Peritoneal device system

• US 4,645,494 A
• Filed: 10/22/1985
• Issued: 02/24/1987
• Est. Priority Date: 10/22/1985
• Status: Expired due to Term

• Current Assignee: Minntech Corporation
• Original Assignee: Renal Systems Incorporated
• Inventors: Lee, Jeffrey A., Martinez, Felix J.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Lester, Michelle N.
• Application Number:
  US06/790,092
• Time in Patent Office: 490 Days
• Field of Search: 604/29, 604/93, 604/99, 604/174, 604/175, 604/249, 604/256, 128/766
• US Class Current: 604/175
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 2039/027 having a particular valve, seal or septum septum A61M2039/0036
• CPC Class Codes: A61M 2039/0273 for introducing catheters into the body
• CPC Class Codes: A61M 2209/04 Tools for specific apparatus
• 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 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24

Abstract

A system for use in peritoneal dialysis consisting of a rigid tubular implantable device, a stabilizing tool and an access set. The implantable device includes a centrally positioned, outwardly projecting cannula spike whose side openings are normally closed by a resilient sleeve member. A stabilizing tool having a broad load distributing base is locked to an upper flange of the implanted device. An access set connected to a dialysis solution system includes a septum which is penetrable by the cannula spike. Penetration simultaneously depresses the resilient cannula sleeve exposing the side openings which allows fluid flow. The access set, stabilizing tool and implant device are locked together whenever fluid is able to flow between the peritoneal cavity and the dialysis solution system.

Claims

1. A percutaneous implant device especially suitable for peritoneal dialysis applications, the device comprising:

(a) a substantially rigid tubular percutaneous body of biologially compatible material which extends through the skin when implanted so as to provide means for accessing the peritoneal cavity through the interior of said device, said body having a distal end and proximal end, the proximal end being nearest the peritoneal cavity when implanted, said distal end including an outer flange about its circumference;

(b) flexible subcutaneous catheter means in fluid-tight communication with the interior of said tubular body for providing fluid communication between an animal body exterior and said animal'"'"'s peritoneal cavity;

(c) cannula means for controlling flow through said tubular body, said cannula means including a rigid tubular member having a closed end and at least one opening in the side wall of said tubular member adjacent said closed end, said tubular member being positioned within said tubular body such that said closed end faces the distal end of said tubular body, the open end of said tubular member being in fluid-tight communication with said tubular body such that all fluid passing from the distal end to the proximal end of said tubular body must pass through said openings in said cannula means; and

(d) flexible cannula sleeve means providing a normally closed seal over said cannula means side openings, said sleeve means including a tubular, flexible sleeve member having a smaller inside diameter than the outside diameter of said cannula tubular member, said sleeve member being positioned over and around said tubular member from the proximal end of said tubular member and distally so as to normally completely cover and seal said tubular member side wall openings;

said cannula means, rigid tubular percutaneous body and flexible sleeve member being constructed and arranged such that pressure exerted on the distal end of said sleeve member will cause same to collapse downwardly and outwardly such that said sleeve member no longer provides a seal over said tubular member side wall openings, said flexible sleeve member being highly resilient so as to return to its original sealing postion when such pressure is released.

2. The device of claim 1 in combination with percutaneous implant device access means for providing fluid communication between said percutaneous implant device and an external peritoneal dialysis bag, said access means comprising:

(a) an access cartridge defining an internal passageway for fluid between its distal and proximal ends, said distal end including means for connecting to tubing so as to provide fluid communication between said tubing and said access cartridge;

(b) end cap means for insertion into said percutaneous implant device so as to depress said sleeve member to provide fluid communication through said percutaneous implant device, said end cap means including a rigid tubular portion having inner and outer diameters sized so as to allow said end cap to freely pass over said cannula means and sleeve member and pass into said tubular percutaneous body, said end cap further including means within the tubular portion projecting inwardly which will abut with the distal end of said sleeve member but not said cannula means when said end cap is inserted into the tubular percutaneous body; and

(c) septum means for sealing the passageway of said access cartridge, said setpum means including an elastomeric septum member and means for holding said septum member in a sealing relationship adjacent said tubular portion projection means such that upon insertion of said end cap with in said rigid tubular percutaneous body, said closed end of said cannular tubular member may pass through said setpum member such that the openings in said tubular member side walls are within the passageway of said access cartridge distally of said septum member which thereby allows fluid flow between said access means and percutaneous implant device.

3. The device of claim 1 in combination with tool means for stabilizing said percutaneous implant device during access with said access means, said tool means comprising:

(a) a pair of opposing handle members having proximal and distal ends, said handle members being joined adjacent their proximal ends with a hinge means for allowing the separation between the handle ends to be varied;

(b) the proximal ends of said handle members having opposing semi-circular faces, each said face having a central groove therein the radius and width of which are substantially equal to the radius and width of said implant device distal end flange; and

(c) the proximal ends of said handle members further including stabilizing platform means for providing a load distributing platform on the skin surrounding the implanted percutaneous device of claim 1, said platform means including an enlarged flange member having a proximal planar, skin contacting surface to distribute pressure from the insertion of an access means into a percutaneous implant device over a relatively large skin area surrounding the implanted device.

4. The combination of claim 3 wherein said hinge means is a flexible connection between said handle members which normally retains said opposing semi-circular faces in a position such that the distance between said faces is less than the external diameter of said implant device, and the flexible connection is constructed and arranged such that pressing said distal ends of said handle members toward each other increases the distance between said faces such that said faces may be positioned over said implant device and release of said pressure causes said semi-circular faces to return to their normal spaced position.

5. The combination of claim 3 in cooperating combination with opercutaneous implant device access means, said access means comprising:

(a) accesses cartridge defining an internal passageway for fluid between its distal and proximal ends, said distal end including means for connecting to tubing so as to provide fluid communication between said tubing and said access cartridge;

(b) end cap means for insertion into said percutaneous implant device so as to depress said sleeve member to provide fluid communication through said percutaneous implant device, said end cap means including a rigid tubular portion having inner and outer diameters sized so as to allow said end cap to freely pass over said cannula means and sleeve member and pass into said tubular percutaneous body, said end cap further including means within the tubular portion porjecting inwardly which will abut with the distal end of said sleeve member but not said cannula means when said end cap is inserted into the tubular percutaneous body; and

(c) septum means for sealing the passageway of said access cartridge, said septum mean=s including an elastomeric septum member and means for holding said septum member in a sealing relationship adjacent said tubular member side walls are within the passageway of said access cartridge distally of said septum member which thereby allows fluid flow between said access means and percutaneous implant device;

the cooperating combination including means for locking said access means to said tool means, said locking means comprising;

(a) a retainer lip member projecting inwardly of each of said semi-circular faces along the upper circumference of said semi-circular faces; and

(b) said access cartridge including a pair of opposing handle members connected to the distal end of said access cartridge, said handle members extending parallel to the longitudinal axis of said access cartridge, said handle members each further including ear members projecting outwardly from the longitudinal axis of said access cartridge and being constructed and arranged such that insertion of said access cartridge into said tool means is accomplished by squeezing said access cartridge handle members together until said ears may pass said retainer lip members, release of said squeezing pressure causing said access cartridge handle members to spring outwardly from the access cartridge longitudinal axis, thereby locking said ears against said semi-circular faces adjacent said retainer lip members so as to prevent disengagement of said access means and tool means until said access cartridge handle member are squeezed together to release the locking relationship.

6. The cooperating combination of claim 5 wherein said retainer lip member of said semi-circular faces is bevelled inwardly from the distal end so as to define a guide for said access means.