Modular implantable medical device

• US 9,427,554 B2
• Filed: 11/10/2011
• Issued: 08/30/2016
• Est. Priority Date: 07/16/2008
• Status: Active Grant

• Current Assignee: Marvao Medical Limited
• Original Assignee: Marvao Medical Limited
• Inventors: Davey, Christopher
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Thomas, Jr., Bradley G
• Application Number:
  US13/293,820
• Publication Number:
  US 20120059327A1
• Time in Patent Office: 1,755 Days
• Field of Search: 604/174, 604/175, 604533-535, 604/288.01, 604/93.01, 604/891.1
• US Class Current: 1/1
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

The present invention is an implantable medical device that is used deliver materials or energy into a patient'"'"'s physiology, or from one region of a patient'"'"'s physiology to another. The device includes a port element with a passageway therethrough for directing and anchoring a conduit element in a desired location. The implantable port stabilizes an elongated conduit within human physiology for long-term use, and includes a support passageway formed through the port and extending between an upper surface and a lower surface of the port, wherein the support passageway is sized and shaped for receiving the elongated conduit slideably inserted therethrough. The device includes a tissue ingrowth scaffold fixedly disposed on at least a portion of at least one surface of the implantable port for positioning in contact with adjacent tissue.

Claims

1. A medical apparatus comprising an implantable port for implanting in a subcutaneous pocket below a skin surface and a modular conduit assembly mated with the port wherein:

the implantable port comprises a port passageway with a passageway side wall formed completely through the port between a skin-facing port surface and a second port surface, and with a tissue ingrowth scaffold disposed along at least one of the port surfaces; and

,

the modular conduit assembly comprises;

a proximal conduit, sized to achieve a slidable fit with the passageway side wall and to extend proximally and distally from the implantable port, and having a tissue ingrowth sleeve disposed along at least an outer surface portion of the proximal conduit, and wherein the at least outer surface portion of the proximal conduit extends proximally and/or distally from the port surfaces;

a separate distal conduit; and

a conduit connector adapted for connecting a distal end of the proximal conduit with a proximal end of the distal conduit at a subcutaneous conduit connection located at an adjustable distance distal of the implantable port whereby, by sliding the proximal conduit in the port passageway, a length of the proximal conduit that extends distally of the implantable port, and a resulting spacing between the second port surface and the subcutaneous conduit connection, can be adjusted such that, with the implantable port and the proximal conduit mated and implanted, and with the proximal and distal conduits connected, a distal tip of the distal conduit is positioned at a selected internal body site;

further wherein the port passageway is sized along its entire length to generally conform with an outer surface of the proximal conduit to achieve the slidable fit between the proximal conduit and the passageway side wail of the passageway, and further wherein one or more gripping elements are disposed at multiple locations along the passageway side wall of the port passageway between the skin-facing port surface and the second port surface for contacting and slidably retaining the proximal conduit in place when it is positioned inside the port passageway.

2. A medical apparatus according to claim 1 wherein the one or more gripping elements comprise a plurality of raised bumps.

3. A medical apparatus according to claim 1 wherein the one or more gripping elements comprise a plurality of ridges.

4. An implantable medical device for stabilizing an elongated transcutaneous conduit within human physiology for long-term use, wherein the device comprises an implantable port with a port passageway formed through the port between a skin-facing port surface and a second port surface in combination with a conduit that can be positioned to extend through the port passageway, the device further comprising:

(a) a modular conduit assembly comprising separate proximal and distal conduit portions which are connectable during an implantation procedure wherein;

the proximal conduit portion has a proximal end section with a proximal end, a distal end section with a distal end, and a continuous middle section that slidably extends through the port passageway to position the proximal end of the proximal conduit portion above a skin surface and the distal end of the proximal conduit portion at a subcutaneous connection that is at an adjustable distance distal of a subcutaneous pocket for receiving the port on implantation; and

, the distal conduit portion has a proximal end section with a proximal end and a distal end section with a distal tip;

