Tissue closure treatment system and method with externally-applied patient interface

• US 6,951,553 B2
• Filed: 12/31/2002
• Issued: 10/04/2005
• Est. Priority Date: 12/31/2002
• Status: Expired due to Term

• Current Assignee: 3M Innovative Properties Company (3M Company)
• Original Assignee: KCI Licensing Incorporated (3M Company)
• Inventors: Bubb, Stephen K., Zamierowski, David S.
• Primary Examiner(s): Schwartz, Larry I.
• Assistant Examiner(s): Bogart, Michael G.
• Application Number:
  US10/334,766
• Publication Number:
  US 20040127862A1
• Time in Patent Office: 1,008 Days
• Field of Search: 604/289, 604/290, 604/304, 604/313, 604/540, 604/541, 604/543, 604/327, 604/268, 601/6
• US Class Current: 604/327
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/915 Constructional details of the pressure distribution manifold
• CPC Class Codes: A61M 1/916 specially adapted for deep wounds
• CPC Class Codes: A61M 1/92 with liquid supply means
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/50 with microprocessors or computers

Abstract

A tissue closure treatment system and method are provided with an external patient interface. A first fluid transfer component FTC.1 comprises a strip of porous material, such as rayon, with liquid wicking properties. FTC.1 can be placed directly on a suture line for transferring fluid exuded therethrough. An underdrape is placed over FTC.1 and includes a slot exposing a portion of same. FTC.2 comprises a suitable hydrophobic foam material, such as polyurethane ether, and is placed over the underdrape slot in communication with FTC.1. Negative pressure is applied to FTC.2 through a connecting fluid transfer component FTC.3. A negative pressure source can comprises a manual device or a power-operated suction device. The tissue closure method includes a manual operating mode using a manual suction device with an automatic shut off for discontinuing suction when a predetermined volume of fluid has been drained. An automatic operating mode utilizes a microprocessor, which can be preprogrammed to respond to various patient and operating conditions. The method proceeds through several phases with different components in place and different patient interface functions occurring in each.

Claims

1. A system for compressively treating a closed wound or incision including first and second tissue portions connected by a suture line located at or near the skin surface, which system includes:

an external patient interface including a first fluid transfer component adapted for placement on the suture line, an underdrape adapted for placement on the skin surface in contact with the first fluid transfer component, a second fluid transfer component comprising a reticulated, compressible foam material placed on the first fluid transfer component in fluidic connection therewith and an overdrape placed over the second fluid transfer component and in contact with the skin surface;

a pressure source connected to the second fluid transfer component and adapted for applying a compressive pressure force thereto, said compressive force transferring from said second fluid transfer component to said closed wound or incision through said first fluid transfer component; and

a control system adapted for selectively operating said pressure source in response to a condition associated with the treatment of the patient.

2. The system according to claim 1, which includes:

a third fluid transfer component connected to said second fluid transfer component and to said pressure source, said third fluid transfer component comprising a hydrophobic foam material core positioned within a membrane cover.

3. The system according to claim 1, which includes said underdrape having perforated tear lines facilitating the removal of said first fluid transfer component and a portion of said underdrape.

4. The system according to claim 1 wherein said second fluid transfer component includes multiple wedge-shaped portions adapted for selective removal for enhancing the flexibility of said second fluid transfer component.

5. The system according to claim 1, which includes a fluid supply subsystem including a fluid source adapted for connection to said external interface.

6. A method of compressively treating a closed wound or incision, which comprises the steps of:

applying a first fluid transfer component to intact skin adjacent to the closed wound or incision;

applying a second fluid transfer component to the first fluid transfer component;

draping said second fluid transfer component with an overdrape and securing same to the surrounding skin surface;

applying a vacuum force to said second fluid transfer component and thereby compressing same; and

transferring a compressive force associated with said second fluid transfer component substantially exclusively to said intact skin adjacent to said closed wound or incision through said first fluid transfer component so as to apply compressive force to subdermal tissue adjacent to said closed wound or incision.

7. The method according to claim 6, which includes the additional steps of:

providing a deep drain tube in said closed wound or incision;

applying negative pressure to said deep drain tube; and

draining said closed wound or incision through said deep drain tube.

8. The method according to claim 6, which includes the additional steps of:

providing a negative pressure source and producing said vacuum force therewith;

providing a controller;

connecting said controller to said negative pressure source and controlling same therewith in response to predetermined system operating conditions.

9. The method according to claim 8, which includes the additional steps of:

providing a fluid reservoir;

connecting said fluid reservoir to said second fluid transfer component through a drain tube;

draining fluid from said patient through said first and second fluid transfer components and said drain tube to said fluid reservoir;

providing said controller with a shut-off valve;

detecting a predetermined fluid volume in said reservoir; and

activating said shut-off valve and thereby discontinuing the application of said vacuum force in response to said predetermined fluid level being detected in said reservoir.

10. The method according to claim 6, which includes the additional steps of:

partially collapsing said second fluid transfer component under the influence of said vacuum force;

discontinuing the application of said vacuum force;

reexpanding said second fluid transfer component against said overdrape;

constraining said second fluid transfer component with said overdrape; and

exciting said compressive force through said reexpanded second fluid transfer component.

11. The method according to claim 6, which includes the additional steps of:

disconnecting said second fluid transfer component and at least a portion of said overdrape by slitting said overdrape around the perimeter of said second fluid transfer component; and

visually inspecting said first fluid transfer component.

