CN110152162A

CN110152162A - It is improved to turn to introducer sheath component

Info

Publication number: CN110152162A
Application number: CN201810146156.9A
Authority: CN
Inventors: J·E·萨拉比亚
Original assignee: 510 Heart Device Co
Current assignee: 510 Heart Device Co
Priority date: 2018-02-12
Filing date: 2018-02-12
Publication date: 2019-08-23
Anticipated expiration: 2038-02-12
Also published as: CN110152162B

Abstract

A kind of introducer sheath component, comprising: a handle part a comprising distal end portion and a proximal end；An and introducer sheath, it extends outwardly from the distal end portion of the handle portion, the introducer sheath include one be configured as the equipment inner cavity slideably received within a corresponding equipment, one be configured as the guide wire inner cavity slideably received within corresponding guide wire and be disposed at least one that at least one radially outward arranged from the equipment inner cavity turns in cable lumen turning to cable, and the handle portion include for modify it is described at least one turn at least one steering assembly of the tension of at least one of cable.

Description

It is improved to turn to introducer sheath component

Technical field

Present disclosure generally relates to Medical Devices, and enter sheath and conduit more particularly, to blood vessel.

Background technique

The treatment catheter-based of minimal invasive is developed more and more, and the treatment allows physician to mention to following patient For treatment: the existing comorbidities (comorbidity) of the patient may interfere with that they are needed but more invasive Surgical operation.In more than 30 years of past, it is related to piercing through/crossing operation (such as, the cardiac ablation catheter-based of atrial septum film And Percutaneous mitral balloon valvuloplasty) become customary.In past 5 to 10 years, new construction openheart surgery is (such as, through conduit Valve reparation/replacement and left atrial appendage occlusion art) have been obtained supervision approve, and have changed into Heart catheterization reality It tests room or mixes the more and more common operation executed in operating room.With the appearance of these technologies, the structure heart is had increasing need for Dirty intervention doctor (the professional physician for executing the operation of these types) engages and crosses the atrial septum film in heart.

In history, the prevalence performed the operation due to needing to cross the cardiac ablation of atrial septum film, crosses diaphragm in children In the limit of power of section cardiologist or electrophysiologist.However, intervention cardiologist just starting more and more it is centripetal Dirty left side provides treatment, and pierces through atrial septum film and provide the demands of these new treatments and increasing.Unfortunately, it is many this A little intervention cardiologists are not carried out the transseptal puncture with enough regularity to become to be versed in this.For these left sides Side operation safely pierces through atrial septum film and enters the left side of heart not enough.These new technologies are crossing atrial septum film Shi Yaoqiu very specific and safe position.It is guided in history by fluoroscopy (X-ray) in addition, crossing atrial septum film, And it is led recently by echocardiogram ultrasound (in heart echocardiogram, transesophageal echocardiography or through thorax echocardiogram) Draw.Fluoroscopy is since it is limited to the ability of soft tissue (such as, atrial septum film) imaging therefore its effect is restricted. Therefore, the operation for guiding these types just rely increasingly upoies echocardiogram.

In this way, the structure Cardiac interventional doctor for these new growth provides and is used to help them safely and accurately crosses The tool of atrial septum film is desired.Preferably, these tools can have convenient for be accurately located vagina vasorum, conduit and Other are used for the feature of the instrument for the treatment of catheter-based, and the treatment catheter-based includes transseptal operation.These tools It can also include that can increase the feature of their practicability about echocardiogram imaging, and echocardiogram can be enhanced Otherwise information is used for convenient for the echocardiogram of certain forms it is not possible that useful is image guided.

Present invention recognizes that and solving the problems, such as construction and method in the prior art.

Summary of the invention

A kind of introducer sheath component, it is characterised in that: a handle part a comprising distal end portion and a nearside End；One introducer sheath, extends outwardly from the distal end portion of the handle portion, which includes one and be configured as to slide Equipment inner cavity, the first steering cable lumen, the second steering cable lumen and the third for receiving a corresponding equipment dynamicly turn To cable lumen and be attached at the distal end portion of the introducer sheath and be disposed in this first turn in cable lumen the One steering cable is attached at the distal end portion of the introducer sheath and is disposed in second turn in the second steering cable lumen To cable and be attached at the distal end portion of the introducer sheath and be disposed in the third turn to cable lumen in third turn To cable, wherein the first steering cable lumen, the second steering cable lumen and the third turn to cable lumen and set from this Standby inner cavity radially outward arranges that wherein the first steering cable lumen and the second steering cable lumen are positioned in and extend through On the opposite side of the perpendicular of the equipment inner cavity and the third cable lumen；First steering assembly is disposed in the handle In part, which includes the element that the proximal end of the first steering cable is attached to and the second steering cable The element that the proximal end of line is attached to；First steering lever is disposed on the outer surface of the handle portion and attached To the first steering column first end, wherein first steering column has second end, the second end and first steering assembly Engagement, so that the steering lever is made to lead to first steering assembly while modify to be somebody's turn to do around the longitudinal axis rotation of first steering column First turns to the tension in cable and the second steering cable；Second steering assembly is disposed in the handle portion, this The proximal end of three steering cables is attached to second steering assembly；And second steering lever, it is disposed in the handle portion Point outer surface on and be attached to the first end of the second steering column, wherein second steering column has second end, this Two ends are engaged with second steering assembly so that make the steering lever around the longitudinal axis rotation of second steering column cause this Two steering assemblies modify the tension in third steering cable.

Another embodiment according to the introducer sheath component of present disclosure includes: a handle part, is had One distal end portion and a proximal end；One introducer sheath, extends outwardly from the distal end portion of the handle portion, the introducer sheath The equipment inner cavity slideably received within a corresponding equipment, the first steering cable lumen, second turn are configured as including one Turn to cable lumen to cable lumen and third and be attached at the distal end portion of the introducer sheath and be disposed in this First in one steering cable lumen turns to cable, is attached at the distal end portion of the introducer sheath and is disposed in this second turn Second into cable lumen turns to cable, is attached at the distal end portion of the introducer sheath and is disposed in third steering cable Intracavitary third turns to cable and is attached at the distal end portion of the introducer sheath and is disposed in the 4th steering cable in line The 4th intracavitary steering cable in line, wherein the first steering cable lumen, the second steering cable lumen, the third turn to cable Line inner cavity and the 4th steering cable lumen radially outward arranged from the equipment inner cavity, wherein this first turn to cable lumen and On the opposite side for the perpendicular that the longitudinal center axis that the second steering cable lumen is positioned in the introducer sheath is located at, And the third turns to cable lumen and the 4th steering cable lumen is positioned in the longitudinal center axis institute position of the introducer sheath In horizontal plane opposite side on；First steering assembly is disposed in the handle portion, which includes The element that the proximal end of element and the second steering cable that the proximal end of the first steering cable is attached to is attached to； Second steering assembly is disposed in the handle portion, which includes the proximal end that the third turns to cable The element that the proximal end of the element being attached to and the 4th steering cable is attached to；Wherein first steering assembly can It is manipulated to modify this simultaneously and first turns to cable and this second turns to tension in cable, and second steering assembly can be by Manipulation turns to cable and the tension in the 4th steering cable to modify the third simultaneously.

Another embodiment according to the introducer sheath component of present disclosure includes: a handle part, is had One distal end portion and a proximal end；One introducer sheath, extends outwardly from the distal end portion of the handle portion, the introducer sheath The equipment inner cavity slideably received within a corresponding equipment is configured as including one, is radially outward arranged from the equipment inner cavity At least one turn to cable lumen, at least one turn to cable, which is attached to the distal end portion of the introducer sheath Locate, be disposed in it is described at least one turn to the steering assembly in cable lumen and being arranged in the handle portion with one and connect It closes；One or more steering levers are disposed on the outer surface of the handle portion and are attached to a steering column First end, wherein the steering column has second end, which engages a steering assembly, so that making the steering lever around this The longitudinal axis rotation of steering column leads to the tension at least one described steering cable of steering assembly modification；And wherein at least One steering lever by limit can make the steering lever around the steering column longitudinal axis rotate degree in a manner of directly Or it is engaged indirectly with the surface of the handle portion.

Another embodiment according to the introducer sheath component of present disclosure includes: a handle part, is had One distal end portion and a proximal end；One introducer sheath, extends outwardly from the distal end portion of the handle portion, the introducer sheath The equipment inner cavity slideably received within a corresponding equipment is configured as including one, is radially outward arranged from the equipment inner cavity At least one turn to cable lumen, at least one turn to cable, which is attached to the distal end portion of the introducer sheath Locate, be disposed in it is described at least one turn to the steering assembly in cable lumen and being arranged in the handle portion with one and connect It closes；One or more steering levers are disposed on the outer surface of the handle portion and are attached to a steering column First end, wherein the steering column has second end, which engages a steering assembly, so that making the steering lever around this The longitudinal axis rotation of steering column leads to the tension at least one described steering cable of steering assembly modification；And wherein at least Engagement between one steering lever and the outer surface of the handle portion is by one at least partially around the steering lever Dome cap mediates, wherein the dome cap is placed in the recess of one in the outer surface of handle corresponding forming.

Another embodiment according to the introducer sheath component of present disclosure includes: a handle part, is had One distal end portion and a proximal end；One introducer sheath, extends outwardly from the distal end portion of the handle portion, the introducer sheath The equipment inner cavity slideably received within a corresponding equipment is configured as including one, is radially outward arranged from the equipment inner cavity At least two steering cable lumens, be attached at the distal end portion of the introducer sheath and be disposed in it is described at least two turn to At least two in cable lumen turn to cable；First steering assembly is disposed in the handle portion, the first steering group Part includes that at least one of described at least two steerings cable turns to the element that the proximal end of cable is attached to；And second Steering assembly is disposed in the handle portion, second steering assembly include it is described at least two turn to cable in extremely The element that the proximal end of few steering cable is attached to；Wherein first steering assembly can be manipulated to modify and be attached to Its tension turned in cable, and second steering assembly can be manipulated to turned in cable that modification is attached to it Power；And a relaxation removes component, when another steering assembly is manipulated to modify at least one in its attachment steering cable When tension in a, which removes component to turning to from least one steering assembly being attached in the steering assembly At least one of cable turns to cable and removes overrelaxation.

Another embodiment according to the introducer sheath component of present disclosure includes: a handle part, is had One distal end portion and a proximal end；One introducer sheath, extends outwardly from the distal end portion of the handle portion, the introducer sheath The equipment inner cavity being configured as including one slideably received within a corresponding equipment；One equipment locked component, by cloth It sets at the rear end of housing parts, which includes: an equipment locking level, limits one and is identified into and can slide The axially extending hole of the corresponding equipment is received dynamicly, which can move axially relative to the handle portion； One fixture is disposed on the equipment locking level, which is selectively located in locked, In the latched position, it is axially fixed the corresponding equipment relative to the equipment locking level, in the unlocked position, this is right The equipment answered can be slided in the axially extending hole of the equipment locking level；Wherein the equipment locked component further includes one Advance knob, which is fixed axially and can rotate relative to the handle portion of main part, wherein before described It further include a threaded hole into knob, which is accordingly threadedly coupled to the outer surface of the equipment locking level, described Equipment locking level and the threaded hole of the advance knob can be connected through a screw thread；And wherein the equipment locking level also with a bar Guide member engagement, the bar guide are placed in the handle portion to prevent from making when rotating knob the locking level to revolve Turn.Such embodiment can also include convenient for the feature of injection moulding manufacturing technology, including in the outer of the equipment locking level Parallel, intermittent flat part in external screw thread on portion surface, and advance knob is further characterized in that the component suspended outward, The component suspended outward limits not connecting for the radius in the distal side aperture that a radius is greater than in the handle portion jointly Continuous radial flange, wherein the discontinuous radial flange allows rotatably to dispose advance knob and is maintained at the handle In the distal side aperture in part, wherein the flange across the opening of the advance knob by being mirrored into.

Another embodiment according to the introducer sheath component of present disclosure includes: a handle part, is had One distal end portion and a proximal end；One introducer sheath, extends outwardly from the distal end portion of the handle portion, the introducer sheath The equipment inner cavity slideably received within a corresponding equipment is configured as including one, is radially outward arranged from the equipment inner cavity At least one turn to cable lumen, be attached at the distal end portion of the introducer sheath, be disposed at least one described steering At least one steering cable that the steering assembly in cable lumen and being arranged in the handle portion with one engages, wherein described Steering assembly can modify the tension at least one described steering cable；And a torque drive lock, it prevents when use The introducer sheath is rotated around longitudinal center axis when at least one turns to the tension in cable described in the steering assembly modification. Torque drive lock can also include a hollow posts with the inside diameter for the radial diameter for being enough to surround the introducer sheath Body, and at least one the nearside knot that can be engaged at least one counter structure of the extension of a face from the handle portion Structure.

Another embodiment according to the introducer sheath component of present disclosure includes: a handle part comprising One distal end portion and a proximal end；One introducer sheath, extends outwardly from the distal end portion of the handle portion, the introducer sheath The equipment inner cavity being configured as including one slideably received within a corresponding equipment；And one in the handle portion Allow user that the corresponding equipment is made to be received the visual aperture of point intracavitary in the equipment of the introducer sheath, And can also include containing markd corresponding equipment, the label can be visualized by the aperture, to mention to user The instruction of degree intracavitary in the equipment of the introducer sheath is had been inserted into for the corresponding equipment.

