Pre-loaded septum for use with an access port

• US 9,089,395 B2
• Filed: 11/16/2011
• Issued: 07/28/2015
• Est. Priority Date: 11/16/2011
• Status: Active Grant

• Current Assignee: Apollo Endosurgery US, Inc. (Boston Scientific Corporation)
• Original Assignee: Appolo Endosurgery Incorporated
• Inventors: Honaryar, Babak
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): COX, THADDEUS B
• Application Number:
  US13/298,247
• Publication Number:
  US 20130123574A1
• Time in Patent Office: 1,350 Days
• Field of Search: 600/37, 604/175, 60428801-28804
• US Class Current: 1/1
• CPC Class Codes: A61F 5/0056 using injection ports
• CPC Class Codes: A61M 2039/0036 characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
• CPC Class Codes: A61M 2039/0072 Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
• CPC Class Codes: A61M 2039/0223 having means for anchoring the subcutaneous access site
• CPC Class Codes: A61M 2039/0229 having means for facilitating assembling, e.g. snap-fit housing or modular design
• CPC Class Codes: A61M 2039/0235 having an additional inlet, e.g. for a guidewire or a catheter tube
• CPC Class Codes: A61M 2039/0255 for access to the gastric or digestive system
• 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 2039/0282 with implanted tubes connected to the port
• 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
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members

Abstract

Generally described herein are apparatus, systems and methods related to a pre-loaded septum insertable in an access port housing for increasing the control of the compression within the septum and the interference between the septum and the housing. For example, a pair of washers having mating portions may be positioned on respective sides of a rubber septum and bent such that the mating portions of one of the washer are interlocked with the mating portions of the other washer, the interlocked portions forming a tight ring about the septum and generating lateral compression on the septum, thereby “loading” the septum. In addition, fluid seals made of a rubber material with lower durometer than the rubber septum may be used at the interface between the rubber septum and the housing to enhance the fluid sealing functionality while promoting the self-sealing features of the rubber septum.

Claims

1. A compressed septum for insertion into an access port housing of a gastric band for the treatment of obesity, the compressed septum comprising:

a septum including a first side and a second side;

a top sheet in the form of a top ring having a first set of radially extending mating members, the top sheet positioned on the first side of the septum, and defining a cavity at a center portion of the top ring; and

a bottom sheet in the form of a bottom ring having a second set of radially extending mating members, the bottom sheet positioned on the second side of the septum, and defining a cavity at a center portion of the bottom ring,

wherein the second set of radially extending mating members of the bottom ring is configured to engage the first set of radially extending mating members of the top ring and cause the septum to be compressed such that the first side of the septum protrudes through the cavity of the top ring when the second set of radially extending mating members of the bottom ring and the first set of radially extending mating members of the top ring are bent to interlock with one another.

2. The compressed septum of claim 1 wherein the septum further includes a circumferential band positioned between the first side and the second side, and further wherein the second set of radially-extending mating members engages the first set of radially-extending mating members while contacting the circumferential band.

3. A compressed septum for insertion into an access port housing of a gastric band for the treatment of obesity, the compressed septum comprising:

a septum including a first side and a second side;

a top ring having a first set of radially extending mating members positioned on the first side of the septum, and defining a cavity at a center portion of the top ring; and

a bottom ring having a second set of radially extending mating members positioned on the second side of the septum, and defining a cavity at a center portion of the bottom ring,

wherein the second set of radially extending mating members of the bottom ring is configured to engage the first set of radially extending mating members of the top ring and cause the septum to be compressed such that the first side of the septum protrudes through the cavity of the top ring when the second set of radially extending mating members of the bottom ring and the first set of radially extending mating members of the top ring are bent to interlock with one another,

wherein each of the first set of radially-extending mating members and each of the second set of radially-extending mating members are “

L-shaped”

fingers.

4. The compressed septum of claim 3 wherein each mating member of the first set of radially-extending mating members contacts and interlocks with a mating member of the second set of radially-extending mating members.

5. A compressed septum for insertion into an access port housing of a gastric band for the treatment of obesity, the compressed septum comprising:

a septum including a first side and a second side;

a top ring having a first set of radially extending mating members positioned on the first side of the septum, and defining a cavity at a center portion of the top ring; and

a bottom ring having a second set of radially extending mating members positioned on the second side of the septum, and defining a cavity at a center portion of the bottom ring,

wherein the second set of radially extending mating members of the bottom ring is configured to engage the first set of radially extending mating members of the top ring and cause the septum to be compressed such that the first side of the septum protrudes through the cavity of the top ring when the second set of radially extending mating members of the bottom ring and the first set of radially extending mating members of the top ring are bent to interlock with one another,

wherein the second set of radially-extending mating members is configured to engage the first set of radially-extending mating members to exert lateral compression on the septum, and

wherein the lateral compression on the septum is configured to cause the septum to protrude out of the cavities of the top ring and the bottom ring.

6. The compressed septum of claim 5 wherein the top ring and the bottom ring are constructed out of titanium.

7. A pre-loaded septum for insertion into an access port housing of a gastric band for the treatment of obesity, the pre-loaded septum comprising:

a septum including a first side and a second side;

a first washer-shaped titanium metal sheet positioned on the first side of the septum, the first washer-shaped titanium metal sheet defining a cavity at a center portion of the first washer-shaped titanium metal sheet, the first washer-shaped titanium metal sheet further including a first set of radially-extending mating members; and

a second washer-shaped titanium metal sheet positioned on the second side of the septum, the second washer-shaped titanium metal sheet defining a cavity at a center portion of the second washer-shaped titanium metal sheet, the second washer-shaped titanium metal sheet further including a second set of radially-extending mating members configured to interlock the first set of radially-extending mating members.

