TW201735957A - Apparatus for needle handling - Google Patents

Abstract

A needle bending assembly (10) for bending a hypodermic needle (18) in a medical device comprises a holder (12) for holding the needle (18) in position along a needle axis (N) and a bending member (50) that is axially movable along a bending axis (B) from an initial state in which the bending member (50) is spaced from the needle axis (N) into a cooperating state in which the bending member (50) is positioned for engagement with the needle (18). The bending axis (B) is non-parallel to the needle axis (N), and the bending member (50) is turnable about the bending axis (B) to apply a bending force to the needle (18) when the bending member (50) is in the cooperating state.

Description

Device for processing needles

The present invention relates to a device for treating a needle. In particular, but not limited to, the invention relates to an apparatus for automatically bending a hypodermic needle.

Certain drugs are most effective for delivery by subcutaneous injection or perfusion. Such drugs are often obtained with prefilled containers or syringes. A common type of prefilled syringe is available from Hypak (Bidi Medical, Inc., New Jersey, USA) and a tubular glass cartridge (staked hypodermic) with a peg-type hypodermic needle at the distal end. Needle), a needle shield that wraps the needle, and a stopper that is slidably received in the cartridge.

Such prefilled syringes are convenient, cost effective and can be standardized in size. For these reasons, drug delivery devices, such as autoinjectors, are increasingly using prefilled syringes that safely and easily inject drugs, even in non-clinical settings.

One of the characteristics of most known prefilled syringes is that the needle is axially aligned with the cartridge. However, for certain medical device applications, such as in a patch pump, the needle may preferably be placed at an angle to the cartridge in use. Therefore, it is desirable to provide a device for self-safety in a self-conscious manner. Dynamically bend the hypodermic needle.

A first aspect of the invention provides a looper assembly for bending a hypodermic needle in a medical device, comprising a holder for securing the needle along a needle axis, and being bendable along a bend The axis is axially moved from an initial state to a bent member in a cooperative state, the bent member being spaced apart from the needle axis in the initial state, the bent member being in a position to engage the needle in the cooperative state . The bending axis is not parallel to the needle axis. The bending member is rotatable about the bending axis to apply a bending force to the needle when the bending member is in the cooperative state.

By providing a bending member, which is first movable along a bending axis to cooperate with the needle and then rotatable about the axis to apply a bending force to the needle, the assembly of the present invention is simple, reliable and The number is small. Therefore, the assembly is suitable for use by non-clinical users in non-clinical settings. For ease of operation, the assembly can be configured such that the rotational movement of the bending member occurs automatically when the bending member is in the cooperative state.

The bending member can include a needle engaging formation having a bent surface for applying the bending force to the needle when the bending member is rotationally moved. The bend face can be spaced and parallel with the bend axis such that the needle axis extends between the bend axis and the bend face when the bend member is in the cooperative state. In one embodiment, the needle engaging formation includes a bent arm body and the bent surface is disposed on the bent arm body.

The assembly may also include a forming surface, It is configured such that upon application of the bending force, the needle conforms to or around the forming surface. The forming surface can be positioned such that the needle axis extends between the forming surface and the bending surface when the bending member is in the cooperative state. The forming surface can be cylindrical or partially cylindrical. By providing a forming surface, the resulting shape of the bending needle can be controlled, which is characterized, for example, by the radius of curvature of the bend to ensure that fluid flow through the needle is maintained.

For convenience, the forming surface is disposed on the bending member. For example, the bending member can include a former disposed coaxially with the bending axis, and the forming surface can include a surface of the former.

The engagement formation can include a slot configured to receive the needle when the bend member enters the cooperative state. The slot can be defined between the forming surface and the bent surface. A member for guiding the needle into the slot may be provided to account for variations in needle position due to manufacturing tolerances and other factors. For example, one end of the bent face and/or one end of the forming face may be shaped to guide the needle into the slot when the bent member enters the cooperative state. For example, the end portion of the bent surface and/or the end portion of the forming surface may be ramped.

A needle shield for protecting the needle can be provided to protect the needle prior to use. By the removal of the needle shield, the movement of the bending member from the initial state to the cooperative state can be triggered. For example, the assembly can include a removable deshielder configured to remove the needle shield from the needle. In this case, by removing the de-shield from the assembly, the movement of the bending member from the initial state to the cooperative state can be triggered. With these configurations, the needle cover can be removed from the needle and the fold can be made with only one user operation. The curved member enters the cooperative state. If the assembly is also configured to automatically occur once the bending member has reached the cooperative state, the rotational movement of the bending member occurs automatically, and the shield can be removed and the needle can be used for a single user operation.

The bending member may be biased against the needle shield or the de-shield when the bending member is in an initial state. Then, when the needle cover is removed, the bending member can enter the cooperative state under the influence of the bias. The de-shield, if present, can be removed from the holder body by applying a force to the de-shield along the needle axis. The holder body can include a sleeve member for receiving the de-shield. The de-shield can include an arm for grasping the needle shield.

The assembly can include a drive member for driving axial movement of the bending member from the initial state to the cooperative state and/or for driving a rotational motion of the bending member to apply the bending force to the needle. In this manner, some or all of the motion required by the bending member to bend the needle can occur without user intervention.

The drive member can include one or more drive springs. For example, the drive member can include a drive spring configured to apply a torque to the bend member to drive the rotational movement of the bend member. In this case, the assembly may include a retainer for maintaining a first end of the drive spring at a fixed angular position with respect to the bending axis and coupling a second end of the drive spring to The bending member.

In a specific embodiment, the drive spring also applies an axial force to the bending member to drive the axial movement of the bending member. Thus, in this particular embodiment, the bend can be driven by a single drive spring The axial and rotational movement of the member.

