TWI749353B - A stent-graft for a central vein - Google Patents

Abstract

A stent-graft comprising a first stent-graft and a second stent-graft for a central vein is provided, in which the first stent-graft and the second stent-graft with the appropriate diameters can be selected depending on patient’s veins and overlappingly connected one to another. Therefore, the stent-graft for central veins of the present invention can improve the matching of the stent-graft with different patients, so that the surgical success rate is increased and the postoperative problems caused by the inappropriate diameters of stent-graft.

Description

Central venous stent graft

The invention relates to a covered stent for blood vessels, in particular to a combined stent for central vein.

For a long time, patients must undergo dialysis when they enter the course of chronic renal failure. For dialysis or other treatment needs, they often need to be intubated through a central venous catheter so that the patient can receive dialysis or other treatments. . However, in clinical experience, about 25% to 40% of patients will have central venous stenosis obstruction. Because of the obstruction of the vein near the heart, the entire hand, forearm and upper arm will gradually develop severe swelling and discomfort, and even skin ulceration. And the wound is difficult to heal. So far, the main way to treat central venous occlusion is to use intravascular balloon dilation. However, at this time, the patient's blood vessel wall has become fibrotic and loses its elasticity. Recurrent stenosis is a common postoperative result.

In addition, in current medical treatment, a single stent is usually used to treat venous occlusion. However, because patients’ central venous vessels have different diameters between their proximal and distal ends depending on the individual, the treatment of venous occlusion must be based on the size of the blood vessels in the affected area. Choose the matching bracket. Standardized stents manufactured by cardiovascular stent suppliers are to avoid increasing manufacturing costs and pressure on inventory. In addition, due to individual differences and differences in the location of the venous obstruction, some patients cannot find a standardized stent suitable for matching the diameters of the blood vessels at both ends of the affected area. Later, various problems caused by the unsuitable size of the stent, such as falling off. Therefore, it is really an important issue to find a stent suitable for matching the vascular caliber of various patients.

The present invention provides a stent combination including a first stent and a second stent. The first stent and the second stent of appropriate calibers can be selected according to the blood vessels of each patient's affected part, and then overlapped and sleeved. Therefore, the stent combination of the present invention can improve the compatibility of the stent with different patients in different positions, reduce postoperative complications, and can reduce the inventory pressure of the producer and thereby reduce the cost.

To solve this problem, the present invention provides a central venous stent graft, which includes a first stent, which includes a proximal part and a socket part; a second stent, which includes a socket part and a telecentric part部; And the end diameter of the proximal portion of the first stent is larger than the end diameter of the distal portion of the second stent. The first stent and the second stent are artificial blood vessel graft stents, which can have two tubular structures with different port diameters after being sleeved with each other.

In the central venous stent graft provided by the present invention, the diameter of the proximal end of the first stent is not particularly limited, and it can be prepared according to the size of the patient’s vein, as long as it can guide blood flow out of the first stent. A stent does not re-infiltrate the gap between the first stent and the blood vessel wall. In a specific embodiment, the diameter of the proximal end of the first stent is 16 mm or more, and the upper limit of the diameter can be determined by the individual patient. In another specific embodiment, the diameter of the proximal end of the first stent is preferably 16 to 20 mm. In another specific embodiment, the diameter of the proximal end of the first stent is more preferably 16, 18 or 20 mm.

In the central venous stent graft provided by the present invention, the end diameter of the distal part of the second stent is not particularly limited, and it can be prepared according to the size of the patient’s vein as long as it can guide blood flow into the second stent. It suffices that it does not penetrate into the gap between the second stent and the blood vessel wall. In a specific embodiment, the end diameter of the distal part of the second stent is 16 mm or less, and the lower limit of the diameter can be determined by the individual patient. In another specific embodiment, the end diameter of the distal portion of the second stent is preferably 8 to 14 mm. In another specific embodiment, the end diameter of the distal portion of the second stent is 8, 10, 12, or 14 mm.

In a specific embodiment, when the end diameter of the proximal portion of the first stent is greater than or equal to 18 mm to 20 mm, the end diameter of the distal portion of the second stent is greater than or equal to 14 mm to 16 mm. mm. In another specific embodiment, when the end diameter of the proximal portion of the first stent is less than 18 mm to 16 mm, the end diameter of the distal portion of the second stent is less than 14 mm to 8 mm.

