Source: http://patents.com/us-9782199.html
Timestamp: 2017-10-22 21:00:13
Document Index: 791839272

Matched Legal Cases: ['Application No. 201380016113', 'art 5', 'art 6', 'art 7', 'art 41', 'art 51', 'art 71', 'art 42', 'art 7', 'art 7', 'art 7', 'art 7', 'art 62', 'art 62', 'arts 5', 'art 5', 'arts 5', 'arts 5', 'arts 5', 'arts 5', 'arts 5', 'arts 5', 'arts 5', 'arts 5', 'arts 5', 'arts 5', 'art 62', 'art 62', 'art 22', 'art 22', 'arts 22', 'arts 5', 'arts 5', 'arts 5', 'art 42', 'art 51', 'arts 22', 'arts 22', 'arts 22']

US Patent # 9,782,199. Puncture device - Patents.com
United States Patent 9,782,199
Tamano , et al. October 10, 2017
To provide a puncture device which prevents components constituting a puncture device from being damaged by buckling (bending) etc., secures safety, and can be handled by a weak user easily. A puncture device is provided with an outer needle, an outer needle hub for retaining a base portion of the outer needle, an inner needle whose tip portion is inserted in the outer needle, an inner needle hub for retaining a base portion of the inner needle, an outer pipe fitted inside the inner needle hub so as to be moveable to and fro, and an inner pipe having a gripping device for gripping the outer needle hub and fitted inside the outer pipe so as to be moveable to and fro, and at least the outer pipe is formed of a soft synthetic resin.
Tamano; Hisami (Fujioka, JP), Sumiyoshi; Satoru (Fujioka, JP), Nakashima; Atsushi (Fujioka, JP), Kyogoku; Yuusuke (Fujioka, JP)
Family ID: 1000002876418
14/384,276
PCT/JP2013/058243
WO2013/141347
US 20150039009 A1 Feb 5, 2015
Mar 23, 2012 [JP] 2012-067144
Oct 2, 2012 [JP] 2012-220072
Oct 2, 2012 [JP] 2012-220073
Mar 19, 2013 [JP] 2013-056567
Mar 19, 2013 [JP] 2013-056568
Current CPC Class: A61M 25/0631 (20130101); A61B 17/3417 (20130101)
Current International Class: A61B 17/34 (20060101); A61M 25/06 (20060101)
5772636 June 1998 Brimhall et al.
5772643 June 1998 Howell et al.
6638254 October 2003 Nakagami
6872193 March 2005 Shaw
7632243 December 2009 Bialecki
7988678 August 2011 Monson
1184677 Jun 1998 CN
9-234250 Sep 1997 JP
10-165511 Jun 1998 JP
2000-501960 Feb 2000 JP
2002-727 Jan 2002 JP
2007-143876 Jun 2007 JP
97/21458 Jun 1997 WO
International Search Report dated May 28, 2013, issued in corresponding application No. PCT/JP2013/058243. cited by applicant .
Office Action dated Feb. 3, 2016, issued in counterpart Chinese Patent Application No. 201380016113A, with English translation. (10 pages). cited by applicant.
1. A puncture device, comprising: an outer needle, an outer needle hub for retaining a base portion of said outer needle, an inner needle whose tip portion is inserted in said outer needle, an inner needle hub for retaining a base portion of said inner needle, an outer pipe fitted inside the inner needle hub so as to be moveable to and fro, an inner pipe having a gripping means for gripping said outer needle hub, the inner pipe being fitted inside said outer pipe so as to be moveable to and fro, wherein the gripping means includes a plurality of arms formed at said inner pipe for gripping said outer needle hub, and an arm opening/closing part that grasps said outer needle hub when said plurality of arms are retracted into the arm opening/closing part and that releases said outer needle hub when said plurality of arms are advanced from the arm opening/closing part, and wherein at least said outer pipe is formed of a soft synthetic resin material.
2. A puncture device as claimed in claim 1, wherein said inner pipe is formed of a soft synthetic resin material.
3. A puncture device as claimed in claim 1, wherein said inner needle hub is formed of a soft synthetic resin material.
4. A puncture device as claimed in claim 1, wherein said inner pipe and said inner needle hub are formed of a soft synthetic resin material.
5. A puncture device as claimed in claim 4, wherein said soft synthetic resin material is a synthetic resin whose elongation percentage is 200% or more.
6. A puncture device as claimed in claim 4, wherein said soft synthetic resin material is polypropylene.
7. A puncture device as claimed in claim 1, wherein said soft synthetic resin material is a synthetic resin whose elongation percentage is 200% or more.
8. A puncture device as claimed in claim 1, wherein said soft synthetic resin material is polypropylene.
9. A puncture device as claimed in claim 1, wherein said inner needle hub is provided with a through hole having a diameter that is smaller than an inner diameter of said inner needle hub, wherein said outer pipe has a diameter smaller than a diameter of the arm opening/closing part, wherein said outer pipe is provided with a shaft that is moveable through the through hole of the inner needle hub, and wherein said shaft passes through the through hole of the inner needle hub when said outer pipe is moved in the inner needle hub.
10. A puncture device as claimed in claim 1, wherein a relay pipe that extends said outer pipe is provided between said inner needle hub and said outer pipe, wherein the relay pipe is accommodated in said inner needle hub and accommodates said outer pipe therein, wherein said inner needle hub is provided with a through hole having a diameter that is smaller than an inner diameter of said inner needle hub, and wherein said relay pipe passes through the through hole of the inner needle hub when said outer pipe is moved in the inner needle hub.
As shown in FIG. 50(A), this puncture device 100 is provided with an outer needle 102a, an outer needle hub 102b, an inner needle 103 whose tip portion is inserted in the outer needle 102a, and a cylindrical inner needle hub 101 for retaining therein a base portion of the inner needle 103.
Further, the use of the puncture device 100 will be described. As shown in FIG. 50(A), in a situation where a slide cover 104 is accommodated in the inner needle hub 101 and a tip 103a of the inner needle 103 has projected from a tip of the outer needle 102a, a puncture (paracentesis) is carried out on a patient's body 110.
