Implantation devices, system, and methods

Patent metadata

Field	Value
Publication number	US-12377252-B2
Application number	US-201916980031-A
Country	US
Kind code	B2
Filing date	Mar 12, 2019
Priority date	Mar 13, 2018
Publication date	Aug 5, 2025
Grant date	Aug 5, 2025

Abstract

Provided herein are devices, systems, and methods for subcutaneous membrane, encapsulation chamber, or reservoir implantation comprising or employing an implantation device configured to insert a membrane, encapsulation chamber, or reservoir into a subject.

First claim

What is claimed is:

1. A device or system for delivering cells to a subject, the device or system comprising:
a first elongate body comprising a proximal portion, a distal portion, and an open volume, wherein the open volume leads to an opening at the distal portion, wherein the opening comprises a dimension equal to or greater than about 1 cm;
an encapsulation chamber disposed in the open volume, wherein the cells are disposed in the encapsulation chamber, wherein the encapsulation chamber includes a membrane configured to allow for diffusion of a therapeutic made by the cells; and
a second elongate body comprising a proximal portion and a distal portion, wherein the distal portion of the second elongate body is sized to fit within the open volume of the first elongate body, and move relative to the first elongate body.

2. The device or system of claim 1 , wherein the first elongate body is generally flat.

3. The device or system of claim 1 , wherein the device or system comprises a volume equal to or less than about 40 cm3.

4. The device or system of claim 1 , wherein a ratio of a width of the first elongate body to a height of the first elongate body is equal to or greater than about 5.

5. The device or system of claim 1 claims, wherein the first elongate body is comprised of titanium.

6. The device or system of claim 1 , wherein the proximal portion of the first elongate body is proximal to the proximal portion of the second elongate body.

7. The device or system of claim 1 , wherein the second elongate body comprises a cross sectional area generally equal to a cross sectional area of the open volume.

8. The device or system of claim 1 , wherein the device or system has an average thickness equal to or less than about 1 cm.

9. The device or system of claim 1 , wherein the device or system has an average thickness equal to or less than about 0.5 cm.

10. The device or system of claim 1 , wherein the device or system has an average width equal to or less than about 5 cm.

11. The device or system of claim 1 , wherein the first elongate body has a length equal to or less than about 30 cm.

12. The device or system of claim 1 , wherein at least one of the first elongate body and the second elongate body have a normal cross-sectional shape comprising a circle, an oval, an ellipse, a triangle, a square, a regular polygon, an irregular polygon, or any combination thereof.

13. The device or system of claim 1 , wherein at least one of the first elongate body and the second elongate body are generally straight in a direction from the proximal portion to the distal portion.

14. The device or system of claim 1 , wherein centroids of cross sections of least one of the first elongate body and the second elongate body in a direction from the proximal portion to the distal portion form a line or a continuous curve, or both.

15. The device or system of claim 1 , wherein the distal portion of the first elongate body comprises at least one of a fillet and a chamfer.

16. The device or system of claim 1 , wherein the distal portion of the elongate body of the second elongate body comprises a divot along a width of the second elongate body.

17. The device or system of claim 16 , wherein the divot is centered along the width of the second elongate body.

18. The device or system of claim 16 , wherein the divot comprises a concave radius.

19. The device or system of claim 1 , wherein at least one of the first elongate body and the second elongate body further comprises a stop, wherein the stop is configured to maintain the second elongate body within the open volume of the first elongate body.

20. The device or system of claim 1 , wherein at least one of the first elongate body and the second elongate body further comprises a bearing.

21. The device or system of claim 1 , wherein at least one of the first elongate body and the second elongate body are composed of metal, plastic, carbon fiber, fiberglass, wood, ceramic, or any combination thereof.

22. The device or system of claim 1 , wherein at least one of the first elongate body and the second elongate body are composed of titanium, aluminum, stainless steel, or any combination thereof.

23. The device or system of claim 1 , further comprising the therapeutic disposed in the encapsulation chamber.

24. The device or system of claim 1 , wherein the therapeutic is insulin.

25. The device or system of claim 1 , wherein the encapsulation chamber comprises a frame, and wherein a distal portion of the second elongate body conforms to a size and shape of the frame.

26. The device or system of claim 25 , wherein the distal portion of the second elongate body comprises a surface with a concave curvature, and wherein the concave surface comprises a divot along a width of the second elongate body.

27. The device or system of claim 26 , wherein the opening comprises a concave out curvature.

28. A method for delivering an encapsulation chamber containing cells to a subject, the method comprising:
directing the encapsulation chamber containing the cells towards a delivery site;
holding the encapsulation chamber containing the cells at the delivery site, wherein the encapsulation chamber is held within an open volume of a first positioning body;
withdrawing the first positioning body while the encapsulation chamber is held at the delivery site; and
delivering the encapsulation chamber containing the cells to the subject, wherein the encapsulation chamber includes a membrane configured to allow for diffusion of a therapeutic made by the cells.

29. The method of claim 28 , further comprising the therapeutic disposed in the encapsulation chamber.

30. The method of claim 28 , wherein the therapeutic is insulin.

31. The method of claim 28 , wherein the encapsulation chamber comprises a frame, and wherein a distal portion of a second elongate body conforms to a size and shape of the frame.

32. The method of claim 31 , wherein the distal portion of the second elongate body comprises a surface with a concave curvature, and wherein the concave surface comprises a divot along a width of the second elongate body.

33. The method of claim 32 , wherein an opening of the first positioning body comprises a concave out curvature.

34. An encapsulation chamber implantation device comprising:
a first elongate body comprising an elongated hollow body comprising an open volume having a distal aperture and a proximal aperture, wherein at least one of the open volume, the distal aperture and the proximal aperture;
an encapsulation chamber disposed in the open volume;
cells disposed in the encapsulation chamber, and wherein the encapsulation chamber includes a membrane configured to allow for diffusion of a therapeutic made by the cells; and
a second elongate body configured to fit within the open volume of the first elongate body and to prevent translation of the encapsulation chamber in a direction from the distal aperture to the proximal aperture.

35. The device of claim 34 , further comprising the therapeutic disposed in the encapsulation chamber.

36. The device of claim 34 , wherein the therapeutic is insulin.

37. The device of claim 34 , wherein the encapsulation chamber compr

Assignees

• Vertex Pharma

Inventors

• Thanos Christopher
• Goddard Moses
• Sandrof Moses
• Mills John
• Billings Megan

Classifications

• A61M2205/586

  Ergonomic details therefor, e.g. specific ergonomics for left or right-handed users · CPC title

• A61M2202/09

  Body tissue · CPC title

• A61M31/002

  Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time (artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50) · CPC title

• A61M5/14276

  specially adapted for implantation · CPC title

• A61M37/00

  Other apparatus for introducing media into the body (for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30); Percutany, i.e. introducing medicines into the body by diffusion through the skin (salt baths A61H33/04) · CPC title