JP3324707B2 - Device for placing a prosthesis in a patient's organ and device for organ transplantation - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

FIELD OF THE INVENTION The present invention relates to a method and apparatus for percutaneously placing a graft in a tubular organ of a patient.

[0002]

2. Description of the Related Art In the abdominal artery, an aneurysm is easily formed between the renal artery and the iliac artery. And this aneurysm is an extremely fatal phenomenon. Conventionally, surgery for this aneurysm has been performed by surgically removing the aneurysm and implanting a prosthesis in that portion. However, this surgery was extremely dangerous, and the aneurysm could rupture during the operation.

A method for operating an aneurysm without performing such a surgical operation is disclosed in US Pat.
Nos. 0126 and 4787899. Also, the University of Texas M .. D. Anderson Cancer Center's Clinical Radiology Journal, 1989, 1033-3
It is described on page 7. The grafts (prostheses) disclosed in these documents have a problem that it is difficult to insert them into a human body.

[0004]

SUMMARY OF THE INVENTION An object of the present invention is to provide a method for operating an aneurysm (although not necessarily limited thereto).
An object of the present invention is to provide a graft (prosthesis) that can be easily inserted and is stably placed after insertion. Another object of the present invention is to provide a device and a method for easily inserting the graft into a patient.

[0005]

SUMMARY OF THE INVENTION The device (graft) of the present invention and the method of insertion thereof are as described in the claims.

[0006]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The graft 1 of FIG. 1 is in the form of an elongated tube and has a plurality of bends 3. This bent part 3
Is for the diameter 5 of the graft 1 to expand or contract. By changing the weaving direction of the material forming the graft 1 or changing the direction of the bent portion 3 (for example, to make it oblique), elasticity can be given diagonally. The material of the graft 1 is preferably made of polyester woven multifilaments, harmless to the human body, biologically safe, and having appropriate strength.

[0007] The graft 1 preferably has a predetermined length in the axial direction, and is preferably less soft in the axial direction than in the radial direction. The length of the graft 1 varies.
For example, two cylindrical pieces may be slidably assembled to change the length.

The spring assembly 6 shown in FIG.
And bent to form an elbow 7. A protrusion 10 having a tip 13 is adhered to the arm 15 and protrudes from the elbow 7. FIG. 3 shows six elbows 7 and projections 1 respectively.
0 is shown. FIG. 4 also shows twelve arms 15 extending from the elbow 7 of the spring assembly 6. The spring assembly 6 is a thin stainless steel wire. When opened, the spring assembly 6 has a zigzag shape having a plurality of elbows 7. In FIG. 5, the spring assembly 6 comprises a simple elbow 7,
It has the shape of an opening wheel 60 having an inflection arch 42 and an opening 50.

An advantage of the shape of the elbow 7 is that the spring assembly 6 can more uniformly expand the axial opening of the graft 1. An advantage of the shape of this reflex arch 42 is that it collapses easily but is more robust. The opening wheel 60 is a flexible spring matching compression resistance member 49.
Used in the assembly of The two bent ends are connected end-to-end to form an annular structure (FIG. 2,
3, 4)

FIG. 6 shows the arm 15 of the spring assembly 6.
The state in which the protrusion 10 is connected to FIG. The spring assembly 6 is sewn to the graft 1 with a thread 36. The spring assembly 6 is formed of a material harmless to the human body, such as titanium or plastic. The spring assembly 6 is annular when viewed from above when expanded. And, when released, its diameter is about twice the diameter of the patient's organ to be inserted. This spring assembly 6 is provided at the distal end or both ends of the graft 1.
The inner wall is sutured with a thread 36. Threads 36 such that most of spring assembly 6 is covered by graft 1
Is connected to the spring assembly 6. In another embodiment, the spring assembly 6 may be connected to the outside of the graft 1, in which case the inner wall has the advantage of a smoother and better blood flow, but is well adapted to the patient's organs. There are disadvantages that cannot be done.

The spring assembly 6 at the distal end of the graft 1
Has a small projection 10 secured to the spring assembly 6. The spring assembly 6 at the root of the graft 1 is also
It has a projection 10. The connection of the projection 10 to the graft 1 or the spring assembly 6 may be made in a permanent and harmless manner, such as by welding. The projection 10 extends radially from the axial direction of the graft 1 and
When is opened in the patient's organ, the tip 13 comes into contact with the wall of the patient's blood vessel. The tip 13 is embedded in the blood vessel wall by the force of the spring assembly 6 and the pressure of the blood flow flowing through the graft 1. This tip 13 is sharp and slightly bent in the direction of the graft 1, forming an anchor in the direction of the blood flow. The arrangement of the protrusion 10 is such that it is upstream of the blood flow relative to the elbow 7 of the spring assembly 12 and does not rupture the blood vessel when the tip 13 is implanted in the blood vessel. The connection of the projection 10 to the spring assembly 6 is made at the center of one of two arms 15 extending from the elbow 7 of the spring assembly 6 via the elbow 7 fixed to the spring assembly 6; This allows the spring assembly 6 to retract or rotate slightly when compressed so that it can be mounted within the introducer sheath 4.

Although the spring assemblies 6 are sutured only at the ends of the graft 1, some of the spring assemblies 6 may be joined together to increase strength. This is necessary while the graft 1 is being removed from the introducer sheath 4.
Is the case for prostheses that need to withstand compression. A certain degree of flexibility is obtained by coupling the spring assemblies 6 to one another so that adjacent 60 can be separated (but without overlap or misalignment).

FIG. 7 shows the flexible spring matching compression resistance member 49. In the figure, a first spring arm 50 and a second spring arm 52 are
4 are connected. The holding bar 54 is formed of a thin wire, and has a protrusion 56 at the tip. FIG.
In, the deformed opening ring 60 has an opening 58 for accommodating the holding bar 54. The holding bar 54 slides through the adjacent first spring arm 50, second spring arm 52, and opening 58 in the opening wheel 60. The rigidity of the retaining bar 54 prevents overlap while compressing and mounting the prosthesis, while the protrusion 56
This can break the chain between the first spring arm 50 and the second spring arm 52 while the graft 1 is curved, preventing this joint from separating. The diameter of the rod portion 62 of the holding bar 54 is slightly smaller than the diameter of the opening 58, and conversely, the diameter of the protrusion 56 is slightly larger than that of the opening 58. The holding bar 54 allows the second
The spring arm 52 and the first spring arm 50 can be separated, and they do not overlap.

The joint between the spring assemblies 6
During the insertion of the graft 1 it is flexible and, once inserted, becomes highly rigid. In FIG. 9, this joint is used while the spring assembly 64 and the spring assembly 66 are compressed (when inserted).
It is more flexible and stiffer while the spring assembly 64 and the spring assembly 66 are not compressed (when insertion is complete). The spring assembly 64 and the spring assembly 66 are connected by a flexible spring matching compression resistance member 49. FIG. 9A illustrates the spring assembly 64 and the spring assembly 66 in a compressed state, and FIG. 9B illustrates the spring assembly 64 and the spring assembly 66 in a non-compressed state. . Angle α
Is the maximum angle when the spring assembly 64 and the spring assembly 66 are compressed, and the angle β is the maximum angle when the spring assembly 64 and the spring assembly 66 are not compressed. Thus, the angle between spring assembly 64 and spring assembly 66 increases as the transverse diameter of spring assembly 64 and spring assembly 66 increases.
Decrease. The angle of bending is maximum when the spring assembly 64 and the spring assembly 66 are compressed (diameter d ₁ ), and the spring assembly 64 and the spring assembly 6
6 is the minimum in the uncompressed state (diameter d ₂ ). Since angle α is greater than angle β, the prosthesis becomes more rigid as its diameter increases. Upon loading, the graft 1 is confined within the introducer sheath 4 and is small and flexible. After being removed from the introducer sheath 4, the graft 1 expands and becomes more rigid.