(b) a measurement marking system integrated into the proximal end section of the distal conduit portion, the distal end section of the proximal conduit portion or both so as to enable precise measuring and trimming of the proximal end of the distal conduit portion and/or the distal end of the proximal conduit portion; and

,

(c) a connector sized and configured at one connector end for connection with the proximal end of the distal conduit portion and sized and configured at a second connector end for connection with the distal end of the proximal conduit portion at the subcutaneous connection after one or both conduit portions have been trimmed so as to position the distal tip of the distal conduit portion at a selected internal treatment site when the medical device is implanted and the conduit portions are connected with the connector;

and also wherein graduated markings that comprise the measurement marking system are arranged and numbered such that subtracting a graduated marking noted on the proximal conduit portion from a corresponding graduated marking noted on the distal conduit portion provides numerical guidance on where to trim the proximal end of the distal conduit portion and/or the distal end of the proximal conduit portion so that the proximal and distal conduit portions engage to form an exact length needed to ensure proper placement of the distal tip of the distal conduit portion at the selected internal treatment site.

5. A medical apparatus for establishing a channel between an external body location and a selected internal body site, the apparatus comprising:

(a) an implantable port for implanting in a subcutaneous pocket below a skin surface, the port having a port passageway formed completely through the port between a skin-facing port surface and a second port surface;

(b) a proximal conduit that can pass completely through the port passageway and has a proximal-conduit mid-section between first and second proximal-conduit end sections, whereby when the port is implanted with the proximal-conduit mid-section in the port passageway, the first proximal-conduit end section extends transcutaneously between the skin-facing port surface and a location external to the skin surface, and the second proximal-conduit end section extends between the second port surface and subcutaneous conduit connection located at an adjustable distance distal of the subcutaneous pocket; and

,

(c) a distal conduit that has first and second distal-conduit end sections, wherein the first distal-conduit end section is connectable to the second proximal-conduit end section at the subcutaneous conduit connection such that, when the port and proximal conduit are mated and implanted, a distal tip of the second distal-conduit end section can be positioned at the selected internal body site which is distal of the subcutaneous conduit connection; and

,

further wherein the proximal conduit comprises proximal-conduit measurement markings along the second proximal-conduit end section and/or the distal conduit comprises distal-conduit measurement markings along the first distal-conduit end section that enable precise measuring and trimming of the second proximal-conduit end section and/or the first distal-conduit end section to properly position the distal tip of the distal conduit when the distal conduit and the proximal conduit are connected and implanted;

and also wherein the measurement markings are arranged and numbered such that subtracting a graduated marking noted on the second proximal-conduit end section from a corresponding graduated marking noted on the first distal-conduit end section provides numerical guidance on where to trim the proximal end of the distal conduit and/or the distal end of the proximal conduit so that the proximal and distal conduits engage to form an exact length needed to ensure proper placement of the distal tip of the distal conduit at the selected internal body site.

6. A modular subcutaneous assembly comprising a modular port component for implanting in a subcutaneous pocket for stabilizing a modular transcutaneous catheter for long-term use wherein:

(a) the modular port component comprises;

(i) a first and second subcutaneous element sized and shaped for subdermal insertion and designed for reversible engagement around a continuous portion of a transcutaneous catheter, the first subcutaneous element comprising engagement elements which cooperate with counterpart engagement elements on the second subcutaneous element for aligning and firmly but reversibly engaging the second subcutaneous element with the first subcutaneous element, the first and second subcutaneous elements each further comprising semi-circular wall portions of a tubular support passageway divided lengthwise along the longitudinal axis which semi-circular wall portions cooperate to define a tubular support passageway when the first and second subcutaneous elements are assembled in an engaged state, the tubular support passageway formed by assembly of the first and second subcutaneous elements and being sized to accommodate a continuous portion of a transcutaneous catheter wherein the semi-circular wall portions of the tubular support passageway are substantially continuous and grip the continuous portion of the transcutaneous catheter thereby stabilizing the catheter position; and

