Sliding Split-Sleeve Implant Compressor

• US 20100057185A1
• Filed: 09/04/2008
• Published: 03/04/2010
• Est. Priority Date: 09/04/2008
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Melsheimer, Jeffry S., Hoffman, Grant T.
• Granted Patent: US 8,359,721 B2
• Time in Patent Office: Days
• US Class Current: 623/1.120
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: Y10T 29/53657 to apply or remove a resilient article [e.g., tube, sleeve, etc.]
• CPC Class Codes: Y10T 29/53678 Compressing parts together face to face
• CPC Class Codes: Y10T 29/53683 Spreading parts apart or separating them from face to face engagement

Abstract

A system and method for loading an endoprosthesis, such as a stent or valve, into an introducer is provided that permits interventionalists to load the endoprosthesis easily at the bedside. The system can include a compressor for compressing the endoprosthesis to a cross-sectional area less than the cross-sectional area of the introducer lumen. The compressor has a funnel portion at one end where the un-compressed endoprosthesis can be introduced and another end where the introducer and sleeves of a split sleeve device are inserted. The sleeves conform to the compressor passage and surround the endoprosthesis to collapse the endoprosthesis. The split sleeve device also includes a mounting device coupled to the sleeves. The endoprosthesis is compressed and loaded into the introducer by the relative movement of the mounting device and the compressor, where the endoprosthesis remains generally stationary while being compressed and loaded in order to avoid potentially compromising the endoprosthesis.

Claims

1. A system for loading a self-expanding stent into an introducer having an outer tube defining a lumen, the system comprising:

a compressor having a stent delivery end, a stent receiving end, and a passage about a longitudinal axis connecting the stent delivery end and the stent receiving end, the passage comprising a funnel portion proximate the stent receiving end and an introducer opening proximate the stent delivery end, the funnel portion at the stent receiving end being sized to receive an un-compressed stent, the introducer opening shaped and sized to receive the outer tube of said introducer; and

a split sleeve device comprising a plurality of flexible sleeves each having a first end and a second end, and a mounting device situated adjacent the stent delivery end of the compressor defining a hole about the longitudinal axis sized to surround the outer tube of the introducer, the first end of each sleeve being coupled to the mounting device, the second end of each sleeve extending through the compressor passage at least to the stent receiving end and being flared outward to surround the un-compressed stent;

the mounting device with the first end of each sleeve being movable away from the compressor, the second end of each sleeve and the surrounded stent being drawn through the funnel portion to collapse the stent to a compressed configuration, the compressed stent being urged into the lumen of said introducer by the movement of each sleeve relative to the compressor and introducer.

2. The system of claim 1, wherein n is the number of sleeves and 2/n is the angle between a center of the body of each sleeve, where a gap is defined between each sleeve, the gap being reduced when the sleeves collapse the stent.

3. The system of claim 1, wherein the body of the one or more sleeves is arcuate about the longitudinal axis to form at least a portion of a tubular body.

4. The system of claim 3, wherein the split sleeve device comprises a first discrete layer of two sleeves with a gap in between the sleeves and a second discrete layer of two sleeves with a gap between the sleeves disposed radially inward of the first discrete layer of sleeves, where the body of each sleeve of each discrete layer forms an angle of about , and the first discrete layer is offset from the second discrete layer by an angle of about /2, and where the first and second discrete layers of sleeves overlap one another.

5. The system of claim 1, wherein the mounting device comprises a cylindrical body having a number (k) of planar surfaces machined on the body of the mounting device proportional to the number of sleeves and 2/k is the angle between a center of the body of each planar surface.

6. The system of claim 5, wherein the first end of the one or more sleeves conforms to the hole of the mounting device, extending outward from the hole and attaching to a respective planar surface of the mounting device.

7. The system of claim 1, wherein the mounting device is fixed relative to the sliding implant compressor.

8. The system of claim 1i wherein the funnel portion of the compressor passage has a first end corresponding to the stent receiving end and a second end, the first end sized to receive the un-compressed stent and the second end having a cross-sectional area substantially the same or less than a cross-sectional area of the lumen of said introducer.

9. The system of claim 1, wherein the passage further comprises a transitioning portion interposed between the funnel portion and the introducer opening, the transitioning portion having a cross-sectional area substantially the same or less than a cross-sectional area of the lumen of said introducer.

10. The system of claim 1, wherein the compressor comprises a seat for said introducer within the introducer opening, the seat sized to prevent said introducer from advancing into the funnel portion.

11. The system of claim 1 further comprising an inserter having a collapsible member configured to retain said stent about the longitudinal axis while said stent collapses to the compressed configuration and is loaded into the lumen of said introducer.

