Percutaneous port catheter assembly and method of use

• US 5,569,217 A
• Filed: 10/27/1994
• Issued: 10/29/1996
• Est. Priority Date: 10/28/1993
• Status: Expired due to Fees

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Luther Medical Products, Inc. (Becton, Dickinson & Co)
• Inventors: Luther, Ronald B.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): NGUYEN, ANH TUAN TUONG
• Application Number:
  US08/331,222
• Time in Patent Office: 733 Days
• Field of Search: 604/164, 604/165, 604/198, 604/280, 604/263, 604/51-52
• US Class Current: 604/539
• CPC Class Codes: A61M 2005/3228 the needle being retracted by a member protruding laterally through a slot in the barrel, e.g. double-ended needles
• CPC Class Codes: A61M 25/0612 Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
• 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 5/3243 being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel devices for protecting guide needles in combination with catheters A61M25/0612
• CPC Class Codes: A61M 5/3271 with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position

Abstract

Apparatus and method for introducing a catheter into a surgically implanted port. The apparatus has a housing attached to a stylet, with the stylet being received in a catheter. Also provided in the apparatus is a casing with a protective cap that slidably fits within the housing. Also disclosed is a method of catheterizing a surgically implanted port by means of inserting a styler encased in a catheter and retracting the stylet.

Claims

1. An apparatus for introducing a catheter into a septum of a surgically implanted port comprising:

a) a catheter for accessing the port, wherein the catheter is comprised of a polytetrafluorethylene polymer;

b) a solid stylet;

c) a housing for securing the stylet within the catheter so that the catheter and styler are maintained in a slidably interconnectible configuration, the housing having at least one member for stably guiding and supporting the interconnected catheter and stylet through the septum of the port;

d) a asking with proximal and distal end portions slidably mounted within the housing, the distal end portion being oriented and designed to simultaneously encase and force the retraction of the stylet, the proximal end portion extending beyond a portion of the housing;

e) a cap fastened to the proximal end portion of the casing, the cap being so connected, that, when depressed, forces the entire length of the casing to advance a distance sufficient to fully retract and encase the styler while permitting the interconnected catheter to disengage from the styler and remain sufficiently embedded within the port;

f) wherein the stylet is internally fastened within the housing;

g) wherein the catheter comprises a tube of flexible material forming distal end proximal end portions, the proximal end portion being connected to a sleeve;

h) wherein the stylet comprises distal and proximal end portions, the distal portion having a shaft and tip, the shaft being shaped and oriented to slidably fit longitudinally within the catheter in a configuration suitable for insertion of both the catheter and the stylet into the septum of the port;

i) wherein the housing comprises a base securely fastened to the proximal end portion of the stylet, the base having at least one passage orifice, the base having a first member protruding axially about the styler toward the distal end of the stylet, the first member being shaped and oriented so as to be received in reversible engagement with the sleeve of the proximal end of the catheter, the base having at least one second member oriented toward the distal end portion of the styler, the second member being shaped and oriented so as to stably hold the catheter and the stylet while the catheter and stylet are in a longitudinally interconnectible configuration suitable for insertion into the septum of the port;

j) wherein the casing comprises a barrel section end portion having at least one member projecting longitudinally from the barrel section so as to form the proximal end portion, the member being designed to be received in the passage orifice and extending longitudinally beyond the housing;

k) wherein the cap comprises an apparatus for fastening the cap to the proximal end portion of the casing, the protective cap having an outer surface that, when depressed, forces the casing to longitudinally advance through the housing toward the distal end of the stylet so that the distal end portion of the casing simultaneously retracts and protectively encases the styler while leaving the catheter embedded within the septum of the port at a depth sufficient to allow for fluid communication between the distal end of the catheter and the reservoir of the port;

l) wherein the base of the housing has two passage orifices, the orifices each having a slot for receiving spring-lock panels;

m) wherein the second member of the base for stably guiding and supporting the interconnected catheter and styler are flexible grips in juxtaposition, the flexible grips each having a slot that, when manually compressed, provides axial support for the interconnected catheter and stylet and provides a structure for applying force to insert the interconnected catheter and styler into the septum of the port;

n) wherein the casing having two proximately projecting members, each member being received in a separate passage orifice; and

o) wherein the cap further comprises two spring-lock panels that descend towards the distal end of the casing that lock the casing into position when the spring-lock panels are compressed into the slots or receiving the spring-lock panels, the slots defining a portion of the passage orifices.

