阅读说明：本技术 医疗支撑套管装置、系统和方法 (Medical support sleeve apparatus, systems and methods ) 是由 格雷戈里·戈登 于 2019-07-24 设计创作，主要内容包括：总体上,描述了至少部分地将患者手臂支撑在选定姿势中的医疗套管系统。在一个实施例中,示例支撑套管包括：限定手臂开口的近端；远端；在近端与远端之间延伸的壁,该壁包括前侧部分和后侧部分；以及靠近远端位于前侧部分上的接入端口。支撑套管可以在第一姿势与第二姿势之间操纵,并且在医疗程序期间至少部分地保持在第二姿势中。(In general, a medical cannula system is described that at least partially supports a patient's arm in a selected posture. In one embodiment, an example support sleeve includes: a proximal end defining an arm opening; a distal end; a wall extending between a proximal end and a distal end, the wall including a front portion and a rear portion; and an access port on the front side portion proximate the distal end. The support sleeve is manipulable between a first pose and a second pose, and is at least partially retained in the second pose during a medical procedure.)

1. A medical cannula system comprising:

a support sleeve, the support sleeve comprising:

a proximal end defining an arm opening;

a distal end;

a wall extending between the proximal end and the distal end, the wall including a front portion and a rear portion; and

an access port located on the front portion proximate the distal end; and

an attachment device configured to attach the wall of the support sleeve to a substrate.

2. The medical cannula system of claim 1, wherein the attachment means comprises an adhesive.

3. The medical cannula system of claim 1, wherein said attachment means is selected from the group consisting of hook and loop fasteners, snaps, hooks, straps, ties, self-adhesive nonwoven materials, and the like.

4. The medical cannula system of claim 2, wherein said attachment means is located on said anterior portion of said wall.

5. The medical cannula system of claim 2, further comprising a stabilizing substrate, wherein the attachment device is located on the stabilizing substrate.

6. The medical cannula system of claim 5, wherein said stabilizing substrate comprises a drape configured to extend at least partially around a torso of a patient.

7. The medical cannula system of claim 5, wherein said stabilizing substrate comprises a strap.

8. The medical cannula system of claim 5, wherein the stabilizing substrate comprises a strap selected from the group consisting of a neck strap and a shoulder strap, wherein the neck strap is configured to extend around a portion of the patient's neck and the shoulder strap is configured to extend over the patient's shoulder.

9. The medical cannula system of claim 1, wherein a central longitudinal axis extends centrally between a proximal end and a distal end of the access port, and the attachment device is offset in a lateral direction from the central longitudinal axis of the access port.

10. The medical cannula system of claim 9, wherein the attachment means includes two or more snaps that are offset in a lateral direction from the central longitudinal axis of the access port, the two or more snaps including a first snap that is offset in a lateral direction on a first side of the central longitudinal axis and a second snap that is offset in a lateral direction on a second side of the central longitudinal axis opposite the first side of the central longitudinal axis.

11. The medical cannula system of claim 9, wherein the support cannula is manipulable from a pronated position toward a supinated position while the support cannula is attached to the substrate by the attachment device such that the access port is visible.

12. The medical cannula system of claim 1, including an adhesive at least partially surrounding the access port on an inner surface of the front portion, the adhesive configured to adhere to a patient's skin when the wall is positioned about a patient's arm.

13. The medical cannula system of claim 1, wherein the wall is made of a fluid impermeable material.

14. The medical cannula system of claim 1, wherein the support cannula includes a pre-shaped articulation region defining an angle between 10 ° and 90 °.

15. The medical cannula system of claim 14, wherein the pre-shaped articulation region is configured to be located at an elbow location of a patient's arm while the access port is located at a medial wrist location of the patient's arm when the support cannula is positioned on the patient's arm during use.

16. The medical cannula system of claim 1, wherein the wall is defined by a first sheet and a second sheet that are bonded together.

17. The medical cannula system of claim 16, wherein the first and second sheets are welded together.

18. The medical cannula system of claim 1, further comprising a flexible drape portion extending from the wall.

19. The medical cannula system of claim 1, further comprising an attachment device extending from the wall.

20. The medical cannula system of claim 18, wherein the flexible sheet portion is configured to move from a first position in which a major surface remains proximate to the rear wall portion under sterile conditions and a second position in which the flexible sheet portion extends outwardly away from the wall.

21. A medical cannula system comprising:

a support sleeve, the support sleeve comprising:

a proximal end defining an arm opening,

at the far-end of the device,

a tubular wall extending between the proximal end and the distal end, the tubular wall including a front portion and a rear portion;

an access port located on the front portion proximate the distal end, an

A first attachment device on the front portion of the tubular wall, the first attachment device configured to attach the tubular wall of the support sleeve to a substrate; and

a stabilizing substrate separate from the support sleeve, the stabilizing substrate including a second attachment means complementary to the first attachment means;

wherein the first attachment device is configured to engage with the second attachment device to at least partially support the support sleeve in a selected pose.

22. The medical cannula system of claim 21, wherein said first and second attachment means comprise hook and loop fasteners.

23. A method of supporting an arm during a medical procedure, comprising:

positioning a support sleeve on an arm of a patient, the support sleeve comprising:

a proximal end defining an arm opening,

at the far-end of the device,

a wall extending between the proximal end and the distal end, the wall including a front portion and a rear portion, an

An access port located on the front portion proximate the distal end;

introducing a medical device through an access port of the support sleeve through an access point in an anatomical vessel of a patient while the patient arm is in a first pose;

supporting the patient's arm in a second posture different from the first posture by engaging the support sleeve with a stabilizing substrate.

24. The method of claim 23, wherein the support sleeve includes an attachment device on the anterior portion of the wall, and supporting the patient's arm in the second position includes engaging the attachment device with the stabilizing substrate.

25. The method of claim 23, wherein the stabilizing substrate comprises an attachment device, and supporting the patient's arm in the second posture comprises engaging the attachment device with the support sleeve.

26. The medical cannula system of claim 23, wherein the wall is defined by a first sheet and a second sheet that are bonded together.

27. The medical cannula system of claim 26, wherein the first and second sheets are welded together.

28. The medical cannula system of claim 23, further comprising a flexible drape portion extending from the wall.

29. The medical cannula system of claim 23, further comprising an attachment device extending from the wall.

30. The medical cannula system of claim 25, wherein the flexible sheet portion is configured to move from a first position in which a major surface remains proximate to the rear wall portion under sterile conditions and a second position in which the flexible sheet portion extends outwardly away from the wall.

31. A medical support cannula comprising:

a proximal end defining an arm opening,

at the far-end of the device,

a wall extending between the proximal end and the distal end, the wall including a front portion and a rear portion,

an access port located on the front portion proximate the distal end, an

An expandable sterile drape portion configured to be expanded to cover a portion of a patient's body.

32. The medical support sleeve of claim 31, wherein the expandable sterile drape portion is adjustable from an unexpanded state to an expanded state after the medical support sleeve is positioned on a patient's arm.

33. The medical support sleeve of claim 32, wherein the expandable sterile drape portion is configured to extend from an ulnar region of a patient's arm when in the expanded state.

34. The medical support sleeve of claim 31, further comprising a pulse oximeter attached to said medical support sleeve proximate said distal end.

35. The medical support sleeve of claim 21, further comprising a pulse oximeter attached to said medical support sleeve proximate said distal end.

Technical Field

This document describes devices, systems, and methods for supporting an arm during a medical procedure, and in some embodiments, devices, systems, and methods for supporting an arm using a sterile disposable support sleeve during a medical procedure.

Background

Many interventional access procedures on a patient's arm involve stabilization of the arm. Various techniques have been developed in an attempt to immobilize the arm during surgery. In some procedures, the arm may move between multiple poses throughout the procedure. For example, during introduction of the interventional tool, the arm may be in a first pose, and while maneuvering the interventional tool through the vasculature of the patient, the arm may be in a second pose. In addition, radiation fields are often employed to facilitate navigation of interventional tools, to monitor the vasculature of a patient, and/or to otherwise visualize one or more portions of the patient's anatomy. Radiation protection in the medical field is of great importance, particularly for medical practitioners. Surgery and therapy are typically designed to minimize patient exposure while allowing medical practitioners to effectively treat patients. However, since medical practitioners typically perform multiple treatments over a typical day, the cumulative exposure of the medical practitioner can be large and can increase depending on where the medical practitioner may need to stand relative to the radiation source in order to effectively perform the procedure.

Disclosure of Invention

Some embodiments described herein include devices, systems, and methods that facilitate patient vascular access and efficient operating room workflow during medical procedures. Some example embodiments may include a support sleeve having a proximal end defining an arm opening, a distal end, and a tubular wall of material extending between the proximal end and the distal end. The support sleeve may include an access opening near the distal end and may be positioned on the arm of the patient to provide a sterile surgical field. The access opening defines a passage through which an interventional tool may be advanced to access a patient's vasculature (such as the radial artery) during a medical procedure. The support sleeve may support the arm of the patient in a selected posture while facilitating movement between the plurality of postures.

In various alternative embodiments, the support sleeve includes one or more attachment locations configured to stabilize the support sleeve (e.g., and the patient's arm within the support sleeve) relative to the substrate. For example, in some embodiments, the support sleeve includes an attachment device that is attachable to a substrate separate from the support sleeve, such as a strap, belt, drape, or the like associated with the patient, operating table, or other substrate in the operating room. In an example embodiment, the attachment device is configured to at least partially stabilize a patient's arm in a pronation or palmdown posture on the patient's torso.

