WO2018121345A1

WO2018121345A1 - Delivery system for left auricle occluder

Info

Publication number: WO2018121345A1
Application number: PCT/CN2017/117171
Authority: WO
Inventors: 江巍; 谢惠雄; 王刚
Original assignee: 先健科技(深圳)有限公司
Priority date: 2016-12-30
Filing date: 2017-12-19
Publication date: 2018-07-05
Also published as: CN108261216A; CN108261216B

Abstract

A delivery system (100) for a left auricle occluder. A delivery sheath (10) comprises: a main part (11), and a molded part (12) connected to the distal end of the main part (11). The molded part (12) comprises: a first molded section (121), and a second molded section (122) connected to the distal end of the first molded section (121). At least two development units (70a, 70b) are provided at the second molded section (122) and the distance between the at least two development units (70a, 70b) in an axial direction of the second molded section (122) ranges from 10 mm to 40 mm. The delivery system (100) uses the distance between the two development units (70a, 70b) as a reference to measure and calculate the size of a left auricle opening, thereby improving measurement accuracy effectively and reducing the possibility of selecting an unsuitable left auricle occluder model. The delivery system also shortens the measurement time, reduces surgery time and costs, and reduces surgical risks.

Description

Left atrial appendage occluder delivery system

Technical field

The invention belongs to the field of interventional medical devices and relates to a delivery system of a left atrial appendage occluder.

Background technique

Catheterization refers to a surgical procedure in which a physician performs a diagnosis or treatment of a disease by placing a catheter, a variety of materials, drugs, or instruments through a catheter to a heart, artery, or vein of a human body. Catheterization is widely used to treat a variety of cardiovascular diseases. For example, a left atrial appendage occluder is implanted into the left atrial appendage by catheter intervention to block blood flow into the left atrial appendage, thereby eliminating thrombosis due to atrial fibrillation at the left atrial appendage, thereby preventing a stroke or other system caused by the thrombus. Sexual embolism.

In the prior art, the left atrial appendage occlusion surgery is generally performed by placing a guide wire through the femoral vein puncture. The puncture needle reaches the right atrium through the guide wire, enters the left atrium after the puncture room interval, and then transports the delivery sheath tube to the right along the guide wire. The atrium enters the left atrium through the puncture at the interatrial septum, thereby establishing a delivery trajectory of the femoral vein puncture to the left atrium. Then, digital subtraction angiography (DSA) was used for angiography, and the diameter of the sheath was measured as a reference. The average diameter at the largest gap of the left atrial appendage was measured, and the left atrial appendage occlusion device with the matching size was selected. The left atrial appendage occluder is then delivered to the left atrial appendage via a delivery sheath to block the left atrial appendage gap.

Since the anatomy of the left atrial appendage is extremely complicated, the diameter of the delivery sheath for reference is small, and the doctor's observation field is limited during the operation, so the prior art determines the left atrial appendage by the diameter of the delivery sheath. The method of notch size has the following defects: (1) the accuracy is low, the possibility of improper selection of the instrument is high; (2) the operation is difficult and the time required is long; (3) the surgical risk and the operation cost are both Higher.

Summary of the invention

Based on this, it is necessary to provide a delivery system that can quickly and accurately measure the size of the opening of the left atrial appendage during the implantation of the left atrial appendage, thereby facilitating the doctor to select a suitable left atrial appendage occlusion device for surgery, reducing Surgical risks and costs.

It is an object of the present invention to provide a delivery system by providing at least two developing units at a distal end section of a delivery sheath or dilation tube, using the distance between two developing units as a reference, by using the reference object The left atrial appendage opening is compared to measure the size of the left atrial appendage opening. Thereby, the accuracy of measuring the size of the opening of the left atrial appendage can be effectively improved during the operation, thereby reducing the possibility of inappropriate selection of the left atrial appendage occluder. It can shorten the measurement time, save the operation time and cost, and reduce the risk of surgery.

The delivery system of the left atrial appendage occluder provided by the present invention comprises a delivery sheath. The delivery sheath includes a body portion and a contoured portion coupled to the distal end of the body portion. The contoured portion includes a first contoured section and a second contoured section coupled to the distal end of the first shaped section. In a natural state, an angle between an extending direction of the first shaping section and an extending direction of the main body portion ranges from 40 degrees to 50 degrees, and an extending direction of the second shaping section is The angle between the first shaping section and the plane in which the body portion is located ranges from 30 degrees to 40 degrees. At least two developing units are disposed in the second shaping section, and a distance between at least two of the developing units in the axial direction of the second shaping section ranges from 10 mm to 40 mm. The extending direction of the first shaping section refers to a direction in which the proximal end of the first shaping section extends toward the distal end of the first shaping section, and the extending direction of the main body section refers to the proximal end of the main body section. The direction in which the distal end of the body portion extends. The direction in which the second shaped section extends extends the direction in which the proximal end of the second shaped section extends toward the distal end of the second shaped section.

The delivery system of the left atrial appendage occluder provided by the present invention comprises a delivery sheath and a dilation tube detachably received in the delivery sheath. The dilation tube includes a body portion and a contoured portion that is coupled to the distal end of the body portion. The contoured portion includes a first contoured section and a second contoured section coupled to the distal end of the first shaped section. In a natural state, an angle between an extending direction of the first shaping section and an extending direction of the main body portion ranges from 40 degrees to 50 degrees, and an extending direction of the second shaping section is The angle between the first shaping section and the plane in which the body portion is located ranges from 30 degrees to 40 degrees. At least two developing units are disposed in the second shaping section, and a distance between at least two of the developing units in the axial direction of the second shaping section ranges from 10 mm to 40 mm. The extending direction of the first shaping section refers to a direction in which the proximal end of the first shaping section extends toward the distal end of the first shaping section, and the extending direction of the main body section refers to the proximal end of the main body section. The direction in which the distal end of the body portion extends. The direction in which the second shaped section extends extends the direction in which the proximal end of the second shaped section extends toward the distal end of the second shaped section.

In one of the embodiments, the distance between the at least two of the developing units in the axial direction of the second shaping section ranges from 15 mm to 25 mm.

In one of the embodiments, the tube wall of the delivery sheath is of a multilayer structure. The developing unit is disposed in at least two layers of the multilayer structure.

In one embodiment, the delivery system further includes a dilation tube removably received in the delivery sheath. The distal end of the dilator tube gradually increases in outer diameter from the distal end to the proximal end.

In one of the embodiments, the tube wall of the dilation tube is of a multi-layered structure. The developing unit is disposed in at least two layers of the multilayer structure.

In one of the embodiments, the distal end of the dilator tube gradually increases in outer diameter from the distal end to the proximal end.

In one of the embodiments, the delivery system further includes a push cable. The push cable includes an elongated wire cable body and a film disposed on an outer surface of the cable body.

In one of the embodiments, the delivery system further comprises a hemostasis device. The hemostatic device includes a hemostatic valve body having a lumen and a seal disposed in the lumen of the hemostatic valve body. The seal is provided with an aperture. After the distal end of the cable body passes through the aperture from the distal end of the hemostatic valve body out of the hemostatic valve body, the membrane of the push cable is matched with the seal to seal the hemostatic valve The distal end of the body is isolated from the outside.

In one of the embodiments, the delivery system further includes a pigtail catheter detachably coupled to the distal end of the hemostatic device. The tube body of the pigtail catheter near the distal end is curved. The tubular body sidewall of the pigtail catheter has at least one side hole.

