US20090234303A1 - Medical Device Needle Receiving Port - Google Patents

Medical Device Needle Receiving Port Download PDF

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Publication number
US20090234303A1
US20090234303A1 US12/372,438 US37243809A US2009234303A1 US 20090234303 A1 US20090234303 A1 US 20090234303A1 US 37243809 A US37243809 A US 37243809A US 2009234303 A1 US2009234303 A1 US 2009234303A1
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United States
Prior art keywords
needle
port
entrance opening
septum
bevel
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
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US12/372,438
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Edgardo C. Halili
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Individual
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Individual
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Priority to US12/372,438 priority Critical patent/US20090234303A1/en
Publication of US20090234303A1 publication Critical patent/US20090234303A1/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A61M2039/0226—Subcutaneous access sites for injecting or removing fluids having means for protecting the interior of the access site from damage due to the insertion of a needle

Definitions

  • This invention relates generally to medical devices and more particularly to a port suitable for use in an implantable drug delivery device for exchanging fluid with a hypodermic needle.
  • Various medical devices e.g., implantable drug delivery devices, have one or more needle receiving ports (e.g. to access a reservoir or a catheter) which may include a needle access hole dimensioned to deny access to needles larger than a predetermined diameter.
  • a needle access hole dimensioned to deny access to needles larger than a predetermined diameter.
  • U.S. Pat. No. 6,293,922 describes a port comprised of a conical depression leading to a central access hole which has “a diameter substantially the same as the predetermined diameter for preventing access to the septum” by oversized hypodermic needles. Needles having diameters smaller than the predetermined diameter are able to pass through the access hole and septum to exchange fluid with the reservoir or catheter.
  • a physical stop e.g., a pad made of firm, biocompatible polymer material
  • a physical stop is inserted below the septum to engage the needle's tip to limit penetration and provide a tactile feedback to the user advising that the tip of the needle has bottomed.
  • the fragile needle tip can sometimes engage a surface which may cause it to curl up like a fish hook. The hook portion can then damage the septum when the needle is withdrawn from the port.
  • Implantable medical device ports may also incorporate some type of filtering means, e.g., a sintered or mesh material, to prevent the introduction of particulate matter into the reservoir or catheter.
  • filtering means e.g., a sintered or mesh material
  • the present invention is directed to a medical device needle receiving port configured to stop a needle's penetration without physically engaging the needle's tip thereby reducing the likelihood of tip damage.
  • Typical hypodermic needles have a cannula or barrel portion whose outer diameter D 1 indicates the needle's size, e.g., a 25 gauge needle has an outer diameter between 0.0205 and 0.0195 inches.
  • the distal end of the cannula typically includes a beveled surface which forms a needle point end having an axial length L 1 and an outer diameter which diminishes from D 1 adjacent to the cannula to D 2 at the needle tip.
  • a port in accordance with the present invention, includes a needle stop member having a hole defining a diameter D 3 where D 1 >D 3 >D 2 such that the needle point end can extend into the hole but is prevented from passing therethrough as a consequence of the point end surface engaging the stop member adjacent to the hole.
  • the hole is configured to define an obstruction-free axial length, or depth, L 2 where L 2 >L 1 .
  • a port in accordance with the invention preferably also includes a particulate collection chamber located beyond the needle stop hole.
  • the collection chamber has one or more fluid outlets dimensioned to prevent particulate matter, introduced by the needle's insertion, from passing through to the reservoir or catheter.
  • FIG. 1 is a plan view of an exemplary implantable drug delivery device having two needle receiving ports
  • FIG. 2 is an enlarged sectional view taken substantially along the plane 2 - 2 of FIG. 1 showing a preferred port construction in accordance with the present invention
  • FIG. 3 is a plan view of FIG. 2 showing the port entrance opening
  • FIG. 4A is an enlarged view of FIG. 2 showing how the penetration of a hypodermic needle is stopped without engaging the needle tip;
  • FIG. 4B is identical to FIG. 4A but shows the needle rotated by 90°;
  • FIG. 5 is an exploded perspective view of the needle receiving port of FIG. 3 ;
