CN1331412A

CN1331412A - Pulling force preventing tester for medical non-hole needle and testing method thereof

Info

Publication number: CN1331412A
Application number: CN 01122138
Authority: CN
Inventors: 松谷贯司
Original assignee: Mani Inc
Current assignee: Mani Inc
Priority date: 2000-06-30
Filing date: 2001-07-02
Publication date: 2002-01-16
Anticipated expiration: 2021-07-02
Also published as: CN1192748C; JP4277943B2; JP2002011013A

Abstract

A device for pull-out testing of an eyeless needle and a testing method of the same can perform a pull out a plurality of needles within short time. and to provide a testing method of the same. The testing device comprises the following part: a holding means 13 holding a plurality of surgical eyeless needles which has a blind hole 1b arranged at its base end part 1c to which a surgical suture is inserted and fixed by clamping, by means of holding either needles or surgical needles collectively; a supporting table 12 supporting the holding means 13 sliding freely; and a weight adding means 18 adding weight to the holding means. The test is carried out by holding and pulling the eyeless needle 1 piece by piece by a needle holder and by adding a prescribed weight.

Description

Medical non-hole needle withdrawal resistance tester and method of testing

The present invention relates to medical non-hole needle withdrawal resistance tester, the test of particularly permissible suture breakaway.

Be used for operating medical suture needle and have two kinds: the pin that has that through hole (springhole), line can pass is thus arranged in the bottom; And eyeless needle.

So-called have the typical feature of a pin to be, the bottom of pin is flat type by punching press, stamps out a hole again in this flat type part; Form to the hole from the bottom end surface of pin then and receive wire casing together, then this hole just becomes a springhole.During use suture passed this springhole.

The structure of eyeless needle as shown in Figure 3.In this figure, an end of eyeless needle 1 is bottom end surface 1a, by laser, electron beam, electric spark, drill or other processing modes, can form blind hole 1b on surperficial 1a, and its diameter has only half of eyeless needle 1 bottom diameter.On the top of eyeless needle is sharp needle point 1d, forms multiple cutting edge 1e downwards thereupon with having a style of one's own.

Eyeless needle 1 comprises into the sword needle body, and the xsect of one-tenth sword needle body shown in Figure 3 is a polygon, and the xsect of round pin (not shown) is a near round shape.According to different biological tissues and the position sewed up, it is suitable to select in the pin of these kinds.

Different according to thickness, material (nylon, silk, etc.) and structure (sub-thread or multiply) can have many kinds of sutures 2.According to different biological tissues and the position sewed up, can in the suture of these kinds, select suitable using.Inject the end of a thread of line 2 among the blind hole 1b and firmly push and clog it, thereby make the end of a thread be fixed on the 1c place, bottom of eyeless needle 1.The line of sewing up Len req is fixed on the eyeless needle from the beginning.The former this means that eyeless needle is better than having a pin, because need not resemble and non-the latter line be pierced in the hole.

In surgical procedure, must guarantee that line and pin connect together all the time.In the situation that a pin is arranged, line be pass springhole thereby two lines and come the both sides in hole.So long as not having only single line that tension force is arranged, line is not just thrown off with pin.

And in the situation of eyeless needle, line with depend on pin and line contact friction force being connected of pin at caulk part.If clog very loosely, when passing biological tissue, line just may throw off with pin.If clog too tightly, line may cause intensity to reduce in when filling fracture.This also may make line break when passing biological tissue.Therefore, for a pin is arranged, can preestablish the permission pull-off force, carry out the withdrawal resistance test and whether meet the demands with the permission stretching resistance of check suture according to the thickness of used suture.

The device shown in Fig. 4 (a) is adopted in traditional withdrawal resistance test.The eyeless needle 1 that links to each other with suture 2 is contained on the anchorage part 3a, and anchorage part 3a then is positioned at the end of a spring gravitometer 3.Fig. 4 (b) is the sectional view of anchorage part, and wherein the groove 3b that processes at anchorage part is bigger but littler than the diameter of pin 1 than the diameter of line 2.Line 2 is placed among the groove 3b, and eyeless needle bottom end surface 1a contacts with anchorage part 3a and is added on the line 2 up to predetermined tension force.Afterburning big I read by the scale 3c of spring gravitometer 3.That is, when the scale of spring gravitometer 3 reaches predetermined value, look at whether the off-line fracture takes place.

Yet this device need be provided with and load application each eyeless needle 1, work complicated and take very long, thereby increased manufacturing cost.

For addressing these problems, the present invention aims to provide a kind of eyeless needle withdrawal resistance proving installation and method of testing, can lift many pieces of eyeless needles in the short time.

For reaching this purpose, the characteristics of the eyeless needle withdrawal resistance proving installation of making according to the present invention can both be clamped many pieces of medical non-hole needles for having (1) clamp device, hold line again, thereby wherein suture is inserted into the blind hole that is arranged on the bottom and is clogged and is fixed; (2) charger is used for loading to above-mentioned clamp device.

