CN115068056A - Dilator assembly suitable for self-expansion device and dilator pushing method - Google Patents
Dilator assembly suitable for self-expansion device and dilator pushing methodDownload PDFInfo
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- CN115068056A CN115068056ACN202210583564.7ACN202210583564ACN115068056ACN 115068056 ACN115068056 ACN 115068056ACN 202210583564 ACN202210583564 ACN 202210583564ACN 115068056 ACN115068056 ACN 115068056A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/34—Trocars; Puncturing needles
- A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0082—Catheter tip comprising a tool
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22001—Angioplasty, e.g. PCTA
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22072—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/34—Trocars; Puncturing needles
- A61B2017/347—Locking means, e.g. for locking instrument in cannula
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0082—Catheter tip comprising a tool
- A61M2025/0096—Catheter tip comprising a tool being laterally outward extensions or tools, e.g. hooks or fibres
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A61M2025/0293—Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/12—Blood circulatory system
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Abstract
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to an expander assembly suitable for a self-expansion device and an expander pushing method.
Background
Deep Venous Thrombosis (DVT) is a blood reflux disorder disease caused by abnormal coagulation, is a very dangerous disease, can cause femoral bruise and pulmonary embolism, even has serious consequences such as shock, venous gangrene and death, and particularly is pulmonary embolism which can enter pulmonary artery along blood flow when the thrombus falls off to cause pulmonary embolism, acute pulmonary embolism is often easy to misdiagnose and miss-diagnose, and the death rate is 20 to 30 percent. According to a series of studies, the use of a venous thrombectomy device is a timely and effective treatment method. The thrombus removal catheter system is mainly used for establishing a passage through a catheter sheath and an expander, sending the thrombus removal catheter system into a blood vessel, unfolding the thrombus removal system, dragging the thrombus removal catheter, pulling out condensed blood clots out of the body, and removing residual thrombus through a suction device. The existing clinical data show that compared with other thrombus taking modes, the vein thrombus taking device is easier to operate, shortens the operation time, has high treatment effectiveness, reduces the bleeding rate and reduces the pain degree of patients.
The existing vein thrombus taking device on the market needs to be matched with a dilator for use in clinical use, and is used for fixing a sheath and hiding a self-expansion device at the tail end of the sheath. However, when vein thrombus taking is carried out, after the dilator enters a human body, the dilator is easy to slide and influence the release of the self-expansion device because the outer diameter of the dilator is smaller than that of the guiding sheath, so that the wall of a blood vessel is easy to be damaged, and certain risk is brought to the operation; devices for removing other obstructions from a patient's body lumen, such as a tubular graft, arterio-venous fistula, endovascular, also face similar problems.
Therefore, there is a need to provide an improved solution to the above-mentioned deficiencies of the prior art.
Disclosure of Invention
The invention aims to provide a dilator assembly suitable for a self-expansion device and a dilator pushing method, so as to solve the problem that uncontrollable sliding is easy to occur in the use process of a dilator.
In order to achieve the above purpose, the invention provides the following technical scheme: an expander assembly suitable for use in a self-expanding device comprising a pusher bar, an impeller housing, and an expander; a plurality of locking pieces are arranged on the circumference of the pushing rod; the proximal end of the dilator is connected with the pushing rod, and the distal end of the dilator extends out of the pusher shell; the dilator is characterized in that a guide rail for accommodating the pushing rod is arranged in the pusher shell, a mounting hole communicated with the guide rail is formed in the pusher shell, a first limiting part is arranged in the mounting hole, and the first limiting part is matched with the end part of the pusher shell to stop the locking part, so that the dilator and the pusher shell are locked with each other.
Preferably, a first locking piece, a second locking piece and a third locking piece are arranged on the circumference of the pushing rod; the first locking piece and the second locking piece are locked with the pusher shell before the distal end of the dilator reaches a blood vessel set position; the first and third locking members lock with the pusher housing after the self-expanding device is released.
Preferably, the first limiting part is used for stopping the first locking part or the third locking part; a near end plate is arranged at the near end of the pusher shell, and a near end through hole allowing the third locking piece and the pushing rod to pass through is formed in the near end plate; in the direction perpendicular to the axis of the push rod, the second locking piece is arranged on the opposite side of the third locking piece, and the near end plate is used for blocking the second locking piece; the first limiting piece is used for stopping the first locking piece when the second locking piece is stopped by the near-end plate.
