WO1989011820A1 - Dispositifs d'implantation de biocapteurs et similaires - Google Patents

Dispositifs d'implantation de biocapteurs et similaires Download PDF

Info

Publication number
WO1989011820A1
WO1989011820A1 PCT/GB1989/000635 GB8900635W WO8911820A1 WO 1989011820 A1 WO1989011820 A1 WO 1989011820A1 GB 8900635 W GB8900635 W GB 8900635W WO 8911820 A1 WO8911820 A1 WO 8911820A1
Authority
WO
WIPO (PCT)
Prior art keywords
biosensor
needle
introducer
arcuate
head member
Prior art date
Application number
PCT/GB1989/000635
Other languages
English (en)
Inventor
David Marston Band
David Gerard Penman
Original Assignee
Surgicraft Limited
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 Surgicraft Limited filed Critical Surgicraft Limited
Publication of WO1989011820A1 publication Critical patent/WO1989011820A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
    • A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
    • A61B5/4343—Pregnancy and labour monitoring, e.g. for labour onset detection
    • A61B5/4362—Assessing foetal parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A61B5/288—Invasive for foetal cardiography, e.g. scalp electrodes

Definitions

  • This invention relates to biosensor introducers, more particularly - but not exclusively - for fetal scalp electrodes, and also to biosensors, more particularly - but, again, not exclusively, fetal scalp electrodes.
  • One object of the invention is to provide a biosensor introducer for introducing a biosensor subcutaneously.
  • Another object is to provide a biosensor introducer that also provides a reference electrode.
  • a biosensor introducer comprises an arcuate needle, a biosensor secured to the arcuate needle behind its point, and means for inserting the needle under the skin so as to introduce the biosensor subcutaneously.
  • the biosensor may be secured to the arcuate needle in such a manner that, after introducing the biosensor subcutaneously, the needle can be withdrawn to leave the biosensor in position like a stitch under the skin.
  • the biosensor may comprise a length of flexible plastics tube having an outside diameter of less than 1.0 mm (preferably
  • the biosensor may be secured permanently to the arcuate needle, which may be adapted to serve as a reference electrode when inserted ith the biosensor under the skin.
  • a biosensor comprising a length of flexible plastics tube with a notch as aforesaid may be bonded to the arcuate needle, preferably both adjacent the notch and at a position remote therefrom, and preferably with the tube disposed on the outside (or underside) of the curve of the needle.
  • the arcuate needle may have a reduced cross-section behind its point to accommodate at least a leading end portion of the biosensor, which may comprise a length of flexible plastics tube (without a notch for engagement by the needle point) permanently bonded along the needle portion of reduced cross- section, which is preferably at the outside of the curve of the needle, with the leading end of the tube abutting a shoulder where the cross-section changes behind the point.
  • the biosensor may comprise a length of flexible plastics tube (without a notch for engagement by the needle point) permanently bonded along the needle portion of reduced cross- section, which is preferably at the outside of the curve of the needle, with the leading end of the tube abutting a shoulder where the cross-section changes behind the point.
  • a biosensor introducer in accordance with the invention with the biosensor bonded to the arcuate needle can in the case of fetal monitoring also serve the function of a CTG or evoked potential sensor.
  • a separate reference electrode needle and/or CTG or evoked potential sensor may be provided.
  • the needle may be incorporated in a device having a head member within which the arcuate needle point and the biosensor engaged therewith are housed inactive, the device also having actuating means remote from the head member for moving the arcuate needle point and the biosensor out from the head member in the same arcuate path, and back again, whereby, after the head member has been placed against the skin (e.g., a fetal scalp) the needle point and biosensor can be moved out from the head member to penetrate the skin.
  • the skin e.g., a fetal scalp
  • Such a device may be as described in GB-PS 1 316 072 or GB-PS 1 523 263 (and US-PS 4 151 835) as a fetal scalp electrode, with a bore along the head member, parallel to the central electrically conductive wire, for a lead from the biosensor, which lead is insulated and together with the insulated central wire extends through the torsion spring (which acts as a good screen) to the electrical connector, from which a co-axial cable provides good screening, maternal vaginal reference on the outside, measuring and reference wires on the inside.
  • the device may consist of or be incorporated in a fetal scalp electrode as described in GB-PS 1 316 072 or GB-PS 1 523 263 (and US-PS 4 151 835) , with the arcuate contact needle that is normally urged by the tubular torsional spring member to extend from the head member and looping back to the head member constituting a reference electrode, the means for introducing the biosensor of the present invention being an additional arcuate needle directed in the opposite rotational sense to the reference electrode arcuate contact needle, and the additional, biosensor- introducing arcuate needle also being normally urged by the tubular torsional spring member to lie within the head member and whereby, when the reference electrode arcuate contact needle has been withdrawn into the head by relative rotation of the electrical connector and the head member, to enable the head member to be placed against a fetal scalp, further rotation of the head
  • FIG. 1 is a general view of a biosensor introducer in accordance with the invention.
  • FIG. 2 is an enlarged fragmentary section taken from the line II-II of Figure 1;
  • Figure 3 is a further enlarged section taken from the line III-III of Figure 2;
  • Figure 4 corresponds to Figure 3 but shows the arcuate needle after having been propelled, with its attached biosensor, out of the head member;
  • Figure 5 is a fragmentary section, on the same scale as Figures 3 and 4, after the introducer of Figures 1 to 4 has left the biosensor in position like a stitch under the skin;
  • FIG. 6 is a greatly enlarged fragmentary side elevation of an arcuate needle for another biosensor introducer in accordance with the invention, showing the biosensor bonded to a portion of the needle of reduced cross- section behind its point;
  • Figure 7 is an even further enlarged cross-section on the line VII-VII of Figure 6;
  • FIG 8 corresponds to Figure 7 but shows an alternative form of biosensor
  • Figure 9 corresponds to Figure 3 but shows the arcuate needle and biosensor of Figures 6 and 7 (or Figure 8) incorporated in the introducer;
  • Figure 10 corresponds to Figure 9 but shows the arcuate needle and biosensor withdrawn into the head member ready for placement of the latter against the skin, e.g., of a fetal scalp;
