WO1995034245A1 - Safety lock needle - Google Patents

Safety lock needle Download PDF

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Publication number
WO1995034245A1
WO1995034245A1 PCT/US1995/007237 US9507237W WO9534245A1 WO 1995034245 A1 WO1995034245 A1 WO 1995034245A1 US 9507237 W US9507237 W US 9507237W WO 9534245 A1 WO9534245 A1 WO 9534245A1
Authority
WO
WIPO (PCT)
Prior art keywords
leg
tip portion
safety lock
needle
shield
Prior art date
Application number
PCT/US1995/007237
Other languages
French (fr)
Inventor
Elliot Lach
Original Assignee
University Of Massachusetts Medical Center
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by University Of Massachusetts Medical Center filed Critical University Of Massachusetts Medical Center
Priority to AU28188/95A priority Critical patent/AU2818895A/en
Publication of WO1995034245A1 publication Critical patent/WO1995034245A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A44—HABERDASHERY; JEWELLERY
    • A44B—BUTTONS, PINS, BUCKLES, SLIDE FASTENERS, OR THE LIKE
    • A44B9/00—Hat, scarf, or safety pins or the like
    • A44B9/12—Safety-pins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0493—Protective devices for suturing, i.e. for protecting the patient's organs or the operator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/1146—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of tendons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004—Means for attaching suture to needle
    • A61B2017/06019—Means for attaching suture to needle by means of a suture-receiving lateral eyelet machined in the needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004—Means for attaching suture to needle
    • A61B2017/06042—Means for attaching suture to needle located close to needle tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0647—Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0801—Prevention of accidental cutting or pricking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0801—Prevention of accidental cutting or pricking
    • A61B2090/08021—Prevention of accidental cutting or pricking of the patient or his organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0804—Counting number of instruments used; Instrument detectors