2. The apparatus of claim 1 wherein:

a) the stylet is internally fastened within the housing;

b) the base of the housing has two passage orifices, the orifices each having a slot for receiving spring-lock panels;

c) the second member of the base for stably guiding and supporting the interconnected catheter and stylet are flexible grips in juxtaposition, the flexible grips each having a slot that, when manually compressed, provides axial support for the interconnected catheter and stylet and provides a structure for applying force to insert the interconnected catheter and stylet into the septum of the port;

d) the casing having two proximately projecting members, each member being received in a separate passage orifice; and

e) the cap further comprises two spring-lock panels that descend towards the distal end of the casing that lock the casing into position when the spring-lock panels are compressed into the slots for receiving the spring-lock panels, the slots defining a portion of the passage orifices.

3. The apparatus of claim 2 wherein the catheter has an inside diameter of substantially 0.012 inch to 0.060 inch, and a length of substantially 1 inch to 6 inches.

4. A method of catheterizing a septum of a surgically implanted port comprising the steps of:

a) providing a catheter for accessing the port, a solid stylet attached to a housing having at least one member for stably guiding and supporting the catheter and stylet when the catheter and stylet are in an interconnected configuration suitable for inserting both stylet and catheter into the septum of the port, a casing with proximal and distal end portions being slidably mounted within a portion of the housing, and a cap fastened to the proximal end portion of the casing;

b) slidably interconnecting the catheter around the stylet so that the catheter and stylet are in a reversibly engaging configuration suitable for insertion of both stylet and catheter into the septum of the port;

c) manipulating the member for stably guiding and supporting the interconnected catheter and stylet so that the interconnected catheter and stylet are axially stabilized and immobilized;

d) applying sufficient force to the member for stably guiding and supporting the interconnected catheter and stylet penetrate the septum and remain embedded therein;

e) disengaging the member for stably guiding and supporting the interconnected catheter and stylet;

f) depressing the cap attached to the proximal end portion of the casing with sufficient force to cause the casing to move through the housing so that the distal end portion of a casing simultaneously retracts and protectively encases the stylet;

g) wherein the catheter comprises a tube of flexible material forming distal and proximal end portions, the proximal end portion being connected to a sleeve;

h) wherein the stylet comprises distal and proximal end portions, the distal portion having a shaft and tip, the shaft being shaped and oriented to slidably fit longitudinally within the catheter in a configuration suitable for insertion of both the catheter and the stylet into the septum of the port;

i) wherein the housing comprises a base securely fastened to the proximal end portion of the stylet, the base having at least one passage orifice, the base having a first member protruding axially about the stylet toward the distal end of the stylet, the first member being shaped and oriented so as to be received in reversible engagement with the sleeve of the proximal end of the catheter, the base having at least one second member oriented toward the distal end portion of the stylet, the second member being shaped and oriented so as to stably hold the catheter and the stylet while the catheter and stylet are in a longitudinally interconnectible configuration suitable for insertion into the septum of the port;

j) wherein the casing comprises a barrel section end portion having at least one member projecting longitudinally from the barrel section so as to form the proximal end portion, the member being designed to be received in the passage orifice and extending longitudinally beyond the housing;

k) wherein the cap further comprising an apparatus for fastening the cap to the proximal end portion of the casing, the cap having an outer surface that, when depressed, forces the casing to longitudinally advance through the housing toward the distal end of the stylet so that the distal end portion of the casing simultaneously retracts and protectively encases the stylet while leaving the catheter embedded within the septum of the port at a depth sufficient to allow for fluid communication between the distal end of the catheter and the reservoir of the port;

