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GB2574820A - Cannula Stabilisation Device - Google Patents

Cannula Stabilisation Device Download PDF

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Publication number
GB2574820A
GB2574820A GB201809974A GB201809974A GB2574820A GB 2574820 A GB2574820 A GB 2574820A GB 201809974 A GB201809974 A GB 201809974A GB 201809974 A GB201809974 A GB 201809974A GB 2574820 A GB2574820 A GB 2574820A
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United Kingdom
Prior art keywords
cannula
receiving portion
patient
received
attachment
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Granted
Application number
GB201809974A
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GB2574820B (en
GB201809974D0 (en
Inventor
Colin Scrivens Christopher
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Individual
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Individual
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Priority to GB1809974.7A priority Critical patent/GB2574820B/en
Publication of GB201809974D0 publication Critical patent/GB201809974D0/en
Priority to PCT/GB2019/051674 priority patent/WO2019243784A1/en
Publication of GB2574820A publication Critical patent/GB2574820A/en
Application granted granted Critical
Publication of GB2574820B publication Critical patent/GB2574820B/en
Active legal-status Critical Current
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A61B2017/3407—Needle locating or guiding means using mechanical guide means including a base for support on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
    • A61B2017/3427—Access ports, e.g. toroid shape introducers for instruments or hands for intercostal space
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/347—Locking means, e.g. for locking instrument in cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3492—Means for supporting the trocar against the body or retaining the trocar inside the body against the outside of 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/024—Holding devices, e.g. on the body having a clip or clamp system
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/0266—Holding devices, e.g. on the body using pads, patches, tapes or the like
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/028—Holding devices, e.g. on the body having a mainly rigid support structure

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Surgery (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Anesthesiology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

A device 1 for, and method of stabilising a cannula (e.g. for use in chest decompression) inserted into a patient’s body 60 at an insertion site comprises of providing a receiving portion 2 for receiving a portion of the cannula (such as the head H), an attachment portion 4 (e.g. an adhesive seating portion, pad or patch) for attachment to the patient’s body and a securement means 30 for securing the portion of the cannula received in the receiving portion relative to the device. The receiving portion may take the form of a hollow channel with walls defining a generally cylindrical or prismatic space there-within and may have one or more features (e.g. cut-outs 24,26 in Fig 2) for matching engagement with a portion of the cannula, providing further stabilisation. The securement means may comprise a moveable engagement member, e.g. a threaded key. An interior of the receiving portion can be accessed through an opening in a lower end thereof, allowing the cannula to be inserted into the device therethrough.

Description

CANNULA STABILISATION DEVICE
TECHNICAL FIELD
This invention relates to a cannula stabilisation device. More particularly, though not exclusively, it relates to a device for stabilising and/or stably positioning a cannula or other tube when inserted into the body of a patient, especially (though not exclusively) into a patient’s chest cavity during the treatment of tension pneumothorax or other condition requiring chest decompression.
BACKGROUND AND PRIOR ART
Tension pneumothorax is a potentially life-threatening condition, commonly known as a “collapsed lung”, in which there is an abnormal collection or build-up of air within a patient’s chest cavity between one or other of the lungs and the inner chest wall. The condition can occur for example as a result of lung disease or lung failure, or from invasive injury or trauma to the chest wall itself from the outside. If not treated quickly, tension pneumothorax may lead to significant impairment of respiration and/or blood circulation, and also abnormal compression of the heart by the inoperative lungs, which can quickly lead to cardiac arrest.
In the rapid treatment of tension pneumothorax in emergency situations, e.g. by paramedics or other medical professionals, it is standard procedure to insert a cannula or chest tube through the chest wall into the chest cavity in order to relieve the air pressure therewithin and thereby decompress the chest cavity. This procedure is typically aided by use of a needle, in particular to aid insertion of the cannula or chest tube through the tough chest wall at the correct location. Typically the insertion site is one of the intercostal spaces in the patient’s ribcage - generally either the 2nd or the 5th intercostal space.
Once the cannula or chest tube has been so inserted and the patient’s chest decompression begun, the construction of typical known cannulae or chest tubes means that at least an upper handling and connection portion thereof remains outside the patient’s chest. However, when it comes to moving or transporting the patient - which typically may be from an emergency treatment setting to a hospital or other medical facility (e.g. by ambulance) for further treatment and care - it is necessary to stabilise the exposed upper handling and connection portion of the inserted cannula/chest tube relative to the patient’s chest outer wall, in order to avoid movement or dislodgment thereof, which could result in internal injury to the patient or even the treatment failing as a result of the cannula/chest tube falling out. Such unwanted movement or dislodgement of the cannula may be more prone to occur when the cannula/tube insertion location is more towards the patient’s underarm region, in particular via the 5th intercostal space.
