COAXIAL BIOPSY NEEDLE WITH INTEGRATED STYLET AND ANESTHESIA NEEDLE ARRANGED WITH LOCKING MEANS WITH PREDETERMINED AND DIFFERENT RELEASE TORQUES
20230096140 · 2023-03-30
Inventors
Cpc classification
A61M29/00
HUMAN NECESSITIES
A61M2025/0687
HUMAN NECESSITIES
A61B17/3496
HUMAN NECESSITIES
International classification
Abstract
The invention relates to coaxial needle assembly (41) for introduction into human tissue, comprising an anesthesia needle (11), a stylet (21) and a coaxial cannula (31), wherein the anesthesia needle is inserted in the stylet and has a distal end (12) that projects out from a distal end (22) of the stylet, and wherein the stylet is inserted in the coaxial cannula and has a distal end (22) that projects out from a distal end (32) of the coaxial cannula, such that, during introduction into and through human tissue, the coaxial needle assembly acts and is manipulated as an integrated device. The assembly is arranged with a predetermined needle-stylet release torque which is required to release the anesthesia needle (11) from the stylet (21), and a predetermined stylet-cannula release torque which is required to release the stylet (21) from the coaxial cannula (31), wherein the value of predetermined needle-stylet release torque is less than the value of predetermined stylet-cannula release torque.
Claims
1. A coaxial needle assembly (41) for introduction into human tissue, comprising an anesthesia needle (11), a stylet (21) and a coaxial cannula (31), wherein the anesthesia needle (11) is inserted in the stylet (21) and has a distal end (12) that projects out from a distal end (22) of the stylet (21), and wherein the stylet (21) is inserted in the coaxial cannula (31) and has a distal end (22) that projects out from a distal end (32) of the coaxial cannula (31), such that, during introduction into and through human tissue, the coaxial needle assembly (41) acts and is manipulated as an integrated device, the stylet (21) is fixedly but detachably connected to the coaxial cannula (31) and the anesthesia needle (11) is fixedly but detachably connected to the stylet (21), a predetermined needle-stylet release torque is required to release the anesthesia needle (11) from the stylet (21), and a predetermined stylet-cannula release torque is required to release the stylet (21) from the coaxial cannula (31), and the value of predetermined needle-stylet release torque is less than the value of predetermined stylet-cannula release torque.
2. The coaxial needle assembly (41) according to claim 1, wherein the anesthesia needle (11) at its proximal end is provided with a needle handle (131) and at the distal end of the needle handle (131) is a needle-stylet connector (133) provided; the stylet (21) at its proximal end (23) is provided with a stylet handle (231) and at the distal end of the stylet handle (231) is a stylet-cannula connector (233) provided, and at the proximal end of the stylet handle (231) is a stylet-needle connector (234) provided; the coaxial cannula (31) at its proximal end is provided with a cannula handle (331) and at the proximal end of the cannula handle (331) is a cannula-stylet connector (333) provided; the needle-stylet connector (133) of the anesthesia needle (11) is engaged with the stylet-needle connector (234) of the stylet (21), forming a needle-stylet connector pair (411), and the stylet-cannula connector (233) of the stylet (21) is engaged with the cannula-stylet connector (333) forming a stylet-cannula connector pair (412); and the predetermined needle-stylet release torque is provided by the needle-stylet connector (133) being engaged with the stylet-needle connector (234) and the predetermined stylet-cannula release torque is provided by the stylet-cannula connector (233) being engaged with the cannula-stylet connector (333).
3. The coaxial needle assembly (41) according to claim 2, wherein the stylet-cannula connector pair (412) is arranged to a have a predetermined friction between the cannula-stylet connector (333) and the stylet-cannula connector (233).
4. The coaxial needle assembly (41) according to claim 2, wherein the needle-stylet connector pair (411) is arranged to a have a predetermined friction between the needle-stylet connector (133) and the stylet-needle connector (234), and friction gives the needle-stylet release torque.
5. The coaxial needle assembly (41) according to claim 2, wherein at least one of the stylet-cannula connector pair (412) and the needle-stylet connector pair (411) comprises a locking arrangement, the locking arrangement comprising a first locking part fixed to one of the connectors in the connector pair and a second locking part fixed to the other connector in the pair, the first locking part which in a first position abutting the second locking part fixed, and in a relative rotational movement between the connectors the first locking part is arranged to pass the second locking part with a predetermined release torque.