Then, after moving the outer needle 102a into the body (see FIG. 50(B)), in a situation where the outer needle 102a is indwelled in the body, when the inner needle hub 101 is pulled towards the user, the slide cover 104 is extended and the tip 103a of the inner needle comes out of the body (see FIG. 50(C)).
By further pulling the inner needle hub 101 in the same direction, the tip 103a of the inner needle 103 is retained in the slide cover 104, without contacting a hand.
As a result, only the outer needle 102a is indwelled inside the body, and the inner needle hub 101 in which the inner needle 103 is accommodated can be removed, and the inner needle 103 can be discarded as it is (see FIG. 50(E)).
FIG. 6 are views showing an outer pipe, in which FIG. 6(a) is a perspective view, FIG. 6(b) is a longitudinal sectional view, and FIG. 6(c) is a longitudinal sectional view whose section is different from that of the longitudinal sectional view of FIG. 6(b) by 90 degrees in a circumferential direction.
FIG. 8 are views showing the inner pipe in an unfolded configuration, in which FIG. 8(a) is a plan view and FIG. 8(b) is a sectional view along the line A-A of FIG. 8(a).
FIG. 9 are views showing a puncture state for explaining a procedure which uses the puncture device shown in FIG. 1 in which FIG. 9(a) is a longitudinal sectional view, and FIG. 9(b) is a longitudinal sectional view whose section is different from that of the longitudinal sectional view of FIG. 9(a) by 90 degrees in a circumferential direction.
FIG. 10 are views showing a situation where the inner needle hub is expanded, for explaining the procedure which uses the puncture device shown in FIG. 1, in which FIG. 10(a) is a longitudinal sectional view and FIG. 10(b) is a longitudinal sectional view whose section is different from that of the longitudinal sectional view of FIG. 10(a) by 90 degrees in a circumferential direction.
FIG. 11 are views showing a situation where the expansion of the inner needle hub is completed, for explaining the procedure which uses the puncture device shown in FIG. 1, in which FIG. 11(a) is a longitudinal sectional view and FIG. 11(b) is a longitudinal sectional view whose section is different from that of the longitudinal sectional view of FIG. 11(a) by 90 degrees in a circumferential direction.
FIG. 12 are views showing a situation where an outer needle is indwelled, for explaining the procedure which uses the puncture device shown in FIG. 1, in which FIG. 12(a) is a longitudinal sectional view and FIG. 12(b) is a longitudinal sectional view whose section is different from that of the longitudinal sectional view of FIG. 12(a) by 90 degrees in a circumferential direction.
FIG. 16 are views of the protector shown in FIG. 15, in which FIG. 16(a) is a perspective view and FIG. 16(b) is a plan view from an inner needle hub inserting side.
FIG. 29 are views illustrating the puncture device shown in FIG. 25, in which FIG. 29(a) is a longitudinal sectional view and FIG. 29(b) is a longitudinal sectional view whose section is different from that of the longitudinal sectional view of FIG. 29(a) by 90 degrees in a circumferential direction.
FIG. 30 are views illustrating the inner needle hub of the puncture device shown in FIG. 25, in which FIG. 30(a) is a side view and FIG. 30(b) is a longitudinal sectional view.
FIG. 35 are views of the puncture device for explaining the procedure which mounts the protector, in which FIG. 35(a) is a side view and FIG. 35(b) is a longitudinal sectional view.
FIG. 48 is a longitudinal sectional view illustrating the puncture device shown in FIG. 44, being different from the longitudinal sectional view of FIG. 47 by 90 degrees in a circumferential direction.
1: puncture device 2: catheter 21: outer needle 22: outer needle hub 22A: wings (projection parts) 22B: branch pipe 22C: step portion 3: inner needle 4: syringe 5: protector 5A-5D: contact portions 5E: outer needle hub supporting portion 5a: outer needle hub supporting portion 5b: main body 5c1: opening (undersurface side) 5c2: opening (cylinder part opposite end side) 5d: rib-like frame 5d1: rib-like frame extension 5e: locked projection 5f: contact portion 5g: contact portion 5h: guided part 5i: guided part 6: outer pipe (cylindrical member) 7: inner pipe (cylindrical member) 7A: lower part 7B: upper part 41: inner needle hub 41A: main body 41a: end portion 41b: fitting portion 41b1: locking hole 41c: opening 41d: through hole 41e: rib-like projection 41f bracing projection 41g: rib-like projection 41h: protrusion 42: plug 42a: needle retaining part 51: outer needle hub supporting portion 52: supporting leg 52c: locking member 53: opening 61: slit 62: arm opening/closing part (gripping means) 71: head part 71A: arm (gripping means) 72: shaft 72A: projection 72B: standing piece 73: through hole 73A, 73B: grooves 110: patient's body
As shown in FIGS. 2 to 5, the above-mentioned syringe 4 is provided with a cylindrical inner needle hub 41 and a plug 42 which is press fitted into and attached to a base portion (right-hand side) of the above-mentioned inner needle hub 41 and has a substantially cylindrical needle retaining part 42a by which the base portion of the above-mentioned inner needle 3 is retained.
As shown in FIG. 5 and FIG. 6(c), the above-mentioned slits 61 are axisymmetrically formed at two places, an upper part and a lower part in the periphery of the above-mentioned outer pipe 6.
Here, as shown in FIG. 8, the above-mentioned inner pipe 7 is a component comprising the lower part 7A (left-hand side) provided with the above-mentioned standing piece 72B and the upper part 7B (right-hand side) which are on opposite sides of a central line 1 and integrally formed. It is formed by folding the above-mentioned lower part 7A and the above-mentioned upper part 7B along a score line (central line 1).
It should be noted that engaging portions are respectively formed at end portions 41a and 63 of the above-mentioned inner needle hub 41 and the above-mentioned outer pipe 6 which are arranged so as not to be separated (spaced apart) from each other, since the engaging portions formed at the above-mentioned end portions 41a and 63 are fit together when they are expanded.