Conventionally paramedics and other medical professionals stabilise the exposed upper handling and connection portion of the inserted cannula/chest tube relative to the patient’s chest outer wall by the application of adhesive tape to affix the handling and connection portion of the cannula against the patient’s skin. This is however a rather crude means of solving the problem. It is also unreliable, owing to the inherent flexibility of adhesive tape and the inevitable weakness and instability of such a fixing. In addition, these shortcomings may be exacerbated by the presence of blood and sweat on the skin of the patient’s outer chest wall in the region of the insertion site, which may lead to failure of the adhesive on conventional sticky tapes. All of the above factors therefore have a propensity for rendering such an improvised tape-based fixing inadequate or practically ineffective and in some cases may even lead to it being tantamount to useless.
There are known in the art certain designs of decompression needles which incorporate an integral upper hub portion that, in addition to providing the required venting function for the removal of air from a patient’s chest cavity once the needle portion has been inserted thereinto, also includes an enlarged seating portion beneath the hub that adheres to the patient’s skin in the vicinity of the insertion site in order to stabilise it and prevent dislodgement of a catheter connected to the device. However, these known “all-in-one” decompression needles are very expensive to manufacture and so are uneconomical for one-off use, especially where medical equipment budgets are tight. Moreover, they are physically somewhat over-engineered for their purpose, and their only means of anchoring the needle portion relative to the patient’s chest wall is still only the adhesive seating portion, which as discussed above can only at best provide limited efficacy.
Thus, in the art of medical devices of the nature of cannulae or decompression needles for insertion through a patient’s chest wall in the treatment of tension pneumothorax, there is a need for a cheap and mechanically simple and easy to use device by which an inserted cannula or needle can be stably and securely anchored and/or positioned against the chest wall, in particular so that any risk of the cannula or needle moving into an unwanted position or becoming dislodged, especially when a catheter is attached thereto and/or upon movement of the patient, is minimised or ameliorated. It is therefore a primary object of the present invention to address and ameliorate these shortcomings and limitations in the known art.
SUMMARY OF THE INVENTION
Accordingly, in a first aspect of the present invention there is provided a device for stabilising a cannula inserted into a patient’s body at an insertion site, the device comprising:
a receiving portion configured for receiving therein a portion of the cannula to be stabilised;
an attachment portion for attachment to the patient’s body adjacent the insertion site; and securement means for securing the portion of the cannula received in the receiving portion relative to the device such that the cannula and the receiving portion are substantially immovable relative to each other.
In deploying a stabilisation device of the first aspect of the invention in its intended use, the present invention further provides, in a second aspect, a method of stabilising a cannula inserted into a patient’s body at an insertion site, the method comprising:
(i) providing a stabilisation device according to the first aspect of the invention or any embodiment thereof;
(ii) bringing the portion of the cannula and the receiving portion of the device into received relationship such that the cannula portion is received in the said receiving portion;
(iii) attaching the attachment portion of the device to the patient’s body adjacent the insertion site; and (iv) actuating the securement means so as to secure the portion of the cannula received in the receiving portion relative to the device such that the cannula and the receiving portion are substantially immovable relative to each other.
In a third aspect the present invention further provides a method of treatment of tension pneumothorax in a patient, the method comprising inserting a cannula into the patient’s body at an insertion site, wherein the method further comprises stabilising the cannula inserted into the patient’s body by the steps of:
(i) providing a stabilisation device according to the first aspect of the invention or any embodiment thereof;
(ii) bringing the portion of the cannula and the receiving portion of the device into received relationship such that the cannula portion is received in the said receiving portion;
(iii) attaching the attachment portion of the device to the patient’s body adjacent the insertion site; and (iv) actuating the securement means so as to secure the portion of the cannula received in the receiving portion relative to the device such that the cannula and the receiving portion are substantially immovable relative to each other.
In some practical embodiments of either of the above-defined methods the step (ii), of bringing the portion of the cannula and the receiving portion of the device into received relationship such that the cannula portion is received in the said receiving portion, may be carried out after the cannula has been inserted into the patient’s body. However, in other embodiments of either defined method the step (ii) may, if desired or appropriate, be carried out prior to the cannula being inserted into the patient’s body.
In practical embodiments of the either of the above-defined methods the step (iii) of attaching the attachment portion of the device to the patient’s body adjacent the insertion site may be effected either as a discrete active step between steps (ii) and (iv) or alternatively as an action substantially simultaneous with the carrying out of either steps (ii) and/or (iv).