  • FIG. 6 is a sectional view taken substantially along the plane 6 - 6 of FIG. 2 .
  • FIG. 1 is a plan view of an exemplary implantable drug delivery device 10 intended to be configured in accordance with the present invention.
  • the device 10 comprises a housing 12 enclosing an interior volume (not shown) and defining first and second needle receiving ports 14 and 16 .
  • Port 14 is adapted for accessing an internal fluid drug reservoir (not shown) to fill or evacuate the reservoir.
  • Port 16 is adapted for accessing, via port 18 , a catheter 19 to either extract a sample and/or introduce a fluid into the catheter.
  • the housing 12 includes one or more interior fluid passageways (not shown) for coupling the reservoir via a controllable fluid transfer device (not shown), e.g., a pump or valve, to the port 16 for delivering fluid medication via catheter 19 to a patient's body site.
  • a controllable fluid transfer device e.g., a pump or valve
  • port 14 typically includes a conical side wall 20 converging toward a central needle receiving entrance hole 21 .
  • the hole 21 is preferably dimensioned to have a diameter small enough to prevent the entry of needles larger than a given size.
  • port 16 includes a side wall 23 converging toward a needle receiving entrance opening 24 which is shown for exemplary purposes as comprising a slot having a width narrow enough to prevent the entry of needles larger than a given size.
  • a port in accordance with the present invention ( FIGS. 2-6 ) can be configured with an entrance opening in the form of either a hole, e.g. 21 , or a slot, e.g. 24 .
  • FIGS. 2-6 illustrate a preferred embodiment of an exemplary port, e.g., port 16 , in accordance with the present invention.
  • the needle receiving port 16 is comprised of an inverted cup shaped port body 30 defining an interior cavity 31 having an internal diameter 32 .
  • a septum 34 typically a pliable self healing membrane, is mounted in the cavity 31 above a needle stop member 36 .
  • a bottom cover 40 is sealed along interface 42 to the inside wall of cavity 31 to retain the septum 34 and stop member 36 in place.
  • the sealed interface 42 is fluid tight to prevent leakage.
  • the needle stop member 36 in a preferred embodiment, includes a funnel shaped recess 44 having a side wall 45 which converges from an entrance mouth 47 to a needle stop hole 48 .
  • the hole 48 has a diameter D 3 ( FIG. 4A ) selected such that D 3 is less than the outer diameter D 1 of the cannula of an acceptable hypodermic needle N 1 ( FIG. 4A ).
  • FIGS. 4A and 4B depict an exemplary needle N 1 having a cannula 49 and a point end 50 formed by an oblique surface 51 .
  • the point end terminates at a needle tip 52 .
  • the outer diameter of the cannula 49 is represented by D 1 .
  • the point end 50 has an outer diameter which diminishes from D 1 adjacent to the cannula to D 2 (close to zero) at the needle tip 52 .
  • the axial length of the point end 50 is represented by L 1 .
  • the stop hole 48 diameter D 3 is selected to be less than D 1 and greater than D 2 .
  • the depth of stop hole 48 is selected such that L 2 , the sum of the hole's axial length plus an obstruction-free depth therebeneath, is longer than the axial length L 1 of the needle point end 50 .
  • the needle point end 50 will be inserted into the port to pierce the septum 34 .
  • the point end will then be guided by side wall 45 of recess 44 into stop hole 48 .
  • D 1 >D 3 >D 2 the point end 50 will project into hole 48 with the oblique, or bevel, surface 51 engaging the stop member 36 adjacent to the hole 48 .
  • L 2 >L 1 the needle tip 52 is held out of engagement with any surface thereby avoiding tip damage.
  • the needle stop member 36 is relieved at 54 to form a particulate chamber 38 between the bottom cover 40 and the stop member 36 .
  • the hole 48 opens into the particulate chamber 38 .
  • the circumferential wall 58 ( FIG. 6 ) of the particulate chamber 38 has one or more radial openings 60 dimensioned no larger in any direction than a dimension M.
  • the opening(s) 60 extend radially outward from the inner surface 62 to the outer surface 64 of the circumferential wall 58 to a circumferential fluid passageway 66 .
  • An inlet tube 68 ( FIG. 2 ) and an outlet tube 70 are coupled to the passageway 66 .
  • the inlet tube 68 typically carries fluid from the aforementioned reservoir and fluid transfer means (not shown) and the outlet tube typically carries fluid to the catheter port 18 .
  • the chamber 38 will retain any particulate matter greater than the dimension M, which otherwise could be disadvantageously introduced by the needle into the fluid flow to the catheter.
  • an improved needle receiving port has been disclosed herein characterized by a stop member having a hole dimensioned to receive a needle point end for stopping axial penetration of the needle without engaging the needle tip.
  • the preferred embodiment efficiently incorporates a chamber for trapping oversized particles.

