GB2577319A

GB2577319A - Universal container holding device and procedure aid for spinal fluid sample collection

Info

Publication number: GB2577319A
Application number: GB1815449.2A
Authority: GB
Inventors: Parmar Sunjay
Original assignee: Individual
Current assignee: Individual
Priority date: 2018-09-22
Filing date: 2018-09-22
Publication date: 2020-03-25
Anticipated expiration: 2038-09-22
Also published as: GB2577319B; GB201815449D0

Abstract

A container holding device 1 for spinal fluid sample collection, the device 1 comprising a concave body that includes an extending neck 5, where the concave body holds a container 12 to collect spinal fluid, and where the device 1 further comprises: an attachment 8 for holding a stop-cock tap 7, the stop-cock tap 7 comprising a supply tube 9 and a fluid exit opening 17; and an attachment 4 for holding a manometer tube 2. Preferably, the container 12 is held in a hollow 15 of the concave body. Two or more containers 12 may be held in the device 1 by a container holding disc. Device 1 may comprise a container holding disc that’s hand rotatable. The attachment 4 for holding the manometer tube 2 may be a collar and hole. The attachment 8 for holding the stop-cock tap 7 may be a cut away section. The device is described as being applicable where it’s desirable to be able to use one hand to hold a spinal fluid collecting container and a vertical lumbar puncture manometer tube whilst allowing the fingers of the same hand to control a stop-cock tap to drain the fluid into the container.

Description

PATENT APPLICATION

OF

SUNJAY PARMAR

FOR

UNIVERSAL CONTAINER HOLDING DEVICE AND PROCEDURE AID FOR SPINAL

FLUID SAMPLE COLLECTION

Field of the Invention

The present invention relates to a device and aid which is used by a doctor or medical professional when removing samples of spinal fluid from a patient.

Background

The use of equipment for extracting cerebrospinal fluid from patients is widely used in medical practice and is often carried out as a two person procedure but modern pressures of work and lower staff numbers mean it is often attempted by one individual. Lumbar puncture (LP), also known as a spinal tap, is a medical procedure in which a needle is inserted into the spinal canal, in order to collect cerebrospinal fluid (CSF) for diagnostic testing. The main reason for a lumbar puncture is to help diagnose diseases of the central nervous system involving the brain and the spine. Examples of these various conditions include meningitis and subarachnoid haemorrhage.

It may also be used therapeutically in some conditions such as idiopathic intracranial hypertension. In some instances a lumbar puncture cannot be performed safely (for example due to a severe bleeding tendency). It is regarded as a generally safe procedure, but possible common complications can include post lumbar-puncture headache and back pain. The procedure is often typically performed under local anaesthesia using a sterile technique. A spinal needle is used to access the subarachnoid space and then the fluid is collected. Fluid may then be sent for biochemical, microbiological, and cytological analysis.

The most common indication for lumbar punctures is for suspected meningitis, since there is no other reliable tool with which meningitis, a life-threatening but highly treatable condition, can be excluded. Young infants are a rising factor in this area and often commonly require lumbar puncture as a part of the routine workup for fever without a source. This is due to higher rates of meningitis than in older persons.

Infants also do not reliably show classic symptoms of meningeal irritation (meningismus) like neck stiffness and headache the way adults do. In any age group, complex issues as subarachnoid haemorrhage, hydrocephalus, benign intracranial hypertension, and many other diagnoses may be supported or excluded with this test. It may also be used to detect the presence of malignant cells in the CSF, as in carcinomatous meningitis or medulloblastoma. CSF containing less than 10 red blood cells (RBCs)/mm3 constitutes a "negative" tap in the context of a workup for subarachnoid haemorrhage, for example. Taps that are "positive" have an RBC count of 100/mm3 or more.

Lumbar punctures may also be done to inject medications into the cerebrospinal fluid ("intrathecally"), particularly for spinal anaesthesia or chemotherapy. Serial lumbar punctures may be useful in temporary treatment of idiopathic intracranial hypertension (IIH). This disease is characterized by increased pressure of CSF which may cause headache and permanent loss of vision. While the mainstay of treatment is medications such as acetazolamide, in some cases lumbar puncture performed multiple times may improve symptoms. It is not recommended as a staple of treatment due to discomfort and risk of the procedure, and the short duration of its efficacy.

