Patent Application
20210068917
Many medical procedures require the accurate positioning, alignment and stabilizing of devices and instruments such as needles, catheters, drains, surgical pins, screws, drains and tubes during medical procedures performed on a patient.
For example, in computed tomography (CT) and fluoroscopic guided procedures, X-ray imaging is employed to guide a needle to a target in a patient. In order to position the needle at the target, a clinician must align the needle axis with the X-ray beam and advance the needle in the patient whilst taking a number of CT or fluoroscopic images which inform the movement of the needle. This process is repeated until the needle is positioned at the desired target. In such procedures, it is important that the position of the needle is maintained and stable while the CT images are being taken e.g. if the needle does not have sufficient traction within the patient's tissue, or if the weight of the proximal end of the needle is excessive, the needle can sag once released and lose its orientation. Patient movement can also result in undesired reorientation of the needle. This undesired movement of the needle results in additional X-ray images being required to correctly re-position the needle so that the clinician and the patient are exposed to increased potentially harmful radiation levels.
Various guide devices have been developed to assist clinicians in guiding and positioning needles and the like during medical procedures. For example, PCT Patent Specification No. 2016/186937 and EP 3 150 150 both describe a needle guide device having a non-resilient slotted sphere defining a guide channel for a needle in which the non-resilient sphere is locked in position by tightening a threaded ring surrounding the stiff slotted sphere to close the slot and tightly grip the needle. Similarly, U.S. Pat. No. 3,021,842 describes a hypodermic needle guide in which a solid ball having a needle passage for guiding the needle can be locked in position with a threaded locking ring. However, the spheres/balls employed in such guide devices simply act as guides for the needle and do not grip the needle passing through the sphere/ball whilst the stiff slotted spheres in combination with the threaded tightening mechanisms lack sensitivity when gripping and controlling movement of the sphere/ball i.e. needles are either tightly gripped in by the sphere when the slot is closed or are free to move unhindered in an uncontrolled manner in the sphere with the slot is open so that controlled and fine movement of the needle in the sphere is not possible. More generally, such devices and other known devices, being formed of multiple components are difficult and expensive to manufacture whilst still failing to allow for fine and accurate adjustment of a locking, gripping and stabilizing force on the needle.
This invention relates to a stabilizer and more particularly to a medical stabilizer for medical devices such as needles and the like.
According to the invention there is provided a medical device stabilizer comprising:
a base member;
a resilient medical device grip on the base member formed from compressible resilient material defining a medical device guide bore through the medical device stabilizer, and
a grip compression mechanism for compressing the compressible resilient material of the medical device grip, the grip compression mechanism being movable between a medical device grip compressed position and a medical device grip non-compressed position.
Preferably, the resilient medical device grip comprises a compressible ball.
Suitably, the compressible resilient material of the compressible ball has a durometer reading of from about 20 A to about 90 A. Preferably, the compressible resilient material of the compressible ball has a durometer reading of from about 40 A to about 80 A. More preferably, the compressible resilient material of the compressible ball has a durometer reading of about 70 A.
Preferably the guide bore passes through the centre of the ball. Advantageously, the guide bore may contain an expanded opening, chamfer or fillet at one or both ends to allow for easy insertion of the medical device through the bore. Advantageously, the guide bore internal diameter can be undersized compared to the medical device that is passed through it, providing a friction grip on the medical device.
Preferably, the grip compression mechanism comprises a two-part grip compression mechanism. More preferably, the two-part grip compression mechanism comprises a collet defining a socket for the compressible ball and an actuator attached to the collet at an actuator mounting defined between the actuator and the collet, the actuator being co-operable with the collet to compress the compressible ball.
Advantageously, the collet is formed by the base member. Preferably, the collet has a partly spherical internal profile forming a socket to accept a compressible ball and allow articulation of the ball. The partially spherical profile is employed to ensure sufficient angular articulation of the medical device that is inserted through the compressible ball. Although the spherical internal profile allows for rotation and articulation of the ball it does not allow for axial movement of the ball.
Advantageously, the collet has one or more slits or openings along its length and these slits can transition into the base member.
Preferably, the actuator comprises a tightening nut surrounding the collet. More preferably, the collet has an oval outer profile and the tightening nut has an oval inner profile complementary with the collet oval outer profile.
