Devices, Systems, and Methods Providing Body Lumen Access

• US 20100152748A1
• Filed: 12/14/2009
• Published: 06/17/2010
• Est. Priority Date: 12/12/2008
• Status: Abandoned Application

• Current Assignee: E-Pacing Inc.
• Original Assignee: E-Pacing Inc.
• Inventors: Ben-Yosef, Alon, Penner, Abraham, Wolinsky, Lone
• Application Number:
  US12/637,081
• Publication Number:
  US 20100152748A1
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61M 2039/0252 for access to the lungs
• CPC Class Codes: A61M 2039/0261 Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
• CPC Class Codes: A61M 2039/0267 comprising sensors or electrical contacts
• CPC Class Codes: A61M 2039/0279 for introducing medical instruments into the body, e.g. endoscope, surgical tools
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile

Abstract

Devices and methods are provided which include access port devices for implantation through a tissue wall of a lumen of patient'"'"'s body and for containing electrical leads therein. An implantable port device includes a body with a first end having a first opening and an opposed second end having a second opening, and a channel extending from between and operably connecting the first opening and the second opening; a first retaining member extending radially from the first end of the body; and a second retaining member spaced apart from the first retaining member, the second retaining member being closer than the first retaining member to the second end of the body, and extending radially from the second end of the body. The first retaining member and the second retaining member are configured to cooperatively engage opposing sides of the tissue wall about edges of an aperture through the tissue wall to secure the body within the aperture.

Claims

1. An implantable port device for providing access through a tissue wall of a lumen of a patient'"'"'s body, comprising:

a body comprising a first end having a first opening and an opposed second end having a second opening, and a channel extending from between and operably connecting the first opening and the second opening;

a first retaining member extending radially from the first end of the body; and

a second retaining member spaced apart from the first retaining member, the second retaining member being closer than the first retaining member to the second end of the body, and extending radially from the second end of the body,

wherein the first retaining member and the second retaining member are configured to cooperatively engage opposing sides of the tissue wall about edges of an aperture through the tissue wall to secure the body within the aperture.

2. The device of claim 1, wherein the first retaining member is tapered toward the first end of the body.

3. The device of claim 1, wherein the first retaining member has a face approximately perpendicular to the outer surface of the body, wherein the face is oriented toward the second end of the body.

4. The device of claim 1, wherein the first retaining member comprises one or more tabs extending radially from, and in an approximately perpendicular direction to, the outer surface of the body.

5. The device of claim 1, wherein the first retaining member is fixed to the first end of the body.

6. The device of claim 1, wherein the first retaining member is removably attachable to the first end of the body.

7. The device of claim 1, wherein the tissue wall comprises a trachea, a bronchus, or a digestive tract.

8. The device of claim 1, wherein the second retaining member comprises a collar adapted to slide over the second end of the body.

9. The device of claim 1, wherein the second retaining member is adapted to threadably engage at least a portion of the second end of the body.

10. The device of claim 1, wherein the second retaining member is adapted to engage at least a portion of the second end of the body at least partially by friction between an inner surface of the second retaining member and an outer surface of the second end of the body.

11. The device of claim 1, further comprising a lead seal comprising a channel, wherein the channel of the lead seal is positionable over at least a portion of the second end of the body.

12. The device of claim 11, wherein the channel of the lead seal has a first inner diameter and a second inner diameter, the first inner diameter being smaller than the outer diameter of the second end of the body, and the second inner diameter being smaller than the first inner diameter.

13. The device of claim 11, wherein the lead seal comprises an elastic biocompatible material.

14. The device of claim 11, wherein the body further comprises one or more lead seal securement fittings extending from at least a portion of the outer surface of the second end of the body, the securement fittings interfacing with at least a portion of the inner surface of the channel of the lead seal.

15. The device of claim 14, wherein the one or more securement fittings are selected from the group consisting of barbs, teeth, spikes, ridges, grooves, collars, etched surface, and any combinations thereof.