Further, in the case where the above-mentioned protector 5 is removed (when it is moved in the direction of the arrow shown in FIG. 13), the above-mentioned contact portions 5A, 5B, 5C, and 5D are not in contact with the arm opening/closing part 62 of the outer pipe 6, or they are not in pressure contact even if they are in contact. Therefore, even if the protector 5 moves, the arm opening/closing part 62 of the outer pipe 6 does not move in the direction of the arrow shown in FIG. 13 and stops in that position.
As shown in FIGS. 17 and 18, a relay pipe 8 which extends the outer pipe 6 is provided between the above-mentioned inner needle hub 41 and the outer pipe 6. This relay pipe 8 is formed in the shape of a cylinder, has an outer diameter allowing itself to be accommodated inside the above-mentioned inner needle hub 41, and has an inner diameter allowing the outer pipe 6 to be accommodated in itself. It is arranged that a catch portion 8a is formed at one end of this relay pipe 8 and catches a projection formed at the end portion 63 of the outer pipe 6. Further, it is arranged that a projection 8b is formed at the other end of the relay pipe 8 and caught by a catch portion formed at the end portion 41a of the inner needle hub 41.
Furthermore, an elongate opening 8c is formed in the outer periphery of the above-mentioned relay pipe 8 in parallel with a central axis of the relay pipe 8. Further, the four above-mentioned openings 8c are formed in a circumferential direction of the relay pipe 8.
Thus, flexibility is given to the relay pipe 8 by forming openings 8c in the outer periphery of the above-mentioned relay pipe 8, so that a direction to pull the inner needle hub 41 is an inclined direction (which is not on an extension of the inner needle 3). Even if bending force is applied to the relay pipe 8, it is possible to prevent the relay pipe 8 from being damaged by buckling etc.
In particular, if the direction to pull the inner needle hub 41 shifts from the extension of the inner needle 3 by an angle .theta. as shown in FIGS. 20 and 21, the bending force is applied to the shaft 64 of the outer pipe 6.
Incidentally, in the conventional puncture device, when the patient's body 110 is punctured with the outer needle 102a, a tip 103a of the inner needle 103 needs to project from the tip of outer needle 102a. Therefore, there is a demand for putting a cap-like protector on the outer needle 102a and the inner needle 103 and for protecting it in terms of safety so that the inner needle 103 and outer needle 102a may not shift in the axial direction before using the puncture device.
However, as shown in FIG. 24, in the puncture device where wings 106 are formed at the sides of the outer needle hub 102b, the above-mentioned wings 106 serve as an obstacle, when putting the above-mentioned protector. That is to say, there is a problem that the whole outer needle hub 102b cannot be covered with the above-mentioned protector. Further, if the protector which can accommodate the wings 106 is formed, there arises a problem that the protector becomes very large in size.
The above-mentioned inner needle hub 41 is formed substantially in the shape of a cylinder. As shown in FIGS. 28 to 31, a cylindrical fitting portion 41b whose diameter is larger than that of a main body 41A is formed at the tip side of the above-mentioned inner needle hub 41. This fitting portion 41b is arranged so as to fit the protector 5.
Further, an opening 41c into which a plug 42 is fitted is provided at a rear end portion of the inner needle hub 41. A through hole 41d into which a shaft 64 of the above-mentioned outer pipe 6 is inserted is provided at the main body 41A side of the cylindrical fitting portion 41b. Furthermore, it is arranged that the above-mentioned outer pipe 6 is accommodated in the main body 41A and the fitting portion 41b of the inner needle hub 41.
A plurality of circumferentially arcuate rib-like projections 41e (arcuate, viewed from the tip side) are formed at the tip portion of the outer periphery of the fitting portion 41b (four rib-like projections are illustrated in the figure). The rib-like projections 41e are locked to locked projections 5e (see FIG. 33) formed in the protector 5 so that the protector 5 is mounted (fixed) to the above-mentioned syringe 4.
Further, adjoining rib-like projections 41e among the above-mentioned rib-like projections 41e are arranged to have a predetermined gap t as shown in FIG. 30.
That is to say, the four rib-like projection 41e make two pairs of rib-like projections 41e, which are arranged symmetrically from left side to right side, viewed from the tip side of the inner needle hub 41. Further, the gap t between the rib-like projections 41e arranged symmetrically from left side to right side is selected to have a predetermined size so that the guided parts 5h and 5i (see FIG. 33) formed in the protector 5 may pass through the gap.
Furthermore, a bracing projection 41f which is elongated along the axis of the inner needle hub 41 and in parallel with this axis is provided behind the rib-like projections 41e formed in the outer periphery of the above-mentioned fitting portion 41b (closer to the inner needle base end portion than the rib-like projections 41e).
An undersurface 41f1 of the bracing projection 41f is arranged on the extension of an undersurface 41e1 of the upper rib-like projection 41e of a pair of rib-like projections 41e as shown in FIGS. 30.
That is to say, it is arranged that each of the guided projections 5h and 5i formed in the protector 5 may be reliably retained by one of the pairs of the above-mentioned rib-like projections 41e and one of the bracing projections 41f.
Further, as shown in FIGS. 32 to 34, the above-mentioned protector 5 is provided with a cylindrical outer needle hub supporting portion 5a which accommodates the above-mentioned outer needle 21, and a main body 5b which is extended in the axial direction from the above-mentioned outer needle hub supporting portion 5a to form an upper surface and side faces of the protector and which has openings 5c1 and 5c2 at the opposite end of the above-mentioned outer needle hub supporting portion and in its bottom.
The above-mentioned outer needle hub supporting portion 5a projects and is formed at the inner periphery of the tip portion of the protector 5 in the shape of a cylinder. It is arranged that the tip of the above-mentioned inner needle 3 is located in a space 5a1 of this supporting portion, and an end 5a2 of the above-mentioned outer needle hub supporting portion 5a comes into abutment with the outer needle hub 22.
The above-mentioned opening 5c1 is an opening for inserting the fitting portion 41b of the inner needle hub 41 into the protector 5. The above-mentioned opening 5c2 is formed in order not to interfere with the wings 22A provided for the outer needle hub 22, when the protector 5 is mounted.
