WO2012159524A1

WO2012159524A1 - Conveying device of intraoperative stent

Info

Publication number: WO2012159524A1
Application number: PCT/CN2012/074813
Authority: WO
Inventors: 王永胜; 徐志云
Original assignee: 先健科技(深圳)有限公司
Priority date: 2011-05-23
Filing date: 2012-04-27
Publication date: 2012-11-29
Also published as: CN102166143B; CN102166143A

Abstract

A conveying device of an intraoperative stent comprises a coating (10) as well as a suture (11) and a pulling stitch (12) that are connected with the coating (10). The suture (11) and the pulling stitch (12) are sewn on the coating (10) and form a releasable connection with the coating (10). An intraoperative stent (1) is folded and wrapped in the coating (10). By cutting an aorta on an end of a pathologic position of a blood vessel, the intraoperative stent mounted on the conveying device can be implanted in corresponding pathologic positions, including pathologic positions of branch blood vessels, quickly and conveniently. The suture (11) can be released by drawing the pulling stitch (12) out, and then the intraoperative stent with branches can be released and positioned in a blood vessel with branches like a main aortic arch, and thereafter the conveying device can be taken out and the cut can be stitched. The quantity of sewn openings during the operation can be reduced, the operation process can be simplified, the operation time can be reduced, the operation complications can be reduced, the survival rate of patients can be improved, the treatment effect can be improved, and the wounds of patients suffering from the diseases of main aortic arch or other diseases can be effectively reduced.

Description

[Name of invention established by ISA in accordance with Rule 37.2] Intraoperative stent delivery device

Technical field

The present invention relates to the field of medical assistive devices for delivering an intraoperative stent to a corresponding lesion location of the aortic arch under conditions of hybrid surgery, and more particularly to an intraoperative stent delivery device and stent installation and release during aortic arch surgery. method.

Background technique

In 1994, American scholar Dake applied intracavitary isolation technology to the treatment of descending aortic dissection and descending aortic aneurysm, which opened up a new way to treat thoracic aortic diseases and was quickly promoted and used around the world. Because the intracavitary isolation technique generally uses the percutaneous interventional delivery device, there is no need to cut the patient's chest cavity. The biggest advantage is that the trauma is small, the operation time is short, and the success rate is high. Therefore, it is highly respected by the scholars of various countries and loved by patients. At present, most of the diseases of the thoracic aorta, abdominal aorta, and ankle blood vessels can be treated by endovascular exclusion.

The aortic arch is a large curved tube with multiple branches, and its uniqueness in anatomy and hemodynamics. With the current design and implementation methods of intracavitary isolation technology, conventional intraluminal isolation cannot be used. Technical treatment of aortic arch lesions.

Therefore, in recent years, many experts have begun to apply intracavitary isolation technology to traditional surgery, that is, the stent is released in the lumen of the blood vessel under direct vision. This method of combining traditional surgery and endovascular isolation surgery is called hybridization. Surgery; this surgical method combines the advantages of both, avoiding the disadvantages of traditional surgical trauma and long operation time, and at the same time solving some problems that cannot be implemented by relying solely on endovascular exclusion.

However, this technique still requires a stent graft that is similar to the stent used in endovascular grafting; and it is necessary to implant the stent into the aortic lesion under surgical conditions, thereby A stent is often referred to as an intraoperative stent. The intraoperative stent must be implanted into the corresponding aortic lesion by means of the delivery device, that is, the diameter of the intraoperative stent is reduced by the delivery device, and then delivered to the corresponding lesion position of the aorta, and the intraoperative stent is released, and finally The conveyor is withdrawn.

However, due to the complexity of the aortic anatomy, there is currently no suitable delivery device that can conveniently and safely deliver the stent in the aortic arch to the corresponding lesion position of the aortic arch; whereas the prior art delivery device is only suitable for delivery. Intraoperative stent with branches.

Therefore, the prior art still needs to be improved and developed.

technical problem

The object of the present invention is to provide an intraoperative stent delivery device and a method for mounting and releasing a stent in aortic arch surgery, which can reduce the number of anastomosis during surgery, simplify the surgical procedure, shorten the operation time, reduce the surgical complications, and improve the survival of the patient. Rate, improve the treatment effect.

Technical solution

The technical solution of the present invention is as follows: an intraoperative stent delivery device, wherein the intraoperative stent is installed and released, including an envelope, a suture, and a wire; the suture and the wire take the two sides of the envelope The suture is sewed so that the intraoperative stent is gathered and wrapped in the envelope, and the suture and the envelope form a connection that can be released by pulling out the wire.

The intraoperative stent delivery device, wherein: the intraoperative stent comprises a body and more than one branch.

The intraoperative stent delivery device, wherein: the coating film is made of one of polyester, polytetrafluoroethylene or a derivative thereof.

The intraoperative stent delivery device, wherein: having a body envelope and more than one branch envelope; a body envelope for wrapping the body, each branch envelope for respectively wrapping one of the branches; the body The envelope and each branch envelope are respectively connected to a pull wire.

The intraoperative stent delivery device, wherein: the suture forms an equally spaced suture point along an edge of the main body envelope or the branch envelope; the suture point is substantially distributed along an axial direction of the body or the branch; Each of the wires passes through all of the suture points on the respective body envelope or branch envelope one by one.

The intraoperative stent delivery device, wherein: the intraoperative stent is an aortic arch stent having three branches; the main capsule is divided into four independent portions; and four independent portions of the main capsule are The branches of the stent in the aortic arch are bounded and share a pull line.

