CN110974484A - Endovascular repair device for optimizing branch blood flow distribution - Google Patents
Endovascular repair device for optimizing branch blood flow distribution Download PDFInfo
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- 208000001750 Endoleak Diseases 0.000 abstract description 4
- 206010064396 Stent-graft endoleak Diseases 0.000 abstract description 3
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- 230000002792 vascular Effects 0.000 description 6
- 238000001356 surgical procedure Methods 0.000 description 5
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
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Abstract
本发明提供一种优化分支血流分布的腔内修复装置，包括髂总支架移植物、髂内支架移植物；髂总支架移植物包括髂总支架近端和髂总支架远端、中部开口；髂内支架移植物还包括髂内支架移植物材料和一个或多个髂内支架环；髂内支架移植物是管状构件，包括髂内支架近端、髂内支架远端；髂内支架移植物材料限定有髂内支架移植物腔体，髂内支架移植物的髂内支架近端配装在髂总支架移植物的中部开口内。本发明提出的支架移植物整体性更强，能有效降低因支架缝合不当引起内漏的风险，而内部缝合的移植物或隔膜均能保证髂内髂外正常的血液分流。
The invention provides an endoluminal repair device for optimizing branch blood flow distribution, comprising a common iliac stent graft and an iliac internal stent graft; the common iliac stent graft comprises a proximal end of a common iliac stent and a distal end and an opening in the middle of the common iliac stent; The iliac internal stent graft also includes the iliac internal stent graft material and one or more iliac internal stent rings; the iliac internal stent graft is a tubular member, including the iliac internal stent proximal end and the iliac internal stent distal end; the iliac internal stent graft The material defines an iliac internal stent-graft cavity, and the iliac internal stent proximal end of the iliac internal stent-graft fits within the central opening of the common iliac stent-graft. The stent graft proposed by the invention has stronger integrity, can effectively reduce the risk of endoleak caused by improper stent suturing, and the internally stitched graft or diaphragm can ensure normal blood shunting inside the iliac and outside the iliac.
Description
Technical Field
The invention relates to an intracavity repair device for optimizing the distribution of branch blood flow, and belongs to the technical field of biomedical engineering.
Background
The aneurysm is rare in clinic when it involves iliac artery, and with the increase of the body, it may be manifested as distending pain of lower abdomen, soreness and discomfort of waist and back or lower limbs, frequent micturition, urgent micturition and hematuria, and the lower abdomen is rarely with pulsive lump. The tumor body is easy to crack, and once the tumor body is cracked, the death rate is up to 15% -70%. Such diseases cannot be cured by conservative treatment, and surgical treatment thereof includes traditional open surgery and intraluminal repair therapy. Compared with the traditional open surgery, the intracavitary repair surgery treatment has the advantages of small surgical trauma, less bleeding during the surgery, quick postoperative recovery, low occurrence rate of perioperative systemic complications and low mortality, and the like. However, endoluminal treatments present themselves with stent-related complications, particularly endoleaks, which occur in relation to the aneurysm itself, anatomical conditions, graft defects and operative techniques.
In the treatment of aneurysms involving the iliac arteries, three stent grafts are typically required in one iliac artery when treated with a stent graft.
Chinese patent No. CN201780023253.2, publication No. CN109069262A, proposes an iliac bifurcation device, which includes an iliac septal limb, configured to be deployed within the common iliac artery. The iliac septal limb includes a graft material, a proximal end, and a septum. The graft material defines a total iliac cavity extending between the proximal end and the septum, the graft material and the septum defining an internal iliac cavity and an external iliac cavity. The iliac branch device includes multiple adjustable modes and has a relatively small cross-sectional area, enabling the iliac branch device to be used to treat relatively small iliac aneurysms in the short common iliac artery. This enables the iliac aneurysm to be treated at a very early stage of the disease. However, the above invention has drawbacks: (1) the bracket assemblies are more, the integrity is not strong, and internal leakage can be caused by improper sewing among the brackets; (2) the support structure is complicated, the conveying is difficult, and the requirement on the operation level of a doctor is high.
Chinese patent No. CN201420764502.7, utility model patent with publication No. CN204364174U proposes an iliac artery collateral blood vessel stent, including with the main vessel stent of iliac artery blood vessel looks adaptation, be equipped with the collateral blood vessel stent with iliac artery branch blood vessel looks adaptation on this main vessel stent, collateral blood vessel stent is located one side that is provided with vertical supporting beam of main vessel stent to both communicate through flexible connection. By adopting the structure, the iliac artery side branch type blood vessel stent can be better matched with iliac artery blood vessels and branch blood vessels thereof, and the adaptability of the blood vessel stent and different patients can be improved. However, the main vessel stent and the side vessel stent are connected in a different manner from the actual iliac branch, which may affect the blood diversion inside and outside the iliac.