In some practical embodiments of either of the above-defined methods the step (ii) of bringing the portion of the cannula and the receiving portion of the device into received relationship may be carried out by placing the receiving portion of the device over and/or around the cannula portion, especially by manipulation primarily of at least the receiving portion of the device. Thus, in many practical scenarios, especially those in which the cannula is inserted into the patient’s body first of all in a discrete insertion step, optionally with the aid of an insertion needle, the receiving portion of the device may then be placed over the alreadyinserted cannula portion so that the latter is received in the former, and only then the securement means may be actuated.
However, in some alternative practical embodiments of either of the above-defined methods, especially in which it may be desired to attach the device to the cannula portion first of all before the cannula itself is inserted into the patient’s body, the same method step (ii) may be carried out by inserting the cannula portion into the receiving portion of the device, especially by manipulation primarily of at least the cannula portion (and optionally by manipulation of both the cannula portion and the device together), and then actuating the securement means, and only then the cannula may be inserted into the patient’s body.
In some embodiments of the invention the cannula may be a decompression cannula, especially a chest decompression cannula.
In many embodiments of the invention the portion of the cannula which is received in, or is constructed and arranged for being received in, the receiving portion of the device, may be a head portion of the cannula.
In some embodiments of the device of the invention the receiving portion may comprise a hollow channel member, such as a hollow channel member with walls defining a generally cylindrical or prismatic space therewithin. The channel member may have any suitable cross-sectional (outer or inner) shape, e.g. rectangular, square, triangular, polygonal, circular, elliptical, etc, optionally with rounded edges and/or corners.
The channel member may desirably be open at at least a lower end thereof, in order to provide access to the interior space therewithin via that open lower end, and through which open lower end the cannula head portion can be inserted so as to be received in the channel member. The interior space within the channel member may be dimensioned, shaped and/or configured so as to suitably accommodate the cannula head portion therewithin. In particular, if desired, the receiving portion may include one or more wall features, especially internal wall features, configured to generally substantially match or to accommodate one or more respective head features, especially external head features, on the head portion of the cannula, whereby inter-engagement or abutment of the respective one or more wall features and the one or more head features may serve to provide a more stable and secure stabilising and/or positioning of the cannula upon actuation of the securement means.
In practical embodiments of the device the opposite, upper end of the channel member may or may not be open, e.g. it may even be closed, as an alternative to it being open.
In some embodiments of the device the channel member forming the receiving portion of the device may include at least one, optionally a pair of diametrically or oppositely arranged, notches or recesses or cut-outs or truncations of one or more respective side walls thereof, which may serve to assist the placement of the cannula head portion within the receiving portion and/or to assist in optimum orientation and positioning of the cannula head portion within the receiving portion, especially upon actuation of the securement means. Alternatively or additionally, such one or more notches or recesses or cut-outs or truncations may serve to accommodate and/or help optimally position one or more respective protruding head portions, e.g. wing portions, located on the head portion of the cannula, especially once the remainder of the cannula head portion is received in the receiving portion of the device and the securement means actuated.
In some embodiments of the device of the invention the attachment portion may comprise a generally substantially flat or planar land or seating portion. In some such embodiments instead of the seating portion being substantially flat or planar, it may instead be specially contoured or even flexible in shape so as to better conform to a curved or other non-flat surface contour of the patient’s body at or adjacent the site of insertion of the cannula.
In some embodiments the receiving portion and the attachment portion may be integrally connected, e.g. through being manufactured as an integral item by a moulding or extrusion process. Suitable materials for such combined receiving and attachment portions may include a plastics material, suitable specific examples of which are widely available in the art. In some embodiments the receiving portion and the attachment portion may be connected via a bridging portion.
Thus, in some practical embodiment forms of the device the attachment portion may be configured as a flange or land extending transversely or radially or peripherally outwardly from the open lower end of the receiving portion. The flange or land - and thus the attachment portion generally in embodiments of the device - may be generally of any suitable outer peripheral shape, e.g. rectangular, square, triangular, circular, elliptical, or other regular or irregular polygonal shape.
In embodiments of the device, in order that the attachment portion is attachable to the patient’s body adjacent the insertion site of the cannula, it may comprise attachment means, in particular an adhesive coating or pad affixed thereto. The adhesive may for example be a contact adhesive, e.g. one that sticks to a patient’s skin upon pressure being applied to the attachment portion, or alternatively it may be in the form of a self-adhesive coating or patch pre-applied thereto and temporarily protected by a removable (e.g. by peeling) cover or layer of material in a similar manner to a conventional sticking plaster wound dressing.
Thus, in deploying such embodiments of the device, immediately before the step (iii) of attaching the attachment portion of the device to the patient’s body adjacent the insertion site of the cannula, the protective cover or layer on the adhesive side of the attachment or bodycontacting portion may be removed, e.g. by peeling, so as to expose the adhesive therebeneath in readiness for attaching to the skin of the patient at or adjacent the insertion site.