Additionally, some people with normal pressure hydrocephalus (characterized by urinary incontinence, a changed ability to walk properly, and dementia) receive some relief of symptoms after removal of CSF. The person is usually placed on their side (left more commonly than right). The patient bends the neck so the chin is close to the chest, hunches the back, and brings knees toward the chest. This approximates a foetal position as much as possible. Patients may also sit on a stool and bend their head and shoulders forward. The area around the lower back is prepared using aseptic technique.

Once the appropriate location is palpated, local anaesthetic is infiltrated under the skin and then injected along the intended path of the spinal needle. A spinal needle is inserted between the lumbar vertebrae L3/L4, L4/L5 or L5/S1 and pushed in until there is a "give" as it enters the lumbar cistern wherein the ligamentum flavum is housed. The needle is again pushed until there is a second 'give' that indicates the needle is now past the dura mater.

The arachnoid membrane and the dura mater exist in flush contact with one another in the living person's spine due to fluid pressure from CSF in the subarachnoid space pushing the arachnoid membrane out towards the dura. Therefore, once the needle has pierced the dura mater it has also traversed the thinner arachnoid membrane. The needle is then in the subarachnoid space. The stylet from the spinal needle is then withdrawn and drops of cerebrospinal fluid are collected. The vital opening pressure of the cerebrospinal fluid may be taken during this collection by using a simple column manometer. The procedure is ended by withdrawing the needle while placing pressure on the puncture site. The spinal level is so selected to avoidspinal injuries. In the past, the patient would lie on their back for at least six hours and be monitored for signs of neurological problems. There is no scientific evidence that this provides any benefit. The technique described is almost identical to that used in spinal anaesthesia, except that spinal anaesthesia is more often done with the patient in a seated position.

The upright seated position is advantageous in that there is less distortion of spinal anatomy which allows for easier withdrawal of fluid. Some practitioners prefer it for lumbar puncture in obese patients, where lying on their side would cause a scoliosis and unreliable anatomical landmarks. However, opening pressures are notoriously unreliable when measured in the seated position. Therefore, patients will ideally lie on their side if practitioners need to measure opening pressure. Reinsertion of the stylet may decrease the rate of post lumbar puncture headaches. Although not available in all clinical settings, use of ultrasound is helpful for visualizing the interspinous space and assessing the depth of the spine from the skin. Use of ultrasound reduces the number of needle insertions and redirections, and results in higher rates of successful lumbar puncture. If the procedure is difficult, such as in people with spinal deformities such as scoliosis, it can also be performed under fluoroscopy (under continuous X-ray imaging). Increased CSF pressure can also indicate congestive heart failure, cerebral edema, subarachnoid haemorrhage, hypo-osmolality which often is resulting from haemodialysis, meningeal inflammation, purulent meningitis or tuberculous meningitis, hydrocephalus, or idiopathic intracranial hypertension. In the setting of raised pressure (or normal pressure hydrocephalus, where the pressure is normal but there is excessive CSF), lumbar puncture may be therapeutic.

Decreased CSF pressure can indicate complete subarachnoid blockage, leakage of spinal fluid, severe dehydration, hyperosmolality, or circulatory collapse. Significant changes in pressure during the procedure can indicate tumours or spinal blockage resulting in a large pool of CSF, or hydrocephalus associated with large volumes of CSF.

During the procedure of extracting the fluid from the spinal region the medical professional or doctor is required to hold the universal container in the same hand which is also having to operate the tap control, whilst the tubes coming from the inserted needle are also needed to be handled. Due to the way in which the fluid passes down to the exit and the upright position of the manometer tube (to measure pressure of fluid) and the release section at the cock stop tap to exit fluid through the tube, the hands have multiple roles and must also be able to hold the universal container in the exact position for the fluid to pass into it. This process is very difficult and the medical professional or doctor has to manage with this process as part of their daily routine.

Prior art does exist in relation to the collection of fluids and attempts to provide improvements in this process.

During the procedure of extracting the fluid from the spinal region the medical professional or doctor is required to hold the universal container in the same hand which is also having to operate the tap control, whilst the tubes coming from the inserted needle are also needed to be handled.

Due to the way in which the fluid passes down to the exit and the upright position of the manometer tube (to measure pressure of fluid) and the release section at the cock stop tap to exit fluid through the tube, the hands have multiple roles and must also be able to hold the universal container in the exact position for the fluid to pass into it. This process is very difficult and the medical professional or doctor has to manage with this process as part of their daily routine. Prior art does exist in relation to the collection of fluids and attempts to provide improvements in this process.

