CN105561475B - A kind of sealing device and plant/interventional medical device containing sealing device - Google Patents
A kind of sealing device and plant/interventional medical device containing sealing device Download PDFInfo
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- CN105561475B CN105561475B CN201410531429.3A CN201410531429A CN105561475B CN 105561475 B CN105561475 B CN 105561475B CN 201410531429 A CN201410531429 A CN 201410531429A CN 105561475 B CN105561475 B CN 105561475B
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Abstract
The invention discloses a kind of sealing device and pacemaker, the sealing device includes seal body, and the seal body is made of insulating materials, and gap is provided through in the seal body, and the gap side is provided with and communicated with blind hole.Sealing device and pacemaker provided by the invention, a blind hole is set by being connected on the gap of sealing device, solves the problems, such as that sealing device gap is easily damaged first；Secondly, blind hole is more obvious than gap more, and constant torque wrench is inserted into easy to doctor's capturing position；Finally the gap of the sealing device can be cut with cutter for single product and be made, and simpler compared to structure for the sealing device of some two semicolumn assembly, joint-cutting better tightness, the required precision to product is lower, and cost is also lower.
Description
Technical field
The present invention relates to the field of medical instrument technology, more particularly to plant/interventional medical device device.
Background technology
For plant/intervention medical treatment device, it is very crucial with the sealing device of human body.Such as pacemaker, its
It is made of impulse generator and electrode cable, electrode cable should be fixedly connected by connector with impulse generator.When using outer
Portion's instrument is when for example torque wrench is fixed, it is necessary to be operated by sealing device.Refer to Fig. 1, currently used heart
Pacemaker is after electrode cable 6 is inserted into the inner cavity of connector 5, it is necessary to is fixed using holding screw 3, which is
Screwed by constant torque wrench 1, to prevent body fluid and blood of latter two holding screw of Pacemaker implantation human body by human body
Conducting Effect of Short Circuit equipment normal operation, generally in one sealing device 2 of the outside of holding screw 3 installation can protect and exhausted
Edge.It is often made of the silastic material for meeting ISO10993-6, its tearing toughness is poor；While for the ease of determining torsion
1 outer-hexagonal metal termination of square spanner can be to pass through sealing device 2, and sealing device 2 has a perforative gap.Actually using
In, doctor is difficult to rectify the outer-hexagonal ferrule of constant torque wrench 1 to be inserted into this gap on sealing device 2, past
Past is first to be pressed in the side in gap and then the gap position concave deformation of sealing device 2 is finally slipped into seam under strong pressure
Gap, this gap for resulting in sealing device 2 are easily damaged under strong pressure, especially in 3 position mistake of holding screw
(see Fig. 3) or even in the case of withstanding 2 gap of sealing device when high, squeezing effect can be produced to gap position, it is easier to cause
The gap position of sealing device 2 is damaged down to leakage, so as to cause whole pacemaker to be scrapped.
For plant/intervention class medical instrument, once opening sterilization packaging, maintenance or recycling can not be recycled.Therefore,
For plant/intervention class medical instrument, one sealing device that can effectively seal and make doctor easy to operate of design seems non-
It is often important.
The content of the invention
The technical problems to be solved by the invention are to provide a kind of sealing device and plant/intervention doctor comprising the sealing device
Device is treated, on the basis of the leakproofness and the passability of instrument for ensureing sealing device, reduces and even eliminates on sealing device
Gap breakage rate, while ensure especially highly enough small of appearance and size, adapt to the miniaturization of pacemaker, improve implantation people
Comfort level after body.
The present invention is to provide a kind of sealing device, including sealing master to solve the technical solution that above-mentioned technical problem uses
Body, the sealed body are made of insulating materials, set and are had the gap easy to external tool by and close on the sealed body
Seal in main body, the gap connecting place is provided with blind hole.
Above-mentioned sealing device, wherein, the connecting place is located at the one end in the gap.
Above-mentioned sealing device, wherein, the sealed body is in frustum cone structure.
Above-mentioned sealing device, wherein, the blind hole section is rounded.
The present invention for another technical solution for using of solution above-mentioned technical problem be to provide a kind of plant containing sealing device/
Interventional medical device, comprising electrode cable, connector, positioning element and above-mentioned sealing device, the electrode cable is inserted in described
Fixed in connector and by the positioning element, the sealing device is installed on outside positioning element.