Another embodiment according to the introducer sheath component of present disclosure includes: a handle part, is had One distal end portion and a proximal end；One introducer sheath, extends outwardly from the distal end portion of the handle portion, the introducer sheath The equipment inner cavity being configured as including one slideably received within a corresponding equipment；Wherein the corresponding equipment includes one Or multiple remodeling for improving ultrasonic visualization.In certain such embodiments, which is hollow with one The expander of axial hole, which contains the remodeling for improving ultrasonic visualization, and the remodeling is located at the interior of the hollow axial hole On portion surface.For example, such expander may include at least one linear grooves, at least one described linear grooves relative to The longitudinal center axis of the expander extends in parallel, and may include that at least one has greatly by another embodiment The linear grooves of about 0.012 inch of width and up to about 0.003 inch of depth, wherein the groove is in certain implementations There is about 0.375 inch of total length, and in certain other embodiments by with about 0.0625 inch in scheme The continuous step of length forms.

Detailed description of the invention

It is included in this specification and the attached drawing formed part of this specification instantiates one or more implementations of the invention Scheme, and be used to explain the principle of the present invention together with specification.

It is elaborated in the specification of reference attached drawing for the of the invention abundant of those of ordinary skill in the art and can The disclosure of realization, the disclosure include its optimal mode, in which:

Figure 1A is the birds-eye perspective for turning to introducer sheath component according to an embodiment of present disclosure；

Figure 1B provides the handle portion for turning to introducer sheath component of an embodiment according to present disclosure Top view, bottom view and side view；

Fig. 1 C provides the top view for turning to introducer sheath component of an embodiment according to present disclosure；

Fig. 1 D provides the side view for turning to introducer sheath component of an embodiment according to present disclosure；

Fig. 2A is the office according to the handle portion for turning to introducer sheath component of an embodiment of present disclosure Portion's bottom view, wherein the bottom part of handle housing is removed to allow for the visualization of internal element；

Fig. 2 B provides the distally end cap for turning to introducer sheath component of an embodiment according to present disclosure Distal view, rearview, side view and perspective view；

Fig. 2 C provides the advance knob for turning to introducer sheath component of an embodiment according to present disclosure Distal view, rearview and perspective view；

Fig. 2 D is the office according to the handle portion for turning to introducer sheath component of an embodiment of present disclosure Portion's bottom view, wherein the bottom part of handle housing is removed to allow for the visualization of internal element；

Fig. 3 A provide for turning to together with introducer sheath component according to an embodiment of present disclosure The viewgraph of cross-section of " four inner cavities " the introducer sheath used；

Fig. 3 B provide for turning to together with introducer sheath component according to an embodiment of present disclosure The viewgraph of cross-section of " five inner cavities " the introducer sheath used；

Fig. 4 A provide for turning to together with introducer sheath component according to an embodiment of present disclosure The decomposition view of the torque drive lock used；

Fig. 4 B provide for turning to together with introducer sheath component according to an embodiment of present disclosure The viewgraph of cross-section of the torque drive lock used；

Fig. 5 A provides the handle portion for turning to introducer sheath component of an embodiment according to present disclosure Perspective view and viewgraph of cross-section, wherein illustration shows additional cross-section details, and depicts steering lever 160 and be in " unlock " position；

Fig. 5 B provides the handle portion for turning to introducer sheath component of an embodiment according to present disclosure Perspective view and viewgraph of cross-section, wherein illustration shows additional cross-section details, and depicts steering lever 160 and be in " locking " position；

Fig. 5 C provides the upper of the handle for turning to introducer sheath component of an embodiment according to present disclosure The cross-sectional view of the inside face of part and lower part；

Fig. 5 D provides bowing for the handle for turning to introducer sheath component of an embodiment according to present disclosure View and perspective view, wherein steering lever and associated dome cap are separated and/or are rotated relative to handle；

Fig. 6 A provides the handle portion for turning to introducer sheath component of an embodiment according to present disclosure Top view, bottom view and side view；

Fig. 6 B provides the saturating of the handle for turning to introducer sheath component of an embodiment according to present disclosure View, wherein the element of distal shell part is helped the visualization of certain features by separating；

Fig. 6 C provides the top view for turning to introducer sheath component of an embodiment according to present disclosure；

Fig. 6 D provides the side view for turning to introducer sheath component of an embodiment according to present disclosure；

Fig. 7 A provides the handle portion for turning to introducer sheath component of an embodiment according to present disclosure Perspective view, wherein a part of handle housing be removed with relaxation configuration (top image) and relaxation remove configure (bottom Image) in allow relaxation eliminate component visualization；

Fig. 7 B provide according to an embodiment of present disclosure, up knob part isolated view (left side), The isolated view (centre) of component is eliminated in the relaxation that relaxation removes the isolation in configuration with the pine of the isolation in rest configuration It relaxes and eliminates the isolated view (the right) of component；

Fig. 8 A is bowing according to the handle portion for turning to introducer sheath component of an embodiment of present disclosure Depending on perspective view.

Fig. 8 B is the side according to the handle portion for turning to introducer sheath component of an embodiment of present disclosure Perspective cross-sectional view；

Fig. 8 C is the side perspective cross-section that the proximal end of handle portion of introducer sheath component can be turned to shown in Fig. 8 B View；

Fig. 8 D is according to the close of the handle portion for turning to introducer sheath component of an embodiment of present disclosure The side perspective cross-sectional view of side；

Fig. 8 E is provided from the handle for turning to introducer sheath component according to an embodiment of present disclosure The perspective view of partial equipment locking level；

Fig. 9 A provides the distal end portion for turning to introducer sheath component of an embodiment according to present disclosure Detailed view, wherein a part of handle housing is removed to allow for the visualization of internal element；

Fig. 9 B is to turn to introducer sheath group according to an embodiment of present disclosure when checking from distal side visual angle The viewgraph of cross-section of the proximal end of the handle portion of part；

Fig. 9 C is for being used together with the introducer sheath component that turns to of an embodiment according to present disclosure Equipment locking level and internal guide member between junction birds-eye perspective；

Figure 10 A provide for turning to together with introducer sheath component according to an embodiment of present disclosure The viewgraph of cross-section of the expander instrument used；And

Figure 10 B is provided to be obtained during the introducing (top left) and removal (on the right of top) of the expander of the prior art Ultrasound image, and an embodiment according to the present invention expander introducing (bottom left) and remove (bottom The right) during obtain ultrasound image.

Appended drawing reference is reused in the present description and drawings to be intended to mean that according to the identical of the invention of present disclosure Or similar feature or element.

Specific embodiment

Now with detailed reference to certain embodiments of the present invention, the embodiment of the embodiment is illustrated in attached drawing In.These embodiments are to be provided by way of embodiment, and be not necessarily to be construed as the model of invention claimed It encloses and is limited to any specific embodiment.In fact, it will be apparent to those skilled in the art that not departing from the present invention Scope and spirit under the premise of, remodeling and variation can be made in the present invention.For example, being exemplified or being described as a reality The feature for applying a part of scheme can use in another embodiment, to generate another embodiment.Therefore, this hair The bright such remodeling covered in the range of falling into documented claim and its equivalent and variation.

In the description provided herein for turning to introducer sheath embodiment, term " distal side " and " nearside " will be used to Description movement and relative position.As can see in Figure 1A-Fig. 1 D, term " distal side " indicates the end in introducer sheath 130 Relative position and/or movement on (that is, on the direction of patient) direction at end 136, and " nearside " is indicated in equipment locking group Relative position and/or movement on the direction of part 192 (that is, on the direction of user).

Within the scope of this specification, term " about " should be interpreted +/- 10%.

It include an introducer sheath part, the introducer sheath part using the introducer sheath component that turns to of present disclosure Extended in a manner of distal side from the handle portion that can be held and be manipulated by user.One or more, which turns to cable and is attached to, draws Enter the distal end portion of device sheath, turn to cable lumen proximally through intrathecal longitudinal of introducer to the inside of handle portion, wherein institute It states the proximal end for turning to cable and allows user by selectively increasing or reducing steering cable tension to manipulate introducer At least one mechanism of the distal end portion of sheath engages.When necessary, the distal end portion for turning to cable is attached to the distal side of introducer sheath Exact position at or near tip can proximally or distally change, with the offer when increasing or reducing steering cable tension The distal flex of desired amount is modified.The introducer sheath part further includes longitudinal equipment inner cavity, which can Slideably received within the instrument of conduit insertion, the instrument of conduit insertion may include expander (for example, such as in Fig. 8 C and Fig. 8 D Middle description), the transseptal equipment of full-length Bayliss RF (is available from Bayliss Medical, Montreal adds and takes Greatly), the transseptal needle of Brockenbrough or other similar instrument pass through the expander.The handle portion further includes allowing to make The instrument that user is finely controlled conduit insertion passes through the feature that introducer sheath advances.

Figure 1A and Fig. 3 A, which is instantiated, turns to showing for introducer sheath component according to an embodiment of present disclosure Example property feature.As in figure 1A best seen from, it may include handle portion 110 and from handle that this, which can turn to introducer sheath component, The outwardly extending introducer sheath 130 of distal end portion (116) of part 110.Such as Fig. 3 A (depict introducer sheath 130 perpendicular to The planar cross section of longitudinal center axis 102) in best seen from, introducer sheath 130 can contain: substantially centralized positioning Equipment inner cavity 140, the instrument which is configured as being inserted into slideably received within conduit is (for example, in Fig. 8 A and Fig. 8 C In the expander 159 that shows and be discussed herein)；First, which turns to cable lumen 146 and second, turns to cable lumen 148, this (difference) is slidably disposed 154 He of the first steering cable in one steering cable lumen 146 and the second steering cable lumen 148 Second turns to cable 156；And third turns to cable lumen 150, turns to slideably cloth in cable lumen 150 in the third It sets third and turns to cable 158.

Referring again to the introducer sheath described in figure 3 a, first, which turns to cable lumen 146 and second, turns to cable lumen 148 can be arranged in the phase of equipment inner cavity 140 along the horizontal plane formed by horizontal axis 104 and longitudinal center axis 102 On opposite side, and symmetrical about the perpendicular formed by vertical axis 103 and longitudinal center axis 102, the wherein horizontal plane It is mutually perpendicular to the perpendicular.Come in this way, turning to the tension in cable 154 and the second steering cable 156 by adjusting first The distal part 132 of the introducer sheath is adjusted to the left side of the perpendicular or the horizontal curvature on the right, while puts down this vertically Potential unintentional movement in face minimizes.As being further depicted as in figure 3 a, third turns to cable lumen 150 and the equipment Inner cavity arranges that wherein third turns to cable lumen 150 and is disposed in 140 top of equipment inner cavity (that is, more leaning on along the perpendicular Closely check that this can turn to the user of introducer sheath from " bowing " view illustrated in fig. 1 c).In this way, adjustment third turns to cable Tension on 158 will adjust "vertical" of the distal part 132 of introducer sheath 130 in the perpendicular and be bent, while make to draw Enter device sheath 130 to minimize to any undesirable deflection on the left side or the right of the perpendicular.In other words, when operator from When the handle portion 110 of nearside is checked sheath component 100 and distad seen along introducer sheath 130, wherein introducer sheath 130 is not Inflection point extends outwardly, and can use the first steering cable 154 and the second steering cable 156 to realize introducer sheath 130 Distal part 132, and can be with respectively to the bending of the "horizontal" on the left side of axis 102 and the right (as in fig. 1 c best seen from) Cable 158 is turned to using third to adjust the curved amount in "vertical" of the distal part 132 of introducer sheath 130, thus by distal side Part 132 from axis 102 " upward " (that is, towards user) promoted (as in Fig. 1 D best seen from).

Other embodiments for turning to introducer sheath component of present disclosure may include such as (depicting and drawing in Fig. 3 B Enter the planar cross section for being transversely to the machine direction central axis 102 of device sheath 1300) in the introducer sheath described, which contains Have: the substantially equipment inner cavity 1400 of centralized positioning, the equipment inner cavity 1400 are configured as slideably received within conduit insertion Instrument (for example, the expander 159 for showing and being discussed herein in Fig. 8 A and Fig. 8 C)；First turns to cable lumen 1460 and second Cable lumen 1480 is turned to, (difference) can be slided in the first steering cable lumen 1460 and the second steering cable lumen 1480 Arrange that the first steering cable 1540 and second turns to cable 1560 dynamicly；And third turns to cable lumen 1500 and the 4th and turns to Cable lumen 1420, the third turn to cable lumen 1500 and the 4th turn to cable lumen 1420 in (difference) slideably Arrange that third turns to cable 1580 and the 4th and turns to cable 1520.As being further depicted as in figure 3b, first is turned in cable Chamber 1460 and second turns to cable lumen 1480 along the horizontal plane formed by horizontal axis 104 and longitudinal center axis 102 It is arranged on the opposite side of equipment inner cavity 1400, and vertical flat about being formed by vertical axis 103 and longitudinal center axis 102 Face is symmetrical, and wherein the horizontal plane and the perpendicular are mutually perpendicular to.Third turns to cable lumen 1500 and the 4th and turns to cable Inner cavity 1420 is arranged in the phase of equipment inner cavity 140 along the perpendicular formed by vertical axis 103 and longitudinal center axis 102 On opposite side, and it is symmetrical about the horizontal plane formed by horizontal axis 104 and longitudinal center axis 102.