In one of the embodiments, the delivery system further includes a hollow loader removably coupled between the delivery sheath and the hemostatic device. The inner cavity of the loader is in communication with the delivery sheath and the lumen of the hemostatic valve body.

The invention also provides a surgical method for left atrial appendage closure, comprising the following steps:

The puncture needle punctures the interatrial septum to form a gap, and the distal end of the delivery sheath tube and the dilation tube is sent to the left atrium through the gap to reach the opening of the left atrial appendage;

Injecting a contrast agent into the left atrial appendage, and measuring a size of the left atrial appendage opening by comparing a distance between the delivery sheath or at least two of the developing units on the dilation tube;

The left atrial appendage occluder is delivered into the left atrial appendage through the delivery sheath and released.

In one embodiment, before the step of forming a gap between the puncture needle and the interatrial septum, the surgical method further comprises forming a small incision in the femoral vein puncture, and delivering the puncture needle to the right atrium through the small incision step.

In one embodiment, the step of delivering the distal end of the delivery sheath and the dilation tube through the gap to the left atrium comprises: penetrating the dilation tube into the delivery sheath such that the expansion tube The distal end passes through the distal port of the delivery sheath, and the distal end of the dilation tube and the delivery sheath is delivered to the right atrium through the small incision, and the dilation tube and the delivery sheath are The distal end of the tube is delivered to the left atrium via the gap.

In one of the embodiments, in the step of measuring the size of the left atrial appendage opening, a plane perpendicular to the opening of the left atrial appendage is used as a reference surface for digital subtraction angiography.

In one embodiment, the step of measuring the size of the left atrial appendage opening and the step of delivering the left atrial appendage occlusion device into the left atrial appendage along the delivery sheath and releasing the procedure The method also includes the step of withdrawing the dilation tube.

The delivery system of the present invention has at least the following beneficial effects compared to the prior art:

(1) The delivery system of the left atrial appendage occluder provided by the present invention, at least two developing units are disposed at a second shaping section near the distal end of the delivery sheath tube or the expansion tube, with the distance between the two developing units as The reference, the size of the left atrial appendage notch was measured by comparing the reference to the left atrial appendage notch. Therefore, the accuracy of measuring the size of the left atrial appendage notch can be effectively improved during the operation, and the measurement time can be shortened, thereby reducing the possibility of inappropriate selection of the left atrial appendage occluder, saving operation time and cost, and reducing the risk of surgery.

(2) In the delivery system provided by the present invention, the second shaping section of the delivery sheath tube or the dilation tube near the distal end is provided with at least two developing units, which facilitates the distal positioning of the delivery sheath tube and ensures the left atrial appendage occluder Release position.

The surgical method of the left atrial appendage closure of the present invention has at least the following beneficial effects compared with the prior art:

(1) In the surgical method of the present invention, the distance between the two developing units is used as a reference, and the size of the largest notch of the left atrial appendage is measured, which can improve the measurement accuracy and shorten the measurement time, thereby reducing the left atrial appendage occluder The possibility of improper selection can save operation time and cost and reduce the risk of surgery.

(2) In the surgical method of the present invention, the position of the distal end of the delivery sheath is determined by observing two development points located at the distal end of the delivery sheath or the dilation tube, which facilitates the distal positioning of the delivery sheath and ensures the closure of the left atrial appendage. The release position of the device.

DRAWINGS

1 is a schematic view of a delivery system according to a first embodiment of the present invention, the delivery system including a delivery sheath, a push cable, a hemostatic valve, and a loader;

Figure 2 is a schematic view of the delivery system of Figure 1 further including a dilation tube;

Figure 3 is a schematic view of the delivery system of Figure 1 further including a pigtail catheter;

4 is a schematic view of the delivery sheath of FIG. 1. The delivery sheath includes a main body portion and a shaping portion, the shaping portion includes a first shaping section and a second shaping section, and the second shaping section is provided with two developments. unit;

Figure 5 is a cross-sectional view of the second shaping section of the delivery sheath of Figure 4 and a cross section of the developing unit in an axial direction perpendicular to the second shaping section;

Figure 6 is a schematic view of the loader of Figure 1;

Figure 7 is a schematic view of the push cable of Figure 1;

Figure 8 is a schematic view of the hemostatic valve of Figure 1;

Figure 9 is a schematic illustration of the expansion assembly of the delivery sheath of Figure 1 assembled with the expansion tube of Figure 2;

Figure 10 is a schematic illustration of the contrast assembly of the delivery sheath and hemostasis valve of Figure 1 assembled with the pigtail catheter of Figure 3;

Figure 11 is a schematic view of the delivery system of Figure 1 after loading the left atrial appendage occluder;

Figure 12 is a schematic view of a dilation tube of a delivery system according to a second embodiment of the present invention;

Figure 13 is a schematic view of the structure of the human heart;

14a to 14i are schematic views of the process of the first surgical method of the present invention, wherein;

Figure 14a is a schematic view of the puncture guidewire entering the right atrium through the femoral vein puncture, the distal end of the interatrial septum sheath and the atrial septum dilation tube reaching the right atrium along the puncture guide wire;

Figure 14b is a schematic view of the interatrial septum needle entering the right atrium through the atrial septum sheath, the needle tip of the interatrial septum needle being aligned with the fossa ovalis;

Figure 14c is a schematic view of the needle tip of the atrial septum needle piercing the fossa ovalis and into the left atrium;

Figure 14d is a schematic view of the distal end of the atrial septum dilation tube and the interatrial septum sheath entering the left atrium;

Figure 14e is a schematic illustration of the withdrawal of the atrial septum needle and the atrial septum dilation tube, retaining the interatrial septum in the left atrium, thereby establishing a passage from the external to the left atrial appendage;

Figure 14f is a schematic view of the distal end of the delivery guidewire entering the left atrium through the interatrial septum sheath, and the distal end of the expansion assembly of Figure 9 entering the left atrium along the delivery guidewire;

Figure 14g is a schematic view of the withdrawal of the dilation tube, assembly of the delivery sheath, hemostatic valve and pigtail catheter into the contrast assembly of Figure 10, with the distal end of the pigtail catheter entering the left atrium;

Figure 14h is a schematic diagram of the injection of a contrast agent, the contrast agent flows into the left atrium and the left atrial appendage through the pigtail catheter, and the distance between the two developing units of the delivery sheath and the maximum opening of the left atrial appendage is compared by DSA;

Figure 14i is a schematic view of the withdrawal of the pigtail catheter, the left atrial appendage occluder into the left atrial appendage through the delivery sheath;

15a to 15c are schematic views of the process of the second surgical method of the present invention, wherein;

Figure 15a is a schematic illustration of establishing a passage from the outside to the left atrial appendage;

Figure 15b is a schematic view showing the injection of a contrast agent into the left atrium and the left atrial appendage, and the distance between the two developing units of the dilatation tube and the maximum opening of the left atrial appendage by DSA;

Figure 15c is a schematic illustration of withdrawal of the dilatation tube, delivery of the left atrial appendage occluder into the left atrial appendage via the delivery sheath.

detailed description

The present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It is understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

To more clearly describe the structure of the delivery system, the term "distal" is used herein to mean the end away from the operator during a surgical procedure, and the "proximal" is the end that is close to the operator during a surgical procedure. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning meaning The terminology used in the description is for the purpose of describing the particular embodiments, and is not intended to limit the invention.

Conveyor system

Specific embodiments of the delivery system provided by the present invention are described in detail below.