In another embodiment, the drive member includes a second drive spring configured to apply an axial force to the bend member to drive the axial movement of the bend member. The retainer, if present, can be configured to be axially movable with the bending member, and the second drive spring can act on the retainer to apply the axial force to the fold Curved member. A guiding arrangement can be provided for guiding the axial movement of the retainer along the bending axis and for preventing rotational movement of the retainer about the bending axis.

In another configuration, the drive member can include a drive spring configured to apply an axial force to the bend member to drive the axial movement of the bend member, and the assembly can include : A cam member for rotating the bending member under the influence of the axial force. In this case, the movement of the bending member can be driven by a single compression spring.

The drive member can include one or more cam configurations configured to apply an axial force and/or a rotational force to the bending member to drive the axial and/or rotational movement of the bending member, respectively. For example, when the assembly includes a de-shield, the drive member can include a cam configuration having a cam member associated with the de-shield and configured to cooperate with the flex member for movement The axial movement of the bending member is driven in addition to the de-shield. Alternatively or in addition, the drive member can include a cam arrangement that includes a helical ramp member and a follower configured to cooperate to drive rotational movement of the bend member as the bend member moves axially.

The assembly may include a guiding member for preventing the bending The member is rotationally moved about the bending axis until the bending member has reached the cooperative state and/or for guiding the bending member to rotate once the bending member has reached the cooperative state. For example, the guiding member can include a rail and a guiding element for cooperation with the rail. The rail may include a first portion and a second portion extending parallel to the bending axis and configured to guide axial movement of the bending member, the second portion being circumferentially about the bending axis Extending and for guiding the rotational movement of the bending member.

The guiding element can project radially from the bending member and the rail can be in a fixed position with respect to the bending axis. For example, the bend member can be housed in a housing and the rail can be a slot, groove, groove, or other suitable configuration in or on the housing.

The guiding member can include a cam surface configured to apply a rotational force to the bending member as the bending member continues to move axially when the bending member has reached the cooperative state. In this way, the rotational movement of the bending member can be driven or assisted by cooperation of the cam surface with the bending member.

The guide member also guides the axial movement of the retainer while preventing rotational movement of the retainer about the bend axis when an axially moveable retainer is provided. For example, when the guiding member comprises a rail, the holder may be provided with a radially protruding guiding element for cooperation with the rail.

The assembly can include a housing for retaining the bent member. The bending member may include a shaft, and the shaft may be supported by the housing Supporting to align the shaft with the bending axis. For example, the housing may be provided with a port for slidably receiving the shaft. Conveniently, when the assembly includes a retainer that is fixed to the bend axis, the retainer can form a portion of the housing.

The needle can be attached or attachable to a drug container, such as a syringe cartridge or cartridge, and the holder can include a carrier for receiving the container. For example, the needle and the drug container can form part of a prefilled syringe.

The holder can include a port through which the needle can extend after the bending force is applied. The bending member is rotatable about the bending axis by any desired angle such that the amount of bending of the needle is optimal for a particular application. For example, the bending member can be rotated from about 45[deg.] to about 110[deg.]. Preferably, the bending member is rotatable by at least 90°. In an embodiment, the bending member is rotatable about the bending axis by at least 95°.

In a second aspect, the invention extends to a medical device comprising a looper assembly according to the first aspect of the invention. The medical device can include, for example, an attached pump.

Other aspects of the invention may also be used in a preferred and/or optional feature of the various aspects of the invention, either alone or in a suitable combination.

10‧‧‧bend needle assembly

12‧‧‧Retainer body

14‧‧‧Prefilled syringe

16‧‧‧Tubular cartridge

16‧‧‧ drug containers

18‧‧‧ hypodermic needle

20‧‧‧Narrow diameter neck

22‧‧‧ 塞子

24‧‧‧ needle cover or needle cover

26‧‧‧Tubular carrier parts

28‧‧‧Coaxial sleeve parts

30‧‧‧Upper side

32‧‧‧Long mouth

34‧‧‧Flange

35‧‧‧Go to the shield

36‧‧‧Needle removal assembly or de-shield

38‧‧‧ disc base

40‧‧‧Body

42‧‧‧Clip or barb

50‧‧‧bend member

52‧‧‧ housing

54‧‧‧Seat

56‧‧‧ Cup-shaped cover

58‧‧‧Connecting parts

60‧‧‧ lugs

62‧‧‧Body

64‧‧‧ head

66‧‧‧Need joint construction

68‧‧‧ shaft

70‧‧‧heart bone or shaper

72‧‧‧Bend arm

74‧‧‧Folding the inner surface/bending surface of the arm body 72

76‧‧‧ slot

78‧‧‧inclined slope/end of curved surface 74

80‧‧‧Sloping slope/end of forming surface 70

82, 84‧‧ ‧ sales guide

86‧‧‧Spring positioning hole

88‧‧‧ collar

90‧‧‧ disc spring retainer

92‧‧‧ center hole

94, 96‧‧‧ radial protruding guide pin

98‧‧‧Spring positioning hole

100‧‧‧ chamber or pupil

102‧‧‧ rear end face

104‧‧‧ mouth

110‧‧‧rails

112‧‧‧ Rear

112‧‧‧ first part

114‧‧‧ front

116‧‧‧Intermediate

116‧‧‧ cam surface

120‧‧‧First drive spring

122‧‧‧Second drive spring

124‧‧‧foot

210‧‧‧bend needle assembly

298‧‧‧Positioning holes

302‧‧‧End

320‧‧‧ Single drive spring

324‧‧‧ feet

B‧‧‧ bending axis

N‧‧‧ needle axis

Specific embodiments of the present invention are illustrated by way of example with reference to the drawings, in which like features

