WO2009047512A1 - Intravenous injection aid - Google Patents
Intravenous injection aid Download PDFInfo
- Publication number
- WO2009047512A1 WO2009047512A1 PCT/GB2008/003425 GB2008003425W WO2009047512A1 WO 2009047512 A1 WO2009047512 A1 WO 2009047512A1 GB 2008003425 W GB2008003425 W GB 2008003425W WO 2009047512 A1 WO2009047512 A1 WO 2009047512A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- needle
- guider
- guide
- base frame
- arms
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
- A61M2005/1585—Needle inserters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/42—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
- A61M5/425—Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/42—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
- A61M5/427—Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates
Definitions
- the present invention relates to an intravenous injection aid system.
- the present invention enables the venipuncture process to be more systematic and easier.
- Intravenous injections are common procedure for medicinal infusion or blood sampling.
- regular administrations of intravenous injections at home by nonprofessional or the patient are also common.
- This procedure is obviously not pleasant and requires not just skills, but confidence in giving a smooth veni-puncture action on a steady site.
- a successful veni-puncture process i.e. putting the needle through the skin and accurately into the vein to the right depth, with minimal damage to the venous and surrounding tissues
- This combination of requirements also coincides with an anticipated inflicting of pain and an anxiety of misplacing the needle, which can lead to further anxiety and additional psychological barriers to a successful injection.
- the invention consists of a guiding apparatus for a winged-type transfusion set where the needle of the latter can be assisted to follow a fixed or adjustable or "feel enhanced" injection trajectory path aided by the guide, thus enabling the IVi process to be made easier and safer.
- the winged-type transfusion set is typically of a modified butterfly® transfusion set, which consists of a buttefly® venous access needle connected to a winged body hub, which is further connected to tubing and connector which can be connected to a syringe.
- the current invention also includes design analysis which enables automation of the IVi process, either via direct robotic control and/or via aid in the design variations of the guiding apparatus mechanism.
- the location of an eventual suitable injection site must still be determined by the IVi administrator either by the usual sighting identification and/or sometimes with the aid of touching and feeling for the pulse or bulge of a vein.
- Some sophisticated imaging vein location technologies e.g. US2007161906 have also been developed.
- the present invention assists the accurate insertion of the shaft of the venous access needle (hereafter simply referred to as the "needle") at the predetermined site, at a predetermined or adjustable path such that the IVi process can be performed with greater confidence, ease and safety.
- the present IVi aid system increases the automation of the veni-puncturing process, since the administrator can accurately guide the transfusion needle into the vein without as much consideration or skill, during the veni-puncture process.
- the present invention can minimise potential tissue damage from over puncture or missing the original target injection site from some last moment error of judgement or through an unsteady hand or from the movement of the patient.
- the actual veni-puncture process is made easier and more certain with the benefit of reducing anxiety and also creating greater confidence for the IVi administrator.
- These benefits are particularly significant for inexperienced IVi administrators or patients with medical condition which may require self injection medication, or in situations where the selected injection site is subject to vibrations (e.g. the patient is inside a moving vehicle, such as an ambulance) or where the patient is uncooperative or an animal.
- the current invention could also be used as a teaching aid, to help improve a student's intravenous injection technique.
- the current invention includes an intravenous injection guide comprising a supporting base frame and one or more guider arms connected to the base frame whereby the guider arm or arms can be used so as to engage with a protrusion from a transfusion set in such a way that the contour of the guider arm or arms helps guide the trajectory of the transfusion set to achieve successful veni-puncture.
- the invention also includes a method of using such an intravenous injection guide in combination with a transfusion set adapted to engage with the guider arm or arms of the intravenous injection guide.
- the invention further includes a method of determining a useful applicational profile for the trajectory of a transfusion set during the execution of an intravenous injection. Embodiments of the invention are now described in more detail.
- FIG. 1 is a schematic sketch of the side profile of the main components of a transfusion set, consisting of the shaft of the venous access needle 11, the body hub 13, and the corresponding tubing component 14.