Embodiment 1

Referring to FIG. 1 to FIG. 3 simultaneously, the delivery system 100 provided in the first embodiment is used for delivering the left atrial appendage occluder to the left atrial appendage and releasing. The delivery system 100 includes a delivery sheath 10, a dilation tube 20 movably received in the delivery sheath 10, a pigtail catheter 30 movably received in the delivery sheath 10, a hemostatic valve 40, and a detachable connection to the delivery sheath A loader 50 between the tube 10 and the hemostatic valve 40 and a push cable 60 movably received in the delivery sheath 10 are provided.

It will be appreciated that the dilation tube 20 may be sold in sets in the delivery sheath 10 as pre-installed by the manufacturer, or the dilator tube 20 may be assembled in the delivery sheath 10 only by surgery prior to surgery or during surgery. The loader 50 may be pre-connected between the delivery sheath 10 and the hemostatic valve 40 by a manufacturer, or the loader 50 may be coupled between the delivery sheath 10 and the hemostatic valve 40 only by the operator before or during surgery. Accordingly, the pigtail catheter 30 can be sold in sets in the delivery sheath 10 and the hemostatic valve 40, or the pigtail catheter 30 can be assembled in the delivery sheath 10 and the hemostatic valve 40 only before or during surgery. . The push cable 60 can be sold in the delivery sheath 10, the loader 50, and the hemostasis valve 40, or the operator can assemble the push cable 60 to the delivery sheath 10 only before or during surgery. Among the loader 50 and the hemostatic valve 40.

Referring to Figure 4, the delivery sheath 10 has opposing proximal and distal ends. A sheath connector is attached to the proximal end of the delivery sheath 10. The proximal end of the delivery sheath 10 is detachably coupled to the distal end of the loader 30 or the distal end of the hemostatic valve 40, and after attachment, the lumen of the delivery sheath 10 and the lumen of the loader 30 and/or the hemostatic valve 40 The inner chambers are connected.

The delivery sheath 10 includes a body portion 11 and a shaping portion 12 connected to the distal end of the body portion 11 in the axial direction. The contoured portion 12 includes a first contoured section 121. In the natural state, the angle between the extending direction of the first shaping section 121 and the extending direction of the main body portion 11 ranges from 40 degrees to 50 degrees. The extending direction of the first shaping section 121 refers to the direction in which the proximal end of the first shaping section 121 extends toward the distal end of the first shaping section 121. The extending direction of the main body portion 11 refers to a direction in which the proximal end of the main body portion 11 extends toward the distal end of the main body portion 11.

The contoured portion 12 also includes a second contoured section 122 that is coupled to the distal end of the first contoured section 121. That is, the first shaping section 121 is coupled between the main body portion 11 and the second shaping section 122. In the natural state, the angle between the extending direction of the second shaping section 122 and the plane in which the first shaping section 121 and the main body portion 11 are located ranges from 30 degrees to 40 degrees. The direction in which the second shaped section 122 extends refers to the direction in which the proximal end of the second shaped section 122 extends toward the distal end of the second shaped section 122. In this way, the shaping portion 12 is adapted to adapt to the physiological anatomy of the left atrial appendage, and can smoothly pass through the interatrial septum into the left atrium to reach the vicinity of the left atrial appendage.

The second shaping section 122 of the delivery sheath 10 is provided with two developing

units

70a and 70b. The developing

units

70a and 70b are not in contact with each other. That is, the developing

units

70a and 70b have a distance L in the axial direction of the second shaping section 122.

In the DSA process, the left atrial appendage can be measured by adjusting the position of the distal end of the delivery sheath 10 (i.e., the distal end of the second shaping section 122) with the distance L between the two developing

units

70a and 70b as a reference. The size of the opening. In the measurement process, since the size of the reference object is much larger than the diameter of the tube sheath of the delivery sheath 10 as a reference in the prior art, the measured size of the opening of the left atrial appendage is relatively accurate, which is beneficial for the surgeon to select a suitable left atrial appendage. The occluder reduces the hazard caused by improper selection of the instrument. At the same time, at least two developing

units

70a and 70b are disposed in the second shaping section 122 of the delivery sheath 10, which is advantageous for improving the recognizability of the distal end of the delivery sheath 10 under the DSA, and facilitating the delivery of the distal end of the sheath 10. Positioning to ensure the release position of the left atrial appendage occluder.

In the case of DSA, the surgeon uses a plane perpendicular to the opening of the left atrial appendage as a reference surface to ensure that the left atrial appendage opening is orthographically projected at the reference surface, and the projected size of the orthographic projection is equal to the actual size of the left atrial appendage opening. Whereas prior art delivery sheaths are generally straight tubular without a shaped portion. When the straight tubular delivery sheath reaches the vicinity of the left atrial appendage, the axial direction of the distal section of the delivery sheath is not parallel to the reference surface, resulting in a projection distance between the developing unit at the reference surface and the actual distance between the developing units. Inconsistent. The surgeon needs to repeatedly adjust the distal end of the delivery sheath, which increases the difficulty of operation, prolongs the operation time, aggravates the damage to the puncture of the interatrial septum, and increases the surgical risk of the patient. Moreover, if the axial direction of the distal end section of the delivery sheath tube is still not parallel with the reference surface of the DSA after multiple adjustments, the operator can only measure the left atrial appendage size by using the projection distance between the developing units as a reference object. The error is large.

The delivery sheath 10 of the present embodiment has a shaping portion 12 adapted to the anatomical structure, and two developing

units

70a and 70b are disposed on the second shaping section 122 of the shaping portion 12. When the distal end of the delivery sheath 10 (ie, the distal end of the second shaped segment 122) reaches the vicinity of the left atrial appendage, the axial direction of the second shaped segment 122 is substantially perpendicular to the plane in which the left atrial appendage is located, ie, the second The axial direction of the shaped section 122 is parallel to the reference surface of the DSA. At this time, the projections of the two developing

units

70a and 70b on the reference surface are also orthographic projections, and the projection distance between the two developing

units

70a and 70b on the reference surface is equal to between the two developing

units

70a and 70b. The actual distance L in the axial direction of the second shaped section 122. Therefore, when the operator uses the projection distance between the two developing

units

70a and 70b as a reference to compare the projection size of the left atrial appendage opening, the actual actual distance L between the two developing

units

70a and 70b is actually used as a reference. The object can effectively reduce the measurement error of the opening of the left atrial appendage.

In order to reduce the measurement error, the distance L between the two developing

units

70a and 70b in the axial direction of the second shaping section 122 should be greater than or equal to 10 mm. Further, in order to ensure that the projection distance between the two developing

units

70a and 70b on the reference surface of the DSA is equal to the actual distance between the two, L should be less than or equal to 40 mm. Preferably, the distance L between the two developing

units

70a and 70b in the axial direction of the second shaping section 122 ranges from 15 to 25 mm. It can be understood that the selection range of L should be different according to the anatomy of the individual patient. Specifically, in the present embodiment, L is 15 mm.

Referring to FIG. 5 together, the wall of the delivery sheath 10 has a multi-layer structure including a Teflon layer, a stainless steel braid layer and a block polyether amide layer from the inside to the outside. The developing

units

70a and 70b are annular and embedded in the wall of the second shaping section 122 of the delivery sheath 10. The developing

units

70a and 70b are made of a radiopaque developing material such as platinum or rhodium.

The forming process of the conveying sheath 10 is as follows: first, the polytetrafluoroethylene layer, the stainless steel braid layer and the block polyether amide layer are assembled from the inside to the outside, and finally the heat shrinkable tube (for example, the fluorinated ethylene propylene copolymer heat) is used. The shrink tube, referred to as FEP heat shrinkable tube, wraps the aforementioned three layers and heats it to the heat shrinkage temperature of the heat shrinkable tube, so that the block polyether amide melts and coats the stainless steel braid, and the heat shrinkable tube shrinks and tightly covers the entire Tube body.