In FIG. 10, the holding bar 54 is fixed to one end of the spring expansion assembly 51 so as not to slide.

In FIG. 11, the tubular carrier 21 has an expansion head 22 at the tip (upstream). The expansion head 22 has an upper conical portion 75 and a cylindrical portion 74. The expansion head 22 has a soft tip wire guide 68 protruding from the tip. The cylindrical portion 74 of the expansion head 22 has a diameter d equal to the inner diameter of the introduction sheath 4.

FIG. 12 shows a "muzzle mounted" device, which comprises a tubular carrier 21 having an expansion head 22 at the tip, an expansion head lip 27, an introducer sheath 4,
A graft 1 over a tubular carrier 21, a spring assembly 12, a spring assembly 31, a spring assembly 21, a central control means 26 inserted into the spring assembly 21, a tip 8 of the graft 1, Graft 1
9, the spring assembly 12 and the spring assembly 31
And a thread 36 which permanently connects the to the graft 1. When the outer diameter of the tubular carrier 21 is equal to the inner diameter of the introducer sheath 4, blood leakage therebetween is minimized. Alternatively, the introduction sheath 4 is sealed at the root with a rubber seal 70 (FIG. 13). The rubber seal 70 has an opening 72 for accommodating the tubular carrier 21.

This “muzzle mounting” device includes an introduction sheath 4
Before the is inserted into the patient's organ, the graft 1 mounted on the tubular carrier 21 is inserted into the distal end of the introduction sheath 4.
In contrast, the “bleach mounting” device inserts the graft 1 into the introduction sheath 4 from the root (downstream) of the introduction sheath 4 after the introduction sheath 4 is placed at a predetermined position of the patient.

The first advantage of this "muzzle mounted" device is that
The possibility of bleeding is smaller than that of the "bleach mounted" device. In the "bleach mounting" device, the expansion head 22 needs to be removed before the graft 1 is inserted.
An efficient sealing of the introducer sheath 4 prevents insertion of the graft 1 (this increases in size) unless this is done in the second sheath. Another way to control bleeding is to clamp the introducer sheath 4 externally,
This clamp is not completely occluded and may damage the introducer sheath 4. This clamp needs to be removed when removing the graft 1.

A second advantage of this "muzzle mounted" device is that
If a single introducer sheath 4 is used in a "bleach" device, the graft 1 needs to be placed in the introducer sheath 4 during surgery. This is particularly difficult when the outer end of the introducer sheath 4 is emitting blood flow.

FIG. 14 shows the femoral artery 30, the root 19 of the introducer sheath 4, the tubular carrier 21, and the iliac artery 34.
Aorta 2, aortic aneurysm 20, dilation head 22,
Central control means 26 is shown.

In FIG. 15, the graft 1 has been inserted into the aorta 2 of the aortic aneurysm 20.

In the "muzzle mounting" device, the graft 1
Is inserted into the distal end of the introduction sheath 4. The introduction sheath 4 is formed of a smooth and flexible sterile tubular tube. A tubular carrier 21 fits on the inner wall of the introducer sheath 4. Since the sizes of the introduction sheath 4 and the tubular carrier 21 are close to each other, buckling of the tubular carrier 21 in the introduction sheath 4 can be avoided.
Blood can be prevented from penetrating between the introduction sheath 4 and the tubular carrier 21. The tubular carrier 21 has an expansion head 22 at its distal end, which expand head 22
5 to facilitate insertion into the body. Extension head 22
Comprises a cylindrical portion 74 at the base thereof,
Compatible with introduction sheath 4.

The introducer sheath 4 fits over the tubular portion 74 of the expansion head 22. The extension head lip 27 at the junction of the tubular portion 74 and the upper conical portion 75 of the extension head 22 overlaps the introduction sheath 4 and does not project outside during introduction of the device. This minimizes vascular damage and prevents thrombus from entering the blood vessel.

The central control means 26 is in the form of a catheter, which is entirely comprised of the expansion head 2.
It is also a thread that extends to the tip of No. 2 and is placed along the already placed guidewire. Alternatively, the central control means 26 can function as a guide wire itself that penetrates the expansion head 22 and moves back and forth in the introduction sheath 4.

In the "bleach mounting" apparatus, the introduction sheath 4 has a tubular structure having a uniform diameter and is formed of the same material as the introduction sheath 4 of the "muzzle mounting" apparatus. Here, the tubular carrier 21 does not have an expansion head 22 because the introducer sheath 4 is placed around a standard dilator and is removed with the graft 1 before the insertion of the tubular carrier 21.

FIG. 16 shows the tubular carrier 21, the anchoring loop (suture) 39, the central control wire 115, the openings 29, 29 'and the openings 101, 101'.

FIG. 17 shows the tubular carrier 21, the anchoring loops 39, 39 ', the openings 29, 29' and the openings 10
1, 101 'and central control thread 25 are shown.

"Bleach mounted" devices (as well as some "muzzle mounted" devices) use central control means 26. This central control means 26 is located in the central part of the tubular carrier 21, where the spring assembly 6 locks and is used to keep the axial position of the graft 1 during removal of the introducer sheath 4. You. This central control means 26 can take various shapes. For example, the wire 115 in FIG. 16, the central control sled 25 in FIG. 17 (passes through the center of the tubular carrier 21 via the anchoring loops 39, 39 ', and returns to the initial point through the center of the tubular carrier 21). ). If the mooring loops 39, 39 'are not present, the central control sled 25 will open
1, 101 '), through the elbow 7 of the spring assembly 6 and the opposite elbow 7 of the spring assembly 6.
And returns through the opening into the organ of the tubular carrier 21 and back to the root of the tubular carrier 21.
Release of the mooring loops 39, 39 'is effected by withdrawing the wire 115 from the tubular carrier 21. Alternatively, one end of the central control sled 25 is released, after which it is removed from the tubular carrier 21.

If each end of the graft 1 is controllable and positioned independently of the other end, the wire 115 will partially extend to a point between the two sets of anchoring loops 39 and 39 '. Partially pulled back. When the central control means 26 is the central control thread 25, a plurality of central control threads 2
5 are used, one of which is mooring loops 39 and 3
9 'for each set.

Since the "bleach mounted" device does not have an expansion head, the carrier of the "bleach mounted" device is:
There is no need to transfer the graft 1 to the distal end of the introducer sheath 4. Instead, it terminates at the distal end of the graft 1 so that it is pushed in rather than pulled out of the introducer sheath 4. No attachments are required for the graft 1. However, the graft 1 is stiffer and its position cannot be controlled very precisely.

The "muzzle mounting" method will be described. In order to assemble the device before insertion, the central control means 26 is inserted over the entire length of the tubular carrier 21, which is then inserted over the entire length of the introducer sheath 4.
With the central control means 26 projecting from the end of the tubular carrier 21 and the tip of the introducer sheath 4, the graft 1 slides over the expansion head 22 and moves the outside of the tubular carrier 21 below the expansion head 22 of the tubular carrier 21. Down to.

