Fistula Repair Plug Having Multiple Layers

• US 20110282382A1
• Filed: 05/13/2010
• Published: 11/17/2011
• Est. Priority Date: 05/13/2010
• Status: Active Grant

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Widenhouse, Tamara S. Vetro, Shelton, Frederick E. IV, McAlister, Gary B., Balek, Stephen J.
• Granted Patent: US 8,486,155 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61F 5/0083 Reducing the size of the stomach, e.g. gastroplasty surgical interventions A61B17/00
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 27/227 Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 27/3616 Blood, e.g. platelet-rich plasma
• CPC Class Codes: A61L 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491

Abstract

A surgical device is operable to coextrude a multilayered biocompatible tissue repair plug in situ within a lumen in a patient. The device comprises a handle, a shaft extending from the handle, a plurality of conduits extending through the shaft, a plurality of media chambers, and an actuator. At least one of the media chambers contains a suspension of at least one tissue fragment having at least one viable cell in a biocompatible carrier. The actuator is operable to cause media in each of the chambers to be urged through, and expelled from the orifice of, the conduit in communication therewith. The orifices are located at the distal end of the shaft such that media from the media chambers may be ejected into a lumen in a patient in order to form a multilayered biocompatible tissue repair plug in situ. The conduits and their orifices are all coaxially aligned.

Claims

1. A surgical device for coextruding a multilayered biocompatible tissue repair plug in situ within a lumen in a patient, the device comprising:

(a) a handle;

(b) a shaft extending distally away from the handle, the shaft having a distal end;

(c) a plurality of conduits extending through at least a portion of the shaft to the distal end of the shaft, each of the fluid conduits having an orifice at the distal end of the shaft for expelling material therefrom;

(d) a plurality of media chambers, wherein each media chamber is in communication with a corresponding one of the conduits, at least one of the media chambers containing a suspension of at least one tissue fragment having at least one viable cell in a biocompatible carrier; and

(e) an actuator operable to cause media in each of the chambers to be urged through, and expelled from the orifice of, the conduit in communication therewith;

wherein the orifices are located at the distal end of the shaft such that media from the media chambers may be ejected into a lumen in a patient in order to form a multilayered biocompatible tissue repair plug in situ.

2. The surgical device of claim 1, wherein at least a distal portion of the conduits are coaxial with each other immediately adjacent the orifices, wherein the orifices are coaxial with each other, such that a tissue repair plug formed by the surgical device comprises a central core of media surrounded by one or more additional media layers.

3. The surgical device of claim 2, wherein the media chambers are removably attached to the handle.

4. The surgical device of claim 2, comprising first, second and third media chambers, the first media chamber containing a suspension of at least one tissue fragment having at least one viable cell in a biocompatible carrier, the second media chamber containing a scaffold material, and the third media chamber containing a biocompatible adhesive.

5. The surgical device of claim 4, wherein at least one of the media chambers contains platelet rich plasma.

6. The surgical device of claim 4, further comprising first, second and third conduits in communication with the first, second and third media chambers, respectively, the first conduit having a central orifice at the distal end of the shaft, the second conduit having an orifice at the distal end of the shaft that extends around the central orifice of the first conduit, and the third conduit having an orifice at the distal end of the shaft that extends around the orifice of the second conduit, such that a tissue repair plug formed by the surgical device comprises a central core of at least one tissue fragment in a biocompatible carrier, surrounded by a second layer comprising media from the second media chamber, and a third layer surrounding the second layer, the third layer comprising media from the third media chamber.

7. The surgical device of claim 2, wherein each of the conduits extends from the interior of one of the media chambers through the entire length of the shaft, and wherein the actuator is operable to expel media from the media chambers into the fluid conduit in communication therewith by selectively forcing gas into the media chambers.

8. The surgical device of claim 7, further comprising an air cylinder and piston for forcing gas into the media chambers in order to expel media therefrom into the conduits and out the orifices, the piston being operatively attached to the actuator.

9. The surgical device of claim 8, wherein the actuator comprises a trigger movably mounted to the housing, and further wherein movement of the trigger drives the piston in order to expel air from the air cylinder into the media chambers.

10. The surgical device of claim 9, further comprising at least one check valve located between the air cylinder and the media chambers.

11. A method of using a surgical device to form a tissue repair plug in situ in a lumen in a patient, wherein the surgical device comprises an elongate shaft, a plurality of conduits, and a plurality of media chambers, wherein the elongate shaft has a distal end, wherein the plurality of conduits extend through at least a portion of the shaft to the distal end of the shaft, wherein each of the fluid conduits has a respective orifice a the distal end of the shaft, wherein each medial chamber is in fluid communication with a corresponding conduit of the plurality of conduits, wherein at least one of the media chambers contains a suspension of at least one tissue fragment having at least one viable cell in a biocompatible carrier, and wherein another of the media chambers contains a flowable tissue treatment media capable of forming a tissue repair plug, the method comprising:

(a) inserting the distal end of the shaft of the surgical device into a lumen in a patient; and

(b) expelling the suspension and the treatment media from the orifices at the distal end of the shaft, while withdrawing the distal end of the shaft from the lumen in the patient, thereby forming a tissue repair plug within the lumen.

12. The method of claim 11, wherein the lumen in the patient has a first opening at one end of the lumen and a second opening at the opposite end of the lumen, wherein the act of inserting comprises inserting the distal end of the shaft through the first opening until the distal end is located adjacent the second opening of the lumen.

13. The method of claim 11, wherein the lumen comprises an anal fistula.

14. The method of claim 11, wherein the flowable tissue treatment media in one of the media chambers comprises platelet-rich plasma.

15. The method of claim 14, wherein the biocompatible carrier comprises a gel solution.

16. The method of claim 13, wherein at least a distal portion of the conduits are coaxial with each other immediately adjacent the orifices, and the orifices are coaxial with each other, such that the tissue repair plug formed in situ comprises a central core of media surrounded by one or more additional media layers.

17. The method of claim 16, wherein the central core of the tissue repair plug comprises the suspension of at least one tissue fragment having at least one viable cell in a biocompatible carrier.

18. The method of claim 16, wherein the tissue repair plug has at least three layers comprising the central core of at least one tissue fragment in a biocompatible carrier, surrounded by a second layer comprising one or more growth factors, and a third layer surrounding the second layer, the third layer comprising platelet-rich plasma.

19. The method of claim 11, further comprising:

(a) harvesting at least one tissue fragment having at least one viable cell from the patient; and

(b) at least partially filling the at least one media chamber with the at least one tissue fragment along with a biocompatible carrier.

20. A biocompatible tissue repair plug for treating a fistula in a patient, the plug comprising:

(a) a core layer comprising at least one tissue fragment in a biocompatible carrier;

(b) a second layer surrounding at least a portion of the core layer, the second layer comprising one or more growth factors; and

(c) a third layer surrounding at least a portion of the second layer, the third layer comprising platelet-rich plasma.