CN2217997Y

CN2217997Y - Ni-Ti shape-memory-alloy dilator for surgery

Info

Publication number: CN2217997Y
Application number: CN 94239757
Authority: CN
Inventors: 宋海瑚
Original assignee: WUSONG CENTRAL HOSPITAL BAOSHAN DISTRICT SHANGHAI
Current assignee: WUSONG CENTRAL HOSPITAL BAOSHAN DISTRICT SHANGHAI
Priority date: 1994-11-30
Filing date: 1994-11-30
Publication date: 1996-01-24
Anticipated expiration: 2004-11-30

Abstract

The utility model relates to a Ni-Ti shape-memory-alloy dilator for the surgery, which is made of Ni-Ti alloy wires whose diameter is from 0.22 mm to 0.44 mm. The appearance of the utility model forms a mesh-shaped tube shape, such as the straight tube shape, the corrugated tube shape, the cone-stripe tube shape, etc. After high-temperature treatment, the dilator can memorize the shape which is designed originally; the dilator can become small and soft in the cold water whose temperature is from 0 DEG to 4 DEG. Under the human body temperature, the dilator can recover the shape which is designed originally and has the effects of the dilatation, the support and the drainage. The dilator can be used in the surgical dilatation in the narrow and obstruction regions which are the vessel cavities in the human body, such as the blood vessel, the urinary tract, the digestive tract, the biliary tract, etc. The dilator has small physiological influence for the patient, no complication caused by the surgical trauma, high safety, favorable effect and simple operation.

Description

The niti-shaped memorial alloy surgical dilator

This utility model belongs to field of medical device technology, is a kind of niti-shaped memorial alloy surgical dilator.

Medically, cause after a lot of diseases or the operation some tube chamber narrow, block, influence rehabilitation, severe patient increases the weight of disease, until threat to life.For this reason, people once used certain apparatus or air bag to expand in the affected part, the operation more complicated, and may concurrent other diseases.

The purpose of this utility model is to utilize the shape memory function of niti-shaped memorial alloy and high flexibility, design body lumen surgical dilator a kind of simple to operate, safe in utilization.

NiTi (NiTi) marmem is as a kind of novel intelligent material, not only have shape memory effect, also have phase transformation pseudoelasticity effect, it is in light weight, corrosion resistance is strong, magnetic is low, and resisting fatigue, tension compressive property are good, to the human body avirulence, cell effect is few, no carcinogenesis has the favorable tissue compatibility, is one of optimal material of present medical domain.This utility model utilizes the above-mentioned characteristic of niti-shaped memorial alloy, has designed the body lumen surgical dilator, and its employing diameter is that the nitinol alloy wire of 0.22～0.44mm is made through bending.This alloy silk bends to the banded shape of a plurality of upper and lower U-shapeds earlier, as shown in Figure 1.Press certain overall diameter then around some circles, surround grid duct shape, as shown in Figure 2.The radius r in crooked half garden of upper and lower U-shaped is generally 0.50～1.50mm, and between upper and lower half garden is 1.0～3.0mm apart from d.Tubular length is determined according to the design needs, is generally 30～70mm.

This utility model can be according to the different tube chambers of human body, the various surgical dilator of design difformity and different size.For example, the profile of grid duct shape dilator can be designed to the straight tube shape, as shown in Figure 3.Its tubular diameter D is 3.0～30.0mm, and length L is 30～70mm, and various size coupling wherein can be arranged, and is as shown in table 1:

Model	A1	A2	A3	A4	A5	A6	A7
Model	A1	A2	A3	A4	A5	A6	A7	D	3.0	7.0	10.0	15	25	30	35

Table 1 the design is primarily aimed at luminal stenosis, blocks serious old age, with the critical illness people of other cardiovascular, liver function, organic disease, applicable to the expansion of urethra, blood vessel.

The profile of grid duct shape surgical dilator can be designed to bellows form, shown in 4.The D1 of maximum gauge place of this corrugated tube is 3.0～35mm, and the D2 of minimum diameter place is 2.4～33mm, and the length L of pipe is 30～70mm, and the coupling of various different sizes wherein also can be arranged, and is as shown in table 2:

Model	B1	B2	B3	B4	B5	B6	B7	B8	B9	B10	B11
Model	B1	B2	B3	B4	B5	B6	B7	B8	B9	B10	B11	D1	3.0	5.0	7.0	8.5	10	12	15	20	25	30	35
D2	2.4	4.4	6.0	7.0	9.0	10	13	18	23	28	33	D1	3.0	5.0	7.0	8.5	10	12	15	20	25	30	35

Table 2 the design is primarily aimed at the characteristics that some luminal stenosis, region of obstruction have wriggling, needs to settle really.Be difficult for to move, be applicable to mainly that digestive tract is narrow, block etc.Narrow as various alimentary tract anastomosis mouths, esophagus, stomach, intestinal canal tumour cause blocks etc.

