STABILISER

Abstract

A medical device stabilizer 1 having a base plate 2 and a compressible medical device grip 3 in the form of a resilient ball 4 with a guide bore 5 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.

Claims

1. A medical device stabilizer comprising a base member; a medical device grip, engageable with the base member, defining a medical device guide bore through the medical device stabilizer, the medical device guide bore being configured to form a slidable friction fit with a medical device, and a coupler on the base member for engaging the medical device grip, the coupler being movable between a medical device grip engaged position and a medical device grip release position.

2. A medical device stabilizer as claimed in claim 1 wherein the medical device stabilizer is a two-part medical device stabilizer in which the medical device grip is separate to the base member.

3. A medical device stabilizer as claimed in claim 1 wherein the medical device grip comprises a ball.

4. A medical device stabilizer as claimed in claim 1 wherein the medical device grip has an ovoidal or tubular shape.

5. A medical device stabilizer as claimed in claim 1 wherein the medical device grip comprises a resilient material.

6. A medical device stabilizer as claimed in claim 5 wherein the resilient material has a durometer reading of from about 20 A to about 90 A.

7. A medical device stabilizer as claimed in claim 6 wherein the resilient material has a durometer reading of from about 40 A to about 80 A

8. A medical device stabilizer as claimed in claim 7 wherein the resilient material has a durometer reading of about 70 A.

9. A medical device stabilizer as claimed in claim 1 wherein the coupler comprises a clamping mechanism.

10. A medical device stabilizer as claimed in claim 9 wherein the clamping mechanism comprises a hinged clamp mechanism.

11. A medical device stabilizer as claimed in claim 10 wherein the clamping mechanism comprises a collet defining a socket for the medical device grip.

12. A medical device stabilizer as claimed in claim 11 wherein the collet is formed around a central opening formed in the base member.

13. A medical device stabilizer as claimed in claim 12 wherein the collet serves as a hinge of the clamping mechanism.

14. A medical device stabilizer as claimed in claim 11 wherein the clamping mechanism comprises at least one fingergrip to effect a ball clamping action.

15. A medical device stabilizer as claimed in claim 14 wherein 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.

16. A medical device stabilizer as claimed in claim 15 wherein 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.

17. A medical device stabilizer as claimed in claim 1 wherein the base member comprises an adhesive layer for adhering the medical device stabilizer to a patient.

18. A medical device stabilizer as claimed in claim 1 wherein the guide bore passes through the centre of the medical device grip.

19. A medical device stabilizer as claimed in claim 1 wherein the medical device grip is provided with grip indents on an outer surface of the medical device grip.

20. A medical device stabilizer as claimed in claim 1 wherein the medical device stabilizer comprises a compression mechanism to compress the medical device grip.

21. A medical device stabilizer as claimed in claim 20 wherein the compression mechanism comprises a compression hinge.

22. A medical device stabilizer as claimed in claim 21 wherein the compression mechanism comprises a pair of compression hinges.

23. A medical device stabilizer as claimed in claim 22 wherein the pair of compression hinges are hingedly openable and closable by fingergrips extending from the compression hinges.

24. A medical device stabilizer as claimed in claim 20 further comprising a locking mechanism to maintain a compression force on the medical device grip.

25. A medical device stabilizer as claimed in claim 24 wherein the locking mechanism comprises a living hinge.

26. A medical device stabilizer system comprising a medical device stabilizer and a medical device wherein the medical device stabilizer comprises a base member; a medical device grip, engageable with the base member, defining a medical device guide bore through the medical device stabilizer, the medical device guide bore being configured to form a slidable friction fit with the medical device, and a coupler on the base member for engaging the medical device grip, the coupler being movable between a medical device grip engaged position and a medical device grip release position.

27. A medical device stabilizer system as claimed in claim 26 wherein the medical device is a needle.

28. 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; a medical device grip, engageable with the base member, defining a medical device guide bore through the medical device stabilizer, the medical device guide bore being configured to form a slidable friction fit with a medical device, and a coupler on the base member for engaging the medical device grip, the coupler being movable between a medical device grip engaged position and a medical device grip release position; 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.

