lower portion 16, to which is attached the steel cannula 13, and a cylindrical inner wall portion 17 that is spaced apart from the lower portion 16. A pre-slit septum 18 encloses an upper portion of the adapter 14, when the hub 22 is not attached to the infusion base 10, as illustrated in FIGS. 3 and 5 .

When the hub 22 is attached to the base 10, the flow cannula 24 penetrates the pre-slit septum 18 of the base 10 so that the steel cannula 13 is in fluid communication with the fluid tubing set 28, via channel 11. This allows the insulin from the pump (not shown) to flow from the fluid tubing set 28 into the steel cannula 13 and the insulin exits the distal opening or tip 131 of the steel cannula 13 into the patient.

FIG. 5 illustrates a cylindrical protector 30 attached to the base 10 to protect the steel cannula 13. Prior to use, the protector 30, which is form-fit in the base 10, is removed, and the protector 30, typically a tubular structure made of plastic, is disposed of.

A problem arises when a steel cannula infusion set is to be disposed. When the steel cannula 13 is removed from the user, which may be two or three days after initial insertion, the user may no longer have the disposable protector 30 or protective tube to cover the steel cannula 13 that may now contain bodily fluids. Even if the disposable protective tube 30 were available, since the attachment to the base 10 is not very secure, the protective tube 30 could easily be detached from base 10 to expose the used steel cannula 13.

A user is supposed to dispose of the steel cannula infusion set 1 in a sharps container designed for disposal of items that include a sharp needle, such as the infusion set 1 and syringes. However, a sharps container may not be readily available when a user wishes to dispose of and replace a used steel infusion set 1.

Accordingly, a need exists for an improved infusion set design and construction that can securely dispose of used steel needle infusion sets such that the steel cannula is not exposed, in order to protect people from such contact.

SUMMARY OF THE INVENTION

Objects of the present invention are to provide an infusion base to securely receive a protective element. In accordance with an aspect of the present invention, the protective element can be the connector of the fluid tubing set.

An objective of the present invention is to provide connecting elements, such as male threads and reciprocal female grooves, on the infusion base and the connector of the fluid tubing set for engagement and disengagement.

Another object of the present invention is to provide one or more flexible tabs on the infusion base that can receive the connector and resist its detachment therefrom.

These and other objects are substantially achieved by modifying elements of an infusion base to protect a steel cannula from unwanted contact.

BRIEF DESCRIPTION OF THE DRAWINGS

The various objects, advantages and novel features of the exemplary embodiments of the present invention will be more readily appreciated from the following detailed description when read in conjunction with the appended drawings, in which:

FIG. 1 is a perspective view of a steel cannula infusion set;

FIG. 2 is a top view of the infusion set of FIG. 1 ;

FIG. 3 is a top view of the infusion set of FIG. 1 in which the line set is detached from the base;

FIG. 4 is a cross-sectional view taken along lines 4-4 of the infusion set of FIG. 1 ;

FIG. 5 is a cross-sectional view of the infusion set of FIG. 4 , after the hub has been removed from the base;

FIG. 6 is a perspective view of an exemplary infusion set of the present invention;

FIG. 7 is a cross-sectional view of the base of the infusion set of FIG. 6 , after the hub has been removed from the base;

FIG. 8 is a cross-sectional view of the base of FIG. 7 , illustrated with the connector attached to the base;

FIG. 9 is a perspective view of an exemplary infusion set of the present invention;

FIG. 10 is a cross-sectional view of the base of the infusion set of FIG. 9 , after the hub has been removed from the base;

FIG. 11 is a cross-sectional view of the base of FIG. 10 , illustrated with the connector attached to the base;

FIG. 12 is a perspective view of another exemplary steel cannula infusion set of the present invention;

FIG. 13 is cross-sectional view of the base of the infusion set of FIG. 12 , after the hub has been removed;

FIG. 14 is cross-sectional view of the base of FIG. 13 , illustrated with the connector securely attached to the base;

FIG. 15 is a perspective view of yet another exemplary steel cannula infusion set of the present invention;

FIG. 15A illustrates a variation of the embodiment shown in FIG. 15 ;