The invention patent of US7846194B2 proposes an iliac artery side branch type stent and a delivery method thereof. Biocompatible graft material is used for both the tubular body and the side branches. A sawtooth-shaped bracket is fixed at the far end of the tubular main body and the far end of the side branch, and a reinforcing ring is sewed at the splicing part. The small zigzag stent is sutured at the near end or the far end of the stent, so that the individual requirements of different distances between the aortic branch and the iliac branch of different patients can be met. But the angle of the connection part of the main body of the bracket and the side branch is fixed, which affects the blood shunting inside and outside the ilium. The small zigzag support is additionally arranged, so that the integrity of the support is influenced, and the risk of internal leakage is increased.
The invention patent of US9408689B2 proposes an iliac artery stent. The bracket is substantially in the shape of an inverted Y. May be roughly divided into three arms, each arm being constructed of a tubular biocompatible graft material, the three arms being joined together at an angle of about 120 degrees. In use, a first arm extends within the common iliac artery to the external iliac artery, a second arm extends within the common iliac artery to the iliac bifurcation, and a third arm extends within the common iliac artery to the internal iliac artery. The support has stronger integrity, and effectively reduces the risk of internal leakage; however, due to the fixed angles of the first arm and the third arm, the requirements of different patients cannot be met, the bifurcation of the internal iliac artery and the external iliac artery is easy to be empty, and the stent is pressed from the outside after blood is filled, so that the flow of blood in the stent is influenced.
Disclosure of Invention
In view of the above technical problems, the present invention provides an intraluminal repair device that optimizes the distribution of branch blood flow, reducing the risk of endoleak due to improper stent suturing.
The specific technical scheme is as follows:
an intracavity repair device for optimizing the distribution of branch blood flow, which comprises an ilium total stent graft and an ilium internal stent graft;
the common iliac stent graft is deployed in the common iliac artery, and the common iliac stent graft has two types, one comprises a stent ring, a graft material and a septum; another includes stent rings, graft materials, and endoleak grafts.
These two types are explained below separately.
The first structure is as follows:
the iliac main stent graft comprises an iliac main stent near end, an iliac main stent far end and a middle opening; the proximal end of the common iliac stent comprises a common iliac proximal opening, and the distal end of the common iliac stent comprises a common iliac distal opening;
the ilium total stent graft comprises a plurality of ilium total stent rings and ilium total stent graft materials, and a graft is sewed in the ilium total stent graft. The iliac total stent graft material defines an iliac total lumen.
The common iliac stent ring is attached to the common iliac stent graft material. The ilium general stent ring is a self-expanding structure.
The internal iliac stent graft includes an internal iliac stent graft material and one or more internal iliac stent rings. The internal iliac stent graft is a tubular member and comprises an internal iliac stent proximal end and an internal iliac stent distal end; an internal iliac proximal opening is formed in the internal iliac stent proximal end, and an internal iliac distal opening is formed in the internal iliac stent distal end;
the internal iliac stent graft material defines an internal iliac stent graft lumen extending between an internal iliac proximal opening and an internal iliac distal opening;
the proximal end of the internal iliac stent graft is fitted in the middle opening of the main iliac stent graft; the diameter of the internal iliac stent graft is sized to match the diameter of the central opening of the total iliac stent graft.
The endoluminal suture graft includes an endoluminal suture graft material and one or more endoluminal suture stent loops. The inner suture graft is a tubular member comprising an inner suture stent proximal end having an inner suture proximal end opening therein and an inner suture stent distal end having an inner suture distal end opening therein; the internally sutured graft material defines an internally sutured graft lumen extending between an internally sutured proximal opening and an internally sutured distal opening.
The main iliac cavity is divided into an inner suture graft cavity and an outer iliac cavity by a main iliac stent graft material.
The distal end of the inner suture graft fits at the central opening of the iliac total stent graft. The internal suture graft cavity is communicated with the internal iliac stent graft cavity through the middle opening.
The second structure is as follows:
the iliac main stent graft comprises an iliac main stent near end, an iliac main stent far end and a middle opening; the proximal end of the common iliac bracket comprises a proximal common iliac opening, and the distal end of the common iliac bracket comprises a distal common iliac opening.
The common iliac stent graft includes one or more common iliac stent rings, a common iliac stent graft material, and a septum.