The artificial blood vessel covering of the first stent and the second stent of the present invention is composed of several elastic support metal stents woven outside the tubular artificial blood vessel covering. The artificial blood vessel membrane is a polymer medical material acceptable to the human body. The conventional medical materials that can be used are, for example, membranes made of polytetrafluoroethylene, polyamide, polyester fiber, polypropylene, etc. Braid. The elastic support metal stent is made of alloys acceptable to the human body, such as nickel-titanium memory alloy, nickel-titanium elastic alloy, medical stainless steel alloy, iron, cobalt, nickel, chromium, molybdenum or their alloys, etc., and The metal bracket of the elastic support body can have a ring shape, a spiral shape, a wave shape or a mesh structure.

In the central venous stent graft provided by the present invention, the second stent is arranged upstream of the first stent, and the sleeve portion of the second stent can be sleeved on the sleeve portion of the first stent. The first stent and the second stent are overlapped and sleeved to form a tubular structure with two ports with different diameters. There is no special restriction on the difference in tube diameter between the two sockets, as long as it can be easily operated during the surgical operation and can be completely fitted after the first stent and the second stent are socketed without leakage of blood. .

In a specific embodiment, the socket part of the first stent and the socket part of the second stent have uniform pipe diameters, and the calibers are each 10 to 14 mm, and the socket part of the first stent and the socket part of the second stent have uniform pipe diameters. The diameter difference of the socket part of the second bracket is preferably 2 to 3 mm. In a specific embodiment, the diameter of the socket part of the first stent is smaller than the diameter of the socket part of the second stent, so the socket part of the second stent overlaps the socket of the first stent部内。 The inner side. Since the second stent has a large caliber, after the overlapping sleeve is connected to the inner side of the sleeve portion of the first stent, the elastic support metal stents of the first stent and the second stent can be expanded by the elasticity of the metal stent. The socket part of the bracket fits perfectly. In another specific embodiment, the diameter of the socket portion of the first stent is larger than the diameter of the socket portion of the second stent, so the socket portion of the first stent is sleeved on the socket portion of the second stent Inside.

In a specific embodiment, after the first bracket and the second bracket are socketed with each other, the length of the overlapping portion can be determined according to factors such as the length of the socket part, the diameter difference between the two stents, and the total length after socketing. After the two stents are sleeved, they are completely attached to each other without blood leakage. For example, those skilled in the art can determine the length of the overlapping portion according to the diameter difference between the sockets of the first stent and the second stent. If the sockets of the first stent and the second stent are different The caliber difference is small, so you can consider overlapping the two sockets completely. In another specific embodiment, the total length of the preset stent after overlapping and sleeved between the first stent and the second stent can be determined according to the length of the stent required by the patient, and the overlap can be adjusted according to the total length of the preset stent The length of the part. In another specific embodiment, the lengths of the socket portions of the first bracket and the second bracket are each 10 to 30 mm, and preferably each are 20 mm. In another specific embodiment, after the first bracket and the second bracket are overlapped and sleeved, the overlapping length of the two sleeve portions is 20 mm.

In the central venous stent graft provided by the present invention, the first stent and the second stent may be of equal length or unequal length. In other words, those with ordinary knowledge in the technical field can understand that after evaluating the vascular structure, size, scope, ease of operation, safety and other factors of the patient's affected part, the appropriate length of the first stent and the second stent can be selected To overlap the socket combination. In a specific embodiment, the total length of the first bracket and the second bracket after being overlapped and sleeved is more than 80 mm, preferably 80 to 200 mm. In another specific embodiment, the total length of the first bracket and the second bracket after being overlapped and sleeved is 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195 or 200 mm.

In the central venous stent graft provided by the present invention, the outer surface of the first stent and/or the second stent is further provided with a plurality of fixing members that can be fixed to the blood vessel wall, and the fixing member may be, for example, a barb-shaped Or an anchor-like structure, through which the plurality of fixing elements can increase the anchoring force of the first stent and/or the second stent in the blood vessel, which contributes to the accuracy and stability of the stent erection. In another specific embodiment, the fixing member is arranged at the outer periphery of the end of the telecentric portion of the second bracket. In another specific embodiment, when the second bracket is sleeved on the inner side of the first bracket branch, the fixing member can be added around the outer periphery of the end of the sleeve portion of the first bracket.