FIG. 16 is a cross-sectional view of the base of the infusion set of FIG. 15 , after the hub has been detached from the base;

FIG. 17 is a cross-sectional view of the base of FIG. 16 , illustrated with the connector attached to the base;

FIG. 18 is a cross-sectional view of another exemplary embodiment of the present invention directed to a soft catheter infusion set;

FIG. 19 is a perspective view of another exemplary infusion set;

FIG. 20 is a cross-sectional view taken along lines 20-20 of the infusion set of FIG. 19 ;

FIG. 21 is a perspective view of another exemplary infusion set; and

FIG. 22 is a cross-sectional view taken along lines 22-22 of the infusion set of FIG. 19 .

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

FIGS. 6-8 illustrate one embodiment of an infusion set in accordance with the present invention. In this embodiment, the infusion set 1 a includes a line set 20 that is attachable to a base 10 a. The line set 20 includes a hub 22 and a fluid tubing set 28 attached to the hub 22. An end of the fluid tubing set 28 is connected to a connector 26 a, such as a conventional ISO 594 threaded connector sold under the trademark Luer-Lok®, that can attach to an infusate reservoir or pump (not shown). In accordance with the present invention, the base 10 a includes an adapter 14 with a tapered or frusto-conical lower portion 16 a whose diameter decreases in the direction from top to bottom, and a threaded cylindrical inner wall portion 17 a. Space is formed between the lower portion 16 a and the inner wall portion 17 a, sufficient to receive the connector 26 a. The connector 26 a includes a tapered or frusto-conical inner wall 260 a whose diameter decreases in the direction from top to bottom, and a cylindrical outer wall 262 a. The tapers (nominally 6%) of the lower portion 16 a and the frusto-conical inner wall 260 a are matching or complementary. Threads 263 are formed on the outer wall 262 a of the connector 26 a (e.g., as in a Luer-Lok®) connector. The connector 26 a is configured to attach to the base 10 a. The threads 263 on the outer wall 262 a of the connector 26 a are configured to be rotatably attached onto corresponding threads or grooves 171 formed on the cylindrical inner wall portion 17 a of the adapter 14, to detachably attach the connector 26 a to the base 10 a, as illustrated in FIG. 8 .

The outer threads 263 also function as a Luer-Lok® connector to interface with corresponding grooves in the pump or reservoir (not shown) to administer the infusate to the user. FIG. 7 illustrates the base 10 a with the hub 22 detached therefrom. The inner wall 17 a of the adapter 14 includes threads or grooves 171 for receiving the threads 263 of the connector 26 a.

FIG. 8 illustrates the base 10 a with the connector 26 a secured on the base 10 a. The connector 26 a is rotatably attached to be secured onto the base 10 a. The threads 263 rotatably insert into the corresponding threads or grooves 171, to securely attach the connector onto the base 10 a. Reversing the rotation of the connector 26 a releases the connector 26 a from the base 10 a. The manner in which the hub 22 is secured onto the base 10 a is similar to that illustrated in the embodiment of FIGS. 1-5 . When the connector 23 is attached to the base 10 a, as illustrated in FIG. 8 , the cannula 13 is protected by the connector 23, with the part of the cannula 13 that extends from the lower portion 16 a of the adapter 14 being housed in the space formed between the cylindrical inner wall 260 a of the connector 26 a, to prevent contact with the cannula 13, including its piercing tip 131.

In a modification of the embodiment of FIGS. 6-8 , as illustrated in FIGS. 9-11 , in the infusion set 1 b, the threads or grooves 171 and the threads 263 (of the embodiment of FIGS. 6-8 ) can be deleted and the attachment between the fluid connector 26 b and the lower portion 16 b of the base 10 b can rely on the frictional interference between the mating tapered or frusto-conical surfaces of the lower portion 16 b and inner wall 260 b, similar to a conventional ISO 594 Luer-type slip fitting.