In FIG. 16, the tip of the graft 1 is
Thereafter, the spring assembly 6 is placed around the central control means 26.
Is locked by the mooring loop 39 which engages with Alternatively, it is sutured to the graft 1. The mooring loop 39 is inserted into the tubular carrier 21 through the openings 29, 29 ',
A mooring loop 39 is formed which engages the central control means 26 so that the mooring loop 39
It does not leave the tubular carrier 21 and this central control means 26 occupies the axial opening of the tubular carrier 21. This anchoring loop 39 remains joined to the graft 1 or the spring assembly 6 after the graft 1 has been deployed. The material of the anchoring loop 39 is preferably formed of a low thrombogenic single filament material. When the central control means 26 is withdrawn, the thread 36 is free to exit the tubular carrier 21. The root (downstream side) of the graft 1 is fixed via a second set of anchoring loops 39 ′ passing through a second set of openings 101, 101 ′ in the tubular carrier 21. This allows independent placement of the two ends of the graft 1. Once the graft 1 has been compressed, the introducer sheath 4 slides over the tubular carrier 21 and the end of the introducer sheath 4 fits exactly into the dilation head lip 27 of the dilation head 22. The protrusion 10 on the spring assembly 12 is completely covered by the introduction sheath 4. The device is now ready for insertion.

FIG. 18 shows another embodiment. The figure shows a cantilever hook 100, an outer carrier (catheter) 102, an inner catheter 104, and an expansion head 22. In this embodiment, a pair of coaxial catheters are joined at the distal end, and the outer carrier 102 expands when the inner catheter 104 is pulled proximally from outside the body. The graft 1 is held in place at the outer outer carrier 102 by a cantilever hook 100 joining the outer carrier 102 to the outer surface. The cantilever hook 100 holds the graft 1 during insertion.
To prevent the graft 1 from changing its axial position while the introducer sheath 4 is withdrawn. When the outer carrier 102 is withdrawn, the graft 1 is released from the cantilever hook 100.

These methods of securing the graft 1 to the carrier 102 for selective release are necessary because the graft 1 expands outward relative to the sheath and must be overcome to withdraw the graft 1. This is because a friction force is generated. Without such a mechanism, graft 1
Has moved with the sheath. Incorrect pulling. The material of the sheath should be formed of a low friction material or coated on its surface to minimize the pull-out force.

The insertion process is performed using surgery or using a guidewire. In surgery, the femoral artery 3
0 is exposed by laparotomy. The complete device is inserted into this femoral artery 30. And the femoral artery 30 and the iliac artery 3
4 and inserted into the aorta 2. The graft 1 is positioned so as to cover the entire length of the aortic aneurysm 20. This arrangement can be confirmed by fluoroscopy and radioscopy. Once proper placement is confirmed, the introducer sheath 4 is withdrawn, exposing the spring assembly 12 and a portion of the graft 1. This sprinkle assembly 12 expands to a point 13 within the wall of the aorta 2.
Press. When the graft 1 is withdrawn from the introducer sheath 4, the central control means 26 is also withdrawn. When the central control means 26 is withdrawn, the graft 1 is
6 passes through a point of engagement via a mooring loop 39 which passes freely through the end of the central control means 26 and through the openings 29 and 29 'of the tubular carrier 21. Become. Blood flow in the aorta 2 helps to spread the fold 3 of the graft 1. This arrangement is performed in two stages. First, the introducer sheath 4 is withdrawn and expanded, exposing the distal end 8 of the half of the graft 1 adhering to the wall of the aorta 2. Thereafter, the central control means 26 controls the tubular carrier 2
1 to the point between the openings 29, 29 'and the openings 101, 101', leaving only the root of the graft 1 in contact with the tubular carrier 21. Graft 1 root 9
Is then independently placed at the distal end 8 of the graft 1. The introducer sheath 4 is then moved to the spring assembly 31
Pulled out of. When the root of the graft 1 is exposed,
It also expands under the action of the spring assembly 31, pushing the projection 10 into the wall of the aorta 2. Thereafter, when the central control means 26 is withdrawn and the central control means 26 passes the point of engagement with the second set of mooring loops 39 ',
Graft 1 is completely released. After the spring assembly 31 is released, the tubular carrier 21, the central control means 26,
The introducer sheath 4 is removed from the patient's body. The femoral artery 30 is then treated and the wound heals.

FIG. 19 is an axial sectional view of the closing umbrella 80. The graft 82 has an open base,
The tip is closed to form a reversing picket 86, which is covered by a tip expander 90. The jaw 92 of the spring assembly 88 extends the open end of the graft 82. An axial bore 110 is connected inside the tip expander 90 and extends through a closed umbrella 80. Push catheter 9
5 contacts the umbrella catheter 110, and the axial opening 111 and the axial opening 112 are aligned. The central pusher wire 93 is inserted through the axial opening 112 of the pusher catheter 95 and further through the axial opening 111 of the umbrella catheter 110 until the central pusher wire 93 hits the pusher catheter 95.

FIG. 20 illustrates an aortic aneurysm 20 extending from the aorta 2 to the iliac artery 34. Graft 1 has been inserted, thereby forming a conduit from aorta 2 to iliac artery 34. Conventional Femoral Artery Bypass Graft 94
Was used to carry blood flow from the side that contained arterial blood flow from the root of the graft to the other limb. This occluded umbrella 80 is a “backing up” in which arterial blood flow (entering the iliac artery 34 via the femoral artery bypass graft 94) is between the graft 1 and the aortic aneurysm 20.
To prevent

Prior to insertion, the occluding umbrella 80 is pryed into the distal end of the introducer sheath 4 until the introducer sheath 4 engages the tip expander 90 and the umbrella catheter 110 meets the pusher catheter 95. Umbrella catheter 110 and pusher catheter 95 are aligned by a central pusher wire 93 inserted through axial openings 111 and 112. The device is inserted into the femoral artery 30 and further into the iliac artery 34. A pushing catheter 95 passes through the introduction sheath 4. The occlusive umbrella 80 is pushed out of the introducer sheath 4 by applying a force to the pusher catheter 95 and the central pusher wire 93 and is withdrawn over the introducer sheath 4. As the spring assembly 88 and jaw 92 disengage from the introducer sheath 4, they extend into the arterial wall securing the occluded umbrella 80. Push catheter 9
5, central pusher wire 93 and introducer sheath 4 are then withdrawn from femoral artery 30 by arteriotomy. The arteriotomy is then glued to the distal end of the femoral artery bypass graft 94.

When using a "bleach mounted" introducer sheath, the sheath is first inserted through the artery into the root of the aneurysm. Thereafter, the dilator is inserted, the sheath is clamped, and the graft is inserted.

Generally, a prosthesis (prosthesis) is composed of a graft and a stent. This stent
It is placed within the organ of the graft orifice to expand and secure the graft in place.

All stents are preferably of the self-expanding type, the segment 201 of which is shown in FIG. One wire loop is folded to form an inflection point 202 between the straight rims 203. The number and length of the limbs depends on their material, the size of the vessel into which the graft is inserted, and the size requirements of the delivery system. However, the diameter of the stent is always larger than the diameter of the vessel into which the graft is inserted. The head stent is secured to the graft. Bends, protrusions, and other surface features of the stent are used as points for appendages 204. Protrusions take the shape of a wire catheter, soldered to the stent,
Or glued. The head stent has a jaw 205. The jaws 205 project outside from the surface of the stent. The jaws are formed on the head or tail, or both. They can adhere to the stent everywhere. The head stent may or may not have protrusions.