The central venous stent graft of the present invention can be used to treat a variety of vascular diseases, such as vascular occlusion, hemangioma, vascular disease and the like. For example, in the treatment of a single obstruction of a blood vessel, the first stent and the second stent can be overlapped and sleeved and then spanned across the single stenosis. If there are multiple obstructions in one area or there will be multiple obstructions, the first stent and the second stent can be overlapped and sleeved across the area. In the case of treating hemangioma, the proximal part of the first stent is placed inside the neck of the proximal end of the hemangioma after the sleeve, and the distal part of the second stent is placed inside the neck of the distal end of the hemangioma, so that The stent of the present invention is overlapped and sleeved across the two ends of the hemangioma tumor body.

As used herein, "a" and "a" refer to one or more than one (ie at least one) or one or more than one (ie at least one) object. For example, "a fixing element" refers to a fixing element or a plurality of fixing elements.

The term "human body acceptable" as used herein means that when administered to the human body, it usually does not cause allergic reactions, rejection, inflammatory reactions or similar reactions.

The "upstream" and "downstream" of the blood vessel described in this article are determined by the direction of blood flow in the blood vessel. In the case of veins, venous blood flows from the peripheral veins to the heart. Therefore, the relative positions of the blood vessels, such as vascular occlusion The position on the side of the peripheral vein is the "upstream" position, and the position on the side of the heart is the "downstream" position. In the case of arteries, arterial blood flows from the heart to the peripheral arteries. Therefore, in the relative position of the blood vessel, such as a clogged blood vessel, the position on the side of the heart is "upstream", and the position on the side of the peripheral artery is "downstream".

It should be understood that the description in the range format of the present invention is only for convenience and brevity, and should not be construed as limiting the scope of the present invention. Therefore, the description of a range should be regarded as a specific disclosure of all possible subranges and a single value within the range. For example, the description of the range of 8 to 14 should be considered to have specifically disclosed the sub-ranges, such as various ranges from 8 to 9, 8 to 10, 8 to 11, 9 to 10, 9 to 11, 10 to 14, and in the range Single and partial numbers within, such as 8, 9, 10, 10.5, 11, 12.6, 13.2, and 14. It applies regardless of the width of the range.

The embodiment of the central venous stent graft according to the present invention will be described in detail with reference to Figs. 1 to 5 below. The embodiment is only to illustrate the present invention and cannot be construed as a limitation to the present invention.

Example 1

1 is a schematic diagram of the central venous stent graft of the present invention. The central venous stent graft includes a first stent 10 and a second stent 20, the first stent 10 and the second stent 10 The stent 20 is in the shape of a thin round tube composed of several elastic support metal stents 17 and 27 woven with artificial blood vessel coverings 16 and 26 respectively.

The first stent 10 includes a proximal portion 11 and a socket portion 13. The diameter of the end 12 of the proximal portion is ψ12. The socket 13 has a uniform pipe diameter, and the diameter of its end 14 is ψ14. A plurality of fixing members 15 that can be fixed to the blood vessel wall are arranged around the outer periphery of the end 14 of the sleeve part.

The second bracket 20 includes a socket part 21 and a telecentric part 23. The socket part 21 has a uniform pipe diameter, and the diameter of the end part 22 is ψ22. The caliber of the end 24 of the telecentric part is ψ24, and a plurality of fixing members 25 that can be fixed to the blood vessel wall are provided around the end 24 of the telecentric part.

The end diameter ψ12 of the proximal part of the first stent is 16 mm, and the end diameter ψ24 of the distal part of the second stent is 8 mm.