12. The system of claim 11, wherein the collapsible member of the inserter comprises a plurality of arms extending radially outward from the inserter, each arm having a stent engaging end to retain said stent about the longitudinal axis while said stent collapses to the compressed configuration, the collapsible member being collapsible to a cross-sectional area less than a cross-sectional area of the introducer lumen, where the collapsible member is inserted into the lumen of said introducer when urging said stent into the lumen of said introducer.

13. A system for loading an endoprosthetic valve, being movable between an expanded configuration and a compressed configuration, into an introducer having an outer tube defining a lumen, the valve including a self expanding stent and at least one valve leaflet of remodelable material, the device comprising:

a compressor having a stent delivery end, a stent receiving end, and a passage about a longitudinal axis connecting the stent delivery end and the stent receiving end, the passage comprising a funnel portion proximate the stent receiving end and an introducer opening proximate the stent delivery end, the funnel portion at the stent receiving end being sized to receive the valve in the expanded configuration, the introducer opening shaped and sized to receive the outer tube of said introducer;

a split sleeve device comprising a first and a second discrete layer of flexible sleeves, the second discrete layer disposed radially inward with respect to the first discrete layer, each sleeve having a body of a given width including a first end and a second end and being separated with respect to the adjacent sleeve of the same discrete layer by a longitudinal gap, the sleeves of the first discrete layer being overlapped by the sleeves of the second discrete layer with each discrete layer covering the longitudinal gap of the other discrete layer, and a mounting device situated adjacent the stent delivery end of the compressor defining a hole about the longitudinal axis sized to surround the outer tube of the introducer and to receive each sleeve therethrough, the first end of each sleeve being coupled to the mounting device, the second end of each sleeve extending through the compressor passage at least to the stent receiving end, the second end of each sleeve being flared outward to surround the valve in the expanded configuration; and

the compressor being movable relative to the mounting device with the first end of each sleeve, the second end of each sleeve and the surrounded valve being drawn through the funnel portion to collapse the valve to the compressed configuration, the compressed valve being urged into the lumen of said introducer by the movement of each sleeve relative to the compressor and introducer and the urging of the inserter.

14. The system of claim 13, wherein the body of each sleeve is arcuate about the longitudinal axis to form a tubular body.

15. The system of claim 13, wherein each sleeve conforms to the hole of the mounting device, the first end of each sleeve extending outward from the hole and attaching to a respective planar surface of the mounting device.

16. The system of claim 13, wherein the funnel portion of the sliding implant compressor passage has a first end corresponding to the stent receiving end and a second end, the first end sized to receive said valve in the expanded configuration and the second end having a cross-sectional area substantially the same or less than a cross-sectional area of the lumen of said introducer;

and wherein the passage further comprises a transitioning portion interposed between the funnel portion and the introducer opening, the transitioning portion having a cross-sectional area substantially the same or less than the lumen cross-sectional area of said introducer.

17. The system of claim 13 further comprising an inserter having a collapsible member configured to retain said valve about the longitudinal axis while said valve collapses to the compressed configuration and is delivered to the lumen of said introducer, wherein the mounting device and the inserter are fixed relative to the movable compressor.

18. The system of claim 17, wherein the collapsible member of the inserter comprises a plurality of arms extending radially outward from the inserter, each arm having a stent engaging end to retain said valve about the longitudinal axis while said valve collapses to the compressed configuration, each arm being collapsible to a cross-sectional area less than a cross-sectional area of the introducer, where each arm is inserted into the lumen of said introducer when urging said valve into the lumen of said introducer.

19. A method of loading a tubular medical device into an introducer, the method comprising the steps of:

(a) providing a tubular medical device, an introducer having an outer tube defining a lumen, and a sliding split-sleeve valve loader system comprising

a compressor comprising a stent delivery end, a stent receiving end, and a passage about a longitudinal axis connecting the stent delivery end and the stent receiving end, the passage comprising a funnel portion and an introducer opening, and a split sleeve device comprising a plurality of flexible sleeves each having a first end and a second end and a mounting device defining a hole about the longitudinal axis sized to receive said introducer and each sleeve therethrough, where the first end of each sleeve is coupled to the mounting device and the second end is flared radially outward;

(b) inserting each sleeve through the passage of the compressor, wherein the second end of each sleeve conforms to the funnel portion;

(c) inserting the introducer into the introducer opening of the compressor;

(d) inserting an un-compressed tubular medical device into the funnel portion at the stent receiving end of the compressor; and

(e) translating the compressor away from the mounting device to urge each sleeve to collapse and compress the tubular medical device into a compressed configuration, and to urge the compressed valve into the lumen of the introducer.

20. The method of claim 19, wherein the tubular medical device includes an endoproshetic valve comprising at least one dehydrated valve leaflet, the method further comprising the step of hydrating the valve leaflet just before inserting the endoprosthetic valve into the funnel portion of the compressor.