CN106267521B

CN106267521B - Safety device, catheter, introducer needle assembly, and indwelling needle

Info

Publication number: CN106267521B
Application number: CN201610770722.4A
Authority: CN
Inventors: 裴鹏; 曹亦峰; 魏薇; 潘晔; 沈长征
Original assignee: Suzhou Yuyue Medical Technology Co Ltd
Current assignee: Suzhou Yuyue Medical Technology Co Ltd
Priority date: 2016-08-30
Filing date: 2016-08-30
Publication date: 2023-04-07
Anticipated expiration: 2036-08-30
Also published as: CN106267521A

Abstract

The invention discloses a safety device, a catheter and an introducing needle assembly with the safety device, and an indwelling needle. The safety device is used for movably matching an introduction needle, and comprises: the needle shield is enclosed into a channel longitudinally extending from a proximal end to a distal end and an accommodating cavity partially crossed with the channel, and the channel is arranged to allow an introduction needle to pass through; the spring clamp is arranged in the accommodating cavity and comprises a first arm and a second arm which are oppositely arranged at two sides of the channel, and a first flag plate and a second flag plate which are respectively arranged on the first arm and the second arm; the limiting piece is used for limiting the distal needle tip of the introducing needle to move out of the needle shield towards the proximal end after the introducing needle is extracted; before the leading needle is extracted, the leading needle is pressed against the first flag plate and the second flag plate so that the spring clamp is positioned in a compression mode; after the introduction needle is withdrawn, at least the first flag is released and moved to the distal end of the needle tip to limit distal movement of the introduction needle out of the needle shield. The invention can reduce the puncture risk and infection risk caused by the leakage of the needle point.

Description

Safety device, catheter, introducer needle assembly, and indwelling needle

Technical Field

The invention belongs to the technical field of medical instruments, and relates to a safety device, a catheter and an introducing needle assembly with the safety device, and an indwelling needle.

Background

Intravascular catheters, particularly intravenous catheters, are commonly used for infusing a patient with a fluid, such as saline solution, various medicaments, and parenteral nutrition, or for withdrawing blood from a patient. Peripheral venous catheters are typically relatively short, on the order of two inches or less in size. The most common type of catheter is a peripheral venous catheter fitted over an introducer needle.

The peripheral intravenous catheter fitted over the introducer needle is fitted over an introducer needle having a sharp needle tip. The catheter and the introduction needle are assembled with the tip of the introduction needle extending beyond the tip of the catheter and with the tip of the introduction needle facing upwards at an incline.

The catheter and introducer needle assembly are inserted at a shallow angle through the patient's skin into the peripheral vessel which is not directly connected to the heart, but rather is connected to one of the central vessel branches to which the heart is directly connected.

After insertion of the catheter and introducer needle assembly into the blood vessel, it is important to confirm that the assembly is properly positioned in the blood vessel. To confirm that the assembly is correctly positioned, the medical personnel need to confirm that flashback blood is present in the introducer needle and in a flashback chamber located at the proximal end of the introducer needle. In the prior art, the introducer needle may be provided with a notch or opening in its distal portion so that flashback of blood can be observed in the annular space between the introducer needle and the catheter. Once proper positioning is confirmed, the medical professional withdraws the introducer needle leaving the catheter in place and then attaches a fluid delivery device such as a plain heparin cap or a head cap to the catheter. Once the introducer needle is withdrawn from the catheter, it will carry a "blood-contaminated needle tip" which must be properly disposed of.

In recent years, there has been considerable interest in the blood that medical personnel may be contaminated with, and it has been recognized that the "blood-contaminated needle tip" must be disposed of immediately. This concern is growing because of the advent of fatal diseases, such as aids, that are not currently treatable and that may be transmitted from one infected person to another by the exchange of bodily fluids. Therefore, contact with the body fluids of aids infected persons must be avoided. As described above, if an introducer needle has been used to place a catheter into the vasculature of an AIDS infected person, the introducer needle is a vehicle for the delivery of the disease. Although medical personnel are already aware of the need to properly handle "blood-contaminated needle tips", unfortunately in certain medical environments, such as emergency situations or due to lack of attention or negligence, there are situations where contaminated introducer needles stick to medical personnel.

