CA1264261A

CA1264261A - Multiple needle holder and subcutanoeus multiple channel infusion port

Info

Publication number: CA1264261A
Application number: CA000532537A
Authority: CA
Inventors: Eric W. Brown
Original assignee: I Flow Corp
Current assignee: I Flow Corp
Priority date: 1986-04-08
Filing date: 1987-03-19
Publication date: 1990-01-09
Anticipated expiration: 2007-01-09
Also published as: US4695273A; EP0241159A2; EP0241159A3; JPS62240069A

Abstract

ABSTRACT OF THE DISCLOSURE

A multiple needle holder and multiple channel subcutaneous infusion port are disclosed. The multiple needle holder carries a plurality of needles which are each in separate fluid communication with a lumen of a plurality of lumens in a multilumen catheter. The multiple infusion port includes a septum which overlies a plurality of isolated chambers. Each chamber is accessed by a tube which connects to a different lumen of a subcutaneous multilumen catheter.
When the needles of said needle holder are inserted through the septum of said infusion port each of said needles is in communication with a different one of said isolated chambers.

Description

¦¦BACKGROUND OF THE INVENTION ,, This invention relates to devices for providing infusions 'lof a plurality of fluids repeatably to a patient. In Iparticular, the invention relates to a multiple needle holder iland subcutaneous multiple channel infusion port.
5 ,' Implantable vascular access devices are well known in the l'art. A conventional implantable port includes a single ,'reservoir having a catheter attached thereto. The catheter is fed into a blood vessel in a patient's body. Fluid , injected into the reservoir of the implanted port flows 10 ,through the catheter and into the blood stream. The infusion port is implanted beneath the skin of the patient. The top of the port has a septum which is penetrable by a hypodermic "needle. Thus, conventional injections of medicament into a Ipatient having an implanted port are made by inserting a 15',needle through the patient's skin and through the septum in the infusion port. Fluid is injected through the needle and llinto the reservoir of the port where it passes into the ,Icatheter and out into the blood stream.
il ~xperimentation and advances in medicine are creating new needs for infusing more than a single fluid into a patient.
~There are many applications for which there is a need for ~intravenous administration of a plurality of fluid solutions. One such applicatlon is the use of chemotherapy ~V~

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~¦to treat such diseases as cancer. Attempts at providing more ¦ladvanced chemotherapy regimens involving the intravenous ¦ladministration of a multiplicity of drug solutions are being !linhibited by a lac~ of equipment to simplify such a 5 ¦~procedure. The use of implantecl infusion ports for ,delivering drug solutions to a patient are desirable since they deliver the fluid solution directly into the blood ,stream where it is quickly delivered throughout the body.
, A dual reservoir double lumen implantable vascular access ~port is presently available. This dual lu~en implantab~e ,port made available by Cormed, Inc. of Medina, New York has ',two separate stainless steel reservoirs mounted in a silicone rubber base. Each reservoir is connected to an individual branch of a double lumen catheter. Each reservoir has its ,own septum through which a needle may be inserted to inject fluid into a patient. This dual lumen port has the "limitation of only allowing for the injection of two fluids simultaneously. A further disadvantage of this device is 'Ithat, when used for continuous infusion, two separate 20 ~catheters would hang from the patient, each connected to one jof two needles.

SUMMARY OF THE INVENTION
This invention is directed to a multiple needle holder adapted for engagement with a multilumen locking connector nd a subcutaneo-- multiple chann-l infusion port.

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¦ According to the multiple needle holder of the present ¦iinvention, a plurality of needles extend from the front face of a housing. At the re2r of the housing are a plurality of linlet openings each opening provided in a separate engagement S jlport. A flange extends from the housing for engagement with ~a locking ring on a multilumen locking connector. Each lumen of the multilumen connector engages one of the engagement ports at the rear of the housing of the needle holder. Each l~of the needles on the needle holder is in communication with 10 ~'an inlet opening at the rear of the housing. Thus, upon connection to a multilumen catheter each needle is in communication with one of the lumens of that catheter.
j In accordance with the multiple channel subcutaneous iinfusion port of the present invention, the infusion port 15 I,provides a plurality of isolated chambers. A penetrable ',septum overlies the isolated chambers. A multilumen catheter jiis connected to the infusion port and extends therefrom.
,Each lumen of the multilumen catheter is connected to a I'ldifferent one of the isolated chambers by a chamber access 20 Ijtube. Each isolated chamber is adjacent the inner surface of ¦the septum such that a plurality of needles aligned in ~5 ¦parallel can be inserted through the septum~each needle

