Low-Profile Vasculare Closure Systems and Methods of Using Same

• US 20080177300A1
• Filed: 01/24/2007
• Published: 07/24/2008
• Est. Priority Date: 01/24/2007
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Mas, Juan-Pablo, Epperly, Scott J., Lobello, Richard D., Eliasen, Kenneth A., Spurchise, Matthew F.
• Granted Patent: US 7,766,208 B2
• Time in Patent Office: Days
• US Class Current: 606/219
• 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 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/0684 having a forming anvil staying above the tissue during stapling
• CPC Class Codes: A61B 17/0686 having a forming anvil staying below the tissue during stapling
• CPC Class Codes: A61B 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61B 2090/0801 Prevention of accidental cutting or pricking
• CPC Class Codes: A61B 2090/08021 of the patient or his organs

Abstract

A closure device for an arteriotomy includes an elongate hollow shaft and an elongate driver slidably disposed therein. The elongate hollow shaft includes a pair of a pair of opposing actuation tips disposed at a distal end thereof defining a staple chamber there between. An anvil extends into the staple chamber from one of the actuation tips. The closure device includes a release mechanism for spreading apart the pair of opposing actuation tips to provide a gap associated with the anvil, the gap dimensioned such that the staple may pass there through. A method of using the closure device is also disclosed.

Claims

1. A closure device for an arteriotomy comprising:

an elongate hollow shaft and an elongate driver slidably disposed therein;

a pair of opposing first and second actuation tips disposed at a distal end of the shaft and defining a staple chamber there between;

a first anvil disposed within the staple chamber and coupled to the first actuation tip;

a staple at least partially disposed within the staple chamber, the staple having a pair of opposing staple legs coupled by a bend at a proximal end of the staple, each staple leg having an expansion ramp extending toward the opposite staple leg and longitudinally slidable along the first anvil to open the staple when the driver pushes the staple distally within the staple chamber;

a deployment configuration wherein the first anvil substantially spans the staple chamber for retaining and deforming the staple therein;

a release configuration wherein the first and second actuation tips are spread apart to provide a gap associated with the first anvil, the gap dimensioned such that the staple may pass there through; and

a release mechanism for transforming the closure device from the deployment configuration to the release configuration.

2. The closure device of claim 1 further comprising a second anvil extending from the second actuation tip such that the first and second anvils mate with each other to substantially span the staple chamber in the deployment configuration for retaining and deforming the staple therein, and wherein the gap provided in the release configuration extends between the first and second anvils,

3. The closure device of claim 1, wherein the release mechanism comprises a first pair of side ramps facing laterally away from each other and coupled to a distal end of the first anvil.

4. The closure device of claim 3 wherein the staple expansion ramps are respectively engageable with the first pair of side ramps to ride laterally there along for transforming the closure device from the deployment configuration to the release configuration when the staple closes.

5. The closure device of claim 3 further comprising a second anvil extending from the second actuation tip such that the first and second anvils mate with each other to substantially span the staple chamber in the deployment configuration for retaining and deforming the staple therein, wherein the gap provided in the release configuration extends between the first and second anvils, and wherein the release mechanism further comprises a second pair of side ramps facing laterally away from each other and coupled to a distal end of the second anvil.

6. The closure device of claim 1, wherein the release mechanism comprises a first ramp disposed on the first anvil and facing proximally and toward the second actuation tip and slidably engageable with the staple bend.

7. The closure device of claim 6 further comprising a second anvil extending from the second actuation tip such that the first and second anvils mate to substantially span the staple chamber in the deployment configuration for retaining and deforming the staple therein, wherein the gap provided in the release configuration extends between the first and second anvils, and wherein the release mechanism further comprises a second ramp disposed on the second anvil and facing proximally and toward the first actuation tip and slidably engageable with the staple bend.

8. The closure device of claim 1, wherein the release mechanism comprises:

a first pair of opposing slots disposed in the first actuation tip proximally adjacent the staple chamber, each of the slots terminating proximally in a ramp; and

a first pair of resilient arms disposed between the first actuation tip and the driver, each arm having a proximal end coupled to the driver and a distal end having a hook engage-able with one of the respective slots and slidable along the proximal ramp of the slot and wedgeable between the first actuation tip and the driver,

9. The closure device of claim 8, wherein the first pair of arms is laterally restrainable between the actuation tips and longitudinally moveable with the driver to align and resiliently engage the hooks on the first pair of arms with the first pair of slots, respectively.

10. The closure device of claim 8, wherein the release mechanism further comprises:

a second pair of opposing slots disposed in the second actuation tip proximally adjacent the staple chamber, each of the slots of the second pair of slots terminating proximally in a ramp; and

a second pair of resilient arms disposed between the second actuation tip and the driver, each arm of the second pair of arms having a proximal end coupled to the driver and a distal end having a hook engageable with one of the respective second pair of slots and slidable along the proximal tamp of the slot and wedgeable between the second actuation tip and the driver.