FIG. 22 shows tail orifices 208 and 209.
Graft 206 having a head and orifice 207
Is illustrated. The bifurcated graft 206 is attached to the main body 2
50, a tail rim 210 and a tail rim 213.
The main body 250 includes a main body bore 251 and a head orifice 207.
And Tail rim 210 has a bore 252 communicating with body bore 251 and a tail orifice 209. The tail rim 213 has a bore 253 communicating with the main body bore 251.
And a tail orifice 208.

Typical 5, grafts are made of durable yarns such as polyester and have no seams. Also,
It has the flexibility of the yarn itself or the moderate flexibility of post-processing. The size of the graft can vary, depending on where it is to be inserted. In any case, the diameter of the graft is selected to be larger than the diameter of the patient's blood vessel. In many cases, the length of the graft is determined such that the tail orifices 208, 209 enter the organ. The material of the graft head rim must be porous and capable of penetrating blood leaks.

Tail rim 2 on the side opposite to the insertion side
10 is marked with a radiopaque line 211 and a radiopaque line 212. These marks are X
It is possible to see through with a device such as a line, a CT, and an MRI. The tail rim 213 has at least two
And two radiopaque lines 214 and 215. In FIG. 23, a prosthesis injection system 180 has a central carrier 216 and a coaxial introducer sheath 217 coaxial therewith. The coaxial introduction sheath 217 has a constant diameter and a constant thickness. The inner diameter of the coaxial introduction sheath 217 is
It corresponds to the outer diameter of the central carrier 216 along two regions. One of them is located at the tail of the carrier shift 218, and the other is located at the head of the carrier head 219. There is a narrower carrier axis region 220 between these two regions.

The coaxial introduction sheath 217 is made of a thin wall made of a material which is harmless to a flexible human body, resists buckling, and has a low surface friction coefficient. This coaxial introduction sheath 21
7 has a constant diameter and a constant thickness other than at the tip 223. The position of the tip 223 is such that the surface 221 of the coaxial introduction sheath 217 is formed in a tapered shape and conforms to the outer surface 222 of the carrier head 219 (FIG. 24,
25). In FIG. 26, hemostatic seal 225 engages outer surface 226 of carrier shift 218. The hemostatic seal 225 has a known lock 227 that grips an outer surface 226. The length of the coaxial introducer sheath 217 depends on the length of the central carrier 216. The coaxial introduction sheath 217 is longer than the entire carrier shaft and covers a part of the carrier head 219 and the carrier shift 218.

26 and 27, the center carrier 21
6 has an inner catheter 229 and an outer catheter 230 coaxial therewith. This inner catheter 229 is
It has a constant diameter and thickness. The tail 231 of the inner catheter 229 has an injection port 232. The inner lumen 233 matches the outer diameter of the inner catheter 229, but the outer diameter of the outer catheter 230 varies. At the tip, this outer diameter corresponds to the inner diameter of the introducer sheath (FIG. 2).
4). This segment of the outer catheter 230 is the carrier head 219.

In FIG. 25, another small enlargement section 234
At the tip, it is the end of the coaxial introduction sheath 217. Furthermore,
A smooth transition from the carrier head 219 to the coaxial introduction sheath 217 occurs.

The inner diameter of the introducer sheath around the tail matches the outer diameter of the tail segment of the carrier shaft 218.
The narrower segment of central carrier 216 between carrier head 219 and carrier shaft 218 is carrier axis region 220. When inserted, the prosthesis assembly 22
8 and its associated catheter system comprise a coaxial introducer sheath 2
It is compression-inserted into the space between 17 and the carrier shaft region 220.

In FIG. 23, two pairs of holes 235 and 23
6 traverses the outer catheter of the carrier axis and one pair traverses the end of the prosthesis assembly 228.

In FIG. 27, the suture loop 237 and the suture loop 238 are now wrapped around the inner catheter 229 and through the hole into the organ of the outer catheter 230. Sutures for this are suture loops 239, 2
As with 40, it traverses some portion of the prosthesis assembly 228. Thereby, both ends of the prosthesis are sutured to the central catheter. The suture loops 237-240 (and the prosthesis) are released by removing the inner catheter 229. The loops in each set must not cross. Otherwise, the central carrier cannot be released even after removing the inner catheter 229.

In FIG. 26, the tail 241 of the inner catheter 229 and the outer catheter 230 has a short and flexible extension. Its size and structure are similar to the carrier axis region 220. Each of the inner catheter 229 and the outer catheter 230 has an injection port 232 and a pressing portion 242 at the tail of the expanded portion. The 232 and the pressing portion 242 are locked by the holding portion 243 to prevent the internal catheter from coming off.

In FIG. 23, the head 244 of the carrier shaft (or the tail end of the carrier shaft region 220) is
It has a tubular groove 245 for connection of the catheter to the suture.

The diameter of the carrier shift 219 and the diameter of the carrier shaft 218 are determined by the diameter of the coaxial introduction sheath 217. And this coaxial introduction sheath 217 is determined by the volume of the prosthesis. Carrier axis region 22
The shortest length of 0 is the distance from the root of the aneurysm to the skin. The maximum length of the carrier shaft region 220 is the length of the introduction sheath. Therefore, the central carrier 216
Equal to twice the total length of the iliac artery and aneurysm.

The tail control mechanism is described below. The tail rim control mechanism is a bifurcated graft 20
6 extend from the tail ends of the tail rims 210 and 213 to the skin. This tail rim control mechanism, as illustrated in FIGS.
The shape is. Alternatively, a combination of a catheter and a suture, as shown in FIGS. 32-35.

Referring to FIG. 28, tubular extensions 246 and 24
7 is the tail rims 213 and 210 of the bifurcated graft 206
Are stitched with rod portions 248 and 249. The rod portions 248 and 249 are locked by 280 and 281.

FIG. 29 illustrates another control mechanism. In the figure, the loop of bores 252 and 253
Each joins the bifurcated graft 206 along the walls of the tubular extensions 246 and 247.

In FIG. 30, a single loop of suture 254 is used as a traction means to one end of tail rim 210.
used. FIG. 31 illustrates a state where the tail rim 210 is connected to a plurality of points at the end. As one side of the suture 254 is cut, traction at the other end pulls the end of the suture within the graft and withdraws it from the body. By confining the suture within the catheter 255, mottling is reduced.

Referring to FIGS. 32 and 33, catheter 255
Side holes 256, and a plurality of 257 of the catheter 255,
The side holes 258 allow for the pulling of multiple points on the graft without approaching the wall of the tail rim 210. Knot 2
59 allows the suture 254 to emerge from the catheter 255 by splitting the ends of the loop. This combination of catheter and suture can provide multiple functions. This is because the pull is transmitted only via the shortest suture 260 as shown in FIG.
Pulling catheter 255 does not tension suture 261 until suture 260 is severed.

FIG. 35 shows the catheter 2 of the tail rim 210.
55 is shown. 262 has catheters 255 and 263. In FIG. 36, the tail lumen of 210 is provided by a suture 264 and a 26
4 is locked to the central carrier such that the suture loops 237 and 238 are locked to the prosthesis. The opposite rim access guide system 265 becomes taut and inflexible when the pull is applied to the outer end. When strained, it causes the catheter 14 to move, as illustrated in FIG.
Acts like a wire guide in the 0 lumen. When the inner catheter 229 is removed, the opposing rim access guide system 265 is released from the central carrier 216. Anchoring loop 266 engages the end of the catheter or extends through its lumen and extends to the tail.
Thus, the suture knot is prevented from being pulled out.
Sutures tied through the side holes 267 in the catheter tend to pull out when strained. However, this is not the case when the catheter is surrounded to distribute the pull more evenly as shown in FIG.