l) wherein the base of the housing has two passage orifices, the orifices each having a slot for receiving spring-lock panels;

m) wherein the second member of the base for stably guiding and supporting the interconnected catheter and stylet are flexible grips in juxtaposition, the flexible grips each having a slot that, when manually compressed, provides axial support for the interconnected catheter and stylet and provides a structure for applying force to insert the interconnected catheter and stylet into the septum of the port; and

n) wherein the cap further comprises two spring-lock panels that descend towards the distal end of the casing that lock the casing into position when the spring-lock panels are compressed into the slots for receiving the spring-lock panels connected to the base of the housing.

5. The method of claim 4 wherein the catheter has an inside diameter within the range of 0.012 to 0.060 inch and a length within the range of 1 inch to 6 inches.

6. A method of catheterizing a septum of a surgically implanted port comprising the steps of:

a) providing a catheter for accessing the port, a solid stylet attached to a housing having at least one member for stably guiding and supporting the catheter and stylet when the catheter and stylet are in an interconnected configuration suitable for inserting both stylet and catheter into the septum of the port, a casing with proximal and distal end portions being slidably mounted within a portion of the housing, and a cap fastened to the proximal end portion of the casing;

b) slidably interconnecting the catheter around the stylet so that the catheter and stylet are in a reversibly engaging configuration suitable for insertion of both stylet and catheter into the septum of the port;

c) manipulating the member for stably guiding and supporting the interconnected catheter and stylet so that the interconnected catheter and stylet are axially stabilized and immobilized;

d) applying sufficient force to the member for stably guiding and supporting the interconnected catheter and stylet penetrate the septum and remain embedded therein;

e) disengaging the member for stably guiding and supporting the interconnected catheter and stylet;

f) depressing the cap attached to the proximal end portion of the casing with sufficient force to cause the casing to move through the housing so that the distal end portion of a casing simultaneously retracts and protectively encases the stylet;

g) wherein the catheter comprises a tube of flexible material forming distal and proximal end portions, the proximal end portion being connected to a sleeve;

h) wherein the stylet comprises distal and proximal end portions, the distal portion having a shaft and tip, the shaft being shaped and oriented to slidably fit longitudinally within the catheter in a configuration suitable for insertion of both the catheter and the stylet into the septum of the port;

i) wherein the housing comprises a base securely fastened to the proximal end portion of the stylet, the base having at least one passage orifice, the base having a first member protruding axially about the stylet toward the distal end of the stylet, the first member being shaped and oriented so as to be received in reversible engagement with the sleeve of the proximal end of the catheter, the base having at least one second member oriented toward the distal end portion of the stylet, the second member being shaped and oriented so as to stably hold the catheter and the stylet while the catheter and stylet are in a longitudinally interconnectible configuration suitable for insertion into the septum of the port;

j) wherein the casing comprises a barrel section end portion having at least one member projecting longitudinally from the barrel section so as to form the proximal end portion, the member being designed to be received in the passage orifice and extending longitudinally beyond the housing;

k) wherein the cap further comprises an apparatus for fastening the cap to the proximal end portion of the casing, the cap having an outer surface that, when depressed, forces the casing to longitudinally advance through the housing toward the distal end of the stylet so that the distal end portion of the casing simultaneously retracts and protectively encases the stylet while leaving the catheter embedded within the septum of the port at a depth sufficient to allow for fluid communication between the distal end of the catheter and the reservoir of the port;

l) wherein the stylet is internally fastened within the housing;

m) wherein the base of the housing has two passage orifices, the orifices each having a slot for receiving spring-lock panels;

n) wherein the second member of the base for stably guiding and supporting the interconnected catheter and stylet are flexible grips in juxtaposition, the flexible grips each having a slot that, when manually compressed, provides axial support for the interconnected catheter and stylet and provides a structure for applying force to insert the interconnected catheter and stylet into the septum of the port;

o) wherein the casing has two proximately projecting members, each member being received in a separate passage orifice; and

p) wherein the cap further comprises two spring-lock panels that descend towards the distal end of the casing that lock the casing into position when the spring-lock panels are compressed into the slots for receiving the spring-lock panels, the slots defining a portion of the passage orifices.