Optionally, the actuator mounting comprises a snap-fit mounting. Preferably, the snap-fit mounting comprises at least one catch on the collet and a flange defined on the tightening nut.
Alternatively, the actuator mounting comprises an outwardly extending finger on the collet inserted in a slit defined in the tightening nut. Preferably, the actuator mounting comprises two oppositely disposed outwardly extending fingers on the collet inserted in two slits defined in the tightening nut.
Alternatively, the actuator mounting comprises a threaded actuator mounting. Preferably, the threaded actuator mounting comprises a thread on the collet and a complementary thread on the actuator.
Alternatively, the grip compression mechanism comprises a band clamp. Preferably, the collet is the band of the band clamp and the actuator comprises a handle attached to the band.
Advantageously, the compressible ball comprises at least one slit to enhance the compressibility of the compressible ball. Preferably, at least one slit comprises a cruciform shaped slit.
Optionally, the medical device stabilizer further comprises an extension piece insertable in and removable from the guide bore to provide increased support for medical devices.
Suitably, the medical device stabilizer further comprises accessory mountings for attaching accessories to the stabilizer. Preferably, the accessory mountings are on the base member. Optionally, the accessory mountings are on the grip compression mechanism.
Advantageously, the medical device stabilizer further comprises a fixing plate mountable over the base member of the medical device stabilizer. Preferably, the base member comprises lugs and the fixing plate comprises lug holes for receiving the base member lugs.
Suitably, the base member comprises segments adapted to flex to meet contours on a patient. Preferably, the base member comprises a central disc and the segments extend laterally outwards from the central disc at flexible joints defined between the segments and the central disc.
Preferably, the base member comprises an adhesive layer for adhering the medical device stabilizer to a patient. Preferably the base member comprises a backing layer to shield the adhesive layer prior to use.
Suitably, the base member comprises a central disc and the segments extend laterally outwards from the central disc at flexible joints defined between the segments and the central disc. Preferably, the base member includes at least one window facilitating the placement of the device on a target area of the body. More preferably, the base member includes four windows. Most preferably, the at least one window comprises an arcuate window.
Advantageously, the at least one window includes a triangular projection pointing towards the centre of the device.
In one embodiment, the compressible ball includes a ruler to accurately target the depth of insertion of a medical device though the guide bore during use.
In a preferred embodiment of the invention, the medical device stabilizer is for a medical device of the type employed in image-guided procedures, for example a medical needle stabilizer. In a preferred embodiment, the medical needle stabilizer is employed as a stabilizer during image guided procedures, for example during ultrasound, fluoroscopic or computed tomography (CT) guidance guided procedures.
The resilient medical device grip of the stabilizer of the invention facilitates sensitive and finely controllable compression of the grip so that medical devices such as CT-guided needles inserted in the guide bore defined in the grip can be gripped and controlled with a high degree of sensitivity whilst being securely held by the stabilizer. Moreover, compression and release of the grip can be even more easily and finely controlled with the two-part grip compression mechanism.
Where the resilient medical device grip is a compressible ball, the ball can articulate and rotate in the collet of the grip compression mechanism to allow for easy positioning of CT-guided needles and the like held by the ball. Moreover, the grip compression mechanism allows for accurate adjustment of the locking, gripping and stabilizing force placed on the needle by the compressible ball. In particular, where the grip compression mechanism is an offset eccentric circle tightening mechanism i.e. the collet and the tightening nut have oval outer and inner profiles respectively, a compressive force can be exerted on and removed from the compressible ball by simply rotating the tightening nut. In addition, due to the grip exerted by the compressible ball, the stabilizer of the invention can also be employed as a depth stop with coaxial needles.
Optionally, the stabilizer device may also be provided with or without one or any of the components described herein, for example it can be provided without the adhesive layer and/or the locking nut.
The stabilizer device of the invention can be manufactured from three simple components—a unitary base plate and collet, the resilient medical device grip (the compressible ball) and the actuator (e.g. the tightening nut)—which facilitates ease of manufacture using cost-effective methods such as injection moulding.
Also described is a method of securing and positioning a medical device with respect to a subject, the method comprising the steps of:
placing a medical device stabiliser according to the invention on a subject;
inserting the medical device into the subject through the medical device guide bore; and actuating the grip compression mechanism to secure the medical device in position.