1 is a perspective view of a looper assembly according to the present invention; and FIG. 2 is a perspective view showing a portion of the looper assembly of FIG. 1 and Obviously omitting some parts; the upper view of the looper assembly of Fig. 1 of Fig. 3; Fig. 4 is a sectional view of the looper assembly of Fig. 1; and Fig. 5 is a perspective view of Fig. 1. The looper member, the spring retainer and the drive spring assembly of the looper assembly; the side view of Fig. 6 illustrates the looper member and the spring retainer assembly of the looper assembly of Fig. 1; Fig. 7 is in an operational state The sequence diagram shows a portion of the looper assembly of Figure 1, wherein Figure 7(a) shows the assembly in the starting state and Figure 7(b) shows the assembly in the intermediate state, and Figure 7(c) shows the assembly in the final state; Figure 8 is a cross-sectional view showing the looper assembly of Figure 1 in an intermediate state; and Figure 9 is a cross-sectional view showing the first state in the final state. The curved needle assembly of the drawing; the perspective view of Fig. 10 illustrates the curved needle assembly of Fig. 1 in the final state; and the eleventh is a sectional view of another curved needle assembly of the present invention, wherein the eleventh (a The diagram illustrates the assembly in the starting state, the 11(b) diagram illustrates the assembly in the intermediate state, and the 11th (c) diagram illustrates the assembly in the final state.

Figures 1 through 4 illustrate a looper assembly 10 in accordance with a first embodiment of the present invention. The assembly 10 is suitable for use in medical equipment and may be part of it, such as a attached pump. Assembly 10 includes a long, generally tubular solid The stator body 12 is adapted to receive the pre-filled syringe 14 (the figure is best illustrated in Figure 4). The syringe 14 includes a tubular cartridge 16 for containing a liquid medication. At the first end (distal end) of the syringe 14, a hypodermic needle 18 is placed in the reduced diameter neck 20 of the cartridge 16. The other end (proximal end) of the cartridge 16 is open to receive a plunger (not shown) of the device, and a stopper 22 is provided in the cartridge 16 to accommodate the drug. Initially, the needle 18 is wrapped and sealed with a needle cover or needle cover 24, as best illustrated in Figure 4, which is push-fit onto the neck 20 of the syringe barrel 16. The needle shield 24 can include an elastic inner member supported by a rigid outer member, which is known in the art as a rigid needle shield. The syringe 14 can be of the type well known in the art.

The holder body 12 includes a tubular carrier member 26 that is sized to receive the cartridge 16 of the syringe 14. The coaxial sleeve member 28 of the holder body 12 extends distally from the carrier member 26. The sleeve member 28 is generally larger than the diameter of the carrier member 26, and flattens its upper and lower surfaces to form an upper side 30 (shown in Figures 1 through 3) and a lower side. An elongated aperture 32 is provided in the upper side 30 of the sleeve member 28 (not visible) to accommodate the needle 18 after the bending operation is completed, as described below.

The end of the syringe barrel 16 opposite the needle 18 is provided with a flange 34 that abuts the proximal end of the carrier member 16 to position the syringe 14 in the holder body 12. When the syringe 14 is in place in the holder body 12, the needle 18 is aligned along the needle axis N at the proximal end of the carrier member 34 with the carrier member 26 and the flange 34 guiding the cartridge 16. The cartridge 16 extends into the sleeve member 28 of the holder body 12, thereby receiving the neck 20 of the barrel 14, the needle 18 and the needle shield 24 in the sleeve member 28.

Needle removal component or go The shroud 36 is received in the distal end of the sleeve member 28 of the holder body 12. The decapper 36 includes a disc shaped base 38 and a pair of parallel arm bodies 40 that extend proximally from the base 38 along opposite sides of the needle shield 24 to embrace the needle shield 24 therebetween. As shown in Fig. 4, the proximal end of the arm body 40 is provided with a clip or barb 42 that engages the proximal end of the needle shield 24. The distal end of the decapper 36 (including the base 38) projects from the open distal end of the sleeve member 28 of the holder body 12, whereby the user can grasp the decapper 36 to pull distally to cause the syringe 14 to be pulled. Separating from the needle shield 24 and removing the needle shield 24 from the holder body 12.

The looper member 50 is laterally mounted to the holder body 12. The bending member 50 is held and guided by the housing 52 for axial movement in the housing 52 along an axis B, hereinafter referred to as a bending axis. Viewed from the top of the device, the bending axis B is at right angles to the needle axis N, whereas the bending axis B does not intersect the needle axis N.

The housing 52 is partially formed by the generally tubular, laterally extending projections 54 of the retainer body 12 and is partially formed by a cup-shaped cover 56 that mates with the projections 54. In the illustrated embodiment, the cover 56 is fastened to the boss 54 by a connector 58 (not shown in FIGS. 2 to 4) having a direction of penetration on one of the bosses 54. A pair of latches (not shown) of the outer extension lug 60 and a corresponding one of the pair of cover arms 56 extending forwardly into the arm body 62, however it will be appreciated that the cover body 56 can be attached to any other suitable member to Protrusion 54. FIG. 2 illustrates the assembly 10 of the cover 56 and the connector 58 omitted for clarity.

Referring additionally to Figures 5 and 6, the bending member 50 is elongate and includes a generally cylindrical head portion 64 at the forward end (the needle axis A closest to the assembly). The shape of the front end of the head 64 is shaped to provide a needle joint A needle engaging formation 66 is formed, and the trailing end of the head 64 is attached to the shaft 68.