Definitions

  • Tendon fixation is typically accomplished by inserting a number of straight needles 2, similar to sewing needles, through the tendons 4 in a manner similar to a skewer, as shown in Figs. 1 and 2.
  • These straight needles referred to as "Keith Needles”, have a sharp tip portion having a triangular cross-section, to enable them to easily pierce body material.
  • Retraction of skin surrounding an incision is usually accomplished by inserting the prongs of a retractor into the insertion, and spreading the prongs of the retractor to retract the skin. While this method is generally effective in retracting the skin, it tends to cause trauma and tissue damage. Moreover, different size retractors must be kept on hand for use with different size incisions, as the prongs of a large retractor will not fit in a small incision, nor will the prongs of a small retractor effectively retract the skin around a large incision. Summary of the Invention The invention features an improved needle for immobilizing body material during surgery.
  • the needle can, advantageously, be moved from an open position, in which a sharp point is exposed to pierce the body material, to a closed position, in which the point is safely shielded to prevent accidental puncture wounds or tissue damage.
  • the needle may be used in a variety of surgical applications, including but not limited to applications in which a Keith Needle is used, e.g., for tendon fixation, and applications in which a retractor is used, e.g., skin retraction.
  • skin retraction the needle is secured to the skin at the edge of the incision and closed, and, in this position, provides a rigid member for the retractor prongs to engage.
  • the retractor prongs never directly engage the skin or tissue and as a result trauma and tissue damage are significantly reduced.
  • a single retractor, the prongs of which are dimensioned to engage the needle can be used with a wide range of incision sizes.
  • the needle of the invention includes an elongated member, comprising a first leg, having a first end including a tip portion having a triangular cross section to enable the tip portion to pierce the body material, a second leg, having a second end, and a resilient portion disposed between said first leg and said second leg; and a blunt shield disposed at said second end and dimensioned to receive said tip portion.
  • the elongated member is bent at an acute angle, and the resilient portion is positioned to enable said first leg to be moveable between an open position, in which the tip portion is exposed and spaced from the shield, allowing the tip portion to pierce and to be inserted through a body material, and a closed position, in which the tip portion is received and enclosed by the shield.
  • the first leg and second leg are unitary (formed from a single member)
  • the resilient portion comprises a coil spring, preferably a single coil spring, disposed between the first leg and second leg to allow the first leg to be moved between its closed and open positions and to bias the moveable region towards the open position.
  • the single coil spring is unitary with said first leg and said second leg, and said first leg and said second leg are substantially equal in length so that said single coil spring is disposed at approximately the midpoint of said elongated member, e.g., as in a conventional "safety pin".
  • the first leg in the open position said first leg is disposed at an angle of from 10 to 60 degrees relative to said second leg, and in the closed position, said first leg is substantially parallel to said second leg.
  • the elongated member preferably comprises instrument grade surgical stainless steel.
  • the tip portion preferably has a length which comprises about 1 / 2 to 1 / 4 , more preferably about 1 / 3 , of the overall length of the first leg.
  • the tip portion is preferably tapered over its length at an angle of less than 30 degrees, the apex of the angle being at the first end; the remainder of the first leg has a substantially round cross-section.
  • the tip portion also preferably includes an aperture dimensioned to receive a suture or wire, to allow the needle to be used to form a stitch, and is diamond coated for optimal sharpness, to minimize tissue trauma.
  • the shield is shaped to allow the elongated member to be moved from its open to its closed position by a gloved hand (i.e., a surgeon wearing surgical gloves) , and has a substantially U-shaped leading edge, to minimize tissue trauma.
  • the metal of some portion of the needle is ferromagnetic, to facilitate retrieval of lost needles in the operating room and thus aid in performing a needle count at the close of surgery.
  • the invention features methods of immobilizing body material during surgery.
  • the method includes providing a safety lock needle of the invention, moving the elongated member to its open position, piercing a body material with the tip portion, inserting the tip portion through the body material until the tip portion protrudes from the body material, and moving the elongated member to its closed position to secure the needle in a desired position.
  • the method includes providing two needles, securing the needles, as described above, to the skin or tissue on opposite sides of an incision, providing a retractor having a pair of opposed prongs, engaging each of the needles with a prong of the retractor, and opening the retractor to retract the skin or tissue.
  • FIG. 1 is a photograph showing a prior art method of tendon fixation, utilizing Keith Needles.