This is shown in patent US6186979 (DYSARZ) wherein a basic solution is shown as a blood collection device combining an elongated needle cannula and vial insertion cannula fixed to a rotatable reel. The rotatable reel is supported in an L-shaped bowl and hollow stem combination. A sloping needle cannula is injected into a body or vein inside of a body so blood or other fluid flows from the body into the needle cannula and into the vial insertion cannula. A vial is inserted into the bowl until the vial insertion cannula penetrates the soft vial plug and the vial then is filled with blood or other fluid. When sufficient blood or fluid is drawn into the vial, the vial is removed and a lever or button is pushed, releasing a biased coil spring which causes the reel to rotate, thus winding the needle cannula and the vial insertion cannula around the reel, destroying the needle cannula and the vial insertion cannula and further pulling the needle cannula into the hollow stem and the vial insertion cannula into the bowl, preventing a person from being accidentally pricked or otherwise injured by either contaminated cannula.

Patent US5097842 (BONN) discloses devices for extracting blood or other body fluids, and particuiarly for extracting blood from the umbilical cord. A hypodermic needle for insertion into the umbilical cord is attached to a valve housing, to which is connected one or more vacuum containers or test tubes. One or more valves in the housing may be positioned to connect the needle with each vacuum container or test tube as desired. Bodily fluids may thus be extracted without the need to perform multiple injections or to stick multiple vacuum containers with the same syringe. The devices lend convenience to the newborn blood testing process and reduce the chances of inadvertent blood Patent US2009/0204086 (KIZER) discloses a cerebrospinal fluid ("CSF") collection tube includes a bottom end portion and a tubular sidewali portion. The tubular sidevvall portion has a first end and a second end, the first end being sealed to the bottom end portion and the second end defining an open end portion of the CSF collection tuba The CSF collection tube further includes a filament element that is attached to an interior surface of the tubular sidevvall portion and projects through the open end portion of the CSF collection tube. The C,'SF. collection tube may further include a removable cap.

The prior art therefore shows that a need for a more effective device to aid the doctor or medical professional when extracting cerebrospinal fluid is required.

The present invention aims to provide a device which is able to be held in one hand and in itself holds the universal container in single or plural amounts, whilst the device simultaneously holds the vertical lumbar puncture manometer tube, allowing the fingers of the same hand to therefore control the cock stop tap to drain the fluid into the universal container thereto. This enables the other hand to have fine control of the lumbar puncture (LP) needle during the process.

Summary of the invention

According to the present invention there is provided a universal container holding device and procedure aid for improved spinal fluid or lumbar puncture (LP) sample collection.

The device in its first embodiment is a shaped and single curvation moulded body which is held in the hand. The main holding area for the hand is a convex form providing an area which is of suitable size for a hand to hold it and has a concave hollow to its interior which accommodates inserted universal containers. The universal containers are pressed directly into the concave hollow which is sized to hold the universal container with the aid of a neck section to the upper of the concave interior, which grips the containers own upper neck area, as shown in the accompanying Figures.

Extending from the shaped rear of the holding area is a vertically curved neck which extends upward, as shown in Figure 1. The neck is formed as part of the mould of the device, which would all be created in a single suitable slightly flexible plastic or other similar composite material. The neck has an oval looped head to its extremity, as shown in Figure 3.

To the oval looped head are two holes which provide insert means for medical tubing used during the process of spinal fluid sample collection.

The hole located to the top of the oval looped head is set vertically into a short collar, as shown in Figures 1 and 3. This is provided to accommodate the inserted vertical lumbar puncture manometer tube, as shown. The vertical lumbar puncture manometer tube is thus held in place by said collar and hole and the vertical position of the manometer tube is adjusted by the doctor or medical professional, upward or downward accordingly therefore when fitting. Sufficient insertion of the manometer tube enables it to extend beneath the collar and hole of the device to accommodate a stop cock tap fitting with a short supply tube with fluid exit opening. A needle extends from this point to be inserted into the subject area. The supply tube is horizontally inserted through a supporting hole cut out which is located to the lower crest of the oval looped head, as shown in Figure 1 in use and in Figure 3 as a frontal view.

With the manometer tube being held vertically by the collar and hole of the device and the short horizontal supply tube, which is perpendicular to it, being held by the cut out hole in the lower crest of the oval looped head, the device is able to be held in one hand and in itself hold the single universal container.