FIGS. 12-14 illustrate another embodiment of an exemplary infusion set of the present invention. In this embodiment, an infusion set 1 c includes a hub 22 attachable to a base 10 c. In this embodiment, the lower portion 16 c of the adapter 14 includes thread portions 161, and the inner wall 260 c of the connector 26 c includes corresponding threads or grooves 261 that receive the threads 161 when the connector 26 c is rotatably attached to the base 10 c. In this embodiment, which is not of the Luer type, the lower portion 16 c and the inner wall 260 c may be cylindrical rather than frusto-conical.

FIG. 13 is a cross-sectional view of the base 10 c, illustrating the lower portion 16 c of the adapter 14 having threads 161 on its outer surface. There is space between the inner wall portion 16 c and the inner wall portion 17 c of the adapter 14 to receive the connector 26 c. In this space, the connector 26 c can be secured to the base 10 c. FIG. 14 illustrates the base 10 c with the connector 26 c secured thereon. In this embodiment, the threads 161 of the lower portion 16 c of the adapter are rotatably attached onto the corresponding grooves 261 of the inner wall of the connector 26 c to attach the connector 26 c to the base 10 c. Thus, the steel cannula 13 is securely protected from unwanted external contact, in order to prevent unwanted or accidental contact with the tip 131 of the steel cannula 13 to avoid contamination.

FIGS. 15-17 illustrate yet another embodiment of the infusion set of the present invention. In this embodiment, the infusion set 1 d includes a base 10 d onto which is attached a line set 20. The line set 20 includes a hub 22 and a fluid tubing set 28, with a connector 26 d attached to an end portion thereof, as illustrated in FIG. 15 . One or more flexible tabs 50 are attached to or formed integrally with a lower surface of the base 10 d. The connector 26 d includes an annular rib 266 and a cylindrical or frusto-conical inner wall 260 d, such that the annular rib 266 can fit into the space between the inner wall portion 17 d and the lower portion 16 d of the adapter 14 d, as the flexible tabs 50 deform to give way. When the flexible tabs 50 revert back to their original shapes, the flexible tabs 50 are able to retain the annular rib, as illustrated in FIG. 17 , absent excessive pulling on the connector 26 d. If the inner wall 260 d is cylindrical, the lower portion 16 d is also cylindrical. Similarly, if the inner wall 260 d is frusto-conical, the lower portion 16 d is also frusto-conical, to permit a Luer-type friction fit when the inner wall 260 d engages the lower portion 16 d, as illustrated in FIG. 17 .

FIG. 15A illustrates a variation of the embodiment of FIG. 15 . In this embodiment, the base 10 d′ includes one or more substantially rigid tabs 50′ attached to or formed integrally with a lower surface of the base 10 d′. The connector 26 e of this embodiment includes one or more rigid tabs 266′, such as Luer-Lok® thread segments, such that when the tabs 266′ of the connector 26 d are slotted into the spaces between the tabs 50′ of the base 10 d′ and the connector 26 d is rotated slightly, the tabs 266′ and 50′ can be frictionally engaged to bind the connector 26 d to the base 10 d′, to provide a protective shield for the cannula 13.

FIG. 16 is a cross-sectional view of the infusion base 10 d of FIG. 15 , and illustrates the flexible tabs 50 secured on the bottom surface of the main base portion 12 of the base 10 d. FIG. 17 illustrates the infusion base 10 d with the connector 26 d secured thereon, after the outer lip 267 of the annular rib 266 of the connector 26 d has been inserted into the space between the inner wall portion 17 d and the lower portion 16 d of the adapter 14. The tabs 50 provide resistance to the outer lip 267 of the connector 26 d to detachably secure the connector 26 d to the adapter 10 d, as illustrated in FIG. 17 . It is conceivable that the one or more flexible tabs 50 can be formed on the lower portion 16 d to secure the connector 26 d to the base 10 d.

In embodiments of the present invention, the protector 30 (illustrated in FIG. 5 ) in the form of a cylindrical tube that is typically included with infusion sets can be eliminated altogether. The

connectors

26 a, 26 b, 26 c, 26 d and 26 e in FIGS. 6-17 can render unnecessary such protectors 30 because the

connectors

26 a, 26 b, 26 c, 26 d and 26 e can be used to shield the steel cannula both before and after the infusion set is used, thereby eliminating a part that can be made redundant and reducing the overall cost of manufacture. The elimination of the plastic protectors 30 also eliminates the need to dispose of such protectors 30 that would otherwise have to be recycled or placed in landfills.

