Implantable therapeutic substance delivery device with septum guide and method of use

• US 20070255234A1
• Filed: 04/28/2006
• Published: 11/01/2007
• Est. Priority Date: 04/28/2006
• Status: Active Grant

• Current Assignee: Beth Bullemer, James Haase, Wende Dewing, William Wenger
• Original Assignee: Beth Bullemer, James Haase, Wende Dewing, William Wenger
• Inventors: Haase, James, Dewing, Wende, Bullemer, Beth, Wenger, William
• Granted Patent: US 8,348,909 B2
• Time in Patent Office: Days
• US Class Current: 604/288.10
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• 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 39/04 having pierceable self-sealing members
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 5/14276 specially adapted for implantation

Abstract

An implantable delivery device including a housing, a port assembly, and a plurality of grooves. The housing includes an outer wall defining an exterior face. The port assembly includes a septum and a port opening that is exteriorly open relative to the housing face. The plurality of grooves are formed in the exterior face proximate the port opening, and are sized to receive a needle tip to guide the needle tip toward the port opening. In one embodiment, the port assembly is fluidly connected to a reservoir, such that the port assembly constitutes a reservoir refill port.

Claims

1. An implantable medical device for delivering a liquid therapeutic substance to a delivery site within a patient, the device comprising:

a housing including an outer wall defining an exterior face;

a port assembly including a port passage terminating at a port opening that is exteriorly open relative to the exterior face, and a septum disposed across the port passage; and

a plurality of grooves formed in the exterior face proximate the port opening, the grooves being open relative to an exterior of the device and sized to receive a needle tip.

2. The device of claim 1, wherein each of the grooves are configured and located to guide a needle tip positioned therein toward the port opening.

3. The device of claim 1, wherein each groove extends continuously between a leading end and a trailing end, the leading end of each groove being formed immediately adjacent the port opening and the trailing end being spaced from the port opening a distance greater than the leading end.

4. The device of claim 3, wherein each of the grooves includes a leading segment terminating in the leading end, and further wherein the leading segment is linear.

5. The device of claim 4, wherein an axis of each of the linear leading segments approximately intersects a center point of the port opening.

6. The device of claim 4, wherein an entirety of each of the grooves is linear.

7. The device of claim 1, wherein the port opening includes an outer perimeter, an inner perimeter, and a conical surface extending between the inner and outer perimeters, and further wherein each of the grooves terminates adjacent the outer perimeter.

8. The device of claim 1, wherein the port opening is defined by the exterior face of the housing.

9. The device of claim 1, wherein the port assembly further includes a port wall forming the port opening and passage, the port wall being assembled to an aperture in the exterior face.

10. The device of claim 1, wherein the plurality of grooves include at least four discrete grooves.

11. The device of claim 1, wherein the plurality of grooves includes at least twelve discrete grooves.

12. The device of claim 1, wherein each of the grooves are formed to extend in a radial fashion relative to a center point of the port opening.

13. The device of claim 1, wherein an equidistant spacing interval is defined between at least three adjacent grooves, the spacing interval being in the range of 15°

-30°

.

14. The device of claim 1, wherein at least two of the grooves have a length of at least 0.125 inch.

15. The device of claim 1, wherein at least two of the grooves have a depth of at least 0.001 inch.

16. The device of claim 1, wherein the housing maintains a reservoir for containing the liquid therapeutic substance, and further wherein the port assembly is fluidly connected to the reservoir such that the port assembly is a reservoir refill port assembly.

17. The device of claim 1, wherein the device further includes an implantable catheter fluidly connected to a reservoir otherwise containing the liquid therapeutic substance, the catheter adapted to deliver the therapeutic substance from the reservoir to a delivery site within the patient, and further wherein the port assembly is fluidly connected to the catheter such that the port assembly is a catheter access port assembly.

18. A method of percutaneously delivering a hypodermic needle to a septum within a port assembly passage of a human implantable therapeutic substance delivery device, the device including a housing having an outer wall defining an exterior surface along which a port opening to the passage is exteriorly accessible, the method comprising:

providing a plurality of grooves in the exterior face of the outer wall such that the grooves are exteriorly open, each groove extending from a trailing end to a leading end located proximate the port opening;

percutaneously directing a tip of the needle toward the delivery device;

locating the tip within one of the grooves at a point spaced from the corresponding leading end;

tracking the needle tip along the groove within which the needle tip is located toward the leading end thereof;

wherein the groove within which the needle tip is located serves a guide for directing the needle tip toward the port opening; and

upon reaching the leading end of the groove within which the needle tip is located, continuing movement of the needle tip beyond the groove and into the port opening for interfacing with the septum.

19. The method of claim 18, wherein the hypodermic needle is provided as part of a syringe assembly further including a handle portion, and further wherein locating the needle tip within one of the grooves and tracking the needle tip along one of the grooves is characterized by a user hand manipulating the handle portion.

20. The method of claim 18, wherein locating the needle tip within one of the grooves includes:

contacting the needle tip against the exterior face of the wall at a point apart from any of the grooves; and

moving the needle tip across the exterior face until the needle tip is located within one of the grooves.

21. The method of claim 20, wherein moving the needle tip across the exterior face further includes:

prior to moving the needle tip across the exterior face, estimating an approximate location of the port opening;

wherein movement of the needle tip across the exterior face to locate one of the grooves occurs in a direction generally perpendicular to the estimated location of the port opening.

22. The method of claim 18, further comprising:

prior to tracking the needle tip across the groove;

implanting the device beneath the skin of a patient;

estimating an approximate location of the port opening;

piercing the needle tip through the patient'"'"'s skin at the estimated port opening location;

tactilely determining whether the needle tip is within the port opening; and

tactilely determining whether the needle tip is located within one of the grooves.

23. An implantable medical device for delivering a liquid therapeutic substance to a delivery site within a patient, the device comprising:

a housing including an outer wall defining an exterior face;

a port assembly including a port passage terminating at a port opening that is exteriorly open relative to the exterior face and a septum disposed across the port passage; and

a plurality of discretely formed needle guide means for guiding a needle tip from a point spaced from the port opening to the port opening.

24. The device of claim 23, wherein each of the guide means is a groove.

25. The device of claim 23, wherein the housing maintains a reservoir within which the liquid therapeutic substance is contained, and further wherein the port is fluidly connected to the reservoir such that the port constitutes a reservoir refill port.

26. A method of manufacturing an implantable medical device for delivering a liquid therapeutic substance to a delivery site within a patient, the method comprising:

providing a housing including an outer wall defining an exterior face;

assembling a port assembly to the housing, the port assembly including a passage and a septum disposed across the passage;

wherein upon assembly of the port assembly to the housing, a port opening to the passage is defined, the port opening being exteriorly open relative to the exterior face; and

forming a plurality of grooves in the exterior face proximate the port opening such that the grooves are open relative to an exterior of the housing.

27. The method of claim 26, wherein forming the plurality of grooves includes one of inscribing or etching the exterior face.