With the device in hand the needle shown from the rear in Figure 1 is inserted and is more able to be finely adjusted with the other now free hand (Not shown). The user's thumb of the hand holding the device is also free to therefore control and rotate the cock stop tap to drain the fluid into the universal container, via the supply tube thereto. As shown in Figure 2. Tentative control of the needle is therefore made possible to the user as described, which is very important to ensure accuracy and fine adjustment. The universal container holding device and procedure ad therefore holds all tubing used when extracting fluid from a patients spine and helps the user to align and adjust the LP needle more finely. This eases the process and enables a single doctor or medical professional to carry out the procedure with more control and accuracy, without the need for a second persons help.

In a second embodiment, the device is a shaped more deeply with a wider body and a more vertical neck, as shown from the side view in Figure 6 and from the frontal view in Figure 10.

The main holding area for the hand is also of a convex form providing an area which is of suitable size for a hand to hold it and has a concave hollow to its interior which accommodates vertically inserted universal containers and a disc to hold them. The universal containers are inserted in a disc holder which is able to rotate due to it being set movably into a wider runner channel within the walled body of the device holding area, the inner area of the runner channel is planar and smoothed to aid rotation, as shown.

The disc holder is of a suitable narrow planar plastic or similar composite material and it tapers slightly to its circular edge. To its surface are open cut away round sections which the universal containers are pressed into. To enable multiple universal containers to be accommodated in the disc, the user rotates the disc to reveal the open cut away sections with their thumb and thus inserts the universal containers, until it is full. The disc may contain between two or four cut away sections to hold the containers. As the universal containers are held directly below the exit opening from the supply tube, as in the first and second embodiments of the invention, the extracted spinal fluids are able to drain directly into the universal tubes open top and are collected for examination, as shown in the accompanying Figures.

In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. As such, those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention.

Further, the purpose of the foregoing abstract is to enable the Patent Office and the public generally, and especially the scientists, engineers and practitioners in the art who are not familiar with patent or legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application. The abstract is neither intended to define the invention of the application, which is measured by the claims, nor is it intended to be limiting as to the scope of the invention in any way.

It is therefore an object of the present invention to provide a new and improved universal container holding device and procedure aid for spinal fluid sample collection which has all the advantages of the prior art spinal fluid extraction aids and none of the disadvantages.

It is another object of the present invention to provide a new universal container holding device and procedure aid for spinal fluid sample collection which may be easily and efficiently manufactured and marketed.

It is a further object of the present invention to provide a new and improved universal container holding device and procedure aid for spinal fluid sample collection which is of durable and reliable construction.

An even further object of the present invention is to provide a new and improved universal container holding device and procedure aid for spinal fluid sample collection which is susceptible of a low cost of manufacture with regard to both materials and labour, and which accordingly is then susceptible of low prices of sale to the consuming public; thereby making such a product available to the buying public.

Still yet another object of the present invention is to provide a new and improved universal container holding device and procedure aid for spinal fluid sample collection which provides in the apparatuses and methods of the prior art some of the advantages thereof; while simultaneously overcoming some of the disadvantages normally associated therewith. These together with other objects of the invention; along with the various features of novelty which characterize the invention, are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and the specific objects attained by its uses; reference should be had to the accompanying drawings and detailed descriptive matter in which there is illustrated preferred embodiments of the invention.

Brief description of figures

Figure 1 shows a side view of the universal container holding device and procedure aid for spinal fluid sample collection in use.

Figure 2 shows a side view of the hands position when using the universal container holding device and procedure aid for spinal fluid sample collection.

Figure 3 shows a frontal view of the universal container holding device and procedure aid for spinal fluid sample collection in use.

Figure 4 shows a plan view (A) and an underside view (B) of the universal container holding device and procedure aid for spinal fluid sample collection in use.

Figure 5 shows a plan view of a rotating holder for multiple universal containers.

Figure 6 shows a side view of the larger multiple universal container holding device and procedure aid for spinal fluid sample collection in use.

Figure 7 shows a plan view of a rotating holder for four universal containers.

Figure 8 shows the insertion method of a single universal container into a universal container holding device and procedure aid for spinal fluid sample collection.

Figure 9 shows a side view of the holding of multiple universal containers on the larger multiple universal container holding device and procedure aid for spinal fluid sample collection.

Figure 10 shows a frontal view of the larger multiple universal container holding device and procedure aid for spinal fluid sample collection.

Detailed description of figures

A typical embodiment of the universal container holding device and procedure aid for spinal fluid sample collection is shown in Figure 1. It comprises the device 1 having a manometer tube 2 with a fitting 3, which is inserted into a collar and hole 4 provided on the upper neck 5.