For having the introducer sheath of cable arrangement shown in figure 3b, cable 1540 and the are turned to by adjusting first Two turn to the tension in cables 1560 to modify the distal part of the introducer sheath on the direction of horizontal axis 104 (that is, to this The left side or the right of perpendicular) "horizontal" bending.This is best shown in Fig. 6 C, and Fig. 6 C, which is depicted, to be had to this vertically The curved introducer sheath 1300 (Fig. 6 C, the left side) in the "horizontal" on the left side of plane does not have the curved introducer sheath in "horizontal" 1300 (Fig. 6 C, centers), and with "horizontal" curved introducer sheath 1300 (Fig. 6 C, the right side to the right of the perpendicular Side).Similarly, the tension that adjustment third turns in cable 1580 and the 4th steering cable 1520 modifies the distal side of the introducer sheath Part is bent (that is, bending to above or below the horizontal plane) in the "vertical" on the direction of vertical axis 103.This is by most It is good to show in figure 6d, Fig. 6 D depict with the curved introducer sheath in "vertical" below the horizontal plane 1300 (Fig. 6 D, The left side), do not have the curved introducer sheath 1300 (Fig. 6 D, center) in "vertical" and with " perpendicular above the horizontal plane Directly " curved introducer sheath 1300 (Fig. 6 D, the right).

It include allowing to make according to the handle portion for turning to introducer sheath component of present disclosure embodiment It is curved with the desired "horizontal" for realizing the distal part of the introducer sheath that user selectively increases or reduces steering cable tension The bent or curved feature in "vertical".Such as the best exemplified in Figure 1B-Fig. 1 D, for example, handle portion 110 may include: to turn to Lever 160, for adjusting the tension in the first steering cable and the second steering cable, to modify the distal side of introducer sheath 130 The "horizontal" bending (such as best depiction in fig. 1 c and be discussed further below) of part 132；And distally end cap 180, it uses The tension in cable is turned in adjustment third, (is such as existed to modify the "vertical" bending of distal part 132 of introducer sheath 130 In Fig. 1 D best depiction and be discussed further below).

In certain embodiments, cable 154 and the second steering cable 156 are turned to adjust the introducing for manipulating first The mechanism of the curved amount in "horizontal" of the distal part 132 of device sheath may include the drive of controller control to steering cable 154 and 156 The external steering lever 160 of the built-in system of moving gear and column spinner.Such as the best exemplified in Fig. 2A, Fig. 5 A and Fig. 5 B, example Such as, the hole that steering lever 160 can receive steering lever pin 198 by being aligned is pivotally secured to the of steering column 164 One end.Steering column 164 is fixed non-rotatably to driving gear 166 at its second end.Driving gear 166 is positioned in handle In 100, enable to simultaneously engage with and revolving first gear component 168 and second gear component 174.It is such as best in fig. 2 It shows, first gear component 168 and second gear component 174 can respectively include a shell from the inside of handle 100 Rotatable column (126,128) that body extends internally, non-rotatably fixed shell portion (172,178) and engagement drive The non-rotatably fixed gear (170,176) of moving gear 166.Column 126 and 128 can be positioned perpendicular to central axis 102 (for example, as described in Fig. 2A, Fig. 5 A and Fig. 5 B), or alternatively with central axis 102 at non-perpendicular angles.Column 126 and 128 It can rotatably be connect by the holding feature to extend internally from the inside face of upper case portion 112, lower housing section 114 or both It closes.For example, such as (depicting base flange in Fig. 5 C and showing column 126 and the base flange 1914 in lower housing section 114 Engagement) in best seen from, in some embodiments, column 126 and 128 can pass through upper case portion 112 and lower case Cup dolly flange 1914 in part 114 rotatably engages.

As described in briefly above and in Figure 1A and Fig. 2A best exemplified, first turns to the distal end portion of cable 154 and the The distal end portion of two steering cables 156 is attached at or near the distal tip 136 of introducer sheath, wherein the cable itself (difference) is extendd proximally across inner cavity 146 and 148 is turned to, until in the inside that proximal end terminates at handle portion 110, wherein The proximal end of two cables can selectively can be increased or reduced by one or more and turn to turning for the tension in cable It is engaged to mechanism.

For example, as best seen from, the first steering cable 154 and the second steering cable 156 can be via phases in fig. 2 The opening 1960 and 1961 answered exits introducer sheath 130, and the opening 1960 and 1961 is located at the terminal part of introducer sheath 130 Near (that is, the part for being located at the inside of handle portion 110).By this method, first turn to cable 154 proximal end and second turn To cable 156 proximal end can (difference) leave from inner cavity 146 and 148 is turned to, and (difference) and the first tooth sector component 168 and second tooth sector component 174 engage.The introducer similar for the introducer sheath 1300 for including with showing in figure 3b The embodiment for turning to introducer sheath component of the present disclosure of sheath, first turns to the proximal end of cable 1540 and second turn To cable 1560 proximal end (difference) via the opening similar with opening (1960 and 1961) shown in fig. 2 from first It turns to cable lumen 1460 and the second steering cable lumen 1480 leaves, and (difference) and the first tooth sector component 168 and the The engagement of two tooth sector components 174.

As in fig. 2 best seen from, for example, in some embodiments, first turns to the proximal end quilt of cable 154 It is attached to the shell portion 172 of first gear component 168, and the proximal end of the second steering cable 156 is attached to second gear The shell portion 178 of component 174.Driving gear 166 is engaged with first gear 170 and second gear 176, so that driving gear 166 rotation leads to first gear component 168 and second gear component 174 while rotating, so as to adjust the first steering is applied to The tension of cable 154 and the second steering cable 156, the first steering cable 154 and the second steering cable 156 are respectively with as follows Mode is attached to shell portion 172 and 178 and is wrapped in around shell portion 172 and 178, so that when due to steering lever 160 Rotation when the tension in described steering one of cable being caused to increase, another turns to the tension in cable and reduces.In this way, first It turns to cable 154 and the second steering cable 156 consistently works to increase or reduce distal part 132 to the left side of axis 102 Or the "horizontal" bending on the right.

In certain embodiments, the first steering cable 154 and the second steering cable 156 are attached to as follows respectively Shell portion 172 and 178 and by shell portion 172 and 178 engage so that from such as " vertical view " of best exemplified is looked into fig. 1 c When seeing handle portion 110, rotate steering lever 160 in a counterclockwise manner (that is, so that the distal end portion phase of steering lever 160 " left side " more is directed toward for longitudinal center axis 102) cause the distal part (136) of introducer sheath 130 to become to longitudinal direction More " horizontally " bending (Fig. 1 C, at the left side) of the left side of central axis 102, makes steering lever 160 in clockwise manner Rotation (that is, so that the distal end portion of steering lever 160 is more directed toward " the right " relative to longitudinal center axis 102) causes to draw Enter device sheath 130 distal part (136) become to the right of longitudinal center axis 102 more " horizontally " bending (Fig. 1 C, At the right), and make steering lever 160 back to center (that is, so that the distal end portion of steering lever 160 is directed toward and longitudinal direction On the parallel direction of central axis 102) cause the distal part 136 of introducer sheath 130 parallel with longitudinal center axis 102 Side upwardly extends and (is bent that is, not having "horizontal", such as in fig. 1 c, at center).By this method, steering lever 160 is remote The orientation of side can provide any " water about the distal part (136) for being introduced into introducer sheath 130 to user It is flat " it is curved exist, the instruction of directionality and relative extent.

In an alternate embodiment, the first steering cable 154 and the second steering cable 156 may be attached to shell portion It 172 and 178 and is engaged by shell portion 172 and 178, so that steering lever is made to rotate will lead in a manner of " counterclockwise " and make to draw The distal part (136) for entering device sheath 130 is horizontally bent to the right, and vice versa.

In the certain embodiments for turning to introducer sheath component according to present disclosure, steering lever 160, driving Interaction between gear 166 and/or first gear component 168 and second gear component 174 can be modified to increase or Reduce " sensitivity " of steering lever 160 (that is, it is curved to introduce "horizontal" when making steering lever 160 rotate to specific degrees Degree).For example, in certain embodiments, can provide gear, which allows user by selectively Gear drive ratio between modification driving gear 166 and/or first gear component 168 and second gear component 174 (gearing ratio) modulates " sensitivity " of steering lever 160.Alternatively, can provide spring-loaded teeth wheel post and/or Flywheel assembly is with the sensitivity for modulating steering lever 160 in the desired manner.

In certain embodiments, it may include once having reached the introducer sheath that this, which can turn to introducer sheath component, Steering lever is just locked mechanism in place by the bending of desired amount.As shown in Fig. 5 A and Fig. 5 B, for example, steering lever 160 may include cam face 162 so that when make steering lever 160 around turn to lever pin 198 from " unlock " position (Fig. 5 A) to On when rotating to " locking " position (Fig. 5 B), cam face 162 becomes to be frictionally engaged with the outer surface of up knob part 112, And steering column 164 is promoted to the inside far from handle in radial directions, so that driving gear 166 becomes and up knob part 112 interior surface is frictionally engaged.It in certain embodiments, can be by providing one or more washers with separated sliding tooth The interior surface of wheel 166 and up knob part 112 rubs to modulate this " locking ", which can be for example including The waveform spring washer 1915 described in Fig. 5 A and Fig. 5 B.

As shown in Fig. 5 A, Fig. 5 B and Fig. 5 D, certain embodiments may include gas dome 1916, the gas dome 1916 are located at out of, the exterior face of up knob part 112 squeezes out gas dome recess 1917, to mediate steering lever 160 Interaction between cam face 162 and the outer surface of up knob part 112.Such as in Fig. 5 D (illustration) best seen from , gas dome 1916, which can be shaped as, provides central slot 1917, and steering lever 160 is prominent across the central slot 1917, Its further groove 1917 is sufficiently wide to adapt to the vertical rotation between " unlock " position and " locking " position, while also turning in manipulation To lever 160 so as to provide cross-brace when steering column 164 rotates for steering lever 160, and also assures and work as from " unlock " position When (Fig. 5 A) is pivoted to " locking " position (Fig. 5 B), steering lever 160 is constrained to the axis perpendicular to steering lever pin 198 Direction.

In certain embodiments, gas dome 1916 and gas dome recess 1917 can be configured as when manipulation steering lever When 160, angular displacement of the limitation steering column 164 around its longitudinal axis.As shown in figure 5d, for example, this can be by from circle Flange (1918 and 1919) Lai Shixian that the downside of top cover 1916 extends, and can with (difference) by corresponding protrusion 1920 and 1921 distal faces formed interact to constrain the rotation of steering lever 160.This makes cable 154 and 156 from may be due to User attempt to make their tensions using steering lever 160 and caused by overstrain.In certain embodiments, protrusion 1920 and 1921 and/or flange 1918 and 1919 can be it is adjustable so that can be modified according to the preference of user The confined degree of the rotation of steering lever 160.

For with the introducer sheath with cable arrangement shown in Fig. 3 B, the steering thick stick with the steering assembly mechanism The embodiment for turning to introducer sheath component of bar and other above-described associated present disclosures being characterized, together Sample can be used to the tension in the first steering cable 1540 of adjustment and the second steering cable 1560, to modify the introducer sheath "horizontal" bending of the distal part on the direction of horizontal axis 104 (that is, to the left side or the right of perpendicular).For in this way Embodiment, first turn to cable 1540 and second turn to cable 1560 with for first turn from introducer sheath 130 Shell portion 172 is attached to the same way of cable 154 and the second steering 156 above description of cable (and illustrating in fig. 2) It is engaged with 178 and by shell portion 172 and 178.In this way, when being checked from " vertical view " as illustrated in Fig. 1 C and Fig. 6 C, Rotate steering lever 160 in a counterclockwise manner (that is, so that the distal end portion of steering lever 160 is relative to longitudinal center axis 102 are more directed toward " left side ") cause the distal part (1360) of introducer sheath 1300 to become the left side to longitudinal center axis 102 Side more " horizontally " bending (Fig. 6 C, at the left side), rotates steering lever 160 in clockwise manner (that is, so that turning More " the right " is directed toward relative to longitudinal center axis 102 to the distal end portion of lever 160) lead to the distal side of introducer sheath 1300 Partially (1360) become more " horizontally " to be bent (Fig. 6 C locates on the right) to the right of longitudinal center axis 102, and make to turn To lever 160 back to center (that is, so that the distal end portion direction of steering lever 160 is parallel with longitudinal center axis 102 Direction) cause the distal part (1360) of introducer sheath 1300 to upwardly extend in the side parallel with longitudinal center axis 102 (being bent that is, not having "horizontal", such as in figure 6 c, at center).Illustrate again herein, the distal end portion of steering lever 160 Orientation representation is introduced into the curved presence in any "horizontal" of the distal part (1360) of introducer sheath 1300, directionality And relative extent.

This is best shown in Fig. 6 C, and Fig. 6 C is depicted with the curved introducing in left side "horizontal" to the perpendicular Device sheath 1300 (Fig. 6 C, the left side) does not have the curved introducer sheath 1300 (Fig. 6 C, center) in "horizontal", and has perpendicular to this The curved introducer sheath 1300 (Fig. 6 C, the right) in the right "horizontal" of straight plane.Similarly, cable is turned to by adjusting third 1580 and the 4th turn to the tension in cable 1520 to modify the distal part of the introducer sheath on the direction of vertical axis 103 "vertical" be bent (that is, bending to above or below the horizontal plane).This is best shown in Fig. 6 D, and Fig. 6 D depicts tool There is the curved introducer sheath 1300 (Fig. 6 D, the left side) in the "vertical" below horizontal plane, have the curved introducing in "vertical" Device sheath 1300 (Fig. 6 D, center), with the curved introducer sheath in "vertical" above the horizontal plane 1300 (Fig. 6 D, it is right Side).

As previously mentioned, according to the handle portion for turning to introducer sheath of present disclosure embodiment It can also include allowing user selectively to increase or reduce to turn to distal part of the cable tension to realize introducer sheath The desired curved feature in "vertical".For example, handle portion 110 may include distally end cap 180, the distally end cap 180 control The axial movement of external thread rod 188 turns to the tension in cable so as to adjust third to modify the "vertical" of distal part 132 Bending, as shown on Fig. 1 D (at the left side and center).