(ii) a tissue ingrowth cuff material fixedly disposed on at least one surface of both of the first and second subcutaneous elements for securing the modular subcutaneous assembly to adjacent tissue such that the tissue ingrowth cuff material fixedly disposed on the first subcutaneous elements and the tissue ingrowth material fixedly disposed on the second subcutaneous elements join to form a continuous surface when the first and second subcutaneous elements are assembled in an engaged state; and

,

(b) the modular transcutaneous catheter comprises;

(i) a proximal conduit that can pass completely through the tubular support passageway of the port component and has a proximal-conduit mid-section between a first and a second proximal-conduit end sections, whereby when the modular port component is implanted with the proximal-conduit mid-section in the tubular support passageway, the first proximal-conduit end section extends transcutaneously between a skin-facing modular port component surface and a location external to the skin surface, and the second proximal-conduit end section extends between a second modular port component surface and a subcutaneous conduit connection located at an adjustable distance distal of the subcutaneous pocket; and

,

(ii) a distal conduit that has first and second distal-conduit end sections, wherein the first distal-conduit end section is connectable to the second proximal-conduit end section at the subcutaneous conduit connection such that, when the port component and proximal conduit are mated and implanted, a distal tip of the second distal-conduit end section can be positioned at a selected internal body site which is distal of the adjustable subcutaneous conduit connection point; and

,

further wherein the proximal conduit comprises proximal-conduit measurement markings along the second proximal-conduit end section and/or the distal conduit comprises distal-conduit measurement markings along the first distal-conduit end section that enable precise measuring and trimming of the second proximal-conduit end section and/or the first distal-conduit end section to properly position the distal tip of the distal conduit when the distal conduit and the proximal conduit are connected and implanted.

7. A subcutaneous assembly according to claim 6 wherein the measurement markings are arranged and numbered such that subtracting a graduated marking noted on the second proximal-conduit end section from a corresponding graduated marking noted on the first distal-conduit end section provides numerical guidance on where to trim the proximal end of the distal conduit and/or the distal end of the proximal conduit so that the proximal and distal conduits engage to form an exact length needed to ensure proper placement of the distal tip of the distal conduit at a selected internal body site.

8. A method of using a medical apparatus for establishing a channel between an external body location and a selected internal body site, wherein the apparatus comprises:

(a) an implantable port for implanting in a subcutaneous pocket below a skin surface, the port having a port passageway formed completely through the port between a skin-facing port surface and a second port surface;

(b) a proximal conduit that can pass completely through the port passageway and has a continuous middle section between a first and a second proximal-conduit end section, whereby when the implantable port is implanted with the continuous middle section in the port passageway, the first proximal-conduit end section extends transcutaneously between the skin-facing port surface and a location external to a skin surface, and the second proximal-conduit end section extends between the second port surface and a subcutaneous conduit connection located at an adjustable distance distal of the subcutaneous pocket; and

,

(c) a distal conduit that has a first and a second distal-conduit end section, wherein the first distal-conduit end section is connectable to the second proximal-conduit end section at the subcutaneous conduit connection such that, when the implantable port and proximal conduit are mated and implanted, a distal tip of the second distal-conduit end section can be positioned at the selected internal body site which is distal of the subcutaneous conduit connection; and

,

further wherein the proximal conduit comprises proximal-conduit measurement markings along the second proximal-conduit end section and/or the distal conduit comprises distal-conduit measurement markings along the first distal-conduit end section that enable precise measuring and trimming of the second proximal-conduit end section and/or the first distal-conduit end section to properly position the distal tip of the distal conduit when the distal conduit and the proximal conduit are connected and implanted;

wherein the method comprises the steps of;

implanting the implantable port into the subcutaneous pocket in a patient'"'"'s physiology;

advancing the distal tip of the distal conduit into the patient until the distal tip reaches the selected internal body site;

determining a measured distance between the subcutaneous pocket and the internal body site; and

, using the measurement markings to trim the distal end section of the proximal conduit, or the proximal end section of the distal conduit, or both, such that after the conduits are trimmed and connected with a conduit connector, the sum of the connected lengths of the distal end section of the proximal conduit, the connector, and the distal conduit equals the measured distance between the subcutaneous pocket and the internal treatment site; and

also wherein at least the distal end section of the proximal conduit is trimmed before being connected to the proximal end section of the distal conduit.