Extension tube 6 provides connection to manometer tube 2 and connection to supply tube 9 which is inserted into cut away 8. The lumbar puncture (LP) needle 28 is located to supply tube 9 and spinal fluids exit from opening 17, as shown.

Spinal fluids are collected using the cock stop tap 7 into universal container 12 which is held inside hollowed container holding area 15 within frontal handle body 13 with the container bottom 16 visible. A holding area 11 forms part of the frontal holding body 13 and the rear holding body 14.

The lower neck 10 extends upwards in a curvature to provide aforementioned holding of equipment.

In Figure 2 the users hand is shown in relation to the device 1A, holding the device using holding area 11A and rear holding body 14A with universal container 12A held within. The users thumb is able to operate the cock stop tap 7A therefore.

Figure 3 shows a frontal view of the device 1B and shows the universal container 12B inserted within the hollow container holding area 15B between the frontal handle body 13B and 18.

The device 1B has a neck 29 which holds the universal container 12B. The lower neck 10B leads to the cut away 8B and the upper neck 5B provides the collar and whole 4B.

In Figure 4, A) shows a plan view of the device with B) showing an underside view of the device.

Figure 5 shows the multiple container holding discs 19 for holding universal containers 12C. The disc body is made up of segments 22, 23, 24 and 25 with cut away sections 20 and 21 in this two universal container holder version.

In Figure 6 the larger device lE which accommodates the multiple container holding disc 19E, is shown as a side view. The collar and whole 4E and upper neck 5E are shown in this embodiment of the device, with the lower neck 10E and the holding area 11E with frontal holding body 13E and the rear holding body 14E also shown.

A multiple container holding disc 19F with four universal containers 12F accommodated is shown in Figure 7.

Figure 8 shows the direction in which the universal containers 12G are inserted into the device 1G.

Figure 9 shows a side view of the larger device 1H with universal containers 12H inserted into the multiple container holding disc 19H thereto.

Figure 10 shows the larger device 11 in a frontal view, which shows the universal containers 121, held in the hollow container holding area 151 within the multiple container holding disc 191. The multiple container holding disc 191 is seated into planar runner channels 26 and 27 which enable the disc 191 to rotate when moved by the users thumb (not shown).

The frontal holding bodies 131 and 181 are also shown.

Claims

Claims 1) A universal container holding device and procedure aid for spinal fluid sample collection comprising; a curved concave body with further extending curved neck; having means within a body to hold universal containers for fluid collection and at least two attachment holding means for a manometer tube and a stop cock tap fitting with a short supply tube with fluid exit opening, together defining a device.
2) A universal container holding device and procedure aid for spinal fluid sample collection as claimed in claim 1 wherein, universal containers which collect spinal fluid samples are held in the concave hollow body of the device.
3) A universal container holding device and procedure aid for spinal fluid sample collection as claimed in claim 1 wherein, the neck of the universal container is held in a cutaway section in the hollow body of the device.
4) A universal container holding device and procedure aid for spinal fluid sample collection as claimed in claim 1 wherein, at least two or more universal containers can be held in the device by means of a container holding disc.
5) A universal container holding device and procedure aid for spinal fluid sample collection as claimed in claim 1 wherein, a container holding disc is rotated using the thumb.
6) A universal container holding device and procedure aid for spinal fluid sample collection as claimed in claim 1 wherein; the device body is suitably curved to be hand held.
7) A universal container holding device and procedure aid for spinal fluid sample collection as claimed in claim 1 wherein; a further extending curved neck provides means for holding a manometer tube; a stop cock tap fitting arid a short supply tube with fluid exit opening.
8) A universal container holding device and procedure aid for spinal fluid sample collection as claimed in claim 1 wherein, means to hold a manometer tube are provided by a collar and hole.
9) A universal container holding device and procedure aid for spinal fluid sample collection as claimed in claim 1 wherein, means to hold a stop cock tap fitting is provided by a cut away section.
10) A universal container holding device and procedure aid for spinal fluid sample collection as claimed In claim 1 wherein, means to hold a supply tube with a fluid exit opening is provided by attachment to the held manometer tube via a stop cock tap and a cut away section.
11) A universal container holding device and procedure aid for spinal fluid sample collection as claimed in claim 1 wherein, a device holds a manometer perpendicularly to a supply tube.
12) A universal container holding device and procedure aid for spinal fluid sample collection according to any preceding claims where the device body is made of flexible material.
13) A universal container holding device and procedure aid for spinal fluid sample collection as substantially herein described with reference to the figures.