3~ b ¦entering a different one of said isolated chambers.
¦ It is an object of the present invention to provide a 25 !jsingle implantable port which can be used in the injection of a plurality of fluid solutions. It is a further advantage of the present invention that it keeps each of the plurality of fluids solutions being injected into the port isolated from one another until the fluid reaches the blood stream. The present invention advantageously provides for infusion of a plurality of fluids into an implanted infusion port through the use of a single catheter and needle holding device.
Other objects and advantages of the invention will become apparent during the following description of the presently preferred embodiments of the invention taken in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DR~WINGS
FIG. 1 is a plan view in partial cross-section of the needle holder and infusion port of the present invention as they would appear in use on a patient.
FIG. 2 is a top view of the multiple channel subcutaneous infusion port of the present invention.
FIG. 3 iS a side view of the infusion port of FIG. 2.
FIG. 4 iS a cross-sectional view of the needle holder of the present invention and a multilumen locking connector.
FIG 5 iS a rear plan view of the needle holder of the FIG. 4.

2~ l IIDETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
¦' Referring now to the drawings, FIG. 1 shows a multiple llchannel needle holder 10 with its needles 12 inserted into a ¦multiple channel subcutaneous infusion port 20. The infusion ¦,port 20 is implanted within the layer of fatty tissue 23 underneath the skin surface 21. Sutures 22 hold the infusion ¦port to the muscle wall 25 beneath the fatty tissue. The '~sutures 22 are applied through slots 24 distribu.ed around ,Ithe edge portion of a base 26 of the infusion port 20. The j,needles 12 penetrate a s~ptum 28 at the top portion of the linfusion port and extend through into a plurality of isolated ~chambers 30. The drawings how a needle holder and multichannel infusion port with four needles and isolated chambers respectively, however, it should be understood that ,Ithe invention is not limited to any specific number of Ineedles or chambers.
The needle holder 10 is shown attached to a multilumen jcatheter 40 by a multilumen locking connector 50. A
multilumen locking connector which may be used in conjunction ~jwith the needle holder of the present invention is described l¦in allowed U.S. Patent Application Serial No. 678,481, filed December 5, 1984 which will issue as U.S. Patent No.
¦¦4,581,012 on April 8, 1986 and sharing the same Assignee as llthe present invention. The disclosure of said patent is jlhereby incorporated by reference herein. As shown in FIG. 1, the locking connector 50 includes a locking ring 52 which engag(s a flange 14 on the outside of the ho~sing of the ~L26~26~L

needle holder 10. FIG. 1 shows the locking ring 52 prior to engagement with the flange 14.
In operation, individual fluid solutions are passed through each lumen of the multilumen catheter 40 into the needle holder 10 where they are injected through the needles 12 into the isolated chambers 30 of the infusion port 20.
The fluids continue out of the infusion port 20 through a subcutaneous multilumen catheter 60. Each fluid solution thus remains isolated from each of the other fluid solutions until it reaches the blood stream at the end o~ the catheter 60.
Referring now to FIGS. 2 and 3, the multichamber subcutaneous infusion port is discussed in greater detail.
The housing of the port includes a housing wall 32 resting upon the base 26 of the port. Located within the housing are sealing walls 34 which isolate each chamber 30 from one another and a septum 28 which o~erlies the sealing walls 34 to enclose the chambers 30. ~ silicon gasket may be placed between sealing walls 34 and base 26 to aid in sealing the chambers. The housing wall 32, base 26 and sealing walls 34 are preferably made out of stainless steel. The inner face of the septum 28 is adjacent the chambers 30 and is on the opposite side of the septum from an outer face which is exposed through the top of the housing. The septum 28 is made of a penetrable self sealing material, typically i2~;~2~
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silicone. A multilumen catheter 60 is connected to the ¦infusion port 20 through a hole in the housing. Each lumen of the multilumen catheter is in communication with a chamber !¦access tube 36. There is a chambex access tube 36 for each Illumen. Each chamber access tube 36 is in communication with a different one of the isolated chambers 30 for conducting fluid out its respective chamber. In the preferred embodiment shown, the hole in the housing is adjacent two ,'chambers 30. The access tubes 36 for these chambers feed ''immediately into the multilumen catheter 60. A conduit 37 'through a sealing w211 34 provides space for the two other ~access tubes 36 which extend into their respective chamber 30 'near the center of the infusion port 20.
In the preferred embodiment, press fit assembly pins 38 1~, hold the housing wall 32 to the base 50. The top portion of .
,,the housing 32 holds the septum 28 in place over the sealing ,walls 34. The top portion of the housing can be shaped as , the sealing walls 34 to provide solid portions over the ~sealing walls and openings superimposed over said chambers so ,Ithat a needle injected into the septum 28 will be inserted into a chamber 30 rather than a sealing wall 34. Slots 24 are provided about the periphery of the base 50. Sutures may be applied through the slots to hold the infusion port in ,!~lace within the patients body.