In some example embodiments, the support sleeve facilitates manipulation of the patient's arm between a first posture, such as a supination or palmtop posture, in which the vasculature is accessible through the anterior side of the patient's arm, to a second posture, such as a pronation or palmtop posture, in which an interventional procedure may be performed. In some embodiments, the support sleeve may facilitate a radial access procedure in which the left arm of the patient is accessed and at least a portion of the interventional procedure is performed by a medical practitioner operating from the right side of the patient, or vice versa (e.g., when the patient's arm rests on the patient's torso in a pronated position).

In various alternative embodiments, an example medical cannula system includes a substrate to which a cannula can be attached. For example, the substrate may be a drape, a belt, a strap, a belt, or the like. In some alternative embodiments, the base sheet may include one or more complementary attachment means, such as an adhesive, hook and loop fasteners (e.g., the base sheet may include an annulus of hook and loop fasteners and the support sleeve may include a hook face, or vice versa), snaps, straps, ties, friction materials, self-adhesive nonwovens, self-adhesive polymeric materials, co-adhesive materials, high-friction polymers, and the like.

The support sleeve can be brought into engagement with the base sheet in a selected orientation and readily attached to the base sheet to at least partially support the arm of the patient in the selected orientation.

Certain embodiments described herein include a medical cannula system. The medical cannula system includes a support cannula including: a proximal end defining an arm opening; a distal end; a wall extending between a proximal end and a distal end, the wall including a front portion and a rear portion; and an access port located on the front portion and proximate the distal end. The system further comprises attachment means to attach the wall of the support sleeve to the substrate.

In some embodiments, the system may optionally include one or more of the following features. The attachment means may comprise an adhesive. The attachment means may be selected from the group consisting of hook and loop fasteners, snaps, hooks, straps, ties, self-adhesive nonwovens, self-adhesive polymeric materials, high friction polymeric materials, co-adhesive materials, and the like.

Attachment means may be located on the front portion of the wall. The medical cannula system may further comprise a stabilizing substrate, wherein the attachment means is located on the stabilizing substrate. The attachment substrate may include a drape configured to extend at least partially around a torso of a patient. The stabilizing substrate may comprise a belt. The stabilizing substrate may include a strap configured to extend around the neck of the patient. A central longitudinal axis may extend centrally between the proximal and distal ends of the access port, and the attachment device may be offset in a lateral direction from the central longitudinal axis of the access port. The attachment means may include two or more snaps that are offset in a lateral direction from a central longitudinal axis of the access port. The access port may be covered by a removable liner. An adhesive may at least partially surround the access port on an inner surface of the front portion, the adhesive may be configured to adhere to the skin of the patient when the tubular wall is positioned around the arm of the patient. The wall may be made of a fluid impermeable material. The support sleeve may include a pre-shaped articulation region defining an angle between 10 ° and 90 °. The pre-shaped articulation region may be configured to be located at an elbow location of the patient's arm while the access port is located at an inner wrist location of the patient's arm when the support sleeve is positioned on the patient's arm during use.

Certain embodiments described herein include a medical cannula system. The medical cannula system may include a support cannula including: a proximal end defining an arm opening; a distal end; a tubular wall extending between a proximal end and a distal end, the tubular wall including a front portion and a rear portion; an access port located on the front portion and proximate the distal end; and a first attachment device on a front side portion of the tubular wall, the first attachment device configured to attach the tubular wall of the support sleeve to the substrate. The medical cannula system may further include a stabilizing substrate separate from the support cannula, the stabilizing substrate including a second attachment means complementary to the first attachment means. The first attachment device is configured to engage with the second attachment device to at least partially support the support sleeve in a selected pose.

In some embodiments, the system may optionally include one or more of the following features. The first and second attachment means comprise hook and loop fasteners.

Certain embodiments described herein include a method of supporting an arm during a medical procedure. The method includes positioning a support sleeve on an arm of a patient, the support sleeve comprising: a proximal end defining an arm opening; a distal end; a wall extending between a proximal end and a distal end, the wall including a front portion and a rear portion; and an access port located on the front portion and proximate the distal end. The method further comprises the following steps: introducing a medical device through an access port of a support cannula through an access point in an anatomical blood vessel of a patient with an arm of the patient in a first position; and supporting the arm of the patient in a second posture, different from the first posture, by engaging the support sleeve with the stabilizing substrate.

In some embodiments, the system may optionally include one or more of the following features. The support sleeve may include an attachment device on a forward portion of the wall, and supporting the arm of the patient in the second posture may include engaging the attachment device with the stabilizing substrate. The stabilizing substrate may include an attachment device and supporting the patient's arm in the second posture may include engaging the attachment device with the support sleeve.

Some embodiments of the devices, systems, and techniques described herein may provide one or more of the following advantages. First, some embodiments described herein may improve operating room workflow by reducing patient preparation time. The support sleeve may facilitate preparation of a sterile surgical field. An access site may be prepared and the support cannula may be easily positioned on the arm of the patient while the access port of the support cannula facilitates vascular access (e.g., of the radial artery).

Second, some embodiments herein may improve operating room workflow by facilitating movement of a patient's arm between a first posture and a second posture. The first posture may be a posture conducive to introduction of the medical device, such as a supination or palms-up posture, in which the anterior side of the wrist is exposed and accessible. The second posture may be a posture conducive to performing at least a portion of a medical procedure, such as a pronation or palmdown posture, in which the wrist rests on the patient's torso (e.g., near the groin area). Thus, the medical device can be easily introduced, and the arm can then be manipulated (e.g., rotated inward) to a position that improves patient comfort, and that facilitates ergonomic handling by the healthcare practitioner and/or handling by the healthcare practitioner from a location remote from the radiation field.

Third, some embodiments herein help to effectively stabilize a patient's arm in a selected orientation. For example, the support sleeve may optionally include one or more attachment devices that stabilize the patient's arms in a selected posture, such as a pronated posture in which the arms are at least partially across the torso and the wrists are near the groin area.

Fourth, some embodiments herein provide a cannula system that is disposable after each use. Single use systems can improve sterility while simplifying pre-and post-operative sterilization skills. The cannula system may be cost-effectively manufactured for a single use, and/or may be safely disposed of through a surgical drape.

Fifth, some embodiments herein provide cannula systems that are adaptable to a variety of patient sizes and anatomical structures. The single sleeve configuration may be suitable for use on either the left or right arm. Also, in some embodiments, the cannula system may be adjustable or otherwise adapted to a range of arm sizes, such as by including stretchable materials, adjustable straps, ties, snaps, and the like, and/or other features.

Sixth, some embodiments herein facilitate specific medical procedures involving radial or vascular access via the wrist or arm, including coronary catheterization, percutaneous peripheral intervention, percutaneous coronary intervention, carotid and subclavian artery intervention for acute stroke, treatment of vascular malformations and aneurysms, central venous access for electrophysiology procedures, hemodialysis intervention, arteriovenous fistula (AVF) intervention, electrophysiology cardiology procedure, pacemaker insertion, mesenteric and renal arterial systems, and/or other applications.

Seventh, some embodiments facilitate a procedure involving a medical practitioner operating from the right side of a patient performing left radial access, or vice versa. For example, some example cannula systems help stabilize a patient's arm in a resting position across the patient's torso. A medical practitioner may manipulate the interventional tool with the access location of the patient's arm while standing in an upright position (which may alleviate stress and fatigue of the practitioner) and/or at a greater distance from the radiation field. During operation, the operator's hand may be positioned outside the radiation field, while the physician's head, neck, and other body parts may be positioned at a greater distance from the radiation field. Alternatively or in addition, the patient's arm may be stabilized in a selected posture from which the medical practitioner may more comfortably manipulate the interventional tool in a natural, ergonomic posture and/or by using a dominant hand. Thus, the cannula system may allow a medical practitioner to operate from a posture selected primarily based on facilitating patient care, for example, from the left radial artery in a percutaneous coronary intervention, with fewer constraints on ergonomic requirements.

The details of one or more implementations are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description and drawings, and from the claims.

Drawings

The specification is further provided with reference to the attached drawings, wherein like structure is referred to by like numerals throughout the several views, and wherein:

FIG. 1 is a perspective view of an example cannula system used in a medical environment.

Fig. 2 is a perspective view of the example cannula system of fig. 1.

Fig. 3 is a perspective view of the example cannula system of fig. 1 with the patient's arm in a first supine position.

FIG. 4 is a perspective view of the example cannula system of FIG. 1 with the patient's arm in a second pronation position.

Fig. 5A is a perspective view of another example cannula system including a plurality of attachment devices with a patient arm in a first supination position.

Fig. 5B is a perspective view of the example cannula system of fig. 5 with the patient's arm in a second pronation position.

FIG. 6A is a perspective view of another example cannula system with a patient arm partially supinated.

Fig. 6B is a perspective view of the example cannula system of fig. 6 with the patient's arm in a pronated position.

FIG. 7 is a perspective view of another example cannula system having an expandable portion.

FIG. 8 is a flow chart of an example process for using the cannula system.

Fig. 9A is a perspective view of another example cannula system.

Fig. 9Bb is a perspective view of the example cannula system of fig. 9A with the patient's arm in a first supine position.

Fig. 9C is a perspective view of the example cannula system of fig. 9A with the patient's arm in a second pronation position.

FIG. 9D is a perspective view of another example cannula system with a patient arm in a first supination position.