In FIG. 38, the lumen access of the tail rim 213 is guided by a wire guide. If the pull is maintained during stent insertion, suture 2
54 is also required for the tail rim 213. The direction of the tail rim 213 towards the catheter must be constant. This is because any twisting is reproduced when the two tip rims are relatively oriented. Carrier axis region 22
Zero locations are marked outside the insertion system.

In FIG. 39, the catheter 140 has a stent pushing device 271 and an outer sheath 268. The structure and function of the tail stent insertion device is substantially similar to that of the prosthesis injection system 180.

The outer sheath 268 has a certain diameter and a certain thickness. However, the portion of the head orifice 269 which becomes a taper on the outer surface of the sheath and smoothly joins the pushing head 270 is excluded. The sheath is a flexible material, the surface of which has a low coefficient of friction. A pushing head 270 is inserted into the head end of the stent pushing device 271.
Are disposed, and the push head 270 has an outer diameter that matches the inner diameter of the introducer sheath. The push head 270 also matches the diameter of the introducer sheath. Between the two is a narrow pusher shaft 273 that passes through the tail stent 275.

In FIG. 40, a catheter 130 directs the position of the tail rim 210 of the bifurcated graft 206.
Disposition of the opposite rim of a bifurcated graft creates twist. A catheter 130 is placed over the distal rim control system to remove twist. The catheter 130 is provided with a fishmouth-shaped split at the head 274. The terminal split occupies the plane containing the long axis of the device. When a pull is applied to the suture 254, the suture 254 is pulled into the catheter into the two walls of the graft. The flattened opposite rim then slides into a slot in the tail 130.

Referring to FIG. 41, tubular extensions 246 and 24
A catheter 131 for use with 7 is shown. The catheter 131 is an expander having a soft spherical tip and an expandable portion 132 at a distal end 133. The expander is inserted into the tubular section, which is placed in tension by pulling on the tail. Due to the tight fit, the torsion force is transmitted to the graft by the frictional force of the surface of the tubular part. If there is no extension of the graft, the catheter 131 advances over the opposing rim access guide system 265. Thereafter, the expander engages the inner surface of the tail orifice 209. Alternatively, if the expander is a balloon (balloon) inflated in the tail rim 210, the catheter 131 may take any shape,
Long enough to reach the end of the tail rim from the aneurysm.

FIG. 42 shows the double lumen catheter 12.
0 is a partial sectional view. This catheter has a through hole 12
1 and 122. One has an arterial catheter inserted and the other has a contrast catheter (or wire)
Is inserted. The tip 123 is inserted so that it can be easily inserted.
It is formed in a slightly tapered shape. Since the catheter is resistant to twisting, the two lumens maintain their shape. The catheter is inserted until the two catheters separate, one catheter being inserted into the base of the artery and the other into the iliac artery.

Hereinafter, a prosthesis device and a method of using the prosthesis device will be described. The patient lies on his back on the operating table.
Access to the arterial bifurcation by manipulating the arterial blood vessels. Alternatively, the prosthesis device is inserted using the introducer sheath. Hemostasis is stopped at the base of the artery with a Thylastik® band and at the tip with a clamp. Also coagulate the patient with heparin (coagulant).

This insertion is guided by a fluorescent instrument.
In particular, a useful device is digital subtraction. This attempts to properly guide the insertion device by combining a real-time fluorescent image and a static image.

First, the first angiography is performed to define a reference point into which a guide is to be inserted. Thereafter, the inserted catheter is removed, and the guide wire is left at the reference position.

A wire, a suture, a catheter, a tape, and the like are inserted. In one method, the catheter or guidewire is sewn to an artery using a Dormier basket. Another method is a method performed by a fluorescent light guide device.

Care must be taken not to wrap the angiographic catheter around the crossed arterial system. For this, 1
20 may be used.

The introduction system is used by being wound around a wire guide. The position of the prosthesis is controlled by manipulating the central catheter. After the introduction system is withdrawn, the stent expands, opening the graft and locking it in place. When the coaxial introduction sheath 217 is further pulled out, the head rim control mechanism and the central carrier 216 come out. This head rim control mechanism, suture loops 237,
38 and other catheters and tubular graft expanders are adhered to the artery using sutures, tapes, clips and the like.

The tail rim 210 may be twisted after being inserted into the artery. This twist is caused by the radiopaque line 21.
It can be confirmed by observing 1 and 212. Using an opposite rim control mechanism, such as a suture loop 237,238, pulls the tail rim 210 and removes it from the catheter 13
Pull over 0,131. Untwisting the tail rim 210 improves the arterial pulse and blood flow.

The stent must prevent blood around the tail limbs 210 and 211 from flowing back into the aneurysm. The stent insertion device extends through the tubular extension 247. Alternatively, the device is overlaid on a wire guide or opposite rim access guide system 265.
In any case, the tail rim needs to be attracted and placed using the tail rim control mechanism.

The prosthesis assembly 228 is released from the central carrier 216 by removing the inner catheter 229. Before removing the mounting device, it is necessary to replace the inner catheter and advance the wire guide through the central lumen, which is necessary to guide the insertion of the stent into the lumen of the tail rim 213. Because there is. After stent insertion, a wire guide is needed to guide the catheter insertion. After the operation is completed, the catheter is withdrawn and
The treatment of the artery ends and the wound is closed.

In FIG. 43, the organ moving device 350 includes:
The prosthesis assembly 228 is placed in place within the bifurcated lumen. 48 and 49, the bifurcated lumen 2
84 is located in the aorta 2 at the iliac arteries 34 and 35. The aortic aneurysm 20 is located at the base of the iliac arteries 34, 35. The arterial lumen 285 forms a main lumen, and the intestinal lumens 286, 287 communicate with the arterial lumen 285.

The prosthesis assembly 228 of FIG. 43 has a bifurcated graft 206,
Main spring assembly 301, rim spring assembly 30
2, 303 (not shown). The main spring assembly 301 and the prosthesis assembly 228 are disposed within a coaxial introducer sheath 217, which is made of polytetrafluoroethylene. Bifurcated graft 20
6 has a main body 250 on which the tail rim 2 is attached.
13 and 210, which are stent boot 3
Partially cover the top of 04 and 305.

The main body 250 has a head orifice 207 and a main body bore 251. Bore 252 and 253 communicate with body bore 251 and tail rims 210 and 2 respectively.
Extends into 13. The tail rim 210 is a tail orifice 2
09 and the tail rim 213 is
Having. The main spring assembly 301 is disposed in the body bore 251 of the body 250, passing through the head orifice 207, and the body 250 matches the inner wall of the arterial lumen 285. When the prosthesis assembly pair is positioned within the bifurcated lumen 284 and released from the coaxial introducer sheath 217, the main spring assembly 301 expands from its compressed state (FIG. 43).

The organ implant device 350 includes a coaxial introducer sheath 2 for holding the main spring assembly 301 in a compressed state.
17 and having a stent boot 304 to hold the spring assembly in a compressed state, and having a stent boot 305 to hold the spring assembly in a compressed state and bifurcating the prosthesis assembly 228. It has a retaining assembly 351 disposed within bores 252 and 253 for retaining within lumen 284. Meanwhile, the outer sheath is withdrawn from the prosthesis assembly 228 and the main spring assembly 3
01 is released from the compressed state.