The step of embedding the developing

units

70a and 70b in the wall of the second shaping section 122 includes: firstly, the two developing

units

70a and 70b are respectively placed on the second shaping section during the molding process of the conveying sheath 10. On the stainless steel braid of 122, a block of polyetheramide is then applied over the outer portion of the stainless steel braid of the delivery sheath 10, and then the block polyether amide is melted by heating and coated with a stainless steel braid, at which time the developing

unit

70a and 70b are coated between the block polyether amide and the stainless steel braid, and then the heat shrinkable tube is wrapped around the entire tube of the delivery sheath 10, and heated to shrink the heat shrinkable tube and tightly cover the entire tube. . It will be appreciated that in other embodiments, the developing

units

70a and 70b may also be secured in the wall of the second contoured section 122 by a crimping apparatus. Alternatively, a plurality of grooves may be first ground in the second shaping section 122, and each developing unit may be separately placed in the groove.

It can be understood that, in other embodiments, more than two developing units may be disposed in the second shaping section 122 of the delivery sheath 10, and then the distance between each two developing units is sequentially followed by the opening of the left atrial appendage. The size is compared multiple times, and the average value of the multiple calculation results is taken as the actual size at the opening of the left atrial appendage to improve the measurement accuracy.

Referring again to FIG. 2, the expansion tube 20 is a hollow, flexible polymer tube. The dilation tube 20 is movably received in the body of the delivery sheath 10 for assisting in the delivery of the sheath 10 to establish a vascular path. The outer diameter of the dilation tube 20 is slightly smaller than the inner diameter of the delivery sheath 10 so that the distal end of the dilation tube 20 can enter the delivery sheath 10 from the proximal port of the delivery sheath 10 and pass through the distal port of the delivery sheath 10. Out. The outer diameter of the proximal end of the dilation tube 20 is slightly larger than the inner diameter of the delivery sheath 10, and the proximal end of the dilation tube 20 is provided with a joint to limit the proximal end of the dilation tube 20 into the delivery sheath 10. The distal end of the distal end of the dilation tube 20 is gradually increased from the distal end to the proximal end to facilitate puncture. The dilation tube 20 includes a body portion and a shaping portion connected to the distal end of the body portion in the axial direction. The shape of the shaped portion of the dilation tube 20 is the same as that of the shaped portion 11 of the delivery sheath 10, and will not be described herein.

Referring again to Figure 3, the pigtail catheter 30 is a hollow, smooth catheter. The proximal end of the pigtail catheter 30 has a joint. The tubular body of the pigtail catheter 30 near the distal end has a curved J shape. The pigtail catheter 30 has at least one side hole near the distal wall to serve as an outflow port for the contrast agent. The number of side holes can be multiple to ensure that the contrast agent rapidly flows into the left atrium and the left atrial appendage at a relatively fast flow rate and a large flow rate.

Referring to FIGS. 1 and 6 simultaneously, the hollow loader 50 is detachably coupled between the delivery sheath 10 and the hemostatic valve 40 as a delivery passage for the left atrial appendage occluder and the push cable 60. The loader 50 is made of a polymer material such as polyethylene.

It will be appreciated that in other embodiments, delivery system 100 may not include loader 50. That is, the proximal end of the delivery sheath 10 is directly coupled to the distal end of the hemostatic valve 40, and the lumen of the delivery sheath 10 is in communication with the lumen of the hemostatic valve 40. In this embodiment, the lumen of the hemostatic valve 40 and the lumen of the delivery sheath 10 serve as a delivery channel for the left atrial appendage occluder and the push cable 60, while the portion of the hemostatic valve 40 that is proximal to the distal end needs to be accommodated. The left atrial appendage occluder in the contracted state, and therefore the portion of the hemostatic valve 40 near the distal end should be a straight tube having an axial length.

Referring also to Figures 1 and 7, the push cable 60 is used to push the left atrial appendage occluder. The push cable 60 includes an elongated cable body 61 and a coating 62 disposed on the outer surface of the cable body 61. The cable body 61 has opposite proximal and distal ends, and the proximal end of the membrane 62 is adjacent the proximal end of the cable body 61.

The cable body 61 includes an elongated inner core. The elongated core is made of at least three strands of steel wire. Specifically, in this embodiment, the inner core is made of three strands of steel wire. The cable body 61 also includes a wire disposed on the inner core. The film 62 is provided on the outer surface of the inner core and the steel wire. The push cable 60 with the cover 62 ensures that the distal compliance is adapted to the curved vascular path while providing better support and pushability. When pushing the left atrial appendage occluder, the left atrial appendage occluder is more difficult to deviate from the predetermined position, shortening the operation time and reducing the risk of surgery for the patient.

It should be understood that the cable body 61 may also include only an elongated inner core made of three strands of steel wire, and no steel wire provided on the inner core. The film 62 is provided on the outer surface of the inner core.

The push cable 60 further includes a cable handle 63 that is coupled to the proximal end of the cable body 61, and a cable fastening screw 64 for connecting the cable body 61 and the cable handle 63 to the distal end of the cable body 61. A bolt 65 for detachable connection to the left atrial appendage occluder. That is, in the present embodiment, the left atrial appendage occluder is screwed to the distal end of the push cable 60. It will be appreciated that in other embodiments, the left atrial appendage occluder may also be coupled to the push cable 60 by other snap-fit connections, magnetic connections, pull wire connections, and the like.

Referring to FIG. 1 and FIG. 8 simultaneously, the hemostatic valve 40 has an inner cavity, and a sealing member 42 is disposed in the inner cavity. The seal 42 is provided with an aperture. The proximal end of the hemostatic valve 40 is provided with a compression nut 41 that is in contact with the seal 42. By rotating the pressing nut 41, the sealing member 42 can be pressed to deform it, and the pores become small, so as to seal the proximal end of the hemostatic valve 40.

The hemostatic valve 40 can be T-shaped or Y-shaped. Preferably, in the present embodiment, the hemostatic valve 40 is a T-valve. The seal 42 is an elastic O-shaped silicone ring.

The side wall of the hemostatic valve 40 is also provided with a connecting hose 43 that communicates with the inner cavity of the hemostatic valve 40. The other end of the connecting hose 43 is connected to the three-way valve. The 6% Luer conical interface of the three-way valve is used to connect an external infusion device or a contrast injection device.

During the procedure, the distal end of the push cable 60 exits the hemostatic valve 40 from the distal end of the hemostatic valve 40 via the aperture of the seal 42. The compression nut 41 is rotated, the seal 42 is deformed, the pores become small and the push cable 60 is gripped, and the film 62 of the push cable 60 cooperates with the seal 42 to isolate the inner cavity of the hemostatic valve 40 from the outside. Referring to FIG. 9, the delivery system 100 of the present embodiment firstly passes the distal end of the dilation tube 20 from the distal end of the delivery sheath 10 during the operation, and connects the proximal ends of the two to be assembled. Expand the component. The distal end of the expansion assembly is then advanced into the blood vessel along the guidewire (not shown) via the vascular puncture port and along the blood vessel to the vicinity of the left atrial appendage, and then the dilation tube 20 is withdrawn, leaving the delivery sheath 10 in the body, thus Establish a pathway from the outside to the left atrial appendage.