Fig. 9E is a perspective view of the example cannula system of fig. 9D with the patient's arm in a second pronation posture.

Detailed Description

Referring to fig. 1-4, an example medical cannula system 10 is shown that includes a support cannula 100 and, optionally, a stabilizing substrate 150, with which the support cannula 100 may be engaged during a medical procedure. The support sleeve 100 is configured to be positioned on the arm of a patient. The support sleeve 100 may allow access to the patient's arm for introducing medical tools, facilitating movement of the arm between poses, and/or stabilizing the arm in a selected pose while the medical practitioner 2 is performing a medical procedure.

The support sleeve 100 includes a proximal end 101 defining an arm opening 101a, a distal end 102, and a wall 103 extending therebetween. Support sleeve 100 may be positioned on the arm of patient 1 by positioning the arm of patient 1 through an arm opening at proximal end 101. In use, the support sleeve 100 can stabilize a patient's arm in a pronated, palmdown position resting on the patient's torso. For example, the wrist may rest near the groin area. The interaction between the support sleeve 100, the stabilizing substrate 150, and/or another feature in the patient's body or operating room at least partially maintains the patient's arm in the selected position. In some embodiments, the support sleeve 100 may at least partially hold the patient's left arm in a pronated, palmdown position, or vice versa, when the medical practitioner is working from the patient's right side.

Referring to fig. 2, a perspective view of an example support sleeve 100 is shown. The support sleeve 100 includes a proximal end 101 and a distal end 102, the proximal end 101 defining an arm opening 101 a. A wall 103 extends between the proximal end 101 and the distal end 102. The wall includes a front portion 104 and a rear portion 105. In some embodiments, support sleeve 100 is configured to be positioned on a patient's arm such that anterior portion 104 of wall 103 is generally located on an anterior side of the patient's arm and posterior portion 105 of wall 103 is generally located on a posterior side of the patient's arm.

Support sleeve 100 includes one or more access ports 106, which access ports 106 facilitate access to the arm of the patient through wall 103. For example, the access port 106 may define an opening through the entire thickness of the wall 103. The medical device may be passed through the access port 106 and through the skin of the patient to the access location. In some embodiments, the access port 106 can include a removable liner that at least partially covers an opening defined by the access port 106. The removable liner may be removed at the time of use, such as in an operating room before or after the support sleeve 100 has been positioned on the arm of a patient.

In an example embodiment, when the support sleeve 100 is positioned on the arm of a patient, the one or more access ports 106 are positioned in alignment with the medial wrist of the patient. For example, the access port 106 may be located on the front portion 104 of the wall 103 near the distal end 102. In this manner, a medical practitioner may access the radial artery or other vascular feature, for example, via one or more access ports 106. Alternatively or additionally, one or more access ports 106 can be located on a front portion 104 of the wall 103 near the proximal end 101, near the inner elbow, etc. (e.g., to facilitate access to other locations on a front portion of a patient's arm), and/or one or more access ports 106 can be located on a rear portion 105 of the wall 103 (e.g., to facilitate access to a rear side of a patient's arm).

The support sleeve 100 may include one or more adhesive regions on the inner surface of the wall 103. For example, the adhesive 106c on the inner surface of the front side portion 104 at least partially surrounds the access port 106. Adhesive 106c improves sterility by separating the access location of the patient's skin from the rest of the patient's arm. In some embodiments, adhesive 106c further improves stability by inhibiting relative movement between support sleeve 100 and the patient's arm during use.

One or more access ports 106 may be generally centrally located on the front portion 104 of the wall 103 and proximate the distal end 102. For example, a central longitudinal axis (a) extending between the proximal end 106a and the distal end 106b of the access port 106 can be collinear with a central longitudinal axis of the front portion 104 of the wall 103. The generally centrally located access port 106 may facilitate alignment with the inner wrist surface when the support sleeve is positioned on the patient's arm.

The support sleeve 100 may include one or more features to improve patient comfort and/or protect the patient's arms. In an exemplary embodiment, the support sleeve 100 includes a padded region 110. The padded region 110 may include a compressible structure that protects and cushions the patient's arm, such as a pad configured to protect the patient's arm from compressive neuropathy and decubitus wounds and for comfort. For example, the pad region 110 may include locations of increased material thickness and/or may include one or more of foam, closed cell foam, open cell foam, compressible nonwoven material, rubber, quilted material, laminate, air pockets, water, gel, styrene beads, and the like. In some embodiments, the cushion area 110 may be at least partially filled with an expandable material such that the cushion material may expand to at least partially conform to the arm of the patient.

The pad area 110 may be present on part or all of the support sleeve 100. In the exemplary embodiment, a padded area 110 is located on the rear portion 105 of the wall 103. Pad region 110 may protect the elbow, triceps arm, and other posterior features of the patient's arm, particularly when the patient's arm rests/is supported on the posterior side in a supine position (e.g., during introduction of the medical device at the inner wrist), and/or when the arm is constrained by an arm plate or other external structure in contact with the posterior portion of support sleeve 100. In an exemplary embodiment, the padded region 110 extends from a proximal position 110a near the proximal end 101 to a distal position 110 b. The distal location 110b may be selected such that when the support sleeve 100 is positioned on a patient's arm in use, the cushion region 110 is present at a location of the patient's elbow (e.g., and extends just beyond the elbow location). Such a configuration may advantageously protect the patient's arm without inhibiting articulation of the support sleeve 100 or the patient's arm (e.g., at an elbow location), and/or while facilitating access through the access port 106.

The support sleeve 100 may include a combination of two or more materials that protect the arm of the patient and/or a plurality of padded regions 110 having different material constructions. In an example embodiment, a shape-stabilized compressible material 111 (fig. 1) may be located at the elbow region. The compressible material 111 may provide additional padding and/or support for the elbow of the patient. In some embodiments, the compressible material 111 may be a foam elbow pad (e.g., open cell foam, closed cell foam, etc.) that provides additional protection to and/or support the elbow in the articulated position.

The support sleeve 100 is capable of articulation at one or more locations between the proximal end 101 and the distal end 102. In an exemplary embodiment, the support sleeve 100 includes a pre-shaped articulation region 108. The articulation region 108 simulates elbow flexion and facilitates positioning of the patient's arm in a non-straight orientation. In some embodiments, the articulation region 108 provides bending such that a lower or distal region of the support sleeve 100 has a first longitudinal axis (a) and an upper or proximal region of the support sleeve has a second longitudinal axis (B) that is angled relative to the first longitudinal axis (a) (e.g., when the support sleeve 100 is not in use resting on a patient's arm). Accordingly, the articulation region 108 may provide a predetermined bend that facilitates articulation and, with the support sleeve 100 positioned on the arm of a user, may reduce bunching or gathering of material as the patient's arm bends at the elbow. Alternatively or additionally, the articulation region 108 may facilitate intuitive positioning on the patient's arm, for example, because the support sleeve 100 is at least partially pre-shaped in a natural articulation posture. In various exemplary embodiments, the articulation region 108 includes a pre-shaped bend that defines an angle between 10 ° and 90 °, between 30 ° and 60 °, or about 45 °. For example, the angle (α) defined between the first longitudinal axis (a) and the second longitudinal axis (B) may be between 10 ° and 90 °, between 30 ° and 60 °, or about 45 °. The articulation region 108 is flexible so that the patient's arm can be easily manipulated when the support sleeve 100 is positioned on the patient's arm. For example, the patient's arm may be manipulated during use such that the angle (α) increases or decreases.

The support sleeve 100 may have a tubular configuration such that the wall 103 defines a circular or rounded arm opening 101a and/or defines a circular or rounded cross-sectional space between the proximal end 101 and the distal end 102. Such a configuration may facilitate positioning of the support sleeve 100 on the arm of a patient while providing a proper fit. In various example embodiments, the wall 103 may include a continuous material portion, such as that present at both the front side portion 104 and the back side portion 105. The ends of the continuous material portion may be joined (e.g., by sewing, welding, bonding, etc.). In some embodiments, the support sleeve 100 may have few or no seams (e.g., such support sleeve 100 has a seamless configuration). Alternatively or additionally, the wall 103 may comprise two or more sheets of planar material joined at a longitudinal seam.

In various example embodiments, the wall 103 may have a flexible, liquid-impermeable construction. For example, the wall 103 may include one or more layers of polyester, polyethylene, cotton, paper, non-woven, fabric, and the like. Alternatively or additionally, the wall 103 may comprise one or more layers that render the liquid impermeable, such as a polymer layer. In some embodiments, the wall 103 may have a laminated structure formed of two or more layers. These layers may be microporous to promote breathability while being liquid impermeable. In some embodiments, the support sleeve 100 may be a stretchable material such that the wall 103 may stretch and flex to accommodate the patient's arm while in intimate contact with or slightly compressing the patient's arm in at least some locations. For example, in use, when the wall 103 is placed on the arm of a patient, the wall 103 may be stretched slightly in at least some locations. The support sleeve 100 may be a sterile support sleeve that protects the patient from the skin flora and the external environment.

The support sleeve 100 may have one or more fixation features that facilitate a secure fit on the patient's arm and/or inhibit relative motion (e.g., relative rotation and/or longitudinal translation) between the support sleeve 100 and the patient's arm during use. For example, the support sleeve may include one or more fixation features 109 near the proximal end 101. The securing features 109 may include one or more of elastic regions, straps, ties, hook and loop fasteners, adjustment mechanisms, and the like to facilitate a secure fit around the upper arm of the patient. In an example embodiment, the securing features 109 do not extend around the entire perimeter of the wall 103. The one or more fixation features 109 may be located elsewhere between the proximal end 101 and the distal end 102, such as above the articulation region 108, below the articulation region 108, near the access port 106, and so forth.

