Device for the delivery of a prosthetic implant and method of use thereof

• US 9,925,028 B1
• Filed: 11/15/2016
• Issued: 03/27/2018
• Est. Priority Date: 11/15/2016
• Status: Active Grant

• Current Assignee: Paul Rosenberg 2022 Family Trust
• Original Assignee: Proximate Concepts, LLC
• Inventors: Rosenberg, Paul
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/352,079
• Time in Patent Office: 497 Days
• Field of Search: 623 7- 8
• CPC Class Codes: A61F 2/0059 Cosmetic or alloplastic implants A61F2/10 - A61F2/16, A61F2/28 take precedence
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/005 differing in colour
• CPC Class Codes: A61F 2250/0056 differing in wettability, e.g. in hydrophilic or hydrophobic behaviours
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

A surgical device for assisting in the placement of a prosthetic implant within a surgical pocket of a patient such that placement minimizes tissue stress along and inside the surgical pocket. The surgical device comprises a bag shaped as a conical frustum in which a proximal end of the conical frustum is sealed and a distal end of the conical frustum is open, with an elongated slit extending from the distal end towards the proximal end. An opening formed by the distal opening and the elongated slit is sufficiently large enough to accept the prosthetic implant into the bag. According to one embodiment, an adhesive is affixed along a portion of the elongated slit to seal the elongated slit such that the distal end remains open, thereby allowing for egress of the implant from the bag and placement into the surgical pocket.

Claims

1. A surgical device for assisting in the placement of a prosthetic implant within a surgical pocket of a patient, the surgical device comprising:

a bag shaped as a conical frustum in which a proximal end of the bag is sealed and a distal end of the bag is open with the bag having an elongated slit extending from the distal end towards the proximal end, the bag further having a single opening formed by the distal opening and the elongated slit, the single opening configured to accept the prosthetic implant into the bag; and

an adhesive affixed along a portion of the elongated slit to seal the elongated slit such that the distal end remains open to allow for egress of the implant from the bag for placement into the surgical pocket.

2. The surgical device of claim 1, wherein the prosthetic implant is selected from the set of prosthetic implants consisting of a breast implant, a pectoral implant, a calf implant and a gluteal implant.

3. The surgical device of claim 1, wherein an inside surface of the bag is treated with a lubricious coating.

4. The surgical device of claim 3, wherein the lubricious coating is water activated.

5. The surgical device of claim 3, wherein the lubricious coating comprises a hydrophilic gel that decreases a coefficient of friction of the inside surface of the bag.

6. The surgical device of claim 1, wherein the bag is composed of a polymer selected from the set of polymers consisting of medical grade vinyl, medical grade PVC, medical grade nylon and polyethylene.

7. The surgical device of claim 6, wherein the medical grade vinyl is between 0.01 inches and 0.005 inches thick.

8. The surgical device of claim 1, wherein the adhesive is affixed entirely along the elongated slit.

9. The surgical device of claim 1, wherein a ridge formed by the sealed elongated slit provides a support guide for the prosthetic implant during placement into the surgical pocket.

10. The surgical device of claim 1, wherein the elongated slit comprises a flap with the adhesive affixed along the flap.

11. The surgical device of claim 1, comprising a marker on the bag to properly align the prosthetic implant for placement into the surgical pocket.

12. The surgical device of claim 11, wherein the marker is printed on the bag.

13. The surgical device of claim 1, wherein the proximal end of the bag is sealed with an RF weld.

14. The surgical device of claim 1, comprising a plurality of size guide lines to properly align a cutting device for excision of excess material from the distal opening of the bag.

15. The surgical device of claim 14, wherein the plurality of size guide lines are printed on the bag.

16. The surgical device of claim 1, wherein the bag is of sufficient capacity to seat the prosthetic implant and activate the adhesive to allow the elongated slit to be sealed with the bag horizontal relative to a standing surgeon.

17. The surgical device of claim 1, comprising a sheet of absorbable material placed within the bag that when exposed to water allows the water to wick through the absorbable material and activate a lubricious coating on an inside surface of the bag.

18. The surgical device of claim 17 wherein the sheet of absorbable material changes color when exposed to water.

19. A surgical device for assisting in the placement of a prosthetic implant within a surgical pocket of a patient, the surgical device comprising:

a bag shaped as a conical frustum in which a proximal end of the bag is sealed and the distal end of the bag is open with, the bag having an elongated slit extending from the distal end towards the proximal end, the bag further having a single opening formed by the distal opening and the elongated slit, the opening configured to accept the prosthetic implant into the bag;

a sheet of absorbable material placed within the bag that when exposed to water allows the water to wick through the absorbable material and activate a lubricious coating on an inside surface of the bag; and

an adhesive affixed along a portion of the elongated slit to seal the elongated slit such that the distal end remains open to allow for egress of the implant from the bag for placement into the surgical pocket.

20. A surgical device for assisting in the placement of a prosthetic implant within a surgical pocket of a patient, the surgical device comprising:

a bag shaped as a conical frustum in which a proximal end of the bag is sealed and the distal end of the bag is open with, the bag having an elongated slit extending from the distal end towards the proximal end, the bag further having a single opening formed by the distal opening and the elongated slit, the opening configured to accept the prosthetic implant into the bag; and

a set of inter-lockable fastener elements disposed along opposing portions of the elongated slit, the set of inter-lockable fastener elements configured to seal the elongated slit such that the distal end remains open to allow for egress of the implant from the bag for placement into the surgical pocket.