29. A method of securing and positioning a medical device with respect to a subject as claimed in claim 28 comprising inserting the medical device into the subject to a predetermined depth determined by the location of the medical device grip on the medical device.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0071] 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.

[0072] FIG. 1 is a perspective view from above and one side of a first embodiment of a medical stabilizer of the invention having a resilient medical device grip in the form of a conformable or compressible ball formed from a compressible resilient material and a ball compression mechanism made up of an outer tightening nut defining an oval opening for receiving an oval collet surrounding the conformable ball so that rotation of the tightening nut causes the collet to compress the ball, the tightening nut being mounted on the collet at a snap-fit mounting;

[0073] FIG. 2 is a top plan view of the medical stabilizer of FIG. 1;

[0074] FIG. 3 is a cross-sectional view along the line III-III of FIG. 2;

[0075] FIG. 4 is a cross-sectional view along the line IV-IV of FIG. 3;

[0076] FIG. 5 is a cross-sectional view along the line V-V of FIG. 3 with the letter P indicating the large diameter of the oval opening in the tightening nut and the oval collet and the letter Q indicating the small diameter of the oval opening in the tightening nut and the oval collet;

[0077] FIG. 6 is an exploded perspective view from above and one side of the medical stabilizer of FIG. 1;

[0078] FIG. 7 is a schematic side elevation of the medical stabilizer of FIG. 1 positioned on a patient with a CT-guided needle inserted in the guide bore of the ball of the stabilizer with the needle in a vertical position oriented towards its target;

[0079] FIG. 8 is a schematic side elevation of the medical stabilizer of FIG. 1 positioned on a patient with a CT-guided needle inserted in the guide bore of the ball of the stabilizer with the ball rotated in the socket so that the needle is articulated offset from the vertical and oriented towards its target;

[0080] FIG. 9 is an enlarged cross-sectional view, similar to the cross-sectional view of FIG. 5, of a second embodiment of the invention in which the conformable ball is provided with slits arranged in a cruciform pattern to increase the compressibility of the ball;

[0081] FIG. 10 is a perspective view from above and one side of a third embodiment of the invention in which the conformable ball is provided with an extension for receiving and supporting a medical device such as a needle;

[0082] FIG. 11 is a perspective view from above and one side of a fourth embodiment of the invention in which the medical stabilizer is provided with accessory mountings for attaching accessories to the stabilizer;

[0083] FIG. 12 is a perspective view from above and one side of a fifth embodiment of the invention holding a needle in which the medical stabilizer includes a fixing plate mountable over and co-operable with the base member of the medical stabilizer to fix the medical stabilizer in position on a patient;

[0084] FIG. 13 is a perspective view from above and one side of a sixth embodiment of the invention in which the base member in the form of a base plate of the medical stabilizer is segmented into flexible petal-like members to enhance contouring of the base plate to a patient's skin;

[0085] FIG. 14 is a perspective view from above and one side of a seventh embodiment of the invention in which the tightening nut is mounted on the collet via outwardly extending fingers on the collet inserted in horizontal slits defined in the tightening nut;

[0086] FIG. 15 is a top plan view of the medical stabilizer of FIG. 14;

[0087] FIG. 16 is a side elevation of the medical stabilizer;

[0088] FIG. 17 is an exploded perspective view from above and one side of the medical stabilizer;

[0089] FIG. 18 is an exploded perspective view from above and one side of an eighth embodiment of the medical stabilizer of the invention in which the actuator mounting is made up of an outer threaded tightening nut and a complementary threaded collet;

[0090] FIG. 19 is a cross-sectional view through the medical stabilizer of FIG. 18 showing the internal threads of the tightening nut;

[0091] FIG. 20 is a perspective view from above and one side of the medical stabilizer of FIG. 18 with the threaded nut secured to the threaded collet;

[0092] FIG. 21 is a cross-sectional view through the medical stabilizer of FIG. 20;