The needle engaging formation 66 includes a generally cylindrical, rod-shaped arbor or former 70 extending from the forward end of the head 64 along the bending axis B, and from the head 64 in parallel with the former 70 and offset from the bending axis B. The front end of the bent arm body 72 extends. The outer surface portion of the bent arm body 72 is cylindrical and is coupled to the outer surface of the head portion 64, while the inner surface 74 of the bent arm body 72 closest to the former 70 includes a flat surface, hereinafter referred to as a curved surface.

As best seen in Figure 6, the former 70 is spaced from the bend surface 74 of the bend arm 72 to define a slot 76 therebetween. The slot 76 has an open end at the front end of the bending member 50. As explained in detail below, when the assembly is used, the bending member 50 is moved to the cooperating position for the needle 18 in which the needle 18 is received in the slot 76. To guide the needle 18 into the slot 76, the bend surface 74 of the bent arm body 72 is angled or chamfered to form an inclined ramp 78 adjacent the open end of the slot 76. The side of the former 70 facing the bent arm body 72 also slopes or chamfers its front end to form a corresponding inclined slope 80 adjacent the open end of the slot 76.

Referring again to Figures 5 and 6, the head 64 is provided with a pair of guide pins 82, 84. The guide pins 82, 84 project radially outward from the cylindrical outer surface of the head 64 and are disposed diametrically opposite each other. The heads 64 are also provided with four spring positioning holes 86 that are angularly spaced apart and extend through the head 64 in parallel with the bending axis B (figure 5 is most clearly illustrated).

The shaft 68 of the bending member 50 includes an elongate rod that projects from the trailing end of the head 64 along the bending axis B. The shaft 68 is formed adjacent to the head The enlarged diameter portion of the collar 88.

The disc spring retainer 90 is slidably mounted on the shaft 68 of the bending member 50. As is apparent from Fig. 5, the spring retainer 90 has a central bore 92 for receiving the shaft 68 and two face-facing radially projecting guide pins 94, 96 extending from the outer ring thereof. The spring retainer 90 is also provided with four angularly spaced spring locating holes 98 extending through the spring retainer 90 in parallel with the bend axis B.

Referring again to FIG. 4, the housing 52 provides a generally cylindrical chamber or bore 100 for receiving the bend member 50 and the spring retainer 90. The head portion 64 of the bending member 50 and the outer diameter of the spring retainer 90 are sized to be slidably fit within the bore 100. The bore 100 is closed by the rear end face 102 of the cover 56, and the rear end face 102 is provided with an orifice 104 for receiving the shaft 68 of the bending member 50. The length of the shaft 68 is such that a portion of the shaft 68 extends out of the housing 52. In this manner, the housing 52 is used to support and guide the axial movement of the bending member 50.

Referring to Figures 2 and 3, the housing 52 includes a pair of rails 110 extending through the wall of the housing 52 in the form of slots. Each rail 110 is generally L-shaped and includes a rear portion 112 that extends parallel to the bending axis B and a front portion 114 that extends around a portion of the circumference of the housing 52. The rear and front portions 112, 114 of each rail 110 are connected by respective curved intermediate portions 116. Figures 2 and 3 only see one rail 110, while Figure 1 shows a portion of the two rails 110. The guide rails 110 are disposed on two opposite sides of the housing 52 on the upper and lower sides of the assembly 10, and the front portions 114 of the respective guide rails 110 also extend around the housing 52 (in this embodiment, viewed from the rear end of the housing 52) It is clockwise).

As best seen in Figures 2 and 3, the rear portion 112 of each rail 110 extends along a portion of the cover 56 of the housing 52 toward the trailing end 102 of the cover 56. The remainder of the rear portion 112 of each rail 110, along with the intermediate and front portions 116, 114, are projections 54 formed in the holder body 12 such that the front portion 114 of each rail 110 is adjacent the sleeve member of the holder body 12. 28.

When the bending member 50 and the spring retainer 90 are seated in the housing 52, both the uppermost guide pin 82 of the head 64 of the bending member 50 and the uppermost guide pin 94 of the spring retainer 90 are in the assembly. The guide rails 110 on the upper surface of the 10 are joined. Similarly, both the head 64 and the lower guide pins 84, 96 of the spring retainer 90 engage the guide rails 110 on the underside of the assembly (not visible from Figures 1 through 4). In this manner, the guide rails 110 are used to control the rotational movement of the bending member 50 and the spring retainer 90 about the bending axis B, as explained in detail below.

In this particular embodiment, two drive springs are provided to drive the movement of the flex member 50 when the assembly 10 is in use. A first drive spring 120 in the form of a compression spring drives axial movement of the bending member 50 along the bending axis B, while a second drive spring 122 in the form of a torsion spring drives rotation of the bending member 50 about the bending axis B. motion. Both of the drive springs 120, 122 are received in the bore 100 of the housing 52 and are disposed about the shaft 68 of the bend member 50. The compression spring 120 acts between the trailing end 102 of the cover 56 and the back of the spring retainer 90, and thus urges the spring retainer 90 against the collar 68 of the shaft 68.

The torsion spring 122 is parallel to the bending axis B at both ends The extended foot 124 ends. The foot 124 at the trailing end of the torsion spring 122 extends through one of the locating holes 98 of the spring retainer 90. The foot 124 at the front end of the torsion spring 122 extends through one of the positioning holes 86 of the head 64 of the bending member 50. The torsion spring 122 is under a torsional load when assembling the device such that the torsion spring 122 applies torque between the spring retainer 90 and the bend member 50. It will be appreciated that although only one of the four locating holes 86, 98 of the spring member 90 and the four locating holes 86, 98 of the spring retainer 90 are used to couple the torsion spring 122 to the components, an additional number of holes may be provided in the device. The number of alignment steps required during assembly. In a variant (not shown), the locating holes are in the form of an annular groove that is advantageously aligned.

