In-situ vascular puncture sheath and puncture sheath combination device

Abstract

This invention relates to an in-situ vascular puncture sheath, comprising a hollow tube body. The hollow tube body has two corresponding side holes on its two opposite sidewalls near its front end, each hole penetrating the inner and outer surfaces of the tube body in the same radial direction. Each side hole also has a lateral slit at its front end, connecting to the side hole and extending forward. The two slits, starting from the top of the front end of the side hole and extending forward, gradually slope towards the same side of the hollow tube wall until they merge to form a guidewire release slit, facilitating guidewire disengagement from the hollow tube body. The opening width of the lateral slit and the guidewire release slit is equal to or slightly larger than the diameter of the guidewire used to pass through the two side holes. By positioning the side holes of the in-situ vascular puncture sheath at the branch vessel opening using a guidewire, in-situ puncture and fenestration of the aortic stent graft at the branch vessel opening can be performed through the opposite side hole. This method offers advantages such as accurate fenestration positioning, convenient surgical operation, and avoidance of arterial damage.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a vascular in-situ puncture sheath and puncture sheath assembly device. Background Technology

[0002] With the advent of an aging society, the incidence of aortic disease is increasing. Traditional surgery is highly invasive and risky, making endovascular treatment techniques widely accepted by vascular surgeons and interventional vascular surgeons. Covered stent grafting is currently a very important method for treating large and medium-sized arteries and has wide clinical applications. However, the preservation of important branches of arteries involved in the covered segment, such as branches of the aortic arch, visceral branches of the abdominal aorta, internal iliac artery, and large lumbar arteries, presents significant challenges.

[0003] Currently, the three main technical approaches used in clinical practice to preserve branch arteries are: custom stents, external fenestration techniques, and in situ fenestration techniques.

[0004] Custom-made stents for specific patients have a long development cycle, high cost, are difficult to operate, and have poor practicality.

[0005] After fenestration, the covered stent needs to be repositioned into the stent guide sheath. The addition of marker rings and other components makes repositioning difficult, and forceful repositioning may damage the stent, potentially leading to stent breakage or accidental release within the body, resulting in catastrophic consequences. Furthermore, the procedure requires excellent three-dimensional observation during fenestration, as malocclusion is highly likely, potentially leading to branch vessel occlusion, stenosis, or failure to align.

[0006] Currently, in cases of cervical arch lesions, some experts use in-situ puncture techniques to reconstruct branch vessels in the head and neck, which has the following drawbacks: 1. It is difficult to perform this procedure on tortuous vessels; 2. It requires dissection of the branch vessels; 3. It requires bypass techniques, otherwise, cerebral infarction complications are likely to occur; 4. It is prone to iatrogenic vascular injury. Furthermore, in-situ puncture cannot be performed on the vertebral artery, visceral branches of the abdominal aorta, and the internal iliac artery. Therefore, a new type of vascular in-situ puncture sheath that facilitates in-situ puncture is needed. Summary of the Invention

[0007] This invention provides an in-situ vascular puncture sheath and a combined puncture sheath device. The in-situ vascular puncture sheath of this invention allows for the positioning of the side port of the in-situ vascular puncture sheath at the opening of a branch vessel via a guidewire before the implantation of an aortic endovascular stent graft. Subsequently, the endovascular stent graft implanted in the aorta is punctured and fenestrated at the opening of the branch vessel through the contralateral side port. This method offers advantages such as accurate fenestration positioning, convenient surgical operation, and avoidance of arterial damage. Furthermore, during the procedure, blood flow can be maintained between the sheath tip and the branch artery through the side port, ensuring continuous blood flow to the branch artery during the surgery and preventing complications caused by ischemia in the organs supplied by the branch artery.