[0093] FIG. 22 is an exploded perspective view from above and one side of a ninth embodiment of the medical stabilizer device in which the grip compression mechanism is made up of a band clamp type mechanism;

[0094] FIG. 23 is a perspective view from above and one side of the medical stabilizer of FIG. 22 with the band clamp type mechanism partially closed,

[0095] FIG. 24 is a perspective view from above and one side of the medical stabilizer with the band clamp type mechanism fully closed;

[0096] FIG. 25 is a perspective view from above and one side of another embodiment of a medical stabilizer of the invention;

[0097] FIG. 26 is a perspective view from above and one side of a further embodiment of the medical device stabilizer system of the invention in which the medical device stabilizer is a two-part stabilizer made up of the medical device grip and, separately, the base member with the medical device grip being slidably mountable on a medical device such as a coaxial delivery needle as shown and being engageable with and detachable from the base member at a coupling/clamping mechanism;

[0098] FIG. 27 is an exploded perspective view from above and one side of the base member, skin adhesive tape and backing tab;

[0099] FIG. 28 is a top plan view of the base member and a cross-sectional view along the line A-A of the base member;

[0100] FIG. 29 is a perspective view from above and one side of the medical device grip mounted on the coaxial delivery needle which is inserted a patient body part;

[0101] FIG. 30 is a perspective view from above and one side of the medical device grip and coaxial delivery needle of FIG. 29 with the base member approaching the medical device grip to clamp the medical device grip via the coupling mechanism with the direction of approach and clamping action indicated by the arrows;

[0102] FIG. 31 is a perspective view from above and one side of the coaxial delivery needle inserted in the patient body part with the medical device grip clamped by the coupling mechanism to hold the coaxial delivery needle in position on the patient, and

[0103] FIG. 32 is a top plan view of the base member of a further embodiment of the invention in which the base member of FIGS. 26 to 31 is also provided with a compression mechanism to compress the medical device grip and firmly lock medical devices in position in the medical device grip.

DETAILED DESCRIPTION

[0104] A description of example embodiments follows.

[0105] The teachings of all patents, published applications and references cited herein are incorporated by reference in their entirety.

[0106] 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.

Definitions and General Preferences

[0107] 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:

[0108] 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.

[0109] 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.

[0110] 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.

[0111] 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.

[0112] 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.

[0113] 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.

[0114] 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.

EXEMPLIFICATION

[0115] 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.

[0116] 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.

[0117] FIGS. 1 to 8 show a first embodiment of a medical device stabilizer 1 of the invention. In the present embodiment, and referring specifically to FIGS. 1 to 5, the circular base plate 2 has a base plate bottom face 8 and a base plate top face 9 provided with two peripheral oppositely disposed first and second finger grips 10, 11 respectively at the base plate edge 12 for holding and positioning the base plate 2.

[0118] 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 FIG. 6, the collet 13 has a spherical socket 14 (complementary in size and shape with the compressible ball 4) for receiving and holding the compressible ball 4 defined by a flexible collet wall 15 upstanding from the base plate 2. The collet wall 15 has an oval outer profile 16 when viewed from above and a circular inner profile 17 when viewed from above defining the circular socket 14 (see in particular FIGS. 2 and 5). The flexible collet wall 15 allows for insertion and retention of the compressible ball 4 in the socket 14 in a press-fit or snap-fit fitting whilst allowing the compressible ball 4 to rotate in the socket 14 i.e. internally, the collet wall 15 is shaped and contoured as indicated by the reference numeral 25 in FIG. 6 so that the socket 14 complements the spherical shape of the ball 4. Accordingly, the flexible collet wall 15 can flex laterally outwards to receive the compressible ball 4 in the socket 14 and then return inwards via the press-fit or snap-fit action to hold the compressible ball 4 in place.

[0119] Referring to FIG. 2, the collet wall 15 is segmented by first and second oppositely disposed first and second flexible ribs 19, 20 defined in the collet wall 15. The ribs 19, 20 are each formed by respective first and second pairs of slots 21, 22 respectively defined in the collet wall 15 so that the flexible collet wall 15 is made up of the oppositely disposed flexible ribs 19, 20 and oppositely disposed flexible wall segments 15a,15b (FIG. 6). At their free ends, the flexible ribs 19, 20 have respective first and second catches 23, 24 (FIG. 4).