Referring to FIG. 10, when the passage from the external body to the left atrial appendage is established, the distal end of the hemostatic valve 40 is first connected to the proximal end of the delivery sheath 10 such that the lumen of the hemostatic valve 40 communicates with the lumen of the delivery sheath 10. . The pigtail catheter 30 is then threaded through the lumen of the hemostasis valve 40 into the delivery sheath 10, the distal end of the pigtail catheter 30 being passed through the distal port of the delivery sheath 10, at which point the side hole of the pigtail catheter 30 and the left atrium and The left atrial is connected. The contrast agent is then injected into the proximal end of the pigtail catheter 30, and the contrast agent flows into the left atrium and the left atrial appendage via the side holes of the pigtail catheter 30, after which the positions of the developing

units

70a and 70b located in the second shaping section 122 can be observed by DSA, and By comparing the projection distance between the two developing

units

70a and 70b (the projection distance is equal to the actual distance) and the projection size at the opening of the left atrial appendage, the actual size at the opening of the left atrial appendage is measured, thereby selecting a suitable left atrial appendage occluder. model.

When the measurement and calculation are completed, the angiography is terminated, the connection between the pigtail catheter 30, the hemostatic valve 40, and the delivery sheath 10 is released, and the pigtail catheter 30 is withdrawn from the patient's body. The proximal end of the loader 50 is coupled to the distal end of the hemostatic valve 40. At this time, the inner cavity of the hemostasis valve 40 is in communication with the inner cavity of the loader 50. The distal end of the push cable 60 is then passed through the loader 50 and the lumen of the hemostatic valve 40 in sequence, and the left atrial appendage occluder is coupled to the distal end of the push cable 60. The retraction push cable 60 pulls the left atrial appendage occluder into the loader 50 (shown in Figure 11). The distal end of the loader 50 is connected to the proximal end of the delivery sheath 10, and the inner cavity of the hemostatic valve 40, the inner cavity of the loader 50 and the inner cavity of the delivery sheath 10 are sequentially connected as a left atrial appendage occluder and a push steel. The conveying path of the cable 60. The compression nut 41 of the hemostatic valve 40 can then be unscrewed such that the seal 42 is in a natural state, pushing the push cable 60 distally until the left atrial appendage occluder is pushed near the left atrial appendage.

During the procedure, the distal end of the push cable 60 exits the hemostatic valve 40 from the distal end of the hemostatic valve 40 via the aperture of the seal 42. At this time, the compression nut 41 is rotated, the sealing member 42 is deformed, the pores become small and the push cable 60 is gripped, and the coating 62 of the push cable 60 cooperates with the sealing member 42 to isolate the inner cavity of the hemostatic valve 40 from the outside. . Therefore, the inner cavity of the loader 50 and the inner cavity of the delivery sheath 10 are both isolated from the outside. At this time, a hand-pushing injection device equipped with a contrast agent is connected through a three-way valve, and a contrast agent is injected into the connection hose 43, a contrast agent. It passes through the connecting hose 43, the lumen of the hemostatic valve 40, the lumen of the loader 50, and the lumen of the delivery sheath 10, and is ultimately discharged from the distal port of the delivery sheath 10 to the left atrium and the left atrial appendage. The position of the left atrial appendage occluder can then be observed by DSA. Before the left atrial appendage occluder is not released from the push cable 60, it is evaluated whether the selection of the left atrial appendage occlusion device is appropriate, whether the release position is reasonable, and whether the expected position can be achieved. Blocking effect. If the left atrial appendage occluder is predicted to achieve the desired occlusion effect, the connection between the left atrial appendage occluder and the push cable 60 is released. After the left atrial appendage occluder is released, the left atrial appendage opening is blocked for therapeutic purposes.

Compared with the prior art, the delivery system provided by this embodiment has at least the following beneficial effects:

(1) The conveying system provided in this embodiment, by providing two developing units in the second shaping section of the conveying sheath, taking the distance between the two developing units as a reference, since the size of the reference object is much larger than the existing one. The diameter of the tube of the delivery sheath as a reference in the technology, thereby effectively improving the contrast accuracy of the reference object and the opening of the left atrial appendage, measuring the size more accurately, reducing the possibility of inappropriate selection of the left atrial appendage occluder, and Reduce measurement time, save operation time and cost, and reduce the risk of surgery.

(2) In the delivery system provided by the embodiment, at least two development points are provided in the second shaping section of the delivery sheath near the distal end, which is advantageous for positioning the distal end of the delivery sheath and ensuring the release position of the left atrial appendage occluder .

(3) In the delivery system provided in this embodiment, when the distal end of the delivery sheath reaches the vicinity of the left atrial appendage, the axial direction of the second shaping segment is substantially perpendicular to the plane in which the opening of the left atrial appendage is located, that is, the second shaping The axial direction of the segment is parallel to the reference surface of the DSA. At this time, the projection distance between the two developing units on the reference surface is equal to the actual distance between the two developing units in the axial direction of the second shaping section, and the operator uses the known actual distance as a reference object. Effectively reduce the measurement error of the left atrial appendage size.

(4) The delivery system provided in this embodiment cooperates with the coating of the push-pull cable by providing a sealing member in the hemostatic valve body, so that the distal end of the hemostatic valve lumen can be isolated from the outside during the operation, and can be performed in real time during the operation. The angiographic evaluation effectively avoids the harm caused to the patient after the release of the device due to the inappropriate selection of the left atrial appendage occluder or the need to adjust the deployment position of the left atrial appendage occluder.

Embodiment 2

The structure of the conveying system provided in this embodiment is basically the same as that of the conveying system 100 provided in the first embodiment. The difference is that in the conveying system provided by the embodiment, the developing unit is disposed on the second shaping section of the expansion tube, and the tube body of the delivery sheath tube is not provided with the developing unit, and the conveying system does not include the pigtail tube. That is, the delivery system provided in this embodiment includes only the delivery sheath, the expansion tube, the hemostatic valve, the loader, and the push cable.

Specifically, referring to Fig. 12, the second shaping section of the expansion tube is provided with two developing units. And the two developing units do not touch each other. That is, the two developing units have a certain distance in the axial direction of the second shaping section of the expansion tube.

The delivery system provided in this embodiment, during the operation, passes the distal end of the dilation tube out of the distal port of the delivery sheath and connects the proximal ends of the two to assemble the expansion assembly. The expansion assembly is then delivered along the guidewire through the vascular puncture into the blood vessel and along the blood vessel to the vicinity of the left atrial appendage. Then, the proximal end of the dilatation tube is connected to the distal end of the hemostatic valve, and the contrast injection device equipped with the contrast agent is connected through the three-way valve, and the contrast agent is injected into the connection hose, and the contrast agent passes through the connection hose and the expansion tube in turn. The lumen, and ultimately the distal port of the self-expanding tube, is discharged to the left atrium and the left atrial appendage. At this time, the two developing units located in the second shaping section of the dilating tube can be observed by DSA, and then by comparing the projection distances between the two developing units and the projection distance (the projection distance is equal to the actual distance) and the size of the opening of the left atrial appendage, Calculate the model and specifications of the left atrial appendage occluder.

The delivery system provided in this embodiment has at least the following beneficial effects compared with the prior art:

(1) The conveying system provided in this embodiment, by providing two developing units in the second shaping section of the expanding tube, with the projection distance between the two developing units as a reference, since the size of the reference object is much larger than the existing one. The diameter of the tube of the delivery sheath as a reference in the technology, thereby effectively improving the contrast accuracy of the reference object and the opening of the left atrial appendage, measuring the size more accurately, reducing the possibility of inappropriate selection of the left atrial appendage occluder, and Reduce measurement time, save operation time and cost, and reduce the risk of surgery.