  • Fig. 2 is a close-up photograph showing the prior art method of Fig. 1.
  • Fig. 3 shows a side view of a safety lock needle according to one embodiment of the invention, in a closed position.
  • Fig. 3a shows the needle in an open position.
  • Fig. 4 shows a cross sectional view of the tip portion of the needle of Fig. 3, taken along line 4-4 of Fig. 3a.
  • Fig. 4a shows a highly enlarged side view of the tip portion of the needle of Fig. 3.
  • Fig. 5 shows a safety lock needle according to an alternate embodiment of the invention.
  • Fig. 6 is a photograph showing a plurality of safety lock needles used in tendon immobilization.
  • Fig. 6a is a close-up view of the tendon immobilization shown in Fig. 6.
  • Fig. 7 is a photograph showing a plurality of safety lock needles used in skin retraction.
  • Needle 10 includes an elongated member 12, which consists of a first leg 14, a second leg 16, and a resilient portion 18.
  • first leg In the open position of the needle (Fig. 3a) , the first leg is disposed at an angle of from 10 to 60 degrees relative to said second leg.
  • the closed position In the closed position (Fig. 3) , the legs are substantially parallel.
  • Resilient portion 18 allows first leg 14 to be moved from its closed position (Fig. 3) to its open position (Fig. 3a) , and biases first leg 14 towards the open position.
  • Resilient portion 18 is preferably a single coil spring, as shown, but could instead be an area of resilient material or other conventional biasing element.
  • the elongated member could be simply bent at approximately its midpoint, in the manner of a "diaper pin", or bent and encapsulated in a plastic block 23, as shown in Fig. 5.
  • First leg 14 terminates in a tip portion 20.
  • Tip portion 20 is sharp, i.e., the tip portion is tapered from the point 21 over the length of the tip portion at an angle of less than about 30 degrees. It is also preferred that the tip have a triangular cross-section, as shown in Fig. 4, to enable the tip portion to more easily pierce and pass through skin, tendon, and other body materials.
  • the triangular cross-section may be in the form of an isosceles triangle or an equilateral triangle.
  • the characteristics of the tip portion may be similar to those of the tip of a standard Keith Needle.
  • the tip portion 20 has a predetermined length L (Fig.
  • First leg 14 is preferably formed from instrument grade surgical stainless steel, most preferably straight chromium type 400 series stainless steel. Other metals may be used, provided that the metal is relatively inert when in contact with body materials, and has sufficient rigidity to allow the first leg to withstand repeated movement between its open and closed positions without excessive permanent deformation.
  • Second leg 16 is approximately the same length as first leg 14.
  • the first and second legs may be part of a single integral elongated member, as shown, or the two legs may be distinct members which converge at the resilient region.
  • Second leg 16 may be formed from any suitable material which is inert when in contact with body material, but is preferably formed from the same material as the first leg, i.e., instrument grade surgical stainless steel, more preferably straight chromium type 400 series stainless steel.
  • Second leg 16 terminates in a shield 22, which is dimensioned to receive the tip portion when the first leg is moved to its closed position, as shown in Fig. 3.
  • Shield 22 comprises a body which defines a cavity that is enclosed on three sides.
  • the body includes a slot 25 that is disposed substantially parallel to second leg 16 and is open at its end which is closest to resilient portion 18. This open-ended slot allows the tip portion 20 to be inserted through the slot and into the cavity.
  • Shield 22 preferably has a U-shaped leading edge, as shown, and has substantially no sharp edges which could injure the surgeon or patient.
  • the shield can have a structure similar to that of a conventional safety pin or diaper pin.
  • Shield 22 may be formed of any suitable material which is inert when in contact with body material, e.g., surgical stainless steel or plastic.
  • the use of the safety lock needle 10 in tendon immobilization is illustrated in Figs. 6 and 6a.
  • the surgeon moves the first leg to its open position, pierces the tendon 4 with the tip portion, pushes the tip portion through the tendon until the tip portion protrudes, and moves the first leg to its closed position by deflecting the shield towards the tip portion until the tip portion is received by the shield.
  • the needle can also be used to impale a tendon, i.e., the needle does not have to emerge and be inserted into the shield, but can instead be embedded in the skin or underlying tissue.
  • the needle can be inserted through the tendon and then through skin or tissue before emerging and being inserted into the shield.
  • a safety lock needle 10 is inserted through the skin or tissue near the incision and closed, in the manner described above, on opposite sides of the incision.
  • the skin is then retracted by placing the opposed prongs 30 of a retractor 32 through the corresponding opposed closed safety needles 10, and opening the retractor to spread the opposed prongs and thus retract the skin.
  • the needles can be used to close a wound or incision, by engaging the needles with a clamp or the like and drawing the edges of an incision together.
  • the drawing together of the edges can be done immediately or over a period of time by stretching the skin, as appropriate.