  • FIG 11 is a greatly enlarged skeletal perspective view of the head member of a further biosensor introducer in accordance with the invention, with an introducer needle and biosensor and a reference electrode needle in initial or neutral position;
  • Figures 12 and 13 correspond to Figure 11 but show ⁇ uccesive operational positions of the needles and biosensor shown in Figure 11;
  • Figure 14 also corresponds to Figure 11 but shows a final neutral position indicative of the biosensor in position like a stitch under the skin and the reference electrode needle likewise inserted under the skin.
  • the biosensor introducer shown in Figures 1 to 4 comprises an arcuate needle 15, a biosensor 16 secured to the arcuate needle behind its point, and means 17 for inserting the needle under the skin 18 (see Figure 5) so as to introduce the biosensor subcutaneously.
  • the biosensor 16 comprises a length of flexible plastics tube with a notch 19 adjacent one leading end 20, whereby the notch can be entered by the needle 15 with its point directed towards the leading end of the biosensor, the notch being close enough to the leading end of the biosensor for the point of the needle to emerge through the leading end of the tube.
  • the means 17 for inserting the needle under the skin 18 is a device based on the "Surgi c aft- Co pel and" fetal scalp electrode (FSE) which is described in GB-PS 1 316 072 or GB- PS 1 523 263 (and US-PS 4 151 835).
  • FSE fetal scalp electrode
  • a rotary actuating means 21, remote from a head member 22, replaces the electrical connector of the aforesaid FSE, and a helical spring 23 does not function as an outer electrically conductive wire, the biosensor 16 having its own electrical lead 24 from its trailing end passing freely through a bore 25 in the head member.
  • a straightened end portion 26 of the spring 23 anchors it in the head member 22 and a similar straightened portion at the other end (not shown) anchors it in the rotary actuating means 21.
  • a central wire 27 has a radial arm 28 integral with one end and with the arcuate needle 15, the other end (not shown) of the central wire also being anchored in the rotary actuating means 21.
  • the head member 22 is formed of plastics material, a plastics sleeve 29 is provided betwen the spring 23 and the central wire, and a flexible sheath 30 is provided along the outside of the spring 23.
  • Figures 2 to 4 show that the head member 22 has a cavity 31 and two holes 32, 33 respectively between the cavity and a flat surface 34 on the outside of the head member.
  • the arcuate needle 15 and the biosensor 16 hooked thereon normally lie within the cavity 31 ( Figures 2 and 3) but when the rotary actuating means 21 is rotated relative to the head member 22 (i.e., in the anti-clockwise direction as viewed in Figure 3) against the urge of the spring 23, after the flat surface 34 has been placed against the skin 18, the central wire 27 is rotated, for the arcuate needle 15 and the biosensor 16 to be urged out through the holes 32 and through the skin, and back to enter the hole 33 ( Figure 4).
  • the outside of the head member 22 is also provided with a concave surface 35 facing oppositely to the flat surface 34, with ribs 36 extending transversely with respect to the axis of the helical spring 23, which ribs deter a finger of one hand engaged therewith from sliding along the head member in a direction away from the rotary actuating member 21 when the adjacent fingers engage the sides 37 of the head member to hold its flat surface 34 against the skin, more particularly, of a fetal scalp.
  • Ribs 38 ( Figure 1) extending longitudinally of the rotary actuating means 21 assist in gaining a good grip with the thumb and fingers of the other hand.
  • the device 17 When the biosensor 16 has been left like a stitch under the skin 18, the device 17 is withdrawn from the skin. thus allowing the lead 24 from the biosensor to be drawn through the bore 25 through the head member 22, and the other end of the lead 24 is connected to monitoring equipment (not shown).
  • the biosensor 16 is secured permanently to the arcuate needle 15, which may be adapted to serve as a reference electrode when inserted (with the biosensor) under the skin in similar manner to the arcuate needle of the "Surgicraf t-Copeland" FSE as aforesaid.
  • the arcuate needle 15 has a portion 39 behind its point having a reduced cross-section to accommodate a leading end portion of the biosensor bonded thereto, with the leading end 20 of the biosensor abutting a shoulder 40 where the cross-section changes behind the point of the arcuate needle.
  • the biosensor 16 may have a solid section, as shown in Figure 7, or it may comprise a length of flexible plastics tube, as shown in Figure 8. Al ernatively, a tubular biosensor as in Figures 2 to 4 may be bonded to the arcuate needle.
  • Figure 9 shows the normal disposition of the arcuate needle 15 (and the biosensor 16 bonded thereto) outside the head member 22, while in Figure 10 it is shown withdrawn into the cavity 31 to enable the flat surface 34 to be placed against the skin.
  • the rotary actuating means 21 for this embodiment also serves as an electrical connector and therefore has, in addition to anchoring for the respective ends of the helical spring 23 and central wire 27, electrical terminals for the central wire 27 and the lead 24, which extends through insulation between the central wire 27 and the helical spring 23, and further leads (not shown) extend from the terminals in the rotary actuating means/electrical connector 21 to monitoring equipment (not shown).
  • this introducer corresponds and operates as does the "Surgi craft- Co pel and" FSE previously referred to.
  • the biosensor 16 (which is of the type shown in Figures 2 to 4) is carried by an arcuate needle 15 which is additional to the arcuate contact needle 15' that is normally urged by the h el ical sp ing 23 to extend from the head member 22* and looping back to the head member in the "Surgicraf t- Copeland" FSE, which arcuate contact needle 15' now constitutes a reference electrode in place of the arcuate needle 15 in the previous embodiment.
  • the needle 15 will be referred to hereinafter as the "introducer needle” while the needle 15' will be referred to as the "reference electrode needle”.
  • the reference electrode needle 15' is connected by an integral radial arm 28' to another central wire 27' parallel to the central wire 27, and a separate cavity 31' is provided in the head member 22' into which the reference electrode needle is withdrawn when the rotary actuating means/electrical connector 21 is rotated in the direction shown in figure 12.
  • rotary actuator means/electrical conector 21 will be adapted for use with the embodiment of Figures 11 to 14 by including anchorages for the respective ends of the helical spring 23 and both central wires 27, 27', and terminals for the central wire 27' and the lead 24 from the biosensor 16, and that further leads will again extend from those terminals to monitoring equipment.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Physics & Mathematics (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Pediatric Medicine (AREA)
  • Public Health (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Reproductive Health (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