The iliac total stent graft material defines an iliac total lumen. The common iliac stent ring is attached to the common iliac stent graft material. The ilium general stent ring is a self-expanding structure. The internal iliac stent graft material defines an internal iliac stent graft lumen extending between an internal iliac proximal opening and an internal iliac distal opening.
The proximal end of the iliac stent graft fits within the medial opening of the iliac main stent graft. The diameter of the internal iliac stent graft is sized to match the diameter D of the central opening of the total iliac stent graft.
The septum is a wall or partition that separates the internal and external iliac cavities. Cylindrical common iliac stent graft material is attached together by attachment structures to form a septum
The intracavity repair device for optimizing the distribution of branch blood flow provided by the invention omits a separate external iliac stent graft, and realizes internal and external iliac shunt by windowing at the designated position of the total iliac stent graft and matching with an internal suture graft or using a diaphragm. The stent graft provided by the invention has stronger integrity, can effectively reduce the risk of internal leakage caused by improper stent suture, and the graft or the septum sutured inside can ensure normal blood shunting outside the internal ilium and the external ilium.
Drawings
FIG. 1 is an exploded perspective view of the apparatus of example 1.
FIG. 2 is an exploded perspective view of the apparatus of example 2.
Fig. 3 is a cross-sectional view of the common iliac stent graft shown in fig. 1.
Fig. 4 is a cross-sectional view of the common iliac stent graft shown in fig. 2.
Fig. 5 is a partial cross-sectional view of a vascular assembly including a common iliac stent graft of the device of fig. 1.
Fig. 6 is a partial cross-sectional view of the vascular assembly of fig. 5 in a subsequent stage of deployment of the device of fig. 1.
Fig. 7 is a partial cross-sectional view of a vascular assembly including the intraluminal repair device of fig. 1.
Fig. 8 is a partial cross-sectional view of a vascular assembly including the intraluminal repair device of fig. 2.
Detailed Description
The specific technical scheme of the invention is described by combining the embodiment.
Example 1
As shown in fig. 1, 3, the endoluminal repair device 10 includes a common iliac stent graft 12, an internal iliac stent graft 14, and an internal suture graft 16.
The proximal end of the prosthesis, such as the iliac total stent graft 12, is the end closest to the heart through the blood flow path, while the distal end of the prosthesis is the end furthest from the heart during deployment. In contrast, the distal end of the catheter is typically the end identified as being furthest away from the operator (handle), while the proximal end of the catheter is the end closest to the operator (handle).
The common iliac stent graft 12 includes a plurality of common iliac stent loops 51 and a common iliac stent graft material 52. A common iliac proximal opening 54 is included at the common iliac stent proximal end 53 of the common iliac stent graft 12. A total iliac distal opening 56 is also included at the total iliac stent distal end 55 of the total iliac stent graft 12. The common iliac stent graft 12 includes a central opening 57. The iliac trunk stent graft material 52 defines an iliac trunk lumen 58.
The common iliac stent loop 51 is attached to the common iliac stent graft material 52. The common iliac stent ring 51 is a self-expanding structure and may be formed from a variety of materials and/or combinations of materials. For example, nitinol (NiTi) is used as the material of the iliac total stent ring 51. Other materials such as stainless steel, polymeric materials, polyamides, polyesters, polyimides, bioabsorbable polymers, cobalt, chromium, nickel alloys or any other suitable material may use biocompatible materials and combinations thereof as the material for the common iliac stent ring 51. The iliac trunk 51 is generally deformable, fatigue resistant, resilient and expandable so that the iliac trunk 51 can conform to the morphology of the surrounding tissue in the surrounding tissue. The common iliac stent graft 12 is deployed in the lumen.
The internal iliac stent graft 14 includes an internal iliac stent graft material 72 and one or more internal iliac stent rings 74. The internal iliac stent graft 14 is a tubular member that includes an internal iliac stent proximal end 60 having an internal iliac proximal opening 62 in the internal iliac stent proximal end 60. The internal iliac stent graft 14 also includes an internal iliac stent distal end 64 with an internal iliac distal opening 66 in the internal iliac stent distal end 64. The internal iliac stent graft material 72 defines an internal iliac stent graft lumen 76, the internal iliac stent graft lumen 76 extending between the internal iliac proximal opening 62 and the internal iliac distal opening 66.
The internal iliac stent proximal end 60 of internal iliac stent graft 14 is configured to fit within the medial opening 57 of total iliac stent graft 12. The diameter of the internal iliac stent graft 14 is sized to match the diameter D1 of the central opening 57 of the total iliac stent graft 12.