The intraoperative stent delivery device includes: a handle, a flexible fixing rod and three flexible branch sheath cores; a proximal end of the fixing rod and a proximal end of the branch sheath core are fixed on the handle, a fixing rod for mounting the aortic arch stent body, each of the three branch sheath cores for mounting a branch of the aortic arch stent; the branch mounted on the branch sheath core It is possible to swing with its connection portion with the main body as a fulcrum.

The intraoperative stent delivery device, wherein: a hollow wire slot and a detachable plug are disposed on the handle; the corresponding cable on the main body envelope and the branch envelope passes through the wire slot, and the proximal end of the wire is connected. Fastened to the plug.

A method for mounting a stent in aortic arch surgery, comprising the steps of: passing a fixation rod of the delivery device through a lumen of a main body of the stent in the aortic arch, and each branch sheath of the delivery device passes through the stent of the aortic arch a branching lumen; compressing the body on the outer surface of the fixing rod, wrapping the main body with a main body envelope, sewing the suture on the main body envelope by the pulling wire, the suture and the pulling wire and the main body envelope Forming a connection that can be released by pulling out the wire; compressing the branch on the outer surface of the corresponding branch sheath core, wrapping the branch with a branching envelope, sewing the stitch on the branching envelope, stitching and pulling the wire The connection with the branch envelope forms a pull-out cable to be released.

A method for releasing a stent in aortic arch surgery, comprising the steps of: positioning a main body of a stent in a compressed state with a delivery device in a blood vessel of the aortic arch, and positioning a branch of the stent in a compressed state in the aortic arch a branching vessel; pulling a wire attached to a suture wrapped around a body envelope of the body to unravel a suture sewn onto the body capsule; the body being released from the aortic arch vessel Pulling a wire attached to a suture wrapped around a branch envelope of the branch to unwind a suture sewn on the branch envelope; the branch bounces release in a branch vessel of the aortic arch.

Beneficial effect

The invention provides an intraoperative stent delivery device and a method for installing and releasing a stent in aortic arch surgery. Because of the technical means of releasing the suture and the wire, the corresponding suture can be released by simply pulling out the wire, and then The intraoperative stent release with branching is positioned in a branching blood vessel such as the aortic arch; compared to prior art techniques for treating aortic disease, the delivery device of the present invention only needs to be at the end of the aortic arch lesion The aorta is incision, and then the aortic arch stent is conveniently and quickly implanted into the corresponding lesion position of the aortic arch by the delivery device, including the lesion position of the branch vessel, and the corresponding suture can be released by simply pulling out the wire, thereby branching. The intraoperative stent release is located in a branching blood vessel such as the aortic arch, and the incision can be sutured after the delivery device is withdrawn. The delivery device is used in the aortic arch hybrid surgery, which greatly reduces the number of anastomosis during surgery compared with the original hybrid surgery. It is only necessary to suture an anastomosis during surgery, thereby simplifying the operation and shortening the operation. Time, reduce the complications of surgery, improve the survival rate of patients, improve the effect of treatment, and more effectively reduce the trauma of patients with aortic arch disease.

DRAWINGS

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a schematic view of a stent for aortic archery involved in the intraoperative stent delivery device of the present invention.

2 is a schematic view showing the structural composition of the intraoperative stent delivery device of the present invention.

Figure 3 is a schematic illustration of the handle portion of the intraoperative stent delivery device of the present invention.

Fig. 4 is a schematic view showing the components of the main body portion of the stent during the intraoperative stent delivery device of the present invention.

Fig. 5 is a schematic view showing the components of the branch portion of the intraoperative stent in the intraoperative stent delivery device of the present invention.

Figure 6 is a schematic view of the components of the intraoperative stent delivery device of the present invention associated with the stent body portion of the stent.

Fig. 7 is a schematic view showing the components of the intraoperative stent branching portion of the intraoperative stent delivery device of the present invention.

Figure 8 is a schematic illustration of one of the branches of the stent in the aortic arch surgery of the intraoperative stent delivery device of the present invention.

Figure 9 is a partially enlarged schematic view of Figure 8.

Figure 10 is a schematic illustration of all branches of the stent in the aortic arch surgery of the intraoperative stent delivery device of the present invention.

Figure 11 is a schematic illustration of the stent body of the intraoperative stent delivery device of the present invention mounted in the aortic arch.

Figure 12 is a schematic illustration of the intraoperative stent delivery device of the present invention after stent placement in the aortic arch.

Figure 13 is a schematic illustration of the body guidewire of the intraoperative stent delivery device of the present invention extending into the aortic arch.

Figure 14 is a schematic illustration of the intraoperative stent delivery device of the present invention being pushed into the aortic arch under the guidance of a guidewire.

Figure 15 is a schematic illustration of the intraoperative stent delivery device of the present invention for pushing a stent in aortic arch.

Figure 16 is a schematic illustration of the intraoperative stent delivery device of the present invention releasing a branch of the stent during aortic arch surgery.

Figure 17 is a schematic illustration of the intraoperative stent delivery device of the present invention for releasing all branches of a stent during aortic arch surgery.

Figure 18 is a schematic illustration of the stent delivery device of the present invention for releasing the stent body during aortic arch surgery.

Figure 19 is a schematic illustration of the stent in the aortic arch after release by the intraoperative stent delivery device of the present invention.

BEST MODE FOR CARRYING OUT THE INVENTION

The specific embodiments and examples of the present invention are described in detail below with reference to the accompanying drawings.

An intraoperative stent delivery device of the present invention is adapted to deliver and release an aortic arch stent, the delivery device comprising a handle, a fixed rod and a branch sheath core, and further comprising a suture and a pull wire; the suture is sewn at the edge of the envelope Preferably, the envelope is wrapped around the body and/or the branch of the stent during aortic arch surgery to compress and retract the intraoperative stent to temporarily prevent the body and/or branches of the intraoperative stent from bounce during transport; sutures and pulls and The capsule and/or branch capsule of the intraoperative stent forms a quick-release or disconnectable connection. After the stent is delivered and properly positioned after the aortic arch, the wire is pulled to simultaneously unravel or break the sewing in the subject. And/or sutures on the branches of the capsule, and the body and/or branches of the intraoperative stent are bounced out in the aortic arch and branch vessels.

