USRE37814EExpiredUtility

Staple and staple applicator for use in skin fixation of catheters

Assignee: DEAN ALLGEYER M D INCPriority: Sep 12, 1996Filed: Mar 15, 2000Granted: Aug 6, 2002

Est. expirySep 12, 2016(expired)· nominal 20-yr term from priority

Inventors:Dean O. Allgeyer

A61B 17/10A61B 17/0682A61B 17/0644

PatentIndex Score

1,700

Cited by

References

Claims

Abstract

An inexpensive surgical stapler, such as for use in securing vascular catheters, has a plastic applicator made for use with a single staple. The applicator has a backbone and two identical arms. The inside face of the backbone has a retaining channel that secures the crown portion of the staple against movement. The inside faces of the arms have guidance grooves that direct the movement of the staple as the applicator arms are squeezed with finger pressure. The outside faces of the arms are configured to permit gripping by the operator's fingers. The stapler can be used in lieu of suturing. Other staple and applicator assemblies can include two or more of such assemblies.

Claims

exact text as granted — not AI-modified

What is claimed is:

1. An assembly for applying a single surgical staple, comprising:
a surgical staple configured to have a crown portion with two ends and two legs disposed at each of said ends, said legs terminating at distal ends with piercing points, each of said legs comprising at least two segments disposed angularly to each other; and
a flexible, anvilless, digitally manipulable staple applicator with inner and outer faces,
said applicator being comprised of a backbone and two arms extending from said backbone and including means for retaining, guiding, and stabilizing said staple,
whereby said staple is releasably mounted in said retaining, guiding, and stabilizing means.

2. The invention of claim 1 further comprising means for facilitating the digital manipulation of said applicator, said means being mounted on said applicator arms.

3. The invention of claim 2 wherein said stabilizing means includes a channel.

4. The invention of claim 3 wherein said channel is disposed within a stabilizing block, said block being disposed upon said inner surface of said backbone.

5. The invention of claim 2 wherein said applicator is manufactured of medical grade plastic.

6. The invention of claim 1 further including at least one groove for guiding said staple during application.

7. The invention of claim 6 wherein said groove is configured to provide all of the functions of retaining, guiding, and stabilizing.

8. The invention of claim 1 wherein each of said staple legs is comprised of at least three adjacent leg segments such that at least a portion of two of said adjacent segments of each of said legs is disposed within said guiding means.

9. The invention of claim 1 wherein said retaining means is located on at least a portion of one of said applicator arms.

10. The invention of claim 9 wherein said retaining, guiding, and stabilizing means comprises at least a pair of tabs mounted on said inner face of said applicator.

11. The invention of claim 1 wherein said retaining and guiding means comprise a groove disposed on said inner face of each of said applicator arms.

12. A dual applicator for holding two surgical staples, each of said staples having a crown portion and two legs, said dual applicator comprising:
two anvilless, digitally manipulable staple applicators with inner and outer faces, each of said applicators being comprised of a backbone and two arm portions extending from said backbone,
each of said applicators including means for retaining, guiding, and stabilizing one of said staples, in which said one staple is releasably mounted; and,
whereby said dual applicator is formed by joining said two applicators.

13. The invention of claim 12 wherein said applicators are arranged in a ferris wheel configuration.

14. The invention of claim 12 , further comprising at least one additional of said surgical staples and one additional of said applicators.

15. A method of applying a surgical staple to a patient comprising the steps of:
furnishing an assembly of a single, pre-formed deformable surgical staple and a digitally manipulable, anvilless staple applicator configured to hold said staple, said staple applicator having a backbone connecting two associated digitally manipulable arm portions, said applicator further having inner and outer faces, and said surgical staple having legs terminating at distal ends with piercing points, said applicator including means for retaining, guiding and stabilizing said surgical staple, whereby said surgical staple is releasably mounted in at least one of said retaining, guiding, and stabilizing means;
holding said assembly in the fingers of one hand;
placing said staple piercing points adjacent to a location on said skin where said surgical staple is to be applied;
squeezing said applicator arms to apply force directly to said surgical staple, wherein said staple will bend in response to said force applied by said arms; and
releasing said digitally manipulable applicator arms and disengaging said applicator from said staple.

16. The method of claim 15 , wherein said staple and applicator assembly comprises at least two applicators and two associated staples, and wherein all steps of claim 11 are performed in applying a first of said two staples, further comprising:
the step of manually repositioning said applicator for application of said second staple; and,
repeating said steps of claim 11 for application of said second staple, beginning with said step of holding said assembly in the fingers of one hand.