The infusion sets 1 a, 1 b, 1 c, 1 d and 1 d′ can be provided to users with

respective connectors

26 a, 26 b, 26 c, 26 d and 26 e that are attached to the

bases

10 a, 10 b, 10 c, 10 d and 10 d′, such that in order to use the infusion sets, users first have to detach the

respective connectors

26 a, 26 b, 26 c, 26 d and 26 e from the

bases

10 a, 10 b, 10 c, 10 d, 10 d′ to expose the cannulas 13 for attachment to the users for infusion therapy. After the

bases

10 a, 10 b, 10 c, 10 d and 10 d′ with the cannulas 13 pierce the user's skin, infusion therapy can occur, as described above, with regard to FIGS. 1-5 . Thereafter, after the user removes the base 10 a, 10 b, 10 c, 10 d, 10 d′ from the user's skin, and the

connector

26 a, 26 b, 26 c, 26 d, 26 e is detached from the pump or reservoir (not shown), the

connector

26 a, 26 b, 26 c, 26 d, 26 e can again be secured over the cannula 13 to protect the cannula 13, containing body fluids, from being contacted.

Thus, a component (protector 30) found in many infusion sets can be eliminated and the cannula 13 can be covered by a part (

connector

26 a, 26 b, 26 c, 26 d) that is already a part of the infusion set 1 a, 1 b, 1 c, 1 d and 1 d′. This solves the problem of proper disposal of used infusion sets that would otherwise be disposed of with cannulas that are exposed. In this manner, the cannulas of infusion sets can be protected before and after infusion therapy and used infusion sets can be securely transported or disposed, with the cannulas secured thereon.

The embodiments described above relate to infusion sets that each include a cannula 13, one that is rigid and typically made of stainless steel. However, the present invention is not restricted to such types of infusion sets. FIG. 18 illustrates a base 10 e of an infusion set 1 e that utilizes a soft (e.g., Teflon®) catheter 30 a instead of a rigid cannula to deliver infusate to a user. As is known in the art, in a soft catheter infusion set, in order to attach the soft catheter 30 a into the skin of a user, an introducer needle 31 is inserted through the soft catheter 30 a, as illustrated in FIG. 18 , and the user pushes the needle hub 40 to which is attached the introducer needle 31 toward the user's skin so that the needle 31 and the soft catheter 30 a both pierce the user's skin. Thereafter, the needle hub 40 is removed from the base 10 e to remove the needle 31 from the user's skin while the soft catheter 30 a remains in the user's skin. In accordance with the present invention, the infusion set can be configured such that the needle 31 and catheter 30 a are both initially protected from exposure. Specifically, in the embodiment of FIG. 18 , the needle hub 40 is initially placed on the base 10 e, with the connector 26 b attached to the base 10 e protecting both the soft catheter 30 a and the introducer needle 31. The manner of attachment of the connector 26 b to the base 10 e can be the same as that which is described for the cannula type infusion sets described in FIGS. 6-17 . To permit infusion therapy, the needle 31 and needle hub 40 are removed and the line set hub 20 is placed on the base 10 e, in the same manner as illustrated in FIG. 4 .

FIGS. 19 and 20 illustrate another soft catheter infusion set if, in which the fluid tubing set 28 is permanently connected to the adapter 14 a of the base 10 f, such that when the needle hub 40 a is removed after its needle 31 a has penetrated, via its tip 32, the user's skin, infusion therapy can occur as infusate is dispensed from the tubing set 28, into the channel 11, and out through the catheter 30 b. The self-sealing septum 18 a self-closes after the needle 31 a is removed from the catheter 30 b and out through the septum 18 a, as the needle hub 40 a is removed from the infusion set 10 a.

