Occlusion device for vascular surgery

• US 9,332,975 B2
• Filed: 08/13/2009
• Issued: 05/10/2016
• Est. Priority Date: 08/13/2008
• Status: Active Grant

• Current Assignee: GEM SRL
• Original Assignee: Andrea Del Corso
• Inventors: Del Corso, Andrea
• Primary Examiner(s): Rozanski, Michael
• Application Number:
  US13/058,870
• Publication Number:
  US 20110178399A1
• Time in Patent Office: 2,462 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive

Abstract

An occlusion device for vascular surgery, suitable for clogging treatments of vascular entry sites and for endovascular interventions such as embolizations of blood vessels, treatment of arteriovenous malformations or small aneurysms, arterial dissections and the like, by releasing in an operation region a quick setting surgical glue or haemostatic fluid, through an outlet mouth of a duct. The device prevents the surgical glue from contacting within the duct a patient'"'"'s biological fluids, in particular blood, which would close the duct. In the case of clogging treatments of vascular entry sites, a backflow preventing device may be provided, preferably provided by a coupling device between the duct and an introducer sheath by which an outlet mouth is kept in contact to keep in a one-way fluid tight contact against the outer surface of the introducer sheath until an injection pressure P2 is applied to cause release of the surgical glue.

Claims

1. A surgical glue-releasing device for closing a blood passage of a blood vessel in an operation region in a patient'"'"'s body, wherein said operation region is located just before said blood passage, the device comprising an injection duct that has an inlet port and an outlet mouth arranged for releasing a surgical glue at said operation region, said injection duct being arranged to move through a biological medium in the patient'"'"'s body from an opening on a skin plane of said patient to said operation region in such a way that, once said operation region has been reached by said injection duct, said outlet mouth is in said operation region and said inlet port remains outside of said opening on said skin plane, said inlet port is configured to be hydraulically connected with a source of said surgical glue and with a piston that can be operated by an operator for applying an injection pressure on said surgical glue and for causing:

flow of said surgical glue through said injection duct, and

a release of said surgical glue at said operation region through said outlet mouth,

wherein said outlet mouth is arranged against an outer surface of an introducer sheath, and said outlet mouth is configured to detach from said introducer sheath only when said piston is operated, in such a way to provide a one-way fluid tight contact against said outer surface of said introducer sheath and to impede a material of said biological medium from penetrating into said injection duct, thus preventing in said injection duct said surgical glue from contacting said biological medium before said surgical glue is released at said operation region through said outlet mouth.

2. A device according to claim 1, wherein said injection duct is arranged to be slidably coupled with said introducer sheath by a slide portion of said injection duct that is associated with a driving portion of said introducer sheath.

3. A device according to claim 1, wherein a short tube is provided that is arranged integrally with said duct and arranged to be coaxially coupled with said introducer sheath.

4. A device according to claim 3, wherein said outlet mouth and said short tube are such that said surgical glue is released in an annular narrow space that is defined between said short tube and said introducer sheath, such that said surgical glue reaches said operation region through said annular narrow space.

5. A device according to claim 4, comprising a seal ring at a rear end of said short tube, said rear end arranged, in use, proximate to said skin plane, said seal ring being suitable for preventing the surgical glue from leaking through a corresponding rear end of said narrow space, said seal ring comprising, in particular, a sealing ring that is arranged inside said narrow space.

6. A device according to claim 3, wherein said short tube has a cut from a front end of said short tube, said front end oriented in use towards said operation region, to a rear end of said short tube, such that by closely aligning and reciprocally compressing said short tube and said introducer sheath, said short tube forms a snap fit with said introducer sheath and a sliding coupling is obtained between said short tube and said introducer sheath.

7. A device according to claim 1, wherein an abutment is provided for blocking a movement of said injection duct with respect to said introducer sheath.

8. A device according to claim 7, wherein said abutment is integral to said injection duct at a distance from said outlet mouth such that said outlet mouth is located at said distance from said skin plane when said abutment abuts against said skin plane.

9. A device according to claim 7, wherein said abutment is arranged to abut against a wall of said blood vessel at an entry site, and said outlet mouth is arranged at a predetermined distance from said abutment, in order to make an operator aware that said outlet mouth of said injection duct is ready for releasing said surgical glue proximate to said entry site.

10. A surgical glue-releasing device for closing a blood passage of a blood vessel in an operation region in a patient'"'"'s body, wherein said operation region is located just before said blood passage, the device comprising an injection duct that has an inlet port and an outlet mouth which is arranged for releasing a surgical glue of quick-setting type at said operation region, said injection duct arranged to move through a biological medium in the patient'"'"'s body from an opening on a skin plane of said patient to said operation region in such a way that, once said operation region has been reached by said duct, said outlet mouth is in said operation region and said inlet port remains outside of said opening on said skin plane, said inlet port configured to be hydraulically connected with a source of said surgical glue and with a piston that can be operated by an operator for applying an injection pressure on said surgical glue and for causing:

a flow of said surgical glue through said injection duct, and

a release of said surgical glue at said operation region through said outlet mouth,

wherein a check valve is arranged at said outlet mouth, said check valve comprising a fixed part that is fixed with respect to said injection duct and a movable part that is movable with respect to said fixed part, wherein, when said piston is operated, said movable part is configured to change its position from;

a closed position, in which said release of surgical glue is hindered, to

an open position, in which said injection pressure causes said release of surgical glue at said operation region, in order to impede in said injection duct said surgical glue from contacting said biological medium before said surgical glue is released at said operation region through said outlet mouth, and to prevent a material of said biological medium from penetrating into said injection duct.