Preferably, a second limiting part is arranged at the far end of the guide rail and used for stopping the first locking part; the first limiting part is used for stopping the third locking part when the second limiting part stops the first locking part.
Preferably, the pusher housing comprises a first housing part and a second housing part, the first housing part being detachably connected with the second housing part.
Preferably, the proximal end of the first shell part is provided with a first shell part proximal end plate, and the first shell part proximal end plate is provided with a first opening; a second shell part proximal end plate is arranged at the proximal end of the second shell part, and a second opening is formed in the second shell part proximal end plate; in the direction perpendicular to the axial direction of the push rod, the sum of the projection lengths of the third locking piece and the push rod is smaller than the length of the first opening, and the sum of the projection lengths of the second locking piece and the push rod is larger than the length of the second opening.
Preferably, the self-expanding pusher further comprises an introducing sheath and a self-expanding device, wherein the proximal end of the introducing sheath is fixedly connected with the distal end of the pusher shell; the self-expanding device is arranged at the distal end of the introducing sheath; a sheath pipe joint is also arranged between the introducing sheath and the pusher shell; the proximal end of the sheath tube joint is connected with the pusher shell, and the distal end of the sheath tube joint is connected with the proximal end of the introducing sheath; the distal end of the pusher shell is provided with an interface which is coaxial with the guide rail, the near end of the sheath pipe joint is provided with a clamping groove, and the clamping groove is in transition fit with the interface.
Preferably, a boss is arranged on the circumference of the interface, and the clamping groove consists of a far-end limiting part, a transition part and a small-diameter part; the inner diameter of the transition part is gradually reduced in the direction from the far end to the near end of the clamping groove; the boss is fixedly connected to the transition portion, and the size of the small-diameter portion is smaller than the outer diameter of the boss of the interface.
The invention also provides a pushing method of the dilator assembly suitable for the self-expansion device, which adopts the following technical scheme: the method for pushing the dilator assembly suitable for the self-expanding device as described above comprises the following steps: (1) fixedly connecting the expander with the pushing rod, mounting the pushing rod on the guide rail, and locking the locking piece and the pushing rod shell; (2) when the far end of the dilator reaches a set position of a blood vessel, the locking piece is unlocked with the pusher shell, and the pushing rod is pushed to enable the dilator to move towards the far end; (3) locking the lockout member with the pusher housing; (4) removing the dilator from the blood vessel.
Preferably, step (1) comprises: A. mounting the push rod on the first housing part to enable the second locking piece to be located at the far end of the near end plate of the second housing part; B. fixedly connecting the first shell part with the second shell part; C. stopping the proximal end plate of the second shell part at the proximal end of the second locking piece; D. stopping the first limiting piece at the far end of the first locking piece;
the step (3) comprises the following steps: a. stopping the second limiting part at the far end of the first locking part; b. and adjusting the length of the first limiting part in the mounting hole to stop the first limiting part at the near end of the third locking part.
Has the advantages that:
the dilator assembly suitable for the self-expansion device can effectively realize locking of the dilator in the use process, and prevent the dilator from uncontrollably sliding after entering a human body and damaging the vessel wall. Wherein the guide rails help to prevent or reduce movement of the push rod in directions other than the distal or proximal direction; the first limiting part and the end part of the pusher shell are matched with each other to stop a plurality of stopping parts arranged on the pushing rod, so that the mutual locking of the expander and the pusher shell can be effectively realized.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate embodiments of the invention and, together with the description, serve to explain the invention and not to limit the invention. Wherein:
FIG. 1 is a general block diagram of a dilator assembly suitable for use with a self-expanding device (after release from the expanding device) according to one embodiment of the present invention;
FIG. 2 is a front view of a push rod provided in accordance with one embodiment of the present invention;
FIG. 3 is a left side view of a push rod provided in accordance with one embodiment of the present invention;
FIG. 4 is a schematic top-down view of a dilator assembly suitable for use with a self-expanding device according to one embodiment of the present invention;
fig. 5 is a cross-sectional view of the locking of the first locking member and the second limiting member and the locking of the third locking member and the first limiting member of the expander assembly suitable for use in a self-expanding device according to an embodiment of the present invention;
FIG. 6 is a top view of the upper half of a dilator assembly suitable for use with a self-expanding device according to one embodiment of the present invention;
fig. 7 is a schematic structural diagram of a first limiting member according to an embodiment of the present invention;
fig. 8 is a schematic view of an internal structure of a sheath joint according to an embodiment of the present invention;
FIG. 9 is a schematic view of a first housing portion according to an embodiment of the present invention;
fig. 10 is a schematic structural view of a second housing part according to an embodiment of the present invention;