6. The coaxial needle assembly (41) according to claim 2, wherein the stylet-cannula connector pair (412) comprises a female connector (501a) and a male connector (502a), the female connector (501a) and the male connector (502a) being arranged with a play in between them, and the female connector (501a) is provided with at least one first protrusion (503a) and the male connector (502a) with at least one second protrusion (504a), and the first protrusion (503a) and the second protrusion (504a) extends in their respective radial direction so that they overlap in the radial direction, thereby forming a locking arrangement as a rotational lock that is passed by the predetermined stylet-cannula release torque.
7. The coaxial needle assembly (41) according to claim 2, wherein the needle-stylet connector pair (411) comprises a female connector (501b) and a male connector (502b), the female connector (501b) and the male connector (502b) being arranged with a play in between them, and the female connector (501b) is provided with at least one first protrusion (503b) and the male connector (502b) with at least one second protrusion (504b), and the first protrusion (503b) and second protrusion (504b) extends in their respective radial direction so that they overlap in the radial direction, thereby forming the locking arrangement as a rotational lock that is passed by the predetermined needle-stylet release torque.
8. The coaxial needle assembly (41) according to claim 2, wherein the stylet-cannula connector pair (412) is a bayonet-type coupling comprising a cylindrical male side (601a) with a pin (602a) and a female receptor (603a) with a matching L-shaped slot (604a), the L-shaped slot is provided with a local narrowing (605a) which is dimensioned to provide a predetermined force for the pin (602a) to pass, giving the stylet-cannula release torque.
9. The coaxial needle assembly (41) according to claim 2, wherein the stylet-cannula needle-stylet connector pair (411) is a bayonet-type coupling comprising a cylindrical male side (601a) with a pin (602a) and a female receptor (603a) with a matching L-shaped slot (604a), the L-shaped slot is provided with a local narrowing (605a) which is dimensioned to provide a predetermined force for the pin (602a) to pass, giving the needle-stylet release torque.
10. The coaxial needle assembly (41) according to claim 2, wherein the stylet-cannula connector pair 412 is provided with a breakable fixture provided in, the breakable fixture being arranged to break at the predetermined stylet-cannula release torque and thereby forming a one-time locking arrangement is provided.
11. The coaxial needle assembly (41) according to claim 1, wherein the value of the needle-stylet release torque is at least 20% lower than the value of the stylet-cannula release torque and even more preferably the value of the needle-stylet release torque is at least 50% lower than the value of the stylet-cannula release torque.
12. The coaxial needle assembly (41) according to claim 11, wherein the stylet-cannula release torque is arranged to be between 0.08 and 0.15 Nm and even more preferably between 0.1 and 0.12 Nm.
13. The coaxial needle assembly (41) according to claim 1, wherein the anesthesia needle (11) is slidable within the stylet (21).
14. The coaxial needle assembly (41) according to claim 1, wherein the distal end (12) of the anesthesia needle (11) projects 10-30 mm out from the distal end (22) of the stylet (21).
15. The coaxial needle assembly (41) according to claim 1, wherein a distal end portion of the anesthesia needle (11) is provided with at least one ecogenic marking.
16. The coaxial needle assembly (41) according to claim 3, wherein the needle-stylet connector pair (411) is arranged to a have a predetermined friction between the needle-stylet connector (133) and the stylet-needle connector (234), and friction gives the needle-stylet release torque.
17. The coaxial needle assembly (41) according to claim 2, wherein the value of the needle-stylet release torque is at least 20% lower than the value of the stylet-cannula release torque and even more preferably the value of the needle-stylet release torque is at least 50% lower than the value of the stylet-cannula release torque.
18. The coaxial needle assembly (41) according to claim 3, wherein the value of the needle-stylet release torque is at least 20% lower than the value of the stylet-cannula release torque and even more preferably the value of the needle-stylet release torque is at least 50% lower than the value of the stylet-cannula release torque.
19. The coaxial needle assembly (41) according to claim 4, wherein the value of the needle-stylet release torque is at least 20% lower than the value of the stylet-cannula release torque and even more preferably the value of the needle-stylet release torque is at least 50% lower than the value of the stylet-cannula release torque.
