Device for locking a catheter sheath and a dilator
Technical Field
The invention relates to the field of disposable medical instruments, in particular to an auxiliary instrument with a hemostatic function, which is used for percutaneous interventional operation and introduces guide wires, surgical instruments, medical instruments and the like into a vascular system (particularly an artery) of a patient.
Background
Modern medical technology has advanced rapidly, resulting in many percutaneous interventional procedures in which Percutaneous Transluminal Coronary Angioplasty (PTCA), X-ray angiography, and other similar procedures are frequently used. There are many techniques for introducing the relevant medical devices into the human vascular system, among which the Seldinger technique (percutaneous vascular puncture technique) is widely used. In the Seldinger technique, a puncture needle is first used to make a small opening in an artery or vein, and a guidewire is then introduced into the artery or vein through the lumen of the puncture needle, and the puncture needle is removed. The dilator is passed through the catheter sheath hemostasis valve into the lumen of the catheter sheath, and the two are locked together and guided through the guide wire into the artery or vein. After the sheath tube of the conduit sheath is fixed, the dilator is withdrawn, and finally the conduit sheath can provide a passage for entering and exiting or replacing various interventional devices.
The catheter sheath and dilator are locked by a snap-fit connection, and after locking is completed, the sheath enters the artery or vein together with the dilator tube. After the sheath tube is fixed, the catheter sheath and the dilator need to be separated, and the dilator needs to be withdrawn. For the buckle type structure, an axial separating force is required to be applied when the catheter sheath and the dilator are separated, at the moment, the sheath tube and the dilator tube are both positioned in the blood vessel of a human body, and the sheath tube is easy to shake at the moment of separation to touch the blood vessel wall, so that vasospasm or injury is caused. For the beginner Seldinger technique, the probability of the occurrence is higher, and the operation time and the pain of the operator are obviously increased.
Disclosure of Invention
The invention aims to provide a device for locking a catheter sheath and a dilator, so that the locking and unlocking of the catheter sheath and the dilator are convenient and fast, and the vascular injury is reduced.
The device for locking and unlocking a catheter sheath and a dilator according to the invention, the catheter sheath comprising a sheath seat and a sheath tube connected to the sheath seat, the dilator comprising a dilator seat and a dilator tube connected to the dilator seat, the dilator tube being inserted into the sheath tube through the sheath seat, wherein the device is used for locking and unlocking the sheath seat and the dilator seat, and comprises a buckling mechanism and a tripping mechanism arranged between the sheath seat and the dilator seat, the buckling mechanism is suitable for enabling the dilator seat to be buckled with the sheath seat during the process that the dilator tube is pushed into the sheath tube; the tripping mechanism is suitable for enabling the dilator to generate moving force relative to the sheath seat during the rotation process of the dilator seat relative to the sheath seat, and further forcing the sheath seat and the dilator seat to trip.
In accordance with a preferred embodiment of the present invention the release mechanism of the device is configured to allow the dilator seat to rotate relative to the sheath seat in either rotational direction, thereby causing the dilator to generate the moving force relative to the sheath seat.
According to a preferred embodiment of the present invention, the trip mechanism of the device includes a trip slope provided on at least one of the sheath holder and the expander holder, and an abutting portion abutting against the trip slope provided on the other, and the expander holder is rotatable to relatively separate the sheath holder and the expander holder by a relative movement of the abutting portion along the trip slope, thereby tripping the sheath holder and the expander.
According to a preferred embodiment of the present invention, the trip ramp is a smooth ramp between the peaks and valleys of the wave-like structure.
According to the preferred embodiment of the present invention, any peak of the wave-shaped structure has a trough on both sides.
In accordance with a preferred embodiment of the present invention the undulating arrangement comprises a first undulating arrangement and a second undulating arrangement, the expander seat having a first undulating arrangement and the sheath seat having a second undulating arrangement, wherein one of the first undulating arrangement and the second undulating arrangement provides the trip ramp and the other provides the abutment.
According to a preferred embodiment of the present invention, the first wavy structure and the second wavy structure are geometrically similar and complementarily engaged with each other.
According to a preferred embodiment of the present invention, the fastening mechanism includes a claw buckle axially protruding from the expander seat and an inverted buckle located on the sheath seat, and the sheath seat and the expander seat are fastened by the claw buckle and the inverted buckle.
According to a preferred embodiment of the present invention, the reverse buckle is formed on an inner peripheral side wall of the sheath seat, the claw buckle can be axially pushed relative to the sheath seat to be elastically deformed radially inward at the inner peripheral side wall, and the claw buckle can be rebounded and clamped with the reverse buckle along with the pushing of the expander seat to realize the locking.
According to a preferred embodiment of the present invention, the sheath holder includes a sheath cap including an upper cap and a lower cap, an outer peripheral side of the upper cap is of a tapered structure, an inner peripheral side of the lower cap is of a tapered structure, the upper cap is seated on the lower die, the outer peripheral side of the upper cap and the inner peripheral side of the lower cap are joined to each other, and the upper cap protrudes radially inward relative to the lower cap to form the undercut.