In various example embodiments, the support sleeve 100 may include one or more finger and/or thumb portions configured to receive a single finger/thumb. Such a configuration may help position the support sleeve, and/or improve patient comfort. In an example embodiment, the support sleeve includes a pulse oximeter 107 in the sleeve configured to monitor (e.g., continuously) the patient's hand oxygen supply.

The support sleeve 100 may be configured to at least partially stabilize the arm of the patient in a selected posture. In an example embodiment, the support sleeve 100 includes one or more attachment devices 120, which attachment devices 120 facilitate engagement with a substrate (such as a complementary stabilizing substrate) in an operating environment. For example, the attachment device 120 includes a region that engages another surface when in contact with the surface to limit relative movement between the support sleeve 100 and the surface. In various example embodiments, the attachment device 120 includes one or more of an adhesive, a hook and loop fastener, a self-adhesive nonwoven material, a self-adhesive polymeric material, a high-friction polymeric material, a co-adhesive material, and the like. In some embodiments, the attachment device 120 may be exposed (e.g., by removing a liner covering the adhesive) and the attachment device 120 is brought into contact with a stabilizing substrate (such as patient skin, sterile surgical drape, belt, neck strap, belt, other stabilizing substrate, etc.).

Referring to fig. 3 and 4, the example support sleeve 100 is shown in use in a first position (fig. 3) and a second position (fig. 4). In the first posture, the arm is in a supine posture, wherein the front side of the patient's arm is facing up. Thus, the inner wrist is facing upward and accessible by the healthcare practitioner (e.g., via the access port 106). Thus, a medical device may be introduced into a patient's arm proximate to the inner wrist for accessing the patient's radial artery or other features.

In various example embodiments, the medical device 160 may include a catheter, such as an access sheath, vascular sheath, intravascular medical device, or the like. The medical device may be configured to extend through a puncture in the patient 1 at the access location 30 and into an anatomical duct (such as a radial artery, other blood vessel, etc.). In an exemplary embodiment, the catheter of the medical device includes a proximal end external to the patient 1, a distal end internal to the patient 1, and defines a lumen extending at least partially between the proximal and distal ends. The lumen defines a path for delivery or withdrawal of a fluid, an instrument (e.g., a guidewire or other interventional tool), or a combination thereof. Thus, with the catheter held in a fixed position relative to the access location 30, the catheter may be adapted for the steering and passage of one or more guidewires or interventional tools.

Medical device 160 may be effectively introduced at access location 30 while the patient's arm is in a first position within support sleeve 100. The supination posture may facilitate access to the radial artery of other anatomical ducts from the anterior side of the patient's arm with the arm resting/supported on the posterior side of the arm.

One or more attachment devices 120 are located on at least a portion of the front section 104 of the support sleeve 100. In an example embodiment, one or more attachment devices 120 are positioned on both the distal and proximal sides of the access port 106 and/or may at least partially wrap around the access port 106. For example, the attachment device 120 can include a region that extends from a location distal to the access port 106 to a location near the proximal end 101 of the support sleeve 100. Alternatively or additionally, the attachment device 120 may be present only on the front portion 104 of the wall 103 (e.g., not on the rear portion 105 of the wall 103). In other example embodiments, the attachment means may be present on the rear portion 105 only, or on both the front portion 104 and the rear portion 105. In some example embodiments, one or more attachment devices 120 (such as straps) may extend at least partially around the support sleeve 100 when attached to a substrate and facilitate pronation or supination.

The medical cannula system 10 includes a stabilizing substrate 150, and the support cannula 100 is engageable with the stabilizing substrate 150 to at least partially support the arm of the patient in a selected posture. In an example embodiment, the stabilizing substrate 150 may be a drape or pad positionable over at least a portion of the torso of a patient and/or at least partially on the back of the patient, the drape or pad being attached to an operating table, other structure in an operating room, or the like. The stabilization substrate 150 may comprise a material complementary to the support sleeve 100 such that the support sleeve may at least partially remain engaged with the stabilization substrate 150. For example, the stabilizing substrate 150 may include complementary attachment means 151 comprising one or more of an adhesive, hook and loop fastener, self-adhesive material, high friction polymer, or the like, complementary to the attachment means 120, the wall 103, and/or other features of the support sleeve 100.

In some embodiments, both the stabilization substrate 150 and the support sleeve 100 include attachment means, and these attachment means are complementary to each other. For example, the support sleeve 100 includes a hook and loop attachment device 120 (e.g., a hook face of a hook and loop fastener) and the stabilizing substrate 150 includes a complementary hook and loop attachment device (e.g., a loop face of a hook and loop fastener). The hook and loop surfaces of the support sleeve 100 and the stabilizing base 150 may be engaged to inhibit relative movement and to at least partially support the support sleeve 100 in a selected position. Alternatively or additionally, the support sleeve 100 may include adhesive attachment means 120 and the stabilizing substrate 150 includes complementary adhesive attachment means or a material that facilitates adhesive engagement with the support sleeve 100. The adhesive attachment device 120 of the support sleeve 100 may engage with the stabilization substrate 150 to inhibit relative movement and at least partially support the support sleeve in a selected pose.

In some embodiments, only one of the support sleeve 100 or the stabilizing substrate 150 includes an attachment device. For example, the support sleeve 100 may include an adhesive attachment device 120 engageable with a surface of the stabilization substrate 150, and the stabilization substrate 150 does not include an additional adhesive attachment device, or vice versa.

The support sleeve 100 and the patient's arm within the support sleeve 100 may be manipulated to a selected posture by moving from a first posture (fig. 3) to a second posture (fig. 4). The support sleeve 100 at least partially holds the patient's arm in a selected position, such as by engaging with a stabilizing substrate 150. For example, when support sleeve 100 is positioned on a patient's arm and medical device 160 is fixedly positioned through access location 30, the patient's arm may be manipulated between a first position and a second position. After medical device 160 has been introduced, the arms may be rotated inward from a first supination posture to a second pronation posture in which the arms rest at least partially on the patient's torso in a palm-down posture. Alternatively or additionally, the bend angle at the elbow of the patient and/or other parameters of the orientation of the arm of the patient may be adjusted to bring the arm of the patient into the selected posture. In some embodiments, the patient's arm is oriented such that the inner wrist is located near the groin area.

The engagement between the support sleeve 100 and the stabilizing substrate 150 inhibits relative movement between the support sleeve 100 and the stabilizing substrate 150 and facilitates supporting the arm of the patient in a selected posture. For example, a medical practitioner may simply lift the patient's arm, move to a selected position, and contact the stabilizing substrate 150. Thus, the medical cannula system 10 facilitates the efficient setup and support of a patient's arm in a selected posture. Moreover, in some embodiments, the support sleeve 100 may be repositionable relative to the stabilization substrate 150 so that a medical practitioner can easily separate the support sleeve 100 from the stabilization substrate 150 for small adjustments to the arm pose, monitoring the access location 30 or other portions of the arm front side, and the like.

In the example second position shown in fig. 4, the patient's arms are in a natural palm-down position in which the arms rest on the torso with the wrists near the groin area. Such a posture may resemble a natural sleep posture and may improve patient comfort. Alternatively or additionally, the second pose may facilitate ergonomic manipulation of the medical device 160 by the medical practitioner, such as by allowing the medical practitioner to operate on the patient's body primarily with a conventional manipulator and/or remotely from the radiation field used during the medical procedure, and so forth. In some example embodiments, an additional support structure may be positioned along at least a portion of the patient's arm, such as along a posterior side of the patient's arm (e.g., along the triceps brachii). The support structure may be a rigid arm plate or other support structure that further supports the arm in the second position and/or prevents the arm from being removed from the body. The padded area 110 (e.g., elbow pad 111) can protect the patient's arm and improve patient comfort when supported by additional structure.

The support sleeve 100 facilitates positioning of the patient's arm in one or more selected postures based on preferences of the medical practitioner, patient anatomy, medical procedure performed, etc. The second posture is not limited to an orientation in which the elbow is bent by approximately 90 °. The medical practitioner may select an appropriate angle, including an angle that allows the wrist to rest at a position near the groin area. The material and construction of the support sleeve 100 allows for articulation of the patient's arm between a plurality of positions while supporting the patient's arm in a selected position.

In various example embodiments, the support sleeve 100 may include one or more expandable portions, such as an expandable sterile drape 118. During use, the expandable sterile drape 118 may be expanded (e.g., unrolled, rolled out, pulled apart, etc.) to cover a patient's arm, selected portions of the body, and/or operating table, other surface, etc. The expandable sterile drape 118 may be manipulated between a folded or unexpanded configuration 118a and an expanded configuration. In an example embodiment, the expandable sterile drape is folded, rolled, furled, etc., at a location of the support sleeve 100 proximate the ulnar region of the patient's arm (e.g., between the anterior wall portion 104 and the posterior wall portion 105). The expandable sterile drape 118 may be unexpanded when the patient's arm is manipulated to a supine position. When the patient's arm is in a supine position (e.g., after the medical device is introduced into the arm), the expandable sterile drape 118 may be accessed so that the medical practitioner may expand and place the sterile drape 118 at a selected location. In some embodiments, the expandable sterile drape 118 may facilitate sterility of the surgical field by covering one or more locations where a patient's arm is positioned during introduction of a medical device or other access to the patient's arm.