Above-mentioned plant/interventional medical device, wherein, the connector is provided with the first cavity for accommodating the positioning element
With the second cavity for accommodating the sealing device.
Above-mentioned plant/interventional medical device, wherein, the height of the sealing device is slightly larger than the depth of second cavity
Degree；The sealing device and the gap location of the second cavity cavity wall are filled with silica gel.
Above-mentioned plant/interventional medical device, wherein, the end of the gap and positioning element is just oppositely arranged, described blind
Hole and the end of positioning element are in staggered distribution.
Above-mentioned plant/interventional medical device, wherein, the positioning element is holding screw.
Above-mentioned plant/interventional medical device, wherein, the external tool is constant torque wrench, the constant torque wrench
Head end screws holding screw after being pushed into gap by the blind hole.
Above-mentioned plant/interventional medical device, wherein, the plant/interventional medical device is heart heartstart, defibrillator, god
Through stimulation instrument or artificial cochlea.
The present invention contrast prior art has following beneficial effect：Sealing device provided by the invention and plant/intervention medical treatment
Apparatus, sets a blind hole by being connected on the gap of sealing device, solves asking for the easy breakage in sealing device gap first
Topic, does not have any obstruction to block positioning element when the metal head end of external tool such as constant torque wrench is pushed into gap, this
Gap can be easily inserted into fully deformed, the outer-hexagonal metal head end of constant torque wrench by allowing for sealing device, and insertion is close
Behind the gap of seal apparatus still further below be inserted into if, the downward deflection of sealing device can be much smaller, though positioning element position compared with
Height is also not easy to rack at the gap position of sealing device；Secondly, blind hole is more obvious than gap more, easy to doctor's capturing position
It is inserted into constant torque wrench；Finally the gap of the sealing device can be cut with cutter for single product and be made, compared to some two
Structure is simpler for the sealing device of semicolumn assembly, joint-cutting better tightness, the gap being combined into different from two semicolumns,
Required precision to product is lower, and cost is also lower.
Brief description of the drawings
Fig. 1 is existing pacemaker electrode conducting wire assembling schematic diagram；
Fig. 2 is the structure diagram of sealing device in the embodiment of the present invention；
Fig. 3 is pacemaker electrode conducting wire assembling schematic diagram in the embodiment of the present invention；
Fig. 4 is the diagrammatic cross-section in the assembling of pacemaker electrode conducting wire in the embodiment of the present invention；
Fig. 5 is the assembling process schematic diagram of holding screw in pacemaker in the embodiment of the present invention.
In figure：
1 constant torque wrench, 11 outer-hexagonal metal head end
2 sealing device, 21 gap, 22 blind hole, 23 second cavity
3 holding screw, 4 side's body, 5 connector, 6 electrode cable
31 first cavitys
Embodiment
The invention will be further described with reference to the accompanying drawings and examples.
Fig. 2 is the structure diagram of sealing device in the embodiment of the present invention.
Fig. 2, sealing device 2 provided by the invention, including sealed body are referred to, the sealed body is by insulating materials system
Into, the silicon rubber for meeting ISO10993-6 can be used to make, gap 21 is provided through on the sealed body, and in sealing master
On body, 21 connecting place of gap is provided with blind hole 22.Preferably, the connecting place is located at the one end in gap 21.21 side of gap
It is provided with and communicated with blind hole 22.The sealed body can be in frustum cone structure, and 22 section of blind hole is rounded.Gap 21 and blind hole 22 make
The cutting of Shi Keyong cutters, which makes, to be formed.
Fig. 3 is pacemaker electrode conducting wire assembling schematic diagram in the embodiment of the present invention.
Fig. 1, Fig. 3 and Fig. 4 are referred to, plant/interventional medical device provided in an embodiment of the present invention, can be cardiac pacing
Device, defibrillator or nerve stimulation instrument etc., in the present embodiment by taking heart heartstart as an example.The heart heartstart include connector 5,
Holding screw 3 and sealing device 2, electrode cable 6 are inserted in the inner cavity of connector 5 and are fixed by holding screw 3, connector 5
The first cavity 31 for accommodating holding screw 3 and the second cavity 23 for accommodating sealing device 2 are additionally provided with, sealing device 2 is installed on
The outside of holding screw 3, for protecting holding screw 3 and holding screw 3 is insulated, is provided through gap 21 on sealed body,
21 side of gap is provided with and communicated with blind hole 22, and the end of gap 21 and holding screw 3 is just oppositely arranged, blind hole 22 and holding screw
3 end is in staggered distribution.
