GB2147813A

GB2147813A - Needle introducer

Info

Publication number: GB2147813A
Application number: GB08425844A
Authority: GB
Inventors: Jan Jiri Stanek
Original assignee: Kinpax & F T Mitchell Group Li
Current assignee: Kinpax & F T Mitchell Group Li
Priority date: 1983-10-14
Filing date: 1984-10-12
Publication date: 1985-05-22
Also published as: GB8425844D0; GB8327620D0

Abstract

A needle introducer (1) for assisting the insertion of a needle (7), e.g. of a syringe (8), into a body cavity, e.g. a rectum, comprises an open-ended protective sheath (4) for protecting the needle (7) during positioning of the needle in the body cavity and securing means for detachably retaining the needle introducer (1) on a wearer's hand, e.g. a finger. The needle introducer (1) is designed so that the sheath (4) extends along the inside of a finger of the wearer so that the tip of the needle can either be positioned inside the protective sheath (4) or projected out through an open end of the sheath, positioned adjacent the tip of said finger, for needle biopsy/injection purposes. The sheath may be incorporated into a glove. <IMAGE>

Description

SPECIFICATION Needle introducer This invention relates to a needle introducer for assisting the insertion of a needle, e.g. of a syringe, into a body cavity, e.g. a rectum. The invention has particular application to the needle biopsy of the prostate but may also be applied to other forms of fluid withdrawal from, or fluid injection into, the body, e.g. via the rectum.

According to one aspect of the invention a needle introducer comprises open-ended sheath means into which a needle, e.g. of a syringe, may be introduced and securing means for releasably securing the needle introducer to a wearer's hand, or part thereof, with the sheath means positioned along the inside of a finger of the wearer's hand with one of the open ends of the sheath means positioned adjacent the tip of the finger.

In use of a needle intoducer according to the invention with a syringe, the sheath means is dimensioned to have a smaller length than that of the needle of the syringe. The needle introducer is detachably secured to a hand of a wearer, e.g. a surgeon performing biopsy of the prostate gland of a patient, and the needle is inserted into the sheath means sufficiently far for the syringe to be held in the palm of the surgeon's hand with the needle protected by the sheath means but not sufficiently far for the end of the needle to project from the open end of the sheath means adjacent the surgeon's finger tip. The surgeon's finger and the ensheathed needle are then inserted into the patient's body cavity, e.g. rectum, and, when the tip of the surgeon's finger senses the desired body area, e.g.

the prostate, of the patient, the surgeon moves the syringe so that the needle is projected from the end of the sheath means adjacent the surgeon's finger tip and into the previously sensed body area. After operating the syringe, the needle is then retracted back into the sheath means and the surgeon's finger and the ensheathed needle are withdrawn from the body cavity. Thus the introducer serves to protect the syringe needle tip during introduction into, and withdrawal from, the body cavity.

Preferably the securing means comprises a collar, e.g. of rubber or rubber-like material, which in use is designed to encircle the base of the wearer's finger.

Preferably the needle intoducer is made of a flexible material, e.g. rubber. Conveniently the introducer includes stiffening means for stiffening the introducer along the sheath means. For example the sheath means may be made of, or include a part made of, a stiffer flexible material than the rest of the introducer. Typically, in this case, the sheath means comprises a tubular liner carried, e.g. removably, in an open-ended tubular portion of the introducer.

Suitably the tubular liner is made of a stiffer material than the tubular portion. Alternatively the needle introducer may be provided with a pocket adjacent, and along the length of, the sheath means for receiving an elongate, flexible stiffener, e.g. of plastics material.

Conveniently the introducer includes a finger portion arranged to at least partly protect the wearer's finger along the length of the sheath means. The finger portion may include a tip portion for protecting the tip of the finger.

