HK1075193B - Hand-held instruments that access interior body regions - Google Patents

Description

Hand-held instrument for accessing interior body regions

RELATED APPLICATIONS

This application is filed on 19/10.1999, and follows U.S. patent application serial No. 09/421,635 entitled "hand-held instrument for accessing interior body regions," which is incorporated herein by reference.

Technical Field

The present invention relates generally to hand-held tools and instruments, and to surgical methods for deploying the instruments through tissue into an internal body region.

Background

There are many different types and styles of hand-held surgical instruments used by surgeons to gain access to internal body regions. These instruments are intended to penetrate tissue by applying pushing forces, twisting forces, or a combination of both.

Often, a surgical procedure requires a surgeon to use surgical instruments of different shapes, functions, and sizes. Surgery often requires the physician to use these instruments in both soft and hard tissues for diagnostic or therapeutic purposes. Physicians often need to improve mechanical advantage to advance through tissue, particularly through dense or hard tissue such as bone.

Given the common need to use different instruments in a procedure, coupled with the need to accurately and reliably deploy both the soft and hard tissues of these different instruments, there is often a need to increase the mechanical advantage, further complicating the already difficult task for the physician. This need to operate different instruments differently for different purposes can distract the surgeon and result in wasted motion, which can extend the overall surgical time.

Disclosure of Invention

The present invention provides a surgical instrument having a handle design that enables both the cannula and the trocar to be initially placed in an area of the body, and that enables the trocar to be withdrawn at a later time leaving the cannula stationary. The invention obviates the need for several instruments during the surgery and simplifies the internal access procedures. At the same time, the handle of the surgical instrument provides increased mechanical advantage to enable the surgeon to reliably transfer both torsional and longitudinal loads to the selected instrument.

In particular, one aspect of the invention provides a tool comprising: a first functional instrument comprising a first handle comprising first and second finger gripping surfaces for simultaneous gripping by at least two fingers of a hand; a second functional instrument comprising a second handle comprising a third finger grip surface and a fourth finger grip surface for simultaneous grasping by at least two fingers of a hand; the first functional instrument engages the second functional instrument to form a composite instrument, and the first handle cooperates with the second handle to form a composite handle when the first functional instrument is engaged with the second functional instrument, the composite handle including first, second, third and fourth finger gripping surfaces mounted together to form a composite finger gripping surface for simultaneous gripping by four fingers of a hand.

In another aspect the invention provides a tool comprising: a first functional instrument comprising a first handle comprising first and second finger gripping surfaces comprising two spaced finger receptacles for simultaneous gripping by at least two fingers of a hand; a second functional instrument comprising a second handle including a third finger gripping surface and a fourth finger gripping surface including two adjacent finger receptacles for simultaneous gripping by at least two fingers of a hand, the first functional instrument engaging the second functional instrument to form a composite instrument, and the first handle cooperating with the second handle to form a composite handle when the first functional instrument is engaged with the second functional instrument, the composite handle including first, second, third and fourth finger gripping surfaces mounted together to form the composite finger gripping surface for simultaneous gripping by four fingers of a hand, the composite finger gripping surface providing a row of adjacent finger receptacles.

In another aspect the invention provides a tool comprising: a first functional instrument comprising a first handle comprising first and second finger gripping surfaces for simultaneous gripping by at least two fingers of a hand; a second functional instrument comprising a second handle comprising a third finger grip surface and a fourth finger grip surface for simultaneous grasping by at least two fingers of a hand; the first functional instrument engages the second functional instrument to form a composite instrument, and the first handle cooperates with the second handle to form a composite handle when the first functional instrument is engaged with the second functional instrument, the composite handle including first, second, third and fourth finger gripping surfaces mounted together to form a composite finger gripping surface for simultaneous gripping by four fingers of a hand, the composite handle including a locking mechanism to prevent disengagement of the first and second functional instruments.

The features and advantages of the invention will be set forth in the description and drawings, and in the claims.

Drawings

FIG. 1 is a perspective view of a first functional instrument engaged with a second functional instrument to form a composite tool having a composite handle formed by first and second instrument handles;

FIG. 2 is a perspective view of a first instrument separated from a second instrument;

FIG. 3 is a perspective view of a composite handle for hand gripping the tool of FIG. 1;

FIG. 4 is a perspective view of a hand grasping a handle of a second functional instrument separated from a first functional instrument;

FIG. 5 is an enlarged perspective view of the handles of the separated first and second functional instruments illustrating the linkage system preventing relative rotation between the functional instruments after the composite tool has been formed;

FIG. 6A is an enlarged side view of the handle shown in FIG. 5, separated;

FIG. 6B is an enlarged side view of the handles shown in FIG. 5 mated to form a composite handle;

FIG. 6C is an enlarged side view of a trocar suitable for use with the composite handle of FIG. 6B;

FIG. 6D is an enlarged side view of a cannula suitable for use in the composite handle of FIG. 6B;

FIG. 7A is a side view of a human spine;

FIG. 7B is a coronal view in cross section and cut away of a human vertebral body that is part of the spinal column;

FIG. 8 is a side elevational view in cross section and sectioned through a plurality of human vertebral bodies that form part of the spinal column;

FIG. 9 is a perspective view illustrating the advancement of the composite instrument through tissue by applying torsional and/or thrust forces using the composite handle;

FIG. 10 is a top view illustrating placement of the composite instrument within a vertebral body by applying axial and/or torsional forces using the composite handle;

FIG. 11 is a top view of a vertebral body illustrating placement of a drill bit through a cannulated instrument forming a portion of the composite tool shown in FIG. 9;

FIG. 12 is a top view of a vertebral body illustrating deployment of an expandable structure in a collapsed state by a cannula instrument forming a portion of the composite tool shown in FIG. 9;

FIG. 13 is a top view of a vertebral body after expansion of the structure of FIG. 12 to compress cancellous bone and form a cavity;

FIG. 14 is a top plan view of a syringe and attached nozzle used to inject material into an introducer instrument that opens into the cavity shown in FIG. 13, in use;