Also described is a further method of securing and positioning a medical device with respect to a subject, the method comprising the steps of:
placing a medical device through the medical device guide bore of a medical device stabilizer according to the invention to a predetermined depth;
actuating the grip compression mechanism; and
inserting the medical device into the subject to the predetermined depth;
The methods of the invention can also include the step of removing the adhesive backing from the adhesive layer at the base of the medical device. This step can be conducted either before or after the medical device has been placed onto the patient's body.
In another embodiment, the invention also extends to a medical device stabilizer comprising
In a preferred embodiment, the medical device stabilizer is a two-part medical device stabilizer in which the medical device grip is separate from but attachable to the base member.
Preferably, the medical device grip comprises a ball. Alternatively, the medical device grip has an ovoidal or tubular shape.
Suitably, the medical device grip comprises a resilient material.
Preferably, the resilient material has a durometer reading of from about 20 A to about 90 A. More preferably, the resilient material has a durometer reading of from about 40 A to about 80 A. Most preferably, the resilient material has a durometer reading of about 70 A.
Advantageously, the coupler comprises a clamping mechanism. Preferably, the clamping mechanism comprises a hinged clamp mechanism.
Suitably, the clamping mechanism comprises a collet defining a socket for the medical device grip. Preferably, the collet is formed around a central opening formed in the base member.
Preferably, the collet serves as a hinge of the clamping mechanism.
Suitably, the clamping mechanism comprises at least one fingergrip to effect a ball clamping action. Advantageously, the clamping mechanism comprises a pair of pinchable fingergrips operable to hingedly open the socket to receive a medical device grip and hingedly close the socket to clamp the medical device grip.
In one embodiment, the fingergrips are formed on a top face of the base member and are spaced apart by a V-shaped indent in the base member.
Suitably, the base member comprises an adhesive layer for adhering the medical device stabilizer to a patient.
Advantageously, the guide bore passes through the centre of the medical device grip.
In one embodiment, the medical device grip is provided with grip indents on an outer surface of the medical device grip.
In another embodiment, the medical device stabilizer comprises a compression mechanism to compress the medical device grip.
Preferably, the compression mechanism comprises a compression hinge. More preferably, the compression mechanism comprises a pair of compression hinges.
Suitably, the pair of compression hinges are hingedly openable and closable by fingergrips extending from the compression hinges.
Suitably, the medical device stabilizer further comprises a locking mechanism to maintain a compression force on the medical device grip. Preferably, the locking mechanism comprises a living hinge.
In another embodiment, invention extends to a medical device stabilizer system comprising a medical device stabilizer and a medical device wherein the medical device stabilizer comprises
In a preferred embodiment, the medical device is a needle.
The invention also extends to a method of securing and positioning a medical device with respect to a subject, the method comprising the steps of:
employing a medical device stabiliser having
a base member;
placing a medical device through the medical device guide bore of the medical device grip;
inserting the medical device into the subject, and
engaging the medical device grip with the coupler to stabilize the medical device.
Advantageously, the medical device is inserted into the subject to a predetermined depth determined by the location of the medical device grip on the medical device.
The present invention therefore provides a device for positioning and securing a medical device, instrument or other piece of equipment. It is particularly suited for securing needles, particularly coaxial needles during image guided procedures.
In summary, the stabilizer of the invention has a simple and effective design which is easy and economical to produce; can be produced as a low-cost disposable item; is lightweight and compact and is ergonomic and easy to use whilst being easily adjustable for repositioning of medical devices such as needles. The stabilizer allows for effective needle grip, support and orientation and can be used for a range of medical and surgical procedures including biopsy, drainage, injection and ablation. The stabilizer of the invention is especially efficacious for difficult angulation and positioning procedures involving difficult targets—especially for targets that are small and deep inside the body—so that procedure lengths and X-ray exposure for patients and clinicians alike are reduced significantly. Due to its ease of use, the stabilizer of the invention is suitable for use in hospitals, ambulatory centres, diagnostic centres, surgical and ablation centres.
The foregoing will be apparent from the following more particular description of example embodiments, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating embodiments.
A description of example embodiments follows.