FIG. 11 is a cross-sectional view of a locking element and a first retaining element and a locking element and a second locking element and a proximal end plate of a second housing portion of a dilator assembly adapted to be used with a self-expanding device, according to an embodiment of the present invention;
FIG. 12 is a cross-sectional view of an expander assembly suitable for use in a self-expanding device according to one embodiment of the present invention, showing the first retaining member and the first retaining member in an unlocked state;
FIG. 13 is a schematic view of the overall structure of a dilator assembly suitable for use with a self-expanding device according to one embodiment of the present invention (prior to release of the self-expanding device);
FIG. 14 is a schematic view of an installation structure of the push rod and the first housing portion according to an embodiment of the present invention;
fig. 15 is a schematic cross-sectional structural view of the first locking member and the second limiting member before locking, and the third locking member and the first limiting member before locking according to an embodiment of the present invention;
reference numbers:
1-a push rod; 2-pusher housing; 3-sheath pipe joint; 4-introducing sheath; 5-a self-expanding device; 6-a dilator;
11-luer fitting; 12-a handle; 13-a third lock; 14-a second lock; 15-a first locking member; 16-inner hole;
21-a first housing part; 211 — a first opening; 212-first housing portion proximal end plate; 22-a second housing portion; 221-a second opening; 222-a second housing portion proximal end endplate; 23-a proximal through hole; 24-a proximal end plate; 251-a mounting hole; 252 — a first stop; 26-a guide rail; 271-positioning holes; 272-locating columns; 28-a second stop; 29-interface; 291-boss;
311-distal end limiting part; 312-a transition; 313-minor diameter portion.
Detailed Description
The technical solutions in the embodiments of the present invention will be described clearly and completely below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments that can be derived by one of ordinary skill in the art from the embodiments given herein are intended to be within the scope of the present invention.
The present invention will be described in detail with reference to examples. It should be noted that the embodiments and features of the embodiments may be combined with each other without conflict.
It will be understood that the terms "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like, are used in an orientation or positional relationship indicated in the drawings for convenience in describing the invention and to simplify the description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and are not to be construed as limiting the invention.
In the description of the present invention, "a plurality" means two or more unless specifically defined otherwise.
In the following, the end far from the operator is the distal end, and the end close to the operator is the proximal end.
The invention provides a dilator assembly suitable for a self-expansion device, aiming at the problem that uncontrollable sliding is easy to occur in the using process of the existing dilator.
As shown in fig. 1-7, the dilator assembly suitable for a self-expanding device of the present invention comprises a push rod 1, apusher housing 2, and adilator 6; a plurality of locking pieces are arranged on the circumference of the push rod 1; the proximal end of thedilator 6 is connected with the pushing rod 1, and the distal end extends out of thepusher shell 2; the inner cavity of thepusher shell 2 is provided with aguide rail 26 for accommodating the pushing rod 1; thepusher housing 2 is provided with amounting hole 251 communicated with theguide rail 26, a first limitingmember 252 is arranged in themounting hole 251, and the first limitingmember 252 is matched with the end of thepusher housing 2 to stop and lock thedilator 6 and thepusher housing 2.
Through setting up guide rail 26 (can refer to fig. 6), help maintaining the movement track of push rod 1 in the propelling movement in-process, avoid push rod 1 to make a round trip to rock the uncontrollable slip that causes push rod 1 in the propelling movement in-process. In the practical application process, the size of theguide rail 26 may be designed to be slightly larger than that of the pushing rod 1, so as to ensure the smoothness of pushing by the pushing rod 1 and move according to a set track to the maximum extent; for example, it is preferable that the push rod 1 is prevented from rotating in the circumferential direction in theguide rail 26 and can be moved only in the distal or proximal direction. Theinstallation hole 251 and the first limitingmember 252 are arranged such that the locking member can be blocked or unblocked by adjusting the length of the first limitingmember 252 in theinstallation hole 251. Specifically, when the first limitingmember 252 extends into themounting hole 251 for such a length that it would cause a steric hindrance to the locking member, it can play a role in limiting the displacement of the locking member; similarly, when the push rod 1 needs to move, the length of the first limitingmember 252 in theinstallation hole 251 can be reduced, so that the first limitingmember 252 and the locking member do not interfere with each other, and the movement of the push rod 1 is realized. Therefore, in the using process of thedilator 6, the locking or unlocking state between the push rod 1 and thepusher shell 2 can be adjusted according to needs, and the uncontrollable sliding of thedilator 6 is avoided; preferably, after the length of the first limitingmember 252 in theinstallation hole 251 is adjusted, the relative position between the first limitingmember 252 and theinstallation hole 251 can be maintained unchanged without the application of an external force. By matching the first limitingmember 252 with the end of thepusher housing 2, the distal end and the proximal end of the pushing rod 1 can be stopped at the same time, and thedilator 6 and thepusher housing 2 can be locked with each other.