Disclosure of Invention

In order to solve the above-mentioned problems, it is an object of the present invention to provide a safety device, a catheter and an introducer needle assembly having the same, and an indwelling needle, in which a needle tip can be closed by the safety device to solve the problem of accidental puncture or infection due to exposure of the needle tip.

To achieve one of the above objects, an embodiment of the present invention provides a safety device for movably engaging an introduction needle, the safety device including:

the needle shield is enclosed to form a channel longitudinally extending from a proximal end to a distal end and a containing cavity partially crossed with the channel, and the channel is arranged to enable the introducing needle to pass through;

the spring clamp is arranged in the accommodating cavity and comprises a first arm and a second arm which are oppositely arranged at two sides of the channel, and a first flag and a second flag which are respectively arranged on the first arm and the second arm;

the limiting piece is used for limiting the distal needle tip of the introducing needle to move out of the needle shield towards the proximal end after the introducing needle is extracted;

wherein, prior to withdrawal of the introducer needle, the introducer needle presses against the first flag and the second flag to place the spring clip in a compression mode; after the introduction needle is withdrawn, at least the first flag is released and moved to the distal end of the needle tip to limit distal movement of the introduction needle out of the needle shield.

As a further development of an embodiment of the invention, after the withdrawal of the introducer needle, the second flag exerts a holding force on the introducer needle, which has a component directed perpendicularly to the first arm.

As a further improvement of an embodiment of the present invention, the spring clip further comprises a positioning portion for engaging with an inner sidewall of the needle shield to limit longitudinal displacement of the spring clip relative to the needle shield.

As a further improvement of an embodiment of the present invention, the catheter assembly is connected to a proximal end of the catheter assembly, the catheter assembly comprises a catheter and a catheter hub connected to the proximal end of the catheter, the proximal end of the catheter hub is provided with a connecting part, and the distal end of the needle shield is provided with a catch, and the catch can be fitted to the connecting part to make the distal end of the needle shield and the proximal end of the catheter hub detachably sleeved with each other.

As a further improvement of one embodiment of the present invention, the proximal end of the catheter hub is sleeved outside the distal end of the needle shield, and the distal end of the needle shield is provided with a plurality of elastic members separated from each other; before the leading-in needle is drawn out, the leading-in needle abuts against a plurality of elastic pieces; after the introduction needle is withdrawn, the elastic member may move radially inward to disengage the catch from the connecting portion.

As a further improvement of an embodiment of the present invention, the spring clip further comprises a pair of third flags vertically disposed on at least one of the first arm and the second arm, the pair of third flags being disposed on opposite sides of the introducing needle, respectively.

To achieve one of the above objects, an embodiment of the present invention also provides a catheter and introducer needle assembly, comprising:

the needle introducing assembly comprises a needle introducing needle and a needle seat fixed at the proximal end of the needle introducing needle, wherein the needle introducing needle comprises a needle rod, a needle point positioned at the distal end of the needle rod and a mutation part arranged between the needle point and the proximal end of the needle rod;

a catheter assembly comprising a catheter and a catheter hub connected to a proximal end of the catheter; it is characterized in that the preparation method is characterized in that,

the safety device as described above, operably coupled to the proximal end of the catheter assembly.

As a further improvement of an embodiment of the present invention, the proximal end of the catheter hub is provided with a connecting portion, and the distal end of the needle shield is provided with a catch, which can be fitted to the connecting portion to detachably socket the distal end of the needle shield and the proximal end of the catheter hub with each other.

As a further improvement of one embodiment of the present invention, the proximal end of the catheter hub is sleeved outside the distal end of the needle shield, and the distal end of the needle shield is provided with a plurality of elastic pieces separated from each other; before the leading-in needle is drawn out, the leading-in needle abuts against a plurality of elastic pieces; after the introduction needle is withdrawn, the elastic member may move radially inward to disengage the catch from the connecting portion.