17. The method of claim 15 , further comprising the additional steps of:
tenting said skin; and,
holding a catheter hub in close proximity with said tented skin such that at least one of said staple points can pass through said hub, securing said hub to said skin said additional steps of tenting the skin and holding the catheter hub being performed proximate the steps of holding and placing in claim 11 .

18. The method of claim 15 , wherein said guiding, retaining, and stabilizing means comprises grooves disposed on said inside face of said applicator arms and at least one of a stabilizing channel, tab, and clip disposed on said inside face of said applicator.

19. The invention of claim 1 wherein said stabilizing means comprises at least one of a stabilizing channel, a clip, and tabs.

20. An assembly for applying a surgical staple, comprising:

a staple applicator with an exterior and an interior, the applicator including first and second digitally manipulable arms with inner and outer surfaces, the first arm being movable toward the interior of the applicator;

a surgical staple disposed between and operatively connected to the inner surfaces of the digitally manipulable applicator arms, the staple terminating with spaced apart piercing points; and

at least one staple holder associated with the interior of the applicator and in which the surgical staple is mounted, whereby digital manipulation of the first applicator arm toward the interior of the applicator reduces the space between the staple piercing points.

21. The invention of claim 20 , wherein the second applicator arm is also movable toward the interior of the applicator.

22. The invention of claim 21 , wherein the first and second applicator arms are flexible.

23. The invention of claim 20 , wherein the staple holder is associated with the inner surface of one of the applicator arms.

24. The invention of claim 23 , wherein the staple holder comprises a groove in the interior surface of the applicator arm.

25. An assembly for applying a surgical staple, comprising:

a digitally manipulable staple applicator with an exterior and interior, the applicator including two connected, digitally manipulable, and oppositely disposed arms with inner and outer surfaces;

a surgical staple disposed between the digitally manipulable applicator arms, the staple having a crown and two legs terminating with spaced apart piercing points; and

a staple holder associated with the inner surface of each arm which receives and holds each staple leg, whereby digital manipulation of the arms toward the interior of the applicator reduces the space between the staple points and facilitates the release of the surgical staple from the applicator.

26. The invention of claim 25 , wherein each staple holder comprises a groove for receiving and holding a staple leg.

27. The invention of claim 25 , further comprising a staple crown holder.

28. The invention of claim 27 , wherein the staple crown holder is a channel.

29. The invention of claim 28 , wherein the channel is disposed in a block extending into the interior of the applicator.

30. The invention of claim 29 , wherein the outer surface of each applicator arm facilitates the digital manipulation of the applicator arm.

31. An assembly for applying a surgical staple, comprising:

an anvilless staple applicator with an exterior and an interior, the applicator including an upper portion connecting two digitally manipulable arms with inner and outer surfaces;

a surgical staple disposed in the interior of the applicator and having an upper portion and legs terminating with spaced apart piercing points, wherein the upper portion of the staple is oriented toward the upper portion of the applicator and the staple legs are operatively connected to the inner surfaces of the digitally manipulable applicator arms; and

at least two staple holders associated with the interior of the applicator and in which the surgical staple is mounted, whereby digital manipulation of the arms moves the staple piercing points toward each other to secure the staple.

32. The invention of claim 31 , further comprising a third staple holder, wherein at least one of the staple holders is associated with the upper portion of the applicator.

33. The invention of claim 31 , wherein each staple holder comprises a groove in the inner surface of each applicator arm.

34. The invention of claim 32 , wherein the staple holder associated with the upper portion of the applicator comprises a channel for receiving and holding the upper portion of the staple.

35. A method for applying a surgical staple to a patient, comprising the steps of:

a) furnishing an assembly for applying a surgical staple, the assembly comprising:

a staple applicator with an exterior and an interior, the applicator including two connected, digitally manipulable arms with inner and outer surfaces, at least one of the arms being movable;

a surgical staple disposed in the interior of the applicator, the staple terminating with spaced apart piercing points; and

at least one staple holder associated with the interior of the applicator, whereby digital manipulation of the at least one movable arm toward the interior of the applicator reduces the space between the staple piercing points;

b) placing the surgical staple piercing points at a location of the patient where the staple is to be applied;

c) digitally manipulating the at least one movable applicator arm to move toward the other arm to secure the surgical staple; and

d) disengaging the applicator from the surgical staple.