According to another aspect of the invention there is provided a needle introducer comprising sheath means having first and second open ends and securing means for releasably securing the needle introducer to a wearer's hand, or part thereof, so that the sheath means is positioned along the inside of a finger of the wearer's hand with said first open end positioned adjacent the tip of said finger, the sheath means being dimensioned to enable a needle to be inserted into the sheath means through said second open end and to enable the tip of a needle so inserted into the sheath means to be projected through said first open end when desired under the control of the wearer.

Embodiments of the invention will now be described, by way of example, with reference to the accompanying drawings, in which: Figure 1 is a front view of one embodiment of a needle introducer according to the invention having a stiffener shown partially inserted, Figure 2 is a rear view of the needle introducer shown in Figure 1 but with the stiffener fully inserted, Figure 3 is a sectional view taken on the line Ill-Ill of Figure 2, Figure 4 is a view on a slightly enlarged scale, showing the needle introducer positioned on the index finger of a user's hand, Figure 5 is a front view of another embodiment of a needle introducer according to the invention, Figure 6 is a side view of the needle introducer shown in Figure 5, and Figure 7 is a sectional view, on an enlarged scale, taken on the line VII-VII of Figure 5.

Figures 1 to 3 show one embodiment of a rectal introducer, generally designated by the reference numeral 1, for application to the hand of a user (e.g.

a surgeon) to shield a needle inserted by the user into a patient's rectum, e.g. during needle biopsy of the patient's prostate gland.

The rectal introducer 1 comprises a flexible collar portion 2 at the base of the introducer, a flexible finger or carrier portion 3 extending upwardly from the base of the introducer and a flexible, tubular sheath 4 mounted on the carrier portion 3 and having opposite open ends 4a and 4b. The collar portion 2, carrier portion 3 and sheath 4 are suitably made of rubber and are formed, e.g. vulcanised or otherwise adhered together, as an integral structure.

The carrier portion 3 is provided with an elongate pocket or slot 5 (shown in dashed lines in Figure 1), closed at its upper end and open at its lower end, into which is inserted an elongate stiffener 6.

Although referred to as a "stiffener", the stiffener 6 is typically made of a flexible plastics material and acts, like a collar bone of a shirt, to provide in use a degree of stiffness and support for the more flexible rubber material of the rest of the introducer 1. When fully positioned in the slot 5 (Figure 1 shows the stiffener 6 only partly inserted in the slot 5), the stiffener 6 lies beneath the sheath 4 along the length thereof.

In use the rectal introducer 1 is positioned with the collar portion 2 around the base of a finger, typically the index finger, of a user (see Figure 4). The introducer is arranged so that the carrier portion 3 and sheath 4 are positioned along the inside of the finger so as to terminate before the end of the finger so that the finger tip is exposed and not covered by any part of the rectal introducer 1. With the introducer 1 so positioned, a needle 7 of a syringe 8 (shown in chain lines in Figure 4) is inserted into the sheath 4 through the open end 4a of the latter adjacent the base of the introducer 1, the needle 7 having a length greater than the sheath 4. At this stage the needle 7 is completely encased inside the sheath 4 and does not project from the open end 4b of the sheath.

The user then inserts his finger carrying the rectal introducer 1 and the ensheathed needle 7 into a patient's rectum and feels, with his exposed finger tip, for the patient's prostate gland. When the correct entry point for the needle 7 is located in the prostate by the user's finger tip, the end of the needle 7 is projected through the open end 4b of the sheath 4 and into the previously sensed needle entry point in the prostate. The syringe 8 is then operated to withdraw fluid from the prostate. When sufficient fluid has been withdrawn, the needle is withdrawn and moved back into the protective sheath 4, and the finger, introducer 1 and ensheathed needle 7 are finally removed from the rectum.

Although a method of needle biopsy has been disclosed, the applicator 1 may also be used for rectal injection.

Another embodiment of a rectal introducer, generally designated by the reference numeral 10, is shown in Figures 5 to 7.