20. The coaxial needle assembly (41) according to claim 5, wherein the value of the needle-stylet release torque is at least 20% lower than the value of the stylet-cannula release torque and even more preferably the value of the needle-stylet release torque is at least 50% lower than the value of the stylet-cannula release torque.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] The present invention will be further explained hereinafter by means of non-limiting examples and with reference to the appended drawings, wherein:
[0025]
[0026]
[0027]
[0028]
[0029]
[0030]
DETAILED DESCRIPTION
[0031] In the figures, same, similar or corresponding elements have been given the same reference numerals.
[0032]
[0033]
[0034]
[0035] The anesthesia needle 11, the stylet 21 and the coaxial cannula 31 have all basically conventional designs, but their specific dimensions and connection couplings are adapted to function and co-operate together as an integrated coaxial needle assembly 41 according to the invention, as will be explained below.
[0036] In
[0037] A needle-stylet release torque can be ascribed to the needle-stylet connector pair 411 defining the torque required to release the needle handle 131 from the stylet handle 231 and thereby the anesthesia needle 11 from the stylet 21, by turning the needle grip portion 132 in relation to the stylet grip portion 232. The turning motion in normal use associated to the operator performing a screwing motion with his thumb and index finger, while holding the cannula grip portion 332 still, for example using the remaining fingers and the palm. A needle-stylet release force will be associated with the release torque and the radial distance from the center axis A to the point on the needle grip portion 132 there the force is applied. If, for example, the needle grip portion 132 is essentially cylindrical, the radial distance will effectively be the radius of the cylindrical needle grip portion 132. If the needle grip portion 132 is provided with protrusions, for example the wing-like structure depicted in
[0038] Similar to above, a stylet-cannula release torque can be ascribed to the stylet-cannula connector pair 412 defining the torque required to release the stylet handle 231 from the cannula handle 331 and thereby the stylet 21 from the coaxial cannula 31, by turning the stylet grip portion 232 in relation to the cannula grip portion 332. A stylet-cannula release force will be associated with the release torque and the radial distance from the center axis A to the point on the stylet grip portion 232 there the force is applied.
[0039] According to one aspect of the invention the needle-stylet release torque of the needle-stylet connector pair 411 is smaller than the stylet-cannula release torque of the stylet-cannula connector pair 412. Preferably, the value of the needle-stylet release torque is at least 20% lower than the value of the stylet-cannula release torque and even more preferably the value of the needle-stylet release torque is at least 50% lower than the value of the stylet-cannula release torque. Preferably the stylet-cannula release torque is between 0.08 and 0.15 Nm and even more preferably between 0.1 and 0.12 Nm. Preferably the needle-stylet release torque is between 0.04 and 0.12 Nm and even more preferably between 0.08 and 0.1 Nm.
[0040] The requirement that the stylet-cannula release torque of the stylet-cannula connector pair 412 should be greater than the needle-stylet release torque of the needle-stylet connector pair 411 and preferably with a margin, ensures that during operation the stylet 21 will not unintentionally be released from the cannula 31 while the needle handled 131 is operated, i.e. then the anesthesia needle 11 is released from the stylet 21 by relative turning motion of the needle handle 131 vis-à-vis the stylet handle 231. In addition, by providing different release torques to the stylet-cannula connector pair 412 and the needle-stylet connector pair 411 the operator is afforded a tactile difference in the handling of the needle grip portion 132 and the stylet grip portion 232, respectively.
[0041] According to one embodiment the stylet-cannula connector pair 412 is arranged to a have a predetermined friction between the cannula-stylet connector 333 and the stylet-cannula connector 233, wherein the friction gives the stylet-cannula release torque. As appreciated by the skilled person a specific friction between the cannula-stylet connector 333 and the stylet-cannula connector 233 may be provided by selecting materials and the design of the connector parts.
[0042] According to one embodiment the needle-stylet connector pair 411 is arranged to a have a predetermined friction between the needle-stylet connector 133 and the stylet-needle connector 234, wherein friction gives the needle-stylet release torque. A specific friction may be provided in the manner described above.
[0043] The skilled person may, faced with the requirements of the two different release torques and their relation adjust the tolerances of the molds typically used for fabricating the parts in order to achieve the desired release torques and their relation.
