CA1238832A

CA1238832A - Iv tube activator

Info

Publication number: CA1238832A
Application number: CA000527062A
Authority: CA
Inventors: Jon Bisha
Original assignee: Jon Bisha; Fisher Scientific Group Inc.; Imed Corporation; Ivac Holdings, Inc.; Alaris Medical Systems, Inc.; Cardinal Health 303, Inc.
Current assignee: CareFusion 303 Inc
Priority date: 1986-03-19
Filing date: 1987-01-09
Publication date: 1988-07-05
Also published as: AU6952487A; US4689043A; JPS62221365A; AU604477B2; JPH0418867B2; EP0238227B1; EP0238227A2; EP0238227A3; DE3774598D1

Abstract

IV TUBE ACTIVATOR
ABSTRACT OF THE DISCLOSURE

An IV tube activator for use with a peristaltic IV
infusion pump comprises means that requires the closure of a tube associated clamp upon engagement of the IV tube with the pump and upon any subsequent disengagement of the IV tube from the pump.
The activator further comprises means which simultaneously move the tube associated clamp to open the IV tube when the pump is being operated.

Description

~ 3~

2BACKGE~OUND OF THE INVE~lTION
3 ___ __ _ 4This invention relates generally to slide clamps used to control fluid flow through an IV line. More specificially, 6 the present invention relates to an apparatus which requires 7 structural cooperation between the slide clamp and an IV infusion 8 medical device for activation and deactivation of the clamp on 9 the IV line. The present invention is particularly, though not exclusively, useful for the operative engagement and subsequent 11 safe disengagement between an IV line and a linear peristaltic IV
12 infusion pump.

15DESCR_TION OF THE PRIOR ART
lG
17The use of medical devices for the IV infusion of medi-18 cal solutions to patients is well known in the medical profes-19 sions. One type of medical device which has been widely used for this purpose is the peristaltic pump. As is well known in the 21 pertinent art, peristaltic pumps create a moving zone of occlu-22 sion along a portion of the IV line to create the pumping action 23 required. However, because they require a patent IV tube for 24 their operation, when the tube is not engaged with the pump, there is the danger of possible unwanted free flow of medical 2G solution from the fluid source directly into the patient.
27 Typically, the times of greatest concern for this danger are 28 during the initial set-up of the IV administration system and at 29 any subsequent times when the IV line is connected between the fluid source and the patient and becomes, for whatever reason, 31 disengaged from the device.

` 123~83~
The control of fluid flow through patent IV lines from a fluid source to a patient i~ an ever pre6ent problem and several devices to help solve this problem have been proposed. For example, slide clamp6 which con6trict or obstruct the IV line are well known. Typically, these are manually operated clamp6 which are found in various configurations. One such clamp is a roller clamp of the type de~cribed in U.S. Patent No. 3,189,038 to Von Pechmann. Another type is the well-known slide clamp, an example of which is disclosed in U.S. Patent No. 2,889,848 to Redmer.
Again, such clamps are manually operated. Further, they must be activated independently and separately from any medical device which may be operatively attached to the IV fluid line.

In situations where a medical device is to be used for the infusion of medical 601utions to a patient, it is necessary to coordinate the use of a tube clamp with the operation of the device. For reasons given above, this is particularly 80 where a peristaltic pump is used. The idea of associating the clamp with the device to bring about a cooperation of structure therebetween is known in the prior art. For example, the invention disclosed 20 in U.S. Patent 4,586,691 to Kozlow, which is as~igned to the assignee of the present invention, discloses a safety slide clamp which requires the cooperation of structure between the device and the clamp itself. Such a clamp as disclosed in the Kozlow patent, however, reguiees manual activation of the clamp to open the tube prior to the actual operation of the pump. Although such a clamp may be acceptable in some cases, in others the additional manipulation required to activate the clamp may be inconvenient or undesirable.

- 2 -:1238133;~

1 In light of the above, it can be appreciated that there 2 is a need to simplify the engagement of an IV tube with a peris-

3 taltic infusion device. Specifically, there is a need to reduce

4 the number of steps necessary to accomplish such an engagement.

Thus, there is a need for a clamping apparatus which eliminates 6 the manual step of activating the tube clamp.