As can see in Figure 1A-Fig. 1 D, handle portion 110 may include upper case portion 112 and bottom housing part Divide 114, the upper case portion 112 and the lower housing section 114 limit the distal end portion (116) for being arranged in handle portion 110 together The distal side aperture 118 at place.In certain embodiments, distal side aperture 118, which can be configured as, rotatably receives distally end cap 180, so that distally end cap 180 is rotated freely relative to handle portion 110.For example, such as being illustrated in Fig. 2A & Fig. 2 B and Fig. 7 B , distally end cap 180 may include the multiple convex ridges 182 to extend radially outwardly from outer surface, so that during use may be used Easily to grasp and rotate distally end cap 180.Distally end cap 180 can also include female thread portion 186, the female thread portion The corresponding threaded rod 188 that 186 engagements are arranged in handle portion 110.Distally end cap 180 can also include being arranged in its nearside The radial flange suspended outward at end, the diameter of the radial flange is greater than the diameter in distal side aperture 118, to allow distal end portion Cap 180 is received and is axially retained the annular chamber limited in the connection by upper case portion 112 and lower housing section 114 To form handle portion 110 in 120.

As best seen from, in certain embodiments, being arranged in distally end cap 180 in Fig. 2A-Fig. 2 B and Fig. 7 B The radial flange suspended outward at proximal end can be made of multiple tabs (tab) 184, and the tab 184 has outstanding outward The component set, the component suspended outward limit discontinuous radial flange together, the radius of the discontinuous radial flange Greater than the radius in distal side aperture 118, so that distally end cap 180 can be received and be axially retained in annular chamber 120. As in fig. 2b best seen from, distally end cap 180 can also be in order to using injection molding technology manufacture distally end cap 180 Arrangement includes multiple ventilation holes (vent) 1850 corresponding to tab 184.

As in Fig. 4 A and Fig. 4 B it can be seen that, external thread rod 188 may include one or more axially extending narrow Slot 189, one or more of axially extending slits 189 can be engaged radially-inwardly to be suspended from the interior surface of handle 110 The axially extending flanges 129 of one or more.When rotating distally end cap 180, the engagement of slit 189 and flange 129 is true It protects external thread rod 188 also not rotate, as a result, external thread rod 188 is in nearside when user rotates distally end cap 180 Axial (that is, being parallel to longitudinal center axis 102) is mobile on direction or distal direction.As discussed in more detail, by remote The axial movement of external thread rod 188 caused by the rotation of side cap 180, which is used to for being bent "vertical", is introduced into introducer sheath 130 Distal part 132.

In order to ensure during operation (for example, when user increases or reduces the one or more steerings turned in cable When tension in cable is to introduce the proximal end of introducer sheath 130 for "horizontal" bending and/or "horizontal" bending) power is appropriate Ground is transferred to the distal part 132 of introducer sheath 130, turns to introducer sheath according to present disclosure embodiment It can also include the torque drive lock for preventing introducer sheath 130 from rotating around longitudinal center axis 102.For example, such as in Fig. 4 A and figure In 4B best seen from, certain embodiments may include torque drive lock 1900, the torque drive lock 1900 include one in Void column body and in recess 1901 at the proximal end, which, which has, allows torque drive to lock across external thread rod 188 The overall diameter of inner hole and it is enough to surround the interior diameter of the radial diameter of introducer sheath 130, which can connect with flange 129 It closes.The distal end portion of torque drive lock 1900 includes external screw thread 1902, which corresponds to the inner hole of transmission lock nut 1903 On screw thread.When being threadingly attached on transmission lock 1900, the proximal side of transmission lock nut 1903 can be with distally end cap 180 Distal face is movably engaged to be fixed on transmission lock 1900 in the hole of external thread rod 188, and wherein recess 1901 is fully engaged To flange 129.In certain embodiments, can be convenient for being driven lock nut 1903 and distal end portion by using thrust bearing 1905 Removable engagement between cap 180, the thrust bearing 1905 can be placed in the impression in the distal face of distally end cap 180 In 1904.In final component, introducer sheath 130 passes through the hole of torque drive lock 1900 and is immovably attached to this, And therefore the engagement of recess 1901 and flange 129 prevents from introducing when "vertical" is bent using distally end cap 180 or turning using Introducing when "horizontal" is bent to lever 160 rotates introducer sheath 130 around longitudinal center axis 102.

The nearside terminal that third turns to cable 158 may be attached to external thread rod 188, allow to by making distal end portion Cap 180 rotation come increase or reduce third turn to cable 158 tension, this cause external thread rod 188 along axis 102 distad Or it is mobile to nearside.As in Figure 1A and Fig. 2 D best seen from, for example, third turn to cable 158 distal side terminal be attached to At or near the distal tip 136 of introducer sheath 130, and extendd proximally therefrom across inner cavity 150 is turned to, until nearside End terminates in the inside of handle portion 110, and then third turns to cable 158 via the terminal part for being located at introducer sheath 130 The opening 1963 of (that is, being located at the part inside handle portion 110) nearby exits introducer sheath 130.By this method, third turns to The distal end portion of cable 158 can leave and become attached to external thread rod 188 from inner cavity 150 is turned to, this comes in the following way It realizes: passing through the axial hole from the flange 400 that the proximal end of external thread rod 188 extends by making third turn to cable 158 1963, and adhere to third after third steering cable 158 is exited from the distal end portion of axial hole 1963 and turn to cable 158. Equally, for present disclosure to turn to the introducer sheath 1300 for including with showing in figure 3b of introducer sheath component similar Introducer sheath embodiment, third turn to cable 1580 distal end portion from turn to cable lumen 1500 leave and via with It is shown in Fig. 2 D and 1963 substantially the same openings of opening discussed above exits introducer sheath 1300.Once it is from drawing Enter device sheath 1300 to leave, third, which turns to cable 1580, to be attached to external thread rod 188 in the following way: by turning third The axial hole 1963 from the flange 400 that the proximal end of external thread rod 188 extends is passed through to cable 1580, and turns to cable in third Line 1580 adheres to third after exiting from the distal end portion of axial hole 1963 and turns to cable 1580.

As in Fig. 2A and Fig. 2 D best exemplified, when the handle portion 110 of operator proximally checks sheath component 100 and edge Introducer sheath 130 when distad seeing, wherein introducer sheath 130 extends outwardly in undeflected position, and distally end cap 180 is suitable Rotation on clockwise causes corresponding threaded rod 188 (that is, towards the inside of handle portion 110, such as to exist in a proximal direction In Fig. 2 D top best seen from) it is mobile, which increase the amount for being placed on third and turning to the tension on cable 158, so as to cause The curved increase in "vertical" of the distal part 132 of introducer sheath 130.On the contrary, the rotation of distally end cap 180 in the counterclockwise direction Transduction causes external thread rod 188, and (that is, the inside far from handle portion 110, such as bottom most preferably shows in figure 2d for movement in a manner of distal side Out), which reduce the amounts for the tension being present in third steering cable 158, and reduce and be present in the remote of introducer sheath 130 The curved amount in this "vertical" in side section 132.It (depicts in Fig. 1 D and such as turns to introducer from what " right hand " side viewed Sheath) in it can be seen that introducer sheath 130 distal part 132 "vertical" bending, Fig. 1 D instantiate when distal side cap 180 by Rotation so that the distal part (136) of the introducer sheath 130 not when applying tensioned on turning to cable 158 of external thread rod 188 how It is upwardly extended (Fig. 1 D, at center) in the side for being parallel to longitudinal center axis 102, and when distally end cap 180 has been revolved Turn by cause external thread rod 188 in a manner of nearside it is mobile and increase turn to the tension on cable 158 when, introducer sheath 130 it is remote How side section (136) becomes more " vertically " bending (figure on the direction raised relative to longitudinal center axis 102 1D, at the left side).It can provide in the following way and keep desired curved " self-locking " function in "vertical": by will be remote The threaded portion and external thread rod 188 of side cap 180 are configured to enough frictions interaction, so that when user stops far When the rotation of side cap 180, external thread rod 188 is remained fixed in its position, so that third be maintained to turn in cable 158 The desired "vertical" bending of power and the distal part 132 of holding introducer sheath 130.

In certain embodiments of the introducer sheath component of present disclosure, between end cap 180 and external thread rod 188 Engagement can be used to modulate the "vertical" bending of the introducer sheath similar with the introducer sheath 1300 described in figure 3b.At this In a little embodiments, (either directly or indirectly) is selectively increased using the nearside movement/distal side movement of external thread rod 188 Or reduction third turns to the relative tension in cable 1580 and the 4th steering cable 1520, to modify the remote of introducer sheath 1300 "vertical" bending of the side section 1360 on 103 direction of "vertical" axis (that is, above or below the horizontal plane).In Fig. 1 D It can see the distal part 136 of introducer sheath 130 in (depict from what " right hand " side viewed and turn to introducer sheath) The bending of this "vertical", Fig. 1 D are instantiated when distal side cap 180 has been rotated such that external thread rod 188 does not turn to cable in third 158 and the 4th how the distal part (1360) of introducer sheath 1300 is being parallel to longitudinal direction when applying tensioned on steering cable 1520 The side of central axis 102 upwardly extends (Fig. 1 D, at center), and when distally end cap 180 has been rotated to lead to outer spiral shell Rasp bar 188 is moved by way of increasing third and turning to the tension on cable 1580 and the tension on the 4th steering cable 1520 of reduction When dynamic, how the distal part (1360) of introducer sheath 1300 becomes on the direction raised relative to longitudinal center axis 102 It " vertically " more is bent (Fig. 1 D, at the left side), and when distally end cap 180 has been rotated to just lead to external thread rod 188 it is mobile in a manner of reducing third and turn to the tension on cable 1580 and increase the tension that the 4th turns on cable 1520 when, How the distal part (1360) of introducer sheath 1300 becomes more on the direction reduced relative to longitudinal center axis 102 " vertically " bending (Fig. 1 D locates on the right).

Certain embodiments that introducer sheath component can be turned to may include being present in the remote of introducer sheath for modulating The "horizontal" steering lever of the curved amount in "horizontal" in side section (is described as described above and in Figure 1A-Fig. 1 D and Fig. 2A ) and "vertical" for modulating the curved amount in "vertical" in the distal part 132 for being present in introducer sheath 130 turn to thick stick Bar.In such " double lever " embodiment, using "vertical" steering lever rather than it is described above to control and " erects Directly " curved distally end cap is provided with external thread rod component relative to the consistent of the curved mechanism for changing introducer sheath Property, that is, the mechanism of same type --- steering lever --- is used to the bending of modification "vertical" and "horizontal" bending.

For example, as shown in Fig. 6 A- Fig. 6 D, draw from turning to of describing in Figure 1A-Fig. 1 C and Fig. 4 A- Fig. 4 B Enter the distally end cap 180 and its associated component (external thread rod 188, torque drive lock 1900, transmission lock nut of device sheath component 1903 and thrust bearing washer 1905) distal shell component 350 can be replaced by, as in fig. 6b best seen from, this is remote Side body component 350 includes distal shell part 361 and 362, which accommodates together by vertical The hinged vertical steering assembly 351 of steering lever 360.As best seen from, vertical steering lever 360 passes through alignment in fig. 6b To receive the first end that the hole of retaining pin is fixed non-rotatably to steering column 364.Steering column 364 passes through distal shell portion in turn Divide 361 and is fixed non-rotatably to main vertical driving gear 365 at its second end.Main vertical driving gear 365 is positioned In distal shell component 350, enable to simultaneously engage with and rotate upper vertical driving gear 366 and lower vertical driving gear 369.Upper vertical driving gear 366 is fixed non-rotatably to rotatable column 367, and the rotatable column 367 is from (difference) remote The shell 374 and 375 of the inside of side body part 361 and 362 extends internally, wherein upper rotatable column 367 is also non-rotatable Ground is fixed to upper shell part 368.Lower vertical driving gear 369 is fixed non-rotatably to down rotatable column 370, can under this Column spinner 370 extends internally from the shell 376 and 377 of (difference) on the inside of distal shell part 361 and 362, wherein should Under rotatable column 370 be also fixed non-rotatably to lower shell part 371.

In the certain embodiments for turning to introducer sheath component of present disclosure, it can combine and retouch in figure 3b The introducer sheath 1300 drawn similar introducer sheath provides above-described vertical steering lever and associated element.? In these embodiments, third turns to cable 1580 and the 4th steering cable 1520 is attached to the distal side end of introducer sheath 1300 At or near the tip 1360, wherein described cable itself (difference) is extendd proximally across inner cavity 1500 and 1420, until proximal end It terminates in the inside of handle interior section 110, then third turns to the proximal end of cable 1580 and the 4th and turns to cable 1520 Proximal end (difference) from turn to cable lumen 1500 and 1420 leave and via in fig. 2 describe those of opening (1960 Introducer sheath 1300 is exited with 1961) similar opening, and becomes selectively increase or reduce with one or more Three turn to steering mechanism's engagement of cable 1580 and the tension in the 4th steering cable 1520.

In these embodiments, the proximal end that third turns to cable 1580 is attached to upper shell part 368, and the 4th The proximal end for turning to cable 1520 is attached to lower shell part 371.The rotation of vertical steering lever 360 leads to main vertical driving Gear 365 is simultaneously engaged with and is rotated in vertical driving gear 366 and lower vertical driving gear 369 and they associated Shell portion 368 and lower shell part 371.This causes third to turn to cable 1580 and the 4th steering cable 1520 in turn becomes point It is not coiled around upper shell part 368 and lower shell part 371, so that when third turns to the tension in cable 1580 and increases, 4th tension turned in cable 1520 reduces, and vice versa.In this way, third, which turns to cable 1580 and the 4th, turns to cable 1520 consistently work, and are being lifted to above horizontal plane or are dropping to increase or reduce the distal part 1320 of introducer sheath 1300 As low as the "vertical" bending on the direction below horizontal plane.

