Control handle for self-expandable medical devices

• US 9,913,741 B2
• Filed: 07/05/2012
• Issued: 03/13/2018
• Est. Priority Date: 07/05/2011
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Melsheimer, Jeffry S., Hoffman, Grant T., Hughes, Joseph E., Frankland, Gregory A., Bunch, Tyler
• Primary Examiner(s): Stransky, Katrina
• Assistant Examiner(s): Rwego, Kankindi
• Application Number:
  US13/542,137
• Publication Number:
  US 20130013049A1
• Time in Patent Office: 2,077 Days
• Field of Search: 623 111, 623 112, 606108, 606109, 606110, 606113, 606114, 606127, 606191, 606194, 606198, 606200, D24144, D24145, D24147
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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

Abstract

A delivery system is provided for a self-expanding medical device. The delivery system has a handle assembly with a housing. The housing has a slot with a deployment knob extending therethrough. The self-expanding medical device is deployed by restraining the housing of the handle assembly and pulling on the deployment knob. This causes an outer sheath to withdraw proximally from an inner catheter to release the self-expanding medical device from a space between the outer sheath and inner catheter.

Claims

1. A delivery system for a self-expanding medical device, comprising:

an inner catheter with a retention surface adapted to longitudinally restrain a self-expanding medical device;

an outer sheath adapted to extend over said self-expanding medical device to radially restrain said self-expanding medical device in a compressed state;

a housing connected to said inner catheter, said housing comprising a top side and a bottom side, said top side comprising a top surface having a longitudinal slot extending therethrough, and said bottom side comprising a generally flat surface, wherein a ratio between a width of said flat surface of said bottom side and a height between said bottom side and said top side is about 2.5;

1 to about 3.5;

1, wherein the top side comprises two opposing first finger recesses disposed above said flat surface of said bottom side, and wherein said two opposing first finger recesses have an upward-facing aspect and are adapted to receive a user'"'"'s fingers for urging said bottom side of said housing against a patient'"'"'s body;

a slide disposed within said housing and being connected to said outer sheath; and

a knob connected to said slide and extending out of said housing through said slot in said housing, the knob being movable from a proximal end of the slot to a distal end of the slot, wherein said first finger recesses each have a nadir disposed distally from said knob when said knob is positioned at a distal terminal end of said slot;

wherein said self-expanding medical device is released at a treatment site by longitudinally restraining said housing with respect to said treatment site and moving said knob longitudinally away from said treatment site within said slot of said housing, said outer sheath thereby being withdrawn from said self-expanding medical device while said inner catheter maintains said self-expanding medical device at said treatment site.

2. The delivery system according to claim 1, wherein said ratio is about 3:

1.

3. The delivery system according to claim 1, wherein said bottom side is entirely flat.

4. The delivery system according to claim 1, wherein said top side comprises a central longitudinal portion defining said height and opposing sloped surfaces extending downward from said central portion within an angular range of about 30°

to about 60°

.

5. The delivery system according to claim 1, wherein said slide comprises a fitting extending through said slot, said fitting comprising an extension with a first width approximately equal to a width of said slot along substantially an entire length of said slot, and a coupling end with a second width larger than said width of said slot, said slot comprising an opening with a width approximately equal to said coupling end, wherein said slide and said housing are assemblable by inserting said coupling end through said opening and connecting said knob to said coupling end.

6. The delivery system according to claim 1, wherein said inner catheter extends longitudinally through said housing to a proximal end of said housing, a hub separate from said housing being in communication with a lumen through said inner catheter, said hub being entrapped within said housing and comprising an external port.

7. The delivery system according to claim 1, wherein said housing comprises a connector at a distal end thereof, said connector having a ribs being adapted to connect to a hub of an introducer catheter.

8. The delivery system according to claim 1, wherein said slide comprises a lateral projection disposed within a longitudinal recess in said housing.

9. The delivery system according to claim 1, wherein said housing comprises a top housing and a bottom housing, said bottom housing forming an entirety of said bottom side.

10. The delivery system according to claim 1, wherein said housing comprises a suture loop adapted to attach said housing to a patient'"'"'s body with a suture.

