Methods of packaging and packaging for sharp-edged tools

Abstract

Packaging and methods for packaging tools having a sharp or cutting edge, such as surgical tools, in which the tool is packaged under sterile conditions. The tool may be packaged first—at least partially—and in particular with its sensitive cutting edges and working surfaces packaged in a protective package. The protective package containing at least the cutting or working surfaces of the tool may then be secured in a fixed position in an outer blister pack, which may be sealed with a sealing film.

Claims

1. A method of packaging sterile surgical tools, the method comprising: placing at least the cutting edges of a surgical tool in a first protective package with internal surfaces that define an interior chamber that completely surrounds said cutting edges of said surgical tool with said cutting edges being spaced apart from all internal surfaces of said first protective package, said first protective package having a first package part that defines said interior chamber into which the cutting edges of the surgical tool protrude without contacting the internal surfaces of the first protective package, said first protective package also having a second package part that accommodates at least a portion of a shaft of the surgical tool, said second package part including at least one holding element that is configured to secure the shaft of the surgical tool in a fixed position; placing at least said first protective package that contains at least the cutting edges of the surgical tool in the shell of a blister pack, such that said first protective package is secured in a fixed position in said shell of said blister pack with at least a portion of the shaft of the surgical tool extending outside of the second package part of the first protective package and protruding into the shell of the blister pack without contacting the inner surfaces of the blister pack; and sealing the blister pack with a sealing film.

2. A package for sterile surgical tools, the package comprising: an inner protective package that is configured to completely surround the cutting edges of a surgical tool, said inner protective package having inner surfaces that define an interior chamber with the cutting edges of said surgical tool being spaced apart from all of said inner surfaces, said inner protective package having a first package part with a surface that defines an interior chamber into which the cutting edges of the surgical tool protrude with the surgical tool being spaced apart from the surface that defines the interior chamber, said inner protective package also having a second package part that accommodates at least a portion of a shaft of the surgical tool, the second package part including at least one holding element that is configured to secure the shaft of the surgical tool in a fixed position within said second package part with at least a portion of the shaft of the surgical tool extending outside of the second package part of the inner protective package; and an outer blister pack that includes a shell that defines an interior space and that is configured to accommodate and secure the inner protective package in a fixed position within the interior space of the shell of said outer blister pack with the portion of the surgical tool that extends outside of the second package part also extends into the interior space of the shell of the blister pack, and with the portion of the surgical tool that extends outside of the second package also being spaced apart from the surface of the shell of the blister pack, said outer blister pack further including a sealing film that cooperates with said shell of the blister pack to seal said inner protective package within said blister pack.

3. The package according to claim 2, wherein the portion of the surgical tool extending outside of the second package part is spaced apart from the surface of the shell of the blister pack and only the inner protective package contacts the inner surface of the shell of the outer blister pack.

4. A method of packaging sterile surgical tools, the method comprising: placing at least the cutting edges of a surgical tool in a first protective package that includes a first package part and a second package part, said first package part having internal surfaces that define an interior chamber into which the cutting edges of the surgical tool protrude without contacting said internal surfaces of the first package part, said second package part accommodating at least a portion of a shaft of the surgical tool and including at least one holding element that is configured to secure said shaft of the surgical tool in a fixed position with at least a portion of said shaft of the surgical tool extending outside of the said second package part; placing at least said first package part in the shell of a blister pack, such that said first package part is secured in a fixed position in said shell of said blister pack with said portion of said shaft of the surgical tool that extends outside of the said second package part protruding into the shell of the blister pack without contacting the inner surfaces of the blister pack; and sealing the blister pack with a sealing film.