For example, in certain embodiments, the first steering cable 1580 and the second steering cable 1520 can be with such as lower sections Formula is attached to their corresponding upper shell part 368 and lower shell part 371 and passes through their corresponding upper shell portion Divide 368 and the engagement of lower shell part 371, so that such as (offer can be turned to from " double lever " that " right hand " side views draws in Fig. 6 D Enter the view of device sheath) in best exemplified, rotate steering lever 360 in a counterclockwise manner (that is, so that steering lever 360 Distal end portion be directed toward the direction raised relative to longitudinal center axis 102) lead to the distal part of introducer sheath 1300 (1360) the "vertical" bending (Fig. 6 D, at the left side) in a manner of raising relative to longitudinal center axis 102, makes steering lever 360 rotate in clockwise manner (that is, so that the distal end portion of steering lever 360 is directed toward relative to the reduction of longitudinal center axis 102 Direction) cause the distal part (1360) of introducer sheath 1300 " perpendicular in a manner of reduction relative to longitudinal center axis 102 Directly " be bent (Fig. 6 D, at bottom), and make steering lever 160 back to center (that is, so that steering lever 360 it is remote Be directed toward the direction parallel with longitudinal center axis 102 in side) cause the distal part (1360) of introducer sheath 1300 with longitudinal direction The parallel side of central axis 102 upwardly extends and (is bent that is, not having "horizontal", such as in figure 6d, at center).With this side The orientation of formula, the distal end portion of steering lever 360 can be provided to user about being introduced into the remote of introducer sheath 1300 The curved presence in any "horizontal" of side section (1360), the instruction of directionality and relative extent.

In an alternate embodiment, third, which turns to cable 1580 and the 4th steering cable 1520, can be respectively attached to cylinder Body portion 368 and 371 and by shell portion 368 and 371 engage so that making vertical steering lever 360 in a manner of " clockwise " The distal part (1360) " vertically " that rotation will lead to introducer sheath 1300 bends to 102 top of longitudinal center axis, and anti- ?.

In certain embodiments of the introducer sheath component of present disclosure, it can combine and draw with what is described in figure 3 a Enter the similar introducer sheath of device sheath 130 to provide and steering as above-described steering lever and certain associated element class Lever and element.For example, vertical steering lever can be fixed to the first end of rotatable column, the rotatable column is extended through The surface of distal side handle assembly 350 and with in fig. 6b relative to vertical steering lever 360 and rotatable column 364 shown in side The similar mode of formula internally terminates.Third from introducer sheath 130 turns to the distal end portion of cable 158 (directly or indirectly Ground) be attached to rotatable column 364 and by can steering column 364 engage so that ought make as described above turn to thick stick When bar 360 rotates, the proximal end that the obtained axial-rotation of rotatable column 364 causes third to turn to cable 158 becomes to coil Shell portion unwinding around the shell portion of rotatable column 364 or from rotatable column 364.Become when third turns to cable 158 When must more be coiled in around the shell portion of rotatable column 364, it is applied to the tension that third turns on cable 158 and increases, And the curved amount in "vertical" being present in the distal part 132 of the introducer sheath equally increases.On the contrary, when third turns to cable 158 when becoming less to be coiled in around the shell portion of rotatable column 364, is applied to third and turns to tension on cable 158 Reduce, and the curved amount in "vertical" being present in the distal part 132 of the introducer sheath 130 equally reduces.For example, certain In embodiment, third turns to cable 158 and can be attached to rotatable column 364 as follows and be connect by rotatable column 364 It closes, so that the preferred example such as in Fig. 6 D (view of introducer sheath can be turned to by providing " double lever " viewed from " right hand " side) Show, rotates steering lever 360 in a counterclockwise manner (that is, so that the distal end portion of steering lever 360 is relative to longitudinal center Axis 102 is raised) cause the distal part (1360) " vertically " of introducer sheath 1300 to bend to 102 top of longitudinal center axis (Fig. 6 D, at the left side), and make steering lever 160 back to center (that is, so that the distal end portion of steering lever 360 refers to To the direction parallel with longitudinal center axis 102) cause the distal part (1360) of introducer sheath 1300 to be restored to be parallel to The side of longitudinal center axis 102 upwardly extends and (is bent that is, not having "vertical", such as in figure 6d, at center).Herein again Illustrate, the orientation of the distal end portion of steering lever 360 is provided about the distal part for being introduced into introducer sheath 1300 (1360) the curved presence in any "vertical", the instruction of directionality and relative extent.

In the certain embodiments for turning to introducer sheath component according to present disclosure, vertical steering lever and phase Interaction between associated tooth sector component (such as, above for those of vertical steering lever 360 description) can be with It is modified to increase or reduce " the vertical sensitivity " of vertical steering lever (that is, when vertical steering lever is rotated to specific journey When spending, "vertical" is bent the degree modified).For example, in certain embodiments, can provide gear, which is passed It is dynamic that user is allowed to pass through the gear drive ratio selectively between modification driving gear and any associated gear assembly To modulate " the vertical sensitivity " (for example, allow user to modify has in vertical steering assembly 351 shown in fig. 6b Corresponding gear drive ratio).Alternatively, spring-loaded teeth wheel post and/or flywheel assembly can be provided, for modulating vertical turn Sensitivity to lever and associated steering assembly.

There is provided the embodiment for turning to introducer sheath component of the vertical steering lever for controlling " vertical bending " (such as It is as detailed above) it include that steering lever is just locked mechanism in place by the bending of the desired amount for once reaching the introducer sheath.Such as It is shown in fig. 6b, for example, distal side handle assembly 350 can be configured as with the vertical steering including cam face 385 Lever 360, so that when steering lever 360 rotates upwards around the steering lever pin for being connected to steering column 364, the CAM table Face becomes to be frictionally engaged with the exterior face of the upper part (361) of distal side handle assembly 350, and steering column 364 (or associated member Part) equally become to be frictionally engaged with the inside face of the upper part 361 of distal side handle assembly 350.This " being engaged by locking " and in Fig. 5 A Identical with " being engaged by locking " for describing in Fig. 5 B, Fig. 5 A and Fig. 5 B are depicted at " unlock " position (Fig. 5 A) and in " lockings " Position (Fig. 5 B) is horizontally diverted handle 160.In certain embodiments, can by provide one or more washers (for example, The waveform spring washer (1915) described in Fig. 5 A and Fig. 5 B) it rubs to modulate this " locking ", to mediate and distal side handle group The inside face of the upper part (361) of part 350 and the frictional engagement of exterior face.

Referring again to Fig. 6 B, provides and turn to introducer sheath component for control the curved vertical steering lever in "vertical" Embodiment can also include vertical steering lever gas dome 380, which is located at from distal side handle In the vertical gas dome recess 381 that the exterior face of the upper part (361) of hand component 350 squeezes out, so that modulation is vertical to turn to thick stick Interaction between the cam face 385 of bar 360 and the exterior face of up knob part 361.Such as in Fig. 6 B (left side illustration) Best seen from, vertical steering lever gas dome 380, which can be shaped as, provides central slot 386, and steering lever 360 passes through should Central slot 386 is prominent, and as shown in Fig. 6 A and Fig. 6 D, central slot 386 has enough width to adapt to vertical turn To vertical rotation of the lever 360 between " unlock " position and " locking " position, while when manipulation steering lever 360 so as to turn to Column 364 is also that steering lever 360 provides cross-brace, and also assures to work as from " unlock " position and be pivoted to " locking " position when rotating When (Fig. 5 B), steering lever 360 is constrained to the side of the axis perpendicular to the steering lever pin that it is attached to steering column 364 To.

Referring again to Fig. 6 B, provides and turn to introducer sheath component for control the curved vertical steering lever in "vertical" Embodiment, vertical gas dome 380 and vertical gas dome recess 381 can be configured as when manipulating vertical steering lever 360 When, angular displacement of the limitation steering column 364 around its longitudinal axis.For example, as in fig. 6b best seen from, this can be by from perpendicular Flange (381 and 382) Lai Shixian that the downside of straight gas dome 380 extends, and can with pass through the example in Fig. 6 B (left side illustration) It is shown as the distal face interaction that 383 and 384 corresponding protrusion is formed, to constrain the rotation of steering lever 360.This makes Three turn to cable 1580 and/or the 4th steering cable 1520 from that may attempt to make it using steering lever 360 due to user Tension and caused by overstrain.In certain embodiments, protrusion 383 and 384 and/or flange 381 and 382 can be It is adjustable, so that the degree that the rotation that can modify steering lever 360 according to the preference of user is restrained.

As discussed above, the first steering cable 154 and the second steering cable 156 consistently work to realize introducer sheath The bending of 130 distal part 132, wherein first gear component 168 and second gear component 174 pass through driving gear simultaneously 166 engagements, so that turning to cable 156 when operator manipulates steering lever 160 and turns to the tension in cable 154 to increase In tension reduce identical amount, and vice versa.Operation prevents from turning when user's manipulation while gear assembly 168 and 174 154 He of cable is turned to first with relaxation when realizing the "horizontal" bending of the distal part 132 of introducer sheath 130 to lever 160 Second turns to the accumulation in any of cable 156.It is also in this way, wherein for the introducer sheath 1300 described in figure 3b The distal part 1320 that "horizontal" bending is introduced into introducer sheath 1300 is not caused equally to relax by manipulation steering lever 160 It is accumulated in the first steering cable 1540 and the second steering cable 1560, because when the tension in one for turning to cable increases When big, another turns to the tension in cable and reduces, and vice versa.

However, when user increases the distal part of introducer sheath 130 by increasing the tension of third steering cable 158 When 132 "vertical" bending, it is tired in cable 154 and/or the second steering cable 154 that this can cause relaxation to turn to first in turn Product.Equally, the tension of cable 1580 and the 4th steering cable 1520 is turned to by modulation third to modify introducer as user The distal part 1320 of sheath 1300 "vertical" bending (raised relative to horizontal plane or reduced direction on) when, this can be with And then relaxation is caused to be accumulated in the first steering cable 1540 and/or the second steering cable 1560.This relaxation accumulation can cause Operator is horizontally diverted lever (for example, above-described steering lever 160) and makes the first steering cable 154 attempting to use And/or second turn to cable 156 (or first turn to cable 1520 and/or second turn to cable 1580) in tension variation so as to It is undergone when modulating the "horizontal" bending of the distal part 132 (or distal part 1320 of introducer sheath 1300) of introducer sheath 130 Undesirable delay response.In order to prevent this situation, the introducer sheath component that turns to of present disclosure may include being used for Remove the mechanism of such relaxation.

For example, as shown in Fig. 7 A and Fig. 7 B, external thread rod 188 can connecting rod flange 400 to extend proximally It is characterized, by the connecting rod flange 400, the axial movement of external thread rod 188 is transferred to the first relaxation and removes component, this first Relaxation removes the flange chain that component includes the first linking arm 401, the second linking arm 402, associated supporting cylinder 406 Connect the linking arm link column 404 and associated supporting cylinder of column 403, associated supporting cylinder 407 408 linking arm holding post 405.More specifically, as best seen from, connecting rod flange 400 is by receiving flange chain in figure 7b The overlapping openings for connecing column 403 are attached to the distal end portion of the first linking arm 401；The proximal end of first linking arm 401 passes through the company of reception The overlapping openings for connecing arm link column 404 are attached to the distal end portion of the second linking arm 402；And second the proximal end of linking arm 402 contain There is an opening, one end of linking arm holding post 405 passes through the opening and is then placed on the inside of lower housing section 114 Linking arm holding post holder 410 in.First, which turns to cable 154, passes through this relaxation removal component threaded connection, such as passes through Fig. 7 B In dotted line shown in, wherein supporting cylinder 406-408 is configured to act as rotating freely around corresponding column 403-405 Roller, so as to be minimized with the friction for turning to cable 154.As being also shown in figure 7b, the second link cable 156 passes through equally quilt The the second relaxation removal component for being connected to link flange 400 is threadedly coupled, and it includes the first company that wherein second relaxation, which removes component, Connect flange the link column 413, associated branch of arm 411, the second linking arm 412, associated supporting cylinder 416 The linking arm link column 414 of cylindrical body 417 and the linking arm holding post 415 of associated supporting cylinder 418 are held, And these components link together as removing described in component above for first relaxation.

As best seen from, when making external thread rod 188 advance in a distal direction, linked 400 He of flange in figure 7b Relaxation remove component between interaction cause column 403-405 and 413-415 (and associated supporting member 406-408 and 416-418) become to be aligned in more linear mode, this allow for turn to cable 154 and 156 along from them in introducer sheath The shorter path of distal side attachment point in 130 to their nearside attachment points at gear assembly 168 and 174 is advanced.On the contrary, working as Make external thread rod 188 before in more proximal direction into when, link flange 400 and interaction that relaxation removes between component led Column 403-405 and 413-415 (and relevant supporting member 406-408 and 416-418) is caused to become with bigger triangular arrangement Alignment, wherein linking arm link column 404 and 414 links column 403 and 413 than flange and linking arm holding post 405 and 415 is obvious More towards the external positioning of handle 110.This triangular arrangement by cause turn to cable 154 and 156 along from they The longer path of distal side attachment point in introducer sheath 130 to their nearside attachment points at gear assembly 168 and 174 is advanced To remove the overrelaxation for carrying out low damage cable 154 and 156.Therefore, when make external thread rod 188 increase third turn to cable The proximal direction of tension (this increases in turn can lead to turn to the "vertical" bending that cable 154 and 156 becomes loose) on 158 When upper advance, above-described relaxation remove component be transferred to by increase cable 154 and 156 from their proximal gear component to The distance that the distal tip of introducer sheath 130 is advanced removes the triangular arrangement of overrelaxation.