[0008] Option 1)

[0009] The in-situ vascular puncture sheath of the present invention adopts the following technical solution:

[0010] A vascular in situ puncture sheath includes a hollow tube body. The hollow tube body has a side hole at corresponding positions on two opposite side walls near its front end, each side hole penetrating the inner and outer surfaces of the wall body in the same radial direction. Each side hole also has a side slit at its front end that connects to the side hole and extends forward. As the two side slits extend forward from the corresponding positions at the top of the front end of the side hole, they gradually slope toward the same side of the hollow tube body wall until they merge and connect to form a guidewire release slit that facilitates the guidewire's exit from the hollow tube body. The opening width of the side slits and the guidewire release slit is equal to or slightly larger than the diameter of the guidewire used to pass through the two side holes.

[0011] The in-situ vascular puncture sheath of this procedure can accurately locate the branch vessels, and then puncture the covered stent implanted in the main vessel to establish access between the main vessel and the branch vessels. After the guidewire passes through the two side holes and reaches the target position, the guidewire can slide out from the side suture and the guidewire release suture in turn. The guidewire is removed by sheath withdrawal, and the in-situ vascular puncture sheath is successfully withdrawn before subsequent surgical operations can be performed.

[0012] To facilitate observation of the position of the in-situ puncture sheath within the blood vessel: a first contrast ring is provided on the edge of each of the two side holes.

[0013] Furthermore, the front end of the hollow tube is provided with a second developing ring.

[0014] Furthermore, the side hole is shaped like a teardrop with a small front end and a large rear end, making it easier for the guide wire that runs through the sheath to be removed from the sheath.

[0015] The outer diameter of the hollow tube is 8F. This section of the sheath is made of rigid material to prevent the side holes from separating from the side seams and guide wires and deforming during use.

[0016] Option 2)

[0017] A puncture sheath assembly device,

[0018] Including the aforementioned in-situ vascular puncture sheath;

[0019] A lateral puncture cannula that is movable inside the hollow tube of the in-situ puncture sheath of the blood vessel, and a puncture needle that is movable inside the lateral puncture cannula.

[0020] The lateral puncture cannula has a channel extending axially along the cannula body, which facilitates the movement of the puncture needle through the channel and is open at one end and closed at the other. The lateral puncture cannula has a puncture opening on the side wall near its closed end to facilitate the extension of the puncture needle. The inner end wall of the closed end of the lateral puncture cannula is inclined to guide the puncture needle into the puncture opening. The inclined guide surface faces the location of the puncture opening and its end connects with the edge of the puncture opening. The edge of the puncture opening is provided with a third imaging ring.

[0021] To prevent damage to the vessel wall during in-situ puncture of the sheath, the present invention preferably employs the following method:

[0022] The puncture sheath assembly also includes an outer long sheath that is movably inserted outside the hollow tube of the in-situ puncture sheath of the blood vessel.

[0023] To prevent damage to the vessel wall from the in-situ puncture sheath, this method pre-places an external long sheath before implanting the aortic stent graft. Then, the in-situ puncture sheath and guidewire of this invention are passed through the external long sheath for subsequent operations.

[0024] To facilitate the introduction or removal of fluid during surgery, the present invention further preferably includes the following solutions:

[0025] The in-situ vascular puncture sheath is further fixedly connected to a sheath seat at its tail end. An extension tube communicating with the hollow tube body of the in-situ vascular puncture sheath is connected to the sheath seat. A tee connector, including an infusion port and an aspiration port, is connected to the tail end of the extension tube. The sheath seat has a channel for inserting the in-situ vascular puncture sheath, and a side hole communicating with the extension tube is also provided on its side wall.

[0026] During surgery, connecting to external infusion and aspiration equipment in advance via infusion and aspiration ports can avoid on-site intervention during the procedure and reduce the risk of cross-infection.

[0027] To facilitate fixation or handheld manipulation of the in-situ vascular puncture sheath, the following preferred embodiment is further proposed:

[0028] The sheath base is provided with a handle for easy fixing and holding.