8 Accordingly, it is an object of the present invention 9 to provide a clamp activation apparatus which ensures safe opera-tion of a peristaltic infusion device. It is another object of 11 the present invention to provide a means which ensures that only 12 a restricted or obstructed IV tube can be engaged with a peris-13 taltic device. Further, it is an object of this invention to 14 provide a device which prevents removal of a patent tube from the device. It is yet another object of the present invention to lG provide an apparatus which automatically makes the tube patent 17 while simultaneously preparing the device for its operation.

1~
SUMMARY_OF THE INVENTION

22 The activation apparatus of the present invention pro-23 vides for the activation of an IV tube associated slide clamp 24 through the operation of structural components of an IV infusion 25 medical device. The present invention includes means for holding 2G the IV tube in operative engagement with the device while a 27 handle which is pivotally mounted on the device is allowed to 28 move into engagement with the clamp. The handle is structured to 29 urge the clamp from a closed position, wherein the clamp con-stricts or restricts the flow of fluid through the tube, to an ~238~332 1 open position wherein the tube is patent. The handle also 2 includes structure to operate reversibly and urge the clamp from 3 the open position to the closed position in preparation for the 4 removal of the tube from the device. The apparatus of the pre-sent invention also comprises a lockout means which is mounted on 6 the device to ensure that initial engagement of the IV tube with 7 the device can only be accomplished when the clamp is in the 8 closed position.

The novel features of this invention as well as the 11 invention itself, both as to its organization and operation, will 12 be best understood from the accompanying drawings taken in ~con-13 junction with the accompanying description in which similar 14 reference characters refer to similar parts and in which:

lG

19 -Fig. l is an elevation view of a peristaltic device incorporating the present invention in operable engagement with 21 an IV tube:

23 Fig. 2 is an elevation view of an IV tube in engagement 24 with a linear peristaltic pump with various components disengaged from one other;

27 Fig. 3A is an exploded perspective view of the slide 28 clamp assembly with portions broken away for clarification;

Fig. 3B is a perspective view of the lower hinge 31 bracket of the present invention;

~238832 1 Fig. 4 is a perspective view of the slide clamp 2 assembly nested in the lower hinge bracket with the slide clamp 3 in a tube constricting position Fig. 5 is a perspective view of the slide clamp 6 assembly nested in the lower hinge bracket with the slide clamp 7 in a tube open position;

9 Fig. 6 is a perspect~ve view of the grip of the present 0 invention;

12 Fig. 7A is an elevation view of the handle and slide 13 clamp assembly in a disengaged configuration with portions of 14 structure omitted for clarity;

lG Fig. 7B is a view of the handle and slide clamp 17 assembly as shown in Fig. 7A in a partially engaged configuration 18 with portions of structure omitted for clarity;

Fig. 7C is a view of the handle and slide clamp 21 assembly as shown in Fig. 7A engaged with the slide clamp closed 22 on the IV tube with portions of structure omitted for clarity;
23 and Fig. 7D is a view of the handle and slide clamp 2G assembly as shown in Fig. 7A engaged with the slide clamp posi-27 tioned for an open IV tube with portions of structure omitted for 29 clarity.

123~3~33;~

3 The intended environment for the present invention is 4 best seen in Fig. 1 where a peristaltic infusion device, generally designated 10, is shown in operative engagement with an 6 IV tube 12. In Fig. 1, it is seen that a fluid source 14 can be 7 suspended from appropriate apparatus associated with an IV pole 8 16 and IV tube 12 connected for fluid communication between fluid 9 source 14 with a patient (not shown).

11 Referring now to Fig. 2, it is seen that IV tube 12 12 includes a pumping section 18 made from any appropriate elas~o-13 meric material which will permit an effective peristaltic action 14 on the pumping section 18. One end of pumping section 18 is con-nected into fluid communication with IV tube 12 by a fitment 22.
lG A slide clamp fitment 20 connects the other end of pumping sec-17 tion 18 with a continuation of IV tube 12. With these connec-18 tions, a continuous fluid path is provided through IV tube 12 and 19 its associated pumping section 18.
21 As shown in Fig. 2, IV tube 12 and its associated 22 pumping section 18 are mounted on the device 10 by the engagement 23 of fitment 22 with upper bracket 26 and the engagement of slide 24 clamp fitment 20 with lower hinge bracket 24. Thus, when IV tube 12 is engaged with device 10, pumping section 18 is positioned 2~ against the peristaltic pumping means 28. Also, with this engage- .
27 ment, pumping section 18 is placed under slight tension to ensure 28 a snug fit between pumping section 18 and the peristaltic device 29 10. The connection of fitment 22 between IV tube 12 and pumping 31 section 18 can be accomplished by any means well known in the , 1238fl~