Further, an arcuate rib-like frame 5d (arcuate, viewed from cylinder part 5a side) which is extended to both the right and left sides of the above-mentioned main body 5b is formed at the opposite end side of the outer needle hub supporting portion 5a on the above-mentioned main body outer periphery side. Furthermore, for the rib-like frame 5d, extension portions 5d1 are provided extending from both the right and left sides of the above-mentioned main body 5b towards the outer needle hub supporting portion 5a.
Still further, the above-mentioned arcuate rib-like frame 5d has a predetermined height h (size) so that a user may touch and remove the protector 5.
In addition, as the main body 5b is provided with the above-mentioned rib-like frame 5d and the extension portions 5d1 of the rib-like frame 5d, it is possible to increase the mechanical strength of the protector 5 having formed therein the openings 5c1 and 5c2 and prevent the protector 5 from deforming.
Further, the locked projection Se is circumferentially formed on the inner periphery of the protector 5.
When mounting the protector 5 on the above-mentioned inner needle hub 41, as the above-mentioned locked projection Se passes over the rib-like projection 41e formed on the outer periphery of the above-mentioned fitting portion 41b, the locked projection Se of the protector 5 is locked to the rib-like projection 41e, and the protector 5 is fixed to the inner needle hub 41 (fitting portion 41b).
Furthermore, the inner periphery of the protector 5 is provided with contact portions 5f and 5g which come into pressure contact with the outer periphery of the fitting portion 41b of the needle hub 41.
These contact portions 5f and 5g have the structure similar to those of the contact portions 5A to 5D illustrated in the second preferred embodiment. In particular, these contact portions 5f and 5g project from the inner periphery of the protector 5 and are elongated along the axis of the protector 5 in parallel with the above-mentioned axis. A plurality of the above-mentioned contact portions 5f and 5g may only be formed. As for the contact pressure between the outer periphery of the above-mentioned fitting portion 41b and the contact portions 5f and 5g, a width and a length of a contact portion, the number, etc. are determined in consideration of slide resistance (pulling force) between the outer periphery of the above-mentioned fitting portion 41b and the contact portions 5f and 5g.
Incidentally, in the case where the above-mentioned slide resistance (pulling force) is not set up suitably, when the outer periphery of the fitting portion 41b of the inner needle hub 41 is in contact with the whole inner periphery of the main body 5b and when the above-mentioned slide resistance is large, at the moment the user removes the protector with a strong hand, there is a possibility of stabbing the user himself/herself or another person with the inner needle accidentally with too strong a hand. On the other hand, when the above-mentioned slide resistance (pulling force) is small, there is a possibility that the protector 5 may be removed from the fitting portion 41b of the inner needle hub 41.
As described above, by providing the inner periphery of the protector 5 with the contact portions 5f and 5g and suitably setting up the width, the length, the number, etc. of the contact portions, it is possible to suitably obtain the above-mentioned slide resistance (pulling force), and safety can be secured.
Further, the inner periphery of the protector 5 is provided with the guided parts 5h and 5i which are the rib-like projections projecting from the inner periphery of the protector 5 in parallel with the above-mentioned contact portions 5f and 5g (along the axis of the main body 5 in parallel with the above-mentioned axis).
When mounting the protector 5, each of the guided parts 5h and 5i passes between one of the pairs of rib-like projections 41e and is guided by the above-mentioned rib-like projections 41e. Therefore, a thickness of the guided parts 5h and 5i is selected to be smaller than the gap t between the pair of rib-like projections 41e.
Further, an upper surfaces of each of the guided parts 5h and 5i passed between one of the pairs of rib-like projections 41e and guided therewith comes into contact with an undersurfaces of one of the bracing projections 41f formed at the fitting portion 41b of the above-mentioned inner needle hub 41 (see FIG. 31).
Thus, since each of the above-mentioned guided parts 5h and 5i is retained by one of the pairs of the rib-like projections 41e and one of the bracing projections 41f, it is possible to prevent the protector 5 from rattling.
In particular, since the mechanical strength of the opening 5c2 side at the undersurface of the protector 5 is small, there is a possibility that the protector 5 may incline (deform) towards the opening 5c2, when the protector 5 is mounted on the fitting portion 41b of the inner needle hub 41.
As this bracing projections 41f push the above-mentioned guided parts 5h and 5i, it is possible to prevent the inclination (deformation) towards the opening of the protector 5.
As shown in FIG. 35, when mounting such a protector 5, in a situation where a pair of wings 22A are arranged at the opening 5c2 on the undersurface side of the protector 5, if the protector 5 is moved in the X direction (towards syringe 4) and each of the guided parts 5e and 5h and 5i is passed between one of the pairs of rib-like projections 41e, 41e, then the guided parts 5h and 5i are moved while being guided by the rib-like projections 41e, 41e. Further, the contact portions 5f and 5g move in pressure contact with the outer periphery of the fitting portion 41b of the inner needle hub 41.
Furthermore, as the locked projection 5e of the protector 5 passes over the rib-like projection 41e formed at the outer periphery of the fitting portion 41b of the inner needle hub 41, the locked projection 5e of the protector 5 is locked to rib-like projection 41e, and the protector 5 is fixed to the inner needle hub 41 (fitting portion 41b).
At this time, the upper surface of each of the guided parts 5h and 5i passed between one of the pairs of rib-like projections 41e comes into contact with the undersurface of one of the bracing projections 41f formed at the fitting portion 41b of the above-mentioned inner needle hub 41, and each of the above-mentioned guided parts 5h and 5i is retained by one of the pairs of rib-like projections 41e and one of the bracing projections 41f.
Further, the tip of the above-mentioned inner needle 3 is located in the space 5a1 of the outer needle hub supporting portion 5a formed at the protector 5, and the tip portion 5a2 of the above-mentioned outer needle hub supporting portion 5a comes into abutment with the outer needle hub 22. Thus, the protector 5 is stably mounted (fitted) to the inner needle hub 41.
