IMPLANT DELIVERY SYSTEM

• US 20150223955A1
• Filed: 09/22/2013
• Published: 08/13/2015
• Est. Priority Date: 09/21/2012
• Status: Active Grant

• Current Assignee: Shanghai Microport Cardioflow Medtech Co., Ltd. (MicroPort Scientific Corp.)
• Original Assignee: Shanghai MicroPort Medical (Group) Co., Ltd. (MicroPort Scientific Corp.)
• Inventors: Li, Yu, Liu, Xiang, Wu, Mingming, Wang, Haishan, Chen, Guoming, Chen, Shaohui
• Granted Patent: US 9,889,029 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9623 the sleeve being reinforced
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61M 2205/0216 Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 3/02 Enemata; Irrigators
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014

Abstract

An implant delivery system is disclosed which includes an inner tube assembly, an outer tube assembly and a functional handle. The functional handle includes a threaded rod, a push-pull control member, a casing tube, a displacement tube, an inner tube fixing member, an outer tube fixing member and a stability tube fixing member. The threaded rod extends through a bore of the displacement tube. A fastener of the push-pull control member is able to engage a thread provided on a leading portion of the threaded rod. A trailing portion of the threaded rod is provided with a knob. The push-pull control member includes a fastener, springs and a button. The fastener is able to extend through a slot to engage a thread of the threaded rod in the displacement tube. The springs are configured to cause an automatic locking of the fastener and the threaded rod. The button is provided on the fastener. A cylindrical shell drives the displacement tube to move forward or backward along its longitudinal axis to cause the outer tube assembly to accordingly advance or retract. The delivery system can quickly, stably and accurately insert an implant into a target location.

Claims

1. An implant delivery system, comprising an inner tube assembly, an outer tube assembly and a functional handle, wherein the inner tube assembly comprises, from a proximal end to a distal end in the sequence set forth, a reinforcing tube, a proximal inner tube, a stent ear holder, a distal inner tube and a tip;

the inner tube assembly is configured to allow a guide wire to extend therethrough;

the outer tube assembly is disposed over the inner tube assembly and comprises, from a proximal end to a distal end, a proximal outer tube and a stent capsule, the proximal outer tube being received within a stability tube;

the functional handle is connected to both the inner tube assembly and the outer tube assembly and the functional handle comprises a threaded rod, a push-pull control member, a casing tube, a displacement tube, an inner tube fixing member, an outer tube fixing member and a stability tube fixing member, the inner tube fixing member being in fixed connection with a proximal portion of the inner tube assembly;

the outer tube fixing member being in fixed connection both with a proximal end of the outer tube assembly and with a distal end of the displacement tube, the stability tube fixing member being in fixed connection with a proximal end of the stability tube and fixed to a distal end of the casing tube;

the displacement tube is received within the casing tube such that the displacement tube moves forward and backward in the casing tube only along its axis direction;

the threaded rod extends through a bore of the displacement tube;

the threaded rod defines a leading portion and a trailing portion, the trailing portion of the threaded rod being provided with a knob;

the push-pull control member comprises a fastener and a button, the button being provided on the fastener;

the displacement tube defines a slot compatible with the fastener, and the fastener is able to extend through the slot to engage a thread of the threaded rod in the displacement tube;

the push-pull control member further comprises a cylindrical shell and springs, and the cylindrical shell is disposed over the casing tube such that the button is able to extend out of the cylindrical shell through an opening thereof;

the fastener assumes an annular shape and is engageable with the thread provided on the leading portion of the threaded rod; and

the springs are disposed between the fastener and the displacement tube and configured to cause an automatic locking of the fastener and the threaded rod.

2. The implant delivery system according to claim 1, wherein an auxiliary tube fits over a periphery of the proximal inner tube, the auxiliary tube having a distal end abutting a proximal side of the stent ear holder and in fixed connection with both the stent ear holder and the proximal inner tube, the auxiliary tube having a proximal end in feed-connection with both the proximal inner tube and the reinforcing tube.

3. The implant delivery system according to claim 1, wherein the tip is made of a flexible polymeric material and has a leading portion with a streamlined shape and a trailing portion with a straight shape, the trailing portion of the tip having a straight shape portion with a beveled or rounded edge;

and/or

the tip is radiopaque.

4. The implant delivery system according to claim 1, wherein the distal inner tube is fabricated from a polymeric tube, a coil reinforced polymeric tube or a braid reinforced polymeric tube;

and/or

the distal inner tube has a stepped profile for loading an implant.

5. The implant delivery system according to claim 1, wherein the stent ear holder is made of a polymeric or metallic material and comprises two or more clasps for connecting an implant, each of the clasps assuming a shape of a cylindrical boss;

and/or

the stent ear holder has end faces each defining an arc-shaped transition area; and

/or

the stent ear holder is radiopaque.

6. The implant delivery system according to claim 1, wherein the proximal inner tube is made of a polymeric or metallic material.

7. The implant delivery system according to claim 2, wherein the auxiliary tube is formed of a polymeric material and it is a polymeric catheter or defines a helical structure at a distal end;

or the auxiliary tube is a metal spring.

8. The implant delivery system according to claim 2, wherein the reinforcing tube is made of a polymeric or metallic material and has one end in connection with both the proximal inner tube and the auxiliary tube;

and the reinforcing tube is coupled to the functional handle via the inner tube fixing member, thereby securing the inner tube assembly to the functional handle.