In the embodiment of FIGS. 19 and 20 , the needle hub 40 a can be placed on the base 10 f, with the connector 26 b attached to the adapter 14 a, to protect both the soft catheter 30 b and the introducer needle 31 a. The manner of attachment of the connector 26 b to the base 10 f can be the same as that which is described for the cannula type infusion sets described in FIGS. 6-17 .

The embodiment of FIGS. 21 and 22 is similar to that of the embodiment of FIGS. 19 and 20 , except that this embodiment is directed to an infusion set 1 g with a rigid or steel cannula 13 instead of a soft catheter. Since the rigid cannula 13 can penetrate the skin on its own, a separate introducer needle is not needed. The infusion set 1 g includes a cannula 13 and a fluid tubing set 28 attached to the adapter 14 b of the base 10 g, such that the fluid tubing set 28, channel 11 and the cannula 13 are in fluid communication, to enable infusion therapy. Similar to the embodiments of FIGS. 6-17 , in the embodiment of FIGS. 20 and 21 , the manner of attachment of the connector 26 b to the base 10 g can be the same as that which is described for the cannula type infusion sets described in FIGS. 6-17 .

Although only a limited number of embodiments of the present invention have been described in detail above, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the appended claims and their equivalents.

Claims

What is claimed is:

1. An infusion set comprising:

an infusion base for connecting to a user, the infusion base including a tab;

an infusion cannula extending from the infusion base; and

a tube set comprising

a first end that is attachable to the infusion base; and

a second end including a pump connector having an opening with an annular rib or tab disposed outside of the opening, the pump connector is

(1) attached to the infusion base in a first position via the tab of the infusion base and the annular rib or tab of the pump connector whereby the infusion cannula is enclosed by the opening of the pump connector to protect the infusion cannula when infusate is not being dispensed; and

(2) removed from the infusion base and attached to an infusion pump in a second position for dispensing infusate through the opening of the pump connector; wherein

the attachment between the pump connector and the infusion base includes the tab of the infusion base and the annular rib or tab of the pump connector.

2. The infusion set as claimed in claim 1, wherein:

the attachment between the pump connector and the infusion base is disposed between the connector and a lower portion of the infusion base; and

the lower portion of the infusion base includes a tapered surface configured to engage the pump connector.

3. The infusion set as claimed in claim 1, wherein:

the attachment between the pump connector and the infusion base is disposed between the pump connector and a lower portion of the infusion base; and

the lower portion of the infusion base includes a frusto-conical surface configured to engage the pump connector.

4. The infusion set as claimed in claim 1, wherein the first end of the tube set and the infusion base comprises a fluid connector that is removably attachable to the infusion base.

5. The infusion set as claimed in claim 1, wherein:

the infusion set includes an introducer needle; and

the infusion cannula comprises a soft catheter.

6. The infusion set as claimed in claim 5, wherein:

the infusion base comprises a septum; and

the introducer needle is configured to penetrate the septum.

7. The infusion set as claimed in claim 4, wherein the fluid connector is configured to engage a top surface of the infusion base.

8. The infusion set as claimed in claim 1, wherein the infusion cannula comprises a rigid cannula.

9. The infusion set as claimed in claim 1, wherein the tab of the infusion base is flexible and deflects when the pump connector is engaging the infusion base.

10. The infusion set as claimed in claim 9, wherein:

the tab of the infusion base reverts to an original shape when the rib of the pump connector is engaged to and disposed in the infusion base; and

the tab of the infusion base retains the pump connector in the infusion base.

11. The infusion set as claimed in claim 1, wherein:

the tab of the infusion base comprises a rigid opening in the infusion base; and

wherein the pump connector comprises the tab and said tab comprises a rigid member in the pump connector.

12. The infusion set as claimed in claim 11, wherein the tab of the pump connector travels through the tab of the infusion base when the pump connector is engaged to the infusion base.

13. The infusion set as claimed in claim 12, wherein the tab of the pump connector rotates in the infusion base to detachably secure the pump connector to the infusion base.

14. An infusion set as claimed in claim 1, wherein the infusion cannula includes a piercing part at an open end for piercing the user's skin.

15. An assembly comprising:

the infusion set of claim 1; and

an infusion pump.