Can be designed to multiple structure, wherein: (1) clamp device is used to clamp the suture of a plurality of medical non-hole needles; (2) supporting base between clamp device and charger is used to support clamp device, thereby it can be free to slide in the horizontal direction, and clamp device has plate up and down, hold wire clamp between these plate front ends for one, and an elastic component, it makes the front end of plate stress on this keeper; (3) holding wire clamp is made by soft resilient material; Or (4) clamp device can be free to slide after installing on the table.

Furthermore, can also design a kind of like this structure, wherein clamp device includes laterally the plate of (or vertical), hold wire clamp between these plate front ends and an elastic component these plate front ends pressed to hold wire clamp; Charger is directly linked the end of clamp device.In this case, the weight of clamp device adds that the weight of charger is exactly the load that is added on caulk part.With this inverted configuration, the design that is equipped with supporting base can be tested with Horizontal Tension, thereby can reduce tester's workload.

Further, eyeless needle withdrawal resistance method of testing designed according to this invention just can reach in the purpose that relates to the test of line being carried out when adopting medical non-hole needle.Be characterized in applying the withdrawal resistance that tension force comes p-wire by each bar suture to medical non-hole needle.

The preferred embodiment of the invention is described below with reference to accompanying drawings.：

Fig. 1 has shown according to the present invention the structure of medical non-hole needle withdrawal resistance tester (hereinafter to be referred as tester);

Fig. 2 is the view of another tester of the present invention embodiment major part;

Fig. 3 is the skeleton view of eyeless needle;

Fig. 4 is the structural representation of conventional medical eyeless needle withdrawal resistance tester.

Tester 10 among Fig. 1 is made of the slidably supporting base 12 and the clamp device 13 that are contained on the table 11, and wherein clamp device 13 is contained in the slidably part 12b of supporting base 12.

Clamp device 13 comprises

plate

14,15, the keeper between the plate front end 16 and these plate front ends is pressed to an elastic component 17 compositions of keeper.And tester 10 has a weight 18 to act on clamp device 13 as charger.

The ball slide assemblies is used for supporting base 12.The fixed part 12a of supporting base 12 is fixed in table 11, and movable part 12b is contained on the clamp device 13.Supporting base 12 be designed to the ball slide assemblies so that between clamp device 13 and the table 11 friction factor reduce to minimum, thereby when load 18 added to clamp device 13, the load deviation that is caused by friction can be ignored and not remember.The sole purpose of this design reduces friction factor exactly.Can expect adopting roller or thin roller to do rolling member thus.When the movable part 12b of supporting base 12 rolled on fixed part 12a, as shown in Figure 1, clamp device 13 can transverse movement.By the retainer (not shown) on movable part 12b or the fixed part 12a, can be moved to the left a limited segment distance at least.

Plate

14 and 15 respectively has a thrust 14a and a 15a up and down, and is linked to each other by a pin 19.So plate 15 can serve as that axle freely rotates with pin 19.The elastic component 17 that is positioned at an end (rear end) is made of the compression ring spring, and therefore

plate

14 and 15 stressed the making in rear end are separated from each other up and down, as shown by arrows; Thereby keeper 16 is clamped between the front end of plate 14 up and down and 15.

Keeper 16 compresses a plurality of sutures 2 on the eyeless needle 1 between the

plate

14 and 15 up and down by Mechanical Contact.Suture 2 is by keeper 16 and the friction force between the

plate

14 and 15 is and clamped up and down, and the material of therefore making keeper 16 will have bigger friction factor.It is also important that, with when compressing line 2 energetically up and down

plate

14 and 15 do not damage line 2.Therefore according to present embodiment, keeper 16 is made by the cylindrical rubber of a hollow, heavy wall.The diameter of keeper 16 will be tried one's best greatly, so that can not keep curved shape after line 2 tests of twining.In order to increase coefficient of friction and protective wire 2, should add

rubber sheet gasket

14b and 15b between the

plate

14 and 15 up and down.

In this embodiment, elastic component 17 adopts ring spring.Other springs also can such as the

leaf spring.Plate

14 and 15 clamps keeper 16 can also to use pneumatic linear actuator to make up and down.

Support 20 is fixed in the left end of table 11 by hand-screw bolt 20b.Support 20 is furnished with pulley 20a free to rotate.Lower surface at lower plate 14 has a fixator 14c, links the rope 21 pile warp pulley 20a of fixator 14c and hangs down to table 11 times.Front end along rope 21 forms a ring 21a, and colluding of weight 18 hangs on this ring.That is, as long as rope 21 does not unclamp, the weight of weight 18 just is added on the clamp device 13 all the time.

How narration carries out the withdrawal resistance test of suture below.