Specific examples of suitable such adhesives are widely available in the art.
In embodiments of the device of the invention the securement means may take any of a variety of possible mechanical forms.
For example, in some embodiments the securement means may comprise a moveable engagement member which is selectively and reversibly moveable between (i) a nonengaging or non-clamping or non-locking position, in which the head portion of the cannula to be received and stabilised within the receiving portion can be freely inserted into the receiving portion, and (ii) an engaging or clamping or locking position, in which the head portion of the cannula to be receiving and stabilised within the receiving portion is fixable, especially clampable or lockable therewithin, relative to the receiving portion.
The movement of the engagement member may for instance be effected by virtue of it being carried on an end of a threaded shaft which is rotatably mounted on or in the receiving portion via a screw-threaded engagement with one or more walls of the receiving portion. In such embodiments, therefore, the engagement member may be carried on an inner remote end of a threaded key, e.g. with an enlarged handle portion at an outer distal end thereof for assisting its manual manipulation.
If desired or necessary the engagement member at the inner end of the threaded shaft may be shaped or contoured to match or optimally abut or bear against a first relevant portion of the head portion of the cannula via which it is to be stably clamped or held in position in the device once the securement means has been actuated.
In some such embodiments there may be additionally provided, especially mounted on an inner wall or side of the receiving portion opposite to that having mounted therein the threaded key providing the engagement member, a seating or balancing member, e.g. in the form of a balance block. Such a seating or balancing block or member may itself be shaped or contoured in order to match or optimally abut or bear against a second relevant portion of the head portion of the cannula, e.g. a portion thereof opposite the first relevant portion thereof, via which it is to be additionally stably clamped or held in position in the device once the securement means has been actuated.
In another aspect of the present invention there is provided a combination of a cannula for insertion into a patient’s body at an insertion site and a device for stabilising the cannula once inserted therein, wherein the device is a device according to the first aspect of the invention or any embodiment thereof.
In many practical embodiments of the above combination the portion of the cannula which is received in, or is constructed and arranged for being received in, the receiving portion of the device may be a head portion of the cannula.
In some practical embodiments of the above combination, the two primary elements thereof - namely the cannula and the stabilising device - may be provided as a kit of parts, in particular a kit of parts for use in the treatment of tension pneumothorax or other condition requiring chest decompression. If desired or necessary the kit may further comprise appropriate instructions for use.
As used herein, the term “cannula” is to be construed broadly as encompassing any tube, or tubular or tube-containing device, or hollow needle or hollow-needle-containing device, that is designed for insertion into the human or animal body, or a selected part thereof, for the removal therefrom or delivery thereinto of any gaseous or liquid substance or composition. Such devices may generally comprise not only a primary tube or hollow needle via which the relevant substance or composition is to be withdrawn from or delivered into the patient’s body, but may also typically comprise a head or hub portion that includes one or more appropriate vents - or connection means for attaching into fluid communication with the tube or needle one or more respective external conduits (e.g. tube(s) or needle(s)) - for the removal from or delivery to the primary tube or needle the relevant fluid substance or composition.
However, in many embodiments of the invention the cannula to which such embodiments may be especially suited to effective use may in particular be a chest decompression cannula.
Within the scope of this specification it is envisaged that the various aspects, embodiments, examples, features and alternatives, and in particular the individual constructional or operational features thereof, set out in the preceding paragraphs, in the claims and/or in the following description and accompanying drawings, may be taken independently or in any combination of any number of same. For example, individual feature(s) described in connection with one particular embodiment is/are applicable to all embodiments, including in any combination with one or more other individual feature(s), unless expressly stated otherwise or such features are incompatible.
BRIEF DESCRIPTION OF THE DRAWINGS
One or more embodiments of the present invention in its various aspects will now be described in detail, by way of example only, with reference to the accompanying drawings, in which:
FIGURE 1 is an explanatory front view through a human chest cavity region, showing the positions of the 2nd and 5th intercostal spaces which typically provide the possible insertion locations of a cannula or chest tube during the treatment of tension pneumothorax or other condition requiring chest decompression;
FIGURE 2 is a front face view of a typical known cannula device used for the treatment of tension pneumothorax or other condition requiring chest decompression;
FIGURE 3 is a perspective view of a cannula stabilisation device according to one embodiment of the present invention;
FIGURE 4 is a top plan view of the cannula stabilisation device of FIG. 3;
FIGURE 5 is a schematic cross-sectional side view of a patient’s chest cavity region into which has been inserted a cannula (such as that of FIG. 2) and which has been stabilised by attachment of the stabilisation device of the embodiment of FIGS. 3 and 4, in which configuration the chest decompression treatment can proceed; and
FIGURE 6 is a schematic cross-sectional side view corresponding to that of FIG. 5, but showing the cannula and the stabilisation device in an alternative relative configuration.