7. A method of catheterizing a septum of a surgically implanted port comprising the steps of:

a) providing a catheter for accessing the port, a solid stylet attached to a housing having at least one member for stably guiding and supporting the catheter and styler when the catheter and stylet are in an interconnected configuration suitable for inserting both stylet and catheter into the septum of the port, a casing with proximal and distal end portions being slidably mounted within a portion of the housing, and a cap fastened to the proximal end portion of the casing;

b) slidably interconnecting the catheter around the stylet so that the catheter and stylet are in a reversibly engaging configuration suitable for insertion of both styler and catheter into the septum of the port;

c) manipulating the member for stably guiding and supporting the interconnected catheter and stylet so that the interconnected catheter and stylet are axially stabilized and immobilized;

d) applying sufficient force to the member for stably guiding and supporting the interconnected catheter and stylet penetrate the septum and remain embedded therein;

e) disengaging the member for stably guiding and supporting the interconnected catheter and stylet;

f) depressing the cap attached to the proximal end portion of the casing with sufficient force to cause the casing to move through the housing so that the distal end portion of a casing simultaneously retracts and protectively encases the stylet;

g) wherein the catheter comprises a tube of flexible material forming distal and proximal end portions, the proximal end portion being connected to a sleeve;

h) wherein the styler comprises distal and proximal end portions, the distal portion having a shaft and tip, the shaft being shaped and oriented to slidably fit longitudinally within the catheter in a configuration suitable for insertion of both the catheter and the stylet into the septum of the port;

i) wherein the housing comprises a base securely fastened to the proximal end portion of the stylet, the base having at least one passage orifice, the base having a first member protruding axially about the stylet toward the distal end of the stylet, the first member being shaped and oriented so as to be received in reversible engagement with the sleeve of the proximal end of the catheter, the base having at least one second ember oriented toward the distal end portion of the stylet, the second member being shaped and oriented so as to stably hold the catheter and the stylet while the catheter and stylet are in a longitudinally interconnectible configuration suitable for insertion into the septum of the port;

j) wherein the casing comprises a barrel section end portion having at least one member projecting longitudinally from the barrel section so as to form the proximal end portion, the member being designed to be received in the passage orifice and extending longitudinally beyond the housing;

k) wherein the cap further comprises an apparatus for fastening the cap to the proximal end portion of the casing, the protective cap having an outer surface that, when depressed, forces the casing to longitudinally advance through the housing toward the distal end of the stylet so that the distal end portion of the casing simultaneously retracts and protectively encases the stylet while leaving the catheter embedded within the septum of the port at a depth sufficient to allow for fluid communication between the distal end of the catheter and the reservoir of the port

l) wherein the catheter is comprised of a polytetrafluorethylene polymer;

m) wherein the stylet is internally fastened within the housing;

n) wherein the base of the housing has two passage orifices, the orifices each having a slot for receiving spring-lock panels;

o) wherein the second member of the base for stably guiding and supporting the interconnected catheter and stylet are flexible grips in juxtaposition, the flexible grips each having a slot that, when manually compressed, provides axial support for the interconnected catheter and styler and provides a structure for applying force to insert the interconnected catheter and stylet into the septum of the port;

p) wherein the casing having two proximately projecting members, each member being received in a separate passage orifice; and

q) wherein the cap further comprises two spring-lock panels that descend towards the distal end of the casing that lock the casing into position when the spring-lock panels are compressed into the slots for receiving the spring-lock panels, the slots defining a portion of the passage orifices.