Abstract

A medical device needle receiving port configured to stop a needle's penetration without physically engaging the needle's tip thereby reducing the likelihood of tip damage. The port preferably incorporates a particulate chamber for collecting particulates larger then a fluid outlet dimension.

Description

    RELATED APPLICATION
  • This application claims the benefit of U.S. provisional application 60/549,288 filed 2 Mar. 2004.
    • FIELD OF THE INVENTION
  • This invention relates generally to medical devices and more particularly to a port suitable for use in an implantable drug delivery device for exchanging fluid with a hypodermic needle.
    • BACKGROUND OF THE INVENTION
  • Various medical devices, e.g., implantable drug delivery devices, have one or more needle receiving ports (e.g. to access a reservoir or a catheter) which may include a needle access hole dimensioned to deny access to needles larger than a predetermined diameter. For example, U.S. Pat. No. 6,293,922 describes a port comprised of a conical depression leading to a central access hole which has “a diameter substantially the same as the predetermined diameter for preventing access to the septum” by oversized hypodermic needles. Needles having diameters smaller than the predetermined diameter are able to pass through the access hole and septum to exchange fluid with the reservoir or catheter. Generally, a physical stop, e.g., a pad made of firm, biocompatible polymer material, is inserted below the septum to engage the needle's tip to limit penetration and provide a tactile feedback to the user advising that the tip of the needle has bottomed. Unfortunately, however, the fragile needle tip can sometimes engage a surface which may cause it to curl up like a fish hook. The hook portion can then damage the septum when the needle is withdrawn from the port.
  • Implantable medical device ports may also incorporate some type of filtering means, e.g., a sintered or mesh material, to prevent the introduction of particulate matter into the reservoir or catheter.
    • SUMMARY OF THE INVENTION
  • The present invention is directed to a medical device needle receiving port configured to stop a needle's penetration without physically engaging the needle's tip thereby reducing the likelihood of tip damage.
  • Typical hypodermic needles have a cannula or barrel portion whose outer diameter D1 indicates the needle's size, e.g., a 25 gauge needle has an outer diameter between 0.0205 and 0.0195 inches. The distal end of the cannula typically includes a beveled surface which forms a needle point end having an axial length L1 and an outer diameter which diminishes from D1 adjacent to the cannula to D2 at the needle tip. A port, in accordance with the present invention, includes a needle stop member having a hole defining a diameter D3 where D1>D3>D2 such that the needle point end can extend into the hole but is prevented from passing therethrough as a consequence of the point end surface engaging the stop member adjacent to the hole. The hole is configured to define an obstruction-free axial length, or depth, L2 where L2>L1. Thus, the fragile needle tip is prevented from engaging any stop surface and damage to the tip is avoided.
  • A port in accordance with the invention preferably also includes a particulate collection chamber located beyond the needle stop hole. The collection chamber has one or more fluid outlets dimensioned to prevent particulate matter, introduced by the needle's insertion, from passing through to the reservoir or catheter.
    • BRIEF DESCRIPTION OF THE FIGURES
  • FIG. 1 is a plan view of an exemplary implantable drug delivery device having two needle receiving ports;
  • FIG. 2 is an enlarged sectional view taken substantially along the plane 2-2 of FIG. 1 showing a preferred port construction in accordance with the present invention;
  • FIG. 3 is a plan view of FIG. 2 showing the port entrance opening;
  • FIG. 4A is an enlarged view of FIG. 2 showing how the penetration of a hypodermic needle is stopped without engaging the needle tip;
  • FIG. 4B is identical to FIG. 4A but shows the needle rotated by 90°;
  • FIG. 5 is an exploded perspective view of the needle receiving port of FIG. 3; and
  • FIG. 6 is a sectional view taken substantially along the plane 6-6 of FIG. 2.
    •  DETAILED DESCRIPTION
  • Attention is initially directed to FIG. 1 which is a plan view of an exemplary implantable drug delivery device 10 intended to be configured in accordance with the present invention. The device 10 comprises a housing 12 enclosing an interior volume (not shown) and defining first and second needle receiving ports 14 and 16. Port 14 is adapted for accessing an internal fluid drug reservoir (not shown) to fill or evacuate the reservoir. Port 16 is adapted for accessing, via port 18, a catheter 19 to either extract a sample and/or introduce a fluid into the catheter. The housing 12 includes one or more interior fluid passageways (not shown) for coupling the reservoir via a controllable fluid transfer device (not shown), e.g., a pump or valve, to the port 16 for delivering fluid medication via catheter 19 to a patient's body site.