Like the central carrier 216, the main holding assembly has an elongated member 352 having an expansion head 353 at its distal end. The dilation head functions to penetrate the organ transplant device into the bifurcated lumen, minimizing bleeding. The elongate member 352 has an intermediate carrier shaft region that includes an outer catheter 318, a connector sleeve 354, and side openings 355, 356 formed therein.
And an inner catheter 3 extending axially in the elongated member.
19, the elongate member has an outer catheter and a connector sleeve 354. This connector sleeve 354
Connects the segments of the outer catheter 318 and facilitates the connecting sutures 357, 358 to connect to the inner catheter 319 via the side openings 355, 356. One end of the connecting sutures 357 and 358 is connected to the outer surface of the outer catheter 318, and the other end is connected to the outer surface of the inner catheter 319. Connecting sutures 357 and 35
8, a loop is formed through the opposite end of the main spring assembly 301 to retain the prosthesis assembly 228 within the bifurcated lumen 284. On the other hand, the coaxial introduction sheath 2
17 is withdrawn from the prosthesis assembly 228 to release the main spring assembly 301 from compression. The outer sheath has a space 359 in which the prosthesis assembly 228 is positioned during its insertion. Connection suture 3
57 and 358, when the prosthesis assembly 228 is positioned within the coaxial introducer sheath 217, the main spring assembly 3
A reversing device is formed so that 01 is temporarily compressed. The distal end of the outer sheath is located near the root of the expansion head 353 to facilitate insertion of the mounting device into the bifurcated lumen.

The elongated member 352 is connected to the carrier shaft 21.
8 has a carrier shaft region 360 similar to that of FIG. 8 and in which a carrier shaft tubular recess 309 is formed.

In FIG. 44, the rim spring assembly 3
02 is a partial sectional view in a compressed state. The rim spring assembly 302 is connected to the inside of the tail rim 213 via sutures 315, 316 and the stent boot 304
Contained within. Prosthesis assembly 228 is used for aortic aneurysm 2
When properly positioned within the rim spring assembly 30
2 is released from compression and expands tail rim 213 to fit the rim to the inner wall of iliac artery 34. The stent boot 304 includes the rim spring assembly 30 in a compressed state.
2 is a container for accommodating 2. Suture 314 is temporarily
The prosthesis assembly 228 is connected to the rim spring assembly 302 and retains the rim spring 302 on the stent boot 304 during placement of the prosthesis assembly 228 within the bifurcated lumen 284.
Suture 314 can be applied to rim spring assembly 3 when prosthesis assembly 228 is within bifurcated lumen 284, particularly when tail rim 213 is properly positioned within iliac artery 34.
02 is formed. Suture 314
Upon release from rim spring assembly 302, stent boot 304 is retracted from rim spring assembly 302, releasing it from compression. When the rim spring assembly 302 is released from compression, the rim spring assembly 302 expands the tail rim 213 and fits the rim to the inner wall of the intestinal lumen 286.

The stent boot 304 is a tube made of polytetrafluoroethylene.
02 is kept in a compressed state. Rim spring assembly 30
2 attaches suture 31 to tail rim 213 in bore 253.
5, 316. Suture 315, 316
Is located on the head from the tail orifice 208,
The tail of the graft rim extends over the top of the stent boot 304. Sutures 314, 317 are temporarily connected to rim spring assembly 302 and hold rim spring assembly 302 within stent boot 304. One end of the sutures 314 and 317 are tied around the outer catheter 318, while the other end is tied around the inner catheter 319 through the openings 320 and 321 of the connector sleeve 322. The inner catheter 319 is temporarily connected to the rim spring assembly 302 and forms part of a release mechanism that releases 314,317. Sutures 314, 31
7. The inner catheter 319 is the stent boot 304
A holding mechanism for holding the rim spring assembly 302 is formed therein. The connector sleeve 322 is a tube having an opening 320 and an inner catheter 319. Connector sleeve 322 has an inner diameter that matches the outer diameter of outer catheter 318. The outer catheter 318 is cut, inserted into the opposite end of the connector sleeve 322, and joined using a medical adhesive. Inner catheter 319
Holds the connecting suture through the passage of the connector sleeve 322 and the external catheter and through the side opening in the sleeve.

In FIG. 45, the stent boot 304
Is connected to the interior of the tail rim 210 and contained within the stent boot 305. Catheter 255 has a suture 254 connected to stent boot 305 and extending through 306. The suture 254 is temporarily connected to the rim spring assembly 303 and retains the rim spring assembly 303 within the stent boot 305 while placing the prosthesis assembly 228 within the lumen 284. The suture 254 is particularly effective when the prosthesis assembly 228 is positioned within the bifurcated lumen 284, particularly when the tail rim 210
Constitutes a release mechanism that releases the rim spring assembly 303 when is disposed within the rim spring assembly 35.
When the suture 254 is released from the rim spring assembly 303, the stent boot 305 is moved to the rim spring assembly 3
03 to release it from its compressed state. When the rim spring assembly 303 is released from compression, the rim spring assembly 303 expands the tail rim 210 and fits the rim to the inner wall of the intestinal lumen 287.

[0084] The catheter 255 is a commercially available copolymer tube to which the stent boot 305 is integrated with a medical adhesive. The stent boot 305 is a tube made of polytetrafluoroethylene that houses the rim spring assembly 303 in a compressed state. Rim spring assembly 303 is connected with sutures 307, 308 to tail rim 210 inside catheter 255. Suture thread 3
07, 308 are located at the head of the tail orifice 209 so that the tail of the tail rim 213 extends over the stent boot 305. The rim spring assembly 303 has hooks that bite into the blood vessel to secure the prosthesis assembly 228. However, the rim spring assembly 303 may or may not have this hook. Suture 254 is temporarily connected to carrier shaft tubular recess 309 via suture 310.

In FIG. 46, the stent boot 305
Is connected to a catheter 255 and this catheter 25
5 is disposed within the axial lumen 311 of the catheter 130. The plurality of splines 312 are formed at the root of the stent boot 305 and conform to the plurality of 313 disposed around the distal end of the axial lumen 311. The splines 313 are engaged with each other and the stent boot 3
05 and the tail rim 210 are rotated so that they are properly positioned within the iliac artery 35. A radiopaque marker is attached to the tail rim 213.

Referring to FIG. 47, the prosthesis assembly 228
Are the bifurcated lumen 284 of the aorta 2 and the iliac arteries 34, 3
5. The main spring assembly 301 is released from compression, expanding the body 250 and conforming the body 250 to the inner wall of the arterial lumen 285. Similarly, 30
2 is also released from compression, and the elongate member 352 and the tail rim 213 conform the tail rim 213 to the inner wall of the intestinal lumen 286 of the iliac artery 34. Rim spring assembly 3
When 03 is released from the compressed state, the tail rim 210 is expanded, and the tail rim 210 is fitted to the inner wall of the intestinal lumen 287 of the iliac intestinal vein 35. The catheter 255 and the stent boot 305 expand the tail rim 210 when withdrawn from the rim spring assembly 303.

Next, a method for arranging the prosthesis assembly 228 at an appropriate point in the bifurcated lumen 284 will be described. First, the iliac artery 3 through the opening 283 and the opening 361.
4, 35 are placed in the intestinal lumen 286,287.
A guide is located between 283 and 361. The organ transplant device 350 has a retaining assembly 351, an elongate member 352, and an associated prosthesis assembly 228 disposed within the bifurcated lumen 284. Coaxial introduction sheath 217
When is withdrawn from prosthesis assembly 228, catheter 255 guides tail rim 210 into intestinal lumen 287 of iliac artery 35. Suture 314 includes main spring assembly 301 and rim spring 30 that place prosthesis assembly 228 within bifurcated lumen 284.
It is released from 2,303. Stent boots 304 and 3
05 are removed from the respective spring assemblies while the elongate member 352 and catheter 255 are withdrawn.