[0029] Compared with the prior art, the present invention has the following advantages:

[0030] The in-situ vascular puncture sheath of this invention allows for pre-placement of an external long sheath before aortic stent graft implantation. A guidewire positions the side port of the in-situ vascular puncture sheath at the branch vessel opening. Then, through the contralateral side port, in-situ puncture and fenestration are performed at the branch vessel opening location of the implanted stent graft in the aorta. This method offers advantages such as accurate fenestration location, convenient surgical operation, and avoidance of arterial damage. Furthermore, during the procedure, blood flow can communicate with the branch artery through the sheath opening at the tip of the in-situ vascular puncture sheath and the side port, ensuring continuous blood flow to the branch artery and preventing complications caused by ischemia in the organs supplied by the branch artery.

[0031] The inclined guide surface of the inner wall of the closed end of the puncture sheath assembly of the present invention facilitates the guidance of the puncture needle into the puncture opening, making the puncture operation easier.

[0032] This invention simplifies the in-situ window opening technology while facilitating its widespread application. Attached Figure Description

[0033] Figure 1 This is a side view of the in-situ vascular puncture sheath in Example 1.

[0034] Figure 2 This is a side view of the other side of the in-situ vascular puncture sheath in Example 1.

[0035] Figure 3 This is a cross-sectional schematic diagram of the assembly of the in-situ vascular puncture sheath and the lateral puncture cannula in Example 2.

[0036] Figure 4 This is a schematic diagram of the structure of Example 2.

[0037] Figure 5 yes Figure 4 Enlarged schematic diagram of part I.

[0038] Figure 6 This is a reference diagram showing the usage status of the in-situ vascular puncture sheath (Status 1).

[0039] Figure 7 yes Figure 6 Enlarged schematic diagram of part A.

[0040] Figure 8 This is a reference diagram showing the usage status of the in-situ vascular puncture sheath (Status 2).

[0041] Figure 9 Figure 8 Enlarged schematic diagram of part B.

[0042] Figure 10This is a reference diagram showing the usage status of the in-situ vascular puncture sheath (Status 3).

[0043] Figure 11 Figure 10 Enlarged schematic diagram of part C.

[0044] Figure 12 This is a reference diagram showing the usage status of the in-situ vascular puncture sheath (Status 4). Detailed Implementation

[0045] The present invention will be further described below with reference to the accompanying drawings and specific embodiments:

[0046] Example 1

[0047] like Figure 1 , 2 As shown, a vascular in situ puncture sheath includes a hollow tube body 1. The hollow tube body 1 has a side hole 1-1 at corresponding positions on two opposite side walls near its front end, which penetrates the inner and outer surfaces of the wall in the same radial direction. Each side hole 1-1 also has a side slit 1-2 at its front end, which connects to the side hole 1-1 and extends forward. As the two side slits 1-2 extend forward from the corresponding position at the top of the front end of the side hole 1-1, they gradually tilt toward the same side of the tube wall of the hollow tube body 1 until they merge and connect to form a guide wire release slit 1-3, which facilitates the guide wire 12 to be released from the hollow tube body 1. The opening width of the side slit 1-2 and the guide wire release slit 1-3 is equal to or slightly larger than the diameter of the guide wire 12 used to pass through the two side holes.

[0048] The in-situ vascular puncture sheath of this procedure can accurately locate the branch vessels, and then puncture the covered stent implanted in the main vessel to establish access between the main vessel and the branch vessels. After the guidewire passes through the two side holes and reaches the target position, the guidewire can slide out from the side suture and the guidewire release suture in turn. The guidewire is removed by sheath withdrawal, and the in-situ vascular puncture sheath is successfully withdrawn before subsequent surgical operations can be performed.

[0049] The hollow tube has an outer diameter of 8F. The side hole 1-1 is shaped like a teardrop with a smaller front end and a larger rear end, making it easy for the guide wire passing through the sheath to detach. This section of the sheath is made of rigid material to prevent the side hole 1-1 from deforming during use, as well as the side seam 1-2 and the guide wire separation seam 1-3.

[0050] To facilitate observation of the position of the in-situ puncture sheath within the blood vessel: a first contrast ring 2-1 is provided on the side hole 1-1.

[0051] The front end of the hollow tube 1 is provided with a second developing ring 2-2.