Le dispositif d'implantation de biocapteur décrit comprend une aiguille recourbée (15), un biocapteur (16) fixé à l'aiguille recourbée à l'arrière de sa pointe, ainsi qu'un organe (17) servant à introduire l'aiguille sous la peau pour permettre une implantation sous-cutanée du biocapteur. Le biocapteur (16) peut comprendre un segment de tube de plastique flexible comportant à proximité adjacente d'une extrémité d'attaque (20) une encoche (19), dans laquelle peut pénétrer l'aiguille (15) et de laquelle l'aiguille peut être retirée pour laisser le biocapteur sous la peau comme s'il s'agissait d'un point de suture. Dans une autre variante, on peut fixer en permanence le biocapteur (16) à l'aiguille (15) en amalgamant une partie d'extrémité d'attaque dans une partie (39) de l'aiguille ayant une section transversale réduite, l'extrémité d'attaque (20) du biocapteur venant s'appuyer contre un épaulement (40) à partir duquel la section transversale change au fur et à mesure qu'on s'éloigne de la pointe de l'aiguille.
PCT/GB1989/000635 1988-06-08 1989-06-08 Dispositifs d'implantation de biocapteurs et similaires WO1989011820A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB888813571A GB8813571D0 (en) 1988-06-08 1988-06-08 Biosensor introducers &c
GB8813571 1988-06-08