In order to achieve one of the above objects, an embodiment of the present invention also provides an indwelling needle comprising the safety device as described above or the catheter and introducer needle assembly as described above.

Compared with the prior art, the invention has the following beneficial effects: through setting up the first flag and the second flag that support respectively and hold the introducing needle, and locating part, make after the introducing needle takes out, its needle point is closed by safety device reduces the puncture risk and the infection risk that the needle point leaks outward and causes.

Drawings

FIG. 1 is a schematic view showing the structure of an indwelling needle according to an embodiment of the present invention;

FIG. 2 is a schematic structural view of a catheter and introducer needle assembly of one embodiment of the present invention, also illustrating a state prior to activation of the spring clip;

FIG. 3 is an exploded view of the structure of a catheter and introducer needle assembly in accordance with one embodiment of the invention;

FIG. 4 isbase:Sub>A longitudinal sectional view taken along line A-A of FIG. 2;

FIG. 5 is an enlarged view of a spring clip according to an embodiment of the present invention;

FIG. 6 is an enlarged partial view of region B of FIG. 4;

FIG. 7 is a state view of the catheter and introducer needle assembly of one embodiment of the present invention after activation of the spring clip;

FIG. 8 is a longitudinal sectional view taken along line C-C of FIG. 7;

FIG. 9 is a schematic view of the construction of a security device according to another embodiment of the present invention;

fig. 10 is a schematic view of another embodiment of the security device of the present invention from a distal to proximal perspective.

Detailed Description

The present invention will be described in detail below with reference to specific embodiments shown in the drawings. These embodiments are not intended to limit the present invention, and structural, methodological, or functional changes made by those skilled in the art according to these embodiments are included in the scope of the present invention.

For clarity of presentation of the positions and orientations described in this application, reference is made to the operator of the instrument, with the end proximal to the operator being the proximal end and the end distal from the operator being the distal end. Meanwhile, in the present application, the direction defined by the proximal end and the distal end is defined as a longitudinal direction, the central axes of the catheter and the introducing needle assembly being parallel to said longitudinal direction; the direction which is vertically far away from the axis is defined as outer, and the direction which is vertically close to the central axis is defined as inner; the direction defined by the inner and outer sides is defined as the radial direction and the plane perpendicular to the longitudinal direction is defined as the cross-section.

Referring to fig. 1, an indwelling needle 100 according to an embodiment of the present invention includes a catheter and introducer needle assembly 1, an extension tube 2 and a positive pressure needle-free connector 3. The catheter and introducer needle assembly 1 is used to puncture tissue to communicate the indwelling needle 100 into a blood vessel. The extension tube 2 is connected between the catheter and the introducer needle assembly 1, the positive pressure needle-free connector 3. The positive pressure needleless connection 3 allows the infusion of drugs or nutrients.

Referring to fig. 2 and 3, a catheter and introducer needle assembly 1 of one embodiment of the present invention includes a catheter assembly 10, a safety device 20, and an introducer needle assembly 30.

The introduction needle assembly 30 comprises an introduction needle 31 and a needle hub 32. The introducer needle 31 has a longitudinally extending needle shaft, a needle tip 311 at a distal end of the needle shaft, a flashback notch 312, and a discontinuity 313. Wherein, the needle point 311 is a sharp bevel for puncturing tissue. The abrupt change 313 is arranged between the needle tip 311 and the proximal end of the needle shaft and is arranged close to the needle tip 311, and the abrupt change 313 may be arranged in particular as an enlarged portion with an increased diameter as shown in the embodiment of the drawings, or as a flattened portion with a larger width at least in a radial direction. In addition, the needle seat 32 is fixedly disposed at the proximal end of the introducing needle 31, and is provided with a holding piece 321 for holding and driving the introducing needle 31 to move along the longitudinal direction through the needle seat 32. Further, the introduction needle 31 is located substantially on the central axis of the catheter and the introduction needle assembly 1.