Furthermore, in a situation where the protector is thus mounted, the forward movement of the outer needle hub 22 (catheter 2) is inhibited by the outer needle hub supporting portion 5a, and the rearward movement of the outer needle hub 22 (catheter 2) is inhibited by the inner needle hub 41 (fitting portion 41b) fixed to the protector 5.
As a result, the catheter 2 is fixed and the movement of the catheter 2 is inhibited. Further, also in the case where the wings 22A are provided for the outer needle hub 22, the protector 5 can reliably be mounted without enlarging. Furthermore, the outer needle 21 and the inner needle 3 projecting from the tip of the outer needle 21 can be accommodated and protected in the space 5a1 of the above-mentioned outer needle hub supporting portion 5a.
Still further, when the above-mentioned protector 5 is removed (when the protector 5 is moved in the Y direction of FIG. 29), the user can touch the rib-like frame 5d and easily remove the protector 5 with one hand. It should be noted that the above-mentioned contact portions 5f and 5g are in contact with the fitting portion 41b but not in contact with the arm opening/closing part 62 of the outer pipe 6, so that the arm opening/closing part 62 of the outer pipe 6 does not move in the Y direction and stops in the position, even if the protector 5 moves.
As described above, the puncture device 1 in accordance with this preferred embodiment is a puncture device 1 provided with an outer needle 21, an outer needle hub 22 which retains a base portion of the above-mentioned outer needle and has a projection part on the side, an inner needle 3 whose tip portion is inserted in the above-mentioned outer needle, a cylindrical inner needle hub 41 for retaining the base portion of the above-mentioned inner needle, and a protector 5 for covering the above-mentioned outer needle, wherein the above-mentioned protector 5 has an outer needle hub supporting portion 5a which accommodates the above-mentioned outer needle, a main body 5b which is extended in the axial direction from the above-mentioned outer needle hub supporting portion 5a to form the upper surface and the side faces of the protector and has openings 5c2 and 5c1 respectively at the undersurface and the opposite end of the above-mentioned outer needle hub supporting portion, a rib-like frame 5d formed on the outer periphery at the end opposite the outer needle hub supporting portion of the above-mentioned main body, and a locked projection 5e formed on the inner periphery of the outer needle hub supporting portion at the end opposite the above-mentioned main body, the above-mentioned inner needle hub 41 has a rib-like projection 41e for locking the above-mentioned locked projection 5e formed on the outer periphery at one end, a projection part 22A of the above-mentioned outer needle hub 22 is disposed at the opening of the undersurface of the above-mentioned protector, the locked projection 5e of the above-mentioned main body 5b is locked to the rib-like projection 41e of the above-mentioned inner needle hub 41 by inserting an end of the inner needle hub 41 from the opening 5C1 at an end opposite the outer needle hub supporting portion of the above-mentioned protector 5, and the above-mentioned outer needle 21 is accommodated in the space 5a1 of the above-mentioned outer needle hub supporting portion 5a.
According to such a structure, since the opening 5c2 is formed at the undersurface of the main body 5b of the above-mentioned protector 5, the projection parts (wings 106 etc. shown in FIG. 24) can be provided for the above-mentioned opening 5c2, and the protector 5 can be fitted to the inner needle hub, without interfering with the above-mentioned projection part 22A.
That is to say, even in the case where the projection parts 22A, such as wings, are provided for the outer needle hub 22, the protector 5 can reliably be mounted, without enlarging. The outer needle and the inner needle projecting from the tip of the outer needle can be accommodated and protected in the above-mentioned outer needle hub supporting portion 5a, and it is possible to prevent them from being displaced and secure safety.
It should be noted that since the rib-like frame 5d is formed in the above-mentioned main body 5b, the mechanical strength of the main body 5b can be increased which has the openings 5c2 and 5c1 at the undersurface and the end opposite the above-mentioned outer needle hub supporting portion respectively, and deformation of the protector 5 can be inhibited.
It is desirable that the height from the main body outer periphery of the above-mentioned rib-like frame 5d is set to a size to allow the user to handle it with his/her finger. In the case where the rib-like frame is thus formed, the user can easily remove the protector 5 from the inner needle hub 41 with one hand, touching the rib-like frame 5d.
Further, it is desirable that the above-mentioned protector 5 has the contact portions 5f and 5g which project from the inner periphery of the main body 5b and are extended from the opening at the end opposite the above-mentioned outer needle hub supporting portion 5a along the axis of the main body 5b in parallel with the above-mentioned axis, and that when one end of the inner needle hub 41 (fitting portion 41b) is inserted from the opening 5c1 at the end opposite the outer needle hub supporting portion of the above-mentioned protector 5, the above-mentioned contact portions 5f and 5g come into pressure contact with the outer periphery of the inner needle hub 41 (fitting portion 41b).
As described above, the outer periphery of the inner needle hub 41 (fitting portion 41b) is not in pressure contact with the whole inner periphery of the main body 5b of the protector 5 but in pressure contact with the above-mentioned contact portions 5f and 5g, so that suitable slide resistance can be obtained and it is possible to prevent accidents when mounting and removing the protector 5.
Furthermore, it is desirable that the above-mentioned protector 5 has the guided parts 5h and 5i which project from the inner periphery of the main body 5b and are extended from the opening 5c1 at the end opposite the above-mentioned outer needle hub supporting portion along the axis of the main body 5b in parallel with the above-mentioned axis, and the above-mentioned rib-like projections 41e are formed to have a predetermined gap, and that when one end of the inner needle hub 41 (fitting portion 41b) is inserted from the opening 5c1 at the end opposite the outer needle hub supporting portion of the above-mentioned protector 5, the above-mentioned guided parts 5h and 5i pass between the above-mentioned rib-like projections 41e and are guided by the above-mentioned rib-like projections 41e.
It is preferable that the bracing projections 41f with which the above-mentioned guided parts come into contact are formed at the outer periphery of the inner needle hub that is closer to the inner needle base end portion than the above-mentioned rib-like projections 41e.
As described above, as the above-mentioned guided parts 5h and 5i come into pressure contact with the bracing projections 41f, it is possible to prevent the protector 5 from rattling with respect to the inner needle hub 41. In particular, when the protector 5 is mounted on the inner needle hub 41, it is possible to prevent the inclination (deformation) towards the opening of at the under surface of the protector 5.