Wherein, "locked" refers to a state in which the push lever 1 cannot move either distally or proximally; when push rod 1 is in the locking state withpusher shell 2, becauseexpander 6 is unchangeable with push rod 1 relation of connection,expander 6 also can be in the state of locking in the lump, effectively avoidsexpander 6 to take place uncontrollable slip, alleviates or avoids the damage that expander 6 caused the vascular wall.
It should be noted that: the locking piece can be arranged in a boss shape protruding out of the surface of the push rod 1 as shown in fig. 2; the shape of the locking member can also be changed by those skilled in the art according to the actual situation, and the details are not described herein; the dimensions of the plurality of locking members (e.g., themembers
In the preferred embodiment of the present invention, the distal end of the push rod 1 is provided with an inner hole 16 (coaxially arranged with the push rod 1) for accommodating the proximal end of thedilator 6, so that the push rod 1 and thedilator 6 can be fixedly connected by inserting the distal end of thedilator 6 into theinner hole 16. Specifically, the length of theinner hole 16 may be 3-5cm, and the proximal end of thedilator 6 is uniformly coated with glue and then inserted into theinner hole 16, so as to fixedly connect thedilator 6 and the push rod 1 (see fig. 5).
In the preferred embodiment of the present invention, the proximal end of the push rod 1 is provided with aluer 11 for injecting liquid medicine or preventing blood leakage during surgery.
In the preferred embodiment of the present invention, the pushing rod 1 is further provided with ahandle 12, which facilitates the operation of the pushing rod 1 to move towards the proximal end or the distal end as a whole.
In a preferred embodiment of the present invention, the mountinghole 251 is a threaded hole, and the first limitingmember 252 is a bolt (see fig. 7). The arrangement enables the threaded connection between the mountinghole 251 and the first limitingmember 252 to be conveniently realized, the length of the first limitingmember 252 extending into the mountinghole 251 is convenient to adjust, and the situation that the first limitingmember 252 slides in the mountinghole 251 without the action of external force is facilitated to be avoided. Preferably, one end of the first limitingmember 252 away from theinstallation hole 251 is provided with a knob, and the knob is still located outside thepush rod housing 2 when the first limitingmember 252 is locked with the first lockingmember 15 or thethird locking member 13, so as to facilitate adjustment of the installation length of the first limitingmember 252 in theinstallation hole 251.
In a preferred embodiment of the present invention, the push rod 1 is circumferentially provided with afirst locking member 15, asecond locking member 14 and athird locking member 13; the first lockingmember 15 and thesecond locking member 14 are locked with thepusher housing 2 before the distal end of thedilator 6 reaches the set position of the blood vessel (see fig. 4), so that the first lockingmember 15 and thethird locking member 13 are locked with thepusher housing 2 after being released from the expansion device 5 (see fig. 5), thereby effectively avoiding or reducing the uncontrollable sliding of thedilator 6 when entering or being pushed out of the blood vessel, and causing damage to the blood vessel wall.
In a preferred embodiment of the present invention, as shown in fig. 4, the first limitingmember 252 is used for stopping the first lockingmember 15 or thethird locking member 13; the proximal end of thepusher housing 2 is provided with aproximal end plate 24, and theproximal end plate 24 is provided with a proximal end throughhole 23 for allowing thethird locking piece 13 and the pushing rod 1 to pass through; in the direction perpendicular to the axis of the push rod 1, thesecond locking member 14 is arranged at the opposite side of thethird locking member 13, and theproximal end plate 24 is used for stopping thesecond locking member 14; thefirst stopper 252 is used for stopping thefirst locking element 15 when thesecond locking element 14 is stopped by theproximal end plate 24. Through the arrangement of thesecond locking member 14, thethird locking member 13 and theproximal end plate 24, theproximal end plate 24 can be used for stopping thesecond locking member 14 without affecting thethird locking member 13. In addition, on the basis that the first limitingmember 252 is used for stopping the first lockingmember 15 as described above, the stopping and stopping of the first lockingmember 15 and the first limitingmember 252 can be realized by adjusting the length of the first limitingmember 252 in the mountinghole 251, and further, the first limitingmember 252 can be stopped at the distal end of the first lockingmember 15 and theproximal end plate 24 can be stopped at the proximal end of thesecond locking member 14 according to actual needs, so as to effectively prevent the push rod 1 from moving towards the proximal end and/or the distal end, realize the locking of the push rod 1 and thepusher housing 2 and the locking of thedilator 6, and avoid the occurrence of uncontrollable sliding of thedilator 6.