[0120] Referring to FIG. 6, the second part of the two-part grip compression mechanism 6 is made up of a manual actuator in the form of a ring-like tightening nut 26 sized and shaped to surround the collet 13. The tightening nut 26 has an annular wall 27 provided with first and second oppositely disposed external wings 28, 29 respectively for turning the tightening nut 26 about the collet 13. Internally, the tightening nut 26 has an annular flange 30 for engaging the first and second catches 23, 24 on the flexible ribs 19, 20. The tightening nut 26 is sized and shaped to fit over the collet 13 in a snap-fit relationship i.e. the first and second catches 23, 24 and the annular flange 30 in combination define a snap-fit actuator mounting 18 between the collet 13 and the tightening nut 26. The tightening nut 26 can be rotated or turned about the collet 13 in the actuator mounting 18.

[0121] Referring to FIGS. 2 and 6, the wall 27 of the tightening nut 26 has a circular outer profile 31 when viewed from above and an oval inner profile 32 when viewed from above which complements the oval outer profile 16 of the collet 13. Accordingly, as shall be explained more fully below, the grip compression mechanism 6 is an offset eccentric circle tightening mechanism in which the tightening nut wall 27 interferes with the collet wall 15 during clockwise and anti-clockwise rotation to displace the collet wall segments 15a, 15b and the flexible ribs 19, 20 inwards and compress the compressible ball 4.

[0122] 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.

[0123] 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. FIGS. 7 and 8 show the stabilizer device 1 in use with a CT-guided needle 37 which is inserted through the guide bore 5 of the ball 4 so that stabilizer device 1 is located on the CT-guided needle 37. If desired, the diameter of the guide bore 5 can be sized so that CT-guided needle 37 enjoys a friction fit in the guide bore 5 to hold the stabilizer device 1 on the CT-guided needle 37.

[0124] 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.

[0125] FIG. 9 is an enlarged cross-sectional view, similar to the cross-sectional view of FIG. 5, of a second embodiment of the stabilizer 1 of the invention that is broadly similar to the stabilizer 1 of FIGS. 1 to 8 and in which parts the same as those described in the previous embodiment are assigned the same reference numerals. However, in the present embodiment, the compressible ball 4 is provided with slits 40 to increase the compressibility of the ball 4 around the CT-guided needle 37. The slits 40 extend through the compressible ball 4 and are arranged in a cruciform pattern 41 about the guide bore 5. The tightening nut 26 of the present embodiment is also provided with four peripheral wings 28, 29.

[0126] FIG. 10 shows a perspective view from above and one side of a third embodiment of the stabilizer 1 also broadly similar to the stabilizer 1 of FIGS. 1 to 8 and like numerals indicate like parts. The stabilizer 1 of the present embodiment is provided with a detachable medical device auxiliary extension piece 42 insertable in and removable from the guide bore 5 to provide increased support for medical devices such as CT-guided needles 37. The extension piece 42 is made up of a tube 43 insertable in the guide bore 5 at its first end and a cylindrical neck 44 at its opposite end for receiving a medical device in a neck opening 45 defined in the neck 44. The extension piece 42 is provided with a locking system 46 to secure a medical device in position in the extension piece 42. The locking system 46 is made up of a screw shaft 47 insertable into the cylindrical neck by rotating a head 48 on the shaft 47 so that the screw shaft 47 is placed into frictional engagement with a medical device positioned in the cylindrical neck 44.

