MEDICAL IMPLANT, MEDICAL DEVICE AND METHOD FOR MAKING A MEDICAL IMPLANT

• US 20170065394A1
• Filed: 02/27/2015
• Published: 03/09/2017
• Est. Priority Date: 03/05/2014
• Status: Abandoned Application

• Current Assignee: Medizinische Hochschule Hannover
• Original Assignee: Medizinische Hochschule Hannover
• Inventors: HAVERICH, Axel
• Application Number:
  US15/121,154
• Publication Number:
  US 20170065394A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 46/10 specially adapted for instruments, e.g. microscopes
• CPC Class Codes: A61B 46/13 the drapes entering the patient's body
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: B65B 31/00 Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
• CPC Class Codes: B65B 5/04 Packaging single articles
• CPC Class Codes: B65B 51/22 by friction or ultrasonic or high-frequency electrical means , i.e. by friction or ultrasonic or induction welding
• CPC Class Codes: B65B 51/26 Devices specially adapted for producing transverse or longitudinal seams in webs or tubes
• CPC Class Codes: B65D 75/305 Skin packages

Abstract

The present invention relates to a medical implant which is vacuum-packed within an air tight cover material. Further, the present invention relates to 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. Further, the present invention relates to a method for making a medical implant covered by an air tight cover material, 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.

Claims

1. Medical implant which is vacuum-packed within an air tight cover material.

2. The medical implant of claim 1, wherein the air tight cover material is a flexible material which rests again the outer surface of the medical implant due to the vacuum within the cover material.

3. The medical implant of claim 1, wherein the cover material is a functionalized cover material, in particular in the form of a foil made of plastic, rubber, latex or any other biologically compatible material.

4. 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.

5. The medical device of claim 4, wherein the cover material is a functionalized cover material, in particular in the form of a foil made of plastic, rubber, latex or any other biologically compatible material.

6. The medical device of claim 4, wherein the medical device comprises at least a control device which is arranged for automatic control at least of the sealing device in dependence of the underpressure generated by the underpressure generating device.

7. The medical device of claim 4, wherein the medical device comprises exchangeable adapter inserts, wherein the medical implant located within the cover material can be put between the adapter inserts for further modification within the medical device.

8. The medical device of claim 7, wherein the adapter inserts are shaped parts which are adapted to the outer shape of the medical implant located within the cover material.

9. The medical device of claim 4, wherein the sealing device comprises at least one welding unit or is a welding unit, wherein the welding unit comprises at least a weld seam producing device for producing a weld seam at the cover material with a defined outline.

10. The medical device of claim 9, wherein the welding unit is arranged for selective creation of heat required for thermal welding of the cover material only in one or more edge areas of the cover material to be welded and is arranged for substantially avoiding heating of the cover material in other areas.

11. The medical device of claim 4, wherein the sealing device is arranged for creation of a circumferential sealing seam only on the outer edges of the cover material, so that the cover material is to be provided as a single-layer, non-bag form material, e.g. in the form of at least two pieces, which are connectable to each other by the sealing seam to a bag.

12. The medical device of claim 4, wherein the sealing device comprises at least a first and a second sealing seam creation device which are separately controllable, whereby different edge areas of the sealing material to be sealed are sealable separately from each other by the first and second sealing seam creation device, in particular at different points in time.

13. The medical device of claim 12, wherein the medical device comprises at least one control device which is arranged for automatic control at least of the sealing device, wherein the control device is arranged for creating a first part of the sealing seam by activating the first sealing seam creation device at a first point in time and for creating a second part of the sealing seam by activating the second sealing seam creation device at a second point in time which is different from the first point in time.

14. Method for making a medical implant covered by an air tight cover material, 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.

15. The method of claim 14, wherein a functionalized cover material is provided as the cover material, in particular in the form of a foil made of plastic, rubber, latex or any other biologically compatible material.

16. The method of claim 14, wherein a connection stud area for connecting the 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.

17. The method of claim 14, 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.

18. The method of claim 14, wherein one or more cords of the medical implant 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.

19. The method of claim 14, wherein the method is executed less than 30 minutes before implantation of the medical implant.

20. The method of claim 14, 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.

21. The method of claim 14, 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 the medical device.

22. The method of claim 14, 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.