GB2580971A

GB2580971A - Manual to electric adapter

Info

Publication number: GB2580971A
Application number: GB1901443.0A
Authority: GB
Inventors: Laurence Cervi Paul
Original assignee: Pace Health Systems Ltd
Current assignee: Pace Health Systems Ltd
Priority date: 2019-02-01
Filing date: 2019-02-01
Publication date: 2020-08-05
Anticipated expiration: 2039-02-01
Also published as: GB2580971B; GB201901443D0

Abstract

An adapter for adapting a manual bone trephine with a T-shaped handle to couple to an electric driver. The adapter comprising: a body with a handle engaging formation with at least a pair of side walls 5 that engage opposite sides of the T-shaped handle so that the trephine is turned by pressure from the walls 5 on the T-shaped handle; and a projection 10 from the body to be grasped by a chuck of the electric driver, where in use, projection 10 defines a longitudinal axis aligned with an axis of the trephine and where the handle-engaging formation extends to either side of the longitudinal axis, with the pair of side walls 5 extending perpendicular to the longitudinal axis. Also a coupling device for coupling a driver to a biopsy needle assembly, the coupling device comprising: a body to engage with a handle of the biopsy-needle assembly; a projection 10 to engage with a chuck of the driver, where in use, projection 10 projects along a rotational axis of a cannula of the biopsy needle assembly; and a needle support 6 extending away from the body, the needle support comprising a recess 8 to intersect the rotational axis.

Description

MANUAL TO ELECTRIC ADAPTER

BACKGROUND OF THE INVENTION

Tissue sampling or biopsy is a common and important investigation in medical practice.

Bone marrow is frequently retrieved for subsequent pathological study-usually taken from the pelvic bone at the posterior superior iliac spine or iliac crest. Such a site is ideally suited to bone marrow sampling, as in adults there is often three to five centimetres of depth of medullary bone (containing bone marrow) sandwiched between two 0.5 cm thick dense cortical walls of bone on the bone surfaces.

In the standard bone marrow procurement protocol, using current standard instruments, (such as those disclosed in US Pat. No. 4,262,676 to Khosrow Jamshidi), the patient is prepared with a suitable local anaesthetic, at the appropriate marrow retrieval site. Then a bone marrow biopsy needle is inserted, the cannula having a lumen which accommodates a stylet for initial insertion.

The needle and stylet are then pushed approximately 4-5 millimetres until the needle appears to be solidly within the outer cortical bone. The stylet is then removed from the proximal end of the needle, which opens up the core of the needle to the now-surrounding marrow tissue.

The outer needle is then usually advanced another one to three centimetres with a twisting and rotating motion. This cores out a cylinder of bone marrow internally.

Occasionally, the operator may encounter very hard bone, and will need to apply considerable manual force to obtain a suitable sample. When fully inserted, the marrow biopsy sample is ready to be removed from the patient. There are a variety of bone marrow devices which have a mechanism to ensure the sample can be retrieved from the device. (US Pat. No. 3,605,721 to Hallac; Islam; US Pat. No. 5,3074,311 to Hasson; US Pat No to Medic; US Patent No. 5,634,473 to Goldenberg).

The current manual procedures and instruments are unsatisfactory in that, in a proportion of cases, the bone is unexpectedly hard, firm or fibrotic. The operator may not be able physically to manually core the sample or retrieve the sample, or retrieve the device, potentially resulting in damage to, or a reduced size of sample, causing unnecessary distress and pain for the patient and additional time, physical effort and expense for the operator. In these circumstances, the operator may abandon the procedure or seek help from an assistant.

SUMMARY

Herein is disclosed a utility patent which describes a manual to electric adapter for a bone marrow biopsy procedure. The adapter is designed to cover the top and sides of a T handle shaped, or similar shaped, bone marrow biopsy device and can be further fixed into position using tapes or fixtures. If resistance is encountered by the operator during a manual bone marrow procedure, the adapter can be applied to the manual device. An electric powered driver is then attached matingly to the assembly through a standard hexagonal or similar shaped extension at the proximal end of the adapter. The operator can then complete the operation with ease and speed, lessening the pain of the procedure for the patient, without seeking assistance, and in a cost effective manner. The adapter is designed to be optionally invoked, and easily attached or detached without interfering with the manual procedure to collect bone marrow aspirate or trephine.

In one aspect of the invention there is provided an adapter for adapting a manual bone trephine device to couple the bone trephine device to an electric driver, the bone trephine device having a T-shaped handle, the adapter comprising: an adapter body with a handle-engaging formation with at least a pair of side walls configured such that when the T-shaped handle engages with the adapter the side walls engage opposite sides of the T-shaped handle so that the bone trephine device can be turned in at least one direction by pressure from the walls on the T-shaped handle; a projection from the adapter body to allow the adapter to be grasped by a chuck of the electric driver; wherein the projection defines a longitudinal axis which aligns with an axis of the bone trephine device, when the bone trephine device is coupled to the adapter, and wherein the handle-engaging formation extends to either side of the longitudinal axis and the pair of side walls extend in a direction perpendicular to the longitudinal axis.