The locking mechanism can lock the catheter sheath and the dilator during pushing, and the rotating mechanism can release the catheter sheath and the dilator through rotation, so that the invention provides a good locking and separating scheme for the catheter sheath and the dilator during an interventional operation, the catheter sheath and the dilator can be effectively and conveniently locked, the shaking of a sheath tube during separation is avoided, and the damage to a blood vessel is effectively reduced.
Drawings
The above and other features, properties and advantages of the present invention will become more apparent from the following description of the embodiments with reference to the accompanying drawings, in which:
FIG. 1 is a partially exploded view of a mating introducer sheath and dilator in accordance with an embodiment of the invention;
FIG. 2 is an exploded view of the sheath cap of the catheter sheath of FIG. 1;
FIG. 3 is a cross-sectional view of the sheath cap of FIG. 2;
FIG. 4 is a schematic view of the expander seat of FIG. 1 pushed into the sheath seat, showing the internal configuration;
FIG. 5 is a schematic view of the expander seat of FIG. 1 pushed into the sheath seat, showing the external configuration;
FIG. 6 is a schematic view of the expander seat of FIG. 1 engaged with the sheath seat, showing the internal configuration;
FIG. 7 is a schematic view of the expander seat of FIG. 1 engaged with the sheath seat, showing an external configuration;
FIG. 8 is a perspective view of the catheter sheath and dilator of FIG. 1 shown assembled;
FIG. 9 is a schematic view of the catheter sheath and dilator of FIG. 8 at the moment of rotational separation, showing the internal configuration;
FIG. 10 is a schematic view of the catheter sheath and dilator of FIG. 8 at a moment of rotational separation showing the external configuration;
FIG. 11 is a schematic view of the catheter sheath and dilator of FIG. 9 after rotational separation;
FIG. 12 is a schematic view of the introducer sheath and dilator of FIG. 10 after rotational separation;
FIG. 13 is a schematic view of the catheter sheath and dilator of FIG. 8 after rotational separation.
Detailed Description
The present invention is further described in the following description with reference to specific embodiments and the accompanying drawings, wherein the details are set forth in order to provide a thorough understanding of the present invention, but it is apparent that the present invention can be embodied in many other forms different from those described herein, and it will be readily appreciated by those skilled in the art that the present invention can be implemented in many different forms without departing from the spirit and scope of the invention.
It is noted that these and other figures which follow are merely exemplary and not drawn to scale and should not be considered as limiting the scope of the invention as it is actually claimed.
As shown in fig. 1, the catheter sheath a includes a sheath seat 5 and a sheath tube 7 connected to the sheath seat 5, and the dilator B includes a dilator seat 1 and a dilator tube 8 connected to the dilator seat 1, and the dilator tube 8 is inserted into the sheath tube 7 through the sheath seat 5. The device for locking the catheter sheath A and the dilator B according to the present invention is used for locking the sheath base 5 and the dilator base 1, and comprises a fastening mechanism and a tripping mechanism, wherein the fastening mechanism is arranged between the sheath base 5 and the dilator base 1, the fastening mechanism is suitable for fastening the sheath base 5 and the dilator base 1 in the process of pushing the dilator tube into the sheath tube, and the tripping mechanism is suitable for generating the moving force of the dilator base relative to the sheath base in the process of rotating the dilator base relative to the sheath base, so as to force the sheath base and the dilator base to trip. The fastening mechanism and the releasing mechanism can be implemented in many ways, and a preferred embodiment will be described later with reference to the accompanying drawings. The catheter sheath A also comprises a hemostasis valve 4 arranged in a sheath seat 5 and a diffusion stress tube 6 sleeved on the outer peripheral side of a sheath tube 7, and the hemostasis valve and the diffusion stress tube are the same as the existing catheter sheath, and the details are not repeated.
As shown in fig. 2 and 3, the sheath holder 5 includes a sheath cap including an upper cap 2 and a lower cap 3, an outer peripheral side of the upper cap 2 is of a tapered structure, similar to a bowl shape, and an inner peripheral side of the lower cap 3 is of a tapered structure, also similar to a bowl shape, the upper cap 2 is seated on the lower die 3, the outer peripheral side of the upper cap 2 and the inner peripheral side of the lower cap 3 are joined to each other, and the upper cap 2 protrudes radially inward relative to the lower cap 3, forming an undercut 10. The sheath cap is formed separately from the upper cap 2 and the lower cap 3, which is mainly considered for convenience of manufacture. In other embodiments, the sheath cap may also be a one-piece molded part.
As shown in fig. 4 and 6, the expander seat 1 has an annular skirt 11A and a plurality of claws 9 projecting axially, and the plurality of claws 9 form a circle having an outer diameter larger than the minimum inner diameter of the upper cap 2. When the dilator B is pushed into the catheter sheath A, the claw buckle 9 can move axially relative to the sheath seat 5 to elastically deform radially inwards at the inner peripheral side wall of the upper cap 2, and along with the pushing of the dilator seat 1, the claw buckle 9 rebounds to be clamped with the reverse buckle 10, so that the locking is realized. The number of the claws 9 is not limited, and may be more than three or less than three. The claws 9 and the undercuts 10 form the fastening mechanism. The fastening mechanism is not limited to this, and for example, a convex ring may be formed on one of the sheath cap and the expander seat, and an annular groove may be formed on the other, and the saddle 5 and the expander seat 1 may be fastened by fitting the convex ring into the annular groove. The fastening mechanism may also be implemented in other ways.