The first step is taken out keeper 16 between the rubber sheet gasket 14b of up and down

plate

14 and 15 front ends and 15b.Then with the suture on the eyeless needle 12 about half-turn to 2 circle on the keeper 16, and it is being held with a firm grip up and down between

plate

14 and 15, as shown in Figure 1.

Calculate it according to the thickness of suture 2 then and allow breakaway, the weight 18 of required weight is hung on ring 21a on the rope 21, contact the floor and the 21 released or clamp devices 13 of restricting move to the left side of Fig. 1 and blocked by the backstop (not shown) up to weight 18.

Pin keeper is clamped in a plurality of eyeless needles, slowly pulls to the right of Fig. 1, is added to up to the weight of weight 18 on the line 2 of the pin 1 that this quilt holds.If line 2 is not thrown off when adding loads 18 or is broken, then this product be tested as qualified.Otherwise, for defective.

Surveyed wherein after of pin 1, the pin keeper holds on the another in a plurality of eyeless needles again, repeats above-mentioned steps.Can test one by one by the eyeless needle that clamp device 13 is held, a kind of effective method of testing is provided thus.Also can draw pin to replace the pin keeper with finger as load.

When using pin keeper or similar tool to hold pin, caulk part may be reinforced if the bottom 1c of eyeless needle 1 is held.For avoiding this point, hold a little and should avoid caulk part.

Fig. 2 is according to another preferred embodiment of the present invention.The characteristics of tester 10 ' are that charger is spring gravitometer 25 but not weight 18.Method of testing is with shown in Figure 1 the same.The scale that predetermined load is looked into spring gravitometer 25 by stretching eyeless needle 1 and sight provides.For the situation of weight shown in Figure 1 18, the load that adds on online 2 is constant, and is also like this even the length of eyeless needle 1 changes.Yet in the embodiment shown in Figure 2, institute's loading is directly proportional with the length of pulling.This has saved the trouble that the line thickness does not need to change load simultaneously.This method can be used to know makes that line 2 takes off, the load value when disconnected.

Also can design another kind of embodiment, wherein clamp device is arranged in vertical direction and without supporting base, charger is linked the top and the bottom of clamp device, and wherein pin is spurred up and down.When charger was linked the lower part of clamp device, weight, spring or pressurized with fluid cylinder all can be used as charger.When charger is linked the upper part of clamp device, available spring or pressurized cylinder.

As previously mentioned, charger promptly can be the also available spring gravitometer 25 of weight 18.Perhaps, hydraulic pressure or pneumatic linear actuator are as charger.When using spring or pressure cylinder, clamp device 13 can any direction (upper and lower, left and right) be installed and is obtained required load.

In the above-described embodiment, the line 2 of eyeless needle 1 is held and is spurred eyeless needle.Conversely, also can hold eyeless needle by clamp device, and pulls wire 2 one by one.

As previously mentioned, the medical non-hole needle withdrawal resistance tester that designs according to the present invention is made up of the two large divisions: (1) clamp device, be used to clamp the suture of a plurality of eyeless needles or medical non-hole needle, thereby wherein suture is inserted into the blind hole that is positioned on the bottom and is clogged and is fixed; (2) charger is used for loading to clamp device.This structure can make the backguy power of a plurality of eyeless needles be tested one by one, thereby guarantees a kind of method of testing efficiently.

Claims

1. medical non-hole needle withdrawal resistance tester, it is made of following part: (1) clamp device be used to clamp the suture of a plurality of eyeless needles or a plurality of medical non-hole needles, thereby wherein suture is inserted into the blind hole that is positioned on the bottom and is clogged and is secured in place; (2) charger is used for loading to described clamp device.

2. medical non-hole needle withdrawal resistance tester as claimed in claim 1 is characterized in that described clamp device clamps the suture of these a plurality of eyeless needles.

3. medical non-hole needle withdrawal resistance tester as claimed in claim 1, it is characterized in that, one supporting base between described clamp device and charger is provided, in order to support this clamp device, make it to be free to slide in the horizontal direction, clamp device has plate up and down, and a keeper is between these plate front ends, and an elastic component, it makes the front end of plate stress on this keeper.

4. medical non-hole needle withdrawal resistance tester as claimed in claim 1 is characterized in that described keeper is made by flexible elastic material.

5. medical non-hole needle withdrawal resistance tester as claimed in claim 1 is characterized in that described clamp device is installed on the table in the mode that can be free to slide.

6. medical non-hole needle withdrawal resistance tester as claimed in claim 1, it is characterized in that, described clamp device is included in the plate of lateral or vertical direction, one keeper is between the front end of plate, an and elastic component, it makes the front end of plate stress on this keeper, and described charger is directly connected to the end of clamp device.

7. method that utilization is carried out the test of suture withdrawal resistance according to any one described medical eyeless needle withdrawal resistance tester of claim 1-6, wherein this for the method that is used for medical non-hole needle withdrawal resistance method of testing is characterised in that, apply tension force by each suture and implement the withdrawal resistance of suture is tested described many pieces of medical non-hole needles.