9. A method of using a medical apparatus for establishing a channel between an external body location and a selected internal body site, wherein the apparatus comprises:

(a) an implantable port for implanting in a subcutaneous pocket below a skin surface, the port having a port passageway formed completely through the port between a skin-facing port surface and a second port surface;

(b) a proximal conduit that can pass completely through the port passageway and has a continuous middle section between a first and a second proximal-conduit end section, whereby when the implantable port is implanted with the continuous middle section in the port passageway, the first proximal-conduit end section extends transcutaneously between the skin-facing port surface and a location external to a skin surface, and the second proximal-conduit end section extends between the second port surface and a subcutaneous conduit connection located at an adjustable distance distal of the subcutaneous pocket; and

,

(c) a distal conduit that has a first and a second distal-conduit end section, wherein the first distal-conduit end section is connectable to the second proximal-conduit end section at the subcutaneous conduit connection such that, when the implantable port and proximal conduit are mated and implanted, a distal tip of the second distal-conduit end section can be positioned at the selected internal body site which is distal of the subcutaneous conduit connection; and

,

further wherein the proximal conduit comprises proximal-conduit measurement markings along the second proximal-conduit end section and/or the distal conduit comprises distal-conduit measurement markings along the first distal-conduit end section that enable precise measuring and trimming of the second proximal-conduit end section and/or the first distal-conduit end section to properly position the distal tip of the distal conduit when the distal conduit and the proximal conduit are connected and implanted;

wherein the method comprises the steps of;

implanting the implantable port into the subcutaneous pocket in a patient'"'"'s physiology;

advancing the distal tip of the distal conduit into the patient until the distal tip reaches the selected internal body site;

determining a measured distance between the subcutaneous pocket and the internal body site; and

, using the measurement markings to trim the distal end section of the proximal conduit, or the proximal end section of the distal conduit, or both, such that after the conduits are trimmed and connected with a conduit connector, the sum of the connected lengths of the distal end section of the proximal conduit, the connector, and the distal conduit equals the measured distance between the subcutaneous pocket and the internal treatment site;

and also wherein the measurement markings are arranged and numbered such that subtracting a graduated marking noted on the second proximal-conduit end section from a corresponding graduated marking noted on the first distal-conduit end section provides numerical guidance on where to trim the proximal end of the distal conduit and/or the distal end of the proximal conduit so that the proximal and distal conduits engage to form an exact length needed to ensure proper placement of the distal tip of the distal conduit at the selected internal body site.

10. A medical apparatus comprising an implantable port for implanting in a subcutaneous pocket below a skin surface and a modular conduit assembly mated with the port wherein:

the implantable port comprises a port passageway with a passageway side wall formed completely through the port between a skin-facing port surface and a second port surface, and with a tissue ingrowth scaffold disposed along at least one of the port surfaces; and

,

the modular conduit assembly comprises;

a proximal conduit, sized to achieve a slidable fit between the proximal conduit and the passageway side wall and to extend proximally and distally from the implantable port, and having a tissue ingrowth sleeve disposed along at least an outer surface portion of the proximal conduit, and wherein the at least outer surface portion of the proximal conduit extends proximally and/or distally from the port surfaces;

a separate distal conduit; and

a conduit connector adapted for connecting a distal end of the proximal conduit with a proximal end of the distal conduit at a subcutaneous conduit connection located at an adjustable distance distal of the implantable port whereby, by sliding the proximal conduit in the port passageway, a length of the proximal conduit that extends distally of the implantable port, and a resulting spacing between the second port surface and the subcutaneous conduit connection, can be adjusted such that, with the implantable port and the proximal conduit mated and implanted, and with the proximal and distal conduits connected, a distal tip of the distal conduit is positioned at a selected internal body site.