In embodiments, each side wall extends to either side of the longitudinal axis to allow the bone trephine device to be turned in two opposite rotational directions by pressure from the walls on the T-shaped handle.

In embodiments, the handle-engaging formation further comprises a pair of end walls. Advantageously, this prevents the T-shaped handle from slipping out of the handle-engaging formation.

In embodiments, the projection comprises a shaft with flattened sides. The shaft may be short. Advantageously, the shaft grips the chuck. The shaft may be hexagonal in cross section.

In embodiments, the bone trephine device has a shaft and the adapter further comprises an arm extending from the adapter body to stabilize the shaft of the bone trephine device. The shaft of the bone trephine device may be a cannula. The bone trephine device has a proximal end bearing the handle and a distal end with a cutting tip, the shaft of the bone trephine device extends between the these.

In embodiments, the bone trephine device comprises a pair of the arms each extending from a respective side wall.

In embodiments, the arms connect to define a bridge, wherein the bridge has a slot to receive the shaft. The shaft may snugly fit in the slot.

In embodiments, the bone trephine device comprises one or more fasteners to fasten the T-shaped handle to the handle-engaging formation.

In embodiments, the fastener comprises hook and loop tape.

In embodiments, the adapter is provided in combination with the manual bone trephine device.

According to another aspect of the present invention, there is provided a coupling device for coupling a driver to a biopsy needle assembly, the coupling device comprising: a body configured to engage with a handle of the biopsy needle assembly; a projection configured to engage with a chuck of said driver, wherein the projection is configured to project along a rotational axis of a cannula of the biopsy needle assembly when the body is engaged with the handle of the biopsy needle assembly; a needle support configured to extend in a direction away from said body, said needle support comprising a recess configured to intersect said rotational axis when the body is engaged with the handle of the biopsy needle assembly. The coupling device may later be referred to as an adapter.

In embodiments, the coupling device may further comprise a fastening means for fastening said body to the handle of the biopsy needle assembly.

In embodiments, said needle support is configured to extend in a direction along said rotational axis when the body is engaged with the handle of the biopsy needle assembly.

In embodiments, two or more of: the needle support; the body; and the projection are integrally formed.

In use, the coupling device may be configured to transfer torque from the driver to the biopsy needle assembly.

According to another aspect of the present invention, there is provided a method of performing a bone trephine procedure comprising: using an embodiment of the adapter of previous aspects to couple the manual bone trephine device to the electric driver; and using the electric driver to drive the manual bone trephine device to perform the bone trephine procedure. Such a method may be performed on dead and/or living bone.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects, advantages and embodiments than those described above will become apparent to those skilled in the art upon reading the following detailed description of the preferred embodiments in conjunction with a review of the appended drawings, in which: 1. FIG. 1 is a front face view of the adapter.

2. FIG. 2 shows side views of adapter.

3. FIG. 3 is a side perspective view of adapter.

4. FIG. 4 is an underside perspective view of adapter.

5. FIG. 5 shows views of a standard bone marrow biopsy device -prior art -which shows a device with a cannula and a T shaped handle.

6. FIG. 6 is a side view of a driver with sheath -prior art.

7. FIG. 7 is a view of the assembly of driver, sterile sheath, bone marrow biopsy device and adapter.

8. FIG. 8 is a side perspective of the assembly of the adapter and bone marrow needle.

9. FIG. 9 shows a view of the adapter.

DESCRIPTION

Typically, the biopsy devices are single use, manual devices, where the operator manually inserts the bone marrow trephine needle. Typically, trephine needles consist of a metal cylindrical coring needle or cannula, with an inner stylet which is inserted into the bone. The needle is disposed at its proximal end with a fixed handle, which allows the operator to manually insert, rotate and withdraw the cannula. The handle can be of many shapes but typically it lies transverse to the cannula, so the assembly forms a T shape. One of the problems with a manual technique is that the operator may encounter unexpected resistance with hard bone, and may not be able to insert, rotate or withdraw the device. On occasion, the operator may have to abandon the procedure, or ask a stronger colleague to help, if available. This can result in increased pain or anxiety for the patient, delay in obtaining a sample, or obtaining a short sample, risking obtaining an sample which may be inadequate for a full diagnosis.