Equally, that of "vertical" steering lever 360 (i) is used in combination with the introducer sheath 1300 described in figure 3b A little embodiments, wherein making the vertical rotation of steering lever 360 to modulate the "vertical" of the distal part 1320 of introducer sheath 1300 Bending (as discussed above and best exemplified in Fig. 6 B and Fig. 6 D), or for (ii) and the introducer sheath described in figure 3 a 130 are used in combination those of "vertical" steering lever 360 embodiment, make the vertical rotation of steering lever 360 to modulate introducer The "vertical" bending (the as discussed above and best exemplified in Fig. 6 B and Fig. 6 C) of the distal part 132 of sheath 130, to first turn Cable 1580 (coming from introducer sheath 1300) or the first steering cable 154 and/or second turn are turned to cable 1520 and/or second Potential relaxation into cable 156 (coming from introducer sheath 1300) introduces can be by the way that steering column 364 to be rotationally coupled to Relaxation removes component to solve.For example, one or more coupling bars or cable can be provided so that steering column 364 is connected to relaxation Component is removed, so that turning to cable when user rotates steering column 364 by using "vertical" steering lever 360 to increase third When tension (thus "vertical" bending for increasing the distal part 132 of introducer sheath 130) in 158, the coupling bar or cable Causing relaxation to remove component becomes to configure alignment with " triangle ", shows, is somebody's turn to do " triangle " as discussed above and in figure 7b Configuration is worked by leading to turn to cable 154 and 156 along from their attachments at the distal tip of introducer sheath 130 The longer path for putting the nearside attachment point to them at gear assembly 168 and 174, which is advanced, to move from steering cable 154 and 156 Except overrelaxation.On the contrary, being turned to when user rotates steering column 364 by using "vertical" steering lever 360 to increase third In cable 158 tension (thus reduce or eliminate the distal part 132 of introducer sheath 130 any "vertical" bending) when, institute Stating coupling bar or cable causes relaxation removal component to become to be aligned in more linear mode, shows as discussed above and in figure 7b , this allow to turn to cable 154 and 156 along from their distal side attachment points in introducer sheath 130 to them in gear set The shorter path of nearside attachment point at part 168 and 174 is advanced.

It can also include equipment locked component, the equipment locking group according to the introducer sheath component that turns to of present disclosure Part allows user selectively to insert the catheter into after having made the advance of introducer sheath (or retraction) to desired degree Instrument be fixed on the introducer it is intrathecal and with further to so adhered to conduit insertion instrument advance or retraction apply Add precise controlling.The instrument of such conduit insertion may include such as expander, and it is long to introduce standard by the expander The Bayliss RF of degree transseptal equipment (being available from Bayliss Medical, Montreal, Canada), Brockenbrough transseptal needle or other similar instrument.As can see in Figure 1A and Fig. 8 A- Fig. 8 D, for example, Such equipment locked component can be disposed in nearside aperture 124 (in Fig. 8 B and Fig. 8 C best seen from), the nearside Aperture 124 links together in the proximal side of upper case portion 112 and the proximal side of lower housing section 114 to form handle portion It is formed when 110.As also shown in Fig. 8 A- Fig. 8 D, which may include that equipment locking level (is schemed in Fig. 8 A- It is shown as 191a in 8C and is shown as 191b in Fig. 8 D), which passes through the proximal side of handle portion 110, Wherein the equipment locking level contains smooth centre bore (199), and the instrument for conduit insertion can pass through the smooth centre bore (199) it and is inserted into and can turn in introducer sheath (130,1300), and the equipment locking level is additionally configured to irremovable Mode changeably adhere to the instrument for conduit insertion.For example, as locked from the equipment shown in Fig. 8 B and Fig. 8 C What the description of bar 191a can most preferably be seen, in certain embodiments, which can be equipped with outer at its nearside Screw thread is inserted into the centre bore 199 of the equipment locking level in the instrument being inserted into for conduit to receive hemostasis bonnet (196a) When interior, the instrument for conduit insertion passes through the hemostasis bonnet (196a), to allow user by tightening or unscrewing Hemostasis bonnet 196a locks the apparatus selection for being used for conduit insertion is attached to equipment in a non-movable manner In bar 191a.Alternatively, as can be most preferably seen from the description to the equipment locking level 191b shown in Fig. 8 D, certain In embodiment, which can limit the distal side collet (collet) 194 with smooth exterior surfaces, allow using The apparatus selection for being used for conduit insertion is attached to by person in a non-movable manner by means of slide lock knob 196b In equipment locking level 191b, slide lock knob 196b defines smooth frusto-conical openings 181, the smooth frusto-conical openings 181 engage with collet 194 and are inwardly compressed collet 194, so that it is around the instrument for conduit insertion, (it is in Fig. 8 D Indicated by expander 159) it tightens.

In certain embodiments, it can provide in the following way to the instrument being inserted into for conduit (for example, Fig. 8 A With expander 159 shown in Fig. 8 D) advance (or retract) further control: by by equipment locking level (191a, It 191b) is configured to wear after adhering to the instrument for conduit insertion in a non-movable manner described above The proximal side for crossing handle portion 110 makes equipment locking level (191a, 191b) mechanically advance (or retraction).For example, such as in Fig. 8 A- Best exemplified, equipment locking level in Fig. 8 C (showing equipment locking level 191a) and Fig. 8 D (showing equipment locking level 191b) It can be configured as with the external screw thread 1923 engaged with the corresponding threaded hole (197) for passing through advance knob (195).Equipment lock External screw thread in fixed pole (191a, 191b) is (including the external screw thread engaged with threaded hole 197, and equipment locking level 191a's The external screw thread of engagement hemostasis bonnet 196a at proximal end) it can be continuous (that is, " carrying through to the end "), or such as (retouched in Fig. 8 E Drawn equipment locking level 191a) in best seen from, " flat part " of the interruption including the length positioning along external screw thread region 1925, in order to use injection moulding manufacturing technology.

It, can be by keeping flange rotatably to receive advance knob and being maintained at handle referring again to Fig. 8 A- Fig. 8 D It is described to keep flange that there is the diameter bigger than nearside aperture 124 from advance knob 195 in the nearside aperture 124 of part 110 Distal part radially extend.This radially extend keep flange can be it is continuous or discontinuous.For example, Fig. 8 D shows tool There is the continuous advance knob 195 for keeping flange (193b).Alternatively, Fig. 2 C is shown with before discontinuous holding flange Into the proximal view, side perspective view and distal view of knob 195, which includes the tab suspended outward 1926, the tab 1926 suspended outward limits flange of the radius greater than the radius in nearside aperture 124 together, thus really Advance knob 195 is protected to be axially retained in handle portion 110 (as can be most preferably seen in Fig. 2 D and Fig. 9 A).Such as may be used With what is most preferably seen in fig. 2 c, wherein advance knob (195) has a discontinuous holding flange, it can also include wearing Multiple ventilation holes 1927 of the proximal side of advance knob 195 are crossed, the multiple ventilation hole 1927 corresponds to the tab suspended outward 1926, and be dimensioned and be oriented that injection molding technology is easy to use to manufacture the advance knob.

As best seen from, the rotation of advance knob 195 causes equipment locking level (191a, 191b) in nearside in figure 9 a On direction (that is, towards user, as shown in figure 9 a, at the left side) or in a distal direction (that is, far from user, And arrive in handle portion 110, as shown in figure 9 a, locate on the right) it is mobile.In certain embodiments, equipment locking level (191a, 191b) and advance knob 195 can be set it is threaded so that the rotation of advance knob 195 in a counterclockwise manner is led Equipment locking level (191a, 191b) is caused to move in a proximal direction, and the rotation of advance knob 195 in clockwise manner causes to set Standby locking level (191a, 191b) is moved in a distal direction；In other embodiments, before screw thread is configured such that this The equipment locking level is caused to move in a proximal direction into the rotation of knob in clockwise manner, and the advance knob is with counterclockwise The rotation of mode causes the equipment locking level to move in a proximal direction.Therefore, engagement equipment locked component 192 (its for Equipment locking level 191a shown in Fig. 9 A will need to tighten hemostasis bonnet 196a) to adhere to the instrument for conduit insertion After (for example, expander (159) shown in Fig. 8 A and Fig. 8 D), user can be practiced by being rotationally advancing knob 195 Accurate control to the advance of the distal tip of the instrument for conduit insertion, so as to cause the equipment locking level (and That axially adheres to is used for the instrument of conduit insertion) (instrument is made to extend towards and/or pass through the introducer sheath in a manner of distal side Distal tip) or (expander to be made to pass through and/or recall far from the distal tip of introducer sheath) in a manner of nearside mobile.This into And convenient for executing exquisite operation (such as, piercing through atrial septum film) in very controlled mode.

It can also include guided inside part that this, which can turn to introducer sheath component, to prevent when rotating advance knob 195 Rotate the equipment locking level irrelevantly around axis 102 together with advance knob 195, this ensures in turn before user's manipulation The equipment locking level is in a manner of appropriate distal side when into knob 195 or nearside mode is moved along axis 102.Such as in Fig. 9 A and figure In 9C best seen from, for example, guided inside part 1950 may include flat cross distal base with a central hole, in this Heart hole is limited by the hollow columnar bar extended in proximal direction.As in figures 9 b and 9 best seen from, guided inside part 1950 Cross base portion to cause it to be placed in a rotationally fixed manner parallel convex by one group of parallel flanges 1927 and corresponding one group In the guiding channel that edge 1928 limits, this group of parallel flanges 1927 extend internally from the inside face of up knob part, this is corresponding One group of parallel flanges 1928 extends internally from the inside face of lower handle portion 114.The proximal end of guided inside part 1950 is also matched It is set to and the equipment locking level is engaged with rotation-fixed manner.For example, as in Fig. 9 C best seen from, guided inside part 1950 with Engagement between the equipment locking level can be by one or more impressions for showing at the distal end portion of locking level 191a (1930) it mediates, one or more of impressions prolong with from the base portion of guided inside part 1950 to nearside with rotation-fixed manner The one or more flank boss (flanking boss) 1929 stretched engage.By this method, it prevents from working as and makes 195 turns of advance knob Make the guided inside part and external thread rod moving in rotation when dynamic, and therefore equipment locking level is restricted to along the suitable of axis 102 When distal movement or proximal movement.

In certain embodiments, handle portion 110 may include provide about hemostasis introducer valve 190 with have already passed through Stop blooding introducer valve 190 insertion and enter introducer sheath 130 equipment inner cavity 140 in expander 159 (or other conduits insertion Instrument) between sealing integrality visual confirmation feature.As best seen from, this can be by upper in fig. 8 a Opening 1931 in housing parts 112 realizes that the opening 1931 is positioned to the nearside side of steering handle 160 and provides one " window " can check the distal face of hemostasis introducer valve 190 by " window ".By inspecting periodically window 1121, use The hemostasis that person can readily recognize between hemostasis introducer valve 190 and expander 159 (or equipment of other conduits insertion) is close Envelope has become impaired sign (leakage including air, blood or other fluids), and takes an immediate action to correct the feelings Shape.The degree that the speed and expander that window 1931 can also allow for user that expander is made to advance have been advanced is visual Change, and for this purpose, the outer surface of expander (or other are used for instruments of conduit insertion) can be with can pass through window 1931 classifications checked mark, and are had progressed to providing expander (or other are used for instruments that conduit is inserted into) to user The instruction of the degree of introducer intrathecal (or pass through introducer sheath and retract).

Certain embodiments of the present invention may include for improving during operation across introducer sheath 130 for leading The feature of the ultrasonic visualization of the instrument of pipe insertion.Under identical image-forming condition, in given background media or tissue, with Instrument without such feature is compared, and it is quantitatively " more than ultrasound image that the instrument for being included in such feature, which is seen, It is bright ", and therefore observed during more easily use.This makes user be easier to make placement and the mobile visible of the instrument Change, this is allowed for coming with higher safety and validity using the instrument, especially ought be used for conduit under discussion The instrument of insertion have sharp point or edge or may cause during use injury other features when (for example, for The bevelled point of the tool of expander 150 shown in Fig. 8 C and Fig. 8 D, situation is in this way).

In certain embodiments, the feature for improving ultrasonic visualization may include to according to present disclosure The interior surface of instrument and/or the framework of outer surface for conduit insertion that introducer sheath component is combined can be turned to change Type (" ultrasonic visualization remodeling ").These ultrasonic visualizations remodeling may include will at the position for being especially desired to enhancing visibility One or more recess or protrusion are introduced into the instrument for conduit insertion.For example, ultrasonic visualization remodeling may include total Body, which shows as the dotted recess of one or more of a group " point " or protrusion, group's " point ", irregularly to be dispersed or with certain The configuration packet or arrangement of rule.Ultrasonic visualization remodeling can also include the longitudinal center axis of instrument relative to remodeling with Vertically, in parallel, one or more linear grooves for extending of angled or spiral way or convex ridge.