In a preferred embodiment of the present invention, as shown in fig. 5, a second limitingmember 28 is disposed at a distal end of theguide rail 26, and the second limitingmember 28 is used for stopping the first lockingmember 15; the first limitingmember 252 is used for stopping thethird locking member 13 when the second limitingmember 28 stops the first lockingmember 15. The second limitingmember 28 is disposed to effectively prevent the pushing rod 1 from separating from theguide rail 26 due to the too long distance of the pushing rod 1 moving to the far end in the process of moving along theguide rail 26. In addition, when the second limitingmember 28 stops the first lockingmember 15, thethird locking member 13 and the first limitingmember 252 can be stopped and released by adjusting the first limitingmember 252, so that when the second limitingmember 28 is stopped at the distal end of the first lockingmember 15, the first limitingmember 252 is stopped at the proximal end of thethird locking member 13, thereby effectively preventing the push rod 1 from moving to the proximal end and/or the distal end, locking the push rod 1 and thepusher housing 2 and locking thedilator 6, and preventing thedilator 6 from uncontrollably sliding.
The second limitingmember 28 may be a plate, that is, a limiting plate is disposed at a distal end of theguide rail 26 to serve as the second limitingmember 28. Those skilled in the art can select the second position-limitingmember 28 with other shapes according to actual needs, and the details are not described herein.
In a preferred embodiment of the invention, as shown in fig. 9-10, thepusher housing 2 comprises afirst housing part 21 and asecond housing part 22, thefirst housing part 21 being detachably connected to thesecond housing part 22.
In a preferred embodiment of the present invention, the proximal end of thefirst housing part 21 is provided with a first housing partproximal end plate 212, and the first housing partproximal end plate 212 is provided with afirst opening 211; the proximal end of thesecond housing part 22 is provided with a second housing partproximal end plate 222, and the second housing partproximal end plate 222 is provided with asecond opening 221; in the direction perpendicular to the axial direction of the push rod 1, the sum of the projected lengths of thethird lock member 13 and the push rod 1 is smaller than the length of thefirst opening 211, and the sum of the projected lengths of thesecond lock member 14 and the push rod 1 is larger than the length of the second opening 221 (see fig. 4-6). Specifically, theproximal end plate 21 is composed of a first casing proximal end plate and a second casingproximal end plate 222, the proximal throughhole 23 is composed of afirst opening 211 and asecond opening 221, since the sum of the projection lengths of thesecond locking member 14 and the push rod 1 is greater than the length of thefirst opening 211, thesecond locking member 14 cannot enter theguide rail 26 from the proximal end of thesecond opening 221, and by providing thefirst casing 21 and thesecond casing 22, thesecond locking member 14 can enter theguide rail 26 by first assembling thefirst casing 21 or thesecond casing 22 with the push rod 1, so as to play a role in blocking thesecond locking member 14 and theproximal end plate 24.
In the preferred embodiment of the present invention, thefirst housing part 21 and thesecond housing part 22 are detachably connected through the matchingpositioning holes 271 and positioning posts 272 (the positioning holes 271 and the positioning posts 272 can be provided in plurality according to actual needs), so as to facilitate the assembly of the push rod 1. Wherein, thepositioning hole 271 is disposed on thefirst housing portion 21, and thepositioning post 272 is disposed on thesecond housing portion 22; alternatively, thepositioning hole 271 is disposed on thesecond housing portion 22, and thepositioning post 272 is disposed on thefirst housing portion 21.
