Background technology
Along with carry out pathological tissue sampling patient get more and more, among the process that patient is carried out biopsy, before or after, it is generally required to carry out tissue mark.
Some labeling methods are known in the art.Such as, in United States Patent (USP) No.5, the electric wire orientation direction method disclosed in 221,269 may be used for positioning the focus in breast.Device described in this patent includes the guide line of tubulose implanting needle and attachment, has helical configuration coil for locking the position of target focus at its end.Pin is imported breast, and by imaging system such as X-ray, ultrasound wave or nuclear magnetic resonance (MRI)) guide lesions position, now the spiral winding of end is arranged at affected area.Subsequently, taking out pin from guide line, guide line end stays focus anchor station, to instruct surgeon to arrive lesions position along this line in operation later.Although this alignment system is effective, it is apparent that this design is the most temporary, once completing performs the operation or need to carry out other program will be drawn off.
The most such as, United States Patent (USP) No.4,080,959 discloses a kind of labelling potential breast focus and the method for tumor.In the process, the chemical substance that skin temperature-sensitive at the skin such as breast of body to be assessed can develop the color is smeared, afterwards by this part of penetrating radiation such as diathermy heating body.Then, whether the body part that scanning is smeared has color to change, and color change is shown as under skin surface hot spot point occur.These so-called hot spot points may represent tumor or focus, and they will not dissipate rapidly, because its blood circulation the poorest (about flowing through the 1/20 of normal body tissue blood).Certainly, the method only can be used as temporary diagnostic tool rather than display tumor or the permanent method of lesions position.
The Chinese invention patent " thermic hydrogel of a class X-ray development and preparation method thereof " of Application No. 201510053193.1, discloses thermic hydrogel of a kind of X-ray development and preparation method thereof.The thermic hydrogel of this X-ray development is collectively constituted by the amphipathic nature block polymer containing iodine and solvent;Wherein, the amphipathic nature block polymer containing iodine is obtained by covalent bonding with amphipathic nature block polymer by the little molecule containing iodine, and its aqueous systems can raise the phase in version that heat-induced gel occurs with temperature.But owing to the time of the swelling of thermic hydrogel He deswelling is longer, it is generally required to improve swelling rate by reducing size, this strongly limits its application at biomedical sector.
In the prior art, female patients is finished soft tissue (being commonly available to female breast) biopsy sampling Post operation by doctor, in order to sampling point tissue is marked, destination organization to be observed in the future, with test-target tissue either with or without expansion or pathological changes etc., need to be placed in patient body tissue marker thing by its transmission system.The material of this kind of label mostly is alloy, such as: gold, titanium alloy, rustless steel etc., mainly strengthens its reflexive.Under the conditions of less than 3.0 Tesla magnetic field strength, it is by standard actinogram (X-ray, Mammography) and ultrasonic, and NMR (Nuclear Magnetic Resonance)-imaging (MRI) is visible.This kind of tissue markers system structure is simple, there is no too much labyrinth, but its material is corresponding with structure with having a very big impact.Such as, the proportion having due to metal material is bigger, and histocompatibility is general, and is difficult to observed in the soft tissue of human body, the most also has certain limitation.
Therefore, there is currently high to histocompatibility, to be prone to observed permanent tissue markers demand.
Utility model content
Based on this, this utility model provides a kind of label, described label can be implanted in focus or other abnormal structure position, location and can readily use imaging technique known in the art and detect easily, and this utility model additionally provides the preparation method of described label and by the delivery apparatus of this marker delivery to desired area and method.
On the one hand, this utility model provides a kind of label 10, it is characterized in that, described label 10 is to limit depression between the column of the fin with longitudinal extension and described fin, described label 10 also has the end face from described column and extends to the through hole 11 of bottom surface, and perforate is in described recess the perforation 12 that connects with described through hole 11.
Preferably, described perforation 12 arranged in rows on the y direction of column;It is highly preferred that the number of described perforation 12 is at least two, such as, can be 3,4,5,6,7,8 or more;It is further preferred that described perforation 12 is a row or multi-row perforation arranged at described recess uniform intervals along the y direction of column;It is further preferred that described column has rows of multiple perforation, such as two rows often arrange three perforation, three rows often arrange two perforation, four rows and often arrange any numbers of suitably boring a hole such as four perforation.
Preferably, the cross section of described label is positive star-shaped cross-section or different star-shaped cross-section;
Preferably, the number of the salient angle of described star is more than or equal to 5, such as, and 5,6,7,8,9,10,11,12,13,14,15.
Preferably, described star is positive pentalpha, positive hexagram, positive heptangle star or positive anistree star;It is highly preferred that described star is positive anistree star;It is further preferred that the re-entrant angle of described positive anistree star is 45 °-180 °;It is preferably 90 °-120 °.
Preferably, a length of 3mm to 6mm of described column, more preferably 4mm to 5.5mm, be further preferably 4.5mm to 5.5mm, such as 5mm.
Preferably, the envelope diameter of a circle of described column is 1mm to 2mm, more preferably 1.2mm to 1.8mm, is further preferably 1.4mm to 1.6mm, such as 1.5mm.
Preferably, so a diameter of 0.4mm to 0.8mm of through hole 11, more preferably 0.4mm-0.6mm, such as 0.5mm.