11. The closure device of claim 1, wherein the release mechanism comprises:

a first wedge disposed on the driver and facing distally toward the first actuation tip; and

a first ramp disposed on the first actuation tip and facing proximally toward the first wedge and slidably engageable with the first wedge to spread apart the driver and the first actuation tip.

12. The closure device of claim 11, wherein the release mechanism further comprises a second wedge disposed on the driver and facing distally toward the second actuation tip;

and

a second ramp disposed on the second actuation tip and facing proximally toward the second wedge and slidably engageable with the second wedge to spread apart the driver and the second actuation tip.

13. The closure device of claim 1, wherein the release mechanism comprises:

a first wedge disposed on the driver and facing proximaly toward the first actuation tip; and

a first ramp disposed on the first actuation tip and facing distally toward the first wedge, wherein the first wedge is slidably engageable with the first ramp to spread apart the driver and the first actuation tip.

14. The closure device of claim 13, wherein the release mechanism further comprises a second wedge disposed on the driver and facing proximally toward the second actuation tip;

and

a second ramp disposed on the second actuation tip and facing distally toward the second wedge, wherein the second wedge is slidably engageable with the second ramp to spread apart the driver and the second actuation tip.

15. The closure device of claim 1, wherein the staple is opened by elastic deformation of at least one bend at a proximal end of the staple.

16. The closure device of claim 15, wherein the staple is closed by plastic deformation of at least one bend at a proximal end of the staple.

17. The closure device of claim 1, wherein the staple comprises an elastic or pseudoelastic material.

18. A method of closing an arteriotomy comprising:

providing a stapler including;

an elongate hollow shaft and an elongate driver slidably disposed therein;

a pair of opposing first and second actuation tips disposed at a distal end of the shaft and defining a staple chamber there between;

a first anvil disposed within the staple chamber and coupled to the first actuation tip; and

a staple at least partially disposed within the staple chamber, the staple having a pair of opposing staple legs coupled by a bend at a proximal end of the staple, each staple leg having a tip and an expansion ramp extending toward the opposite staple leg;

delivering the stapler to the arteriotomy in a deployment configuration wherein the first anvil substantially spans the staple chamber for retaining and deforming the staple therein;

pushing the driver distally within the shaft to advance the staple in the staple chamber such that the expansion ramps slide along the first anvil to open the staple;

piercing tissue adjacent the arteriotomy with the staple tips;

pushing the driver distally within the shaft to advance the staple in the staple chamber such that the expansion ramps clear the first anvil to close the staple; and

actuating a release mechanism for spreading apart the first and second actuation tips to provide a gap associated with the first anvil, the gap dimensioned such that the staple may pass there through.

19. The method of closing an arteriotomy according to claim 18 wherein the release mechanism comprises a first, pair of side ramps facing laterally away from each other and coupled to a distal end of the first anvil, and wherein closing the staple causes the staple expansion ramps to wedge between the second actuation tip and the first side ramps, respectively to actuate the release mechanism.

20. The method of closing an arteriotomy according to claim 18 wherein the release mechanism comprises a first ramp disposed on the first anvil and facing proximally and toward the second actuation tip, and wherein pushing the driver distally within the shaft after closing the staple wedges the staple bend between the second actuation tip and the first ramp to actuate the release mechanism.

21. The method of closing an arteriotomy according to claim 18 wherein the release mechanism comprises:

a first pair of opposing slots disposed in the first actuation tip proximally adjacent the staple chamber, each of the slots terminating proximally in a ramp; and

a first pair of resilient arms disposed between the first actuation tip and the driver, each arm having a proximal end coupled to the driver and a distal end having a hook slidable in the respective slot, wherein pulling the driver proximally within the shaft after closing the staple slides each hook in the respective slot ramp and wedges each hook between the first actuation tip and the driver to actuate the release mechanism.

22. The method of closing an arteriotomy according to claim 18 wherein the release mechanism comprises:

a first wedge disposed on the driver and facing distally toward the first actuation tip; and

a first ramp disposed on the first actuation tip and facing proximally toward the first wedge, wherein pulling the hollow shaft proximally along the driver engages the first wedge and the first ramp to actuate the release mechanism.

23. The method of closing an arteriotomy according to claim 18 wherein the release mechanism comprises:

a first wedge disposed on the driver and facing proximally toward the first actuation tip; and

a first ramp disposed on the first actuation tip and facing distally toward the first wedge, wherein pulling the hollow shaft proximally along the driver after closing the staple engages the first wedge and the first ramp to actuate the release mechanism.