1 art, such as solvent bonding. Likewise, the connection between 2 slide cla~p fitment 2~ and pumping section 18 and IV tube 12 can 3 be accomplished by any means well known in the pertinent art.

Fig. 3A shows an exploded perspective view of the slide ~ clamp assembly for the present invention, generally designated 7 30. As shown, slide clamp assembly 30 includes slide clamp fit-8 ment 20 which is formed with a tab 34 and a tab 36. Further, tab 9 36 is formed with a key 38. Slide clamp fitment 20 is also formed with guides 40a and 40b and with retaining snaps 42a, b, c 11 and d. The retaining snaps 42a, b, c and d allow for a snap fit 12 engagement of the slide clamp 32 with slide clamp fitment 2~ into 13 a structure which is best seen in Figs. 4 and 5. Further, the 14 engagement of slide clamp 32 with slide clamp fitment 20, which permits the sliding of clamp 32 relative to fitment 20, is lG restrained by the mating engagement of ridges 44 with guides 40a 17 and 40b. Although not shown specifically in Fig. 3A, it can be 18 appreciated that ridges 44 are formed around the periphery of 19 slide clamp 32 simply by forming a depression on the surface of slide clamp 32 (depression not shown in Fig. 3A).

22 In light of the foregoing, and since IV tube 12 is 23 fixedly attached to slide clamp fitment 20, the engagement of 24 slide clamp 32 with slide clamp fitment 20 allows for reciprocal motion of the slide clamp 32 relative to IV tube 12. Accordingly 2G this motion will cause either a patent IV tube 12 or a restricted 27 IV tube 12. More specifically, by positioning clamp 32 relative 28 to IV tube 12 so that IV tube 12 is in the enlarged portion 48 of 29 aperture 46, a patent IV tube 12 is obtained. Subsequently, IV
tube 12 can be restricted by moving slide clamp 32 relative to IV

1238~3Z

1 tube 12 so as to position IV tube 12 within the slotted portion 2 S0 of aperture 46 when it is desired to restrict or occlude IV
3 tube 12. Reference to Fig. 4 and Fig. 5 shows the positioning of 4 slide clamp 32 relative to IV tube 12 and its respective posi-tioning relative to slide clamp fitment 20 when the slide clamp 6 32 occludes IV tube 12 and when slide clamp 32 allows fluid flow 7 through IV tube 12.
9 As shown in Fig. 2, lower hinge braket 24 is mounted to 0 the front of the device 10. A more detailed description of lower 11 hinge bracket 24 and its structure for the present invention is, 12 however, best appreciated with reference to Fig. 3B. As shown in 13 Fig. 3B, the lower hinge bracket 24 is formed with a yoke 52.
14 Also formed on lower hinge bracket 24 is a recess 54 adapted for mating engagement with key 38 of slide clamp fitment 20. Addi-1~ tionally, lower hinge bracket 24 is formed with a platform 56 and 17 a platform 58 which are adapted to respectively urge against tab 18 34 and tab 36 of slide clamp fitment 20. Also shown in Fig. 3B
19 is sear 60 which is formed on lower hinge bracket 24.
21 The cooperation of structure between slide clamp 22 assembly 30 and lower hinge bracket 24 is shown by the combina-23 tion of these components in Fig. 4 or Fig. 5. In cross-24 referencing Fig. 3B with Fig. 4 or Fig. 5, it will be appreciated that the slide clamp fitment 20 of slide clamp assembly 30 nests 2~ in lower hinge bracket 24. It will further be appreciated that 27 the mating engagement of key 38 with recess 54 can only be accom-28 plished upon a specific orientation of slide clamp fitment 20 29 with respect to lower hinqe bracket 24. This requirement for specific orientation of key 38 with recess 54 is a safety feature 123~3#32 1 which prevents an inadvertent mating o~ slide clamp fitment 20 2 with lower hinge bracket 24 in an inoperable condition.