- Step 1 The IVi administrator must first identify an ideal vein and location of the injection site. Once a site is identified, the needle should enter the injection site, through the skin layer, and then into the vein at an appropriate angle.
- the steepness of the initial entry angle depends on how far the vein is below the surface of the skin and the size of the vein. The IVi administrator will in general decide on the steepness of entry before he/she starts the puncturing motion.
- the injection site should be as close as possible to the middle section of the vein to minimise unnecessary venous damage and vein movement. Hence, to summarise, the administrator takes aim, at desired injection site 10, with needle 11 at an initial entry angle ⁇ o with respect to the surface of the injection site 15.
- Step 2 The administrator makes a sharp straight through venipuncture at fixed angle ⁇ o up to the desired depth.
- This desired depth optimally corresponds to when the tip of the needle has safely passed the upper side of the vein 16, but before it hits the underside of the same vein 17, the vein's side profile outline being shown as a dashed line.
- the length of this desired depth is represented by I 0 , as measured along the longitudinal length of the needle.
- Step 3 The administrator now inserts the needle further into the vein, accompanied by a simultaneous levelling of the needle (i.e. reducing the angle of penetration as shown by the direction arrow 18) until the needle is felt to be quite securely within the volume of the vein.
- the side vein profile i.e. 16 and 17
- the plane of the paper defined by the (x,y) coordinate system.
- Step 4 Assuming the veni-puncture has been successful, as can be assessed from observation of blood 'flashback' in the tubing of the transfusion set, the administrator stops the veni-puncture motion which may be accompanied by some minor adjustment, such that the body hub 13 part of the transfusion set is more or less resting stably on the patient's skin, at an orientation which ideally minimises tearing stress to the tissues at the injection site.
- the IVi action can be systematically represented by following the motion of any particular point in the needle.
- the motion of the IVi processes as described above can be analysed by following the motion of the point 12 (r, ⁇ ) relative to the injection site 10, at the origin.
- FIG. 2 shows a plot of point 12 in the polar coordinate system (r, ⁇ ).
- Pi 2 represents the path described between Step 1 and Step 2
- P 3 4 is the path described in Steps 3 and 4, where r 34 ( ⁇ ) is the general equation representing this path.
- the arrows in Pi 2 and P 34 simply indicate the temporal order of the dynamical IVi process.
- the supposed paths can be emulated best from models which follow the time evolution of the IVi processes.
- the time dependency can be introduced via the speed at which the needle is being inserted in the IVi steps described.
- the path Pi 2 can in general be described by
- Pi 2 is a straight line motion with the anticipated gradient tan( ⁇ o).
- the path P 34 can be deduced by substituting Eq. (6b) into Eqs(3a,3b) or Eqs (4a, 4b).
- Figure 5A and 5B show respectively plots of (x,y) and its corresponding instantaneous gradient y/x (equivalents, the slope of the needle) of the point 12.
- point 12 is also known as the Top Needle point or the TN-point as labelled in the title of Figures 5A and 6A.
- the desirable IVi path of the needle can be usefully anticipated and therefore potentially controllable.
- One method of controlling the needle to follow the desirable IVi path is to handle or assist guiding a 'component' or part of the transfusion set which is rigidly connected with the needle, such that the point 12 follows the desirable path.
- This 'component' can be a thin rod or bar or specially adapted shaped structure extending out of the body hub 13 of the transfusion set, whereby this component acts as a gliding mechanism, or as a holding system for robotic handling control.
- this 'component' may be located away from the body hub 13 of the transfusion set.
- FIG. 7 A shows a new type of winged like transfusion set (hereafter referred to as the "glider transfusion set” or abbreviated to the G-transfusion set) with this 'component' part labelled by the numeral 20.
- this gliding transfusion set is shown with the needle 11 pointing upward and tilting slightly away from the plane of the paper.
- Figure 7B shows the gliding transfusion set in the same side- on view in the same sense as Figure 1, where the dotted point 21 is the geometric central point of the tip of the thin extended bar component 20.
- component 19 will be referred as the handling wing
- component 20 as the glider
- the geometric central point of the tip of the glider i.e. dotted point 21
- G- point the glider point or G- point.