(2) In the delivery system provided in this embodiment, the second shaping section of the dilation tube is provided with at least two development points, which facilitates the distal positioning of the delivery sheath tube when the expansion tube is inserted into the delivery sheath tube. Ensure the release position of the left atrial appendage occluder.

(3) In the delivery system provided in this embodiment, when the distal end of the expansion assembly reaches the vicinity of the left atrial appendage, the axial direction of the second shaping segment of the dilation tube is substantially perpendicular to the plane in which the opening of the left atrial appendage is located, that is, the second The axial direction of the shaped section is parallel to the reference surface of the DSA. At this time, the projection distance between the two developing units on the reference surface is equal to the actual distance between the two developing units in the axial direction of the second shaping section, and the operator uses the known actual distance as a reference. The measurement error of the left atrial appendage size can be effectively reduced.

(4) The delivery system provided by the embodiment cooperates with the coating of the push-pull cable by providing a sealing member in the hemostatic valve body, so that the distal end of the hemostatic valve body can be isolated from the outside during the operation, and can be performed in real time during the operation. The angiographic evaluation can effectively avoid the harm caused to the patient after the release of the left atrial appendage occluder due to the inappropriate selection of the left atrial appendage occluder or the adjustment of the left atrial appendage occlusion device.

Surgical methods

The method of transporting the left atrial appendage occluder 200 to the left atrial appendage opening of the human body by the delivery device 100 will be described in detail below.

First surgical method

The first surgical procedure is a method of performing left atrial appendage closure using the delivery system 100 provided in the first embodiment. In the surgical method, the left atrial appendage occluder 200 is delivered to the left atrial appendage by the delivery system 100 and the left atrial appendage occluder 200 is released to block the left atrial appendage. The left atrial appendage occluder 200 includes two occlusion disks and a occlusive membrane disposed inside one of the occlusion disks. The plugging disc is made of a material with a shape memory function and can be stretched into a line shape when used. The plugging membrane consists of a good biocompatible polytetrafluoroethylene material.

A schematic diagram of the structure of the human heart is shown in Fig. 13, wherein 91 is the inferior vena cava, 92 is the right atrium, 93 is the fossa ovalis, 94 is the left atrium, 95 is the left atrial appendage, 96 is the right ventricle, and 97 is the left ventricle.

The first surgical method specifically includes the following steps:

In the first step, referring to Fig. 14a, after the femoral vein puncture, the puncture guide wire 83 is sequentially passed through the femoral vein and the inferior vena cava 91 through the femoral vein puncture to the right atrium 92. After the atrial septum sheath 84 is coupled to the interatrial dilatation tube 85, it is pushed along the puncture guidewire 83 until the distal end of the interatrial septum sheath 84 is within the right atrium 92.

In the second step, referring to Fig. 14b, the puncture guide wire 83 is withdrawn, and the interatrial septum needle 86 is inserted into the interatrial septum expansion tube 85 from the proximal end of the interatrial septum dilation tube 85 and pushed to the distal end of the interatrial septum needle 86. Proximate to the distal end of the atrial septum dilation tube 85, the needle tip at the distal end of the interatrial septum needle 86 remains within the interatrial dilatation tube 85. The atrial septum sheath 84, the interatrial septum dilation tube 85, and the interatrial septum needle 86 are slowly moved so that the distal end of the interatrial dilatation tube 85 (with the tip of the interatrial septum needle 86) is aligned with the interatrial septum for the best puncture. The oval nest is 93.

In the third step, referring to Fig. 14c, the interatrial septum needle 86 is pushed distally until the needle tip of the interatrial septum needle 86 pierces the fossa ovalis 93, forming a small gap in the fossa ovalis 93, and the interatrial septum needle 86 The distal end enters the left atrium 94 via the small gap.

In the fourth step, referring to Fig. 14d, the distal end of the interatrial septum needle 86 is maintained in the left atrium 94, and the interatrial septum expansion tube 85 and the interatrial septum sheath 84 are passed along the interatrial septum needle 86 through the fossa ovalis A small gap of 93 is delivered into the left atrium 94.

In the fifth step, referring to Fig. 14e, when the distal end of the atrial septum sheath 84 also enters the left atrium 94, the interatrial septum needle 86 and the interatrial septum dilation tube 85 are withdrawn, and the interatrial septum sheath 84 is retained within the left atrium 94. .

In the sixth step, referring to Fig. 14f, the distal end of the delivery guidewire 88 is delivered into the left atrium 94 through the interatrial septum sheath 84, and the interatrial septum sheath 84 is withdrawn. In vitro, the dilation tube 20 is first threaded into the delivery sheath 10 and the proximal ends of the two are assembled into an expansion assembly as shown in FIG. The expansion assembly is then passed along the delivery guidewire 88, sequentially through the femoral vein, inferior vena cava 91, right atrium 92, fossa ovalis 93, into the left atrium 94, to the opening of the left atrial appendage 95. Thereby, a passage from the external body to the left atrial appendage 95 is established. At this time, the axial direction of the second shaping section 122 of the delivery sheath 10 is substantially perpendicular to the plane in which the left atrial appendage is located.

It can be understood that, in the sixth step, the assembly of the expansion assembly can also be performed at any time in the first step to the sixth step, as long as the assembled expansion assembly is sent to the left along the delivery guide wire 88 of the sixth step. The atrium 94 can reach the opening of the left atrial appendage 95.

It can be understood that in the sixth step, the proximal end of the expansion component can also be connected with the hemostatic valve to facilitate the operator's grip.

In the seventh step, the connection between the dilation tube 20 and the delivery sheath 10 is released and the dilation tube 20 is withdrawn. The proximal end of the delivery sheath 10 is coupled to the distal end of the hemostatic valve 40 such that the lumen of the hemostatic valve 40 communicates with the lumen of the delivery sheath 10. The pigtail catheter 30 is then fed into the delivery sheath 10 along the delivery guidewire 88 through the hemostasis valve 40. The distal end of the pigtail catheter 30 is passed through the distal port of the delivery sheath 10, at which point the side hole of the pigtail catheter 30 is The left atrium 94 is connected. The delivery sheath 10, the hemostatic valve 40, and the pigtail catheter 30 are assembled into a contrast assembly as shown in FIG. The delivery guidewire 88 is withdrawn (as shown in Figure 14g).

In the eighth step, referring to Fig. 14h, the proximal end of the pigtail catheter 30 is connected to a hand-pushing syringe containing a contrast agent. The contrast agent is slowly pushed into the proximal end of the pigtail catheter 30, and the contrast agent flows into the left atrium 94 via the side hole of the pigtail catheter 30. At this time, the morphology of the left atrial appendage 95 can be observed by DSA, and the plane perpendicular to the opening of the left atrial appendage 95 is used as a reference surface, and the left atrial appendage opening is orthographically projected on the reference surface, and the projection size of the orthographic projection is equal to the opening of the left atrial appendage 95. Actual size. At this time, the axial direction of the second shaping section 122 is parallel to the reference surface of the DSA. Then by comparing the projection distance between the two developing units at the reference surface (the projection distance is equal to the actual distance between the two developing units in the axial direction of the second shaping section) and the size of the maximum opening of the left atrial appendage, The size of the largest opening of the left atrial appendage is measured and the appropriate model of the left atrial appendage occluder 200 is selected accordingly.

