Implantable access port device having a safety cap

• US 9,023,063 B2
• Filed: 03/30/2010
• Issued: 05/05/2015
• Est. Priority Date: 04/17/2008
• Status: Active Grant

• Current Assignee: Apollo Endosurgery US, Inc. (Boston Scientific Corporation)
• Original Assignee: Apollo Endosurgery, Inc. (Boston Scientific Corporation)
• Inventors: Franklin, Ethan, Olroyd, Craig, Mudd, Christopher S.
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): Papeika, Rachel S
• Application Number:
  US12/750,565
• Publication Number:
  US 20100217198A1
• Time in Patent Office: 1,862 Days
• Field of Search: 600/37, 600/184, 606/139, 606/140, 606/142, 606/157, 623/23.64, 623/23.65, 623/23.72, 623/902
• US Class Current: 606/139
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• CPC Class Codes: A61F 5/0056 using injection ports
• CPC Class Codes: A61M 2039/009 Means for limiting access to the septum, e.g. shields, grids
• CPC Class Codes: A61M 2039/0223 having means for anchoring the subcutaneous access site
• CPC Class Codes: A61M 2039/0261 Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
• CPC Class Codes: A61M 2039/027 having a particular valve, seal or septum septum A61M2039/0036
• CPC Class Codes: A61M 2039/0276 for introducing or removing fluids into or out of the body
• CPC Class Codes: A61M 2039/0288 protectors, caps or covers therefor
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053

Abstract

A system for attaching an access port to bodily tissue includes an access port assembly and including an access port having a generally central axis. The access port assembly further includes an attachment mechanism structured to enable the access port to be attached, for example, to an abdominal muscle of a patient. The system includes a safety cap which lies substantially flush against the anchor base to provide no space for movement of the anchors. The safety cap prevents the anchors from deploying prematurely.

Claims

1. An access port assembly comprising:

an access port having a generally central axis and including a bottom, a sidewall, and a needle penetrable septum;

a housing that houses the access port, the housing including an actuator element rotatable about the central axis, the actuator element having a plurality of force protrusions extending radially outwardly from the actuator element; and

an attachment mechanism structured to enable the access port to be attached to bodily tissue, the attachment mechanism having a plurality of rotatable anchors movable from an undeployed state to a deployed state,

wherein each rotatable anchor has a main body and a separately formed shaft immovably secured to the main body, the shaft defining an axis of rotation of the anchor, wherein the anchors are concealed and contained by the housing when in the undeployed state, wherein the main body includes (1) an inner concave portion that extends from the shaft to a first end, (2) an outer concave portion that extends about the inner concave portion from a second end to a tip portion at a distal end of the main body, and (3) a locking bend portion extending in a curve from the first end of the inner concave portion to the second end of the outer concave portion, wherein the cross section of the main body is constant at least between the shaft and the tip portion, and wherein the main body is a continuously formed member, and

wherein the inner concave portion has opposing concave and convex surfaces and wherein the force protrusion portions glide on the concave surface of the inner concave portion when the actuator element is rotated about the central axis to effect rotation of the anchor about the shaft.

2. The access port assembly of claim 1, wherein the main body is cut from a sheet of material.

3. The access port assembly of claim 1, wherein the main body has radiused edges.

4. The access port assembly of claim 1, wherein the main body is stamp cut from a sheet of material.

5. The access port assembly of claim 1, wherein the shaft has a head abutting a portion of the main body.

6. The access port assembly of claim 1, wherein the main body has an aperture, the aperture having a diameter, the shaft having a first shaft diameter and a second shaft diameter different from the first shaft diameter.

7. The access port assembly of claim 6, wherein the shaft has a third shaft diameter greater than the diameter of the aperture of the main body.

8. The access port assembly of claim 1, wherein the force protrusion portions glide on the concave surface of the inner concave portion when the anchor is rotated about the shaft between the undeployed and the deployed state.

9. The access port assembly of claim 1, wherein the force protrusions do not move with respect to the actuator element.

10. The access port assembly of claim 1, wherein when the force protrusions are rotated, they rotate in a single plane transverse to the central axis.

11. The access port assembly of claim 1, wherein the force protrusion portions glide on both the concave and convex surfaces of the inner concave portion when the actuator element is rotated about the central axis to effect rotation of the anchor about the shaft.