FIG. 15 is a side view illustrating the advancement of a tamping instrument into the cannula instrument to move and distribute material from the cannula instrument into the cavity shown in FIG. 13;

FIG. 16 is a side view of a syringe attached to a cannula instrument forming part of the composite tool of FIG. 9 for delivering material through the cannula instrument and into bone;

FIGS. 17A and 17B are perspective views illustrating material deformation in each handle due to heat sterilization to prevent subsequent formation of composite handles;

FIG. 18 is a perspective view of another embodiment of a composite tool similar to that shown in FIG. 1, having a lumen for receiving a spinal needle channel to assist in deployment;

FIG. 19 is another embodiment of a composite tool formed by a first functional instrument engaged with a second functional instrument, also having a composite handle formed by first and second instrument handles;

FIG. 20 is a rear view of the composite tool of FIG. 19;

FIG. 21 is a perspective view of the composite tool of FIG. 10 with the first and second tools being separated;

FIG. 22 is a perspective view of the first instrument separated from the second instrument;

FIG. 23 is a cross-sectional view of the composite tool locking device taken generally along line 23-23 of FIG. 20; while

FIG. 24 is a cross-sectional view of the locking device of FIG. 23 with the associated locking bolt moved out of its normal, locked position due to the application of an external force.

The present invention may be embodied in many forms without departing from its spirit or essential characteristics. The scope of the invention is defined by the claims rather than the description preceding them. Therefore, all embodiments that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Detailed Description

The present specification describes novel instruments for penetrating tissue. The present specification also describes systems and methods for treating bone using the expandable body in combination with novel instruments that penetrate tissue.

The use of expandable bodies to treat bone is generally disclosed in U.S. Pat. Nos. 4,969,888 and 5,108,404, both of which are incorporated herein by reference. Improvements in this regard are disclosed in U.S. patent application 08/188,224 filed on 26.1.1994, U.S. patent application 08/485,394 filed on 7.6.1995, and U.S. patent application 08/659,678 filed on 5.6.1996, which are all incorporated herein by reference.

The novel instruments, systems and methods are described below with reference to vertebral body processing. It should be understood, however, that the illustrated handle configurations, instruments, systems and methods are not limited in application to vertebrae. The systems and methods described may be used to treat various bone types. In addition, the handle configuration may also be used with instruments other than trocars and cannulas.

1. Instrument and method for operating the same

Fig. 1 illustrates a composite instrument 10 for penetrating tissue. Composite instrument 10 includes a first functional instrument 20 and a second functional instrument 40, and a composite handle 12 having a first handle 22 and a second handle 42. Composite handle 12 assists the surgeon in manipulating composite instrument 10, but in use the surgeon may also manipulate first instrument 20 independently using first handle 22 or second instrument 40 independently using second handle 42 as desired.

The number and type of instruments 20 and 40 may vary. Fig. 1 shows two representative instruments 20 and 40, each of different size and function. In a preferred embodiment, the first functional instrument 20 is a trocar device and the second functional instrument 40 is a cannula device.

A. Trocar device

Referring to fig. 1-4, the first instrument 20 functions as a trocar that penetrates tissue. Trocar 30 has a proximal end 32 and a distal end 34. Distal end 34 is tapered to create a piercing surface 35. In use, the puncture surface 35 is intended for penetrating soft tissue and/or bone under the influence of a pushing and/or twisting force applied by a surgeon to the first handle 22 or the composite handle 12.

First handle 22 is attached to trocar 30 at the proximal end of trocar 32. As best seen in FIG. 6C, proximal end 32 of trocar 30 may be formed in a T-shape with first handle 22 molded about the T-shaped end. This arrangement significantly improves the mechanical strength of the bond between the handle 22 and the trocar 30 and allows significant longitudinal and torsional forces to be transmitted from the handle 22 to the trocar 30 without failure of the bond. Alternatively, the proximal end 32 of the trocar 30 may be scored (shown as scored region 33 in FIG. 6C) with or without a T-shaped end to improve the mechanical bond strength between the trocar 30 and the handle 22, or an adhesive may be used to achieve different results.

The first handle 22 preferably includes a viewing window 24, an alignment ridge receiver 26, a handle bore receiver 28, and a handle key 36, which are used as described below.

In an alternative embodiment (see FIG. 18), the trocar 30 includes a lumen 21 through the handle 22 and the trocar 30 needle. The lumen 22 accommodates passage of a core needle and/or a conventional spinal needle assembly 23 to guide deployment of the first instrument 20, by itself or in combination with a second instrument 40 (as shown in FIG. 18), through soft tissue to a target site for bone treatment.

B. Intubation device

The second instrument 40 functions as a cannula instrument or introducer sheath, including the cannula 50. The cannula 50 of the second instrument 40 is preferably larger in diameter but not longer than the trocar 30 of the first instrument 20. As can be seen more clearly in fig. 1 and 2, the second instrument 40 includes a lumen 44 extending therethrough from a distal end 54 of the instrument to a proximal end 52 thereof. The lumen 44 is sized to receive the trocar 30. Lumen 44 is preferably sized to allow second instrument 40 to slide and/or rotate relative to first instrument 20, and vice versa, as will be described in greater detail below.

The distal end 54 of the second instrument 40 presents an end face 60. In use, the end face 60 of the second instrument 40 preferably presents a low profile surface that can penetrate the soft tissue surrounding the first instrument 20 under the thrust and/or torsional forces applied by the physician to the composite handle 12 or the second handle 42.

The proximal end 52 is connected to the second handle 42. As best seen in FIG. 6D, the proximal end 52 of the cannula 50 preferably includes a flared and slotted distal end "A", and a textured surface "B" about which the second handle 42 is molded. The flared and grooved tip "a" and textured surface "B" serve to increase the mechanical bond strength between the cannula 50 and the second handle 42, allowing significant longitudinal and torsional forces to be transmitted between the second handle 42 and the cannula 50 without binding failure. With respect to trocar 30, other bonding methods such as scoring cannula 50 and/or applying an adhesive may be employed to achieve different results.