5. A package for sterile surgical tools, the package comprising: an inner protective package that is configured to contain at least the cutting edges of a surgical tool, said inner protective package having a first package part and a second package part, said first package part having a surface that defines an interior chamber into which the cutting edges of the surgical tool protrude with the surgical tool being spaced apart from the surface that defines the interior chamber; and said second package part accommodating at least a portion of a shaft of the surgical tool with at least a portion of the shaft of the surgical tool extending outside of the second package part, said second package part including at least one holding element that is configured to secure the shaft of the surgical tool in a fixed position within said second package part; and an outer blister pack that includes a shell that defines an interior space and that is configured to accommodate and secure the inner protective package in a fixed position within the interior space of the shell of said outer blister pack with the portion of the surgical tool that extends outside of the second package part also extending into the interior space of the shell of the blister pack and spaced apart from the surface of the shell of the blister pack, said outer blister pack further including a sealing film that cooperates with said shell to seal said inner protective package within said blister pack.

6. The package according to claim 5, wherein the portion of the surgical tool extending outside of the second package part is spaced apart from the surface of the shell of the blister pack and only the inner protective package contacts the inner surface of the shell of the outer blister pack.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The invention is explained in greater detail below, illustrating only one type of embodiment. Additional features that are essential to the invention and advantages of the invention are derived from the drawings shown herein, which include:

(2) FIG. 1 illustrates a schematic view from above of an opened blister pack containing a protective package with a surgical tool packaged therein;

(3) FIG. 2 illustrates a top view of the arrangement from FIG. 1;

(4) FIG. 3 illustrates the section through the arrangement according to FIG. 1 and FIG. 2;

(5) FIG. 4 illustrates the section through the arrangement according to FIG. 2 as seen in the direction of the arrow IV-IV;

(6) FIG. 5 illustrates the section through the arrangement according to FIG. 2 as seen in the direction of the arrow V-V;

(7) FIG. 6 illustrates the same diagram as that in FIG. 3 except that it shows a detail according to FIG. 7;

(8) FIG. 7 illustrates the detail from FIG. 6 illustrating the engagement opening for removing the protective package.

DETAILED DESCRIPTION

(9) Referring now to the drawings, FIGS. 1-7 illustrate embodiments of the packaging system of the presently disclosed invention. The figures illustrate in general a bottom shell 1 of a blister pack made of a deep-drawable plastic material. A safety container or protective container 13 may be inserted into the bottom shell in a secured position which is inserted into the interior 29 of bottom dish 1 of the blister pack.

(10) In the exemplary embodiment shown here, stop surfaces 21, which cooperate with the respective stop surfaces on the outside wall of the protective container 13 are provided in the interior 29 of the bottom shell 1 of the blister pack, so that the protective container 13 is held in a fixed position in the bottom shell 1 without tilting or twisting.

(11) The protective container 13 in turn accommodates the surgical tool 15 to be protected, wherein the sensitive blade 14 of the tool 15 is accommodated in the protective container 13 at a distance from all the inside surfaces of the protective container 13 in a non-contact accommodation. This ensures that the blade 14 of the tool 15 will not come in contact with a plastic surface of the protective container 13.

(12) The tool shaft 17 of the tool 15 protrudes out of the rear side of the protective container 13 and protrudes with play and while maintaining a distance (without contact) into the interior of the bottom shell 1. Consequently, only the protective container 13 may be held in a secure position and the tool shaft 17 protruding out of the protective container 13 may be supported in a smaller assigned receiving opening 10 in the bottom shell 1, while retaining a contact distance. The rear part of the tool shaft 17 may be held in a round receptacle opening 11 while retaining a contact distance.

(13) This ensures that the tool shaft 17 of the tool 15 accommodated in the protective container 13 will not come in contact with the material of the bottom shell 1 of the blister pack at any point and be unintentionally contaminated there. This is thus a free-standing support of the surgical tool, as is also apparent from FIG. 6.

(14) The bottom shell 1 has a top peripheral sealing face 19 and forms a pull strip 2 directed toward the front. The pull strip 2 may be connected to the remaining material of the bottom shell 1 as one piece of material. The sealing film 20 lies loosely over the pull strip 2 and can be pulled away there. It rests on the surrounding sealing face 19 and may be sealed there in an airtight manner.

(15) The surface 3 of the pull strip 2 sits below the plane of the sealing face 19, so that the sealing film 20 can be gripped easily by hand in this area and pulled upward.