[0044] According to one embodiment at least one of the stylet-cannula connector pair 412 and the needle-stylet connector pair 411 is a connector comprising a female part and a male part in a tight fit arrangement and the predetermined friction is provided between the inner surface of the female part and the outer surface of the male part. If one or both connector pairs are of Luer-type or any other type of threaded connector the friction would typically originate from the interacting threads. Similar as with the tight fit embodiment, the skilled person would know how to select materials and/or threading to provide a predetermined friction and hence a predetermined release torque. According to one embodiment both the stylet-cannula connector pair 412 and the needle-stylet connector pair 411 are Luer-type connectors. According to one embodiment at least one of the stylet-cannula connector pair 412 and the needle-stylet connector pair 411 is of Luer-type. According to one embodiment the needle-stylet connector pair 411 is a tight fit connector and the stylet-cannula connector pair 412 is of Luer-type. The desired respective release torques may have been accomplished by carefully adjusting the respective molds to provide the friction giving the torques.
[0045] According to one embodiment at least one of the stylet-cannula connector pair 412 and the needle-stylet connector pair 411 comprises a locking arrangement. The locking arrangement comprises a first locking part fixed to one of the connectors in the connector pair which in a first position abuts a second locking part fixed to the other connector in the pair. In a relative rotational movement between the connectors the first locking part passes the second locking part and wherein the interaction between the first locking part and the second locking part defines the release torque. In the following, the figures illustrating various locking arrangements the size of the locking arrangement parts as well as the play between the connector parts are greatly exaggerated. This is to illustrate their function only.
[0046] According to one embodiment, schematically illustrated in a cross-sectional view in
[0047] According to one embodiment, also schematically illustrated in a cross-sectional view in
[0048] One embodiment, schematically illustrated in a perspective side-view in
[0049] According to one embodiment, also schematically illustrated in a side view in
[0050] According to one embodiment the locking arrangement is formed by a breakable fixture provided in the stylet-cannula connector pair 412, the breakable fixture for example being glue or a local deformation caused by an indentation or by melting. A breakable fixture may also be provided on the outside of the stylet-cannula connector pair 412 by applying a piece of tape or plastic film. The breakable fixture is arranged to break or give in at the predetermined stylet-cannula release torque and thereby a one-time locking arrangement is provided.
[0051] According to one embodiment only the stylet-cannula connector pair 412 is provided with a locking arrangement and the needle-stylet connector pair 411 is of tight fit type or Luer-type.
[0052] In the coaxial needle assembly according 41 to the present invention, the anesthesia needle 11, the stylet 21 and the coaxial cannula 31 can all have sizes that are commonly used today, and the anesthesia needle 11 can, for example, have a size in the interval of 20-25 G, where G is the Birmingham gauge number, which in medicine specifies the outside diameter of devices like suture wires, cannulae, catheters and needles, where the highest gauge number is 36, which corresponds to the smallest diameter of 0.10 mm. The coaxial cannula 31 can, for example, have a size in the interval of 10-19 G, and the stylet 21 can, for example, have a size in the interval of 11-24 G. In practice, the respective sizes of the anesthesia needle 11, the stylet 21 and the coaxial cannula 31 are selected such that there is a snug fit between the anesthesia needle 11 and the stylet 21 and between the stylet 21 and the coaxial cannula 31.
[0053] The proximal end 23 of the stylet 21 is fixedly but detachably connectable to the proximal end 33 of the coaxial cannula 31 by, for example, a bayonet coupling or a luer coupling, where the latter is almost standard within the field of medical devices. The proximal end 13 of the anesthesia needle 11 can be fixedly but detachably connectable to the proximal end 23 of the stylet 21 by, for example a bayonet or luer coupling. It may, however, be preferred that the anesthesia needle 11 only is inserted in the stylet 21 in a tight fit, such that the anesthesia needle 11 can slide backwards within the stylet 21 in case the distal end 12 of the anesthesia needle 11 encounters hard tissue, such as bone, when the coaxial needle assembly 41 is in operation and is penetrating tissue. In this case, the doctor may hold a finger on the proximal end 13 of the anesthesia needle 11 to secure that the anesthesia needle 11 is in place within the stylet 2 during the medical operation.
[0054] Although the present invention has been described with reference to specific embodiments, also shown in the appended drawings, it will be apparent to those skilled in the art that many variations and modifications can be done within the scope of the invention as described in the specification and defined with reference to the claims below.