The catheter assembly 10 includes a catheter 11 and a catheter hub 12. The catheter tube 11 extends in a longitudinal direction and is fixedly connected at its proximal end to the catheter hub 12. The introduction needle 31 may be placed through the catheter 11 with the needle tip 311 projecting distally out of the distal end of the catheter 11. Preferably, the catheter 11 is made of transparent or translucent material to observe the backflow of blood at the blood returning groove 312.

In one embodiment of the present invention, the safety device 20 is slidably disposed between the introducer needle assembly 30 and the catheter assembly 10, and includes a needle shield 21, a spring clip 22, and a stopper 23.

Specifically, referring to fig. 4 to 8, the needle shield 21 encloses a passage 202 and a receiving cavity 201. The channel 202 extends in the longitudinal direction and allows the introduction needle 31 to pass through the needle shield 21. Preferably, the cross-section of the channel 202 is circular and has a diameter larger than the diameter of the introduction needle 31. The accommodating cavity 201 and the channel 202 are partially overlapped in a crossing manner.

The spring clip 22 is disposed in the accommodating cavity 201 and includes a compression mode and an expansion mode. When the introduction needle 31 is withdrawn distally proximally, the spring clip 22 is movable from the compressed mode to the expanded mode for limiting distal movement of the needle tip 311. Wherein the process defining the movement of the spring clip 22 from the compressed mode to the expanded mode is the triggering of the spring clip 22.

Specifically, the spring clip 22 includes a first arm 222, a second arm 223, a first flag 2221 disposed on the first arm 222, and a second flag 2231 disposed on the second arm 223. Wherein the first arm 222 and the second arm 223 are disposed on two opposite sides of the passage 202, and when the introducing needle 31 passes through the passage 202 and passes through the needle shield 21, the first arm 222 and the second arm 223 are separated from two opposite sides of the introducing needle 31.

The first flag 2221 and the second flag 2231 are connected to the first arm 222 and the second arm 223 at an included angle, respectively. Before the introduction needle 31 is withdrawn, the introduction needle 31 presses against the first flag 2221 and the second flag 2231 so that at least the first flag 2221 is compressively deformed, and the spring clip 22 is in the compression mode. After the introduction needle 31 is withdrawn, the spring clip 22 is located at the open module, i.e. at least the first flag 2221 is released to bounce and move to the distal end of the needle tip 311 to restrict the introduction needle 311 from moving distally out of the needle shield 21.

Further, the spring clip 22 comprises a third arm 221 connecting the proximal end of the first arm 222 and the proximal end of the second arm 223, the third arm 221 being substantially parallel to the cross-section. The third arm 221 includes a first through hole 2210, and the introduction needle 31 may pass through the first through hole 2210 and be clamped between the first arm 222 and the second arm 223.

Further, the spring clip 22 further comprises a positioning portion 224, and the positioning portion 224 is used for being engaged with the inner side wall of the needle shield 21, so as to at least limit the relative movement of the spring clip 22 and the needle shield 21 in the longitudinal direction. In this way, the spring clip 22 is prevented from leaving its preset position.

In an embodiment of the present invention, the positioning portion 224 is provided as two elastic pieces protruding outward from two opposite sides of the positioning member 224, and the elastic pieces are in interference fit with the inner sidewall of the needle shield 21. In this way, the position of the spring clip 22 can be made more stable.

Further, the first flag 2221 and the second flag 2231 extend toward the second arm 223 and the first arm 222, respectively, so that the first flag 2221 and the second flag 2231 respectively abut against two opposite sides of the introducing needle 31. Preferably, the first flag 2221 and the second flag 2231 have a spacing in the longitudinal direction, and the second flag 2231 is located at a proximal end of the first flag 2221. Both the first flag 2221 and the second flag 2231 are compressed before the introducer needle 31 is withdrawn. After the introduction needle 31 is withdrawn, the first flag 2221 is released to close the channel 202 distal to the needle tip 311; while the second flag 2231 still abuts the needle 31 and exerts a force on the needle 31 that has a component directed perpendicularly to the first arm 222. In this way, the tendency of the tip 311 of the introducer needle 31 to bend towards the first arm 222 to move away from the channel 202 further ensures the sealing effect of the first flag 2221 on the introducer needle 31.