In the ninth step, the connection between the pigtail catheter 30, the hemostatic valve 40 and the delivery sheath 10 is released, and the pigtail catheter 30 is withdrawn from the patient's body. The proximal end of the loader 50 is coupled to the distal end of the hemostatic valve 40 such that the loader 50 is in communication with the lumen of the hemostatic valve 40. The distal end of the push cable 60 is then passed through the loader 50 and the lumen of the hemostatic valve 40 in sequence, and the left atrial appendage occluder 200 is coupled to the distal end of the push cable 60. The retraction push cable 60 pulls the left atrial appendage occluder 200 into the loader 50 (shown in Figure 11). The distal end of the loader 50 is coupled to the proximal end of the delivery sheath 10, and the push cable 60 is pushed distally until the left atrial appendage occlusion device 200 is pushed to the left atrial appendage 95 and deployed.

In the tenth step, the compression nut 41 of the hemostatic valve 40 is tightened. At this time, the sealing member 42 in the hemostatic valve 40 is pressed by the compression nut 41 to hold the coating 62 of the push cable 60 to isolate air or blood. The pores of the self-sealing member 42 enter the hemostatic valve 40, the loader 50, and the lumen of the delivery sheath 10. The three-way valve is opened, and the residual air in the lumen of the hemostatic valve 40, the loader 50, and the delivery sheath 10 is discharged, and the contrast-loaded syringe is connected to the Luer connector of the three-way valve.

In the eleventh step, referring to Fig. 14i, a contrast agent is introduced, and the contrast agent is passed through the connecting hose 43, the inner cavity of the hemostatic valve 40, the inner cavity of the loader 50, and the inner cavity of the delivery sheath 10, and finally the sheath 10 is transported. The remote port flows into the left atrial appendage 95. It is observed by DSA whether the selection of the left atrial appendage occluder 200 is appropriate and whether the release position is reasonable.

In the eleventh step, since the left atrial appendage occluder 200 and the push cable 60 are still connected, if the selection of the left atrial appendage occlusion device 200 is not suitable by DSA observation, it is necessary to replace other types of left atrial appendages. In the case of the occlusion device, first, the compression nut 41 of the hemostatic valve 40 is loosened. The cable 60 is then withdrawn proximally to drive the left atrial appendage occluder 200 into the delivery sheath 10. The connection between the loader 50 and the delivery sheath 10 is released. The inappropriate left atrial appendage occluder 200 is then withdrawn from the patient via the delivery sheath 10. The connection between the left atrial appendage occluder 200 and the push cable 60 is released. Replace the new left atrial appendage occluder. The retraction push cable 60 pulls the new left atrial appendage occluder into the loader 50. The distal end of the loader 50 is coupled to the proximal end of the delivery sheath 10, and the push cable 60 is pushed distally until a new left atrial appendage occluder is pushed to the left atrial appendage 95 and deployed again. The steps of

steps

10 and 11 can then be repeated for angiographic evaluation.

In the eleventh step, since the left atrial appendage occluder 200 and the push cable 60 are still connected, if the release effect of the left atrial appendage occlusion device 200 is found to be poor by DSA observation, the hemostatic valve 40 can be loosened. The compression nut 41 retracts the push cable 60, pulls the left atrial appendage occluder 200 back into the delivery sheath 10, and adjusts the distal end of the delivery sheath 10 to a better position. Push the left atrial appendage occluder 200 to the adjusted better position and deploy. At this time, the compression nut 41 was tightened again, and DSA contrast evaluation was performed.

In the twelfth step, when the left atrial appendage occluder 200 is properly selected by the DSA and the release position is reasonable, and the left atrial appendage occlusion device 200 is released to achieve the desired sealing effect, the left atrial appendage occluder 200 can be released. With the connection between the push cable 60, the left atrial appendage occluder 200 is released. After the left atrial appendage occluder 200 is deployed and the left atrial appendage is occluded, the push cable 60 and the delivery sheath 10 are withdrawn to complete the operation.

Compared with the prior art, the surgical method has at least the following beneficial effects:

(1) In the surgical method, the distance between the two developing units along the axial direction is used as a reference, and the size of the largest notch of the left atrial appendage is measured, which can improve the measurement accuracy and shorten the measurement time, thereby reducing the left atrial appendage conveyor. The possibility of improper selection, saving operation time and cost, and reducing the risk of surgery for patients.

(2) In the surgical method, the distal position of the delivery sheath is judged by observing two development points located at the distal end of the delivery sheath tube, which facilitates the distal positioning of the delivery sheath tube and ensures the release position of the left atrial appendage.

(3) In the surgical method, when the distal end of the delivery sheath reaches the vicinity of the left atrial appendage, the axial direction of the second shaping section is substantially perpendicular to the plane in which the opening of the left atrial appendage is located, that is, the axial direction of the second shaping section Parallel to the reference plane of the DSA. At this time, the projection distance between the two developing units on the reference surface is equal to the actual distance between the two developing units in the axial direction of the second shaping section, and the measurement error of the left atrial appendage size can be effectively reduced.

(4) In the surgical method, the seal in the hemostatic valve is matched with the membrane of the push cable, so that the distal end of the hemostatic valve lumen is isolated from the outside, and real-time contrast evaluation is performed during the operation. Therefore, it is possible to evaluate whether the selection of the left atrial appendage occluder is appropriate and whether the release position is reasonable before the release of the left atrial appendage occluder, and to judge the surgical effect. Effectively avoiding the harm caused to the patient after the left atrial appendage is released due to the inappropriate selection of the left atrial applicator or the adjustment of the left atrial applicator deployment position.

Second surgical method

The surgical method of delivering the left atrial appendage occluder 200 and performing left atrial appendage occlusion by the delivery system provided in the second embodiment will be described in detail below. In the conveying system provided in the second embodiment, two developing units are disposed at the distal end section of the expanding tube, and the two developing units have a certain distance in the axial direction. Therefore, during the operation, the size of the largest opening of the left atrial appendage can be measured by using the distance between the two developing units as a reference. Therefore, it is not necessary to use the pigtail catheter as the outflow channel of the contrast agent in the surgical method.

Specifically, the surgical method includes the following steps:

From the first step to the sixth step, the passage from the extracorporeal to the left atrial appendage 95 is established. The specific steps of the first step to the sixth step are the same as the first step to the sixth step of the first surgical method, and will not be described herein.

In the seventh step, referring to Figure 15a, connect the proximal end of the dilation tube to the distal end of the hemostatic valve, tighten the compression nut of the hemostatic valve, open the three-way valve of the hemostatic valve, and let the blood discharge residual air. The push-in injection device of the contrast agent is connected to the Luer connector of the three-way valve.

In the eighth step, referring to Figure 15b, the contrast agent is slowly pushed into the connection hose of the hemostatic valve, and the contrast agent flows into the left atrium 94 through the distal port of the delivery sheath. The axial direction of the second shaped section of the dilation tube is substantially perpendicular to the plane in which the left atrial appendage is located. The morphology of the left atrial appendage 95 is observed by DSA, with the plane perpendicular to the opening of the left atrial appendage 95 as the reference surface, and the left atrial appendage opening is orthographically projected at the reference surface, and the projected size of the orthographic projection is equal to the actual size of the opening of the left atrial appendage 95. At this time, the axial direction of the second shaping section of the dilation tube is parallel to the reference surface of the DSA. Then comparing the projection distance between the two developing units at the reference surface (the projection distance is equal to the actual distance between the two developing units in the axial direction of the second shaping section) and the size of the maximum opening of the left atrial appendage, The size of the largest opening of the left atrial appendage, and select the appropriate type of left atrial appendage occluder.