Publications (1)

Publication Number Publication Date
WO1989011820A1 true WO1989011820A1 (fr) 1989-12-14

Family

ID=10638289

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB1989/000635 WO1989011820A1 (fr) 1988-06-08 1989-06-08 Dispositifs d'implantation de biocapteurs et similaires

Country Status (3)

Country Link
ES (1) ES2014649A6 (fr)
GB (1) GB8813571D0 (fr)
WO (1) WO1989011820A1 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5330525A (en) * 1993-04-29 1994-07-19 Medtronic, Inc. Epicardial lead having dual rotatable anchors
EP0678308A1 (fr) * 1994-03-15 1995-10-25 Minimed Inc. Dispositif d'insertion pour capteur transcutané
WO2003080169A1 (fr) * 2002-03-22 2003-10-02 Novo Nordisk A/S Insertion non traumatique d'un dispositif sous-cutane
GB2410442A (en) * 2004-01-28 2005-08-03 Surgicraft Ltd Foetal scalp electrode with orientation marking
EP2404632A1 (fr) 2010-07-10 2012-01-11 Roche Diagnostics GmbH Système d'insertion pour des aiguilles
EP2422699A1 (fr) * 2010-08-30 2012-02-29 Arkray, Inc. Dispositif d'insertion et retrait de capteurs
EP2934315A4 (fr) * 2012-12-18 2016-08-17 Abbott Diabetes Care Inc Dispositifs et procédés de détection d'analyte dans une couche dermique
CN108903916A (zh) * 2018-07-31 2018-11-30 浙江大学 柔性植入式生物传感器及光电器件的植入针及植入方法
CN110731801A (zh) * 2018-07-20 2020-01-31 上海志朗医疗科技有限公司 一种抽吸活检针