The rectal introducer 10 comprises a flexible collar portion 12 at the base of the introducer, a flexible finger portion 13 extending upwardly from the base of the introducer 10 and an open-ended flexible, tubular portion 14 having opposite open ends 14a and 14,o. The portions 12-14 are suitably made of rubber or a rubber-like material moulded as an integral component. Inside the elongate tubular portion 14 there is positioned, e.g. removably to enable replacement, an open-ended tubular member 11 which acts both as a "stiffener" and as a sheath for protecting or shielding a needle of a syringe (not shown). The tubular portion 11 is typically made of a flexible plastics material, e.g. PVC, which provides a degree of stiffness and support for the more flexible rubber or rubber-like material of the rest of the introducer 10.

The rectal introducer 10 is used in much the same way as described with reference to the rectal introducer 1. One difference between the introducers, however, is that the finger portion 13 has a tip portion 1 3a which partly protects the wearer's finger tip during use. Thus, in this case, the finger tip of the user is protected during exploration for the patient's prostate gland, the finger tip feeling the patient through the flexible wall of the tip portion 13a.

In other embodiments of the invention, the stiffener 6 may be omitted or, if provided, be permanently fixed in the introducer 1. Furthermore, as an alternative construction, a needle introducer according to the invention may be in the form of a glove, e.g. a rubber glove, with the open-ended sheath fixed to the "glove" so as to lie along the inside of a glove finger and to terminate adjacent the wearer's finger tip. On positioning the glove on the wearer's hand the sheath is automatically secured in the correct position for use. The tip of the glove finger may be exposed or protected.

It will be appreciated that although the invention has been disclosed with particular reference to its preferred use as a rectal introducer, a needle introducer according to the invention may be used for assisting the insertion of a needle into other male or female body cavities and in particular, but not exclusively, for biopsies.

Claims

1. A needle introducer comprising open-ended sheath means into which a needle may be introduced and securing means for releasably securing the needle introducer to a wearer's hand or part thereof, with the sheath means positioned along the inside of a finger of the wearer's hand with one of the open ends of the sheath means positioned adjacent the top of the finger.

2. A needle introducer according to claim 1, wherein said securing means comprises collar means designed in use to encircle the base of a wearer finger.

3. A needle introducer according to claim 2, wherein said collar means is made of rubber or a rubber-like material.

4. A needle introducer according to claim 1 or 2 made of a flexible material.

5. A needle introducer according to any of the preceding claims, comprising stiffening means in the region of the sheath means.

6. A needle introducer according to claim 5, wherein the stiffening means comprises a pocket adjacent to, and along the length of, the sheath means and an elongate flexible stiffener received in said pocket.

7. A needle introducer according to claim 6, in which said stiffener is made of a plastics material.

8. A needle introducer according to any of claims 1 to 4, in which the sheath means comprises an open-ended flexible tubular portion and an openended tubular liner, for receiving the said needle, removably inserted into the said tubular portion.

9. A needle introducer according to claim 8, in which the tubular liner acts as a stiffener.

10. A needle introducer according to claim 8 or 9, in which the tubular liner is made of a plastics material, e.g. PVC.

11. A needle introducer according to any of the preceding claims, including a finger portion for at least partly surrounding at least part of a wearing finger of the wearer's hand.

12. A needle introducer according to claim 11, in which the finger portion includes a tip portion for protecting the tip of said wearing finger.

13. A needle introducer comprising sheath means having first and second open ends and securing means for releasably securing the needle introducer to a wearer's hand, or part thereof, so that the sheath means is positioned along the inside of a finger of the wearer's hand with said first open end positioned adjacent the tip of said finger, the sheath means being dimensioned to enable a needle to be inserted into the sheath means through said second open end and to enable the tip of a needle so inserted into the sheath means to be projected through said first open end when desired under the control of the wearer.

14. A glove having glove finger means and incorporating a needle introducer according to any of the preceding claims, the sheath means being arranged on the inside of one of the glove finger means and the securing means being constituted by the glove.

15. A needle introducer constructed and arranged, substantially as herein described with reference to, and is illustrated in, Figures 1 to 4 or Figures 5 to 7 of the accompanying drawings.