12. The access port assembly of claim 1, wherein when the anchor is in the deployed state, the force protrusions are engaged with the locking bend portion.

13. An access port assembly comprising:

an access port having a generally central axis and including a bottom, a sidewall, and a needle penetrable septum;

a housing that houses the access port, the housing including an actuator element rotatable about the central axis, the actuator element having a plurality of force protrusions extending radially outwardly from the actuator element; and

an attachment mechanism structured to enable the access port to be attached to bodily tissue, the attachment mechanism having a plurality of rotatable anchors movable from an undeployed state to a deployed state,

wherein each rotatable anchor has a main body and a separately formed shaft immovably secured to the main body, the shaft defining an axis of rotation of the anchor, wherein the anchors are concealed and contained by the housing when in the undeployed state, wherein the main body includes (1) an inner concave portion that extends from the shaft to a first end, (2) an outer concave portion that extends about the inner concave portion from a second end to a tip portion at a distal end of the main body, and (3) a locking bend portion extending in a curve from the first end of the inner concave portion to the second end of the outer concave portion, wherein the cross section of the main body is constant at least between the shaft and the tip portion, and wherein the main body is a continuously formed member, and

wherein the actuator element is constructed for rotation about the central axis to effect rotation of the anchor about the shaft between the undeployed and the deployed states, wherein the force protrusions do not move with respect to the actuator element, and

wherein in the undeployed state the force protrusions engage the inner concave portion and in the deployed state the force protrusions engage at least the locking bend portion.

14. The access port assembly of claim 13 wherein the main body of each anchor is 316 stainless steel.

15. The access port assembly of claim 13, wherein the main body is formed by an initial stamp cutting step for forming a general shape of the anchor and a subsequent stamp cutting step for forming a faceted distal tip of the anchor.

16. The access port assembly of claim 15 wherein the faceted distal tip is not subjected to further sharpening or polishing procedures prior to clinical use of the port assembly.

17. The access port assembly of claim 15 wherein the main body of each anchor is 316 stainless steel and wherein the faceted distal tip is not subjected to further sharpening or polishing procedures prior to clinical use of the port assembly.

18. An access port assembly comprising:

an access port having a generally central axis and including a bottom, a sidewall, and a needle penetrable septum;

a housing that houses the access port, the housing including an actuator element rotatable about the central axis, the actuator element having a plurality of force protrusions extending radially outwardly from the actuator element; and

an attachment mechanism structured to enable the access port to be attached to bodily tissue, the attachment mechanism having a plurality of rotatable anchors movable from an undeployed state to a deployed state,

wherein each rotatable anchor has a main body defining a sharp tip portion at a distal end of the main body and a shaft secured relative to the main body, the shaft defining an axis of rotation of the anchor, wherein the sharp tips are concealed and contained by the housing when in the undeployed state, wherein the main body includes (1) an inner concave portion that extends from the shaft to a first end, (2) an outer concave portion that extends about the inner concave portion from a second end to the tip portion, and (3) a curved portion extending in a curve from the first end of the inner concave portion to the second end of the outer concave portion, the outer concave portion being radially outward of the inner concave portion, the cross section of the main body is constant at least between the shaft and the tip portion, and wherein the main body is a continuously formed member,

wherein the actuator element is constructed for rotation about the central axis to effect rotation of the anchor about the shaft between the undeployed and the deployed states, wherein as the force protrusions rotate with the actuator element the force protrusions rotate in a single plane that is transverse to the central axis, and

wherein in the undeployed state the force protrusions engage the inner concave portion and in the deployed state the force protrusions engage at least the locking bend portion.

19. The access port assembly of claim 18, wherein the main body is cut from a sheet of material.

20. The access port assembly of claim 18, wherein the main body has radiused edges.

21. The access port assembly of claim 18, wherein the main body is stamp cut from a sheet of material.

22. The access port assembly of claim 18, wherein the shaft has a head abutting a portion of the main body.

23. The access port assembly of claim 18, wherein the main body has an aperture, the aperture having a diameter, the shaft having a first shaft diameter and a second shaft diameter different from the first shaft diameter.

24. The access port assembly of claim 23, wherein the shaft has a third shaft diameter greater than the diameter of the aperture of the main body.

25. The access port assembly of claim 18, wherein shaft is separately formed from the main body and is immovably secured to the main body.