Incidentally, in addition to the outer needle hub 102b having formed thereon the wings 106 as shown in FIG. 24, there is another outer needle hub 102b having formed thereon a branch pipe 105 at the side face as shown in FIG. 36. When putting such a protector as described above, the above-mentioned projecting branch pipe 105 and wings 106 may serve as an obstacle. That is to say, there is a problem that the whole outer needle hub 102b cannot be covered with the above-mentioned protector. Further, when the protector which can accommodate the branch pipe 105 and wings 106 is formed, there arises a problem that the protector is considerably large in size.
As shown in FIGS. 40 to 42, the above-mentioned syringe 4 is provided with a cylindrical inner needle hub 41, and a plug 42 attached to the base end (left-hand side) of the above-mentioned inner needle hub 41 in a press fit manner and having a substantially cylindrical needle retaining part 42a by which the base portion of the above-mentioned inner needle 3 is retained.
Further, the cylindrical fitting portion 41b whose diameter is larger than that of the main body is formed at the outer periphery of the tip of the above-mentioned inner needle hub 41. A rib-like projection 41g is formed in the shape of a ring along a circumferential direction at the outer periphery of this fitting portion 41b. This rib-like projection 41g is provided in order to fit the inner needle hub 41 to the protector 5 more reliably.
Furthermore, a protrusion 41h that is a rib-like projection extended in the axial direction is formed on the inner periphery of the above-mentioned fitting portion 41b. This protrusion 41h is provided in order to fit the inner needle hub 41 to the protector 5 more reliably and to prevent a circumferential displacement of the protector 5.
Still further, as shown in FIG. 43, the protector 5 has a cylindrical outer needle hub supporting portion 51 (see FIGS. 41 and 42) which can accommodate the outer needle 21 and the inner needle 3 projecting from the tip of the outer needle 21, and a pair of supporting legs 52 extended with increasing diameter in the axial direction from the outer periphery of the outer needle hub supporting portion 51. When the protector 5 is mounted to the catheter 2, a rear end of the outer needle hub supporting portion 51 comes into abutment with a step portion 22C formed at the outer needle hub 22, so as to fix the catheter 2.
Further, formed at the tips of the above-mentioned supporting legs 52 are slits 52a curved along a concentric circle of the cylinder part 51 (along the circumferential direction of the fitting portion 41b), and the slits 52a have predetermined length and width. Furthermore, a rib-like projection 52b extended in the circumferential direction is formed on an inner face of the outside wall which forms the slit 52a. This rib-like projection 52b passes over and overlaps (in the axial direction) the rib-like projection 41g of the fitting portion 41b provided for the above-mentioned inner needle hub 41 to carry out the snap-fit. Still further, since the protrusion 41h extended in the axial direction is formed on the inner periphery of the fitting portion 41b as described above, if the above-mentioned fitting portion 41b is fitted into the slit 52a, then the above-mentioned protrusion 41h comes into abutment with the inner face of the slit 52a, so that the displacement in the axial direction of the protector 5 is prevented.
When mounting the protector 5, as shown in FIG. 41, parts of the fitting portion 41b of the inner needle hub 41 are respectively fitted into the slits 52a provided for the ends of the pair of supporting legs 52, and the rib-like projections 52b in the slits 52a are locked to the rib-like projection 41g of the fitting portion 41b, thus leading to a situation where the protector 5 is stably mounted (fitted) to the inner needle hub 41. So, the outer needle 21 and the inner needle 3 projecting from the tip of the outer needle 21 are accommodated in the space of the outer needle hub supporting portion 51 supported by the supporting legs 52 of the protector 5.
Further, as shown in FIGS. 37 and 38, the branch pipe 22B of the outer needle hub 22 is arranged at the upper opening 53 provided on the side of the protector 5, and the pair of wings 22A are arranged at the lower opening 53, so that the supporting legs 52 are fitted to the fitting portion 41b of the inner needle hub 41, without interfering with the above-mentioned branch pipe 22B and the pair of wings 22A.
That is to say, even in the case where the branch pipe 22B or wings 22A are provided for the outer needle hub 22, the protector 5 can reliably be mounted without enlarging, and the outer needle 21 and the inner needle 3 projecting from the tip of the outer needle 21 can be accommodated and protected by the outer needle hub supporting portion 51.
That is to say, even if the branch pipe 22B or wings 22A are provided for the outer needle hub 22, the protector 5 can reliably be mounted without enlarging, the outer needle 21 and the inner needle 3 projecting from the tip of the outer needle 21 can be accommodated and protected by the outer needle hub supporting portion 51, and it is possible to prevent them from being displaced and secure safety.
Further, in the above-mentioned preferred embodiment, the rib-like projection 52b which projects inwardly is provided on a side face of the slit 52a of the supporting leg 52, the rib-like projection 41g which projects outwardly is provided on an outer face of the fitting portion 41b, these rib-like projections are locked to each other, but the present invention is not limited thereto.
For example, the rib-like projection which projects outwardly along the circumferential direction may be provided on the side face of the slit 52a of the supporting leg 52, and the rib-like projection which projects inwardly along the circumferential direction may be provided on the inner face of the fitting portion 41b, and they may be locked to each other.
In either case, it follows that at least two rib-like projections are interposed between the side face of the slit 52a of the supporting leg 52 and the inner face or the outer face of the fitting portion 41b. Thus, the protector 5 can be firmly fitted to the inner needle hub 41 by locking them mutually.
Alternatively, the rib-like projection which is circumferentially extended can be provided for the slit 52a of the supporting leg 52 or either the inner face or the outer face of the fitting portion 41b.
Even in such an arrangement, it follows that the above-mentioned rib-like projections are interposed between the side face of the slit 52a of the supporting leg 52 and the inner face or the outer face of the fitting portion 41b. Thus, the above-mentioned fitting portion 41b can be fitted into the above-mentioned slit 52a.