[0127] FIG. 11 shows a perspective view from above and one side of a fourth embodiment of the stabilizer 1 also broadly similar to the stabilizer 1 of FIGS. 1 to 8 and like numerals indicate like parts. However, in the present embodiment, the stabilizer 1 is provided with accessory mountings 49 for attaching accessories to the stabilizer 1 as required. Two oppositely disposed accessory mountings 49 extend upwards from the top face 9 of the base plate 2 either side of the grip compression mechanism 6 while the first and second wings 28, 29 of the tightening nut 26 are also replaced by similar accessory mountings 49 extending laterally outwards from the tightening nut wall 27. Each accessory mounting 49 is made up of a shaft 50 attached at one end to the base plate 2 or the tightening nut wall 27 and a spherical mounting head 51 at its opposite end. However, the accessory mountings 49 can be shaped and dimensioned as required.

[0128] FIG. 12 shows a perspective view from above and one side of a fifth embodiment of the stabilizer 1 of the invention similar to the stabilizer 1 of FIG. 9 with a CT-guided needle 37 gripped in the ball 4 of the stabilizer 1. Like numerals indicate like parts. However, the stabilizer 1 of the present embodiment is provided with a fixing plate 52 mountable over and co-operable with the base plate 2 of the medical stabilizer 1 to assist in fixing the medical stabilizer 1 in position on a patient. More particularly, base plate 2 has four spaced-apart peripheral upstanding fixing lugs 53 for engagement with the fixing plate 52 which has an annular fixing ring 54 provided with spaced apart lug holes 55 for receiving the fixing lugs 53 on the base plate 2. In use, the fixing plate 52 is placed over the base plate 2 so that the fixing lugs 53 are received in the lug holes 55 while the annular fixing ring 54 is provided with an adhesive layer 56 to adhere the annular ring 54 to a patient. The adhesive layer 56 is protected by a removable backing 57 prior to use.

[0129] FIG. 13 shows a perspective view from above and one side of a sixth embodiment of the stabilizer 1 similar to the stabilizer 1 of FIGS. 1 to 8. Like numerals indicate like parts. In the present embodiment, the base plate 2 of the medical stabilizer 1 is segmented so that base plate 2 can flex to meet contours on a patient. More particularly, the base plate 2 is formed from a central disc 58 on which the conformable ball 4 and grip compression mechanism 6 are mounted as previously described. However, four spaced apart petal-like base plate segments 59 extend laterally outwards from the central disc 58 at flexible joints 60 defined between the base plate segments 59 and the central disc 58 so that each base plate segment 59 can flex and bend independently as required in accordance with a patient's surface contours. Each base plate segment 59 is provided with a finger hold 61 on its upper surface while adhesive tabs 62 are provided on the lower surface of each base plate segment 59 to adhere the base plate segments 59 to patients.

[0130] FIGS. 14 to 17 show a seventh embodiment of the stabilizer 1 of the invention similar in function to the medical stabilizer 1 of FIGS. 1 to 13 but in which the snap fit actuator mounting 18 is replaced by an alternative actuator mounting. Like numerals indicate like parts.

[0131] 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 FIG. 15). However, the collet 13 of the present embodiment has two oppositely disposed slots 65 to define the oppositely disposed flexing collet wall segments 15a, 15b. Externally, the collet wall 15 is provided with oppositely disposed outwardly extending fingers 66 for insertion in complementary substantially horizontal slits 67 defined in the tightening nut 26 so that the tightening nut 26 is mounted on the fingers 66 and can also be rotated about the collet 13 on the fingers 66 along a path defined by the slits 67. The fingers 66 are received in the slits 67 via slit mouths 68 defined in the tightening nut 26. The fingers 66 on the collet wall 15 and the complementary slits 67 therefore form the actuator mounting 18 of the present embodiment.

[0132] 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.

[0133] FIGS. 18 to 21 show an eighth embodiment of the medical stabilizer 1 of the invention broadly similar to the medical stabilizer of previous embodiments and like numerals indicate like parts. However, in the present embodiment, the collet wall 15 is provided with two oppositely disposed slots 65 to define two wall segments 15a, 15b similar to the collet 13 of FIGS. 14 to 19 and is further provided with a collet screw thread 70 on the collet wall 15 engageable with a complementary screw thread 71 defined on the internal face of the tightening nut 26. The collet 13 and the tightening nut 26 have circular profiles when viewed from above while the collet wall 15 is inclined inwards to retain the compressible ball 4 in the socket 14 defined by the collet 13. The external wall of the wall segments 15a, 15b is chamfered to correspond to a similarly chamfered internal wall of the tightening nut 26. The screw threads 70,71 therefore form the actuator mounting 18 while rotation of the tightening nut 26 on the collet 13 causes the chamfered wall segments 15a, 15b to flex and compress the compressible ball 4.