The expandable sterile drape 118 may be formed as a single, unitary component with one or more other portions of the support sleeve 100. For example, the expandable sterile drape 118 may be formed as part of the support sleeve 100, such as the wall 103. Alternatively or additionally, the expandable sterile drape 118 may be formed separately and subsequently attached to one or more portions of the support sleeve 100, such as the wall 103. The expandable sterile drape 118 may include one or more fold lines 118 b. The medical practitioner may expand the sterile drape 118 to a selected degree by unfolding the sterile drape 118 at one or more fold lines 118 b.

The expandable sterile drape 118 may include one or more radiation blocking materials to shield radiation from reaching the patient and/or medical practitioner. In an example embodiment, the expandable sterile drape 118 is positioned over at least a portion of the back wall portion 105 of the support sleeve 100 (e.g., such that the back wall portion 105 is between the expandable sterile drape 118 and the arm of the patient).

Alternatively or additionally, the support sleeve may include one or more expandable portions proximate the front portion of the support sleeve 100. For example, the support sleeve 100 may include an expandable sterile drape 119 (fig. 3), the expandable sterile drape 119 being manipulable between a folded or unexpanded configuration and an expanded configuration. The expandable sterile drape may be positioned under at least a portion of the anterior wall portion 104 of the support sleeve 100 (e.g., such that the anterior wall portion 104 is between the expandable sterile drape 119 and the patient's arm), and may cover the access port 106. The expandable sterile drape 119 may include one or more radiation blocking materials to provide radiation shielding for the patient and/or medical practitioner.

Referring now to fig. 5A-5B, an example medical cannula system 50 is shown that includes a support cannula 500, a stabilizing substrate 550. The support sleeve 500 is configured to be positioned on the arm of a patient. The support sleeve 500 may allow access to a patient's arm for introduction of medical tools, may facilitate movement of the arm between a plurality of positions, and/or may stabilize the arm in a selected position while a medical practitioner is performing a medical procedure. In various example embodiments, the medical cannula system 50 may include one or more features as described with reference to the medical cannula system 10 described herein with reference to fig. 1-4.

The support sleeve 500 includes a proximal end 501 defining an arm opening, a distal end 502, and a wall 503 extending between the proximal end 501 and the distal end 502. Support sleeve 500 may be positioned on the arm of patient 1 by positioning the arm through an arm opening at proximal end 501. In use, the support sleeve 500 may stabilize the patient's arm in a pronated, palmdown position resting on the patient's torso (fig. 6). For example, the wrist may rest near the groin area. The interaction between the support sleeve 500, the stabilization substrate 550, and/or another feature in the patient's body or operating room at least partially maintains the patient's arm in the selected position. In some embodiments, the support sleeve 500 may at least partially hold the patient's left arm in a pronated, palms down position, or vice versa, when the medical practitioner is working from the patient's right side.

The wall 503 of the support sleeve 500 includes a front portion 504 and a rear portion 505. In some embodiments, support sleeve 500 is configured to be positioned on a patient's arm such that anterior portion 504 of wall 503 is generally located on an anterior side of the patient's arm and posterior portion 505 of wall 503 is generally located on a posterior side of the patient's arm. Support sleeve 500 includes one or more access ports 506 that facilitate access to the patient's arm through wall 503. In some embodiments, access port 506 may include a removable liner that at least partially covers an opening defined by access port 506. The removable liner may be removed at the time of use, such as in an operating room before or after the support sleeve 500 has been positioned on the arm of a patient.

The one or more access ports 506 can be configured to align with the medial wrist of the patient when the support sleeve 500 is positioned on the arm of the patient. For example, the access port 506 can be located on a front portion 504 of the wall 503 near the distal end 502. In this manner, a medical practitioner may access the radial artery or other vascular feature, for example, via one or more access ports 506. Alternatively or additionally, one or more access ports 506 can be located on a front portion 504 of the wall 503 near the proximal end 501, near the inner elbow, etc. (e.g., to facilitate access to other locations on the front side of the patient's arm), and/or one or more access ports 506 can be located on a rear portion 505 of the wall 503 (e.g., to facilitate access to the rear side of the patient's arm).

One or more access ports 506 can be generally centrally located on the front portion 504 of the wall 503 and proximate the distal end 502. For example, a central longitudinal axis (a) extending between the proximal and distal ends of the access port 506 can be collinear with a central longitudinal axis of the front portion 504 of the wall 503. The generally centrally located access port 506 may facilitate alignment with the inner wrist surface when the support sleeve is positioned on the patient's arm.

The support sleeve 500 may include one or more features that may improve patient comfort and/or protect the patient's arm. In an exemplary embodiment, the support sleeve 500 includes a pad region 510. The padded area 510 may include a compressible structure that protects and cushions the arm of the patient. For example, padding region 510 may include locations of increased material thickness, and/or may include one or more of foam, closed cell foam, open cell foam, compressible nonwoven material, rubber, quilted material, laminate, air pockets, gel, and the like. In some embodiments, the cushion area 510 may be at least partially filled with an expandable material such that the cushion material may expand to at least partially conform to the arm of the patient.

The pad area 510 may be present on part or all of the support sleeve 500. In an example embodiment, the pad area 510 is located on the rear portion 505 of the wall 503. In an exemplary embodiment, the padded region 510 extends from a proximal position near the proximal end 501 to a distal position. The distal position may be selected such that when support sleeve 500 is positioned on a patient's arm in use, cushion region 510 is present at a location of the patient's elbow (e.g., and extends just beyond the elbow location). Such a configuration may advantageously protect the patient's arm while not inhibiting articulation of the support sleeve 500 or the patient's arm (e.g., at an elbow location), and/or while facilitating access through the access port 506.

In various example embodiments, the wall 503 may have a flexible, liquid-impermeable construction. For example, the wall 503 may include one or more layers of polyester, polyethylene, cotton, paper, non-woven, fabric, and the like. Alternatively or additionally, the wall 503 may include one or more layers that render the liquid impermeable, such as a polymer layer. In some embodiments, the wall 503 may have a laminated structure formed of two or more layers. These layers may be microporous to promote breathability while being liquid impermeable. In some embodiments, the support sleeve 500 may be a stretchable material such that the wall 503 may stretch and flex to accommodate the patient's arm while in intimate contact with or slightly compressing the patient's arm in at least some locations. For example, in use, when the wall 503 is positioned on the arm of a patient, the wall may stretch slightly in at least some locations. The support sleeve 500 may be a sterile support sleeve that protects the patient from the skin flora and the external environment.

The medical cannula system 50 may be configured to at least partially stabilize the patient's arm in a selected posture. In an exemplary embodiment, the support sleeve 500 includes one or more attachment devices 520 that facilitate engagement with a substrate (such as a complementary stabilizing substrate 550) in an operating environment. For example, the attachment devices 520 may engage with complementary features of the stabilization base plate 550 to limit relative movement between the support sleeve 500 and the stabilization base plate 550.

The example support sleeve 500 is shown in use in a first position (fig. 5A) and a second position (fig. 5B). In the first posture, the arm is in a supine posture in which the front side of the patient's arm is facing up. Thus, the inner wrist is facing upward and accessible by the healthcare practitioner (e.g., via access port 506). Thus, medical device 560 may be introduced into a patient's arm near the inner wrist for accessing the patient's radial artery or other features. When the patient's arm is in a first position within support sleeve 500, medical device 560 may be effectively introduced at access location 530. The supination posture may facilitate access to the radial artery of other anatomical ducts from the anterior side of the patient's arm with the arm resting/supported on the posterior side of the arm.

In various exemplary embodiments, the support sleeve 500 includes one or more attachment devices 520 (such as one or more of an adhesive tape, hook and loop tape, clip, hook, snap, tie, ring, etc.), which attachment devices 520 are engageable with complementary features of the stabilization substrate 550. The stabilizing substrate 550 may likewise include one or more complementary attachment devices, such as adhesive strips, hook and loop tape, clips, hooks, snaps, ties, loops, and the like. For example, the attachment means 520 of the support sleeve 500 may comprise one or more snaps 521 which are capable of engaging with complementary snaps 551 of the stabilization base sheet 550. The catches 521 are fixedly positioned relative to each other along the walls 503. In an example embodiment, one or more catches 521c are centrally located on the front portion 504, such as along a central longitudinal axis of the support sleeve 500. Alternatively or additionally, the one or more snaps 521 are not centrally located, but are offset from a central longitudinal axis, e.g., offset from the longitudinal axis (a) of the access port 506. For example, catch 521a is located near an inner or bottom side of support sleeve 500 (e.g., a side near the patient's little or fifth digit), and catch 521b is located near an outer or top side of the support sleeve (e.g., a side near the patient's thumb). A plurality of snaps 521 at different locations of the support sleeve 500 facilitate positioning of the patient's arm in a selected posture.

Alternatively or additionally, the attachment means 520 of the support sleeve 500 may comprise one or more straps 522. The strap 522 may be configured as a complementary strap, loop, or the like to attach to the stabilizing substrate. A plurality of straps 522 may be positioned on the wall 503 of the support sleeve 500 and facilitate engagement between the support sleeve 500 and the stabilizing substrate in a selected pose. In some embodiments, the belts 522a, 522b are offset from the central longitudinal axis. The deviating strap 552 may facilitate manipulation of the patient's arm while the support sleeve 500 remains engaged with the stabilizing substrate 550 such that the patient's arm may rotate slightly from a pronated position to a supinated position, for example, when one or more straps (e.g., strap 522a) located near a bottom edge of the support sleeve 500 is engaged with the stabilizing substrate 550. Also, the strap 522b may limit or prevent rotation when attached.