  • As depicted in FIG. 1, port 14 typically includes a conical side wall 20 converging toward a central needle receiving entrance hole 21. The hole 21 is preferably dimensioned to have a diameter small enough to prevent the entry of needles larger than a given size. As depicted, port 16 includes a side wall 23 converging toward a needle receiving entrance opening 24 which is shown for exemplary purposes as comprising a slot having a width narrow enough to prevent the entry of needles larger than a given size. A port in accordance with the present invention (FIGS. 2-6) can be configured with an entrance opening in the form of either a hole, e.g. 21, or a slot, e.g. 24.
  • Attention is now directed to FIGS. 2-6 which illustrate a preferred embodiment of an exemplary port, e.g., port 16, in accordance with the present invention. The needle receiving port 16 is comprised of an inverted cup shaped port body 30 defining an interior cavity 31 having an internal diameter 32. A septum 34, typically a pliable self healing membrane, is mounted in the cavity 31 above a needle stop member 36. A bottom cover 40 is sealed along interface 42 to the inside wall of cavity 31 to retain the septum 34 and stop member 36 in place. The sealed interface 42 is fluid tight to prevent leakage.
  • The needle stop member 36, in a preferred embodiment, includes a funnel shaped recess 44 having a side wall 45 which converges from an entrance mouth 47 to a needle stop hole 48. In accordance with the present invention, the hole 48 has a diameter D3 (FIG. 4A) selected such that D3 is less than the outer diameter D1 of the cannula of an acceptable hypodermic needle N1 (FIG. 4A).
  • More particularly, FIGS. 4A and 4B depict an exemplary needle N1 having a cannula 49 and a point end 50 formed by an oblique surface 51. The point end terminates at a needle tip 52. As depicted in FIG. 4A, the outer diameter of the cannula 49 is represented by D1. The point end 50 has an outer diameter which diminishes from D1 adjacent to the cannula to D2 (close to zero) at the needle tip 52. The axial length of the point end 50 is represented by L1. In accordance with the present invention, the stop hole 48 diameter D3 is selected to be less than D1 and greater than D2. Furthermore the depth of stop hole 48 is selected such that L2, the sum of the hole's axial length plus an obstruction-free depth therebeneath, is longer than the axial length L1 of the needle point end 50.
  • In use, the needle point end 50 will be inserted into the port to pierce the septum 34. The point end will then be guided by side wall 45 of recess 44 into stop hole 48. Because D1>D3>D2, the point end 50 will project into hole 48 with the oblique, or bevel, surface 51 engaging the stop member 36 adjacent to the hole 48. Because L2>L1, the needle tip 52 is held out of engagement with any surface thereby avoiding tip damage.
  • In the preferred embodiment of the invention, the needle stop member 36 is relieved at 54 to form a particulate chamber 38 between the bottom cover 40 and the stop member 36. The hole 48 opens into the particulate chamber 38. The circumferential wall 58 (FIG. 6) of the particulate chamber 38 has one or more radial openings 60 dimensioned no larger in any direction than a dimension M. The opening(s) 60 extend radially outward from the inner surface 62 to the outer surface 64 of the circumferential wall 58 to a circumferential fluid passageway 66. An inlet tube 68 (FIG. 2) and an outlet tube 70 are coupled to the passageway 66. The inlet tube 68 typically carries fluid from the aforementioned reservoir and fluid transfer means (not shown) and the outlet tube typically carries fluid to the catheter port 18. By limiting the dimensions of openings 60, the chamber 38 will retain any particulate matter greater than the dimension M, which otherwise could be disadvantageously introduced by the needle into the fluid flow to the catheter.
  • From the foregoing, it should be recognized that an improved needle receiving port has been disclosed herein characterized by a stop member having a hole dimensioned to receive a needle point end for stopping axial penetration of the needle without engaging the needle tip. Moreover, the preferred embodiment efficiently incorporates a chamber for trapping oversized particles.
  • Although only a single specific embodiment has been described in detail herein, it should be understood that this embodiment is exemplary of various alternative configurations which may occur to those skilled in the art which are consistent with the teachings of the present invention and within the scope of the appended claims.