[0134] FIGS. 22 to 24 show a ninth embodiment of the medical stabilizer device 1 similar to the stabilizer devices 1 previously described but in which the grip compression mechanism 6 is a band clamp 72 and the tightening nut 26 is omitted. Like numerals indicate like parts.

[0135] 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.

[0136] 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 FIG. 23 and a closed position shown in FIG. 24 where the arcuate handle 82 abuts the collet wall 15 exerts a pulling action on the screw 78 to close the mounting block slit 74 and the base plate slit 77 so that the collet wall 15 clamps and compresses the compressible ball 4 to grip a medical device such as a CT-guided needle 37 (not shown) in the guide bore 5 of the compressible ball 4.

[0137] FIG. 25 shows a tenth embodiment of medical stabiliser device 1 of the invention in which parts described with reference to the previous embodiments are assigned the same reference numerals. In this embodiment, the circular base plate 2 includes four arcuate windows 80 for the purpose of facilitating the placement of the device on a target area of the body. An outer circumference of each window 80 includes a triangular projection 81 pointing towards the centre of the device. In addition, the compressible ball 4 includes a ruler 82 that projects upwardly from the ball, and is used to accurately target the depth of insertion of a medical device though the guide bore 5 during use.

Example

[0138] A device as shown in FIG. 1-FIG. 6 was created to evaluate different ball materials and durometers. The base plate 2 and tightening nut 26 were created from polylactic acid (PLA) using an Ultimaker 2 rapid prototyping machine. In the present Example, a selection of balls of diameter and of different materials and durometers were employed. The molded ball was formed by making a spherical mold and injecting it with degassed silicone (Dragon Skin FX-Pro, Smooth-On Inc., USA). A central guide bore of approx. 1.5 mm diameter was cored out of each ball using a coring drill bit so that each ball fitted snugly, with a friction fit, on to a 17 Gauge needle (OD approx. 1.5 mm). The guide bore was slightly conical in profilebeing slightly wider on the needle entry side compared to the needle exit side. Each ball was inserted into the device assembly and the assembly was evaluated in bench testing. The same base plate, needle and tightening nut were used in each case and the balls were swapped in and out. Each assembly was evaluated according to the attributes as outlined in Table 1.

TABLE-US-00001 TABLE 1 Device description and evaluation of device performance in relation to the ball material and durometer. Device 1 Device 2 Device 3 Device 4 Ball Material: Silicone Nitrile Viton Polyurethane Ball Durometer: 2A 70A 70A 95A Vendor/Supplier Molded The Precision Dejay Dejay Plastic Ball Distribution Distribution Co. Ltd (UK) Ltd (UK) Ltd (UK) Grip of ball on High level of Good grip - Good grip - Difficult to needle without grip, difficult friction fit but friction fit but achieve reasonable locking: to slide needle easy to move easy to move friction fit Ability to rotate Not easily Easily rotated Easily rotated Easily rotated in socket when rotated in in assembly in assembly in assembly nut is disengaged: assembly Ability to lock Tightly grips Tightly grips Tightly grips Does not grip to needle when and locks needle and locks needle and locks needle needle tightening nut is engaged:

[0139] 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.

[0140] FIGS. 26 to 31 show a further embodiment of the medical device stabilizer 1 of the invention similar in function to the medical device stabilizer 1 of FIGS. 1 to 25 and like numerals indicate like parts. However, in the present embodiment, the medical device stabilizer 1 is a two-part medical device stabilizer 1 made up of the base member 2 and the medical device grip 3 with the medical device grip 3 being separate/independent of the base member 2 to be slidably mountable on a medical device (which in the present embodiment is exemplified in the form of a coaxial delivery needle 85) without the base member 2, and being engageable with and detachable from the base member 2 at a coupler 86 in the form of a hinged clamping mechanism 87 and the coupler 86 is movable between a medical device grip engaged position and a medical device grip release position.