Extending from the lumen 44 at the proximal end 52 of the cannula 50, the second handle 42 may preferably include a handle bore 48, preferably co-circumferential with the cannula 50. The second handle 42 includes an alignment ridge 46, and a handle slot 56, which is used as described below.

C. Drill bit instrument

As shown in fig. 11, an optional third functional apparatus 70 functions as a drill. The drill bit instrument 70, having a distal end 72 and a proximal end 74, is typically slightly longer than the trocar 30 and has generally the same physical dimensions as the trocar 30. Similar to the trocar 30, the drill bit instrument 70 is intended to fit within the lumen 44 of the second instrument 40 for sliding and rotating movement during use.

The distal end 72 of the drill bit instrument 70 preferably includes a cutting edge 76. In use, the cutting edge 76 is intended to penetrate hard tissue under torsional and longitudinal loads exerted on the proximal end 74 of the drill bit instrument 70.

The drill bit instrument 70 may have a known construction and may vary widely. Preferably, the drill instrument 70 has a smaller diameter than the lumen 44 of the second instrument 40 and a greater length than the cannula 50 so that the drill instrument 70 can enter deeper tissue than the cannula 50 when the cannula 50 is loaded into a patient.

II. instrument handle

First handle 22 and second handle 42 are designed to comfortably accommodate a human hand, to preferably interlock to form composite handle 12, wherein handle 12 prevents relative rotation between first handle 22 and second handle 42, and advantageously indicates whether the instrument is reusable and/or resterilized.

A. Human hand adaptation

As shown in fig. 1-4, the composite handle 12 is shaped to be comfortably and securely held by a normal human hand, as shown in fig. 3. The composite handle 12 is preferably rounded in profile to provide a comfortable grip and to minimize friction with surgical gloves.

As shown in FIG. 3, in the preferred embodiment, the first handle 22 is preferably provided with a two-finger receptacle 38 intended to receive the index and little fingers of a surgeon.

As shown in FIG. 4, in the preferred embodiment, the second handle 42 is preferably provided with two finger receptacles 58 intended to receive the doctor's middle and ring fingers.

Of course, the first handle 22 and the second handle 42 may differ in shape and size. In a first embodiment shown in FIG. 1, the composite handle 12, and in particular the first handle 22, including the strike plate 14, is made slender to comfortably fit the entire palm of the hand. The impingement plate 14 is also configured to receive an impact, as will be described below.

B. Interlocking configuration

In order to properly interact when impact, thrust and/or torsional forces are applied to composite handle 12, first handle 22 is preferably not rotatable relative to second handle 42. Referring now to fig. 5, 6A and 6B, to prevent relative rotation, the first handle 22 preferably includes an alignment ridge receiver 26 to receive an alignment ridge 46 of the second handle 42. Although illustrated and described as ridges, the alignment mechanism that interacts between first handle 22 and second handle 42 may comprise any number of non-arcuate shapes, such as block-shaped or star-shaped.

In use, the first handle 22 and the second handle 44 may be mated together to form the composite handle 12 as the trocar 30 of the first instrument 20 is slid through the cannula 50 of the second instrument 40. In addition to the alignment ridge 46 being prevented from rotating by the alignment ridge receiver 26, the first handle 22 may include a handle key 36 for engaging a handle slot 56 of the second handle 42.

If handle slot 56 is not aligned with handle key 36, and thus alignment ridge 46 is not aligned with alignment ridge receiver 26, handle bore 48 of second handle 42 advantageously cannot be fully inserted into handle bore receiver 28 of first handle 22. In this alignment, the viewing window 24 shows a trocar 30, which preferably extends through the viewing window 24. Also, in this alignment, first handle 22 is preferably capable of rotating independently of second handle 42.

However, as shown in fig. 6B, if handle slot 56 is aligned with handle key 36 such that alignment ridge 46 is aligned with alignment ridge receiver 26, handle bore 48 of second handle 42 may be fully inserted into bore receiver 28 of first handle 22.

In this operational alignment, the viewing window 24 displays the handle bore 48. Preferably, the handle bore 48 is colored differently than the trocar 30 so that it may be easily viewed. Also, in this aligned condition, first handle 22 preferably does not rotate independently of second handle 42. In this aligned state, composite handle 10 is sized and shaped to accommodate four fingers, with first handle 22 and second handle 42 each accommodating two fingers.

Of course, it should be understood that the first and second handles 22 and 42 may be designed to engage in a non-parallel orientation such that the first and second handles 22 and 42 are not parallel when properly engaged to form the composite handle 10. For example, the first handle 22 may be provided with a star or hexagonal opening into which a corresponding star or hexagonal second handle may be engaged in a plurality of orientations.

In use, the plurality of forces resist relative movement between the first and second instruments 20, 40. As shown in FIG. 3, when the composite handle 10 is held in the hand, the upward force exerted by the fingers cooperates with the downward force exerted by the palm of the hand to press the first and second instruments 20, 40 together. As previously mentioned, relative rotation of the instrument may also be advantageously limited when appropriately configured.

C. Handle material

1. Structural integrity

The materials selected for first handle 22 and second handle 45 preferably provide sufficient structural integrity to withstand the forces expected from manual handling and manual impact. First handle 22 and second handle 42 are made of a molded or cast hard material that is strong enough to withstand impact, thrust, and torsional forces without significant deformation.

Another preferred feature of the handle composite is that the first and second handles 22, 42 may be roughened or otherwise textured to provide a secure gripping surface.

2. Can be repeatedly used

In order to encourage disposability and inhibit re-use and/or re-sterilization, it is preferred to distinguish a new hand tool from a hand tool that has been re-used and/or re-sterilized.

Impacting and applying manual pressure to any of the instruments and structures described herein during first use can create stress on the material from which the instrument and/or structure is constructed. Material stresses from operation during first use can significantly alter the molded morphology of the structure, making future performance of the structure unpredictable.