The inner suture graft 16 includes an inner suture graft material 92 and one or more inner suture stent loops 94. The inner suture graft 16 is a tubular member that includes an inner suture stent proximal end 80 having an inner suture proximal opening 82 within the inner suture stent proximal end 80. The inner suture graft 16 also includes an inner suture stent distal end 84 having an inner suture distal end opening 86 within the inner suture stent distal end 84. The internally sutured graft material 92 defines an internally sutured graft lumen 96, the internally sutured graft lumen 96 extending between the internally sutured proximal opening 82 and the internally sutured distal opening 86.
The iliac trunk lumen 58 is divided by the iliac trunk stent graft material 52 into an inner suture graft lumen 96 and an iliac external lumen 98.
The inner suture graft distal end 84 of the inner suture graft 16 is configured to fit at the central opening 57 of the common iliac stent graft 12. The internal suture graft lumen 96 communicates with the internal iliac stent graft lumen 76 through the central opening 57.
The iliac total stent graft material 52, the iliac inner stent graft material 72, and the internal suture graft material 92 are impermeable materials, such as expanded polyterephthalate (ePE) or other impermeable graft materials, such as, but not limited to, silicone, urethane, polyester, and combinations thereof. Blood and other fluids do not pass through the graft material.
The internal suture graft 16 is sutured to the lumen of the common iliac stent graft 12 and the internal suture graft lumen 96 communicates with the internal iliac stent graft lumen 76 through the central opening 57 of the common iliac stent graft 12.
Fig. 5 is a partial cross-sectional view of a vascular assembly 200 including a common iliac stent graft 12 of the endoluminal repair device 10. The vascular assembly 200 includes a common iliac artery 204, an internal iliac artery 208, and an external iliac artery 212. The common iliac artery 204 descends into a common iliac bifurcation 216 from which common iliac bifurcation 216 extends internal iliac artery 208 and external iliac artery 212. Wherein the common iliac artery 204 includes an aneurysm 220.
The common iliac stent graft 12 is deployed within the common iliac artery 204. Prior to introduction of the common iliac stent graft 12, a guidewire 224 is placed through the femoral artery through the incision in the femur. After deployment of the common iliac stent graft 12, the main body is inside the common iliac artery 204 and external iliac artery 212, with the central opening 57 near the common iliac bifurcation 216.
A second guidewire 228 is introduced through the respective femoral artery, through the central opening 57 into the inner suture graft cavity 96, and out the proximal opening 82.
As in fig. 6, the internal iliac stent graft 14 is advanced over the second guidewire 228 and into the internal iliac artery 208. The internal iliac stent ring 74 of the internal iliac stent graft 14 is released to self-expand into the medial opening 57 of the total iliac stent graft 12. This secures the internal iliac stent graft 14 to the common iliac stent graft 12 and to healthy tissue within the internal iliac artery 208.
Fig. 7 shows a schematic view of the implantation of the endoluminal repair device 10 with the guidewire removed.
Example 2
As shown in fig. 2 and 4, the endoluminal repair device 20 includes a main iliac stent graft 112 and an internal iliac stent graft 114.
The common iliac stent graft 112 includes one or more common iliac stent rings 150, a common iliac stent graft material 152, and a septum 154. A total iliac proximal opening 122 is included at the proximal iliac stent end 120 of the total iliac stent graft 112. A main iliac distal opening 126 is included at the main iliac stent distal end 124 of the main iliac stent graft 112. The common iliac stent graft 112 includes a central opening 128. The iliac trunk stent graft material 152 defines an iliac trunk lumen 158.
The common iliac stent ring 150 is attached to a common iliac stent graft material 152. The common iliac stent ring 150 is a self-expanding structure, and, illustratively, nitinol (NiTi) is used as the material of the common iliac stent ring 150. Other materials such as stainless steel, polymeric materials, polyamides, polyesters, polyimides, bioabsorbable polymers, cobalt, chromium, nickel alloys or any other suitable material may use biocompatible materials and combinations thereof as the material for the common iliac stent ring 150. The iliac total stent ring 150 is generally deformable, fatigue resistant, resilient and expandable so that the iliac total stent ring 150 can conform to the morphology of the surrounding tissue in the surrounding tissue. The common iliac stent graft 112 is deployed in the lumen.