FIGS. 1 through 4 illustrate the assembly 10 in the initial configuration in which the syringe 14 is seated in the holder body 12 and the decapper 36 is placed over the needle shield 24. As is clear from Fig. 4, the axial movement of the bending member 50 toward the needle axis N is blocked by one of the arms 40 of the de-shield 35. Thus, at the beginning of the configuration, the bending member 50 remains in the initial state, at which time the bending member 50 is away from the needle axis N such that the needle engaging formation 66 does not cooperate with the needle 18. In other words, when the bending member 50 is in the initial state, the needle engagement configuration 66 does not overlap the needle axis N.

FIG. 7 is a schematic view showing the position of the head 64 of the bending member 50 and the spring retainer 90 with respect to the guide rail 110 in the housing 52. When the bending member 50 is in the initial state, as shown in FIG. 7(a), the head portion 64 of the bending member 50 and the uppermost guide pins 82, 94 of the spring holder 90 are positioned at the guide rail 110 at the assembly 10. The axial extension in the upper surface is in the rear portion 112. Although not visible in Figure 7(a), the lowermost guide pins 64, 96 are also located on the lower side rail. In the rear 112 of the 110. Therefore, in this initial state, neither the bending member 50 nor the spring retainer 90 can rotate about the bending axis B.

To operate the looper assembly 10, the user pulls the de-shield 36 of the holder body 12. Once the de-masker 36 and the needle shield 24 are removed from the holder body 12, the bending member 50 is free to move into the sleeve member 28 of the holder body 12 under the influence of the compression spring 120. The compression spring 120 urges the spring retainer 90 against the collar 88 of the bending member shaft 68 such that the spring retainer 90 moves with the bending member 50 toward the needle axis N such that the needle engaging formation 66 overlaps the needle axis N position. Thus, removal of the decapper 36 causes the bending member 50 to move to a cooperating state, at which point the bending member 50 is positioned to engage the needle 18.

The bending member 50 is oriented such that when the bending member 50 overlaps the needle axis N, the needle 18 is received in the slot 76 of the needle engaging formation 66. The inclined ramps 78, 80 on the bent arm body 72 are used with the former 70 to guide the needle 18 into the slot 76 to compensate for any misalignment between the needle 18 and the slot 76, such as by the assembly or syringe. Caused by manufacturing tolerances. During the first phase of axial movement of the bending member 50, the bending member 50 is still not possible to rotate because the guide pins 82, 84 on the head 64 of the bending member 50 are still linearly rear 112 of each rail 110. guide.

Figures 7(b) and 8 illustrate an assembly 10 in an intermediate position during axial movement of the bending member 50, wherein the guide pins 82, 84 on the head 64 of the bending member 50 have reached the respective rails The front end of the rear portion 112 of the 110 (not shown in Fig. 8).

The bending member 50 is shown in Figure 7(b) and Figure 8 When the intermediate position is further axially moved, the guide pins 82, 84 on the head 64 of the bending member 50 each move to the intermediate portion 116 of the guide rail 110. When the guide pins 82, 84 each move through the intermediate portion 116 of the guide rail 110 and into the circumferentially extending front portion 114, the rotational movement of the bending member 50 can occur at this time.

The rotational movement of the bending member 50 is driven by the action of the torsion spring 122. The guide pins 82, 84 on the spring retainer 90 remain in the linear rear portion 112 of the guide rail 110 over the entire range of motion of the bend member 50 such that the trailing end of the torsion spring 122 cannot rotate with respect to the housing 52. Moreover, during the initial portion of the rotational motion, as the compression spring 120 continues to drive the axial movement of the bending member 50, the curved intermediate portion 116 of the guide rail 110 acts to apply additional rotational force to the bending member 50 with the guide pins 82, 84. Cam. During this initial portion of the rotational motion, the bending member 50 is advanced further to the sleeve member 28 of the holder body 12 such that the needle engagement formation 66 further slides over the needle 18 and at the same time an initial bending motion occurs.

Once the guide pins 82, 84 of the head 64 of the bending member 50 reach the front portion 114 of the guide rail 110, axial movement of the bending member 50 no longer occurs. The torsion spring 122 alone drives the bending member 50 to further rotational movement until the guide pins 82, 84 each reach the front end of the guide rail 110.

The rotational movement of the bending member 50 causes the bending arm body 72 to apply a bending force to the needle 18. This bending force causes the needle 18 to be bent against the cylindrical former 70. In this manner, the needle 18 conforms to the shape of a portion of the cylindrical section of the surface of the former 70, resulting in a smooth bend of the needle 18, which does not substantially limit fluid flow through the needle. When the needle 18 is bent, it emerges from the upper side 30 of the holder body 12 through the aperture 32. Figure 7(c), Figure 9 and 10 illustrates the assembly 10 in a final position, wherein the guide pins 82, 84 on the head 64 of the bending member 50 are each at the end of the front portion 114 of the guide rail 110 (as clearly seen from Figure 7(c), Also, the looper 18 passes through the exit hole 32 (refer to Fig. 10).

The radius of curvature of the needle 18 depends on the radius of the former 70, and the angle at which the needle 18 is bent depends on the angle of rotation of the bending member 50. It will be appreciated that due to component clearance, manufacturing tolerances and elastic deformation of the assembly, the needle 18 will tend to bend at an angle that is slightly less than the angle of rotation of the bending member 50. In the illustrated embodiment, the front portion 114 of the guide rail 110 is sized to rotate the bend member 50 a total of about 95 degrees, which causes the needle 18 to be bent at an angle of about 90 degrees. For some applications, a bend angle of less than or greater than 90 degrees may be appropriate.