The teachings of all patents, published applications and references cited herein are incorporated by reference in their entirety.
All publications, patents, patent applications and other references mentioned herein are hereby incorporated by reference in their entireties for all purposes as if each individual publication, patent or patent application were specifically and individually indicated to be incorporated by reference and the content thereof recited in full.
Where used herein and unless specifically indicated otherwise, the following terms are intended to have the following meanings in addition to any broader (or narrower) meanings the terms might enjoy in the art:
Unless otherwise required by context, the use herein of the singular is to be read to include the plural and vice versa. The term “a” or “an” used in relation to an entity is to be read to refer to one or more of that entity. As such, the terms “a” (or “an”), “one or more,” and “at least one” are used interchangeably herein.
As used herein, the term “comprise,” or variations thereof such as “comprises” or “comprising,” are to be read to indicate the inclusion of any recited integer (e.g. a feature, element, characteristic, property, method/process step or limitation) or group of integers (e.g. features, element, characteristics, properties, method/process steps or limitations) but not the exclusion of any other integer or group of integers. Thus, as used herein the term “comprising” is inclusive or open-ended and does not exclude additional, unrecited integers or method/process steps.
As used herein, the term “disease” is used to define any abnormal condition that impairs physiological function and is associated with specific symptoms. The term is used broadly to encompass any disorder, illness, abnormality, pathology, sickness, condition or syndrome in which physiological function is impaired irrespective of the nature of the aetiology (or indeed whether the aetiological basis for the disease is established). It therefore encompasses conditions arising from infection, trauma, injury, surgery, radiological ablation, poisoning or nutritional deficiencies.
As used herein, the term “treatment” or “treating” refers to an intervention (e.g. the administration of an agent to a subject) which cures, ameliorates or lessens the symptoms of a disease or removes (or lessens the impact of) its cause(s) (for example, the reduction in accumulation of pathological levels of lysosomal enzymes). In this case, the term is used synonymously with the term “therapy”.
Additionally, the terms “treatment” or “treating” refers to an intervention (e.g. the administration of an agent to a subject) which prevents or delays the onset or progression of a disease or reduces (or eradicates) its incidence within a treated population. In this case, the term treatment is used synonymously with the term “prophylaxis”.
As used herein, an effective amount or a therapeutically effective amount of an agent defines an amount that can be administered to a subject without excessive toxicity, irritation, allergic response, or other problem or complication, commensurate with a reasonable benefit/risk ratio, but one that is sufficient to provide the desired effect, e.g. the treatment or prophylaxis manifested by a permanent or temporary improvement in the subject's condition. The amount will vary from subject to subject, depending on the age and general condition of the individual, mode of administration and other factors. Thus, while it is not possible to specify an exact effective amount, those skilled in the art will be able to determine an appropriate “effective” amount in any individual case using routine experimentation and background general knowledge. A therapeutic result in this context includes eradication or lessening of symptoms, reduced pain or discomfort, prolonged survival, improved mobility and other markers of clinical improvement. A therapeutic result need not be a complete cure.
In the context of treatment and effective amounts as defined above, the term subject (which is to be read to include “individual”, “animal”, “patient” or “mammal” where context permits) defines any subject, particularly a mammalian subject, for whom treatment is indicated. Mammalian subjects include, but are not limited to, humans, domestic animals, farm animals, zoo animals, sport animals, pet animals such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, cattle, cows; primates such as apes, monkeys, orangutans, and chimpanzees; canids such as dogs and wolves; felids such as cats, lions, and tigers; equids such as horses, donkeys, and zebras; food animals such as cows, pigs, and sheep; ungulates such as deer and giraffes; and rodents such as mice, rats, hamsters and guinea pigs. In preferred embodiments, the subject is a human.
The invention will now be described with reference to specific Examples. These are merely exemplary and for illustrative purposes only: they are not intended to be limiting in any way to the scope of the monopoly claimed or to the invention described. These examples constitute the best mode currently contemplated for practicing the invention.
