Sternal closure device

• US 5,423,821 A
• Filed: 01/18/1994
• Issued: 06/13/1995
• Est. Priority Date: 01/18/1994
• Status: Expired due to Fees

• Current Assignee: Pasque, Michael K.
• Original Assignee: Pasque, Michael K.
• Inventors: Pasque, Michael K.
• Primary Examiner(s): Graysay, Tamara L.
• Application Number:
  US08/181,827
• Time in Patent Office: 511 Days
• Field of Search: 606/228, 606/230, 606/231, 606/224, 606/226, 606/215, 606/216, 606/151, 606/157, 606/74, 606/232, 24/543, 24/503, 24/507, 24/136 L, 24/136 R, 24/94, 24/101 B, 24/113 MP, 206/63.3
• US Class Current: 606/74
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/06133 of parallelepipedal shape, e.g. made of rectangular or slightly oval panels
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/82 for bone cerclage apparatus for manipulating wires or straps A61B17/8861; wires, bands or straps other than cerclage A61B17/842
• CPC Class Codes: A61B 17/823 for the sternum
• CPC Class Codes: A61B 17/848 Kirschner wires, i.e. thin, long nails
• CPC Class Codes: A61B 17/8861 Apparatus for manipulating flexible wires or straps devices for inserting Kirschner wires A61B17/1697
• CPC Class Codes: A61B 2017/045 snug fit within the anchor
• CPC Class Codes: A61B 2017/06185 hollow or tubular hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 2050/3006 Nested casings
• CPC Class Codes: A61B 2050/314 Flexible bags or pouches

Abstract

A surgical device and method are disclosed for closing the sternum following a median sternotomy. Instead of using stainless steel wire or a flat steel band, a strand of thin flexible suture material is used which is compressible in its radial dimension (either because of a hollow tubular shape, or due to solid material properties), while remaining strong and inelastic in its longitudinal dimension. The longitudinal strength may be maintained by using selected plastics, or by using nylon fibers or other materials for reinforcement. When not compressed, the strand has a diameter slightly larger than the diameter of the needle used to place the strand in position around the sternal halves, between the ribs. After insertion, the expandable suture material will provide gentle pressure against the surrounding tissue to minimize bleeding in the needle track. The soft suture material will also help cushion, distribute, and minimize the stresses and damage inflicted on the sternum or ribs during postoperative ambulation. A fastener device which provides additional advantages is also disclosed.

Claims

1. A method of surgically reapproximating a sternal bone which has been divided into two or more segments, comprising the following steps:

a. providing a surgical needle and a radially compressible suture strand which is firmly coupled to the needle, wherein the needle has a size and shape suitable for positioning the suture strand around a sternal bone that has been divided into two or more sections, and wherein the thickness of the suture strand is greater than the thickness of the needle;

b. inserting the needle through tissue surrounding the sternal bone, thereby creating a needle track through said tissue;

c. emplacing the radially compressible suture strand in the needle track in a manner that (1) forms a loop around the sternal bone which has been divided, and (2) causes the radially compressible suture strand to exert gentle pressure against surrounding tissue, to minimize bleeding;

d. forming a plurality of such loops around the sternal bone; and

,

e. securing the loops at a level of tension suitable for maintaining closure and healing of the sternal bone segments.

2. The method of claim 1 wherein the suture strand is made of a flexible material having a hollow tubular shape.

3. The method of claim 1 wherein the suture strand is made of an outer layer of compressible material which surrounds at least one inner reinforcing strand.

4. The method of claim 1 wherein the suture strand is coated with a compound that can reduce friction as the suture strand is emplaced in the needle track.

5. The method of claim 1 wherein the securing step further comprises:

a. providing a suture strand fastener device comprising a cylinder, a plunger which is slidably enclosed within said cylinder, and securing means to hold the plunger in a depressed position after the plunger is depressed, wherein the plunger contains a plunger orifice through which the suture strand can pass;

b. passing the suture strand through the orifice;

c. depressing the plunger into the cylinder in a manner which crimps the suture strand passing through the plunger orifice; and

,

d. engaging the securing means, to secure the plunger in a depressed position which secures the crimped suture strand passing through the plunger orifice.