16. The device of claim 11, wherein the lead seal further comprises an inner seal extending radially in an inward direction from the inner surface of the channel of the lead seal.

17. The device of claim 16, wherein the inner seal has an annular shape.

18. The device of claim 16, wherein the inner seal is substantially disc-shaped and comprises one or more slits extending therethrough.

19. The device of claim 18, further comprising a seal compression member adapted to engage the second end of the body over the inner seal, and to cause at least partial inward radial compression of the inner seal.

20. The device of claim 1, wherein the at least one member extending radially from the first end of the body further comprises one or more sharp-edged members extending therefrom, wherein the one or more sharp-edged members facilitate forming an aperture in the tissue wall during insertion of the first end of the body.

21. The device of claim 1, wherein at least one of the first end of the body or the second end of the body forms an angled channel, wherein the each angled channel facilitates placement of one or more electrical leads extending through the channel of the body.

22. The device of claim 1, further comprising:

a guidewire adapted to penetrate the tissue wall to form an aperture therein; and

a removable dilator adapted to slide over the guidewire and to expand the aperture when inserted therethrough.

23. The device of claim 22, wherein the dilator is adapted to be removably affixed the guidewire, wherein pulling the guidewire pulls the dilator when affixed thereto.

24. The device of claim 22, wherein the dilator is adapted to fit within at least a portion of the channel of the body, and wherein inserting the dilator through the aperture formed in the tissue wall facilitates insertion of the first end of the body positioned thereover.

25. The device of the claim 22, wherein the dilator comprises an at least partially conical end adapted for insertion through the aperture formed in the tissue wall, and wherein the conical end of the dilator narrows to a diameter more narrow than the inner diameter of the channel of the body at the first end.

26. A method of implanting an access port device in a patient in need thereof, comprising:

penetrating a lumenal tissue wall using a guidewire, forming an aperture therein;

attaching an access port device to the guidewire;

pulling the guidewire through the tissue wall in a manner effective to pull the access port into a position within the aperture of the tissue wall;

detaching the guidewire from the access port device; and

removing the guidewire from the lumen of the lumenal tissue wall.

27. The method of claim 26, wherein the guidewire and the access port are inserted into the tissue wall from the thoracic cavity.

28. The method of claim 26, wherein the guidewire and the access port are inserted into the tissue wall from the lumen of the lumenal tissue wall.

29. The method of claim 26, further comprising removably attaching a dilator in front of or integrated with the access port prior to pulling the guidewire.

30. The method of claim 26, further comprising removably attaching a pull plate to the access port device, wherein attaching the guidewire to the access port device comprises attaching the guidewire to the pull plate.

31. The method of claim 26, further comprising deploying at least one electrical lead carrying at least one electrode through a channel in the access port device, wherein the at least one electrical lead is inserted from within the lumen into the thoracic cavity or inserted from the thoracic cavity into the lumen.

32. The method of claim 26, further comprising:

after positioning the access port device in the tissue wall, grasping at least one of an electrical lead or a guidewire using a grasping instrument; and

pulling said grasping instrument causing the guidewire or the electrical lead to pass through said access port device.

33. The method of claim 26, further comprising:

accessing the tissue wall using an endoscope; and

deploying the guidewire to the tissue wall through a working channel of the endoscope.

34. A kit for implanting an access port device in a tissue wall of a lumen of a patient'"'"'s body, comprising:

an access port device comprising;

a body comprising a first end having a first opening and an opposed second end having a second opening, and a channel extending from between and operably connecting the first opening and the second opening;

a first retaining member extending radially from the first end of the body; and

a second retaining member spaced apart from the first retaining member, the second retaining member being closer than the first retaining member to the second end of the body, and extending radially from the second end of the body;

a guidewire for penetrating the tissue wall and forming an aperture therein, and/or for inserting the access port device through the aperture formed in the tissue wall; and

a dilator for enlarging the aperture formed in the tissue wall.