Further, the preferred embodiments above are such that the protrusion 41h (rib-like projection) extended in the axial direction is provided on the inner face of the fitting portion 41b, and this protrusion 41h is interposed between the inner face of the slit 52a and the inner face of the fitting portion 41b.
However, the present invention is not limited to the above structure, but the protrusion extending in the axial direction may be provided on the inner face of the slit 52a of the supporting leg 52, for example, and it may be interposed between the inner face of the slit 52a and the inner face or the outer face of the fitting portion 41b.
Alternatively, the protrusion extending in the axial direction may be provided on the outer face of the fitting portion 41b, and it may be interposed between the inner face of the slit 52a and the outer face of the fitting portion 41b.
In any structure, the protrusion 41h can be interposed between the side face of the slit 52a of the supporting leg 52 and the inner face or the outer face of the fitting portion 41b, and the above-mentioned fitting portion 41b can be fitted into the above-mentioned slit 52a.
As described above, the puncture device 1 in accordance with the seventh preferred embodiment is a puncture device provided with an outer needle 21, an outer needle hub 22 which retains the base portion of the above-mentioned outer needle 21 and has a projection part on the side face, an inner needle 3 whose tip portion is inserted in the above-mentioned outer needle 21, a cylindrical inner needle hub 41 for retaining the base portion of the above-mentioned inner needle, a protector 5 for covering the above-mentioned outer needle, wherein the above-mentioned protector 5 has an outer needle hub supporting portion 51 which accommodates the above-mentioned outer needle 21, and a supporting leg 52 which is extended in the axial direction from the above-mentioned outer needle hub supporting portion 51 to form the side face of the protector and has an opening 53 at the side face, a fitting portion 41b formed along a circumferential direction of the inner needle hub is provided on one end side of the above-mentioned inner needle hub 41, a slit 52a which is formed along a circumferential direction of the above-mentioned fitting portion 41b and has predetermined length and width is provided on one end side of the above-mentioned supporting leg 52, projection parts 22A and 22B of the above-mentioned outer needle hub 22 are arranged at an opening at a side face of the above-mentioned protector 5, part of the above-mentioned fitting portion 41b is fitted into the slit 52a of the above-mentioned supporting leg 52, and the above-mentioned outer needle 21 is accommodated in a space of the above-mentioned outer needle hub supporting portion 51.
That is to say, even in the case where the projection parts 22A and 22B, such as the branch pipe and wings, are formed at the outer needle hub 22, the protector 5 can reliably mounted without enlarging, the outer needle 21 and the inner needle 3 projecting from the tip of the outer needle can be accommodated and protected by the above-mentioned outer needle hub supporting portion 51, and it is possible to prevent them from being displaced and secure safety.
In addition, it is desirable that a plurality of the above-mentioned supporting legs 52 are extended from the above-mentioned portion outer needle hub supporting portion 51 along the axial direction, and the above-mentioned opening 53 is formed between a plurality of the above-mentioned supporting legs 52.
Further, it is desirable that the rib-like projections 52b and 41g extending along a circumferential direction are respectively formed on the side face of the slit 52a of the above-mentioned supporting leg 52 and the inner face or the outer face of the above-mentioned fitting portion 41b, and the above-mentioned rib-like projections 52b and 41g are interposed between the side face of the slit 52a of the above-mentioned supporting leg 52 and the inner face or the outer face of the above-mentioned fitting portion 41b, and they are engaged mutually.
As the thus engaged rib-like projections 52b and 41g are provided, it is possible to more reliably prevent the protector 5 from falling off the inner needle hub 41.
Alternatively, the rib-like projection extending along a circumferential direction may be provided at the side face of the slit 52a of the above-mentioned supporting leg 52 or at either the inner face or the outer face of the above-mentioned fitting portion 41b, and the above-mentioned rib-like projection may be disposed between the side face of the slit 52a of the above-mentioned supporting leg 52 and the inner face or the outer face of the above-mentioned fitting portion 41b, and the above-mentioned fitting portion 41b may be fitted into the slit 52a of the above-mentioned supporting leg 52.
As described above, by providing the rib-like projection extending in the circumferential direction at the side face of the slit 52a of the above-mentioned supporting leg 52 or at either the inner face or the outer face of the above-mentioned fitting portion 41b, it is possible to obtain the effect of preventing the protector 5 from falling off the inner needle hub 41.
Further, it is desirable that the rib-like projection 41h extending in the axial direction is provided at the side face of the slits 52a of the above-mentioned supporting leg 52, or at either the inner face or the outer face of the above-mentioned fitting portion 41b, the above-mentioned rib-like projection 41h is interposed between the side face of the slit 52a of the above-mentioned supporting leg 52 and the inner face or the outer face of the above-mentioned fitting portion 41b, and the above-mentioned fitting portion 41b is fitted into the slit 52a of the above-mentioned supporting leg 52.
As describe above, by providing the rib-like projection 41h extending in the axial direction, it is possible to prevent the protector 5 from being displaced in the axial direction.
As for this puncture device 1, a cylindrical fitting portion 41b whose diameter is larger than that of the main body 41A is formed at the tip side of the inner needle hub 41 integrally therewith (or the portion is firmly fitted to the main body 41A, if it is not integral with the inner needle hub 41). A pair of opposed locking hole portions 41b1 which are penetrated in the axial direction are formed on the outer periphery of this fitting portion 41b. The above-mentioned pair of locking hole portions 41b1 protrude radially outwardly from the outer periphery of the fitting portion 41b respectively, and have a predetermined length along a circumferential direction of the fitting portion 41b. It should be noted that the above-mentioned pair of locking hole portions 41b1 are formed in order to fit the inner needle hub 41 to the protector 5.
Further, as shown in FIG. 49, the protector 5 has a cylindrical outer needle hub supporting portion 51 (see FIGS. 47 and 48) which can accommodate the inner needle 3 projecting from the outer needle 21 and the tip of the outer needle 21, and a pair of supporting legs 52 extended with increasing diameter in the axial direction from the outer periphery of the outer needle hub supporting portion 51. The above-mentioned pair of supporting legs 52 are formed by cutting off both the right and left sides of a cap-like hollow cone along the axial direction, for example. Thus, openings 53 are formed between the pair of supporting legs 52 at the sides of the protector 5.