DETAILED DESCRIPTION OF EMBODIMENT(S)
Referring firstly to FIG. 1, this shows in a simplified explanatory manner a front view through a human chest cavity region, and the positions of the 2nd and 5th intercostal spaces which typically provide the possible insertion locations of a cannula or chest tube during the treatment of tension pneumothorax or other condition requiring chest decompression. In some instances the 2nd intercostal space provides an appropriate insertion site, although in other instances the 5th intercostal space (i.e. more toward the patient’s armpit region) may be more convenient or appropriate, e.g. depending on the physical nature of the patient’s condition or the relative accessibility of the two sites. In typical practical scenarios, when the insertion site corresponds to the 5th intercostal space, this may tend to create greater risks of displacement or dislodgement of the cannula once it has been inserted into the chest cavity, especially upon movement of the patient, e.g. from an emergency setting to a hospital or other medical facility where post-emergency treatment may be given.
FIG. 2 is a front face view of one example of a known cannula device C, such as that used for the treatment of tension pneumothorax or other condition requiring chest decompression. The cannula device C comprises a main elongate hollow tube or hollow needle T carried beneath a head H, which head H provides the necessary means for fluid communication between the interior of the tube or needle T and the outside. The head H also comprises an upper terminal needle or tube insertion aperture N, as well as a side vent V, either of which can be used for attaching into fluid communication with the main tube or needle T a catheter or external tube or needle (not shown) for use in extracting or releasing, or alternatively inserting or injecting, any gaseous or liquid medium or substance or composition out of or into the main tube or needle T during the tension pneumothorax or other treatment in question.
The head H of the cannula device C includes, in this example, a pair of sideways-projecting wings or ears W, for use in manually manipulating the cannula device C and assisting its insertion into the patient’s chest cavity, usually with the aid on an insertion needle (not shown) which is generally then withdrawn immediately after the insertion procedure. According to known conventional medical practice, such wings or ears W also provide a useful site for affixation of adhesive tape for use in the stabilisation of the cannula device C once the main tube or needle T has been inserted into the patient. It is this rather crude use of sticky tape that has been found to be unsatisfactory in practice and has led to the making of the present invention by the present inventor.
The components of the cannula device C are generally manufactured from suitable plastics material(s).
Turning to FIG. 3, here there is shown one embodiment of a cannula stabilisation device according to the invention, in particular a device for stabilising a chest decompression cannula. The device 1 comprises generally a hollow rectangular-cylindrical receiving portion 2, which has two pairs of oppositely arranged generally planar side walls joined by rounded or arcuate uniting edge portions. The oppositely facing side walls in each pair are substantially parallel to one another. The base of the receiving portion 2 is open, e.g. by virtue of having an aperture therein or being formed with an open mouth, so that the interior space within the receiving portion 2 is accessed upwardly through its base - in which direction the head portion H of a cannula C to be stabilised is inserted into the receiving portion 2 during deployment of the device 1.
Extending from, or attached to, the base of the receiving portion 2 is a generally flat, planar attachment portion 4 in the form of a land 4 which extends transversely outwardly from the receiving portion 2 in the form of a flange 4 around the external basal periphery thereof. The attachment land 4 carries on its lower face either a coating of a pressure-activated contacttype adhesive, or alternatively it may have pre-affixed thereto an adhesive patch or pad whose adhesive surface is temporarily protected by a peel-off covering layer or strip which can remain thereon until such time as deployment of the device is needed, upon which the protective layer or strip can be peeled off to expose the adhesive ready for affixing the attachment portion 4 to the patient’s skin in the vicinity of the cannula insertion site. Practical examples of suitable such adhesives are well-known in the art of medical device fixings, wound dressings, and suchlike.
For convenience the tubular receiving portion 2 and the attachment land 4 may usefully be formed as a unitary integral combination, e.g. in an integral moulding operation, and of a suitable plastics material, specific practical examples of which are well-known in the art. Alternatively, they may be formed separately, e.g. in respective extrusion or moulding operations, and bonded together using e.g. welding or fusing or a suitable adhesive.
If desired, and as represented schematically by way of example in FIG. 3, the tubular receiving portion 2 and the attachment land 4 may even be connected and/or united together by means of an intermediate bridging portion 12.