Further, in an embodiment of the present invention, a pair of third flags is vertically disposed on at least one of the first arm 222 and the second arm 223. In the embodiment of the figures, the first arm 222 is provided with a pair of the third flags 2222, the pair of the third flags 2222 are separated from two opposite sides of the introducing needle 31 and each of the third flags 2222 extends along a longitudinal direction perpendicular to the plane of the first arm 222; the second arm 223 is provided with a pair of the third flags 2232, the pair of the third flags 2232 being separated from opposite sides of the introduction needle 31 and each of the third flags 2232 extending in a longitudinal direction perpendicular to a plane of the second arm 223. In this way, the offset of the introduction needle 31 can be limited by the

third flag

2222, 2232.

Further, after the introduction needle 31 is withdrawn, the stopper 23 is used for limiting the needle tip 311 from moving out of the needle shield 21 in the proximal direction.

Specifically, the needle shield 21 includes a second receiving cavity 212, and the stopper 23 is disposed in the receiving cavity 212. The middle of the limiting member 23 has a second through hole 231, and the second through hole 231 is located on the channel 202 and is configured to allow the needle bar to pass through, but not allow the abrupt change portion 313 to pass through. That is, the inner diameter of the second through hole 231 is slightly larger than the outer diameter of the needle bar and smaller than the outer diameter of the abrupt change 313.

Further, in one embodiment of the present invention, the safety device 20 is detachably connected to the catheter assembly 10. The distal end 211 of the needle shield 21 is provided with a retaining part 2111, the proximal end 121 of the catheter hub 12 is provided with a connecting part 1211, and the retaining part 2111 can be matched with the connecting part 1211, so that the distal end 211 can be detachably sleeved on the proximal end 121. Thus, the removal of the safety device 20 from the catheter assembly 10 after the introduction needle 31 has been withdrawn is less cumbersome and labor-saving.

In the embodiment of the drawings, the retaining portion 2111 is configured as an annular protrusion protruding out of the outer surface of the distal end 211, and the connecting portion 1211 is configured as an annular groove recessed into the inner surface of the proximal end 121, so that the distal end 211 is sleeved inside the proximal end 121.

Referring to fig. 9 and 10, there is illustrated a security device 20' according to another embodiment of the present invention, which differs from the previous embodiment in that: the distal end 211 'of needle shield 21' is differently configured. Except for this difference, the other structures are the same as those of the previous embodiment, and are not described again here. This difference will be described in detail below.

The distal end 211 'of the needle shield 21' is provided as a number of resilient members separated from each other, which are movable radially inwards. Prior to withdrawal of the introducer needle, the introducer needle extends through the needle shield 20' in the passageway 202', the introducer needle bearing against the resilient member to limit radially inward movement of the resilient member to connect the safety device 20' to the catheter assembly; after the introduction needle is withdrawn, the elastic member may move radially inward to disengage the catch 2111 'from the connection (not shown), which may allow the safety device 20' to be more smoothly disengaged from the catheter assembly.

Specifically, the needle shield 21 'includes a first dividing groove 2101' and a second dividing groove 2102 'perpendicular to each other, so that the distal end 211' forms four elastic members separated from each other. The four elastic members surround the channel 202', and before the introduction needle is extracted, the introduction needle passes through the needle shield 20' in the channel 202', and the introduction needle abuts against the elastic members so as to limit the inward movement of the elastic members in the radial direction; after withdrawal of the introducer needle, the introducer needle is disengaged proximally from the distal end 211 'and no longer against the resilient member, which is movable radially inwardly to disengage the catch 2111' from the connection. Thus, the safety device 20' can be more easily and smoothly pulled off from the catheter base.

Of course, in other embodiments, the number of the elastic members may be two or other, and the shape is not limited to the right-angle sector of the embodiment.