Example 2

1 and 2, FIG. 2 is a schematic diagram of the first stent and the second stent of the central venous stent graft of the present invention after being overlapped and sleeved. After the first stent 10 and the second stent 20 are overlapped and sleeved, the central venous stent graft of the present invention generally assumes a circular tube shape that tapers from the proximal portion 11 of the first stent to the distal portion 23 of the second stent. When the socket part 21 of the second stent is inserted into the inside of the socket part 13 by the socket part port 14 of the first stent, the overlapping part of the socket part 13 and the socket part 21 is about 20 mm, and the The diameter ψ14 of the end 14 of the socket part of the first stent must be smaller than the diameter ψ22 of the end 22 of the socket part of the second stent. The difference between the diameter ψ14 and ψ22 is about 2 mm. Since the end diameter ψ22 of the socket part of the second stent is slightly larger than the end diameter ψ14 of the socket part of the first stent, when the second stent is inserted into the first stent, it is supported by the elasticity of the socket part The expansion elasticity of the body metal stents 17, 27 can completely fit the outer surface of the sleeve portion 21 of the second stent to the inner side of the sleeve portion 13 of the first stent, which can effectively prevent blood leakage and is beneficial to the central vein of the present invention. Long-term use with stent graft.

Example 3

3, FIG. 3 is another schematic diagram of the central venous stent graft of the present invention. The central venous stent graft includes a first stent 10' and a second stent 20'. The first stent 10' and the second stent 20' are in the shape of a thin round tube formed by braiding several elastic support metal stents 17, 27 with artificial blood vessel coverings 16, 26 respectively.

The first stent 10' includes a proximal portion 11' and a socket portion 13, and the diameter of the end 12' of the proximal portion is ψ12'. The socket 13 has a uniform pipe diameter, and the diameter of its end is ψ14. A plurality of fixing members 15 that can be fixed to the blood vessel wall are arranged around the outer periphery of the end 14 of the sleeve part.

The second bracket 20' includes a socket part 21 and a telecentric part 23'. The socket part 21 has a uniform pipe diameter, and the diameter of the end part 22 is ψ22. The caliber of the end 24' of the telecentric part is ψ24', and a plurality of fixing members 25 that can be fixed to the blood vessel wall are provided around the end 24' of the telecentric part.

The end diameter ψ12' of the proximal part of the first stent is 20 mm, and the end diameter ψ24' of the distal part of the second stent is 16 mm.

Example 4

3 and 4, FIG. 4 is another schematic diagram of the first stent and the second stent of the central venous stent graft of the present invention after being overlapped and sleeved. After the first stent 10' and the second stent 20' are overlapped and sleeved, the central venous stent graft of the present invention has a substantially circular tube shape as a whole. When the socket part 21 of the second stent is inserted into the inside of the socket part 13 by the socket part port 14 of the first stent, the overlapping part of the socket part 13 and the socket part 21 is about 20 mm, and the The diameter ψ14 of the end 14 of the socket part of the first stent must be smaller than the diameter ψ22 of the end 22 of the socket part of the second stent. The difference between the diameter ψ14 and ψ22 is about 2 mm. Since the end diameter ψ22 of the socket part of the second stent is slightly larger than the end diameter ψ14 of the socket part of the first stent, when the second stent is inserted into the first stent, it is supported by the elasticity of the socket part The expansion elasticity of the body metal stents 17, 27 can completely fit the outer surface of the sleeve portion 21 of the second stent to the inner side of the sleeve portion 13 of the first stent, which can effectively prevent blood leakage and is beneficial to the central vein of the present invention. Long-term use with stent graft.

Example 5

1 and FIG. 5, FIG. 5 is a schematic diagram of the stent of the present invention installed in a blood vessel. When setting up the stent, first select the first stent 10 with an appropriate proximal end diameter ψ12 according to the diameter of the blood vessel downstream of the vascular obstruction 34 of the left brachiocephalic vein 31, and place the first stent in the stent delivery device. Downstream of the venous blood vessel obstruction 34, a plurality of fixing members 15 arranged around the end 14 of the first stent socket part can fix the first stent 10 at a preset position in the blood vessel to avoid damage due to blood flow. Its displacement. Then, according to the vascular diameter upstream of the left brachiocephalic vein 31 vascular obstruction 34, select the second stent 20 with an appropriate distal end diameter ψ24, and use the stent delivery device to sleeve the socket 21 of the second stent onto the first stent. Inside the sleeve 13 of a stent, the second stent is arranged upstream of the venous vessel obstruction 34, and the fixing member 25 arranged around the end 22 of the distal part of the second stent can fix the second stent in the blood vessel The preset position. After installation, the central venous stent of the present invention can guide blood flow from the end 24 of the distal part of the second stent, pass through the venous vessel obstruction 34 without obstruction, and flow out and enter from the end 12 of the proximal part of the first stent. The superior vena cava 32 flows back to the heart 33. Since there are a plurality of fixing members 15, 25, there is no danger of displacement or being rushed to the heart 33 by blood flow.