The stabilizing substrate 550 may include one or more straps (such as a strap 553 and/or a neck or shoulder strap 554) that secure the stabilizing substrate 550 relative to the patient 1. The belt 553 may pass at least partially over the back of the patient 1 (e.g., around the waist, torso, chest, etc. of the patient). The strap 554 may be passed around the patient's neck or may pass over the shoulders (e.g., a belt 553 extending under the patient and connected to the back side of the patient). In various exemplary embodiments, the stabilizing substrate 550 may include only the belt 553, only one or more straps 554, and/or a combination of the belt 553 and straps 554. The strap 553 and/or the strap 554 may be integral or otherwise connected with a drape that at least partially covers the patient. Alternatively, the strap 553 and/or the strap 554 may be separate from the drape (e.g., separately positioned on the drape).

The support sleeve 500 and the patient's arm within the support sleeve 500 may be manipulated into a selected pose by moving from a first pose (fig. 5A) to a second pose (fig. 5B). The support sleeve 500 at least partially holds the patient's arm in a selected position, such as by engaging with a stabilizing substrate 550. For example, when support sleeve 500 is positioned on a patient's arm and treatment device 560 is fixedly positioned through access location 530, the patient's arm may be manipulated between a first position and a second position. After introduction of the medical device 560, the arms may be rotated inward from a first supination posture to a second pronation posture in which the arms rest at least partially on the patient's torso in a palm-down posture. Alternatively or additionally, the bend angle of the elbow of the patient and/or other parameters of the orientation of the arm of the patient may be adjusted to bring the arm of the patient into the selected posture. In some embodiments, the patient's arm is oriented such that the inner wrist is located near the groin area.

The engagement between the support sleeve 500 and the stabilization substrate 550 inhibits relative movement between the support sleeve 500 and the stabilization substrate 550 and facilitates support of the patient's arm in a selected posture. For example, the medical practitioner may simply lift the patient's arm, move to a selected position, and engage one or more attachment devices 520 of the support sleeve 500 and/or attachment devices 551 of the stabilization base sheet 550. The presence of multiple attachment means of the stabilization substrate 550 and/or the support sleeve 500 facilitates engagement in a selected posture. The medical cannula system 50 may facilitate effective setting and support of a patient's arm in a selected pose. Also, in some embodiments, the support sleeve 500 may be repositionable with respect to the stabilization substrate 550 (e.g., by disengaging one or more attachment devices) so that a medical practitioner may easily separate the support sleeve 500 from the stabilization substrate 550 to make small adjustments to the arm pose, monitor the access location 530 or other portions of the front side of the arm, or the like.

The support sleeve 500 facilitates positioning of the patient's arm in one or more selected postures based on preferences of the medical practitioner, patient anatomy, medical procedure performed, etc. The second posture is not limited to an orientation in which the elbow is bent by about 90 °. The medical practitioner may select the appropriate angle, including an angle that allows the wrist to rest at a position near the groin area. The material and structure of the support sleeve 500 allows for articulation of the patient's arm between a plurality of positions while supporting the patient's arm in a selected position.

In the example second position shown in fig. 5B, the patient's arms are in a natural palm-down position in which the arms rest on the torso with the wrists near the groin area. Such a posture may resemble a natural sleep posture and may improve patient comfort. Alternatively or additionally, the second pose may facilitate ergonomic manipulation of the medical device 560 by a medical practitioner, such as by allowing the medical practitioner to operate on the patient's body primarily with a conventional manipulator and/or remotely from a radiation field used during a medical procedure, or the like. In some example embodiments, the additional support structure may be positioned along at least a portion of the patient's arm, such as along a posterior side of the patient's arm (e.g., along the triceps brachii). The support structure may be a rigid arm plate or other support structure that further supports the arm in the second position and/or prevents the arm from being removed from the body. When supported by additional structure, the padded area 510 can protect the patient's arm and improve patient comfort.

In some embodiments, the snaps 521 and/or straps 522 that are offset from the central longitudinal axis facilitate manipulation of the patient's arm while the support sleeve 500 remains engaged with the stabilizing substrate 550. For example, when one or more snaps 521a or straps 522a located near the bottom side of the support sleeve 500 (e.g., near the side of the patient's little or fifth finger) engage the stabilizing substrate 550, the patient's arm may rotate slightly from a pronated position to a supinated position. In this manner, a medical practitioner can monitor the access location 30 and/or other features on the front side of the patient's arm without completely disengaging the support sleeve 500 from the stabilizing substrate 550. Clasp 521a and/or strap 522a may function like a hinge, such that the patient's arm is held in a cross-torso position while allowing rotation. One or more snaps 521, straps 522, etc. on the top side or near the patient's thumb may be secured to prevent or limit rotation toward a supination posture, such as by attachment to straps 552 and/or 554.

For example, a medical cannula system 50 is shown in fig. 6A and 6B, with the catch 521 omitted for illustrative purposes. Fig. 6A shows the patient's arm in a supine position, in which the support sleeve 500 is attached to the stabilizing substrate 550. Strap 552a is engaged with strap 552 such that support sleeve 500 and the patient's arm within support sleeve 500 can be rotated about the attachment location. In this manner, the physician can rotate the patient's arm from a partial supine position (fig. 6A) to a pronated position (fig. 6B) or vice versa, while the support sleeve 500 is attached to the stabilizing substrate 550. Attaching the strap 522b to the stabilizing substrate 550 (such as to the strap 554) when in the pronated position may prevent or limit rotation toward the supinated position of fig. 6A.

Referring now to FIG. 7, an example medical cannula system 70 is shown that includes a support cannula 700, the support cannula 700 having an expandable portion 740. The support sleeve 700 is configured to be positioned on the arm of the patient 1. The support sleeve 700 may allow access to the patient's arm for introduction of medical tools, facilitate movement of the arm between multiple positions, and/or stabilize the arm in a selected position while the medical practitioner 2 is performing a medical procedure. In various example embodiments, the medical cannula system 70 may include one or more features as described with reference to the medical cannula systems 10 and 50 described herein with reference to fig. 1-6.

The support sleeve 700 includes a proximal end 701 defining an arm opening, a distal end 702, and a wall 703 extending between the proximal end 701 and the distal end 702. The support sleeve 700 may be positioned on the arm of the patient 1 by positioning the arm through an arm opening at the proximal end 701.

The support sleeve 700 includes an expandable portion 740. The expandable portion includes one or more regions that can change volume. For example, after positioning the support sleeve on the patient's arm, the expandable portion 740 may expand to conform to and/or compress slightly around the patient's arm. The expandable portion 740 may provide additional support to the patient's arm, facilitate a particular angle/orientation, inhibit relative movement between the patient's arm and the support sleeve 700, and/or provide additional protection to the patient's arm.

In an exemplary embodiment, the expandable portion 740 includes one or more inflatable balloons that are inflatable via pressurized air. For example, the expandable portion may include an inlet 741 that may be connected to a source of pressurized air (such as an air compressor, air tank, manual pump, etc.) to inflate the expandable portion 740. Alternatively or additionally, the expandable portion 740 may include an integrated manual pump 742. The manual pump 742 can be squeezed or otherwise manipulated to draw air through the inlet to expand the expandable portion 740.

In various other example embodiments, the expandable portion 740 may include an expandable material, such as an expandable foam, a phase change material, a heat activated expandable material, or the like. The material may expand irreversibly. The irreversible swelling material can prevent reuse and improve sterility.

The expandable portion 740 may be located on only a portion of the support sleeve 700 and not be present in the entire support sleeve 700. In an exemplary embodiment, the expandable portion 740 extends from a proximal end 745 near the proximal end 701 of the support sleeve 700 to a distal end 746 located distal to the elbow (e.g., but not to the distal end 702 of the support sleeve 700). Alternatively or additionally, the expandable portion 740 may extend around the entire perimeter of the support sleeve 700, or may extend around less than the entire perimeter of the support sleeve 700. In an exemplary embodiment, the expandable portion 740 covers the entire posterior portion 705 of the support sleeve 700 between the proximal end 745 and the distal end 746 of the expandable portion 740. For example, the expandable portion may not be present on at least a portion of the front side portion 704 along the entire length between the proximal and distal ends 701, 702.

Referring to fig. 8, an example flow chart illustrating a method of performing a medical procedure using an example medical cannula system is shown. The example method 800 may include an operation 802 of positioning a support sleeve on an arm of a patient. The support sleeve may be positioned such that the access port of the support sleeve is aligned with the inner wrist of the patient. In some embodiments, the patient's arm, and in particular the access location to the patient's skin (such as the inner wrist), is sterilized prior to positioning the support sleeve on the patient's arm.

The example method 800 may include operation 804: in a state in which the patient's arm is in the first position, the medical device is positioned through an access point in an anatomical vessel of the patient via the access port of the support sleeve. The medical device may be a catheter (such as an access sheath, vascular sheath, intravascular medical device, etc.) configured to extend through a puncture of a patient at an access point and into an anatomical duct (such as a radial artery or other blood vessel, etc.). In an exemplary embodiment, after insertion, the catheter has a proximal end external to the patient, a distal end internal to the patient, and at least one lumen extending between the proximal end and the distal end. The lumen defines a path for delivery or withdrawal of a fluid, an instrument (such as a guidewire or other interventional tool), or a combination thereof.