As shown in the drawings, a medical device stabilizer in accordance with the invention is generally indicated by the reference numeral 1 and is made up of a base member in the form of a substantially circular base plate 2 and a compressible medical device grip 3 on the base plate 2 which can articulate for gripping and positioning medical devices such as CT-guided needles held in the medical device grip 3. In this embodiment, the base plate is circular, but it may be a different shape such as square, rectangular or oval. The medical device grip 3 is in the form of a resilient and compressible ball 4 formed from a compressible resilient material having a guide bore 5 therethrough for receiving and holding the medical devices with the degree of compression of the ball 4, and hence the grip on medical devices in the guide bore 5, being controllable by a grip compression mechanism 6 surrounding the ball 4 which is movable between a ball compressed position and a ball non-compressed position. The guide bore 5 is sized so that resilient and conformable material of the compressible ball maintains a constant friction-fit type contact with medical devices inserted in the guide bore 5. The medical device stabilizer 1 can be secured to a patient via an adhesive e.g. in the form of an adhesive layer or tape 7 provided on the base plate 2.
The grip compression mechanism 6 is a two-part mechanism made up firstly of a collet 13 centrally formed on the base plate 2. The collet 13 is integrally formed by the base plate 2 so that the collet 13 and base plate 2 constitute a unitary piece which can be injected moulded if desired. Referring to
Referring to
Referring to
Referring to
The adhesive layer 7 of the medical device stabilizer 1 is made up of a circular adhesive tape 33 attached to the bottom face 8 of the base plate 2. Removable backing tabs 34 and 35 are provided to protect the circular adhesive tape 33 prior to use of the stabilizer device 1.
In use, the stabilizer device 1 can be used with a range of medical devices and in a variety of procedures such as biopsy, drainage, injection and ablation procedures.
The CT-guided needle 37 is then inserted into a patient body part and, following removal of the removable backing tabs 34 and 35 from the adhesive tape 33, the base plate 2 is positioned as required on the patient body part 38 adjacent a desired target 39 in the body part 38. Under X-ray guidance, the CT-guided needle 37 can be positioned as required via the rotatable and articulatable ball 4 which can be compressed by the grip compression mechanism 6 as previously described when required to hold, fix and stabilise the CT-guided needle 37 in a desired position in the stabilizer 1. More particularly, as the resilient and conformable material of the spherical ball 4 is in constant friction-fit type contact with CT-guided needle 37, the CT-guided needle 37 is constantly supported in place in medical device stabilizer 1 so that no undesirable translational or sliding movement of the CT-guided needle 37 occurs i.e. the CT-guided needle 37 must be deliberately slid in the guide bore 5 by a user to effect movement of the CT-guided needle 37. This in contradistinction with devices of the prior art where needles and the like are supported in rigid materials which either fully grip the needles preventing all sliding movement or allow full sliding movement of the needles resulting in poor sensitivity and movement control in use.
As shown in the drawings, the base plate 2 of the present embodiment is provided with peripheral laterally extending and oppositely disposed tags 63 to facilitate contouring of the base plate 2 against a patient and gripping of the base plate 2. In addition, flexing of the base plate 2 is enhanced by a channel 64 defined in the base plate 2 which extends across the base plate 2. The grip compression mechanism 6 is made up of a collet 13 and an annular tightening nut 26 having oval outer and inner profiles when viewed from above respectively as previously described (see
The stabilizer 1 is further provided with an annular base plate cover 69 with an adhesive layer 7 to further assist in securing the medical stabilizer to a patient.
As shown in the drawings, in the present embodiment, the collet wall 15 of the collet 13, which forms the band of the band clamp 72, is provided with a mounting block 73 to one side of the collet wall 15. A single mounting block slit 74 is defined in the mounting block 73 to form a handle mounting portion 75 and a screw mounting portion 76 separated by the mounting block slit 74. The collet wall 15 defines a socket 14 for the compressible ball 4 which can be compressed by urging the handle mounting portion 75 towards the screw mounting portion 76 to close the slit 74. In addition, the base plate 2 is provided with a base plate slit 77 contiguous with the mounting block slit 74 which closes with the mounting block slit 74.