One way of overcoming this problem is to provide the operator with a dedicated power assisting bone marrow trephine device. Prior art is disclosed by the US Pat. No. US2008045965 and UK Pat No. GB2347862 wherein samples are obtained with the assistance of a battery powered driver, which is designed to fit the cannula with a custom-built adapter. Some of the issues with these systems, include the high cost; the need for training and lack of flexibility in allowing the operator to choose his/her preferred manual device.

Accordingly, it is desirable to provide an improved apparatus for extracting a bone sample. It is also desirable to provide an apparatus, as described in the preceding paragraphs, in which an adapter can be applied to any standard bone marrow device handle, and attached reversibly to it. The procedure can be carried out at low cost as the additional adapter and driver are only used when needed. There is therefore a reduced risk of abandoning the procedure, failing to obtain a sample, or obtaining an inadequate sample. It is still further desirable to provide the adapter, as described in the preceding paragraphs, in which the revised handle can be attached to an electric or battery powered driver. Typically these drivers are hand held, high torque, low speed, typically 75 to 150 revolutions per minute, and can operate in clockwise or anti-clockwise direction. The operator, can optionally take advantage of the powered drive, making the procedure easier, quicker, and ensure a good sized sample. The adapter can be easily detached and reattached so that stylets can be removed, and samples can be aspirated or withdrawn from the needle. At the end of the procedure, the adapter can be reattached, with the driver placed in reverse gear, to assist in the withdrawal of the device. It is useful to ensure obtaining a biopsy sample at each attempt with increased speed compared to a manual method, thus decreasing the number of biopsy attempts, and reduce the pain experienced by the patient. It is also desirable to provide an adapter to convert a manual bone marrow biopsy procedure into electric assisted procedure to assist in the penetration of bone in those circumstances where additional power is necessary or desirable. It is also useful to provide a means of using an electric driver in an aseptic surgical procedure and this is achieved by providing a sterile surgical sheath which covers the said electric driver. It is also useful to provide a sterile sheath which is manufactured from a plastic or rubber compound which is sized to fit around the electric driver and to therefore permit the use of this assembly in an aseptic surgical procedure. It is also useful to provide a procedure which can be adopted with minimal training.

Herein is disclosed an adaptor, which can be optionally invoked by the operator when desired during the performance of a standard manual procedure. The manual procedure is initiated using a prior art manual device, with a standard T handle. If no difficulty is encountered, the procedure can be completed as a totally manual procedure. If difficulty is encountered, such as unexpectedly hard bone, then the operator can opt to convert the procedure to a power assisted method by applying the adapter over the T handle (13), and further fix it into co-axial alignment with the cannula (7) and hexagonal extension (10) using hook and loop tapes (9) and positioning the recess (8) around the cannula (7). At the proximal end of the adapter, there is, axially aligned with the cannula, an hexagonal extension (10), which can be attached to and detached from a hand held electric or battery powered driver (11) by means of a matingly sized chuck which, in the preferred embodiment, can lock the hexagonal extension (10) into position. The operator can complete the operation using electrical assistance, without inserting another needle, with ease and speed and without calling for an assistant. The adapter is sized to fit commonly used T handled manual devices, but could be sized to fit other shaped handles. In the preferred embodiment the adapter is manufactured from plastic, which covers the upper surface (1) and side walls (2,3,4,5) of the T handle (13), a stabilising pillar (6) extends from the body of the adapter (1) to be fixed to the cannula (7) by means of a recess (8). In the preferred embodiment reversible hook and loop or adhesive tape (9) is applied over the adapter (1) to further fix and stabilise the attachment of the adapter to the T-handle (13). The adapter can be used in addition to assist in the withdrawal of the device in the same manner as the driver (11) can be placed in reverse gear. In the preferred embodiment, the driver (11) can be draped in a sterile sheath (12) to maintain an aseptic field.

The details of the described embodiments may be varied within the scope of the invention. Apart from bone marrow biopsy, in which the intention is to retrieve a solid sample of bone tissue, the described device or aspects thereof can equally be applied to the aspiration of fluid from the bone marrow cavity which may be undertaken for diagnostic purposes, or for the retrieval of large volumes of fluid for the purpose of bone marrow transplant from one person to another or for bone biopsy in humans or animals.

Further aspects of the device are defined in the following clauses: 1. An adapter which comprises a top surface, and side walls which substantially cover the handle of a manual bone marrow trephine device and an extension at the proximal end of said adapter which may be coupled reversibly to an electric driver.

2. The adapter as described in clause 1 in which the said adapter covers a T-shaped handle of a bone marrow biopsy device.

3. The adapter as described in clause 1 in which the said adapter is fixed reversibly onto the handle by means of a reversibly binding tape, or mechanical fixture.

4. The adapter as described in clause 1 in which the said adapter can be fixed separately to the cannula of the bone marrow biopsy device by means of a stabilising pillar which extends from the body of the adapter to enclose or partially enclose the cannula.