Thus, the above assembly allows the needle 18 to be automatically bent when the needle shield 24 of the syringe 14 is removed, without further interaction by the user. With the assembly 10 in the final position as shown in Fig. 10, the needle 18 can be inserted into the patient's skin and the upper side 30 of the holder body 12 is parallel to the skin. During insertion of the needle 18 and subsequent delivery of the medicament from the syringe 14, the bending member 50 is still engaged with the needle 18, thereby supporting the needle 18.

Figure 11 illustrates a looper assembly 210 in accordance with another embodiment of the present invention. The assembly 210 of Fig. 11 is in most respects the same as the assembly 10 of Figs. 1 to 10, and therefore only the differences will be described.

In the assembly 210 of Figure 11, a single drive spring 320 is provided to drive the movement of the bending member 50 rather than a separate compression and torsion spring. The single drive spring 320 functions as both compression and torsion, and In this embodiment, it comprises an open-coil spring, the ends of which are terminated by a foot 324 extending parallel to the bending axis, in a manner similar to the first to tenth drawings. The foot portions 124 of the torsion springs 122 of 10 are the same. However, in the assembly 210 of Fig. 11, there is no movable spring retainer, and instead the trailing end 302 of the bent member housing 52 serves as a spring retainer having four positioning holes 298 disposed around the central opening 104. The foot portion 324 at the trailing end of the drive spring 320 extends through one of the positioning holes 298, and the foot portion 324 at the front end of the drive spring 320 extends through one of the positioning holes 86 of the head portion 64 of the bending member 50. By. During loading into the housing 52, compressing and twisting the drive spring 320 causes the drive spring 320 to apply both axial and torque to the bending member 50.

The 11th (a) diagram illustrates the assembly 210 in which the bending member 50 is in an initial state, at which time the de-shield 36 blocks the axial movement of the bending member 50. Upon removal of the shroud 36 and the needle shield 24, the flex member 50 is axially movable into a cooperating state and the needle 18 is received in the slot 76 of the needle engaging formation 66. The axial movement of the bending member 50 is driven by the compression of the loose drive spring 320, but the rotational movement of the bending member 50 is extended by the guide pins 82, 84 on the head portion 64 of the bending member 50 and the axial direction of the guide rail 110. The joint is blocked (not visible in Fig. 11, but as described above in the description of Fig. 7(a)).

Figure 11(b) illustrates the assembly 210 when the guide pins 82, 84 have reached the forward end of the rear portion 112 of the rail 110. When the bending member 50 is further axially moved, the guide pins 82, 84 are moved to the intermediate portion 116 of the guide rail 110 (as described above in the description of Fig. 7(b)) and the rotational movement of the bending member 50 is started so that A bending force is applied to the needle 18. The initial rotational motion is driven by the drive The torsion and axial force exerted by the spring 320 are driven, and the intermediate portion 116 of the guide rail 110 acts as a cam, as described above in describing the first embodiment.

Once the guide pins 82, 84 reach the front portion 114 of the rail 110, the axial movement of the bending member 50 ceases and the remaining rotational motion is solely driven by the torque applied by the drive spring 320. Figure 11(c) illustrates the final configuration of the assembly 210 in which the needle 18 has been bent at the desired angle.

When a high bending force is required, it may be preferable to use the first to tenth drawings of the independent compression and torsion springs. However, when the small bending force is sufficient, the use of a single drive spring assembly (and thus fewer components), as shown in Figure 11, may be preferred.

It will be appreciated that other configurations for driving the axial and rotational movement of the bending members are possible. For example, in a variation of the assembly of Figure 11 (not shown), the single drive spring is a simple compression spring and the guide rail is modified such that the axial movement of the bending member during the entire rotational movement of the bending member Can continue. In this way, the rotational movement of the bending member is solely driven by the cam action between the guide rail and the guide pin of the head of the bending member, and the drive spring does not provide a torsional force. In this variant, the spring retainer or bending element does not need to provide a spring positioning hole.

In another unillustrated embodiment that is a variation of the assembly of Figures 1 through 10, the guide rails in the housing have no intermediate portion, and instead the axially extending rear portions of the respective guide rails directly meet the circumferentially extending front portion. In this case, the compression spring only drives the axial movement of the bending member, and the rotational movement of the bending member is only driven by the torsion spring. With this configuration, the bending member does not move axially during the bending of the needle, thus avoiding lateral loads during bending.

Instead of using a compression spring, a tension spring is used to drive the axial movement of the bending member. For example, the first end of the tension spring can be attached to a housing adjacent the holder body or the holder body, and the second end of the tension spring can be attached to a suitable spring retention configuration that is associated with the bending member and away from the needle engagement Constructed to bias the bending member in the forward direction. By appropriately modifying the assembly of Fig. 11, a single drive spring having tension and torsion can also be used to drive the axial and rotational movement of the bending member.

Many alternative mechanisms for driving and guiding the movement of the bending members are possible. For example, other spring types may be used or instead of energy storage members instead of one or more helical drive springs. Some or all of the bending member can be manually moved, such as by directly manipulating the shaft of the bending member, or indirectly through a suitable mechanism.

Instead of or in addition to the drive spring, the movement of the bending member can be driven by one or more cam-type configurations that operate when the assembly assembly is relatively displaced.