In the ninth step, referring to Figure 15c, the connection between the dilation tube, the hemostatic valve, and the delivery sheath is released, and the dilation tube is withdrawn from the patient's body. The proximal end of the loader is coupled to the distal end of the hemostatic valve such that the loader is in communication with the lumen of the hemostatic valve. The distal end of the push cable is then passed through the interior of the loader and hemostasis valve in turn, and the left atrial appendage occluder 200 is coupled to the distal end of the push cable. The retraction push cable pulls the left atrial appendage occluder into the loader. The distal end of the loader is coupled to the proximal end of the delivery sheath, and the push cable is pushed distally until the left atrial appendage occluder 200 is pushed to the left atrial appendage 95 and deployed.

The tenth step to the twelfth step are the same as the steps from the tenth step to the twelfth step in the first method, and are not described herein again.

(1) In the surgical method, the axial distance between the two developing units of the second shaping section of the dilation tube is used as a reference, and the size of the maximum notch of the left atrial appendage is measured, which can effectively improve the measurement accuracy, and Shorten the measurement time, thereby reducing the possibility of inappropriate selection of instruments, saving operation time and cost, and reducing the risk of surgery for patients.

(2) In the surgical method, by observing the two developing units of the second shaping section of the dilating tube, when the dilating tube is inserted into the conveying sheath tube, the accuracy of the distal positioning of the conveying sheath tube can be improved, and the accuracy is ensured. The release position of the left atrial appendage occluder.

(3) In the surgical method, when the distal end of the expansion assembly reaches the vicinity of the left atrial appendage, the axial direction of the second shaping segment of the dilatation tube is substantially perpendicular to the plane in which the opening of the left atrial appendage is located, that is, the second shaped segment The axial direction is parallel to the reference surface of the DSA. At this time, the projection distance between the two developing units on the reference surface is equal to the actual distance between the two developing units in the axial direction of the second shaping section, and the measurement error of the left atrial appendage size can be effectively reduced.

(4) In the surgical method, the seal in the hemostatic valve is matched with the membrane of the push cable, so that the distal end of the hemostatic valve lumen is isolated from the outside, and real-time contrast evaluation is performed during the operation. Therefore, it is possible to evaluate whether the selection of the left atrial appendage occluder is appropriate and whether the release position is reasonable before the release of the left atrial appendage occluder, and to judge the surgical effect. Effectively avoiding the harm caused to the patient after the release of the left atrial appendage occluder due to the inappropriate selection of the left atrial appendage occluder or the need to adjust the deployment position of the left atrial appendage occluder.

In summary, in the delivery system provided by the present invention, at least two developing units are disposed in the second shaping section of the conveying sheath or the expanding tube, and the distance between the two developing units along the axial direction of the second shaping section As a reference, the size of the left atrial appendage opening was measured by comparing the reference to the opening of the left atrial appendage. Thereby, the accuracy of measuring the size of the opening of the left atrial appendage during the operation can be effectively improved, and the measurement time is shortened. In turn, the possibility of inappropriate selection of the left atrial appendage occluder is reduced, the operation time and cost are saved, and the surgical risk of the patient is reduced.

At the same time, since the axial direction of the second shaping section of the delivery sheath or dilation tube is substantially perpendicular to the plane in which the opening of the left atrial appendage is located, that is, the axial direction of the second shaping section is parallel to the reference surface of the DSA. At this time, the projection distance between the two developing units on the reference surface is equal to the actual distance between the two developing units in the axial direction of the second shaping section, and therefore, when the operator is between the two developing units The projection distance is used as a reference to the projection size of the left atrial appendage opening. Actually, the known actual distance L between the two developing units is used as a reference object, which can effectively reduce the measurement error of the left atrial appendage size and avoid repeated adjustment and expansion. The distal end of the assembly leads to increased difficulty in operation, prolonged operation time, and atrial septal injury, reducing the risk of surgery for the patient.

In the surgical method of the left atrial appendage occlusion provided by the present invention, a plane perpendicular to the opening of the left atrial appendage 95 is used as a reference surface of the DSA to be disposed in the second shaping section of the delivery sheath or the second shaping section of the expansion tube The projection distance between the two developing units is used as a reference to measure the size of the largest notch of the left atrial appendage, which can effectively improve the measurement accuracy and shorten the measurement time, thereby reducing the possibility of inappropriate selection of the left atrial appendage occluder. It saves surgery time and cost and reduces the risk of surgery for patients.

The embodiments of the present invention have been described above with reference to the drawings, but the present invention is not limited to the specific embodiments described above, and the specific embodiments described above are merely illustrative and not restrictive, and those skilled in the art In the light of the present invention, many forms may be made without departing from the spirit and scope of the invention as claimed.

Claims

A delivery system for a left atrial appendage occluder, comprising a delivery sheath, wherein the delivery sheath comprises a body portion and a contoured portion connected to a distal end of the body portion, the shaping portion comprising a first plastic a segment and a second shaping segment connected to the distal end of the first shaping segment, in an natural state, an angle between an extending direction of the first shaping segment and an extending direction of the main body portion The range of 40 degrees to 50 degrees, and the angle between the extending direction of the second shaping section and the plane of the first shaping section and the main body portion ranges from 30 degrees to 40 degrees, at least two The developing unit is disposed in the second shaping section, and a distance between the at least two of the developing units in the axial direction of the second shaping section ranges from 10 mm to 40 mm.
A delivery system for a left atrial appendage occluder, comprising a delivery sheath and a dilation tube removably received in the delivery sheath, wherein the expansion tube includes a body portion and is coupled to a distal end of the body portion The shaping portion, the shaping portion comprising a first shaping section and a second shaping section connected to the distal end of the first shaping section, in the natural state, the extension of the first shaping section The angle between the direction and the extending direction of the main body portion ranges from 40 degrees to 50 degrees, and the extending direction of the second shaping segment and the plane of the first shaping segment and the main body portion The angle between the two ranges from 30 degrees to 40 degrees, at least two developing units are disposed on the second shaping section, and at least two of the developing units are in the axial direction of the second shaping section The distance ranges from 10 mm to 40 mm.
A conveyor system according to claim 1 or 2, wherein a distance between at least two of said developing units in the axial direction of said second shaping section ranges from 15 mm to 25 mm.
The delivery system according to claim 1, wherein said tube wall of said delivery sheath is of a multi-layer structure, and said developing unit is disposed in at least two layers of said multilayer structure.
The delivery system of claim 1 wherein said delivery system further comprises a dilation tube removably received in said delivery sheath, said distal end of said dilation tube being distal to proximal The diameter gradually increases.
The delivery system according to claim 2, wherein the tube wall of the dilation tube is of a multi-layer structure, and the developing unit is disposed in at least two layers of the multi-layer structure.
The delivery system of claim 2 wherein the distal end of the dilation tube has an increasing outer diameter from the distal end to the proximal end.
A conveyor system according to claim 1 or 2, wherein said conveyor system further comprises a push cable, said push cable comprising an elongated wire cable body and an outer surface of said cable body Laminating.
The delivery system according to claim 1 or 2, wherein the delivery system further comprises a hemostasis device comprising a hemostatic valve body having a lumen and a lumen disposed in the lumen of the hemostatic valve body a seal having an aperture.
The delivery system of claim 9 wherein said delivery system further comprises a pigtail catheter removably coupled to the distal end of said hemostatic device, said tubular body of said pigtail catheter being curved toward said distal end, The tubular body sidewall of the pigtail catheter has at least one side hole.
The delivery system of claim 9 wherein said delivery system further comprises a hollow loader removably coupled between said delivery sheath and said hemostatic device, said inner lumen of said loader It is in communication with the delivery sheath and the lumen of the hemostatic valve body.