Based on the above-described intraoperative stent delivery device, the present invention also provides a method of installing a stent in aortic arch surgery, and a method for releasing a stent in aortic arch surgery.

The method for installing the stent in the aortic arch surgery comprises the steps of: passing the fixing rod of the conveying device through the lumen of the main body of the stent in the aortic arch, and each branch sheath of the conveying device passes through a branch of the stent in the aortic arch; The main body of the stent in the aortic arch is compressed on the outer surface of the fixed rod, and the main body is wrapped with the capsule, and the suture is sewn on the envelope of the main body of the stent by the pulling wire to prevent the main body of the intraoperative stent from bounce off. The suture and the pull wire form a connection with the envelope of the main body by pulling the wire; then the branch of the stent in the aortic arch is compressed on the outer surface of the corresponding branch sheath, and the branch of the intraoperative stent is wrapped with another envelope. Live, the suture is sewn on the envelope of the branch of the intraoperative stent through another pull wire to prevent the branch of the intraoperative stent from bounce, and the suture and the pull wire are connected with the envelope of the intraoperative stent to form a pull-out connection. . Or: the suture is first sewn on the envelope of the branch of the intraoperative stent to form a detachable connection with the branch capsule; the suture is then sewn on the envelope of the main body of the intraoperative stent, and the main body The envelope forms a detachable connection.

The method for releasing the stent during aortic arch surgery comprises the steps of: positioning the main body of the intraoperative stent in a compressed state in the aortic arch using a stent delivery device in the aortic arch, and positioning the branch of the intraoperative stent in the compressed state on the aortic arch. In the branch vessel; first pull the wire connected to the suture on the main body of the stent to unravel the suture stitched on the capsule of the compressed stent body, and release the body in the aortic arch And then pull the wire connected to the suture on the branch of the intraoperative stent to unravel the suture stitched on the envelope of the compressed intraoperative stent branch, and release the intraoperative stent branch to release the aortic arch Branching blood vessels. Or: first pull the wire connected to the suture on the branch of the intraoperative stent to unravel the suture stitched on the envelope of the compressed intraoperative stent branch, and release the intraoperative stent branch release position. In the branch vessel of the aortic arch; pull the wire connected to the suture on the main body of the stent to unravel the suture stitched on the envelope of the compressed stent body, and release the main body In the aortic arch.

In the preferred embodiment of the intraoperative stent delivery device and the aortic arch stent assembly and release method, the method of installing and releasing the intraoperative stent delivery device and the aortic arch stent in the present invention will be further described in detail with reference to the accompanying drawings.

As shown in Figure 1, the overall structure of the stent during aortic arch surgery is usually designed as a self-expanding structure consistent with the morphology of the aortic arch. The stent is composed of a main body 1 and one to three

branches

2, 3, 4 during aortic arch surgery. The main body 1 of the stent corresponds to the aortic arch of the human body, and one to three

branches

2, 3, and 4 respectively correspond to the three branch vessels of the brachial trunk, the left common carotid artery, and the left subclavian artery on the aortic arch. In the aortic arch, the stent body 1 and the

branches

2, 3, 4 are generally compressible tubes having elastic tube walls, a continuous insulating membrane covering the tube wall, and a flexible connection between the body 1 and the

respective branches

2, 3, 4. Therefore, after the

branches

2, 3, and 4 of the intraoperative stent are inflated and deployed, the

branches

2, 3, and 4 can swing forward and backward with the respective flexible connections as the fulcrums, so that the directions of the

branches

2, 3, and 4 are respectively aligned with the corresponding ones. Branch vessels.

In the aortic arch surgery, the delivery process of the stent is complicated. First, the main body 1 and the

branches

2, 3, and 4 of the stent in the aortic arch are simultaneously sent to the lumen of the aortic arch and the branch artery lumen thereof through the incision at one end of the ascending aorta. Inside, then the main body 1 and each

branch

2, 3, 4 of the stent in the aortic arch are sequentially released, and finally the delivery device is safely withdrawn, but the positioning of the released stent cannot be affected.

As shown in FIG. 2, the delivery device of the stent in the aortic arch includes a handle 5, a fixing rod 6, a seeker 7, a branch guide wire 8, a branching envelope 9, a main body envelope 10, a suture 11, a wire 12, and a plug 13. The plug 14, the plug 15, the plug 16, the nut 17, the main body sheath 19, the luer connector 20, the branch sheath core 21, and the body guide wire 22 (see Fig. 13) and the like. Herein, the distal end of each component refers to the end remote from the handle 5, and the other end relative to the distal end is referred to as the proximal end.

As shown in FIG. 3, the handle 5 is a tubular member having two openings, and the plug 13, the plug 14, the plug 15, and the plug 16 are disposed on the handle 5. (in FIG. 2) the proximal ends of each of the pull wires 12 are respectively fixedly connected to their respective plugs; for example, the pull wire 12 (in FIG. 2) corresponding to the intraoperative support branch 2 (in FIG. 1) is fixed to the plug 13, corresponding ( In Fig. 1) the cable 12 of the intraoperative stent branch 3 (in Fig. 2) is fixed to the plug 14, corresponding to (in Fig. 1) the cable 12 of the intraoperative stent branch 4 (in Fig. 2) is fixed to the plug 15, corresponding ( In Fig. 1, the pull wire 12 (of Fig. 2) of the body 1 of the intraoperative stent is fixed to the plug 16. Each of the

plugs

13, 14, 15, 16 is provided with a nut 17 for fixing the corresponding plugs 13, 14, 15, 16 on the handle 5 to prevent the corresponding pull wire 12 from being pulled out. After the nut 17 is loosened, the corresponding plugs 13, 14, 15, 16 can be removed from the handle 5, and the cable 12 connected to the

plugs

13, 14, 15, 16 can be removed. Alternatively, each of the nuts 17 on the

plugs

13, 14, 15 or 16 can be replaced with other forms of releasable fixed connectors such as snaps, magnets, suction cups and the like.