Such as contact with surrounding cortical and cancellous bone as the trocar and cannula are advanced into cancellous bone during a single use. Such contact can damage the structure, creating localized areas of weakness that are often not visually detectable. The presence of local areas of weakness can unpredictably cause structural failure upon subsequent use. Such contact may also cause the cannula end to flatten and/or curl or blunt the trocar's puncture surface.

In addition, exposure to blood and tissue during a single use may trap biological components on or in the trocar or handle. Despite cleaning and subsequent sterilization, the presence of entrapped biological components can lead to unacceptable pyrogenic reactions.

As a result, after a first use, the structure may not meet regulatory performance and sterilization regulations. The stress and trauma of the material during a single use, coupled with the possibility of a pyrogenic reaction even after sterilization, reasonably justify and support the single use of instruments and handles deployed in tissues and bones.

To protect patients from adverse consequences of repeated use, including disease transmission, or material stress and instability, or reduced or unpredictable performance, among others, a variety of materials may be used to indicate and possibly prevent repeated use and/or re-sterilization of the hand tool.

For example, heat-denaturant materials may be used to indicate by deformation whether the hand tool has been autoclaved. Alternatively, a chemically sensitive color, such as ink sold by Tempil, may be applied to composite handle 12 to indicate by a change in color whether the hand tool has been chemically sterilized, such as with ethylene oxide (ETO), as described in ANSI/AAMI/ISO 11135: 1994, sterilization apparatus standard. In addition, various materials that can change color and/or physical composition upon the advent of other sterilization methods, such as radiation sterilization, can be used in the hand tool to indicate sterilization.

One material that provides sufficient structural rigidity and also indicates whether the instrument has been subjected to conventional heating for sterilization is the LUSTRAN sold by Bayer corporation^TMA material. As shown in fig. 17A and 17B, when the material is used in a handle construction, the material typically deforms during heat sterilization, preferably preventing the handle slots 56 from aligning with the handle keys 36, and thus preventing the alignment ridges 46 from aligning with the alignment ridge receivers 26. In addition, after deformation, the handle bore 48 of the second handle 42 preferably cannot be fully inserted into the handle bore receptacle 28 of the first handle 22.

Exemplary use of the System

The use of composite device 10, devices 24, 40 and 70, in conjunction with catheter assembly 130, diagnostic or treatment member 132, syringe 136 and tamping device 142, is described below in connection with the treatment of bone disorders, as shown in Figs. 9-15. As these items can be advantageously used for this purpose. It should also be understood, however, that the composite device 10 is not limited to use in treating bone disorders, nor to devices intended to contact tissue to perform diagnostic or therapeutic functions. The composite handle 12 structure associated with the first handle 22 and the second handle 42 may be used in association with various other hand-held instruments.

The composite instrument 10, handles 12, 22 and 42, and instruments 20, 40, 64 and 70 are described below in relation to treating a human vertebral body. It should be understood, however, that its use is not limited to human vertebral bodies. The handle 18 may be used in association with a hand-held instrument for treating various types of bones of a human or animal.

A. Vertebral dissection

One use of the system is in the treatment of vertebral bodies. As shown in FIG. 7, the spinal column 80 contains several uniquely shaped bones, referred to as vertebrae 82, sacrum 84, and coccyx 86. The number of vertebrae 82 making up the spine 80 depends on the animal species. In the human body (shown in fig. 7A), there are twenty-four vertebrae 82, including seven cervical vertebrae 88, 12 thoracic vertebrae 90, and five lumbar vertebrae 92.

Viewed from the side, as shown in FIG. 7A, the spine 80 forms an S-shaped curve. This curvature serves to support the heavy head. In quadrupeds, the curvature of the spine is relatively simple.

As shown in fig. 7A, 7B and 8, each vertebra 82 includes a vertebral body 96 that extends on an anterior (or thoracic) side of the vertebra 82. As shown in fig. 7A, 7B and 8, the vertebral body 96 is oval-shaped. As shown in fig. 7B and 8, the vertebral body 96 includes an exterior formed of dense cortical bone. The compact bone 98 encloses an interior space 100 formed of cancellous, or called cancellous, bone 102 (also referred to as medullary bone or trabecular bone). A type of "pad" known as an intervertebral disc 104 is positioned between adjacent vertebral bodies 96.

An aperture, referred to as an intervertebral foramen 106, is located on the posterior (i.e., dorsal) side of each vertebra 82. The spinal ganglion 109 passes through the foramen 106. The spinal cord 108 passes through the spinal canal 107.

The vertebral arch 110 surrounds the spinal canal 107. The lamina 112 of the vertebral arch 110 abuts the vertebral body 96. The spinous process 114 extends posteriorly from the vertebral arch 110, and the left and right transverse processes 116 also extend from the vertebral arch.

B. Surgical technique

In a typical procedure, the patient lies on an operating table and the surgeon inserts the composite instrument 10 into the soft tissue (denoted by S in FIG. 9) in the back of the patient. The patient takes a prone position, either lying on either side, or lying on an incline, depending on the preference of the operator. However, the procedure may be performed by an open anterior procedure, or may be performed by an endoscopic anterior procedure.

1. Enter into cancellous bone

Under radiologic or CT monitoring, the physician advances composite instrument 10 through soft tissue down target vertebra 82 and into vertebra 82, as shown in FIG. 9, and typically applies a local anesthetic, such as lidocaine, to the target area. In some cases, physicians may prefer to use other forms of anesthesia, such as general anesthesia.

As shown in FIG. 10, the physician guides the composite instrument 10 such that the trocar 30 of the first instrument 20 and the cannula 50 of the second instrument 40 penetrate through the cortical bone 98 and then through the cancellous bone of the vertebra 82. If desired, the physician twists composite handle 10 while applying a longitudinal force to the handle. Under this action, the puncture surface 35 of the trocar 30 and the end surface 60 of the cannula 50 rotate and penetrate the soft tissue and/or bone.