5. The adapter as described in any preceding clause in which the said adapter can be moulded over the bone marrow handle.

6. The adapter as described in clause 1 in which the said adapter is disposed at its proximal end with an axially aligned hexagonal or similar extension which fits matingly the chuck of an electric or battery powered driver.

7. The adapter as described in any preceding clause in which the said adapter can be attached reversibly to an electric or battery powered driver.

8. The adapter as described in clause 7 in which a driver connected to said needle by means of said adapter may be activated to rotate the needle through the bone and into the marrow.

9. The adapter as described in clause 7 in which a driver connected to said needle by means of said adapter to be placed in reverse gear to assist in the withdrawal of the biopsy device assembly.

10. A method which enables an operator to convert a manual bone marrow biopsy surgical procedure to a power assisted procedure, without removing the cannula, or risking failure of retrieval of an adequate bone sample. The driver and adapter can be optionally invoked, and may be easily attached and detached from the manual device, enabling the withdrawal of the stylet, or sample of fluid or bone marrow biopsy, without interference with the existing collection procedures advised by the manufacturer. Once the samples are obtained, the adapter, and driver may be optionally reapplied in reverse gear to assist in the removal of the cannula from the bone.

Claims

CLAIMS: 1. An adapter for adapting a manual bone trephine device to couple the bone trephine device to an electric driver, the bone trephine device having a T-shaped handle, the adapter comprising: an adapter body with a handle-engaging formation with at least a pair of side walls configured such that when the T-shaped handle engages with the adapter the side walls engage opposite sides of the T-shaped handle so that the bone trephine device can be turned in at least one direction by pressure from the walls on the T-shaped handle; a projection from the adapter body to allow the adapter to be grasped by a chuck of the electric driver; wherein the projection defines a longitudinal axis which aligns with an axis of the bone trephine device, when the bone trephine device is coupled to the adapter, and wherein the handle-engaging formation extends to either side of the longitudinal axis and the pair of side walls extend in a direction perpendicular to the longitudinal axis.
2. An adapter as claimed in claim 1 wherein each side wall extends to either side of the longitudinal axis to allow the bone trephine device to be turned in two opposite rotational directions by pressure from the walls on the T-shaped handle.
3. An adapter as claimed in claim 1 or 2 wherein handle-engaging formation further comprises a pair of end walls.
4. An adapter as claimed in any one of claims 1-3 wherein projection comprises a shaft with flattened sides.
5. An adapter as claimed in any one of claims 1-4 wherein the bone trephine device has a shaft, the adapter further comprising an arm extending from the adapter body to stabilize the shaft.
6. An adapter as claimed in claim 5 comprising a pair of the arms each extending from a respective side wall.
7. An adapter as claimed in claim 6 wherein the arms connect to define a bridge, wherein the bridge has a slot to receive the shaft.
8. An adapter as claimed in any one of claims 1-7 further comprising one or more fasteners to fasten the T-shaped handle to the handle-engaging formation.
9. An adapter as claimed in claim 9 wherein the fastener comprises hook and loop tape.
10. An adapter as claimed in any one of claims 1-9 in combination with the manual bone trephine device.
11. A coupling device for coupling a driver to a biopsy needle assembly, the coupling device comprising: a body configured to engage with a handle of the biopsy needle assembly; a projection configured to engage with a chuck of said driver, wherein the projection is configured to project along a rotational axis of a cannula of the biopsy needle assembly when the body is engaged with the handle of the biopsy needle assembly; a needle support configured to extend in a direction away from said body, said needle support comprising a recess configured to intersect said rotational axis when the body is engaged with the handle of the biopsy needle assembly.
12. The coupling device of claim 11 further comprising a fastening means for fastening said body to the handle of the biopsy needle assembly.
13. The coupling device of claim 11 or 12 wherein said needle support is configured to extend in a direction along said rotational axis when the body is engaged with the handle of the biopsy needle assembly.
14. The coupling device of claim 11, 12 or 13 wherein two or more of: the needle support; the body; and the projection are integrally formed.
15. The coupling device of any one of claims 11-14 wherein, in use, the coupling device is configured to transfer torque from the driver to the biopsy needle assembly.
16. A method of converting a manual bone trephine device to a power-assisted bone trephine device, the method connecting the comprising manual bone trephine device to an electric driver using the adapter of any one of claims 1-10 or the coupling device of any one of claims 11-15.
17. A method of performing a bone trephine procedure comprising: using the adapter of any one of claims 1-10 or the coupling device of any one of claims 11-15 to couple the manual bone trephine device to the electric driver; and using the electric driver to drive the manual bone trephine device to perform the bone trephine procedure.