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2532242A1 (de) * 1975-07-18 1977-02-10 Gerhard Seeh Nadel fuer chirurgische zwecke
US4151835A (en) * 1978-03-08 1979-05-01 John Copeland Foetal scalp electrodes
DE2749048A1 (de) * 1977-11-02 1979-05-03 Siemens Ag Elektrode zum ansetzen an oder in koerperteilen
US4355642A (en) * 1980-11-14 1982-10-26 Physio-Control Corporation Multipolar electrode for body tissue
EP0216538A1 (fr) * 1985-09-06 1987-04-01 MICRA Ltd. Aiguille chirurgicale

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2532242A1 (de) * 1975-07-18 1977-02-10 Gerhard Seeh Nadel fuer chirurgische zwecke
DE2749048A1 (de) * 1977-11-02 1979-05-03 Siemens Ag Elektrode zum ansetzen an oder in koerperteilen
US4151835A (en) * 1978-03-08 1979-05-01 John Copeland Foetal scalp electrodes
US4355642A (en) * 1980-11-14 1982-10-26 Physio-Control Corporation Multipolar electrode for body tissue
EP0216538A1 (fr) * 1985-09-06 1987-04-01 MICRA Ltd. Aiguille chirurgicale

Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5330525A (en) * 1993-04-29 1994-07-19 Medtronic, Inc. Epicardial lead having dual rotatable anchors
EP0678308A1 (fr) * 1994-03-15 1995-10-25 Minimed Inc. Dispositif d'insertion pour capteur transcutané
WO2003080169A1 (fr) * 2002-03-22 2003-10-02 Novo Nordisk A/S Insertion non traumatique d'un dispositif sous-cutane
GB2410442A (en) * 2004-01-28 2005-08-03 Surgicraft Ltd Foetal scalp electrode with orientation marking
GB2410442B (en) * 2004-01-28 2005-12-07 Surgicraft Ltd Fetal scalp electrodes
US8679132B2 (en) 2010-07-10 2014-03-25 Roche Diagnostics Operations, Inc. Insertion system
EP2404632A1 (fr) 2010-07-10 2012-01-11 Roche Diagnostics GmbH Système d'insertion pour des aiguilles
EP2422699A1 (fr) * 2010-08-30 2012-02-29 Arkray, Inc. Dispositif d'insertion et retrait de capteurs
CN102440784A (zh) * 2010-08-30 2012-05-09 爱科来株式会社 传感器插入/回收装置
CN102440784B (zh) * 2010-08-30 2014-04-09 爱科来株式会社 传感器插入/回收装置
US9066696B2 (en) 2010-08-30 2015-06-30 Arkray, Inc. Sensor insertion/recovery device
US9636060B2 (en) 2012-12-18 2017-05-02 Abbott Diabetes Care Inc. Dermal layer analyte sensing devices and methods
EP2934315A4 (fr) * 2012-12-18 2016-08-17 Abbott Diabetes Care Inc Dispositifs et procédés de détection d'analyte dans une couche dermique
US10624567B2 (en) 2012-12-18 2020-04-21 Abbott Diabetes Care Inc. Dermal layer analyte sensing devices and methods
EP3735896A1 (fr) * 2012-12-18 2020-11-11 Abbott Diabetes Care, Inc. Dispositifs et procédés de détection d'analyte de couche dermique
EP4393395A3 (fr) * 2012-12-18 2024-10-30 Abbott Diabetes Care, Inc. Dispositifs et procédés de détection d'analytes de couche dermique
CN110731801A (zh) * 2018-07-20 2020-01-31 上海志朗医疗科技有限公司 一种抽吸活检针
CN108903916A (zh) * 2018-07-31 2018-11-30 浙江大学 柔性植入式生物传感器及光电器件的植入针及植入方法
CN108903916B (zh) * 2018-07-31 2024-04-02 浙江大学 柔性植入式生物传感器及光电器件的植入针及植入方法

Also Published As

Publication number Publication date
GB8813571D0 (en) 1988-07-13
ES2014649A6 (es) 1990-07-16

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