(16) The protective container 13 may be held in the larger receptacle opening 4 in the area of the interior 29 of the bottom shell 1 in a fixed position. The protective container has counter faces 22, which cooperate with the respective stop faces 21 in the bottom shell 1, to thereby hold the protective container 13 in the receptacle opening 4 of the bottom shell 1, so that it is fixed in position and is free of tilting and twisting.

(17) This ensures that the protective container 13 can be removed from the bottom shell 1 when the sealing film 20 is torn off. A handle opening 6 in the bottom shell 1, which may be arranged in the area of the pull strip 2 and maintains the distance at the end face, can be used for removal of the protective container 13 from the bottom shell 1.

(18) According to FIG. 7, the protective container 13 is removed in the direction of the arrow 31 by gripping with the finger 25 on one hand into the handle. The hand thus holds the protective container 13 securely and the sensitive blade 14 of the tool 15 is still held free-standing and in a secured position in the protective container 13. In this situation, the protective container 13 is gripped and the tool shaft 17 is supplied to a tool (not shown in detail here) with its coupling receptacle 18, which establishes a coupling with the tool shaft 17.

(19) The protective container 13 may be removed only when the tool 15 has been coupled by the tool shaft 17 to the machine while still packaged. This is done in a sterile atmosphere because the sealing film 20 is removed from the blister pack according to the invention only in the sterile operating room.

(20) FIGS. 4 and 5 show that the bottom side of the protective container 13 is a distance away from the bottom 7 of the bottom shell 1, and there are spacer ribs 30, which maintain the protective container 13 with respect to the bottom of the bottom shell 1.

(21) FIG. 1 shows that the side edges 8 in the area of the protective container 13 form the stop faces for the holder in the area of the larger receptacle opening 4.

(22) The closure 23 of the protective container 13 established by catch means is held in a clearance, namely in a receptacle opening 9, to also prevent the closure 23 from coming in contact with the container surfaces of the bottom shell 1.

(23) A folding hinge 24, preferably embodied as a film hinge, is integrally molded on the side of protective container 13 opposite the closure 23.

(24) The tool 15 to be protected is held in the protective container 13 by the fact that the tool shaft 17 is enclosed with a gripping effect between the top and bottom sides by two elastomeric holding elements 27. This is illustrated in a sectional view in FIG. 5.

(25) However, the end of the tool shaft 17 pointing in the direction of the front end (blade 14) is free of any contact with surfaces of the blister pack, so that the blade 14 protrudes completely freely into the interior of the protective container 13 without any contact, as shown in FIG. 4. Thus the interior 28 of the protective container 13 is held without contact with the blade 14.

(26) FIG. 5 shows that the protective container 13 can be carried and supported in its rear part by molded ribs 30 on the bottom 7 of the bottom shell 1. This shaping of the bottom shell is designed with a receptacle opening 4, so that the receptacle opening 4 surrounds the protective container 13 at least partially in a form-fitting manner, so that only the protective container 13 is accommodated in a fixed position in the bottom shell 1, but the tool 15 accommodated in the protective container 13 does not come in contact with any surface of the bottom shell 1.

(27) This creates a blister pack which is opened only in the sterile operating room, where the protective container 13 is gripped with a finger 25, while the sensitive blade 14 is protected from contact and the tool 15, which is still packaged in the protective container, is inserted into a machine and coupled there. Only then is the protective container 13 removed just before the tool 15 is used for an operation.

LEGEND TO THE DRAWINGS

(28) 1 Bottom shell 2 Pull strip 3 Surface (of 3) 4 Receptacle opening (large) 5 6 Gripping opening 7 Bottom 8 Side edge 9 Receptacle opening (small) 10 Receptacle opening (small) 11 Receptacle opening (round) 12 13 Protective container 14 Blade 15 Tool 16 Holding part 17 Tool shaft 18 Coupling receptacle 19 Sealing face 20 Sealing film 21 Stop face 22 Counter face 23 Closure 24 Folding hinge 25 Finger 26 27 Holding element 28 Interior (of 13) 29 Interior (of 1) 30 Molded rib 31 Direction of arrow