A diameter of 0.1mm to 0.3mm of described perforation 12, it is therefore preferable to 0.25mm.
The label that this utility model provides can be observed under X-ray, MRI and ultrasound wave, and this label can be kept under ultrasound wave as thus provide low shadow image.
Label of the present utility model can use the processing method machine-shaping that this area is conventional, such as by blow molding, or injection mo(u)lding etc..
Another further aspect, this utility model provides the delivery apparatus of described label, and described delivery apparatus includes:
Piston 1, push rod 2, label 3, handle 4, sleeve pipe 5 and casing cover 6;
Wherein said piston 1 is connected with push rod 2, it is internal that label 3 is preset in sleeve pipe 5, sleeve pipe 5 has design profile not drop along needle point for blocking label 3 near needle point position, when pushing hard piston 1, in succession push rod 2, enter into sleeve pipe 5 along handle 4 internal, label 3 can be touched, when continuing to press on along needle point direction, label 3 enters into target area along the track of sleeve pipe 5.
The marker delivery device that this utility model provides, simple in construction ETTHER-OR operation, and can well label be included before use, it is unlikely to drop, in use effectively tissue markers can be put into tissue.
This utility model additionally provides a kind of for marked lesion or the Mk system of abnormal structure, and described Mk system includes label 10 that this utility model provides, for delivering the delivery apparatus of label 10 and for indicating the device of the Imaging Guidance of delivery location.Described Imaging Guidance device such as X ray image device.
Wherein, described delivery apparatus includes:
Piston 1, push rod 2, label 3, handle 4, sleeve pipe 5 and casing cover 6;
Wherein said piston 1 is connected with push rod 2, it is internal that label 3 is preset in sleeve pipe 5, sleeve pipe 5 has design profile not drop along needle point for blocking label 3 near needle point position, when pushing hard piston 1, in succession push rod 2, enter into sleeve pipe 5 along handle 4 internal, label 3 can be touched, when continuing to press on along needle point direction, label 3 enters into target area along the track of sleeve pipe 5.
In a specific embodiment, marker delivery device of the present utility model can be used to target area by marker delivery, after target area (such as breast) is carried out biopsy, marker delivery device sleeve pipe 5 is inserted in the patient by the vestige following movable detecting apparatus.The regulation delivery apparatus device of Imaging Guidance (use have) is correct to guarantee the needle placement of sleeve pipe 5.When position to be marked has confirmed that, user promote piston 1 with by label 3 along the sleeve pipe 5 of delivery apparatus, from the opening of sleeve pipe 5, label 3 is released.
In another specific embodiment, before the label of use the application and delivery apparatus, verify all invasive instrument and the compatibility of adnexa.
It has been observed that current label is the most all gold, titanium alloy, rustless steel or Nitinol, shape is the most single.And label of the present utility model uses the macromolecular material of biocompatibility, and it is prepared as specific shape so that it is preferably merge with human body, is difficult to displacement, and very light weight, under X-ray or magnetic resonance, there is good reflecting effect.Compared with prior art, the label that this utility model provides has the advantage that
1) label that this utility model provides has the cross section of star, when it receives the monitoring of ultrasound wave or X-ray or MRT etc. in tissue, can substantially clearly indicate out, therefore can be easier to be identified in human body.
2) this utility model provide label on there is special through hole and perforation so that this label in human body can well with tissue merge, it is not easy to displacement, can be long-term carry out tissue positioned.
3) specific shape and through hole and the perforation accordingly of the label that this utility model provides can increase the reflection of ray, is more easy to manifest under X-ray.
Embodiment
3
Marker delivery device of the present utility model is used to provide label
Described delivery apparatus includes piston 1, push rod 2, label 3, handle 4, sleeve pipe 5 and casing cover 6;
Wherein said piston 1 is connected with push rod 2, it is internal that label 3 is preset in sleeve pipe 5, sleeve pipe 5 has design profile not drop along needle point for blocking label 3 near needle point position, when pushing hard piston 1, in succession push rod 2, enter into sleeve pipe 5 along handle 4 internal, label 3 can be touched, when continuing to press on along needle point direction, label 3 enters into target area along the track of sleeve pipe 5.
First, all invasive instrument and the compatibility of adnexa are verified before using.Check that tissue mark's device is packed to guarantee that package integrity properties is not destroyed.Until effective date product is still aseptic, unless bad seals.Use standard sterilization aseptic technique, takes out from the package by Beacon tissue mark device.Remove needle point lid.The damage sign of examination apparatus.Apparatus is advanced into target location.Use suitable target area, imaging device location.Push rod fully pushes ahead to discharge Beacon tissue mark device from apparatus.(guaranteeing that pusher is in bottom part body).In the case of push rod is abundant the most forward, slowly move apparatus.Appropriate processor tool, confirms final marker positions.
After target area (such as breast) is carried out biopsy, marker delivery device sleeve pipe 5 is inserted in the patient by the vestige following movable detecting apparatus.The regulation delivery apparatus device of Imaging Guidance (use have) is correct to guarantee the needle placement of sleeve pipe 5.When position to be marked has confirmed that, user promote piston 1 with by label 3 along the sleeve pipe 5 of delivery apparatus, from the opening of sleeve pipe 5, label 3 is released.