Each of two opposite side walls of the tubular receiving portion 2 of the device 1 are formed, e.g. by suitable moulding or post-production cutting or machining, with respective ones of a pair of notches, recesses, cut-outs or truncations 24, 26. Each respective notch, recess, cutout or truncation 24, 26 extends part-way down (e.g. from about 20 or 30 or 40 or 50% of the height to about 60 or 70 or 80 or 90 or 95% of the height of) the respective sidewall in which it is formed. The pair of notches, recesses, cut-outs or truncations 24, 26 serve to provide better access, especially by use of the finger(s), to the interior space within the receiving portion 2, which therefore can help in the proper and efficient placement, positioning and/or orientation of a cannula head portion H within the receiving portion 2 of the device 1 during deployment of the device 1, and especially upon actuation of the securement means 30. The pair of notches, recesses, cut-outs or truncations 24, 26 also help achieve an optimum overall positioning and stabilising of the head portion H of the cannula C by accommodating and/or aiding correct positioning of the respective wings or ears W protruding from the cannula head portion H, especially once the remainder of the cannula head portion H has been received in the receiving portion 2 of the device 1 and the securement means 30 actuated.
As shown in FIGS. 3 and 4, the securement means 30 comprises a threaded key 30, with an enlarged head 30H to assist its manual manipulation, which is screw-threadedly mounted in one of the sidewalls of the receiving portion 2. The forward, remote end of the screwthreaded shaft 30S of the key 30 carries an enlarged engagement head 30R for bearing against or abutting an appropriate part of the head portion H of the cannula C - once the head portion 2 thereof has been received in the receiving portion 2 - as the key 30 is rotated and the engagement head 30R thereby moved inwardly further into the interior space within the receiving portion 2 into its clamping or engaging or locking position against the cannula head portion H.
When it is desired to remove the device 1 from the cannula head portion H, e.g. prior to or perhaps even after removal of the cannula tube or needle portion T from the patient’s body, for this purpose the engagement head 30R carried on the end of the securement key 30 can be released from its clamping or engaging or locking position against the cannula head portion H by simply rotating the key head 30H in the reverse direction, upon which the forward, remote engagement head end 30R of the key 30 is retracted towards the outside of the receiving portion 2, thereby enabling the cannula head portion H and the receiving portion 2 of the device 1 to be moved apart and separated.
For the purpose of additionally seating and stabilising the cannula head portion H as it is clamped and locked within the receiving portion 2 of the device 1, a seating or balancing block 32 is mounted on an inner wall of the receiving portion 2 opposite to that wall having mounted therein the shaft 30S of the threaded key 30. The seating or balancing block 32 is positioned on its sidewall of the receiving portion 2 substantially coaxially with the axis of the key shaft 30S, whereby the clamping or locking action of the screwing up of the key 30 against the cannula head portion H within the receiving portion 2 effectively occurs between the forward remote engagement head 30R of the key 30 and the seating or balancing block 32 itself.
FIGS. 5 and 6 are schematic cross-sectional side views, showing the cannula C and the stabilisation device 1 in alternative relative configurations, of a patient’s chest cavity region into which has been inserted the cannula of FIG. 2, which has been stabilised by attachment of the stabilisation device 1 of FIGS. 3 and 4. Thus, in the united configuration of the inserted cannula C and the device 1 as shown in either of FIGS. 5 and 6, the chest decompression treatment can proceed.
In the condition shown in FIGS. 5 and 6, the cannula main tube or needle portion T has been inserted through the patient’s skin and outer chest wall 60 into the patient’s chest cavity at a desired or appropriate insertion site via a selected intercostal space between a respective pair of the patient’s ribs 50, and the stabilisation device 1 has been deployed by having been attached to the cannula head portion H, and clamped or anchored or locked thereon in accordance with the general procedural steps described above.
The remaining reference numerals shown in each of FIGS. 5 and 6 referring to various features and components of the cannula C and the stabilisation device 1 are the same as those same reference numerals identifying the same features or components thereof in the earlier FIGS., so they will be self-explanatory and not need repeated explanation or discussion of here.
In deploying the stabilisation device 1 for its intended use, it may typically be placed over and around the exposed cannula head portion H and the securement key 30 actuated to clamp and anchor the head portion H and the tubular receiving portion 2 of the device 1 together, only after or once the cannula C has been inserted into the patient’s chest cavity at the desired insertion site in accordance with known medical practice, such as with the aid of an insertion needle which may be withdrawn immediately afterwards.
Alternatively, however, if it is desired or appropriate, it may be possible for the stabilisation device 1 to be attached to the cannula head portion H - including with actuation of the securement key 30, so that the cannula head portion H and the device are securely clamped and anchored together in a preliminary pre-insertion stage - before the cannula C is actually inserted into the patient’s chest cavity.
Furthermore, in deploying the stabilisation device 1 for its intended use, the precise stage of the overall device attachment procedure in which the attachment land 4 is stuck or otherwise affixed onto the patient’s skin at or adjacent the cannula insertion site, may vary. Generally, however, the affixing of the attachment land 4 onto the patent’s skin may occur either as a discrete active step between the steps of bringing together the cannula and the device into their received relationship and the actuating of the securement key 30, or alternatively as an action substantially simultaneous with the carrying out of those preceding steps.