Preferably, the penetration depth of the distal end 34 of the trocar 30 and the end surface 60 of the cannula 50 is through the first wall of cortical bone 98 into the cancellous bone 102. However, if access to cancellous bone 102 through the first wall of cortical bone 98 is not achievable by manually advancing the composite instrument 10, the surgeon may continue to penetrate by tapping the strike plate 14 with a blunt instrument such as a surgical hammer (not shown), or otherwise applying an appropriate additional longitudinal force to the composite handle 12 to advance the distal end 34 of the trocar 30 and the end face 60 of the cannula 50.

If desired, the physician may utilize the spinal needle assembly and the core needle to gain initial access to the vertebral body 82 and then employ the alternative embodiment shown in FIG. 18 to complete the access procedure. The embodiment shown in fig. 18 allows the physician to place the core pin 23 into the targeted vertebral body 82 and then to introduce the device 10 through soft tissue along the core pin 23 into the targeted vertebral body 82, which passes through the trocar lumen 21 as the composite device 10 is advanced through soft tissue into the vertebral body 82. Once the trocar 30 has sufficiently penetrated the cortical bone, the physician may withdraw the spinal needle assembly 23.

If desired, after penetrating the cortical bone 98, the physician may continue to advance the composite instrument through the cancellous bone 102 of the vertebral body 96 to create a passage through the cancellous bone 102. Preferably this passageway will extend through no more than 95% of the vertebral body. The physician then withdraws the instrument 10, leaving the cannula 50 in the compact bone 98 and/or extending only partway into the cancellous bone 102. The trocar 30 may then be withdrawn from the cannula 50 to allow access to the passageway formed through the cannula 10 and within the vertebral body.

Alternatively, after penetrating the cortical bone 98, the physician may choose to withdraw the trocar 30 from the cannula 50 and then form a passage in the cancellous bone 102 using the drill bit 70. In this case, the surgeon removes the first functional instrument 20 by holding the second instrument 40 in place and manually withdrawing the first instrument 20.

Next, as shown in FIG. 11, the physician advances the drill bit 70 through the cannula 50. Under X-ray control (or using other imaging systems), the physician applies appropriate torsional and longitudinal forces to the drill 70 to rotate and advance the cutting edge 76 of the drill 70 to open a passage through the bone tissue and completely into the cancellous bone 102. The drilled passage preferably extends through no more than 95% of the vertebral body 96.

At this point in the procedure, access to cancellous bone 102 has been completed and the end face 60 of the cannula 50 extends into the interior space 100, leaving only the cannula instrument 50 in place.

2. Bone treatment

As shown in fig. 12, the physician may now access the catheter component 130. The physician can advance a diagnostic or therapeutic member 132 carried by the catheter component 130 through the handle bore 48 and the cannula 50 toward the interior space 100 of the vertebral body 96.

The diagnostic or therapeutic member 132 of the catheter component 130 can be configured to perform a variety of functions. For example, member 132 may contain a biopsy instrument to obtain a sample of cancellous bone or to collect bone marrow. Alternatively, distal end member 132 may be a core needle for introducing drugs or the like into cancellous bone. Alternatively (as shown in fig. 13), the distal end member 132 may comprise an expandable body for compressing cancellous bone 102 and forming a cavity 134 in the vertebral body 96 in the manner disclosed in U.S. patents 4969888, 5108404, and 5827289, which are incorporated herein by reference. The distal member 132 may also include a nozzle 140 for injecting material into the cavity formed when compressing cancellous bone 102.

After the cavity 134 is formed, the physician accesses the syringe 136 and the injection nozzle 140. As shown in fig. 14, the nozzle 140 is sized to pass through the cannula 50 and into the cavity 134. The nozzle 140 is connected to the syringe 136 by a threaded connector 186. The nozzle 140 may be formed of a rigid metallic material such as stainless steel.

As shown in FIG. 14, the physician fills the syringe 136 with a desired volume of fill material 138. The physician connects the nozzle 140 to the filling syringe 136. The physician inserts the nozzle 140 a selected distance beyond the distal end 54 of the cannula 50 and into the cavity, as indicated by the markings 166 on the nozzle 140. The physician then operates the syringe 136 to force the material 138 through the nozzle 140 and into the cavity 134.

Preferably, the physician first introduces material 138 into cavity 134 in a region remote from distal end 54 of cannula 54. The physician injects the material 138 to fill the remainder of the cavity 54 while continuing to withdraw the nozzle 140 toward the distal end 54 of the cannula 50.

At this stage, the nozzle is not unscrewed from the syringe 104. As shown in FIG. 15, the physician then advances a filling instrument 142 through the nozzle 140. The distal end of the filling instrument 142 is in contact with the remaining material 138 in the nozzle 140. Advancement of the filling instrument 142 expels the remaining material 138 from the nozzle 140, forcing it into the cavity 134. The material 138 is forced into the cavity 134 by the advancement of the filling instrument 142 for evenly distributing the material 138 and compacting the material 138 in the cavity 134 without applying undue pressure.

As an alternative to connecting the nozzle 140 to the syringe 136, the physician may connect the syringe 136 directly to the handle bore 48 of the second instrument 40, as shown in fig. 16. As shown in the alternative embodiment of fig. 16, the syringe 136 may have screws 137 or other fastening means. The screw 137 is threadedly engaged with a bore contained in the handle bore 48. The physician then operates the syringe 136 to expel the material 138 through the handle bore 48 and cannula 50 and into the cavity 134. With this arrangement, the physician disconnects the syringe 136 and advances the filling instrument 142 through the handle bore and cannula 5048 to expel the remaining material 138 from the cannula 50, forcing it into the cavity 134.

The use of the filling instrument 142 with the syringe 136 with or without the nozzle 140 allows the physician to exert accurate control in filling the cavity 134 with the material 138. The physician can adjust the volume and rate of application on the fly depending on the particular local physiological conditions encountered. The low pressure uniformly applied with the filling instrument 142 (i.e., preferably no more than 360psi at the distal end of the cannula, more preferably no more than 190psi at the distal end of the cannula, and most preferably no more than 100psi at the distal end of the cannula) enables the physician to quickly respond to filling volume, flow resistance, and flow path conditions. Thereby significantly reducing the chance of overfilling material 138 and material 138 spilling outside of the cavity.