In an example embodiment, the first posture may be a supination posture in which the palm and inner wrist of the patient are facing upward when the arm is on or extending away from the patient side.

The example method 800 may include operation 806: the arm of the patient is supported in a second selected posture, different from the first posture. For example, a medical practitioner may manipulate a patient's arm to a selected pose and may support the patient's arm in the selected pose by engaging one or more attachment features of the medical cannula system. The patient's arm may be supported by engagement between one or more attachment means of the support sleeve and a stabilizing substrate, such as one or more of an adhesive, hook and loop fastener, self-adhesive nonwoven, self-adhesive polymer, high friction polymer, snap, strap, tie, friction material, co-adhesive material, or the like.

The example method 800 may include operation 808: one or more operations of the medical procedure are performed while supporting the arm of the patient in the second posture. The medical procedure may involve radial access (e.g., left radial access by a practitioner operating from the right side of the patient), and may include coronary catheterization, percutaneous peripheral intervention, percutaneous coronary intervention, carotid and subclavian intervention for acute stroke, treatment of vascular malformations and aneurysms, central venous access for electrophysiology procedures, hemodialysis intervention, arteriovenous fistula (AVF) intervention, electrophysiology cardiology procedure, pacemaker insertion, mesenteric and renal arterial systems, and/or other applications.

The example method 800 may optionally include one or more additional operations, such as removing the support sleeve from the patient and safely handling the support sleeve (e.g., with other surgical drapes used during a medical procedure).

Referring to fig. 9A, a perspective view of an example support sleeve 900 is shown. Support sleeve 900 includes a proximal end 901 defining an arm opening 901a and a distal end 902. A wall 903 extends between proximal end 901 and distal end 902. The wall includes a front portion 904 and a rear portion 905. In some embodiments, support sleeve 900 is configured to be positioned on a patient's arm such that anterior portion 904 of wall 903 is generally located on an anterior side of the patient's arm and posterior portion 905 of wall 903 is generally located on a posterior side of the patient's arm. The support sleeve 900 may be at least partially tapered between the proximal end 901 toward the articulation region 908 and/or the distal end 902. The larger arm opening 901a may facilitate positioning on the patient's arm, particularly in the upper arm/bicep region, which is typically larger in circumference than the lower arm or hand region.

Support sleeve 900 includes one or more access ports 906 that facilitate access to the arm of a patient through wall 903. For example, the access port 906 may define an opening through the entire thickness of the wall 903. The medical device can be advanced through the access port 906 and through the skin of the patient into the access location. In some embodiments, access port 906 may include a removable liner that at least partially covers an opening defined by access port 906. The removable liner may be removed at the time of use, such as in an operating room before or after the support sleeve 900 has been positioned on the arm of a patient.

In an example embodiment, when support sleeve 900 is positioned on a patient's arm, one or more access ports 906 are positioned in alignment with the patient's medial wrist. For example, access port 906 may be located on a forward portion 904 of wall 903 near distal end 902. In this manner, a medical practitioner may access the radial artery or other vascular feature, for example, via one or more access ports 906. Alternatively or additionally, one or more access ports 906 can be located on a front portion 904 of the wall 903, near the proximal end 901, near the inner elbow, etc. (e.g., to facilitate access to other locations on the front side of the patient's arm), and/or one or more access ports 906 can be located on a rear portion 905 of the wall 903 (e.g., to facilitate access to the rear side of the patient's arm).

The support sleeve 900 may include one or more adhesive regions on the inner surface of the wall 903. For example, an adhesive 906c on an inner surface of the front side section 904 at least partially surrounds the access port 906. Adhesive 906c improves sterility by separating the access location of the patient's skin from the rest of the patient's arm. In some embodiments, adhesive 906c further improves stability by inhibiting relative movement between support sleeve 900 and the patient's arm during use.

One or more access ports 906 can be generally centrally located on the forward portion 904 of the wall 903 and near the distal end 902. For example, a central longitudinal axis (a) extending between the proximal end 906a and the distal end 906b of the access port 906 can be collinear with a central longitudinal axis of the front portion 904 of the wall 903. The generally centrally located access port 906 may facilitate alignment with the inner wrist surface when the support sleeve is positioned on the patient's arm.

The support sleeve 900 may include one or more features that enhance patient comfort and/or protect the patient's arms. In an exemplary embodiment, support sleeve 900 includes an optional pad region 910. The padded region 910 may include a compressible structure that protects and pads the patient's arm, such as a pad configured to protect the patient's arm from compressive neuropathy and decubitus wounds and for comfort. For example, padding region 910 may include locations of increased material thickness and/or may include one or more of foam, closed cell foam, open cell foam, compressible nonwoven material, rubber, quilted material, laminate, air pockets, water, gel, styrene beads, and the like. In some embodiments, the padding region 910 may be at least partially filled with an expandable material such that the padding material may expand to at least partially conform to the arm of the patient.

The padded region 910 may be present on some or all of the support sleeve 900. In the exemplary embodiment, cushioned region 910 is located on a back side portion 905 of wall 903. Pad region 910 may protect the elbow, triceps, and other posterior features of the patient's arm, particularly when the patient's arm rests/is supported on the posterior side in a supinated position (e.g., during introduction of a medical device at the inner wrist), and/or when the arm is constrained by a armboard or other external structure in contact with the posterior portion of support sleeve 900. In an exemplary embodiment, the padded region 910 extends from a proximal location 910a near the proximal end 901 to a distal location 910 b. Distal location 910b may be selected such that when support sleeve 900 is positioned on a patient's arm in use, padding region 910 is present at (e.g., and extends just beyond) the elbow location of the patient. Such a configuration may advantageously protect the patient's arm without inhibiting articulation of the support sleeve 900 or the patient's arm (e.g., at an elbow location), and/or simultaneously facilitate access through the access port 906.

Support sleeve 900 may include a combination of two or more materials that protect the arm of the patient and/or a plurality of padded regions 910 having different material configurations. In an example embodiment, a shape-stabilized compressible material 111 (fig. 1) may be located at the elbow region. The compressible material 111 may provide additional padding and/or support for the elbow of the patient. In some embodiments, the compressible material 111 may be a foam elbow pad (e.g., open cell foam, closed cell foam, etc.) that provides additional protection to and/or support the elbow in the articulated position.

Support sleeve 900 is capable of articulation at one or more locations between proximal end 901 and distal end 902. In an exemplary embodiment, the support sleeve 900 includes a pre-shaped articulation region 908. The articulation region 908 simulates elbow flexion and helps position the patient's arm in a non-straight posture. In some embodiments, articulation region 908 provides bending such that a lower or distal region of support sleeve 900 has a first longitudinal axis (a) and an upper or proximal region of the support sleeve has a second longitudinal axis (B) that is angled relative to the first longitudinal axis (a) (e.g., when support sleeve 900 is resting on a patient's arm and not in use). Accordingly, articulation region 908 may provide a predetermined curvature that facilitates articulation and may reduce bunching or gathering of material when the patient's arm is bent at the elbow in a state where support sleeve 900 is positioned on the user's arm. Alternatively or additionally, the articulation region 908 may facilitate intuitive positioning on the patient's arm, for example, because the support sleeve 900 is at least partially pre-shaped in a natural articulation posture. In various exemplary embodiments, the articulation region 908 comprises a pre-formed bend that defines an angle of between 10 ° and 90 °, between 30 ° and 60 °, or about 45 °. For example, the angle (α) defined between the first longitudinal axis (a) and the second longitudinal axis (B) may be between 10 ° and 90 °, between 30 ° and 60 °, or about 45 °. The articulation region 908 is flexible so that the patient's arm can be easily manipulated when the support sleeve 900 is positioned on the patient's arm. For example, the patient's arm may be manipulated during use such that the angle (α) increases or decreases.

Support sleeve 900 may have a generally tubular configuration such that wall 903 defines a circular or rounded arm opening 901a, and/or defines a circular or rounded cross-sectional space between proximal end 901 and distal end 902. Such a configuration may help position support sleeve 900 on the arm of the patient while providing a proper fit. In various example embodiments, the wall 903 may include a continuous material portion, such as that present at both the front side portion 904 and the back side portion 905. The ends of the continuous material portion may be joined (e.g., by sewing, welding, bonding, etc.). In some embodiments, support sleeve 900 may have few or no seams (e.g., such support sleeve 900 has a seamless construction). Alternatively or additionally, the wall 903 may comprise two or more planar sheets of material joined at a longitudinal seam, such as longitudinal seam 917. For example, the support sleeve 900 may include two or more planar sheets that are cut into shapes that provide the various features described herein. The first sheet may be cut into a shape that includes the flexible sheet 940 and the back side portion 905, and the second sheet may be cut into a shape that includes the attachment 960 and the front side portion 904. The first and second sheets may be joined (e.g., sewn, welded, etc.) to connect the sheets and define a tubular wall 903 configured to receive a patient's arm. Likewise, flexible sheet 940 and attachment device 960 may be portions of the same sheet.

In various example embodiments, the wall 903 may have a flexible, liquid-impermeable construction. For example, the wall 903 may comprise one or more layers of polyester, polyethylene, cotton, paper, non-woven, fabric, and the like. Alternatively or additionally, the wall 903 may comprise one or more layers that impart impermeability to liquids, such as a polymer layer. In some embodiments, the wall 903 may have a laminated structure formed of two or more layers. These layers may be microporous to promote breathability while being liquid impermeable. In some embodiments, the support sleeve 900 may be a stretchable material such that the wall 903 may stretch and bend to accommodate the arm of the patient while in at least some positions in intimate contact with or slightly compressing the arm of the patient. For example, in use, when the wall 903 is positioned on a patient's arm, the wall may stretch slightly in at least some locations. The support sleeve 900 may be a sterile support sleeve that protects the patient from the skin flora and the external environment.