In a preferred embodiment of the present invention, as shown in fig. 1, 6 and 8, the dilator assembly suitable for a self-expanding device of the present invention further comprises anintroducer sheath 4 and a self-expandingdevice 5, wherein the proximal end of theintroducer sheath 4 is fixedly connected with the distal end of thepusher housing 2; the self-expansion device 5 is arranged at the distal end of the introducingsheath 4; a sheath pipe joint 3 is also arranged between the leading-insheath 4 and thepusher shell 2; the proximal end of the sheath tube joint 3 is connected with thepusher shell 2, and the distal end of the sheath tube joint 3 is connected with the proximal end of the leading-insheath 4; the distal end of thepusher housing 2 is provided with a connector 29 (communicated with theguide rail 26 to facilitate thedilator 6 to enter the guiding sheath 4) coaxially arranged with theguide rail 26, and the proximal end of thesheath tube connector 3 is provided with a clamping groove in transition fit with theconnector 29. By arranging the sheath pipe joint 3, the fixed connection between the guide-insheath 4 and thepusher shell 2 can be conveniently realized. The mutual locking of thepusher housing 2 and the sheath tube joint 3 (the guide-in sheath 4) can be effectively realized by the transition fit of the clamping groove and theinterface 29.
In the preferred embodiment of the present invention, theinterface 29 is circumferentially provided with aboss 291, and the slot is composed of a distalend limiting portion 311, atransition portion 312 and asmall diameter portion 313; the inner diameter of thetransition portion 312 decreases gradually in the direction from the distal end to the proximal end of the card slot; theboss 291 is fixedly connected to thetransition portion 312, and the size of thesmall diameter portion 313 is smaller than the outer diameter of theinterface 29 at the position of theboss 291. The arrangement of the far-end limiting portion 311, thetransition portion 312 and the small-diameter portion 313 of the clamping groove enables the portion, which is not provided with theboss 291, of theinterface 29 to smoothly pass through the small-diameter portion 313, and the portion provided with theboss 291 needs to overcome a certain resistance to be fixed to thetransition portion 312, so that theinterface 29 cannot be separated from the clamping groove under the condition of no external force, and the transition connection between theinterface 29 and the clamping groove and the mutual locking between thepusher housing 2 and thesheath tube connector 3 are realized.
The present invention also provides a method of pushing a dilator assembly suitable for use with a self-expanding device, as described above, comprising the steps of: (1) fixedly connecting theexpander 6 with the push rod 1, and mounting the push rod 1 on theguide rail 26 to lock the locking piece and the shell of the push rod 1 (see fig. 11); (2) when the distal end of thedilator 6 reaches the blood vessel setting position, the locking piece is unlocked with thepusher shell 2, and the pushing rod is pushed, so that thedilator 6 moves towards the distal end (see fig. 12-13); (3) locking the locking element to the pusher housing 2 (see fig. 5); (4) thedilator 6 is removed from the blood vessel.
In a preferred embodiment of the present invention, the step (1) comprises: A. the push rod 1 is mounted on thefirst housing part 21, so that thesecond locking member 14 is located at the distal end of theproximal end plate 222 of the second housing part (see fig. 12 and 14); B. fixedly connecting thefirst housing part 21 with thesecond housing part 22; C. stopping the second housingproximal end plate 222 at the proximal end of thesecond locking member 14; D. the first limitingmember 252 is stopped at the distal end of the first lockingmember 15.
In the preferred embodiment of the present invention, the locking member in the step (2) is the first lockingmember 15.
In a preferred embodiment of the present invention, step (3) comprises: a. stopping the second limitingmember 28 at the distal end of the first locking member 15 (limiting the movement of the pushing rod 1 to the distal end); b. the length of the first limitingmember 252 in the mountinghole 251 is adjusted to stop the first limitingmember 252 at thethird locking member 13 and the proximal end (refer to fig. 15, which limits the proximal movement of the pushing rod 1).
In the preferred embodiment of the present invention, step (4) further comprises the step of disconnecting thepusher housing 2 from the introducer sheath 4 (or sheath connector 3) before removing thedilator 6 from the blood vessel.