11. A medical apparatus according to claim 10 wherein the distal conduit and the proximal conduit comprise different cross sectional geometries and the conduit connector is adapted to accommodate both geometries.

12. A medical apparatus according to claim 10 wherein the tissue ingrowth scaffold along the at least one of the port surfaces comprises a tissue ingrowth scaffold that forms a continuous tissue ingrowth surface with the tissue ingrowth sleeve along the proximal conduit.

13. A medical apparatus according to claim 12 wherein the tissue ingrowth sleeve along the proximal conduit forms a continuous tissue ingrowth surface with the tissue ingrowth scaffold on both of the port surfaces with the port passageway passing therethrough.

14. A medical apparatus according to claim 10 wherein at least a portion of the tissue ingrowth scaffold is bioabsorbable.

15. A medical apparatus according to claim 14 wherein the bioabsorbable tissue ingrowth scaffold is a polymer selected from a group consisting of polyglycolide, polylactide, 1-lactide, poly(dl-lactide), polycolactide, poly(e-caprolactone), polydiaxanone, polyglyconate, and poly(lactide-co-glycolide).

16. A medical apparatus according to claim 10 wherein the distal tip of the distal conduit comprises a specific design feature that must be retained for proper operation of the apparatus and that prevents trimming at the distal tip of the distal conduit.

17. A medical apparatus according to claim 10 wherein the conduit connector is preassembled either with the distal end of the proximal conduit or with the proximal end of the distal conduit.

18. A medical apparatus according to claim 10 wherein the conduit connector and/or one or more parts of the distal conduit are too large to fit through the port passageway.

19. A medical apparatus according to claim 10

further wherein the proximal conduit comprises proximal-conduit measurement markings along its distal end section and/or the distal conduit comprises distal-conduit measurement markings along its proximal end section that enable precise measuring and trimming of the distal end section of the proximal conduit and/or the proximal end section of the distal conduit to properly position the distal tip of the distal conduit when the distal conduit and the proximal conduit are connected and implanted.

20. A medical apparatus according to claim 19 wherein the distal end of the proximal conduit can be trimmed to a suitable length, based on the measurement markings, before being connected with the proximal end of the distal conduit.

21. A medical apparatus according to claim 19 wherein both the distal end of the proximal conduit and the proximal end section of the distal conduit can be trimmed to suitable lengths, based on the measurement markings, before the conduits portions are connected.

22. A method of using the medical apparatus of claim 19 comprising the steps of:

implanting the port into the subcutaneous pocket in a patient'"'"'s physiology;

sliding the proximal conduit through the port passageway so that the distal end of the proximal conduit extends distally of any portion of the port;

advancing the distal tip of the distal conduit into the patient until the distal tip reaches the selected internal body site;

determining a measured distance between the subcutaneous pocket and the internal body site; and

, using the measurement marking system, trimming the distal end of the proximal conduit, or the proximal end of the distal conduit, or both, such that after the conduits are trimmed and connected with the conduit connector, a sum of the connected lengths of the distal end section of the proximal conduit extending between the second port surface and the conduit connection point, the conduit connector, and the distal conduit equals the measured distance between the subcutaneous pocket and the internal treatment site.

23. A medical apparatus according to claim 10 wherein the implantable port is a unitary port.

24. A medical apparatus according to claim 10 wherein the implantable port is a modular port.

25. A medical apparatus according to claim 10, further wherein one or more gripping elements are disposed at multiple locations along the passageway side wall of the port passageway between the skin-facing port surface and the second port surface for contacting and slidably retaining the proximal conduit in place when it is positioned inside the port passageway.

26. A medical apparatus according to claim 10, wherein the tissue ingrowth sleeve is disposed along substantially an entire outer surface portion of the proximal conduit that is inside the port passageway after the conduits are connected.

27. A medical apparatus according to claim 26 wherein, after the port is implanted, the tissue ingrowth sleeve extends along an outer surface of the proximal conduit at least from the skin-facing port surface to the skin surface, and also extends along at least a portion of the outer surface of the proximal conduit between the second port surface and the conduit connector.