Multiple needle holder and subcutaneous multiple channel infusion port.

0001This invention relates to devices for providing infusions of a plurality of fluids repeatably to a patient. In particular, the invention relates to a multiple needle holder and subcutaneous multiple channel infusion port.

0002Implantable vascular access devices are well known in the 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 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 patient having an implanted port are made by inserting a needle through the patient's skin and through the septum in the infusion port. Fluid is injected through the needle and into the reservoir of the port where it passes into the catheter and out into the blood stream.

0003Experimentation 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 application is the use of chemotherapy to treat such diseases as cancer. Attempts at providing more advanced chemotherapy regimens involving the intravenous administration of a multiplicity of drug solutions are being inhibited by a lack of equipment to simplify such a procedure. The use of implanted 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.

0004A dual reservoir double lumen implantable vascular access port is presently available. This dual lumen implantable 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 that, when used for continuous infusion, two separate catheters would hang from the patient, each connected to one of two needles.

0005This invention is directed to a multiple needle holder adapted for engagement with a multilumen locking connector and a subcutaneous multiple channel infusion port.

0006According to the multiple needle holder of the present invention, a plurality of needles extend from the front face of a housing. At the rear of the housing are a plurality of inlet openings each opening provided in a separate engagement port. Preferably, the 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 of the needles on the needle holder is in communication with 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.

0007Also in accordance with the present invention, a multiple channel subcutaneous infusion port provides a plurality of isolated chambers. A penetrable septum overlies the isolated chambers. A multilumen catheter is connected to the infusion port and extends therefrom. Each lumen of the multilumen catheter is connected to a different one of the isolated chambers by a chamber access tube. Each isolated chamber is adjacent the inner surface of the septum such that a plurality of needles aligned in parallel can be inserted through the septum, each needle entering a different one of said isolated chambers.

0008It is an advantage of the present invention that it provides a single 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.

0009Other 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, in which:- <ul id="ul0001" list-style="none"><li>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;</li><li>FIG. 2 is a top view of the multiple channel subcutaneous infusion port of the present invention;</li><li>FIG. 3 is a side view of the infusion port of FIG. 2;</li><li>FIG. 4 is a cross-sectional view of the needle holder of the present invention and a multilumen locking connector; and</li><li>FIG. 5 is a rear plan view of the needle holder of the FIG. 4.</li></ul>

0010Referring now to the drawings, FIGS. 1 to 3 shows a multiple channel 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 distributed around the edge portion of a base 26 of the infusion port 20. The needles 12 penetrate a septum 28 at the top portion of the infusion port and extend through into a plurality of isolated chambers 30. The drawings show a needle holder and multichannel infusion port with four needles and isolated chambers respectively, however, it should be understood that the invention is not limited to any specific number of needles or chambers.

0011The needle holder 10 is shown attached to a multilumen catheter 40 by a multilumen locking connector 50. A multilumen locking connector which may be used in conjunction with the needle holder of the present invention is decribed in U.S. Patent No. 4,581,012. The disclosure of said patent is hereby incorporated by reference herein. As shown in FIG. 1, the locking connector 50 includes a locking ring 52 which engages a flange 14 on the outside of the housing of the needle holder 10. FIG. 1 shows the locking ring 52 prior to engagement with the flange 14.

0012In 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 of the catheter 60.

0013Referring 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 overlies the sealing walls 34 to enclose the chambers 30. A 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 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 chamber access tube 36 for each lumen. 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 wall 34 provides space for the two other access tubes 36 which extend into their respective chamber 30 near the centre of the infusion port 20.

0014In the preferred embodiment, press fit assembly pins 38 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 that 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 26. Sutures may be applied through the slots to hold the infusion port in place within the patients body.

0015The needle holder 10 of the present invention shall now be 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, preferably made from plastic. 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 secured within the housing 11 by a conventional bonding technique, such as gluing or potting. The insertion end of the needles extend out from the front face of the housing 11. The needles 12 are in fluid communication with the inlet openings 18 at the rear face of the housing 11. Each of the openings 18 is located within an engagement port 16. In the embodiment shown the engagement port 16 are female connectors for engagement with the male connectors of a multilumen catheter connector 50. It would be equally possible to interchange 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 the needle holder 10 for engaging the multilumen locking connector 50. As shown in FIG. 4, the multilumen locking connector 50 includes a locking 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 holder. The combination of multilumen catheter 40, multilumen catheter connector 50 and needle holder 10 provide four individual passageways for four separate fluid solutions.

0016The 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 body when the needle holder 10 is inserted into the infusion port 10.

0017Of course, it should be understood that various other changes and modifications to the preferred embodiments described above will be apparent to those skilled in the art. For example, the subcutaneous catheter can be connected to the infusion port through the base instead of the housing.