In certain embodiments, ultrasonic visualization remodeling can be only introduced into and a reality according to present disclosure Apply the interior surface for turning to the instrument for conduit insertion that introducer sheath component is combined of scheme.By ultrasonic visualization Remodeling, which is placed on instrument surface, allows to keep external instrument smooth surface and without irregular, and to which help to prevent may be By external irregular during introducing, manipulating and/or recalling the instrument for conduit insertion with external ultrasound visualization modification Caused damage or undesirable change to surrounding tissue.It is equally anti-that ultrasonic visualization remodeling is restricted to interior instrument surface Only such modification becomes to change or reduce themselves and with potentially damage performance contact in efficiency, and also prevents Probably due to contacting the thus knot for turning to introducer sheath component receiving by present disclosure with the external instrument surface of remodeling Structure damage or function inhibitio are (including for example to introducer sheath and/or being used in the concentration " equipment " that passes through of instrument of conduit insertion The damage of inner cavity).

Ultrasonic visualization remodeling may include the physics change or structure change to instrument, and the physics change or structure are more Change subjective improvement or the objective improvement of the ultrasonic visibility for leading to the instrument retrofited compared with the instrument that do not retrofit.Subjectivity improves can With include when under the same conditions visually compared with the instrument do not retrofited when using ultrasonic visualization remodeling instrument " more It is bright " or otherwise more different appearances.For example, as discussed further below, Figure 10 B is depicted according in the disclosure Ultrasound image (the image of bottom left of the distal tip of the expander with improved visualization feature of the embodiment of appearance With the image of bottom right), the ultrasound image relative to viewing at identical conditions in identical background media Seem the distal tip (image and the image on the right of top of top left) of the expander of the prior art qualitatively " brighter ".It examines Consider this, can be used and any of on inspection and compared using comparable ultrasonic technique and item for obtaining and analyzing Part is (for example, MA McCulloch et al., " Limitations of Echocardiographic Periarterial Brightness in the Diagnosis of Kawasaki Disease ", Journal of The American Society of Echocardiography 768-770 (2005)) view the subjective appearance of test object it is personal The method of subjective observation, to confirm determining for the ultrasonic visibility with the instrument retrofited according to the ultrasonic visualization of present disclosure Property improve.For example, when (i) has the instrument retrofited according to the ultrasonic visualization of present disclosure and (ii) without such The instrument of remodeling is inserted into standardization body or tested media, the manipulation and from standardization in standardization body or medium Tissue or test organization be when recalling, can obtain (i) have the instrument retrofited according to the ultrasonic visualization of present disclosure and (ii) a series of ultrasonic imaging sessions of the instrument without such remodeling.The video clipping of these imaging sessions then can be with (it is removed or masked that any of them potentially identifies information) is randomly edited, and by being invited to each instrument being so imaged The person skilled in the art of qualitative " brightness " of device or " dissimilarity " classification is (for example, have the experience using instrument under discussion Interventional Radiography doctor, ultrasonic technique person, cardiologist or other expert physicians) independently assess.Evaluator point Grade is checked and processed, and applied statistical method (such as, the kappa coefficient of Cohen and the examination of Wilcoxon sum of ranks) is with true Recognize whether the instrument with ultrasonic visualization remodeling seems than not having the instrument of such remodeling subjectively " brighter " or more It is different.

Opposite in ultrasonic visualization improves can also be by for quantifying and comparing the instrument by retrofiting and do not retrofit The known method for the ultrasonic signal that instrument returns determines, the known method includes being designed to from from control and test article The ultrasonic echo signal of return extracts the signal processing and measuring technique of information.For example, D.Dalecki et al. is identified and is retouched recently Some exemplary " high frequency quantitative ultrasound techniques, including elastogram, for structure, biology and the machinery of engineering construction are stated The qualitative assessment of attribute provides measurement " (D.Dalecki et al., Quantitative Ultrasound for Nondestructive Characterization of Engineered Tissues and Biomaterials, 44ANN.BIOMED.ENG ' G, 636-648 (2016)).It can be advanced optimized by implementing computer aided diagnosing method The use of these technologies, the computer aided diagnosing method include such as machine learning algorithm, as being used by J.Y.Wu et al. Those of " train classifier and be normal VS. abnormal by image labeling based on the identification feature of image " machine learning is calculated Method (J.Y.Wu et al., Quantitative analysis of ultrasound images for computer-aided Diagnosis, 3J.MED.IMAGING, 014501-1-014501-9 (2016)).For this purpose, many commercially available software packages It can be used together with commercial ultrasound system with identification, be isolated and quantify various picture characteristics.For example, being available from The advanced quantization software of the QLAB of Philips Medical System (Advanced Quantification Software) can To be used in combination with commercial ultrasound system, in order to Analysis of echocardiography (I.S.Salgo, the Clinical of structure and function benefits of QLAB software for advanced 2D and 3D echo quantification, Koninklijke Philips Electronics N.V.(2006))。

In view of above-described quantification tool and method (and this field it is also known that other quantification tools and side Method), when the instrument that (i) there is the instrument retrofited according to the ultrasonic visualization of present disclosure and (ii) not to have such remodeling Be inserted into standardization body or tested media, in standardization body or tested media manipulation and from standardization body or When tested media is recalled, can by obtain first (i) have instrument retrofit according to the ultrasonic visualization of present disclosure with (ii) do not have the ultrasonic imaging session of the instrument of such remodeling to confirm the ultrasound of the instrument with ultrasonic visualization remodeling The quantitative improvement of visibility.For quantitative analysis, these imaging sessions are extracted by the expert being skilled in technique or clinician Video clipping and for formed the implicit ultrasound information of image for analysis.For example, analyst can be by limiting containing The interested region in part (ROI) of ultrasonic visualization remodeling instrument is had received to start, possibly in standardization body or survey It so does at defined position in examination medium or in the time limited in advance (for example, the three phases for experiment (are inserted into Manipulated in standardization body or tested media, in standardization body or tested media) in one ROI of each restriction).Have The technology of referred to as densitometry can be used the implicit ultrasound by ROI circular image is isolated in the ROI of restriction, analyst Information.To which the implicit relevant portion corresponding to instrument be isolated (that is, wherein adding or being not added with ultrasonic visualization modification Part) ROI original acoustic information, and this original acoustic information then can be processed to provide to receive ultrasonic visible Change qualitative assessment of those of the remodeling for the structure of the instrument of conduit insertion, biology and mechanical attributes, and by them and not The instrument that those of such remodeling is received for conduit insertion compares.These tests are checked and processed, and answer when necessary It is repaired with confirming with without ultrasonic visualization with statistical method (such as, the kappa coefficient of Cohen and the examination of Wilcoxon sum of ranks) The instrument changed compares, with having the instrument quantitative of ultrasonic visualization remodeling " brighter " or more different, or relative in isolation Other visual characteristics of some reflected in ultrasound data quantitatively improve.

As described above, ultrasonic visualization remodeling may include being generally represented as a group " point " or showing as relative to remodeling The instrument for conduit insertion extended with vertical, parallel, angled or spiral way one or more of longitudinal center axis The dotted recess of the one or more of a linear grooves or convex ridge or protruding portion.Linear grooves for improving ultrasonic visualization can be with Continuous, or by smaller segment (themselves can by it is continuous it is end-to-end in a manner of link or slightly separated but still formed The linear groove of observable) composition.For example, Figure 10 A, which is depicted, turns to introducer sheath component one with present disclosure The expander (1920) for conduit insertion risen, wherein the expander has 0.033 inch of distal openings, wherein described Opening increases at least 0.057 inch of maximum diameter of bore (note that figure as the expander extends in a distal direction The representative that 10A provides expander not in scale is described).As shown in Figure 10 A, expander embodiment (1920) It has been modified by by the way that three longitudinal grooves (1906) are introduced into the internal bore surface of distal tip (1908) nearby (1907) Lai Gaishan ultrasonic visualization, wherein the groove is separated from each other in a radial manner around inner hole, 120 degree of settings (are such as being schemed In 10A best seen from, upper left side illustration), and with step side on the distal side to proximal direction also parallel with longitudinal axis 102 Formula extend parallel to each other (as in Figure 10 A best seen from).The each tool being introduced into three grooves of expander 1920 There are 0.012 inch of recess width (1909) and 0.375 inch of total groove length (1109), total groove length (1910) quilt Six equal steps of end-to-end connection are further subdivided into, wherein each step has 0.0625 inch of groove length of bench (1911) and 0.003 inch groove step depth (1912) (such as in Figure 10 A best seen from (on the right of main body and top Illustration)).

Ultrasonic visualization remodeling including retrofiting similar with those ultrasonic visualizations shown in Figure 10 A is convenient for using The instrument visualization of conduit insertion is used in during the operation that ultrasonic imaging carries out.This can see in fig. 1 ob, and Figure 10 B is retouched The introducing (top left) and removal (top right in the expander (it is modified without containing ultrasonic visualization) of the prior art are drawn Side) during obtain ultrasound image, and illustrated in Figure 10 A expander (1920) (it include be in above-described step The ultrasonic visualization of the form of groove is retrofited) introducing (bottom left) and the ultrasound that obtains during removing (bottom right) scheming Picture.With the appearance (expansion from the prior art for passing through the distal side expander tip that arrow 1910 and 1911 indicates in Figure 10 B Device) compare, the appearance of the distal side expander tip indicated by arrow 1912 and 1913 is (from the description in Figure 10 A and originally The expander for " stepped recesses " the ultrasonic visualization remodeling that text discusses) significantly increasing for brightness is shown, this is as from distal side Series of parallel " striped " observable that the above the fold of tip extends downwardly.This brightness increased is convenient in turn using super The distal tip of expander is visualized during the operation that acoustic imaging carries out.

In certain embodiments, expander 159 can also be included in barium impregnated polymer, which can be (for example, turning to introducer sheath component using according to an embodiment of present disclosure) enhancing should when introducing expander The fluorescence visibility of expander.

Claims

1. a kind of introducer sheath component, it is characterised in that:

A handle part a comprising distal end portion and a proximal end；

One introducer sheath, extends outwardly from the distal end portion of the handle portion, which includes:

One equipment inner cavity is configured as slideably received within a corresponding equipment；

First, which turns to cable lumen, the second steering cable lumen and third, turns to cable lumen；

Be attached at the distal end portion of the introducer sheath and be disposed in this first turn to cable lumen in first turn to cable, Be attached at the distal end portion of the introducer sheath and be disposed in this second turn to cable lumen in second turn to cable and It is attached at the distal end portion of the introducer sheath and is disposed in the third that the third turns in cable lumen and turn to cable,

Wherein the first steering cable lumen, the second steering cable lumen and the third turn to cable lumen out of this equipment Chamber radially outward arranges, wherein the first steering cable lumen and the second steering cable lumen, which are positioned in, extends through this and set On the opposite side of the perpendicular of standby inner cavity and the third cable lumen；

First steering assembly is disposed in the handle portion, which includes the close of the first steering cable The element that the proximal end of element and the second steering cable that side is attached to is attached to；

First steering lever is disposed on the outer surface of the handle portion and is attached to the first of the first steering column End, wherein first steering column has second end, which engages with first steering assembly, so that making the steering lever Around first steering column longitudinal axis rotation lead to first steering assembly and meanwhile modify this first turn to cable with this second Turn to the tension in cable；

Second steering assembly is disposed in the handle portion, the third turn to cable proximal end be attached to this second Steering assembly；And

Second steering lever is disposed on the outer surface of the handle portion and is attached to the first of the second steering column End, wherein second steering column has second end, which engages with second steering assembly, so that making the steering lever Longitudinal axis rotation around second steering column causes second steering assembly to modify the tension in third steering cable.

2. introducer sheath component according to claim 1, it is further characterized in that:

First lever realizes orientation of the tip of the introducer sheath in the first three-dimensional planar；And

Second lever realizes orientation of the tip of the introducer sheath in the second three-dimensional planar.

3. introducer sheath component according to claim 1, wherein at least one steering lever can be selectively positioned In latched position or unlocked position, in the latched position, this steering lever is fixed non-rotatably to the handle portion； In the unlocked position, this steering lever can be made to rotate relative to the handle portion.

4. introducer sheath component according to claim 1, its corresponding steering assembly of wherein at least one steering lever Engagement, so that the positioning of the lever provides the directionality and size for shifting the introducer sheath from its longitudinal center axis Instruction.

5. introducer sheath component according to claim 1, wherein at least one steering lever, steering column and steering assembly it Between engagement mediated by one or more gears, one or more of gears can be adjusted to modify when making the steering thick stick The degree for shifting the introducer sheath from its longitudinal center axis when bar is around the longitudinal axis rotation of its corresponding steering column.

6. introducer sheath component according to claim 1, wherein at least one steering assembly draw with one perpendicular to this Enter the steering column engagement being located in the handle portion in the orientation of the longitudinal axis of device sheath.

7. a kind of introducer sheath component, it is characterised in that:

A handle part a comprising distal end portion and a proximal end；

One equipment inner cavity is configured as slideably received within a corresponding equipment,

First, which turns to cable lumen, the second steering cable lumen, third, turns to cable lumen and the 4th steering cable lumen；

Be attached at the distal end portion of the introducer sheath and be disposed in this first turn to cable lumen in first turn to cable, Be attached at the distal end portion of the introducer sheath and be disposed in this second turn in cable lumen second turn to cable, attached At the distal end portion of the introducer sheath and be disposed in the third that the third turns in cable lumen and turn to cable and attached At the distal end portion of the introducer sheath and be disposed in the 4th steering cable lumen in the 4th turn to cable,

Wherein the first steering cable lumen, the second steering cable lumen, the third turn to cable lumen and the 4th turn It is radially outward arranged to cable lumen from the equipment inner cavity, wherein the first steering cable lumen and the second steering cable lumen It is positioned on the opposite side for the perpendicular that the longitudinal center axis of the introducer sheath is located at, and the third turns in cable Chamber and the 4th steering cable lumen are positioned in the opposite of the horizontal plane that the longitudinal center axis of the introducer sheath is located at On side；

Second steering assembly is disposed in the handle portion, which includes that the third turns to the close of cable The element that the proximal end of element and the 4th steering cable that side is attached to is attached to；And

Wherein first steering assembly can be manipulated to modify simultaneously in the first steering cable and the second steering cable Tension, and second steering assembly can be manipulated to modify in third steering cable and the 4th steering cable simultaneously Power.