8. The pre-loaded septum of claim 7 wherein the second set of radially-extending mating members are further configured to interlock the first set of radially-extending mating members when both sets of radially-extending mating members are bent towards each other.

9. The pre-loaded septum of claim 8 wherein the septum further includes a circumferential band positioned between the first side and the second side, and further wherein the second set of radially-extending mating members interlocks the first set of radially-extending mating members while contacting the circumferential band.

10. The pre-loaded septum of claim 9 wherein each of the first set and the second set of radially-extending mating members is a “

L”

shaped finger.

11. The pre-loaded septum of claim 9 wherein each mating member of the first set contacts and interlocks with a different mating member of the second set.

12. The pre-loaded septum of claim 7 wherein the second set of radially-extending mating members is configured to engage the first set of radially-extending mating members to exert lateral compression on the septum.

13. The pre-loaded septum of claim 12 wherein the lateral compression on the septum is configured to cause the septum to protrude out of the cavities of the first washer-shaped titanium metal sheet and the second washer-shaped titanium metal sheet.

14. A gastric banding system for the treatment of obesity, the gastric banding system comprising:

a gastric band disposed about an upper-stomach region, the gastric band including an inflatable portion configured to be inflated with the addition of fluid and deflated with the removal of fluid;

an access port fluidly connected to the inflatable portion of the gastric band via a connecting tube, the access port penetrable by a syringe for receiving the fluid to be added to the inflatable portion and for delivery of fluid from the inflatable portion to the syringe, the access port including;

a housing defining a septum-receiving portion and a fluid reservoir for holding of the fluid received by the syringe or the fluid to be delivered to the syringe, and

a pre-loaded septum positioned within the septum-receiving portion, the pre-loaded septum having;

a rubber member including a first side and a second side,

a top compressing sheet positioned on the first side of the rubber member, the top compressing sheet including a first inner ring defining a cavity at a center portion of the top compressing sheet, the top compressing sheet further including a first set of radially-extending mating members, and

a bottom compressing sheet positioned on the second side of the rubber member, the bottom compressing sheet including a second inner ring defining a cavity at a center portion of the bottom compressing layer, the bottom compressing sheet further including a second set of radially-extending mating members configured to engage the first set of radially-extending mating members,

wherein at least one of the first set and second set of radially-extending mating members is bent to interlock with the other of the first set and second set of radially-extending mating members.

15. The gastric banding system of claim 14 further including a fluid seal positioned within the septum-receiving portion of the access port housing and interfacing between the pre-loaded septum and the access port housing.

16. The gastric banding system of claim 15 wherein the fluid seal is constructed out of a rubber material of a first durometer, and the rubber member of the pre-loaded septum is constructed out of a rubber material of a second durometer higher than the first durometer.

17. The gastric banding system of claim 15 wherein the rubber member further includes a circumferential band positioned between the first side and the second side, and further wherein the second set of radially-extending mating members engages the first set of radially-extending mating members while contacting the circumferential band.

18. The gastric banding system of claim 14 wherein the top compressing sheet and the bottom compressing sheet are constructed out of a titanium material.

19. A gastric banding system for the treatment of obesity, the gastric banding system comprising:

a gastric band disposed about an upper-stomach region, the gastric band including an inflatable portion configured to be inflated with the addition of fluid and deflated with the removal of fluid;

an access port fluidly connected to the inflatable portion of the gastric band via a connecting tube, the access port penetrable by a syringe for receiving the fluid to be added to the inflatable portion and for delivery of fluid from the inflatable portion to the syringe, the access port including;

a housing defining a septum-receiving portion and a fluid reservoir for holding of the fluid received by the syringe or the fluid to be delivered to the syringe, and

a pre-loaded septum positioned within the septum-receiving portion, the pre-loaded septum having;

a rubber member including a first side and a second side,

a top compressing layer positioned on the first side of the rubber member, the top compressing layer including a first inner ring defining a cavity at a center portion of the top compressing layer, the top compressing layer further including a first set of radially-extending mating members, and

a bottom compressing layer positioned on the second side of the rubber member, the bottom compressing layer including a second inner ring defining a cavity at a center portion of the bottom compressing layer, the bottom compressing layer further including a second set of radially-extending mating members configured to engage the first set of radially-extending mating members,

wherein at least one of the first set and second set of radially-extending mating members is bent to interlock with the other of the first set and second set of radially-extending mating members,

wherein each of the first set and the second set of radially-extending mating members is an “

L”

shaped finger.

20. The gastric banding system of claim 19 wherein each mating member of the first set contacts and interlocks with a different mating member of the second set.

21. The gastric banding system of claim 19 wherein the second set of radially-extending mating members is configured to engage the first set of radially-extending mating members to exert lateral compression on the rubber member.

22. The gastric banding system of claim 19 wherein a lateral compression on the rubber member is configured to cause the rubber member to protrude out of the cavities of the top compressing layer and the bottom compressing layer.