As shown in Fig. 4, the components for mounting and guiding the portion of the stent body 1 in the aortic arch, including the fixation rod 6, the body inner sheath 19, the luer connector 20, and the body guide wire 22 (see Fig. 13). The distal end of the body inner sheath 19 is in communication with the proximal end 18 of the fixation rod 6, the luer connector 20 is disposed on the proximal end of the body inner sheath 19, and the proximal end 18 of the fixation rod 6 and the majority of the body inner sheath 19 are fixed The inside of the handle 5 has a longitudinal inner cavity in the fixed rod 6 and the main body sheath 19 for the passage of the main body guide wire 22. The distal end of the main body guide wire 22 can extend from the distal end of the fixed rod 6, the main body guide wire 22 and the fixation rod 6 together guide the main body 1 of the stent in the aortic arch to enter the aortic arch vessel from the incision end of the ascending aorta. The fixation rod 6 can be a flexible straight rod, while the body inner sheath 19 can be a softer elbow, and the body guide wire 22 can be made from a 0.035 inch superhard guidewire. In addition, a seeker (not shown) having a streamlined outer contour such as a conical shape may be provided at the distal end of the fixing rod 6 to reduce the frictional resistance of the fixing rod 6 when entering the blood vessel, and to facilitate the stent in the aortic arch. The body 1 enters the blood vessel through the seeker. In order to improve the overall continuity of the fixation rod 6 and the main body sheath 19, a longer main body sheath 19 may be employed, and the main body guide wire 22 only passes through the inner lumen of the main body inner sheath 19, and an outer wall of the main body inner sheath 19 The complete fixing rod 6 is formed by overmolding, and the distal end of the main body sheath 19 is provided with the seeker, and the seeker is also connected to the distal end of the fixing rod 6.

As shown in FIG. 5, the substantially elongated main body envelope 10 is wrapped on the stent body 1 in the aortic arch in a compressed state, and the side edges of the main body envelope 10 parallel to the axial direction of the main body 1 pass through the suture 11 and The pull wires 12 are sewn together, and the stitching points are lined up at equal intervals or at unequal intervals along the edge of the main body envelope 10. The pull wire 12 sequentially passes through each suture point of the suture 11 on the main body envelope 10 along the axial direction of the main body 1; the proximal end of the pull wire 12 passes through the hollow wire groove inside the handle 5 from the outer side of the main body envelope 10 (in the figure) Not shown) is connected to the plug 16. The suture 11 and the pull wire 12 can be sutured in a variety of easy-to-release manners, and only the proximal end of the pull wire 12 is pulled out from the outside of the main body envelope 10, and the suture 11 is self-disengaged due to the loss of the constraint of the pull wire 12, thereby causing The main body capsule 10 is self-releasing due to the loss of the constraint of the suture 11. In the aortic arch, the stent body 1 automatically bounces and expands due to the loss of the constraint of the main body capsule 10, and is fixed to the stent body 1 in the aortic arch surgery. The rod 6 is separated from the inner wall of the lumen of the body 1 to facilitate withdrawal of the body inner sheath 19 and the fixation rod 6.

Taking the plug 15 corresponding to the branch 4 as an example, as shown in Fig. 6, like the main body envelope 10 wrapped on the stent main body 1 in the aortic arch, an approximately elongated branch capsule 9 is wrapped in the aortic arch under compression. On the branch 4 of the intraoperative stent, the two side edges of the branch envelope 9 are also sewn together by the suture 11 and the other pull wire 12, and the suture points are lined up at equal intervals or unequal intervals along the edge of the branch envelope 9. . The pull wire 12 sequentially passes through each suture point of the suture 11 on its branching envelope 9 in the axial direction of the branch 4; the proximal end of the pull wire 12 passes through the hollow wire groove inside the handle 5 from the outside of the branching envelope 9 (Fig. Not shown) is connected to the corresponding plug 15. The suture 11 and the pull wire 12 can also be sutured in a variety of easy-to-release manners, simply by pulling the proximal end of the pull wire 12 out of its corresponding branch envelope 9 and the suture 11 on the branch 4 envelope is Losing the constraint of the wire 12 and releasing it by itself, thereby causing the branch capsule 9 to loosen by itself due to the loss of the constraint of the suture 11, the branch automatically bounces and expands due to the loss of the constraint of the branching capsule 9, and is originally attached to the aortic arch The seeker 7 on the branch sheath core 21 of the branch 4 of the intraoperative stent is separated from the lumen inner wall of the branch 4 to facilitate withdrawal of the branch sheath core 21 and its seeker 7.