For example, the de-shield can be associated with a cam element configured to cooperate with the bending member such that movement of the de-shield along the needle axis during removal drives axial movement of the flex member along the bending axis. . For example, in a variation of the assembly of Figures 1 to 10, the compression spring is omitted and the cam member attached to the de-shield extends to or near the housing to guide the spring retainer Cooperate to drive the axial movement of the bending member. When the guide pin of the head of the bending member reaches the circumferentially extending portion of the guide rail, the rotational movement of the bending member is driven by the torsion spring.

In another variation, the total of Figures 1 through 10 is omitted. The torsion spring is formed and the rotational movement of the bending member is driven by the cam arrangement. For example, cam elements comprising one or more helical ramp configurations may be provided on the front side of the spring retainer to each cooperate with a follower that projects rearwardly from the rear side of the head of the bent member. In this case, the axial movement of the bending member urges the spring retainer toward the head of the bending member, and cooperation of the cam member with the follower produces a torque that is applied between the spring retainer and the bent member. The torque drives the rotational movement of the bending member when the guide pin of the bending member reaches the circumferentially extending portion of the rail. In a convenient configuration, the helical ramp configuration and the follower each take the form of a helical tooth that protrudes from the spring retainer and the bent member toward each other such that the teeth engage each other as the spring retainer moves in the forward direction.

In another variation, both the axial and rotational movements of the bending member are each driven by a cam configuration. In this case, there is no need to drive the spring, however it will be appreciated that the annular retainer assembly as described above as a spring retainer can still be provided to form a portion of one or more cam configurations. It is also contemplated that a combination of one or more drive springs and one or more cam configurations may be used in combination to drive axial and/or rotational movement of the bending members. In such cases, the force provided by the drive spring and cam arrangement can act simultaneously or sequentially (in any order) to cause the desired movement of the bending member.

In the illustrated embodiment, the bending member is maintained in an initial state with a de-shield. In other embodiments, a retaining member, such as a clip, can be provided to maintain the flex member in an initial state. The retaining member is releasable to allow the bending member to move from an initial state to a cooperative state. The release of the retaining member can be automated when the needle cover is removed, or additional on the user side action. It is also conceivable that the axial movement of the bending member can be automatically triggered when the needle cover is removed to engage the bending member with the needle while the rotational movement of the bending needle can be independently triggered. In another configuration, the bending member can be held in an initial state with a needle shield, in which case the de-shield can be omitted and the user can access the needle shield directly for removal.

The holder body and the housing can be formed in a different manner than the illustrated embodiment. For example, the holder body and housing may form part of a clamshell or other configuration. The assembly can include a housing, and the holder body and/or housing can be integrally formed with or supported by the housing. It will be appreciated that the rails or other guiding members can be mounted or disposed in or on any convenient portion or portions of the holder body, housing and/or other components of the assembly.

The assembly can be configured to substantially create any desired needle shape and angle, such as the direction of the bending axis relative to the needle axis, by suitable design of the needle engaging configuration of the bending member and the guide rail and other parameters. It is also conceivable that the angle of the looper can be adjusted. For example, during the manufacturing assembly, the number of rotational motions can be selected and can be adjusted prior to use of the assembly.

The looper assembly of the present invention is particularly suitable for use in attaching pumps or other medical devices, although other applications are possible. The above embodiments illustrate that the assembly uses a pre-filled syringe with a permanently attached needle, but the assembly can also use other configurations, such as a drug container with independently attachable needles. The assembly can also be used to bend a needle that is not attached to a drug container or syringe.

The above-described configurations are merely examples and many variations and modifications are possible without departing from the scope of the invention as defined by the appended claims.

10‧‧‧bend needle assembly

12‧‧‧Retainer body

14‧‧‧Prefilled syringe

18‧‧‧ hypodermic needle

26‧‧‧Tubular carrier parts

28‧‧‧Coaxial sleeve parts

50‧‧‧bend member

52‧‧‧ housing

64‧‧‧ head

66‧‧‧Need joint construction

68‧‧‧ shaft

70‧‧‧heart bone or shaper

72‧‧‧Bend arm

88‧‧‧ collar

90‧‧‧ disc spring retainer

114‧‧‧ front

120‧‧‧First drive spring

122‧‧‧Second drive spring

B‧‧‧ bending axis

N‧‧‧ needle axis

Claims (37)