[0052] Example 2

[0053] like Figure 3 , 4 As shown: a puncture sheath assembly device.

[0054] Including the aforementioned in-situ vascular puncture sheath;

[0055] A lateral puncture cannula 3, which is movable and inserted into the hollow tube body 1 of the in-situ puncture sheath of the blood vessel, and a puncture needle 4, which is movable and inserted into the lateral puncture cannula 3.

[0056] The lateral puncture cannula 3 has a channel extending axially along the tube body, which facilitates the insertion of the puncture needle 4 and is open at one end and closed at the other. The lateral puncture cannula 3 has a puncture opening 3-1 on the side wall near its closed end to facilitate the extension of the puncture needle 4. The inner end wall of the closed end of the lateral puncture cannula 3 is inclined to guide the puncture needle 4 into the puncture opening 3-1. The inclined guide surface 3-2 faces the location of the puncture opening 3-1 and its end is connected to the edge of the puncture opening 3-1. The edge of the puncture opening 3-1 is provided with a third imaging ring 3-3.

[0057] The guide surface 3-2 in this embodiment is made of metal.

[0058] To facilitate the introduction or withdrawal of fluid during surgery, the tail end of the in-situ puncture sheath described in this embodiment is also fixedly connected to a sheath seat 5. An extension tube 6, which communicates with the hollow tube body 1 of the in-situ puncture sheath, is connected to the sheath seat 5. The tail end of the extension tube 6 is connected to a three-way connector 7, which includes an infusion port 7-1 and a suction port 7-2.

[0059] During surgery, connecting to external infusion and aspiration equipment in advance via infusion port 7-1 and aspiration port 7-2 can avoid on-site intervention during the operation and reduce the risk of cross-infection of pathogens.

[0060] To facilitate fixing or holding the in-situ vascular puncture sheath, the sheath seat 5 in this embodiment is provided with a handle 8 for easy handing.

[0061] To prevent damage to the vessel wall during use, the puncture sheath assembly also includes an outer sheath 13 that is movably inserted outside the hollow tube body 1 of the in-situ puncture sheath.

[0062] The usage process is as follows: Figure 6-12 As shown:

[0063] like Figure 6 , 7As shown, first, the 8F outer long sheath 13 is placed near the branch vessel within the main blood vessel. Then, the in-situ puncture sheath of this embodiment extends from the front end of the 8F outer long sheath 13 and is pre-placed within the main blood vessel. A guidewire 12 is inserted from the rear end to the front end of the in-situ puncture sheath. Under the guidance of the guidewire, one side hole 1-1 of the in-situ puncture sheath is aligned with the opening of the branch vessel. After the covered stent 9 of the main blood vessel is inserted and deployed, the front opening of the in-situ puncture sheath extends beyond the covered stent 9 and communicates with the main blood vessel, allowing blood flow from the main blood vessel to communicate with the branch artery through the front sheath opening and the side hole during the procedure. Figure 8 , 9 As shown, next, through the other side hole 1-1 of the in-situ puncture sheath of this scheme, the side puncture cannula 3 is inserted from the rear end to the front end of the in-situ puncture sheath, so that the puncture opening 3-1 of the side puncture cannula 3 is connected to the other side hole 1-1 of the in-situ puncture sheath (aligned through the respective contrast rings of the two holes). Then, the puncture needle 4 is inserted into the side puncture cannula 3, and the covered stent 9 is punctured by extending sequentially from the puncture opening 3-1 and the other side hole 1-1 of the in-situ puncture sheath. This puncture connects the main vessel and the branch vessel. After successful puncture, a guidewire is inserted into the main vessel through the puncture needle 4, and the puncture needle 4 and the puncture cannula 3 are withdrawn. The puncture site of the covered stent 9 is then dilated with a 2mm diameter balloon through the guidewire, as shown. Figure 10 , 11 As shown, the guidewire is then captured from the covered stent 9. Using a guiding technique, the guidewire passes through the perforation on the covered stent 9 and then enters the branch vessel through two side holes. The angle of the in-situ puncture sheath and the outward pulling force are then adjusted to allow the guidewire to slide out of the guidewire release suture and be sheathed. The in-situ puncture sheath can then be withdrawn into an 8F long sheath and exited from the main vessel 11. (As shown...) Figure 12 The guidewire 12 then allows for subsequent surgical procedures on the branch vessels. This invention offers the advantages of accurate fenestration positioning and convenient surgical operation. During the procedure, blood flow is maintained through the front sheath opening and side hole 1-1, ensuring continuous blood flow to the branch artery and preventing complications caused by ischemia in the organs supplied by the branch artery.