- An important feature of the current invention is the control of the glider 20, or effectively the control of the G-point 21 path to realise an effective IVi aid.
- it is an aim to emulate the same desirable point 12 path, via the equivalent path dynamic of another point (i.e. the G-point 21) away from the point 12 where it can be controlled or handled.
- This figure shows that the positioning of the G- point 21 (and so the glider 20) allows a flexible or optimal design solution for any IVi aid that may rely on the principle of controlling the path and gradient of the needle via a mechanical control and constraints placed on the movement of the glider 20.
- the G-point 21 location for the curve B case approximates the common relative position where an IVi administrator would be holding the needle by the folded wing of a conventional butterfly® wing transfusion set.
- curve B illustrates best the path taken by the holding fingers of the IVi administrator when administering this particular IVi.
- Note the above model involves two distinct set of parameters a) those specific to the nature of the IVi process involving human interaction and decision, corresponding to the variables ⁇ Of ⁇ f, I 0 , U, to and t f and b) those variables specific to the design of the IVi transfusion set, corresponding to the variables L, I 9 , and ⁇ .
- the above mathematical analysis can be used to define how the orientation and movement of the needle is best controlled via appropriate handling and constraints applied to a rigid body part of the transfusion set (i.e. control in which the G-point path emulates the desirable calculated IVi path).
- the analysis sets out design equations which can be used with relevant parameters to achieve accurate predictions of the G-point path, and thus also enable optimal design and control of any IV needle, via control on the G- point movement.
- the use of this analysis and equations can achieve the automation of the IVi administration process e.g. by robotic control. It can also achieve the optimum design of the G- transfusion set, with handling component 19, and gliders 20 enabling control of the G-point path via means of a "guiding apparatus".
- the invention comprises two parts as described in a) and b) below: -
- a complementary designed wing type transfusion set i.e. the G-transfusion set designed to work with the S-guider.
- FIGURE 9 shows schematic of a S-guider at several viewing angles.
- FIGURE 1OA shows a G-transfusion set for use with above.
- FIGURE 1OB shows a G-transfusion set with stabilising flexible wings 27, and gliders 20 located on an extended handling tail wing.
- FIGURE HA shows an S-guider without the guider arms.
- FIGURE HB shows close-up views of the target vein stabiliser 28.
- FIGURE 12A shows a guider arm component 22 for shallow entry injection.
- FIGURE 12B shows a guider arm component 22 for a G-transfusion set with gliders 20 positioned significantly away from the hub line.
- FIGURE 13A shows detail features of the glider component 20.
- FIGURE 13B shows an additional feature to the glider component.
- FIGURE 14 shows a multi-adjustable S-guider.
- FIGURE 15 shows a transfusion set stabiliser aid 30 in action.
- FIGURE 16 shows an alternative handling wing design 19a.
- Figure 9 shows a S-guider with its main features at several viewing angles, suitable for use as an IVi aid for an injection site where the initial veni-puncture process is relatively steep e.g. ⁇ o around 30°, similar to the situation for Figure 6A.
- the S-guider consists of the following key components; a narrow base frame chassis 23 consisting a short side 23a and the pair of long sides 23b. Attached to 23b is a pair of guider arms 22, a pair of flexible wings 24, a pair of "needle depth” limiters 25, and an injection site indicator 26.
- Figure 1OA shows the G-transfusion set to be used with the S- guider of Figure 9. This is similar to the set shown in Figure 7, except the glider 20 is fixed to the body hub 13 (i.e.
- the dimensions (e.g. I 9 , length of needle L, size of the handling wing 19 and the gliders 20) of the G-transfusion set are designed to work with the corresponding dimensions of the S-guider or vice versa.
- the current invention works by: a) locating a suitable injection site location (i.e. corresponding to 10 in Figure 1), b) placing the S-guider on the location such that injection site 10 is at the geometric centre of the imaginary line joining the injection site markers 26, as indicated by the arrow heads in Figure 9.
- the S-guider can then be securely fixed to the patient by overlaying tapes on the flexible wings 24 and the patient's surrounding skin.
