Method of using ultrasonic vibration to secure body tissue with fastening element

• US 8,747,439 B2
• Filed: 07/10/2006
• Issued: 06/10/2014
• Est. Priority Date: 03/13/2000
• Status: Expired due to Fees

• Current Assignee: P TECH, LLC
• Original Assignee: P TECH, LLC
• Inventors: Bonutti, Peter M., Cremens, Matthew J., Ruholl, Kevin
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US11/456,221
• Publication Number:
  US 20060241695A1
• Time in Patent Office: 2,892 Days
• Field of Search: 24 24-129 R, 24 24-129 D, 24 24-129 W, 24 24-115 A, 24 24-115 J, 24 24-115 K, 606/232
• US Class Current: 606/232
• 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 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0619 thermoplastic, e.g. for bonding, welding, fusing or cutting the suture by melting it suture cutters A61B17/0467; ultrasonic cutters A61B17/320068; electrically heated instruments A61B18/08
• CPC Class Codes: B29C 65/08 using ultrasonic vibrations non-plastics element to plastics elements B29C65/645
• CPC Class Codes: B29C 65/4815 Hot melt adhesives, e.g. thermoplastic adhesives
• CPC Class Codes: B29C 65/5071 and being composed by one single element
• CPC Class Codes: B29C 65/5085 and comprising grooves, e.g. being E-shaped, H-shaped
• CPC Class Codes: B29C 66/1122 Single lap to lap joints, i.e. overlap joints B29C66/45, B29C66/472, B29C66/52272 take precedence
• CPC Class Codes: B29C 66/526 Joining bars
• CPC Class Codes: B29C 66/5261 for forming coaxial connections, i.e. the bars to be joined forming a zero angle relative to each other
• CPC Class Codes: B29C 66/69 General aspects of joining filaments bundling articles B65B13/00; interconnecting successive lengths of material B65H69/00
• CPC Class Codes: B29C 66/71 characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/7379 degradable
• CPC Class Codes: B29C 66/73791 biodegradable
• CPC Class Codes: B29C 66/81423 being concave
• CPC Class Codes: B29C 66/8322 Joining or pressing tools reciprocating along one axis
• CPC Class Codes: B29C 66/83221 : cooperating reciprocating tools, each tool reciprocating along one axis
• CPC Class Codes: B29C 66/83241 : cooperating pivoting tools
• CPC Class Codes: B29C 66/861 : Hand-held tools
• CPC Class Codes: B29C 66/8614 : Tongs, pincers or scissors
• CPC Class Codes: B29C 66/951 : by measuring or controlling the vibration frequency and/or the vibration amplitude of vibrating joining tools, e.g. of ultrasonic welding tools
• CPC Class Codes: B29C 66/9513 : characterised by specific vibration frequency values or ranges
• CPC Class Codes: B29C 66/9517 : characterised by specific vibration amplitude values or ranges
• CPC Class Codes: B29K 2059/00 : Use of polyacetals , e.g. POM, i.e. polyoxymethylene or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2067/003 : PET, i.e. poylethylene terephthalate
• CPC Class Codes: B29K 2067/006 : PBT, i.e. polybutylene terephthalate
• CPC Class Codes: B29K 2067/043 : PGA, i.e. polyglycolic acid or polyglycolide
• CPC Class Codes: B29K 2077/00 : Use of PA, i.e. polyamides, e.g. polyesteramides or derivatives thereof, as moulding material

Abstract

A suture and a suture retainer are positioned relative to body tissue. Ultrasonic vibratory energy is utilized to heat the suture retainer and effect a bonding of portions of the suture retainer to each other and/or to the suture. Portions of the body tissue may be pressed into linear apposition with each other and held in place by cooperation between the suture and the suture retainer. The suture retainer may include one or more portions between which the suture extends. The suture retainer may include sections which have surface areas which are bonded together. If desired, the suture may be wrapped around one of the sections of the suture retainer. The suture retainer may be formed with a recess in which the suture is received. If desired, the suture retainer may be omitted and the sections of the suture bonded to each other.

Claims

1. A method of using ultrasonic vibratory energy to secure an object within a body, the method comprising:

providing a polymeric fastening element having a base portion and first and second arm portions, the base and first arm portions connected together to form a first recess and a first opening into the first recess, the first arm having a first detent portion extending into the first opening, the first detent portion operative to narrow the first opening, to partially block the first opening; and

the base and second arm portions connected together to form a second recess and a second opening into the second recess, the second arm having a second detent portion extending into the second opening, the second detent portion operative to narrow the second opening, to partially block the second opening;

passing a first portion of the object larger than said narrowed first opening through the first opening thereby pushing the first detent portion and resiliently bending the first arm to widen the first opening sufficiently for the first portion of the object to pass through the first opening past the first detent portion, whereby the first arm resiliently returns to a position narrowing the first opening, the first detent portion thereby operating to retain the first portion of the object within the first recess;

applying ultrasonic vibratory energy to the fastening element to heat the polymeric material such that the material becomes moldable and flows when subjected to pressure;

interrupting the application of ultrasonic vibratory energy such that as the heated material of the first side cools, a bond between the fastening element and the object is formed.