The profile of grid duct shape surgical dilator can be designed to the sylphon shape shape, as shown in Figure 5.The diameter D1 of its small end place is 3.0～10.0mm, and the big diameter D2 of end place is 6.0～20.0mm, is provided with 2～4 pipeline sections of the different-diameter of transition gradually between the big small end, and the coupling of various different sizes wherein also can be arranged, and is as shown in table 3:

Model	C1	C2	C3	C4	C5	C6	C7
Model	C1	C2	C3	C4	C5	C6	C7	D1	3.00	4.00	5.00	6.00	7.00	8.50	10.00
D2	6.00	8.00	10.00	12.00	14.00	17.00	20.00	D1	3.00	4.00	5.00	6.00	7.00	8.50	10.00
D2	6.00	8.00	10.00	12.00	14.00	17.00	20.00	D3	3.60	4.80	6.00	7.20	8.40	10.20	12.00
D4	3.20	4.60	6.00	7.40	8.80	10.90	13.00	D3	3.60	4.80	6.00	7.20	8.40	10.20	12.00
D4	3.20	4.60	6.00	7.40	8.80	10.90	13.00	D5	4.80	6.40	8.00	9.60	11.20	13.60	16.00
D6	4.40	6.20	8.00	9.80	11.60	14.30	17.00	D5	4.80	6.40	8.00	9.60	11.20	13.60	16.00

That table 3 the design is primarily aimed at is narrow, block serious and do not have luminal stenosis that the various tumors of operation indication cause, block situation, can improve patient's quality of life, alleviate patient's misery, play the effect of expansion, support, drain, mainly be applicable to biliary tract, pancreas, urinary tract narrow, block.

The surgical dilator of this utility model design is carried out 500 ℃～600 ℃ pyritous processing by design shape, makes it remember original design shape.It is soft that dilator can become in 0 ℃～4 ℃ cold water, and changeable shape, makes it to become tiny, soft, is convenient to operation technique.When temperature reaches 30 ℃～40 ℃, as when reaching human body temperature (about 37 ℃), dilator can recover original form, simultaneously, makes it the high resilience that becomes, and produces pressure, plays expansion, support, drainage.

Use the operation sequence of this surgical dilator as follows: 1, by B become, endoscope, the appearance of X line etc. determine narrow, region of obstruction, length; 2, select the dilator of suitable types specification; 3, dilator and operating apparatus are lowered the temperature in 0 ℃～4 ℃ cold water, the dilator deliquescing is diminished; 4, perspective or electricity are saturating under local anesthesia, by operating apparatus dilator are placed in narrow, region of obstruction, and adjust its length; 5, after expansion finishes, inject 0 ℃～4 ℃ normal saline at affected part, with pincers dilator is taken out then by endoscope etc.

The surgical dilator of using this utility model design is than traditional air bag expansion technology, and easy to operate, expansion effect is better.With there not being supporting role behind the air bag expansion, recur easily narrow, block.And this dilator has supporting role, avoids recurrence.But and this dilator instead of part luminal stenosis, block patient's operative treatment, a kind of Therapeutic Method of novelty is provided for modern surgery.Use this dilator to have following characteristics:

Little to patient's physiological effect, be particularly suitable for high risk patient with complication; The post-operative complication that no operation wound causes uses fool proof.No operative mortality and disability rate have the favorable tissue compatibility, and non-carcinogenesis is settled for a long time in the body and can be played lasting expansion, support, drainage; Operational approach is simple, arrangement, convenient to remove.

The treatment that this utility model can be widely used in the narrow of various tube chambers and block.As digestive tract, biliary tract, blood vessel, urinary tract etc. because that various diseases or operation cause is narrow, block etc.

U-shaped links shape to Fig. 1 for nitinol alloy wire bends to up and down.Fig. 2 is a kind of design shape of this surgical dilator.Fig. 3 is the profile of straight tube shape surgical dilator.Fig. 4 is the profile of bellow-shaped surgical dilator.Fig. 5 is the profile of sylphon shape surgical dilator.

Embodiment: adopt 0.30mm NiTi alloy silk, bend to the banded shape of the upper and lower U-shaped of one-tenth as shown in Figure 1 earlier, half garden part radius r=1.5mm of U-shaped, go up between second garden apart from d=2mm, the size that provides by table 2 again, make the surgical dilator of bellows form, be placed on 600 ℃ of high-temperature process at last and got final product in 3 hours.

Claims

1, a kind of niti-shaped memorial alloy surgical dilator, with diameter is that the NiTi alloy silk bending of 0.22～0.44mm is made, it is characterized in that this alloy silk alternating bending is the banded shape of U-shaped up and down, and press certain overall diameter around some circles, surround grid duct shape, the radius r at place, crooked half garden of U-shaped is 0.50～1.50mm up and down, and between last second garden is 1.0～3.0mm apart from d.

2, niti-shaped memorial alloy surgical dilator according to claim 1 is characterized in that the grid duct shape that the crooked NiTi alloy of U-shaped silk surrounds is a straight tube shape, and the outer diameter D of pipe is 3.0～30.0mm, and the length of pipe is 30～70mm.

3, niti-shaped memorial alloy surgical dilator according to claim 1, it is characterized in that the grid duct shape that the crooked NiTi alloy of U-shaped silk surrounds is a bellow-shaped, the D1 of maximum gauge place of corrugated tube is for being 3.0～35mm, and the D2 of minimum diameter place is 2.4～33mm, and the length of pipe is 30～70mm.

4, niti-shaped memorial alloy surgical dilator according to claim 1, it is characterized in that the grid duct shape that the crooked TiNi alloy of U-shaped silk surrounds is a sylphon shape, the diameter D1 of its small end place is 3.0～10.0mm, the big diameter D2 of end place is 6.0～20.0mm, be provided with 2-4 pipeline sections of gradually locating the different-diameter of transition between the big small end, total length is 45～70mm.