When the physician is satisfied that the material 138 has been adequately distributed within the cavity portion, the physician withdraws the filling instrument 142 from the cannula 50 and the handle bore 48. The physician preferably first twists the filling instrument 142 to cleanly break contact with the material 138.

Of course, the procedure may be repeated to access and manipulate a vertebral body multiple times in multiple directions, thereby creating multiple cavities that may or may not be interconnected. After the cavity has been filled and filled in the manner described above, the instrument can be withdrawn and the incision sutured closed. The bone treatment is completed.

C. Recommended materials

Preferably, material 13B will provide sufficient support within the vertebral body to prevent further fractures. Thereby improving the load resistance of the vertebral body. The material may also promote healing of the vertebral body.

The selected material 138 may be bone cement, or conventionalAutograft or allograft Bone Graft tissue harvested in a defined manner, for example in the form of a Paste (see: Dick "A Using of the Experimental reactor to Harvest automatic Bone grade Material: organism Method for Producing Bone Paste"Archives of Orthopaedic and Traumatic Surgery(1996),105: 235-International Orthopaedics(SICOT)(1993)17: 310-312). Alternatively, bone graft tissue may be obtained using a bone graft harvester sold by SpineTech corporation. The paste or sheet graft material is added to the cannula 50 using a funnel. The filling instrument 142 is then advanced into the cannula 50 in the manner described above, expelling the paste or sheet graft material out of the cannula 50 and into the cavity 134.

The selected material 138 may also comprise particulate bone material collected from coral, such as ProOsteon sold by Interpore corporation^TMCalcium carbonate particles. Using a funnel, the particles are added to the cannula 50 and then advanced into the cannula 50 with the filling instrument 142.

The selected material 138 may also contain a demineralized bone matrix suspended in glycerol (e.g., Grafton, sold by Osteotech corporation)^TMAllograft material), or SRS sold by Nivian corporation^TMCalcium phosphate cement. A viscous material such as the aforementioned bone cement may be added to the syringe 136 and then injected directly into the cavity, or injected into the cavity using a nozzle 140 inserted into the cavity 134 through the cannula 50. As previously described, the filling instrument 142 is used to force the remaining material out of the cannula 50 into the cavity 134.

The selected material 138 may also be in the form of a slab using Collagraft made from calcium carbonate powder and bovine bone collagen^TMA material. The sheet may be rolled into a tube and then manually inserted into the cannula 50. The filling instrument 142 is then advanced through the cannula 50 to push and compact the material in the cavity 134.

Interlocking hand-held instruments

Fig. 19 and 20 illustrate a composite instrument 210 for penetrating tissue that shares many features in common with the composite instrument 10 described above. When disassembled, as shown in fig. 22, the composite instrument 210 includes a first functional instrument 220 and a second functional instrument 240, similar to the composite instrument 10 described above. When assembled (as shown in fig. 19 and 20), handle 212 couples the two instruments 220 and 240 together. Composite handle 212 includes a first handle 222 (associated with first instrument 220) and a second handle 242 (associated with second instrument 240) (also shown in fig. 22). Like compound handle 12 of compound instrument 10, compound handle 212 of compound instrument 210 assists the surgeon in manipulating compound instrument 210, but in use the surgeon may also preferably independently manipulate first instrument 220 using first handle 222 or second instrument 240 using second handle 242.

As previously explained, the number and type of instruments 220 and 240 may of course also differ. In the illustrated implementation, each of instruments 220 and 240 has a different size and function. In a preferred embodiment, the first functional instrument 220 is a trocar device and the second functional instrument 240 is a cannula device.

A. Trocar device

Referring to FIG. 22, the first instrument 220 is used as a trocar instrument 230 that penetrates tissue. Trocar 230 has a proximal end 232 and a distal end 234. Distal end 234 is intended to penetrate soft tissue and/or bone in response to the application of pushing and/or twisting forces applied by the surgeon to first handle 222 or composite handle 212. If desired, distal end 234 may terminate in a substantially blunt and/or tubular tip, or alternatively a sharpened tip, for cutting through tissue, as is well known in the art.

First handle 222 is attached to proximal end 232 of trocar 230. Similar to that shown for trocar 30 in FIG. 6C, proximal end 232 of trocar 230 may similarly be formed with a T-shape, with first handle 222 molded about the T-shaped end. As previously described for the trocar 230, this arrangement significantly improves the mechanical bond strength between the handle 222 and the trocar 230 and allows significant longitudinal and torsional forces to be transmitted from the handle 222 to the trocar 230 without bond failure. Alternatively, with or without a T-shaped end, the proximal end 222 of the trocar 230 may be scored (as shown by the scored region shown in FIG. 6C relative to the trocar 30) to improve the mechanical bond strength between the trocar 230 and the handle 22, or a variety of adhesives may be used to achieve different results.

The first handle 222 may preferably include a receiving channel 226 with a viewing window 224 and a locking mechanism 236 (see also fig. 23 and 24), the structure and function of which will be described later.

Similar to trocar 30, trocar 230 may include a lumen (not shown) through handle 222 and the trocar 230 body for receiving a passage of a core needle and/or a conventional spinal needle assembly for guiding first instrument 220 through soft tissue to a bone treatment target site, either by itself or in combination with second instrument 240 (as shown in FIG. 18 for the first-described embodiment).

B. Intubation device

Still referring primarily to fig. 22, the second instrument 240 functions as a cannula instrument or introducer sheath and includes a cannula 250. The cannula 250 of the second instrument 240 is preferably larger in diameter but less long than the trocar 230 of the first instrument 220. As can be seen more clearly in fig. 21, the second instrument 240 includes a lumen 244 extending therethrough from a distal end 254 of the instrument to a proximal end 252 thereof. The lumen 244 is sized to receive the trocar 230 (shown in figure 21). Lumen 244 is preferably sized to allow second instrument 240 to slide and/or rotate relative to second instrument 240, and vice versa, unless the two handles 220 and 240 are interlocked together, as described in more detail below.