In a preferred embodiment of the present invention, the method for pushing the dilator assembly adapted to the self-expanding device of the present invention comprises the steps of: during assembly, glue is uniformly applied to the proximal end of the dilator 6 and is inserted into the inner hole 16 at the distal end of the push rod 1 by about 3-5cm, after the dilator 6 is fixed, the push rod 1 together with the dilator 6 is inserted into the guide rail 26 inside the first shell part 21 (the first shell part 21 is used as an upper shell) of the pusher housing 2, and attention is paid to that the first locking piece 15 and the third locking piece 13 are kept on the same side as the first shell part 21, as shown in fig. 14; inserting the 6 positioning holes 271 of the first housing portion 21 tightly against the 6 positioning posts 272 of the second housing portion 22 (using the second housing portion 22 as a lower shell), inserting the distal end of the dilator 6 into the sheath connector 3 until the distal end of the dilator 6 exceeds the self-expanding device 5, hiding the self-expanding device 5 in the distal gap of the dilator 6, then moving the pushing rod 1 backward until the second locking member 14 contacts the proximal end of the second housing portion 22, after the movement is stopped, using a force of 10-15N to screw the first limiting member 252 clockwise into the mounting hole 251 on the first housing portion 21 until the bottom of the first limiting member 252 contacts the pushing rod 1, at which time the first locking member 15 is blocked by the first limiting member 252 and cannot move forward (i.e., cannot move distally), the second locking member 14 contacts the proximal end plate 222 of the second housing portion and cannot move backward (i.e., cannot move proximally), the first locking piece 15 and the second locking piece 14 cannot move left and right in the guide rail 26, and the pushing rod 1 and the pusher housing 2 are kept in a locking state, as shown in fig. 4 and 11; the distal most end of the pusher housing 2 is inserted into the notch at the proximal end of the sheath hub 3 with a force of 10-15N and the pusher (including the pusher rod 1 and pusher housing 2) along with the dilator 6 remains locked to the sheath hub 3 and introducer sheath 4 as shown in fig. 13.
During operation, in the process of inserting the dilator assembly into a human blood vessel, the dilator 6 is always kept in a locked state with the sheath of the introducing sheath 4 by virtue of the proximal pushing rod 1, the first limiting piece 252, the pusher housing 2, the sheath joint 3 and the sheath, as shown in fig. 13; the injury to the vessel wall and the obstacle caused by the operation in the process that the dilator 6 enters the human body are avoided, after the distal end of the dilator 6 reaches the designated position, the first limiting piece 252 is rotated counterclockwise by 10-15N force, the first limiting piece 252 is slowly screwed out of the mounting hole 251, the first limiting piece 252 does not need to be completely screwed out, during the rotation, the push rod 1 is tried to be pushed forward (at the distal end) until the first limiting piece 252 no longer blocks the first locking piece 15, and at the moment, the locking between the push rod 1 and the pusher housing 2 is released, as shown in fig. 12; pushing the pushing rod 1 forward (distally) until the first locking member 15 contacts the second limiting member 28 at the most distal end of the guiding rail 26 of the pusher housing 2 and can not move forward (distally), and at the same time, the self-expanding device 5 hidden at the distal end of the dilator 6 is released, and the self-expanding device 5 can prevent thrombus fragments from being generated during the operation and causing distal embolism along with blood, as shown in fig. 1 and 15; after the self-expanding device 5 is completely released, the first limiting member 252 is rotated clockwise with a force of 10-15N until the first limiting member 252 contacts the push rod 1, at this time, the first limiting member 252 prevents the third locking member 13 on the push rod 1 from moving backward (proximal end), the second limiting member 28 prevents the first locking member 15 from moving forward (distal end), and the push rod 1 and the expander 6 are locked, as shown in fig. 1 and 5; the pusher housing 2 is then grasped and the pusher housing 2 is pulled out of the sheath fitting 3 with a force of 10-15N to remove the dilator 6 and continue with the next procedure.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. An expander assembly suitable for use in a self-expanding device, comprising a pusher rod, a pusher housing, and an expander;
a plurality of locking pieces are arranged on the circumference of the pushing rod;
the proximal end of the dilator is connected with the pushing rod, and the distal end of the dilator extends out of the pusher shell;
the dilator is characterized in that a guide rail for accommodating the pushing rod is arranged in the pusher shell, a mounting hole communicated with the guide rail is formed in the pusher shell, a first limiting part is arranged in the mounting hole, and the first limiting part is matched with the end part of the pusher shell to stop the locking part, so that the dilator and the pusher shell are locked with each other.
2. A dilator assembly adapted for use with a self-expanding device according to claim 1, wherein said push rod is circumferentially provided with a first lock, a second lock and a third lock;
the first locking piece and the second locking piece are locked with the pusher shell before the distal end of the dilator reaches a blood vessel set position;
the first and third locking members lock with the pusher housing after the self-expanding device is released.