As shown in Fig. 7, in order to guide the components of the

branches

2, 3, and 4 of the aortic arch, each set of components includes a seeker 7, a branch sheath 21, a luer 20, and a branch guide 8. The head of the seeker 7 has a streamlined outer contour such as a tapered shape, the seeker 7 and the luer 20 are respectively disposed at the distal end and the proximal end of the branch sheath core 21, and the proximal end portion of the branch sheath core 21 is fixed to the handle 5 The inner portion has a longitudinal lumen in the seeker 7 and the branch sheath core 21 so that the branch guide wire 8 passes, and the distal end of the branch guide wire 8 can extend from the head of the seeker 7, each group The branching guide wire 8 and the seeker 7 together guide the

corresponding branches

2, 3, and 4 of the aortic arch to enter the three branches of the corresponding aortic arch, the forearm trunk, the left common carotid artery, and the left subclavian artery. Preferably, the branch sheath core 21 is configured to fit the curved catheter of the shape of the

corresponding branch

2, 3, 4 of the stent in the aortic arch and its position, and the branch sheath core 21 is branched, 2, 3, and 4 nodes in the aortic archery (ie, The flexible joints of the

branches

2, 3, 4 and the body 1 have an angle of about 90 degrees.

In the above embodiments, the handle 5 and the

plugs

13, 14, 15, and 16 may be made of polyoxymethylene (POM) material, and the fixing rod 6 may be made of low density polyethylene (LDFE) material, and the seeker 7 may be Made of nylon elastomer (Pebax) material, the main body sheath 19, the branch sheath core 21, the main body guide wire 22 and the branch guide wire 8 can be made of SUS304 stainless steel material, and the main body envelope 10 and the branch envelope 9 can be aggregated. Made of tetrafluoroethylene (PTFE) material, the suture 11 can be made of polytetrafluoroethylene suture, and the wire 12 can be made of polypropylene material.

Since the fixing rod 6 is required to have a certain degree of softness, it can be correspondingly deformed according to the curved shape of the main body guide wire 22 in the aortic arch, so the fixing rod 6 can be made of a polymer material having good biocompatibility, such as low. Density polyethylene (LDFE) material, nylon elastomer (Pebax) material, or other polymer materials with the same properties.

Since the distal end of the seeker 7 is designed as a streamline body (for example, a cone), and can smoothly and evenly transition with the distal end of the intraoperative stent body 1 and the end portions of the

branches

2, 3, and 4 in a compressed state, Therefore, the seeker 7 can also be made of a polymer material having good biocompatibility, such as an LDFE material, a Pebax material, or other polymer materials having the same properties.

The host envelope 10 and the branch envelope 9 may each have at least one of polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), and the like having good biocompatibility. Material production. When the intraoperative stent release is completed, both the body capsule 10 and/or the branch capsule 9 can be withdrawn, or the body capsule 10 and/or the branch capsule 9 can be retained within the blood vessel; for example, the body envelope 10 And/or the branching capsule 9 can be sandwiched between the outer wall of the intraoperative stent and the inner wall of the blood vessel, and the body capsule 10 and/or the branching capsule 9 are not displaced by the radial supporting force of the intraoperative stent; It is also possible to suture both ends of the main body envelope 10 or the branching capsule 9 with the intraoperative stent to ensure that the main body envelope 10 and/or the branching envelope 9 are not displaced.

The suture 11 can be sutured for use in surgery, such as PTFE suture, PET suture, polypropylene suture, and the suture 11 can be pulled out or left in the blood vessel after the intraoperative stent is released. The pull wire 12 can be used with a surgical suture having a desired strength, such as a PTFE suture, a PET suture, a polypropylene suture, and the pull wire 12 needs to be withdrawn from the body when the surgery is completed.

Before the hybridization operation, the intraoperative stent needs to be assembled on the delivery device. When the aortic arch stent is installed on the delivery device, the main body 1 and each of the

branches

2, 3, and 4 are respectively compressed in the diameter direction thereof, and then respectively The envelope is wrapped and then the side edges of the respective envelopes are stitched together with the stitches 11 with the aid of the pull wires 12, and the stitches 11 and the pull wires 12 are sewn in a quick release manner. A pull wire 12 is respectively disposed on the main body 1 of the intraoperative stent and each of the

branches

2, 3, 4, and the pull wire 12 passes through each of the edges of the respective envelopes substantially along the axial direction of the main body 1 or the

respective branches

2, 3, 4. At the suture point, a pull wire 12 is respectively pulled out to release the suture 11 on the corresponding envelope to spread the envelope, and the proximal end of each pull wire 12 is respectively extended and fixed to the handle 5. The fixing rod 6 of the distal end with the seeker 7 passes through the lumen of the intraoperative stent body 1, and the lumen of each of the

branches

2, 3, 4 has a branch sheath of the distal end with the guiding head 7 respectively. 21 through. The proximal end of the fixation rod 6 and the proximal end of each of the branch sheath cores 21 are passed out from the proximal end of the lumen of the intraoperative stent body 1, and the distal end of the stent body 1 and each of the

branches

2, 3, and 4 are respectively The fixing rod 6 is brought into contact with the seeker 7 of the corresponding branch sheath 21 to form a smooth transition outer contour. The fixing rod 6 and the proximal end of each of the branch sheath cores 21 are assembled with the handle 5, and the central shaft of the main body sheath 19 and the fixing rod 6 (and its seeker 7) are provided with a longitudinal inner cavity, which is The cavity is used to slide the body guidewire 22; each of the branch sheath cores 21 and its seeker 7 also has a longitudinal lumen for sliding the branch guidewire 8.

Specifically, still taking the aortic arch stent in FIG. 1 as an example, firstly, the fixing rod 6, all the branch sheath cores 21 and the respective guiding heads 7 are inserted from the proximal end of the stent body 1 in the aortic arch, each The seekers 7 connected to the branch sheath core 21 respectively enter the

corresponding branches

2, 3, 4 of the aortic arch, and a part of the distal end of each seeker 7 is exposed at the end of the

corresponding branches

2, 3, 4 Outside the opening, the seeker 7 at the distal end of the fixed rod 6 is exposed outside the distal opening of the body 1. Compressing the main body 1 and the

corresponding branches

2, 3, 4 of the stent in the aortic arch, respectively, so that the contact portion of the guiding rod 7 of the fixing rod 6 and the body 1 have a smooth transition outer contour fit, so that the guiding of each branch sheath 21 The contact of the leader 7 with the

respective branches

2, 3, 4 has a smooth transition outer contour fit. Then, three different sets of branch capsules 9 are wrapped around the corresponding

branches

2, 3, and 4 of the aortic arch, and sutured with suture 11 and pull wire 12; a set of body envelopes 10 are wrapped in aortic arch surgery The stent body 1 is also sewn with the suture 11 and the wire 12.