- the underneath of 24 may have non permanent adhesive properties which can be simply attached securely onto the skin.
- the IVi administrator can now hold the G-transfusion set via the handling wing 19 and manoeuvre it through the empty gap between the pair of guider arms 22 e.g.
- the size and shape of the handling wing 19 enables the IVi administrator to effectively control the G-transfusion set without being hindered by the potential obstacles of the guiding arms 22, especially during the final stages of the IVi process when the transfusion set is at an low angle relative to the surface of the injection site.
- the handling wing 19 needs to be bigger for deep initial entry IVi, because the guider arms 22 would be taller relative to the surface of the injection site.
- the gliders 20 can then be slotted into hooked end 22d of the guider arm 22 so that a glider 20 on each side of the S-guider engages with the hooked end 22d of the corresponding guide arm 22.
- Adjacent to the hooked end 22d is an edge 22a of the guider arm 22 which has a straight line contour for a distance between the hooked end 22d and a transition point 22c.
- a contour edge 22b of the guider arm 22 On the other side of the transition point 22c is a contour edge 22b of the guider arm 22 which has a profile which is contoured.
- the straight edge 22a of each glider arm 22 corresponds to aiding the emulation of the initial venipuncture process associated with steps 1 and 2 of the IVi process (i.e. see Figure 1 or equivalents path Pi 2 of Figure 2).
- Step 3 and path P 34 in Figure 2 are emulated by the glider 20 following one or more contour edges 22b of the guider arm 22.
- contour edge is positioned on the contour arm 22, starting at point 22c and continuing for a distance towards the end of the arm 22 closest to the base side 23b.
- the path of the glider 20 may be further defined by an additional or alternative contour edge 22b positioned at the open end of the hook 22d (ie at the end of arm 22 furthest from base side 23b in circumstances where the arm 22 bends back on itself to form the hooked end 22d as shown in Figure 9).
- the needle 11 is then angled to aim at the injection site, so that it is parallel to the straight line edge 22a i.e. the line describing edge 22a is in the same direction as the straight line defining the direction of the transfusion set as shown in step 1 of Figure 1.
- the IVi administrator can now simply administer the veni- puncture according to the normal IVi process as described in the four steps of Figure 1, except step 2 and the transition from step 2 to the early part of the step 3 of the IVi processes are aided and constrained by the contour and constraints set by the straight line edge 22a and the contour edges 22b of the guider arms 22 respectively, the latter initiating the change of gradient of the needle.
- the guider arm 22 does not need to have contour edges 22b which follow the entire Step 3 veni-puncture process i.e. only the early part of the P34 path (see Figure 2) need to be emulated by the contour edges 22b of the glider arm 22.
- the rest of the P 34 motion in practice will be quite intuitive and natural after the initial guiding by the current invention.
- the final step of the IVi process is to stop the needle at a desirable penetration, which is achieved by the gliders 20 hitting the position adjustable needle depth limiters 25, which physically prevent the needle from travelling deeper than required.
- the limiters 25 should provide a sufficient resistance to the gliders 20, so that the IVi administrator is given a physical and enhanced feedback warning to stop the needle, and so prevent accidental or careless over puncture.
- the limiters 25 resistance should not be an absolute hard stop. If the IVi administrator feels that he needs to insert the needle a little further, then the construction should enable him to do so by using a little more force to counter the nominal resistance of the limiters.
- Figure HA illustrates a base frame 23 of the S-guider, with the guider arms 22 removed from the illustration. It illustrates the component parts: short side of base frame 23a, connected to pair of long sides of base frame 23b, with part 23a connecting rigidly the latter components 23b.
- Side 23a is preferably shaped or positioned such that it minimises contact with the skin surface e.g. 23a can be slightly arched in shape. This is because near the vicinity of the injection site 10, it is desirable to prevent possible compression of the target vein ahead of the injection site 10 by any object which may be in contact with the skin.
- the pair of base frame long sides 23b comprise or are attached to the other chief components of the S-guider: the guider arms 22 (not shown), the injection site indicator 26, needle depth limiters 25 and flexible wings 24.
- the injection site indicator 26 is simply a marker or markers on the frame 23b (as indicated by the arrows, marked at the appropriate position commensurate with the engineering criteria as discussed above), or marked on a slightly protruding structure 28.
- This structure 28 can act as a vein stabiliser since some visible target veins can be quite prominent; the edge structure of 28 minimises side movement of the prominent vein making it more stable during the veni-puncture action.
- a slight cusp or lip structure 28a (see Figure HB) added to the underside structure of the protruding structure 28 can assist vein stability.
- the cusp 28a has the effect of slightly digging into the tissue surrounding the target vein 29, thus having a desirable effect of making the target vein more stable and prominent.
- an appropriate size and width separation would be chosen as is most appropriate for the size and width of the target vein.
- the S- guider can be secured to the injection site area using the flexible wing structure 24 secured by tapes or backing adhesive.
- the flexible wings 24 shown in Figure HA are a variation of those shown in Figure 9.
- Each wing is connected to the long side frame 23b as shown.
- the wing can be split into two or more smaller strips, and shaped such that when tied down, it offers an improved secure arrangement against forced movement. Note the splitting of the wing into smaller strips can be essential for secure attachment to the injection site area, where there may be local curvature.
- the needle depth limiter 25 is an adjustable slider moveable on a track connected to the side of the base frame 23b.
- the slider 25 may be situated on either side of the base frame 23b, depending on the situation and design of the G-transfusion set.
- the prefered designs shown have the limiters 25 and the relevant tracks situated on the inside of the base frame 23b. This design enables the G-guider to be as compact as possible, which can be an important consideration since the vicinity of most injection sites are not entirely level surfaces.
- the example limiter 25 is simply based on a raised slider, which is moveable under control resistance along a track adjacent the inside side surface of the base frame 23b).
- the limiter 25 When positioned appropriately before the veni-puncture process, it provides a positive feedback as well as physical resistance to unintentional excessive penetration of the needle, when the gliders 20 of the G-transfusion set hit the limiter 25.
- One possible design option is to have the base of the limiter 25 in contact with the skin, so that the friction between the base and the skin contributes to the control resistance, as well as providing an enhanced feedback when the gliders 20 reach the preset position of the limiters.
- the limiter is not totally immovable and so, unless it has reached the track limit, the transfusion needle can be further adjusted if necessary.
- Figures 12A,and 12B show in more detail structure designs for the guider arm 22. Since the pair of guider arms 22 is symmetrically identical, only the profile of one of the arms is shown.
- Part of Figure 12A shows a side profile of a guider arm 22 suitable for an initial shallow needle entry (e.g. ⁇ O « 1O°) case.
- Figure 9 note how the guiding edges (22a, 22b) of the guider arm 22 are now more commensurate with the profiles deduced for Figure 5A.
- the paths Pi 2 and the early stage of P 3 4 are aided via the profile of edges 22a and 22b.
- An important feature shown is that the size (i.e. length and size of the gap) within the hooked end 22d along the straight section edge 22a will always have space for the gliders 20 to manoeuvre, and is not tightly constrained. Some spare room for manoeuvre is also true along the contour edges 22b.
- FIG 12A Also shown in Figure 12A is a bird's eye view of the S-guider together with a G-transfusion set ready primed (i.e. as in Step 1 of Figure 1) to carry out the IVi process.
- the gliders 20 are now inside the hooked end 22d adjacent the straight line edge 22a of the guider arm, with the tip of the needle 11 just above the injection site 10.
- One useful feature of the guider arm 22, indicated by this figure, is that only near the base region of the arm 22 is it in line with the base chassis sides 23b. Further towards the hooked end 23d of the guider arm 22, the arm 22 is closer to the needle 11 than are the sides 23b.
- the guiders 20 can be shorter and therefore more rigid; the lateral available curvature deviation about the injection site is smaller; and the G-transfusion set can lie completely flat (rather than the tips of the gliders 20 resting on the base chassis sides 23b). Note, the latter is not an issue if the gliders 20 are placed above the level of the hub 13 e.g. as in the G-transfusion set shown in Figure 1OB.
- Figure 12B shows a side profile of a guider arm 22 suitable for a deeper initial needle entry (e.g. ⁇ o «3O°), but for use with an S- transfusion set where the gliders 20 are situated on the handling wing 19 (e.g. similar to the situation for the result obtained for curve B of Figure 8A).
- an S- transfusion set where the gliders 20 are a further distance up from the hub 13 is it allows the design of a less 'cramped' S-guider.
- the guider arm 22 shown in Figures 12A or 12B is securely attached to the base chassis edges 23b via a permanent construction casting.
- the end 22e of arm 22 is connected to the base of the guider arm 22.
- the IVi administrator would have to choose the appropriate S-guider with the appropriate angled guider arm 22 for the particular relevant target vein situation.
- the guider arm base 22e it is possible to design the guider arm base 22e to be detachable from the base chassis sides 23b. This can be done via a number of usual secure detachable means, a neat solution being the use of a powerful magnetic attachment method e.g. with powerful rare earth type magnets embedded in the guider arm base 22e, which is attracted to a magnetically attractive base chassis side 23b; or vice versa.
- This design enables quick interchange of the guider arms for optimal application of the current invention.
- Figures 13A and 13B show some additional features to the design of glider 20.
- Figure 13A shows a cross sectional view 20a of the glider 20 of the G-transfusion set.
- the frontal side profile should be slightly sloped as shown magnified at 20a.
- Figure 13B shows an additional feature in the glider 20 by way of the addition of a small upturn tip 20b to the end of the glider 20.
- the purpose of the tip 20b is to prevent excessive sideward mishandling during the venipuncture process, when the gliders 20 are inside the guided sections 22a, 22b of the guider arm.
- the length of the glider is selected so that the tip 20b is just on the outside of each guider arm.
- Figure 14 shows an adjustable S-guider where the initial angle of injection ( ⁇ o) can be adjusted, where the top illustration has high ⁇ o and the lower illustration has lower ⁇ o-
- the guider arm 22 can be rotated via a joint/hinge mechanism built at the base 22e of the arm 22 so easily to achieve the aim of varying ⁇ o.
- the length of the guider arm can also be varied via telescopic mechanism as indicated at 22f.
- the straight line section edge 22a guides the glider 20 through steps 1 and 2 of the IVi process.
- Guidance of the glider 20 through steps 3 and 4 of the IVi process is achieved by the inclusion of an additional slider 22g with a changing slope profile as shown in the Figure 14.
- the slider 22g has a profile designed to guide glider 20 (indicated by 22h) and a vertical edge adjacent that profile (indicated by 22i).
- This 'sloping' slider 22g is attached to the inside of the base chassis sides 23b in a similar way to the limiter 25 and has sufficient sliding resistance to resist movement when the glider 20 is only sliding past its contour profile 22h, but moves more readily when glider 20 hits the vertical side 22i.
- the gliders 20 of the transfusion set would be guided by the high slope profile suitable for such IVi as shown on the top figure.
- the slider 22g and the guider arm 22 (and if necessary the length of the arm via 22f) can be adjusted to provide the appropriate contour guide.
- the S-guider shown in Figure 14 is suitable for a G-transfusion set where the position of the gliders 20 is situated at the hub 13.
- An adjustable S-guider suitable for a G-transfusion set where the position of the glider 20 is not situated at the hub i.e. ⁇ 0
- long sides 23b for better fit on not so level surfaces such as the kooks of the arm.
- long sides 23b may be attached to short sides 23a via a resistive adjustable hinge/joint mechanism, so that sides 23b can be rotated relative to the surface 15 of the injection site 10 which may not be exactly smooth and flat.
- the Flexible wings 24 for secure attachment may be substituted by a wrap around hook and loop (e.g. Velcro® type) fastener.
- a light source e.g. LED
- various colours to suit different skin tones, which may be embedded in the protruding side structure 28 to improve vein contrast.
- reddish/purple colour light shone from the side level is particularly effective for making the target vein clearer.
- External power sources via batteries or mains connected via wire to the S-guider would be required for the S-guider to remain compact and light.
- the transfusion set is pulled towards an orientation which is not ideal as it can cause unnecessary tissue damage, and sometimes even leads to the needle loosing the vein connection.
- the transfusion set is stabilised by securing it e.g.
- the current invention can facilitate a secure connection without the inconvenience of applying taping procedure by incorporating a simple weighty and flexible string or strap 30 connected to the S-guider (e.g. attached to the open end section of side 23b).
- the underside of the strap 30 is made of material which does not easily slip against the surface (i.e. skin) on which it lays.
- the flexibility of the strap enables it to contour and sit itself securely with the surrounding skin area.
- the string or strap 30 is connected so that it can be manoeuvred (i.e.
- a flexible strap 30 is installed on each side of the S-guider base side 23b in order to facilitate the optimal placement option as the transfusion set tubing 14 could be in an awkward position.
- the weight of the strap prevents unintentional movement of the transfusion set during normal routine medication or blood sampling.
- the strap can simply be pulled away without any interference to the transfusion set.
- the above functionality associated with the stabilising strap 30, also constitutes an IVi aid.
- strap 30 does not necessarily have to be connected with the S-guider as shown, and may be used on its own. 6)
- the handling wing 19 described above consists of a single wing design with gliders 20 on each side. This necessitates that the handling wing 19 is relatively rigid and rigidly attached to the hub 13 of the transfusion set.
- the gliders 20 could be positioned along the hub or on the handing wings 19a as shown in Figure 16. Standard simple locking mechanisms (e.g. plug and hole method) could be utilised so that when the two wings are held in the vertical wing position, the folded wings remain so.
- An S-guider comprising only one guider arm 22.
- Such an S- guider could simply be similar to either of the sides of the S- guider associated with Figure 9, but without the edge 23a.
- part of the wing structure 24 close to the base 23b would no longer be flexible, although malleable , so as to give this S-guider structural integrity and adjustability to rest securely near the injection site.
- the base 23b could be shaped more broadly or have a malleable protrusion part to enable it to rest securely near the injection site.
- the S-guider would be applied next to the target vein with the single injection site indicator 26 pointing in the direction of the injection site.
- a G-transfusion set similar to those shown in Figures 1OA or 1OB would still be used, although its handling wing 19 could be reoriented to enable easier handling . For example, if a right sided single armed
- the handling wing 19 of the G- transfusion set shown in Figure 1OA would be preferentially tilted away (in a rotational sense) from the central vertical position, with the orientation of the needle 11 and the single glider 20 remaining identical as before. This ensures that the handling wing 19 and the fingers holding such tilted handling wing 19 are not blocked or prevented from free movement due to the nearby guider arm 22. Positioning the handling wing 19 like this could also assist feel and handling. Such positioning would counter balance the slightly uneven force that would otherwise be felt due to the loss of a symmetrical reaction from a pair of guider arms.
- An advantage of the single armed S-guider is that it has a much smaller footprint, and is therefore not as affected by excessive local curvature deviation or bumps near the injection site.
- the simpler S-guider described is expected to be disposable, although the more sophisticated versions described may be reusable after sterilisation.
- the material used for the S-guider should ideally be hypoallergenic or have anti-bacterial property, especially if it is designed to be reusable.
- the S-guider, and especially the guider arm 22 should ideally be made of transparent or translucent materials e.g. clear acrylics plastics.