2. The method of claim 1, wherein the object is selected from the group consisting of:

bone, tendon, ligament, suture, implant, arthroplasty component, fastener.

3. The method of claim 1, further including squeezing the base and first arm portions together.

4. The method of claim 3, wherein the step of squeezing is carried out for about 1 second after ultrasonic vibratory energy is stopped.

5. The method of claim 3, wherein in said step of squeezing, the base and first arm portions are moved from 0.010 inches to 0.050 inches closer together.

6. The method of claim 3, wherein said step of squeezing further includes reducing the size of the first recess and increasing a contact pressure between the base and first arm portions and the passed object.

7. The method of claim 3, wherein said step of squeezing further includes squeezing one of the base and first arm portions with an ultrasonic end effector and the other of the base and first arm portions with a rigid element.

8. The method of claim 1, wherein the object is of a different material than the fastening element.

9. The method of claim 1, wherein the first recess is separated from the second recess by a connector section.

10. The method of claim 9, further including passing a second portion of the object larger than said narrowed second opening through the second opening thereby pushing the second detent portion and resiliently bending the second arm to widen the second opening sufficiently for the second portion of the object to pass through the second opening past the second detent portion, whereby the second arm resiliently returns to a position narrowing the second opening, the second detent portion thereby operating to retain the second portion of the object within the second recess.

11. A method of using ultrasonic vibratory energy to secure an object within a body, the method comprising:

providing a fastening element including polymeric material and having a recess, with a first portion of the fastening element cooperating with a base portion of the fastening element to define an opening to the recess, wherein the first portion of the fastening element has a cam surface that at least partially blocks the opening to the recess;

inserting at least a portion of the object into the recess, the first portion deflecting outward to widen the opening as the object is pushed against the cam surface to admit the object into the recess, the first portion subsequently deflecting inward returning to a position with the cam surface at least partially blocking the opening, the cam surface thereby retaining the object within the recess;

applying ultrasonic vibratory energy to the fastening element to heat the polymeric material such that the material becomes moldable and flows when subjected to pressure; and

interrupting the application of ultrasonic vibratory energy such that as the heated material cools, a bond between the fastening element and the object is formed.

12. The method of claim 11, wherein the ultrasonic vibratory energy is between 20 and about 70 kilohertz.

13. The method of claim 11, wherein the ultrasonic vibratory energy is applied for a period of time between 0.25 and about 1.0 seconds.

14. The method of claim 11, wherein the base portion includes polymeric material, and wherein said applying step includes applying ultrasonic vibratory energy to the base portion of the fastening element to heat the base portion polymeric material such that the base portion polymeric material becomes moldable and flows when subjected to pressure.

15. The method of claim 14, wherein the base portion polymeric material is selected from the group consisting of:

amorphous thermoplastic material, biodegradable polymer, crystalline polymer, amorphous polymer.

16. The method of claim 11, further comprising the steps of:

providing a force distribution member; and

disposing the force distribution member between the first and base portions of the fastening element and the body.

17. The method of claim 11, wherein the polymeric material is selected from the group consisting of:

biodegradable polymer, amorphous thermoplastic material, crystalline polymer, amorphous polymer.

18. The method of claim 11, wherein the ultrasonic vibratory energy is generated by an apparatus that includes a horn and the horn contacts the first portion of the fastening element during the application of the ultrasonic vibratory energy.

19. The method of claim 11, wherein the apparatus includes an anvil and the anvil contacts the base portion of the fastening element during application of the ultrasonic vibratory energy.

20. The method of claim 19 wherein the horn and anvil apply a predetermined force against the first and base portions of the fastening element.

21. The method of claim 11, wherein a compressive force is applied to urge the first and base portions together, reducing the size of the recess, and increasing the transmission of ultrasonic energy to the recess.

22. The method of claim 11, wherein the base portion further includes at least one projection extending in a direction away from the recess, and further including, after the step of inserting, the step of:

pushing at least one of the projection and the base portion in a direction of the recess to reduce the size of the recess and apply pressure to the retained object.

23. The method of claim 11, wherein the object is of a different material than the fastening element.