As shown in Fig. 8, a schematic diagram of the effect of the branching envelope 9 wrapping one of the branches 4 on the stent in the aortic arch and sewing with the suture 11 and the pull wire 12 is shown. The branch 4 is first compressed, and then wrapped on the branch 4 in a compressed state by the corresponding branch envelope 9. At the edges of the two sides of the branch envelope 9, the branch is wrapped at equal intervals by the suture 11 and the pull wire 12. The film 9 is sewn on the branch 4; the suture 11 is detachably sewn on the branch envelope 9, and at the same time, the suture points of the suture 11 are strung together by the pull wire 12, and the pull wire 12 is supported in the aortic arch. The outside. As shown in Fig. 9, the branch envelope 9 is wrapped around the compressed branch 4, and all the stitching points of the suture 11 are on the overlapping side edges of the branch envelope 9, and the drawn pull wires 12 string the stitch points. stand up.

Next, the remaining two

branches

2, 3 on the stent in the aortic arch are compressed and wrapped with the respective branch envelopes 9, and the both edges of the branching envelope 9 are sewn together by the suture 11 and the corresponding wire 12. As shown in Fig. 10, the

branches

2, 3, and 4 are all covered by the respective branch envelopes 9, and a total of three pull wires 12 are drawn at this time. It should be noted that branch 2, branch 3, and branch 4 have no sequential restrictions on the operation sequence.

Next, the main body 1 of the stent in the aortic arch is recompressed and wrapped with the main body envelope 10, and then the two sides of the main body envelope 10 are sutured with the suture 11 and the other pull wire 12, and the suture 11 is detachable. The method is sewn on the main body envelope 10, and the suture points of the suture 11 are strung by the pull wire 12, and these suture points are preferably disposed on the side of the stent adjacent to the

branches

2, 3, and 4 of the aortic arch; after sewing A schematic view of the effect is shown in Fig. 11. In fact, the main body 1 of the stent in the aortic arch is compressed onto the outer surface of the fixed rod 6, and a portion of the proximal end of the main body 1 also tightly surrounds all of the branch sheath cores 21.

Finally, the pull wire 12 connected to the suture 11 of each branch capsule 9 is taken out from the proximal end of the stent body 1 in the aortic arch and guided to the handle 5, and the wire 12 attached to the suture 11 of the main body envelope 10 is attached to the main body. The outer surface of the envelope 10 is also directed toward the handle 5; as shown in Figure 12, the stent is tightly wrapped over the fixation rod 6 of the delivery device and the respective sheath cores 21, while the fixation rod 6 and the respective sheath sheaths A proximal portion of the core 21 is fixedly disposed on the handle 5; a proximal end of each of the pull wires 12 is respectively connected with a

plug

13, 14, 15, 16 on the handle 5; the aortic arch is assembled with the transport device, The aortic arch stent is thus positioned and released by the handle 5.

Preferably, in order to reduce the possible involvement of the pull wire 12, an axial passage may be provided in the interior of the handle 5 to protect the pull wire 12, the passage having an axial opening at the distal end of the handle 5 and the other opening of the passage. Close to the mounting position of the

plugs

13, 14, 15, 16 on the handle 5. The proximal end of each of the pull wires 12 from the

stent branches

2, 3, 4 or the main body 1 in the aortic arch can pass through the passage on the handle 5, and the pull wires 12 corresponding to the

branches

2, 3, 4 and the

plugs

13, 14 respectively 15 is connected, and the pull wire 12 of the corresponding body 1 is connected with the plug 16; the nut 17 on each

plug

13, 14, 15, 16 can be screwed to fix the

plugs

13, 14, 15, 16 respectively. On the handle 5; the fixing rod 6 and the branch sheath core 21 connecting the main body sheath 19 also pass through the handle 5, and the Luer fittings 20 at the proximal ends of the respective branch sheath cores 21 are located outside the proximal end of the handle 5. The body guide wire 22 can penetrate from the distal end of the fixed rod 6, passes through the body inner sheath 19, and passes through the luer connector 20 connected to the main body sheath 19; each branch guide wire 8 can be respectively obtained from each branch sheath core 21. The distal end of the seeker 7 penetrates through the respective sheath cores 21 and is respectively passed through the luer connector 20 connected to each of the branch sheath cores 21.

During surgery, a body guide wire 22 can be inserted into the aortic arch along the incision at one end of the ascending aorta, and the distal end of the body guide wire 22 penetrates into the descending aorta; the proximal end of the body guide wire 22 is inserted into the aortic arch The distal end opening and the inner cavity of the stent delivery device fixing rod 6 (and the seeker), the fixation rod 6 of the delivery device is slid forward along the main body guide wire 22; and the delivery device for assembling the aortic arch stent is assembled It is transported along the body guidewire 22 to a position near the ascending aortic incision. At this time, each branch guide wire 8 can be inserted into the inner cavity of the corresponding branch sheath core 21 from the luer connector 20 of the branch sheath core 21 of each

branch

2, 3, 4 of the aortic arch; And adjusting the position of the delivery device, so that the distal end of each branch guide wire 8 passes through the distal end of the seeker 7 of the