A looper assembly (10; 210) for bending a hypodermic needle (18) in a medical device, comprising: a holder (12) for positioning the needle (18) along a needle axis ( N) fixed; and a bending member (50) axially moved from an initial state to a cooperative state along a bending axis (B), the bending member (50) in the initial state and the needle axis (N) spaced apart, the bending member (50) is in a position to engage the needle (18) in the cooperative state, the bending axis (B) being non-parallel to the needle axis (N); wherein When the bending member (50) is in the cooperative state, the bending member (50) is rotatable about the bending axis (B) to apply a bending force to the needle (18). The looper assembly of claim 1 is configured such that when the bend member (50) is in the cooperative state, the rotational movement of the bend member (50) occurs automatically. The looper assembly of claim 1 or 2, wherein the bending member (50) comprises a needle engaging structure (66) having a bent surface (74) for The bending force is applied to the needle (18) when the bending member (50) is rotated. The curved needle assembly of claim 3, wherein the bending surface (74) is spaced apart from and parallel with the bending axis (B) such that the bending member (50) is in the cooperative state. The needle axis (N) extends between the bending axis (B) and the bending surface (74). The looper assembly of claim 3, wherein the needle engaging structure (66) comprises a bent arm body (72), and wherein the bent surface (74) is provided The bent arm body (72). The looper assembly of any of claims 3 to 5, further comprising a forming surface (70) configured to apply the bending force to the needle (18) It conforms to the forming surface (70). The looper assembly of claim 6, wherein the forming surface (70) is positioned such that the needle axis (N) is at the forming surface when the bending member (50) is in the cooperative state (70) extends between the bent surface (74). The looper assembly of claim 6 or 7, wherein the forming surface (70) is cylindrical or partially cylindrical. The looper assembly of any one of clauses 6 to 8, wherein the forming surface (70) is disposed on the bending member (50). The looper assembly of claim 9, wherein the bend member (50) comprises a former (70) configured to be coaxial with the bend axis (B), and wherein the forming The face comprises a surface of the former (70). The looper assembly of claim 9 or 10, comprising a slot (76) configured to receive the needle when the bend member (50) enters the cooperative state (18) The slot (76) is defined between the forming surface (70) and the bend surface (74). The looper assembly of claim 11, wherein one of the end portions (78) of the bent surface (74) and/or one end portion (80) of the forming surface (70) is formed into a shape The needle (18) can be guided into the slot (76) when the bending member (50) enters the cooperative state. The looper assembly of any one of clauses 1 to 11, further comprising a needle cover (24), and wherein the needle is removed from the assembly (10) A cover (24) triggers movement of the bending member (50) from the initial state to the cooperative state. The looper assembly of claim 13 further comprising a removable de-shield (36) configured to remove the needle shield (24) from the needle (18), Wherein, the movement of the bending member (50) from the initial state to the cooperative state is triggered by removing the de-shield (36) from the assembly (10). The looper assembly of claim 14, wherein the bending member (50) is biased against the de-shield (36) when the bending member (50) is in an initial state. And wherein, when the de-shield (36) is removed, the bending member (50) enters the cooperative state under the influence of a bias voltage. The looper assembly of claim 14 or claim 15, wherein the holder (12) includes a sleeve member (28) for receiving the de-shield (36). A looper assembly according to any one of claims 1 to 16, comprising a drive member (120, 122; 320) for driving the bend member (50) from the initial state The axial movement to the cooperative state and/or for driving the bending member (50) to move the bending force to apply the bending force to the needle (18). The looper assembly of claim 17, wherein the drive member includes a drive spring (122; 320) configured to apply a torque to the bend member (50) to drive the fold The rotation of the curved member (50) Turn to exercise. The looper assembly of claim 18, comprising a retainer (90; 302) for causing a first end of the drive spring (122; 320) for the bend axis (B) Maintained in a fixed angular position wherein a second end of the drive spring (122; 320) is coupled to the bend member (50). The looper assembly of any one of clauses 17 to 19, wherein the drive member comprises a second drive spring (120) configured to apply an axial force to The bending member (50) drives the axial movement of the bending member (50). The looper assembly of claim 20, wherein the retainer (90) is configured to be axially engageable with the bend member (50), as claimed in claim 20, wherein the retainer (90) is configured to be axially attached to the bend member (50). Linked, and wherein the second drive spring (120) acts on the retainer (90) to apply the axial force to the bend member (50). The looper assembly of claim 21, comprising a guiding arrangement (94, 96, 110) for guiding the axial direction of the spring retainer (90) along the bending axis (B) Movement and for preventing rotational movement of the retainer (90) about the bending axis (B). The looper assembly of claim 18 or claim 19, wherein the drive spring (320) is configured to apply an axial force to the bending member (50) to drive the bend This axial movement of the member (50). The looper assembly of claim 17, wherein the drive member includes a retainer (90; 302) configured to apply an axial force to the bend member (50) to drive the fold The axial movement of the curved member (50) And wherein the assembly includes a cam member for rotating the bending member (50) under the influence of the axial force. A looper assembly according to any one of claims 1 to 24, comprising a guiding member (84, 86, 110) for preventing the bending member (50) from being wound around the folding member The bending axis (B) is rotationally moved until the bending member (50) has reached the cooperative state and is used to guide the bending member (50) to rotate motion once the bending member (50) has reached the cooperative state. The looper assembly of claim 25, wherein the guide member comprises a rail (110) and a guiding member (84, 86) for cooperation with the rail (110). The curved needle assembly of claim 26, wherein the guide rail (110) includes a first portion (112) extending parallel to the bending axis (B) for guiding the bending member The axial movement of (50) and a second portion (114) extending circumferentially about the bending axis (B) are used to guide the rotational movement of the bending member (50). The looper assembly of claim 26 or 27, wherein the guiding member (84, 86) projects radially from the bending member (50), and wherein the rail (110) is The bending axis (B) is in a fixed position. The looper assembly of any one of clauses 25 to 28, wherein the guide member comprises a cam surface (116) configured to have the bend member (50) When the cooperation state is reached, a rotational force can be applied to the bending when the bending member (50) continues to move axially. Member (50). A looper assembly according to any one of claims 1 to 29, comprising a housing (52) for holding the bent member (50). The looper assembly of claim 30, wherein the bending member (50) comprises a shaft (68), and wherein the shaft (68) is supported by the housing (52) such that The shaft (68) is aligned with the bending axis (B). The looper assembly of any one of clauses 1 to 31, wherein the needle (18) is attached or attachable to a drug container (16), and wherein the holder ( 12) A carrier (26) for containing the container (16). The looper assembly of claim 32, wherein the needle (18) and the medicament container (16) are part of a prefilled syringe (14). The looper assembly of any one of clauses 1 to 33, wherein the holder (12) includes the needle (18) extending through the bending force after the application of the bending force A hole (32). The looper assembly of any of claims 1 to 34, wherein the bend member (50) is rotatable about the bend axis (B) by at least 90°. A medical device comprising a looper assembly (10; 210) according to any one of claims 1 to 35. The medical device of claim 36, which comprises a patch pump.