As shown in fig. 5 and 7, the expander seat 1 has a first wave-shaped structure 11, and the sheath seat 5 has a second wave-shaped structure 12, which are geometrically similar, so that the first wave-shaped structure 11 and the second wave-shaped structure 12 are complementary to each other and are engaged with each other. More importantly, the first wave-like structure 11 and the second wave-like structure 12 are allowed to rotate relative to each other, such that during rotation a force is generated which forces the wave-like structures apart from each other due to the slope between the wave crests and the wave troughs. Those skilled in the art will understand that the first wavy structure 11 and the second wavy structure 12 constitute the tripping mechanism, but the implementation of the tripping mechanism is not limited thereto, and for example, a tripping slope may be provided on one of the sheath seat 5 and the expander seat 1, and an abutting portion abutting against the tripping slope may be provided on the other, and the abutting portion may also be a slope, for example, a lift force generated by the slope during rotation is used to force the two to separate, further, the buckling mechanism may be separated. The trip mechanism is primarily intended to convert rotation to linear motion, thereby producing a linear separation force.
In the foregoing embodiments, the wave-shaped structure may be formed along a part of the outer circumference or the entire outer circumference of the sheath seat 5 and the expander seat 1. The number of peaks or valleys is not limited. The wave crests may be provided on one side of one trough, or on both sides.
As shown in fig. 4 and 5, the first wavy structure 11 is an end surface of the skirt 11A on the outer peripheral side of the expander seat 1, and the second wavy structure 12 is a shoulder surface of the outer peripheral side wall of the sheath seat 5.
As shown in fig. 9 to 11, in the separation process, the catheter sheath a and the dilator B are held by hands, the dilator seat 1 is axially rotated clockwise or counterclockwise, the rotation direction is not considered, the catheter sheath a and the dilator B are relatively separated from each other until the claws 9 are separated from the reverse buckles 10, and then the axial separation force is applied to the catheter sheath a and the dilator B, so that the shake-free separation can be realized.
In contrast to the above-mentioned embodiments, in the snap-in locking structure, during the detachment of the catheter sheath and the dilator, the binding force between the sheath seat and the dilator seat is significantly reduced at the moment of detachment due to the axial detachment force applied by the operator. At this time, the operator has no time to adjust the separating force, which causes the sheath tube staying in the blood vessel to shake significantly, resulting in vasospasm or injury. In addition, if the saddle 5 and the expander seat 1 are connected by a rotary locking structure such as a screw, the locking and unlocking processes need to be rotated, and the locking and unlocking can be realized only by rotating in a fixed direction, so that the operation complexity is increased. The above-mentioned embodiment can make the dilator seat 1 and the sheath seat 5 separate gently by rotating in any direction, such as clockwise rotation or counterclockwise rotation, so as to avoid the shaking of the sheath seat 5 during separation, thereby reducing the vasospasm and injury. In an embodiment of the present invention, the trip mechanism may also be configured such that rotation in one direction causes the snapping mechanism to trip.
It is to be noted that, unless otherwise defined, all technical terms used in the foregoing description have the same meaning as commonly understood by one of ordinary skill in the art. Specific methods, devices are described in this application, but any methods and materials similar or equivalent to those described in the foregoing can be used in the practice of the present technology. Although embodiments of the technology have been described in some detail and by way of illustration, the illustration is for clarity of understanding only and is not intended to be limiting. Various terms have been used in the description to convey an understanding of the present technology, with the understanding that the meaning of the various terms extends to common linguistic or grammatical variations or forms of the various terms. It is also to be understood that when a term refers to a device or an apparatus, that term or name is provided as a contemporary example and that the present technology steps are not limited by the scope of that literal. The foregoing terms will be understood to have been described by present day contemporary terms, which may reasonably be understood as derivatives of the contemporary terms or of the systematic subsets encompassed by the contemporary terms. Furthermore, any one or more features of any implementation of the technology may be combined with any one or more other features of any implementation of the technology without departing from the scope of the disclosed technology. Still further, it should be understood that the present technology is not limited to the embodiments that have been set forth for purposes of illustration, but is to be defined only by a fair reading of the claims that follow the patent application, including the full range of equivalents to which each element of the technology is entitled. Therefore, although the present invention has been disclosed in terms of preferred embodiments, it is not intended to limit the invention, and those skilled in the art can make variations and modifications without departing from the spirit and scope of the invention. Therefore, any modification, equivalent change and modification of the above embodiments according to the technical essence of the present invention are within the protection scope defined by the claims of the present invention, unless the technical essence of the present invention departs from the content of the present invention.