9. The implant delivery system according to claim 1, wherein the outer tube assembly has a tapering shape, with the stent capsule having an outer diameter greater than an outer diameter of the proximal outer tube;

and/or

both the stent capsule and proximal outer tube are fabricated from a polymeric tube and comprise an outer layer, an intermediate layer and an inner layer, wherein;

the outer layer is formed of a high-strength polymeric material;

the intermediate layer is a coil layer or a braid layer, and the inner layer is formed of a low-friction polymeric material.

10. The implant delivery system according to claim 9, wherein in case that the intermediate layer is a coil layer or a braid layer, axial stiffening ribs are evenly spaced about the periphery of the stent capsule.

11. The implant conveying system according to claim 1, wherein a section of the proximal outer tube adjacent to the stent capsule is fabricated from a coil reinforced tube or a pure tube and a section of the proximal outer tube remote from the stent capsule is fabricated from a braid reinforced tube;

and/or

the remote section of the stent capsule is provided with a radiopaque ring.

12. The implant delivery system according to claim 1, wherein the stability tube is fabricated from a coil or braid reinforced polymeric tube or a pure polymeric tube.

13. The implant delivery system according to claim 1, wherein the inner tube fixing member is formed of a high-strength polymeric material or a metallic material, and the reinforcing tube of the inner tube assembly extends through a bore of the inner tube fixing member and is connected to the inner tube fixing member.

14. The implant delivery system according to claim 1, wherein the outer tube fixing member comprises an outer tube fixing base, an outer tube fixing screw cap, an outer tube sealing screw cap and an outer tube sealing ring;

the proximal outer tube has an end portion expandable to a flare-shape and can thereby be connected to a distal portion of the outer tube fixing base, the distal portion of the outer tube fixing base having a conical structure matching in shape the flare-shaped end portion of the proximal outer tube;

the outer tube fixing screw cap is fastened over the distal portion of the outer tube fixing base such that the flare-shaped end portion of the proximal outer tube is pressed against, and thus in fixed connection with, the outer tube fixing base;

the outer tube sealing screw cap is in connection with a proximal end of the outer tube fixing base; and

the outer tube sealing ring is disposed between the outer tube sealing screw cap and the proximal end of the outer tube fixing base and is configured to seal a lumen between the outer tube assembly and the inner tube assembly.

15. The implant delivery system according to claim 14, wherein the outer tube fixing base defines an aperture between the flare-shaped end portion of the proximal outer tube and the outer tube sealing ring, the aperture being in connection with an outside of the implant delivery system via an outer tube flush port.

16. The implant delivery system according to claim 1, wherein the stability tube fixing member comprises a stability tube fixing base, a stability tube fixing screw cap, a stability tube sealing screw cap and a stability tube sealing ring;

the stability tube has an end portion expandable to a flare shape and can thereby be connected to a distal portion of the stability tube fixing base, the distal portion of the stability tube fixing base having a conical structure matching in shape the flare-shaped end portion of the stability tube;

the stability tube fixing screw cap is fastened over the distal portion of the stability tube fixing base such that the flare-shaped end portion of the stability tube is pressed against, and thus in fixed connection with, the stability tube fixing base;

the stability tube sealing screw cap is in connection with a proximal end of the stability tube fixing base; and

the stability tube sealing ring is disposed between the stability tube sealing screw cap and the proximal end of the stability tube fixing base and is configured to seal a lumen between the stability tube and the proximal outer tube.

17. The implant delivery system according to claim 16, wherein the stability tube fixing base defines an aperture between the flare-shaped end portion of the stability tube and the stability tube sealing ring, the aperture being in connection with an outside of the implant delivery system via a stability tube flush port.

19. The implant delivery system according to claim 1, wherein a Luer lock is in connection with the proximal portion of the inner tube assembly and thus with a lumen of the inner tube assembly.

18. (canceled)

20. An implant delivery system, comprising an inner tube assembly, an outer tube assembly and a functional handle, wherein the inner tube assembly comprises, from a proximal end to a distal end in the sequence set forth, a reinforcing tube, a proximal inner tube, a stent ear holder, a distal inner tube and a tip;

the inner tube assembly is configured to allow a guide wire to extend therethrough;

the outer tube assembly is disposed over the inner tube assembly and comprises, from a proximal end to a distal end, a proximal outer tube and a stent capsule, the proximal outer tube being received within a stability tube;

the functional handle is connected to both the inner tube assembly and the outer tube assembly and comprises a threaded rod, a push-pull control member, a casing tube, a displacement tube, an inner tube fixing member, an outer tube fixing member and a stability tube fixing member, the inner tube fixing member being in fixed connection with a proximal portion of the inner tube assembly, the outer tube fixing member being in fixed connection with a proximal end of the outer tube assembly and with a distal end of the displacement tube, the stability tube fixing member being in fixed connection with a proximal end of the stability tube and fixed to a distal end of the casing tube;

the displacement tube is disposed within the casing tube such that the displacement tube moves forward and backward in the casing tube only along its axis direction;

the threaded rod extends through a bore of the displacement tube;

the threaded rod is relatively fixed with the casing tube;

in axis direction and relative rotary with the casing tube in circumferential direction;

the threaded rod defines a leading portion and a trailing portion, the leading portion defining a thread, the trailing portion being provided with a knob;

the push-pull control member comprises a fastener and a button, the button being provided on the fastener;

the displacement tube defines a slot compatible with the fastener, and the fastener is able to extend through the slot to engage the thread of the threaded rod in the displacement tube; and

the threaded rod is provided, on its periphery, with a boss received in a recess formed in the casing tube, alternatively, the threaded rod defines, on its periphery, a recess accommodating a boss provided on the casing tube.

21. The implant delivery system according to claim 20, wherein the inner tube fixing member is disposed inside and fixed to the casing tube.