Medical implant, medical device and method for making a medical implant

Patent metadata

Field	Value
Publication number	US-11116619-B2
Application number	US-201816185148-A
Country	US
Kind code	B2
Filing date	Nov 9, 2018
Priority date	Mar 5, 2014
Publication date	Sep 14, 2021
Grant date	Sep 14, 2021

Abstract

A medical implant which is vacuum-packed within an air tight cover material and a medical device for making the same is provided. Also described herein is a method for making a medical implant covered by an air tight cover material, comprising the steps of a) providing the medical implant, b) providing sterile cover material in the form of at least one or at least two pieces, c) placing the medical implant within a space surrounded by the at least one or at least two pieces of the cover material, d) creating an underpressure within the space surrounded by the at least one or at least two pieces of the cover material by evacuating air from this space, and e) air tight sealing of the cover material.

First claim

The invention claimed is:

1. Method for making a medical implant covered by an air tight cover material and implanting the medical implant within a subject, comprising the steps
a) providing the medical implant,
b) providing sterile cover material in the form of at least one or at least two pieces,
c) placing the medical implant within a space surrounded by the at least one or at least two pieces of the cover material,
d) creating an underpressure within the space surrounded by the at least one or at least two pieces of the cover material by evacuating air from this space,
e) air tight sealing of the cover material, wherein the medical implant has one or more cords which extend through a sealing seam area of the cover material, wherein a sealing seam is created on the cover material at least in the sealing seam area through which the one or more cords extend, and
f) implanting the covered medical implant sealed in step e) within the subject.

2. The method of claim 1 , wherein a functionalized cover material is provided as the cover material in the form of a foil made of plastic, rubber, latex or any other biologically compatible material.

3. The method of claim 1 , wherein a connection stud area for connecting an underpressure creating device is provided on the cover material, and the connection stud area is sealed in an air tight manner after creation of a certain underpressure within the space surrounded by the cover material while the evacuation suction of the underpressure creating device is maintained.

4. The method of claim 1 , wherein the cover material is provided as at least two separate pieces, the at least two separate pieces are coupled to each other in a first sealing step, which is executed before an underpressure is created within the space surrounded by the cover material, then the underpressure is created and then the cover material is sealed in an air tight manner in a second sealing step.

5. The method of claim 1 , wherein steps a) through e) are executed less than 30 minutes before implantation of the medical implant.

6. The method of claim 1 , wherein the cover material is provided in the form of one or more tailored pieces according to the physical dimensions and/or outer shape of the medical implant at least in one viewing direction on the medical implant.

7. The method of claim 1 , wherein the medical implant located within the space surrounded by the cover material is placed for further modification between at least two exchangeable adapter inserts of a medical device.

8. The method of claim 1 , wherein the method is executed using a medical device for making a medical implant covered by an air tight cover material, wherein the medical device comprises at least an underpressure generating device and a sealing device, wherein the sealing device is arranged for air tight sealing of the cover material while the medical implant is located within the cover material, wherein the underpressure generating device is coupled or can be coupled with a space which is surrounded by the cover material, and wherein the underpressure generating device and the sealing device are controllable such that after generating a certain underpressure within the space surrounded by the cover material through the underpressure generating device the sealing device is activatable to seal the cover material in an air tight manner to form an air tight protection cover around the medical implant located therein.

9. A method of implanting a medical implant within a subject, comprising the steps
i) obtaining a covered medical implant made by a method comprising
a) providing the medical implant,
b) providing sterile cover material in the form of at least one or at least two pieces,
c) placing the medical implant within a space surrounded by the at least one or at least two pieces of the cover material,
d) creating an underpressure within the space surrounded by the at least one or at least two pieces of the cover material by evacuating air from this space, and
e) air tight sealing of the cover material, wherein the medical implant has one or more cords which extend through a sealing seam area of the cover material, wherein a sealing seam is created on the cover material at least in the sealing seam area through which the one or more cords extend, and

ii) implanting the covered medical implant within the subject.

10. The method of claim 9 , wherein a functionalized cover material is provided as the cover material in the form of a foil made of plastic, rubber, latex or any other biologically compatible material.

11. The method of claim 9 , wherein a connection stud area for connecting an underpressure creating device is provided on the cover material, and the connection stud area is sealed in an air tight manner after creation of a certain underpressure within the space surrounded by the cover material while the evacuation suction of the underpressure creating device is maintained.

12. The method of claim 9 , wherein the cover material is provided as at least two separate pieces, the at least two separate pieces are coupled to each other in a first sealing step, which is executed before an underpressure is created within the space surrounded by the cover material, then the underpressure is created and then the cover material is sealed in an air tight manner in a second sealing step.

13. The method of claim 9 , wherein steps a) through e) are executed less than 30 minutes before implantation of the medical implant.

14. The method of claim 9 , wherein the cover material is provided in the form of one or more tailored pieces according to the physical dimensions and/or outer shape of the medical implant at least in one viewing direction on the medical implant.

15. The method of claim 9 , wherein the medical implant located within the space surrounded by the cover material is placed for further modification between at least two exchangeable adapter inserts of a medical device.

16. The method of claim 9 , wherein steps a) through e) are executed using a medical device for making a medical implant covered by an air tight cover material, wherein the medical device comprises at least an underpressure generating device and a sealing device, wherein the sealing device is arranged for air tight sealing of the cover material while the medical implant is located within the cover material, wherein the underpressure generating device is coupled or can be coupled with a space which is surrounded by the cover material, and wherein the underpressure generating device and the sealing device are controllable such that after generating a certain underpressure within the space surrounded by the cover material through the underpressure generating device the sealing device is activatable to seal the cover material in an air tight manner to form an air tight protection cover around the medical implant located therein.

Assignees

• Medizinische Hochschule Hannover

Inventors

• Haverich Axel

Classifications

• A61F2/0095 Primary

  Packages or dispensers for prostheses or other implants (for intraocular lenses A61F2/1691; for dental surgery A61C19/02) · CPC title

• A61N1/375

  Constructional arrangements, e.g. casings · CPC title

• B65B31/00

  Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers · CPC title

• B65D75/305

  Skin packages · CPC title

• A61B2017/00526

  Methods of manufacturing · CPC title