Shape, the size of 2 and second cavity 23 of sealing device match, and sealing device 2 uses after loading the second cavity 23
Silica gel is pasted and sealing.The height of sealing device 2 may be slightly larger than the depth of the second cavity 23, i.e. the end of sealing device 2 is slightly prominent
For the outer end face of the second cavity 23, larger projection is not formed, after adapting to the miniaturization raising implantation human body of pacemaker
Comfort level.
Fig. 5 is referred to, by increasing a small blind hole 22 in 21 side of gap of sealing device 2, doctor will first can determine
The outer-hexagonal metal head end of torque wrench 1 is gently inserted into the blind hole 22, as shown in Figure 5 a, then pushes away to the right to be inserted into sealing device
Among 2 gap 21, as shown in Figure 5 b；Then touch and be firmly downwardly into the Hexagon hole of holding screw 3 again, screw tightening
Screw 3, as shown in Figure 5 c.
The present invention solves the problems, such as that sealing device gap 21 is easily damaged first, when by the ferrule of constant torque wrench 1
Its right side is no any obstruction when end is pushed into the right gap 21, this allows for sealing device 2 can be fixed with fully deformed amount
The outer-hexagonal metal head end of torque wrench 1 is easily inserted into gap 21, is inserted into still further below after being inserted into the gap 21 of sealing device 2
If, the downward deflection of sealing device 2 can be much smaller, is also not easy sealing device 2 even if 3 position of holding screw is higher
21 position of gap racks.
Secondly, blind hole 22 is significantly more than gap 21, and constant torque wrench 1 is inserted into easy to doctor's capturing position.
Finally the gap 21 of the sealing device 2 makes for the cutting of single product cutter, is spelled compared to some two semicolumns
Structure is simpler for the sealing device of dress, joint-cutting better tightness, the gap being combined into different from two semicolumns, to product
Required precision is lower, and cost is also lower.
Experiment test is carried out as follows to the sealing device of structure of the present invention below：
1st, plugged and unscrewed repeatedly using constant torque wrench after the sample made is checked and screw holding screw and every
It is secondary will extract spanner metal head end when allow the position of holding screw as far as possible upwards close to sealing device, but it is not so high so that
Split in the gap of the sealing device on top, totally 10 times.Pacemaker, which needs to unscrew holding screw, in theory is inserted into electrode cable,
Holding screw is finally screwed, needs to plug twice altogether, and pacemaker is disposable intervention class medical instrument, it is not possible to repeats profit
With so sealing device, which is plugged 10 times, can meet to be actually needed.
2nd, low pressure test (LPT)：Sample is completely immersed in blue physiological saline, -50kpa simultaneously pressurize 3 minutes is evacuated to, releases
Vacuumize and kept for 2 minutes again after bleeding off pressure power to 0 value, and the pumpdown time is not more than 3 minutes, totally 25 circulations.High-potting：
Then it is forced into 304kpa (absolute value) and is kept for 2 minutes, when discharges repressurization after pressure is worth to 0 and kept for 2 minutes, and pressurizeing
Between be not more than 2 minutes, totally 40 circulation.Test foundation refers to the 25th parts of ISO14708-2-2012.
3rd, sample is taken out, is dried sample using non-dust cloth, whether observe at sealing device joint-cutting has blue liquid exudation,
Sample surfaces are rinsed well with clear water again, sealing device is peelled off in surface after drying 30 minutes, checks whether intracavitary has blue liquid
Body exists.
Experimental result：
1st, joint-cutting state, criterion of acceptability are checked after plugging 10 times：Without breakage.
Conclusion：
Using 10 amplification sem observations after sealing device is splitted along joint-cutting, some without any breakage, some has about 1 square of milli
The breakage of rice, estimation is caused when doing marginal test, but its closest joint-cutting distance is more than 0.8mm.
2nd, pressure cycling test, criterion of acceptability are carried out after being plugged 10 times to sealing device：No leakage.