36. The method of claim 35 wherein the at least one staple holder is associated with one of the applicator arms.

37. The method of claim 36 , wherein the staple holder comprises a groove for receiving and holding the staple.

38. The method of claim 35 further comprising the step of supplying a catheter with a hub, whereby when the staple is secured, the catheter hub is attached to the patient.

39. A method for applying a surgical staple to a patient, comprising the steps of:

a) furnishing an assembly for applying a surgical staple, the assembly comprising:

a staple applicator with an exterior and an interior, the applicator including an upper portion connecting two oppositely disposed, digitally manipulable arms with inner and outer surfaces;

a surgical staple disposed in the interior of the applicator, the staple having an upper portion and terminating with spaced apart piercing points; and

at least one staple holder associated with the upper portion of the applicator which receives and holds the upper portion of the staple, whereby movement of the digitally manipulable applicator arms toward the interior of the applicator reduces the space between the staple piercing points;

b) placing the surgical staple piercing points at a location of the patient where the staple is to be applied;

c) digitally manipulating the applicator arms to move toward the interior of the applicator to secure the surgical staple; and

d) disengaging the applicator from the surgical staple.

40. The method of claim 39 , further comprising a second staple holder associated with the upper portion of the applicator.

41. The method of claim 39 , wherein the at least one staple holder comprises a channel for receiving and holding the upper portion of the staple.

42. The method of claim 39 , wherein the channel is disposed within a block extending from the upper portion of the interior of the applicator.

43. The method of claim 39 , wherein the staple holder comprises at least one pair of tabs extending from the upper portion of the interior of the applicator.

44. A method for applying a surgical staple to a patient, comprising the steps of:

a) furnishing an assembly for applying a surgical staple, the assembly comprising:

a staple applicator with an exterior and an interior, the applicator including an upper portion connecting two oppositely disposed, digitally manipulable arms with inner and outer surfaces;

a surgical staple disposed between the digitally manipulable applicator arms, the staple having a crown and two legs terminating with spaced apart piercing points;

a staple holder associated with the upper portion of the applicator which receives and holds the staple crown; and

a staple holder associated with the inner surface of each digitally manipulable applicator arm which receives and holds each staple leg, whereby digital manipulation of the applicator arms toward the interior of the applicator reduces the space between the staple piercing points;

b) placing the staple piercing points at a location of the patient where the surgical staple is to be applied;

c) moving one applicator arm toward the other arm to secure the surgical staple; and

d) disengaging the applicator from the surgical staple.

45. The method of claim 44 , further comprising the step of supplying a catheter with a hub, whereby when the staple is secured, the catheter hub is attached to the patient.

46. The method of claim 44 , wherein the holder associated with the inner surface of each arm comprises a groove for receiving and holding each staple leg.

47. The method of claim 44 wherein the holder associated with upper portion of the applicator comprises a channel for receiving and holding the staple crown.

48. The method of claim 44 , wherein the staple crown holder comprises a pair of tabs extending from the upper portion of the interior of the applicator.

49. A digitally manipulable applicator for applying a surgical staple terminating in piercing points, comprising:

a first digitally manipulable arm with an inner and outer surface;

a connecting member connected to the first digitally manipulable arm;

a second digitally manipulable arm with an inner and outer surface, the second arm being connected to the first arm by the connecting member and movable toward an applicator interior defined by the first and second digitally manipulable arms and the connector member; and

a surgical staple holder associated with the interior of the applicator and disposed to hold the surgical staple, whereby digital manipulation of the second arm toward the applicator interior secures the staple.

50. The applicator of claim 49 , wherein the first arm is also movable toward the interior of the applicator.

51. The applicator of claim 50 , wherein both arms are flexible.

52. The applicator of claim 51 , wherein the staple holder is associated with one of the arms of the applicator.

53. The applicator of claim 52 , further comprising a second staple holder associated with the other arm of the applicator.

54. The applicator of claim 53 , wherein each of the staple holders is a groove in the interior of the applicator arms.

55. The applicator of claim 53 , further comprising a third staple holder associated with the connecting member.

56. The applicator of claim 49 , further comprising an additional staple holder associated with the interior of the applicator, wherein at least one of the staple holders is a pair of tabs.

57. The invention of claim 22 , wherein the staple applicator is a unitary structure.

58. The assembly of claim 31 , wherein the staple applicator is a unitary structure.

59. The assembly of claim 58 , wherein the applicator arms are flexible.

60. The method of claim 35 , wherein the two digitally manipulable arms are both movable.

61. The method of claim 60 , wherein the staple applicator comprises a unitary structure with flexible arms.

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