4 Grip 64, which is shown by itself in Fig. 6, includes a pair of hooks 66a and 66b which straddle the channel 74 formed on 6 grip 64. Also formed on grip 64 is a sear cam 68 and a pivot 70.
7 It is to be appreciated that grip 64 is pivotally attached to 8 handle 72 at pivot 70 as shown in Fig. 2. A spring bias (not 9 shown) urges grip 64 in the direction opposite to that indicated by the arrow 78 and into its position relative to door 72 sub-11 stantially as shown in Fig. 2. Impliedly, grip 64 can be rotated 12 around pivot 70 in the direction indicated by arrow 78 but the 13 spring bias tends to restore grip 64 into the position shown in 14 Fig. 2.

lG To consider the cooperation of structure between handle 17 72, its associated grip 64 and slide clamp assembly 30, it should 18 be appreciated that the closure of door 76 onto device lO places 19 handle 72 relative to slide clamp assembly 30 as shown in Figs.
7A, 7B, 7C and 7D. These figures need to be considered se~uen-21 tially. In Fig. 7A it can be appreciated that the handle 72 is 22 rotatably attached to door 76 (not shown in Fig. 7A) at a pivot 23 point 82. Rotation of handle 72 about pivot 82 in the direction 24 of arrow 80 brings both handle 72 and grip 64 into initial con-tact with slide clamp 32 as shown ~n Fig. 7B. The comparision of 2G Fig. 7B with Fig. 7A shows that when in the position shown in 27 Fig. 7B, hooks 66a and 66b of grip 64 make contact with projec-2~ tions 62a and 62b of slide clamp 32 and are urged to rotate yrip 29 64 about pivot 70 in the direction shown by arrow 78 in Fig. 2.
3~ Further, and more specifically, movement of handle 72 from its 1231~83~

1 position in Fig. 7A to Fig. 7B causes handle 72 to contact end 2 portion 84 of slide clamp 32. A slightly further rotation of 3 handle 72 in the direction of arrow 80 about pivot point 82 4 causes hooks 66a and 66b to engage with projections 62a and 62b as shown in Fig. 7C. Specifically, cross-referencing Fig. 7s 6 with Fig. 7C shows that the movement of handle 72 into its posi-7 tion as shown in Fig. 7C causes grip 64 to ride over the projec-8 tions 62a and 62b of slide clamp 32 and allow the spring biased 9 grip 64 to move into its position as shown in Fig. 7C.

11 The relation of slide clamp 32 to slide clamp assembly 12 30, as shown in Fig. 7C, corresponds to the configuration of 13 slide clamp assembly 30 as shown in Fig. 4. Thus, as seen in 14 Fig. 7C, IV tube 12 is still restricted and complete engagement of the handle 72 with device 10 has not yet been accomplished.
lG Further rotation of handle 72 in the direction of arrow 80 brings 17 handle 72 into position with slide clamp 32 as shown in Fig. 7D.

19 -Fig. 7D shows the locked engagement which results by closing door 76 on device 10. The lock is accomplished by 21 bringing latch extension 86 of handle 72 into position relative 22 to anchor pin 88. As best seen in Fig. 2, anchor pin 88 is 23 fixedly attached to device 10. It can be appreciated that the 24 rotation of handle 72 in the direction of arrow 80, as shown sequentially in Figs. 7A, 7s, 7C and 7D, wraps latch extension 86 2~ around anchor pin 88 to lock door 76 against the device 10. This 27 locking accomplishes several purposes. Importantly, it positions ~8 door 76 against pumping section 18 for the purpose of acting as a 29 platen in the peristaltic action of peristaltic pumping means 28.
Additionally, when locked on device 10, door 76 protects the 31 engagement of fitments 20 and 22 with their respective brackets 32 24 and 26.