Claims (21)

1-11. (canceled)
12. A needle port, comprising:
a needle entrance including an entrance opening that defines a width and a length that is greater than the width;
a needle stop including a converging wall and a stop hole that is smaller than the width of the entrance opening; and
a septum located between the entrance opening and the needle stop hole.
13. A needle port as claimed in claim 12, wherein the entrance opening comprises a slot.
14. A needle port as claimed in claim 12, wherein the needle entrance includes a converging wall that terminates at the entrance opening.
15. A needle port as claimed in claim 12, wherein the stop hole defines a diameter that is less than the width of the entrance opening.
16. A needle port as claimed in claim 12, wherein the needle stop converging wall terminates at the stop hole.
17. A needle port as claimed in claim 12, wherein the needle stop converging wall defines a funnel-shaped recess.
18. A needle port as claimed in claim 12, wherein a portion of the septum is located within the needle stop.
19. A needle port as claimed in claim 12, wherein
the needle stop includes a recess; and
the stop hole is located between recess and the converging wall.
20. A needle port as claimed in claim 19, wherein the recess defines a particulate chamber.
21. A needle port for use with a needle having a pointed distal tip and a bevel where the needle diminishes in size down to the pointed distal tip, the needle port comprising:
a needle entrance including an entrance opening;
a surface located in spaced relation to and aligned with the entrance opening; and
means, located between the entrance opening and the surface, for preventing the pointed distal tip of the needle from contacting the surface by engaging the needle bevel after the needle passed through the entrance opening.
22. A needle port as claimed in claim 21, further comprising:
a septum located between the entrance opening and the means for preventing.
23. A needle port as claimed in claim 21, wherein the entrance opening defines a width and a length that is greater than the width.
24. A needle port as claimed in claim 21, wherein the entrance opening comprises a slot.
25. A needle port as claimed in claim 21, wherein the needle entrance includes a converging wall that terminates at the entrance opening.
26. A needle port as claimed in claim 21, further comprising:
a converging wall located between the entrance opening and the means for preventing.
27. A method for use with a needle having a pointed distal tip and a bevel where the needle diminishes in size down to the pointed distal tip, the method comprising the step of:
engaging the bevel after the needle has passed through a septum to prevent further movement of the needle.
28. A method as claimed in claim 27
wherein the engaging the bevel comprises engaging the bevel with a surface after the needle has passed through a septum to prevent further movement of the needle; and
the method further comprises the step of funneling the needle toward the surface that engages the bevel after the needle has passed through the septum.
29. A method as claimed in claim 27
wherein the engaging the bevel comprises engaging the bevel with a surface that defines a hole after the needle has passed through a septum to prevent further movement of the needle; and
the method further comprises the step of funneling the needle toward the hole after the needle has passed through the septum and the pointed distal tip has passed through the hole.
30. A method as claimed in claim 27, further comprising the step of:
funneling the needle toward an entrance opening before the needle passes through the septum.
31. A method as claimed in claim 27, further comprising the step of:
funneling the needle toward an entrance opening defining a width and a length that is greater than the width before the needle passes through the septum.
US12/372,438 2004-03-02 2009-02-17 Medical Device Needle Receiving Port Abandoned US20090234303A1 (en)

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US12/372,438 US20090234303A1 (en) 2004-03-02 2009-02-17 Medical Device Needle Receiving Port

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US54928804P 2004-03-02 2004-03-02
US11/069,296 US7497850B2 (en) 2004-03-02 2005-02-28 Medical device needle receiving port
US12/372,438 US20090234303A1 (en) 2004-03-02 2009-02-17 Medical Device Needle Receiving Port

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US11/069,296 Continuation US7497850B2 (en) 2004-03-02 2005-02-28 Medical device needle receiving port

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US12/372,438 Abandoned US20090234303A1 (en) 2004-03-02 2009-02-17 Medical Device Needle Receiving Port

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US9901687B2 (en) * 2008-01-03 2018-02-27 University Of Southern California Implantable drug-delivery devices, and apparatus and methods for refilling the devices

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