Distal end 254 of second instrument 240 has an end surface that preferably has a low profile surface that can penetrate the soft tissue surrounding first instrument 220 under the pushing and/or twisting forces applied by the surgeon to composite handle 212, or second handle 242.

The proximal end 252 is connected to the second handle 242. As described in fig. 6D for cannula 50, proximal end 252 of cannula 250 may preferably include a flared and slotted tip "a" and/or a textured surface "B" about which second handle 242 is molded. The flared and grooved tip "a" and/or the textured surface "B" function to improve the mechanical bond strength between the cannula 50 and the second handle 42, allowing significant longitudinal and torsional forces to be transmitted between the second handle 242 and the cannula 250 to the trocar 30 without bond failure. As with the trocar 230, other bonding methods such as scoring the cannula 250 and/or using various adhesives may be employed to achieve different results.

Extending from the inner lumen 244 at the proximal end 252 of the cannula 250, the second handle 242 may preferably include a handle bore 248, preferably co-circumferential with the cannula 250. The second handle 242 includes a transverse shoulder 246 and at least one notch 256 in the shoulder 246, the structure and function of which will be described hereinafter.

C. Handle (CN)

The first handle 222 and the second handle 242 are designed to comfortably fit in a human hand to advantageously interlock to form a composite handle 212 that prevents relative rotation between the first handle 222 and the second handle 242.

D. Human hand adaptation

Similar to composite handle 12, composite handle 212 is shaped to be comfortably and securely held by a normal human hand, as generally shown in FIG. 21. The profile of composite handle 212 is preferably similarly rounded to provide a comfortable grip and minimize friction with surgical gloves. The first handle 222, in the same manner as shown for handle 12 in FIG. 3, is preferably provided with two finger receptacles 238 intended to receive the index and little fingers of the surgeon.

The second handle 242 is preferably provided with two finger receptacles 258 for receiving the doctor's middle and ring fingers, in the same manner as shown for handle 42 in fig. 4.

Of course, the first handle 222 and the second handle 242 may differ in shape and size. In the implementation shown in fig. 19-21, composite handle 212, and in particular first handle 222, includes strike plate 214, which is elongated to comfortably fit the entire palm of the hand. The impingement plate 214 is also configured to receive impingement for the uses described above.

The materials selected for the first handle 222 and the second handle 242 preferably provide sufficient structural integrity to withstand the forces expected from manual handling and manual impact. The first and second handles 222, 242 are made of a molded or cast hard material that is strong enough to withstand impact, thrust and torsional forces without significant deformation. Representative materials for the first and second handles 222 and 242 include various plastics, metals, and/or ceramics known in the art. In one disclosed embodiment, the first handle 222 and the second handle 242 are Lustran sold by Bayer corporation^(R)ABS (acrylonitrile-butadiene-styrene polymer).

Another preferred feature of the handle composite is that the first handle 222 and the second handle 242 may be roughened or otherwise textured to provide a secure gripping surface.

E. Interlocking structure

When the two handles 222 and 242 are secured together, the first handle 222 is preferably not rotatable relative to the second handle 242 in order to properly interact when impact, thrust and/or torque forces are applied to the composite handle 212. To prevent relative rotation, the first handle 222 preferably includes a receiving channel 226 into which a shoulder 246 of the second handle 242 is pushed and nested (see fig. 23 and 24).

In use, the first handle 222 and the second handle 242 may be mated together to form the composite handle 212 (as shown in FIG. 19) as the trocar 230 of the first instrument 220 is slid through the cannula 250 of the second instrument 240 (see FIG. 21). A shoulder 246 nested within locking groove 226 prevents first instrument 220 from rotating relative to second instrument 240.

Further, when locking shoulder 246 is advanced a desired distance through groove 226, locking mechanism 236 on first handle 222 engages locking notch 256 on second handle 242 to prevent separation of the two instruments 220 and 240.

The locking mechanism 236 may be constructed in various ways. As shown in fig. 23 and 24, the locking mechanism 236 includes a locking bolt 260 adapted to engage a locking notch 256 on the second handle 242. The locking bolt 260 is carried on a hinge 262 of the first handle 222. The hinge 262 is preferably made of a resilient plastic and has a resilient memory, forming a so-called "living hinge".

The locking bolt 260 is cantilevered or located on a hinge 262 to pivot within the first handle 222. The plastic memory of the hinge 262 normally biases the latch 260 toward the normal position shown in fig. 23, wherein the latch 260 is seated in the notch 256 as long as the two components are aligned. Locking bolt 260 may be pushed out of its normal position (as shown in fig. 24) in response to the application of force F. After the force F is removed, the hinge 262 returns the latch 260 to its normal position.

In the illustrated embodiment, the force F is applied in at least two different ways. One mode operates in response to the shoulder 246 being urged toward the locking mechanism 236 via the groove 226. This serves to secure the two instruments 220 and 240 together to function as the composite instrument 210. The other way works in response to manual pressure exerted by the operator on the locking mechanism 236. This serves to separate the two instruments 220 and 240 for use of the instruments 220 and 240, respectively.

For the first mechanism, the locking bolt 260 includes a latch surface 264 (best seen in FIG. 24). As shoulder 246 travels through groove 226, leading edge 266 of locking shoulder 246 slides or rides along lock catch surface 264. Advancing leading edge 266 of locking shoulder 246 along lock catch surface 264 applies force F to pivot locking bolt 260 on hinge 262. When the locking notch 250 on shoulder 246 and locking bolt 260 are aligned with each other, force F is released and locking bolt 260 resiliently returns to its normal position. This moves the locking bolt 260 into the notch 256 into a snap fit. The plastic memory of the hinge prevents the notches 256 from moving out of engagement with the locking bolt 260, effectively locking the two handles 222 and 242 together into the composite handle 212.

Shoulder 246 preferably includes a locking notch 256 on the opposite side of shoulder 246. In this manner, the fit of the shoulder 246 into the groove 226 is insensitive to the mutual alignment of the two handles 222 and 242.

