Void containment apparatus and method of use for creating a sealed environment for product delivery

• US 9,622,804 B2
• Filed: 10/26/2015
• Issued: 04/18/2017
• Est. Priority Date: 03/07/2010
• Status: Active Grant

• Current Assignee: Faisal Mohammed Mirza
• Original Assignee: Faisal Mohammed Mirza
• Inventors: Mirza, Faisal Mohammed
• Primary Examiner(s): Ramana, Anu
• Application Number:
  US14/922,628
• Publication Number:
  US 20160106487A1
• Time in Patent Office: 540 Days
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/58 for osteosynthesis, e.g. bone plates, screws , setting implements or the like A61B17/14, A61B17/16 take precedence
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8808 with sealing collar for bone cavity
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/564 Methods for bone or joint treatment

Abstract

A void containment apparatus and its method of use during an invasive procedure on the body are disclosed. The void containment apparatus includes an elongated housing and a balloon. The balloon is capable of being inflated and deflated. When inflated, the balloon provides a seal around a void and allows delivery or extraction of material into or out of the void with minimal leakage outside the void.

Claims

1. A method for contained delivery or removal of any material, implant or device to and from a bone or soft-tissue void in an arthroscopic, laparoscopic or endoscopic environment said method comprising:

(a) providing an apparatus for providing a seal around a void, wherein said void is a cavity or defect in a bone or a missing piece of the bone material which starts on the outer surface of a bone and varies in depth, shape, and size and often contains uneven surfaces, the apparatus comprising;

an elongated housing having a double chamber comprised of (1) a hollow outer chamber and (2) a hollow inner chamber positioned inside and surrounded by said hollow outer chamber,

wherein both the inner chamber and the outer chamber have a proximal end and a distal end, wherein each of the inner and outer chambers has an opening on its proximal end, an opening on its distal end, and the opening on the proximal end is connected there-through to the opening on the distal end,

wherein the outer chamber includes multiple ports that allow entry and exit of a first medium, wherein the first medium delivered into the outer chamber remains isolated from the inner chamber; and

wherein the inner chamber allows entry of a second medium through its proximal end; and

an inflatable balloon coupled to the distal end of the outer chamber of the elongated housing such that the only ingress and egress to the balloon is through the outer chamber, wherein the inflating of the inflatable balloon is performed through entry of the first medium from the outer chamber into the balloon, and wherein the first medium is contained within the boundaries of the inflatable balloon and the outer chamber thereby preventing leakage of the first medium outside the balloon and outer chamber to any of the surroundings of the apparatus, wherein said apparatus provides a sealed environment to permit product flow to and from said void

wherein the balloon in its inflated stage sits on the outside of the bone and surrounds the periphery of the void thereby creating a seal surrounding the void, wherein the seal allows deposition of the second medium through the inner chamber into the void without leakage of the second medium outside the sealed environment,

(b) making an incision to allow surgical access to said void;

(c) inserting said apparatus to abut the void; and

(d) inflating the inflatable balloon such that the balloon in its inflated state sits on the outside of the bone and surrounds the periphery of the void creating seal around the void; and

thereby delivering filler material, implant or device to said void through said apparatus.

2. The method of claim 1, wherein the first medium is liquid, gas, or other material to be used to inflate or deflate the balloon.

3. The method of claim 1, further comprising an insertion device, wherein the insertion device can be inserted into the inner chamber from its proximal end.

4. The method of claim 3, wherein the insertion device is a piston.

5. The method of claim 1, wherein the second medium is gas, liquid, filler material or bone cement substance for filling bone defects.

6. The method of claim 5, wherein said second medium comprises medication.

7. The method of claim 1, wherein both the inner chamber and the outer chamber have a separate port that projecting outwardly from an outer surface of said housing.

8. The method of claim 7, wherein the separate port of the outer chamber and the separate post of the inner chamber are located towards the proximal end of the apparatus.

9. The method of claim 7, further comprising an insertion device, wherein the insertion device can be inserted into the inner chamber from its proximal end and pushed there-through the inner chamber from its proximal end towards its distal end thereby pushing the second medium through the inner chamber to exit from its distal end and into the void.

10. The method of claim 9, wherein the insertion of the insertion device into the inner chamber forms a seal from the outside environment preventing the entry or exit of air, liquid, or material from the inner chamber.

11. The method of claim 7, wherein the inner chamber is used for storing or inserting filler material into a void and the outer chamber is used for inflating or deflating the inflatable balloon, and wherein the inner chamber is larger in volume than the outer chamber.

12. The method of claim 11, wherein the port of the outer chamber is connected to an inflation source that allows insertion and extraction of a gas or liquid into the inflatable balloon for inflating and deflating the balloon to a desired size for creating a seal around the periphery of the void.

13. The method of claim 1, further comprising a deposition tool located inside the inner chamber, wherein the deposition tool is capable of depositing solid matter, such as a fixation implant or device, inside the void.

14. A method for contained delivery or removal of any material, implant or device to and from a bone or soft-tissue void in an arthroscopic, laparoscopic or endoscopic environment said method comprising:

(a) providing an apparatus comprising;

an elongated tubular housing having a plurality of chambers, which includes an inner chamber having an inside wall and an outside wall, and an outer chamber surrounding said inner chamber, wherein each chamber is isolated from the other chamber, the inner chamber has an opening providing an entrance at the proximal end and an outlet at the distal end, wherein the inner chamber is used for housing material,

a piston disposed in said inner chamber and movable relative to the chamber between the proximal end and the distal end of said inner chamber, wherein one end of the piston that is disposed in the said chamber includes a sealing engagement member that abuts the inner wall of the inner chamber thereby creating a seal between the inner wall of the inner chamber and the piston, and

a plurality of inflatable balloons coupled to the elongated tubular housing, wherein one of the inflatable balloons is located at the distal end of the elongated tubular housing and is used for creating a seal between the void, its surrounding environment, and the apparatus thereby allowing deposition of material located in the inner chamber, wherein said method comprises;

(b) making an incision to allow surgical access to said void;

(c) inserting said apparatus to abut the void; and

(d) inflating the inflatable balloons such that the inflated balloons sits on the outside of the bone and surrounds the periphery of the void thereby creating a seal surrounding the void; and

delivering filler material, implant or device to said void through said apparatus.

15. The method of claim 14, wherein at least one of the plurality of inflatable balloons is attached on the outside of the elongated housing towards its proximal end thereby covering the entire outer periphery of the elongated housing and used for preventing any tissue from entering a surgical space.

16. The method of claim 14, wherein the inflatable balloon at the distal end surrounds the outer periphery of the apparatus and is connected to at least one chamber, wherein the chamber includes a port that allows flow of air or gas from outside of apparatus to enter through the port and inflate the inflatable balloon, wherein the inflatable balloon in its inflated stage allows deposition of material into the void and thereafter containment of the material within the void while a pressurization technique is applied to push the material into the interstices of the bone for creating a strong bond due to interdigitation of the material with the bone.