Apparatus for implementing a standardized skin incision

• US 4,643,189 A
• Filed: 02/19/1985
• Issued: 02/17/1987
• Est. Priority Date: 02/19/1985
• Status: Expired due to Term

• Current Assignee: International Technidyne Corporation (Sphingotec GMBH)
• Original Assignee: W T Associates
• Inventors: Mintz, Michael
• Primary Examiner(s): Mancene, Gene
• Assistant Examiner(s): SHEDD, CHARLES W
• Application Number:
  US06/703,199
• Time in Patent Office: 728 Days
• Field of Search: 128/314, 128/315, 128/305
• US Class Current: 606/182
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150458 Specific blade design, e.g. for improved cutting and penetration characteristics
• CPC Class Codes: A61B 5/150465 Specific design of proximal end
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin

Abstract

There is disclosed apparatus for implementing a standardized skin incision which apparatus includes a housing having a base containing an elongated slot. The base is adapted to be held flush against a patient'"'"'s skin prior to making an incision. The housing has an internal hollow which contains a movable pivot arm having a first pivotal end and a second end having a cam follower. Located within the housing is a cam surface upon which the cam follower of the pivot arm rides. The pivot end of the arm contains a cutting edge and is coupled to the housing such that it is enabled to move transversely while pivoting. The cam which has a given surface configuration controls the path of the pivot arm and therefore controls the path of the cutting edge as it enters the slot when triggered. The device produces a standard incision of a given length and a given depth as controlled by the reciprocating pivot arm and the cam surface. The device is completely disposable and further possesses the advantage that the cutting edge is always located within the housing except when the unit is triggered where the edge transverses and projects through the slot in the housing for an extremely short period of time. The unit can be fabricated from molded plastic and simple metal parts and is ordinarily sterilized prior to use. Its economy of materials and assembly permit marketing as a completely disposable device.

Claims

1. Apparatus for implementing a standardized skin incision, comprising:

a housing having an internal hollow and having located on a surface an elongated slot, with said slotted surface adapted to be placed flush against the skin,

an arcuate cam surface having a series of convolutions located within said hollow, a movable arm having a first pivotal end and a second end having means adapted to engage with the cam surface, with said pivotable and end coupled to a surface of said housing to allow said arm to pivot at a location apart from said cam surface, means associated with said arm to allow said arm to move in a transverse direction to said slot while pivoting along said slot, said arm further including a cutting edge coupled thereto which cutting edge extends through said slot when said arm is pivoted, and

spring biasing means coupled to said arm to bias said arm in a first position where said cutting edge is within said housing and an activatable trigger means coupled to said arm to hold said arm in said first position and to release said arm when activated to cause said edge to traverse through and along said slot in a path according to said cam surface to provide an incision in the skin of a given length and substantially of a uniform depth.

2. The apparatus according to claim 1, additionally comprising an extending rod coupled to said housing surface, and said pivotable end of said arm having an elongated aperture for positioning about an extending rod coupled to said housing surface to allow said arm to move in said transverse direction to follow said convolutions when pivotally moving along said slot.

3. The apparatus according to claim 1, wherein said housing surface includes an elongated aperture, and said pivotable arm has an extended pivot rod at said pivotable end, for engaging said elongated aperture for accommodating said rod to allow said arm to move in said transverse direction to follow said convolutions when pivotally moving along said slot.

4. The apparatus according to claim 1, wherein said spring bias means is a spring wire having one end secured to said arm and directed about the pivot point end and said other end secured to said housing to enable said spring wire as directed about said pivot point end to store energy in said first position.

5. The apparatus according to claim 1, wherein said trigger means comprises a movable member having a first end located outside said housing and a second end in contact with said arm to hold the same in said first position, said trigger means when moved adapted to release said arm to allow said arm to move under the influence of said spring bias means.

6. The apparatus according to claim 1, wherein said means on said arm adapted to engage with said arcuate cam surface comprises an extending rod coacting with said arcuate cam surface whereby said rod follows said surface as said arm is pivoted.

7. The apparatus according to claim 1, wherein said cam surface is configured to cause an incision approximately 5 mm long by 1 mm in depth.

8. The apparatus according to claim 1, wherein said housing is generally rectangular in shape with said bottom surface having said elongated slot adapted to be placed flush against the skin.

9. Apparatus for implementing a standardized skin incision comprising:

a housing having an internal hollow and having located on a surface an elongated slot with said surface configured to be placed flush against the skin of a patient,

cam means coupled within the hollow of said housing and having a given arcuate surface having a series of convolutions and directed above said housing surface and positioned above said slot,

a movable arm pivotally secured to said housing on a surface within said hollow and having a pivot point on a surface and having a cam coacting means whereby said arm can pivot along a path traversing said slot, and means coupled to said arm to allow said arm to also move transverse to said slot while pivoting along said slot, cutting edge means coupled to said arm and positioned within said housing in a first position of said arm and adapted to extend through said slot when said arm is moving,

spring bias means coupled to said arm to exert a spring force on said arm in said first position, activatable releasing means coupled to said housing and coacting with said arm when activated whereby said arm due to said spring energy traverses said slot causing said cutting edge means to enter said slot and perform an incision according to the movement of said arm as controlled by said cam surface.

10. The apparatus according to claim 9, wherein said means coupled to said arm to allow said arm to move in a transverse direction includes an elongated aperture in said arm and a rod extending from a housing wall and directed through said aperture to serve as a pivot point with said aperture allowing said arm to move transverse to said slot as riding along said rod and according to the convolutions on said arcuate cam surface.