_ ~238~3;~

1 An important safety feature of the present invention 2 can be appreciated by cross-referencing Fig. 2 with Fig. 3s.
3 Both Fig. 2 and Fig. 3B show a lockout spring 90. It is to be 4 understood that in its unbiased position, lockout spring 90 is positioned to prevent the movement of slide clamp 32 from the 6 position as shown in Fig. 4 to a position as shown in Fig. 5 when 7 slide clamp assembly 30 is joined to lower hinge bracket 24.
8 However, as door 76 is closed onto device 10, a pin 92 which is 9 attached to door 76 as shown in Fig. 2 makes contact with lockout spring 90 and bends it in the direction of arrow 94 to allow the 11 sliding movement o slide clamp 32 past lockout sprirlg 90. Thus, 12 with lockout spring 90 cleared from the path of slide clamp 32, 13 slide clamp 32 is capable of being moved from a position as shown 14 in Fig. 4 to the position shown in Fig. 5.

lG It should be appreciated that the disengagement of IV
17 tube 12 from the device 10 can be accomplished by reversal of the 18 steps previously discussed and that the cooperation of structure 19 between grip 64 and slide clamp 32 would be substantially as shown by sequentially considering Figs. 7D, 7C, 7B and 7A. Fur-21 ther, it should be appreciated that as door 76 is unlocked by the 22 movement of handle 72, slide clamp 32 is repositioned to constrict 23 IV tube 12. Accordingly, the removal of IV tube 12 from device 24 10 can only be accomplished when IV tube 12 is constricted to prevent fluid flow therethrough.

For its operation the present invention requires that 1238~3:2 1 IV tube 12 be engaged with peristaltic device 10. This is accom-2 plished by positioning fitment 22 on IV tube 12 in upper bracket 3 26. The pumping section 18 of IV tube 12 is then stretched to 4 allow the positioning of slide clamp fitment 20 into lower hinge bracket 24. This placement of IV tube 12 on device 10 places 6 pumping section 18 of IV tube 12 against peristaltic pumping 7 means 28. The initial engagement of slide clamp fitment 20 with 8 lower hinge bracket 24 positions the slide clamp assembly 30 9 against lower hinge bracket 24 in the manner shown in Fig. 4.
Thus, for its initial engagement the slide clamp 32 is positioned 11 relative to IV tube 12 to constrict and prevent fluid flow there-12 through. In both Fig. 2 and Fig. 4, it is seen that the ke~ 38 13 of slide clamp fitment 20 requires that the engagement of slide 14 clamp fitment 20 with lower hinge bracket 24 be accomplished only as shown in Fig. 4. This places tab 34 and tab 36 respectively lG against the platforms 56 and 58 of lower hinge bracket 24.

18 With IV tube 12 positioned against device 10, door 76 19 can be clo~ed onto device 10. This results in a sequence of operations which will be best appreciated by reference to Figs.
21 7A, 7B, 7C and 7D. As the door 76 is closed onto device 10, the 22 latch extension 86 of handle 72 is positioned around anchor pin 23 88. Additionally, the grip 64 comes into contact with projection~
24 62a and 62b of slide clamp 32. Also, handle 72 makes contact with slide clamp 32 against its end portion 84. Movement of 2G handle 72 in a rotational motion about the pivot point 82 in the 27 direction of arrow 80 causes handle 72 to urge against slide 28 clamp 32 and engage hooks 66a and 66b on grip 64 with the projec-29 tions 62a and 62b on slide clamp 32. Further movement of handle 72 in the direction of arrow 80, as shown in-the progression from 1238f33~

1 Fig. 7B to Fig. 7C, causes the grip 64 to engage with slide clamp 2 32. Additional movement of handle 72 from its position in Fig.
3 7C to a position in Fig. 7D causes handle 72 to urge against 4 slide clamp 32 and position slide clamp 32 relative to slide clamp assembly 30 in a position as shown in Fig. 5. Accordingly, 6 when handle 72 has been completely engaged with door 76, IV tube 7 12 is made patent for the passage of fluid therethrough. Simul-8 taneous with the opening of slide clamp 32 on IV tube 12, the 9 closure of door 76 causes pin 92 to contact lockout spring 90 and 0 bend it in a direction indicated by arrow 94 to allow further motion of the handle 72 against slide clamp 32. As lockout 12 spring 90 is moved out of the way to allow for the movement ~of 13 handle 72, the sequence of engagement discussed above for Fig. 7A
14 through Fig. 7D is accomplished.