Throughout the description and claims of this specification, the words “comprise” and “contain” and linguistic variations of those words, for example “comprising” and “comprises”, mean “including but not limited to”, and are not intended to (and do not) exclude other moieties, additives, components, elements, integers or steps.
Throughout the description and claims of this specification, the singular encompasses the plural unless expressly stated otherwise or the context otherwise requires. In particular, where the indefinite article is used, the specification is to be understood as contemplating plurality as well as singularity, unless expressly stated otherwise or the context requires otherwise.
Throughout the description and claims of this specification, features, components, elements, 5 integers, characteristics, properties, compounds, chemical moieties or groups described in conjunction with a particular aspect, embodiment or example of the invention are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith or expressly stated otherwise.

Claims (24)

1. A device for stabilising a cannula inserted into a patient’s body at an insertion site, the device comprising:
a receiving portion configured for receiving therein a portion of the cannula to be stabilised;
an attachment portion for attachment to the patient’s body adjacent the insertion site; and securement means for securing the portion of the cannula received in the receiving portion relative to the device such that the cannula and the receiving portion are substantially immovable relative to each other.
2. A device according to claim 1, wherein the receiving portion comprises a hollow channel member with walls defining a generally cylindrical or prismatic space therewithin.
3. A device according to claim 2, wherein the channel member is open at at least a lower end thereof, in order to provide access to the interior space therewithin via that open lower end, and through which open lower end the cannula head portion can be inserted so as to be received in the channel member.
4. A device according to claim 2 or claim 3, wherein the receiving portion includes one or more wall features configured to generally substantially match or to accommodate one or more respective head features on a head portion of the cannula, whereby inter-engagement or abutment of the respective one or more wall features and the one or more head features serves to further stabilise and secure the positioning of the cannula upon actuation of the securement means.
5. A device according to any one of claims 2 to 4, wherein the channel member forming the receiving portion of the device includes at least one, optionally a pair of diametrically or oppositely arranged, notches or recesses or cut-outs or truncations of one or more respective side walls thereof.
6. A device according to any preceding claim, wherein the attachment portion comprises a generally substantially flat or planar land or seating portion, or optionally is contoured or flexible in shape such as to conform to a curved or other non-flat surface contour of the patient’s body at or adjacent the site of insertion of the cannula.
7. A device according to claim 6, wherein the attachment portion is configured as a flange or land extending transversely or radially or peripherally outwardly from an open lower end of the receiving portion.
8. A device according to claim 6 or claim 7, wherein the attachment portion comprises attachment means in the form of an adhesive coating or pad affixed thereto, wherein the adhesive is selected from:
(i) a contact adhesive that sticks to a patient’s skin upon pressure being applied to the attachment portion; or (ii) a self-adhesive coating or patch pre-applied to the attachment portion and temporarily protected by a removable cover or layer of material that is removable prior to attachment of the attachment portion to the patient’s skin.
9. A device according to any preceding claim, wherein the receiving portion and the attachment portion are integrally connected.
10. A device according to any preceding claim, wherein the securement means comprises a moveable engagement member which is selectively and reversibly moveable between (i) a non-engaging or non-clamping or non-locking position, in which the head portion of the cannula to be received and stabilised within the receiving portion can be freely inserted into the receiving portion, and (ii) an engaging or clamping or locking position, in which the head portion of the cannula to be receiving and stabilised within the receiving portion is fixable, especially clampable or lockable therewithin, relative to the receiving portion.
11. A device according to claim 10, wherein movement of the engagement member is effectable by virtue of it being carried on an end of a threaded shaft which is rotatably mounted on or in the receiving portion via a screw-threaded engagement with one or more walls of the receiving portion.
12. A device according to claim 11, wherein the engagement member is carried on an inner remote end of a threaded key, optionally with an enlarged handle portion at an outer distal end thereof for assisting its manual manipulation.
13. A device according to claim 11 or claim 12, wherein the engagement member at the inner end of the threaded shaft is shaped or contoured to match or optimally abut or bear against a first relevant portion of the head portion of the cannula via which it is to be stably clamped or held in position in the device once the securement means has been actuated.
14. A device according to claim 13, wherein there is additionally provided, mounted on an inner wall or side of the receiving portion opposite to that having mounted therein the threaded key providing the engagement member, a seating or balancing member in the form of a balance block.
15. In combination, a cannula for insertion into a patient’s body at an insertion site, and a device for stabilising the cannula once inserted therein, wherein the device is a device according to any one of claim 1 to 14.