corresponding branches

2, 3, 4 of the aortic arch, and penetrates into the corresponding branch vessels of the aortic arch respectively; The delivery device is then pushed along the body guidewire 22 and all of the branch guides 8 toward the interior of the aortic arch. Guided by the main body guidewire 22 and the branching guidewire 8, the delivery device will properly position the main body 1 and the

respective branches

2, 3, 4 of the stent in the aortic arch with the aid of the streamlined outer contour of the conical seeker 7 The aortic arch and its various branches of the arteries. At this time, the position of the handle 5 is held and the stent body 1 and the pull wires 12 on the

respective branches

2, 3, 4 are respectively withdrawn in the aortic arch, and the stent body 1 and the

branches

2, 3, 4 are automatically bounced during the aortic arch surgery. Attached to the corresponding vessel wall. Then, the delivery device and all the guide wires are withdrawn, and the proximal end of the intraoperative stent body 1 is sutured to the aortic vessel wall at the incision end of the ascending aorta, and the vascular incision is finally sutured.

Specifically, as shown in FIG. 13, the operation is first incision at the end of the patient's aortic arch near the ascending aorta, and a superhard guide wire (ie, the main guide wire 22) is inserted from the position of the incision, and the superhard guide wire is far. The end extends into the lumen of the descending aorta.

Then, as shown in Fig. 14, the proximal end of the superabrasive guide wire is inserted through the distal opening of the delivery device fixing rod 6 which has been assembled with the aortic arch, through the fixing rod 6 and the body communicating with the fixing rod 6. After the inner sheath 19, a Luer connector 20 is inserted from the proximal end of the delivery device handle 5; at the same time, the distal ends of the three branch guide wires 8 on the delivery device are respectively inserted through the remaining Luer connectors 20, through corresponding After branching the sheath core 21 and its seeker 7, the distal end of the corresponding seeker 7 is inserted into the lumen of the innominate artery, the left common carotid artery, and the left subclavian artery respectively into the aortic arch; The

branches

4, 3, 2 enter the aortic arch and tilt the corresponding

branches

4, 3, 2 toward the main body side.

As shown in Fig. 15, under the guidance of the super-hard guide wire and the three branch guide wires 8, the contour of the transitional shape is assisted by the tapered seeker 7, and finally the main body 1 of the aortic arch stent assembled on the delivery device and

Branches

2, 3, and 4 are appropriately positioned at corresponding positions of the aortic arch, and the overall shape and position of the stent in the aortic arch is matched with the aortic arch and branch vessels.

As shown in Figure 16, when the aortic arch is fully positioned in the proper position of the aortic arch vessel, the nut 17 on the plug 15 can be loosened, the plug 15 can be pushed out of the handle 5, and the plug 15 will be grasped. The pull wire 12 on 4 is withdrawn to release the suture 11 sewn on the branching envelope 9 of the branch 4, after which the branch 4 automatically expands and is stably supported in the corresponding branch vessel.

As shown in Fig. 17, according to the same release method, the corresponding two pull wires 12 on the other two

branches

3 and 2 are respectively extracted; the three

branches

2, 3, and 4 of the stent in the aortic arch are all released and stably supported in the aortic arch. Branches within the blood vessels.

As shown in Fig. 18, the nut 17 on the plug 16 is finally loosened, the plug 16 is removed from the handle 5, and the corresponding pull wire 12 on the main body 1 of the aortic arch is removed. The main body 1 of the stent is bounced during aortic arch surgery. Supported in the lumen of the aortic arch.

Because of the good elasticity of the stent during aortic arch surgery, the outer wall of the stent is moderately attached to the inner wall of the aortic arch and the branch vessel during aortic arch surgery. The stent's own isolation membrane can block the leakage site on the corresponding vessel during aortic arch surgery.

As shown in Fig. 19, when the stent is completely released during aortic arch surgery, the delivery device is withdrawn from the blood vessel, and then the proximal end of the stent body 1 and the aortic vessel wall are sutured together in the vicinity of the ascending aortic incision. In order to ensure that the stent will not be displaced in the aortic arch surgery; finally, the aortic incision is sutured to complete the operation.

In addition, during the release of the stent during aortic arch surgery, the corresponding pull wire 12 on the stent body 1 in the aortic arch can also be first removed, first let the main body 1 bounce first, and then the corresponding

branches

2, 3, 4 respectively. The pull wire 12 is removed, and the

branches

2, 3, and 4 are sequentially opened.

Preferably, in order to make the main body 1 of the intraoperative stent easier to bounce, more than two envelopes may be used to wrap the main body 1 of the intraoperative stent. For example, in the case of an aortic arch stent with three

branches

2, 3, and 4, four capsules can be used to wrap the body 1 of the stent in the aortic arch. Wherein, the portion from the distal end of the body 1 to the branch 4 may be covered with the first envelope 10; the portion between the branch 3 and the branch 4 is covered with a second envelope; The portion between the branches 3 is covered with a third envelope; the portion from the proximal end of the body 1 to the branch 2 is covered with a fourth envelope. The two sides of each envelope are respectively sewn with a suture 11 and the four envelopes can share a single pull wire 12. The advantage of using multiple body capsules in the intraoperative stent is that the main body 1 is more easily popped open. Usually, the size of the four envelopes is different, and the second envelope and the third envelope are smaller than the first envelope and the fourth envelope. In addition, according to the actual needs, under the premise of ensuring that the main body 1 is easy to bounce, the main body 1 of the intraoperative stent can also be divided into two parts or three parts, and two or three envelopes are respectively used. Wrapping and stitching are simpler than stitching the four body envelopes 10.