[0141] 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.

[0142] 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.

[0143] 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.

[0144] 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.

[0145] 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.

[0146] 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.

[0147] 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.

[0148] 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.

[0149] 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. FIGS. 29 to 31 show the stabilizer device 1 in use with the CT-guided coaxial needle 85 which is first inserted through the guide bore 5 of the ball 4 so that the ball 4 is mounted on the CT-guided needle 85 in a frictionally slidable relationship i.e. the ball 4 can be slidably positioned as required on the co-axial needle 85 to select the desired insertion depth and remains in the desired position on the co-axial needle 85 due to the friction forcei.e. the guide bore 5 can be configured in size, structure and/or material so that medical devices enjoy a slidable friction fit in the guide bore 5 to hold the ball 4 on the CT-guided needle 85.

[0150] 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.

[0151] The CT-guided needle 85 is then inserted into a patient body part 38 (see FIG. 29) under X-ray guidance and the CT-guided needle 85 can be positioned as required with the ball 4 fixed in place on the needle 85 under a frictional force, and, following removal of the removable backing tab 35 from the adhesive tape 7, the ball 4 is then clamped by the clamping mechanism 87 as previously described to hold the ball 4 and hence the needle 85 in the desired position (see FIGS. 30 and 31). The CT-guided needle 85 is therefore supported in place in the medical device stabilizer 1 with the clamping mechanism 87 preventing undesirable translational or sideways movement of the CT-guided needle 85 and the frictional sliding relationship between the bore 5 and the CT-guided needle 85 allowing controlled sliding movement of the needle as required.

[0152] FIG. 32 shows a top plan view of the base member 2 of a further embodiment of the stabilizer 1 of the invention in which the base member 2 of FIGS. 26 to 31 is also provided with a compression mechanism 97 to compress the ball 4, which in the present embodiment is a compressible ball 4, and firmly lock medical devices in position in the ball 4. Like numerals indicate like parts.

[0153] In the present embodiment, the medical device stabilizer 1 is employed in the same manner as the medical device of FIGS. 26 to 31 to stabilize medical devices. However, once stabilized, the medical devices can be fully locked in position by the compression mechanism 97 which is made up of a pair of compression hinges 98 formed on the top face 9 of the base plate 9 at the collet wall 15 and disposed opposite to the slit 89 and the gap 91. The compression hinges 98 can be hingedly opened and closed by second fingergrips 99 extending from the compression hinges 98 towards the base plate edge also with a V-shaped indent 94 therebetween formed in the base plate 2. In order to hold the compression mechanism 97 in place a locking mechanism 100 is provided on the base plate 2 in the form of a living hinge 100. The living hinge 100 is disposed between the second fingergrips 99 to be lockable in position to maintain the compression force at the socket 14. More particularly, the living hinge is made up of a finger 101 on one fingergrip 97 and a catch 102 on a second finger grip 97.

[0154] As will be appreciated by those skilled in the art, the present invention, and in particular in the embodiments shown in FIGS. 26 to 32, also extends to a medical device stabilizer system made up of the medical device stabilizer 1 and a medical device.

[0155] 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.

[0156] 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.

[0157] 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.

[0158] 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 FIGS. 26 to 32, can be formed from polymeric materials exhibiting suitable mechanical properties e.g. sufficiently high yield strain characteristics to enable the hinged opening and closing of the socket 14 i.e. so that the hinge 92 can undergo repeated compression and extension forces to enable repeated opening and closing of the socket 14 in an analogous manner to a clothes peg. Examples of suitable materials are medical grade polymers such as acrylonitrile butadiene styrene (ABS), polyamide, polypropylene, polyethylene and polyether ketone (PEEK).

[0159] 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.

[0160] 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.

[0161] 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.

EQUIVALENTS

[0162] 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.