Support sleeve 900 may have one or more fixation features that promote a secure fit on the patient's arm and/or inhibit relative motion (e.g., relative rotation and/or longitudinal translation) between support sleeve 900 and the patient's arm during use. For example, the support sleeve may include one or more securing features 909 near the proximal end 901. The securing features 909 may include one or more of elastic regions, straps, ties, hook and loop fasteners, adjustment mechanisms, etc., that facilitate a secure fit around the upper arm of the patient. In the exemplary embodiment, securing feature 909 does not extend around the entire perimeter of wall 903. One or more securing features 909 may be located elsewhere between the proximal end 901 and the distal end 902, such as above the articulation region 908, below the articulation region 908, near the access port 906, and so forth.

In various example embodiments, the support sleeve 900 may include one or more finger and/or thumb portions configured to receive a single finger/thumb. Such a configuration may help position the support sleeve and/or improve patient comfort. In an example embodiment, the support sleeve includes a pulse oximeter 907 in the sleeve that is configured to monitor (e.g., continuously) the patient's hand oxygen supply.

The support sleeve 900 may be configured to at least partially stabilize the arm of the patient in a selected posture. In an example embodiment, the support sleeve 900 optionally includes one or more attachment devices 970a, 970b and 960a, 960b that facilitate engagement with a substrate (such as a complementary stabilizing substrate) in an operating environment. For example, the attachment means 960a, 960b comprise regions 963a, 963b (and the attachment means 970a and 970b have regions 973a and 973b, respectively) that engage another surface when in contact with that surface to limit relative movement between the support sleeve 900 and that surface. In various example embodiments, the attachment devices 960a, 960b, 970a, and 970b comprise one or more of an adhesive, a hook and loop fastener, a self-adhesive nonwoven material, a self-adhesive polymeric material, a high friction polymeric material, a co-adhesive material, and the like. In some embodiments, the areas 963, 973a, and 973b of the attachment device may be exposed (e.g., by removing a liner covering the adhesive) and brought into contact with a stabilizing substrate (not shown in fig. 9A), such as the patient's skin, sterile surgical drapes, straps, neckbands, straps, other stabilizing substrates, and the like. In various embodiments, only the areas 963a, 963b, 973a, 973b of the attachment devices 960, 970 include one or more of an adhesive, hook and loop fasteners, self-adhesive nonwoven materials, self-adhesive polymeric materials, high friction polymeric materials, co-adhesive materials, and the like. Alternatively or additionally, the entire attachment device 960, 970 may comprise such a material.

As shown in fig. 9A, the attachment device 960 may comprise a flexible sheet attached to the support sleeve 900 along or near the end 964 a. In one embodiment, the attachment means may include a wide first end 964a at the attachment line and then narrow at least partially along its length 962 toward a second end 964 b. Attachment 960 optionally may be folded along its length 962 prior to use (e.g., at lines 965a, 965b, 965c, 965d, etc.), or attachment 960 may be rolled up. For example, the attachment device 960 may be folded and/or rolled at the time of manufacture and unfolded/unrolled before positioning on the patient's arm or after positioning on the patient's arm during use.

As shown in fig. 9A, attachment device 960 may comprise a flexible sheet 940 (or multiple narrower sheets 940a, 940b, which may overlap, for example, at the articulation region of support sleeve 900) attached to support sleeve 900 along edge 941 or near edge 941. In one embodiment, flexible sheet 940 is initially folded along attachment line 941 such that first major surface 953 of flexible sheet 940 is adjacent to the rear major surface of support sleeve 900. In use, the support sleeve 900 may be provided in a sterile condition. The patient's arm may be inserted into the device while flexible sheet 940 is folded along edges 941. The covered arm of the patient (palm facing up) may then be placed on the patient, for example, with the flexible sheet 940 placed adjacent the patient's body. The attachment devices 970a and 970b may be secured to the patient (or stabilizing substrate) and the arms rotated to assume a second, palm-down position. Flexible sheet 940 may then be unrolled to expose the still sterile inner major surface 953 of the sheet.

Flexible sheet 940 protects the sterility of surfaces 905 and 953 when in its initial folded configuration and creates a sterile zone at these major surfaces exposed when the patient's arms are placed in the "cross-abdomen" second position as shown in fig. 9C. In an example embodiment, first sheet 940a and second sheet 940b are portions formed of different sheets from one another that are attached to one or more portions of support sleeve 900. For example, the first sheet 940a may be cut from a first sheet of material that also defines the front side portion 905, and the second sheet 940b may be cut from a second sheet of material that also defines the back side portion 905. Such a configuration may aid in the manufacture of support sleeve 900 and facilitate articulation of first sheet 940a and second sheet 940b relative to one another (e.g., during movement of a patient's arm).

With reference to fig. 9B and 9C, the example support sleeve 900 is shown in use in a first posture (fig. 9B) and a second posture (fig. 9C), which may be similar to the postures described above with reference to fig. 3-6B, for example. In the first posture, the arm is in a supine posture in which the front side of the patient's arm is facing up. Thus, the inner wrist is facing upward and accessible by a medical practitioner (e.g., via access port 906). Thus, a medical device may be introduced into a patient's arm near the inner wrist to access the radial artery or other features of the patient. The attachment devices 970a and/or 970b may be secured to the stabilizing substrate 150 or a lower portion of the shoulder strap 955 b. When the arm is rotated to a second position as shown in fig. 9C, the attachment device 960 may be attached to the stabilizing substrate 150 or to an upper portion of the shoulder straps 955a and/or 955 b.

Referring to fig. 9D and 9E, an example support sleeve 900 is shown for use with a stabilizing substrate in the form of a neck bib 957. The stabilizing substrate 957 may comprise a length of material configured to extend around the neck of a patient and/or attach to itself. An attachment feature 958a at a first end of the stabilizing base sheet 957 may be attached to a complementary feature 958b along the length of the stabilizing base 957 to maintain the stabilizing base sheet 957 in a desired position about the patient's neck. The neck bib includes one or more features that may be attached with the support sleeve 900 to stabilize the support sleeve in a selected position.

In an example embodiment, the stabilizing substrate 957 may be packaged under sterile conditions. At least a portion of the stabilizing substrate 957 (e.g., the portion positioned under or attached to the support sleeve during use) can be packaged in a folded or rolled configuration. In some embodiments, the stabilizing substrate 957 may be secured to the patient by extending around the patient's neck in a state at least partially in a folded or rolled-up state. Such a configuration may improve sterility and provide an additional sterile zone (e.g., which remains sterile until deployment/unrolling).

The example support sleeve 900 is shown in a first posture (fig. 9D) and a second posture (fig. 9E), which may be similar to the postures described above with reference to fig. 3-9C, for example. In the first posture, the arm is in a supine posture in which the front side of the patient's arm is facing up. Thus, the inner wrist is facing upward and accessible by a medical practitioner (e.g., via access port 906). A medical device may be introduced into the patient's arm near the inner wrist to access the radial artery or other features of the patient.

When the arm is in a first supine position (e.g., prior to attachment with stabilizing substrate 957), attachment region 959 of stabilizing substrate 957 may be at least partially folded or rolled upon itself. In such a configuration, the sterility of the folded or rolled surface of the stabilizing substrate 957 may be maintained. The attachment region 959 may be rolled out/deployed to facilitate attachment to the medical support sleeve 900. For example, attachment region 959 may be rolled out/unrolled such that attachment device 960 may be attached to stabilization substrate 957, such as at attachment feature 959a of attachment region 959, as the patient's arm is rotated from a first supination posture to a second pronation posture.

In various example embodiments, the support sleeve 900 (e.g., attachment device 960) includes one or more attachment devices, such as one or more of an adhesive, hook and loop fastener, clasp, strap, tie, friction material, self-adhesive nonwoven material, self-adhesive polymeric material, co-adhesive material, high friction polymer, or the like. Stabilizing substrate 957 may likewise include one or more complementary attachment means, such as complementary adhesives, hook and loop fasteners, snaps, straps, ties, friction materials, self-adhesive nonwovens, self-adhesive polymeric materials, co-adhesive materials, high friction polymers, and the like.

The engagement between support sleeve 900 and stabilization substrate 957 inhibits relative movement between support sleeve 900 and stabilization substrate 957 and facilitates support of a patient's arm in a selected posture (e.g., as shown in fig. 9E). The support sleeve 900 facilitates positioning of the patient's arm in one or more selected postures based on preferences of the medical practitioner, patient anatomy, medical procedure performed, etc. The second posture is not limited to an orientation in which the elbow is bent by about 90 °. The medical practitioner may select an appropriate angle, including an angle that allows the wrist to rest at a position near the groin area. The material and construction of the support sleeve 900 allows for articulation of the patient's arm between a plurality of positions while supporting the patient's arm in a selected position at least in part by engagement with the stabilizing substrate 957.

While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any technology or claims, but rather as descriptions of features specific to particular embodiments. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment, in part or in whole. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Moreover, although features may be described herein as acting in certain combinations and/or initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.

Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all operations shown be performed, to achieve desirable results. In some cases, multitasking and parallel processing may be advantageous. Specific embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims.