A MEDICAL DEVICE

Abstract

This invention relates to a medical device (20, 40, 60) for use in aiding the successful placement of a needle tip in a blood vessel. The medical device comprises a resiliently deformable collapsible body (21) defining a pressure chamber therein. The body further comprises a port (29) for engagement of a hub of a needle, the port defining a fluid passageway from the exterior of the body to the interior of the pressure chamber. The device further comprises means to generate an audible noise (31, 41) upon expansion of the collapsible body from a collapsed configuration to an expanded configuration. In this way, as the tip of the needle enters the lumen of the blood vessel, the collapsible body is configured to transition from a contracted to an expanded configuration, thereby causing the auditory cue. This auditory cue indicates to the medical professional that the tip of the needle is in the lumen of the blood vessel.

Claims

1) A medical device for use in aiding the successful placement of a needle tip in a blood vessel, the medical device comprising a resiliently deformable collapsible body defining a pressure chamber therein, a biasing means operable to urge the resiliently deformable collapsible body from a collapsed configuration to an expanded configuration, a port for engagement of a hub of a needle, the port defining a fluid passageway from the exterior of the resiliently deformable collapsible body to the interior of the pressure chamber, and in which the medical device further comprises means to generate an audible noise upon expansion of the collapsible body from a collapsed configuration to an expanded configuration.

2) The medical device as claimed in claim 1 in which the resiliently deformable collapsible body has a bellows-like configuration with a pair of sides and a bladder therebetween.

3) The medical device as claimed in claim 2 in which the bladder is constructed from a resiliently deformable material, the natural resilience of the bladder providing the biasing means operable to urge the resiliently deformable collapsible body from a collapsed configuration to an expanded configuration when the bladder is in a collapsed configuration.

4) The medical device as claimed in claim 2 in which the pair of sides are dimensioned to be grasped between the thumb and the forefinger of an operator.

5) The medical device as claimed in claim 2 in which the bladder is concertinaed.

6) The medical device as claimed in claim 5 in which the concertinaed bladder is constructed from a resiliently deformable material, the concertinaed bladder providing the biasing means operable to urge the resiliently deformable collapsible body from a collapsed configuration to an expanded configuration when the concertinaed bladder is in a collapsed configuration.

7) The medical device as claimed in claim 5 in which the means to generate an audible noise comprises a scraper arm, one end of which is connected to one of the pair of sides of the body and the other, free end of which is inwardly depending towards and for engagement of one or more of the folds of the concertinaed bladder.

8) The medical device as claimed in claim 7 in which the free end of the scraper arm is resiliently biased towards the folds of the concertinaed bladder.

9) The medical device as claimed in claim 7 in which the scraper arm is dimensioned so that when the concertinaed bladder is in a fully collapsed configuration, the inwardly depending end of the scraper arm (31, 41) extends beyond and along portion of the other side of the body and is operable to releasably secure the two sides of the body together.

10) The medical device as claimed in claim 9 in which one of the inwardly depending end of the scraper arm and the side of the body is provided with a protrusion and the other of the inwardly depending end of the scraper arm and the side of the body is provided with a complementary recess for reception of the protrusion.

11) The A medical device as claimed in claim 9 in which the scraper arm further comprises a tab extending outwardly therefrom beyond the inwardly depending end of the scraper arm.

12) The medical device as claimed in claim 1 in which the port is angularly offset from a longitudinal axis of the resiliently deformable collapsible body.

13) The medical device as claimed in claim 1 in which the port is provided with a side port branching off therefrom, the side port having a closure thereon.

14) The medical device as claimed in claim 13 in which the closure comprises a valve.

15) The medical device as claimed in claim 13 in which the closure comprises an end cap.

16) The medical device as claimed in claim 5 in which the means to generate an audible noise comprises a surface coating on the folds of the concertinaed bladder that generate a noise when two abutting surfaces are separated apart from each other.

17) The medical device as claimed in claim 5 in which the means to generate an audible noise comprises a spring force holding the folds of the concertinaed bladder together that generate a noise when two sides of a fold are separated apart from each other.

18) (canceled)

19) (canceled)

20) The medical device as claimed in claim 1 in which there is provided a spring operable to return the body from a collapsed configuration to an expanded configuration.

21) The medical device as claimed in claim 1 in which there is provided means to generate a haptic feedback upon expansion of the collapsible body from a collapsed configuration to an expanded configuration.

22) The medical device as claimed in claim 1 in which there is provided means to releasably secure the resiliently deformable collapsible body in a collapsed configuration.

23) (canceled)

24) (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0039] The invention will now be more clearly understood from the following description of some embodiments thereof given by way of example only with reference to the accompanying drawings, in which:—

[0040] FIG. 1 is a photograph of a medical professional demonstrating a technique known in the art on a test apparatus;

[0041] FIG. 2 is a photograph of a medical professional demonstrating a technique known in the art on a test apparatus;

[0042] FIG. 3 is a photograph of a medical professional demonstrating an alternative technique known in the art on a test apparatus;

[0043] FIG. 4 is a front perspective view of a first embodiment of medical device according to the invention;

[0044] FIG. 5 is a rear perspective view of the medical device of FIG. 4;

[0045] FIG. 6 is another rear perspective view of the medical device of FIG. 4;

[0046] FIG. 7 is a rear view of the medical device of FIG. 4;

[0047] FIG. 8 is a front view of the medical device of FIG. 4;

[0048] FIG. 9 is a perspective view of the medical device being introduced into a needle;

[0049] FIG. 10 is a side view of a second embodiment of medical device according to the invention;

[0050] FIG. 11 is a top plan view of the medical device of FIG. 10;

[0051] FIG. 12 is a rear view of the medical device of FIG. 10;

[0052] FIG. 13 is a view from underneath of the medical device of FIG. 10;

[0053] FIG. 14 is a rear perspective view of the medical device of FIG. 10;

[0054] FIG. 15 is an enlarged view of the scraper arm and portion of the resiliently deformable collapsible body; and

[0055] FIG. 16 is a top plan view of a third embodiment of medical device according to the invention.

DETAILED DESCRIPTION OF THE DRAWINGS

[0056] Referring to FIG. 1, there is shown a photograph of a medical professional, indicated generally by the reference numeral 1, demonstrating a technique known in the art for performing a central line insertion on a test apparatus 3. In their left hand, the medical professional is holding an ultrasound probe 5 whilst viewing the ultrasound of the test area on an ultrasound monitor 7. In their right hand, the medical professional holds a syringe 9 with a needle 11 thereon.

[0057] Referring to FIG. 2, there is shown an enlarged photograph of the medical professional's grip on the syringe as they perform the known technique for inserting a central line. For ease of understanding and so as not to obscure features, the syringe 9 is now shown in the left hand of the medical professional. The medical professional grasps the chamber 13 of the syringe 9 between their thumb, index and middle fingers and operates the plunger 15 of the syringe 9 using their remaining fingers. The plunger of the syringe is slowly extracted from the chamber. As the end of the needle 11 is located inside the test subject in the absence of air, a partial vacuum is created inside the syringe chamber 13 between the internal end of the plunger 15 and the needle 11. When the tip of the needle is inserted into the lumen of the blood vessel, the operator of the needle will experience a reduction in resistance and furthermore, the partial vacuum will act to draw blood inwardly from the vein into the syringe chamber. The appearance of blood in the syringe and the reduction of resistance will be sufficient to indicate that the tip of the needle is in the lumen of the blood vessel. Once in position, the remaining steps of the Seldinger technique may be performed.

[0058] It can be seen that in such a configuration shown in FIG. 2, fine movement of the hand to position the needle is impractical. Referring once again to FIG. 1, it will be appreciated that the muscles in the shoulder and the elbow region are used to insert the needle as the hand muscles are used to grip the syringe and operate the plunger. The shoulder and elbow muscles are not however suitable for fine adjustment, thereby increasing the difficulty in correct placement of the tip of the needle.

[0059] Referring to FIG. 3, there is shown a photograph of an alternative technique for inserting a central line known in the art. In the photograph, the medical professional holds the probe 5 of the ultrasound in their left hand and a needle 11 in their right hand. Effectively, the needle is provided without the syringe. Accordingly, the medical professional can grasp the hub 17 of the needle between their thumb and forefinger and use their hand muscles to more accurately position the tip of the needle. This grip will permit the operator to advance the sheath using the index or middle finger of the same hand. This also makes positioning the tip of the needle easier than the technique described with reference to FIGS. 1 and 2 as the muscles of the hand, rather than the muscles of the shoulder and elbow, are used for needle tip positioning.

[0060] However, as there is no syringe provided in the technique described with reference to FIG. 3, there is no vacuum created with which to draw in blood into the needle and provide an indication to the medical professional that the tip of the needle is in fact inside the lumen of the blood vessel. Instead, the medical professional must guide the tip of the needle using ultrasound guidance to a position where they believe that the tip of the needle is inserted into the blood vessel and wait until blood begins to enter into the needle. In cases where the blood pressure is low, this can take a significant length of time which is highly undesirable. This delay can lead to the medical professional believing that the tip of the needle is not correctly placed inside the lumen of the blood vessel and either progressing the needle further thereby penetrating through the other side wall of the blood vessel or making a second or subsequent attempt to locate the tip of the needle in the blood vessel. The present invention attempts to address the shortcomings of the known methods and apparatus.

[0061] Referring now to FIGS. 4 to 9 inclusive, there are shown a number of representations of a first embodiment of a medical device according to the invention, indicated generally by the reference numeral 20. The medical device 20 comprises a resiliently deformable, collapsible body 21 defining a pressure chamber (not shown) therein. In the embodiment shown, the body 21 is provided in the form of a bellows comprising a pair of sides 23, 25, and a concertinaed bladder 27 therebetween. The construction is such that the concertinaed bladder is in a state where it urges the sides 23, 25 apart. The body further comprises a port 29 defining a fluid passageway from the exterior of the body to the interior of the pressure chamber. The port 29 is dimensioned to engage the hub of a needle (as illustrated in FIG. 9 in which the port is about to be introduced into the hub of the needle and will form a push fit in the hub).

[0062] Referring specifically to FIGS. 5 to 7, there is shown a scraper arm 31. The scraper arm 31 is connected at one of its ends to one of the sides 23. The other, free, end 33 of the scraper arm is cranked inwardly towards the folds of the concertinaed bladder. The free end 33 of the scraper arm contacts against the folds of the concertinaed bladder. As the bladder expands from a contracted configuration with the folds of the bladder in close proximity to each other, the free end 33 of the scraper arm will scrape over the folds causing vibrations and a “clicking” noise as the bladder expands.

[0063] In use, the port 29 is introduced into the hub 17 of the needle 11. Instead of providing a push fit, the port may have a luer lock component for complementary engagement of a luer lock fitting on the hub 17 of the needle. Once the needle 11 and the medical device are in engagement, the sides 23, 25 are grasped between the operators thumb and forefinger and brought towards each other. This will expel any air from the internal pressure chamber of the resiliently deformable, collapsible body 21. In the compressed state, the inwardly depending end of the scraper arm will extend around the lower side 25 and engage the face of the lower side, thereby holding the sides 23 and 25 of the collapsible body in a fixed relationship with respect to each other and also the concertinaed bladder in a compacted configuration. If desired, the sides can be brought together before connection of the needle to the hub.

[0064] The operator will then grasp the hub of the needle between the thumb and the forefinger of their hand and the tip of the needle is then inserted into the patient and the free end of the scraper arm is moved free of the side 25. The sides 23, 25 will move slightly apart from each other under the resilience of the concertinaed bladder, thereby forming a partial vacuum inside the body in the pressure chamber. The tip of the needle is then further guided into the patient, under ultrasound guidance, towards the blood vessel. The concertinaed bladder will not expand further as the tip of the needle passes through muscle and tissue. It will be appreciated that the device may be easily “flushed” by squeezing the two sides together. Furthermore, advantageously, the device is formed as a single unit.

[0065] When the tip of the needle enters the blood vessel, the partial vacuum will cause blood to be drawn into the pressure chamber of the medical device. When the tip of the needle is located inside the fluid inside the lumen of the blood vessel, the resiliently deformable bladder will be able to expand further, drawing more blood into the pressure chamber as the bladder expands. Most importantly, as the bladder expands, the free end 33 of the scraper arm will scrape against the folds of the concertinaed bladder causing vibrations and a clicking noise. This clicking noise will indicate to the medical professional that the bladder is expanding and by extension that the tip of the needle is in the lumen of the blood vessel. This auditory and haptic cue will enable the medical professional to keep their eyes on the ultrasound monitor throughout. Once the medical professional is confident that the tip of the needle is located inside the lumen of the blood vessel, they can obtain further assurance by examining the presence of blood in the needle hub and/or the medical device (if constructed at least in part from a transparent/translucent material).

[0066] Referring now to FIGS. 10 to 15 inclusive, there is shown a second embodiment of medical device, indicated generally by the reference 40, where like parts have been given the same reference numeral as before. The medical device 40 also comprises a resiliently deformable, collapsible body 21 defining a pressure chamber therein. The body 21 is provided in the form of a bellows comprising a pair of sides 23, 25, and a concertinaed bladder 27 therebetween. The construction is such that the concertinaed bladder urges the sides 23, 25 apart when the concertinaed bladder is in a collapsed configuration. The body 21 further comprises a port 29 dimensioned to engage the hub of a needle and defining a fluid passageway from the exterior of the body to the interior of the pressure chamber. As before, there is further provided a scraper arm 41, the scraper arm 41 being connected at one of its ends to one of the sides 23 and the other, free, end 33 of the scraper arm is cranked inwardly towards the folds of the concertinaed bladder. The free end 33 of the scraper arm contacts against the folds 43 of the concertinaed bladder so that as the bladder expands from a contracted configuration with the folds of the bladder in close proximity to each other to an expanded configuration, the free end 33 of the scraper arm 41 will scrape over the folds causing a “clicking” noise and vibrations as the bladder expands. More specifically, the free end of the scraper arm contacts against a flange 45 of each fold 43.

[0067] Referring specifically to FIG. 10, it can be seen that the scraper arm 41 differs from the scraper arm 31 of the first embodiment shown in FIGS. 3 to 9 inclusive in that the scraper arm 41 comprises a tab 47 extending upwardly from the free end 33 of the scraper arm 41. In use, when an operator has inserted the tip of the needle (not shown) into the patient and wishes to release the scraper arm 41 from holding the two sides 23, 25 of the resiliently deformable collapsible body together, the operator slides their finger or a thumb rearwards to press against the tab 47 and release the inwardly depending end 33 from the side 25 of the resiliently deformable collapsible body. The resiliently deformable collapsible body will expand to a degree until the side 25 is free of the free end 33 of the scraper arm 41.

[0068] In the embodiment shown, the orientation is such that the tab 47 will, in use, be to the side of the device 40 remote from the patient for ease of access. In this way, if the port 29 or the hub of the needle is held between the operator's thumb and their middle finger, the operator's index finger may be slid rearwards to disengage the scraper arm 41 from the side of the resiliently deformable collapsible body.

[0069] In addition, the inwardly depending end 33 of the scraper arm 41 is provided with a protrusion 49 and the side 25 of the body is provided with a complementary recess 51 for reception of the protrusion 49. This will provide a more secure engagement between the scraper arm and the side when the two sides of the resiliently deformable collapsible body are being held together.

[0070] In addition to the forgoing, it can be seen that the port 29 of the medical device 40 is angularly offset from a longitudinal axis of the resiliently deformable collapsible body. This is envisaged to be advantageous as it will allow the expansion of the resiliently deformable collapsible body without it being impeded by the patient. It will also enable the device and the needle attached thereto to be introduced at a shallower angle to the patient's skin than would otherwise be the case which has advantages for needle tip placement. Finally, this configuration may be particularly relevant and advantageous when attempting to introduce a needle into a jugular vein or other vein in the patient's neck where space is limited, and it is desirable to have a shallow angle of attack. It is envisaged that the port could be angularly offset from the longitudinal axis of the resiliently deformable collapsible body by of the order of 5° to 75°, preferably between 10° to 70°, more preferably between 20° to 60°. It is envisaged that the ideal angular offset could be of the order of 45°.

[0071] Referring now to FIG. 16, there is shown a third embodiment of medical device, indicated generally by the reference 60, where like parts have been given the same reference numeral as before. The medical device 60 is similar in construction to the medical device 40 illustrated in FIGS. 10 to 15 inclusive with the exception that the medical device 60 comprises a side port 61 branching off the port 29. The side port 61 may be used for the introduction of a wire through the side port 61 and into the patient's vessel when the tip of the needle (not shown) has been introduced into the patient. The side port 61 may have a valve and/or a removable end cap at its free end remote from the port 29 that will prevent ingress of air into the patient or into the pressure chamber before the tip of the needle is in place in the vessel.

[0072] It will be understood that various modifications could be made to the constructions described. For example, it is envisaged that the resiliently deformable body may take a form other than bellows-shaped. For example, the resiliently deformable body may be balloon-shaped or indeed pillow-shaped. The balloon-shaped or pillow-shaped resiliently deformable body may be sandwiched between two sides 23, 25 such as those shown in the embodiments hereinbefore described.

[0073] Furthermore, instead of a scraper arm, other means could be provided for generating a sound on the expansion of the resiliently deformable body. For example, if there is a concertina arrangement, the sides of the folds may be provided with an adhesive material so that as the sides separate, there is a tearing sound as the side come apart from each other. Similarly, the sides of the folds could act in a manner similar to over-centre springs in that they would “pop” as they expand. Alternatively, a sensor and a sensor target could be provided, one on either side of the bellows-like body and effectively a capacitive sensor could be provided. This however would require a buzzer or like electrically powered device and a power supply and is not therefore preferred. Ideally, the means to generate an audible noise of the device will do so mechanically. In other words, it will be configured to create a noise without any external electrical power supply. Instead, the noise will be created by two components moving against or apart from each other such as the scraper arm impacting and/or releasing from a fold of the concertinaed bladder.

[0074] It is envisaged that the means for providing the sound as the resiliently deformable body expands could comprise an arm mounted on one side of the device with a plurality of protrusions such as bosses or “sharks teeth” formed along a surface thereof. The arm could be led through a complementary groove or an aperture in the opposite side of the device with the protrusions abutting against the other side of the device. In this way, as the sides of the device are separated apart from each other, the arm will be withdrawn from the complementary groove or aperture and the protrusions on the arm will rub against the side wall of the aperture of groove, resulting in a noise that can be heard by the operator of the device and preferably also a vibration that may be sensed by the operator of the device.

[0075] It is envisaged that the medical device could be provided with a needle and, if desired, a sheath on the needle so that it may be used in the Seldinger or modified Seldinger techniques. The components could be provided already constructed and packaged if desired with wire and any other tubing or like components required to carry out the procedure. It will be understood that the present invention has been described in terms of inserting a central line however it is not limited to such a procedure as would be readily understood by the skilled addressee. It is envisaged that the port of the medical device may be permanently connected to the hub of a needle.

[0076] Throughout the specification, reference is made to the medical device having a body that is resiliently deformable and there being provided a biasing means operable to urge the resiliently deformable collapsible body from a collapsed configuration to an expanded configuration. The biasing means could be provided by way of a spring such as, but not limited to a helical spring or a leaf spring that could be located internal or external the body, for example pressing against the two sides 23, 25, urging them apart. Preferably however, the biasing means operable to urge the resiliently deformable collapsible body from a collapsed configuration to an expanded configuration will be provided by the natural elastic properties of the body itself, that when compressed into a collapsed configuration, will have a tendency to urge the sides 23, 25 of the body apart towards an expanded configuration. To this end, the body may be constructed from a suitable material with these elastic properties.

[0077] In this specification the terms “comprise, comprises, comprised and comprising” and the terms “include, includes, included and including” are all deemed interchangeable and should be afforded the widest possible interpretation.

[0078] The invention is not limited to the embodiments hereinbefore described but may be varied in both construction and detail within the scope of the claims.