Compared with the prior art, the invention has the following beneficial effects: through the arrangement of the first flag plate and the second flag plate which respectively abut against the introducing needle and the limiting part, after the introducing needle is drawn out, the needle point of the introducing needle is sealed by the safety device, and the puncture risk and the infection risk caused by the leakage of the needle point are reduced.

The detailed description set forth above is merely a specific description of possible embodiments of the present invention and is not intended to limit the scope of the invention, which is intended to include within the scope of the invention equivalent embodiments or modifications that do not depart from the technical spirit of the present invention.

Claims

1. A safety device for movably engaging an introducer needle, the safety device comprising:

the spring clamp is arranged in the accommodating cavity and comprises a first arm and a second arm which are oppositely arranged at two sides of the channel, a first flag plate and a second flag plate which are respectively arranged on the first arm and the second arm, and a pair of third flag plates which are vertically arranged on at least one of the first arm and the second arm, wherein the second flag plate is relatively positioned at the near end of the first flag plate; the pair of third flag plates are respectively arranged on two opposite sides of the introducing needle;

the limiting piece is used for limiting the distal needle tip of the introducing needle to move out of the needle shield towards the proximal end after the introducing needle is extracted; the introducing needle is provided with a needle rod extending along the longitudinal direction, a needle point positioned at the far end of the needle rod and an abrupt change part, and the longitudinal distance from the abrupt change part to the needle point is greater than the longitudinal distance from the second flag to the limiting part and is less than the longitudinal distance from the first flag to the limiting part; the limiting piece is provided with a second through hole, and the second through hole is used for limiting the abrupt change part to pass through so that the needle point is positioned between the first flag plate and the second flag plate;

wherein, before the introduction needle is withdrawn, the introduction needle is pressed against the first flag and the second flag to place the spring clip in a compression mode; after the introduction needle is withdrawn, at least the first flag is released and moved to the distal end of the needle tip to restrict the introduction needle from moving distally out of the needle shield; after the introducing needle is drawn out, the second through hole limits the abrupt change part to pass through, so that the needle point is located between the first flag and the second flag, the first flag is released to close the channel at the far end of the needle point, the second flag supports the introducing needle, and a supporting force is applied to the introducing needle, so that the needle point is bent towards the first arm to be far away from the axis of the channel at the far end of the needle point.

2. The safety device of claim 1, wherein the spring clip further comprises a detent for engaging with an inner sidewall of the needle shield to limit longitudinal displacement of the spring clip relative to the needle shield.

3. The safety device of claim 1, connected to a proximal end of a catheter assembly comprising a catheter and a catheter hub connected to the proximal end of the catheter, wherein the proximal end of the catheter hub is provided with a connection portion and the distal end of the needle shield is provided with a catch engageable to the connection portion to releasably engage the distal end of the needle shield and the proximal end of the catheter hub with one another.

4. The safety device according to claim 3, wherein the proximal end of the catheter hub is sleeved outside the distal end of the needle shield, and the distal end of the needle shield is provided with a plurality of elastic pieces separated from each other; before the introducing needle is extracted, the introducing needle abuts against the elastic pieces; after the introduction needle is withdrawn, the elastic member may move radially inward to disengage the catch from the connecting portion.

5. A catheter and introducer needle assembly comprising:

the safety device of any one of claims 1 to 4, being movably connected to the proximal end of the catheter assembly.

6. The catheter and introducer needle assembly of claim 5, wherein the proximal end of the catheter hub is provided with a connection, and the distal end of the needle shield is provided with a catch that is engageable to the connection to releasably mate the distal end of the needle shield and the proximal end of the catheter hub to one another.

7. The catheter and introducer needle assembly of claim 6, wherein the proximal end of the catheter hub is sleeved outside the distal end of the needle shield, and the distal end of the needle shield is provided as a plurality of elastic members that are separated from each other; before the leading-in needle is drawn out, the leading-in needle abuts against a plurality of elastic pieces; after the introduction needle is withdrawn, the elastic member may move radially inward to disengage the catch from the connecting portion.

8. An indwelling needle comprising the safety device according to any one of claims 1 to 4 or the catheter and introducer needle assembly according to claim 5.