A screw 78 with a screw thread 79 is held in the screw mounting portion 76 at a first screw hole 80 and extends through a similar second screw hole 81 in the handle mounting portion 75 to engage an arcuate handle 82 at a threaded opening 83 defined in an insert 84 supported in the handle 82. Movement of the arcuate handle 82 between an open position as shown in
A device as shown in
From the results in Table 1 it is clear that a low durometer ball (Silicone, durometer: 2 A) is effective at gripping the needle, but not fully suitable for this application due to its high degree of friction exerted by the ball on the socket that prevents the user from easily articulating the needle in the device. On the other hand, a higher durometer material (polyurethane, durometer 95 A) can easily rotate within the socket but due to its high stiffness cannot easily be tightened and locked to the needle. Of the devices tested in Table 1, optimal results were achieved for a 70 A durometer ball with both Nitrile and Viton materials providing positive results.
More particularly, as shown in the drawings, the medical device stabilizer 1 is made up of the base member 2 which is in the form of a base plate 2 and the medical device grip 3 which is in the form of a ball 4. As discussed in more detail below, the ball 4 can be detachably coupled to the base plate 2 at the coupler 86 formed on the base plate 2 which can be in the form of a clamping mechanism 87 as shown in the present embodiment.
The base plate 2 is a substantially circular or disc-like base plate 2 and has a base plate bottom face 8 and a base plate top face 9. The coupler 86 is centrally formed on the top face 9 and is made up of the clamping mechanism 87 which is formed by an adjustable socket 14 sized and shaped for receiving and holding the ball 4. The socket 14 is defined by a collet 13 centrally formed on the base plate 2. The collet 13 is integrally formed by the base plate 2 so that the collet 13 and base plate 2 constitute a unitary piece which can be injected moulded if desired.
The collet 13 and spherical socket 14 are sized to be complementary in size and shape with the ball 4 to receive and hold the ball 4. More particularly, the collet 13 is formed by a flexible collet wall 15 upstanding from the base plate 2. Internally, the collet wall 15 is shaped and spherically contoured as indicated by the reference numeral 25 so that the socket 14 complements the spherical shape of the ball 4.
In one embodiment of the present embodiment, the hinged clamping mechanism 87 is not a compression mechanism and does not exert a compressing force on the bore 5 of the medical device grip 3. In a second embodiment, the collet 13 and spherical socket 14 are undersized to the ball 4 and can be used to exert a clamping force on the bore 5 of the medical device grip 3.
The collet wall 15 is formed around a central opening 88 formed in the base plate 2 and a slit 89 extends from the central opening 88 to the edge 90 of the base plate 2 so that the collet wall 15 is not continuous i.e. is provided with a gap 91 contiguous with and defined by the slit 89. The socket 14 can therefore be opened and closed i.e. increased and decreased in size to receive and release the ball 4 by increasing and decreasing the size of the slit 89 and gap 91. To achieve this, the vicinity of the collet 13 serves as a hinge 92 so that the clamping mechanism 87 is a hinged clamping mechanism 87. More particularly, the collet wall 15 is provided with a pair of fingergrips 93 which can be pinched by a user to effect a ball clamping action. The fingergrips 93 are formed on the top face 9 of the base plate 2 and are spaced apart by a V-shaped indent 94 formed in the base plate 2. Accordingly, pinching together of the fingergrips 93 causes the socket 14 to hinge open to receive a ball 4 while release of the fingergrips causes the socket 14 to hinge closed to clamp the ball 4.
As indicated above, the medical device grip 3 is in the form of a ball 4 having a guide bore 5 therethrough for receiving and holding the medical devices in a slidable friction fit relationship. In one embodiment, the ball can be formed from a resilient material. The ball 4, and in particular the surface of the guide bore 5, is configured so that the ball 4 can maintain a constant friction-fit type contact with medical devices inserted in the guide bore 5. The ball 4 can be so configured by appropriate selection of the material of the ball e.g. a suitably resilient material or the material properties or structure of the surface defining the guide bore 5. Accordingly, when mounted on a medical device such as the co-axial needle 85, the ball 4 can be slid to a selected position on the co-axial needle 85 to mark the depth of insertion of the co-axial needle into a subject. The insertion depth can be indicated by depth markers 96 on the co-axial needle 85.
The outer surface 94 of the ball 4 can be provided with grip indents 95 to assist in maneuvering the ball 4 and to assist in injection molding of the ball 4 by providing a uniform cross-sectional wall thickness throughout the ball 4.
The medical device stabilizer 1 can be secured to a patient via an adhesive e.g. in the form of an adhesive layer or tape 7 provided on the base plate 2 which is generally provided with a backing tab 35.