10, 10’: The first bracket 11, 11’: The proximal part of the first stent 12, 12’: The end of the first stent near the heart 13: The first bracket socket 14: The end of the socket of the first bracket 15, 25: fixed parts 16, 26: Artificial blood vessel covering 17, 27: Elastic support metal bracket 20, 20’: Second bracket 21: The second bracket cover 22: The end of the second bracket socket 23, 23’: The telecentric part of the second stent 24, 24’: the end of the telecentric part of the second stent ψ12, ψ12’: the end diameter of the proximal part of the first stent ψ14: The end diameter of the socket of the first bracket ψ22: The end diameter of the second bracket socket ψ24, ψ24’: the end diameter of the distal part of the second stent 31: left brachiocephalic vein 32: superior vena cava 33: Heart 34: Blood vessel obstruction

Fig. 1 is a schematic diagram of the stent graft for central vein of the present invention. Fig. 2 is a schematic diagram of overlapping and sleeved connection of the first bracket and the second bracket of the present invention. Fig. 3 is another schematic diagram of the stent graft for central vein of the present invention. Fig. 4 is another schematic diagram of the overlapping and sleeved connection of the first bracket and the second bracket of the present invention. Figure 5 is a schematic diagram of the stent of the present invention being placed in a blood vessel.

10: The first bracket

11: Near the heart of the first stent

12: The end of the proximal part of the first stent

13: The first bracket socket

14: The end of the socket of the first bracket

15, 25: fixed parts

16, 26: Artificial blood vessel covering

17, 27: Elastic support metal bracket

20: second bracket

21: Second bracket socket

22: The end of the second bracket socket

23: The telecentric part of the second stent

24: The end of the telecentric part of the second stent

ψ12: The end diameter of the proximal part of the first stent

ψ14: The end diameter of the socket of the first bracket

ψ22: The end diameter of the second bracket socket

ψ24: The end diameter of the distal part of the second stent

Claims (6)

A stent graft for the treatment of central venous obstruction, which comprises a first stent, which is a self-expanding elastic artificial blood vessel graft stent, and includes a proximal part and a sleeve part. The end diameter of the proximal part is 16-20mm, the end diameter of the socket part of the first stent is 10-14mm; and a second stent, which is a self-expanding elastic artificial blood vessel graft stent, including a socket part and a telecentric part, The end diameter of the socket part of the second stent is 10 to 14 mm, and the end diameter of the telecentric part is 8 to 14 mm or less, wherein the socket parts of the first stent and the second stent have uniform pipe diameters, The socket part of the second stent is overlapped and socketed with the socket part of the first stent, and the end diameter difference between the two is 2 to 3mm, wherein the first stent and the second stent are overlapped and socketed Afterwards, it presents a circular tube shape gradually tapering from the proximal part of the first stent to the distal part of the second stent, wherein the total length of the first stent and the second stent after being sleeved is 80 to 200 mm. As for the central venous stent graft described in item 1 of the scope of patent application, the sleeve portion of the second stent overlaps the sleeve portion of the first stent and has a length of 10 to 30 mm. The central venous stent graft described in the first item of the scope of patent application, wherein the sleeve portion of the second stent overlaps with the sleeve portion of the first stent and has a length of 20 mm. The central venous stent graft as described in claim 1, wherein when the end diameter of the proximal part of the first stent is greater than 16mm to less than 18mm, the end diameter of the distal part of the second stent It is greater than 8mm to less than 14mm. The central venous stent graft as described in the first item of the scope of patent application, wherein a plurality of fixing members that can be fixed to the blood vessel wall are arranged around the end of the distal part of the second stent. The central venous stent graft according to the first item of the scope of patent application, wherein a plurality of fixing members that can be fixed to the blood vessel wall are arranged around the end of the sleeve part of the first stent.

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