Furthermore, the above-mentioned supporting leg 52 is provided, at its tip, with a locking member 52c which is formed and curved concentrically about the outer needle hub supporting portion 51 (along the circumferential direction of fitting portion 41b), and the locking member 52c has a predetermined length in the circumferential direction.
In particular, the locking member 52c is sized such that it can be inserted into the locking hole portion 41b1 provided for the inner needle hub 41, and is fitted into the locking hole portion 41b1 as it is completely inserted into locking hole portion 41b1. Further, widths in the radial direction of the above-mentioned locking member 52c and the above-mentioned locking hole portion 41b1 are arranged such that, after the above-mentioned locking member 52c is fitted into the locking hole portion 41b1, the locking member 52c can forcibly be depressed radially inwardly so as to be disengaged from the locking hole portion 41b1.
Furthermore, one end of a spring 54 (elastic component) which is compressible in the axial direction is provided at the rear end of the outer needle hub supporting portion 51. When the protector 5 is mounted, the other end of this spring 54 comes into abutment with a step portion 22C formed in the outer needle hub 22 and the spring is compressed (see FIGS. 47 and 48).
As shown in FIG. 47, when mounting the protector 5, the locking members 52c formed in the pair of supporting legs 52 provided for the protector 5 are inserted and fitted into the locking hole portions 41b1 respectively provided for the fitting portions 41b of the inner needle hub 41. At this time, the spring 54 is compressed between the outer needle hub supporting portion 51 and the outer needle hub 22, to produce biasing force in the direction to separate the protector 5 from the inner needle hub 41, leading to a situation where the protector 5 is firmly and stably mounted (fitted) to the inner needle hub 41. So, the outer needle 21 and the inner needle 3 projecting from the tip of the outer needle 21 are accommodated by the outer needle hub supporting portion 51 supported by the supporting legs 52 of the protector 5.
Further, as shown in FIGS. 44 and 45, since the branch pipe 22B of the outer needle hub 22 and the pair of wings 22A are arranged at the opening 53 provided at the side of the protector 5, the supporting leg 52 is fitted to the fitting portion 41b of the inner needle hub 41, without interfering with the above-mentioned branch pipe 22B and the pair of wings 22A.
That is to say, even if the branch pipe 22B or wings 22A are provided for the outer needle hub 22, the protector 5 can reliably be mounted, and the outer needle 21 and the inner needle 3 projecting from the tip of the outer needle 21 can be accommodated and protected by the outer needle hub supporting portion 51.
Furthermore, when the above-mentioned protector 5 is removed, the locking member 52c at the tip of the supporting leg 52 is depressed radially inwardly to become disengaged from the locking hole portion 41b1 of the inner needle hub 41. When the above-mentioned locking member 52c is disengaged from the above-mentioned locking hole portion 41b1, the above-mentioned locking member 52c easily falls out of the above-mentioned locking hole portion 41b1 because of the biasing force of the spring 54. Further, the protector 5 is separated from the inner needle hub 41 by pulling out the protector 5 relatively to the inner needle hub 41 in the axial direction (direction to separate).
As described above, the puncture device 1 in accordance with the eighth preferred embodiment is a puncture device provided with an outer needle 21, an outer needle hub 22 which retains the base portion of the above-mentioned outer needle and has a projection part on the side face, an inner needle 3 whose tip portion is inserted in the above-mentioned outer needle 21, a cylindrical inner needle hub 41 for retaining the base portion of the above-mentioned inner needle, a protector 5 for covering the above-mentioned outer needle, wherein the above-mentioned protector 5 has an outer needle hub supporting portion 51 which accommodates the above-mentioned outer needle 21, and a supporting leg 52 which is extended in the axial direction from the above-mentioned outer needle hub supporting portion 51, forming a side face of the protector, and forms an opening at the side face, a locking member 52c is provided at one end side of the above-mentioned supporting leg 52, a locking hole portion 41b1 into which the locking member 52c of the above-mentioned supporting leg 52 is inserted is formed at one end side of the above-mentioned inner needle hub 41, the projection parts 22A and 22B of the above-mentioned outer needle hub 22 are arranged at an opening 53 at the side face of the above-mentioned protector 5, the locking member 52c of the above-mentioned supporting leg 52 is inserted and fitted into the locking hole portion 41b1 of the above-mentioned inner needle hub 41, and the above-mentioned outer needle 21 is accommodated in the above-mentioned outer needle hub supporting portion 51.
That is to say, even in the case where the projection parts, such as the branch pipe and wings, are formed at the outer needle hub 22, the protector 5 can reliably be mounted without enlarging, the outer needle 21 and the inner needle 3 projecting from the tip of the outer needle can be accommodated and protected by the above-mentioned outer needle hub supporting portion 51, and it is possible to prevent them from being displaced and secure safety.
In addition, it is desirable that a plurality of the above-mentioned supporting legs 52 are extended from the above-mentioned outer needle hub supporting portion 51 along the axial direction, and a plurality of the above-mentioned locking hole portions 41b1 are formed at one end side of the above-mentioned inner needle hub 41 corresponding to the locking members 52c provided at one end side of a plurality of the above-mentioned supporting legs 52.
As described above, since it is arranged that each of the locking members 52c provided for a plurality of supporting legs 52 may be fitted into one end side of the inner needle hub 41, the outer needle hub supporting portion 51 can be supported stably.
Further, it is desirable that a plurality of the above-mentioned supporting legs 52 are extended along the axial direction from the above-mentioned outer needle hub supporting portion 51, and the above-mentioned opening 53 is formed between a plurality of the above-mentioned supporting legs 52.
Furthermore, it is desirable that the above-mentioned protector 5 has the elastic component 54 which is compressible in the axial direction, and the above-mentioned elastic component 54 is compressed in a situation where the locking member 52c of the above-mentioned supporting leg 52 is fitted into the locking hole portion 41b1 of the above-mentioned inner needle hub 41, thus biasing the protector 5 in the direction to separate it from the above-mentioned inner needle hub 41.
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