A viewing window 224 on the first handle 222 reveals that the shoulder 246 enters through the groove 226 and engages the locking mechanism 236. This provides visual confirmation of the locking engagement. Preferably, the shoulder 246 is a different color than the first handle 220 to further facilitate viewing.

In the same manner as shown for composite handle 10 in fig. 3, composite handle 210 is sized and shaped to accommodate four fingers when formed, with first handle 222 and second handle 242 each accommodating two fingers.

For the second mechanism that applies force F to lock bolt 260, locking mechanism 236 also includes a detent surface 268. Pressing against the detent surface 268 applies a force F to the locking bolt 260 causing the bolt 260 to pivot on the hinge 262. The locking mechanism 236 also preferably includes a stop 280 that limits the displacement of the locking mechanism during release. Force F releases pin 260 from notch 256 allowing shoulder 246 to be withdrawn from groove 226. The operator can thus separate the two handles 222 and 224 (as shown in fig. 21).

Composite instrument 210, and instruments 220 and 240 can be used in conjunction with catheter member 130, diagnostic or therapeutic member 132, and other instruments, in the same manner as described above for composite instrument 10.

The disclosed composite instrument 210 also greatly facilitates the operation and use of the instrument by physicians with lead-lined and/or lead-lined gloves during surgery. Because many procedures are performed under fluoroscopy, physicians who repeatedly do such procedures often wear lead gloves to minimize exposure of their hands to harmful radiation. Such gloves are often thick, uncomfortable, and contain radiopaque materials, such as lead, and typically negatively impact the surgeon's ability to manipulate small objects or "feel" surgical instruments during surgery. With the disclosed composite instrument 210, a surgeon can hold the instrument in a single hand and press the detent surface 268 with a single finger to separate the two handles 222 and 242. Detent surface 268 is preferably sized so that it can be easily sensed and manipulated, even through a leaded glove.

Moreover, because stop 280 preferably limits the displacement of detent surface 268 during release, locking mechanism 236 can withstand a significant amount of force F without damaging hinge 262. This is particularly important when the surgeon is wearing leaded gloves, as the surgeon may not be able to accurately control the amount of force he applies to a given tool. Thus, even if the surgeon releases the instrument with excessive force, the disclosed instrument 210 is less likely to be subject to error during the procedure.

Claims (14)

1. A tool, comprising:

a first functional instrument comprising a first handle comprising first and second finger gripping surfaces for simultaneous gripping by at least two fingers of a hand,

a second functional instrument comprising a second handle comprising a third finger grip surface and a fourth finger grip surface for simultaneous gripping by at least two fingers of one hand,

the first functional instrument is engaged with the second functional instrument to form a composite instrument, and

the first handle cooperates with the second handle to form a composite handle when the first functional instrument is engaged with the second functional instrument, the composite handle including first, second, third and fourth finger gripping surfaces mounted together to form a composite finger gripping surface for simultaneous gripping by four fingers of a hand.

2. The tool according to claim 1, wherein the tool is a single-piece tool,

wherein the first functional instrument is a trocar instrument.

3. The tool according to claim 1, wherein the tool is a single-piece tool,

wherein the second functional instrument is an intubation instrument.

4. The tool according to claim 1, wherein the tool is a single-piece tool,

wherein the composite handle is configured to transmit longitudinal forces to the composite instrument in use.

5. The tool according to claim 1, wherein the tool is a single-piece tool,

wherein the compound handle is arranged, in use, to transmit a rotational force to the compound instrument.

6. The tool according to claim 1, wherein the tool is a single-piece tool,

wherein the composite handle is configured to transmit both longitudinal and rotational forces to the composite instrument in use.

7. The tool according to claim 1, wherein the tool is a single-piece tool,

wherein the composite handle is configured to receive an impact force during use.

8. The tool according to claim 1, wherein the tool is a single-piece tool,

wherein the composite handle is made of a material that resists deformation when an impact force is applied.

9. The tool according to claim 1, wherein the tool is a single-piece tool,

wherein the second functional instrument is a cannula and the first functional instrument is a trocar sized to pass through the cannula.

10. The tool of claim 9, wherein the tool is,

wherein the trocar is longer than the cannula.

11. The tool according to claim 1, wherein the tool is,

further comprising two spaced finger receptacles and two adjacent finger receptacles mounted between the two spaced finger receptacles to provide a row of adjacent finger receptacles forming a composite clamping face.

12. The tool according to claim 1, wherein the tool is,

wherein the compound handle includes a locking mechanism to prevent disengagement of the first and second functional instruments.

13. A tool, comprising:

a first functional instrument comprising a first handle comprising first and second finger gripping surfaces including two spaced finger receptacles for simultaneous gripping by at least two fingers of a hand,

a second functional instrument comprising a second handle including a third finger gripping surface and a fourth finger gripping surface including two adjacent finger receptacles for simultaneous gripping by at least two fingers of a hand, the first functional instrument engaging the second functional instrument to form a composite instrument, and

the first handle and the second handle cooperate to form a composite handle when the first functional instrument is engaged with the second functional instrument, the composite handle including first, second, third and fourth finger gripping surfaces mounted together to form a composite finger gripping surface for simultaneous gripping by four fingers of a hand, the composite finger gripping surface providing a row of adjacent finger receptacles.

14. A tool, comprising:

a first functional instrument comprising a first handle comprising first and second finger gripping surfaces for simultaneous gripping by at least two fingers of a hand,

a second functional instrument comprising a second handle comprising a third finger grip surface and a fourth finger grip surface for simultaneous gripping by at least two fingers of one hand,

the first functional instrument is engaged with the second functional instrument to form a composite instrument, and

the first handle and the second handle cooperate to form a composite handle when the first functional instrument is engaged with the second functional instrument, the composite handle including first, second, third and fourth finger gripping surfaces mounted together to form a composite finger gripping surface for simultaneous gripping by four fingers of a hand, the composite handle including a locking mechanism to prevent disengagement of the first and second functional instruments.