12. The method according to claim 11, which includes the additional step of changing said external interface by applying replacements thereof to the remaining margins of the previous underdrape and overdrape.

13. The method according claim 6, which includes additional steps of prepackaging said first and second fluid transfer components and said overdrape and changing the external interface by removing a previous external interface and applying said prepackaged fluid transfer components and overdrape in place thereof.

14. The method according claim 6, which includes additional steps of providing a fluid supply subsystem and fluidicaily connecting same to said second fluid transfer component and transferring fluid therefrom to said closed wound or incision through said first and second fluid transfer components.

15. A system for treating a closed wound or incision, which system comprises:

an external patient interface including a fluid transfer component adapted for transferring fluid from the closed wound or incision;

said external patient interface including an overdrape placed over said fluid transfer component in contact with a surrounding skin surface;

an underdrape placed under said fluid transfer component and adapted for engaging intact skin surface adjacent to said dosed wound or incision; and

a pressure source connected to the fluid transfer component.

16. The system according to claim 15, which includes said fluid transfer component being adapted for transferring a compressive force to said closed wound or incision and said pressure source being adapted for exerting said compressive force.

17. The system according to claim 16, which includes said fluid transfer component comprising a first fluid transfer component, a second fluid transfer component and said compressive force being exerted by said pressure source on said second fluid transfer component and transferred to said closed wound or incision through said first fluid transfer component.

18. The system according to claim 15, which includes:

said fluid transfer component comprising a strip of wicking material.

19. The system according to claim 17, which includes:

said underdrape being placed between the first and second fluid transfer components.

20. The system according to claim 19, which includes:

said first fluid transfer component comprising a strip of rayon material; and

said uuderdrape including an opening through which said first fluid transfer component engages said second fluid transfer component.

21. The system according to claim 17, which includes said second fluid transfer component comprising a hydrophobic foam material.

22. The system according to claim 15, wherein said pressure source is connected to a fluid reservoir adapted to receive fluid from said system.

23. The system according to claim 22, which includes:

said pressure source being manually-operated.

24. The system according to claim 23, which includes:

said reservoir having a finite capacity; and

a shut-off valve associated with said reservoir and adapted for discontinuing fluid drainage upon said reservoir reaching a predetermined patient fluid volume.

25. A system for treating a closed wound or incision, which system comprises:

an external patient interface including a fluid transfer component adapted for transferring fluid from the closed wound or incision;

said external patient interface including an overdrape placed over said fluid transfer component in contact with a surrounding skin surface;

an underdrape placed under said fluid transfer component and adapted for engaging intact skin surface adjacent to said closed wound or incision;

said under drape including an opening through which said fluid transfer component is exposed and adapted for engaging intact skin surface adjacent to said closed wound or incision; and

a pressure source connected to the fluid transfer component.

26. A system for treating a closed wound or incision, which system comprises:

an external patient interface including a fluid transfer component adapted for transferring fluid from the closed wound or incision;

said external patient interface including an overdrape placed over said fluid transfer component in contact with a surrounding skin surface;

a pressure source connected to the fluid transfer component; and

said first fluid transfer component being adapted for transferring a compressive force to intact skin surface adjacent to said closed wound or incision and said pressure source being adapted for exerting said compressive force.

27. The system according to claim 26, which includes:

said pressure source comprising a power-actuated vacuum source; and

a programmable controller connected to said vacuum source and adapted for preprogramming for controlling the operation of same.

28. The system according to claim 27, which includes:

a sensor associated with said patient interface and connected to said controller for controlling the operation of same; and

a valve associated with said pressure source and said controller and adapted for controlling fluid flow in response to a predetermined condition.

29. A system for treating a closed wound or incision, which system comprises:

an external patient interface including a first fluid transfer component and a second fluid transfer component placed on the first fluid transfer component in fluidic communication therewith, said fluid transfer components being adapted for transferring fluid from the closed wound or incision;

said external patient interface including an overdrape placed over said second fluid transfer component in contact with a surrounding skin surface;

a pressure source connected to the second fluid transfer component;

a deep drain located below the skin in said tissue separation; and

said deep drain being connected to said pressure source.

30. The system according claim 29, which includes said deep drain being connected to a common fluid reservoir with said external patient interface.

31. The system according to claim 29, which includes:

a deep drain negative pressure source connected to said deep drain; and

a deep drain fluid reservoir connected to said deep drain negative pressure source.

32. The system according to claim 29, which includes:

a third fluid transfer component removably mounted on said overdrape in fluidic communication with said second fluid transfer component; and

said deep drain including a drain tube connected to said third fluid transfer component and to said pressure source for draining said patient interface through said third fluid transfer component.

33. The system according to claim 32, wherein said third fluid transfer component comprises a hydrophobic foam material core exposed to said second fluid transfer component, and a membrane placed over said hydrophobic foam material component and adapted for mounting said third fluid transfer component on said overdrape.

34. The system according to claim 32, wherein said third fluid transfer component comprises an elbow adapted for placement on said overdrape over an opening in same.

35. A system for creating a closed wound or incision, which system comprises:

an external patient interface including a first fluid transfer component and a second fluid transfer component placed on the first fluid transfer component in fluidic communication therewith, said fluid transfer components being adapted for transferring fluid from the closed wound or incision;

said external patient interface including an overdrape placed over said second fluid transfer component in contact with a surrounding skin surface;

a pressure source connected to the second fluid transfer component; and

said first fluid transfer component including multiple, removable pieces adapted for reconfiguring same for greater flexibility.