11. A device according to claim 10, wherein said injection duct is arranged to be coupled with an elongated introducer sheath that can extend between said opening on said skin plane and a vascular entry site, said introducer sheath having an outer surface, and is adapted to be engaged with said outer surface of said introducer sheath.

12. A device according to claim 11, wherein said injection duct is arranged to be slidably coupled with said introducer sheath by a slide portion of said injection duct that is associated with a driving portion of said introducer sheath.

13. A device according to claim 11, wherein a short tube is provided that is arranged integral to said duct and is arranged to be coaxially coupled with said elongated introducer sheath.

14. A surgical glue-releasing device for closing a blood passage of a blood vessel in an operation region in a patient'"'"'s body, wherein said operation region is located just before said blood passage, the device comprising an injection duct that has an inlet port and an outlet mouth which is arranged for releasing a surgical glue at said operation region, said injection duct arranged to move through a biological medium in the patient'"'"'s body from an opening on a skin plane of said patient to said operation region in such a way that, once said operation region has been reached by said duct, said outlet mouth is in said operation region and said inlet port remains outside of said opening on said skin plane, said inlet port configured to be hydraulically connected with a source of said surgical glue and with a piston that can be operated by an operator for applying an injection pressure on said surgical glue and for causing:

a flow of said surgical glue through said injection duct, and

a release of said surgical glue at said operation region through said outlet mouth,

wherein said injection duct is configured for retaining a barrier liquid,

wherein an outflow actuator is provided that can be operated by said operator for causing an outflow of said barrier liquid through said injection duct, in such a way that;

said barrier liquid interposes between said surgical glue and said outlet mouth, and

by operating said outflow actuator and said piston, said barrier liquid flows out of said outlet mouth before said surgical glue is released at said outlet mouth, in such a way that said surgical glue is substantially undiluted when it is released at said operation region, in order to impede in said injection duct said surgical glue from contacting said biological medium before said surgical glue is released at said operation region through said outlet mouth.

15. A device according to claim 14, comprising a container for said barrier liquid, said container selected from the group consisting of:

a portion of said injection duct; and

a receptacle that in use is hydraulically connected to said injection duct.

16. A device according to claim 15, wherein said container contains said barrier liquid selected from the group consisting of:

a saline solution;

a glucose solution;

distilled water; and

a liquid contrast agent.

17. A device according to claim 15, wherein a seal is provided for isolating said barrier liquid in said container, wherein said seal can be removed or broken by at least one action selected from the group consisting of:

operating said outflow actuator;

operating said piston; and

connecting said injection duct with said container of said barrier liquid.

18. A device according to claim 15, comprising a double syringe which comprises:

an internal syringe that comprises said piston that one-way fluid-tightly slides inside a first cylinder, said first cylinder having a base with a portion that comprises a frangible seal and is opposite to said piston;

an external syringe that comprises a second cylinder and said internal syringe that one-way fluid tightly slides in said second cylinder, said second cylinder having a base that is opposite to said internal syringe with a tail portion, said tail portion having an outlet hole, and a tip member that is oriented towards the inside of said second cylinder and is arranged to break said frangible seal when said base of said first cylinder approaches said base of said second cylinder,

wherein said internal syringe provides said receptacle for said surgical glue,

wherein said external syringe provides said receptacle for said barrier liquid and said outflow actuator which can be operated independently from said piston,

wherein locking teeth integral to said internal syringe are arranged to engage with respective locking teeth integral to said second cylinder, so as to mechanically lock said internal syringe at a final position within said second cylinder,

wherein a protrusion is provided fixed inside said first cylinder arranged to abut against a portion of said piston, so as to lock said piston at a predetermined starting position within said first cylinder, and

wherein a cap is provided which is releasably connected with said first cylinder for avoiding accidental operation of said piston.

19. A device according to claim 14, wherein said outflow actuator is arranged to be operated independently from said piston.

20. A device according to claim 19, wherein a seal is arranged for avoiding accidental operation of said piston before said outflow of said barrier liquid.

21. A device according to claim 14, wherein said injection duct is arranged to be coupled with an elongated introducer sheath that can extend between said opening on said skin plane and a vascular entry site, said introducer sheath having an outer surface, and is adapted to be engaged with said outer surface of said introducer sheath.

22. A device according to claim 21, wherein said injection duct is arranged to be slidably coupled with said introducer sheath by a slide portion of said injection duct that is associated with a driving portion of said introducer sheath.

23. A device according to claim 21, wherein a short tube is provided that is arranged integral to said duct and is arranged to be coaxially coupled with said elongated introducer sheath.