16. The combination according to claim 15, wherein the portion of the cannula which is received in, or is constructed and arranged for being received in, the receiving portion of the device, is a head portion of the cannula.
17. The combination according to claim 15 or claim 16, which is provided as a kit of parts for use in treatment of tension pneumothorax or other condition requiring chest decompression.
18. A method of stabilising a cannula inserted into a patient’s body at an insertion site, the method comprising:
(i) providing a stabilisation device according to any one of claims 1 to 14;
(ii) bringing the portion of the cannula and the receiving portion of the device into received relationship such that the cannula portion is received in the said receiving portion;
(iii) attaching the attachment portion of the device to the patient’s body adjacent the insertion site; and (iv) actuating the securement means so as to secure the portion of the cannula received in the receiving portion relative to the device such that the cannula and the receiving portion are substantially immovable relative to each other.
19. A method of treatment of tension pneumothorax in a patient, the method comprising inserting a cannula into the patient’s body at an insertion site, wherein the method further comprises stabilising the cannula inserted into the patient’s body by the steps of:
(i) providing a stabilisation device according to any one of claims 1 to 14;
(ii) bringing the portion of the cannula and the receiving portion of the device into received relationship such that the cannula portion is received in the said receiving portion;
(iii) attaching the attachment portion of the device to the patient’s body adjacent the insertion site; and (iv) actuating the securement means so as to secure the portion of the cannula received in the receiving portion relative to the device such that the cannula and the receiving portion are substantially immovable relative to each other.
20. A method according to claim 18 or claim 19, wherein in either of the said methods the step (ii), of bringing the portion of the cannula and the receiving portion of the device into received relationship such that the cannula portion is received in the said receiving portion, is carried out after the cannula has been inserted into the patient’s body.
21. A method according to claim 18 or claim 19, wherein in either of the said methods the step (ii), of bringing the portion of the cannula and the receiving portion of the device into received relationship such that the cannula portion is received in the said receiving portion, is carried out prior to the cannula being inserted into the patient’s body.
22. A method according to any one of claims 18 to 21, wherein in either of the said methods the step (iii) of attaching the attachment portion of the device to the patient’s body adjacent the insertion site is effected either as a discrete active step between steps (ii) and (iv) or alternatively as an action substantially simultaneous with the carrying out of either steps (ii) and/or (iv).
23. A method according to any one of claims 18 to 22, wherein in either of the said methods the step (ii) of bringing the portion of the cannula and the receiving portion of the device into received relationship is carried out by either:
(i) placing the receiving portion of the device over and/or around the cannula portion, optionally by manipulation primarily of at least the receiving portion of the device; or (ii) inserting the cannula portion into the receiving portion of the device, optionally by manipulation primarily of at least the cannula portion, and optionally by manipulation of both the cannula portion and the device together.
24. A method according to claim 23, in which either:
(iii) step (i) is carried out, and the method comprises inserting the cannula into the patient’s body first of all in a discrete insertion step, optionally with the aid of an insertion needle, and then the receiving portion of the device is then placed over the already-inserted cannula portion so that the latter is received in the former, and only then the securement means is actuated; or (iv) step (ii) is carried out, and the method comprises inserting the cannula portion into the receiving portion of the device, optionally by manipulation primarily of at least the cannula portion, and optionally by manipulation of both the cannula portion and the device together, and then actuating the securement means, and only then the cannula is inserted into the patient’s body.
GB1809974.7A 2018-06-18 2018-06-18 Cannula Stabilisation Device Active GB2574820B (en)

Priority Applications (2)

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GB1809974.7A GB2574820B (en) 2018-06-18 2018-06-18 Cannula Stabilisation Device
PCT/GB2019/051674 WO2019243784A1 (en) 2018-06-18 2019-06-17 Cannula stabilisation device

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US5263939A (en) * 1992-10-09 1993-11-23 Surgin Surgical Instrumentation, Inc. Retainer for laparoscopic cannula
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US2402306A (en) * 1943-10-07 1946-06-18 Turkel Henry Retaining guard guide for needles
US20090182283A1 (en) * 2008-01-11 2009-07-16 Tri-State Hospital Supply Corporation Catheter securement device
WO2014036347A1 (en) * 2012-08-31 2014-03-06 3M Innovative Properties Company Medical article securement systems comprising a bracket and a flap
WO2014149668A1 (en) * 2013-03-15 2014-09-25 Venetec International, Inc. Securement device having an integral strap and dressing
CN203749995U (en) * 2014-04-12 2014-08-06 徐洁 Catheter fixing device
CN106267525A (en) * 2016-08-11 2017-01-04 四川众药业有限公司 A kind of rotary fixer of drainage tube

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WO2019243784A1 (en) 2019-12-26
GB201809974D0 (en) 2018-08-01

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