Conclusion：
After pressure testing, take out sample and wipe surface blue liquid with non-woven fabrics, sealing device does not find obvious
Leakage, i.e., do not find blueness by the silica gel of positive and negative, peels off one of sealing device observation inner cavity and also finds no indigo plant
Color liquid, it is believed that the product is qualified.
Although the present invention is disclosed as above with preferred embodiment, so it is not limited to the present invention, any this area skill
Art personnel, without departing from the spirit and scope of the present invention, when can make a little modification and it is perfect, therefore the present invention protection model
Enclose to work as and be subject to what claims were defined.
Claims (10)
1. a kind of sealing device, it is characterised in that including sealed body, the sealed body is made of insulating materials, described close
Set and had the gap easy to external tool by and being provided with blind hole with the gap connecting place on sealed body in envelope main body；
The connecting place is located at the one end in the gap.
2. sealing device according to claim 1, it is characterised in that the sealed body is in frustum cone structure.
3. sealing device according to claim 1, it is characterised in that the blind hole section is rounded.
4. a kind of plant/interventional medical device containing sealing device, it is characterised in that include electrode cable, connector and location division
Part, the sealing device are claim 1-3 any one of them sealing devices, and the electrode cable is inserted in the connector
And fixed by the positioning element, the sealing device is installed on outside the positioning element.
5. plant/interventional medical device as claimed in claim 4, it is characterised in that it is described fixed that the connector is provided with receiving
First cavity of position component and the second cavity for accommodating the sealing device.
6. plant/interventional medical device as claimed in claim 5, it is characterised in that the height of the sealing device is slightly larger than institute
State the depth of the second cavity；The sealing device and the gap location of the second cavity cavity wall are filled with silica gel.
7. plant/interventional medical device as claimed in claim 4, it is characterised in that the gap and the end of positioning element are just
It is oppositely arranged, the end of the blind hole and positioning element is in staggered distribution.
8. plant/interventional medical device as claimed in claim 4, it is characterised in that the positioning element is holding screw.
9. plant/interventional medical device as claimed in claim 4, it is characterised in that the external tool is constant torque wrench, institute
The head end of constant torque wrench is stated by screwing holding screw behind blind hole push-in gap.
10. plant/interventional medical device as claimed in claim 4, it is characterised in that the plant/interventional medical device is heart
Artificial or electronic heart pacemaker, defibrillator, nerve stimulation instrument or artificial cochlea.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410531429.3A CN105561475B (en) | 2014-10-10 | 2014-10-10 | A kind of sealing device and plant/interventional medical device containing sealing device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410531429.3A CN105561475B (en) | 2014-10-10 | 2014-10-10 | A kind of sealing device and plant/interventional medical device containing sealing device |
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| Publication Number | Publication Date |
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| CN105561475A CN105561475A (en) | 2016-05-11 |
| CN105561475B true CN105561475B (en) | 2018-04-27 |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN203017582U (en) * | 2012-12-28 | 2013-06-26 | 苏州景昱医疗器械有限公司 | Implantable medical device and system with anti-bolt screw-out structure |
| CN103458960A (en) * | 2011-01-27 | 2013-12-18 | 普卢格梅德哈特公司 | Percutaneous power delivery system for permanently implanted medical devices and manufacturing method |
| CN204170292U (en) * | 2014-10-10 | 2015-02-25 | 创领心律管理医疗器械（上海）有限公司 | A kind of sealing device and containing sealing device plant/interventional medical device |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040215282A1 (en) * | 2003-04-23 | 2004-10-28 | Hans Van Der Weijden | Connector module designs for implantable medical devices |
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2014
- 2014-10-10 CN CN201410531429.3A patent/CN105561475B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103458960A (en) * | 2011-01-27 | 2013-12-18 | 普卢格梅德哈特公司 | Percutaneous power delivery system for permanently implanted medical devices and manufacturing method |
| CN203017582U (en) * | 2012-12-28 | 2013-06-26 | 苏州景昱医疗器械有限公司 | Implantable medical device and system with anti-bolt screw-out structure |
| CN204170292U (en) * | 2014-10-10 | 2015-02-25 | 创领心律管理医疗器械（上海）有限公司 | A kind of sealing device and containing sealing device plant/interventional medical device |
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| CN105561475A (en) | 2016-05-11 |
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