Abstract

An improved needle (10) for fixing body material, e.g., tendons, during surgery is provided. The needle includes an elongated member (12), comprising a first leg (14), having a first end including a tip portion (20) having a triangular cross section to enable the tip portion to pierce the body material, a second leg (16), having a second end, and a resilient portion (18) disposed between said first leg and said second leg; and a blunt shield (22) disposed at said second end and dimensioned to receive said tip portion. The elongated member (12) is bent at an acute angle, and the resilient portion (18) is positioned to enable said first leg (14) to be moveable between an open position, in which the tip portion is exposed and spaced from the shield (22), allowing the tip portion (20) to pierce and to be inserted through a body material, and a closed position, in which the tip portion is received and enclosed by the shield.

Description

SAFETY LOCK NEEDLE Background of the Invention During surgery, surgeons frequently need to immobilize body material in a desired position. Examples of situations in which immobilization is necessary include tendon fixation and retraction of the skin surrounding an incision.
Tendon fixation is typically accomplished by inserting a number of straight needles 2, similar to sewing needles, through the tendons 4 in a manner similar to a skewer, as shown in Figs. 1 and 2. These straight needles, referred to as "Keith Needles", have a sharp tip portion having a triangular cross-section, to enable them to easily pierce body material.
While the Keith Needle is generally effective in holding the body material in position, it poses a danger to the surgeon. As more needles are required in the surgical procedure, it becomes almost inevitable that the surgeon's fingers will be punctured. Because of the risk of disease (e.g., AIDS) transmission through blood, such a puncture could be extremely dangerous.
Retraction of skin surrounding an incision is usually accomplished by inserting the prongs of a retractor into the insertion, and spreading the prongs of the retractor to retract the skin. While this method is generally effective in retracting the skin, it tends to cause trauma and tissue damage. Moreover, different size retractors must be kept on hand for use with different size incisions, as the prongs of a large retractor will not fit in a small incision, nor will the prongs of a small retractor effectively retract the skin around a large incision. Summary of the Invention The invention features an improved needle for immobilizing body material during surgery. The needle can, advantageously, be moved from an open position, in which a sharp point is exposed to pierce the body material, to a closed position, in which the point is safely shielded to prevent accidental puncture wounds or tissue damage. The needle may be used in a variety of surgical applications, including but not limited to applications in which a Keith Needle is used, e.g., for tendon fixation, and applications in which a retractor is used, e.g., skin retraction. In skin retraction, the needle is secured to the skin at the edge of the incision and closed, and, in this position, provides a rigid member for the retractor prongs to engage. Thus, the retractor prongs never directly engage the skin or tissue and as a result trauma and tissue damage are significantly reduced. Moreover, a single retractor, the prongs of which are dimensioned to engage the needle, can be used with a wide range of incision sizes.
The needle of the invention includes an elongated member, comprising a first leg, having a first end including a tip portion having a triangular cross section to enable the tip portion to pierce the body material, a second leg, having a second end, and a resilient portion disposed between said first leg and said second leg; and a blunt shield disposed at said second end and dimensioned to receive said tip portion. The elongated member is bent at an acute angle, and the resilient portion is positioned to enable said first leg to be moveable between an open position, in which the tip portion is exposed and spaced from the shield, allowing the tip portion to pierce and to be inserted through a body material, and a closed position, in which the tip portion is received and enclosed by the shield. Preferably, the first leg and second leg are unitary (formed from a single member) , and the resilient portion comprises a coil spring, preferably a single coil spring, disposed between the first leg and second leg to allow the first leg to be moved between its closed and open positions and to bias the moveable region towards the open position. More preferably, the single coil spring is unitary with said first leg and said second leg, and said first leg and said second leg are substantially equal in length so that said single coil spring is disposed at approximately the midpoint of said elongated member, e.g., as in a conventional "safety pin". It is also preferred that, in the open position said first leg is disposed at an angle of from 10 to 60 degrees relative to said second leg, and in the closed position, said first leg is substantially parallel to said second leg. Other preferred embodiments include the following features. The elongated member preferably comprises instrument grade surgical stainless steel. The tip portion preferably has a length which comprises about 1/2 to 1/4, more preferably about 1/3, of the overall length of the first leg. The tip portion is preferably tapered over its length at an angle of less than 30 degrees, the apex of the angle being at the first end; the remainder of the first leg has a substantially round cross-section. The tip portion also preferably includes an aperture dimensioned to receive a suture or wire, to allow the needle to be used to form a stitch, and is diamond coated for optimal sharpness, to minimize tissue trauma. Preferably, the shield is shaped to allow the elongated member to be moved from its open to its closed position by a gloved hand (i.e., a surgeon wearing surgical gloves) , and has a substantially U-shaped leading edge, to minimize tissue trauma. Preferably the metal of some portion of the needle is ferromagnetic, to facilitate retrieval of lost needles in the operating room and thus aid in performing a needle count at the close of surgery.
In another aspect, the invention features methods of immobilizing body material during surgery.
In one aspect, the method includes providing a safety lock needle of the invention, moving the elongated member to its open position, piercing a body material with the tip portion, inserting the tip portion through the body material until the tip portion protrudes from the body material, and moving the elongated member to its closed position to secure the needle in a desired position.