[0064] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made based on the principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A puncture sheath assembly device, characterized in that: The device includes a vascular in situ puncture sheath, which includes a hollow tube body (1). The hollow tube body (1) has a side hole (1-1) at corresponding positions on two opposite side walls near its front end, which penetrates the inner and outer surfaces of the wall in the same radial direction. Each side hole (1-1) also has a side slit (1-2) at its front end that connects to the side hole (1-1) and extends forward. As the two side slits (1-2) extend forward from the corresponding position at the front top of the side hole (1-1), they gradually tilt toward the same side of the hollow tube body (1) until they merge and connect to form a guide wire release slit (1-3) that facilitates the guide wire (12) to exit the hollow tube body (1). The opening width of the side slit (1-2) and the guide wire release slit (1-3) is equal to or slightly larger than the diameter of the guide wire (12) used to pass through the two side holes. It also includes a lateral puncture cannula (3) that is movably inserted into the hollow tube body (1) of the in-situ puncture sheath of the blood vessel and a puncture needle (4) that is movably inserted into the lateral puncture cannula (3); the lateral puncture cannula (3) has a channel extending along the axial direction of the tube body to facilitate the movable insertion of the puncture needle (4) and is open at one end and closed at the other end; the lateral puncture cannula (3) has a puncture opening (3-1) on the side of the tube wall near its closed end to facilitate the extension of the puncture needle (4), and the inner end wall of the closed end of the lateral puncture cannula (3) is an inclined guide surface (3-2) to facilitate the guidance of the puncture needle (4) into the puncture opening (3-1); the inclined guide surface (3-2) faces the location of the puncture opening (3-1) and its end is connected to the edge of the puncture opening (3-1); the edge of the puncture opening (3-1) is provided with a third contrast ring (3-3). The hollow tube (1) has an opening at its front end, through which the blood flow of the main blood vessel communicates with the branch artery via a side hole (1-1). The puncture needle (4) is inserted into the side puncture cannula (3) and extends out from the other side hole (1-1) of the in-situ puncture sheath to puncture the covered stent (9) to form a perforation; The guidewire (12) enters the branch vessel through the perforation on the covered stent (9) and then through the two side holes (1-1), and the guidewire (12) can be detached from the sheath by the wire release suture (1-3).

2. The puncture sheath assembly device according to claim 1, characterized in that: The two side holes (1-1) each have a first developing ring (2-1) on their edges.

3. The puncture sheath assembly device according to claim 1, characterized in that: The front end of the hollow tube (1) is provided with a second developing ring (2-2).

4. The puncture sheath assembly device according to claim 1, characterized in that: The side hole (1-1) is in the shape of a teardrop, with a small front end and a large rear end.

5. The puncture sheath assembly device according to claim 1, characterized in that: The puncture sheath assembly also includes an outer long sheath (13) for moving and sleeved outside the hollow tube body (1) of the in-situ puncture sheath of the blood vessel.

6. The puncture sheath assembly device according to claim 1, characterized in that: The sheath of the in-situ puncture sheath is also fixedly connected to a sheath seat (5). The sheath seat (5) is connected to an extension tube (6) that communicates with the hollow tube body (1) of the in-situ puncture sheath. The end of the extension tube (6) is connected to a three-way connector (7) including an infusion port (7-1) and a suction port (7-2).

7. The puncture sheath assembly device according to claim 6, characterized in that: The sheath (5) is provided with a handle (8) for easy hand holding.

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