In use, the stabilizer device 1 can be used with a range of medical devices and in a variety of procedures such as biopsy, drainage, injection and ablation procedures.
At the start of a CT-guided procedure, it may be necessary for the clinician to reposition the co-axial needle 85 to a preferred insertion position in the body. Having the ball 4 independent of the base member 2, allows the clinician greater flexibility in repositioning the co-axial needle 85 if required as the clinician does not have to attach and then detach the base member 2 at this stage. The base member 2 is engaged with the ball 4 when the preferred insertion position is confirmed under CT-guidance.
The CT-guided needle 85 is then inserted into a patient body part 38 (see
In the present embodiment, the medical device stabilizer 1 is employed in the same manner as the medical device of
As will be appreciated by those skilled in the art, the present invention, and in particular in the embodiments shown in
The stabilizer 1 of the invention can be formed from any suitable materials provided the material of the conformable or compressible medical device grip is sufficiently resilient to deform to provide a medical device gripping force in use. More particularly, the compressible and conformable resilient material of the compressible medical device grip should be sufficiently stiff to enable the compressible ball 4 to articulate and rotate and remain within the socket 14 using the snap-fit mechanism previously described whilst also being sufficiently resilient and compressible to grip the medical device when required. For example, the material of the compressible ball 4 should have a durometer reading of from about 10 A to about 100 A, more preferably from about 20 A to about 90 A and more preferably from about 40 A to about 80 A. During initial prototyping, a compressible ball 4 having a durometer reading of about 70 A has been found to have a desirable resilience for articulation/rotation and compression of the compressible ball 4. Particularly suitable materials for the compressible ball include rubbers, nitriles, polyurethanes, neoprenes and silicones.
Nevertheless, where the medical device grip is not required to be compressible, it has also been found that a medical device grip formed from a resilient material is particularly suitable. For example, in this embodiment, a ball 4 formed from a resilient material having a durometer reading of from about 10 A to about 100 A, more preferably from about 20 A to about 90 A and more preferably from about 40 A to about 80 A is also suitable. A ball 4 having a durometer reading of about 70 A has been found to have a desirable resilience for articulation/rotation. Again, particularly suitable materials for the compressible ball include rubbers, nitriles, polyurethanes, Pebax®, neoprenes and silicones.
In a preferred embodiment the medical device grip 3 may be a formed from a ball 4 with a guide bore 5. However, in another embodiment its profile may also be ovoidal, tubular, or of any cross sectional shape containing a guide bore 5. The socket 14 of the base member 2 can be tailored to accept the profile medical device grip 3.
The base member 2 can also be formed from any suitable materials such as polymeric materials. In particular, the base member 2 of the embodiments shown in
In other embodiments of the invention, the hinged clamping mechanism can be formed by and/or augmented with biasing means to create a biased clamping mechanism. The biased hinged clamping mechanism can be formed by the materials of the base member 2 or by mechanical means such as springs and the like. The effect of the biasing hinge clamping mechanism is to ensure that the socket 14 returns to its closed configuration after opening. The biasing hinge clamping mechanism may also be used to apply a clamping force on the medical device grip 3.
If desired, the stabilizer can be formed from transparent materials to allow for skin visualisation while various components can be colour coded in accordance with the size of the medical device to be used with the stabilizer e.g. needle gauges and can also be provided with inserts to adapt the guide bore to different needle gauges if desired. Alternatively, due to the use of the compressive grip, the stabilizer can be a one size fits all universal stabilizer for all needle gauge sizes.
If desired, the stabilizer can be provided with other features such as a protractor to show the angle of orientation of medical devices gripped in the stabilizer.
While example embodiments have been particularly shown and described, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the embodiments encompassed by the appended claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 18163103.7 | Mar 2018 | EP | regional |
This application is a continuation-in-part of International Application No. PCT/EP2019/057110, which designated the United States and was filed on Mar. 21, 2019, published in English, which claims priority under 35 U.S.C. § 119 or 365 to European, Application No. 18163103.7, filed Mar. 21, 2018. The entire teachings of the above applications are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/EP2019/057110 | Mar 2019 | US |
| Child | 17027561 | US |