6. The method of claim 5 wherein the securing step further comprises providing the suture strand fastener device with at least one extendable fixation prong which is forced into an extended position when the plunger is depressed, wherein the fixation prong when forced into an extended position reduces the likelihood of migration of the suture strand through peristernal tissue after said fixation prong has been extended.

7. A method of closing the sternum following a thoracic surgical operation which involves cutting the sternal bone into two or more divided segments, comprising the following steps:

a. using a needle having a first thickness to draw a suture strand having a second thickness into position around the divided segments of the sternal bone, wherein the needle creates a needle track through peristernal tissue, and wherein the suture strand occupies the needle track after passage of the needle; and

,

b. securing the suture strand in a manner which forms a secure loop which encircles the divided segments of the sternal bone,

wherein the suture strand is made of a flexible radially compressible material having a thickness larger than the thickness of the needle, wherein the radial compressibility is sufficient to allow the suture strand to exert gentle pressure on tissue which encloses the needle track, thereby allowing the suture strand to help reduce bleeding generated by such tissue.

8. The method of claim 7 wherein the suture strand is made of a flexible material having a hollow tubular shape.

9. The method of claim 7 wherein the suture strand is made of an outer layer of compressible material which surrounds at least one inner reinforcing strand.

10. The method of claim 7 wherein the suture strand is coated with a compound that can reduce friction as the suture strand is pulled through bone or peristernal tissue.

11. The method of claim 7 wherein the securing step further comprises:

a. providing a suture strand fastener device comprising a cylinder, a plunger which is slidably enclosed within said cylinder, and securing means to hold the plunger in a depressed position after the plunger is depressed, wherein the plunger contains a plunger orifice through which the suture strand can pass;

b. passing the suture strand through the orifice;

c. depressing the plunger into the cylinder in a manner which crimps the suture strand passing through the plunger orifice; and

,

d. engaging the securing means, to secure the plunger in a depressed position which secures the crimped suture strand passing through the plunger orifice.

12. An article of manufacture useful for surgical closure of sternal bone segments following a median sternotomy, comprising:

(a) at least one strand of suture material suitable for securing closure of surgically-divided sternal bone segments without damaging the sternal bone segments during post-operative ambulation, wherein the suture strand has a diameter of at least about 2 mm and is made of a longitudinally-inelastic flexible material which will not stretch significantly in the longitudinal direction but which is radially compressible and which will attempt to expand radially after compression, thereby allowing the suture material, after emplacement in a needle track created by a needle having a diameter smaller than the suture strand, to provide gentle pressure against tissue surrounding the needle track, to minimize bleeding in such tissue; and

,

(b) a packaging enclosure which encloses the suture material, and which has been sealed and sterilized, and which maintains sterility of the suture strand.

13. The article of manufacture of claim 12 wherein the package also contains at least one surgical needle which is firmly coupled to the suture material, wherein the surgical needle has a thickness which is sufficiently less than the diameter of the suture strand to allow the radially compressible suture strand to exert pressure against peristernal tissue surrounding the needle track, to minimize bleeding of said tissue.

14. The article of manufacture of claim 12 wherein the package also contains at least one fastener device capable of securely gripping the suture strand in a manner that will not allow significant slippage of the suture strand during post-operative ambulation after the suture strand has been used to reapproximate sternal bones during thoracic surgery.

15. The article of manufacture of claim 14 wherein the suture strand fastener device comprises a cylinder and a plunger which is slidably enclosed within said cylinder, wherein the plunger contains an orifice through which a suture strand can pass, and wherein the suture strand passing through the orifice is crimped and held securely when the plunger is depressed, and wherein the cylinder and plunger are provided with interacting means to hold the plunger in a depressed position after the plunger is depressed to crimp the suture strand passing through said orifice.

16. The article of manufacture of claim 15, wherein the suture strand fastener device is provided with at least one extendable fixation prong which is forced into an extended position when the plunger is depressed, and wherein the fixation prong reduces the likelihood of migration of the suture strand though peristernal tissue after said fixation prong has been extended.