The internal iliac stent graft 114 includes an internal iliac stent graft material 172 and one or more internal iliac stent rings 174. The internal iliac stent graft 114 is a tubular member that includes an internal iliac stent proximal end 160 with an internal iliac proximal opening 162 in the internal iliac stent proximal end 160. The internal iliac stent graft 114 also includes an internal iliac stent distal end 164 having an internal iliac distal opening 166 in the internal iliac stent distal end 164. The internal iliac stent graft material 172 defines an internal iliac stent graft lumen 176, the internal iliac stent graft lumen 176 extending between the internal iliac proximal opening 162 and the internal iliac distal opening 166.
The internal iliac stent proximal end 160 of internal iliac stent graft 114 is configured to fit within the medial opening 128 of total iliac stent graft 112. The diameter of the internal iliac stent graft 114 is sized to match the diameter D2 of the central opening 128 of the total iliac stent graft 112.
The iliac total stent graft material 152, the iliac inner stent graft material 172, and the septum 154 are impermeable materials, such as expanded polyterephthalate (ePE) or other impermeable graft materials, such as, but not limited to, silicone, urethane, polyester, and combinations thereof. Blood and other fluids do not pass through the graft material. The septum 154 is a wall or partition that separates the internal iliac cavity 142 from the external iliac cavity 144. The septum 154 is formed by attaching cylindrical iliac total stent graft material 152 together by the attachment structure 146.
The method of implantation of the endoluminal repair device 20 is the same as the method of implantation of the endoluminal repair device 10 of example 1.
Fig. 8 shows a schematic view of the implantation of the endoluminal repair device 20 with the guidewire removed.
Claims (8)
1. An intracavity repair device for optimizing the distribution of branch blood flow is characterized by comprising an iliac general stent graft and an iliac internal stent graft;
the iliac main support graft comprises an iliac main support near end, an iliac main support far end and a middle opening; the proximal end of the common iliac stent comprises a common iliac proximal opening, and the distal end of the common iliac stent comprises a common iliac distal opening;
the internal iliac stent graft further comprises an internal iliac stent graft material and one or more internal iliac stent rings; the internal iliac stent graft is a tubular member and comprises an internal iliac stent proximal end and an internal iliac stent distal end; an internal iliac proximal opening is formed in the internal iliac stent proximal end, and an internal iliac distal opening is formed in the internal iliac stent distal end;
the internal iliac stent graft material defines an internal iliac stent graft lumen extending between an internal iliac proximal opening and an internal iliac distal opening;
the proximal end of the internal iliac stent graft is assembled in the middle opening of the main iliac stent graft; the diameter of the internal iliac stent graft is sized to match the diameter of the central opening of the total iliac stent graft.
2. The endoluminal repair device according to claim 1, wherein said common iliac stent graft comprises a plurality of common iliac stent rings, a common iliac stent graft material, and further comprising an internal suture graft.
3. The branched blood flow optimized endoluminal repair device according to claim 2, wherein said common iliac stent graft material defines a common iliac lumen; the common iliac stent ring is attached to the common iliac stent graft material; the ilium general stent ring is a self-expanding structure.
4. The branched blood flow distribution optimized endoluminal repair device according to claim 2 or 3, wherein said endoluminal graft comprises an endoluminal graft material and one or more endoluminal graft loops;
the inner suture graft is a tubular member comprising an inner suture stent proximal end and an inner suture stent distal end, the inner suture stent proximal end having an inner suture proximal end opening therein and the inner suture stent distal end having an inner suture distal end opening therein; the internally sutured graft material defines an internally sutured graft lumen extending between an internally sutured proximal opening and an internally sutured distal opening;
the main iliac cavity is divided into an inner suture graft cavity and an external iliac cavity by a main iliac stent graft material;
the distal end of the internal suture graft is assembled at the middle opening of the iliac main stent graft; the internal suture graft cavity is communicated with the internal iliac stent graft cavity through the middle opening.
5. The endoluminal repair device according to claim 1, wherein the common iliac stent graft comprises one or more of a common iliac stent ring, a common iliac stent graft material, and a septum.
6. The branched blood flow optimized endoluminal repair device according to claim 5, wherein said common iliac stent graft material defines a common iliac lumen; the common iliac stent ring is attached to the common iliac stent graft material; the ilium general stent ring is a self-expanding structure.
7. The endoluminal repair device for optimizing the distribution of branched blood flow according to claim 5 or 6, wherein the septum is a wall or partition separating the iliac and external iliac cavities.
8. The branched blood flow distribution optimizing endoluminal repair device according to claim 7, wherein said membrane is formed of a common iliac stent graft material attached together by attachment structures.
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Application publication date: 20200410 |