11. The apparatus according to claim 9, wherein said means coupled to said arm to allow said arm to move in a transverse direction includes an extending rod located on said arm defining a pivot point, with an internal surface of said housing having a transverse slot into which said rod is inserted to allow said arm to move in said transverse direction according to said convolutions on said arcuate cam surface.

12. The apparatus according to claim 9, wherein said cam coacting means comprises an extending projection located on said arm at said other end for coacting with said cam surface.

13. The apparatus according to claim 9, wherein said housing is generally rectangular in configuration with said bottom surface having said elongated slot adapted to be placed flush against the skin.

14. The apparatus according to claim 9, wherein said spring bias means is a wire spring having one end coupled to said arm and looped about the pivot end of said arm with the other end coupled to said housing whereby when said arm is placed in said first position said loop portion compresses to exert said spring force.

15. The apparatus according to claim 9, wherein said activatable releasing means includes an elongated plunger member having first and second ends, said housing having an aperture in a sidewall for accommodating said member with one end extending through said aperture outside said housing and said other end contacting said arm in said first postion to hold said arm whereby when said plunger member is moved with respect to said housing said arm is released to pivot.

16. The apparatus according to claim 15, further including removable safety means coupled to said plunger to prevent movement of said plunger when said plunger holds said arm in said first position and when removed allows said plunger to be manually moved.

17. The apparatus according to claim 9, wherein said cam surface is configured to cause an incision approximately 5 mm long and 1 mm in depth.

18. The apparatus according to claim 9, wherein said housing is fabricated as first and a second sections which are secured together to form said housing with said internal hollow.

19. The apparatus according to claim 9, wherein said cutting edge means is a blade of a triangular configuration with an apex of said triangle being directed towards said elongated slot to provide said incision.

20. An improved device for forming a skin incision, said device of the type including a cutting edge which is caused to traverse a path upon the pivotal movement of an arm member coupled to said cutting edge, the improvement for causing said edge to traverse a relatively linear path when said member is pivoted, comprising in combination:

a single cam member including a single slotted cam surface taking the form of a cross section of an inverted trough, said cam surface including first and second slotted sides of opposite slope and of equal length forming sides of said trough, said first and second slotted sides converging in a direction away from said edge, a central slotted straight line portion joining opposing ends of said first and second sides to define a closed portion of said trough to compensate for an arcuate path movement, and

cam follower means coupled to said arm member to control movement of said arm and means coupled to said arm to allow said arm to move in directions transverse to said arcuate path while pivoting to thereby cause said cutting edge to provide an incision in the skin of a patient of a given length and substantially of a predetermined depth along said given length with the first side of said cam surface constraining said cutting edge to move in a direction to penetrate said patient'"'"'s skin at a given depth and to travel a given distance at said depth due to said central portion and then to withdraw as constrained by said second side.

21. An apparatus for implementing a standardized skin incision comprising:

a housing having an internal hollow and having located on a surface an opening, with said surface adapted to be placed flush against a patient'"'"'s skin,

a movable member within said hollow,

a blade coupled to said movable member having a cutting edge and a sharpened apex,

a single cam including a single slotted cam surface taking the form of a cross-section of an inverted trough, said slotted cam surface having first and second sides of equal length and opposite slope forming sides of said trough, said first and second sides diverging with respect to said opening and converging toward a closed portion of said trough, a central slotted atraight line portion joining opposing ends of said first and second sides to define said closed portion of said trough to define a controlled path including cam follower means associated with said housing and said movable member to allow said movable member to move within constraints imposed by said cam and follower means and causing said apex of said blade to trace a controlled path through said opening with the first side of said cam surface constraining said blade to move through said opening and out of said hollow to penetrate said patient'"'"'s skin at a given depth and to travel a given distance at said depth due to said central portion and then to withdraw back into said hollow constrained by said second side to cause said cutting edge to incise said patient'"'"'s skin,

activatable trigger means coupled to said movable member to hold said movable member in a first position where said cutting edge and sharpened apex are within said housing and to release said movable member to cause said apex to traverse said controlled path when activated,

biasing means coupled to said movable member to bias said movable member in said first position and to provide a motivating force to move said movable member when said trigger means is activated.

22. The apparatus according to claim 21, wherein said controlled path comprises essentially three-segments, a first segment comprising essentially a line, normal to said housing surface and extending from said apex in said first position to a second position below the surface of said patient'"'"'s skin a second segment comprising essentially a line, parallel to said housing surface and extending from said second position to a third position below the surface of said patient'"'"'s skin, a third segment comprising essentially a line, normal to said housing surface and extending from said third position to a final position within said housing.

23. The apparatus according to claim 21, wherein said opening is a slit through which said blade may pass without interference when said apex traces said path.

24. The apparatus according to claim 21, wherein there is provided pivot means associated with a wall of said internal hollow and said movable member whereby said movable member may move with both translational and rotational motion.

25. The apparatus according to claim 21, wherein said movable member is a pivot arm member having a pivotable end including means for allowing said arm to reciprocate transversely with respect to said opening and having a cam follower at said other end for coacting with said cam.

26. The apparatus according to claim 21, wherein said movable member includes said cam means comprising a slot in said movable member of a configuration for defining said controlled path and follower means coupled to said housing to cause said movable member to follow said controlled path when moving.

27. The apparatus according to claim 21, wherein said movable member comprises an elongated bar having said cutting edge coupled to one end with said bar adapted to move parallel to said slot, and having located on said bar a cam surface aperture to allow said bar when moving to pivot transversely to said opening, with follower means coupled to said housing and coacting with said cam surface aperture to thereby cause said bar to follow said controlled path.