In another aspect, the method includes providing two needles, securing the needles, as described above, to the skin or tissue on opposite sides of an incision, providing a retractor having a pair of opposed prongs, engaging each of the needles with a prong of the retractor, and opening the retractor to retract the skin or tissue.
Other features and advantages of the invention will be apparent from the Description of the Preferred Embodiments, the drawings, and the claims.
Brief Description of the Drawings Fig. 1 is a photograph showing a prior art method of tendon fixation, utilizing Keith Needles.
Fig. 2 is a close-up photograph showing the prior art method of Fig. 1.
Fig. 3 shows a side view of a safety lock needle according to one embodiment of the invention, in a closed position. Fig. 3a shows the needle in an open position.
Fig. 4 shows a cross sectional view of the tip portion of the needle of Fig. 3, taken along line 4-4 of Fig. 3a. Fig. 4a shows a highly enlarged side view of the tip portion of the needle of Fig. 3. Fig. 5 shows a safety lock needle according to an alternate embodiment of the invention.
Fig. 6 is a photograph showing a plurality of safety lock needles used in tendon immobilization. Fig. 6a is a close-up view of the tendon immobilization shown in Fig. 6.
Fig. 7 is a photograph showing a plurality of safety lock needles used in skin retraction.
Description of the Preferred Embodiments
A preferred safety lock needle 10 is shown in Figs. 3 and 3a. Needle 10 includes an elongated member 12, which consists of a first leg 14, a second leg 16, and a resilient portion 18. In the open position of the needle (Fig. 3a) , the first leg is disposed at an angle of from 10 to 60 degrees relative to said second leg. In the closed position (Fig. 3) , the legs are substantially parallel.
Resilient portion 18 allows first leg 14 to be moved from its closed position (Fig. 3) to its open position (Fig. 3a) , and biases first leg 14 towards the open position. Resilient portion 18 is preferably a single coil spring, as shown, but could instead be an area of resilient material or other conventional biasing element. For example, the elongated member could be simply bent at approximately its midpoint, in the manner of a "diaper pin", or bent and encapsulated in a plastic block 23, as shown in Fig. 5.
First leg 14 terminates in a tip portion 20. Tip portion 20 is sharp, i.e., the tip portion is tapered from the point 21 over the length of the tip portion at an angle of less than about 30 degrees. It is also preferred that the tip have a triangular cross-section, as shown in Fig. 4, to enable the tip portion to more easily pierce and pass through skin, tendon, and other body materials. The triangular cross-section may be in the form of an isosceles triangle or an equilateral triangle. The characteristics of the tip portion may be similar to those of the tip of a standard Keith Needle. The tip portion 20 has a predetermined length L (Fig. 3a) which comprises about 1/2 to 1/ , more preferably about 1/3, of the length of first leg 14. The remainder of the length of first leg 14 preferably has a substantially round cross section. However, if desired for a particular application, the entire first leg could have a triangular cross section, or the remainder of the first leg could have a cross section of a different shape, e.g., oval. First leg 14 is preferably formed from instrument grade surgical stainless steel, most preferably straight chromium type 400 series stainless steel. Other metals may be used, provided that the metal is relatively inert when in contact with body materials, and has sufficient rigidity to allow the first leg to withstand repeated movement between its open and closed positions without excessive permanent deformation.
Second leg 16 is approximately the same length as first leg 14. The first and second legs may be part of a single integral elongated member, as shown, or the two legs may be distinct members which converge at the resilient region. Second leg 16 may be formed from any suitable material which is inert when in contact with body material, but is preferably formed from the same material as the first leg, i.e., instrument grade surgical stainless steel, more preferably straight chromium type 400 series stainless steel.
Second leg 16 terminates in a shield 22, which is dimensioned to receive the tip portion when the first leg is moved to its closed position, as shown in Fig. 3. Shield 22 comprises a body which defines a cavity that is enclosed on three sides. The body includes a slot 25 that is disposed substantially parallel to second leg 16 and is open at its end which is closest to resilient portion 18. This open-ended slot allows the tip portion 20 to be inserted through the slot and into the cavity. Shield 22 preferably has a U-shaped leading edge, as shown, and has substantially no sharp edges which could injure the surgeon or patient. The shield can have a structure similar to that of a conventional safety pin or diaper pin. Other structures are suitable, as long as the tip portion can be easily moved in and out of the shield with a gloved hand, but is retained securely enough to minimize the risk of inadvertent removal of the tip portion from the shield. Shield 22 may be formed of any suitable material which is inert when in contact with body material, e.g., surgical stainless steel or plastic.
The use of the safety lock needle 10 in tendon immobilization is illustrated in Figs. 6 and 6a. To use the needle, the surgeon moves the first leg to its open position, pierces the tendon 4 with the tip portion, pushes the tip portion through the tendon until the tip portion protrudes, and moves the first leg to its closed position by deflecting the shield towards the tip portion until the tip portion is received by the shield. The needle can also be used to impale a tendon, i.e., the needle does not have to emerge and be inserted into the shield, but can instead be embedded in the skin or underlying tissue. Moreover, the needle can be inserted through the tendon and then through skin or tissue before emerging and being inserted into the shield.
The use of the safety lock needle in skin retraction is shown in Figs. 7. To retract the skin around an incision, a safety lock needle 10 is inserted through the skin or tissue near the incision and closed, in the manner described above, on opposite sides of the incision. The skin is then retracted by placing the opposed prongs 30 of a retractor 32 through the corresponding opposed closed safety needles 10, and opening the retractor to spread the opposed prongs and thus retract the skin.
In the same manner, the needles can be used to close a wound or incision, by engaging the needles with a clamp or the like and drawing the edges of an incision together. As is known in the art, the drawing together of the edges can be done immediately or over a period of time by stretching the skin, as appropriate.
Other embodiments are within the claims.