lG A consideration of Figs. 7A, 7B, 7C and 7D in reverse 17 order discloses the cooperation of structure required for dis-18 engagement of the IV tube 12 from device 10. Specifically, as 19 handle 72 is rotated about pivot point 82 in a direction opposite to arrow 80, the grip 64 is withdrawn in a manner which urges the 21 hooks 66a and 66b against projections 62a and 62b to cause move-22 ment of slide 32 from a position relative to IV tube 12 as shown 23 in Fig. 5 to a position for slide clamp 32 relative to IV tube 12 24 as shown in Fig. 4. It is important that once grip 64 is with-drawn to the position as shown in Fig. 7C, the sear cam 68, which2G is clearly shown on grip 64 in Fig. 6, rides over sear 60, which 27 is shown in Figs. 4 and 5 as part of the lower hinge bracket 24, 28 to urge grip 64 in the direction of arrow 78. This motion clears 29 the grip 64 from the projections 62a and 62b of slide clamp 32 and allows for further rotation of handle 72. It will be lZ38~3Z

1 appreciated that the further rotation of handle 72 is continued 2 until latch extension 86 is cleared from its engagement with 3 anchor pin 88, thus, unlocking door 76 from device 10 and 4 allowing the opening of door 76~ Once door 76 has been opened, the IV tube 12 can be removed from its fittings with device 10 6 and used as desired by the operator. It will be apreciated that 7 the action of grip 64 in opening door 76 has caused slide clamp 8 32 to constrict upon IV tube 12 and prevent fluid flow through IV
9 tube 12 upon the removal of IV tube 12 from the device 10.

11 While the IV tube activator has herein shown and 12 disclosed in detail is fully capable of obtaining the object~and 13 providing the advantages herein before stated, it is to be under-14 stood that it is merely illustrative of the presently preferred embodiment of the invention and that no limitations are intended 16 to the details of construction or design herein shown other than 17 as defined the appended claims.

24 .

Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE PROPERTY OR PRIVILEGE
IS CLAIMED ARE DEFINED AS FOLLOWS:

1. An apparatus for engaging an IV tube with a device used to infuse medical solutions to a patient which comprises:
a rigid clamp having relatively fixed clamping surfaces engageable with said IV tube and moveable relative to said tube between an open position wherein fluid can flow through said tube and a closed position wherein said tube is occluded by said clamp;
means for holding said IV tube in operative engagement with said device;
lockout means mounted on said device to establish said clamp in said closed position before operative engagement of said IV tube with said device;
and a handle associated with said device and moveable for engagement with said clamp to urge said clamp between said open position and said closed position.

2. An apparatus as cited in claim 1 which further comprises:
means associated with said device to disengage said lockout means and allow engageable movement of said handle with said clamp.

3. An apparatus as cited in claim 2 wherein a section of said IV tube has a first end and a second end and is made of a stretchable material.

4. An apparatus as cited in claim 3 wherein said IV tube further comprises:
a first fitment associated with said first end;
a second fitment associated with said second end; and said holding means comprises a first bracket for engageably receiving said first fitment and a second bracket spaced from said first bracket for engageably receiving said second fitment to stretch said section between said first and second brackets.

5. An apparatus as cited in claim 4 wherein said clamp is formed with a projection and said handle has a hook engageable with said projection to urge said clamp from said open position to said closed position.

6. An apparatus as cited in claim 5 further comprising:
a door hingedly mounted on said device for enclosing said IV tube between said door and said device when said door is closed.

7. An apparatus as cited in claim 6 wherein said handle is mounted on said door and said lockout disengaging means is mounted on said door.

8. A tube restrictor which comprises:
a base;
a rigid clamp having relatively fixed clamping surfaces slidably mountable on said base having a first end and a second end and formed with a generally tear-drop shaped aperture having its wide portion adjacent said first end and its narrow portion adjacent said second end;
a projection extending from said clamp;
a tube extending through said aperture;
a first means mounted on said base for urging against said first end to position said tube in said wide portion of said aperture and allow fluid flow through said tube;
a second means mounted on said first means for urging against said projection to position said tube in said narrow portion of said aperture and occlude said tube; and a lockout means mounted on said base to position said tube in said narrow portion of said aperture upon initial mounting of said clamp on said base.

9. A tube restrictor as cited in claim 8 wherein said base is a device used for the infusion of medical solutions to a patient.