As a modification, the stent boots 304 and 3
05 is fixed to an external catheter or slidably fixed. Similarly, the stent boot 304 may be glued or slidably secured to the end of the tail.
The coaxial introducer sheath 217 is made of semi-rigid polytetrafluoroethylene and can accommodate the prosthesis assembly 228. The spring assembly or stent can be any shape that automatically expands when it is withdrawn.

[0089]

As described above, the graft of the present invention is
The graft can be placed within the aneurysm and treated without major surgery. Furthermore, the prosthesis insertion device of the present invention allows such a graft to be safely and reliably placed in a patient.

[Brief description of the drawings]

FIG. 1 is a perspective view of a tubular graft according to one embodiment of the present invention.

FIG. 2 is a perspective view of a spring extension assembly according to one embodiment of the present invention.

FIG. 3 is a sectional view taken along line AA of FIG. 2;

FIG. 4 is a sectional view taken along line BB in FIG. 2;

FIG. 5 is a perspective view of a spring extension assembly according to another embodiment of the present invention.

FIG. 6 is a perspective view of a spring expansion assembly sutured to a graft.

FIG. 7 is a perspective view of a flexible spring alignment and compression resistance assembly.

FIG. 8 illustrates an elbow and a retaining bar of a flexible spring alignment and compression resistance assembly.

FIG. 9 shows an axial cross-sectional view of two spring expansion assemblies in a compressed state and two spring expansion assemblies in a non-compressed state, which are combined by a flexible spring alignment and compression resistance assembly FIG. It is a figure showing the state performed.

FIG. 10 illustrates a flexible spring alignment and compression resistance assembly with a retaining bar secured to one of the spring expansion assemblies.

FIG. 11 is an axial cross-sectional view of a tubular carrier having an expansion head disposed at a distal end.

FIG. 12 is an axial sectional view of the “muzzle insertion” device.

FIG. 13 is an axial cross-sectional view of the root end of the introduction sheath.

FIG. 14 is a longitudinal sectional view of an aortic aneurysm, an iliac artery, and a femoral artery in which an expansion head, an introduction sheath, a tubular carrier, and a central control unit have been inserted.

FIG. 15 is a longitudinal sectional view of an aortic aneurysm, an iliac artery, and a femoral artery into which a graft has been inserted.

FIG. 16 is a longitudinal sectional view of the tubular carrier into which the engagement loop and the central control means are inserted.

FIG. 17 is a longitudinal sectional view of the tubular carrier into which the engagement loop and the central control means are inserted.

FIG. 18 is a longitudinal sectional view of another graft bonding means.

FIG. 19 is a longitudinal sectional view of a closed umbrella.

FIG. 20 is a longitudinal sectional view of an aortic aneurysm, an iliac artery, and a femoral artery into which an occluded umbrella and a graft have been inserted.

FIG. 21 illustrates a segment of a self-expanding stent.

FIG. 22 shows a bifurcated graft.

FIG. 23 illustrates a tubular carrier.

FIG. 24 illustrates one embodiment of an introducer sheath having a tapered head end.

FIG. 25 illustrates another embodiment of an introducer sheath having a tapered head end.

FIG. 26 is a diagram illustrating an example of a tubular carrier.

FIG. 27 is a view showing another embodiment of the tubular carrier.

FIG. 28 illustrates one embodiment of a tubular extension sutured to a bifurcated graft.

FIG. 29 illustrates another method of suturing a tubular extension to a graft.

FIG. 30 illustrates a single loop of suture pulling the rim of the tail end.

FIG. 31 illustrates a loop of a suture pulled through a plurality of holes in a rim at the tail end.

FIG. 32 illustrates a loop of suture pulled through a plurality of holes in the side hole of the catheter and the rim at the tail end.

FIG. 33 illustrates a loop of suture pulled through side holes in the catheter and holes in the rim at the tail end.

FIG. 34 is a diagram illustrating a state where the catheter is pulled up via a suture.

FIG. 35 illustrates a tail end rim control catheter of a tail end rim control system.

FIG. 36 illustrates a tail end rim control catheter of a tail end rim control system.

FIG. 37 illustrates a suture surrounding a catheter of an opposing lumen access guide system.

FIG. 38 is a diagram illustrating a state in which the rim lumen on the same side is accessed by an insertion wire.

FIG. 39 is a side view of the distal stent of the present invention.

FIG. 40 illustrates an opposite rim for straightening a graft.

FIG. 41 illustrates another embodiment of an opposite rim for straightening a graft.

FIG. 42 is a cross-sectional view of a double lumen catheter for preventing torsion.

FIG. 43 is a partial cross-sectional view of the portion of the prosthetic implant device of the present invention that positions the prosthesis in place.

FIG. 44 is a partial cross-sectional view of the ipsilateral rim spring assembly of the prosthesis assembly of FIG. 43 and a stent boot of the prosthetic implant device.

FIG. 45 is a partial cross-sectional view of the contralateral spring assembly and control rim insertion catheter of the prosthesis assembly of FIG. 43.

FIG. 46 is a partial cross-sectional view of the contralateral stent boot provisionally connected to the control rim insertion catheter of FIG. 45.

FIG. 47 is a view showing a state where the prosthesis assembly of the present invention has been inserted into an aneurysm, an artery and an iliac artery.

FIG. 48 illustrates a method of controlling sutures with a wire guide inserted into the artery and iliac artery.

FIG. 49 illustrates a method of controlling sutures with a wire guide inserted into the artery and iliac artery.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Graft (graft) 2 Aorta 3 Bending part 4 Introducing sheath 5 Diameter 6 Spring assembly 7 Elbow 8 Tip part 10 Projection 12 Spring assembly 13 Tip 15 Arm 19 Root part 20 Aortic aneurysm 21 Tubular carrier 22 Expansion head 25 Central control Thread 26 Central control means 27 Extended head lip 29, 29 'opening 30 Femoral artery 31 Spring assembly 34, 35 Iliac artery 36 Thread 39, 39' Mooring loop 42 Recoil arch 49 Flexible spring matching compression resistance member 50 First spring Arm 51 Spring expansion assembly 52 Second spring arm 54 Holding bar 56 Projection 58 Opening 60 Opening ring 62 Rod part 64, 66 Spring assembly 68 Wire guide 70 Rubber seal 72 Opening 74 Cylindrical part 75 Upper conical part 80 Closure Umbrella 82 Graft 86 Inverted Picket 88 Spring Assembly 90 Tip Expander 92 Jaw 93 Central Push Wire 95 Push Catheter 94 Femoral Artery Bypass Graft 96 Femoral Artery 100 Cantilever Hook 101, 101 'Open 102 External Carrier 104 Internal Catheter 110 Umbrella Catheter 111, 112 Axial opening 180 Prosthesis injection system 201 Segment 202 Inflection point 203 Straight rim 204 Attachment 205 Chin 206 Bifurcated graft 207 Head orifice 208, 209 Tail orifice 210, 213 Tail rim 211, 212 No radiation Transmission line 214, 215 Radiopaque marker 216 Central carrier 217 Coaxial introduction sheath 218 Carrier shaft 219 Carrier head 20 Carrier Shaft Area 222 Outer Surface 223 224 Tail 225 Hemostatic Seal 226 Outer Surface 227 Lock 228 Prosthesis Assembly 229 Inner Catheter 230 Outer Catheter 231 Tail 232 Injection Port 233 Inner Lumen 234 Small Enlargement 235, 236 Holes 237, 238, 239, 240 suture loop 241 tail 242 pressing part 243 holding part 244 head 245 tubular groove 246, 247 tubular extension 248, 249 rod part 250 body 251 body bore 252, 253 bore 254 suture thread 255 catheter 256, 258 side hole 259 knot 260, 261, 263 Suture 265 Opposite rim access guide system 266 Mooring loop 267 Side hole 268 Outer sheath 269 Head orifice 270 Push head C 271 Stent pushing device 272 Push shaft 273 Push shaft 274 Head 275 Tail stent 284 Bifurcated lumen 285 Arterial lumen 286, 287 Bowel lumen 301 Main spring assembly 302, 303 Rim spring assembly 304, 305 Stent boot 306 307, 308 Suture 309 Carrier shaft tubular recess 310 Suture 311 Axial lumen 312, 313 Spline 314, 315, 316 Suture 318 Outer catheter 319 Inner catheter 320, 321 Opening 322 Connector sleeve 350 Organ implant device 351 Retaining assembly 352 Elongate member 353 Expansion head 354 Connector sleeve 355, 356 Side opening 357, 358 Connecting suture 360 Carrier shaft area 380 381 lock hook 382 and 383 lock hook 388,389 engagement portion