11. The delivery system according to claim 1, wherein said housing comprises a top housing and a bottom housing, said bottom housing forming an entirety of said bottom side, said slide comprises a lateral projection disposed within a longitudinal recess in said housing between said top and bottom housings, said slide comprises a fitting extending through said slot, said fitting comprising an extension with a first width approximately equal to a width of said slot along substantially an entire length of said slot, and a coupling end with a second width larger than said width of said slot, said slot comprising an opening with a width approximately equal to said coupling end, wherein said slide and said housing are assemblable by inserting said coupling end through said opening and connecting said knob to said coupling end, and said top side comprises a central longitudinal portion defining said height and opposing sloped surfaces extending downward from said central portion within an angular range of about 30°

to about 60°

.

12. The delivery system according to claim 4, wherein said housing comprises opposing side surfaces that are rigid and about 0.090″

to about 0.25″

in height.

13. The delivery system according to claim 4, comprising an indicator window extending through at least one of said sloped surfaces, said housing comprising a colored portion viewable through said indicator window, and said slide comprising a slidable colored portion with a different color, wherein said slidable colored portion is viewable through said indicator window when said slide has reached a predetermined location and thereby blocks said colored portion of said housing.

14. The delivery system according to claim 7, wherein said connector comprises three flexible ribs, each of the three flexible ribs having different diameters.

15. A delivery system for a self-expanding medical device, comprising:

an inner catheter with a retention surface adapted to longitudinally restrain a self-expanding medical device;

an outer sheath adapted to extend over said self-expanding medical device to radially restrain said self-expanding medical device in a compressed state;

a housing connected to said inner catheter, said housing comprising a top side and a bottom side, said top side comprising a top surface having a longitudinal slot extending therethrough, and said bottom side comprising a generally flat surface, wherein a ratio between a width of said flat surface of said bottom side and a height between said bottom side and said top side is about 2.5;

1 to about 3.5;

1, and wherein the top side comprises two opposing first finger recesses disposed distally beyond a distal terminal end of the slot above said flat surface of said bottom side, two opposing second finger recesses along said top side proximal from said first finger recesses, and a raised flat portion being disposed between said first and second finger recesses, wherein said two opposing first finger recesses are upwardly-inclined and are adapted to receive a user'"'"'s fingers for urging said bottom side of said housing against a patient'"'"'s body;

a slide disposed within said housing and being connected to said outer sheath; and

a knob connected to said slide and extending out of said housing through said slot in said housing;

wherein said self-expanding medical device is released at a treatment site by longitudinally restraining said housing with respect to said treatment site and moving said knob longitudinally away from said treatment site within said slot of said housing, said outer sheath thereby being withdrawn from said self-expanding medical device while said inner catheter maintains said self-expanding medical device at said treatment site.

16. The delivery system according to claim 15, wherein said top side comprises a central longitudinal portion defining said height and opposing sloped surfaces extending downward from said central portion within an angular range of about 30°

to about 60°

.

17. The delivery system according to claim 16, wherein said bottom side is entirely flat.

18. The delivery system according to claim 17, wherein said ratio is about 3:

1.

19. A delivery system for a self-expanding medical device, comprising:

an inner catheter with a retention surface adapted to longitudinally restrain a self-expanding medical device;

an outer sheath adapted to extend over said self-expanding medical device to radially restrain said self-expanding medical device in a compressed state;

a housing connected to said inner catheter, said housing comprising a top side and a bottom side, said top side comprising a top surface having a longitudinal slot extending therethrough, and said bottom side comprising two opposable bottom recesses separated by a generally flat surface, wherein a ratio between a width of said flat surface of said bottom side and a height between said bottom side and said top side is about 2.5;

1 to about 3.5;

1, and wherein the top side comprises two opposing first finger recesses disposed above said flat surface of said bottom side, wherein said two opposing first finger recesses have an upward-facing aspect and are adapted to receive a user'"'"'s fingers onto the top surface for urging said bottom side of said housing against a patient'"'"'s body, and extend distally beyond a distal terminal end of the slot in the housing;

a slide disposed within said housing and being connected to said outer sheath; and

a knob connected to said slide and extending out of said housing through said slot in said housing, wherein said first finger recesses are disposed distally from said knob when said knob is adjacent a distal end of said slot; and

wherein the knob comprises a port situated out of said housing, wherein the port is in fluid communication with an annular space inside the outer sheath;

wherein said self-expanding medical device is released at a treatment site by longitudinally restraining said housing with respect to said treatment site and moving said knob longitudinally away from said treatment site within said slot of said housing, said outer sheath thereby being withdrawn from said self-expanding medical device while said inner catheter maintains said self-expanding medical device at said treatment site.

20. The delivery system according to claim 19, wherein the knob further comprises a cap and a luer fitting, wherein the cap may be coupled to the luer fitting to seal said port.