8. introducer sheath component according to claim 7, it is further characterized in that:

First steering assembly realizes orientation of the tip of the introducer sheath in the first three-dimensional planar；And

Second steering assembly realizes orientation of the tip of the introducer sheath in the second three-dimensional planar.

9. introducer sheath component according to claim 7, wherein second steering assembly further include:

One distal side cap is rotatably disposed in an aperture of the distal end portion of the handle portion, and

One external thread rod, pass through the distal side cap in a corresponding threaded central aperture, wherein the external thread rod with should The proximal end that third turns to the proximal end of cable and the 4th turns to cable engages；

Wherein the distal side cap causes the external thread rod in the longitudinal direction for being parallel to the introducer sheath relative to the rotation of the external thread rod It is moved in the proximal direction or distal direction of central axis；And

The tension that wherein rotation of the distal side cap causes the third to turn in cable and the 4th steering cable in turn is repaired simultaneously Change.

10. introducer sheath according to claim 9, wherein the external thread rod further includes that at least one is axially extending narrow Slot, the interior surface of at least one axially extending slit engagement from the handle portion is outstanding, and at least one is axially extending Flange so that when make the distal side cap relative to the external thread rod rotation when, which is merely able to be parallel to the introducing It is moved in the proximal direction or distal direction of the longitudinal center axis of device sheath.

11. introducer sheath according to claim 9, wherein the distal side cap is further characterized in that the component suspended outward, institute It states the component suspended outward and limits a discontinuous radial flange jointly, the radius of the discontinuous radial flange is greater than this The radius in the distal side aperture in hand portion, wherein the discontinuous radial flange allows rotatably to pacify the distal side cap Set and in the distal side aperture that is maintained in the handle portion, and wherein the flange by the opening across the distal side cap at Mirror image.

12. introducer sheath component according to claim 7, wherein at least one steering assembly is terminated by the second of a column It closes, wherein the column has first end, which, which is attached to one and is arranged on the outer surface of the handle portion, turns To lever, so that the steering lever is made to lead to the steering assembly while modify to be attached to around the longitudinal axis rotation of the column The tension of the steering assembly turned in cable.

13. introducer sheath component according to claim 12, wherein at least one steering lever can be by selectively fixed Position is in latched position or unlocked position, and in the latched position, this steering lever is fixed non-rotatably to the handle portion Point；In the unlocked position, this steering lever can be made to rotate relative to the handle portion.

14. introducer sheath component according to claim 13, its corresponding steering group of wherein at least one steering lever Part engagement, so that the positioning of the lever provides the directionality and size that shift the introducer sheath from its longitudinal center axis Instruction.

15. introducer sheath component according to claim 14, between wherein at least one steering lever, column and steering assembly Engagement mediated by one or more gears, one or more of gears can be adjusted to modify when making the steering lever The degree for shifting the introducer sheath from its longitudinal center axis when around the longitudinal axis rotation of its corresponding column.

16. introducer sheath component according to claim 15, wherein at least one steering assembly and one are perpendicular to this The steering column engagement being located in the orientation of the longitudinal axis of introducer sheath in the handle portion.

17. a kind of introducer sheath component, it is characterised in that:

A handle part a comprising distal end portion and a proximal end；

At least one radially outward arranged from the equipment inner cavity turns to cable lumen；

At least one turns to cable, is attached at the distal end portion of the introducer sheath, is disposed at least one described steering The steering assembly in cable lumen and being arranged in the handle portion with one engages；

One or more steering levers are disposed on the outer surface of the handle portion and are attached to a steering column First end, wherein the steering column has second end, which engages a steering assembly, so that making the steering lever around this The longitudinal axis rotation of steering column leads to the tension at least one described steering cable of steering assembly modification；And

Wherein at least one steering lever is to limit the degree that the steering lever can be made to rotate around the longitudinal axis of the steering column Mode either directly or indirectly engaged with the surface of the handle portion.

18. introducer sheath component according to claim 17, wherein between the steering lever and handle portion surface, limit The engagement for the degree that system can enable the steering lever rotate is adjusted by user to increase or reduce and can make the steering thick stick The degree of bar rotation.

19. a kind of introducer sheath component, it is characterised in that:

A handle part a comprising distal end portion and a proximal end；

Engagement between wherein at least one steering lever and the outer surface of the handle portion by one at least partially around The dome cap of the steering lever mediates, wherein the corresponding forming that the dome cap is placed in the outer surface of handle In recess.

20. introducer sheath component according to claim 19, wherein the surface of the dome cap includes and the handle portion At least one structure feature of at least one structure feature engagement on outer surface, can make the steering lever around it with limitation The degree of the longitudinal axis rotation of steering column.

21. introducer sheath component according to claim 20, wherein the degree that limitation can be such that the steering lever rotates At least one of structure feature can be adjusted by user to increase or reduce and the steering lever can be made around its steering column The degree of longitudinal axis rotation.

22. introducer sheath component according to claim 19, wherein the dome cap is engaged with the steering lever, ought make The steering lever provides guiding and knot when rotating around the longitudinal axis of its steering column and it is made to go to unlocked position from latched position Structure support.

23. a kind of introducer sheath component, it is characterised in that:

A handle part a comprising distal end portion and a proximal end；

One is configured as the equipment inner cavity slideably received within a corresponding equipment；

At least two radially outward arranged from the equipment inner cavity turn to cable lumen；

Be attached at the distal end portion of the introducer sheath and be disposed in it is described at least two turn to cable lumen at least two A steering cable；

First steering assembly is disposed in the handle portion, which includes at least two steerings cable At least one of line turns to the element that the proximal end of cable is attached to；And

Second steering assembly is disposed in the handle portion, which includes at least two steerings cable At least one of line turns to the element that the proximal end of cable is attached to；

Wherein first steering assembly can be manipulated to the tension turned in cable that modification is attached to it, and second steering Component can be manipulated to the tension turned in cable that modification is attached to it；And

One relaxation removes component, to turn to cable from least one steering assembly being attached in the steering assembly At least one of turn to cable and remove overrelaxation, be manipulated to modify the steering cable of its attachment in another steering assembly At least one of turn to cable in tension in the case where.

24. introducer sheath component according to claim 23, wherein the relaxation removes component further include:

First link arm,

Second link arm, and

First column；

Wherein first link arm is rotatably linked to second link arm via a fastener, second link arm via One fastener is rotatably linked to first column, and at least one steering assembly and first link arm, this second links Arm and first column engage, to turn to cable from least one of the cable that turns to for being attached to another steering assembly and removed Degree relaxation.

25. a kind of introducer sheath component, comprising:

A handle part a comprising distal end portion and a proximal end；

One introducer sheath, extends outwardly from the distal end portion of the handle portion, which is configured as including one can Slidably receive the equipment inner cavity of a corresponding equipment；

One equipment locked component, is disposed at the rear end of housing parts, which includes:

One equipment locking level limits an axially extending hole being identified into slideably received within the corresponding equipment, The equipment locking level can be moved axially relative to the handle portion；

One fixture is disposed on the equipment locking level, which is selectively located latched position reconciliation lock-bit In setting, in the latched position, it is axially fixed the corresponding equipment relative to the equipment locking level, in the unlocked position In, which can slide in the axially extending hole of the equipment locking level；

Wherein the equipment locked component further includes an advance knob, which is fixed axially and can be relative to master The handle portion of body portion rotates, wherein the advance knob further includes a threaded hole, which is connected by accordingly screw thread It is connected to the outer surface of the equipment locking level, the threaded hole of the equipment locking level and the advance knob can be connected by screw thread It connects；And

Wherein the equipment locking level is also engaged with a bar guide, which is placed in the handle portion to prevent Only rotate when knob is rotated the locking level.

26. introducer sheath component according to claim 25, wherein the bar guide further includes having dagger Guide member, the dagger lead to that the guide member is placed in a guiding channel with rotation-fixed manner, the guiding Channel is limited by the parallel flanges extended from least one inside face of the handle portion.

27. a kind of introducer sheath component, comprising:

A handle part a comprising distal end portion and a proximal end；

One equipment locking level limits an axially extending hole being identified into slideably received within the corresponding equipment, The equipment locking level can be moved axially relative to the handle portion,

Wherein the equipment locked component further includes an advance knob, which is fixed axially and can be relative to master The handle portion of body portion rotates, wherein the advance knob further includes a threaded hole, which is connected by accordingly screw thread It is connected to the outer surface of the equipment locking level, the threaded hole of the equipment locking level and the advance knob can be connected by screw thread It connects；And the external screw-thread on the outer surface of the equipment locking level includes flat part that is parallel, interrupting.

28. a kind of introducer sheath component, comprising:

A handle part a comprising distal end portion and a proximal end；

One advance knob, the advance knob are fixed axially and can rotate relative to the handle portion of main part, Described in advance knob further include a threaded hole, which is accordingly threadedly coupled to the external table of the equipment locking level The threaded hole in face, the equipment locking level and the advance knob can be connected through a screw thread；

Wherein the advance knob is further characterized in that the component suspended outward, the component suspended outward limit one not jointly Continuous radial flange, the radius of the discontinuous radial flange are greater than the radius in the distal side aperture in the handle portion, Wherein the discontinuous radial flange allows rotatably to dispose advance knob and be maintained at described in the handle portion In the aperture of distal side, and wherein the flange by being mirrored into across the opening of the advance knob.

29. a kind of introducer sheath component, it is characterised in that:

A handle part a comprising distal end portion and a proximal end；

At least one turns to cable, is attached at the distal end portion of the introducer sheath, is disposed at least one described steering The steering assembly in cable lumen and being arranged in the handle portion with one engages, wherein the steering assembly can modify institute It states at least one and turns to the tension in cable；

One torque drive lock is prevented when being modified the tension at least one described steering cable using the steering assembly Rotate the introducer sheath around longitudinal center axis.

30. introducer sheath component according to claim 29, wherein torque drive lock, which further includes one, has and is enough to wrap The hollow cylinder of the inside diameter of the radial diameter of the introducer sheath is enclosed, and can be extended with a face from the handle portion The engagement of at least one counter structure to prevent from making, torque drive lock rotates around the longitudinal axis of the introducer sheath at least one A structure.

31. a kind of introducer sheath component, comprising:

A handle part a comprising distal end portion and a proximal end；

One introducer sheath, extends outwardly from the distal end portion of the handle portion, which is configured as including one can Slidably receive the equipment inner cavity of a corresponding equipment；And

One aperture in the handle portion, the aperture allow user that the corresponding equipment has been received the introducing Intracavitary point visualization in the equipment of device sheath.

32. introducer sheath component according to claim 31, which is characterized in that the corresponding equipment contains label, described Label can be visualized by the aperture, have been inserted into the introducer sheath to provide the corresponding equipment to user The instruction of intracavitary degree in the equipment.

33. introducer sheath component according to claim 31, wherein the equipment inner cavity of the introducer sheath is corresponding with this Connection between equipment is mediated by balanced valve.

34. a kind of introducer sheath component, comprising:

A handle part a comprising distal end portion and a proximal end；

Wherein the corresponding equipment includes one or more remodeling for improving ultrasonic visualization.

35. introducer sheath component according to claim 34, wherein one or more improve the remodeling position of ultrasonic visualization At the distal part of the corresponding equipment.

36. introducer sheath component according to claim 34, wherein one or more improve the remodeling packet of ultrasonic visualization Include one or more dotted recess or protrusion.

37. introducer sheath component according to claim 34, wherein one or more improve the remodeling packet of ultrasonic visualization Include one or more extended relative to the longitudinal center axis of the corresponding equipment with vertical, parallel, angled or spiral way A linear grooves or convex ridge.

38. introducer sheath component according to claim 34, wherein one or more improve the remodeling position of ultrasonic visualization In in the interior surface of the corresponding equipment.

39. introducer sheath component according to claim 34, wherein the corresponding equipment is that have a hollow axial hole Expander, which contains one or more remodeling for improving ultrasonic visualizations, and these remodeling are located at the hollow axial direction In the interior surface in hole.

40. introducer sheath component according to claim 39, wherein one or more improve the remodeling position of ultrasonic visualization Near the distal tip of the expander.

41. introducer sheath component according to claim 40, wherein one or more improve the remodeling packet of ultrasonic visualization Include one or more dotted recess or protrusion.

42. introducer sheath component according to claim 40, wherein one or more improve the remodeling packet of ultrasonic visualization One or more linear grooves or convex ridge are included, one or more of linear grooves or convex ridge are relative in the longitudinal direction of the expander Mandrel line is extended with vertical, parallel, angled or spiral way.

43. introducer sheath component according to claim 40, wherein one or more improve the remodeling packet of ultrasonic visualization At least one linear grooves extended in parallel relative to the longitudinal center axis of the expander are included, wherein described at least one A linear grooves have about 0.012 inch of width and up to about 0.003 inch of depth of groove.

44. introducer sheath component according to claim 43, wherein at least one described linear grooves have about 0.375 The total length of inch.

45. introducer sheath component according to claim 43, wherein at least one described linear grooves are further segmented At the equal step of end-to-end connection, wherein each step has about 0.0625 inch of length.

46. introducer sheath component according to claim 43, further include along the expander inner hole equidistant interval extremely Few two linear grooves.