────────────────────────────────────────────────── (5) Reference US Pat. No. 4,140,126 (US, A) US Pat. No. 4,562,596 (US, A) European Patent Application Publication No. 472731 (EP, A1) (58) Fields Inquired (Int. Cl. ⁷ , DB name) A61B 17/00 320 A61F 2/02

Claims (13)

(57) [Claims] 1. An apparatus for placing a prosthesis assembly of a predetermined shape and size on an inner wall of a patient's organ, said prosthesis assembly comprising a spring assembly (6, 1).
2, 31) having a graft (1), said spring assembly having an arm (15) and folding
To form an elbow (7) and have a tip (13)
A projection (10) is adhered to the arm,
And the spring assembly is at the distal end or both ends of the graft.
Wherein the inner wall is sutured with thread (36), the device comprising: an introducer sheath (4) surrounding the prosthesis assembly when the prosthesis assembly is in place; and an introducer sheath (4). Means (36, 21, 26) for holding said prosthesis assembly in place while the garment is removed
And wherein the holding means comprises a connection device (3) temporarily connected to the prosthesis assembly at a location remote from the prosthesis assembly.
6) A device for placing a prosthesis in a patient's organ, which is connected to 6). 2. The holding means includes an elongated member (21) extending into the assembly, and the connecting device (36) includes a predetermined spacing between the elongated member (21) and the prosthesis assembly. 2. The device of claim 1, wherein the device extends to a designated location. 3. The elongated member (21) is tubular and has an expansion head (22) at its distal end, the expansion head being connected to the connecting device (3) into the organ.
3. The device according to claim 2, wherein the insertion of step (6) is facilitated. 4. The prosthesis assembly is in a compressed state when the prosthesis assembly is within the sheath.
The device of claim 26, further comprising a retracting device (36, 21) for temporarily pulling and a disabling device (26) for expanding and releasing the prosthesis assembly during or after removal of the sheath. The device of 3. 5. The retraction device (36, 21) and the disabling device (26) form a part of the connection device (36), the part being disposed in an elongated member, 4. The apparatus of claim 3, wherein the apparatus is controlled from: 6. The connecting device (36) has one end connected to the prosthesis assembly and the other end connected to the inside of the elongated member through an opening (29, 101).
6. The apparatus of claim 5, including a connector that is 6), wherein the disabling device releases the thread from within the elongate member. 7. The bifurcated organ for accommodating the graft, the graft having a common body (250) and two bifurcated portions (213, 210), wherein the spring assembly comprises: Another spring assembly is associated with the common body of the graft and one of the bifurcations (213),
7. The method according to claim 1, wherein the first and second arrangements are arranged within 0).
Equipment. 8. The device according to claim 7, wherein an identification marker is provided on at least the other of said forked parts. 9. Apparatus according to claim 7, wherein the other of the bifurcated parts comprises a device which is drawn to a position within the respective organ. 10. Apparatus according to claim 1, wherein the spring assembly or graft has a jaw at its distal end. 11. One end of the graft is provided with a seal (8).
7. Apparatus according to claim 1, wherein 0) is performed. 12. An organ transplantation device for positioning a prosthesis assembly in a predetermined position within a bifurcated lumen, the bifurcated lumen having a main lumen, and first and second lumens branching from and communicating with the main lumen. The prosthesis assembly includes a bifurcated graft having a main body and first and second rims extending therefrom, the main body extending axially therethrough and having a main bore having a head orifice. Wherein the first rim extends axially therethrough and communicates with the main bore and has a first tail orifice; the second rim extends axially therethrough and A second tail orifice communicating with the prosthesis assembly, the prosthesis assembly including a main spring assembly having a compressed state and a first spring assembly, wherein the main spring assembly includes a bifurcated prosthesis assembly. Inside the lumen When the main spring assembly is released from the compressed state, the main body is radially expanded to fit the main body to the inner wall of the main lumen, and the first spring assembly includes the prosthesis. When the assembly is positioned in place within the bifurcated lumen and the first spring assembly is released from compression, the first rim is radially expanded to extend the first rim to the inner wall of the main lumen. Wherein the organ transplant device comprises: main container means for storing the main spring assembly in a compressed state; first container means for storing the first spring assembly in a compressed state; and a main bore and a second bore in the graft. Holding means for holding the prosthesis assembly in place in the bifurcated lumen disposed within one bore, wherein the main container means pulls away from the prosthesis assembly. Once unplugged, organ transplantation apparatus characterized by releasing the spring assembly from a compressed state. 13. An organ transplant apparatus for positioning a prosthesis assembly in a predetermined position within a bifurcated lumen, the bifurcated lumen having a main lumen and first and second lumens branching off and communicating with the main lumen. The prosthesis assembly includes a bifurcated graft having a main body and first and second rims extending therefrom, the main body extending axially therethrough and having a main bore having a head orifice. Wherein the first rim extends axially therethrough and communicates with the main bore and has a first tail orifice; the second rim extends axially therethrough and The prosthesis assembly includes a main spring assembly having a compressed state, a first spring assembly, and a second spring assembly, wherein the prosthesis assembly has a second tail orifice. Prosthesis When the body is positioned at a predetermined position within the bifurcated lumen and the main spring assembly is released from the compressed state, the main body is radially expanded to fit the main body to the inner wall of the main lumen; A spring assembly is disposed at a predetermined position within the bifurcated lumen, and when the first spring assembly is released from compression, the first rim is radially expanded to extend the first rim. A rim adapted to the inner wall of the main lumen, wherein the second spring assembly is positioned when the prosthesis assembly is in place in the bifurcated lumen and the second spring assembly is released from compression. Radially expanding the second rim to conform the second rim to the inner wall of the main lumen, the organ transplant device comprising: main container means for storing the main spring assembly in a compressed state; First container means for accommodating the first spring assembly in a contracted state; second container means for accommodating the second spring assembly in a compressed state; and disposed in a main bore and a first bore of the graft. Main holding means for holding the prosthesis assembly in a predetermined position of the bifurcated lumen; and holding the first spring assembly temporarily connected to the first spring assembly in the first container means. A first holding means, and a second holding means temporarily connected to the second spring assembly for holding the second spring assembly in the second container means, wherein the main container means The organ transplant device releases the spring assembly from a compressed state when pulled out of the prosthesis assembly.