The method for installing and releasing the intraoperative stent delivery device and the stent in the aortic arch surgery provided by the invention has the technical means of releasing the suture and the pulling wire, and only needs to take out the pulling wire to release the corresponding suture, and then the belt The intraoperative stent release of the branch is located in a branching blood vessel such as the aortic arch; compared to prior art techniques for treating aortic disease, with the delivery device of the present invention, only the aorta at the end of the aortic arch lesion is required Incision, the intraoperative stent mounted on the delivery device can be conveniently and quickly implanted into the corresponding lesion position, including the lesion position of the branch vessel, and the corresponding suture can be released by simply pulling out the wire, and then the branch with the branch The stent is released in a branching blood vessel such as the aortic arch and sutured the incision after withdrawal of the delivery device. The delivery device is used in the aortic arch hybrid surgery, which greatly reduces the number of anastomosis during surgery compared with the original hybrid surgery. It is only necessary to suture an anastomosis during surgery, thereby simplifying the operation and shortening the operation. Time, reduce the complications of surgery, improve the survival rate of patients, improve the effect of treatment, and more effectively reduce the trauma of patients with aortic arch disease.

By adopting the intraoperative stent delivery device provided by the invention, the stent can be put into practical use in the aortic arch surgery, and the hybrid surgery combining the intravascular invasive technique and the surgical operation can be more effectively used for the treatment of the aortic arch disease, so that the operation can be performed. A successful completion, and reduce the three to five anastomosis required in traditional surgery to an anastomosis, greatly reducing the difficulty and risk of surgery, shortening the operation time, and reducing the trauma to the patient. The intraoperative stent delivery device of the present invention can simultaneously transport the main body and the plurality of branches of the stent in the aortic arch to the aortic arch through a single incision at one end of the ascending aorta, and align each branch of the aortic arch with the aortic arch one by one. The corresponding branch vessel is then positioned within the branch vessel. The main body of the stent and the branches thereon are released by pulling out the wire, and then the delivery device can be safely withdrawn without affecting the positioning of the stent in the aortic arch.

It should be understood that the above description is only the preferred embodiment of the present invention, and is not sufficient to limit the technical solutions of the present invention. Those skilled in the art can, according to the spirit and principle of the present invention, The instructions are to increase, decrease, replace, change or improve. For example, the delivery device of the intraoperative stent of the present invention is not limited to the delivery and release of the aortic arch stent, and can be used for sewing, transportation, and the like after proper deformation and modification. All other intraoperative stents with at least one branch are released; and all such additions, substitutions, alterations, or improvements are intended to fall within the scope of the appended claims.

Claims

An intraoperative stent delivery device for mounting and releasing the intraoperative stent, including an envelope, a suture, and a pull wire; the suture and the pull wire suturing the two sides of the envelope to The intraoperative stent is gathered and wrapped in the envelope, and the suture and the envelope form a connection that can be released by pulling out the wire.
The intraoperative stent delivery device of claim 1 wherein said intraoperative stent comprises a body and more than one branch.
The intraoperative stent delivery device according to claim 1 or 2, wherein the envelope is made of one of polyester, polytetrafluoroethylene or a derivative thereof.
The intraoperative stent delivery device according to claim 2, comprising: a main body envelope and one or more branching envelopes; a main body envelope for wrapping the main body, each branching envelope for respectively wrapping the One of the branches; the main body envelope and each of the branch envelopes are respectively connected to a pull wire.
The intraoperative stent delivery device of claim 4 wherein the suture forms an equally spaced suture point along the edge of the main body envelope or branching envelope; said suture point substantially along said body or said branch Axial distribution; each of the pull wires passes through all of the suture points on the respective body envelope or branch envelope one by one.
The intraoperative stent delivery device according to claim 5, wherein the intraoperative stent is an aortic arch stent having three branches; the main capsule is divided into four separate portions; The four separate sections are bounded by the branches of the stent in the aortic arch and share a pull line.
The intraoperative stent delivery device of claim 6 including a handle, a flexible fixation rod and three flexible branch sheath cores; a proximal end of the fixation rod and a proximal end of the branch sheath core Fixing on a handle for mounting the aortic arch stent body, each of the three branch sheath cores for mounting a branch of the aortic arch stent; mounted on the branch sheath The branch on the core can swing with its connection to the body as a fulcrum.
The intraoperative stent delivery device according to claim 7, wherein a hollow wire slot and a detachable plug are disposed on the handle; and the pull wire corresponding to the main body envelope and the branch envelope passes through the wire groove. The proximal connection of the cable is fixed to the plug.
A method for installing a stent in aortic arch surgery, comprising the steps of:

Passing the fixation rod of the delivery device through the lumen of the main body of the stent in the aortic arch, and each branch sheath of the delivery device passes through a lumen of a branch of the stent in the aortic arch;

The main body is compressed on the outer surface of the fixing rod, and the main body is wrapped by the main body envelope, the suture is sewn on the main body envelope by the pulling wire, and the suture and the pulling wire and the main body film form a drawing pull line to be released. The branch is compressed on the outer surface of the corresponding branch sheath core, the branch is wrapped with a branching envelope, the suture is sewn on the branching envelope, and the suture and the pull wire are formed with the branching capsule. Pull the cable to release the connection.
A method for releasing a stent in aortic arch surgery, comprising the steps of:

Positioning the main body of the aortic arch in the compressed state with the delivery device in the aortic arch vessel, and positioning the branch of the aortic arch in the compressed state in the branch vessel of the aortic arch;

Pulling a wire connected to a suture wrapped around a main body envelope of the main body to unravel a suture sewn on the main body envelope; the main body is bounced and released in the aortic arch vessel; A pull wire connected to the suture on the branch envelope of the branch, unwinding the suture sewn on the branch envelope; the branch bounces off and is released in the branch vessel of the aortic arch.