_~_ The needle holder 10 of the present invention shall now lbe described with reference to FIGS. 4 and 5. The needle :,holder 10 of FIG. 4 is shown with curved needles 12. The ¦,needle holder is made with a housing 11, preferahly made from llplastic. Curved needles are an alternative to the straight needles shown in FIG. 1. Curved needles advantageously hold 'more securely onto an infusion port. The needles 12 are isecured within the housing 11 by a conventional bonding ltechnique, such as gluing or potting. The insertion end of ,jthe needles extend out from the front face of the housing '~11. The needles 12 are in fluid communication with the inlet openings 18 ak the rear face of the housing 11. Each of the openings 18 i5 located within an engagement port 16. In the embodiment shown the engagement port 16 are female connectors 'i .
,for engagement with the male connectors of a multilumen l~catheter connector 50. It would be equally possible to jinterchange this arrangement and provide male engagement ports 16 on the needle holder 10 and female connectors on the !multilumen catheter connector 50. A flange 14 extends from i~the needle holder 10 for engaging the multilumen locking connector 50. As shown in FIG. 4, the multilumen locking connector 50 includes a loc~ing ring 52 which has a threaded ¦interior. The threaded interior engages the flange 14 and ¦allows the connector to be screwed tightly onto the needle ¦~older. The combination of multilumen catheter 40, ¦~ultilumen catheter connector 50 and needle holder 10 provide ¦~our individual passageways for four separate fluid ~olutions.

2~;3 The needle holder may be changed so that the front face ¦and rear face of the needle holder housing are perpendicular ',to each other. This would advantageously allow the external ¦catheter 40 to lie flat against a patient's boay when the ¦needle holder 10 is inserted into the infusion port 10.
', Of course, it should be understood that various other l'changes and modifications to the preferred embodiments ,described a~ove will be apparent to those skilled in the 'jart. For example, the subcutaneous catheter can be connected ',,to the infusion port through the base instead of the housing.
This and other changes can be made without departing frcm the spirit and the scope of the invention and without diminishing iits attendent advantages. It is therefore intended that such changes and modifications be covered by the following claims:

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Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE PROPERTY
OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A multiple needle holder comprising:
a housing having a housing wall surrounding a plurality of conduits extending from a rear face on said housing to a front face;
a plurality of needles secured within said housing so that each of said needles is in communication with one of the said conduits, said needles extending outwards from the front face of said housing;
a plurality of engagement ports on the rear face of said housing each having an opening in communication with one of said conduits, said engagement ports being arranged so as to be matingly aligned with a plurality of ports on a multilumen catheter connector; and means extending outwardly from said housing wall for engaging a locking mechanism.

2. The needle holder of Claim 1 wherein said means for engaging a locking mechanism comprises a flange extending outwardly from said housing wall.

3. The needle holder of Claim 1 wherein each of said plurality of needles is curved.

4. The needle holder of Claim 1 wherein the rear face of said housing is perpendicular to the front face of said housing.

5. A multiple channel infusion port comprising:
a housing including a housing wall and a base;
a penetrable self-sealing septum held within said housing and having an outer face adjacent at least one opening in said housing and an inner face on the opposite side of said septum from said outer face;
a plurality of isolated chambers adjacent the inner face of said septum;
a sealing wall separating each of said isolated chambers from one another; and a plurality of access tubes each in communication with one of said isolated chambers for conducting fluid out of the isolated chambers.

6. The mutliple channel infusion port of claim 5 further comprising a multilumen catheter, each lumen of said catheter being in communication with one of said access tubes.

7. The multiple channel infusion port of claim 5 further comprising slot means in the base of said housing for enabling sutures to be applied therethrough.

8. The multiple channel infusion port of claim 5 wherein said housing includes a top portion having solid portions overlying said sealing wall and openings superimposed over said chambers.

9. A multiple needle holder and infusion port comprising:
a housing having a rear face and a front face, a plurality of needles secured within said housing and extending from the front face of said housing;
a plurality of engagement ports on the rear face of said housing each having an opening in communication with one of said needles; and an infusion port having a plurality of isolated chambers beneath a self-sealing septum such that when the needles of said needle holder penetrate through said septum each needle is in communication with a different one of said chambers.

10. The multiple needle holder and infusion port of claim 9 wherein said infusion port includes a plurality of access tubes each in communication with one of said isolated chambers for conducting fluid out of the isolated chambers.

11. The multiple needle holder and infusion port of claim 10 further comprising a multilumen catheter, each lumen of said catheter being in communication with one of said access tubes.

12. The multiple needle holder and infusion port of claim 9 further comprising slot means on said infusion port for enabling sutures to be applied therethrough.

13. The multiple needle holder and infusion port of claim 9 wherein the rear face of said housing is perpendicular to the front face of said housing.