Claims

1. A safety lock needle for immobilizing body material during surgery comprising: an elongated member, comprising a first leg, having a first end including a tip portion having a triangular cross section to enable the tip portion to pierce the body material, a second leg, having a second end, and a resilient portion disposed between said first leg and said second leg; and a blunt shield disposed at said second end and dimensioned to receive said tip portion; said elongated member being bent at an acute angle, and said resilient portion being positioned to enable said first leg to be moveable between an open position, in which the tip portion is exposed and spaced from the shield, allowing the tip portion to pierce and to be inserted through a body material, and a closed position, in which the tip portion is received and enclosed by the shield.
2. The safety lock needle of claim 1 wherein said first leg and said second leg are unitary and said resilient portion comprises a coil spring disposed between the first leg and second leg to allow the first leg to be moved between its closed and open positions and to bias the moveable region towards the open position.
3. The safety lock needle of claim 2 wherein said single coil spring is unitary with said first leg and said second leg, and said first leg and said second leg are substantially equal in length so that said single coil spring is disposed at approximately the midpoint of said elongated member.
4. The safety lock needle of claim 1 wherein, in said open position, said first leg is disposed at an angle of from 10 to 60 degrees relative to said second leg.
5. The safety lock needle of claim 1 or 4 wherein, in said closed position, said first leg is substantially parallel to said second leg.
6. The safety lock needle of claim 1 wherein said elongated member is formed of instrument grade surgical stainless steel.
7. The safety lock needle of claim 1 wherein said tip portion has a predetermined length which comprises about 1/2 to 1/4, more preferably about 1/3, of the overall length of the first leg, and the remainder of the first leg has a substantially round cross-section.
8. The safety lock needle of claim 1 or 7 wherein the tip portion includes an aperture dimensioned to receive a suture or wire.
9. The safety lock needle of claim 1 wherein the tip portion is diamond coated for sharpness.
10. The safety lock needle of claim 1 wherein at least a portion of the elongated member is formed of a ferromagnetic metal.
11. The safety lock needle of claim 1 wherein the shield is shaped to allow the elongated member to be moved from its open to its closed position by a gloved hand.
12. The safety lock needle of claim 1 wherein the shield has a substantially U-shaped leading edge to minimize tissue trauma.
13. The safety lock needle of claim 1 or 11 wherein said shield comprises a body which defines a cavity, enclosed on three sides, and which includes a slot, dimensioned and positioned so that the tip portion can be inserted through said slot into said cavity.
14. The safety lock needle of claim 7 wherein said tip portion is tapered over its length at an angle of less than about 30 degrees, the apex of said angle being at said first end.
15. A method of immobilizing body material during surgery comprising the steps of:
(a) providing a safety lock needle comprising: an elongated member, comprising a first leg, having a first end including a tip portion having a triangular cross section to enable the tip portion to pierce the body material, a second leg, having a second end, and a resilient portion disposed between said first leg and said second leg; and a blunt shield disposed at said second end and dimensioned to receive said tip portion; said elongated member being bent at an acute angle, and said resilient portion being positioned to enable said first leg to be moveable between an open position, in which the tip portion is exposed and spaced from the shield, allowing the tip portion to pierce and to be inserted through a body material, and a closed position, in which the tip portion is received and enclosed by the shield. (b) moving the first leg to its open position,
(c) piercing a body material with the tip portion,
(d) inserting the tip portion through the body material until the tip portion protrudes from the body material, and
(e) moving the elongated member to its closed position, to secure the needle in a desired position.
16. A method of retracting skin from the area of an incision comprising the steps of:
(a) providing two safety lock needles, each needle comprising: an elongated member, comprising a first leg, having a first end including a tip portion having a triangular cross section to enable the tip portion to pierce the body material, a second leg, having a second end, and a resilient portion disposed between said first leg and said second leg; and a blunt shield disposed at said second end and dimensioned to receive said tip portion; said elongated member being bent at an acute angle, and said resilient portion being positioned to enable said first leg to be moveable between an open position, in which the tip portion is exposed and spaced from the shield, allowing the tip portion to pierce and to be inserted through a body material, and a closed position, in which the tip portion is received and enclosed by the shield,
(b) moving the first leg of one of the needles to its open position,
(c) piercing the skin in a first region on one side of the incision with the tip portion,
(d) inserting the tip portion through the skin and underlying body material until the tip portion protrudes from the skin in a second region, spaced from the first region, and
(e) moving the elongated member to its closed position, to secure the needle,
(f) repeating steps (b) - (e) with the second needle on the opposite side of the incision,
(g) providing a retractor having a pair of opposed prongs,
(h) engaging each of the needles with a prong of the retractor, and
(i) spreading the prongs of the retractor to retract the skin or tissue.
PCT/US1995/007237 1994-06-10 1995-06-06 Safety lock needle WO1995034245A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU28188/95A AU2818895A (en) 1994-06-10 1995-06-06 Safety lock needle