3. The dilator assembly adapted for use with a self-expanding device according to claim 2, wherein said first retaining member is adapted to retain said first or third locking member;
a near end plate is arranged at the near end of the pusher shell, and a near end through hole allowing the third locking piece and the pushing rod to pass through is formed in the near end plate;
in the direction perpendicular to the axis of the push rod, the second locking piece is arranged on the opposite side of the third locking piece, and the near end plate is used for blocking the second locking piece;
the first limiting piece is used for stopping the first locking piece when the second locking piece is stopped by the near-end plate.
4. The dilator assembly adapted for use in a self-expanding device according to claim 2, wherein said distal end of said guide track is provided with a second stop for stopping said first stop;
the first limiting part is used for stopping the third locking part when the second limiting part stops the first locking part.
5. The dilator assembly adapted for use with a self-expanding device according to claim 2, wherein the pusher housing comprises a first housing portion and a second housing portion, the first housing portion being removably connected to the second housing portion.
6. The dilator assembly adapted for use with a self-expanding device according to claim 5, wherein the proximal end of the first sheath portion is provided with a first sheath portion proximal end plate, the first sheath portion proximal end plate being provided with a first opening;
a second shell part proximal end plate is arranged at the proximal end of the second shell part, and a second opening is formed in the second shell part proximal end plate;
in the direction perpendicular to the axial direction of the push rod, the sum of the projection lengths of the third locking piece and the push rod is smaller than the length of the first opening, and the sum of the projection lengths of the second locking piece and the push rod is larger than the length of the second opening.
7. A dilator assembly according to any of claims 1 to 6, further comprising an introducer sheath and a self-expanding device, wherein the proximal end of the introducer sheath is fixedly connected to the distal end of the pusher housing;
the self-expanding device is arranged at the distal end of the introducing sheath;
a sheath pipe joint is also arranged between the guide sheath and the pusher shell;
the proximal end of the sheath tube joint is connected with the pusher shell, and the distal end of the sheath tube joint is connected with the proximal end of the introducing sheath;
the distal end of the pusher shell is provided with an interface which is coaxial with the guide rail, the near end of the sheath pipe joint is provided with a clamping groove, and the clamping groove is in transition fit with the interface.
8. An expander assembly suitable for use in a self-expanding device according to claim 7, wherein the hub is circumferentially provided with a boss and the slot is comprised of a distal stop, a transition and a small diameter;
the inner diameter of the transition part is gradually reduced in the direction from the far end to the near end of the clamping groove;
the boss is fixedly connected to the transition portion, and the size of the small-diameter portion is smaller than the outer diameter of the boss of the interface.
9. A method of pushing a dilator assembly adapted for use with a self-expanding device according to any of claims 1 to 8, comprising the steps of:
(1) fixedly connecting the expander with the pushing rod, mounting the pushing rod on the guide rail, and locking the locking piece and the pushing rod shell;
(2) when the far end of the dilator reaches a set position of a blood vessel, the locking piece is unlocked with the pusher shell, and the pushing rod is pushed to enable the dilator to move towards the far end;
(3) locking the lockout member with the pusher housing;
(4) removing the dilator from the blood vessel.
10. The method for advancing a dilator assembly suitable for a self-expanding device according to claim 9, wherein step (1) comprises:
A. mounting the push rod on the first housing part to enable the second locking piece to be located at the far end of the near end plate of the second housing part;
B. fixedly connecting the first shell part with the second shell part;
C. stopping the proximal end plate of the second shell part at the proximal end of the second locking piece;
D. stopping the first limiting piece at the far end of the first locking piece;
the step (3) comprises the following steps:
a. stopping the second limiting part at the far end of the first locking part;
b. and adjusting the length of the first limiting part in the mounting hole to stop the first limiting part at the near end of the third locking part.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210583564.7ACN115068056B (en) | 2022-05-25 | 2022-05-25 | Expander assembly suitable for self-expanding device and expander pushing method |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202210583564.7ACN115068056B (en) | 2022-05-25 | 2022-05-25 | Expander assembly suitable for self-expanding device and expander pushing method |
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| CN115068056B CN115068056B (en) | 2023-05-12 |
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| CN114052826A (en)* | 2021-12-03 | 2022-02-18 | 上海玮琅医疗科技有限公司 | Dilator assembly |
- 2022
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| CN107405474A (en)* | 2014-08-15 | 2017-11-28 | 易卜拉欣·拉希德·艾拉斯丹 | Expandable introducer sheath and system for inserting medical device into vessel through expandable introducer sheath |
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| CN115068056B (en) | 2023-05-12 |
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