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB1006039.0A GB2467244B (en) | 2007-10-12 | 2008-10-09 | Intravenous injection aid |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB0719976.3 | 2007-10-12 | ||
GB0719976A GB0719976D0 (en) | 2007-10-12 | 2007-10-12 | Intravenous injection aid |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2009047512A1 true WO2009047512A1 (en) | 2009-04-16 |
WO2009047512A4 WO2009047512A4 (en) | 2009-06-11 |
Family
ID=38788078
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/GB2008/003425 WO2009047512A1 (en) | 2007-10-12 | 2008-10-09 | Intravenous injection aid |
Country Status (2)
Country | Link |
---|---|
GB (2) | GB0719976D0 (en) |
WO (1) | WO2009047512A1 (en) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2404632A1 (en) * | 2010-07-10 | 2012-01-11 | Roche Diagnostics GmbH | Insertion system for needles |
WO2014114671A1 (en) * | 2013-01-23 | 2014-07-31 | Fresenius Medical Care Deutschland Gmbh | Vascular access device for reproducibly inserting a cannula into a puncture point |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN115501423A (en) * | 2022-09-23 | 2022-12-23 | 中国人民解放军陆军军医大学第一附属医院 | Simple auxiliary device for transfusion port |
Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4332248A (en) * | 1980-07-31 | 1982-06-01 | Devitis Thomas N | Medical apparatus |
US4930525A (en) * | 1989-03-28 | 1990-06-05 | Palestrant Aubrey M | Method for performing C.T. guided drainage and biopsy procedures |
US5167630A (en) * | 1991-09-26 | 1992-12-01 | Paul Kamaljit S | Blood vessel cannulation device |
US20040015130A1 (en) * | 2002-07-16 | 2004-01-22 | Neumann Calvin Lee | Vein retaining device |
US20040204662A1 (en) * | 1997-11-21 | 2004-10-14 | Perez Edward P. | Methods and apparatus for expressing body fluid from an incision |
US20050257795A1 (en) * | 2004-05-20 | 2005-11-24 | Yu Hsiu-Chen | Method and apparatus for locating superficial veins or specific structures with a LED light source |
US20060211987A1 (en) * | 2005-03-18 | 2006-09-21 | Williams Arthur M | Vein stabilizer devices and methods of using same |
US20070232999A1 (en) * | 2006-03-30 | 2007-10-04 | James Gerard Perez | Artery stabilizer device with a syringe slide |
-
2007
- 2007-10-12 GB GB0719976A patent/GB0719976D0/en not_active Ceased
-
2008
- 2008-10-09 GB GB1006039.0A patent/GB2467244B/en not_active Expired - Fee Related
- 2008-10-09 WO PCT/GB2008/003425 patent/WO2009047512A1/en active Application Filing
Patent Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4332248A (en) * | 1980-07-31 | 1982-06-01 | Devitis Thomas N | Medical apparatus |
US4930525A (en) * | 1989-03-28 | 1990-06-05 | Palestrant Aubrey M | Method for performing C.T. guided drainage and biopsy procedures |
US5167630A (en) * | 1991-09-26 | 1992-12-01 | Paul Kamaljit S | Blood vessel cannulation device |
US20040204662A1 (en) * | 1997-11-21 | 2004-10-14 | Perez Edward P. | Methods and apparatus for expressing body fluid from an incision |
US20040015130A1 (en) * | 2002-07-16 | 2004-01-22 | Neumann Calvin Lee | Vein retaining device |
US20050257795A1 (en) * | 2004-05-20 | 2005-11-24 | Yu Hsiu-Chen | Method and apparatus for locating superficial veins or specific structures with a LED light source |
US20060211987A1 (en) * | 2005-03-18 | 2006-09-21 | Williams Arthur M | Vein stabilizer devices and methods of using same |
US20070232999A1 (en) * | 2006-03-30 | 2007-10-04 | James Gerard Perez | Artery stabilizer device with a syringe slide |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2404632A1 (en) * | 2010-07-10 | 2012-01-11 | Roche Diagnostics GmbH | Insertion system for needles |
US8679132B2 (en) | 2010-07-10 | 2014-03-25 | Roche Diagnostics Operations, Inc. | Insertion system |
WO2014114671A1 (en) * | 2013-01-23 | 2014-07-31 | Fresenius Medical Care Deutschland Gmbh | Vascular access device for reproducibly inserting a cannula into a puncture point |
Also Published As
Publication number | Publication date |
---|---|
GB0719976D0 (en) | 2007-11-21 |
WO2009047512A4 (en) | 2009-06-11 |
GB2467244A (en) | 2010-07-28 |
GB201006039D0 (en) | 2010-05-26 |
GB2467244B (en) | 2012-08-08 |
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