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US25848094A 1994-06-10 1994-06-10
US08/258,480 1994-06-10

Publications (1)

Publication Number Publication Date
WO1995034245A1 true WO1995034245A1 (en) 1995-12-21

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ID=22980724

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Application Number Title Priority Date Filing Date
PCT/US1995/007237 WO1995034245A1 (en) 1994-06-10 1995-06-06 Safety lock needle

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WO (1) WO1995034245A1 (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003028563A2 (en) * 2001-10-01 2003-04-10 The Cleveland Clinic Foundation Skin lesion exciser and skin-closure device therefor
EP2022411A1 (en) * 2007-07-25 2009-02-11 Ethicon Endo-Surgery, Inc. Tissue manipulator
US7513902B2 (en) 2001-10-01 2009-04-07 The Cleveland Clinic Foundation Skin lesion exciser and skin-closure device therefor
US7799042B2 (en) 2004-05-13 2010-09-21 The Cleveland Clinic Foundation Skin lesion exciser and skin-closure device therefor

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US1354094A (en) * 1920-09-28 Island
GB296426A (en) * 1927-09-01 1928-10-25 Georges Leighton Improvements in safety pins
US3851359A (en) * 1973-05-02 1974-12-03 L Wilson Disposable safety pin
US4699142A (en) * 1985-06-21 1987-10-13 D. Drukker & Zn. N.V. Microsurgical suture needles
US4896680A (en) * 1987-02-10 1990-01-30 Bernard Hirshowitz Method of extending a flap of skin
US5263974A (en) * 1991-01-09 1993-11-23 Matsutani Seisakusho Co., Ltd. Suture needle and method of and apparatus for grinding material for suture needle

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1354094A (en) * 1920-09-28 Island
GB296426A (en) * 1927-09-01 1928-10-25 Georges Leighton Improvements in safety pins
US3851359A (en) * 1973-05-02 1974-12-03 L Wilson Disposable safety pin
US4699142A (en) * 1985-06-21 1987-10-13 D. Drukker & Zn. N.V. Microsurgical suture needles
US4896680A (en) * 1987-02-10 1990-01-30 Bernard Hirshowitz Method of extending a flap of skin
US5263974A (en) * 1991-01-09 1993-11-23 Matsutani Seisakusho Co., Ltd. Suture needle and method of and apparatus for grinding material for suture needle

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003028563A2 (en) * 2001-10-01 2003-04-10 The Cleveland Clinic Foundation Skin lesion exciser and skin-closure device therefor
WO2003028563A3 (en) * 2001-10-01 2003-08-07 Cleveland Clinic Foundation Skin lesion exciser and skin-closure device therefor
AU2002327785B2 (en) * 2001-10-01 2006-06-01 The Cleveland Clinic Foundation Skin lesion exciser and skin-closure device therefor
US7513902B2 (en) 2001-10-01 2009-04-07 The Cleveland Clinic Foundation Skin lesion exciser and skin-closure device therefor
US7806907B2 (en) 2001-10-01 2010-10-05 The Cleveland Clinic Foundation Skin lesion exciser and skin-closure device therefor
US7799042B2 (en) 2004-05-13 2010-09-21 The Cleveland Clinic Foundation Skin lesion exciser and skin-closure device therefor
EP2022411A1 (en) * 2007-07-25 2009-02-11 Ethicon Endo-Surgery, Inc. Tissue manipulator

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